One of the most frustrating parts of preparing for the USMLE as an international medical graduate (IMG) is realizing that sometimes you actually do know the medicine, but still miss the question.

Many IMGs walk away from practice blocks thinking:
“I knew that diagnosis. How did I not see it?”

If this happens often, it usually does not mean you have major knowledge gaps. More commonly, it means you are still learning how the NBME wants you to interpret clinical vignettes.

This is an incredibly common challenge because many international medical education systems emphasize precision, memorization, and attention to detail. Those are valuable skills clinically, but on the USMLE they can sometimes work against students when they become too focused on isolated clues instead of the overall clinical picture.

The NBME is usually not testing whether you can identify the most obscure detail in the vignette. More often, it is testing whether you can recognize the dominant pattern of disease and make good clinical decisions from it.

In other words, they want you to zoom out.

The “Zoomed-In” Thinking Pattern You Must Develop

One of the biggest differences between struggling and high-scoring students is the ability to identify the bulk of the question quickly. Many IMGs naturally approach vignettes by carefully analyzing every sentence equally, and in great detail. Early on, this creates a huge amount of cognitive overload because suddenly every detail feels important. And the question stems can get LONG. 

For example, a question may clearly describe septic shock, but the student becomes distracted by one unusual lab value or one symptom that feels slightly atypical. Instead of trusting the overall presentation, they begin searching for a rare diagnosis that perfectly explains every single detail.

This is where overthinking becomes dangerous.

The reality is that NBME questions are usually far more representative than students think. Most of the time, the exam writers are not trying to trick you into picking a zebra diagnosis. They are testing whether you can recognize the most likely and clinically important explanation for the patient’s presentation.

Strong USMLE test-takers identify the central story of the vignette first and then use the smaller details to support that interpretation rather than replace it.

Why the NBME Wants You to Focus on the “Bulk” of the Question

Many IMGs assume every detail in the vignette carries equal weight. In reality, the NBME prioritizes patterns. A patient may not present with every classic symptom. A lab value may be slightly atypical. Real patients are messy, and NBME questions are designed to reflect that reality. If 90% of the vignette points toward one diagnosis, that overall pattern usually matters far more than one small inconsistency.

This is why students often hurt themselves by trying too hard to explain every detail perfectly and getting hung up on questions when they can’t make all the pieces fit.

You may correctly recognize myocardial infarction initially, then suddenly abandon that reasoning because of one extra sentence that makes you wonder about a rarer diagnosis. Or you may identify nephrotic syndrome immediately, only to second-guess yourself because one lab value does not fit your mental textbook definition exactly.

The USMLE absolutely rewards careful reading, but it rewards prioritization far more than perfectionism. In fact, the questions are designed for you not to be able to reach perfection in most answer explanations.

The Fear of “Missing the Trick”

Another major issue for IMGs is becoming overly worried that the exam is trying to fool them. Because the USMLE style feels unfamiliar at first, many students start assuming every unusual phrase must completely change the diagnosis. Ironically, this often leads students to change correct answers into incorrect ones.

The NBME does include distractors and subtle wording differences, but the majority of questions are still testing common disease patterns and core clinical reasoning. The exam is difficult because it requires integration and prioritization, not because every question hides a rare diagnosis behind one strange clue. Overwhelmingly, the NBME is NOT trying to trick you. 

Learning to trust the overall clinical picture is one of the biggest turning points in preparation.

How to Retrain Your Brain During Questions

If you notice that you’re making some of these strategy errors, that’s an excellent first step because once you know the mistakes you’re making you can work toward fixing them. One of the most helpful habits is learning to summarize the vignette before looking at the answer choices.

Instead of trying to decode every individual sentence, pause and ask yourself:
“What is the overall clinical picture here?”

Even a quick mental summary like:
“This sounds like heart failure,”
“This sounds like adrenal insufficiency,”

or

“This sounds like nephritic syndrome”
can anchor your reasoning and prevent spiraling into overanalysis.

Over time, this becomes more automatic and you’ll do it instinctively while you’re reading through the question. It takes practice…so be patient. 

With enough repetition, your brain stops processing every line independently and starts recognizing entire clinical patterns. This is why experienced test-takers can often answer questions quickly without feeling rushed. They are not necessarily smarter or reading faster — they simply recognize the overall presentation earlier.

Why Practice Questions Matter So Much

This skill cannot be developed through passive studying alone.

Question interpretation improves through repeated exposure to NBME-style reasoning. Every practice question teaches you something about how the exam prioritizes information, frames distractors, and signals important diagnoses.

Eventually, you begin to recognize which findings are usually high-yield and which details mainly exist to create realism. Questions feel less chaotic because you develop a better filter for what actually matters most.

This is also why delaying question practice can hurt IMG students significantly. Many students wait until they “finish content review” before doing enough questions, but interpretation skills only improve through active engagement with vignettes themselves. The content review and practice must happen simultaneously. 

Final Encouragement

If you constantly feel like you “knew the material but interpreted the question wrong,” try not to view that as failure. Interpretation is a skill, and like any skill, it improves with intentional practice and repetition.

Eventually, the NBME style begins to feel familiar. You stop fighting the vignette and start understanding what the exam writers actually want you to see. That is often the moment everything finally starts to click.

If you know the material but struggle to apply it to exam questions, EMP’s personalized USMLE tutoring can help you identify recurring mistakes, refine your question approach, and build confidence in your clinical reasoning.

The post Why IMGs Struggle with USMLE Question Interpretation (And How to Fix It Fast) appeared first on Elite Medical Prep.

Christoper Tredwin explains why a dental handpiece’s true value extends far beyond its initial purchase price.

When investing in dental equipment, it can be tempting to focus on the purchase price. After all, practices are businesses, and controlling capital expenditure is an important part of running a successful one. But when it comes to handpieces, the cheapest option on the market is not necessarily the most economical choice.

As both a dentist, practice owner and dean of a dental school, I have come to appreciate that the true cost of a handpiece extends far beyond the figure on the invoice. Reliability, performance, maintenance, longevity and the effect on the wider practice all need to be considered. A handpiece that appears inexpensive at the point of purchase can quickly become a false economy if it compromises efficiency or creates unexpected costs further down the line.

Looking beyond the purchase price

A handpiece is a fundamental part of everyday dentistry. It is used repeatedly throughout the working day, often under demanding clinical conditions. That means even relatively small performance issues can have a significant cumulative effect.

An unreliable handpiece can require more frequent repairs, replacement parts or servicing. There is also the potential cost of having to replace it earlier than expected. When these expenses are added to the original purchase price, the apparent saving can disappear surprisingly quickly.

However, some of the most significant costs are less obvious. If a handpiece fails during a busy clinical session, the immediate issue may not be the repair bill – it is the time lost while dealing with the problem.

The cost of downtime

Clinical time is one of the most valuable resources in a dental practice and clinic. A handpiece that is unexpectedly unavailable can disrupt the entire workflow.

A procedure may need to be paused while another handpiece is located, sterilised and prepared. If a suitable backup is not immediately available, an appointment could potentially need to be delayed or rescheduled. That can have a knock-on effect, creating pressure for the dental team and inconvenience for patients.

Even when an alternative handpiece is available, changing equipment during a procedure interrupts concentration and momentum. For a clinician, this can make a straightforward appointment feel unnecessarily difficult. For the team, it may mean adapting instrument setups or finding alternative equipment at short notice. While for reception, an unexpected delay can affect the remainder of the day’s schedule.

These are difficult costs to capture on a balance sheet, but they are very real.

Performance matters clinically

Reliability is only one part of the equation. Consistent handpiece performance can also influence how predictably procedures are carried out.

A handpiece should feel comfortable and dependable throughout treatment. Factors such as cutting efficiency, torque, spray performance, illumination, vibration and ergonomics can all contribute to the clinical experience. When equipment performs consistently, the clinician can concentrate on the procedure rather than compensating for limitations in the equipment.

That predictability becomes particularly important in a busy practice. The objective is not simply to complete one procedure successfully; it is to create a workflow that can be repeated consistently, appointment after appointment.

The wider impact on the practice

Equipment problems can also affect the patient experience. Patients may not know exactly what has gone wrong when a handpiece stops working, but they will notice delays, interruptions or a change in the atmosphere of the surgery.

For the dental team, repeated equipment issues can become frustrating. Nurses need confidence that the instruments they prepare will perform as expected. Clinicians need to know that their equipment will support rather than hinder their work. Practice managers need to consider servicing, repairs, stock levels and replacement planning.

Reliable equipment therefore has a value that extends beyond the individual clinician. It contributes to a smoother, more predictable working environment for the whole team.

Thinking about total cost of ownership

For practice owners, I think the more useful question is not simply, ‘How much does this handpiece cost?’ but, ‘What will this handpiece cost us over its working life?’

That means considering the purchase price alongside expected longevity, servicing requirements, repair costs, warranty and manufacturer support, availability of parts, downtime and the impact of equipment failure on clinical productivity.

It is also worth considering ergonomics and usability. A handpiece that supports efficient clinical work can potentially provide value every time it is used. Conversely, a cheaper product that is uncomfortable, inconsistent or regularly unavailable can carry an ongoing operational cost.

Why reliability is an investment

I have seen the importance of looking at handpieces as part of the overall clinical workflow rather than as individual pieces of equipment. My W&H handpieces have supported my approach by combining performance and reliability with the practical requirements of everyday dentistry.

For me, the key lesson is that purchasing decisions should be based on value rather than simply price. That does not mean that the most expensive handpiece is automatically the right choice. It means considering what you are actually getting for your investment and how that equipment will perform over months and years of clinical use.

A handpiece may be relatively small in the context of a dental practice, but its impact is anything but small. When it is working reliably, it becomes almost invisible – allowing the clinician and dental team to focus on patients and dentistry. When it is unreliable, its cost becomes much more apparent.

Ultimately, the cheapest handpiece is only the cheapest option if it remains reliable, performs consistently and delivers value throughout its working life. For a busy practice, that is why the real question should be about total cost of ownership, not simply the initial price tag.

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The following Permanente Medical Groups are current honorees of the American Medical Association (AMA) Joy in Medicine® Health System Recognition Program:

Gold

• The Permanente Medical Group (2025–2026)

Silver

• Mid-Atlantic Permanente Medical Group (2025–2026)
• Northwest Permanente (2025–2026)
• The Southeast Permanente Medical Group (2025–2026)
• Washington Permanente Medical Group (2025–2026)

Bronze

• Colorado Permanente Medical Group (2026–2027)

They are among 194 organizations currently recognized by the program, representing 428,583 physicians.

“Supporting physician well-being helps create better care for everyone,” said Willie Underwood III, MD, MSc, MPH, president of the AMA. “Studies show that when physicians are supported, patients benefit from safer care, higher quality, and a better overall experience.”

For more on addressing barriers to physician mental health and fostering a culture of wellness, listen to Dr. Underwood’s PermanenteDocs Chat conversation, “Addressing the mental health elephant in the room.”

Joy in Medicine: A commitment to physician well-being

The Joy in Medicine program recognizes organizations for sustained efforts to reduce physician burnout and enhance well-being. Applicants complete a self-assessment and submit documentation of their work to address the systemic causes of burnout across 6 domains. Recognition is valid for 2 years, and organizations are encouraged to advance to higher levels over time:

• Assessment
• Commitment
• Efficiency of practice environment
• Teamwork
• Leadership
• Support

Embedding physician well-being into organizational strategy

In Northern California, The Permanente Medical Group (TPMG) uses multiple years of physician well-being survey data to identify trends, set priorities, and address factors driving burnout across its workforce of nearly 10,000 physicians. The medical group translates those insights into operational changes, leadership practices, and local interventions designed to improve physicians’ day-to-day work.

“The [2025 Gold] award is a recognition of our commitment as an organization to prioritize the well-being of our people,” said Ellie Farahabadi, MD, an internist and associate executive director at TPMG. “We don’t think of Gold as the end of our journey. We see it as validation that we’re on the right path and demonstrating our ongoing commitment.”

That commitment includes making physician well-being a shared responsibility across operational, technology, clinical, and leadership teams rather than the work of a single committee. “This recognition helps us with accountability and momentum, with continued improvement as our overarching goal,” said Amanjot Sethi, MD, a urologist and director of wellness operations for TPMG.

Developing physician leaders at every career stage

Along with making well-being a strategic priority, Permanente Medical Groups develop physicians who bring clinical insight to leadership, a pillar of the Joy in Medicine program. Physician leadership gives doctors an opportunity to shape organizational culture while bringing firsthand knowledge of the workload challenges in medicine today.

To guide physicians who want to lead, Mid-Atlantic Permanente Medical Group (MAPMG) adopted a “hire to retire” program that offers leadership development opportunities at 4 career stages.

“At every leadership stage, we are led by physicians,” said Ameya Kulkarni, MD, associate medical director at MAPMG. “That is a really important part of this physician leadership journey and also in terms of things like protecting physicians from burnout because it really forces that thoughtful balance of physician needs, patient needs, and the system needs.”

Equipping leaders with a wellness lens

A projected physician shortage and growing demand for services are also driving health care leaders to view issues through a well-being lens. This means considering how new protocols, technologies, and other changes affect the workforce.

To promote this approach, Washington Permanente Medical Group offers Wellness-Centered Leadership and onboarding programs, well-being workshops, retreats, and team-building sessions for leaders and teams. These initiatives are designed to strengthen leadership skills and address burnout risks.

“The broader goal is to really encourage all leaders to apply that wellness lens to a policy decision they’re making or a process that is being changed or implemented and think about how it is going to impact the well-being of our people,” said Mary Pan, MD, chief wellness officer.

Doing the right work in a team-based environment

At The Southeast Permanente Medical Group (TSPMG), building collaborative, unit-based teams and ensuring that everyone works within the appropriate scope of practice are key. A 2023–2024 gap analysis helped standardize roles, enabling physicians and nurses to focus on their strengths and deliver optimal care together.

This work led to teams of physicians, nurses, medical assistants, and other health care professionals practicing at the top of their scope. Team members support physicians with tasks such as updating patient charts before physician review. By reducing physicians’ administrative burden and collaboratively addressing operational challenges, TSPMG demonstrates that team-based care is integral to delivering high-quality health care and supporting workforce retention.

“It’s really centered around process improvement, and it’s also centered around making our place of work the best place to work, helping us to deliver the highest quality in patient care and improving affordability in patient care as well,” said Nikki Baker, MD, associate medical director for People and Culture.

Supporting each other in challenging work

Addressing burnout in a challenging specialty such as oncology is critical for care teams. “Cancer is rewarding in the work that we do with patients, but it also can take a toll on all physicians and the teams that take care of patients,” said Tasha McDonald, MD, chief of radiation oncology and associate medical director at the Northwest Permanente Cancer Center.

The center made well-being a priority by establishing a wellness advisory committee, a peer support program, and daily huddles to encourage teamwork and mutual support. The Northwest Permanente Cancer Center also worked to reduce physician burden through a robust nurse navigator program; support from nurses and medical assistants with in-baskets and patient communication; and a pilot project engaging community health workers to address patients’ social needs.

The latest AMA data show progress but underscore the need for sustained organizational action. In 2025, 41.9% of physicians reported experiencing at least one symptom of burnout, down from 43.2% in 2024 and 48.2% in 2023. Administrative burden and staffing challenges remain persistent system-level pressures. The Joy in Medicine honors reflect the Permanente Medical Groups’ ongoing commitment to improving the practice environment and supporting physician well-being.

You can read the full list of currently recognized organizations, including the 2025–2026 and 2026–2027 honorees, on the AMA’s website.

The post Six Permanente Medical Groups recognized by AMA for advancing physician wellness appeared first on Permanente Medicine.

Now, a new study has found that people with the sickle cell variant are almost exclusively infected by a distinct variety of malaria parasites, which might contribute to their lower rates of disease.

“Sickle cell trait may protect against malaria, not only by changing how the human host responds to infection, but also by shaping which parasites are able to survive and establish infection,” says Sandrine Nsango, PhD, associate professor of molecular biology at the University of Douala and researcher at the Centre Pasteur du Cameroun, Head of the Department of Biomedical Sciences, Faculty of Science, University of Bertoua.

This work is published in Nature Microbiology in the paper, “Sickle cell haemoglobin status shapes malaria parasite genotype in asymptomatic infections.”

Previous work had discovered the unusual strain of malaria by investigating the rare cases where people with the sickle cell variant develop disease symptoms. The new research extends these findings to asymptomatic infections, in which people are infected by the parasite but don’t get sick. While less visible than the disease itself, asymptomatic infections were extremely common, affecting three-quarters of the healthy study population.

HbS carriers with symptomatic malaria harbor parasites enriched for P. falciparum sickle-associated alleles (Pfsa+). While these may partially overcome HbS-mediated protection, their role in asymptomatic infections is unclear. Researchers analyzed the genetics of over 2,246 healthy schoolchildren in a region of high malaria transmission in Mfou, Cameroon, as well as the malaria parasites infecting them. The team found that people with and without the sickle cell variant tend to be infected by genetically different varieties of malaria parasites.

In addition, specific varieties of the parasite infect people with and without the sickle cell variant at similar overall rates. They write, “analyzing the parasite Pfsa and the human HbS genotypes for 1,701 asymptomatic P. falciparum infections confirmed that heterozygous HbS (HbAS) and homozygous non-HbS (HbAA) genotypes have similar rates of asymptomatic infection.” However, despite being infected at similar rates, people carrying the sickle cell variant are much less likely to develop symptomatic malaria.

The researchers found that which parasites are present in an asymptomatic infection differs based on if the infected person has the sickle cell variant. They write, “the HbS genotype is strongly associated with parasites carrying the Pfsa+ alleles at the Pfsa1 and Pfsa3 loci, indicating a selective advantage for these alleles in HbS carriers.” These findings suggest that the sickle cell variant influences which parasites can infect a person, whether or not they develop disease symptoms.

People with the sickle cell variant are just as likely to become infected—albeit with a different variety of the parasite—but they’re a tenth as likely to develop harmful disease. These observations suggest that the biological characteristics of this parasite variety may contribute, at least in part, to the protection against disease conferred by the sickle cell trait.

To understand why people with sickle cell don’t get disease as often—and use that knowledge to develop better therapies—researchers should not only look at the biology of the sickle cell variant but also investigate the differences in the malaria parasite.

Nsango says that their findings emphasize that malaria is an example of a continued evolutionary interaction between humans and the parasite. “The sickle cell mutation is one of the clearest examples of how infectious diseases can shape human evolution, but our findings suggest that humans also shape the evolution of the parasite in return,” Nsango says. “Understanding these interactions may help us anticipate how malaria parasites adapt in the future and design more effective strategies for malaria control.”

The post Sickle Cell Trait Linked to Distinct Malaria Parasite Variants appeared first on GEN - Genetic Engineering and Biotechnology News.

What additional roadblocks might accompany ambitious multiomics projects in 2026? Could any bottlenecks emerge in cost, sample preparation, data integration, or AI implementation? We recently interviewed experts from five companies to gain their perspectives. Here is what they had to say.

Sample preparation

“I sound like a broken record because I can’t stop talking about the importance of sample prep in multiomics work,” says Michael Easterling, PhD, vice president of MALDI/Imaging at Bruker Daltonics.

Easterling stresses challenges such as section-to-section variability, internal standards, FFPE samples, and long sample runs that complicate downstream algorithms. “For multiomics imaging, these issues are not as well defined as some of the bulk methods that have been around much longer,” he notes.

Scott Jelinsky, PhD, senior director of R&D at Thermo Fisher Scientific, agrees. “Different molecular classes have different requirements for sample collection, storage, and preparation,” he says. “Therefore, careful experimental design and standardization are essential.”

Easterling mentions the consequences of inadequate freezing during biopsies, which can disrupt cell structures and lead to ice crystal artifacts. “It is important to really make sure that you have a solid workflow to correctly harvest tissue and provide a good chain of custody from the point that it’s harvested all the way to the analyzer.”

What are some tips for multiomics researchers hoping to prepare their samples in an optimal way? “Community networking is key here,” argues Easterling. “I would say get involved with the overall spatial imaging community and network and find out exactly how to do these things.”

Another practical consideration, according to Jelinsky, is planning the workflow from the beginning so that sample collection, aliquoting, storage, and analytical requirements are compatible across different assays. “Decisions made early in the study can have a significant impact on what can be measured and how confidently the different datasets can be interpreted together,” he notes.

Data integration and analysis

Multiomics technologies generate vast amounts of high-resolution data across modalities that often behave differently from a statistical perspective, notes Najiba Mammadova, PhD, associate director of product management at 10x Genomics. “Multiomics assays have advanced incredibly quickly, and now the analysis and interpretation tools need to keep pace,” she notes.

Mammadova specifically highlights the challenges of computationally aligning multiple omics from different cells or tissues. After all, how can researchers be certain that they are measuring the same cells and biological features?

“That’s why I think measuring multiple modalities from the same cell or tissue is so important,” she adds. “It reduces the need to reconstruct the biology after the fact and gives researchers a more direct view of what’s happening in the sample.”

Vanee Pho-Conners, PhD, vice president of global marketing at Mission Bio, agrees that data integration is often a major hurdle with multiomics work. “Each omics layer has its own data structure, distributions, and variabilities, so combining them isn’t plug-and-play,” she explains. Multiomics analysis also often requires cross-disciplinary expertise in biostatistics, machine learning, and biology—capabilities many labs lack in-house.

“It’s important to ask how you can combine these data sets in a clean way where you preserve all the information, reduce the noise, and start to make biological inferences,” adds Easterling. “It’s not something that’s routine today, but the situation is changing rapidly, and new ways to integrate these datasets of varying dimensionality are starting to appear.”

Timing is yet another important consideration, notes Jelinsky. Proteins, RNA, and metabolites may exhibit different kinetics and respond on different timescales, so measurements collected at the same time may not always align. “Understanding those temporal relationships is essential when integrating and interpreting the results,” he says.

AI and multiomics

“I think the rate-limiting multiomics questions are shifting from ‘Can we measure this?’ to ‘Can we interpret it?’ And that’s where AI has enormous potential,” notes Mammadova. “We’re generating increasingly rich, high-dimensional datasets, and AI can help researchers identify patterns, interpret those data more quickly, and ultimately build models that can predict things like disease progression or treatment response.”

However, Easterling warns that even the most advanced AI technologies often cannot overcome challenges associated with inadequate sample preparation. “Unfortunately, if a model’s trained on an inconsistently prepared section, it’ll give you a confident biological story that’s completely wrong. And the reader of this data may have no way to tell.”

As an example of recent AI advances, Easterling highlights multiomic workflows pioneered at the Medical University of South Carolina for single-cell analysis. The group has developed an AI algorithm that assists lasers in targeting individual cells rather than clusters of cells.⁴ Pho-Conners also emphasizes how Mission Bio is using machine learning to jointly cluster DNA, RNA, and protein—referred to as triomics—from the same cell. “We are using a combination of triomics and AI-driven integration to establish disease resistance. This really goes beyond correlations using a single omics layer,” she says.

Although Jelinsky is generally optimistic about AI advances in multiomics, he foresees fundamental limitations. “I see AI as a tool that can help researchers navigate complexity and generate better hypotheses rather than as a replacement for scientific judgment. AI does not remove the need for rigorous experimental design or biological validation,” he stresses.

Challenges with extracellular vesicles

Distinct multiomics challenges also exist in analyzing extracellular vesicles (EVs), small membrane spheres released by cells that contain multiple omics (DNA, RNA, protein, metabolites, and lipids).

“EVs are how cells talk to each other, and a living cell sends up to ten thousand a day. This makes them good biomarkers,” says Pierre Arsène, founder and CEO of Mursla Bio.

However, with traditional EV analysis, each potential omics layer is measured from EVs derived from an unknown blend of cells. There is usually no way to know whether a protein signal and an RNA signal came from the same tissue, for instance.

“Tissue-specific extracellular vesicles (TS-EVs) are how we recover that record,” explains Arsène. Mursla’s technology begins with a blood draw. Liver-specific EVs are then captured using antibodies against proprietary surface markers (more specifically, hepatocyte-EV markers). Finally, proteomics and RNA sequencing are performed on two milliliters of plasma for biomarker discovery.

“The great thing about TS-EVs is that they arrive addressed, carrying surface proteins specific to the sending cell and sealed behind a membrane that shields proteins and RNA from the enzymes that would destroy them in blood.”

EvoLiver, Mursla’s blood test for liver cancer surveillance in cirrhotic patients, holds an FDA Breakthrough Device Designation. It analyzes three proteins and five microRNAs derived from hepatocytes. Proteins provide information about tumor surface phenotype and metabolic reprogramming, while microRNAs reveal the regulatory programs driving that phenotype.

As with so many other multiomics platforms, Arsène stresses the importance of TS-EV sample preparation. “Blood handling standards for EVs lag well behind standard liquid biopsy, so our clinical work relied mostly on prospective collection under a common protocol rather than using legacy biobanks.”

The future of multiomics

Mammadova highlights the potential for cost-related challenges in multiomics, particularly as the field moves toward larger studies. “Making these technologies more scalable and cost-effective will be critical to expanding their use across research,” she adds.

“However, I see more overall challenges than roadblocks in multiomics work,” she concludes. “They’re the kind of problems the field works through as technologies mature.”

Spatial multiomic layers will also become increasingly critical for decoding the complexity of disease biology, predicts Prajan Divakar, PhD, Bruker Spatial Biology vice president of product management. “Investigators continue to demonstrate the need for more complete spatial datasets, and we are seeing clear applications and momentum for clinical translation,” he says. Divakar highlights Bruker’s CosMx^® spatial molecular imager, which measures the whole transcriptome and over 64 proteins.

Finally, Arsène argues that simply adding more layers of analysis without biological resolution is unlikely to advance multiomics research in the future. For instance, in the largest study of a blood-based cancer test ever run (involving around 50,000 participants), incorporating an additional protein layer in advanced adenoma increased the sensitivity only modestly—from about 15% to 16%.⁵ “More and more layers allow you to gain dimensions, but you end up losing coherence. And no cohort in the world is large enough to train that coherence back computationally.”

Jelinsky agrees that the value of multiomics will lie not in generating more data, but in selecting complementary measurements that address a specific biological question. “I think the future of multiomics will be less about generating the largest possible number of measurements and more about determining which combination of measurements provides the most meaningful biological insight,” he says.

References

1. Behrens LMP, Fernandes GDS, Gonçalves GF, et al. Limitations and opportunities in multi-omics integration for neurodevelopmental, neurodegenerative and psychiatric disorders: A systematic review. Neuroscience. 2026;599:76-93. doi: 10.1016/j.neuroscience.2026.01.019.
2. Hayes CN, Nakahara H, Ono A, Tsuge M, Oka S. Genes (Basel). From Omics to Multi-Omics: A Review of Advantages and Tradeoffs. 2024;15(12):1551. doi: 10.3390/genes15121551.
3. Baião AR, Cai Z, Poulos RC, et al. A technical review of multi-omics data integration methods: from classical statistical to deep generative approaches. Brief Bioinform. 2025;26(4):bbaf355. doi: 10.1093/bib/bbaf355.
4. Dressman JW, Bayram MF, Angel PM, Drake RR, Mehta AS. Single-Cell Multiomic MALDI-MSI Analysis of Lipids and N-Glycans through Affinity Array Capture. Anal Chem. 2025;97(24):12493-12502. doi: 10.1021/acs.analchem.4c06233.
5. Shaukat A, Burke CA, Chan AT, et al. Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer. JAMA. 2025;334(1):56-63. doi: 10.1001/jama.2025.7515.

The post Multiomics in 2026 and Beyond appeared first on GEN - Genetic Engineering and Biotechnology News.

Rather than relying on static X-ray crystallographic structures of the enzyme, the Oxford University team, collaborating with partners from Diamond Light Source, Lawrence Berkeley National Laboratory, PAL-XFEL, and SLAC National Accelerator Laboratory, followed the reaction in real time. To do this they used X-ray free-electron lasers (XFEL) to observe the enzyme isopenicillin N synthase, (IPNS) as it converts its linear peptide substrate into the β-lactam ring system of penicillin.

The study brought together expertise in structural biology, spectroscopy, chemistry, computation and enzyme engineering. The approach, they say, provides a powerful way to study fleeting chemical intermediates that have previously been inaccessible, both in antibiotic biosynthesis and in other biologically important enzyme reactions.

The team captured several rapid stages in the reaction. These included a thioaldehyde intermediate formed just before the β-lactam ring is created, and a monocyclic β-lactam intermediate, representing the first ring-shaped structure on the way to forming the complete penicillin scaffold. These steps provide the clearest picture yet of how the IPNS enzyme assembles the penicillin scaffold. Subtle movements throughout the enzyme help guide these chemical steps, showing that both the enzyme’s shape and its chemistry work together to control penicillin formation.

The results show, in unprecedented detail, how the enzyme IPNS achieves an exceptionally complex transformation in a single step. Christopher Schofield, PhD, Professor of Chemistry, University of Oxford, said, “Penicillin has shaped modern medicine, but there is still much to learn about how nature builds this important antibiotic structure. By capturing these fleeting steps, we can better understand how enzymes control complex chemistry with remarkable precision … As rates of antimicrobial resistance continue to rise, understanding this process will ultimately help us make existing antibiotics more efficient and design new antibiotic structures.”

Allen M Orville, PhD, group leader of the XFEL Hub, further commented, “The XFEL Hub at Diamond brought specialist expertise in time-resolved X-ray methods and XFEL-based structural biology to this study. Working closely with our colleagues in Oxford and at partner facilities, we helped bring together the experimental approaches needed to capture these fleeting stages of enzyme catalysis. The results show the power of combining complementary expertise and X-ray techniques to move beyond static structures and reveal how enzymes work in real time. It is a great example of how time-resolved structural biology can uncover new principles of enzyme function and, ultimately, inform the design of new catalysts and therapeutics.”

Schofield is co-senior author of the researchers’ published paper in Nature Catalysis, titled “Unanticipated intermediates during isopenicillin N synthase catalysis identified by time-resolved X-ray free-electron laser studies.”

Ever since penicillin was developed into a working drug at the University of Oxford in the early 1940s, β-lactam antibiotics have been among the most important medicines for treating bacterial infections. Their activity depends on a special ring—the β-lactam ring—a highly strained chemical ring system that interferes with bacterial cell wall synthesis, ultimately causing the cell wall to fail and the bacteria to die. “Isopenicillin N synthase (IPNS) catalyses the biosynthesis of isopenicillin N (IPN), forming the fused four-membered β-lactam and five-membered thiazolidine ring system that is characteristic of the penicillins,” the authors explained.

Rising rates of antimicrobial resistance are undermining the effectiveness of existing antibiotics. Today, one in six bacterial infections is resistant to antibiotics, the authors noted, citing WHO figures. With too few new antibiotics in development, understanding how nature builds these molecules is an important step towards replenishing the antibiotic pipeline.

Scientists have been studying how nature constructs this β-lactam ring for decades, but the key fleeting reaction intermediates have been too difficult to observe directly.

To capture the reaction in real time, the researchers used a system in which thousands of tiny droplets containing anaerobic enzyme microcrystals were deposited onto a moving 2 mm wide tape. As the tape entered an oxygen filled chamber, oxygen rapidly diffused into the crystals and initiated the reaction simultaneously across the sample. By precisely controlling the speed of the tape, the researchers could determine how long each crystal reacted before reaching the X-ray interaction point, where an ultrafast XFEL pulse recorded an atomic resolution snapshot.

Combining thousands of these snapshots allowed the team to build a frame-by-frame “molecular movie” of penicillin biosynthesis. This method allows individual reaction intermediates that exist only for tiny fractions of a second to be observed at atomic resolution, and under physiological temperature and pressure, before they disappear.

The newly reported findings help to resolve a long-standing mechanistic question that has remained unanswered for more than four decades. The work also showed that water molecules inside the enzyme play a key role in guiding the reaction. The combined results of their studies, they noted, “… reveal unexpected insight into the IPNS reaction mechanism including the vital roles of active-site water molecules.”

The study ultimately builds on the work of Nobel prize-winning Oxford chemist Dorothy Hodgkin, PhD, who first solved the structure of penicillin in 1945 using X-ray crystallography.

Beyond penicillin, IPNS belongs to a large family of iron-dependent oxygenase enzymes involved in human biology, including those that enable us to sense and respond to changes in oxygen availability. The mechanistic insights from this work could therefore have implications beyond antibiotics, offering new principles for enzyme engineering and catalyst design.

“These findings provide structural insight into IPNS catalysis, inform on the wider Fe(II) oxygenase superfamily and highlight the power of X-ray free-electron laser methods for resolving transient enzymatic intermediates,” the team stated in their paper. First author Patrick Rabe, PhD, Wellcome Career Development Award Investigator, University of Oxford, said, “These insights matter because they can inform how we think about antibiotic biosynthesis and future strategies for developing antibacterial medicines. The ability to capture structural snapshots over milliseconds to seconds of reaction time allows us to connect enzyme motion, iron chemistry and water-mediated proton transfer. This gives us a much richer view of how IPNS controls a difficult chemical transformation. By understanding this process in atomic detail, we can begin to think about engineering these enzymes to produce new or improved antibiotic scaffolds.”

The post ‘Molecular Movie’ of Penicillin Synthesis Could Inform Future Antibiotic Development appeared first on GEN - Genetic Engineering and Biotechnology News.

According to the paper, a ratio between two immune cell types can reveal whether someone stays healthy or may face risk of future disease. To get to this insight, the scientists first analyzed approximately 12.4 million individual immune cells from the blood of over 2,600 mainly healthy adults ages 20 to 90-plus across eight cohorts in North America, the United Kingdom, Asia, and Australia. 

Their analysis showed that while the blood of younger people was uniformly enriched with naive immune cells that had not been exposed to specific pathogens and remained adaptable to new infections or vaccines, older immune systems were more diverse. Specifically, some older participants had a greater abundance of immune cells that reflect inflammation.

To map this shift, the researchers placed each participant on a spectrum based on the ratio between two types of white blood cells: specifically, granzyme B-producing cells and granzyme K-producing cells. Some white blood cells, known as effector memory CD8 T cells, use granzymes to destroy target cells or coordinate immune responses. While granzyme B-producing cells serve as direct destroyers of diseased cells, granzyme K-producing cells have been less studied and may play a role in boosting immune responses. 

Next, the researchers evaluated whether participants’ positions on the spectrum, which corresponds to a specific type of CD8 T cell, could dictate their risk of getting sick. In other words, they looked at whether having more of one type of CD8 T cell has an impact on the person’s health as they age. To answer that question, the scientists turned to the UK Biobank. 

While that dataset includes protein information from the participants, it lacks counts of CD8 T cells. To get around this hurdle, the scientists used a smaller dataset of seemingly healthy adults that included data on CD8 T cell counts and blood proteins to create a computer model to map out the protein tracks left behind when either granzyme B-producing or granzyme K-producing cells dominated. They then applied this model to the baseline blood protein samples of 50,000 participants from the UK Biobank, calculating their position on the immune cell spectrum.

Using this approach, the scientists were able to draw out some useful insights for their work. Specifically, they found that healthy adults whose immune system leaned heavily toward granzyme B cells at baseline tipped the scale toward a higher risk of death a decade later compared to those with more granzyme K cells. The granzyme B-dominant group also was more likely to develop chronic conditions, including Type 2 diabetes, hypertension, liver disease, and renal failure, among others, over the following decade.

“A higher level of granzyme B cells in a healthy state means the immune system might be already reacting to something,” said Marina Terekhova, MD, a professor in pathology & immunology at WashU Medicine and one of the co-authors on the paper. “It isn’t a formal disease diagnosis, but it may indicate the body is off track.”

A healthy immune system gradually shifts toward granzyme K cells over time, while an immune system that leans toward granzyme B cells signals unhealthy aging. Because individuals can reach this granzyme B state much earlier in life, their immune systems age on different trajectories, explaining why two people born in the exact same year can face different risks for chronic disease and death decades later.

These findings point to “clues in the blood that can tell us whether someone is on a healthy or unhealthy aging trajectory,” said Maxim Artyomov, PhD, the alumni endowed professor of pathology and immunology at WashU Medicine and one of the corresponding authors on the paper. Artyomov and his lab are now adapting their research into a simple blood test that can be processed using standard equipment. “Identifying specific biological red flags in the immune system could pave the way for early-warning tests that spot disease risks years before a clinical diagnosis.”

The post Immune Cell Atlas Charts How People’s Aging Paths Diverge appeared first on GEN - Genetic Engineering and Biotechnology News.

The Wallprotex Stainless Steel Crash Rail is a wall-protection system intended for areas subject to impacts from carts, equipment and other traffic. The product is positioned for applications including hospitals, kitchens and corridors, where repeated contact can damage wall surfaces. The crash rail is available in two profiles: v-groove and flat-face. The stainless steel construction provides a durable surface while maintaining a relatively clean, streamlined appearance. The system is supplied with mounting brackets and associated installation hardware, with installation requiring the brackets to be positioned and leveled before attachment to the wall surface. Wallprotex provides technical resources including product specifications, installation instructions, maintenance information, BIM files and CAD files. The product is available in standard configurations, with longer lengths requiring separate ordering or quotation.

The post Wallprotex Stainless Steel Crash Rail appeared first on HCO News.

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Rutman received her Doctor of Medicine from Stanford University School of Medicine and holds a of Master of Public Health from the University of California, Berkeley. 

She is an invited member of the international SQUIRE 3.0 Advisory Committee, Associate Editor of Pediatric Quality & Safety and Quality Section Editor for Pediatric Emergency Care and has co-chaired the Academic Pediatric Association Quality Improvement Research Meeting. She has also served as Co-Leader of the Children’s Hospital Association IPSO Research Workgroup. 

The post Lori Rutman Named Vice President of Quality and Safety at Seattle Children’s appeared first on HCO News.

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The post Society Submits Comments on the Medicare Physician Fee Schedule Proposed Rule appeared first on Endocrine News.

This week in dentistry, analysis found that dental practices could continue managing amalgam waste for decades after the global phase-out in 2034 – plus more news and updates from the profession.

NHS England has confirmed that manufacture, import and export of dental amalgam will be phased out, although dentists can still use it where clinically necessary. However, millions of existing fillings will remain in patients’ mouths, generating waste when restorations are replaced or teeth extracted.

Using the Adult Oral Health Survey 2023 and Office for National Statistics population figures, BusinessWaste.co.uk estimated that around 27.2 million adults in England could have at least one amalgam filling. This includes approximately 1.3 million people aged 16-24, suggesting that the issue extends beyond older patients.

According to the analysis, individual fillings in use around 2034 could remain until the 2040s or 2050s – though some restorations will be removed earlier, while others could last much longer.

Mark Hall, dental waste disposal expert at BusinessWaste.co.uk, said: ‘The amount of amalgam being used may fall, but existing fillings will continue to be removed for many years. That means practices will still need suitable processes for separating, storing and transferring amalgam waste, even when they are dealing with much smaller amounts of it.’

Practices removing amalgam must use separators retaining at least 95% of amalgam particles and arrange collection by an authorised hazardous waste operator.

BSPD and RCPCH launch oral health toolkit for non-dental professionals

The British Society of Paediatric Dentistry (BSPD) and the Royal College of Paediatrics and Child Health (RCPCH) have launched an oral health toolkit for non-dental professionals working with children, alongside a Mini Mouth Care Matters implementation guide.

BSPD’s Oosh Devalia OBE said the resources would help professionals address children’s oral health confidently. RCPCH’s Helen Stewart highlighted evidence supporting brief interventions by non-dental staff.

The toolkit complements existing guidance, professional judgement and local pathways; it does not set mandatory standards of care.

CDS delivers oral health session for Luton’s Over 50s Black Men Forum

Community Dental Services CIC (CDS) partnered with Luton’s Over 50s Black Men (O5BM) Forum to deliver an oral health session supporting prevention and tackling inequalities.

Held at the Luton Co-op Social Club on Stockingstone Road, the event combined education, health screening and practical advice. Its content reflected feedback from forum members, who identified oral cancer awareness, oral hygiene, tooth loss and dentures as priorities.

Interactive health stations offered personalised advice, while CDS clinicians explained connections between oral disease, diabetes, cardiovascular health and healthy ageing. Participants also completed surveys and received blood pressure and finger-prick blood glucose measurements.

Chidi Umeano, the forum’s partnership and engagement lead, said members had reported difficulties accessing reliable oral health information. The collaboration brought expert support directly into the community, helping participants take positive steps towards better oral and general health.

CDS chief operating officer Glen Taylor emphasised the importance of prevention and early intervention, welcoming the opportunity to provide accessible information, screening and guidance.

The event also helped build understanding of older Black men’s oral health needs in Luton and explore opportunities for future community outreach to support preventative healthcare and reduce barriers to services.

Gillian Leng named Medical Protection Society president

Professor Gillian Leng CBE has been named president of the Medical Protection Society (MPS), which includes Dental Protection, effective 1 October 2026.

Leng succeeds Professor Dame Jane Dacre, whose eight-year tenure ended in June 2026.

She said she looked forward to working with MPS Council and Dental Protection’s dento-legal team to ensure dental professionals had the confidence and protection needed to care for patients safely.

Dr Graham Stokes, dentist and chair of council at MPS, welcomed her appointment, saying her healthcare experience and passion would help shape support for members. He also thanked Dacre for her advocacy and service.

Apheon acquires majority stake in Hager & Meisinger

European private equity firm Apheon has acquired a majority stake in Hager & Meisinger Group, a global provider of premium dental instruments and workflow solutions under the Meisinger and Jota brands.

Current shareholders and co-CEOs Dr Burkard Höchst and Sebastian Voss will retain a meaningful shareholding and remain actively involved in the Group’s development.

Founded in 1888 and headquartered in Neuss, Germany, Hager & Meisinger specialises in high-precision dental rotary instruments. Together with Switzerland-based Jota AG, it offers more than 12,000 product references, with particular strengths in diamond and carbide instruments. The group also provides bone management and implant dentistry solutions developed with clinicians, supported by a global clinical education network.

The partnership will support organic growth and selective acquisitions, with a focus on US expansion, international commercial reach and distributor relationships.

Höchst and Voss said Apheon shared their long-term perspective and commitment to the group’s heritage, quality and customer relationships. Apheon’s Nils Lüssem and Finn Pilath highlighted the group’s established brands, engineering expertise and international growth potential.

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After spending months or even years learning basic science concepts, memorizing pathways, and mastering Step 1-style thinking, students often assume Step 2 will feel easier because it is “more clinical.” In some ways, that’s true. You’ve also likely had your clerkship exams for practice. But Step 2 also requires a major mindset shift that catches many students off guard.

One of the biggest mistakes students make is approaching Step 2 with the exact same study strategies they used for Step 1. While there is certainly overlap between the exams, the way you think through questions changes significantly.

Step 1 Rewards Memorization More Than Step 2

Step 1 often emphasizes foundational science knowledge and mechanistic thinking. Students spend enormous amounts of time memorizing details, pathways, pharmacology, and physiology. Even though critical reasoning matters on Step 1, there is still a strong emphasis on recalling specific facts quickly. I notice this difference a lot when I tutor my Step 1 vs. Step 2 students. On Step 1, test taking strategies are definitely helpful, but there are a lot of details that you either know…or don’t. 

Step 2 is different.

Clinical questions are often less about identifying a disease and more about determining what to do next. Two answer choices may both technically describe the same diagnosis, but the real challenge becomes choosing the best management step, interpreting risk factors, prioritizing interventions, or understanding hospital workflow. There is a tremendous amount of logic and test taking strategy that can be used to your advantage. 

Many students transitioning to Step 2 continue studying as if brute-force memorization alone will carry them through. They spend too much time rereading notes or trying to memorize every guideline detail instead of practicing logical clinical reasoning.

The students who improve the fastest on Step 2 are usually the ones who learn how to think like clinicians rather than just test takers.

Overvaluing Content Review and Undervaluing Questions

Another major mistake is spending too much time on passive review early in Step 2 prep.

After Step 1, students are often used to long content review phases involving textbooks, sketch resources, flashcards, and detailed memorization. But Step 2 learning tends to happen much more effectively through questions.

This is partly because clinical reasoning is difficult to learn passively. You need repeated exposure to patient presentations, management algorithms, diagnostic patterns, and decision-making frameworks. Questions teach you how diseases actually appear in real clinical scenarios rather than in perfectly organized textbook chapters.

Students often delay question-heavy studying because they feel “not ready yet.” But unlike Step 1, where content gaps can feel very obvious, Step 2 improvement often comes from learning how questions are framed and how clinicians prioritize information. My biggest piece of advice is to keep up with practice questions and anki cards for all specialties throughout your clerkship year. Don’t be done studying for one specialty after that clerkship is over because it’s difficult to retain that information by the time Step 2 rolls around. 

Many students are surprised by how much their scores improve once they stop obsessing over memorizing and start focusing more heavily on application, especially when they have kept up their knowledge for each specialty throughout clerkship year.

Forgetting That Third Year Is Already Step 2 Preparation

As I alluded to previously, one of the most important mindset shifts students miss is realizing that clerkships themselves are Step 2 studying.

Students sometimes separate “rotation studying” from “Step 2 studying” when, realistically, they are one in the same. Shelf exams, patient encounters, oral presentations, and daily clinical exposure all build the foundation for Step 2 success. In fact, the clerkship questions literally are Step 2 questions about that specialty that could come up on the exam.

The students who tend to struggle most are often those who treat third year as something to simply survive before worrying about Step 2 later.

In reality, consistent shelf preparation throughout the year makes Step 2 dedicated far less stressful. Students who build strong clinical reasoning gradually during rotations often require much less cramming later.

Comparing Your Dedicated Period to Everyone Else’s

One issue students rarely anticipate is how variable Step 2 dedicated time can be.

Unlike Step 1, where many schools historically built in 4-6 week long dedicated periods, Step 2 timing often depends heavily on fourth-year scheduling, away rotations, residency application timelines, and specialty-specific demands.

Some students may get six weeks of dedicated study time. Others may only have two or three. Students pursuing competitive specialties may need to schedule away rotations early, limiting flexibility even further. Some students are balancing sub-internships, research, residency applications, or travel during the same period they are trying to prepare for Step 2.

This creates a major problem: comparison.

Students often panic when they hear classmates discussing eight-week study plans while they only have a short dedicated window. But Step 2 preparation is much more cumulative than many students realize. Your third-year foundation matters enormously.

A shorter dedicated period does not automatically mean lower performance if you built strong habits throughout clinical rotations. Whatever your study timeline looks like, prepare accordingly so that your schedule demands are realistic for what you need to accomplish. 

Waiting Too Long to Take NBMEs Seriously

Another common mistake is delaying self-assessment exams because students feel anxious about scores. Many students avoid NBMEs early because they worry about underperforming. Others save practice exams until very late in dedicated, leaving little time to identify weaknesses properly.

But practice exams are one of the most valuable tools for understanding how you are thinking clinically. They often reveal timing problems, management gaps, and reasoning issues that question banks alone may not fully expose.

My recommendation is to take one of the NBME self assessments about 4-6 weeks out from your Step 2 test date to establish a baseline and then take 1 self assessment weekly to evaluate your progress. 

The Step 1 Flavor to Step 2 Questions

One subtle but important mistake is underestimating the value of a solid pre-clinical foundation. Step 2 rewards prioritization and efficiency much more heavily than Step 1, but you may notice that many Step 2 questions have a Step 1 flavor to them. For example, you may see a gram stain pop up that you never thought you’d see again after Step 1 was over! 

Students who have a solid pre-clinical foundation and performed well on Step 1 often do very well on Step 2. So, it is important to carry those strong study habits and spaced repetition forward into your clinical year. 

Ignoring Fatigue and Burnout

By the time students begin Step 2 prep, many are already exhausted.

Third year can be emotionally and physically draining. Students are balancing shelf exams, long clinical hours, evaluations, residency planning, and constant transitions between rotations. You’re basically working a full-time job and studying full-time as well. Unlike Step 1 studying, which often occurs during preclinical years, Step 2 preparation happens while many students are already running low on energy.

One mistake students make is underestimating burnout. Some assume they should be able to study with the same intensity they used during Step 1 dedicated. But the reality is that Step 2 preparation often requires more balance and sustainability.

Students who maintain realistic expectations and flexible schedules often perform better than those trying to force extreme study hours while mentally depleted.

Resource Overload Happens Again

Just like Step 1, students frequently fall into the trap of using too many resources. One classmate recommends one question bank. Another swears by a specific podcast. Someone else says a certain Anki deck is essential. Suddenly students are juggling UWorld, AMBOSS, CMS forms, podcasts, flashcards, videos, and review books simultaneously.

Most students eventually realize that mastering a few core resources is much more effective than spreading themselves thin across everything available.

For many students, high-quality questions and careful review of targeted content gaps become the true backbone of Step 2 preparation. And don’t be afraid to switch up your routine if you find that it’s not yielding the results you are aiming for. 

The Bottom Line

The transition from Step 1 to Step 2 is not just about learning new material, it is about learning a new way to think.

Students who continue relying entirely on memorization-based strategies often feel frustrated when their scores plateau despite long study hours. Meanwhile, students who embrace clinical reasoning, question-based learning, and gradual skill-building often improve much more efficiently.

It is also important to remember that Step 2 preparation looks different for everyone. Some students have longer dedicated periods, while others are balancing away rotations, research months/years, and residency applications simultaneously. Comparing timelines rarely helps.

At the end of the day, Step 2 is less about becoming a perfect encyclopedia of medical facts and more about becoming a thoughtful clinical decision-maker. The earlier students recognize that mindset shift, the smoother the transition tends to be.

If you need support adapting your study approach, EMP’s 1:1 Step 2 CK tutoring can help you strengthen your clinical reasoning, address knowledge gaps, and build a study plan that fits your schedule.

The post The Biggest Study Mistakes Students Make When Transitioning from USMLE Step 1 to Step 2 appeared first on Elite Medical Prep.

Canadian researchers are advancing two initiatives aimed at improving the diagnosis and treatment of rare childhood diseases, supported by approximately $1.77 million in new funding from Canadian non-profit organization Conscience.

The projects include expanding an artificial intelligence system developed at the CHEO Research Institute in Ottawa and advancing plans for a Canadian clinical trial of an experimental gene therapy for CLN7 Batten disease.

AI helping diagnose rare diseases

The ThinkRare system uses artificial intelligence to analyze electronic medical records and identify patterns that may indicate an undiagnosed genetic condition.

Rare diseases can be difficult to recognize because symptoms often resemble those of more common illnesses. As a result, children may undergo years of medical appointments and testing before receiving an accurate diagnosis.

According to Conscience, ThinkRare has already contributed to 23 rare-disease diagnoses at CHEO, with a reported diagnostic yield of approximately 70 per cent among patients referred for further assessment and testing.

In one case, the technology helped identify a rare condition in a patient who had attended 153 outpatient appointments over 17 years without receiving a diagnosis.

Conscience is providing $1 million to support the system’s expansion to additional pediatric institutions, including McMaster Children’s Hospital in Hamilton, Alberta Children’s Hospital in Calgary and Stollery Children’s Hospital in Edmonton.

The technology is designed to support physicians and genetic specialists by identifying patients who may benefit from further investigation.

Advancing experimental gene therapy

A second initiative will receive $768,823 to support efforts to bring a clinical trial for CLN7 Batten disease to Canada.

The rare inherited neurological disorder can cause progressive vision loss, seizures and deterioration of motor and cognitive abilities.

The project involves CureSPG50, The Hospital for Sick Children (SickKids) and Elpida Therapeutics.

Researchers are developing an experimental gene therapy designed to introduce a functional copy of the MFSD8 gene, which is affected in children with the disease.

An earlier Phase 1 study involving four patients provided preliminary safety information and early indications of possible benefit. The proposed Phase 1/2 trial would involve nine additional children.

The treatment remains experimental, and further research is required to establish its safety and effectiveness.

Improving care for children with rare diseases

Together, the initiatives highlight the growing role of artificial intelligence and genetic medicine in pediatric healthcare.

Earlier diagnosis could help reduce unnecessary testing, improve care coordination and provide families with answers sooner. Meanwhile, advances in gene therapy offer opportunities to investigate treatments for conditions with few existing options.

The projects also demonstrate the importance of collaboration among Canadian hospitals, researchers and non-profit organizations in addressing complex healthcare challenges.

The post Canadian children’s hospitals expand AI-powered rare disease detection as gene therapy research advances appeared first on Hospital News.

BayCare’s Morton Plant Hospital in Florida recently became the first site to implant an investigational heart-failure monitoring system as part of the international FUTURE-HF2 clinical trial.

The technology is designed to continuously monitor changes associated with fluid buildup, one of the major problems experienced by people living with heart failure.

The miniature sensor is implanted in the inferior vena cava, the large vein responsible for returning blood from the lower body to the heart.

Once implanted, the device measures pressure inside the vein.

Patients can take readings from home, allowing information to be transmitted to their healthcare team without requiring a hospital or clinic visit.

That could provide clinicians with an important early-warning system.

When the heart cannot pump effectively, fluid can begin accumulating in the body. Patients may eventually experience shortness of breath, swelling, fatigue and rapid weight gain.

But physiological changes can begin before those symptoms become obvious.

By identifying increasing venous pressure earlier, physicians may be able to adjust medications or other treatment before a patient’s condition deteriorates enough to require hospitalization.

Reducing hospital admissions is particularly important in heart failure, where patients frequently experience repeated episodes of worsening disease.

Implantable monitoring technologies are therefore becoming an increasingly important area of cardiovascular medicine.

Rather than relying primarily on symptoms, weight changes and periodic clinical examinations, these systems can provide physicians with physiological information while patients go about their normal lives.

The investigational system being studied in FUTURE-HF2 could potentially extend that approach by using the inferior vena cava as a location for monitoring changes in cardiovascular pressure.

Researchers will evaluate the safety and effectiveness of the technology and whether information generated by the implant can help clinicians improve heart-failure management.

The device remains investigational, and its participation in a clinical trial does not mean it has received authorization for widespread clinical use.

If successful, however, technologies like this could contribute to a larger shift in chronic disease management — from responding to deterioration after symptoms appear to detecting physiological changes early enough to intervene.

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The federal government has announced plans to introduce significant changes to Canada’s medical assistance in dying (MAID) legislation, addressing two of the most debated aspects of the country’s assisted-dying framework: eligibility for people with mental illness and advance requests for individuals who may lose the capacity to provide consent.

The proposed changes, announced October 7, 2026, would indefinitely maintain the exclusion of people whose sole underlying medical condition is a mental illness. The government also intends to introduce legislation addressing advance requests for MAID.

Mental illness exclusion

Under current federal legislation, individuals whose only underlying medical condition is a mental illness are temporarily excluded from eligibility for MAID until March 17, 2027.

The federal government now proposes making that exclusion indefinite, rather than allowing eligibility to expand when the existing deadline expires.

The issue has generated considerable discussion among healthcare professionals, mental health advocates, policymakers and disability rights organizations.

Supporters of maintaining the exclusion have raised concerns about assessing whether psychiatric conditions are irremediable, protecting vulnerable patients and ensuring adequate access to mental healthcare.

Others argue that excluding mental illness as a sole qualifying condition raises questions about equitable access to MAID for people experiencing severe and persistent psychiatric disorders.

Advance requests for MAID

The government is also proposing a legislative framework that would address advance requests for medical assistance in dying.

Advance requests would allow eligible individuals diagnosed with certain serious, incurable conditions to document their wishes while they retain decision-making capacity, in anticipation of potentially losing that capacity as their illness progresses.

The issue is particularly relevant for people diagnosed with neurodegenerative conditions, including Alzheimer’s disease and other forms of dementia.

Under the proposed approach, provinces and territories would have a role in determining whether advance requests are available within their healthcare systems.

Quebec has already established a framework permitting certain advance requests for MAID.

Implications for Canadian healthcare providers

The proposed changes could have important implications for hospitals, physicians, nurse practitioners and healthcare organizations responsible for assessing and delivering MAID services.

Healthcare providers would need to understand any new eligibility requirements, consent procedures and documentation obligations arising from future legislation.

Advance requests could also introduce additional clinical and ethical considerations involving patient autonomy, capacity assessments and the interpretation of previously expressed wishes.

The federal government is expected to introduce legislation later this fall.

The proposed changes have not yet become law. Existing federal MAID eligibility requirements and safeguards remain in effect.

The post Canada proposes major changes to medical assistance in dying legislation appeared first on Hospital News.

The expansion, announced October 8, is projected to support more than 3,000 additional procedures annually once the upgraded facilities are fully operational.

Construction is expected to begin in the coming weeks, with completion anticipated by 2029. The hospital will continue providing surgical and other healthcare services throughout the renovation period, with construction scheduled in phases to minimize disruptions.

Expanding surgical capacity

The project will modernize several areas of the hospital to accommodate growing demand for surgical services in Fort Saskatchewan and surrounding communities northeast of Edmonton.

Planned improvements include expanded day surgery facilities, relocation of outpatient and intravenous therapy services, and upgrades to the hospital’s Medical Device Reprocessing Area.

Medical device reprocessing is an essential component of surgical operations, ensuring reusable instruments and equipment are properly cleaned, disinfected and sterilized before use.

The hospital currently provides ophthalmology, gynecology, general surgery and endoscopy procedures.

The expansion is intended to increase the number of patients who can receive surgical care closer to home while reducing pressure on other healthcare facilities in the region.

Part of a broader surgical investment

The Fort Saskatchewan project is being funded through the Alberta Surgical Initiative, a three-year, $284-million program focused on upgrading operating rooms, modernizing surgical infrastructure and purchasing equipment at hospitals across the province.

The initiative is intended to improve surgical access and make better use of existing hospital resources.

According to the provincial government, Alberta completed 332,847 surgeries during the previous fiscal year, exceeding its annual target and establishing a new provincial record.

The province has also committed $525 million toward delivering 50,000 additional publicly funded surgeries over three years.

Meeting growing healthcare demand

Fort Saskatchewan and neighbouring communities have experienced population growth, increasing demand for healthcare services.

By expanding surgical facilities within the existing hospital, the province aims to accommodate more procedures locally while supporting the healthcare needs of the growing region.

The project also illustrates the importance of investing in supporting hospital infrastructure, including instrument reprocessing and outpatient services, alongside operating room capacity.

Once complete, the upgrades are expected to provide additional surgical capacity and improve access to treatment for patients throughout the region. Alberta.ca

The post Alberta hospital expansion to add more than 3,000 surgeries annually appeared first on Hospital News.

The facility features two International Organization for Standardization-7 (ISO-7) cleanrooms alongside five ISO-8 multifunctional cleanrooms for GMP small molecule production and material handling.

It was established to help developers address industry-wide production challenges, including the need to standardise workflows, reduce batch variability, and scale output from initial research through to commercialisation while complying with evolving regulatory expectations.

Industry discussions have increasingly pointed to manufacturing scalability as a central requirement for broadening patient access to advanced cell therapies.

Bio-Techne president and CEO Kim Kelderman said: “As the cell therapy field continues to mature, success increasingly depends on the ability to manufacture therapies consistently and at scale.

“Our investment in Bristol demonstrates Bio-Techne’s commitment to providing customers with the GMP materials, manufacturing expertise, and supply chain reliability needed to accelerate development and ultimately bring transformative therapies to patients worldwide.”

The Bristol site expands the company’s manufacturing operations across the UK and the US. Bio-Techne also operates recombinant protein production in Minneapolis, Minnesota, alongside GMP facilities in St Paul.

In conjunction with cell culture device maker Wilson Wolf Corporation, developer of the G-Rex platform, Bio-Techne supplies analytical solutions, custom manufacturing services, GMP cell media, proteins, small molecules, and process development support across the cell therapy workflow.

Headquartered in Minnesota, Bio-Techne operates across 34 locations worldwide and employs over 3,000 people.

During fiscal year 2025, the company generated net sales exceeding $1.2bn.

It supplies biopharmaceutical companies, academic researchers, clinical diagnostic laboratories, and biotechnology firms with over 500,000 products across three commercial divisions: Bio-Techne Diagnostics, Bio-Techne Spatial, and R&D Systems.

The post Bio-Techne opens GMP small molecule facility in Bristol, UK appeared first on Pharmaceutical Business review.

Rafina O’Brien shares the signs of perimenopause and menopause that should prompt dental professionals to ask more questions.

Perimenopause and menopause can bring a wide range of physical and psychological changes, but oral health is an area that can easily be overlooked.  

For some women, the menopausal transition may coincide with symptoms such as dry mouth, altered taste, burning or oral discomfort, alongside changes in gingival and periodontal health. However, the evidence is complex, and these symptoms should not automatically be attributed to hormonal changes. Age, medication, systemic health, hydration, oral health behaviours and other factors can all contribute.  

For dental professionals, menopause should therefore be a prompt to ask more questions, rather than make assumptions.  

Start with a question  

A simple conversation can uncover problems that might otherwise remain unreported.  

Rather than waiting for a patient to volunteer information, dental professionals can ask whether they have noticed any changes in their mouth, particularly if they mention changes to their menstrual cycle or other symptoms associated with perimenopause or menopause.  

A question such as: ‘Have you noticed any changes in your mouth since your periods or other menopausal symptoms started changing?’ can open the door to a much broader assessment.  

This is relevant because an integrative review examining oral healthcare among women during perimenopause and menopause identified limited oral health knowledge and unmet oral-health needs, alongside gaps in advice from healthcare professionals. The authors also highlighted the limitations of the existing evidence base, reinforcing the need for caution when interpreting associations between menopause and oral health (Thomas et al, 2025).  

The conversation does not need to become another lengthy medical history. It is about creating an opportunity for the patient to tell us what has changed.  

Look beyond the scale and polish  

Menopause does not create a separate set of periodontal protocols. The fundamentals of prevention and periodontal care remain the same.  

However, the menopausal transition can be a useful prompt to reassess the patient’s individual risk. Plaque control, bleeding, periodontal probing findings, recession and attachment levels should be considered within the context of the patient’s overall periodontal assessment and established risk factors.  

A 2026 systematic review found associations between postmenopausal status and several periodontal clinical outcomes, including greater clinical attachment loss, probing depths and periodontal inflammation compared with premenopausal women. However, the certainty of the evidence ranged from moderate to low, and there was considerable variation between studies. The authors concluded that higher-quality prospective research is required (Civiletto-S Martín et al, 2026).  

That distinction is important in practice.  

We should be attentive to changes in periodontal health, but we should not tell a patient that menopause itself means they will develop periodontal disease.  

Don’t overlook dry mouth  

Xerostomia is another symptom worth exploring.  

Patients may describe waking with a dry mouth, needing to sip water frequently, difficulty eating dry foods, changes in taste or general oral discomfort. However, dry mouth has numerous potential causes, including medication, dehydration and mouth breathing. A careful medical and medication history is therefore essential.  

Medication review is particularly important because xerostomia can be associated with a wide range of commonly prescribed medicines and should not automatically be attributed to hormonal change.  

Saliva has an important protective role within the oral environment. Reduced salivary flow can increase susceptibility to caries and contribute to difficulties with eating, speaking and maintaining oral comfort.  

Management should be individualised according to the patient’s symptoms, clinical findings and underlying risk. Depending on the circumstances, this may include advice on hydration, reducing the frequency of free sugars, stimulating saliva, using saliva substitutes and optimising fluoride exposure.  

Current UK prevention guidance recommends that adults brush twice daily with toothpaste containing 1,350 to 1,500ppm fluoride. Additional fluoride measures may be appropriate where an individual’s caries risk indicates a need for them (Department of Health and Social Care, NHS England, Welsh Government, Department of Health Northern Ireland, 2025).  

Burning, altered taste and oral discomfort  

Burning oral symptoms can be particularly challenging for both patients and clinicians because significant symptoms may occur despite little or no obvious clinical abnormality.  

A 2026 systematic review examining the relationship between menopause and burning mouth syndrome reported an association between the two, but also highlighted the multifactorial nature of the condition (Qaderi et al, 2026).  

This means that persistent burning symptoms should not simply be explained away as ‘hormones’.  

A thorough history and appropriate examination remain important. Consider the timing and nature of symptoms, medications, oral habits, dietary factors and relevant systemic conditions, alongside the clinical examination. Where symptoms persist or the diagnosis is uncertain, further investigation or referral may be appropriate.  

The patient’s experience should be taken seriously even when the clinical examination appears relatively normal.  

Don’t miss what isn’t menopause  

Perhaps the most important clinical message is that menopause should never become a diagnostic shortcut.  

A new ulcer, persistent red or red-and-white patch, unexplained lump or other concerning mucosal change should be assessed on its own clinical merits rather than attributed to perimenopause or menopause.  

NICE recommends referral through a suspected cancer pathway for unexplained oral ulceration lasting more than three weeks. It also recommends urgent assessment of a lump on the lip or in the oral cavity and of a red or red-and-white patch consistent with erythroplakia or erythroleukoplakia.   

This is not about alarming patients. It is about good clinical examination, appropriate documentation and recognising when a finding does not fit the expected clinical picture.  

Make prevention personal  

The menopause conversation does not need to become another lengthy checklist, instead:  

• Ask what has changed
• Assess periodontal and caries risk
• Check saliva, medication and relevant medical history
• Reinforce fluoride and effective plaque removal
• Discuss interdental cleaning where appropriate
• Examine the oral mucosa carefully
• Investigate persistent or unexplained symptoms rather than automatically attributing them to menopause. 

And where a patient is experiencing wider menopausal symptoms, dental professionals can signpost them towards an appropriate healthcare professional for further discussion.  

Our role is not to diagnose or manage menopause treatment. It is to recognise potential oral-health changes, assess what we can clinically assess, identify problems that require further investigation and support patients with appropriate prevention and signposting.  

NICE recommends an individualised approach to identifying, discussing and managing perimenopause and menopause, with care adapted according to the person’s symptoms and changing circumstances.   

The menopausal transition is not a dental diagnosis. It is a life stage that can intersect with oral health in several different ways.  

As dental professionals, we do not need to label every symptom as hormonal. We need to notice, ask, assess and act appropriately.  

Sometimes, making oral health part of the perimenopause and menopause conversation is the most useful place to start.  

References  

• Civiletto-S Martín F, Rus MJ, de la Cruz Gándara Alvarez A, Simon-Soro A, Cantiga-Silva C (2026) Impact of menopause on clinical periodontal outcomes: a systematic review. Clinical Oral Investigations 30: 143  
• Department of Health and Social Care, NHS England, Welsh Government, Department of Health Northern Ireland. Delivering Better Oral Health: An evidence-based toolkit for prevention. Updated 10 September 2025 
• Labunet A et al (2025) Oral Manifestations in Menopause: A Scoping Review. Medicina. 61(5): 837  
• National Institute for Health and Care Excellence. Suspected cancer: recognition and referral (NG12). Recommendations 1.8.2-1.8.4 
• National Institute for Health and Care Excellence. Menopause: identification and management (NG23). Updated 15 April 2026 
• Qaderi K, Eghdampour F, Mallah MA, et al (2026) Exploring the association between menopause and burning mouth syndrome: an updated review. BMC Oral Health 26: 1517  
• Thomas N, Peters K, O’Reilly K, Sousa MS, George A (2025) Oral health care among women in perimenopause or menopause: an integrative review. Journal of Midwifery & Women’s Health 70(1): 17-31.

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Anthony Gedge revisits his 2020 predictions for private dentistry and asks whether practices are ready for patients to compare prices, treatment promises and clinical responsibility.

I got the patient behaviour broadly right. Jane would find a practice on her phone, look at reviews and images, have a remote first conversation, consent digitally and use app-based monitoring. That is now familiar.

I got the practice economics wrong. I forecast smaller clinics, half the reception team and fivefold profitability with the certainty of a man who had not yet met the real cost of finishing a case. Technology has not removed diagnosis, accountability or the need to get a patient back through the door when a case drifts.

Orthodontics exposes the problem first. Jane can put two aligner quotations beside each other and compare appliance and headline price. She cannot tell, from a smiling photograph, whether assessment, monitoring, refinements, finishing and escalation are comparable. The fee has to explain the clinician’s work when the case stops being straightforward.

In my 2014 book, Invasion Of The Straight Teeth Snatchers, I warned that ‘a price war will erupt and a flurry of price shoppers will waste everyone’s time’. The warning was not that patients should not compare. They should. The danger is making price the only thing they can compare.

SmileDirectClub showed the cost of creating demand from scratch. Its 2022 accounts reported $290.2 million in marketing and selling costs, equivalent to 88.5% of its $327.9 million gross profit. That figure includes selling operations and SmileShop costs, not advertising alone. A clinic starts with a patient base, a team and a place where trust can be earned.

The appliance is becoming the easy part

Smile White offers partner dentists prepaid patients and centrally handled marketing, laboratory work and communications, while the dentist approves the plan. It uses ‘smile advisor’, a title I advocated in Chapter 3. Shared terminology is not evidence that it borrowed the phrase from me.

Invisiblebraces4u combines virtual consultation with local care. Dental Beauty Group Limited has been the legal majority controller of IB4U Ltd since September 2024. Its first filed accounts report eight-figure revenue for the 471 days to 31 December 2025. That is turnover over an extended period, not an annual figure or a valuation.

It also points to a harder commercial question. IB4U advertises Sunday appointments at Islington and Battersea addresses where Dental Beauty lists Sunday as closed. The accounts do not prove a tenancy model or session profitability. They do show the opportunity: rent does not stop when the surgery lights go out. Extra sessions still need to cover clinicians, decontamination and follow-up.

The groups need not own the factory to change the market. mydentist’s 2021 article says its ClearCorrect relationship began in 2019 and had trained 500 clinicians on more than 2,000 cases. Those are historic figures. Nick Marston’s recent teaser proves no new product, but the group already has patients, premises and trained people.

In America, Aspen Dental sells its proprietary Motto brand through its network. Eon Dental says it designed the customised enterprise solution behind Motto, including production-back-end integration. Pacific Dental Services extended its Envista relationship around Spark. Fixed braces are open too: LightForce, KLOwen and Brava use digital planning in different ways.

None of that reduces clinical responsibility. Remote monitoring changes who sees an alert and when, not who owns the decision. Mild-to-moderate cases can be handled by trained GDPs within competence; complex care still needs a specialist-led plan and clear escalation. Orthodontic therapists work under prescription and direction. ‘Anyone with crooked teeth’ is a category, not a market.

The price comparison arrives next

The Competition and Markets Authority’s July 2026 update records CMA-issued information notices to more than 20 dental groups on pricing, plans, complaints and incentives. These are evidence-gathering requests, not conclusions. Which?’s submission argues for clearer ‘From £x’ pricing and early disclosure of extras.

The General Dental Council already requires clear website pricing and guarantee information. The likely change is aggregation. The veterinary remedy package requires price data to support an improved Find a Vet service and approved comparison providers. Dentistry has no equivalent remedy yet; the CMA’s study remains open and its final report is due by 4 March 2027.

DentaClarity’s March 2026 submission described a platform in development for comparing treatment costs and facilities by location. It is a prospective entrant, not a finished consumer product. But it tells you where the pressure is coming from.

My forecast is simple. Jane will open a private-dentistry comparison app, see item fees, finance, maintenance plans, availability and reviews, then compare what is included. She may upload selfies and a treatment plan to compare stated scope. Paid placement will need a label. Her clinical assessment remains essential; an app cannot prescribe treatment or certify consent.

After a proper discussion of options, risks, benefits and costs, Jane may record consent and submit remote-monitoring images in the same app. A named clinician still reviews the case, decides what matters and brings her in. Comparison will not replace the relationship. It will make a vague offer much harder to defend.

Three decisions before 2029

First, publish fees, inclusions and exclusions in readable text before someone else scrapes them. Separate a maintenance plan from borrowing. Show the deposit, annual percentage rate, term and total repayable together.

Second, make the clinical promise visible. State who assesses, monitors, changes the plan, provides refinements, finishes the case and handles trouble. A lower price can reflect efficiency or a narrower service. A higher price proves nothing by itself.

Third, stop marketing to ‘people with crooked teeth’. Build offers around an identifiable person and a real moment, then make sure the clinical route suits that person. A generic smile advert is a letter addressed to ‘Occupier’.

My next forecast ends where this one began: Jane puts two quotations on the desk. She should see price, scope and the clinician responsible. If she cannot, you have handed your margin to the comparison engine.

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This week my colleague Antonio Regalado had an interesting update on GLP-1 weight-loss drugs. According to research presented at an aging meeting in Boston, these drugs seem to affect at least some measures of biological age.

Overweight and diabetic people who take GLP-1s have a biological age around two to three years younger than similar individuals who take a placebo, according to findings from Eli Lilly and Novo Nordisk, two pharmaceutical companies that make the drugs.

I’ve heard people in the aging field describe GLP-1s as longevity drugs for a while now (even if they only benefit people who are overweight or diabetic in the first place). This latest announcement comes after we’ve seen a raft of other benefits associated with taking these drugs. But there are also some weird side effects.

So far, GLP-1 agonist drugs—which repress hunger—have been approved for treating diabetes, chronic kidney disease, and obesity, and they can also be prescribed for some people who are overweight or at risk of certain cardiovascular diseases. But there is research to suggest they might also help people with substance-use disorders, and they’ve been investigated for potential benefits in neurodegenerative disease and cancer.

And a lot of people are taking them. According to a recent Gallup poll, 11% of Americans are taking a GLP-1 drug for weight loss, up from 3% in 2024. And 15% of Americans say they’ve used one for weight loss at some point.

They can be incredibly effective. But, like any drug, they can come with side effects. And we’re still figuring out exactly what those might be, and how widespread they are.

The most common side effects are gastrointestinal—nausea, vomiting, diarrhea, and constipation. The drugs have also been linked to pancreatitis and gallstone disease. 

Some claim that, in rare cases, the drugs might cause damage to nerves behind the eye. Dozens of people are suing Novo and Eli Lilly after developing a condition that can lead to sudden vision loss. They’re claiming that their symptoms were brought on by the GLP-1 drugs that these companies manufacture. Both companies dispute the claims. Research into the link is mixed.

We’re still getting to grips with the effects of weight-loss drugs on hair and nails, too. When Savanna Vidal at the George Washington University School of Medicine and Health Sciences in Washington, DC, and colleagues assessed electronic health data from 67 US health-care organizations, they found that GLP-1 use was associated with an increased risk of hair loss. It’s still not thought to be common, however.

And at a conference in Austria last week, another group presented the results of a smaller study suggesting that 66% of GLP-1 users reported at least one nail disorder—in some cases involving nail detachment. Nail conditions were also fairly common among people who didn’t take the drugs, though. The authors don’t claim that the drugs are causing nails to fall out (as I’m sure 11% of the American population will be relieved to hear).

The side effects might look different in children, but there’s not much data on those at the moment. Still, pediatric side effects will be something to watch given that, between 2019 and 2026, there was a 310-fold increase in GLP-1 prescriptions for eight- to 11-year-old children with obesity in the US. Child prescriptions are still rare, but they’ve been rising.

On Wednesday, the World Health Organization released its first guidelines on managing obesity in children and adolescents. Despite the scale of the issue—the WHO estimates that 70 million children aged five to nine were living with obesity in 2024—the organization explicitly says it does not recommend pharmacological treatment for kids under 10.

“This recommendation accounts for the lack of evidence on both benefits and the potential adverse events and consequences of the different medications and/or their active ingredients on normal growth, development, physiological parameters, and mental health,” the guidelines state.

I get press releases about GLP-1s on an almost daily basis. There’s been a ton of research into these drugs, and there are probably hundreds of other studies underway. There will likely be plenty more on this from The Checkup as the evidence evolves.

This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

The financial consideration includes an initial payment of $80m at closing alongside a $20m milestone payment anticipated within 12 months.

Biohaven is also eligible to receive royalties of around 20% on net product sales generated within the licensed territory.

The company retains all rights to the MoDE IgG degrader assets across all other international markets, including China, Europe, and the US.

The partnered assets target IgG-mediated autoimmune disorders. The principal candidate, BHV-1300, is an investigational small-molecule degrader currently under evaluation in a pivotal Phase III clinical study for Graves’ disease.

In ongoing Phase I testing administered subcutaneously, the compound achieved reductions in total IgG of up to 87% while sparing IgG3. The agreement also incorporates next-generation follow-on degraders BHV-1310 and BHV-1320.

Biohaven chairman and CEO Vlad Coric said: “Ono will be the ideal partner to bring this innovative immune-modulating technology to patients across Japan and key Asian markets.

“This is the first regional collaboration for an extracellular protein degrader, and it validates a platform that began with pioneering chemistry from the Spiegel Lab at Yale University and now spans a broad and diverse portfolio of MoDE and TRAP degraders.

“Few companies in the world can match Ono’s innovation in drug development or its demonstrated ability to translate breakthrough science into transformative therapies, as it did in helping to define modern cancer immunotherapy. We are excited for an outstanding collaboration to accelerate new therapeutics to patients.”

The underlying MoDE degrader platform originated from scientific research at Yale University. For this transaction, J.P. Morgan Securities acted as exclusive financial advisor to Biohaven, and Sullivan & Cromwell served as legal advisor.

In April 2025, Biohaven secured a funding deal worth up to $600m from Oberland Capital Management, providing the biotech with non-dilutive capital as it prepares for a potential US launch of troriluzole for spinocerebellar ataxia (SCA).

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Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.

The USFDA has approved Lupin’s Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems, Limited.

The product is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K deficiency.

According to IQVIA MAT August 2026 data, Phytonadione Injectable Emulsion had estimated annual sales of USD 52.3 million in the US.

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The Government has approved a cap on trade margins charged in the supply and sale of non-scheduled anti-cancer drugs at 30 per cent of the Maximum Retail Price (MRP). The measure is expected to reduce medicine prices by up to 70 per cent and help cancer patients save ₹2,500 crore annually.

Essential cancer medicines included in the scheduled list are already subject to government-set ceiling prices. The new decision extends price protection to non-scheduled cancer medicines, which fall outside the list, by limiting the margins added before the medicines reach patients.

An expert committee under the Directorate General of Health Services (DGHS) will finalise the list of medicines to be covered. The National Pharmaceutical Pricing Authority (NPPA) will then take a decision and issue the notification.

Cancer incidence in India is rising, with approximately 60 people per one lakh population affected by the disease. Treatment places a financial burden on patients and their families, who often have to pay substantial amounts from their own pockets.

NPPA’s analysis of market data found that non-scheduled anti-cancer medicines carry an average price mark-up of approximately 170 per cent, reaching 700 per cent or more in some cases. The price increases as medicines move through the supply chain before reaching patients.

Prices also vary depending on whether medicines are purchased from a retail pharmacy, a hospital pharmacy or an online pharmacy.

State authorities, including those in Maharashtra, Rajasthan and Karnataka, along with patients and civil society, have raised concerns about medicine prices. These concerns have also been voiced on public platforms, particularly regarding the gap between the price at which medicines are purchased for sale and the MRP charged to consumers.

The Government said the margin cap will curb excessive profiteering, address unfair pricing practices in the market and help ensure fairer prices for patients.

In February 2019, on the Government’s direction, NPPA capped trade margins on 42 selected non-scheduled anti-cancer drugs under Paragraph 19 of the Drugs (Prices Control) Order, 2013.

The decision reduced MRPs by up to 91 per cent, with reported annual savings of ₹984 crore across 526 brands. It reduced the financial burden on cancer patients and improved their ease of living.

Building on that experience and addressing pricing issues identified in the supply chain, the Government has now approved the wider cap. The expected annual savings of ₹2,500 crore are intended to provide further relief to patients undergoing cancer treatment.

To ensure the continued availability of these medicines, manufacturers of non-scheduled anti-cancer drugs will be required to maintain their current production levels.

The intervention will cover non-scheduled anti-cancer medicines across categories, including branded and generic, domestically produced and imported, and patented and non-patented medicines. The measure aims to enable patients to benefit from lower prices while ensuring the continued availability of the medicines they need.

Commenting on the Government’s Trade Margin Rationalisation (TMR) announcement, Mr Anil Matai, Director General, OPPI, said:

“OPPI welcomes the Government’s Trade Margin Rationalisation (TMR) initiative aimed at improving the affordability and accessibility of cancer medicines for patients across India. We support measures that help reduce the treatment burden on patients while ensuring continued access to quality therapies. We believe that improving patient outcomes requires sustained collaboration among government, industry and other stakeholders. As the implementation progresses, it will be important to maintain a balanced and predictable environment that supports patient access, healthcare system sustainability and the continued introduction of innovative treatments. OPPI remains committed to working with all stakeholders towards the shared goal of advancing patient-centric healthcare in India.”

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Lupin is moving towards a fully integrated, technology enabled operations ecosystem. How is the integration of manufacturing, supply chain and procurement helping the company build greater agility and resilience in an increasingly volatile global environment? 

The biggest change is that we no longer treat manufacturing, supply chain and procurement as separate functions. Under Global Technical Operations, we have brought Manufacturing, Supply Chain, Procurement, Engineering, Operational Excellence and EHS into one integrated operating model. This matters because some of the greatest opportunities to improve performance and efficiency lie at the interfaces between functions. By managing these interdependencies more effectively, we are able to improve throughput and resilience while making decisions across the value chain with a balanced focus on quality, service, compliance, cost and sustainability. This has helped us build a truly global operating model, allowing us to leverage capabilities, scale, best practices and insights across our network more effectively. 

In today’s environment, supply chain resilience starts with de-risking. This includes reducing dependency on single sources, strengthening supplier diversification, enhancing strategic sourcing and investing in backward integration where it creates long-term value. We view our suppliers of products and services as long-term partners in value creation, and we invest in partnerships that enhance reliability, innovation and continuity across the supply chain. 

Technology is the connective tissue that brings this model to life. Through digitalisation, automation and AI-enabled insights, we are improving visibility, accelerating decision-making and strengthening our ability to anticipate and respond to change. But technology creates value only when it improves outcomes for customers, patients and the business. Our focus is therefore not on technology for its own sake, but on applying it in ways that strengthen quality, service, resilience and performance. 

Ultimately, resilience is engineered through the seamless integration of quality, technology, supply planning and people. This is how we strengthen throughput and ensure a dependable and uninterrupted flow of medicines to patients worldwide. 

India has long competed on cost. From your experience across markets, is that advantage still enough? What will drive competitiveness over the next five years? 

Affordability is fundamental to ensuring broad and equitable access to quality medicines. However, cost advantage alone is no longer sufficient to create sustainable differentiation. 

Across global markets, success is increasingly being defined not just by scale and cost efficiency, but by quality, reliability, scientific excellence, innovation, technology adoption and speed of execution. 

In my opinion, four factors will shape the next phase of growth for the industry. First is patient centricity. Every decision across the value chain, from procurement and manufacturing to supply chain and quality, must ultimately be guided by patient needs. Organisations that can consistently ensure quality, reliability and uninterrupted access to medicines will be best positioned to build trust and create long-term value.

Second is quality. As we often say, compliance is the license to operate, but quality is what differentiates an organisation over time. Regulators, customers and patients expect consistent, world-class standards. Organisations that anticipate regulatory and industry trends, rather than simply follow them, will be better positioned to participate in more complex and highervalue segments. 

Third is innovation. As the industry evolves, long-term competitive advantage will depend on our ability to develop innovative solutions for complex healthcare challenges. Simply replicating what already exists is unlikely to create lasting value. The future will belong to organisations that can combine scientific expertise, technology and deep customer understanding to deliver differentiated products, processes and solutions.

Fourth is capability. As digitalisation, automation and AI redefine manufacturing and supply chains, lasting advantage will depend not on technology alone, but on how effectively it is combined with scientific expertise, process excellence and skilled talent. Technology is a means to an end; the real measure is the impact created for customers and patients. 

For years, India’s cost competitiveness laid the foundation for its success as a global pharmaceutical manufacturing hub. The next phase of growth will be driven by our ability to deliver quality, innovation, reliability and advanced manufacturing at scale, particularly in complex generics, biologics, specialty medicines and emerging modalities. 

The global pharma supply chain is being reshaped by geopolitics, China dependence and the push for local manufacturing. Where does this leave India? 

Over the last two decades, India has built a strong reputation as a trusted supplier of high-quality medicines to patients around the world. At the same time, recent geopolitical developments have highlighted the importance of building greater resilience across supply networks, particularly for APIs and key starting materials. Today, there is a greater focus on reducing concentration risk and creating more diversified, reliable supply chains. 

In this evolving landscape, India is well positioned to play a larger role. The country is already the world’s third largest pharmaceutical producer by volume, supplies nearly 50 per cent of all generic prescriptions dispensed in the United States, and is home to more than 750 US FDA-approved manufacturing facilities, the largest outside the United States. These strengths, combined with deep scientific talent, manufacturing scale and regulatory expertise, make India a natural partner for companies looking to build more diversified and resilient supply networks. 

As a trusted supplier to patients worldwide, the industry must continue to raise the bar on quality, reliability, compliance and supply continuity while investing in the capabilities needed to support future healthcare needs. If India continues to strengthen these foundations, it can elevate its position as a global manufacturing hub to a strategic partner in innovation, manufacturing and supply reliability for the global pharmaceutical industry. 

Resilience comes at a cost. How should pharma companies decide how much resilience they really need without losing their cost advantage? 

Resilience should be a calibrated capability, not a blanket strategy. The right approach is to understand where risks truly exist, assess their potential impact on patients and business continuity, and invest accordingly. 

At Lupin, we use a risk-segmented lens. For high volume, low-margin generics, cost efficiency remains the primary driver because patients depend on affordability. However, for critical therapies or products where we serve a large patient population and hold significant market share, the calculus changes. The higher the market share and the greater the potential impact on patients, the more deliberately we must focus on resilience. In such cases, the cost of a stockout or regulatory failure can far outweigh the cost of redundancy. 

Data and technology allow us to build resilient supply networks in a targeted and efficient way. We use AI-driven risk modeling to map our supply chain end-to-end, identify genuine vulnerabilities and quantify actual exposure — investing in dual sourcing, safety stock or nearshoring only where risk justifies it, while optimising aggressively elsewhere. 

The other lever is efficiency itself — automation, better yield management and leaner processes fund the resilience investments we need. The ultimate goal is to allocate resources where they can create the greatest impact, balancing affordability, supply reliability and patient needs in a disciplined and sustainable way. 

Lupin and other Indian companies are moving into more complex products. What changes when you move from high-volume manufacturing to more complex, high-value manufacturing? 

The model changes fundamentally. In traditional high-volume manufacturing, scale, standardisation and cost efficiency are the primary differentiators. In more complex products, success increasingly depends on scientific capability, deep process understanding, advanced technologies, manufacturing expertise and the ability to consistently meet stringent quality and regulatory standards. 

Complex products also carry higher execution risk — longer development cycles, more demanding technology transfer, higher regulatory expectations, and manufacturing processes that require greater precision and control. This is why we’re investing deliberately across complex generics, injectables, inhalation therapies, biosimilars, peptides and specialty products. 

The shift to complex, highvalue products is a shift from competing on efficiency alone to competing on capability. The organisations that succeed will be those that can consistently translate scientific innovation into highquality, differentiated therapies for patients at scale. 

Success therefore depends on the ability to connect science, quality, digital capability, manufacturing expertise and talent within one integrated operating system. 

Technology, AI and automation are changing manufacturing. Where do you see the biggest opportunity to create real business value, rather than simply improve efficiency? 

Technology, AI, and automation have traditionally been viewed from the lens of efficiency, but their greatest value lies in enabling better decisions, agility, and resilience across manufacturing operations. 

One of the most significant opportunities is in creating more predictive and proactive operations. By combining AI, advanced analytics and realtime manufacturing data, organisations can anticipate potential issues before they occur, whether that is equipment reliability, process variability or supply risks. The value extends beyond cost savings to improving quality, reliability and speed of execution. 

Another important area is end-to-end visibility across the value chain. Manufacturing does not operate in isolation, and the ability to connect demand signals, production planning, inventory, procurement and logistics enables faster, more informed decision-making. 

Technology also has the potential to accelerate innovation. Digital tools can improve process understanding, support smoother technology transfers and help bring new products to patients more efficiently. At the same time, particularly in a highly regulated industry like pharmaceuticals, technology adoption must be accompanied by strong governance, data integrity, transparency, clear accountability and appropriate human oversight. Ultimately, we do not get paid for technology itself; we get paid for the positive impact it helps us create for customers and patients. 

You have managed large, multi-country operations. What is the biggest shift you see coming in pharma manufacturing in the way companies invest, operate or compete? 

The biggest shift is that pharmaceutical manufacturing is moving from a scale-driven model to a capability-driven one. As products become more complex, supply chains more interconnected, and regulatory expectations more demanding, competitive advantage will increasingly depend on an organisation’s ability to combine scientific expertise, operational excellence, innovation and quality at scale. 

Technology, automation and AI will undoubtedly reshape how companies operate, but technology alone does not create value. The real differentiator will be an organisation’s ability to translate these tools into better quality, greater agility, stronger resilience and improved outcomes for patients. In that sense, the industry is moving from an era of manufacturing efficiency to one of manufacturing intelligence. 

India is uniquely positioned in this regard, with a deep pool of young, highly talented scientific, technical and engineering professionals. At Lupin, we believe strategy and capability building must go hand in hand. As we expand our focus on complex products, advanced manufacturing and digital technologies, we are equally committed to investing heavily in our talent pipeline, developing future-ready skills and building the leadership capabilities required for long-term growth. This requires one connected operating model in which strategy, capability building and execution reinforce one another. Sustainable performance is created when teams take shared ownership across functions and geographies, rather than optimising individual parts of the organisation in isolation. 

In line with that vision, Lupin’s FY26 investments included capacity enhancement and debottlenecking, infrastructure modernisation, technology upgrades, automation and process efficiency. These investments are not simply about adding capacity; they are about strengthening capability, improving utilisation, enhancing supply reliability and supporting sustainable long-term performance. 

Looking at India from both a local and global perspective, what is the one capability the industry must build now if it wants to remain a leading pharma manufacturing hub? 

The one capability India must continue to build is the ability to combine manufacturing excellence with innovation. India’s opportunity lies not just in manufacturing medicines efficiently, but in becoming a partner of choice for complex products. 

Innovation does not always mean inventing entirely new technologies. It is also about finding smarter ways to apply technology, science and data to solve complex challenges more effectively. As products, processes and supply chains become more sophisticated, the companies and countries that succeed will be those that can manage an important paradox: delivering greater complexity, quality and resilience while remaining competitive and affordable. 

That requires an ecosystem, not a single intervention: investment in technology, process science, digital systems, regulatory capability, infrastructure and people, alongside stronger collaboration between industry, technology providers, academia, regulators and specialised talent. 

References: 

https://static.pib.gov.in/WriteReadData/specificdocs/documents/2026/mar/doc2026321831401.pdf https://www.ibef.org/exports/ph armaceutical-exports-fromindia 

lakshmipriya.nair@expressindia.com

laxmipriyanair@gmail.com

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India has traditionally been seen as a strong talent pool for the global pharmaceutical industry. What needs to change for India to become a stronger global hub for healthcare R&D and innovation? 

Today, India is well established as a major global talent and capability hub. The number of global pharma and healthcare GCCs operating here, and the growing complexity of the work they bring, reflect that well. We are no longer contributing scale alone. We are increasingly contributing to the science, the thinking and the decisions that shape global healthcare R&D. 

What needs attention now is depth. Two things can make a real difference. First, institutions such as the NIPERs must be strengthened as true centres of excellence, so that more advanced work in biologics, translational science and data-driven research finds a stronger home here within our ecosystem. Second, initiatives such as the Biopharma SHAKTI mission need sustained followthrough, because capability in specialised emerging science is built over years, not through one cycle of investment. 

Alongside this, addressing supply chain dependencies, particularly around critical APIs, will be important for India to hold a more central role in global R&D. The foundation is in place. What matters now is consistent follow-through. 

As pharmaceutical R&D becomes more complex and technology-driven, what new skills will the next generation of R&D professionals need? 

Science is changing faster than any curriculum can keep up. Deep scientific grounding in biologics, genomics and translational research remains nonnegotiable, but it must now be complemented by fluency in computational biology, AIenabled analytics and digital tools that can compress timelines and improve probability of success. 

This is not an either-or shift. Tomorrow’s breakthroughs will come from scientists who are comfortable with interpreting data and algorithms, and equally strong in understanding the science. They also need to collaborate across borders as the normal way of working. R&D today is continuous, not sequential. For example – Our teams here work on the same datasets and participate in the same decision-making forums as global counterparts. That requires confidence beyond execution: the ability to shape thinking, challenge assumptions and own outcomes.

What role should universities play in preparing students for areas such as clinical research, pharmacovigilance, regulatory affairs, data science and other emerging R&D functions? 

Universities no doubt play a foundational role, but they need to move beyond teaching concepts alone and also teach context. A student can understand pharmacovigilance in theory, but real exposure shows how a safety signal is evaluated, documented and acted upon. That kind of applied understanding is difficult to build entirely within a classroom, which is why closer industry engagement is so important. 

What universities can do well is build the foundation: strong scientific fundamentals, analytical thinking, and curiosity that stays sharp even as functions evolve. Where they truly add value is by inviting industry in early, through curricula that reflect real R&D functions, faculty who stay connected to practice, and structured collaborations that let students engage with live problems, not simulated ones. 

The strongest outcomes happen when academia and industry design that exposure together. 

How can stronger industry–academia partnerships help bridge this gap and make students more industry-ready? 

Industry academia collaboration provides the students an opportunity to interact with and learn from seasoned professionals solving real R&D problems, in various R&D functions such as pharmacovigilance, medical writing, regulatory affairs, scientific communication etc. That shift changes how a student thinks, not just what they know. 

This is why we have built Catalyst with a growing network of academic partners, including prestigious institutions such JSS Academy of Higher Education & Research (AHER), Dayananda Sagar University, Manipal Academy of Higher Education (MAHE), NITTE and NMIMS Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management (SPPSPTM). 

The idea is simple: keep academic rigor intact but give students a chance to apply what they are learning against real industry expectations early enough that the gap between classroom and career starts to reduce.

Done well, these partnerships do not just prepare students for interviews. They prepare them to contribute from day one. Through Catalyst, we have already seen this play out: some of the students trained through the programme have gone on to join us and are doing exceptionally well. 

Merck has partnered with eight academic institutions and launched the Catalyst programme in few of them. What are the learnings from these collaborations about the skills and expectations of today’s students? 

Working with academic institutions through Catalyst has taught us a few important things about today’s students. What stands out first is scientific curiosity, and a genuine eagerness to work on problems that carry real world impact, not just theoretical ones. 

What’s equally clear is that students are looking beyond technical knowledge. They want to build skills like problem-solving, collaboration, adaptability, and communication capabilities that matter as much as domain expertise in today’s innovation environment. 

We have also seen that students respond best to experiences that are interactive and industry connected. Direct engagement with practitioners helps them understand not only possible career pathways, but also what the workplace actually expects from them in terms of problem-solving, collaboration, accountability and communication. 

If there’s one thing these collaborations have reinforced, it’s this: academia-industry partnerships don’t just build skills, they build readiness and confidence for the professional roles ahead. 

Beyond employability, can academia–industry collaboration help strengthen India’s overall innovation capacity? If so, what would a successful model look like? 

Yes, and this is where the real potential lies. Employability is often the visible outcome, but the deeper value of these partnerships is in building research culture, curiosity, and problem solving ability that extends beyond any single job outcome. 

A successful model is one where industry does not just guest lecture but co-designs the learning experience around real R&D problems. 

When this becomes consistent, not episodic, universities start producing not just job-ready graduates, but young professionals who can think originally. That, over time, is what strengthens a country’s innovation capacity.

Looking ahead, what should industry, academia and policymakers do together to ensure that India has the talent needed for the next phase of pharmaceutical and healthcare R&D? 

We are no longer dealing with talent availability alone; the bigger issue now is coordination. The pieces already exist: policy frameworks like Biopharma SHAKTI, institutions like the NIPERs, and industry programmes building earlycareer pipelines. What is missing is better alignment between them. In my experience, real progress happens when good ideas are connected into one system, instead of being left to work in separate lanes. 

Policymakers need to treat talent infrastructure with the same urgency as R&D infrastructure. Academia needs to treat curriculum renewal as a continuous process, tied directly to where science and technology are moving. Industry needs to move from occasional engagement to sustained ownership of talent pipelines, not only at the point of recruitment, but much earlier in the learning journey. 

The real shift happens when these three stakeholders stop working in parallel and start working to a shared timeline. We already have strong initiatives in place. What we need now is that they move together, with discipline, coordination and urgency.

If we get this right, the impact will not be limited to any one organisation or institution. It will show up in the quality of science we produce, in the confidence with which young researchers step into complex roles, and in how the world begins to see our ecosystem: not just as a place where healthcare R&D happens, but as a place where it is shaped. 

swati.rana@expressindia.com 

Swatirana.express@gmail.com

The post Why industry-academia collaboration will shape India’s next R&D chapter appeared first on Express Pharma.

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Panelists:

Chris Nieder

Senior Director and Head of Technical Development
SK pharmteco

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Panelist

Chris Nieder

Christopher Nieder is senior director and head of technical development at SK pharmteco, where he has spent more than five years supporting the development and scale-up of advanced therapies. He leads Technical Development across upstream, downstream, drug product, and analytical development and has supported a broad range of AAV, LVV, adenovirus, and HSV vector programs. Chris brings almost 20 years of industry experience spanning process development, scale-up, tech transfer, and GMP manufacturing.

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To move viral vector programs from early research toward the clinic, sponsors have to generate the right material and data during development. Non-GMP production of adeno-associated virus (AAV), lentiviral, and adenoviral vectors can support applications ranging from R&D and animal studies to assay development, toxicology planning, and early manufacturability assessments. But to be successful, sponsors have to align production scale, analytical testing, documentation, and material use with the specific questions their studies aim to answer.

In this GEN webinar, Chris Nieder, an expert in viral vector programs, will examine how strategically designed preclinical manufacturing campaigns provide a practical foundation for GMP production. He will discuss topics such as how to select from among shake flasks, development-scale bioreactors, and pilot-scale approaches; and how to use early process and analytical data to identify yield and scalability challenges. Attendees will also learn how early CDMO engagement can clarify manufacturing scope, timelines, costs, and GMP-readiness without compromising expectations for non-GMP material. Key takeaways from the webinar include:

• How early-stage sponsors can use non-GMP AAV, lentiviral, and adenoviral production to support R&D, animal studies, toxicology planning, assay development, and manufacturability assessment
• How process and analytical data generated before GMP can reduce duplicated prep work, lower technical risk, and streamline later scope definition
• When shake flasks, development-scale bioreactors, or pilot-scale production can provide the most useful insight for the next development step
• How to align material use, analytical testing, documentation, and expectations without over-positioning preclinical material as clinical-grade supply

A live Q&A session will follow the presentation offering you a chance to pose questions to our expert panelist.

Produced with support from:

The post How Preclinical Manufacturing Can De-Risk the Path to GMP-Ready Viral Vector Programs appeared first on GEN - Genetic Engineering and Biotechnology News.

The Era of Modality Convergence: Why Drug Development Is Being Rewritten

The life sciences industry is entering a new era, defined not by a single breakthrough technology but by the convergence of many. Artificial intelligence is accelerating drug discovery, cell and gene therapies are expanding treatment possibilities, and antibody engineering continues to evolve beyond traditional monoclonal antibodies. Meanwhile, mRNA platforms, viral vectors, antibody-drug conjugates (ADCs), multispecific antibodies, and other advanced therapeutic modalities are transforming how developers approach previously intractable diseases. Taken individually, each of these innovations represents a significant advancement. Together, they are reshaping the drug development landscape.

For decades, therapeutic development followed a familiar path: identify a target, optimize a lead candidate, advance through preclinical studies, and move into clinical evaluation. While the science was challenging, the overall framework remained relatively consistent. Today, that framework is evolving rapidly. Developers are no longer limited to choosing between small molecules and conventional biologics. Instead, they have access to a growing toolkit of therapeutic technologies, each with unique advantages, manufacturing requirements, analytical challenges, and regulatory considerations. At the same time, advances in computational biology and AI-driven discovery are generating more candidates than ever before.

As a result, the challenge is no longer simply finding promising molecules. Increasingly, success depends on identifying candidates that can be manufactured, scaled, and translated into viable therapies. Decisions once reserved for later stages, including developability, manufacturability, analytical characterization, and clinical strategy, must now be addressed much earlier in the process. Drug development is becoming a continuous, interconnected journey rather than a series of separate steps.

The boundaries between traditional disciplines are also beginning to blur. Cell therapies may incorporate viral vectors. Gene therapies may leverage lipid nanoparticles. Antibody programs may evolve into multispecific or conjugated formats. The future of drug development is not defined by any single modality, but by the ability to integrate technologies effectively.

Organizations that combine discovery expertise, modality-specific knowledge, CMC capabilities, and manufacturing execution will be best positioned to navigate this increasingly complex environment. The articles that follow examine key trends driving this transformation, from AI-enabled discovery and experimental validation to advanced cell, gene, and biologic platforms, and explore how the next generation of therapies will move from concept to clinic.

The post From Discovery to Development appeared first on GEN - Genetic Engineering and Biotechnology News.

The team from the Science study was led by co-senior authors Jay Shendure, PhD, professor of genome sciences at the University of Washington School of Medicine and a Howard Hughes Medical Institute investigator, and Chengxiang Qiu, PhD, a molecular and systems biologist at Dartmouth College. Their approach centered on DNA Typewriter, a lineage-tracing technology developed by Shendure and Junhong Choi, PhD, that uses a cell’s DNA as a recording medium.

The researchers redesigned the system’s recording “tape” to make its history easier to recover from individual cells, then inserted it into the genome of a fertilized mouse egg. As cells divided, “a burst of editing unequivocally marks the daughters of the first cleavage, which serve as inline replicates,” the authors wrote in the Science paper. Because daughter cells inherited the marks already written before acquiring new ones, shared patterns revealed common ancestry and the order of developmental branching.

“Most biological measurements are based on either live imaging, which is limited by the fact that most animal tissues are not transparent, or genomics, which are destructive and only measure a single timepoint,” Shendure said. “Recording techniques like the ones in these studies enable measurements over time including in settings that we can’t directly visualize.”

The experiment was attempted in 100 fertilized eggs and yielded 10 embryos for examination. One embryo carried the most informative record, allowing the team to trace nearly every profiled cell back to one of the first two cells formed after the fertilized egg divided. Although one founding cell produced more descendants, the two branches generated diverse cell types in nearly equal proportions.

The ordered recording also allowed the researchers to estimate when cell types diverged from shared developmental paths. Blood and retinal cells committed relatively early, whereas cells forming the skin’s outer layer committed later. The results indicate that cell identity is not fixed in a single coordinated step; instead, different lineages become restricted on distinct schedules.

Earlier lineage-tracing approaches often relied on DNA-cutting enzymes that could damage cells, erase previous records, exhaust recording capacity, or leave unordered marks whose chronology had to be inferred. “DNA Typewriter avoids all of this,” said co-first author Haedong Kim, PhD, a postdoctoral scientist in genome sciences at UW Medicine. “It writes without fully severing the DNA, keeps recording relatively steadily, and writes everything in strict order, so we can record cell lineages at much higher resolution for a longer time.”

In the Cell paper, Jonathan Weissman, PhD, and colleagues used a prime-editing system called PEtracer to map lineage dynamics across more than 1.4 million cells from 16 mouse embryos. Together with the DNA Typewriter study in Science, the work demonstrates that mammalian cellular family trees can be reconstructed at unprecedented scale. “It’s really proof of principle that we can do what was done with the roundworm in 1983, but for mammals like you and me,” Weissman said.

The work provides a framework for investigating how normal organs form and where development can go awry. More complete lineage records could help researchers study congenital malformations, neurodevelopmental and genetic disorders, and cancer, as well as guide stem cell engineering. As Shendure explained, “Recording techniques like the ones in these studies enable measurements over time including in settings that we can’t directly visualize.” Scaling the methods across additional embryos and experimental conditions could support more quantitative—and eventually predictive—models of mammalian development.

The post DNA Typewriter, PEtracer Map Mouse Development Through Organogenesis appeared first on GEN - Genetic Engineering and Biotechnology News.

Rising prescription drug costs are creating difficult choices for patients, clinicians, employers, and health care systems. At the same time, breakthrough therapies and other health care innovations are expanding treatment possibilities — raising urgent questions about how to improve access while keeping care affordable and sustainable.

In this Permanente Live fireside chat, Stephen Parodi, MD, executive vice president at The Permanente Federation and The Permanente Medical Group, speaks with national health care leaders Peter J. Neumann, ScD, director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, and Maisha Draves, MD, MPH, associate executive director of The Permanente Medical Group.

Watch the webinar or read the transcript for insights on:

• Balancing access to life-changing medications with the need to manage rising costs
• The growth of GLP-1 therapies, the promise of biosimilars, and the growing role of artificial intelligence
• Evaluating value of pharmaceuticals through clinical outcomes, safety, patient experience, and total cost of care
• Using deprescribing and coordinated care to improve outcomes and reduce unnecessary spending

Transcript

Transcript is autogenerated. Although edited for clarity, it should not be considered an exact replication of the webinar and may also be updated as needed.

Stephen Parodi, MD: Hello, and thank you for joining Permanente Live. I’m Dr. Steve Parodi, an executive vice president with The Permanente Federation, and we’re here to talk about “A tough pill to swallow — Balancing access and affordability in pharmacy.” Now, if there is one word that captures the concerns of Americans today, it is affordability. Health care and prescription drugs in particular is central to that concern. We have more pharmaceutical treatments at our disposal than ever before, but many come with tremendous price tags. In fact, the Bureau of Labor Statistics recently reported that drug prices have risen three times as fast as overall inflation since the 1980s. On average, medications account for 11% of individual patients’ health care spending, and about 21% of health care costs born by employer-based insurance. Now, there are many reasons for these trends, including the cost of drug discovery, clinical trials, regulatory approval, and bringing those medications to market.

Pharmacy benefit managers and other middlemen may provide efficiencies, but also introduce complexities. Pricing arrangements seem to defy traditional supply-demand economics. The U.S. is one of two countries in the world that allows influence through direct to consumer marketing. On top of that, patent laws, generic drug manufacturing, and emerging biosimilars complicate the picture. Biologics bring these affordability challenges into sharp focus. Made from living cells, these products have transformed treatment for cancer and rare diseases, but can cost $30,000 a month or even more. Biosimilars have no clinically meaningful differences from approved biologics and offer the promise of expanding access to these therapies, and yet the United States still lags behind other countries in adoption. That gives us a lot to dig into today. Where the public policy and where can we actually address these costs? What can the U.S. health care system do to achieve responsible pharmaceutical use and spending?

What roles do health systems and pharmaceutical companies have to address this situation? And most importantly, how can physicians ensure that prescribing decisions are driven by clinical need and not by what patients or insurers can afford? To address these important questions, I am joined by two experts today. Peter Neumann directs the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center and is a professor of medicine at Tufts University School of Medicine. His work focuses on the use of clinical and economic evidence to inform decisions about value, cost, coverage, and reimbursement of health care treatments. He’s authored hundreds of papers and three books on the value in medicine, including The Price is Right: A Value-Based Prescription for Drug Costs. Thank you, Peter, for joining us today. We’re also joined by Dr. Maisha Draves, who is an associate executive director at The Permanente Medical Group and a practicing family medicine physician, literally a few doors down from me.

She leads work across the clinical quality, health outcomes, and economic value, including pharmacy, behavioral health, addiction medicine, resource utilization, and pain management. Again, thank you both for joining me. So Peter, I’m going to go ahead and kick it off with you. You’ve spent a career measuring value of pharmaceutical drugs and whether they’re “worth it.” How would you define value and worth? When is a drug effective when in fact we’re facing some of the biggest barriers when it comes to price, budget, and the scale of need?

Peter J. Neumann, ScD: Well, first of all, thank you very much, Dr. Parodi, for inviting me and for holding this webinar. We do measure the effectiveness and cost-effectiveness of drugs. There are methods that are used in conventional analyses. There are debates about some of those methods and certainly questions about appropriate endpoints and timeframes and the perspective of the analysis. But that said, we do have ways of measuring benefit. Value to your question is the benefits produced for the resources required. What are we getting for what we’re spending? And that’s a very important question to ask, not only about pharmaceuticals, but for about medicine in general. And these studies are being done and they can be used to inform decisions by health insurers, by clinicians. We do want to get the best value for our money, and that means measuring value and disseminating that information.

SP: Dr. Draves, I’m going to ask you a similar question here, which is from a health system perspective or even as a physician leader, how do you look at that from a value-based perspective, right? I mean, there’s the short-term benefits, long-term benefits. Some of these medications, you don’t see the actual — from a clinical care delivery perspective — return for many years, especially with some of the newer agents that are on the market. So I’m curious, has that changed over the last several years, decades that we’ve been practicing?

Maisha Draves, MD, MPH: Thank you for that question, and also thank you for allowing me to join you today. When you think about it from a system or from a physician point of view, you think about the individual patient, and then you also think about either your whole panel or the whole population. And really whether or not a medication works is just a starting point. That’s the initial value of the medicine is we’re going to use it for treating of X condition and does it actually work? But there are also a lot of other considerations in its value. How safe is it? What are some of the risks? And also some of the long-term benefits. A lot of studies are done showing benefit at year one and year two. But to your point, sometimes we care about year five and year 10. And can the patient stay on the treatment for that long?

They’re switching insurances sometimes depending on where they’re employed. The cost of the medication may dictate how long they can afford to stay on it and the side effects, how long they can tolerate it. Really, it’s a lot about their quality of life, how well the drug performs on what it’s supposed to, the safety issues, and then the total cost of that care. I think as a system, it also is really important that we keep reevaluating the medication when it gets expanded uses, when longer term evidence does become available, and when other treatments come on the market. So the answer is really about the access to medications that are effective and safe and that are going to make really clinically meaningful differences in a patient’s lives and their health outcomes, and then really thinking through that value in terms of affordability, not just the one time you pick up the medicine, but over that full cost of care.

SP: Thank you both. And for the audience here, if you have a question for our speakers, please submit it through the chat, through the webinar. We’ll be selecting those questions and definitely working them into the Q&A portion when we get done with some of the questions. I’ve got so many for both of you, but I’m going to hold my fire because we want to make sure we get to the audience’s questions too. So Dr. Draves, sort of pivoting on this, there’s a big set of medications that have hit the market just recently. They’re really transforming clinical care as well as pushing the boundaries when it comes to scale and pharmaceuticals. So of course we can’t have this conversation without talking about GLP-1s. And so I think there’s general agreement that GLP-1s do have clinical effectiveness, still studying at scale for what that looks like. And from the standpoint of tolerability, also a number of open questions, but we’re talking about a huge share of the population that potentially could benefit from the use of GLP-1s, and yet employers are excluding them from their plans and insurers have excluded them from formularies and out-of-pocket costs have been shifted to people, whether they’re consumers and/or patients, however you want to characterize that.
And interestingly, Medicare is kind of a first mover here. So CMS has cited to statutorily launch a pilot program around this. So what do you think this all speaks to in terms of pharmaceutical costs, efficacy, safety of these drugs, scalability of the drugs? And Maisha, what do you think we’re going to do with all of this?

MD: Thank you for that question. No day goes by without talking about a GLP-1 either with a patient or as we’re trying to solve real problems and access in the full system, so thank you. One, I want to say thank you for GLP-1s. It has opened the conversation up that obesity is a condition that our health care system can and should address with our patients. And for our patients, there are therapies that can be effective and it’s de-stigmatizing talking about it. So as a family physician, I’ll just say that being able to talk about and address obesity both with an individual patient in my exam room as well as in a population or across the system is a new conversation that’s now only a couple of years old, and yet obesity has been here for a very, very long time. Also, GLP-1s are in a milieu of treatment options.

We have to remember that even if you’re taking the medication, you must follow good nutrition. You have to still get protein and fiber and water in there. Otherwise, there are the safety issues that must be dealt with and considered about muscle loss and frailty or falls and hip breaks. You have to think about the other medications that there are to offer. And for some people, surgery may still be the right option. Sometimes a GLP-1 with a surgery may be the right option. Really what this comes down to is the science in GLP-1s have almost moved faster than our ability as a system to figure out the fair and affordable way to get these to patients who need it. There’s the coverage that looks at the evidence of the care, the price, the payment, and the ability to support the treatment, nutrition, exercise, and they’re all still aligning while we’re really going through a huge experiment when you think of the bridge program of putting it out there in a very wide population and seeing how it performs.

The evidence really wasn’t based on patients over 65. Some of the treatment indications are much more expansive than what may have been studied. So really through this Bridge system with Medicare, we’re going to be learning how does it perform in the older population? How does it perform with other types of medical conditions? Making it more important as doctors and as a health care system to have the right wraparound support. Is this the right drug for the patient? Is it going to give the right benefit? What are the safety risks? What is the monitoring program around it for that patient? And how do we still support proper nutrition and exercise? That way you get the best value out of the medication and the strongest chance of having a meaningful benefit. And in the meantime, the system is really catching up with how to navigate paperwork, how to navigate payment.

What we’re dealing with now is less about which patient is going to receive the medicine, but what channel? Is it through their employer? Is it through a government payer? Is it through a direct consumer? And where and how as clinicians are we there to support the patient no matter where they’re getting the medicine from? Because it still has to clinically produce a good outcome. It still has to be safe and they still need nutrition and exercise support.

SP: That’s incredible, right? I mean, the comprehensive nature of what these pharmaceuticals could achieve and the need that needs to wrap around it. So thank you for framing that. Peter, I am curious, as Dr. Draves sort of referenced here, I mean, we are embarking on a natural history experiment nationally with these particular drugs. And I’m curious from an economics perspective, I mean, what should we be studying here? Because that kind of has gotten lost if you want my opinion. We haven’t really actually overtly said we need to look at this. So from your perspective, what should we be doing?

PN: First of all, Dr. Draves made many good points, but let me add a little bit on the economics of these therapies. So in addition to being effective in the way she described, the studies have shown they’re cost-effective, at least in many eligible and adherent populations. There’s the promise of cost offsets, cost savings even, avoiding long-term complications, which are costly, avoiding hospitalizations. There’s the prospect that these drugs not only are effective, but in the long term, they can offset cost and save money. In addition, the prices of these drugs have been coming down over the years pretty rapidly with competition. Generic drugs in these classes are coming, not soon enough, I know for many people, but they are going to be coming over the years. Medicare has already negotiated for Medicare beneficiaries the price of semaglutide. New drugs are coming, which presumably will be better than the existing drugs for these indications.

All of that I think is part of the good news story here. Now, clearly there are short-term severe budget issues, and we’re seeing the kinds of restrictions that you mentioned at the outset. So what do we do? Part of it is a government response. Dr. Draves has mentioned the Bridge program, which Medicare has launched, which has a $50 copay for Medicare beneficiaries and has had pretty good uptake so far. There may need to be other responses by government bodies and private payers. Price volume caps, for example, are talked about. There could be some more creative financing mechanisms. The other thing we should say, and the economists often emphasize, if we have new therapies or for that matter, new procedures or other interventions that are good value, we should look really carefully at the medical system for things that are lower value or not good value or even sometimes harmful or wasteful and displace those kinds of things even as we add new interventions like the GLP-1s that are good value.

SP: Peter, it’s interesting where you went with your comments because if you look at it with the GLP-1 story, I’ll call it, there was an initial price point. And do you think that what combination actually drove this in terms of the prices coming down? Because there’s a supply-demand issue and then there’s clearly there was in some form, although not price controls, there was a government intervention. So I’m curious. It’s

PN: Likely a combination of real competition. We had two companies with products. We had injectables, now we have orals. There’s, again, the promise of new therapies coming. So there is this debate about whether to what degree competition works in health care and in pharmaceutical markets in particular. And it does seem like competition works in many cases, though not all. We don’t see a lot of competition, for example, traditionally in oncology or in cancer drugs and rare disease drugs. We do see it in some of the more crowded therapeutic classes. We do see it when there’s genuine substitutions and alternatives, and I think that’s been part of the story of the GLP-1s. Now, clearly there’s also been government intervention. The government has stepped in and negotiated lower prices for Medicare. I mentioned semaglutide, that’s part of the Inflation Reduction Act, Medicare drug price negotiations. The Bridge program is separate from that.

That’s another way the government has stepped in and said, “We need to make these drugs available.” So that’s not just competition, that’s the combination of competition and the government coming in. And that’s probably what we need in that scenario and in other drug classes where we want patients to have these worthy medications.

SP: Dr. Draves, can I ask you a hard question? Let me ask you a hard question. So I’m going to riff off of what Peter was just talking about, and I actually happen to prescribe some drugs that are kind of old and are orphaned and used to be cheap and are now expensive because there isn’t any competition, and actually there’s no incentive to create a new competitor. And I know that you and your role have had to wrestle with that over the years. So I’m curious, so there’s some solutions for some particular products that maybe make sense, and then there’s some where because of patents or because of other issues where they’re orphaned, you don’t have those same options that we were just talking about with the GLP-1s.

MD: I think what’s really important here is where we get into trouble is when the transparency of pricing is not very clear, when we don’t have competition, and so prices can go up even if the cost of goods to make that drug is not that high. And then the other is really through the supply chain itself. You have the manufacturer that sets initial price and has the cost of goods understanding to make the medication. But then as you go into the PBMs, the warehousing, the health care system, the pharmacies, along that whole chain, each player has to be incented to provide the right high quality care and at affordable and reasonable prices for, at the end, the patient themselves, both in their premiums, their copays, their cost shares, the health care system itself, the payers, the employers, and the providers to be able to provide that medication.

Right now we have a system that is pretty opaque. We have a system where how a price of a drug is set is very opaque, and we can often end up with a lack of competition in the pharmacy industry. And so I think the trifecta is always when we can have the transparency in price setting, the transparency across the whole chain that eventually gets a medication to a patient, maintaining competition even with orphan drugs, and then finding affordable solutions. And then at the patient and the provider level, it’s a lot of shared decision making, really making sure you’re giving the right treatment. It’s the right care at the right time for the right patient.

SP: Peter, I want to keep this competition theme alive for just a second here and talk to you a little bit about biosimilars. What do you think needs to change when it comes to the U.S. and how would we or what would foster more widespread adoption of biosimilars?

PN: So we have seen biosimilar uptake in the U.S. over the past years, decade. It has not been as strong as in Europe, that’s clear. There are concerns that going forward, there are lots of biologics that may not attract biosimilar competition. We have complicated molecules and small populations and we may not see it. We’ll see. So I think we’ve had a real mixed story in biosimilars in the U.S. As far as what we can do better, I think two things I would highlight. One, interchangeability. They seem to do a better job at that in Europe. Interchangeability laws I think still impede biosimilar uptake in the U.S., that’s one. The other is incentives in the system. A big theme I think of any discussion of, well, health care generally, but pharmaceuticals in particular, there are still incentives in many cases to use higher price drugs. There may be higher rebates and higher prices for that reason.
We do have reimbursement rules that lead some physicians to reimburse or to prescribe rather higher cost drugs because reimbursement is higher. So I think we have to look at incentives like that.

SP: Peter, I want to also touch on Dr. Draves’ comments about transparency and ask you a question about PBMs. And you know that at the federal level, there’s been a number of actions, even actual bipartisan support for reducing the cost of middlemen with PBM legislation and attempting to directly contract with manufacturers or systems. So I’m curious what you think about that. Is that getting at some of the root of the problem? Is there more that needs to be done?

PN: I think the answer to those questions are yes, it’s getting at some of the root of the problem and there’s more to be done. So the PBMs negotiate prices, they manage formularies, they process claims, they do some good things. There have been concerns and problems. One is transparency as was mentioned. It’s been hard to really know how the money flows. That’s been a bit of an opaque kind of black box in many cases. Secondly, the incentive issues, this idea that you’re better off with higher list prices because your rebates are higher has led to concerns. And by the way, the list prices still are the things that drive the patient cost sharing, so it’s not clear where those rebates are really going inside the PBMs. The other issue has been an issue of market power and vertical integration. There are three large PBMs.

They’re buying up the pharmacies, they’re steering patients there. So how do we deal with those three problems? And the legislation began to get at this more transparency about where the money’s flowing, ending some of the rebating practices, at least starting to do that. It did not go as far as ending some of the ownership agreements or antitrust kinds of solutions that some people have advanced. I think it’s an area where we need more competition as well, and this is something that the employers need to be aware of, and maybe it’s something for the regulators to be looking much more closely at.

SP: I see some really good questions coming in, so keep them coming. Dr. Draves, I’m going to ask you a question that gets at the heart of us as prescribers. So where do you think de-prescribing actually fits into the conversation? Obviously we want to provide high quality care, but is there also questions of affordability, access, and safety that are folded into that?

MD: I think it’s important every time you see a patient to check up their meds. What list of meds does the patient think they’re taking? What list do we have? Are they the same? I think it’s about the biggest thing we do in a health care system is give a patient a medication to help them with their health conditions, and they go home and they have to manage that on their own every day of the week. So really important to get that list right. Within that, really, you hit it right. Is the medication providing the benefit that it should? Is it safe? Is the patient having side effects from it? Are those side effects tolerable? The other is are there duplicate medications that a patient should stop taking? The other is how many of the medications are actually to address a side effect of another medication?

And if you can pare down that list, does a patient actually just have a better quality of life? You also have to look at the drug interactions, and then just the treatment burden and confusion that can come with being on so many medications, which ones are in the morning, which are at night, which is with food, which is on an empty stomach, which one I can’t have hot water with, can be pretty complex. It may lower the cost overall for that individual patient and as a system, but really the benefit is around making sure that they’re effective medications, they’re safe, and that the full quality of life of the patient is being maintained. Definitely, we should review that and consider de-prescribing when a harmful event happens, when a patient is hospitalized, goes to the ER, even during routine visits. The biggest therapeutic tool we have, a medication list, is as appropriate as it can be.
And again, it changes over a patient’s life depending on their life goals and depending on the severity of some of the conditions. So at the right time, it can be different answers for the same patient.

SP: I’m hearing a theme here, Dr. Draves, that when you’re thinking about pharmaceuticals, you can’t look at it in isolation. I mean, it really is a comprehensive total patient approach and care, and what you’re getting at is not just even the medical needs, there’s also the broader social health angles of care that need to be accounted for. Thank you so much for this conversation. I’m going to pivot us to some of the audience questions which are coming in fast and furious and I think are actually pretty interesting. So let me kick it off with the first one. And without naming names here, we’re familiar with some of the newer therapies that are out there that are potentially curative, but cost for a single episode of care or dose, somewhere between $2 million and $4 million.

And this really is pushing the boundaries of what anybody can actually afford. So whether you’re a large insurer, whether you’re an employer that’s self-insured or a health system, these costs based on the levels of population that might have these diseases that could be cured are cost prohibitive, to just be frank. And so the question that really comes up here is, do we need a new financing model to account for these multimillion dollar drugs? Do we need national risk pools? Is reinsurance a question? This is somebody who’s pretty sophisticated here. Are there multi-year payments? Is it amortized? All those sorts of questions are wrapped up in here. So I’m going to open that up to both of you. Maybe Peter, I’ll ask you to kick it off.

PN: All of the above I think is the short answer. These are obviously very, very expensive. They tend to be small populations, sometimes ultra orphan populations. So we’re not typically talking about a lot of patients with these $2-4 million drugs, but they clearly raise challenges. So I would say a few things. First of all, we should be measuring the not only effectiveness, but the cost effectiveness. Some of these drugs promise very strong lifelong health benefits. And when you consider those, the $2-4 million becomes a bit of a different conversation because we are, for many chronic therapies, paying quite a bit of money, tens of thousands or more sometimes every year. So the $2-4 million one-time therapies, sometimes it’s an empirical question, but sometimes look favorable by comparison or at least equal by comparison, not always, but that’s one that we should be measuring that and thinking about the value being delivered here.

But to the financing questions, even if that’s true that the cost effectiveness is reasonable by some measure, there are short-term budget realities. And so there we get into some of the alternative financing. And you mentioned a couple paying over time and installments, outcomes-based agreements where you stop paying if it’s not working, if that’s possible. And that raises a lot of measurement questions and clinical questions about appropriate endpoints and such. But there’s certainly work being done in those areas. Multi-state purchasing, federal oversight of Medicaid programs to pool the states together and negotiate on behalf of all the states. We’re seeing that. The federal government is negotiating sickle cell therapies, for example, right now. It’s just starting, but there could be models like that. Reinsurance, stop loss, government stepping in at some point. I think those are kinds of things we have to look at. And there may be more creative financing even beyond all of those options, but definitely we can’t rely on old ways of paying for things in light of some of these new therapies.

SP: I got a question for you, Dr. Draves, because I don’t disagree with what Peter was saying. On the other hand, we’re probably one of the few industries where we price things, or at least these are being priced based on what maybe traditional or standard therapy would’ve cost over a given lifetime, which may or may not be actually relevant to how much it costs to actually develop the drug or produce it. And so I’m curious your perspective on that. Does that make sense economically speaking?

MD: I think you bring up a really good nuance and there are a few components to it. The cost of a curative drug, if it’s priced to say the patient is cured to the point where they no longer need any other health care service over their entire lifetime, then wanting to ensure that that full cost of a cure is then attributed solely to that one portion of the treatment or drug in time. And I think you bring up a really important point. The patient, it may be a cure, but they may not return back to a baseline. We don’t know the durability of those cures. We have one-year, two-year, three-year, five-year studies. When you’re talking about a cure and never needing any other health care again for that disease, now look at the durability in year 10 and year 20. The other that needs to be taken into consideration are the multiple parts of the health care system that are still needed to deliver that one treatment.

So if you have to pay for the one drug itself of the full cost of care, then how do we account for the cost for the referrals, the cost for the pre-treatment workups, the cost for the centers of excellence, the hospitalization, the post-treatment ongoing monitoring, the side effects that can occur, the travel and the caregiver support that’s sometimes needed. Those are actually all part of the care, not just the cost of the single medication. And then again, really what we often see in the cures is it halts a condition or it can be fully curative and restore, but it doesn’t mean that the patient never needs health care again for that condition. And the treatments themselves can cause new side effects that now are a new set of care and utilization that that patient must undergo. So I think there are some flaws in thinking that a curative treatment should be equal to the full cost of all care that that patient may need because they still do need a lot of care across the health system pre, post, and long durability.

SP: Peter, I’ve got AI questions coming in fast, so I’m going to ask one of them, not all of them. And the one that’s sort of interesting here is you’re probably familiar with the Utah example where they are now allowing autonomous AIs to refill medications for patients if they’re “deemed to be stable.” I’m curious, from an economic perspective, what do you think that the potential is there? Is that going to help control costs? Could that actually blow up costs if things are just renewed without necessarily review or what?

PN: So like all things AI, there’s a lot of uncertainty here about where this will go and what its impact will be. And I have listened to debates on both sides of this, and I think you can make arguments on both sides. There are really compelling reasons to believe AI will bring efficiencies and lower costs in some cases, reducing administrative costs, making it easier to get diagnoses quickly and accurately, and avoiding some of the costs of the diagnostic odyssey that would otherwise occur on and on. Billing, quality control, all kinds of things that go on now with a lot of labor costs and inefficiencies could be done in theory with AI and save a lot of money for the system. And we know that the U.S. has many flaws in its health care system, one of which is very high administrative costs compared to other countries say.

On the other hand, you can think of ways that AI might increase costs, help hospitals up code. You could think of ways to identify real comorbidities and symptoms that people have which might not otherwise have been recognized. There’s a lot of unmet need in the system and AI might help drive more people to more care. There’s all kinds of telehealth that might become possible and that could just raise costs for people who would otherwise have gone without care. And that’s just scratching the surface of some of these impacts. It could help the hospitals up code, it could help the insurance companies guard against those kinds of things. So how this will play out, I think really is not very clear. There is a kind of cynical view that nothing new in health care saves money, even though it seems like it should.
I don’t know that good quality control often saves certain money, but drives costs elsewhere and those kinds of things. So I think we’re going to have to wait and see, but certainly that’s not the only part of this. If AI can help improve health and improve outcomes, that’s really the important question alongside the cost question.

SP: Thank you, Peter. Dr. Draves, I’m going to throw you the last question here, which is you work in a health system, you’re familiar with an internal pharmacy system as well. What role do those types of systems, whether it’s this system that you work in or other large integrated models, have to play in making pharmaceuticals more affordable and what system changes could be made to make them better?

MD: I’d say in a system where you’re integrated and the full health care team — payer, provider, inpatient, outpatient, pharmacy, lab, radiology — are all under one roof, there’s really just a lot of opportunity. It means that from every angle we can sit at the table together to make good decisions. Since we’re talking about medications, I’ll talk about formulary. When we look at formulary and we choose medications that’ll be our first line or second line or preferred therapy, formulary, non-formulary, the physicians and the pharmacists are sitting together reviewing the clinical evidence. It’s non-biased. We do our own academic detailing and we review really the methodology, the results of any drug. We make decisions together about which medication is going to be the right medication for our formulary as well as in practice recommendations, first line, second line, third line. That insurance that those practicing, those pharmacists that are practicing, those physicians that are practicing and in that specialty are making those decisions, looking at it from a quality point of view, a safety point of view, an access point of view, and an affordability point of view really ensures a lot of trust in the system, a lot of trust in the decision making, and both a responsibility and an accountability to then to adhere to those decisions that we’ve made together.

That drives market, that drives volume, and then people understand that that can bring prices to something that’s more affordable when we are negotiating through contracts. Then we monitor our own performance and we have conversations again about how we are adhering to our own recommendations without prior authorization, but really through a shared trust, responsibility, accountability for, like I said, the quality, the safety, the access, and the affordability to really good care for patients. So I think when you have a system like that that’s rowing together from all of those angles and you’re making decisions together, you own your decisions and then it’s easier to adhere to your decisions rather than a third party or someone else making and enforcing a decision upon you that you may never have really agreed to. So I think the system can drive high-quality care and can drive affordability through that shared decision-making process.

SP: Well, thank you so much, and I want to thank the Permanente Live audience for joining us today. We have definitely covered a lot of ground today. And one theme that stands out is that medications, while they can deliver, their greatest value only comes when the people who need them can access them. And addressing affordability will require more than just one single policy and one single program. It’s going to take evidence, incentives, responsible prescribing, and collaboration across health care, government, and industry. Peter and Maisha, thank you so much for bringing your expertise, your perspective to this important conversation. Thank you to everyone who joined us, and we hope today’s discussion gives you new ways to think about how we can protect access, improve value, and keep patients’ needs at the center of our decisions when it comes to pharmaceuticals. Thank you and have a great day.

The post Can we afford the cure? Exploring drug costs, access, and outcomes appeared first on Permanente Medicine.

Rising prescription drug costs are creating difficult choices for patients, clinicians, employers, and health care systems. At the same time, breakthrough therapies and other health care innovations are expanding treatment possibilities — raising urgent questions about how to improve access while keeping care affordable and sustainable.

In this Permanente Live fireside chat, Stephen Parodi, MD, executive vice president at The Permanente Federation and The Permanente Medical Group, speaks with national health care leaders Peter J. Neumann, ScD, director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, and Maisha Draves, MD, MPH, associate executive director of The Permanente Medical Group.

Watch the webinar or read the transcript for insights on:

• Balancing access to life-changing medications with the need to manage rising costs
• The growth of GLP-1 therapies, the promise of biosimilars, and the growing role of artificial intelligence
• Evaluating value of pharmaceuticals through clinical outcomes, safety, patient experience, and total cost of care
• Using deprescribing and coordinated care to improve outcomes and reduce unnecessary spending

Transcript

Transcript is autogenerated. Although edited for clarity, it should not be considered an exact replication of the webinar and may also be updated as needed.

Stephen Parodi, MD: Hello, and thank you for joining Permanente Live. I’m Dr. Steve Parodi, an executive vice president with The Permanente Federation, and we’re here to talk about “A tough pill to swallow — Balancing access and affordability in pharmacy.” Now, if there is one word that captures the concerns of Americans today, it is affordability. Health care and prescription drugs in particular is central to that concern. We have more pharmaceutical treatments at our disposal than ever before, but many come with tremendous price tags. In fact, the Bureau of Labor Statistics recently reported that drug prices have risen three times as fast as overall inflation since the 1980s. On average, medications account for 11% of individual patients’ health care spending, and about 21% of health care costs born by employer-based insurance. Now, there are many reasons for these trends, including the cost of drug discovery, clinical trials, regulatory approval, and bringing those medications to market.

Pharmacy benefit managers and other middlemen may provide efficiencies, but also introduce complexities. Pricing arrangements seem to defy traditional supply-demand economics. The U.S. is one of two countries in the world that allows influence through direct to consumer marketing. On top of that, patent laws, generic drug manufacturing, and emerging biosimilars complicate the picture. Biologics bring these affordability challenges into sharp focus. Made from living cells, these products have transformed treatment for cancer and rare diseases, but can cost $30,000 a month or even more. Biosimilars have no clinically meaningful differences from approved biologics and offer the promise of expanding access to these therapies, and yet the United States still lags behind other countries in adoption. That gives us a lot to dig into today. Where the public policy and where can we actually address these costs? What can the U.S. health care system do to achieve responsible pharmaceutical use and spending?

What roles do health systems and pharmaceutical companies have to address this situation? And most importantly, how can physicians ensure that prescribing decisions are driven by clinical need and not by what patients or insurers can afford? To address these important questions, I am joined by two experts today. Peter Neumann directs the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center and is a professor of medicine at Tufts University School of Medicine. His work focuses on the use of clinical and economic evidence to inform decisions about value, cost, coverage, and reimbursement of health care treatments. He’s authored hundreds of papers and three books on the value in medicine, including The Price is Right: A Value-Based Prescription for Drug Costs. Thank you, Peter, for joining us today. We’re also joined by Dr. Maisha Draves, who is an associate executive director at The Permanente Medical Group and a practicing family medicine physician, literally a few doors down from me.

She leads work across the clinical quality, health outcomes, and economic value, including pharmacy, behavioral health, addiction medicine, resource utilization, and pain management. Again, thank you both for joining me. So Peter, I’m going to go ahead and kick it off with you. You’ve spent a career measuring value of pharmaceutical drugs and whether they’re “worth it.” How would you define value and worth? When is a drug effective when in fact we’re facing some of the biggest barriers when it comes to price, budget, and the scale of need?

Peter J. Neumann, ScD: Well, first of all, thank you very much, Dr. Parodi, for inviting me and for holding this webinar. We do measure the effectiveness and cost-effectiveness of drugs. There are methods that are used in conventional analyses. There are debates about some of those methods and certainly questions about appropriate endpoints and timeframes and the perspective of the analysis. But that said, we do have ways of measuring benefit. Value to your question is the benefits produced for the resources required. What are we getting for what we’re spending? And that’s a very important question to ask, not only about pharmaceuticals, but for about medicine in general. And these studies are being done and they can be used to inform decisions by health insurers, by clinicians. We do want to get the best value for our money, and that means measuring value and disseminating that information.

SP: Dr. Draves, I’m going to ask you a similar question here, which is from a health system perspective or even as a physician leader, how do you look at that from a value-based perspective, right? I mean, there’s the short-term benefits, long-term benefits. Some of these medications, you don’t see the actual — from a clinical care delivery perspective — return for many years, especially with some of the newer agents that are on the market. So I’m curious, has that changed over the last several years, decades that we’ve been practicing?

Maisha Draves, MD, MPH: Thank you for that question, and also thank you for allowing me to join you today. When you think about it from a system or from a physician point of view, you think about the individual patient, and then you also think about either your whole panel or the whole population. And really whether or not a medication works is just a starting point. That’s the initial value of the medicine is we’re going to use it for treating of X condition and does it actually work? But there are also a lot of other considerations in its value. How safe is it? What are some of the risks? And also some of the long-term benefits. A lot of studies are done showing benefit at year one and year two. But to your point, sometimes we care about year five and year 10. And can the patient stay on the treatment for that long?

They’re switching insurances sometimes depending on where they’re employed. The cost of the medication may dictate how long they can afford to stay on it and the side effects, how long they can tolerate it. Really, it’s a lot about their quality of life, how well the drug performs on what it’s supposed to, the safety issues, and then the total cost of that care. I think as a system, it also is really important that we keep reevaluating the medication when it gets expanded uses, when longer term evidence does become available, and when other treatments come on the market. So the answer is really about the access to medications that are effective and safe and that are going to make really clinically meaningful differences in a patient’s lives and their health outcomes, and then really thinking through that value in terms of affordability, not just the one time you pick up the medicine, but over that full cost of care.

SP: Thank you both. And for the audience here, if you have a question for our speakers, please submit it through the chat, through the webinar. We’ll be selecting those questions and definitely working them into the Q&A portion when we get done with some of the questions. I’ve got so many for both of you, but I’m going to hold my fire because we want to make sure we get to the audience’s questions too. So Dr. Draves, sort of pivoting on this, there’s a big set of medications that have hit the market just recently. They’re really transforming clinical care as well as pushing the boundaries when it comes to scale and pharmaceuticals. So of course we can’t have this conversation without talking about GLP-1s. And so I think there’s general agreement that GLP-1s do have clinical effectiveness, still studying at scale for what that looks like. And from the standpoint of tolerability, also a number of open questions, but we’re talking about a huge share of the population that potentially could benefit from the use of GLP-1s, and yet employers are excluding them from their plans and insurers have excluded them from formularies and out-of-pocket costs have been shifted to people, whether they’re consumers and/or patients, however you want to characterize that.
And interestingly, Medicare is kind of a first mover here. So CMS has cited to statutorily launch a pilot program around this. So what do you think this all speaks to in terms of pharmaceutical costs, efficacy, safety of these drugs, scalability of the drugs? And Maisha, what do you think we’re going to do with all of this?

MD: Thank you for that question. No day goes by without talking about a GLP-1 either with a patient or as we’re trying to solve real problems and access in the full system, so thank you. One, I want to say thank you for GLP-1s. It has opened the conversation up that obesity is a condition that our health care system can and should address with our patients. And for our patients, there are therapies that can be effective and it’s de-stigmatizing talking about it. So as a family physician, I’ll just say that being able to talk about and address obesity both with an individual patient in my exam room as well as in a population or across the system is a new conversation that’s now only a couple of years old, and yet obesity has been here for a very, very long time. Also, GLP-1s are in a milieu of treatment options.

We have to remember that even if you’re taking the medication, you must follow good nutrition. You have to still get protein and fiber and water in there. Otherwise, there are the safety issues that must be dealt with and considered about muscle loss and frailty or falls and hip breaks. You have to think about the other medications that there are to offer. And for some people, surgery may still be the right option. Sometimes a GLP-1 with a surgery may be the right option. Really what this comes down to is the science in GLP-1s have almost moved faster than our ability as a system to figure out the fair and affordable way to get these to patients who need it. There’s the coverage that looks at the evidence of the care, the price, the payment, and the ability to support the treatment, nutrition, exercise, and they’re all still aligning while we’re really going through a huge experiment when you think of the bridge program of putting it out there in a very wide population and seeing how it performs.

The evidence really wasn’t based on patients over 65. Some of the treatment indications are much more expansive than what may have been studied. So really through this Bridge system with Medicare, we’re going to be learning how does it perform in the older population? How does it perform with other types of medical conditions? Making it more important as doctors and as a health care system to have the right wraparound support. Is this the right drug for the patient? Is it going to give the right benefit? What are the safety risks? What is the monitoring program around it for that patient? And how do we still support proper nutrition and exercise? That way you get the best value out of the medication and the strongest chance of having a meaningful benefit. And in the meantime, the system is really catching up with how to navigate paperwork, how to navigate payment.

What we’re dealing with now is less about which patient is going to receive the medicine, but what channel? Is it through their employer? Is it through a government payer? Is it through a direct consumer? And where and how as clinicians are we there to support the patient no matter where they’re getting the medicine from? Because it still has to clinically produce a good outcome. It still has to be safe and they still need nutrition and exercise support.

SP: That’s incredible, right? I mean, the comprehensive nature of what these pharmaceuticals could achieve and the need that needs to wrap around it. So thank you for framing that. Peter, I am curious, as Dr. Draves sort of referenced here, I mean, we are embarking on a natural history experiment nationally with these particular drugs. And I’m curious from an economics perspective, I mean, what should we be studying here? Because that kind of has gotten lost if you want my opinion. We haven’t really actually overtly said we need to look at this. So from your perspective, what should we be doing?

PN: First of all, Dr. Draves made many good points, but let me add a little bit on the economics of these therapies. So in addition to being effective in the way she described, the studies have shown they’re cost-effective, at least in many eligible and adherent populations. There’s the promise of cost offsets, cost savings even, avoiding long-term complications, which are costly, avoiding hospitalizations. There’s the prospect that these drugs not only are effective, but in the long term, they can offset cost and save money. In addition, the prices of these drugs have been coming down over the years pretty rapidly with competition. Generic drugs in these classes are coming, not soon enough, I know for many people, but they are going to be coming over the years. Medicare has already negotiated for Medicare beneficiaries the price of semaglutide. New drugs are coming, which presumably will be better than the existing drugs for these indications.

All of that I think is part of the good news story here. Now, clearly there are short-term severe budget issues, and we’re seeing the kinds of restrictions that you mentioned at the outset. So what do we do? Part of it is a government response. Dr. Draves has mentioned the Bridge program, which Medicare has launched, which has a $50 copay for Medicare beneficiaries and has had pretty good uptake so far. There may need to be other responses by government bodies and private payers. Price volume caps, for example, are talked about. There could be some more creative financing mechanisms. The other thing we should say, and the economists often emphasize, if we have new therapies or for that matter, new procedures or other interventions that are good value, we should look really carefully at the medical system for things that are lower value or not good value or even sometimes harmful or wasteful and displace those kinds of things even as we add new interventions like the GLP-1s that are good value.

SP: Peter, it’s interesting where you went with your comments because if you look at it with the GLP-1 story, I’ll call it, there was an initial price point. And do you think that what combination actually drove this in terms of the prices coming down? Because there’s a supply-demand issue and then there’s clearly there was in some form, although not price controls, there was a government intervention. So I’m curious. It’s

PN: Likely a combination of real competition. We had two companies with products. We had injectables, now we have orals. There’s, again, the promise of new therapies coming. So there is this debate about whether to what degree competition works in health care and in pharmaceutical markets in particular. And it does seem like competition works in many cases, though not all. We don’t see a lot of competition, for example, traditionally in oncology or in cancer drugs and rare disease drugs. We do see it in some of the more crowded therapeutic classes. We do see it when there’s genuine substitutions and alternatives, and I think that’s been part of the story of the GLP-1s. Now, clearly there’s also been government intervention. The government has stepped in and negotiated lower prices for Medicare. I mentioned semaglutide, that’s part of the Inflation Reduction Act, Medicare drug price negotiations. The Bridge program is separate from that.

That’s another way the government has stepped in and said, “We need to make these drugs available.” So that’s not just competition, that’s the combination of competition and the government coming in. And that’s probably what we need in that scenario and in other drug classes where we want patients to have these worthy medications.

SP: Dr. Draves, can I ask you a hard question? Let me ask you a hard question. So I’m going to riff off of what Peter was just talking about, and I actually happen to prescribe some drugs that are kind of old and are orphaned and used to be cheap and are now expensive because there isn’t any competition, and actually there’s no incentive to create a new competitor. And I know that you and your role have had to wrestle with that over the years. So I’m curious, so there’s some solutions for some particular products that maybe make sense, and then there’s some where because of patents or because of other issues where they’re orphaned, you don’t have those same options that we were just talking about with the GLP-1s.

MD: I think what’s really important here is where we get into trouble is when the transparency of pricing is not very clear, when we don’t have competition, and so prices can go up even if the cost of goods to make that drug is not that high. And then the other is really through the supply chain itself. You have the manufacturer that sets initial price and has the cost of goods understanding to make the medication. But then as you go into the PBMs, the warehousing, the health care system, the pharmacies, along that whole chain, each player has to be incented to provide the right high quality care and at affordable and reasonable prices for, at the end, the patient themselves, both in their premiums, their copays, their cost shares, the health care system itself, the payers, the employers, and the providers to be able to provide that medication.

Right now we have a system that is pretty opaque. We have a system where how a price of a drug is set is very opaque, and we can often end up with a lack of competition in the pharmacy industry. And so I think the trifecta is always when we can have the transparency in price setting, the transparency across the whole chain that eventually gets a medication to a patient, maintaining competition even with orphan drugs, and then finding affordable solutions. And then at the patient and the provider level, it’s a lot of shared decision making, really making sure you’re giving the right treatment. It’s the right care at the right time for the right patient.

SP: Peter, I want to keep this competition theme alive for just a second here and talk to you a little bit about biosimilars. What do you think needs to change when it comes to the U.S. and how would we or what would foster more widespread adoption of biosimilars?

PN: So we have seen biosimilar uptake in the U.S. over the past years, decade. It has not been as strong as in Europe, that’s clear. There are concerns that going forward, there are lots of biologics that may not attract biosimilar competition. We have complicated molecules and small populations and we may not see it. We’ll see. So I think we’ve had a real mixed story in biosimilars in the U.S. As far as what we can do better, I think two things I would highlight. One, interchangeability. They seem to do a better job at that in Europe. Interchangeability laws I think still impede biosimilar uptake in the U.S., that’s one. The other is incentives in the system. A big theme I think of any discussion of, well, health care generally, but pharmaceuticals in particular, there are still incentives in many cases to use higher price drugs. There may be higher rebates and higher prices for that reason.
We do have reimbursement rules that lead some physicians to reimburse or to prescribe rather higher cost drugs because reimbursement is higher. So I think we have to look at incentives like that.

SP: Peter, I want to also touch on Dr. Draves’ comments about transparency and ask you a question about PBMs. And you know that at the federal level, there’s been a number of actions, even actual bipartisan support for reducing the cost of middlemen with PBM legislation and attempting to directly contract with manufacturers or systems. So I’m curious what you think about that. Is that getting at some of the root of the problem? Is there more that needs to be done?

PN: I think the answer to those questions are yes, it’s getting at some of the root of the problem and there’s more to be done. So the PBMs negotiate prices, they manage formularies, they process claims, they do some good things. There have been concerns and problems. One is transparency as was mentioned. It’s been hard to really know how the money flows. That’s been a bit of an opaque kind of black box in many cases. Secondly, the incentive issues, this idea that you’re better off with higher list prices because your rebates are higher has led to concerns. And by the way, the list prices still are the things that drive the patient cost sharing, so it’s not clear where those rebates are really going inside the PBMs. The other issue has been an issue of market power and vertical integration. There are three large PBMs.

They’re buying up the pharmacies, they’re steering patients there. So how do we deal with those three problems? And the legislation began to get at this more transparency about where the money’s flowing, ending some of the rebating practices, at least starting to do that. It did not go as far as ending some of the ownership agreements or antitrust kinds of solutions that some people have advanced. I think it’s an area where we need more competition as well, and this is something that the employers need to be aware of, and maybe it’s something for the regulators to be looking much more closely at.

SP: I see some really good questions coming in, so keep them coming. Dr. Draves, I’m going to ask you a question that gets at the heart of us as prescribers. So where do you think de-prescribing actually fits into the conversation? Obviously we want to provide high quality care, but is there also questions of affordability, access, and safety that are folded into that?

MD: I think it’s important every time you see a patient to check up their meds. What list of meds does the patient think they’re taking? What list do we have? Are they the same? I think it’s about the biggest thing we do in a health care system is give a patient a medication to help them with their health conditions, and they go home and they have to manage that on their own every day of the week. So really important to get that list right. Within that, really, you hit it right. Is the medication providing the benefit that it should? Is it safe? Is the patient having side effects from it? Are those side effects tolerable? The other is are there duplicate medications that a patient should stop taking? The other is how many of the medications are actually to address a side effect of another medication?

And if you can pare down that list, does a patient actually just have a better quality of life? You also have to look at the drug interactions, and then just the treatment burden and confusion that can come with being on so many medications, which ones are in the morning, which are at night, which is with food, which is on an empty stomach, which one I can’t have hot water with, can be pretty complex. It may lower the cost overall for that individual patient and as a system, but really the benefit is around making sure that they’re effective medications, they’re safe, and that the full quality of life of the patient is being maintained. Definitely, we should review that and consider de-prescribing when a harmful event happens, when a patient is hospitalized, goes to the ER, even during routine visits. The biggest therapeutic tool we have, a medication list, is as appropriate as it can be.
And again, it changes over a patient’s life depending on their life goals and depending on the severity of some of the conditions. So at the right time, it can be different answers for the same patient.

SP: I’m hearing a theme here, Dr. Draves, that when you’re thinking about pharmaceuticals, you can’t look at it in isolation. I mean, it really is a comprehensive total patient approach and care, and what you’re getting at is not just even the medical needs, there’s also the broader social health angles of care that need to be accounted for. Thank you so much for this conversation. I’m going to pivot us to some of the audience questions which are coming in fast and furious and I think are actually pretty interesting. So let me kick it off with the first one. And without naming names here, we’re familiar with some of the newer therapies that are out there that are potentially curative, but cost for a single episode of care or dose, somewhere between $2 million and $4 million.

And this really is pushing the boundaries of what anybody can actually afford. So whether you’re a large insurer, whether you’re an employer that’s self-insured or a health system, these costs based on the levels of population that might have these diseases that could be cured are cost prohibitive, to just be frank. And so the question that really comes up here is, do we need a new financing model to account for these multimillion dollar drugs? Do we need national risk pools? Is reinsurance a question? This is somebody who’s pretty sophisticated here. Are there multi-year payments? Is it amortized? All those sorts of questions are wrapped up in here. So I’m going to open that up to both of you. Maybe Peter, I’ll ask you to kick it off.

PN: All of the above I think is the short answer. These are obviously very, very expensive. They tend to be small populations, sometimes ultra orphan populations. So we’re not typically talking about a lot of patients with these $2-4 million drugs, but they clearly raise challenges. So I would say a few things. First of all, we should be measuring the not only effectiveness, but the cost effectiveness. Some of these drugs promise very strong lifelong health benefits. And when you consider those, the $2-4 million becomes a bit of a different conversation because we are, for many chronic therapies, paying quite a bit of money, tens of thousands or more sometimes every year. So the $2-4 million one-time therapies, sometimes it’s an empirical question, but sometimes look favorable by comparison or at least equal by comparison, not always, but that’s one that we should be measuring that and thinking about the value being delivered here.

But to the financing questions, even if that’s true that the cost effectiveness is reasonable by some measure, there are short-term budget realities. And so there we get into some of the alternative financing. And you mentioned a couple paying over time and installments, outcomes-based agreements where you stop paying if it’s not working, if that’s possible. And that raises a lot of measurement questions and clinical questions about appropriate endpoints and such. But there’s certainly work being done in those areas. Multi-state purchasing, federal oversight of Medicaid programs to pool the states together and negotiate on behalf of all the states. We’re seeing that. The federal government is negotiating sickle cell therapies, for example, right now. It’s just starting, but there could be models like that. Reinsurance, stop loss, government stepping in at some point. I think those are kinds of things we have to look at. And there may be more creative financing even beyond all of those options, but definitely we can’t rely on old ways of paying for things in light of some of these new therapies.

SP: I got a question for you, Dr. Draves, because I don’t disagree with what Peter was saying. On the other hand, we’re probably one of the few industries where we price things, or at least these are being priced based on what maybe traditional or standard therapy would’ve cost over a given lifetime, which may or may not be actually relevant to how much it costs to actually develop the drug or produce it. And so I’m curious your perspective on that. Does that make sense economically speaking?

MD: I think you bring up a really good nuance and there are a few components to it. The cost of a curative drug, if it’s priced to say the patient is cured to the point where they no longer need any other health care service over their entire lifetime, then wanting to ensure that that full cost of a cure is then attributed solely to that one portion of the treatment or drug in time. And I think you bring up a really important point. The patient, it may be a cure, but they may not return back to a baseline. We don’t know the durability of those cures. We have one-year, two-year, three-year, five-year studies. When you’re talking about a cure and never needing any other health care again for that disease, now look at the durability in year 10 and year 20. The other that needs to be taken into consideration are the multiple parts of the health care system that are still needed to deliver that one treatment.

So if you have to pay for the one drug itself of the full cost of care, then how do we account for the cost for the referrals, the cost for the pre-treatment workups, the cost for the centers of excellence, the hospitalization, the post-treatment ongoing monitoring, the side effects that can occur, the travel and the caregiver support that’s sometimes needed. Those are actually all part of the care, not just the cost of the single medication. And then again, really what we often see in the cures is it halts a condition or it can be fully curative and restore, but it doesn’t mean that the patient never needs health care again for that condition. And the treatments themselves can cause new side effects that now are a new set of care and utilization that that patient must undergo. So I think there are some flaws in thinking that a curative treatment should be equal to the full cost of all care that that patient may need because they still do need a lot of care across the health system pre, post, and long durability.

SP: Peter, I’ve got AI questions coming in fast, so I’m going to ask one of them, not all of them. And the one that’s sort of interesting here is you’re probably familiar with the Utah example where they are now allowing autonomous AIs to refill medications for patients if they’re “deemed to be stable.” I’m curious, from an economic perspective, what do you think that the potential is there? Is that going to help control costs? Could that actually blow up costs if things are just renewed without necessarily review or what?

PN: So like all things AI, there’s a lot of uncertainty here about where this will go and what its impact will be. And I have listened to debates on both sides of this, and I think you can make arguments on both sides. There are really compelling reasons to believe AI will bring efficiencies and lower costs in some cases, reducing administrative costs, making it easier to get diagnoses quickly and accurately, and avoiding some of the costs of the diagnostic odyssey that would otherwise occur on and on. Billing, quality control, all kinds of things that go on now with a lot of labor costs and inefficiencies could be done in theory with AI and save a lot of money for the system. And we know that the U.S. has many flaws in its health care system, one of which is very high administrative costs compared to other countries say.

On the other hand, you can think of ways that AI might increase costs, help hospitals up code. You could think of ways to identify real comorbidities and symptoms that people have which might not otherwise have been recognized. There’s a lot of unmet need in the system and AI might help drive more people to more care. There’s all kinds of telehealth that might become possible and that could just raise costs for people who would otherwise have gone without care. And that’s just scratching the surface of some of these impacts. It could help the hospitals up code, it could help the insurance companies guard against those kinds of things. So how this will play out, I think really is not very clear. There is a kind of cynical view that nothing new in health care saves money, even though it seems like it should.
I don’t know that good quality control often saves certain money, but drives costs elsewhere and those kinds of things. So I think we’re going to have to wait and see, but certainly that’s not the only part of this. If AI can help improve health and improve outcomes, that’s really the important question alongside the cost question.

SP: Thank you, Peter. Dr. Draves, I’m going to throw you the last question here, which is you work in a health system, you’re familiar with an internal pharmacy system as well. What role do those types of systems, whether it’s this system that you work in or other large integrated models, have to play in making pharmaceuticals more affordable and what system changes could be made to make them better?

MD: I’d say in a system where you’re integrated and the full health care team — payer, provider, inpatient, outpatient, pharmacy, lab, radiology — are all under one roof, there’s really just a lot of opportunity. It means that from every angle we can sit at the table together to make good decisions. Since we’re talking about medications, I’ll talk about formulary. When we look at formulary and we choose medications that’ll be our first line or second line or preferred therapy, formulary, non-formulary, the physicians and the pharmacists are sitting together reviewing the clinical evidence. It’s non-biased. We do our own academic detailing and we review really the methodology, the results of any drug. We make decisions together about which medication is going to be the right medication for our formulary as well as in practice recommendations, first line, second line, third line. That insurance that those practicing, those pharmacists that are practicing, those physicians that are practicing and in that specialty are making those decisions, looking at it from a quality point of view, a safety point of view, an access point of view, and an affordability point of view really ensures a lot of trust in the system, a lot of trust in the decision making, and both a responsibility and an accountability to then to adhere to those decisions that we’ve made together.

That drives market, that drives volume, and then people understand that that can bring prices to something that’s more affordable when we are negotiating through contracts. Then we monitor our own performance and we have conversations again about how we are adhering to our own recommendations without prior authorization, but really through a shared trust, responsibility, accountability for, like I said, the quality, the safety, the access, and the affordability to really good care for patients. So I think when you have a system like that that’s rowing together from all of those angles and you’re making decisions together, you own your decisions and then it’s easier to adhere to your decisions rather than a third party or someone else making and enforcing a decision upon you that you may never have really agreed to. So I think the system can drive high-quality care and can drive affordability through that shared decision-making process.

SP: Well, thank you so much, and I want to thank the Permanente Live audience for joining us today. We have definitely covered a lot of ground today. And one theme that stands out is that medications, while they can deliver, their greatest value only comes when the people who need them can access them. And addressing affordability will require more than just one single policy and one single program. It’s going to take evidence, incentives, responsible prescribing, and collaboration across health care, government, and industry. Peter and Maisha, thank you so much for bringing your expertise, your perspective to this important conversation. Thank you to everyone who joined us, and we hope today’s discussion gives you new ways to think about how we can protect access, improve value, and keep patients’ needs at the center of our decisions when it comes to pharmaceuticals. Thank you and have a great day.

The post Can we afford the cure? Exploring drug costs, access and outcomes appeared first on Permanente Medicine.

• Phelps Health and McCarthy Building Companies marked completion of the emergency department addition’s steel framework Sept. 22 in Rolla, Mo. 
• The department will nearly double the size of the existing emergency department, with 32 treatment beds, observation rooms, larger behavioral health spaces and on-site imaging. 
• The project includes 40,000 square feet of shell space for future needs. Concrete slabs and facade work are next.  

ROLLA, Mo. — Construction of Phelps Health’s expanded emergency department advanced Sept. 22 as McCarthy Building Companies placed the project’s final structural beam, completing the steel framework for the addition and renovation. 

Planned at 38,000 square feet, the $60 million project will nearly double the size of the existing emergency department. The expansion will have 32 treatment beds, observation rooms and larger spaces for behavioral health care. Alongside the additional treatment space, the department will add on-site imaging services, including CT, radiology and ultrasound. 

For longer-term needs, the construction scope includes another 40,000 square feet of shell space. Phelps Health will be able to customize that area in the future as the needs of patients and staff change. 

At the ceremony, Phelps Health leaders discussed both the community’s investment in the project and the growing regional need for emergency services. The Rolla campus, located in the Ozark Highlands, is described in McCarthy’s release as the largest rural-serving hospital in south-central Missouri. 

“There is a real need for these new services in Rolla, and McCarthy is here to help build a facility with greater capacity and resources that fulfill the region’s healthcare needs,” said Tim Kehr, McCarthy’s Senior Project Manager. 

The gathering included Phelps Health employees, McCarthy leaders and project personnel, subcontractors and members of the community. In addition to marking the structural milestone, the event recognized McCarthy’s steel team’s work, which involved erecting about 616 tons of steel in less than three months. Concrete slabs and the building facade are the next focus for construction crews.

Hospital staff, patients and local residents had an opportunity to sign the final beam while it was displayed in the main lobby before the ceremony. Their signatures accompanied an American flag and an evergreen tree on the beam. McCarthy described the event as a continuation of community involvement dating to the project’s September 2025 groundbreaking. 

This article is based on a press release from McCarthy Building Companies, dated Sept. 25, 2026.  

The post Phelps Health Emergency Department Expansion Tops Out in Missouri appeared first on HCO News.

The post Phelps Health Emergency Department Expansion Tops Out in Missouri appeared first on HCO News.

Aliza Apple, PhD

Vice President
Catalyze360 AI/ML, Eli Lilly

View Bio

Panelist

Aliza Apple, PhD

Aliza Apple, PhD, is a vice president of Catalyze360 AI/ML at Eli Lilly, where she leads the strategy, build and launch of Lilly’s external-facing AI/ML efforts for drug discovery. She previously served as the COO and head of Lilly Gateway Labs West Coast, where she supported the local biotech ecosystem through early engagement and providing tailored offerings to meet their needs. Prior to Lilly, Aliza served as a co-founder at Santa Ana Bio, a venture-backed precision biologics company focused on autoimmune disease, and as an advisor to the founders of Firefly Biologics. Prior to biotech, Aliza was a partner in McKinsey’s life sciences practice. During her nine years at McKinsey in New York and San Francisco, she collaborated with leaders from more than 20 biopharma companies to develop their corporate and portfolio strategies, evaluate business development opportunities, and improve their organizational effectiveness.

Aliza completed her PhD in bioengineering at UC Berkeley and UCSF and holds a BS in physics from Georgetown University. She completed a postdoctoral fellowship at Cornell Medical College, supported by the NIH Kirschstein National Research Service Award.

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Sam Rodriques, PhD

Co-Founder, Director, and CEO
Edison Scientific and FutureHouse

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Panelist

Sam Rodriques, PhD

Physicist and bioengineer Sam Rodriques, PhD, is the co-founder, director, and CEO of Edison Scientific and FutureHouse. Sam has invented technologies for spatial and temporal transcriptomics, brain mapping, gene therapy, and nanofabrication, and briefly ran an academic lab at the Francis Crick Institute in London prior to launching FutureHouse in San Francisco in 2023. FutureHouse is a new research lab focused on building an AI Scientist to accelerate research in biology and other complex sciences. In 2025, Sam launched Edison Scientific to commercialize the agents being built at FutureHouse, with the goal of wanting “science to move faster.”

Sam graduated summa cum laude with highest honors in physics from Haverford College, where he worked on new methods for calculating quantum entanglement in multipartite quantum systems. He holds a PhD in physics from MIT, having worked between the MIT Media Lab, the MIT Department of Brain and Cognitive Sciences, and the Broad Institute. Among his awards and fellowships are the Hertz Foundation Graduate Fellowship, an NSF Graduate Research Fellowship, and a Churchill Scholarship.

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Peyton Greenside, PhD

Co-Founder and CEO
BigHat Biosciences

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Panelist

Peyton Greenside, PhD

Peyton Greenside, PhD, is the co-founder and CEO of BigHat Biosciences, a Bay Area biotechnology company pioneering an ML-driven platform to accelerate the design of next-generation antibodies and other therapeutic proteins.

Peyton holds a BA in applied mathematics from Harvard University, a PhD from Stanford University, and an MPhil in computational biology from the University of Cambridge, U.K.

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Marc Tessier-Lavigne, PhD

Co-Founder, Chairman, and CEO
Xaira Therapeutics

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Panelist

Marc Tessier-Lavigne, PhD

Marc Tessier-Lavigne, PhD, is the co-founder, chairman, and CEO of Xaira Therapeutics. Previously, he held executive positions in the private sector at Genentech, where he was executive vice president for research and chief scientific officer, and in the academic sector, where he served as president of The Rockefeller University and then for seven years at Stanford University, where he remains a professor of biology (on leave). He also served previously on the faculty of the University of California, San Francisco, and was an investigator with the Howard Hughes Medical Institute. A Rhodes Scholar, Marc has been a leader in understanding mechanisms that direct the wiring of the brain and has helped elucidate mechanisms of neurodegeneration. He is the recipient of numerous scientific awards, including the 2020 Gruber Neuroscience Prize, and has been elected to multiple scientific societies, including the U.S. National Academy of Sciences and U.S. National Academy of Medicine; he is also an officer of the Order of Canada, one of that country’s highest honors. Marc is the co-founder of two neuroscience biotech companies, Renovis and Denali, and has served on the boards of Agios, Regeneron, Pfizer, Juno, and Denali.

Marc holds a BS degree in physics from McGill University in his native Canada. He earned a BA in philosophy and physiology from the University of Oxford as a Rhodes Scholar, and a PhD in physiology from the University of London.

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Broadcast Date: Tuesday, November 4, 2025

• Time: 08:00 PST, 11:00 EST, 16:00 GMT

From billion-dollar funding rounds and waves of IPOs to the first AI-guided molecules entering the clinic, the industry is signaling a clear inflection point: AI is set to fundamentally reshape drug discovery. At the center of this shift are maturing foundation models for molecules and cellular systems that unveil insights into complex biology.

Yet the challenge is no longer prediction alone. Building the infrastructure that connects accelerated computing, generative design, and experimental feedback will be critical for transforming AI into a fully integrated engine for therapeutic innovation.

GEN’s virtual summit, The State of AI in Drug Discovery, returns on November 4 to examine how AI is reshaping R&D timelines and real-world patient translation. From big pharma to AI-natives, this year’s program features the leaders of many of today’s outstanding companies and organizations powering the AI revolution, including Xaira Therapeutics, Edison Scientific, Eli Lilly, Chai Discovery, Lila Sciences, BigHat Biosciences, and more!

Among the program highlights during this 4-hour event are:

• Building the AI scientist with Sam Rodriques, PhD (Edison Scientific)  
• A fireside chat with Xaira Therapeutics CEO Marc Tessier-Lavigne, PhD 
• Powering AI adoption through strategic enterprise partnerships with Aliza Apple, PhD (Lilly TuneLab), Simon Barnett (Dimension), and Elliot Hershberg, PhD (Amplify Ventures)  
• The role of agentic workflows in accelerating drug discovery with Le Cong, PhD (Stanford and Phylo) and Andrew Beam, PhD (Lila Sciences) 
• The new era of programmable therapeutics with Josh Meier (Chai Discovery) and Peyton Greenside, PhD (BigHat Biosciences) 
• And breakout sessions from our four event sponsors: A-AlphaBio, Benchling, LabVantage, and Revvity Signals.

Don’t miss this exceptional virtual summit, featuring many of the visionaries shaping the future of AI in drug discovery and biotech. Registration, as always, is free.

Guest Speakers Include

Produced with support from:

The post The State of AI in Drug Discovery appeared first on GEN - Genetic Engineering and Biotechnology News.

Research professor Noah Snyder-Mackler, PhD, at Arizona State University School of Life Sciences, and colleagues developed an epigenetic clock that predicted mortality in dogs and showed that epigenetic aging is fastest early in life. The study results indicated that male dogs and larger dogs undergo accelerated molecular aging, with male dogs exhibiting pronounced DNA methylation (DNAm) changes on the X chromosome, and larger animals exhibiting methylation changes at transposable elements (TEs), stretches of DNA that can influence genome stability and gene regulation.

Snyder-Mackler is senior and corresponding author of the researchers’ published paper in Science (“Epigenetic aging and transposon dysregulation reflect size-related lifespan compression in dogs,”) in which they concluded, “Our findings broadly establish companion dogs as a translational model for uncovering molecular mechanisms of lifespan variation, epigenomic instability, and age-related disease.”

Aging is a universal process, but its pace and biological mechanisms substantially differ between individuals within even the same species, the authors wrote. “Whether shorter-lived individuals simply die earlier or instead experience accelerated biological aging throughout life remains unclear,” they noted. And while comparative studies across species have identified mechanisms associated with exceptional longevity, they may not be as well suited to identifying the molecular drivers of aging variation. “Domestic dogs provide a model for addressing this challenge because body size strongly predicts lifespan, with larger breeds living substantially shorter lives than smaller breeds despite sharing many physiological and environmental conditions,” the team continued.

In fact, smaller breeds can live nearly twice as long as larger breeds. And companion dogs live in human environments, consume commercial diets, and receive routine medical care, making them a relevant translational model for studying how genetic background and environmental exposures shape aging, the investigators pointed out.

But how intrinsic factors such as size and biological sex influence variation in dog aging and lifespan remains unclear. “It is well established that size and sex influence lifespan in dogs, but it remains unclear whether shorter-lived dogs experience accelerated epigenetic aging,” they stated. Previous research has demonstrated that DNAm is a useful indicator of biological aging, with “epigenetic clocks” offering a way to understand the factors that accelerate or decelerate biological aging. “DNA methylation (DNAm) has emerged as a robust molecular biomarker of age, with ‘epigenetic clocks’ offering a quantitative framework for identifying factors that accelerate or decelerate biological age.”

For their newly reported study Snyder-Mackler, together with first author Blaise Mariner, PhD, and colleagues generated 1,640 methylomes from a cohort of 894 dogs in the Dog Aging Project. They combined the molecular data with detailed genetic and demographic data. The results indicated that molecular aging occurs most rapidly early in a dog’s life. The study also found that larger and male dogs—both of which have shorter lifespans than their respective counterparts—age more quickly at the molecular level.

The authors identified different epigenetic patterns underlying these effects. According to the findings, sex-related changes were concentrated on the X chromosome, while body-size-related changes were especially prominent in TEs. “Thus, size and sex, two axes associated with shorter expected lifespan in dogs, appear to shape aging through partially distinct epigenetic architectures,” they stated. “Larger dogs show greater methylation loss at TEs with age, consistent with increased immune remodeling and genomic instability … These data address a major gap in comparative epigenomics by providing evidence that, within a species, demographic groups with shorter expected lifespans show faster epigenetic aging.”

The post Epigenetics Underlies Comparatively Accelerated Molecular Aging in Larger and Male Dogs appeared first on GEN - Genetic Engineering and Biotechnology News.

The teams have been tasked with pursuing new technologies that confer long-term, shelf-life stability to cell-based therapies and biologics making it possible to store and ship them without refrigeration. To accomplish this goal, BoSS teams will work across two technical areas. They will work on interventions to stabilize cells for storage and then reactivate them on demand as well as on creating novel processing systems that ensure these interventions are efficient and scalable for manufacturing. 

This week, members of the Reversible Ambient Temperature (RAB) team said that they have been awarded up to $7.3 million initially from ARPA-H. The RAB team includes representatives from Draper, a non-profit research, development, and manufacturing company, which serves as the administrative lead,and Likarda, a biotechnology company that develops hydrogel technologies for delivering and preserving cell therapies and biologics, which serves as the technical lead for the team. Other members of the team include scientists from CaseBioscience, CPSI Biotech, Fresenius Kabi, MiNK Therapeutics, and University of Colorado. 

For their part, this team will use AI-assisted design of experiments to optimize formulation, quiescence induction parameters, hydrogel composition, and recovery media as well as freeze-assisted droplet drying to achieve a stable product. Specifically, the RAB team’s biostabilization strategy, led by Likarda, will focus on simultaneous control of cell state, physical environment, and the cellular stress responses activated during freezing, dehydration, storage, and recovery. Meanwhile, the bioprocessing engineering team, led by Draper, will convert the manual steps of biostabilization into an automated, commercially viable workflow and will develop custom instruments to scale up the processes.

Likarda will contribute its proprietary Core-Shell Spherification hydrogel technology, which is designed to encapsulate and protect living cells while maintaining viability and function. CaseBioscience will provide expertise in clinical media formulation, biopreservation, and cellular metabolism to the development and evaluation of novel approaches for long-term ambient stabilization of therapeutic cells.

“The RAB team brings together deep expertise in cryoprotection, encapsulation, and cell state, with a focus on protecting cell viability throughout the stabilization and reanimation process, and the team has direct experience bringing products to market,” said Jason Fiering, distinguished technical staff at Draper. “Working in parallel, our interdisciplinary engineering team will develop the customized instruments needed to transfer these processes to clinical manufacturing environments.” 

In his comments, John Baust, PhD, an expert in biopreservation and collaborator on the project with CPSI Biotech noted that “the concept of preserving living cells in a dry state has been pursued for more than two decades, but significant scientific and engineering barriers have yielded limited success.” The BoSS program is an opportunity “to tackle this from multiple scientific and engineering directions simultaneously” that if successful “could represent a paradigm shift in how biologics are preserved, stored, and distributed.”

Other teams announced by ARPA-H include one led by DesiCorp. This team includes members from the University of Louisville, University of Texas at Austin, Via Therapeutics, VeriSIM Life, and Ossium Health. They will leverage high-throughput screening to identify biocompatible formulations that slow cellular metabolism and AI-assisted process optimization to develop a thin-film freeze-drying (TFFD) system that stabilizes cells at room temperature. 

DesiCorp will lead integration of the overall workflow by using a high-throughput screening platform to rapidly identify biocompatible formulations that enable cells to survive TFFD and resume function after rehydration. Meanwhile, UT Austin researchers will help optimize the TFFD critical process parameters and composition/material attributes, while also contributing expertise in aseptic processing and scaling up the technology. 

A third team is led by the University of California, Davis and includes scientists from Mayo Clinic, Case Western Reserve University, University of Georgia, and Sersense. The team will induce a low metabolic state in cells using light-responsive gels and microfluidic processing techniques to produce cells that are stable at room temperature. 

Recently, that team announced that it had been awarded up to $6 million, initially,  from ARPA-H to fund its project dubbed CYBORGEL. Their efforts will leverage research done in the laboratory of Cheemeng Tan, PhD, a professor of biomedical engineering at UC Davis. Previously, he and his collaborators formed water-rich polymer networks inside living cells to create cell-material hybrids. This process, called intracellular gelation, forms a gel inside the cell and is capable of halting cell division while preserving cellular function. Tan and his team dubbed this cellular product a “cyborg” since the gelation process combines living cells with synthetic materials. 

Through CYBORGEL, the collaborators will investigate whether this intracellular gelation process can be extended to reduce the cost and simplify the storage, transportation and delivery of cellular therapies. The researchers will also test whether CYBORGEL cells remain therapeutically useful after being returned to their original state. For instance, one study will test the effectiveness of reanimated CAR T cells for existing clinical trials on cancer immunotherapies. Another will test it on placental mesenchymal stem cells used to treat spina bifida, a medical intervention being developed by UC Davis researchers. 

As part of the initiative, the American Type Culture Collection (ATCC) has been tapped to serve as the IV&V partner. ATCC will provide working cell banks of government-selected cell types that will be used for demonstrations. They will also provide unbiased assessments of both the viability and function of the preserved products and the design features of the preservation systems.  

The first phase of the BoSS program kicked off in September and is expected to run for 15 months. Over the four-year multi-phase program, the teams’ approaches will be evaluated against increasingly stringent benchmarks for cell viability, production speed, and shelf-life stability. If successful, work under the BoSS program could enable lower costs for cell-based drugs, reduce the risk of therapeutic and pharmaceutical product losses, and enable domestic reserves for public health preparedness. 

The post ARPA-H’s BoSS Program Funds Three Teams Tackling Cold Chain Challenges for Cell Therapies appeared first on GEN - Genetic Engineering and Biotechnology News.

The General Dental Council’s (GDC) chair has warned that rising fitness to practise concerns are putting ‘substantial pressure’ on costs ahead of a decision on registration fees later this month.

Dr Helen Phillips reiterated that the annual retention fee (ARF) could be adjusted in 2027 and 2028, with any increase normally limited to the rate of the Consumer Price Index (CPI).

Fitness to practise concerns increased by 26% in 2025, from 1,401 to 1,766. The GDC reported a further 20% year-on-year increase between January and August 2026.

In a blog post, Phillips said the council was examining how operational improvements could limit the financial impact.

Future reserves forecast not explained

Phillips stressed that current reserves remained within the GDC’s target range and that there was no short-term pressure on its finances.

Her comments followed Dentistry’s report on the forecast published in September, which projected free reserves equivalent to 1.5 months of operating expenditure by the end of 2028, below the target range of between 2.5 and 4.5 months.

While Phillips said the updated business plan would take account of expected reserves at the end of 2029, she did not explain whether the previously published 2028 forecast had changed.

The council is due to consider the updated business plan on 30 October and set the annual retention fee in light of its decisions.

Could the annual retention fee rise again?

Phillips repeated previous guidance about possible future fee increases.

She wrote: ‘We announced last year that the level of the ARF would be adjusted as necessary for 2027 and 2028, but that other than in exceptional circumstances, any increase will not exceed the rate of the Consumer Price Index.’

The latest CPI inflation rate was 3.1%, covering the year to August 2026. An increase at that rate would add approximately £22 to dentists’ current £698 annual retention fee. However, the GDC has not announced any decision on this.

The annual retention fee rose for 2026, from £621 to £698 for dentists and from £96 to £108 for dental care professionals.

Phillips said the GDC was seeking efficiencies within fitness to practise and across its wider operations, including through its MyGDC registration and renewal service.

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The post Longer Sleep May Be Linked to a Higher Risk of Kidney Disease in People with Type 2 Diabetes appeared first on Endocrine News.

Two dentists have been erased from the General Dental Council (GDC) register after falsifying documents, including fabricated employment references and fake indemnity certificates.

In a hearing concluding on 29 September, the Professional Conduct Committee (PCC) said the first dentist had knowingly supplied fake Medical and Dental Defence Union of Scotland (MDDUS) indemnity certificates to the GDC. Proper indemnity cover was not in place for a period of approximately 15.5 months, with the dentist continuing to treat patients throughout.

Clinical failings were also reported, such as inadequate assessment and treatment, not taking a necessary radiograph, insufficient discussion of treatment risks and benefits, and failure to obtain valid consent.

The committee also found that they failed to treat a patient with ‘dignity and respect’, with the patient describing the dentist as ‘dismissive and belittling’.

Evidence of patient harm was given, as an open contact point left between teeth had caused ‘inflammation, discomfort and pain from food packing’.

The committee determined that erasure with immediate suspension was the only appropriate sanction. It concluded that the dentist’s ‘dishonest behaviour towards his regulator, (their) blatant disregard of the GDC’s rules and regulations as well as (their) lack of insight is incompatible with being a registered dentist’.

Falsified employment references

In a separate hearing earlier in September, the GDC also ordered the erasure of a second dentist after they admitted falsifying employment references.

In 2023, a witness reported hiring the dentist after reaching out to two email addresses they provided as referees, receiving positive feedback on the candidate from both.

However, the PCC found that the email addresses were fake and, along with the responses, had been created by the dentist themself.

After the dentist had stopped working at the practice, the practice owner discovered that one referee’s email address was incorrect. Both supposed referees then confirmed they had not supplied references.

The dentist admitted that this conduct was misleading, dishonest and lacked integrity. While the PCC acknowledged this remorse and some ‘very difficult personal circumstances’ when the misconduct occurred, it remained concerned that the clinician had not explained why they falsified the references.

Ultimately, the committee found that a lesser sanction than erasure with immediate suspension would not maintain public confidence or uphold professional standards.

Unless an appeal is initiated, both dentists’ names will be erased from the register within 28 days of the determination being served.

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Under the partnership, the organisations will carry out two studies to generate clinical evidence for oncology diagnostics.

One study centres on acute myeloid leukaemia to assess whether single cell analysis can enhance existing gold-standard methods for tracking residual disease.

Care teams currently depend on multiple separate tools to monitor remaining leukemic cells after treatment. For this investigation, researchers will employ the Flex Apex platform.

A second project focuses on advanced bladder cancer, analysing tissue from patients who received antibody-drug conjugates, immune checkpoint inhibitors, and other therapies.

It intends to link clinical outcomes and therapy responses with tumour microenvironment characteristics and drug target expression, with the aim of identifying biomarkers that assist oncologists in therapy selection.

The team will deploy the Flex Apex and Xenium platforms, with future plans to incorporate the Atera platform.

Fred Hutchinson Cancer Center Integrated Immunotherapy Research Center scientific director Lawrence Fong leads the collaboration and treats patients with bladder, kidney, and prostate cancers.

Fong said: “This project will help us better characterise the cellular and molecular responses to cancer treatments. We look forward to seeing how the results of this research could help guide treatment decisions for people with cancer.”

10x Genomics co-founder and CEO Serge Saxonov said: “Across cancer care, we have more effective therapies than ever, and too little insight into which patient will actually benefit from which one.

“Single cell and spatial biology let us look directly at the biology that drives treatment response, whether it’s in a tumour or in the blood, and we believe that’s the missing foundation for precision oncology. We’re excited to work with Fred Hutch on this research.”

Alongside a planned Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, the programme supports future diagnostic uses in autoimmune disease and oncology.

Both groups also intend to establish guidelines for clinical reporting to define how spatial and single cell data can inform patient treatment plans.

The post 10x Genomics and Fred Hutch partner on cancer technologies appeared first on Pharmaceutical Business review.

The regulatory decision introduces an oral tyrosine kinase inhibitor to the frontline maintenance setting, providing a chemotherapy-free option intended to delay disease progression.

Regulatory clearance was based on findings from the double-blind, placebo-controlled Phase III HER2CLIMB-05 trial.

Investigators evaluated the three-drug combination against a regimen of pertuzumab, placebo, and trastuzumab in patients who showed no disease progression following taxane-based induction therapy.

In the trial, adding Tukysa lowered the risk of disease progression or death by 35.9% compared to the control arm.

Patients receiving the Tukysa regimen achieved a median investigator-assessed progression-free survival of 24.9 months, compared to 16.3 months for those receiving placebo, marking an 8.6-month extension.

Overall survival remains a key secondary endpoint.

Pfizer executive vice-president and US chief commercial officer Aamir Malik said: “Since its first approval in 2020, Tukysa has become an important treatment for patients with second-line HER2+ metastatic breast cancer.

“Today’s FDA approval marks the next chapter for Tukysa, bringing it into the front-line maintenance setting and offering patients a chemotherapy-free option that can help delay disease progression after initial treatment.

“This approval reflects Pfizer’s commitment to advancing therapies across the breast cancer treatment journey and delivering meaningful new options for people living with metastatic breast cancer.”

Adverse events reported in at least 20% of participants included, fatigue, diarrhoea musculoskeletal pain, hepatotoxicity, rash, vomiting, and nausea.

Hepatotoxicity occurred at higher severity than previously observed, though cases were largely asymptomatic and reversible via dose adjustments or treatment halts.

Serious adverse reactions involving hepatotoxicity occurred in 3.9% of patients, including one fatal case of drug-induced liver injury.

Tukysa previously gained US approval alongside capecitabine and trastuzumab for patients with pretreated HER2-positive metastatic disease, including those with brain metastases.

In August 2026, the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) from Pfizer and Valneva for their Lyme disease vaccine candidate, PF-07307405.

The post FDA approves Pfizer’s Tukysa regimen for metastatic breast cancer appeared first on Pharmaceutical Business review.

Table of Contents

1. Introduction: Appeals Are Won on Procedure Before They Are Won on Merits
2. The Architecture: Five Levels, Three Escalation Rights, Two Clocks
3. Before You File Anything: The Appeal Decision Itself
4. The Two Clocks: Appeal Deadlines Versus Recoupment Deadlines
5. Level 1: Redetermination by the Medicare Administrative Contractor
6. What Actually Wins at Redetermination
7. Level 2: Reconsideration by the Qualified Independent Contractor
8. The Evidence Rule That Decides Cases Two Levels Later
9. Level 3: The Administrative Law Judge Hearing
10. Why the ALJ Level Is Where Providers Win
11. The Backlog, the 90-Day Standard, and the Escalation Right
12. Level 4: The Medicare Appeals Council
13. Level 5: Judicial Review in Federal District Court
14. The Preservation Doctrine: Arguments Not Raised Are Arguments Waived
15. The Money During the Appeal: Recoupment, Interest, and Repayment
16. A Strategic Framework: Which Cases to Appeal and How Far to Take Them
17. The Ten Most Common Fatal Errors
18. How DoctorsManagement Supports Providers Through All Five Levels
19. Frequently Asked Questions
20. External Resources and References

Introduction: Appeals Are Won on Procedure Before They Are Won on Merits

Most providers who lose Medicare appeals do not lose because their claims were indefensible. They lose because of something procedural: a deadline calendared from the wrong date, evidence submitted one level too late, an argument raised for the first time at a level where it had already been waived, or an appeal abandoned at exactly the level where it was most likely to succeed.

The Medicare administrative appeals process has five levels. Each has its own adjudicator, its own filing deadline, its own evidentiary rules, and its own realistic probability of changing the outcome. The levels are not five chances to make the same argument to five different audiences. They are a sequence in which the early levels build the record that the later levels decide on, which means the work done at Level 1 and Level 2 largely determines what is even possible at Level 3.

Two structural facts shape everything in this guide. The first is that the evidentiary record effectively closes at the second level. Evidence a provider fails to submit before the reconsideration decision is generally excluded from the Administrative Law Judge hearing absent good cause, and the good cause exception is narrow. Providers routinely hold their strongest material for the hearing, on the intuition that you save your best argument for the judge, and discover that the material is inadmissible precisely because it was saved.

The second is that the level where providers most often win, the ALJ hearing, is the third level, not the first. The first two levels are decided on the paper record by contractors operating inside the same framework that produced the denial. The ALJ hearing is the first point at which a human adjudicator outside the contractor system hears testimony, weighs expert evidence, and evaluates the matter fresh. Providers who treat Levels 1 and 2 as the main event exhaust their effort where it matters least. Providers who treat them as record-building for Level 3 arrive at the hearing with everything they need.

This guide walks each level in sequence: who decides, the deadline, what the level can realistically deliver, and the strategic use each one serves. It covers the two separate clock systems that govern appeals and recoupment, the 2026 amount in controversy thresholds, the escalation rights that exist when adjudicators miss their own deadlines, and the preservation doctrine that silently disposes of more provider arguments than any adjudicator ever does.

The Architecture: Five Levels, Three Escalation Rights, Two Clocks

The five levels, in order:

• Redetermination, conducted by the Medicare Administrative Contractor that processed the claim, performed by personnel who were not involved in the initial determination. Filing deadline: 120 days from receipt of the initial determination or demand.
• Reconsideration, conducted by a Qualified Independent Contractor, an entity separate from the MAC. Filing deadline: 180 days from receipt of the redetermination decision.
• Administrative Law Judge hearing, conducted through the Office of Medicare Hearings and Appeals. Filing deadline: 60 days from receipt of the reconsideration decision. Minimum amount in controversy for 2026: $200.
• Medicare Appeals Council review, conducted by the Departmental Appeals Board. Filing deadline: 60 days from receipt of the ALJ decision.
• Judicial review, a civil action in federal district court. Filing deadline: 60 days from receipt of the Council decision. Minimum amount in controversy for 2026: $1,960.

The Receipt Presumption

Every filing deadline runs from receipt of the prior decision, and receipt is presumed to occur five days after the date on the notice unless there is evidence to the contrary. The practical rule: calendar every deadline from the date printed on the decision plus five days, and then file well inside it. A deadline missed by one day is, with narrow good cause exceptions, a right extinguished.

The Escalation Rights

Each adjudicator from Level 2 upward operates under its own decision deadline, and when the adjudicator misses it, the appellant gains the right to escalate to the next level rather than continuing to wait. A QIC that does not decide within its 60-day timeframe must offer escalation to OMHA. An ALJ matter not decided within the 90-day adjudication standard may be escalated to the Council. A Council review not completed within its 90-day standard may be escalated to federal court. Escalation moves the record forward as it stands, which is sometimes valuable and sometimes a mistake, a judgment addressed later in this guide.

Amounts in Controversy Are Reset Annually

The ALJ and judicial review thresholds are recalculated each calendar year under a statutory formula, and the amounts that apply are the ones in effect when the request is filed. For requests filed on or after January 1, 2026, the thresholds are $200 for an ALJ hearing and $1,960 for judicial review. Claims may be aggregated to meet the threshold where they involve common issues of law and fact, which matters for practices appealing a batch of related denials individually too small to qualify alone. The applicable amounts are stated in each level’s decision notice.

Before You File Anything: The Appeal Decision Itself

Not every denial should be appealed, and the decision deserves five minutes of analysis before the machinery starts.

• Is the denial actually wrong? An independent review of the claim against the documentation, by someone other than whoever coded it, answers the threshold question. Appealing correct denials consumes staff time, accrues interest, and builds a record of unsuccessful appeals.
• What is the real amount at stake? For an individual claim denial, the math is the claim value against the cost of pursuing it. For a denial that is one instance of a pattern, or a finding that has been extrapolated, the stakes are the pattern and the projection, and the appeal economics change completely.
• Does the finding have consequences beyond the money? Denial rates feed contractor targeting. Findings left unchallenged become part of the practice’s compliance history. An extrapolated finding sustained without challenge becomes the template for the next review.
• Is the rebuttal process being confused with the appeal? The rebuttal opportunity in the first 15 days after a demand letter is not an appeal, does not stop recoupment, and does not preserve anything. The companion article in this series on responding to a Medicare records request covers the demand letter timeline in detail.
• For RAC findings, has the discussion period been considered? The RAC discussion period and the redetermination request are mutually exclusive paths that must be sequenced deliberately, since requesting redetermination closes the discussion option.

Where the answer is to appeal, the rest of this guide is the map.

The Two Clocks: Appeal Deadlines Versus Recoupment Deadlines

This is the most financially consequential distinction in the entire process, and it is the one providers most often miss.

The appeal clock answers whether you preserve the right to challenge the decision. The recoupment clock answers whether Medicare starts taking the money back while you do. They run on different schedules, and satisfying one does not satisfy the other.

For an overpayment demand, the appeal deadline for redetermination is 120 days. But recoupment begins on day 41 unless a valid redetermination request is filed by day 30. A provider who files on day 100 has preserved the appeal and lost the cash flow: the appeal proceeds while the money is withheld.

The same structure repeats at Level 2. Filing the reconsideration request within 60 days of the redetermination decision prevents recoupment from resuming. Filing later, but within the 180-day appeal deadline, preserves the appeal while recoupment proceeds.

The protection ends after Level 2. Once the QIC issues its reconsideration decision, the limitation on recoupment is exhausted. Recoupment may proceed during the ALJ, Council, and judicial review stages regardless of how promptly those appeals are filed. A provider carrying a large demand into Level 3 should plan for the cash flow consequences, through an extended repayment schedule where needed, rather than assuming the appeal continues to hold the money in place.

There is a counterweight. Under the limitation on recoupment framework established by Section 935 of the Medicare Modernization Act, amounts recouped are returned with interest if the provider ultimately prevails. That makes a later win financially whole in principle, but it does not meet payroll in the interim, which is why the day 30 and 60-day protective filings are the operative deadlines for any practice where the demand is material to operations.

Level 1: Redetermination by the Medicare Administrative Contractor

Who Decides

The same contractor that issued the initial determination, with the requirement that the redetermination be performed by personnel who were not involved in the initial decision. It is a fresh look within the same organization, on the paper record.

Deadline and Mechanics

• Filing deadline: 120 days from receipt of the initial determination, with receipt presumed five days after the notice date. The protective filing date for stopping recoupment on an overpayment demand is day 30.
• How to file: Form CMS-20027 or a written request containing the required elements: beneficiary name and Medicare number, the specific claims and dates of service, the reason for disagreement, and the signature of the requester or representative.
• Decision timeframe: The MAC generally issues its redetermination within 60 days of receiving the request.
• No minimum amount: There is no amount in controversy requirement at this level or at reconsideration.

Representation

Where a consultant, billing company, or attorney will act for the provider, an appointment of representative should be executed on Form CMS-1696 or an equivalent writing at the outset, since the appointment carries forward through the process and filing without it generates avoidable correspondence.

Build the Submission Deliberately

The redetermination request should include everything that supports the claims: the complete medical records, a claim-by-claim explanation connecting the documentation to the coverage criteria, any signature attestations, and records from outside entities. The temptation is to file a short disagreement letter and save the full presentation for later. The evidence rule discussed below is the reason that instinct is exactly backward.

What Actually Wins at Redetermination

Redetermination overturns a meaningful share of denials, but the wins concentrate in specific categories:

• Documentation that existed but was never reviewed. Records that did not make it into the original submission, attachments that failed to transmit, and components held by outside facilities. If the denial says insufficient documentation and the documentation exists, this is the level that fixes it.
• Clerical and processing errors. Wrong dates, transposed identifiers, misapplied edits, and claims denied against the wrong policy.
• Signature deficiencies cured by attestation. A properly executed signature attestation accompanying an otherwise complete record.
• Plain misapplication of the coverage policy. Where the reviewer applied criteria the policy does not contain, a direct citation to the policy language can resolve the matter.

What rarely wins here is a contested medical necessity judgment. The redetermination reviewer sits inside the same contractor applying the same review framework, and asking that framework to reverse its own clinical judgment on the same record seldom succeeds. For those disputes, the function of Level 1 is different: it is the first opportunity to put the complete record and the complete argument in place, including the preliminary statement of any statistical challenge to an extrapolation, so that nothing is waived and everything is positioned for the levels where contested judgments actually get reweighed.

Level 2: Reconsideration by the Qualified Independent Contractor

Who Decides

A Qualified Independent Contractor, an entity separate from the MAC that had no role in the earlier decisions. For medical necessity disputes, the reconsideration includes review by a panel that brings clinical expertise to the question, which makes this the first level at which a clinical argument is evaluated by clinicians outside the originating contractor.

Deadline and Mechanics

• Filing deadline: 180 days from receipt of the redetermination decision. The protective filing date for keeping recoupment stopped is 60 days.
• How to file: Form CMS-20033 or a compliant written request, directed to the QIC identified in the redetermination notice.
• Decision timeframe: Generally 60 days from receipt of the request. Submitting additional evidence after filing extends the timeframe, which is a fair trade when the evidence matters.
• Escalation: If the QIC cannot decide within its timeframe, it must notify the parties and offer escalation to OMHA, with the record moving forward as it stands.

What Reconsideration Is Really For

Reconsideration decisions do overturn denials, particularly where the redetermination missed something the independent reviewer catches. But the strategic function of Level 2 is larger than its win rate: it is the last point at which the evidentiary record can be freely built. Whatever the provider intends to rely on at the ALJ hearing, at the Council, or in federal court needs to be in the record before the QIC decides. That makes the reconsideration submission the single most important filing in the entire appeal, which is the subject of the next section.

The Evidence Rule That Decides Cases Two Levels Later

This section is the reason this article exists. If a practice internalizes one procedural rule from the entire appeals process, it should be this one.

Under 42 CFR 405.966, a full and early presentation of evidence is required: evidence not submitted before the QIC issues its reconsideration decision is generally not considered at subsequent levels absent good cause. At the ALJ stage, 42 CFR 405.1018 requires that any new evidence be accompanied by a written statement explaining why it was not submitted to the QIC, and without a showing of good cause the ALJ does not consider it.

How Narrow the Exception Is

Good cause generally reaches situations such as evidence responding to an issue the lower levels did not identify as material, records the provider made documented and reasonable efforts to obtain before the QIC decided, or material that was in fact submitted earlier to a contractor. What it does not reach is the ordinary case: evidence the provider possessed and simply did not submit, whether through oversight, workload, or a deliberate decision to hold it for the hearing. Strategy is not good cause.

What This Means in Practice

• The expert work happens before Level 2 closes, not before Level 3 opens. A statistical analysis of an extrapolation, a clinical expert’s report on medical necessity, a specialty society guideline supporting the treatment decision: all of it belongs in the reconsideration submission. The expert may testify at the ALJ hearing, but the report the testimony rests on must already be in the record.
• The position paper belongs at reconsideration. A written argument connecting each claim’s documentation to the governing coverage criteria, and setting out every ground of challenge including the statistical ones, should accompany the Level 2 filing.
• Outside records cannot wait. Hospital, imaging, and laboratory records take weeks to obtain. Requests made after the reconsideration decision produce evidence that may never be admitted.
• Document the efforts. Where a record genuinely cannot be obtained in time, the contemporaneous trail of requests and follow-ups is what later supports a good cause showing.

The asymmetry is stark. Submitting evidence at Level 2 that turns out to be unnecessary costs nothing. Withholding evidence that turns out to be necessary can cost the appeal.

Level 3: The Administrative Law Judge Hearing

Who Decides

An Administrative Law Judge within the Office of Medicare Hearings and Appeals, an HHS component independent of CMS and its contractors. This is the first adjudicator in the process who is not a contractor.

Deadline and Threshold

• Filing deadline: 60 days from receipt of the reconsideration decision. Note how much shorter this is than the 120 and 180 day windows at the first two levels; providers accustomed to the earlier cadence miss this one.
• Amount in controversy: $200 for requests filed in calendar year 2026, recalculated annually, with aggregation of claims permitted where they present common issues of law and fact.
• How to file: A request for hearing on the OMHA form or a compliant written request, with copies sent to the other parties.

What a Hearing Looks Like

Hearings are generally conducted by video teleconference or telephone. The provider presents testimony, including from the treating or supervising clinicians and from retained experts, and the ALJ questions witnesses directly. CMS or its contractors may elect to participate, as a participant or as a party, and where they do, their positions can be met and countered in real time. The ALJ reviews the matter de novo on the record built below, subject to the new evidence restrictions already discussed.

Prepare It Like Litigation

• A hearing memorandum organizing the claims, the issues, and the record citations, filed in advance
• Witnesses prepared for direct testimony and for the ALJ’s questions, including the clinicians whose documentation is at issue
• The expert ready to explain, in accessible terms, the clinical judgment or the statistical defect at the center of the case
• A clean exhibit set keyed to the record, so every assertion can be located in seconds
• Anticipation of the contractor’s position from the lower-level decisions, with direct responses prepared

Why the ALJ Level Is Where Providers Win

Across the matters DoctorsManagement has supported and across what practitioners in this field consistently report, the ALJ hearing is where contested cases most often turn. The structural reasons are worth understanding, because they explain what the earlier levels are for.

• The first independent human adjudication. Levels 1 and 2 are paper reviews conducted by contractors inside the payment system. The ALJ is an independent judge hearing the people involved.
• Testimony changes medical necessity cases. A treating physician explaining the clinical picture, under questioning, conveys what a chart excerpt cannot. Many medical necessity denials that survived two paper reviews do not survive the physician explaining the decision.
• Expert evidence gets weighed, not filed. A statistician walking the judge through a sampling defect, or a coding expert reconciling the documentation to the code, is engaging an adjudicator with authority to act on it.
• Extrapolations fall here. As the companion article in this series on statistical extrapolation covers in depth, methodology challenges succeed most often at the ALJ level, and a successful challenge collapses liability from the projected amount to the sampled amount. For an extrapolated demand, this level is usually the whole case.
• The contractor’s work gets examined. An OIG review found Medicare contractors inconsistent in how they handled extrapolated overpayments during appeals. The hearing is where that inconsistency is exposed, because it is the first forum where the contractor’s methodology is tested rather than presumed.

None of this works for a provider whose record was not built. The hearing rewards the practice that treated Levels 1 and 2 as preparation, and punishes the one that arrives intending to introduce its case for the first time.

The Backlog, the 90-Day Standard, and the Escalation Right

The regulations contemplate an ALJ decision within 90 days of the hearing request. Reality has historically diverged. For much of the past decade, OMHA carried a backlog that pushed waits for a hearing to multiple years, until court-ordered reduction targets and expanded funding brought the backlog down substantially. Timelines have improved markedly, but providers should still plan for the possibility that this level takes longer than the standard contemplates, and should confirm current expectations when filing.

The Escalation Decision

When the adjudication period passes without a decision, the appellant may escalate to the Medicare Appeals Council. Whether to do so is a genuine strategic choice. Escalation trades the hearing itself, with its testimony and its independent judge, for speed, since the Council then reviews the written record without the hearing having occurred. For a case built on documents alone, that trade can make sense. For a case that depends on testimony or expert presentation, escalating past the hearing usually surrenders the appeal’s best forum. Most providers with strong cases are better served by waiting for the hearing.

Plan the Finances for the Duration

Because recoupment is no longer stayed at this level, a long ALJ timeline means a long period of withheld payments or repayment obligations on a demand the provider may ultimately defeat. The extended repayment schedule process, interest planning, and cash flow modeling belong in the appeal plan from the moment the reconsideration decision arrives.

Level 4: The Medicare Appeals Council

Who Decides

The Medicare Appeals Council within the Departmental Appeals Board, reviewing the ALJ’s decision on the written record. There is no new hearing, and the new evidence restrictions continue to apply.

Deadline and Mechanics

• Filing deadline: 60 days from receipt of the ALJ decision, identifying the specific parts of the decision the appellant disputes and why.
• Scope of review: The Council may adopt, modify, or reverse the ALJ decision, or remand for further proceedings. It reviews for error rather than retrying the case.
• Own motion review: CMS may also refer an ALJ decision to the Council on its own initiative, which means a favorable ALJ decision is not final until the review window passes. A provider who wins at Level 3 should understand that the matter can continue without the provider having appealed anything.
• Escalation: If the Council does not act within its adjudication standard, the appellant may escalate to federal court.

The Strategic Function

For most providers, the Council is either the forum for correcting a legal error in an adverse ALJ decision or the procedural gate that must be passed to reach federal court, since judicial review requires exhausting the administrative process. Council briefs are appellate work: focused on identified errors, grounded in the record, and precise about the relief sought. A Council filing that re-argues the facts generally accomplishes nothing the ALJ decision has not already resolved.

Level 5: Judicial Review in Federal District Court

Who Decides

A United States district judge, in a civil action against the Secretary of Health and Human Services, typically filed in the district where the provider resides or has its principal place of business.

Deadline and Threshold

• Filing deadline: 60 days from receipt of the Council’s decision, or following proper escalation.
• Amount in controversy: $1,960 for actions filed in calendar year 2026, recalculated annually.
• Exhaustion: The administrative levels must have been completed. The record built below is, with limited exceptions, the record the court reviews.

The Standard of Review Changes the Game

Federal court is not a sixth chance to argue the facts. The agency’s factual findings are reviewed under the substantial evidence standard, which asks whether the record contains adequate support for the conclusion, not whether the judge would have decided differently. Factual disputes that lost below usually stay lost. Where providers win at this level is on questions of law and procedure: the agency applied the wrong legal standard, departed from its own regulations, denied a fair process, or sustained a methodology that cannot withstand legal scrutiny. This is also why the record and the preserved arguments matter so much: the legal issues a court can reach are the ones raised and preserved on the way up.

The Practical Reality

Judicial review involves federal litigation costs, government counsel on the other side, and timelines measured in years. It is the right forum for large extrapolated demands turning on legal or methodological questions, for matters with precedential consequence to the practice, and for cases where the administrative process produced a clear legal error. It is rarely the right forum for a factual dispute over a modest sum. The decision to file belongs to experienced healthcare counsel, made with full knowledge of the record that the earlier levels created.

The Preservation Doctrine: Arguments Not Raised Are Arguments Waived

Running underneath all five levels is a quiet rule that disposes of more provider arguments than any adjudicator: issues and objections must be raised at each level to remain available at the next.

The clearest illustration is the statistical challenge. A provider facing an extrapolated overpayment who contests only the individual claim denials at redetermination and reconsideration, intending to retain a statistician for the ALJ hearing, may find the methodology arguments unavailable at precisely the level where they succeed. The challenge to the sampling must be asserted from the first filing, even in preliminary form, and developed consistently at every level thereafter.

The same logic applies to every category of argument: coverage policy interpretation, procedural defects in the audit, due process objections, and underpayment offsets. The working rule for every filing at every level is simple to state and demanding to execute: state every ground of disagreement you may ever want to rely on, support each with what the record allows, and never let a level pass in silence on an issue you intend to raise later.

This is also the deepest reason the appeal should be planned as a whole at the outset rather than level by level. The redetermination request written with the federal court standard of review in mind looks different from one written to persuade the MAC, and the difference is what survives.

The Money During the Appeal: Recoupment, Interest, and Repayment

A five-level appeal can run a long time, and the financial mechanics during that time deserve their own planning.

• Interest accrues from day 31 on an unpaid overpayment demand and continues through the appeal, regardless of timely filings. Interest stops only when the debt is paid or extinguished.
• Recoupment is stayed only through Level 2, and only by the day 30 and 60-day protective filings. From the reconsideration decision forward, Medicare may recoup during the remaining levels.
• Prevailing later makes the provider whole with interest. Amounts recouped are returned with interest where the provider ultimately wins, which changes the economics of a strong case: the carrying cost of the fight is recoverable, though the liquidity strain in the meantime is real.
• Voluntary repayment is a strategic option, not a concession. Paying the demand stops interest from accruing while the appeal continues, and a provider who pays and then prevails is refunded. For a practice with the liquidity, paying a demand it expects to fight for years can cost less than letting interest run.
• Extended repayment schedules address liquidity, not liability. Where recoupment of the full amount would threaten operations, an extended repayment schedule through the contractor spreads the obligation. Interest generally continues, and the schedule should be sought early rather than after recoupment has begun.

The right financial posture depends on the size of the demand, the strength of the case, and the practice’s cash position, and it should be modeled at the start of the appeal rather than improvised when the reconsideration decision arrives.

A Strategic Framework: Which Cases to Appeal and How Far to Take Them

• Audit the denials independently before deciding. The appeal portfolio should contain the denials that are wrong, not all of them. An independent coding and documentation review sorts the two.
• Treat extrapolated matters as a separate category. Any demand carrying a projection justifies a full five-level plan from day one, with statistical expertise engaged before the redetermination filing so the methodology challenge is preserved and the Level 2 record is complete.
• Decide the endpoint at the beginning. For routine single-claim denials, the realistic endpoint is often Level 1 or 2, where documentation-based wins occur cheaply. For contested medical necessity and for anything extrapolated, the plan should run through Level 3, with Levels 4 and 5 reserved for legal error and large stakes.
• Build every filing for the record, not just the reader. Each submission should assume it will be read two levels later. Complete evidence by reconsideration, every argument preserved, every assertion citable.
• Use the protective deadlines even when more time is available. File redetermination by day 30 and reconsideration within 60 days whenever the demand is material, treating the longer appeal windows as the outer boundary they are.
• Match the team to the level. Levels 1 and 2 are documentation and argumentation work suited to credentialed audit consultants. Level 3 adds hearing preparation, testimony, and expert presentation. Levels 4 and 5 are legal practice and belong to counsel, supported by the analytical record the earlier levels created.
• Feed the results back into operations. Appeals won on documentation that existed reveal submission process failures. Appeals lost on documentation that did not exist reveal clinical documentation gaps. Either way, the overturn analysis belongs in the compliance program, and a pattern of findings raises the obligations covered in the companion article on the 60-day overpayment rule.

The Ten Most Common Fatal Errors

• Calendaring deadlines from the wrong date. Deadlines run from presumed receipt, five days after the notice date. Everything else is risk.
• Confusing the appeal deadline with the recoupment deadline. Filing on day 100 preserves the appeal and surrenders the cash flow.
• Holding evidence for the ALJ hearing. The record closes at reconsideration. Material withheld for the judge is material the judge may never see.
• Raising the statistical challenge late. Methodology arguments not asserted from the first filing can be waived by the level where they win.
• Filing bare disagreement letters at Levels 1 and 2. Thin early filings build a thin record, and the later levels decide on the record.
• Missing the shortened 60-day window at Level 3. After 120 and 180 day windows, the cadence changes, and providers calendar by habit.
• Escalating past the hearing reflexively. Escalation trades the appeal’s best forum for speed. For testimony-dependent cases, that trade loses.
• Ignoring the amount in controversy mechanics. Related small denials that could aggregate to meet the threshold are abandoned individually instead.
• Treating a favorable ALJ decision as final on day one. Own motion review exists, and the matter is not closed until the window passes.
• Leaving the financial plan for later. Interest from day 31, recoupment after Level 2, and multi-year timelines are knowable at the start, and practices that model them at the start make better decisions at every level.

How DoctorsManagement Supports Providers Through All Five Levels

DoctorsManagement has represented physician practices, groups, and healthcare organizations through every level of the Medicare appeals process, from first-level redeterminations through support of counsel in federal litigation. Our role is the analytical and evidentiary engine of the appeal: the record built at Levels 1 and 2 and the expert presentation that carries Level 3.

Our auditors hold both the Certified Professional Coder and Certified Professional Medical Auditor credentials and receive ongoing training through NAMAS, our education division. For matters involving extrapolation, our team includes statisticians, economists, and data analysts who evaluate sampling methodology on its own terms.

Our appeal services include:

• Appeal Portfolio Triage: Independent review of denials to determine which are wrong, what each is worth, and how far each should be taken
• Redetermination and Reconsideration Preparation: Complete evidentiary submissions and claim-by-claim position papers built for the record the later levels will decide on, with every ground of challenge preserved from the first filing
• Extrapolation Defense: Statistical methodology analysis, recalculation under corrected assumptions, and the expert reports that must be in the record before the reconsideration decision
• ALJ Hearing Support: Hearing memoranda, exhibit preparation, witness preparation, and testifying expert services on coding, documentation, medical necessity, and statistical methodology
• Litigation Support: Analytical and expert support for counsel at the Council and in federal court, built on the record our earlier work created
• Financial Strategy: Recoupment timeline modeling, interest analysis, and extended repayment schedule support so the appeal plan and the cash flow plan are the same plan

DoctorsManagement is a healthcare consulting, accounting, and auditing firm, not a law firm. We do not provide legal advice or court representation; at the levels where those are required, we work alongside your healthcare counsel and supply the record and the experts the legal strategy depends on.

If your practice has received an unfavorable determination at any level, contact DoctorsManagement at www.doctorsmanagement.com/audit-appeal-defense or call (800) 635-4040. The earlier in the process we are involved, the more of the record we can still shape.

Frequently Asked Questions

What are the five levels of Medicare appeals?

Redetermination by the Medicare Administrative Contractor, reconsideration by a Qualified Independent Contractor, a hearing before an Administrative Law Judge at the Office of Medicare Hearings and Appeals, review by the Medicare Appeals Council at the Departmental Appeals Board, and judicial review in federal district court. Each level has its own filing deadline, and the ALJ and judicial review levels carry minimum amount in controversy thresholds, which are $200 and $1,960 respectively for requests filed in 2026.

How long do I have to file at each level?

120 days from receipt for redetermination, 180 days for reconsideration, and 60 days each for the ALJ hearing, Council review, and federal court. Receipt is presumed five days after the date on the notice. For overpayment demands, the protective deadlines that stop recoupment are shorter: 30 days for redetermination and 60 days for reconsideration.

Does filing an appeal stop Medicare from taking the money back?

Only at the first two levels, and only with timely protective filings. Filing redetermination within 30 days of the demand prevents recoupment from beginning, and filing reconsideration within 60 days of the redetermination decision keeps it stopped. After the QIC issues its reconsideration decision, recoupment may proceed during the ALJ, Council, and court stages. If the provider ultimately prevails, recouped amounts are returned with interest.

When do I need to submit my evidence?

Before the QIC issues its reconsideration decision. Under the full and early presentation requirement at 42 CFR 405.966, evidence not in the record by then is generally excluded at later levels absent good cause, and 42 CFR 405.1018 requires a written good cause explanation for any new evidence offered to the ALJ. Expert reports, statistical analyses, position papers, and outside records all need to be in by Level 2.

Which level gives me the best chance of winning?

It depends on the dispute. Documentation gaps, clerical errors, and signature issues are frequently corrected at redetermination. Contested medical necessity judgments and extrapolation challenges most often succeed at the ALJ hearing, which is the first level with an independent adjudicator, live testimony, and weighed expert evidence. The first two levels largely determine whether the ALJ level can be won, because they build the record it is decided on.

What is the amount in controversy requirement?

A minimum dollar amount that must be at stake to reach the ALJ and judicial review levels. For requests filed on or after January 1, 2026, the thresholds are $200 for an ALJ hearing and $1,960 for federal court, recalculated annually under a statutory formula. Claims presenting common issues of law and fact may be aggregated to meet the threshold, and the applicable amounts are stated in each decision notice.

What happens if the QIC or the ALJ misses its decision deadline?

An escalation right arises. A QIC that cannot decide within its timeframe must offer escalation to OMHA, an ALJ matter exceeding its adjudication standard may be escalated to the Council, and a delayed Council review may be escalated to federal court. Escalation moves the record forward as it stands, so a provider whose case depends on testimony usually does better waiting for the hearing than escalating past it.

Do I need a lawyer to appeal?

Not at the early levels. Redetermination and reconsideration are commonly handled by the practice with experienced audit defense consultants preparing the record. Counsel becomes important for ALJ hearings in high-stakes matters, is effectively necessary at the Council where the work is appellate in nature, and is required as a practical matter for federal litigation. Whoever represents the practice should be appointed in writing at the outset so the appointment carries through the process.

Can I still appeal if I already repaid the overpayment?

Yes. Repayment does not waive appeal rights, and it stops interest from accruing while the appeal continues. A provider who pays and then prevails is refunded. For a practice with the liquidity to pay a demand it expects to contest for an extended period, voluntary repayment is sometimes the cheaper path, and the choice between paying, recoupment, and an extended repayment schedule should be modeled at the start of the appeal.

How can DoctorsManagement help with my appeal?

We provide appeal triage, complete redetermination and reconsideration submissions built for the later record, extrapolation defense with statistical experts, ALJ hearing preparation and testifying expert services, litigation support for counsel, and recoupment and repayment financial modeling. We are a consulting, accounting, and auditing firm rather than a law firm, and we work alongside your counsel at the levels that require one. Contact us at www.doctorsmanagement.com/contact-us or call (800) 635-4040.

External Resources and References

• Federal Register: Medicare Appeals, Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2026
• CMS: Third Level of Appeal, Decision by the Office of Medicare Hearings and Appeals
• CMS: Fifth Level of Appeal, Judicial Review in Federal District Court
• First Coast Service Options: Changes to the Amount in Controversy for Appeals in 2026
• Federal Register: Medicare Program, Limitation on Recoupment of Provider and Supplier Overpayments
• CMS Medicare Overpayments Fact Sheet (MLN006379)
• OIG Report: Medicare Contractors Were Not Consistent in How They Reviewed Extrapolated Overpayments in the Provider Appeals Process
• OIG Work Plan
• CMS Regulations and Guidance
• DoctorsManagement Audit Appeal and Defense
• DoctorsManagement Coding and Documentation Review
• DoctorsManagement Healthcare Compliance Audit
• DoctorsManagement Total Compliance Solution

This article is provided for informational and educational purposes only and does not constitute legal advice. DoctorsManagement is a healthcare consulting, accounting, and auditing firm. It is not a law firm, does not practice law, and does not represent parties in court. Appeal deadlines, amount in controversy thresholds, adjudication timeframes, and evidentiary rules are subject to change, and their application depends on the facts of each matter. Providers pursuing an appeal, particularly at the Administrative Law Judge level and above, should consult qualified healthcare counsel. DoctorsManagement is available to provide audit defense, appeal preparation, expert witness, and litigation support services at every level of the process.

The post The Five Levels of Medicare Appeals: A Provider’s Guide to Redetermination Through Judicial Review appeared first on DoctorsManagement.

Table of Contents

1. Introduction: The Audit Letter That Looks Like Medicare and Is Not
2. The Numbers: Why Commercial Recoupments Are Rising
3. The Fundamental Difference: Your Contract Is the Rulebook
4. The Three Rulebooks: Contract, State Law, and ERISA
5. Who Is Actually Auditing You
6. The Contract Provisions That Decide Everything
7. State Lookback and Notice Protections
8. Offsets: How Commercial Payers Actually Take the Money
9. Extrapolation Without the Statutory Guardrails
10. The Response Playbook: The First 30 Days
11. Fighting Back: The Dispute and Appeal Path
12. When the Letter Comes From the Special Investigations Unit
13. Prevention: Winning the Audit Before It Starts
14. How DoctorsManagement Defends Commercial Payer Audits
15. Frequently Asked Questions
16. External Resources and References

Introduction: The Audit Letter That Looks Like Medicare and Is Not

A records request arrives from a commercial payer. The letter looks familiar: a list of claims, a demand for documentation, a deadline, references to audit findings and potential recoupment. A practice that has been through a Medicare review reaches for the Medicare playbook, assumes the familiar deadlines, assumes the familiar appeal levels, assumes the familiar limits on how far back the payer can reach and how aggressively it can project an error rate.

Every one of those assumptions is wrong, and each one costs leverage.

Medicare audits operate inside a dense statutory and regulatory framework: fixed response windows, five defined appeal levels, a statutory limitation on when extrapolation may be used, a limitation on recoupment that timely appeals can invoke, and a body of published manuals the contractor must follow. Commercial payer audits operate inside a contract. The participation agreement your practice signed, often years ago and possibly never read since, defines the payer’s audit rights, the lookback period, the deadline to respond, the dispute process, and the payer’s right to simply deduct the money from your next remittance. Where the contract is silent, state insurance law may fill the gap for some plans, and federal ERISA law governs others. There is no Program Integrity Manual, no Administrative Law Judge, and no Section 1893(f)(3).

That difference cuts both ways. Commercial payers have freedoms Medicare contractors do not, including offset rights that let them collect without your consent and extrapolation unconstrained by federal statute. But providers also have leverage against commercial payers that does not exist against Medicare: the payer needs the network, state law imposes real limits on many plans, the contract binds the payer as much as the practice, and everything is ultimately negotiable in a way a Medicare demand is not.

This guide covers why commercial audit activity is rising, which of three distinct legal frameworks governs any given audit, the contract provisions that determine your position before the first letter arrives, the state law protections most practices never invoke, how offsets and commercial extrapolation actually work, and the response and dispute playbook that preserves leverage instead of surrendering it.

The Numbers: Why Commercial Recoupments Are Rising

The rise in commercial audit activity is not an impression. It is measurable, and the 2025 data is stark.

Benchmark data drawn from a network of more than 1.2 million providers, published by the billing compliance platform MDaudit covering the first three quarters of 2025, found that external payer audit activity rose 30 percent year over year measured by total dollars at risk per organization, with the average at-risk amount per audited claim up 18 percent. Commercial payers accounted for 45 percent of the at-risk dollars, substantially more than Medicare and Medicaid combined at 28 percent. In the professional setting, the average audited claim carried $1,172 at risk, with missing information, coding errors, and billing errors as the leading triggers. Telehealth-related denials rose 84 percent, and Medicare Advantage denial amounts rose more than 22 percent, a reminder that MA plans are commercial payers wearing a federal program’s name.

What Is Driving It

• Payment integrity has become an industry. Payers increasingly outsource post-payment review to third-party payment integrity vendors, many compensated on contingency. Like Recovery Audit Contractors in the Medicare program, these vendors are paid to find overpayments, and the volume of review scales with the size of the industry built to perform it.
• Data mining selects the targets. Claims analytics flag providers whose coding distribution, modifier usage, visit frequency, or billing growth deviates from specialty norms. Audits that once required manual selection now begin with an algorithm scoring every claim a practice submits, and medical margin pressure gives payers every reason to run those models harder.
• The Medicare playbook migrated. Techniques refined in federal program integrity work, including statistical sampling and extrapolation, prepayment review flags, and high-dollar claim targeting, are now standard commercial practice.
• Virtual care created new review categories. Telehealth, remote monitoring, and the documentation conventions around them are young enough that payers and providers routinely disagree about what supports a claim, and the 84 percent rise in telehealth denials shows where that disagreement lands.

The practical conclusion for a physician practice: the probability of facing a commercial audit in any given year is rising, the average dollars at stake per audit are rising, and the payer side of the table is increasingly professionalized. The provider side should be too.

The Fundamental Difference: Your Contract Is the Rulebook

Everything in this guide follows from one structural fact: a commercial audit is a contract dispute, not an administrative proceeding. The contrasts with Medicare are worth stating plainly, because each one changes the correct response.

• Response deadlines. Medicare documentation requests carry regulatory deadlines of 30 or 45 days. A commercial records request carries whatever deadline the contract or the letter states, which may be shorter, longer, or negotiable. Read the letter and the contract rather than assuming.
• Appeal structure. Medicare provides five statutory appeal levels with defined deadlines and an independent judge at the third. Commercial contracts typically provide one or two internal appeal levels, sometimes followed by arbitration or litigation, all defined by the agreement.
• Extrapolation limits. Medicare Parts A and B extrapolation is restricted by Section 1893(f)(3) of the Social Security Act to sustained or high error rates or failed educational intervention. No comparable statute restrains a commercial payer. Whether extrapolation is permitted at all is a question of what the contract says and what state law allows.
• Recoupment protection. Timely Medicare appeals stop recoupment through the second level under the Section 935 limitation. Commercial contracts typically authorize the payer to offset the alleged overpayment against future remittances, sometimes after a short notice period, whether or not a dispute is pending, unless the contract or state law says otherwise.
• Lookback periods. Medicare’s framework sets defined look-back windows by contractor type. Commercial lookbacks are set by contract and, for state-regulated plans, capped by state statutes that vary enormously, from months to years.
• Leverage. A practice cannot negotiate with CMS about whether to be audited. A practice absolutely can negotiate with a commercial payer, because the relationship is mutual: the payer markets its network, needs its directory full, and faces state regulators and contract law on its own conduct. Providers hold more cards in commercial disputes than most ever play.

The Three Rulebooks: Contract, State Law, and ERISA

The first analytical question in any commercial audit is which legal framework governs, because the answer determines which protections exist. Three overlap.

Rulebook One: The Participation Agreement

The contract governs every audit regardless of plan type. Its audit, records, overpayment, offset, and dispute provisions are the baseline rules, and they are examined in detail in the next section. Where the contract and state law conflict, state law generally prevails for the plans it regulates, which is why the second rulebook matters.

Rulebook Two: State Insurance Law, for Fully Insured Plans

Fully insured employer plans, individual and small group policies, and HMOs are regulated by the state insurance department. Many states have enacted provider protections that override contrary contract terms for these plans: limits on how far back a payer may recoup, written notice requirements before recoupment or offset, a defined window to dispute before the money moves, and prompt payment rules. These protections are real, they are frequently stronger than the contract, and practices routinely fail to invoke them because nobody on staff knows they exist.

Rulebook Three: ERISA, for Self-Funded Plans

Self-funded employer plans, which cover roughly 63 percent of workers with employer coverage, are governed by federal ERISA law, and state insurance protections generally do not apply to them. For these plans, the plan document and the provider contract set the rules, and disputes travel through the plan’s claims and appeals procedures under federal regulations rather than through the state insurance department. Providers typically pursue ERISA remedies through an assignment of benefits from the patient, and many plans now include anti-assignment clauses intended to block exactly that, which is a question for counsel when the stakes justify it.

The First Question in Every Audit

Is this plan fully insured or self-funded? The answer determines whether your state’s lookback cap and notice requirements protect you, whether the state insurance department is an escalation venue, and what the dispute path looks like. The member ID card sometimes indicates it, the payer must tell you if asked, and the analysis of any multi-claim audit should sort the claims by funding type before anything else, because the same payer letter frequently mixes both.

Who Is Actually Auditing You

Commercial audit letters come from three different kinds of entities, and the sender changes the stakes.

Payment Integrity and Recovery Units

The payer’s internal post-payment review operation, focused on coding accuracy, bundling, medical necessity under the payer’s policies, coordination of benefits, and duplicate payments. These reviews are about money. They are the commercial analogue of a MAC or RAC review, and they resolve through documentation, argument, and negotiation.

Third-Party Payment Integrity Vendors

Outside firms engaged by the payer to conduct post-payment review, data mining, itemized bill review, or specialty-specific audits, frequently compensated on a contingency percentage of recoveries. The contingency structure matters for the same reason it matters with RACs: the entity reviewing your claims is paid to find errors. Vendor findings deserve independent verification as a matter of course, including recalculating the math, because vendor demand letters containing duplicated claims, already-adjusted claims, and arithmetic errors are a recurring phenomenon.

The Special Investigations Unit

Every major payer maintains an SIU with a mandate that is not payment accuracy but fraud, waste, and abuse. SIU involvement changes the character of the matter: SIUs can place providers on prepayment review, refer matters to state insurance fraud bureaus and law enforcement, share information with other payers through industry anti-fraud organizations, and initiate network termination. An SIU letter is the commercial counterpart of a UPIC letter, and it calls for the same posture, which is addressed in its own section below.

Reading the Letterhead

Identify the sender before responding: internal recovery unit, named outside vendor, or SIU. The letter’s own language usually tells you. References to payment accuracy, coding review, or overpayment identification indicate a financial review. References to investigation, fraud, waste and abuse, or an interview request indicate the SIU. The response strategy, and the decision about involving counsel, follows from that identification.

The Contract Provisions That Decide Everything

Your position in a commercial audit was largely fixed on the day the participation agreement was signed. These are the provisions that matter, and they should be located and read now, not after a letter arrives.

• Audit rights. What the payer may review, how often, with how much notice, and whether on-site access is permitted. Some contracts limit audit frequency or scope; most practices never check.
• Lookback period. How far back the payer may reach to recoup. Contracts commonly specify 12 to 36 months, state law may cap it shorter for fully insured plans, and fraud allegations typically remove the cap entirely.
• Records deadlines. How long the practice has to produce documentation, and what happens on non-response. As with Medicare, an unanswered request converts to a denial and then to a demand.
• Overpayment notice and dispute window. What notice the payer must give before recovering, and how many days the practice has to dispute before recoupment or offset begins. This window is the commercial equivalent of Medicare’s day 30, and missing it has the same consequence: the money moves while you argue.
• Offset rights. Whether the payer may deduct alleged overpayments from future remittances, and on what notice. This clause is how commercial payers collect without your consent, and its terms are negotiable at contracting time.
• Dispute resolution. The internal appeal levels, their deadlines, whether binding arbitration applies, which state’s law governs, and where disputes must be brought. Arbitration clauses in particular shape the endgame and are routinely discovered only when the endgame arrives.
• Amendment by notice. Most agreements let the payer amend terms, including audit and recoupment provisions, by notice with continued participation deemed acceptance. The contract you signed is not necessarily the contract in force. Request the current agreement with all amendments and policy manuals incorporated by reference, because incorporated manuals frequently contain the actual audit procedures.

A practice that maintains a current, indexed file of every participation agreement, amendment, and incorporated manual, with the audit-relevant terms summarized on one page per payer, enters every audit knowing its rights. A practice that has to request its own contract from the payer after the demand arrives starts the dispute already behind.

State Lookback and Notice Protections

For fully insured plans, state law frequently gives providers protections stronger than anything in the contract, and they operate whether or not the contract mentions them.

Lookback Caps

Most states limit how far back a state-regulated payer may recoup a paid claim, with caps commonly falling in the range of 12 to 24 months from the payment date. The variation is wide: published compilations show examples running from 6 months in Maryland, through 12 months in Alaska, 15 months in Tennessee, and 18 months in Hawaii and South Carolina, up to 30 months in Florida. A recoupment demand reaching claims older than your state’s cap is, for fully insured plans, demanding money the payer may have no right to recover, and identifying those claims is one of the fastest ways to cut a demand down.

Notice and Dispute Requirements

Many states also require written notice before recoupment or offset, commonly 15 to 30 days, with the notice identifying the specific claims and the basis for the overpayment determination, and some states guarantee a dispute window during which the payer may not take the money. A payer that offsets first and explains later may be violating these requirements, which is both a defense and an escalation lever with the state insurance department.

The Exceptions and the Caveats

• Fraud exceptions are nearly universal. Allegations of fraud typically extend or eliminate the lookback cap, which is one reason payers sometimes characterize ordinary coding disputes in fraud language, and one reason that characterization should be contested rather than accepted.
• Self-funded plans are outside all of it. These protections bind state-regulated plans only. For the roughly 63 percent of covered workers in self-funded arrangements, the contract and ERISA govern.
• Verify your own state. Compilations of these laws vary in currency and some flag entries as unverified. Before building a defense on a lookback cap or notice statute, confirm the current provision, which is a task for your consultant or counsel at the start of the engagement, not an assumption.

Offsets: How Commercial Payers Actually Take the Money

Medicare recoups through a defined demand and collection process. Commercial payers mostly use something blunter: the offset, meaning the payer deducts the alleged overpayment from what it owes you on current and future claims, for different patients and different services, until the balance is satisfied.

Why Offsets Are Operationally Dangerous

• They scramble the books. Remittances arrive short, with the reductions spread across unrelated claims. Practices without disciplined payment posting lose track of what was taken, for which alleged overpayments, and whether the deductions match the demand. Reconciling offsets to the claim level is tedious and absolutely necessary, because duplicate and erroneous offsets are common and invisible without it.
• They reverse the burden. In a demand process, the payer must pursue the money while the practice holds it. An offset means the payer holds the money while the practice pursues it. Every dynamic of the dispute changes when the funds have already moved.
• They can precede the dispute. Unless the contract or state law requires notice and a dispute window, the offset can begin before the practice has meaningfully contested anything. This is why the notice protections in the prior section, and the dispute-window deadline in the contract, are the commercial equivalents of Medicare’s day 30 filing.

Cross-Plan Offsetting

Some payers have gone further, offsetting an alleged overpayment from one plan against payments owed on claims under entirely different plans the payer administers. Federal courts examining the practice under ERISA have treated it with notable skepticism, and a practice seeing deductions that cross plan lines should flag the issue for counsel rather than absorbing it as ordinary accounting noise.

The Standing Defenses

• Demand a claim-level accounting. For every offset, the payer should identify the original claim, the alleged overpayment, the amount taken, and the remittance it was taken from. Refuse to reconcile against lump sums.
• Match offsets against the demand. Confirm that nothing is being taken twice, that disputed claims are not being offset during a contractual dispute window, and that amounts match the payer’s own findings.
• Invoke the notice requirements. Where state law or the contract requires pre-offset notice and a dispute period, a payer that skipped them has handed you both a defense and a regulator-ready complaint.

Extrapolation Without the Statutory Guardrails

Commercial payers and their vendors use statistical sampling and extrapolation exactly as Medicare contractors do: review a sample, compute an error rate, and project it across the universe of comparable claims to produce a demand many multiples of the actual findings.

The critical difference is that none of the Medicare limits apply. Section 1893(f)(3) restricts extrapolation in Medicare Parts A and B to sustained or high error rates or failed educational intervention. No such statute constrains a commercial payer. Whether extrapolation is permitted at all, against claims under a given contract, is a question with three possible sources of an answer: the contract, state law, and the defensibility of the methodology itself.

Ground One: The Contract

Many participation agreements say nothing about extrapolation. A payer projecting a sample error rate across thousands of unexamined claims, under a contract that authorizes review of claims and recovery of overpayments but never mentions statistical estimation, is asserting a right the agreement does not clearly grant. Silence is an argument, and demands have been reduced to the actual sampled findings on exactly that ground.

Ground Two: State Law

Some states regulate or restrict extrapolated recoupment against providers for state-regulated plans, and the lookback caps discussed earlier bound the universe a projection may lawfully cover regardless of what the sample shows.

Ground Three: The Methodology

Every methodological defect catalogued in the companion article in this series on statistical extrapolation applies with equal force to a commercial projection: a contaminated universe, an unreproducible sample, inadequate precision, variable methods applied to binary determinations, systematic bias, and a one-directional review that counted no underpayments. Commercial vendor methodologies are frequently less rigorous than contractor methodologies built under the Program Integrity Manual, which makes them more vulnerable, not less. The forum differs, since the challenge is pressed through the contract’s dispute process rather than before an ALJ, but the statistics are the statistics, and an expert analysis that would win at OMHA is equally potent in a payer negotiation.

The practical rule: never accept a commercial extrapolated demand at face value. Demand the complete methodology, the universe definition, the sampling frame, and the claim-level findings, and have both the sampled denials and the statistics independently reviewed before any number is discussed.

The Response Playbook: The First 30 Days

• Identify the sender and the plan types. Internal recovery unit, contingency vendor, or SIU, and for each claim, fully insured or self-funded. These two determinations set the risk level and the applicable rulebook.
• Calendar the deadline from the letter and the contract, not from Medicare habit. Commercial windows vary, extensions are frequently available on request, and a documented extension request is itself evidence of good faith.
• Pull the current contract, every amendment, and the incorporated manuals. Locate the audit, lookback, overpayment, offset, and dispute provisions before producing anything. If the practice does not hold the current version, request it in writing immediately.
• Check the state law overlay. For the fully insured claims, confirm the lookback cap and notice requirements and identify every claim in the demand that falls outside them.
• Demand specificity. A compliant response requires knowing exactly what is alleged: claim-level findings, the policy basis for each, the review criteria applied, and the complete sampling methodology if anything is extrapolated. A demand that cannot be tied to specific claims and policies is not yet a demand you can evaluate, and saying so in writing is a legitimate first response.
• Audit your own claims before producing. The same discipline the companion article on Medicare records requests prescribes applies here: an independent pre-submission review by credentialed auditors tells you your actual exposure, surfaces documentation that exists but was not going to be included, and reveals whether the problem is isolated or systemic.
• Implement a documentation hold and produce a complete, organized response. Legible, indexed, claim by claim, with signature attestations where needed, retained in full with proof of delivery. Commercial reviewers deny on incomplete submissions exactly as Medicare reviewers do.
• Verify the math on any findings. Recalculate the payer’s numbers against the contracted fee schedule and your remittance data. Vendor demands containing duplicated claims, previously adjusted claims, and incorrect contracted rates are common enough that the recalculation routinely pays for itself.
• Do not sign anything reflexively. Settlement offers, repayment agreements, and education attestations presented with the findings can waive dispute rights, admit error characterizations, and establish knowledge relevant to future matters. Every such document gets reviewed before signature, by counsel where the stakes or the language warrant it.

Fighting Back: The Dispute and Appeal Path

The Internal Appeal

The contract defines the appeal levels, their deadlines, and the required contents, and the deadlines are enforced. The appeal itself should be built like a reconsideration filing in the Medicare process: claim-by-claim argument tied to the documentation and the payer’s own published policies, the state law defenses asserted expressly, the extrapolation methodology challenged with expert support where one exists, and every ground stated, because arguments omitted early are harder to introduce late in commercial disputes too.

The Escalation Venues

• The state insurance department, for fully insured plans. A complaint documenting lookback violations, skipped notice requirements, or prompt pay failures invokes a regulator the payer answers to, and the prospect of one changes negotiating behavior.
• The ERISA claims process, for self-funded plans, pursued through the plan’s required appeal procedures, typically on an assignment of benefits and with counsel’s involvement where anti-assignment clauses or litigation are in play.
• Arbitration or litigation, as the contract’s dispute resolution clause directs, for matters that do not resolve below. This is legal territory and belongs to counsel, supported by the audit, coding, and statistical record built earlier.

The Negotiation, Which Is Where Most of These End

Unlike Medicare demands, commercial disputes overwhelmingly resolve by negotiation, and the practice’s leverage is real: the quality of the findings once independently audited, the state law defenses, the methodology defects in any projection, the payer’s need for the network and its exposure to its own regulator, and the relationship’s ongoing value. Practices that arrive with an independent audit showing the payer’s error rate is overstated, a list of claims outside the lawful lookback, and an expert report dismantling the extrapolation routinely settle for a fraction of the demand. Practices that arrive with an apology settle for the demand.

Negotiate the Future, Not Just the Number

A settlement is also the moment to address the terms that produced the dispute: prospective clarification of the documentation standard at issue, removal from prepayment review, and where the relationship justifies it, amendment of the audit and offset provisions themselves. Money resolves the past. Terms prevent the sequel.

When the Letter Comes From the Special Investigations Unit

An SIU matter is categorically different from a payment integrity review, and it calls for the posture a UPIC letter calls for on the Medicare side.

• Engage healthcare counsel before responding. SIU productions can become evidence in insurance fraud referrals, law enforcement matters, and network terminations. Scope, privilege, and strategy decisions belong with counsel from the first letter, with DoctorsManagement supplying the coding, documentation, and statistical analysis under counsel’s direction.
• Expect information sharing. SIUs participate in industry anti-fraud organizations and share findings across payers, which is how one payer’s investigation becomes several payers’ audits.
• Watch for the fraud framing. Characterizing a coding disagreement as fraud conveniently removes lookback caps and escalates leverage. The characterization itself should be contested where the facts are a documentation or interpretation dispute, which they usually are.
• Remember the federal spillover. Where the claims involve Medicare Advantage or other federally funded plans, the matter can carry False Claims Act exposure, and findings of systemic error raise the identification and repayment obligations covered in the companion article on the 60-day overpayment rule.
• Protect the network relationship deliberately. Prepayment flags and termination threats are SIU tools. Both are negotiable, and both are far easier to resolve before they take effect than after.

Prevention: Winning the Audit Before It Starts

• Review audit terms at contracting, when you have leverage. Lookback length, audit frequency, offset notice, extrapolation rights, and dispute procedures are all negotiable before signature and nearly impossible to change during a dispute. Every new agreement and every amendment deserves that review.
• Maintain the contract file. Current agreements, all amendments, incorporated manuals, and a one-page summary of audit-relevant terms per payer.
• Hold documentation to one standard. Practices that document to the Medicare standard across all payers rarely face commercial findings they cannot defend, because the commercial policies largely track the same medical necessity and documentation logic.
• Watch your own data the way the payer does. The analytics that flag outliers are not secret in principle: coding distribution, modifier rates, and utilization against specialty norms. Internal monitoring finds the outliers first and either corrects them or documents why they are legitimate.
• Audit the payers back. Recoupment flows one direction only if the practice lets it. Systematic underpayment against contracted rates is at least as common as overpayment, and a practice that reconciles remittances to its fee schedules enters every audit negotiation holding its own demand. DoctorsManagement’s published work on recovering payer underpayments covers that discipline, and it belongs in the same operational rhythm as audit defense.

How DoctorsManagement Defends Commercial Payer Audits

DoctorsManagement defends practices in commercial payer audits with the same combination that drives our Medicare audit work: credentialed coding and documentation expertise, statistical and economic analysis for anything extrapolated, and managed care experience on the contract and negotiation side. Our auditors hold both the Certified Professional Coder and Certified Professional Medical Auditor credentials and train continuously through NAMAS, our education division.

Our commercial audit services include:

• Audit Response Management: Sender and plan-type analysis, deadline management, demand-for-specificity correspondence, pre-submission internal audit of the requested claims, and preparation of a complete, defensible production
• Findings Verification: Independent review of every denied claim, recalculation of the payer’s math against contracted rates and remittance data, and identification of duplicated, previously adjusted, and out-of-lookback claims
• Extrapolation Defense: Statistical analysis of the vendor’s sampling methodology and recalculation of the demand under corrected assumptions, by the same statisticians and economists who challenge Medicare projections
• Dispute and Negotiation Support: Appeal preparation under the contract’s dispute process, settlement analysis, and negotiation support grounded in the independently verified findings
• Managed Care Contract Review: Business-terms review of audit, lookback, offset, and dispute provisions at contracting and renewal, and underpayment recovery analysis against contracted fee schedules
• SIU Matter Support: Coding, documentation, and statistical analysis performed under the direction of your healthcare counsel

DoctorsManagement is a healthcare consulting, accounting, and auditing firm, not a law firm. We do not provide legal advice, interpret contracts as a legal matter, litigate, or represent practices in arbitration or before regulators; for SIU matters, ERISA disputes, and contract enforcement, we work alongside your healthcare counsel and supply the analytical record the legal strategy depends on.

If your practice has received a commercial payer audit letter or is watching offsets erode its remittances, contact DoctorsManagement at www.doctorsmanagement.com/audit-appeal-defense or call (800) 635-4040.

Frequently Asked Questions

How is a commercial payer audit different from a Medicare audit?

A Medicare audit operates inside a statutory framework: fixed response deadlines, five defined appeal levels, statutory limits on extrapolation, and a limitation on recoupment during early appeals. A commercial audit is governed by your participation agreement, supplemented by state insurance law for fully insured plans and by ERISA for self-funded plans. Deadlines, appeal rights, lookbacks, extrapolation, and offset rights are all contract and state law questions, which means the first document to read is your contract, not a CMS manual.

Why are commercial payer audits increasing?

Benchmark data covering the first three quarters of 2025 showed external payer audit activity up 30 percent year over year in dollars at risk, with commercial payers accounting for 45 percent of at-risk amounts versus 28 percent for Medicare and Medicaid combined. The drivers are a growing payment integrity vendor industry, often paid on contingency, data mining that scores every submitted claim, migration of Medicare-style techniques including extrapolation into commercial review, and new dispute categories such as telehealth, where denials rose 84 percent.

How far back can a commercial payer recoup?

For fully insured, state-regulated plans, most states cap recoupment lookbacks, commonly in the 12 to 24 month range, with published examples running from 6 months in Maryland to 30 months in Florida, and fraud allegations typically extending or removing the cap. For self-funded ERISA plans, which cover roughly 63 percent of workers with employer coverage, state caps generally do not apply and the contract governs. Always confirm your state’s current statute before relying on a specific figure.

Can a commercial payer just deduct the money from my future payments?

Usually, yes, through offset rights in the participation agreement, subject to any state notice and dispute-window requirements for fully insured plans. Offsets reverse the leverage of the dispute because the payer holds the money while you contest it. The defenses are claim-level accounting of every deduction, reconciliation against the demand to catch duplicates and errors, and enforcement of any required pre-offset notice. Deductions that cross plan lines raise additional issues under ERISA and belong with counsel.

Can commercial payers use extrapolation?

There is no commercial equivalent of the Medicare statute that restricts extrapolation, so the answer depends on the contract, state law, and the methodology. Many contracts never mention extrapolation, which supports an argument that the payer is asserting a right the agreement does not grant. Where a projection is used, every methodological challenge available against a Medicare extrapolation applies: universe defects, unreproducible samples, inadequate precision, bias, and one-directional review. Demand the full methodology and have it independently analyzed before negotiating any number.

What is a Special Investigations Unit and why does it matter who sent the letter?

The SIU is the payer’s fraud, waste, and abuse arm, distinct from its payment accuracy and recovery operations. SIUs can impose prepayment review, refer matters to state fraud bureaus and law enforcement, share findings with other payers through industry anti-fraud organizations, and initiate network termination. A payment integrity letter is a financial dispute; an SIU letter is a potential enforcement matter and calls for healthcare counsel before any response.

Does it matter whether the patient’s plan is fully insured or self-funded?

It is the single most important classification in the audit. State lookback caps, notice requirements, prompt pay rules, and the state insurance department as an escalation venue apply to fully insured plans. Self-funded ERISA plans sit outside those protections, governed by the plan document, the contract, and federal claims procedures. A single audit frequently mixes both, so sort the claims by funding type before building the defense.

Should I just repay to protect the network relationship?

Not before verifying the findings. Vendor demands routinely contain duplicated claims, previously adjusted claims, out-of-lookback claims, and inflated projections, and commercial disputes overwhelmingly resolve by negotiation, where an independent audit of the findings is the leverage. Repaying unverified findings also concedes an error characterization that feeds future targeting. The relationship argument runs the other way: payers respect practices that dispute professionally and document thoroughly.

What should I negotiate in my payer contracts to protect against audits?

Lookback length, audit frequency and scope, advance notice before recoupment or offset, a defined dispute window during which no offset may occur, limits or clarity on extrapolation, reasonable records deadlines, and a workable dispute resolution process. These terms are negotiable at contracting and renewal and essentially fixed once a dispute begins, which is why contract review belongs in the compliance calendar rather than the crisis response.

How can DoctorsManagement help with a commercial payer audit?

We manage the response end to end: sender and plan-type analysis, pre-submission internal audit by credentialed auditors, findings verification and recalculation against contracted rates, statistical analysis of any extrapolation, appeal preparation under the contract’s process, negotiation support, and managed care contract review on the business terms. We are a consulting, accounting, and auditing firm rather than a law firm, and for SIU, ERISA, and litigation matters we work alongside your counsel. Contact us at www.doctorsmanagement.com/contact-us or call (800) 635-4040.

External Resources and References

• Fierce Healthcare: Payer Audits, Denial Amounts Rise Again in 2025, Vendor Data Show
• American Medical Association: Payor Audits on the Rise, How Private Practices Can Get Ready
• CareCost Estimate: Recoupment Limits by State, Lookback Windows, Notice and Offset
• Department of Justice: The False Claims Act
• OIG Fraud and Abuse Laws for Physicians
• OIG Work Plan
• CMS Regulations and Guidance
• DoctorsManagement Audit Appeal and Defense
• DoctorsManagement Coding and Documentation Review
• DoctorsManagement Healthcare Compliance Audit
• DoctorsManagement Blog: The Silent Revenue Leak, Payer Underpayments
• DoctorsManagement Blog: 10 Pitfalls to Avoid in Managed Care Contract Negotiations
• DoctorsManagement Blog: The 7 Types of Medicare Audits Explained
• DoctorsManagement Total Compliance Solution

This article is provided for informational and educational purposes only and does not constitute legal advice. DoctorsManagement is a healthcare consulting, accounting, and auditing firm. It is not a law firm, does not practice law, and does not interpret contracts as a legal matter, litigate, arbitrate, or represent providers before regulators.

Commercial payer audit rights, state recoupment and notice statutes, and ERISA requirements vary by state, by plan, and by contract, and the figures and state examples cited reflect published compilations that should be independently verified before being relied upon. Practices facing a commercial audit, and particularly any matter involving a Special Investigations Unit, should consult qualified healthcare counsel. DoctorsManagement is available to provide the audit, coding, statistical, and negotiation support components of the defense alongside counsel.

The post Commercial Payer Audits: Why Private Insurance Recoupments Are Rising and How to Fight Them appeared first on DoctorsManagement.

Some awards reward the achievement that’s easiest to see, the biggest numbers, the fastest growth. nGAGE wanted its name next to the one that rewards something harder to spot: a practice genuinely getting patient experience right. That’s why nGAGE chose to back the Patient Experience Award.

Why patient experience, specifically

Dental care gets judged often on clinical outcomes. But ask most patients what actually shapes how they feel about a practice, and it’s rarely just the treatment chair. It’s whether the reminder arrived on time. Whether rescheduling took one message or five. Whether the practice seemed to know them, or just processed them.

That’s not a small operational detail. For a DSO managing communications across dozens or hundreds of sites, it’s the difference between patients who feel looked after and patients who feel handled. 

Rebecca Lyon, general manager at nGAGE Dentally, puts it plainly: ‘We built nGAGE because the gap between good clinical care and good patient experience usually comes down to communication. Communication can be the thing that’s easiest to get right, and yet the easiest to let slip.

‘The benefit of keeping the door open for existing patients, rather than just focusing on acquiring new patients is something our customers have seen first-hand with nGAGE. Sponsoring this award isn’t about visibility for us. It’s about putting a spotlight on something the industry doesn’t talk about enough.’

Why it matters to nGAGE

nGAGE exists to help practices communicate with their patients with the ‘right message at the right time’ reliably and without it becoming another admin burden on already-stretched front-desk teams. Every improvement we chase in the product comes back to one question: does this make a patient feel more looked after, or less?

There’s another layer to this that’s easy to miss. Patient experience isn’t only about being on time with a reminder, it’s about noticing what a patient might actually want next, and saying so, rather than letting the moment quietly pass. A check-up is often the natural point to mention a hygiene appointment. A hygiene visit can be exactly the right moment to talk through tooth whitening.

An extraction might open a conversation about an implant, if that’s genuinely the right path for that patient. None of this works as a script. It only works when it’s offered at the point it’s relevant, so patients feel given a real choice, not sold to, and not overlooked either.

Leanne Smith, head of commercial operations adds: ‘The DSO Awards celebrate a lot of things worth celebrating; growth, innovation, clinical leadership. We wanted to make sure patient experience had its own moment too, because it’s the hardest thing to measure and often the easiest to overlook when a group is scaling fast.’

What the Patient Experience Award recognises

Not the biggest practice group, and not the flashiest technology, but the entries that show a genuine, considered approach to making patients feel informed, respected, and in control of their own care. That might be a DSO that rebuilt its communication system from scratch. It might be one that simply listened harder to what patients were telling them and changed something small but meaningful as a result.

Whoever wins, nGAGE thinks the shortlist alone says something useful: that patient experience is being taken seriously as a strategic priority, not treated as a soft add-on to the ‘real’ metrics.

A note on where this sits for nGAGE

This sponsorship isn’t a one-off. It reflects what nGAGE thinks the next few years of dental communications should look like, less about which platform sends the most messages, and more about which organisations use communication to make patients feel genuinely cared for. If this award pushes that conversation forward even slightly, it’s done its job.

Find out more about the DSO Awards.

Find out more about nGAGE.

This article is sponsored by nGAGE.

ACG has launched RecycloPod PP Ultra, a polypropylene-based blister packaging system that combines moisture and oxygen barrier protection with design for recyclability.

The company identified a gap in the market where existing polypropylene blister solutions can meet moisture barrier requirements, while oxygen protection can remain a challenge. RecycloPod PP Ultra has been developed to address both requirements and provide a barrier solution for sensitive pharmaceutical formulations.

The launch also introduces ACG’s ‘Pod’ family of sustainable packaging solutions. Inspired by the way a pea pod protects what is inside, the range is designed with sustainability, future packaging needs and evolving regulatory requirements in mind.

Developed in collaboration with customers, RecycloPod PP Ultra uses a PP/EVOH/PP forming structure with a water vapour transmission rate of less than 0.60 g/m² per day and an oxygen transmission rate of less than 0.20 cm³/m² per day.

Used with a PP lidding film, the system creates a predominantly polypropylene blister structure designed for thermoforming and sealing on pharmaceutical packaging lines.

The development comes as manufacturers prepare for evolving requirements, including the EU Packaging and Packaging Waste Regulation (PPWR), and an increased focus on packaging recyclability.

Dr Akbar Ali, Head – Development & Technology at ACG Packaging Materials, said: “Pharmaceutical companies should not have to choose between protecting their product and progressing their packaging sustainability objectives.”

“With RecycloPod PP Ultra, our objective was to provide both high moisture and oxygen barrier protection while meeting the practical requirements of pharmaceutical manufacturing and supporting design for recyclability.”

SR Shivshankar CEO, ACG Packaging Materials, adds: “RecycloPod PP Ultra forms part of our wider sustainability strategy. We are participating in the Science Based Targets initiative (SBTi) as part of its net-zero ambitions and using digitalisation to support more efficient and sustainable manufacturing, with facilities recognised by the World Economic Forum’s Global Lighthouse Network.

At ACG, we also monitor more than 125 sustainability parameters through the framework underpinning our Sustainability Report.

Together with continued investment in packaging innovation, these initiatives reflect ACG’s focus on future readiness – helping both our own operations and pharmaceutical customers prepare for a lower-impact, increasingly circular manufacturing environment.”

The post ACG launches RecycloPod PP Ultra polypropylene blister packaging system appeared first on Express Pharma.

Deal value in the pharmaceuticals industry decreased by 78.8 per cent in September 2026 compared to September 2025, according to GlobalData.

In September 2026, the healthcare industry reported 85 deals worth $6.2 billion, compared to the last 12 months’ average of 90 deals worth $31.8 billion for the period from September 2025 to August 2026.

The three major deals reported in September 2026 were Telix Pharmaceuticals Limited’s acquisition of ITM Isotope Technologies Munich SE, a biotechnology company that develops and produces therapeutic and diagnostic radiopharmaceuticals and radioisotopes to treat cancer, for up to $2.3 billion; Puig’s acquisition of a 50 per cent stake in ISDIN SA, a pharmaceutical company that produces and distributes skin care products, for $1.39 billion; and GSK plc’s acquisition of a potential best-in-class trispecific T cell-engager (TCE) from Chimagen Biosciences Ltd, a clinical-stage biotechnology company focused on discovering and developing innovative multi-specific antibody therapeutics, for a total transaction value of up to $750 million.

VC funding increases 21.6 per cent

Venture capital funding increased by 21.6 per cent in September 2026 compared to September 2025.

The healthcare industry reported 124 venture capital (VC) deals worth $4.2 billion in September 2026, compared to the last 12 months’ average of 114 deals worth $3.4 billion for the period from September 2025 to August 2026.

The three major VC deals reported in September 2026 were Enveda Therapeutics Inc.’s $311 million Series E financing to advance ENV-294, ENV-308, and ENV-6946 into later-stage trials and additional indications; Anew Labs, a China based full-chain artificial intelligence drug discovery and development platform, raising $290 million in a financing round to establish a suitable organisational incentive system around its AI-driven pharmaceutical business; and Encoded Therapeutics Inc., a clinical-stage biotechnology company developing precision genetic medicines for severe neurological disorders, raising $275 million in a Series F financing round to support the pivotal study of ETX101.

The post Pharma deal value falls 78.8% in September 2026: GlobalData appeared first on Express Pharma.

Receiving a complaint, claim or GDC letter can leave dentists feeling overwhelmed. Hannah from Densura explains how the team provides dental complaints support, from gathering clinical records and arranging dento-legal advice to keeping policyholders informed.

For most dentists, a letter of complaint, a solicitor’s claim, or an envelope from the General Dental Council is one of the worst moments of their professional life. It’s daunting, it’s personal, and it can feel very lonely.

At Densura, the person many policyholders speak to first is Hannah, client advocacy lead in the advocacy team. Her job is to be the calm, capable voice on the other end of the phone – the one who turns a frightening situation into a manageable plan.

We sat down with Hannah to find out exactly what happens when a dentist picks up the phone to Densura, and why she loves doing the job she does.

Could you introduce yourself and your role at Densura?

My name’s Hannah. I’m the client advocacy lead for Densura, and I assist at the first point of contact with our dentists when they’ve received a complaint or a claim. I help facilitate arranging documentation and introduction to the dento-legal advisors.

You’re right at the very front of the business. When a dentist gets a complaint, how do they get help, and how do they get started?

First and foremost, it’s the most daunting experience for a dentist. In order to contact us, you can find contact details for the notifications department on the website by going to densura.com, or having a little look through the policy documentation – your policy schedule has a list of useful contacts within that information. You can contact us by telephone and by email.

We completely appreciate that receiving a complaint can be the worst feeling in the world. I always say to our policyholders, try not to worry too much at this stage. I always look at complaints like a bit of a puzzle that we must piece together, and I explain to them that we will get them to support and we are absolutely on their side.

When a dentist knows they’ve got a complaint and they’re going to need help from Densura, what should they provide right at the beginning of a matter?

The first step is the complaint correspondence and the clinical records. The clinical records give us a full background of the treatment and any follow-up care, but they also allow us to understand the dates of the treatment – we have our own checks to complete to make sure there’s cover in place at the material times of the incident, or the treatment in question.

The clinical records add invaluable data and information to allow the dento-legal advisors to understand that story and form a view to enable them to provide that advice. We pride ourselves on the quality of advice our dento-legal advisors provide, so it’s really important that dentists prepare this documentation from the outset.

What if a dentist is in a situation that feels quite urgent – maybe they’ve got a patient coming in later that day and they just want to talk to somebody? How can we help with that?

I look at things like that from a risk management perspective. I’ll go through the details of the concerns, ascertain whether or not that patient is due in that day. If there’s an opportunity to get those clinical records at an early stage, we will. If not, again, it’s about risk assessing – is there any immediate medical emergency associated with the situation that needs an urgent clinical opinion?

We will always do what we can to help in times of emergencies. Densura are always on your side, and we will do what we can to make sure a dentist feels heard before the end of the day.

You ask for a lot of information – detailed records, radiographs, correspondence, the complaint letter. Why do you need so much information so quickly, and how does it help the dento-legal advisor?

It’s about piecing together a puzzle. A dentist may remember certain things from an appointment many months later that differ to the clinical records. The clinical records are contemporaneous – they were written in live time during that appointment – so we’ll have that full story from the outset. It helps our dento-legal advisors review everything and provide the most appropriate, bespoke advice.

If you’re asking for clinical records and X-rays, is it okay for a practice manager to help a dentist and send that material to you?

I fully understand that some practices work very differently in ways of authority to accessing the records. Some dentists might not be able to download records, and the authority might only rest with the practice manager. I tend to say, as standard, to a lot of dentists that call me: ‘I’m going to email you a full list of the information that we need – feel free to forward it to your practice manager. I’m sure they would be more than happy to assist, and arrange dispatch to me as soon as possible.’

Sometimes a claim can take months or even years to progress, which is frustrating. How do you ensure clients are kept up to date with what’s happening and what the progress of that claim is?

Claims can often bubble on in the background for a very long time, and it’s the most frustrating, unsettling and upsetting period of time for a dentist. We completely appreciate that. They sometimes feel alone in situations like that, because updates can often be few and far between, depending on the progress of the case, the claimant solicitor, and whether there are any other dentists or co-defendants involved.

As the advocacy team, we always ensure there’s a rolling diary on our claims, so we’re constantly seeking updates from insurers, finding out the latest position. Whatever the update is, no matter how big or how small, either the dento-legal advisor or someone from the advocacy team will reach out and update the policyholder. Sometimes those updates may seem a little confusing, and that’s absolutely fine – we’re just a phone call away, and we’re more than happy to talk things through to make sure the understanding is there.

If a dentist gets a letter from the GDC, what happens, and how can they get help?

The GDC process can involve a few different types of letters. There are two very early-stage letters. One’s called an Initial Inquiries Pilot, and the other is a generalised Request for Records. They differ slightly – the Initial Inquiries Pilot will only ask you for a copy of the patient records, or it might just say we’ve received concerns, we don’t need anything from you, we will review and come back to you in due course.

The Request for Records involves sending records, copies of your indemnity history certificates and working arrangements – you usually have around seven days to provide that information. The GDC will then review everything and come back with any outcome, whether they want to investigate further or not.

And once a dentist or policyholder has received that letter from the GDC, does the same notification process apply?

Yes – do contact the Densura complaints and advocacy team as soon as physically possible. We will review, arrange to ask for all of the relevant records and any previous complaint correspondence, and get you in touch with a dento-legal advisor. We’ll continue to support you throughout the process, and advise you appropriately on what information you need to gather and send to the GDC.

Who else can dentists turn to for support?

We always say do rely on support from your practice managers, friends and family. When times do feel quite heavy, we also include within our policies a counselling helpline that’s completely confidential – it’s just that extra layer of support, should they feel they need it, and I think it’s a really, really good benefit to have; this benefit is not limited to work related matters, any of our Densura policyholders and their families can use this helpline for personal matters too.

Whilst our team here at Densura will do absolutely everything, I tend to say to dentists quite a lot: I know these situations feel incredibly heavy and isolating – just please feel free to ring me. Whilst I can’t help clinically, I am that moral support on the front end, so please do reach out.

You’re obviously very experienced in this role, and dentists are lucky to have you on the front line. How did you get to this point, and what’s your background?

“I’ve got an extensive background in complaints management, in a couple of large dental corporate groups. I’ve done around eight years in complaints management, assisting predominantly practices at practice level – explaining how the complaint process should work and ensuring the process is in compliance with the General Dental Council standards, specifically Principle Five, and how a dentist needs to manage in accordance with those standards.

I came to a point where I really decided I just wanted to help dentists. I’ve always loved dealing with complaints and tricky situations, but I felt like there was a time I didn’t feel very valuable to dentists, and I really wanted to explore that route – to understand a bit more about the dentist journey when receiving a complaint, because I did know it can be quite isolating, and I wanted to see if I was able to make a difference with that. So I decided to explore my career with a dental indemnity provider, and that’s how I’ve ended up with Densura.

Finally, what does support mean to you as an advocacy team member?

Support means an awful lot, especially to the wider advocacy team. We support each other in ways that are really quite admirable. Between our small team and the dento-legal advisors, we lean on each other, and I think that really does show with our policyholders. If we don’t know the answer to something, but we’re very aware that a dentist really needs some urgent advice, we will make sure we find the answer, or arrange someone that does.

The job doesn’t just end once a complaint response has been provided to a dentist – it’s about risk managing the situations before us. Risk management as a whole is such an important thing in the world of dental indemnity. We want to support our dentists to make them the very best dentists they can continue to be. We’re always pushing and encouraging each other – policyholders, dentists and colleagues.

I’m just proud to be able to work for Densura. Being able to say that we support, both professionally and personally – that’s a really big thing.

If you need us

Whether it’s a complaint, a claim, or a letter from the GDC, the process starts the same way: contact the Densura complaints and advocacy team as soon as you can, by phone or email – details are on your policy schedule or at densura.com. Have your clinical records, correspondence and any radiographs ready to send across, and someone like Hannah will take it from there.

As Hannah puts it: you’re never alone.

This article is sponsored by Densura.

The Ministry of Health has proposed, through draft G.S.R. 791(E) dated 8 September 2026, mandatory CCTV surveillance at pharmacies for the retail supply of prescription medicines, with recordings retained for at least three months. The proposal aims to strengthen oversight of Schedule H, H1 and X drugs and curb unauthorised sales. It remains a draft, pending stakeholder comments and final notification.

The objective is legitimate. The question is whether the regulatory design is proportionate to the problem. The Drugs Rules, 1945 already prescribe significant controls, and stronger enforcement is a legitimate regulatory objective. But CCTV may strengthen evidentiary oversight; it cannot, by itself, substitute for an effective prescription-control regime.

The draft refers to “any drug”, while the Government’s stated objective is to strengthen oversight of Schedule H, H1 and X drugs. As drafted, Rule 65(2A) could therefore require CCTV surveillance for the retail supply of any prescription drug, not merely drugs falling within those schedules. If the intended scope is limited to higher-risk medicines, the rule should say so expressly. An obligation of this breadth should not be left to interpretation, as ambiguity could result in inconsistent enforcement, compliance exposure and avoidable litigation.

A pharmacist can still sell a prescription drug without a valid prescription in front of a camera. CCTV does not authenticate the prescription, establish that the prescriber actually issued it, determine whether the quantity is appropriate, or verify that the medicine supplied corresponds to the prescription. At best, it creates retrospective evidence of the transaction. If CCTV is to have genuine regulatory value, it should form part of an auditable evidentiary chain linking the prescription to the dispensing record, transaction receipt and CCTV timestamp. The draft does not establish this linkage. CCTV should therefore operate as corroborative evidence, not as a substitute for prescription verification and transaction records.

The draft also leaves fundamental compliance questions unanswered. How many cameras are required? Which areas must they cover? Must the dispensing counter be visible? What resolution is required? Is continuous recording necessary? Must the system have time-stamping, backup and tamper protection? Can cloud storage be used? Does the prescription itself need to be captured? An obligation without objective standards can invite subjective enforcement. If the Government mandates technology, it should also define minimum technical standards for compliance.

The proposed three-month retention period is understandable from an enforcement perspective, but it is not matched by an equivalent framework for access, security and use. Who may access the footage? Can a Drugs Inspector demand the entire archive? What happens after three months? These questions matter because pharmacy CCTV can reveal information about an individual’s treatment and health, including when a person sought a particular medicine.

Privacy should therefore be addressed through design. The final rules should establish purpose limitation, controlled access, security, disclosure protocols and deletion requirements. If the State requires the private sector to create and retain a sensitive surveillance record, it should also prescribe the conditions under which that record may be accessed and used. The interaction with the DPDP Act, the constitutional right to privacy and patient confidentiality merits careful consideration.

Operational failures also require attention. A patient may present a valid prescription while CCTV is temporarily unavailable because of a power interruption or hardware failure. The final framework needs a clear downtime protocol and should distinguish deliberate evasion from bona fide technical failure despite reasonable maintenance.

The compliance burden will not be uniform. Large pharmacy chains may already have sophisticated CCTV systems, while a small independent pharmacy may face significant costs of installation, storage, maintenance and data security. If the regulatory concern is concentrated in particular categories of medicines, a risk-based approach should be considered. Regulation should target risk rather than impose identical technological obligations regardless of the nature, scale or risk profile of the dispensing activity.

Hospitals, institutional pharmacies and e-pharmacies also require express treatment. Dispensing may occur pursuant to inpatient orders or emergency protocols, while online transactions may involve digital prescription verification, warehouses and fulfilment centres. Where does “supply” occur for purposes of the CCTV requirement? The framework should be technologically neutral and clarify how these models are covered.

The more fundamental question is whether CCTV is the right regulatory intervention. Other tools could strengthen compliance: electronic prescription verification, transaction-level digital records, prescription identifiers, stronger Schedule H1 record systems, targeted inspections, risk-based surveillance and supply-chain traceability. CCTV may complement these mechanisms, but it should not become a substitute for them.

A workable framework should therefore define the drugs and premises covered; connect prescription, dispensing, transaction and CCTV records; prescribe minimum technical and data-governance standards; provide a safe harbour or alternative process for bona fide technical failures; and address hospitals, institutional pharmacies, e-pharmacies and fulfilment centres.

The Government’s objective is legitimate, but the instrument must be proportionate, precise and workable. As drafted, the proposal is potentially overbroad, under-specified and insufficiently attentive to the sensitivity of the data captured. A more workable pathway would be to define the drugs and premises covered, prescribe clear technical and data-governance standards, phase in compliance, and begin with risk-based inspections and audits before considering a broader CCTV mandate. The issue is not whether pharmacies need stronger oversight; it is whether a blanket CCTV mandate is the right regulatory tool. A camera can record a transaction; it cannot make the transaction lawful. Regulation must do that

(Disclaimer: The above views are based on a review of the quoted draft rules and are views of the author based on his experience in the sector. The views are not to be considered as legal advice.)

The post CCTV at pharmacies: Is surveillance enough to curb unauthorised drug sales? appeared first on Express Pharma.

Now, a new study shows that the antimicrobial protein calprotectin, found in high concentrations in the guts of newborn mice, is expressed by intestinal epithelial cells in response to commensal bacteria colonizing the gut. More specifically, the healthy newborn mice “express high concentrations of the S100 calcium-binding protein A8/A9 antimicrobial heterodimer calprotectin” and that this early up-regulation in the intestine is driven by initial exposure to commensal bacteria.

They also found that newborn mice with impaired calprotectin expression or poor microbiota colonization were more susceptible to sepsis and death post-infection. However, when the mice were given calprotectin, it rescued the microbiota-depleted pups from infection.

This work is published in Science Translational Medicine in the paper, “Early-life microbiota direct an epithelial S100 program required for neonatal immunity.”

The main source of calprotectin in the neonatal intestine was found to be microbiota colonization induced S100A9 expression by intestinal epithelial cells (IECs) and epithelial cells. And neonatal IEC-specific S100A9 knockout pups were highly susceptible to infection.

The study also sheds light on the specific mechanisms that provide early-life immunity against potentially deadly pathogens such as Staphylococcus aureus, Listeria monocytogenes, and Streptococcus pneumoniae, at a crucial time when newborns lack other immune defenses.

In mice and in human intestinal organoids, the researchers demonstrated that commensal microbes such as Lactobacillus produce the metabolite indole-3-lactic acid (ILA), which activates signaling in neonatal epithelial cells to increase the production of intestinal calprotectin.

Together, these findings suggest that microbiota-epithelial dynamics at birth can help program early-life immunity, the researchers write, with potential implications for probiotic approaches that target epithelial cells to prevent neonatal sepsis. This result, plus the authors’ finding that calprotectin is present in the guts of human newborns less than two days old (but not in seven-year-old infants), suggests a similar early-life immune mechanism may be at play in humans.

The post Gut Microbes Trigger Calprotectin to Protect Newborns from Infection appeared first on GEN - Genetic Engineering and Biotechnology News.

Headed by Stephen Clark MD, PhD, founder of the Kallel Foundation, the team sequenced Jonathan’s genome and identified 287 unique gene variants in this remarkably old Aldabra giant tortoise (Aldabrachelys gigantea) that may reduce the usual effects of aging.

When comparing Jonathan’s epigenome—the “on/off” switches on his genes—with that of younger giant tortoises of the same species, the team found that switches controlling Jonathan’s DNA repair and metabolism genes were very similar to those in his younger relatives. Usually, the epigenome changes over time, contributing to the aging process. This is a key reason why things start to go wrong in older bodies.

“We found that the gene regulators involved in energy production and DNA repair have remained incredibly stable in Jonathan over almost two centuries,” said Justin Gerlach, PhD, at Peterhouse at the University of Cambridge, who was involved in the study.

The study marks the first time the epigenome of a giant tortoise has been investigated. It was led by researchers at the longevity research non-profit Kallel in the U.S., who say that cracking the genetic code of a multi-century life offers unprecedented insights into extreme lifespan.

Clark is senior and corresponding author of the researchers’ published paper in Science Advances, titled “Epigenetic insights into extreme longevity in the world’s oldest terrestrial animal, Jonathan,” in which they concluded “Our findings support a model for aging wherein the maintenance of low methylation entropy in gene promoters is coupled to efficient mitochondrial energy production, efficient RNA processing, and efficient genomic repair.”

The giant tortoises of the Galapagos and Seychelles islands are the extraordinary last survivors of animals that used to dominate the ecology of many of the world’s islands. Aldabra giant tortoises are exceptionally long-lived, but Jonathan is about 100 years older than most of his species. He’s thought to have hatched in 1832—making him a contemporary of Charles Darwin and Queen Victoria.

Jonathan has lived most of his life on the island of St. Helena—a British Overseas Territory in the South Atlantic Ocean—in the grounds of the residence of the governor of St. Helena. Jonathan arrived from the Seychelles 144 years ago, already fully grown, as a gift to the governor.

Gerlach has studied the ecology and conservation of giant tortoises for several decades, but this is the first time he has studied their exceptionally long lives. Gerlach said, “There are few creatures that could tell us more about aging than the giant tortoises of the Galapagos and Seychelles islands. Working with a really old giant tortoise is such a privilege: you get a sense of the tortoise being your collaborator, not your study subject.”

For their study the team extracted Jonathan’s genetic material from cheek scrapings rather than a blood draw (they teased the tortoise with a promise of food until he opened his jaws wide), so that they could compare his genome and methylome with those of four other Aldabras, ranging in age from juveniles to older adults. “Because of concerns for Jonathan’s health and his iconic status on St. Helena, a blood draw for DNA sequencing was not permitted,” the authors explained. “Instead, we collected buccal scrapes and saliva samples for genomic DNA (gDNA) isolation.”

The team’s analyses identified genetic variants associated with several known aging pathways, including DNA repair, telomere maintenance, insulin regulation, mitochondrial function, and cancer. The investigators also analyzed Jonathan’s genome’s methylome—or the total picture of his genome’s methylation, which refers to the addition to DNA of tiny methyl chemical tags that impact gene expression. Methylation entropy, a sign of aging, occurs as random changes in methylation patterns accumulate over time. This analysis showed low entropy within specific gene promoters for mitochondrial function, RNA processing, and genome repair. The regions of low methylation entropy observed in Jonathan “suggest that high-fidelity transcription of genes in these pathways may be crucial for long-lived species,” the researchers noted.

“Nature has already solved the puzzle of aging in remarkable ways, and Jonathan’s genome provides a blueprint for cellular resilience,” said Clark. “Our goal is to take these evolutionary insights and immediately translate them into practical, affordable treatments for everyday people. Aging is the greatest risk factor for nearly every chronic disease we face, and through the generosity of philanthropic partners, we can democratize access to longevity medicine.”

In their paper the authors wrote in summary, “… while we identified many genetic variants in Jonathan associated with known aging pathways, our most notable finding is the low entropy maintained within specific gene promoters. This stability is exceptionally pronounced in promoters of genes involved in mitochondrial function and RNA processing. We hypothesize that maintaining this low-entropy state ensures high-fidelity expression in these critical pathways, partially protecting him from age-related decline.”

The post Secrets of Oldest Land Animal’s 194-Year Lifespan Revealed with Epigenetics appeared first on GEN - Genetic Engineering and Biotechnology News.

It might be good to take a look at some of the most common pitfalls that physicians (and other employers) make with their Employee Handbooks:

The Wrong Introduction and Tone

The introduction of any multi-part document sets the tone for the entire piece. And the introduction of your Employee Handbook says a lot about you, your vision, your expectations, and your practice. It’s a good idea to start out welcoming new employees, and letting the staff know that their efforts as a team to build your practice and make it successful are appreciated.

A good exercise would be to read through the first section of your Handbook with an open and objective mind, and then ask yourself: How is that introduction going to come across to an employee? Does it sound like you are welcoming them, or admonishing them?

One tricky issue to navigate is determining the extent to which the language of the Handbook sounds like “legalese.” Certainly, there are a number of core legal / regulatory concepts you should include in your Employee Handbook (like “At Will” employment, in most states), but you don’t want to overwhelm your employees with heavy-handed tone and language.

Using Language That Is Too Vague, or Too Absolute

Obviously, you want an Employee Handbook that is meaningful. And to be meaningful, it should have structure and specifics. For example, stating that a good record of Attendance and Punctuality is important. And you want to give that policy some teeth by stating that employees who do not display good attendance and punctuality are subject to disciplinary actions that may lead to termination.

However, you don’t want to “paint yourself into a corner” by stating an absolute, something like “Employees who are absent 4 or more times within a month will be terminated.” Not only could there be legal reasons that you should not terminate that employee, but you shouldn’t be at the mercy of your own stated policies.

Only make statements in the Handbook that you are prepared to back up 100% of the time, for all employees. (Even your favorite employee, that medical assistant who has been your right-hand person for the last 9 years…) Because showing favoritism when administering your stated policies could easily lead to disgruntled employees.

Forgetting That Healthcare Is Different

One pitfall I see quite frequently is when a medical practice downloads a generic Employee Handbook that could just as easily apply to an auto parts store or a landscaping company. Healthcare employers have some unique issues that often deserve special attention.

For example, does your Handbook clearly address patient confidentiality and HIPAA expectations? Employees should understand that protecting patient information is not optional and that violations can have serious consequences.

Many medical practices also employ individuals whose jobs depend upon maintaining active licenses, certifications, registrations, or continuing education requirements. If a Nurse, Radiology Technician, or other licensed professional allows a credential to expire, what happens then? Spelling out the employees’ responsibility in this regard is a good, proactive practice.

Finally, some practices have vaccine policies or infection-control requirements that should be addressed in writing. Whether it is an annual flu vaccine requirement, an exemption request process, or other workplace health and safety expectation, it is generally better to communicate those expectations clearly before an issue arises, rather than after.

Not Getting Signed Acknowledgement Forms From All Employees

One of the most important functions of the Employee Handbook is that it serves as a compilation of important guidelines and expectations of behaviors that all employees will follow. To ensure that there is widespread understanding and commitment to follow those guidelines, you should ensure that all employees acknowledge that they have received a copy of the Handbook, OR, at the very least, have easy access to a digital copy, AND understand that they are responsible for complying with the stated policies.

Copies of those signed acknowledgment forms should be filed in each employee’s personnel file. Documenting employees’ receipt of your Handbook can be extremely valuable in unemployment hearings, employee relations matters, and employment litigation.

Ignoring Differences in State Regulations

As mentioned above, the concept of “At Will” employment is one of the most important elements that should be included and emphasized in those states where it applies. And it applies in almost all states. (“At Will” employment is the concept whereby the employment is voluntary for both the employer and the employee. Either party may choose to end the relationship at any time, for any lawful reason, or for no reason at all.)

However, there are states where that concept is conditional, rather than absolute. And there is one state (Montana) where it does not apply at all to employees after their probationary period.

There are also differences between the states in numerous issues like:

• Paid and unpaid sick leave requirements (which can change constantly, from year to year)
• Continuation of benefits after termination of employment
• Federal OSHA vs. state-level OSHA
• Granting time off for employees to vote… and more!

Ignoring Local Ordinances

Some markets, like New York City, Los Angeles, Chicago, and many other larger cities have local ordinances that need to be considered when constructing a compliant Employee Handbook.

But you know what? There are some smaller towns and cities that have differences that need to be considered as well. For example, Bloomington, Minnesota has its own sick leave time ordinance… Bernalillo County in New Mexico has paid leave requirements at a county level. So, it’s important to factor in local ordinances, where applicable, when formatting your Employee Handbook.

Forgetting to Update the Handbook When You Make Internal Changes

Many employers put organizational charts in their Handbook, or mention specific Managers or Administrators by name. Which of course, means the Handbook needs to be updated when individuals leave. Sometimes the changes are less obvious. You may decide to update your Benefit offerings to employees, change your office hours on Fridays, or decide you want to prohibit employees from wearing Meta glasses. All these operational changes might well warrant updates to the Handbook.

Not Being Aware of Changes in the Law

If you have not updated your Employee Handbook in the last 5 years, there’s a good chance you have not included mention of the Pregnant Workers Fairness Act (“PWFA”) or the PUMP Act. The PWFA became effective in 2023 and was based on many of the reasonable accommodation concepts of the Americans with Disabilities Act (ADA). This law applies to employers with 15 or more employees and requires employers to provide reasonable accommodations for known limitations due to pregnancy, childbirth, or related medical conditions.

The PUMP Act addresses reasonable break time for nursing mothers, also became effective in 2023, and applies to most employers.

There are other lesser-known revisions to laws that evolve over the years; For example, many employers are surprised to learn that employees generally have a protected right under the National Labor Relations Act to discuss wages and working conditions with each other. Yet many Employee Handbooks still say that discussing wages is prohibited and subject to disciplinary action, thus creating unnecessary legal risk for the employer.

Not Keeping Up With the Times

Sometimes the language within an Employee Handbook will prove just how outdated it is. Does your Social Media policy mention “Twitter”? Because that social media platform was renamed as “X” for years now. Or… your policy on non-smoking may mention “juuling” when, these days, it’s more commonly referred to as “vaping.”

And you might want to take a good hard look at your Dress Code policy. That is where I often find outdated concepts. From listing gender specific lists (“Ladies skirts should not be too short…”) , to some policies banning all tattoos. (Surely, many of your employees under the age of 35 will have tattoos, often very visible.) Times have certainly changed, and many practices will want to keep up with the times.

Not Communicating Handbook Revisions Effectively

When you do end up revising your Employee Handbook, there are a few HR-Best-Practice guidelines that should be followed. First, be sure to tag the revised policy or section with a Revised Date. If you make multiple revisions in various sections at the same time, compile a meaningful summary of the revisions and share it with your employees.

And finally, it is advisable to get each employee to sign a form acknowledging that they were notified of the revisions and have easy access to the new Handbook in its entirety.

HR Services at DoctorsManagement LLC

Employee Handbooks are not set in stone and really should be reviewed periodically for needed updates and other pitfalls. The good news is that we can help you with this task.

Updating Employee Handbooks is one of the many services we provide for our clients here at DoctorsManagement. Whether you just need a fine-tuning, or need to start from scratch with a whole new Handbook, we can tailor one for you that factors in your state/location, as well as the size of your practice and number of employees you have.

Please contact our Director of Human Resources at 865-288-9930 or complete this form if you would like to learn more.

The post Common Employee Handbook Pitfalls for a Medical Practice appeared first on DoctorsManagement.

• The danger of chasing perfection
• Social media before training: a performance killer?
• Are female athletes underfuelled and underhydrated?

The danger of chasing perfection

The High Performance Podcast recently featured former England footballer Michael Owen, and a clip shared on Instagram sparked a fascinating debate about the potential dangers of chasing perfection.

In the clip, Owen discussed former England rugby star Jonny Wilkinson and his relentless approach to practice. According to Owen, Wilkinson would line up 20 balls and try to kick all 20 successfully. If he missed even one, however, he would reset the 20 balls and start again from ball one. Owen admitted that Wilkinson’s mentality fascinated him because it was completely different from his own. Although he acknowledged that this mindset can certainly help an athlete reach the top, he also described it as “pretty damn dangerous.”

Although Owen was fascinated by this relentless pursuit of perfection, he knew that such a mentality would never have worked for him. Instead, he described himself as having what he called a “shit filter.” If he had a bad touch during a game, rather than dwelling on it, he would tell himself: “That’s my bad touch out the way.” This allowed him to move on immediately while continuing to believe that he could be the best player on the pitch.

This clip from The High Performance Podcast is particularly thought-provoking because it highlights two very different approaches to elite performance. Jonny Wilkinson and Michael Owen both reached the highest level of their respective sports, yet they appeared to have very different relationships with mistakes and perfection.

Social media before training: a performance killer?

Lars Johansen, a sports psychologist at Denmark’s national high-performance organisation, recently warned that using social media before exercise can cause mental fatigue and impair physical performance (see here). Johansen highlighted a study showing that participants who used social media for 30 minutes before taking a Yo-Yo Intermittent Recovery Test performed approximately 10% worse than a control group that did not.

The study Johansen referenced examined young football players after 30 minutes of cognitively demanding smartphone use. In the test, players covered an average of 1,610 m compared to 1,780 m in the control condition—a 10.56% reduction in running distance. However, the task was not simply scrolling through Instagram or TikTok; it involved a specifically designed, cognitively demanding smartphone application.

Nevertheless, Johansen likened the physical decline from pre-exercise social media use to “smoking three to four cigarettes before you train.” While acknowledging that a total ban on social media is unrealistic, he strongly advises against using it in the hours leading up to training and competition, when peak physical and mental performance is required.

While the study Johansen cited may be more nuanced than everyday scrolling, his core message about social media’s impact on athletic performance has never been more relevant. If you would like to learn more about mental fatigue, our course, Mental Fatigue in Elite Sport, is definitely worth checking out!

Are female athletes underfuelled and underhydrated?

Recent research from the Gatorade Sports Science Institute has revealed some concerning findings regarding the nutrition and hydration habits of female athletes. The research included over 500 female athletes across various sports and found that 43% of participants began their training in a dehydrated state. Additionally, most athletes failed to sufficiently replenish the sodium they lost while sweating, and over half weren’t taking in enough carbohydrates to support their performance.

These results are troubling and suggest that many female athletes may not be performing at their full potential due to poor hydration, insufficient sodium intake, and inadequate carbohydrate consumption. The researchers also recommend establishing female-specific hydration guidelines instead of relying on data primarily derived from male athletes. By developing female-specific sweat-rate classifications, awareness can be raised about the importance of individualised hydration and sodium replacement strategies for female athletes.

It is important to note that this research was conducted by the Gatorade Sports Science Institute, which may introduce some bias due to industry affiliation. However, the research highlights a significant issue and emphasises the need for greater focus on hydration and fuelling practices among female athletes.

From us this week:

>> New course: Observation Before Intervention: Building Better Coaching Environments
>> New podcast: What Saliva Testing Can Tell Us About Athletes
>> New infographic: Basic Movement Patterns
>> New article: ESSA and Science for Sport Announce Strategic Professional Development Partnership

Access to a growing library of sports science courses

SFS Academy is an all-access membership to premium sports science education.

With SFS Academy, you’ll learn from some of the best coaches around the world as they teach you how to apply the latest research and practice with your athletes.

The post The Danger Of Chasing Perfection appeared first on Science for Sport.

Machine learning models have the potential to make biopharmaceutical process development faster and more efficient by, in theory, allowing scientists to predict the impact of changes to parameters ahead of time.

The problem, according to recent research, is that the high-fidelity process information required to train machine learning models is expensive to generate and, as a result, in short supply.

One potential solution would be to include low-fidelity data, which indicate general process trends, in training sets, says lead author Mohammad Golzarijalal, PhD, a research fellow at the University of Melbourne’s digital bioprocess hub.

“The basic idea is that abundant low-fidelity data teach the model the broad global trend of the process, while a smaller amount of high-fidelity data corrects and refines these trends, aligning surrogate model predictions more closely with the available ground truth.

“A model trained only on limited high-fidelity data can overfit and perform poorly outside the conditions it has already observed. By learning useful trends from lower-cost data, a multi-fidelity model can improve predictive accuracy and explore a wider process space without requiring the same number of expensive experiments,” he says.

More accurate models could improve predictions about cell growth, viability, metabolite concentrations, and product titer. They could also guide media optimization, feeding schedules, seeding density, and operating conditions.

“One example discussed in our review is a recent study, which was performed in our own group, that combined 20,000 simulated CHO fed-batch data points with experimental data from 65 bioreactor runs.

“The multi-fidelity Gaussian-process models predicted final monoclonal-antibody titer more accurately than a model trained only on the experimental data,” Golzarijalal says.

Low-fidelity data

Low-fidelity process data can be from previous production runs or from cultures grown in bioreactor configurations that differ from those in the process under development. Such data can also be generated using low-cost mechanistic or empirical models.

Drug firms already use low-fidelity data to an extent, although, as Golzarijalal points out, use is usually limited. For example, scientists routinely draw on previous experiments to define parameter ranges, develop design-of-experiments studies, and guide process optimization.

“There is an opportunity to use these data more systematically,” he says, adding, “Multi-fidelity algorithms provide a structured way to determine how much information should be transferred from historical or simulated data to a current problem.

“This can make past experience more useful for prediction and decision-making, rather than treating each new program largely in isolation,” Golzarijalal adds.

The post Adding Low-Fidelity Data to ML Training Sets Could Yield Better Process Models appeared first on GEN - Genetic Engineering and Biotechnology News.

Researchers led by Roger Hart, PhD, senior fellow, Big Data Project lead, National Institute for Innovation in Manufacturing Biopharmaceuticals, and senior researcher Kelvin Lee, PhD, professor, University of Delaware, make the case not only for leveraging big data in your own company, but standardizing and sharing key insights industry-wide…without compromising proprietary information.

That opinion is based on results from a big data model developed through the MELLODDY Consortium (Amgen, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, GSK, Janssen, Merck KGaA, Novartis, and Servier).

As Hart, Lee, and colleagues report in a recent paper, the consortium pooled decades of proprietary data—some 2.6 billion data points spanning more than 21 million molecules and more than 40 thousand assays in on-target and secondary pharmacodynamics and pharmacokinetics—using a secure computing platform to jointly train a predictive drug-activity model. That shared quantitative structure-activity relationship model used “the chemical structure of potential drug compounds to predict how they will function,” they note.

Results, they say, significantly outperformed those of any of the individual members. Detailing those results in a separate article, Wouter Heyndrickx, PhD, machine learning scientist from consortium lead Janssen Pharmaceuticals, reports benefits in “most of the classification or regression tasks,” writing that the model generally enhanced predictivity, sometimes substantially. Notably, the median Relative Improvement of Proximity to Perfection for conformal efficiency exceeded 12%, with one exceeding 20%.

Prepping to share

“Many organizations are already pursuing in-house solutions,” Lee tells GEN. “The benefits are the ability to tailor the solution to one’s specific situation. But by participating in larger-scale efforts, one can benefit from shared learnings and efforts to accelerate the digital transformation. Ecosystem-wide efforts can enable the entire industry to advance digital tools and benefits in ways that might not be apparent to individual organizations.”

Achieving such results takes a lot of data management preparation, the researchers admit. They must:

• Standardize ontologies, schemas, and holistic data integration and break down data silo enterprise-wide
• Enable predictive strategies to optimize processes, such as those supported by digital twins, in silico process design, and hybrid mechanistic/ AI models
• Develop secure, shared datasets that enable data to be pooled while protecting sensitive and proprietary data
• Ensure interoperability and real-time data connectivity among sensors from multiple vendors so they can communicate accurately and in real- or near-real time
• Industry guidance and buy-in, including regulatory clarity, workforce development, and shared business cases that lower adoption barriers

It is, in a word, challenging.

Redesigning legacy data infrastructure is expensive and time-consuming, and multivendor operability is a low priority for equipment developers, Hart says. There are additional barriers, too. Regulators have not yet determined how such models will be evaluated in data submissions. And, finally, workers with combined expertise in biomanufacturing and data science are scarce.

Yet, there are clear advantages to standardizing big data and using it to populate shared models.

“Many organizations face similar challenges and opportunities related to development and manufacturing,” Lee says. “Supporting an industry-wide set of solutions can accelerate the learnings of individual organizations, facilitate tech transfers…foster greater flexibility and interoperability, and support federated learning.”

As the team emphasizes, “Companies that do not adopt these capabilities are competitively disadvantaged from realizing the full benefits of their big data in the biopharmaceutical manufacturing marketplace.”

The post Big Data Opportunities in Biomanufacturing appeared first on GEN - Genetic Engineering and Biotechnology News.

“We’ve been focused on combining this mechanistic model with the data-driven AI model to create a hybridized model,” explains Dong-Yup Lee, PhD, professor and head of the Bioprocess Digital Twin Lab at Sungkyunkwan University.

According to Lee, their digital twin differs from a conventional simulator or standalone model because it’s continuously connected to a multi-sensory modeling system, which collects relevant data from the bioreactor in their lab. The team, he says, has developed mathematical models of mammalian Chinese Hamster Ovary (CHO) cells and uses them to make predictions about how the cells will behave under different bioreactor conditions.

However, he says, predictions from the mechanistic model alone do not always achieve the accuracy or adaptability required for real-time operation. As such, the team has incorporated data-driven AI as a complement to provide more adaptive control of the bioreactor.

“One of the limitations of AI is, if you have lots of data, it’s good for prediction, but it can’t explain why,” he says. “So, we use what is called explainable (XAI).”

XAI can provide information about what input conditions are most strongly affecting process outputs, he says, rather than just providing a prediction. This added interpretability can provide multiple options for improving and controlling bioprocess performance.

According to Lee, the biggest challenge for the team so far has been integrating the mechanistic model with XAI in a way that connects data collection, prediction, and forecasting directly with process control.

“We’re probably at 80% on [developing] the hybridized model,” he says. “The remaining 20% is working out how these models can be linked to and interact with the control system and our future robotics.”

Bringing these aspects together, he says, will be a key focus of the team’s future research, with the ultimate aim of moving beyond predictive digital twins toward increasingly autonomous process operation.

Lee is open to industry collaborations, particularly around digital twins, advanced bioprocess monitoring, and autonomous biomanufacturing.

The post Hybrid Digital Twins Developed for Future Autonomous Labs appeared first on GEN - Genetic Engineering and Biotechnology News.

The opportunity is particularly compelling in biologics manufacturing, where the authors call real-time monitoring of cell health a “critical bottleneck.” Conventional apoptosis measurements, including offline fluorescent staining and lactate dehydrogenase release assays, can be destructive and provide limited temporal resolution. Dielectrophoresis (DEP), which exploits how polarizable cells respond to nonuniform electric fields, offers another approach: tracking the changing electrical signature of cells without labeling or destroying them.

Chinese hamster ovary (CHO) cells, which the review calls the “industry workhorse,” provide a striking example. Studies using dual-frequency DEP cytometry followed CHO cells during nutrient-starvation-induced apoptosis and found two distinguishable electrical phases. First came membrane remodeling and a reduction in membrane capacitance. Then cytoplasmic conductivity dropped sharply as ionic homeostasis broke down. In one study, apoptotic populations began appearing between 24 and 36 hours, and cytoplasmic conductivity fell to approximately 0.05 siemens per meter (S/m) compared with about 0.45 S/m in viable cells. A follow-up similarly found membrane capacitance declining gradually before cytoplasmic conductivity plunged to 0.07 S/m in apoptotic cells by 52 hours. Together, the changes provide an electrical timeline of cell death rather than merely an endpoint measurement.

Speed could make those signatures especially valuable on the manufacturing floor. The commercially available 3DEP platform has been used to capture electrical signatures from populations of roughly 20,000 cells within seconds. According to the review, such measurements can reveal emerging apoptotic subpopulations “hours before traditional biochemical markers become detectable.” Earlier warning could allow operators to adjust a process or select a more favorable harvest time before culture performance deteriorates.

The next step might be turning those measurements into automated decisions. The review highlights a 2026 analysis integrating electrical impedance data with supervised machine learning; a tuned random-forest model achieved 90% predictive accuracy and was proposed as a label-free “traffic-light” system for batch monitoring. Combining rapid electrical measurements with computational analysis could ultimately support autonomous intervention and optimized harvesting.

That vision is not yet routine bioprocess control, but the technology is moving beyond specialized laboratory experiments. Commercial DEP platforms are already increasing accessibility, and the authors see continued integration with computational modeling and machine learning as a route toward real-time automated systems. For biomanufacturing, the electrical life of a cell may become another process signal—one capable of warning that a culture is changing before conventional assays catch up.

The post Electrical Signals Sharpen Bioprocess Control appeared first on GEN - Genetic Engineering and Biotechnology News.

The post Endocrine Society Rallies for the NIH appeared first on Endocrine News.

The University of Dundee has taken first place in a new Dentistry ranking designed around the factors we believe matter most in dental education.

Queen’s University Belfast finished narrowly behind Dundee, with Birmingham, Glasgow and Sheffield completing the top five.

Prospective dental students face no shortage of university league tables. But each provider measures something different, from graduate salaries and institutional spending to entry grades, student satisfaction and research. That can produce sharply different results and leave applicants unsure what each ranking actually says about a dental school.

We developed our own table to provide a distinctly dental comparison. It gives almost equal weight to students’ experience of their course and the strength of dentistry research produced by each university.

What did we measure?

The ranking draws on student responses covering teaching, assessment and feedback, as well as research influence, publication quality, entry standards, continuation rates and international research collaboration.

It excludes graduate employment because dentistry graduates generally enter a regulated profession with consistently strong employment prospects. University-wide spending and student-staff ratios were also removed because the published figures could not reliably show what was being spent on, or provided within, the dental school itself.

Dundee led the completed ranking with a score of 75.2, followed by Queen’s University Belfast on 74.3. Birmingham placed third on 68.5 and Glasgow fourth on 66.1.

Three dental schools not ranked

Three universities were not given numerical positions because comparable data covering all eight measures were not available. Their omission should not be interpreted as placing them below the 15 ranked universities.

Dentistry application deadline

Applications for most dentistry courses starting in 2027 must reach the Universities and Colleges Admissions Service by 18:00 UK time on 15 October 2026 to receive equal consideration.

Applicants should check the deadline attached to their chosen course before applying.

Read the full UCAS deadline information.

Scores show relative performance under the Dentistry methodology. They are not pass marks or absolute measures of course quality.

Create a free account for unlimited access — plus the Dentistry Bulletin delivered to your inbox.

The year’s prize recognized foundational discoveries that helped explain a chemical asymmetry observed in living organisms.  Small molecules like amino acids exist as two variants that are mirror images, yet living organisms contain only one of these images while the other is rarely found in nature. Kagan and Soai’s work provided the answer to the question of how homochirality can emerge. Their discoveries have enabled chemists to drive chemical reactions that lead to homochirality, and have been beneficial to scientists that design reactions used in manufacturing to develop new drugs, flavors, scents, and other materials. 

Their combined efforts “have provided a solution to a chemical mystery that is over a century old,” said Heiner Linke, PhD, chair of the Nobel Committee for Chemistry. “The chemical reactions they have developed are spectacular.”

How homochirality emerges is “probably the most fundamental question in life,” explained Peter Somfai, PhD, a professor of organic chemistry at Lund University and a member of the Nobel committee for Chemistry, in an interview. Scientists have long wondered how it happened billions of years ago. “Now we mimicked it in a lab today, not the way it happened four billion years ago, it’s important to stress, but we have for the first time mimicked it.”

The core scientific question

Though chiral molecules exist as non-identical mirror images with potential biological effects, life is homochiral and built exclusively from left-handed amino acids and right-handed sugars. And different enantiomers can have dramatically different properties. “Many molecules occur in two different versions, like my hands. They are one another’s mirror image. They look alike, but they’re not identical,” Linke said. 

When scientists began experimenting with chemical reactions that can form two mirrored molecules, they typically obtained equal proportions of both. But attempts to produce only one of the mirror images, in the context of pharmaceutical development, for example, proved challenging. Some of the earliest discoveries about chirality can be traced back to the mid-19^th century to Louis Pasteur and his efforts to investigate the behavior of tartaric acid. The field also owes some insights to the work of the chemist Willy Marckwald, who carried out the first successful asymmetric reaction in the early 1900s. He succeeded by using a chiral catalyst which boosted the formation of one mirror image over the other. 

In their respective laboratories, Kagan and Soai made their contributions to the question of how homochirality emerges spontaneously. In 1986, Kagan discovered a new way of manipulating chemical reactions that made it possible to create a larger quantity of one of the images than had previously been thought possible. 

At the time, he and other chemists were working to refine asymmetric reactions with an eye towards producing pure enantiomers. Building on the work done by Marckwald and others, as well as mathematical contributions from Charles Frank, PhD, a theoretical physicist at the University of Bristol, scientists typically used catalysts comprising a metal atom and a chiral substance. They typically used an enantiomer that was as pure as possible the catalyst assuming that combining two mirrored enantiomers would result in a product with equivalent proportions of mirror images. 

Kagan questioned this belief that mixing left- and right-handed catalysts would produce a linear relationship in product chirality, explained Somfai in his remarks during the announcement. “For a long time, it was believed that if we mix a left and right-handed catalyst, the proportion of an ancillary in the product would correlate linearly to that in the catalyst.”

Kagan’s question led him to test driving a reaction with different combinations of enantiomers in the catalyst. Ultimately, he realized that the relationship to the proportions of enantiomers in the product was not linear as previously thought. One form of the catalyst, the left-right catalyst, drove the chemical reaction in a different way than the two other forms of the catalyst — the right-right or left-left forms. This meant that he had found a way to enhance the formation of one enantiomer over the other. In 1986, he described at least three different asymmetric reactions that displayed what chemists call non-linear effects. 

Other scientists were keen to build on Kagan’s discovery, including Soai. While studying an asymmetrical chemical reaction with a non-linear effect, he discovered similarities between the structure of the reaction’s catalyst and the products. That discovery suggested that it may be possible to design a reaction in which the catalyst formed itself in an autocatalytic process. After experimenting with different molecules, Soai published a paper in 1995, where he described finding a chiral substance that could create itself although it did not achieve 100 percent enantiomeric purity. 

Eight years later, in 2003, he was finally able to present a chemical reaction, dubbed the Soai reaction,  in which only one of the two possible mirror images was formed. Specifically, the chemical reaction results in an excess of an enantiomer which then forms copies of itself, marking the first time a scientist successfully generated chirality from achiral or racemic conditions outside of nature.  As Somfai put it in his remarks “this is probably the coolest experiment in organic chemistry.”

Following the award announcement, Soai took questions from the press during which stated that he was out shopping near his home in Hiroshima, Japan when he got the call from the committee letting him know he and Kagan would share this year’s prize. “There are many excellent researchers in this field, so I’m very especially glad to receive this prize” and “to share the prize with Professor Henri Kagan, such a famous organic chemist,” he said. 

Basic research with a broad impact

Though this award recognizes basic organic chemistry research, Kagan and Soai’s work has been hugely impactful in both industrial and pharmaceutical manufacturing. Many active drug molecules are also chiral with only one compound having a desired therapeutic effect. The other might have no therapeutic effect or even be harmful. Given these risks, “we need methods to selectively prepare them, and in developing such methods, the findings of this year’s Nobel laureates are important. They provided powerful tools for this,” Somfai said.

The post Kagan, Soai Win 2026 Nobel Prize in Chemistry for Discoveries Related to Asymmetric Organic Synthesis appeared first on GEN - Genetic Engineering and Biotechnology News.

The $2 million in combined funding comes from Hamilton philanthropist Teresa Cascioli and The Juravinski Foundation and represents the first major philanthropic investments in the centre, which was launched last fall.

CHIRP is examining whether carefully controlled, medical-grade psychedelic compounds could eventually provide new treatment options for patients living with conditions that can be difficult to treat using existing therapies.

Research areas include chronic pain, addiction, treatment-resistant depression, post-traumatic stress disorder and neurodegenerative disease. Researchers are also investigating potential applications in women’s mental health and supportive care for people facing serious or terminal illnesses.

The centre is led by Dr. Anthony Adili, St. Joseph’s chief innovation officer and CHIRP’s founding director.

Importantly, the work is taking place in a clinical research environment rather than promoting recreational psychedelic use. Psychedelic compounds remain tightly regulated in Canada, and experimental treatments are being investigated through controlled research and regulatory pathways.

One of CHIRP’s research programs is examining psilocybin — the psychoactive compound found in some mushrooms — as a potential treatment for chronic pain.

The centre is also collaborating with the Michael G. DeGroote Centre for Medicinal Cannabis Research at McMaster University on research examining psilocybin-assisted therapy for cannabis use disorder.

St. Joseph’s is additionally participating in a national research initiative examining psychedelic-assisted therapies. According to the hospital, the centre’s work includes clinical trials authorized through appropriate Health Canada pathways.

The new funding will help CHIRP build research infrastructure, recruit specialized personnel and support clinical trials.

Interest in psychedelic medicine has increased considerably in recent years as researchers revisit substances that were largely excluded from mainstream medical research for decades.

Early studies have suggested potential therapeutic applications for certain psychedelic compounds, particularly for some mental health conditions, but significant questions remain about effectiveness, patient selection, dosing, safety and how treatments should be delivered.

That makes hospital-based research particularly important. Clinical trials can evaluate potential benefits while monitoring adverse effects and determining whether promising results can be reproduced in larger and more diverse patient populations.

For Canadian hospitals, the research also raises broader questions about how psychedelic-assisted treatments might eventually fit into existing mental health, pain, addiction and palliative-care programs if future clinical evidence supports their use.

CHIRP is part of the Research Institute of St. Joseph’s Health System. St. Joseph’s Healthcare Hamilton has longstanding clinical and research programs in mental health and addictions, making the hospital a significant Canadian centre for investigating emerging approaches to treatment.

The $2-million investment will allow researchers to move several areas of psychedelic research forward while building the clinical evidence needed to determine where — and whether — these therapies ultimately have a role in routine patient care.

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Called the Skincubator, the device is designed to bring some of the protective conditions of a neonatal incubator directly onto a parent’s chest, allowing premature infants to receive prolonged skin-to-skin care while remaining warm, humidified and supported.

Children’s Memorial Hermann Hospital in Houston recently became the first hospital in the United States to introduce the technology as part of a clinical trial.

For extremely premature infants, skin-to-skin contact — often called kangaroo care — can be difficult to provide for extended periods. Babies may require respiratory support, intravenous lines, monitoring equipment and carefully controlled temperature and humidity.

Moving a medically fragile infant from an incubator to a parent can therefore require significant assistance from the neonatal care team and carries concerns about temperature loss and displacement of tubes and lines.

The Skincubator was developed to address those barriers.

The wearable, non-electrical system secures the infant to the caregiver’s chest while helping maintain warmth and humidity. It also provides a system for organizing and securing respiratory tubing, catheters, probes and other medical lines during transfer and while the baby is being held.

The technology is designed to allow infants receiving respiratory support to remain on a parent’s chest for hours rather than shorter periods of conventional skin-to-skin care.

Early research is encouraging.

A 2026 study published in the American Journal of Perinatology evaluated the Skincubator 2.0 and found that it allowed infants to be transferred to and from skin-to-skin care within a warm and humidified environment. Parents participating in the study reported greater satisfaction with the device’s safety and convenience compared with traditional skin-to-skin care.

Researchers said the technology could help parents provide longer periods of skin-to-skin care for premature infants.

The potential benefits are significant. Skin-to-skin care has been associated with improved temperature regulation, more stable heart and breathing patterns, better sleep and growth, pain reduction and stronger parent-infant bonding.

For parents, the technology could also change the experience of having a child in intensive care.

Instead of watching their newborn primarily through the walls of an incubator, parents may be able to participate more directly in their baby’s care during the earliest and most vulnerable days of life.

The Skincubator has received Breakthrough Device Designation from the U.S. Food and Drug Administration, a designation intended to accelerate the development and regulatory review of certain technologies addressing serious or life-threatening conditions.

Importantly, Breakthrough Device Designation does not mean the device has received FDA marketing authorization. The technology remains under clinical investigation as researchers continue to evaluate its safety, performance and potential benefits.

The Skincubator has now been used with dozens of premature infants at clinical sites on several continents, according to its developer.

If larger clinical studies confirm its early results, the technology could represent an important shift in neonatal intensive care — allowing advanced medical support and prolonged parent-infant contact to occur at the same time rather than requiring clinicians and families to choose between them.

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Research in JAMA Network noted that while many countries have mandatory retirement policies for judges, commercial pilots and air traffic controllers, no developed country has similar policies policing physicians. “Most jurisdictions rely on self-regulation, collegial oversight and broad professional requirements for maintenance of competency rather than proactive cognitive screening,” researchers found.

Thee study pointed to possible signs of change as the physician workforce ages. The authors noted, for example, that in the U.S., 25 health systems had publicly available cognitive-screening policies for physicians between 70 and 75. Only three of those systems, however, said they used a validated screening instrument like the Montreal Cognitive Assessment, more commonly known as the MicroCog.

While researchers said that cognitive screening for physicians should be viewed as a patient-safety tool, not a punishment, attempts to implement age-based policies are often attacked as discriminatory. A MedPage Today analysis of the study, for example, looked at a cognitive screening program for physicians at Yale New Haven Hospital. That program was rolled out between 2016 and 2019.

A JAMA study of that policy found that of 141 physicians screened for cognitive impairment, 13% had cognitive issues that were “likely” to impair their ability to practice medicine. Despite those findings, Yale New Haven was sued by the Employment Opportunity Commission for age and disability discrimination.

The lawsuit reached the courts in August of 2026, but no decision has been reached. Legal analysts said that any decision reached in the case will likely head to the Supreme Court.

The recent study in JAMA Network cited data that found increased 30-day mortality among patients cared for by physicians aged 60 years or older with low to medium caseloads. That study, however, found no differences among high-volume physicians.

Researchers in the JAMA Network study pointed out that other data have found that the trajectory of cognitive decline is “highly variable,” with many physicians remaining “cognitively intact” well into older age. Researchers said that makes evaluating cognitive impairment in older physicians “complex,” and that there are “substantial limitations to using age alone as a proxy for clinical ability.”

The MedPage Today article noted that when health care organizations launch programs to screen late-career physicians, there’s often a wave of retirements. One researcher interviewed by MedPage Today said that in those situations, physician retirements are often viewed a good thing for patient safety.

But there’s also a possibility that some physicians are retiring simply to avoid testing that they may think is unfair. And in a health care system with a chronic shortage of physicians, that outcome is likely hurting, not helping, patient safety.

The post Screening physicians for cognitive impairment remains rare in U.S. appeared first on Today's Hospitalist.

Anton Paar India hosted the first day of NEXUS 2026 at Ramada by Wyndham, Navi Mumbai, bringing together experts, scientists, researchers and industry professionals from the pharmaceutical and food sectors for discussions on how analytical technologies can address challenges in product development, quality, regulatory compliance and manufacturing.

The two-day industry forum is being held under the theme “Industry Insights. Technology. Experience.” and combines expert-led sessions with live demonstrations of analytical and measurement technologies.

Nitin Prabhakar, Managing Director, Anton Paar India, said “NEXUS is designed to take analytical science beyond theoretical discussions and connect it directly with the challenges faced by industry. The first day demonstrated the value of bringing pharmaceutical and food experts together with application specialists and live technologies on one platform. From understanding the structure of pharmaceutical materials and improving regulatory preparedness to analysing food texture, flow and processing behaviour, the discussions highlighted how the right measurements can support better decisions across the product lifecycle.”

The pharmaceutical sessions brought together perspectives from drug development, formulation, analytical research and regulated laboratory environments. Dr. Benedikt Schrode, Global Product Manager – X-ray Diffraction, Anton Paar GmbH, discussed how X-ray diffraction can provide insights into APIs and pharmaceutical materials.

Dr. Vaibhav Dubey, Senior General Manager, Sun Pharma, highlighted the importance of understanding particles, interfaces and stability in next-generation drug delivery systems. Dr. Amit Gosar, Vice President – Analytical Research, Indoco Remedies, addressed the changing regulatory landscape, including trace-level impurities, nitrosamines, NDSRIs, elemental impurities and advanced solid-state characterisation.

The programme also explored how laboratories can move beyond compliance towards greater confidence in analytical processes. Jörg Bämpfer, Global Product Manager, Anton Paar GmbH, shared insights into data integrity, traceability, qualification, digital data management and integrated laboratory workflows.

The food-focused sessions examined the relationship between raw materials, processing behaviour, structure and finished-product quality. Prof. Dr. Narpinder Singh, Vice Chancellor, Graphic Era (Deemed to be University), discussed rheological characterisation and extrusion technology, while Dr. Suresh Sakhare, Scientist G, CSIR-CFTRI, Mysuru, examined flour, dough and starch behaviour for improved food products.

Dr Nitin further added “Food science is increasingly moving towards a deeper understanding of what happens between raw material and consumer experience. The sessions by Prof. Dr. Narpinder Singh and Dr. Suresh Sakhare showed how rheology, starch behaviour, dough characteristics and processing conditions can influence consistency and product quality. Dr. Banu Sezer’s session further connected particle size, viscosity, rheology, texture, crystallisation and other measurements with practical considerations such as processing, stability and consumer acceptance.”

A key highlight of Day One was the NEXUS Technology Expo, where participants experienced live demonstrations of Anton Paar’s analytical and measurement technologies and interacted with application specialists. The showcase covered rheology and viscometry, density and concentration, particle characterisation, surface and material characterisation, FTIR and Raman spectroscopy, X-ray analysis, microwave sample preparation, true density, flash point and petroleum testing, process measurement and laboratory automation.

The day concluded with participants gaining practical insights into how complementary analytical techniques can be integrated into measurement workflows.

The second day of NEXUS 2026 will continue on October 8, bringing industry perspectives and analytical technologies together. The platform will further focus on enabling industries to understand materials, optimise processes and make informed technology-driven decisions.

The post Anton Paar India hosts NEXUS 2026 to discuss analytical technologies for pharma and food sectors appeared first on Express Pharma.

Dr Sam Saleh opened his Rodeo Drive practice with no patients and no reputation in Los Angeles. A quarter of a century later, he explains why social media gives today’s young dentists an easier route to visibility, and what they must deliver once people start watching.

Dr Sam Saleh was in his 20s, had no patients in Los Angeles and was being warned that his new dental practice would fail.

Despite having no established reputation in the city, he committed to a space on Rodeo Drive, one of Beverly Hills’ most expensive addresses. Other dentists in the area, he recalls, were waiting for the venture to collapse.

‘I had no patients, I had no history,’ he tells Alan Clarke in the latest Stateside Sessions interview. ‘I literally came and took on probably the most expensive real estate rental that you could.’

Working through the uncertainty

Saleh admits there were moments when he feared that his critics might be right.

‘Were there times when I felt like it was going to fail? Were there times when I felt like we weren’t going to be able to make it? Yes, 100%,’ he said. ‘But we just worked through it.’

Now, 25 years later, the King’s College London graduate practises in Beverly Hills and London, travelling between the two cities around once a month. He treats patients from several countries and has developed an online following measured in hundreds of thousands.

Saleh believes social media has removed one of the barriers he faced at the beginning of his career.

‘Today, it is easier than it was when I started,’ he says. ‘Social media was not a viable option for expansion of a practice.’

Dentists can now publish their clinical work without waiting for traditional media coverage. Over time, that visibility can help them find an audience and demonstrate where their strengths lie.

What happens once people are watching

Saleh warns that attracting attention is only part of the task. Dentists must be able to support their online claims through the treatment they provide.

‘Once you have a voice and you have a platform, the onus is on you to provide the work and provide what it is that you’re telling people you can do for them,’ he says.

His advice is to identify an area of strength and continue developing it.

‘If you’re good at something, work harder at becoming better at what you know,’ he says. ‘That will be your natural edge because people will then be drawn to whatever it is that you do better than the average person.’

The interview also explores Saleh’s life between London and Los Angeles, the demands of treating an international patient base and why he considers an in-house ceramist essential to his aesthetic workflow.

Catch up on previous Stateside Sessions:

• Inside Hollywood dentist to the stars Jon Marashi’s smile studio
• US and UK dentistry: ‘the future is together’
• US dentistry: a new world of possibilities.
• A cosmetic dental giant’s journey to $10 million revenue.

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Yousuf Ibrahim explores gaps in dental trauma first aid and how dentists can help parents, teachers and coaches act before an injured patient reaches the surgery.

When a patient arrives with an avulsed permanent tooth, we ask how long it has been out of the mouth, how it was handled and whether it was kept moist. Those answers help determine what treatment is possible. Yet the decisions were usually made by someone without dental training.

The International Association of Dental Traumatology recommends immediate replantation of an avulsed permanent tooth when this can be done safely. If it cannot, the tooth should be kept from drying out while urgent dental care is arranged. An avulsed primary tooth must not be replanted (Fouad et al, 2020).

We know these distinctions. The people beside the patient at the time of injury may have never heard them.

The guidance beyond the surgery

I asked numerous first aid trainers how dental injuries feature in their courses. One includes dental trauma in sports training but not the standard three-day First Aid at Work course they deliver. Another covers it across all courses. A third said dental injuries receive brief attention in general training and arise more often on outdoor courses.

One trainer said learners commonly regard a knocked-out tooth as ‘a job for the dentist’ and are surprised to hear that something can be done before the patient gets there. Andy Crowhurst, director of 4 Minutes Training Ltd, described first aid advice for dental injuries as ‘minimal’.

In the trainers’ accounts, coverage varied by course and provider. These conversations are too few to establish how common each approach is across the UK.

Research gives us further reason to look beyond the dental surgery. An international review found recurring gaps in schoolteachers’ knowledge of dental-trauma prevention and emergency management (Tewari et al, 2020). In a London study published in 2007, school staff who had received advice about avulsion were three times more likely to say they would attempt replantation. Respondents also raised concerns about their ability to intervene and the possible consequences of getting it wrong (Addo et al, 2007). The study cannot tell us how prepared schools are today, but it identifies questions that still deserve attention.

In informal conversations with patients while developing ToothRevive, a dental trauma kit, I have noticed a similar distinction. Many know that a knocked-out tooth needs urgent dental attention. Fewer know what to do with the tooth before they arrive. Those conversations have changed how I discuss dental trauma with patients. They reflect my own patient group and should not be read as a measure of public knowledge.

What dentists can contribute

For patients with children, a brief conversation about injury can be as useful as one about prevention. A parent who understands the difference between a primary and permanent tooth, knows to handle an avulsed permanent tooth by the crown and knows to seek urgent help has information they may need at a school gate or sports ground. It need not become a lecture at every appointment. It can be part of relevant, timely advice.

We also meet people whose responsibilities extend beyond their own families: teachers, coaches, school staff and others involved in sport. If dental trauma comes up, that conversation can reach an entire setting. We can ask whether staff have accessible guidance for dental injuries and direct them towards established resources, including those from the IADT and Dental Trauma UK. Sharing an authoritative guide is a useful starting point.

Our own practices are part of the first aid pathway too. Reception teams regularly speak to callers before a dentist can assess an injury. Clear, clinically reviewed instructions on what to say about a knocked-out tooth, and where to direct someone for urgent care, can help prevent uncertainty during that call. The advice must distinguish permanent from primary teeth and encourage immediate action rather than implying that an appointment later in the day is soon enough.

These steps have limits. A scoping review of dental-trauma education found that knowledge can fade and that many interventions were assessed through questionnaires rather than responses to real injuries (Nowosielska et al, 2022). A conversation or poster cannot guarantee the right action months later. Making reliable instructions easy to find when they are needed remains part of the task.

There is a wider role for dentistry in working with first aid providers on guidance that people can actually use. The trainers I spoke to already differ in what they teach; their practical experience should inform that work alongside the clinical evidence. In the meantime, opportunities arise within our surgeries. We see the parents and people responsible for children who will be there long before we are.

References

1. Fouad AF, Abbott PV, Tsilingaridis G, Cohenca N, Lauridsen E, Bourguignon C, O’Connell A, Flores MT, Day PF, Hicks L, Andreasen JO, Cehreli ZC, Harlamb S, Kahler B, Oginni A, Semper M, Levin L. International Association of Dental Traumatology guidelines for the management of traumatic dental injuries: 2. Avulsion of permanent teeth. Dent Traumatol. 2020 Aug;36(4):331-342. doi: 10.1111/edt.12573. Epub 2020 Jun 13. PMID: 32460393.
2. Tewari N, Goel S, Rahul M, Mathur VP, Ritwik P, Haldar P, Priya H, Pandey RM. Global status of knowledge for prevention and emergency management of traumatic dental injuries among school teachers: A systematic review and meta-analysis. Dent Traumatol. 2020 Dec;36(6):568-583. doi: 10.1111/edt.12579. Epub 2020 Jul 2. PMID: 32516464.
3. Addo ME, Parekh S, Moles DR, Roberts GJ. Knowledge of dental trauma first aid (DTFA): the example of avulsed incisors in casualty departments and schools in London. Br Dent J. 2007 May 26;202(10):E27. doi: 10.1038/bdj.2007.328. Epub 2007 Apr 13. PMID: 17435696.
4. Nowosielska M, Bagińska J, Kobus A, Kierklo A. How to Educate the Public about Dental Trauma-A Scoping Review. Int J Environ Res Public Health. 2022 Feb 21;19(4):2479. doi: 10.3390/ijerph19042479. PMID: 35206665; PMCID: PMC8872546.

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The joint work is intended to focus on targeted, practical use cases designed to simplify operational procedures, streamline technical delivery, and enable Gilead’s project teams to implement priority technology programmes more efficiently.

Gilead Global CIO Anna Berg Asberg said: “Our focus is on giving our teams reliable, efficient technology that helps them move important work forward.

“This agreement provides additional support as we strengthen our DevOps capabilities and evaluate practical, responsible uses of AI across our technology environment—all in service of our broader mission to deliver for patients.”

Cognizant Americas president Surya Gummadi said: “We value the opportunity to continue supporting Gilead’s technology priorities. Our work will bring together life sciences experience, DevOps capabilities and AI tools to help Gilead improve delivery across selected programmes.”

This agreement builds on over a decade of collaboration between the two companies.

Over that timeframe, Cognizant has provided ongoing technical support for elements of Gilead’s worldwide information technology infrastructure, software platforms, enterprise applications, and advanced analytics capabilities.

The expanded remit provides additional resources for selected DevOps and AI-driven capabilities, supporting the core technical foundations that underpin Gilead’s business and research priorities.

Last month, Gilead Sciences and the Pan American Health Organization (PAHO) signed an agreement to expedite access to the company’s twice-yearly lenacapavir injection for human immunodeficiency virus (HIV) prevention as pre-exposure prophylaxis (PrEP) across Latin America and the Caribbean.

The post Gilead Sciences signs five-year DevOps agreement with Cognizant appeared first on Pharmaceutical Business review.

Rocket plans to use the proceeds to advance its clinical pipeline, primarily focusing on its pivotal Phase II trial of RP-A501 for Danon disease.

As of 30 June 2026, the company held $283.7m in cash, cash equivalents and investments. Under the terms of the agreement, Rocket drew an initial $35m upon closing.

An additional $35m remains accessible at Rocket’s option during designated periods, subject to contractual terms.

A further $30m tranche may become available upon reaching a specified clinical milestone in the Danon programme, whilst the final $50m tranche remains subject to approval by the investment committee at Hercules Capital.

Rocket Pharmaceuticals CEO Gaurav Shah said: “Building on the sale of our priority review voucher, this financing diversifies our sources of capital and strengthens our ability to execute and deliver on our cardiovascular strategy.

“The staged structure provides flexibility to align additional funding with progress across our programmes. We remain focused on allocating capital thoughtfully, executing the pivotal Danon study and advancing genetic medicines for patients with serious inherited heart diseases.”

Hercules Capital senior managing director and life sciences group head R. Bryan Jadot said: “Rocket is advancing toward important milestones across its cardiovascular pipeline, led by the pivotal Danon programme.

“We are pleased to provide a flexible financing solution that supports the Company’s development priorities. We look forward to working alongside Rocket as it builds on its expertise in cardiovascular genetic medicines.”

The facility carries an initial 30-month interest-only period alongside a 48-month maturity, with extensions accessible upon achieving designated milestones.

The transaction also includes warrants to purchase shares of common stock in Rocket Pharmaceuticals.

LifeSci Capital acted as financial adviser to Rocket on the term loan, while PJT acted as capital markets adviser. Additional details regarding the credit agreement will be submitted in regulatory filings with the Securities and Exchange Commission.

Rocket Pharmaceuticals develops genetic medicines for rare as well as life-threatening diseases, with a focus on cardiovascular disorders that are inherited.

In April this year, Rocket Pharmaceuticals signed an agreement to sell its rare paediatric disease priority review voucher (PRV) for $180m to advance its gene therapy pipeline.

The post Rocket receives $150m credit facility to advance cardiovascular portfolio appeared first on Pharmaceutical Business review.

Eris Lifesciences has announced the appointment of Chirag Mehta as Executive Director. He will be based at the company’s Mumbai office and will report to the CMD.

In his non-statutory executive role, Mehta will oversee Finance, Investor Relations and the International Business.

Mehta brings over two decades of senior leadership experience in finance, strategy and M&A across the Indian and international pharmaceutical industry. He was most recently CFO at Bharat Serums and Vaccines Ltd., a Mankind Group company. Earlier, he served as SVP & CFO at Biological E. Ltd., Hyderabad, and CFO – International at Cipla.

He holds an MBA from Grand Valley State University, Michigan, USA.

Commenting on the appointment, Amit Bakshi, CMD, Eris Lifesciences, said, “We are happy to have Chirag with us. He brings a strong base in finance, international business and biotech, which is a good fit for the phase we are entering.”

The post Eris Lifesciences appoints Chirag Mehta as Executive Director appeared first on Express Pharma.

Granules India Limited (GIL) announced that it has submitted a Paragraph IV certification in connection with its ANDA for Ruxolitinib Extended-Release Tablets with respect to applicable patents listed in the US Food and Drug Administration’s (FDA) Orange Book. The company has also provided the required notice to the relevant parties in accordance with applicable US regulatory requirements.

Based on the timing and status of its ANDA and Paragraph IV certification, and subject to FDA review and determination, GIL believes that it is eligible for first-to-file status for Ruxolitinib Extended-Release Tablets. If confirmed by the FDA and all applicable statutory and regulatory requirements are satisfied, first-to-file status may provide eligibility for 180 days of generic drug exclusivity under US law.

The ANDA remains subject to FDA review. The announcement should not be construed as FDA approval of the product or confirmation by the FDA of first-to-file status or exclusivity.

Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India, said, “First-to-file opportunities are an important part of our strategy to build a more differentiated and higher-value product portfolio in the U.S. This filing reflects our focus on identifying technically and commercially attractive opportunities where our development and manufacturing capabilities can create sustainable value. We look forward to progressing the product through the regulatory process.”

The company will provide further updates, as appropriate, in accordance with applicable disclosure requirements.

The post Granules India files Paragraph IV certification for Ruxolitinib Extended-Release Tablets appeared first on Express Pharma.

Roberto Sleiter and Vittorio Procopio present a case of bar-supported zirconia bridges on implants and Zirkonzahn multi unit abutments to explain how Prettau 2 Dispersive and Titanit 5 provide a perfect balance of stability and aesthetics.

An older patient with advanced generalised periodontitis, severely compromised dentition and distal edentulous areas in both jaws presented to the dental practice with the request for complete functional and aesthetic restoration within a reduced treatment time (Figures 1a and 1b).

The treatment included the following steps:

Firstly, extraction of all teeth in the upper and lower jaw, and immediate implantation following the all-on-four concept.

Then, parallelisation of implant positions with Zirkonzahn Multi Unit Abutments (Figures 2, 3, 4). Zirkonzahn Multi Unit Abutments are characterised by a 17° or 30° angle to compensate for any implant inclinations and with two different anti‑rotation connection types which allow intermediate positions.

Like all Zirkonzahn implant prosthetic components, the Multi Unit Abutments are available for more than 140 implant systems and are fully integrated into Zirkonzahn Software and workflow via corresponding libraries.

Exocad and 3Shape users may also download and implement the components for free in their design software through a dedicated portal.

Directly after implantation, a definitive impression and bite registration is taken.

This is followed by fabrication and insertion of fixed temporary bridges made from Prime Multistratum resin on the day of surgery (immediate implantation and immediate loading).

The next step is CAD/CAM-supported manufacturing of titanium bars in Titanit 5 as well as of two full arches in Prettau 2 Dispersive zirconia and subsequent sintering of the zirconia structures (Figures 5 and 6).

After this comes bonding of zirconia secondary structures onto the titanium bars and layering the zirconia structures with Fresco Ceramics.

– Individualisation of tooth shape and surface texture as well as characterisation with ICE Stains 3D by Enrico Steger to fulfil the patient’s aesthetic demands (Figures 7-9).

The final step is placement of the restorations on the implants using Zirkonzahn Multi Unit Abutments.

For more information about Zirkonzahn’s workflow and implant prosthetics components, visit www.zirkonzahn.com or contact Carmen Ausserhofer, T: +39 0474 066 662, carmen.ausserhofer@zirkonzahn.com.

This article is sponsored by Zirkonzahn.

Aragen Life Sciences has begun operations at Aragen OneHP, a high-potency development and manufacturing platform at its Nacharam campus in Hyderabad.

The platform adds capabilities for highly potent molecules, including cytotoxic payloads used in oncology, and provides customers with an integrated pathway from milligram-scale discovery through process development and multi-kilogram cGMP manufacturing.

Aragen OneHP spans approximately 15,000 sq ft and operates one manufacturing line with a designed capacity of 500 to 600 kg of active pharmaceutical ingredient a year. The platform supports highly potent compounds, including cytotoxic molecules and targeted oncology therapies, and will lay the foundation for future expansion into advanced modalities.

OneHP provides an integrated pathway from development through clinical and commercial supply worldwide. Manufacturing covers small-scale chemistry synthesis of up to 10 g, non-GMP process development and scale-up of up to 500 g, and cGMP manufacturing from 500 g to 5 kg per batch.

Advanced containment systems are designed to handle compounds at occupational exposure limits of up to 10 ng/m³, subject to ongoing validation.

The platform is the latest addition to Aragen’s expansion programme, which is adding new capabilities. Aragen spent more than ₹1,000 crore on capital expenditure over the three years to March 2026, building capabilities across small molecules and biologics.

Its contract development and manufacturing business grew at a 19% compound annual rate over the period, while its contract research arm grew at 12%. Installed small-molecule capacity stood at 364 KL across Hyderabad and Visakhapatnam as of March 31, 2026.

The company drew nearly 95% of its revenue from global customers in the year ending March 2026 and served 591 customers globally during the year, including 16 of the world’s Top 20 Big pharmaceutical companies.

Mr. Aniel Khubchandani, Chief Executive Officer – Small Molecules-CDMO, Aragen Life Sciences, said, “With OneHP, we are bringing discovery, development and cGMP manufacturing for highly potent molecules onto a more integrated platform. This can reduce handoffs between providers, while keeping process knowledge and programme context connected as a molecule moves from early development towards commercial supply.”

Highly potent molecules, including cytotoxic compounds, require specialised handling, containment and manufacturing infrastructure. OneHP brings together capabilities across small-scale chemistry synthesis, process development, scale-up and cGMP manufacturing, enabling customers to progress programmes through an integrated platform.

The platform also lays the foundation for Aragen’s future expansion into advanced modalities such as antibody-drug conjugates and peptide-drug conjugates.

Aragen’s Hyderabad manufacturing and analytical operations are accredited by the USFDA, EDQM, PMDA, MFDS, ANVISA, WHO Geneva and CDSCO.

The post Aragen Life Sciences begins operations at high-potency platform in Hyderabad appeared first on Express Pharma.

According to a Tracxn report, funding in the HealthTech, Life Sciences and Healthcare sectors in India stood at $256.7M across 22 rounds in September 2026. The funding was 30.87 per cent lower than the previous month and 99.85 per cent higher than the same month last year.

The data covers September 1 to September 30, 2026. The previous month refers to August 1 to August 31, 2026, while the same month last year refers to September 1 to September 30, 2025.

Funding in September 2026 stood at $256.7M, compared with $371.3M in August 2026. Funding in October 2025 stood at $161.8M, followed by $25.3M in November, $162.1M in December, $177.1M in January 2026, $51.5M in February, $235.7M in March, $305.8M in April, $119.0M in May, $106.4M in June, $80.6M in July and $371.3M in August.

The stagewise funding split in September 2026 comprised 63.1 per cent late-stage funding, 31.6 per cent early-stage funding and 5.3 per cent seed funding.

The top deals in September 2026 included Linux Laboratories and Ultrahuman, with $70.0M each, followed by Nua with $50.0M, Marengo Asia Healthcare with $41.9M, Disha Health with $4.6M, Rio Health with $4.5M and Fundly with $4.0M.

Among the most active venture capital investors, Peak XV Partners participated in two rounds involving Nua and August AI. Equentis Wealth Advisory Services participated in two rounds involving MeduLance and DocPharma, while Qualcomm Ventures participated in one round involving Ultrahuman.

The data is for the HealthTech, Life Sciences and Healthcare sectors in India, with Tracxn cited as the source.

The post India pharma and healthcare funding falls to $256.7M in September 2026 appeared first on Express Pharma.

As genomic research tackles increasingly complex biological questions, researchers need tools capable of looking beyond the most readily resolved regions of the genome. Repetitive sequences, structural variation, and other complex genomic features can be challenging to resolve with many conventional sequencing workflows. At the same time, laboratories must balance accuracy and speed with practical considerations, including read length, throughput, batch size, and access to data.

Sequencing by expansion (SBX), the technology underlying Roche’s AXELIOS 1 platform, takes a different approach to these challenges by physically expanding the space between encoded bases before detection.

Creating space for a clearer signal

SBX leverages a specialized polymerase that converts the sequence of a target DNA or RNA molecule into a measurable surrogate polymer called an Xpandomer, using nucleotide analogs. The resulting Xpandomer is approximately 50 times longer than the original molecule, creating greater physical separation between encoded bases.

The Xpandomer is then measured as it passes through a reusable complementary metal-oxide semiconductor (CMOS) sensor containing millions of nanopores. Its high signal-to-noise reporters are designed to support accurate, ultra-rapid single-molecule sequencing with near real-time base calling and analysis. This architecture may help researchers investigate a range of genomic features, including single nucleotide variants, insertions and deletions, copy-number alterations, repetitive sequences and other complex structures.

Flexibility beyond chemistry

The utility of a sequencing technology depends on more than chemistry alone. Research needs can vary substantially from one project to another and even within the same laboratory. AXELIOS 1 pairs SBX chemistry with a sequencing architecture designed to accommodate that variability. The system offers configurable batch sizes, allowing researchers to run smaller batches without waiting to accumulate enough samples for a larger run.

Researchers can also adjust read length according to experimental needs, with reads up to approximately 1,500 base pairs (with a distribution from ~200bp to ~1500 bp) under appropriate sample and library preparation conditions. The platform is capable of end-to-end, same-day whole genome sequencing (WGS) in research workflows, while near real-time base calling and analysis enable access to data as a run progresses.

This flexibility extends across multiple research applications. SBX has been tested in proof-of-principle studies for WGS, RNA sequencing (RNA-seq), single-cell RNA sequencing (scRNA-seq), spatial analysis, and methylation studies. For each application, the AXELIOS 1 Platform sequences Xpandomer molecules that were created from libraries made with the AXELIOS 1 DNA Library Prep Kit. The data is then analyzed using the no-cost, open-source XOOS bioinformatics analysis suite tailored for SBX. Collaborations also support applications and tools across the sequencing ecosystem, including support for SBX through Google DeepVariant.

Broadening the genomic picture

Modern genomics rarely relies on a single experimental approach. Researchers may need to examine genomic variation, gene expression, cellular heterogeneity, or epigenetic changes to build a more complete biological picture. Sequencing platforms that accommodate different applications and project sizes can allow laboratories to design workflows around the scientific question rather than instrument constraints.

By combining a new approach to sequencing chemistry with flexible read lengths, batch sizes, and research applications, AXELIOS 1 is designed to expand the range of genomic questions researchers can pursue. As sequencing continues to evolve, these capabilities could help scientists interrogate previously challenging regions of the genome and build a more complete foundation for biological discovery.

For Research Use Only. Not for use in diagnostic procedures. AXELIOS is a trademark of Roche.

To learn more, visit go.roche.com/AXELIOS1article

The post Expanding the Possibilities of Next-Generation Sequencing appeared first on GEN - Genetic Engineering and Biotechnology News.

The drug, Aqneursa^® (levacetylleucine), was approved by the FDA in September 2024 for neurological manifestations of Niemann-Pick disease Type C (NPC) in adults and children weighing 15 kg (33 pounds) or more,  and by the European Medicines Agency (EMA) in January.

On September 18, the FDA approved a supplemental New Drug Application expanding the label of Aqneursa to become the first and to date only drug approved for the treatment of ataxia in ataxia-telangiectasia (A-T) patients weighing 15 kg (33 pounds) or more. Aqneursa is now under review by the EMA for adults and children diagnosed with A-T.

“The planned acquisition of IntraBio actively demonstrates Shionogi’s solid commitment to building a leading global rare disease business,” Isao Teshirogi, PhD, Shionogi’s president, CEO, and representative director said Monday in a statement. “Bringing Aqneursa to Shionogi after our acquisition of Radicava^® will deepen our commitment to rare disease communities, expand our capabilities and strengthen our portfolio as we advance future innovation for patients with significant unmet needs.”

Investors initially appeared less enthusiastic about the IntraBio acquisition, as Shionogi’s shares traded on the Tokyo Stock Exchange fell about 4.5% Monday, from ¥2,786 ($17.61) to ¥2,661 ($16.82)—but the stock bounced back Tuesday, all but recovering with a 3.8% gain that sent shares up to Y2,763 ($17.47).

However, Sumant Kulkarni, a senior analyst covering biotechnology with Canaccord Genuity, viewed the deal more positively.

“In summary, this transaction underscores our view that companies with approved products for rare indications, neuro or otherwise, present significant scarcity value for strategics and investors alike,” Kulkarni wrote Monday in a research note. “We are not entirely surprised by this development, but are encouraged by the upfront consideration.”

Kulkarni added: “In fact, we were surprised that IntraBio had remained independent for the time it did, but the timing makes sense given the recent approval for A-T, which adds another leg to its story.”

‘Plenty of financial firepower’

The acquisition of IntraBio comes two months after Teshirogi told Bloomberg News in an interview that Shionogi was “actively pursuing” at least three acquisition opportunities: “From a cash flow perspective, we’ve become a company with plenty of financial firepower. If a good opportunity comes along, there’s absolutely no reason for us to hesitate over any M&A.”

Teshirogi also said Shionogi was looking to expand its U.S. and European manufacturing capacity in order to diversify its production base beyond Japan and thus reduce geopolitical risk over the next decade.

To that end, Shionogi pursued and won a U.S. government contract in April to establish a Stateside drug product manufacturing site for its Fetroja^® cefiderocol), a cephalosporin antibacterial indicated to treat adults with complicated urinary tract infections (cUTI) including pyelonephritis; as well as hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

The contract—awarded through the Biomedical Advanced Research and Development Authority’s (BARDA) Project BioShield—was initially funded at $119 million with multiyear options for a total of up to $482 million.

Shionogi signaled its intent to focus on rare disease drugs in April when it agreed to acquire Radicava (edaravone), a small molecule treatment for amyotrophic lateral sclerosis (ALS), from Tanabe Pharma for $2.5 billion and a potential royalty on future sales. At the time, Shionogi said the deal would benefit it by adding approximately $700 million in annual global sales during the company’s current 2026 fiscal year, which began on April 1.

59% leap

That would represent a 59% leap from Shionogi’s entire FY 2025 earnings before interest taxes, depreciation, and amortization (EBITDA) of ¥187.72 billion ($1.187 billion), up 4.7% from ¥179.296 billion ($1.134 billion) in FY 2024.

Radicava generated ¥94.491 billion ($597.582 million) in the 2025 fiscal year that ended on March 31 of this year.

“Through this acquisition, the Company aims to strengthen its business foundation and enhance its corporate value over the medium to long term by maximizing the value of edaravone and expanding its provision of solutions in the rare disease area,” Shionogi explained in reporting fiscal Q1 (April-June) 2026 results in August.

Radicava is marketed under that name as an intravenous (IV) infusion, and as an oral suspension called Radicava ORS. The IV version was approved by the FDA in 2022 and the oral suspension version, two years later.

Based in Austin, TX, IntraBio was established in 2015 to discover, develop, and commercialize therapies for neurodegenerative diseases with high unmet medical need, by commercializing research generated by its scientific co-founders—Professors Grant Churchill, PhD, Antony Gallone, PhD, and Frances Platt, PhD, all of the University of Oxford; and Michael Strupp, MD, of the University of Munich.

Privately held IntraBio finished last year with a $35.8 million net loss on net sales of $67.867 million—all of it generated from sales of Aqneursa—according to data disclosed by Shionogi in its announcement of the acquisition.

Shionogi is expected to close on its acquisition of IntraBio during this quarter, subject to customary closing conditions.

The post Shionogi Grows Rare Disease Portfolio with $2B IntraBio Acquisition appeared first on GEN - Genetic Engineering and Biotechnology News.

Panelists:

Erin Dieveney

Vice President, Quality Assurance
Aldevron

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Panelist

Erin Dieveney

Erin Dieveney leads quality assurance at Aldevron where she helps ensure the quality, compliance, and reliability of products that enable next-generation genomic medicines. Throughout her career, Erin has assumed increasing leadership responsibilities across quality, regulatory affairs, product development, and customer support, developing deep expertise in bringing innovative life sciences technologies to market.

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Khaled Yamout

Founder & CEO
Y-Chem Consulting

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Panelist

Khaled Yamout

Khaled Yamout is a thought leader in analytical sciences, quality and manufacturing. He was previously senior director of analytical services and quality control at TriLink Biotechnologies, where he oversaw the Analytical Sciences Center of Excellence and all analytical aspects of method development and validation to product release and stability, in support of regulatory filings for both small and large molecules. Prior to TriLink, Khaled held various positions in quality control, R&D, and manufacturing where he supported several drug products (small molecules and biologics) from clinical phase to commercial. His experience spans Fortune 500 firms as well as small entrepreneurial businesses in the areas of synthetic, analytical, colloidal, surface modification, protein, and antibody modification and purification.

Khaled holds a BS degree in chemistry from the University of Texas at Arlington.

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Kok-Seong Lim, PhD

Founder and Principal
Eight Crest Strategies

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Panelist

Kok-Seong Lim, PhD

Kok-Seong Lim, PhD, is a pharmaceutical leader with more than 20 years of experience in biological research and development, specializing in analytical sciences, quality control, and CMC strategy for advanced therapy platforms. He has held multiple management roles at Metagenomi, Aura Biosciences, Editas Medicine, and Thermo Fisher Scientific (formerly Brammer Bio), where he contributed to the advancement of more than ten gene therapies and CRISPR-based medicines for rare diseases and oncology indications.

Throughout his career, Kok-Seong has led the buildout of GMP-compliant facilities and analytical infrastructures to support early- and late-stage development. He has managed complex, multimillion-dollar budgets and contributed to regulatory submissions in both the U.S. and EU. Kok-Seong has served on committees such as the USP Biologics Expert Committee for Cell and Gene Therapy and the Standards Coordinating Body, helping to shape best practices and standards for the cell and gene therapy community.

Kok-Seong earned his PhD in biochemistry from the National University of Singapore and holds a BSc in pharmacy from the University of Strathclyde, Scotland.

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Michael Lehmicke

Senior Vice President, Scientific Affairs
Alliance for Regenerative Medicine

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Panelist

Michael Lehmicke

Michael Lehmicke joined the Alliance for Regenerative Medicine in 2019 as its first director of science and industry affairs. Michael has over 20 years of R&D experience in biomaterials, medical devices, and regenerative medicine. He has led product development teams for class II devices, human cell and tissue-based products, and drug/device combination products. He is a creator and an inventor with multiple U.S. patents to his name.

Michael has an MSc in biomedical engineering, with a focus on tissue engineering, from Drexel University. Michael’s areas of expertise include cell-based tissue engineering, bioceramics, biodegradable polymers, project management, strategic pipeline development, and business development.

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As biologics become more diverse, complex, and faster-moving, how can the biotech and biopharma industry ensure that quality standards keep pace with innovation? We will address this fundamental question in the latest GEN Spotlight on Biologics Standards for Innovation, Quality and Access, presented in partnership with USP. This virtual event will explore how evolving standards can provide a stronger foundation for developing and manufacturing next-generation therapeutics.

This Spotlight on Biologics Standards for Innovation, Quality and Access brings together experts from across biopharma, standards development, and analytical science to examine the challenges of testing increasingly complex modalities, including monoclonal antibodies, cell and gene therapies, and RNA therapeutics. Sessions will explore when and how to standardize emerging therapies, a practical layered framework for quality—from raw materials and analytical methods to identity, purity, and potency—and the growing importance of community input in developing standards for new modalities.

Session highlights include:

• A roundtable explores layered frameworks to ensure quality in multi-modal therapeutic development featuring Erin Dieveney (Aldevron) and Kok-Seong Lim, PhD (Eight Crest Strategies).
• A panel discussion on building standards for a multi-therapeutic modality future, featuring Khaled Yamout (Y-Chem Consulting) and Michael Lehmicke(Alliance for Regenerative Medicine)
• And a discussion featuring senior executives from USP on the importance of community input in developing standards for new modalities.

Join us on Wednesday, October 14, to discover how standardization can reduce development risk, support innovation, and help establish a shared foundation for the future of biologics.

Registration for this 2.5-hour event is free.

Produced with support from:

The post Biologics Standards for Innovation, Quality and Access appeared first on GEN - Genetic Engineering and Biotechnology News.

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Panelists:

Kevin Lance, PhD

Director, Product Management
Unchained Labs

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Panelist

Kevin Lance, PhD

Kevin Lance covers the Stunner portfolio globally at Unchained Labs. His expertise includes biophysical characterization of proteins, ADCs, nucleic acids, viral vectors, and LNPs. Prior to Unchained Labs, his research experience covered the fields of sustained antibody delivery and nanotechnology. He earned his Ph.D. in Bioengineering from the joint UC Berkeley – UCSF Bioengineering Graduate Program.

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Oligonucleotide therapeutics, including ASOs, siRNAs, aptamers, and now antibody- and peptide-oligonucleotide conjugates (AOCs and POCs) are gaining momentum fast. But the chemical modifications and conjugations that make them work also make them harder to characterize than classic nucleic acids. Accurate quantification is the foundation of almost every assay and understanding how to arrive at the right concentration factor is the critical first step that echoes through every downstream decision.

This webinar follows oligo quantification from method development through conjugate characterization. We’ll cover what to consider when setting concentration factors and how UV-Vis extends to measuring conjugation ratio in AOCs and POCs.

We’ll also explore the boundaries of dynamic light scattering in oligo and nucleic acid formulation development. Oligos are flexible and sticky, which makes them hard to characterize by DLS. We’ll show what DLS can and can’t tell you across different lengths of nucleic acid constructs, up through mRNA.

Finally, we’ll look at viscosity data for oligonucleotides and nucleic acids to answer in-demand questions on high-concentration formulation and subcutaneous delivery.

Key learning objectives

• Understand the pieces that influence concentration factors for oligonucleotide quantification
• Extend UV-Vis quantification to AOC and POC characterization, including conjugation ratio
• Set realistic expectations for DLS in nucleotide and nucleic acid characterization
• Understand the relationships between viscosity, formulations, and nucleic acids

A live Q&A session will follow the presentation offering you a chance to pose questions to our expert panelist.

Produced with support from:

The post Lock Down the Critical Factors in Oligo and Oligo-Conjugate Characterization with Stunner and Honeybun appeared first on GEN - Genetic Engineering and Biotechnology News.

Published in Nature Biotechnology, the paper, “Deep Learning Perturbation Models Can Outperform Baselines on Calibrated Metrics,” introduces a positive-control baseline and a framework for testing whether commonly used metrics can distinguish meaningful model predictions from less informative ones.

Genetic perturbation models, a subset of AI virtual cells, predict how activating or inhibiting genes will alter a cell’s transcriptome. If reliable, these models could support scalable in silico screens for therapeutic targets. However, recent studies found that sophisticated deep learning systems often failed to outperform simple baselines, raising doubts about whether the models captured perturbation-specific biology.

The researchers argued that part of the problem lies in the benchmarks themselves. “The promise of in silico perturbation models, or ‘virtual cells,’ is that the same scaling laws will apply, and that providing them with ever-increasing quantities of biological data and compute will improve their prediction of real-world experimental results,” Brendan Swain, PhD, CSO and founder of Shift Bioscience, told GEN. “However, early benchmarks of virtual cell models revealed apparently poor performance, casting doubt on their potential.”

To assess this issue, the team developed an “interpolated duplicate” positive control that combines the average perturbation profile with an independent technical duplicate, weighting each gene by the strength of evidence that it was affected. They then introduced the dynamic range fraction, or DRF, which measures how effectively a metric separates this positive control from a negative control.

Across 14 genetic perturbation datasets and 18 evaluation metrics, commonly used measures such as mean squared error and control-referenced Pearson correlation were often poorly calibrated, particularly in datasets with weaker perturbations. The authors also added that, “In contrast, weighted and rank-based metrics—including WMSE, weighted R_Δ²​, and normalized inverse rank (NIR)—consistently exhibited higher calibration across datasets, reflecting their shared design principle of emphasizing perturbation-specific signal.”

Using the better-calibrated measures, the researchers benchmarked nine deep learning models on tasks involving unseen single-gene perturbations and unseen gene combinations. Earlier models, including scGPT and GEARS, often surpassed uninformative baselines once their predictions were evaluated with calibrated metrics. More recent systems, including PRESAGE and scLambda, showed stronger performance, although results varied by dataset and metric.

The analysis also highlighted the importance of dataset design. In Norman19, where the training data covered only 0.63% of possible gene combinations, a simple additive baseline remained difficult to beat. In Wessels23, which covered 10.3% of possible combinations, multiple models surpassed the additive baseline, indicating that deep learning models can outperform additivity when trained on broader portions of the combinatorial landscape.

“Our findings show that by using well-calibrated metrics and the right dataset, virtual cell models can generate biologically meaningful insights,” said Swain. “As a result, we can use them with greater confidence to identify promising new targets that are relevant to aging and disease. We are applying this framework directly in our target identification program, focusing on targets whose inhibition can support both rejuvenation and treatment of age-related disease, giving us a clearly defined route towards clinical development.”

Shift Bioscience, a Cambridge, U.K.–based biotechnology company, plans to apply the framework in large-scale in vitro and in silico screens for inhibition targets relevant to cellular rejuvenation and age-related disease, initially focusing on fibrosis. “Ultimately, we hope these tools will guide researchers as they develop better and better virtual cell models,” Swain told GEN.

The post New Calibration Framework Improves Confidence in AI Virtual Cell Models appeared first on GEN - Genetic Engineering and Biotechnology News.

The partnership also offers an exclusive annual membership discount and a collaborative initiative to co-develop new curriculum.

ESSA Member Benefits & Savings

Every course in the Science for Sport library counts directly toward ESSA learning hours, offering members a flexible, self-paced way to meet annual requirements through high-value, practical content.

As part of the partnership, ESSA members will receive an exclusive 20% discount on annual Science for Sport memberships. Eligible members will receive their redemption code via email, with full instructions to claim the offer.

ESSA CEO, Katie Lyndon, said, “We are proud to partner with Science for Sport in delivering accessible and nationally recognised training for ESSA members.

“This partnership reflects ESSA’s commitment to providing meaningful value for our members by securing access to the knowledge, tools, and support they need to succeed.”

Exclusive Launch Giveaway: Win Catapult Performance Tech 

To celebrate  the new partnership, any ESSA member who joins Science for Sport during  the first month will automatically be entered into a competition to win a high-performance tech package, including:

• Perch P2 Setup – camera-based velocity training, jump testing and weight-room performance feedback, compatible with existing gym equipment.
• Catapult Vector Core System – GPS and inertial monitoring for workload,  performance, and recovery tracking.
• Free second-year membership – An additional 12 months of full access to Science for Sport.

“Professional development is most valuable when practitioners can see a clear connection between what they are learning and the work they do every day,” said Will Saville, Senior Operations Manager, Science for Sport.” Our content is built by working practitioners, for working practitioners, ensuring members get real-world education they can immediately apply. This partnership gives ESSA members on-demand access to a vast library of specialized and practical education in one place, while allowing us to collaborate directly with ESSA to develop new courses targeted to their members’ exact needs.” 

Co-Developed Content and Ongoing Collaboration

The new partnership marks the start of an ongoing content roadmap for  ESSA and Science for Sport. Over the coming year, both partners will co-develop three new courses tailored to member priorities. ESSA will identify key subject areas and connect subject matter experts from its professional network with the Science for Sport production team to build the curriculum..

Beyond course development, the collaboration will feature joint webinars and podcast appearances. Science for Sport will also share data-driven insights with ESSA regarding course engagement to help inform future course initiatives.

How to Get Started

The partnership launches on Wednesday, 7th October, 2026. Eligible ESSA members will receive an email with their exclusive 20% discount code. Redemptions completed within the first month automatically qualify for the Catapult launch competition.

Members can find details on how to access this offer via My ESSA > My discounts > personal and professional support to see your discount code.

Science for Sport × ESSA Competition: Terms and Conditions

Promoter and competition period

1. The promoter is Catapult Pty Ltd (ABN 66 137 513 378), trading as Science for Sport, of Level 2, 630 Church Street, Richmond VIC, Australia (Promoter). ESSA is a partner in the promotion but is not the promoter. Competition enquiries can be sent to will.saville@catapultsports.com.
2. The competition opens at 12:00 pm Australian Eastern Standard Time (AEST) on Wednesday 7 October 2026 and closes at 11:59 pm AEST on Friday 6 November 2026. All times in these terms are AEST (UTC+10).

Eligibility and entry

3. Entry is open to people aged 18 or over who are current financial ESSA members when they make their qualifying purchase and when the winners are drawn. ESSA members may enter wherever they live, subject to applicable law.
4. Employees and officers of the Promoter or ESSA who are involved in conducting the competition, and their immediate families, cannot enter.
5. To enter, an eligible ESSA member must purchase and pay for a Science for Sport annual licence during the competition period using the ESSA member discount code supplied to them. Each qualifying paid annual licence receives one entry. Entry is automatic once the purchase is completed; there is no separate entry form or competition entry fee. Both [Standard and Premium] annual licences qualify. [Confirm whether renewals qualify.]
6. Monthly licences, free accounts, purchases without the ESSA member discount code, and purchases cancelled or fully refunded before the draw do not qualify. Purchasing additional qualifying annual licences provides additional entries, but does not guarantee a prize. Each valid entry has an equal chance of winning the first prize drawn.

Prizes

7. There are five prizes:
   • One Perch P2 camera and system, including the camera, equipment for a full setup and a one-year software licence.
   • One Vector Core system, including the full hardware and software setup and a one-year software licence.
   • Three complimentary second-year Science for Sport annual licences. Each provides a further 12 months on the same annual tier as the winner’s qualifying purchase, starting immediately after their first paid year ends. 

Draw and winners

8. Winners will be selected at random from all valid entries on Wednesday 11 November 2026 at 8pm AEST. The Vector Core prize will be drawn first, the Perch P2 prize second, followed by the three annual licence prizes. A winning entry will be removed before the next draw. If a person holds another valid entry, that entry remains in the draw. Entrants do not need to attend. The Promoter will keep a record of the draw.
9. Before awarding a prize, the Promoter may reasonably verify a selected entrant’s identity, qualifying paid purchase and current ESSA membership. If a selected entry is invalid, another valid entry will be selected at random, subject to applicable law.
10. Winners will be notified by email, using the address associated with their qualifying purchase, by Friday 13 November 2026. The Promoter will make reasonable efforts to contact each winner. A winner must respond within 14 days of receiving the notification and provide the information reasonably needed to receive their prize.
11. Subject to applicable law, any prize that remains unclaimed after the response deadline will be awarded in a further random draw from the remaining valid entries on Tuesday 1 December 2026 at AEST. Any further-draw winner will be notified by email within two business days. If applicable law or an approval requires a different process or date for an unclaimed prize, that requirement will apply.
12. Results will be published at www.scienceforsport.com by Friday 11 December 2026, with winner details published to the extent required by applicable law.

Privacy and general terms

14. The Promoter will use entrants’ purchase and membership information to administer the competition, verify eligibility, contact winners and deliver prizes. It may ask ESSA to confirm a selected entrant’s membership status. Personal information will be handled in accordance with the Science for Sport privacy policy: https://www.scienceforsport.com/privacy-policy/. Entry does not require consent to receive unrelated marketing communications.
15. The Promoter may amend or suspend the competition only where permitted by applicable law and any relevant approval conditions, and will take reasonable steps to notify affected entrants. Nothing in these terms limits rights under Australian Consumer Law that cannot lawfully be excluded.

The post ESSA and  Science for Sport  Announce Strategic Professional Development Partnership appeared first on Science for Sport.

Drug giants Eli Lilly and Novo Nordisk say patients taking their drugs age less quickly, according to readouts from molecular “aging clocks.”

Such clocks assess a person’s biological age by looking at changes to DNA that accumulate with time, or, in newer versions, by tracking levels of key proteins.

Both companies found that overweight or diabetic patients taking the drugs, called GLP-1s, had reduced biological age compared to those taking a placebo, although the difference varied widely, depending on which type of clock was used, and what organ was tested. 

Overall, the difference was around “two to three years,” according to Nikolaj Roed, a global project leader at Novo, who says the company has been seeing “improved biological age in our patients across trials and across different tissues.” 

The findings add to wide speculation among scientists that GLP-1 drugs, as they are known, are acting on basic causes of aging and might be a true longevity treatment.

“Two years is a pretty strong effect, in my book,” says Steve Horvath, a professor at the University of California, Los Angeles, who’s credited with inventing aging clocks. Horvath says the emerging data could provide “evidence that these GLP-1 drugs are actually what is known as geroprotectors, medications that slow or possibly even reverse biologic aging.”

The companies shared their findings over the weekend during Aging Research & Drug Discovery, a conference devoted to seeking scientific remedies for old age. While that quest has not yet produced any clear-cut success, some scientists now think Novo’s drug semaglutide (sold under the names Ozempic and Wegovy) is coming close.

“In an unhealthy population, I do think it’s an anti-aging drug,” says Vadim Gladyshev, a Harvard biologist who assisted Novo with its molecular measurements. “But in a healthy population, no one knows.”

The drugs cause weight loss by stimulating a receptor, GLP-1, that tells your brain you’re not hungry. Yet real-world studies have shown much wider benefit. The drugs improve kidney function, reduce blood pressure, and even sharply cut the overall chance of death.

“If the question is,‘Can semaglutide reach several diseases relevant to health span and aging?’ we know we can say the answer is yes,” said Alejandro Aguayo-Orozco, a senior scientific director at Novo, the Danish drug giant, during the meeting.

The next question to answer, he said, is whether such effects are accompanied by changes to molecular measures of biological aging: “When you intervene with semaglutide, does it actually move the clocks in any direction? And the answer is yes.” 

The company found that, over time, the drugs cause a wide slowdown in aging clocks—as much as 4 years in the case of a clock that looks at heart proteins. “I think it’s pretty clear that the organ age is shifting,” said Aguayo-Orozco.

The studies are also a huge boost for the science of aging clocks. Although these measures reflect a person’s age, it’s been uncertain if they are useful as true biomarkers. Now clock makers have evidence  that their readouts show a drop in age when people take drugs with broad, well-demonstrated benefits.  

“The clock people have been pushing for a decade to get this kind of study done,” says Yuge Ji, a biologist who previously worked in the field and now runs a startup, Reflector Bio. “It’s huge for them.”

As part of its study, Novo took blood draws from 10,052 people, half on the drug and half on a placebo. Their blood, collected at the start of the study as well as months later, was then measured with “proteomic clocks,” which use levels of key proteins to predict a person’s age and risk of dying. 

Scientists at Eli Lilly performed similar research on their GLP-1 drug, tirzepatide, using so-called “epigenetic” clocks that assess age by counting accumulated changes to DNA. Lilly’s study was smaller, but also found that for the most part, molecular time moved more slowly for people on the drug.  

“All the clocks are telling a consistent story that we’re seeing a reduction in age,” Kevin Duffin, vice president for aging research at Lilly, said during the conference. “It’s not like we’re going to reverse age by 30 years or something, but it’s a significant reduction.”

The molecules have become the best selling drugs in the world,, with Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, topping the list with more than $36 billion in revenue to the company last year. Novo’s semaglutide, also sold under more than one name, was a close second.

Alex Zhavoronkov, the founder of Insilico Medicine, and the organizer of the Boston meeting, says that extending lives by even one year across the world’s population would be equal to tens of millions of lifetimes.  

Last month Zhavoronkov showed that one of his company’s drugs, for a lung disease, also reversed the signals from aging clocks. That drug is experimental, but Zhavoronkov has sought to promote the idea that humanity is entering a new era of longevity medicines. He also disclosed during the event that he has been “microdosing” the available weight-loss drugs, even though he is not overweight.

“I am on tirzepatide and I am an equal-opportunity injector of semaglutide as well,” Zhavoronkov said.

It was part of an effort to directly raise the question of whether the first mass-market anti-aging remedy is already here.

“Do you think a reasonable person should start taking semaglutide?” he asked Aguayo-Orozco, the Novo scientist, in front of a crowded audience.

“I am not a physician. I cannot answer that question,” Aguayo-Orozco replied.

Several people cautioned that GLP-1 drugs do have side effects, including muscle loss. That is one reason they might not help most people, says Horvath, who says he isn’t ready to take the drugs himself, although he’s thought about it.

“Clearly, the drugs have many benefits in obese people, but I did not yet see sufficient evidence that they will benefit skinny people,” he said. “I guess we will have to wait.”

Answers could start to emerge in a year or two. This past January, a US agency, ARPA-H, put $38 million toward a study in Texas that will attempt to determine whether semaglutide has anti-aging effects in healthy people over 60. That research will look at changes in cognition, mobility, and acuity of the senses.

That project also seeks to help define a regulatory pathway for anti-aging drugs and to “build a new therapeutic industry” around longevity.

Messenger RNA (mRNA) is expanding from pandemic-scale vaccines toward a wider therapeutic portfolio. Recent Phase 3 success for an individualized neoantigen therapy from Moderna reinforces the clinical relevance of the lower-volume end of that spectrum, while COVID-19 established the opposite extreme. Clinical success is encouraging emerging and established developers to advance RNA medicines either through CDMOs or by building internal capacities. For increased development and production efficiency, CDMOs and drug developers need fast changeovers and flexibility across sequences and scales. All-ScaleFlow integrates RNA synthesis, purification, buffer exchange, and LNP formation to help democratize development.

A patented semi-continuous IVT core

RNA synthesis begins with fixed IVT unit volumes injected into Dillico’s patented, spiral-shaped semi-continuous reactor (Fig 1). The reactor is held in a temperature-controlled environment. Each unitary volume (UnV) advances by one loop periodically and the mature IVT crude UnV exits for optional enzymatic treatment and quenching. This design preserves defined batch reaction conditions without relying on progressively larger batch vessels.

Continuous purification and RNA-LNP formulation

As illustrated in the process flow diagram (Fig 2), All-ScaleFlow integrates alternating multi-column chromatography (dT Oligo resin or monolith) and multi-stage SPTFF for RNA purification, concentration, and buffer exchange. Surge tanks buffer cyclic chromatography eluate and maintain controlled flow into continuous purification SPTFF and LNP mixing. After encapsulation, a second multi-stage SPTFF step removes ethanol and performs final buffer exchange before in-line dilution or excipient addition and sterile filtration. By coordinating flow rates and interfaces, the platform maintains continuous production from IVT crude to formulated mRNA-LNP while minimizing intermediate holds.

Automated cleaning and sterilization onboard

To reduce supply chain risks and achieve long-term sustainability, an automated clean-in-place and sterilization-in-place (CIP/SIP) station is integrated on the system. It uses common cleanroom utilities to clean and sanitize the stainless-steel process path. This could save up to 450 kg of single-use plastic (~200 k$) for a large-scale batch IVT production.

Demonstrated across RNA sequence types

The synthesis approach has been successfully demonstrated with multiple mRNA and self-amplifying RNA (saRNA) sequences with length ranging from 400 bp to 12,000 bp. Working across different sequences is important for a platform intended to serve diverse vaccines and therapeutics.

The Process Simulator turns a sequence into a master recipe

Dillico’s Process Simulator embeds mechanistic process models built from an empirical knowledge base generated through experiments with mainstream, off-the-shelf process components. From product and process requirements, it calculates the global constraints needed to operate the continuous process as a coordinated system and identifies robust conditions that meet quality attributes and throughput targets. This reduces the physical experiments required during process development and supports right-first-time execution, avoiding costly trial-and-error with production materials and analytical testing. Thanks to the Process Simulator, users will be guided through a structured, step-by-step workflow that facilitates technology transfer and lowers the entry barrier for teams new to continuous processing. As part of the digital infrastructure, real process data are contextualized, making them data-lake-ready.

Explore All-ScaleFlowTM and request the Evidence Package

The post Inside All-ScaleFlow: Continuous End-to-End RNA-LNP Manufacturing appeared first on GEN - Genetic Engineering and Biotechnology News.

Introduction

Prions are infectious proteins that cause neurodegenerative diseases in animals including bovine spongiform encephalopathy (cattle), Creutzfeldt-Jakob disease (humans), and chronic wasting disease (deer, elk and other cervids).¹ Prion diseases, also known as transmissible spongiform encephalopathies, result from misfolded proteins that accumulate primarily in the cells of the nervous system including the brains of infected animals. More widely, protein misfolding is linked to diverse neurological and non-neurological diseases and further research is needed in many areas due to the central importance of protein folding and aggregation in biology.

Prions propagate after regularly folded prion proteins (PrP^C) are converted into misfolded, aggregation-prone PrP^Sc proteins that build up and yield amyloids. These misfolded proteins and their aggregates damage nerve and other cells and, over time, lead to a decline in brain function and ultimately death.  With no cure available for prion diseases, researchers are striving to improve assay sensitivity and exploit the benefits of real-time monitoring to support the development of better diagnostic and treatment approaches.

RT-QuIC assays and microplate readers for prion analysis

Prions typically replicate by a series of sequential, amplifying events. Misfolded PrP^Sc acts as a point of recruitment of normal PrP^C cellular prion proteins. This interaction converts the recruited normal protein into the abnormal conformation setting in place a chain reaction where the protein-protein aggregates grow to produce a larger seed of misfolded proteins. As the aggregates grow, they can fragment to produce new nucleation sites. The seeds are eventually transformed into fibers of amyloid-rich assemblies that comprise significant amounts of beta-sheet conformations of the misfolded proteins.

The most widely used assay for detecting misfolded prions in biological samples is the RT-QuIC (Real-time quaking-induced conversion) assay. RT-QuIC assays are highly sensitive, seeding amplification assays that detect disease-associated prion activity. Formation of amyloid proteins is measured in real time using the fluorescent dye thioflavin T (ThT) whose emission increases significantly upon binding to beta-sheet-rich amyloid structures. Other dyes such as Congo Red are available that bind to amyloid but show reduced specificity for fibril proteins. Cyclic shaking accelerates fragmentation of the growing fibrils and produces a rapid amplification of the original prion seed. In practice, RT-QuIC assays generate characteristic amplification curves (figure 1) that comprise a baseline phase, an exponential increase in fluorescence, and a plateau phase. The lag time, maximum fluorescence, and reaction kinetics can provide quantitative or semi-quantitative measurements of prion seeding activity.

In the experiments shown in figure 1, scrapie brain homogenates were harvested 10 days after inoculation, incubated over time with shaking for the specified serial dilutions of Syrian hamster 263K cells, and ThT fluorescence was measured. The assays were quantified by measuring the loss of seeding activity at the end-point dilution.

Microplate readers and detection technologies for the investigation of amyloid

Microplate readers offer a robust platform for performing prion assays and measuring protein misfolding and aggregation. The ability to combine sensitive, high-performance kinetic fluorescence measurements with periodic cycles of rigorous shaking and consistent temperature control makes them the most widely adopted and practicable system for effective RT-QuIC assays.

Originally, the RT-QuIC assay was developed on the FLUOstar^® Omega microplate reader from BMG LABTECH which quickly became an international standard for prion analysis. BMG LABTECH readers, which continue to lead the way for prion detection and activity measurements, offer a robust platform for shaking for extended periods of time (over multiple days), while periodically reading the fluorescent signal as ThT is incorporated into amyloid aggregates.

Applications for protein misfolding

As mentioned earlier, protein misfolding has impact beyond prion disease and is a hallmark of impaired function in a wide range of conditions including Alzheimer’s disease, Parkinson’s disease, Huntington’s disease and amyotrophic lateral sclerosis. The way certain proteins misfold and aggregate is closely tied to how proteins become toxic and cause neurodegenerative diseases.

BMG LABTECH´s application note “Monitoring amyloid-beta aggregation in real-time using a FLUOstar Omega microplate reader²” provides one example where the accumulation of misfolded amyloid protein aggregates linked to Alzheimer’s disease is measured using ThT. Figure 2 shows some signal curves for samples and controls where ThT incorporation into newly formed amyloid-beta fibrils is measured.

In figure 2, error bars represent the deviation of replicate wells within one plate from the mean. All signal curves show a clear increase in fluorescence with time. This increase illustrates the incorporation of ThT into the newly formed amyloid-beta fibrils. After some time, a plateau is reached that is considered as the endpoint of amyloid formation and ThT incorporation process.

Protein misfolding and aggregation are likely to play a critical role in many processes related to aging. Misfolded proteins are also thought to influence different aspects of metabolic dysfunction and amyloid accumulation although the mechanism for most of these effects remains poorly understood. ThT assays thus offer applications across multiple disease areas and research domains.

Future developments

RT-QuIC assays have significantly accelerated research and analysis into prions compared with earlier more costly and lengthy bioassays where infected animals were studied over months. RT-QuIC assays also offer potential for disease surveillance in populations of prion-infected animals in the wild that could impact public health. Researchers are also looking at ways to use RT-QuIC-based screening assays to ensure the safety of human food chains. In this context, microplate readers and RT-QuIC assays have been used in experimental settings to characterize prion-seeding activity in samples of tissue from wild and farmed deer that may have been exposed to chronic wasting disease.³

Beyond surveillance, new drugs are actively being sought for different targets related to protein folding and amyloid accumulation. In clinical trials, translatable biomarkers are needed that track the progression and severity of the neurodegenerative diseases impacted by protein misfolding and aggregation. Progress in artificial intelligence and modeling techniques will enhance studies of protein folding and misfolding which should bring further advances to the drug discovery space.

Demand for ThT assays is poised to increase due to the lack of interventions for neurological and non-neurological diseases caused by protein misfolding and aggregation events and the potential for other high-impact applications.

ThT-related assays are therefore moving away from being a means for a rapid diagnosis towards offering a quantitative tool for disease surveillance, pathogenesis, and therapeutic development across a wide range of disease and fundamental research areas in the life sciences.

BMG LABTECH offers a portfolio of single- to multimode microplate readers ideally suited for studying protein misfolding and aggregation. While the FLUOstar Omega remains the gold standard for RT-QuIC and seeding assays, the PHERAstar^® FSX was specifically conceived for screening campaigns and is the go-to reader for high-performance high-throughput screening. Both the VANTAstar^® and CLARIOstar^® Plus allow for wavelength flexibility and include Enhanced Dynamic Range technology for superior performance and ease of use. Collectively, these multimode readers combine high performance with miniaturized assays and short measurement times, delivering considerable savings on materials and other resources.

References

1. Dong TT, Satoh K. The Latest Research on RT-QuIC Assays-A Literature Review. Pathogens. 2021 Mar 5;10(3):305. doi: 10.3390/pathogens10030305.
2. Baumann F. Following Abeta Fibrillization/Aggregation in Real-Time | BMG Labtech. n.d. [Last accessed: 9/14/2026].
3. Li M et al. RT-QuIC detection of CWD prion seeding activity in white-tailed deer muscle tissues. Sci. Rep. 2021 Aug 18;11(1):16759. doi: 10.1038/s41598-021-96127-8. PMID: 34408204; PMCID: PMC8373970.l

If you are interested in further details about microplate-based evaluation of prions and protein misfolding, please contact us at applications@bmglabtech.com or scan the QR code on the right-hand side

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Today, despite the astounding breakthroughs of the past quarter-century, positive responses to advanced therapies such as checkpoint inhibitors and cell and gene therapies are still limited to a relatively small subset of patients. To improve efficacy and understand patient response, Stengel says, “We need to consider all layers of epigenetic regulation to better understand gene regulation and build better models of biology, especially right now, with AI enabling the integration of huge amounts of data.”

Despite the increasing influx of information, “We still have gaps in our understanding of how information flows from DNA to proteins and ultimately phenotype,” Stengel says. In a multiomics environment, RNA modifications—which she calls “an essential layer of that multiomic stack”—have received relatively little attention because they are considered particularly hard to measure accurately.

To help resolve that issue, AlidaBio is focusing on three of the most important RNA modifications as a way to create better and more useful epitranscriptomics models to improve scientists’ understanding of the many layers of epigenetic regulation.

Why epitranscriptomics

“Epitranscriptomics are a readout of the cell state,” Stengel says. “Single-cell transcriptomics and spatial transcriptomics have shown a huge amount of heterogeneity—similar cell types are characterized by different RNA expression patterns that define what a cell is doing at a given time.” As an example of the timescales of response, she says, “To reset DNA methylation can take up to two weeks. To reset an RNA expression pattern can take a day, and RNA modifications can change RNA expression within a few hours.” Understanding those patterns and their time to action can significantly affect a cell’s response to therapeutics.

“RNA modifications don’t change the genetic code, but they change what RNA does,” Stengel emphasizes. “N6-methyladenosine (m6A), the most important mRNA modification, can quickly mark RNA transcripts associated with a previous cell state for degradation and, at the same time, promote the translation of genes that are associated with the future cell state. It is also involved in alternative splicing regulation, which creates more protein diversity.”

Epitranscriptomics method development has gained significant momentum in recent years. Current nanopore-based direct RNA sequencing can detect a subset of modifications in native, long RNA molecules. However, the approach currently requires relatively large quantities of high-quality full-length RNA.

Short-read, one-pot detection

Alida Biosciences expanded the industry’s capabilities in 2025 by launching its EpiPlex platform. It was the first commercial solution to analyze sparse and highly-degraded RNA often found in clinical samples and provide simultaneous, one-pot detection, localization, and quantification of three of the best-studied and most frequently occurring mRNA modifications: N6-methyladenosine (m6A), inosine, and pseudouridine, along with gene expression. The company offers kits, analysis software, and services.

“To develop clinical and translational applications, you need to look at clinical samples (fresh-frozen or formalin-fixed paraffin-embedded tissues, and liquid biopsies, for example) that are present at low quantities or that may be highly degraded,” she explains.

The long list of potential applications includes patient stratification for specific therapies and response monitoring, as well as therapeutic development of cancer drugs and measuring immune cell fitness. “m6A, the most common modification, plays a huge role in cell differentiation and cell fate,” Stengel says.

Entrepreneurial leanings

Stengel formed the company five years ago, leaving a safe corporate position on the belief that she could create a company that would fill a key knowledge gap.

“I had spent a significant number of years in large companies—including Illumina—developing genomics technologies,” she says. Researchers at such companies, however, tend to be involved in either the inception or the development of a product. “I wanted to see things through from the beginning to the end. I thought a smaller company would be the ideal environment to do exactly that. I resigned my job and started putting the pieces together.

“When I started the company, many [in the industry] had never heard of epitranscriptomics,” she says. Nonetheless, she secured venture capital funding within six months and built a small, core team.

Those early days found her in the lab, working with just a few scientists. “Getting the first, preliminary data was so exhilarating!” she recalls. “It’s a good day when everything works in the lab.”

Epitranscriptomics is emerging from a niche discipline, so now most conference attendees, “regardless of the conference,” Stengel adds, are aware of the field. Although, she admits, “not everybody knows why they are important. Yet, that’s a huge step forward.”

Commercial vision

As scientists increasingly recognize the role RNA modifications play in therapeutic development and outcomes, she can focus on scaling the company and its commercial capabilities. “We started out very R&D heavy,” and now are beginning to earn revenue to fund further innovations. Potential clients include multiomics companies, research hospitals, and “to some extent, diagnostics,” she says.

Currently, AlidaBio is working with the oncology company STORM Therapeutics to understand the mechanism of action and to stratify patients for a Phase II drug that acts on methyltransferase-like 3 (Mettl3), the m6A writer enzyme. This is one of a few areas in which RNA modification can make breakthroughs in patient treatment and stratification, she says. “We’re also very interested in predicting response to PD-L1 inhibitors.”

For AlidaBio, bioinformatics is an area of continual focus, along with making analysis output more interactive. “We also are applying machine learning models to integrate the amount of information between RNA modifications and gene expression, so there will be significant updates to the EpiScout^® analysis software,” Stengel says. Other plans remain confidential.

For both the company and the industry, “I think the next inflection point is when epitranscriptomics becomes part of mainstream multiomics,” Stengel says. When that happens, researchers will consider RNA expression data incomplete without information about RNA modification.

Therefore, eventually, “RNA modifications will become another standard layer that’s integrated into AI models of biology,” she continues. “The real test will be demonstrating that this layer improves patient stratification, predicts treatment response, or identifies new therapeutic opportunities. Once that happens, I think the field will move from being scientifically interesting to clinically indispensable.”

The post The Epitranscriptome Heads Toward Clinical Necessity appeared first on GEN - Genetic Engineering and Biotechnology News.

Created from BoardVitals library of up-to-date content, these front-and-back cards give you a quick, focused way to review important information and strengthen your recall as you prepare for exam day. 

Why Add Flashcards to Your Study Routine? 

It is easy to recognize a familiar fact on the page and assume you know it. Recalling that same fact without a prompt is harder. Flashcards put your memory to work by asking you to retrieve an answer, check your response, and return to important concepts over time. 

That repeated retrieval can support long-term retention and help you quickly spot the topics that need more attention. Whether you are a medical student balancing coursework and clinical rotations or a resident fitting study time into a demanding schedule, flashcards can help you make the most of shorter study sessions. 

Build Stronger Recall for Board Exam Day 

Board exams require you to remember a wide range of information, retrieve it quickly, and apply it to specific situations. With Claire AI flashcards from BoardVitals, you’ll review these key terms and concepts with just a few clicks.  

Claire AI flashcards reinforce the essential details and relationships found in your question content, helping you build a stronger foundation for answering board-style questions. Use them alongside your review questions to revisit what you have learned and keep important concepts fresh. 

After completing questions, review flashcards to strengthen your knowledge of terminology, mechanisms, diagnostic clues, and other high-yield connections. Over time, combining practice questions with active recall can help you move beyond recognizing the right answer to retrieving and applying what you know. 

Make Every Study Session Count 

Add flashcards to the BoardVitals routine that already works for you. Review them after a quiz, return to them during a quick study break, and spend extra time on the concepts that are still difficult to recall. Flashcards should not be used as a replacement for practice questions, but as another way to reinforce the knowledge you need to pass your board exam.   

Meet Claire AI for BoardVitals 

Meet Claire AI, now available with most BoardVitals question banks. From explaining challenging topics and summarizing key points to creating flashcards and generating additional practice questions, Claire AI gives you more ways to engage with the material you are already reviewing. And because Claire AI pulls only from BoardVitals’ up-to-date question bank content, you can trust that the study support stays grounded in the same reliable material you already use to prepare. 

With AI-powered support built directly into the BoardVitals experience, Claire AI makes each study session more focused and responsive. You’ll get the help you need to study effectively when you need it most. However you choose to use it, Claire AI can help you understand, review, and practice material with greater confidence throughout your board prep. 

The post Claire AI® Feature Spotlight: Flashcards  appeared first on BoardVitals Blog.

Whether you are preparing for a USMLE® exam, a shelf exam, or specialty boards, Claire AI makes it easy to turn one review question into a focused learning session, allowing you to stay with a challenging concept and practice it from multiple angles before moving on. 

This kind of targeted practice is especially useful when you miss a question, hesitate between two answer choices, or reach the correct answer for the wrong reason. Instead of saving the topic to revisit later, you can reinforce it right away while the concept – and your reasoning – are still fresh.  

More Questions, More Prep 

Looking for additional ways to study a concept? Ask Claire AI to generate more questions related to the topic you are reviewing. The questions appear directly in your conversation, so you can keep practicing without stopping to create a separate quiz. 

For example, if a cardiology question reveals uncertainty about murmurs, ask Claire AI for additional questions about murmurs to keep reviewing. Confused two pharmacology mechanisms of action? Practice the concept again in a new context before moving on. 

These questions are designed for quick, in-the-moment reinforcement and are not saved as a quiz in your BoardVitals account. Use them as a flexible supplement to your broader study plan. Your question bank, performance insights, detailed explanations, and exam-style practice remain essential for tracking progress and preparing across the full exam blueprint. 

How More Questions Can Strengthen Your Board Prep 

Practice Active Recall 

Answering a question asks you to retrieve and use information, not simply recognize it on a page. More questions extend that practice and help you confirm what you know before returning to passive review. 

Apply Concepts in New Contexts 

Board-style questions often test familiar material through unfamiliar clinical details. Related questions help you separate the core concept from one specific vignette and build the flexibility to apply your knowledge when the presentation changes. 

Find Gaps Before Test Day 

One correct answer does not mean you have mastered a topic, and one missed question does not always mean the entire topic is weak. More practice gives you a clearer picture. If your reasoning holds across several questions, you can move forward with greater confidence. If it doesn’t, you have found a specific area to revisit before exam day. 

Meet Claire AI for BoardVitals 

Meet Claire AI, now available with most BoardVitals question banks. From explaining challenging topics and summarizing key points to creating flashcards and generating additional practice questions, Claire AI gives you more ways to engage with the material you are already reviewing. And because Claire AI pulls only from BoardVitals’ up-to-date question bank content, you can trust that the study support stays grounded in the same reliable material you already use to prepare. 

With AI-powered support built directly into the BoardVitals experience, Claire AI makes each study session more focused and responsive. You’ll get the help you need to study effectively when you need it most. However you choose to use it, Claire AI can help you understand, review, and practice material with greater confidence throughout your board prep. 

The post Claire AI® Feature Spotlight: Generate More Practice Questions appeared first on BoardVitals Blog.

That’s where the new Claire AI summarize feature in BoardVitals can help. It turns the material behind each question into a concise, focused overview, making it easier to understand key concepts, revisit challenging topics, and keep your study sessions moving. 

Make Every Study Minute Count 

Medical students and residents have a lot to learn and limited time to learn it. You need to understand the reasoning behind each question while reinforcing the high-yield takeaways most likely to matter on exam day. Claire AI helps bridge that gap by condensing complex topics into focused reviews. 

When you answer a BoardVitals question, Claire AI uses the question’s context to create an easy-to-digest overview of the related content and key concepts. Instead of sorting through every detail again, you can quickly focus on what matters most and get back to studying.  

Use a summary when an explanation brings together several ideas, when a topic feels unfamiliar, or when you want to lock in the main point before moving on. With the key details easier to spot, you can spend less time sorting through information and more time practicing where it counts. 

Build Claire AI into Your Study Routine 

During a focused review session, use Claire AI to quickly revisit a weak area without rereading every detail. As exam day approaches, turn to these overviews for a quick way to refresh. 

Claire AI works best alongside your own clinical reasoning. Use each summary to reinforce learning and guide your next step, and refer to the complete question explanation whenever you need more context or detail. 

As you work through your question bank, Claire AI summaries make it easier to return to missed or challenging material. They do not replace BoardVitals’ complete explanations; they give you another quick way to reinforce the central lesson and keep building momentum.  

Meet Claire AI for BoardVitals 

Meet Claire AI, now available with most BoardVitals question banks. From explaining challenging topics and summarizing key points to creating flashcards and generating additional practice questions, Claire AI gives you more ways to engage with the material you are already reviewing. And because Claire AI pulls only from BoardVitals’ up-to-date question bank content, you can trust that the study support stays grounded in the same reliable material you already use to prepare. 

With AI-powered support built directly into the BoardVitals experience, Claire AI makes each study session more focused and responsive. You’ll get the help you need to study effectively when you need it most. However you choose to use it, Claire AI can help you understand, review, and practice material with greater confidence throughout your board prep. 

The post Claire AI® Feature Spotlight: Summarize Key Concepts  appeared first on BoardVitals Blog.

The post Where Care Meets Calling: Q&A with Lisa B. Nachtigall, MD appeared first on Endocrine News.

Human stem cells have been used to grow miniature gland structures that were successfully deployed for salivary gland regeneration in mice.

Stem cells can be easily extracted from human sources such as blood or skin, which researchers from the University at Buffalo, New York, said makes them attractive for therapeutic applications.

The researchers transplanted the organoids into the salivary glands of 12 immunodeficient mice, which allowed for the effects to be studied without immune rejection.

Stelios Andreadis, co-principal investigator on the study, said his team was guiding stem cells through a process similar to how salivary glands form during human development. After more than 40 days, the transplanted organoids contained major gland cell types, including saliva-producing cells.

He continued: ‘These newly formed glands looked similar to native salivary glands and even developed lumens, or the hollow spaces where saliva would normally flow.’

Human salivary glands may be damaged by radiation used during cancer treatment or autoimmune conditions such as Sjögren’s disease, resulting in chronic dry mouth. Andreadis suggested that the stem cell derived glands could be implanted into an individual’s mouth to replace the damaged ones.

He added: ‘Our findings suggest that salivary gland organoids may hold promise for studying salivary gland development, disease progression and drug screening, as well as for development of cell therapies for salivary gland regeneration.’

Are there other applications for stem cells in oral health?

Researchers have previously dubbed whole tooth regeneration with stem cells ‘a realistic aim’. A review from the Sharad Pawar Dental College and Hospital said that regeneration of damaged dentine and pulp using stem cells had already been proved possible.

However, it also identified immunological rejection as a key barrier against using stem cells to regenerate whole teeth, particularly when embryonic cells were used. This did not rule out the use of stem cells from other sources – transplant rejection was uncommon when adult stem cells taken from organs such as tooth pulp or umbilical cords were used.

Additionally, researchers from the University of Washington School of Dentistry succeeded in creating stem-cell-based organoids which secrete proteins that form dental enamel in 2023.

Professor Hai Zhang, co-author of the study, called this a ‘critical first step’ in the development of stem cell-based dental treatments.

Find out more about developments in tooth regeneration.

Create a free account for unlimited access — plus the Dentistry Bulletin delivered to your inbox.

According to the company, the funds will support the development of what it claims is a first-of-its-kind platform for naturally modified mRNA medicines. The so-called Versatile Engine for Cell-based Therapeutic Optimization of RNA (VECTOR) platform integrates computational and artificial intelligence-enabled sequence optimization, high-throughput screening, and proprietary engineered eukaryotic cells to design and manufacture mRNA. Meanwhile, the company’s PromPT technology is designed to capture and protect mRNA inside cells before it is purified for therapeutic use. 

Specifically, Sensible will use the funds to expand VECTOR’s AI-enabled mRNA design and automated high-throughput screening capabilities as well as support the development of clinical-grade manufacturing capabilities. Sensible’s platform harnesses the natural machinery of living cells to produce naturally modified mRNA with reduced immunogenicity and high protein expression while avoiding double-stranded RNA contamination. Furthermore, by using engineered living cells, Sensible reduces reliance on specialized raw materials and manufacturing inputs, enabling more scalable production and expanding mRNA into therapeutic applications that require higher or repeated dosing.

Rather than relying on synthetic manufacturing technology developed more than 40 years ago, “we are taking a fundamentally different approach, using living cells to produce naturally modified mRNA while reducing the cost and supply-chain constraints of conventional production,” said Miroslav Gasparek, Sensible’s co-founder and CEO. “With this financing, we can scale our platform and expand mRNA into therapeutic applications requiring high or repeated dosing that have historically been limited by cost.”

The Series A includes participation from new investors OTB Ventures and In-Q-Tel, alongside existing investors Recode Ventures, Isomer Capital, Y Combinator, Backed VC, Kaya VC, Civilization Ventures, and BlueYard Capital, as well as the family office of Christoph Huber, co-founder of BioNTech, and Tim Garnett, former chief medical officer of Eli Lilly, and other individual investors.

In connection with the financing, Vishal Gulati, MD, FMedSci, managing partner at Recode Ventures, and Joel Schoppig, partner at Oxford Science Enterprises, will join Sensible’s board of directors alongside Miroslav Gasparek and Marian Kupculak, PhD, CSO and co-founder.

The post Sensible Biotechnologies Raises $47M to Expand Next-Generation Platform for mRNA Medicines appeared first on GEN - Genetic Engineering and Biotechnology News.

A Canadian-developed system known as HALO – Human Attended Live Observation – combines bedside audiovisual technology with trained remote safety observers who continuously monitor patients considered at elevated risk.

The technology originated at University Health Network (UHN) in Toronto, where it was developed by clinicians to address the challenge of providing continuous observation for patients who might fall, wander, remove oxygen or other medical equipment, or otherwise require close supervision.

Traditionally, hospitals may assign a staff member to remain at the bedside of one patient requiring constant observation. The approach can provide important protection, but it also ties up healthcare workers who could otherwise be providing direct patient care.

HALO takes a different approach. A portable device equipped with cameras and two-way communication is placed near the patient’s bedside. Trained virtual safety observers monitor patients from a centralized command centre and can communicate directly with a patient if they identify potentially unsafe behaviour.

If further intervention is required, the observer alerts the patient’s care team.

According to HALO, one observer can monitor as many as 12 patients simultaneously. The company says the technology is now deployed at approximately 30 healthcare sites across Canada; more recent industry reporting places its footprint at 34 sites.

The system has grown considerably from its beginnings within UHN.

At UHN, virtual observation has become part of routine patient care across inpatient services. UHN describes the technology as a health human resources tool that can help allocate nursing and other healthcare staff where they are most needed while maintaining continuous observation of eligible patients.

Expansion has also moved well beyond Toronto.

Recent deployments or agreements have included Unity Health Toronto, Waterloo Regional Health Network, Niagara Health, Oak Valley Health, St. Joseph’s Healthcare Hamilton and Georgian Bay General Hospital. Deployments at Sunnybrook Health Sciences Centre and Montreal’s Jewish General Hospital are also planned for late 2026, according to recent reporting.

Newfoundland and Labrador represents one of the technology’s most significant expansions.

NL Health Services first introduced the system in four acute-care hospitals and healthcare centres in 2024. At the time, the health authority said the technology could help care teams identify changes in patients’ conditions and intervene when necessary while making more efficient use of healthcare personnel.

That deployment has since expanded substantially. Recent reporting says HALO now supports 11 hospitals and six long-term-care homes in Newfoundland and Labrador, including rural and remote communities where maintaining one-to-one patient observation can be particularly challenging.

The technology may also offer measurable patient-safety benefits.

Recent Canadian Healthcare Technology reporting says one Western Canadian hospital experienced a 75 per cent reduction in high-risk patient falls during its first year using the system. At UHN, HALO is reported to have reduced the need for one-to-one constant observation by an average of approximately 40 per cent.

Privacy and consent remain important considerations whenever cameras are introduced into patient-care environments.

UHN says the HALO system provides a secure livestream of images and sound rather than recording patients. Patients are informed about the monitoring and can decline the service.

The technology does not eliminate the role of nurses or other frontline caregivers. Instead, remote observers provide another layer of continuous surveillance and alert the clinical team when bedside intervention is required.

For Canadian hospitals facing simultaneous pressures around patient safety, workforce shortages and rising costs, virtual observation represents one example of how technology developed inside the healthcare system is moving from a local innovation to a broader model of care.

The post Canadian ‘virtual sitter’ technology expands as hospitals look to improve patient safety and ease staffing pressures appeared first on Hospital News.

Under the agreement, Pacira will obtain an undisclosed upfront payment, alongside a supply price and royalties generated from future commercial sales across the licensed territories.

Pacira will be responsible for manufacturing the therapy. Molteni Farmaceutici will manage regulatory procedures, market access, and commercialisation efforts in the designated markets.

Molteni Farmaceutici plans a phased commercial rollout of the analgesic, starting in Austria, Germany, Italy, and Poland, while also seeking regulatory approval in Switzerland.

The companies expect the first commercial sale under the partnership to occur in 2027. Locust Walk served as the exclusive financial advisor to Pacira for the transaction.

Pacira BioSciences CEO Frank Lee said: “We are excited to announce another strategic partnership that advances our 5×30 growth strategy and reinforces our commitment to expanding patient access to best-practice opioid-sparing postsurgical pain management.

“With Molteni Farmaceutici’s longstanding leadership in pain management and extensive distribution network across Europe, they are ideally positioned to unlock EXPAREL’s full potential in key European markets.”

Molteni Farmaceutici focuses on specialty healthcare, operating in the fields of hospital-based treatments, oncology supportive care, and pain management.

Alongside Exparel, Pacira’s commercial portfolio includes Zilretta (triamcinolone acetonide extended-release injectable suspension), an intra-articular extended-release injection indicated for managing osteoarthritis knee pain.

The company is also developing a pipeline of clinical-stage candidates for musculoskeletal pain and related conditions.

Its investigational product, PCRX-201 (enekinragene inzadenovec), is a locally administered gene therapy currently undergoing Phase II clinical development for knee osteoarthritis.

In November 2025, AmacaThera entered into an exclusive worldwide licensing agreement with Pacira BioSciences for up to $230m for AMT-143, an investigational long-acting non-opioid anaesthetic.

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Combined with the company’s genomic medicine facility at 100 Binney Street, the site located in Kendall Square, Cambridge will accommodate around 2,000 researchers and scientists.

The expansion will increase AstraZeneca’s Massachusetts workforce by more than 50% in the coming years.

Research teams at the Kendall Square centre will focus on developing therapies across several disease areas, including breast cancer, chronic obstructive pulmonary disease (COPD), metabolic disease, obesity, oncology, and rare conditions, alongside work in biologics and cell therapy.

AstraZeneca CEO Pascal Soriot said: “Kendall Square is a leading innovation ecosystem, and it is one of the key locations where AstraZeneca will discover the next generation of scientific breakthroughs.

“Our new R&D centre not only reflects AstraZeneca’s long-term commitment to Massachusetts but also our belief in delivering US-led innovation to patients around the world.”

The Massachusetts project forms part of a wider $50bn investment programme by AstraZeneca in the US, where the business has operated in the state for more than 75 years.

AstraZeneca currently employs over 25,000 staff across 24 corporate, commercial, manufacturing, and research sites nationwide, supporting nearly 100,000 jobs.

The Kendall Square opening expands AstraZeneca’s global research network across over 40 countries, including its other primary US strategic R&D centre located in Gaithersburg, Maryland.

Prior to this, AstraZeneca and Daiichi Sankyo partnered with Summit Therapeutics to explore the potential of their co-developed antibody-drug conjugate (ADC), Datroway (datopotamab deruxtecan), alongside Summit’s in-licensed candidate, ivonescimab.

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Pharmaceuticals accounted for 88.8 per cent of healthcare M&A activity by value in September 2026, while investment activity in the private equity space was led by hospitals and healthcare technology, according to an Equirus analysis of the healthcare sector.

The healthcare sector saw three major M&A deals in September, with the pharmaceutical sector accounting for the bulk of transaction value during the month.

Pharmaceuticals and biotech accounted for 88.8 per cent of M&A transactions by value in September, followed by healthcare technology at 10 per cent and other segments at 1.2 per cent. For comparison, pharmaceuticals accounted for 71 per cent of M&A transaction value in CY25 and 91.4 per cent in YTD 2026.

Healthcare M&A activity stood at INR 19 billion in September 2026, compared with INR 354 billion in CY25 and INR 1,386 billion in YTD 2026.

The private equity market also remained active, with hospitals and healthcare technology emerging as the key areas of investment during September. The average deal size during the month stood at around INR 2,220 million, while the healthcare sector saw one major PE deal and one VC deal during the period.

“In terms of deal value in the September’26 period, investment in the hospital sector is the highest followed by healthcare technology sector,” the analysis said.

The pharmaceutical segment also witnessed consolidation activity during the month. Anupam Rasayan India acquired a 50.1 per cent controlling stake in Bliss GVS Pharma for about INR 1,750 crore, marking its entry into pharmaceutical formulations.

Separately, RPG Life Sciences acquired the API and intermediates business of Raghava Life Sciences for INR 135 crore through its wholly owned subsidiary RPG Active Pharma. The transaction is expected to expand RPG Life Sciences’ API manufacturing operations product portfolio and scale in pharmaceutical APIs and intermediates.

The healthcare capital markets also remained active. The healthcare and pharma ECM data showed that Symbiotec Pharmaceuticals’ IPO, which opened on September 1, 2026, raised INR 17,570 million and was subscribed 71.3 times, with the stock listing at an initial gain of 0 per cent.

The September healthcare data also comes against a broader backdrop of sustained capital deployment across the sector, with healthcare M&A activity in YTD 2026 standing at INR 1,386 billion and private equity activity at INR 79 billion.

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Treeline Dental Care brought teams from all 15 practices together in Nottingham for its annual Growth and Development Day, combining expert training, collaboration and inspiration from Gladiators star Giant to support staff development and strengthen patient care.

Treeline Dental Care gathered teams from every practice for its annual Growth and Development Day, held on 17 July 2026 at the Jubilee Hotel in Nottingham. With a programme built around learning, collaboration and development, the event reinforced Treeline’s commitment to investing in its people and strengthening the culture that underpins its approach to modern dentistry.

Treeline Dental Care has always been a group that prioritises its people, and this year’s Growth and Development Day demonstrated that commitment in full. Bringing together staff from every Treeline site, the event created a rare opportunity for the entire organisation to learn, connect and look forward to the year ahead. From clinicians and practice managers to nurses and reception teams, the day offered a shared space for development and a renewed sense of unity across the group.

Growth and resilience

The event opened with a welcome from co‑founder Dr Jimmey Palahey, who spoke about Treeline’s continued growth and the importance of building a resilient, forward‑thinking team. This introduction set the tone for a day focused on proactive development, encouraging staff to take ownership of their learning and to contribute to the evolving identity of Treeline Dental Care, a rapidly growing dental group comprising 15 practices in the East Midlands and South Yorkshire.

A key strength of the Growth and Development Day was the breadth of training available. Treeline was supported by a strong line‑up of sponsors, including Henry Schein, Orascoptic, Densura, AES Dent Care, Dental Nurse Network, Denplan, vVARDIS and Dandy. Their involvement brought industry expertise directly into the room, giving teams the chance to consider new products, technologies and clinical approaches that could enhance patient care across Treeline practices.

Inspiration from Gladiators‘ Giant

One of the standout moments of the day came from guest speaker Jamie Bigg, widely known as Giant from Gladiators. Drawing on his experience in high‑performance environments, Jamie delivered a session on the importance of being proactive rather than reactive. He encouraged the team to anticipate challenges, embrace change and build habits that support long‑term success. His message resonated strongly with attendees, offering a fresh perspective on personal resilience and team dynamics within a fast‑moving dental landscape.

Throughout the day, the atmosphere reflected Treeline’s culture: warm, collaborative and energised. Staff commented on how valuable it was to come together as a whole group, particularly in a sector where busy practice schedules can make cross‑site connection difficult. Many noted that the event helped them understand the wider Treeline vision more clearly, strengthening their sense of belonging and reinforcing the shared standards that define the group’s approach to patient care.

As the event drew to a close, there was a clear sense of momentum. Treeline’s Growth and Development Day not only provided practical learning but also reaffirmed the group’s commitment to building a supportive, ambitious and united organisation. With the group continuing to expand and evolve, events like this play a vital role in ensuring that every team member feels equipped, valued and connected to the journey ahead.

Discover more about Treeline Dental Care here.

This article is sponsored by Treeline Dental Care.

Joe and Courtney Dion came to Washington to share their story: Peter, age 10, and Maggie, age 6, were born with limb-girdle muscular dystrophy (LGMD-R5, formerly known as LGMD-2C), a rare disease that would eventually rob the children of their ability to walk, move independently, and breathe on their own. 

At the time, there was little hope on the horizon.

“Our first conversation with the Dions was incredibly powerful—it became clear that they had done their homework. They identified a company with a promising gene therapy, but which could not progress to the clinic without significant investment,” explains Michele Oshman, BIO’s Chief Patient Advocate. “They also understood that investment could very well depend on the reauthorization of a little-known, but incredibly powerful federal program called the pediatric priority review voucher (PPRV). … For the cynics out there who think that maybe patient advocacy is not truly organic, they are wrong. It really is.”

From that day, the Dions made it their mission to get the PPRV reauthorized in time for Peter and Maggie to benefit from gene therapy. 

Oshman, along with Maggie, mom Courtney, and dad Joe Dion, was a keynote speaker at the Rare Trials Summit, held in Boston in September. The summit’s aim is to act as a working meeting for those responsible for advancing rare disease clinical programs. 

Oshman and the Dion’s conversation was a perfect example of just how effective patient advocacy can be when patients, innovators, and Congress work together toward solutions.  

What is the PPRV and how does it help patients?

Developing medicines for rare childhood illnesses is very expensive and risky because the market favors medicines that will be used in larger populations. 

Enter the Rare Pediatric Priority Review Voucher program. If a company develops and achieves FDA approval for a rare pediatric disease medicine, the FDA gives them a “voucher”. This voucher acts like a fast-pass ticket. The company can use it to buy time in the form of a 6-month FDA review instead of the standard 10-month review for their next innovation. The voucher is also an extremely high value asset that can be sold to another pharmaceutical company, thus enabling the rare disease innovator to invest tens of millions of dollars back into their R&D efforts.

The program is something many small, rare-disease-focused companies use to fund their current and future work, and has been a game changer for rare disease patients.

“Our children Maggie and Peter were diagnosed with limb-girdle muscular dystrophy in 2022,” explained Joe Dion. “At first, we didn’t know what to do. There was no cure. There were no trials. But there was one company that was potentially going to start a trial; it was a waiting game.”

But not content to just sit and wait, the Dion family got to work. 

“We started advocating and, fast forward to 2025, we got the first ever trial started,” he continued. “At the time, the PPRV program was something that made sense because this is an ultra rare disease. There weren’t enough patients to make it lucrative for investors to come in and invest in the typical pathway to get a drug developed. So the PPRV program was a big, big part of what helped us move things forward.”

In addition to advocacy, the Dions also hit the fundraising trail to supplement the research and development of treatment—including Joe being on Harpoon Hunters, a Discovery Channel reality TV show, to raise awareness. But an interesting thing to note about the Dion’s story is that their advocacy played a major role in bringing research into the United States.

The company that the Dions were working with was originally based in France and had already compiled pre-clinical data as a foundation for their work. It was the PPRV program that incentivized them to bring their business stateside and break the technology in the American market first. 

“The PPRV program was clutch in getting it to move forward,” said Joe.

Today, the company is still working to get their treatment to market and the Dions are continuing to ring the bell every step of the way. 

Navigating treatment—and recovery

“When we had the chance to be able to get our children treated with gene therapy, we put everything else on hold,” explained Courtney Dion. “We would have moved mountains. We would have gone to France. We would have gone to a third-world country if we had to. We would have sold our house. We would have done anything that we could have to have this opportunity.”

Luckily, the Dions only had to move to Florida for a short time.

And so the family moved and worked directly with the team down in Florida to navigate the clinical trial process, as well as see how it affected Maggie and Peter differently. For example, Maggie, who was able to get the treatment at a younger age, had a 92% expression in her recovery—an unprecedentedly successful amount—indicating the importance of getting these treatments out into the world faster and to patients earlier.

As Oshman pointed out, however, the Dions are in the game for the long run because there are more trials that need to be done, and more children that need to be helped. “These trials aren’t getting stalled because the medicine’s not working,” she reminded. “But because of the financing.” As such, the Dions have prioritized their fundraising efforts so that more children just like theirs can get access to these trials. 

Additionally, because of the work the Dions and advocates like them are doing, the PPRV program was reauthorized in February of 2026—ensuring that doors were opening for rare disease clinical research and development, not closing.

The power of the patient voice

The Dion’s experience is reflective of the power of patient advocacy: patient voices change the world, and their stories can put a human face on complex policy issues.

Another patient advocate at the event, Effie Parks, host of the Once Upon a Gene Podcast and mother to her son Ford, who was diagnosed with CTNNB1 syndrome, opened the event by saying, “When a trial becomes a possibility, we bring our children, our hope, our questions, and our trust. We can want progress with everything we have and still be frightened by what comes next.”

As Maggie Dion explained, “I love fighting for kids who don’t get a chance to go up and talk.” Not every child has the opportunity to speak as she does, she said; it is not a responsibility she takes lightly. 

The post In Rare Trials Summit keynote, BIO expert highlights lives touched by PPRV appeared first on Bio.News.

Deisseroth is a Professor of Bioengineering and of Psychiatry and Behavioral Sciences at Stanford University and an HHMI Investigator; Hegemann is the Hertie Senior Research Chair for Neurosciences and a professor of Experimental Biophysics at Humboldt University and Nagel is a professor at the Department for Neurophysiology at the University of Würzburg, in Germany.

“Optogenetics provides opportunities for mapping the brain in a way that we could once only dream of,” says Per Svenningsson, MD, PhD, Chair of the Nobel Committee for Physiology or Medicine.

Although optogenetics is a relatively new technology, the seminal paper from the Deisseroth lab was published in 2005. However, the concept of manipulating specific neuronal cell types within intact circuits on a millisecond timescale was considered long before. Indeed, Francis Crick, PhD, once proposed a method where “all neurons of just one type could be activated or inactivated, leaving the others more or less unaltered.” He speculated that to “turn the firing of one or more types of neurons on and off in the alert animal in a rapid manner … the ideal signal would be light,” acknowledging at the time that his idea was “rather far-fetched.” In addition, scientists have been working on laying the foundation for this technology since the 1970s. For example, when Richard Fork, PhD, at Bell Laboratories in New Jersey at the time, published the stimulation of neurons in Aplysia with laser light in Science.

It was the discovery of the algal protein channelrhodopsin that led the way in making the vision into a reality. Microbial rhodopsins—found across archaea, eubacteria, and eukaryotic microalgae—harness light for cellular bioenergetics. Channelrhodopsin is found on the surface of Chlamydomonas, a single-celled alga with the ability to swim towards a light source. Researchers discovered that the protein can directly convert photon energy into transmembrane ion flux.

The first direct evidence of a light-gated ion channel was named channelrhodopsin-1 (ChR1), discovered and coined by the Hegemann lab. The arguably more consequential breakthrough came just a year later: a collaborative team led by Georg Nagel, demonstrated that a second protein, named channelrhodopsin-2 (ChR2), functioned distinctly from ChR1, and exhibited a blue-shifted activation spectrum and operated as a broad, non-selective cation channel.

Finding a microbial protein that could act as a single unit, simultaneously as a photoreceptor and an ion channel, and the discovery that ChR1 and ChR2 were single-component, light-gated ion channels, provided the precise tools that neuroscientists had been looking for—for fast, genetically targetable optical activation of neurons.

The team in the Deisseroth lab took the baton and performed the first successful demonstration that ChR2 could be expressed in neurons, using a construct provided by Nagel. They introduced the gene for channel-rhodopsin into nerve cells from rats and was able to trigger a nerve signal by illuminating the cells with blue light.

Deisseroth’s lab published this breakthrough in 2005 in the Nature Neuroscience paper, “Millisecond-timescale, genetically targeted optical control of neural activity.” The study demonstrated that expressing the microbial protein channelrhodopsin-2 (ChR2) from green algae in cultured mammalian neurons allowed precise, millisecond-timescale control of action potentials using flashes of blue light.

The paper’s first author was Ed Boyden, PhD, professor in Neurotechnology at MIT who has been developing the field of optogenetics for the past two decades. Interestingly, CRISPR pioneer Feng Zhang, PhD, is the second author on the 2005 paper. Two years later, Deisseroth’s lab made this light-controlled switch for nerve cells work in the brains of living mice.

Over the past two decades, optogenetics has been used to unpack many biological questions, primarily (but not exclusively) in the field of neuroscience. One early in vivo application of optogenetics probed the causal relationship between the activation of orexin/hypocretin neurons in the lateral hypothalamus and the transitions from sleep to wakefulness. Other notable applications were the search for the memory engram—the physical cellular substrate encoding a specific memory—and unpacking the complexity of dopaminergic neurons in the retina, showing that functionally distinct dopaminergic populations are anatomically intermingled yet strictly segregated by their circuit connectivity.

Optogenetics has also moved into clinical applications, such as the expression of ChR2 in retinal circuitry. In one experiment, intraocular injection of an adeno-associated viral (AAV) vector encoding ChR2 led to expression in retinal ganglion cells in rodents. More specifically, light depolarized the ChR2 expressing retinal ganglion cells, restoring retinal photosensitivity and allowing light signals to reach the visual cortex in a mouse model of retinitis pigmentosa. Expression of ChR2 in surviving retinal neurons could therefore serve as a potential strategy for restoring vision after rod and cone degeneration.

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Glenmark Therapeutics Inc., USA (Glenmark) has announced the launch of Adapalene Gel USP, 0.1 per cent (OTC) in new pump packs in the US.

Glenmark’s Adapalene Gel USP, 0.1 per cent can be compared to the active ingredient of Differin Gel, 0.1 per cent.

According to Nielsen syndicated data for the latest 52-week period ending September 5, 2026, the Differin Gel, 0.1 per cent (OTC) market achieved annual sales of approximately $45.8 million*.

Commenting on the launch, Marc Kikuchi, President & Business Head, North America, said, “The introduction of Adapalene Gel USP, 0.1 per cent (OTC) in a new pump pack enhances consumer experience by offering a convenient and easy to use dispensing option while further strengthening our growing U.S. dermatology portfolio. This launch reflects our commitment to delivering high-quality and affordable healthcare solutions that meet evolving consumer needs.”

*Nielsen® NIQ Discover; Syndicated Data for Period Ending September 5, 2026

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Zydus Lifesciences (Zydus), in partnership with MSN Laboratories (MSN), has announced the launch of Riociguat Tablets, 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg, in the United States. Zydus and MSN are the first companies to launch a generic version of Adempas (riociguat) in the US market. The product was developed and is manufactured by MSN.

Riociguat Tablets are approved by the United States Food and Drug Administration (USFDA) as a generic equivalent of Adempas Tablets in all five strengths. Riociguat is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class; and for adults with pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise capacity, improve WHO functional class and to delay clinical worsening.

Commenting on the development, Dr Sharvil Patel, Managing Director, Zydus Lifesciences, said, “Being first to market with generic riociguat is a milestone for our U.S. business and for patients with pulmonary hypertension. It reflects the strength of our complex-generics pipeline, our ability to execute day-one launches in specialty categories, and the strength of our partnerships that complement our commercial reach in the United States. We are pleased to enable access to the drug across all five strengths, allowing physicians and pharmacies to transition patients with confidence.”

Dr MSN Reddy, Founder & CMD, MSN Laboratories, said, “Riociguat is a technically demanding molecule, and bringing the first generic to the U.S. demonstrates the depth of MSN’s integrated API and formulation R&D and the scale of our manufacturing. Together with Zydus’ established U.S. commercial platform, we are confident of delivering consistent, high-quality supply of this important therapy.”

PAH and CTEPH are rare, progressive and life-threatening conditions in which patients typically remain on therapy for life. So far, riociguat was available in the United States only as the branded product.

Sales of riociguat are not reported by IQVIA. According to Bayer’s Annual Report 2025, the global sales of Adempas were approximately EUR 745 million (approximately USD 850 million) in 2025.

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Lupin has launched Formoflo-G MDI, the world’s first fixed-dose triple combination metered-dose inhaler (MDI) for chronic obstructive pulmonary disease (COPD) in India, following approval from the Drug Controller General of India (DCGI).

Lupin Formoflo-G is a first-of-its-kind MDI that combines Glycopyrronium Bromide, Formoterol Fumarate and Fluticasone Propionate for the long-term management and treatment of moderate to severe COPD. The product is available as a twice-daily, single-strength fixed dose, bringing hope to more than 55 million people living with COPD in India, a condition that remains a leading cause of death and disability.

Commenting on the launch, Nilesh Gupta, Managing Director, Lupin, said, “As respiratory diseases continue to impact millions across India, access to effective therapies remains critical. Formoflo-G MDI reflects our commitment to addressing unmet patient needs through differentiated, high-quality therapies. By combining innovation with accessibility, we aim to improve outcomes for patients living with respiratory diseases.”

Rajeev Sibal, President – India Region Formulations, Lupin, said, “Formoflo-G MDI marks an important addition to our respiratory portfolio, bringing together three established therapies in a single inhaler. It strengthens Lupin’s respiratory portfolio and provides healthcare professionals with an important treatment option for appropriate COPD patients. It reflects our commitment to delivering innovative, high-quality therapies that help improve patient outcomes.”

Ranked #2 in the respiratory therapy segment in India (IQVIA, MAT Mar 2026), Lupin continues to strengthen its leadership in respiratory care with the launch of Formoflo-G MDI, reinforcing its focus on addressing unmet patient needs through innovation-driven therapies.

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The scientists say the research creates one of the most comprehensive reference maps of early human embryo development, which they used to benchmark the biological accuracy of stem-cell-derived embryo models. They systematically evaluated four leading human blastoid-generation methods and found substantial differences in how faithfully they reproduce the cell types and developmental processes seen in natural human embryos.

Pengyi Yang, PhD, associate professor at the University of Sydney and an ARC Future Fellow in the School of Mathematics and Statistics and Unit Head of Computational Systems Biology at the Children’s Medical Research Institute, said the work gives scientists a more objective way to understand the strengths and limitations of embryo models. “Human embryo models have enormous potential for studying the earliest days of an embryo’s development, but there has been no consistent way to assess how accurately these reflect real human development. Our framework allows researchers to compare these models against a detailed biological reference and determine which cell types and developmental processes are faithfully reproduced, and which are not.”

Yang, who also leads the Trans-Regulatory Biology group at the Charles Perkins Centre, is senior and corresponding author of the team’s published paper in Cell Systems, titled “Systematic transcriptomic evaluation of blastoid models of early human development.” In their paper the team stated, “The reference map generated from this study enables the benchmarking of blastoids that may guide the optimization of the protocol for the generation of high-fidelity blastoid models that faithfully recapitulate the natural human blastocyst.”

The study of early human embryogenesis from blastocyst formation to gastrulation has been constrained by what the authors describe as “… technical challenges and ethical concerns associated with human embryo research.” But research on blastoid embryo models, which are derived from stem cells, offers scientists a way to study the biological events that underpin fertility, pregnancy success, and early human development without relying on donated human embryos.

While these research models are not actual human embryos—current models cannot develop into a human embryo—they could help answer questions that have long been difficult to investigate because of technical and ethical constraints. “Recent achievements in generating blastocyst-like structures from stem cells, the blastoids, that are reminiscent of human blastocysts in morphology and cellular composition have opened an avenue to glean knowledge of the biology of early human embryogenesis,” the team continued.

However, just because something looks like an embryo, does that mean it is behaving like one biologically? The University of Sydney team developed a computational framework that helps answer that question. “Establishing a systematic evaluation framework for assessing the fidelity of blastoids in modeling the human blastocyst is critical for enhancing the quality of these stem cell-based embryo models (SCBEMs),” they noted. “… we set out to develop a computational workflow for systematically assessing how closely blastoids generated by current state-of-the-art protocols recapitulate human blastocyst cell states and develop mental features.”

To do this the team combined and harmonized more than 14,000 single-cell transcriptomes—the set of RNA molecules in a cell—from human embryos spanning key stages of their development. This allowed them to create a reference map of how cells normally differentiate and organize themselves during the days immediately before and after implantation.

The investigators then compared that reference against four widely used blastoid-generation protocols developed by international research groups. Rather than assessing whether the models simply resembled embryos under a microscope, the researchers examined their molecular identities, developmental timing, lineage structure, and other biological characteristics.

The results showed that some blastoid models reproduced all three major cell lineages of a natural human blastocyst, or the early embryo, relatively well, while others failed to accurately represent certain cell types or contained large numbers of cells that could not be confidently matched to any known embryonic state. No single model perfectly replicated a natural human blastocyst. “Results of the benchmarking revealed substantial differences between protocols in recapitulating the composition, developmental timing, and coordinated lineage specification of the human blastocyst, highlighting that high-fidelity SCBEMs should reproducibly generate appropriately staged and developmentally coordinated blastocyst cell states,” the authors reported.

Yang said the findings highlight both the promise and current limitations of embryo models. “The encouraging finding is that some models capture important aspects of early embryonic development relatively well, although each model has limitations,” he said. “But our study also shows that current models are not biologically equivalent to real human embryos, and researchers need to be careful about the conclusions they draw from them.”

By providing a standardized benchmark, the researchers hope future models can be improved more rapidly and evaluated more rigorously. “Collectively, our work provides a comprehensive and systematic evaluation of the developmental authenticity of in vitro cultured SCBEMs generated by the state-of-the-art protocols,” they concluded. “Yang added, “If we’re going to use these systems to answer important biological questions, we first need to know what they can reliably tell us. Our work provides a roadmap for improving embryo models and ensuring scientific claims remain grounded in what the models can actually support.”

The researchers have made their reference datasets and benchmarking tools publicly available, enabling scientists worldwide to test new embryo models against the same standards.

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New official data show 93.5% of recent private dental patients were satisfied with their care, challenging the picture presented by a Which? investigation limited to people who had experienced a problem.

Data published by the Office for National Statistics (ONS) found that 89.9% of recent NHS dental patients were satisfied with their care, rising to 93.5% among private patients. The ONS said the difference was statistically significant.

The self-reported data were collected between 21 July and 12 August 2026 as part of the Health Insight Survey. The satisfaction findings were based on 8,098 recent NHS dental patients and 8,336 recent private patients who were asked about dental appointments attended during the previous 28 days.

Who did Which? survey?

By comparison, the Which? investigation on hidden costs, treatment quality and complaints in private dentistry, surveyed 1,009 people, all of whom said they had experienced a problem with private dental treatment during the previous two years.

Among that selected group, 39% felt charges were excessive, 22% paid more than they had been quoted and 21% said upfront pricing was unclear.

A further 26% were dissatisfied with treatment quality and one in 10 said they had experienced a clinical mistake. Some respondents also reported feeling pressured to accept treatments or join monthly payment plans.

The concerns of those patients remain valid. However, The British Dental Association (BDA) said it was misleading to present the results as representative of the millions of patients receiving private dental care.

BDA chair Eddie Crouch said: ‘Every dental patient deserves safe, high-quality care, clear information about costs and somewhere meaningful to turn when they’re not satisfied.

‘But these findings need to be put firmly in perspective. Which? set out to survey people who had already experienced a problem with private dental care.’

He added: ‘Dentists work incredibly hard to maintain the trust of their patients. The evidence is clear the overwhelming majority are satisfied with the care they receive.’

What happens when private dental care goes wrong?

Which? also found that 62% of its respondents had not complained to the practice about the problem they experienced.

The most commonly reported reasons included concern about damaging their relationship with their dentist and a belief that complaining would make no difference, both cited by 31%.

Which? called for private dental patients to have access to a mandatory independent ombudsman with the power to investigate disputes, make binding decisions and award redress.

Sue Davies, head of consumer protection policy at Which?, said: ‘Our research found people facing unexpected bills, treatment problems and complaints that ended with little more than an apology, while some were too worried about damaging their relationship with their dentist to complain at all.

‘Private dental patients deserve the same level of protection as people using other essential services. The government and regulators must ensure that consumers can access a mandatory independent ombudsman for private dentistry, with powers to make binding decisions and award redress, alongside compulsory signposting to the complaints process.’

Patients can currently raise concerns with their dental practice before escalating unresolved complaints about private treatment to the Dental Complaints Service.

Why is private dentistry under scrutiny?

Private care now accounts for a substantial part of UK dental provision. Among dentists responding to the General Dental Council’s latest cumulative working-pattern survey, 20% provided private care only and a further 14% worked predominantly in private practice.

The balance also varies considerably across England. ONS estimates reported by Dentistry found that more adults had a private dentist than an NHS dentist in nine of England’s 36 integrated care board areas.

The scale of reliance on private care also strengthens the case for fundamental NHS dental contract reform. Read Dentistry’s extended analysis of what has changed and what still needs to happen.

In November 2025, the government ordered an investigation into the costs and practices of private dentistry. Dental supply chain expert Rasnaam Tiwana told Dentistry this was a sign of the public looking for a scapegoat for rising dental costs.

He said: ‘Dentistry has not become more expensive because dentists and owners suddenly developed a taste for excess profit and juicier EBITDA. It has become more expensive because the economic system around it has changed, and it’s government policy that has quietly shaped that change.’

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Stuart Orkin, MD, and his former trainees Vijay Sankaran, MD, PhD, and Daniel Bauer, PhD, were joined by Swee-Lay Thein, MD, PhD, and John Tisdale, MD, both at the NIH. Their contributions helped to identify BCL11A as a major regulator of the fetal-to-adult hemoglobin switch, paving the way for the development of the first CRISPR medicine, Casgevy, for sickle cell disease (SCD) and thalassemia. 

Opening the symposium, HMS Dean George Daley, MD, paid tribute to Janet Watson, MD, the Brooklyn pediatrician who concluded in 1948 that fetal hemoglobin (HbF) was somehow protective against SCD. “The mechanism behind the switch would remain an enigma for decades,” Daley said.  

Each of the five honorees had “distinct and complementary roles” in the effort, Daley said, which culminated in the approval in December 2023 of Casgevy as well as Lyfgenia, a beta-globin gene therapy. Thein and Sankaran identified and characterized BCL11A as a critical regulator of HbF expression. Orkin and Bauer identified the enhancer sequence within BCL11A that controls erythroid gene expression and would become the specific target for Casgevy to restart HbF production. 

“We should hustle to make therapies that are simpler, safer and scalable,” Daley said. Bolstering newborn screening for SCD and expanding global distribution would be major steps to producing a bigger impact, such that “fewer people will have their lives upended by these devastating hemoglobinopathies.” 

Editing out disease 

The symposium’s keynote speaker—2020 Nobel laureate Jennifer Doudna, PhD—said, “Drug success requires a deep understanding of biology.” Having a functional cure for SCD less than 15 years after her team’s initial development of CRISPR-Cas9 gene editing was “just incredible,” she said. 

Doudna paid particular credit to patient volunteers such as Victoria Gray and Jimi Olaghere. “You can’t have success if you don’t have people willing to try it,” she said. According to Doudna, Casgevy is now approved in 39 countries across North America, Europe, and the Middle East. More than 90 percent of SCD patients in the U.S. qualify for reimbursement coverage for Casgevy. And more than 500 patients globally have begun Casgevy treatment.  

Naturally, challenges remain. Doudna focused on four: 1) Conditioning toxicity, 2) cost, 3) infrastructure, and 4) expanding global access. “How do we get from one CRISPR therapeutic to CRISPR-for-many? I think it’s achievable,” she said, citing the 2025 Baby KJ story as an example. In vivo gene editing will be critical in the future, Doudna said, but the toolbox for delivery is growing fast. She noted two recent preprints from her lab advancing novel strategies—NANITE and JET—as examples of works in progress. 

Beginning with BCL11A 

The symposium was organized by Ed Benz, MD, a renowned hematologist and President and CEO emeritus of the Dana Farber Cancer Institute. In SCD, the red blood cells (RBCs) become rigid and adhere to blood vessel walls. Tissues become ischemic resulting in pain crises and start to deteriorate. Many patients lose the function of key organs, especially the kidney, heart, and lungs. Life for people with SCD is “constantly dealing with pain, anemia, brain fog, etc. They rarely live a normal lifespan.” 

Orkin noted that this was not his first time winning the Alpert prize. He previously won in 1993 for his research providing a complete molecular genetic description of thalassemia. “A lot has happened in 33 years,” Orkin joked, noting profound changes in presidents, AI, and scientific landmarks.  

Orkin’s team has spent years defining the mechanism of BCL11A regulation of globin gene transcription, a process he likened to “going to the thermostat.” He highlighted a key paper along the way led by his former trainee Jian Xu, PhD, now at St. Jude Children’s Research Hospital. In 2011, Xu took an SCD mouse model, knocked out the Bcl11a gene in the erythroid lineage, and rescued the phenotype of RBCs. This prevented SCD symptoms and validated BCL11A as a therapeutic target in humans.  

The Casgevy results, Orkin said, were “spectacular… remarkable, transformative.” Orkin listed several advantages of the HbF reactivation pathway (as opposed to correctional gene therapy), including the validation provided by Casgevy; the balance of globin gene expression, and the fact it offered “one-stop shopping” for all hemoglobinopathies. But this ex vivo approach cannot reduce the global burden of SCD and thalassemia, Orkin said. Reasons include high cost, the complex nature of the process, and a lack of infrastructure. 

Still, the clinical success of Casgevy points to a clear target for small molecule drug discovery programs. “I argue that BCL11A is the preferred target,” Orkin continued. The protein acts directly on the gamma-globin promoter and has a steeper dose-response than other regulators, such as LRF. The protein “looks like spaghetti,” based on AlphaFold, Orkin said. It is an obligate multimer, which is critical for gene repression activity.  

Although highly stable, BCL11A is degraded in proteasomes as a monomer, raising the possibility that this pathway provides targeting opportunities for small molecules. “The goal should be development of therapies that can be delivered to the majority, if not all, patients with SCD and thalassemia,” Orkin closed. 

Oxford calling 

The focus of Thein’s research, beginning in Oxford when she joined Sir David Weatherall’s group in 1982, was a tantalizing question: Why are some patients with beta-thalassemia relatively mild and transfusion-independent? 

Thein focused on two large hemoglobinopathy families, finding high levels of HbF reduced the need for blood transfusions. She also found that HbF levels were independent of inherited mutations in the beta-globin gene.  

In 2007, Thein and colleagues performed a groundbreaking genome-wide association study (GWAS), looking at more than 5,000 participants of Northern European descent. Those with extreme phenotypes were genotyped using a panel of 300,000 single nucleotide polymorphisms. One of the three major signals was an unexpected signal that mapped to chromosome 2, which Thein further refined to the second intron of BCL11A. That unexpected signal eventually became a therapeutic target.  

Sankaran and Orkin independently confirmed Thein’s findings. That study was published in 2008 in Science. But how to go after BCL11A? Ironically, Sankaran observed, the answer was on the next page of the journal: a landmark paper in the early stages of CRISPR research published by Luciano Marraffini, PhD, and Eric Sontheimer, PhD. “I wish I’d paid more attention!” Sankaran quipped. 

Sankaran asked: How can we improve available hemoglobinopathy therapies globally? “We need to invest in all of these pathways—ex vivo, in vivo, and small molecules,” he said. With perfect timing, Sankaran’s team had just published an interesting new candidate for an HbF regulator—BACH2, which inhibits binding of NRF2. Although very early days, inhibiting BACH2 offers another intriguing drug target. “Much more biology remains to be understood,” he said. 

Gene replacement 

While the other four awardees played a role in characterizing the Casgevy pathway, Tisdale was recognized for his work as the lead clinical site for the Lyfgenia trial, sponsored by Bluebird.  

“When I hit the scene in the ‘90s, we had zero drugs to treat [SCD],” he said. The disease produces complications “literally from head to toe,” including strokes in children. The pain is so crippling that patients “can’t plan and can’t hold a job.” Building on the first allogeneic bone marrow transplant in 1996, by Mark Walters, MD, Tisdale’s group looked for less toxic chemotherapy options and established a non-myeloablative approach. 

“Luigi Naldini threw us a lifeline,” Tisdale said, with a report in Science in 1996 that lentiviruses could transduce non-dividing cells (like HSCs). Deleting the 3’ LTR reduced the risk of integration turning on adjacent genes. Tisdale’s group partnered with Bluebird for the HBG-206 clinical trial. While initial results were modest, in the Group C cohort, successfully treated patients behaved as if their disease had resolved to sickle cell trait. Lyfgenia was also approved by the FDA in December 2023 and is currently sponsored by Genetix Pharmaceuticals. 

Tisdale was asked how he counsels patients interested in signing up for gene therapy. “Most patients don’t understand the options,” he said. The discussion starts with a bone marrow transplant, but many insist they want gene therapy. “The first thing is to optimize hydroxyurea,” which is an inclusion criterion. “Most [patients have failed to try; many can improve that way, especially children.”  

Cognitive dissonance 

“Our field is facing a moment of cognitive dissonance,” said Bauer, in the fifth and final talk from the 2026 laureates. The excitement over gene therapies is balanced, he said, by “the frustration that current therapies are too complex to even dent the global burden of disease.” 

Bauer briefly described prime assembly, a new technology from his lab led by grad student Sebastian Levesque, which was published in Nature last month. The technology shows similar activity in dividing and non-dividing cells and “raises the prospect of mutation-agnostic gene correction for many diseases.” 

At the American Society for Hematology conference in 2016, Bauer recalled showing a slide of a mountain with several paths drawn to the top representing different potential approaches for treating SCD. He juxtaposed that slide with a photo of Casgevy trial volunteer Jimi Olaghere proudly standing at the summit of Mt. Kilimanjaro in 2024.  

The field has come a very long way, but still has further to travel. 

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Using live cultures of human brain cells and slices of brain tissue obtained during neurosurgery, the researchers, headed by Nicholas Barnes, PhD, professor at the University of Birmingham College of Medicine and Health, investigated the role of the P2X7 receptor, which is responsible for triggering inflammatory signaling. Their findings revealed that these P2X7 receptors drive the release of cytokines involved in controlling inflammation. By blocking this receptor with a specific antagonist, the team was able to significantly reduce the inflammatory response in human brain tissue.

The team suggests that their results could open the door to treating a wide spectrum of chronic neurological conditions, including TBI, neurodegenerative diseases, and even psychiatric disorders such as depression and psychosis, which are increasingly understood to have a neuroinflammatory component.

Barnes said, “This exciting discovery marks a major step toward repurposing existing therapeutics to combat neuroinflammation at its source. The identification of this receptor could have far-reaching implications for some of the most debilitating and widespread brain disorders such as Alzheimer’s disease, Parkinson’s, and multiple sclerosis, or inflammation-linked psychiatric conditions like schizophrenia and depression.”

Barnes is senior and corresponding author of the team’s published paper in Brain, titled “P2X7 receptor-mediated IL-1β release by human brain tissue: the impact of CNS-penetrant potential therapeutics,” in which they concluded “Our findings provide direct relevant evidence for the use of P2X7R antagonism to inhibit human microglia-mediated inflammation, with arising potential benefits for patients with TBI and other neuroinflammatory diseases.”

TBI is a major cause of death globally, and there are currently there are no approved therapeutic drugs to improve clinical outcomes, “… emphasizing the clear unmet substantial clinical need,” the authors wrote.

The mechanical damage associated with TBI drives a neuroinflammatory response. “The purinergic P2X7 receptor (P2X7R) is a key driver of neuroinflammation in a range of animal models of traumatic brain injury,” the team continued. P2X7R is expressed by microglia, the resident immune cells in the CNS that are involved in many developmental, homeostatic and pathological roles. “It is well recognized that microglial activation and the hostile neuroinflammatory response arising after the initial insult provide a therapeutic window for pharmacological intervention,” the investigators further stated.

For their reported study investigating how brain cells respond to and manage inflammation, the team developed a way of turning a type of white blood cell into microglia, replicating a normal cellular transformation that has recently been identified to occur in the brain as a natural part of human aging. These microglia are the central coordinators of the immune system in the brain.

Using readily accessible human peripheral monocytes taken from blood samples, the researchers converted them into microglia-like cells—human monocyte-derived microglia (hMDM)—that were used to see how microglia are likely to respond to the inflammation signals. “This enabled us to demonstrate the ability of clinically relevant P2X7R antagonists, including brain-penetrant molecules, to curtail pro-inflammatory cytokine release,” they wrote.

The team showed that administering a P2X7 receptor antagonist interrupted the triggers that these microglia give off as they are damaged and die. Barnes said, “Studying human microglia has long been a major challenge: once removed from their native brain environment, they rapidly lose their defining characteristics, likely due to the absence of critical regulatory signals. Our approach involved the use of monocyte-derived microglia which provide a powerful, scalable, and virtually unlimited platform for studying human microglial biology with unprecedented precision.”

The team confirmed their results using adult human precision-cut brain slices that had been generated subsequent to neurosurgical resections. “Having identified the response in the human monocyte-derived microglia, this provided the impetus to translate these findings with human brain obtained following neurosurgical procedures, Barnes continued. “This successful translation means the next stage for this research is the development of clinical trials in patients with neurodegenerative conditions and patients with TBI where there are no effective pharmacological treatments to reduce the neuroinflammation and arising damage.”

In their paper the authors concluded, “The present study provides direct translational evidence from human cellular and brain tissue models to support the clinical use of P2X7R antagonists to limit secondary ATP-driven neuroinflammatory events, such as those that occur in TBI, and thus might improve the clinical outcomes for patients.”

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Now, new research has revealed that bacteria detect viruses when a viral enzyme cuts an important sensor molecule in the bacterium, kicking off the immune response. Discoveries of bacterial defenses can pave the way for the development of better phage therapies that can evade the bacterial immune system.

The results are published in Science in the paper, “Phage proteases activate CBASS antiphage immunity.”

 “This is one of the most common forms of bacterial immunity, so when we finally figured it out, it was a total eureka moment,” said Sam Hobbs, PhD, assistant professor of biochemistry at University of Utah Health.

One component of the bacterial immune system is the cyclic oligonucleotide–based antiphage signaling systems (CBASS) which lead to a “last resort” immune response that kills the bacterium before viruses can spread to neighbors.

Precise sensing of the viral trigger is a necessity. In CBASS, cGAS/DncV-like nucleotidyltransferase (CD-NTase) enzymes sense phage infection and synthesize nucleotide signals to initiate antiviral defense. This new work found that the sensing mechanism detects a molecule that the virus needs to survive. More specifically, that phage prohead protease activity is a widespread mechanism of CD-NTase activation.

“We found that the protease from the phage actually acts directly on the host protein, and that is the signal that turns on the whole signaling pathway,” explained Hobbs.

This trigger mechanism is distinct when compared to related antiviral immune pathways, which are activated by the presence of viral genetic material. “This is a totally new mechanism for how these host proteins are activated,” Hobbs said.

Hobbs added that understanding CBASS may advance our knowledge of the human immune system. CBASS is related to a similar immune pathway in humans, indicating that this pathway has persisted at least since bacteria and humans had a common ancestor. And because bacteria have such a rapid life cycle, scientists can use them to very quickly answer questions about how the immune system works, which they can then test in models closer to people.

“The fact that these systems are conserved between bacteria and humans suggests that they’ve been maintained in these different organisms for that entire evolutionary trajectory,” Hobbs said. “The cells are telling us that this is a really important pathway because they’ve maintained it for billions of years. It’s incredibly fascinating, and it’s a cool window into what’s important in maintaining the ability to fight viruses.”

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The New Jersey ASP is the 19^th to open globally, with the first launching in Japan and then expanding globally to facilities in places like China, the United Kingdom, and now the United States. 

During his opening remarks, Koutara Kato, executive vice president and assistant general manager, commercial operations, at HORIBA Instruments Incorporated, highlighted some of the industries that HORIBA is involved in, such as the semiconductor market, as well as where it plans to concentrate additional resources in future. That list includes energy and environment as well as biopharma and healthcare. Each area the company focuses on “gives us a lot of opportunities and challenges,” he said.

ASPs provide a space for HORIBA to apply its technology and scientific expertise to customers’ challenges and try to find possible solutions. It could especially benefit customers working with tight budgets amidst rising costs for lab equipment, space, and other factors, noted Michael Oweimrin, national sales manager at HORIBA, in his remarks. “We have a plethora of capabilities to address many different markets.” 

Over 280 heads at HORIBA report to the New Jersey facility which is about 130,000 square feet. And roughly 200 people work at the site. Among other features, the ASP features multiple labs, where HORIBA scientists work on customer projects as well as technical rooms for training application scientists. A key part of the ASP is its modularity. Instruments are placed or bolted to tables with wheels making it possible to move them seamlessly between labs as needed. 

A tour of a section of HORIBA’s facility, following the opening remarks and a traditional sake barrel opening ceremony, revealed space for stockrooms, manufacturing, and rooms testing and quality control as well as for training field service engineers. The tour included a look at the ASP labs where scientists leverage HORIBA’s expertise in instruments for modular spectroscopy, particle characterization, and Raman microscopy. Scientists in the ASP labs utilize these technologies to address applications in energy and environment, healthcare, and materials and semiconductors. They utilize HORIBA instruments including LabRAM Odyssey and LabRAM Soleil Raman microscopes as well as the Veloci Biopharma Analyzer, which is designed specifically for biopharma and pharma applications. 

Crucially, the ASP is HORIBA’s answer to an important question, Jeff Julien, PhD, life science applications manager at HORIBA, said in his opening comments. Specifically, “how to leverage what HORIBA does well” to shift the conversation from “what instrument is needed” to “what problem to solve.” Using biopharma as an example, he noted that companies developing therapeutic proteins often rely on input from multiple instruments and techniques during development. These are capabilities that the ASP scientists can provide, he said. 

As noted earlier, in each ASP lab, instruments sit on modular wheel-based carts and lab benches. This makes it possible to reconfigure the lab space for different customers’ pain points as well as to bring in technologies that  “we think could be applicable to those use cases,” Julien said. “It’s really an exciting time to be a part of HORIBA and doing this ASP development” particularly “as the markets change in terms of requirements and what customers are after,” he added. “It changes the way we think [and] the way we approach all of these problems.”

Shifting from sales to solutions

HORIBA’s ASPs  reflect a broader corporate strategy to move beyond purely transactional sales towards problem-solving partnerships. In the NJ facility, the focus is specifically in the life science and biopharma sectors. Here, HORIBA is positioning its core technologies as an underutilized set of orthogonal tools for various applications including biotherapeutic characterization.

To be clear, HORIBA’s primary business is still selling instrumentation, but moving forward, the company wants to do more to help customers utilize its instruments to solve problems, Kato said during a conversation with the press where he discussed some of the thinking behind setting up the ASP. “If a customer [is] facing some issues and difficulties, prior to having those instrumentation, we can address this” through the ASP, he said, by showing them how they can use HORIBA’s instruments and what kinds of outcomes they can expect. In most cases, to use the ASP’s capabilities, customers bring samples in and work with HORIBA scientists and tools. There are some cases where HORIBA can deliver needed instruments to customers’ labs to run their analysis on site.  

The company has no current plans to increase its headcount, rather it is leveraging expertise it already has in house to support customers looking to utilize the ASP’s capabilities. There are a few types of customer profiles that ASP scientists are working with and these typically are people working in research and development with specific pain points that they hope HORIBA’s fluorescence or Raman spectroscopy or its particle characterization capabilities could solve, Julien explained. 

Feasibility testing is a key step, often starting with simplified samples before graduating to real process samples. HORIBA emphasizes rapid pivoting between fluorescence, Raman, and particle characterization depending on what customer samples reveal. 

For example, “perhaps we’re anticipating [doing] a demo with fluorescence and we very quickly learn more about the customer samples or their process and then say … we need to pivot to Raman because that’s actually going to be a better fit for your use case,” he explained. Furthermore, “if we’ve exhausted our options in terms of what we think we can provide as a solution and it’s not meeting customer needs, we then can engage in conversation and … perhaps work together and develop a custom solution or a fit for purpose solution that’s going to meet those particular needs.”

HORIBA plans to launch additional ASPs in other locations—setups differ across the company’s offices. The strategy is one ASP per country in strategic locations rather than multiple per country, Kato said. This way, rather than having U.S. customers send samples all the way to an ASP in Japan, for example,, they can access a facility closer to them. ASPs are also customized to local industry needs, for example the ASP in Taiwan is semiconductor focused. The U.S. ASP leverages HORIBA’s location in the tri-state biopharma corridor. Conversations with company representatives highlighted HORIBA’s intent to make deeper inroads into the biopharma and life sciences market in particular.  

One area that the company is interested in broadening its footprint is in the biotherapeutics market. A key solution for the market is the Veloci Biopharma Analyzer which is designed for tasks such as analyzing antibody-drug conjugates, differentiating AAV subtypes, and for analyzing protein stability, among others. “We [are] now in an age where for a lot of therapeutics … [with] some of these stable technologies like near-IR that have been used historically … you’re infringing on the limits of detection for that technology” leading customers to seek out novel orthogonal measurement methods, Julien said. “That’s ultimately where we feel like we can add value.”

The company is working on some new products but HORIBA representatives declined to provide specific details about what they are.

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Deisseroth is a Professor of Bioengineering and of Psychiatry and Behavioral Sciences at Stanford University and an HHMI Investigator; Hegemann is the Hertie Senior Research Chair for Neurosciences and a professor of Experimental Biophysics at Humboldt University and Nagel is a professor at the Department for Neurophysiology at the University of Würzburg, in Germany.

“Optogenetics provides opportunities for mapping the brain in a way that we could once only dream of,” says Per Svenningsson, MD, PhD, Chair of the Nobel Committee for Physiology or Medicine.

Although optogenetics is a relatively new technology, the seminal paper from the Deisseroth lab was published in 2005. However, the concept of manipulating specific neuronal cell types within intact circuits on a millisecond timescale was considered long before. Indeed, Francis Crick, PhD, once proposed a method where “all neurons of just one type could be activated or inactivated, leaving the others more or less unaltered.” He speculated that to “turn the firing of one or more types of neurons on and off in the alert animal in a rapid manner … the ideal signal would be light,” acknowledging at the time that his idea was “rather far-fetched.” In addition, scientists have been working on laying the foundation for this technology since the 1970s. For example, when Richard Fork, PhD, at Bell Laboratories in New Jersey at the time, published the stimulation of neurons in Aplysia with laser light in Science.

It was the discovery of the algal protein channelrhodopsin that led the way in making the vision into a reality. Microbial rhodopsins—found across archaea, eubacteria, and eukaryotic microalgae—harness light for cellular bioenergetics. Channelrhodopsin is found on the surface of Chlamydomonas, a single-celled alga with the ability to swim towards a light source. Researchers discovered that the protein can directly convert photon energy into transmembrane ion flux.

The first direct evidence of a light-gated ion channel was named channelrhodopsin-1 (ChR1), discovered and coined by the Hegemann lab. The arguably more consequential breakthrough came just a year later: a collaborative team led by Georg Nagel, demonstrated that a second protein, named channelrhodopsin-2 (ChR2), functioned distinctly from ChR1, and exhibited a blue-shifted activation spectrum and operated as a broad, non-selective cation channel.

Finding a microbial protein that could act as a single unit, simultaneously as a photoreceptor and an ion channel, and the discovery that ChR1 and ChR2 were single-component, light-gated ion channels, provided the precise tools that neuroscientists had been looking for—for fast, genetically targetable optical activation of neurons.

The team in the Deisseroth lab took the baton and performed the first successful demonstration that ChR2 could be expressed in neurons, using a construct provided by Nagel. They introduced the gene for channel-rhodopsin into nerve cells from rats and was able to trigger a nerve signal by illuminating the cells with blue light.

Deisseroth’s lab published this breakthrough in 2005 in the Nature Neuroscience paper, “Millisecond-timescale, genetically targeted optical control of neural activity.” The study demonstrated that expressing the microbial protein channelrhodopsin-2 (ChR2) from green algae in cultured mammalian neurons allowed precise, millisecond-timescale control of action potentials using flashes of blue light.

The paper’s first author was Ed Boyden, PhD, professor in Neurotechnology at MIT who has been developing the field of optogenetics for the past two decades. Interestingly, CRISPR pioneer Feng Zhang, PhD, is the second author on the 2005 paper. Two years later, Deisseroth’s lab made this light-controlled switch for nerve cells work in the brains of living mice.

Over the past two decades, optogenetics has been used to unpack many biological questions, primarily (but not exclusively) in the field of neuroscience. One early in vivo application of optogenetics probed the causal relationship between the activation of orexin/hypocretin neurons in the lateral hypothalamus and the transitions from sleep to wakefulness. Other notable applications were the search for the memory engram—the physical cellular substrate encoding a specific memory—and unpacking the complexity of dopaminergic neurons in the retina, showing that functionally distinct dopaminergic populations are anatomically intermingled yet strictly segregated by their circuit connectivity.

Optogenetics has also moved into clinical applications, such as the expression of ChR2 in retinal circuitry. In one experiment, intraocular injection of an adeno-associated viral (AAV) vector encoding ChR2 led to expression in retinal ganglion cells in rodents. More specifically, light depolarized the ChR2 expressing retinal ganglion cells, restoring retinal photosensitivity and allowing light signals to reach the visual cortex in a mouse model of retinitis pigmentosa. Expression of ChR2 in surviving retinal neurons could therefore serve as a potential strategy for restoring vision after rod and cone degeneration.

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The province says the move is intended to protect infants from severe respiratory illness while reducing RSV-related emergency department visits and hospital admissions during the fall and winter respiratory season.

RSV affects the lungs and can cause illnesses including bronchiolitis and pneumonia. Although many infections are mild, the virus can cause serious disease in infants. According to the New Brunswick government, RSV is the leading cause of hospitalization among babies during their first year of life.

Under the expanded program, babies born between April 1 and October 12, 2026 can receive RSV immunization through regional public health clinics or their primary care provider.

Babies born between October 13, 2026 and March 31, 2027 will be able to receive the immunization following birth and before leaving hospital. Families can also access it later through regional public health offices or primary care providers. The timing is intended to provide protection as RSV circulation increases during the colder months.

“Immunizing in October, just before RSV season begins, will help ensure babies have the strongest protection against RSV during the time of year when it is most common,” New Brunswick Chief Medical Officer of Health Dr. Yves Léger said in announcing the program.

New Brunswick previously provided RSV monoclonal antibodies to infants considered at high risk during the 2025–26 respiratory season. The new approach extends publicly funded protection to all infants for the upcoming season.

The province has also progressively expanded RSV prevention among older adults. Publicly funded vaccination is available to several higher-risk groups, including adults 75 and older, Indigenous adults 60 and older, and certain older adults receiving long-term, rehabilitation or hospital care.

The broader infant program could also have implications for hospital capacity. Respiratory illnesses can contribute to significant seasonal pressure on pediatric services, emergency departments and inpatient units.

Dr. Ariadna Grigoriu, medical director of the New Brunswick Perinatal Health Program, described universal infant RSV protection as an important step toward reducing both severe illness and hospitalization.

The program comes as health systems across Canada prepare for the 2026–27 respiratory illness season.

Source: Government of New Brunswick — Free RSV immunization for all New Brunswick newborns

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For decades, much of cardiovascular research and many diagnostic standards were developed using evidence drawn predominantly from male patients. Researchers and clinicians are increasingly recognizing that this can affect how quickly cardiovascular disease is identified in women.

Heart & Stroke reports that approximately two-thirds of heart disease and stroke clinical research has focused on men, while half of women who experience a heart attack have their symptoms go unrecognized.

One important issue involves how women experience and describe symptoms.

Although chest pain or discomfort remains an important warning sign, women may also experience shortness of breath, unusual fatigue, nausea or indigestion, and pain in the back or neck. Women are also more likely to experience disease involving the heart’s smaller blood vessels, which can make some traditional diagnostic approaches less effective.

Canadian cardiovascular experts have identified disparities within emergency departments as a particular concern.

The Canadian Women’s Heart Health Alliance has reported that women experiencing ST-elevation myocardial infarction can encounter longer delays from arrival at hospital to receiving an electrocardiogram and subsequent treatment.

The Alliance recommends greater use of sex-specific diagnostic protocols, including sex-specific thresholds for high-sensitivity troponin testing in patients presenting with acute chest-pain symptoms. It also recommends incorporating differences in symptoms and female-specific cardiovascular risk factors into clinical assessment.

Troponin is released into the bloodstream when heart muscle is damaged and is commonly measured when clinicians suspect a heart attack. Using diagnostic thresholds that better account for biological differences between women and men may help identify cases that could otherwise be missed or recognized later.

The issue extends beyond laboratory testing.

Experts have called for greater education of healthcare professionals about cardiovascular disease in women, more representation of women in clinical trials and increased incorporation of sex and gender into cardiovascular guidelines and medical education.

Awareness among patients is also important. Symptoms such as fatigue, nausea, dizziness, sweating and shortness of breath can sometimes be attributed to other causes, potentially delaying emergency care.

Heart disease remains a major health burden in Canada. Statistics Canada reports that heart disease was the country’s second-leading cause of death in 2023, accounting for 57,890 deaths.

Efforts to close the cardiovascular gender gap increasingly focus on a combination of better research, clinician education, diagnostic protocols and greater public awareness.

For hospitals and emergency departments, the objective is straightforward: recognize cardiovascular disease in women sooner so appropriate treatment can begin sooner.

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Life-changing medical advice does not always begin with a diagnosis or a prescription. Often, it begins with a conversation, one that helps patients understand what is driving their health and empowers them to ask critical questions to build healthier, more sustainable habits. That’s why I believe one of the most effective interventions in a physician’s toolbox is also one of the least conspicuous: weaving in health education as an active part of the visit.

Studies have found that when patients understand their health, the factors shaping it, and how their physician’s recommendations can improve it, they are better equipped to make informed decisions and more confident in their ability to succeed. This is especially powerful when physicians and patients build a care plan together that makes the diagnosis, recommendation, and next steps clear and actionable.

Health education starts with connection

Physicians may be experts on medicine, but patients are experts on themselves. Building trusting relationships creates space for patients to share the behaviors and habits that shape their health, even when it’s deeply personal information. Once this connection is established, it becomes my job to offer educational pathways that patients can act on and apply.

Related health education podcast: How patient education drives lasting behavior change

I have seen the power of that connection firsthand in caring for a patient I’ll call Rosa. Rosa cleaned hotel rooms by day and helped her two children with homework at night. Her blood sugar level had climbed to 10.2, and when money was tight, she stretched her medication. Although well-meaning doctors had warned her about amputations and blindness, those warnings only left her feeling ashamed rather than empowered. When we met, I asked a different question: What mattered most to her? “My kids,” she said. “I want to see them graduate.” Together, we built a plan around her own ideas. Our Spanish-language diabetes self-management workshop gave her practical support. A health educator taught her how to plan affordable meals, a pharmacist simplified her medication regimen, and a care navigator connected her with food assistance and a medication savings program. 6 months later, her blood sugar level was 7.1. Now Rosa walks with her children after dinner. “They watch everything I do,” she says. “Now they see me taking care of myself.”

The patient-physician partnership

At Kaiser Permanente, I lead the Center for Healthy Living, a dedicated resource in Southern California specializing in evidence-based lifestyle and health behavior change programs and services. We rely on the “5 As” framework to develop and steward trusting patient-physician relationships while addressing critical health issues. This communication model was originally developed to help patients quit smoking but can be used to shape the formation of any new healthy habit. We:

• Ask if we can discuss the issue
• Advise with our expertise
• Assess willingness to change
• Assist with goal-setting, in consultation with patients
• Arrange next steps

We always guide rather than dictate. We spend time creating care plans together; our goal is to offer the right resources for the right needs that meet people where they are.

Where technology fills in the gaps

Doctors have long been the primary providers of health education, but with easy access to online resources, it’s no surprise that patients are turning to other venues for answers. Artificial intelligence chatbots have quickly become a top option for patients seeking more knowledge of and control over their health. Recent studies have found that 3 in 10 Americans turn to social media or chatbots for health advice or health education.

With such a vast amount of often inconsistent health information out there, physicians must remain the trusted, primary source for our patients. And we use technology to help provide this expertise. At Kaiser Permanente, we have comprehensive electronic health records to give us a complete picture of our patients’ health history. Ambient scribes help write clinical notes, giving us the time for health education and partnership. Implementation of artificial intelligence in our online patient portal in Southern California also makes reaching physicians faster and easier, especially with urgent concerns.

Health education should be our first prescription

In an integrated, value-based care system, providing patient education is a priority. It’s an investment that pays dividends, and I see it work every day. Positive lifestyle changes are possible when we partner with patients but bringing healthy habits home and making them stick requires intentional effort. Patients need self-belief and motivation, while physicians need to provide education and answers to questions that fuel both. Health education isn’t an add-on to the next appointment — it’s an intervention in and of itself.

The post Health education: The clinical intervention for long-term health appeared first on Permanente Medicine.

The post Moving Targets: Epigenetics and Disease Progression in Neuroendocrine Neoplasms appeared first on Endocrine News.

There needs to be greater recognition of how workforce design, care-delivery patterns and ergonomic pressures affect women in midlife, says Makbule Sipahi.

Life as a midlife female dentist can be challenging. While everyone discusses the impact of menopause on patients’ oral health, it can be equally tough for professionals experiencing these changes. From hot flushes during procedures to brain fog mid-discussion, such moments are part of daily life for female practitioners. 

Dentistry demands a kind of resilience that is quiet, steady, and often invisible. By midlife, many of us have honed not only our clinical skills but also our emotional endurance – handling anxious patients, leading teams and working precisely under pressure. However, I hadn’t fully realised how perimenopause would affect that professional rhythm.  

This lack of awareness is common. In 2026, US researchers published a collaborative study with Flo, the women’s health app, to assess perimenopausal symptoms among 17,494 people from 158 countries (Hedges et al, 2026).   

They found that fatigue, physical and mental exhaustion, mood changes, digestive issues, and sleep disturbances were all central to many people’s perimenopause experiences, with hot flushes way down the list of reported symptoms.  

The researchers recommend that future studies should focus on how demographic and lifestyle factors, social determinants of health, attitudes about perimenopause and menopause, and knowledge-seeking behaviours affect these differences. Understanding these factors, they say, will help create targeted educational initiatives for patients and healthcare providers.  

Commenting on the results, the study’s first author, Mary Hedges, a community internal medicine physician at Mayo Clinic, said: ‘This study shines a light on how little we still understand about perimenopause and how much it affects people’s daily lives.’  

Increased demands 

Perimenopause doesn’t have a clear start or set rules. It can begin subtly with poor sleep, a shorter temper, and mental fog creeping in.   

In dentistry, where focus and fine motor skills are critical, even small changes can feel magnified. A restless night can lead to a longer clinical day. Decisions that once felt instinctive may now require more conscious effort. It’s not that competence vanishes; it’s that it sometimes demands more of you.  

Physical demands 

Fatigue remains a major challenge. Dentistry is physically demanding, and hormonal shifts can make energy levels unpredictable. On some days, maintaining good posture, focus, and pace feels disproportionately difficult.  

It’s therefore important to plan carefully by spacing procedures, allowing breaks between patients, and knowing when to step back rather than push through.  

Emotional demands 

Emotional challenges are also significant. Perimenopause can heighten anxiety or reduce stress tolerance, which is hardly ideal for a profession that depends on calm reassurance. Most days, we stay steady, but maintaining that calm can take more effort internally. Difficult interactions or delays may linger longer than they used to.  

Comfort levels 

There are other unexpected issues, too. For example, dry eyes can affect daily work. Long sessions under loupes and bright lights can become uncomfortable. Anything tight-fitting can become unbearable. Scrubs are not always designed with women’s needs in mind; white scrubs, in particular, can be problematic for menstrual hygiene.  

In addition to fluctuating temperatures, skin sensitivity and bloating can occur. Choosing lightweight, stretchable, moisture-wicking fabrics and layering with a breathable undershirt can improve comfort, while seamless or tagless designs can prevent skin irritation. Incorporating adjustable features, such as drawstrings or Velcro, can also enhance fit and support.  

The clinical setting can impact the ability to practise. It is essential to have well-ventilated treatment rooms, and women experiencing symptoms should feel at ease discussing any necessary workplace adjustments.   

Adaptation

While not insurmountable, these issues can accumulate, highlighting the need to adapt rather than resist. Small changes – such as reviewing clinic templates, improving ergonomics, staying hydrated, and consulting healthcare providers – can make a significant difference.  

Open conversations are vital to this. Although we discuss clinical complications readily, personal health topics such as menopause often remain unspoken.  

Midlife offers a valuable perspective; experience brings confidence, and understanding of patient care deepens beyond technical skills. Communication improves, empathy grows, and priorities are clarified. Perimenopause prompts a re-evaluation, not just of health but of our practice.  

For those of us at this stage, the goal isn’t to match the pace of youth but to sustain an effective and humane workstyle for ourselves and our patients.  

Make some noise 

Dentistry is a long career, and midlife is a transition, not a decline. With awareness and support, it can be navigated with the same professionalism and care we bring to our work every day.  

But we do need a cultural shift within the profession, involving regulatory and representative bodies, to raise awareness of the challenges midlife women face in dentistry, including workforce design, care delivery patterns, and ergonomic issues.  

Awareness is slowly improving, particularly in patient care. When discussing personal health topics such as menopause, we should approach these conversations openly yet professionally. Menopause and other midlife changes should not be taboo, especially in a predominantly female profession.  

Honest conversations with colleagues help normalise experiences and foster support. With patients, I will always discuss relevant health topics sensitively and only when appropriate, as hormonal changes can affect oral health and wellbeing.  

Long, healthy careers 

However, the profession hasn’t yet made sufficient progress in addressing the unique challenges midlife women face in dentistry. While menopause and wellbeing are discussed more openly, meaningful structural change remains slow.  

As dentistry becomes more feminised, a major shift in how midlife professional women are understood is necessary.  

There needs to be greater recognition of how workforce design, care-delivery patterns and ergonomic pressures affect women in midlife. Greater flexibility, stronger support, and sustainable working practices are essential to retain experienced clinicians and support long, healthy careers.  

Given the feminisation of dentistry, the profession must recognise that a one-size-fits-all career model is unsustainable. Midlife women often face overlapping challenges, including menopause, caring responsibilities and physical demands.  

Without evolving workforce planning, ergonomics and career flexibility, we risk losing highly experienced clinicians at a time when their expertise is most valuable.  

Maintaining resilience has meant accepting that I cannot work exactly as I did 20 years ago. Prioritising ergonomics, taking regular breaks, being selective about my workload, and focusing on wellbeing have helped. Most importantly, being kinder to myself and recognising that adapting in midlife isn’t a weakness but is vital for a long, healthy career in dentistry.  

 Reference  

• Hedges MS, Hewings-Martin Y, Karam J, Castaneda R, Cunningham AC, Xu Y, Zhaunova L, Faubion SS, Shufelt CL (2026) Global perspectives on perimenopause: a digital survey of knowledge and symptoms using the Flo application. Menopause 33(7): 789-798.  

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This investment adds to more than $7bn spent by the company on pharmaceutical research, development, and manufacturing in the US over the past five years.

The planned site will operate as a modular facility merging drug substance and drug product manufacturing, incorporating automated and digital systems.

It will support treatments across cardiovascular, oncology, and renal care. Production will roll out in stages, with the initial drug substance module scheduled to open in 2031, followed by a drug product manufacturing unit in 2034.

Construction of the site is expected to generate nearly 1,500 jobs, whilst ongoing operations are projected to create approximately 600 roles.

Bayer also intends to integrate the facility into a US-based collaboration network linking commercial manufacturing with academic research.

Bayer CEO Bill Anderson said: “Bayer has long seen the US as a key manufacturing base and innovation hub. This landmark investment underscores our commitment.

“The new site will be home to manufacturing expertise and a skilled workforce that will strengthen our ability to deliver innovative, high-quality medicines to patients both in the US and abroad.”

The Ohio project will complement Bayer’s US pharmaceutical headquarters in Whippany, New Jersey, as well as facilities in Berkeley, California; Cambridge, Massachusetts; Pittsburgh, Pennsylvania; Research Triangle Park, North Carolina; and San Diego, California.

In fiscal 2025, Bayer employed nearly 88,000 staff worldwide, reporting total sales of €45.6bn ($51.3bn) and research and development expenditure of €5.8bn.

In June 2026, the European Medicines Agency (EMA) validated Bayer’s marketing authorisation application for asundexian, an oral Factor XIa inhibitor, to prevent ischaemic stroke.

The post Bayer plans $2.2bn pharmaceutical manufacturing facility in Ohio, US appeared first on Pharmaceutical Business review.

The regulatory decision is supported by data from the primary analysis of the global, open-label Phase III BRUIN CLL-313 clinical study.

The trial randomised 282 treatment-naive patients to receive either single-agent pirtobrutinib or a chemoimmunotherapy regimen of bendamustine and rituximab.

Over a median follow-up period of 28 months, pirtobrutinib demonstrated a statistically significant improvement in progression-free survival assessed by an independent review committee, recording a hazard ratio of 0.20.

Median progression-free survival was not reached in the pirtobrutinib cohort compared to 33.5 months in the comparator arm. The overall response rate reached 94% for pirtobrutinib and 81% for the control group.

Lilly Oncology executive vice-president and president Jacob Van Naarden said: “This additional approval for Jaypirca, based on BRUIN CLL-313, marks a significant step forward, expanding its potential to reach more patients who may benefit – this time as an initial treatment for certain previously untreated patients with CLL or SLL.

“This milestone underscores Jaypirca’s versatility in the CLL continuum of care, from the first-line setting for appropriate patients to its valuable role in the relapsed or refractory post-covalent BTK inhibitor setting, reinforcing Jaypirca’s broad applicability as a meaningful treatment option for people with CLL or SLL.”

During the Phase III trial, serious adverse reactions occurred in 28% of patients treated with Jaypirca, with pneumonia observed in 5%. Adverse events resulted in dose reductions for 3.6% of patients and treatment discontinuation for 4.3%.

The National Comprehensive Cancer Network guidelines include Jaypirca as a Category 2A recommendation for untreated CLL/SLL patients without 17p deletions who are older with cardiac comorbidities.

It is also listed as a Category 1 preferred option for patients with relapsed or refractory disease following prior covalent BTK inhibitor therapy.

Both CLL and SLL are slow-growing non-Hodgkin lymphomas that originate in lymphocytes.

Last month, the US FDA approved Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults with type 2 diabetes (T2D).

The post FDA approves expanded indication for Lilly’s Jaypirca appeared first on Pharmaceutical Business review.

India’s pharmaceutical industry has built its global reputation on scale, quality, scientific capability and affordability. As the industry enters its next phase of growth, technology will play an increasingly important role in strengthening these foundations. Artificial intelligence (AI), in particular, has the potential to make pharmaceutical manufacturing more predictive, efficient and responsive. Most important “First Time Right”.

But the opportunity is not simply about introducing AI into Pharma manufacturing sites. The real question is how manufacturers can deploy it responsibly, at scale and in a way that strengthens quality and consistency and safe for patients.     

The first step is to focus on the problem, not the technology. Manufacturers should identify where AI can create measurable value addition, whether in predictive maintenance, process optimisation, early warnings on potential failures, visual inspection, Quality monitoring, deviation analysis, failure investigations and root cause analysis. AI should solve a clearly defined manufacturing challenge rather than become another technology pilot.

The second requirement is a strong data foundation. Modern pharmaceutical plants generate vast amounts of information through manufacturing equipment, laboratory instruments, equipment sensors and quality processes. Yet data which is fragmented, inconsistent or difficult to access limits the implementation and value of AI. Manufacturers therefore need reliable, connected and well-governed data, with appropriate controls for integrity, traceability and access.

This becomes particularly important in pharmaceuticals because AI should operate within a highly regulated environment. Quality cannot be an afterthought. AI-enabled systems must be developed with a clear understanding of their intended use, validation requirements, risk management and ongoing performance. As India strengthens its manufacturing quality framework, digital technologies must support, rather than complicate, the industry’s commitment to GMP and regulatory excellence.

There is also a need to keep people at the centre of this transformation. AI should augment human expertise, not replace it. Experienced manufacturing, engineering and quality professionals bring contextual knowledge that cannot always be captured in datasets. AI can help them identify patterns, anticipate risks and analyse information faster, enabling better and more timely decisions.

This makes talent development as important as technology investment. India’s pharmaceutical ecosystem already benefits from strong scientific, engineering and technical capabilities. The next step is to build digital fluency across the manufacturing workforce so that employees understand both the potential and limitations of AI-enabled systems.

The bigger challenge will be moving from isolated pilots to scalable implementation. A successful AI application should be capable of being governed, monitored and responsibly extended across value chain of the pharma manufacturing setup. Recognising that different plants and processes may require different models and controls. This calls for collaboration between manufacturers, technology providers, scientists, engineers and regulators.

This is also where India’s existing manufacturing strengths can become a competitive advantage. The country has spent decades building capabilities in process engineering, quality systems, regulatory compliance and large-scale production. AI can build on this foundation rather than replace it, helping manufacturers turn accumulated operational data into actionable intelligence.

For India, the opportunity is significant. The country has already demonstrated that it can combine scientific capability, manufacturing scale and cost competitiveness to serve the ever increasing needs of the patients globally. AI can help add another dimension to that advantage: manufacturing intelligence.

The future factory should therefore not be defined by how much AI it uses, but by how effectively it combines technology with science, quality and human judgement. If implemented on these foundations, AI can help Indian pharmaceutical manufacturers detect problems earlier, improve consistency, strengthen quality and build more resilient operations.

India’s pharmaceutical journey has always been about capability building. The next chapter can be about using intelligence at scale, while keeping quality, trust and the patient at the centre.

References: 

1.  U.S. Food and Drug Administration (FDA), Artificial Intelligence in Drug Manufacturing / Advanced Manufacturing Framework

2. European Medicines Agency (EMA), Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle, 2024

3. International Council for Harmonisation (ICH), ICH Q9(R1): Quality Risk Management.

4. Central Drugs Standard Control Organisation (CDSCO), Revised Schedule M, Government of India.

5. EMA & U.S. FDA, Guiding Principles of Good AI Practice in Drug Development, 2026

6. Government of India, Press Information Bureau, Steps taken to ensure drug quality and curb counterfeit medicines, 2026

The post Making AI work on the shop floor: What pharma manufacturers need to get right appeared first on Express Pharma.

Sun Pharmaceutical Industries announced that LEQSELVI (deuruxolitinib) will be featured in seven presentations at the 2026 European Academy of Dermatology and Venereology (EADV) Congress, including a featured oral presentation reporting long-term safety results from a European open-label extension (OLE) study evaluating up to two years of treatment in adults with severe alopecia areata (AA).

Results from the featured oral presentation found that the safety profile of LEQSELVI remained generally consistent with previous clinical experience through up to two years of open-label treatment in adults with severe AA. Most treatment-emergent adverse events were mild or moderate in severity, treatment discontinuations due to adverse events were uncommon, and no deaths, thrombosis or major adverse cardiovascular events were reported among patients receiving the FDA-approved dose of 8 mg twice-daily.

Long-term efficacy analyses presented in a poster also showed scalp hair regrowth through Week 108 in patients receiving LEQSELVI in the European OLE. Of OLE baseline treatment responders (SALT score ≤20) maintaining response at Week 52 and continuing in the study, 93.9 per cent maintained response at Week 108. Nonresponders completed the study at Week 52.

Among patients who were baseline nonresponders (SALT score >20), 76.6 per cent achieved response by Week 52. At Week 52, only responders continued in the study, and of these, 96.8 per cent maintained that response at Week 108. A Severity of Alopecia Tool (SALT) score of 100 represents total scalp hair loss, whereas a score of 0 represents no scalp hair loss.

“Severe alopecia areata is a chronic autoimmune disease, making long-term treatment considerations particularly important for both patients and their clinicians,” said Arash Mostaghimi, MD, MPA, MPH, FAAD, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women’s Hospital. “Collectively, these data show durable efficacy and maintenance of response for deuruxolitinib over time and reinforce the growing body of evidence supporting its use as a long-term treatment option for eligible adults.”

Data presented at the EADV Congress 2026 provide additional insights into the long-term treatment experience with LEQSELVI in a chronic autoimmune disease that often requires ongoing management. Additional presentations of pooled post hoc analyses of THRIVE-AA1 and THRIVE-AA2 showed consistent efficacy across clinically relevant patient subgroups, including patients with baseline eyebrow, eyelash or nail involvement, and those with both shorter- and longer-duration disease episodes.

“Our data at EADV 2026 expands our understanding of LEQSELVI beyond initial treatment response and provides important evidence for dermatologists and advance practice providers into long-term tolerability, durability of response, and maintenance of clinical benefit in adults with severe alopecia areata,” said Ahmad Naim, MD, Senior Vice President, North America Chief Medical Officer, Sun Pharma. “We remain committed to advancing research that addresses the significant unmet needs of people living with this autoimmune disease impacting their daily lives.”

Summary of Safety for the Patient

LEQSELVI can lower the ability to fight infections. LEQSELVI is not for CYP2C9 poor metabolizers or anyone taking a CYP2C9 inhibitor. Before and during treatment, test for TB and do bloodwork. Serious infections, blood clots, cancers including lymphoma, stomach or intestinal tears have occurred. People 50+ taking a JAK inhibitor with risk for heart disease may have a greater chance of heart attack, stroke, or death. Doctors should be informed about an infection, hepatitis B or C, or when patients are pregnant or planning or have any problems with low blood sugar. Please full Prescribing Information, including Boxed Warning and Medication Guide, and see below for Important Safety Information.

The LEQSELVI data presentation is one of 22 presentations from Sun Pharma across its dermatology and immunology portfolio.

The post Sun Pharma presents LEQSELVI long-term data at EADV Congress 2026 appeared first on Express Pharma.

Kusum Healthcare said its manufacturing facility in Sumy, Ukraine, was hit by a Russian drone attack, resulting in the death of one employee and injuries to several others. The company said the total damage is projected to exceed USD 50 million.

Kusum Healthcare, which exports to 22 nations worldwide, including through KUSUM IN UKRAINE, condemned the attack on its manufacturing facility in Sumy, Ukraine.

The company said the facility is dedicated to manufacturing life-saving drugs. It also said the incident follows an attack on its Ukrainian warehouse on April 14, 2025, when a Russian drone destroyed the facility.

Kusum Healthcare said it has manufacturing facilities in India, including two units in Bhiwadi, Rajasthan, and one unit in SEZ-Pithampur, Indore, Madhya Pradesh.

According to the company, losses from the previous attack exceeded UAH 1 billion, while the total current damage is projected to exceed USD 50 million. Kusum Healthcare said it had made repeated pleas through Indian pharma forums for intervention at the international diplomatic level to protect private healthcare businesses from the conflict.

The company said one employee was confirmed dead at the site and several others were injured. The India business and management authorities at Kusum Healthcare are reviewing the situation.

The Federation of Pharma Entrepreneurs (FOPE) also expressed concern over the reported attack. In a statement posted on LinkedIn by Harish Jain, President, FOPE, the organisation offered condolences to the family of the employee who died and wished those injured a speedy recovery.

FOPE said pharma manufacturing facilities form part of healthcare infrastructure and that their safety and continued operation are important during a conflict. The organisation said it stands with Kusum Group, the affected employees and their families, and hopes the company can assess the damage, protect its workforce and restore operations when conditions permit.

FOPE also reiterated its support for India’s position on the Russia-Ukraine conflict, stating that a lasting resolution should be pursued through dialogue and diplomacy, with respect for sovereignty and territorial integrity. It also said that medicines, healthcare and humanitarian needs should be insulated from the consequences of conflict as far as possible.

“FOPE stands in solidarity with Kusum Group and hopes for the safety of all its employees and for peace and stability to return to the region at the earliest,” said the organisation.

The post Kusum Healthcare facility in Ukraine hit by drone attack appeared first on Express Pharma.

China’s new five-year plan for its pharmaceutical sector, released on September 18, places innovation and globalisation at the centre of a major repositioning from scale to innovation driven growth. 

If this sounds similar to India Pharma Inc’s stated volume to value transition, it is only to be expected, as both move from their generics moorings. 

A few days later, on September 22, an open letter from nine European pharma companies, cautioned that “Europe (is) losing ground to global competition” as “over $600 billion in pharmaceutical investment has been announced in the US and China in the last two years alone.” It makes the case that “European governments must create conditions that attract investment in next-generation medicines before it’s too late.” 

Industry observers in India point out that what worries EU pharma leaders is a worry for India too. The question is, how will we respond? And will we respond fast enough? 

China’s move away from its traditional APIs and intermediates towards innovative medicines could in fact be a short term opportunity for India. 

Commenting on this aspect of China’s 15th five year plan Bharat Shah, MD, S Kant Healthcare and National President, IDMA pointed out that IDMA’s members are MSMEs with strong technical skills, so moving into and competing in this API space is not difficult, but what they need is more regulatory support, low interest rates and faster approvals. 

But Namit Joshi, Chairman, Pharmexcil went to the heart of the issue when he pointed out that China has state owned companies so when Indian pharma companies go up against their Chinese counterparts, they are actually competing with a country, not a company. Both Shah and Joshi were part of a panel discussion at the Peptides & Complex Generics Symposium 2026 (PCG 2026). 

China is already on this path and the new plan is designed to accelerate this transition. Dr Mahesh Bhalgat, CEO and founder, AAPM Therapeutics and an independent consultant, terms it “a bold plan where China displays ambition to further significantly step up its innovation game.” He also points out that the journey from being a leader in quantity (of pharma manufacturing) to a leader in quality (of pharma innovative assets) is already demonstrated by China having increased deal value considerably from single digit to $130+billion in 2025. 

As per media reports quoting a Nomura research analysis, the plan lays out targets in 10 areas, including raising the average R&D expenditure-to-sales ratio, increasing the global market share of first-in-class and having more than five drugs with global annual sales exceeding $1 billion. These are framed as goals, without legal binding. The plan does not give details of how the companies are to achieve this nor an implementation path. 

India Pharma Inc and policy makers must closely analyse the plan and modify India Pharma Inc’s strategic blueprint because it would have crucial implications for India.

But China’s government and regulators have traditionally supported the pharma industry with industry-friendly policies, geared towards growth. The plan does mention 20 pharma parks, which would no doubt help Chinese pharma companies meet these goals.

And where does India stand? The average R&D expenditure-to-sales ratio for most listed pharma companies in India is estimated to be below 10 per cent. The good news is that India is on the same path, with a clear push to move from volume to value. 

In the near term, India’s pharma sector seems to be weathering the current turbulence reasonably well. The latest Crisil Ratings report predicts that the pharma sector will see stronger dose of revenue growth at 11-13 per cent this fiscal, up from 8 per cent last fiscal, driven by accelerating exports and firmer domestic demand. The analysis is based on nearly 190 Crisil-rated pharma companies, accounting for about half of the sector’s revenue last fiscal. 

The caveat is that this growth spurt is unlikely to flow through fully to earnings, as inflation in raw material, energy and freight costs is expected to compress operating margins by 150-200 basis points (bps). 

In tune with the experts in our cover story in this edition (Read story, Beyond US: New shores, new bets), India’s exports now show a balance between regulated and semiregulated markets, with approximately 57 per cent to the former, as per Crisil. 

Also of significance is the fact that the sector’s domestic and export revenues are almost equal. The strong domestic buffer will be crucial, as potential US tariffs on pharma exports still hang over the sector. 

Zooming back to the open letter from nine EU pharma leaders and China’s new five year pharma plan, these are the latest and clearest signals that the stakes are only getting higher. 

Each country’s healthcare leadership is lobbying their governments and regulators for more supportive policies, to double down on securing the sovereignty and sustainable future of its pharma and biopharma sector, so that they are positioned to best serve the medical needs of their patient populations. 

India Pharma Inc too will need much more policy and regulatory support, with quality and pricing guardrails, to map a future path that is sustainable, plays to its strengths, and safeguards patients’ lives in India and beyond. 

VIVEKA ROYCHOWDHURY, Editor 

viveka.r@expressindia.com 

viveka.roy3@gmail.com 

The post Does India Pharma Inc need a new blueprint? appeared first on Express Pharma.

Skin Beyond Borders announced its audited skincare marketplace in August. What industry gap are you trying to address?

My experience in the industry spans around 20 years. I formally started working in dermatology in 2009, although before that I was in formulation development and clinical research. In 2009 I started Adroit Digital Ideas, a medical marketing company, doing product-launch support, technical brochures, training decks and product-information material for doctors, for clients including GSK, Abbott, Ranbaxy and Clariant. 

Over time we realised that model could not be scaled. We also had an opportunity around a drug for skin cancer, which moved us into dermatology marketing. In 2011, Adroit Digital Ideas became Adroit Biomed. My background has always been on the science side — formulation development and clinical research but dermatology is also a dynamic and creative industry. Every day something new emerges.

 should say where that ended, because it is relevant to why I am doing this now. We sold Adroit Biomed to Alkem Laboratories in April last year

We were involved in introducing concepts such as 20 per cent vitamin C topical gel and 1 gram vitamin C effervescent in India in 2012. One of those, Enerc 1000, went on to become the third largest vitamin C brand in India on ORG data in 2015. We were also among the early companies working with glutathione in the dermatology space. At that time many doctors were not familiar with glutathione, because it was not extensively covered in their academic training.

That experience showed us how much happens after a person starts using a product. We had both doctor and direct channels, so we heard from very different users. Some reported significant changes. Others said they had seen nothing after months. That made us look more closely at the science behind efficacy and individual response.

You have worked extensively with glutathione. What does the science say about absorption and efficacy?

One of the fundamental challenges with glutathione is absorption. It has been known for some time that oral glutathione is poorly absorbed, which is one reason different delivery systems, including liposomal formulations, have been explored. Intravenous administration is considered different because it delivers the ingredient directly into the bloodstream.

However, getting glutathione into the blood is not the same as getting glutathione into the cell. Glutathione does not enter the cell intact, and the reason is not its size — it is a small molecule. It stays out because it is electrically charged and highly water-soluble, so it does not readily cross a lipid membrane, and because no import route for intact glutathione operates at a meaningful rate in most mammalian cells. The dominant route is breakdown at the cell surface. The fragments are taken in separately and used to build glutathione again inside.

There is a second factor: the enzyme glutamate-cysteine ligase, or GCL. It runs the first step of glutathione synthesis and is the rate-limiting one. Its activity and expression decline with age and can be affected by chronic conditions and higher levels of inflammation. 

There is also a control mechanism I think the category has paid too little attention to. GCL is inhibited by glutathione itself — as glutathione accumulates, the enzyme slows down.

So if the cell has sufficient GCL but lacks raw materials, supplying those building blocks may help. But if GCL activity itself is low, simply supplying more glutathione or its precursors may not produce the increase people expect.

Does that mean higher doses are more effective, particularly as a person ages?

Not necessarily. If only a proportion of oral glutathione is absorbed, increasing the dose may increase what reaches the bloodstream. But that does not automatically mean more glutathione enters the cell.

The bigger question is what is happening inside the cell. Someone may have adequate GCL activity but insufficient amino-acid availability, and in that situation providing the raw materials could support production. If GCL activity is inadequate, increasing the supply of raw materials may not have the same effect. That can partly explain why people respond differently to glutathione supplementation.

Where does gamma-glutamylcysteine fit, and what is your interest in it?Let me put the commercial position first. We retail Continual-G, a gamma-glutamylcysteine supplement, on our platform. So I have an interest here, and it is better that I say so than that somebody else points it out.

Gamma-glutamylcysteine, or GGC, is one step before glutathione in the cellular biosynthesis pathway — the same pathway, one piece short of finished. The proposition is that GGC is absorbed, enters the cell, and joins the pathway after the first step, so the rate-limiting enzyme is not the constraint.

Two qualifications belong with that. The uptake mechanism has not been established — the published work says so directly. And GGC is also cleaved at the cell surface by the same enzyme that cleaves glutathione; a 2022 study found it handles GGC comparably. So what can reasonably be claimed is that uptake outruns breakdown, not that GGC avoids breakdown. 

And the human evidence?

There is one published pharmacokinetic trial, and I would rather describe it accurately than favourably, because anybody can read it.

Zarka and Bridge, Redox Biology, 2017. A single 2 gram oral dose raised glutathione inside lymphocytes by 53 per cent within 90 minutes, peaking at around three hours and returning close to baseline by five.

The caveats matter. Fourteen trials in thirteen participants. Doses of 2 grams and 4 grams. Individual responses ranged from 10 to 161 per cent, so 53 is an average across a very wide spread. There was no placebo control — placebo capsules were used only to match capsule count between the two doses. The pharmacokinetic arm had six people; one withdrew during the study and one 4 gram dataset was excluded, so five carry the 2 gram data and four the 4 gram. And the authors hold the manufacturing patents.

It is a pilot study and should be called one. I would add two things. There is no head-to-head trial of oral glutathione against GGC — the comparison is drawn across separate studies with different designs, and it should be labelled that way. And the dose studied is not the dose sold: the trial used 2 and 4 grams, and the product is 400 milligrams. A 400 milligram study is registered in India, sponsored by the manufacturer, and has not yet begun recruiting.

That is where the evidence currently stands.

Glutathione injections have attracted attention for skin brightening. What are the safety considerations?

There is an important distinction between glutathione’s use for established medical indications and its off-label use for skin brightening. Glutathione is naturally present in the body and is an important antioxidant. It is also used in medical settings for certain conditions.

When physiologically unusual amounts are administered, there can be effects on the body’s redox balance. Some patients report symptoms such as tingling. There is also the possibility of hypersensitivity or other adverse reactions.

For skin lightening specifically, the regulatory position is clearer than the market appears to assume. The Philippines FDA attributes to injectable glutathione used this way toxic effects on the liver, kidneys and nervous system, the possibility of Stevens-Johnson syndrome, and — where it is given by a non-medical practitioner in a non-sterile facility — transmission of infectious agents including HIV and hepatitis B and C. Its advisory also states there are no published clinical trials evaluating injectable glutathione for skin lightening, and no published guidelines for dosing or duration.

 In India, CDSCO issued a public notice on 18 May this year clarifying that injectable preparations do not fall within the definition of a cosmetic, and that no cosmetic may be administered by injection — by consumers, professionals or aesthetic clinics. Trade coverage has read glutathione drips as falling within its scope. Enforcement is uneven, though, and a range of other intravenous products continue with very little oversight.

The larger issue, in my view, is not the molecule. It is who is administering it, and in what setting.

A qualified medical professional takes an appropriate history, understands the protocol, is trained to manage an adverse event, and has the infrastructure to respond if something goes wrong. There are instances where procedures are offered in inappropriate settings without adequate medical support — people may book hotel rooms, bring clients in, and conduct procedures without the necessary emergency infrastructure. That is a serious concern. 

Glutathione is not an alien substance to the human body, but that does not mean its administration is risk-free.

You have spoken about the need for indigenous innovation in skincare. What prompted that?

In 2017 I was at a cosmetics exhibition in Paris. We were using a cinnamon extract supplied from France, for acne and oily skin. At the supplier’s stall, the product manager told me they were buying the raw material from India, processing it into an extract in France, and selling that extract back to India.

I knew this at some level already. Hearing it said out loud made me look at the larger pattern.

India has a strong pharmaceutical industry, a large scientific talent pool and significant IT capability. Yet in cosmetics and skincare we have historically been more dependent on imported active ingredients and technologies. At Adroit, most of our active ingredients were imported. We would talk about an active coming from Japan, Korea or the US, because that was how the market operated.

Alongside that there was a perception that products associated with international brands were inherently better. That mindset persists, even though there are several good products being developed in India now.

The same issue now extends to technology. Many of the facial-scanning technologies being integrated into skincare platforms originate outside India. Indian brands pay licence fees to use them, while the systems may also learn from data generated by Indian users, depending on the terms of the licence.

That is a strange equation. We are paying for the technology and, in the process, providing the data that helps improve it.

I should be straightforward that we are building a facial scanner ourselves and we collect user data, so I am not standing outside this. The question I care about is who collects more. It is where the data sits and who it ultimately benefits. 

India has the IT capability. We have one of the world’s largest pools of dermatologists. We have the scientific and clinical ecosystem. Data and technical capabilities are not necessarily scarce. What has been missing is the initiative to bring these capabilities together and build the technology here.

That is the gap I wanted to address.

Is the larger objective to make India a centre for skincare innovation?

Yes. My objective is to see India become a centre of innovation for the world in skincare by 2035. Skin Beyond Borders is the first step in that direction.

I don’t see it simply as a skincare brand. It is a platform, which means it can work with brands, ingredient suppliers, manufacturers, researchers and other stakeholders in India and internationally.

One of the components we have developed is the Skin Friendliness Index, or SFI, which is a composite score developed by us. I would not call it clinically validated at this stage, because we do not yet have sufficient data to substantiate it. That is precisely why data generation matters.

We are also working with a research group in Brazil that studies similar areas and has published in this field. We see scope for exchanging data and developing a more robust scoring mechanism over the next two to three years.

How is Skin Beyond Borders different from a conventional beauty marketplace?

I would start by saying we do not see a platform like Nykaa as a competitor. It is a different category of business. A marketplace of that kind is built to help someone reach a purchasing decision, and it does that job well. Our role begins after the purchase, when the person actually starts using the product.

SkinBB is a collaborative platform and an audited marketplace, and what we intend to build on top of that is a predictive intelligence layer for the industry. 

The starting point is understanding what happens over time. Does the user continue with the product or switch? What changes are taking place in the skin? How consistently is the routine actually followed?

We are developing a facial-scanning capability, and alongside it a daily-log feature through which users can take selfies and track changes over time. After 14 days, the system should be able to show how the skin looked on day one against day 14, with quantitative comparisons across different parameters.

The idea is to link those changes with the user’s routine — which products, adherence to them, environmental conditions, outdoor activity, food, and other parameters they choose to log.

Collected consistently and at scale, that record is what makes prediction possible — for the individual, and for an industry that has had very little visibility into how its products behave in real use. That is the objective, rather than simply recommending a product. 

For a data-driven platform, getting users to engage consistently is difficult. How are you approaching it?

That is probably one of the biggest challenges. Getting users to log in every day and consistently provide data is difficult.

At present the platform is free. We are not funded currently, and every aspect of operating it has a cost, so we will eventually have to determine a sustainable model. We are considering a subscription, but we first want to understand how users actually use the platform, what their behaviour looks like, and what the average cost of serving a user is.

For the first few months our focus is therefore usage and data generation rather than monetisation. I don’t want to ask users to pay significant amounts and, at the same time, expect them to continuously provide data.

Selfies and daily skin logs put you squarely inside India’s data protection regime. How are you approaching that?

We treat it as a design constraint rather than a compliance exercise bolted on afterwards. With this kind of data you cannot retrofit it.

The DPDP Act makes a platform like ours a data fiduciary. The Rules were notified in November 2025 and set an eighteen-month transition running to May 2027, so although enforcement is still in its early phase, the obligations are already known. For us the binding ones are the ordinary ones — notice, purpose limitation, consent that is specific and can be withdrawn, retention limits, deletion on request, breach reporting. All of those are far easier to build in now than to add at scale later.

The provision that deserves more attention than it gets is Section 9. Under the Act anyone below eighteen is a child. Processing their data requires verifiable consent from a parent or guardian, and tracking, behavioural monitoring and targeted advertising directed at children are prohibited outright. A longitudinal skin diary is behavioural monitoring on any reasonable reading. So for a platform like ours this is not a consent checkbox — it decides whether you can serve that age group at all. 

There is also a point that matters to me beyond the legal minimum. We ask people to contribute data over months, which only works if they understand what they are contributing and why. If consent is buried, we have not really obtained it — whatever the law allows. 

We want to encourage users to contribute data because, ultimately, that data can help them understand their own skin better.

This becomes particularly relevant for chronic skin conditions, where the skin may remain stable for a period and then suddenly flare. With a longitudinal record you can begin to identify patterns around those changes, instead of only asking why something happened suddenly.

That is the direction in which we want to take the platform.

The post Getting glutathione into the blood is not the same as getting glutathione into the cell appeared first on Express Pharma.

For many years, dentistry has been framed as a binary choice: NHS or private. But for many practices across Scotland, that framing no longer reflects reality – Selina Alexander examines the rise of the mixed practice.

Fully NHS or fully private? That’s how many dentists have seen their choices in the past. However, rather than being a case of choosing sides, the situation now is more about finding a sustainable way forward that works for clinicians and teams, as well as for patients.

Increasingly, I am seeing practices moving towards a more blended or mixed model. This is because the pressures within the system are making a purely NHS approach harder to maintain. As a consequence, this is leading to the emergence of a mixed dental economy with its roots in necessity rather than ideology.

Why the NHS model is under pressure

For most practices, the strain on NHS dentistry has a number of causes. Costs are rising, but remuneration hasn’t kept up, making it harder to maintain standards. At the same time, admin continues to grow, often eating into time with patients. Add to these recruitment difficulties and the result is less flexibility in how care is delivered, and more pressure on the day-to-day.

Meanwhile, patient demand continues to increase meaning access is becoming more stretched.

The rise of private dentistry: pull factors as well as push

While NHS pressure is clearly part of the picture, it’s not the only reason things are shifting. Around 20% of dentists are now fully private, and that number has been building steadily.  For a lot of dentists, the move towards private care is as much about what they gain.

In practical terms, it often comes down to a number of things. Private dentistry offers more consistency in income, making it easier to plan and invest. It also gives more freedom in how to approach treatment with fewer constraints on time or materials.

Importantly, it also gives practices more scope to reinvest money into the business, whether that’s in equipment, the environment, or simply creating a better overall experience for patients. In Scotland, that shift is becoming more noticeable. Private practices are attracting more interest and stronger valuations, which suggests growing confidence in that model.

However, none of this means private is the ‘better’ route. For many, it’s starting to feel more manageable and a bit easier to build something sustainable.

Mixed practice: the middle ground gaining momentum

For many practices, it’s no longer about choosing NHS or private but more about making the two work together. A mixed model combines both, and is a deliberate, practical approach rather than a compromise. It allows practices to keep a broad base of patients while at the same time helps spread risk and bring more consistency financially.

For patients, it retains NHS access where possible, while giving the option of private treatment when needed. In reality, it reflects how dentistry is already working shaped by what patients need and what practices can sustain.

The role of payment plans

For practices exploring a mixed model, patient membership plans are often part of the consideration.

As well as giving patients a way to spread the cost of care, they provide practices with a consistent monthly income. However, dentists are often as concerned about how a plan will land and whether patients will see it as fair or changes the tone of the relationship. Opting for a plan that’s branded to the practice, rather than a provider, can help underline a sense of belonging and increase patient loyalty. Patients have chosen to join the practice’s membership plan, rather than simply changed the way they pay for their treatment. 

In practice, this is affected by how it’s introduced. Plans that are clear, straightforward and genuinely reflect the care being provided tend to be something both the team and patients can accept and feel comfortable about. In this case, especially, there’s no need for hard selling, just an open conversation about options.

When that balance is right, plans can have the effect of strengthening the relationship. Patients know where they stand, are more likely to attend regularly, and practices have more certainty to plan for the future. In the current climate, that kind of stability is becoming increasingly important.

Scotland-specific dynamics: pressure driving change

Scotland’s dental model has long been rooted in a strong NHS foundation which is now under strain. Practices remain committed to NHS care, yet tightening fees, rising costs, and recruitment challenges are making the traditional model harder to sustain. The shift toward mixed dentistry is a practical response rather than ideological.

There’s also a geographical split:

• Urban practices are moving faster, balancing high demand with growing patient expectations for private options and enhanced care
• Rural practices face different pressures such as workforce shortages and access responsibilities, making change more gradual but no less necessary.

Behind the scenes, buyer behaviour is reinforcing this trend. Investors and acquirers are increasingly drawn to practices with a balanced NHS/private mix and established membership plans, viewing them as more stable and scalable. Pure NHS models, while essential, are now seen as harder to future-proof without evolution.

Scotland is becoming an indicator for the wider UK. What’s emerging rather than simply NHS versus private, is a steady, practice-led shift toward a blended model with membership plans playing a central role. In that sense, Scotland is showing what the future is likely to look like.

From ideology to practicality

Rather than the NHS vs private debate, most teams are grappling with a much simpler question:
how do you keep NHS access going without the numbers getting tighter every year?

Dentists are business owners as well as clinicians and right now, the system doesn’t fully support both sides of that. That’s one of the things driving the shift toward mixed models and membership plans to try to make the model work.

At its core, this is about bringing three things back into line:

• What patients need
• What clinicians can realistically deliver
• And what the numbers will support.

The move to a mixed model is more about finding a way for both to coexist without constant strain than a move away from NHS dentistry.

Adaptation, not abandonment

This is a way to keep NHS dentistry workable. Most practices are simply trying to hold onto NHS care while making the day-to-day reality stack up. Looking ahead, the practices that adapt and stay flexible will be the ones that manage it best, both clinically and commercially.

Practice Plan has been welcoming practices into the family since 1995, helping them to grow profitable businesses through the introduction of practice-branded membership plans.

With over 300 years’ dental experience in our field team, if you’re looking for a provider that has that family feel but knows a thing or two about dentistry then you’re in safe hands. Be Practice Plan and get in touch. Call 01691 684165 or visit www.practiceplan.co.uk/be-practice-plan/.

This article is sponsored by Practice Plan.

Retention is an integral part of Invisalign treatment – Aligner Dental Academy presents a guide to the different options and a practical post-Invisalign retention protocol.

When the last aligner comes off, the attachments are removed and the patient finally sees the result they have been waiting for. It is tempting to think the treatment is finished. Biologically, it is not.

The first few months after active orthodontic treatment are a vulnerable period. Periodontal and gingival tissues are reorganising, occlusal contacts are settling, and teeth remain susceptible to movement. Longer term, growth, ageing and normal dentoalveolar change continue throughout life (Littlewood et al, 2017). Retention is therefore not optional after Invisalign; it is part of the treatment.

Fixed, removable, or both?

Vacuum-formed retainers (VFRs) are a good foundation for retention following Invisalign. They retain the whole arch, are aesthetic and do not require bonded hardware.

However, there are situations where adding a bonded retainer makes clinical sense. British Orthodontic Society guidance has long recommended permanent retention following closure of generalised spacing or a midline diastema (BOS, 2013). There is also evidence that bonded retention can provide particularly good stability of the mandibular anterior segment.

In a five-year randomised controlled trial, Krämer and colleagues found only small post-treatment changes overall, but mandibular anterior alignment was more stable with a bonded canine-to-canine retainer than with a removable VFR: median irregularity increased by 0.1 mm with bonded retention compared with 0.6 mm with a VFR (Krämer et al, 2023). For a patient with a previously irregular lower anterior segment, that is clinically useful information.

A practical approach would therefore be VFR alone for many routine cases, but dual retention for cases where the consequences or likelihood of anterior relapse justify extra security.

The fixed retainer wires

This is an important conversation to have with patients.

Patients often assume that once a bonded wire is fitted, they no longer need their removable retainer. In reality, bonded retainers are not maintenance-free.

A 2023 systematic review and meta-analysis of 34 studies involving 3,484 patients estimated an overall bonded-retainer failure prevalence of approximately 35%. Failure increased with time, reaching more than 50% in studies with longer follow-up (Aye et al, 2023).

If a bond fails, the VFR can help maintain tooth position while the patient arranges a repair. If the patient has stopped wearing it, surprisingly rapid movement can occur before the failed wire is noticed.

For this reason, a practical dual-retention workflow is to place the passive fixed retainer first, then scan or take the impression over the bonded retainer so that the VFR is manufactured to fit accurately over it.

How many hours should the VFR be worn?

The early months deserve particular attention. In an RCT comparing mandibular VFR and bonded retention, most measurable post-treatment change occurred during the first six months (Krämer et al, 2020). This makes the first six to 12 months a sensible period for closer supervision.

The 2023 Cochrane review found the available comparisons between retention schedules to be of low certainty, and trials have not demonstrated a compelling clinical advantage for routine full-time wear over part-time wear (Martin et al, 2023; Iliadi et al, 2016).

A pragmatic protocol is therefore six months’ full-time wear of VFRs & then night-time wear as the baseline, increasing wear for patients who demonstrate instability.

Give patients a simple feedback mechanism: the retainer should remain passive.

If a patient misses several nights and the retainer suddenly feels tight, the teeth are telling them something. Advise more frequent wear until it becomes passive again. If it remains tight, no longer seats fully, or a tooth has visibly moved, review the patient rather than simply asking them to force the appliance into place.

If you bond a retainer, make it genuinely passive

Bonded retention introduces its own risks. A retainer can remain attached and still cause unwanted movement if it was active when bonded or subsequently becomes distorted.

‘Wire syndrome’ describes unexpected torque, inclination or other tooth movement associated with an apparently intact bonded retainer (Charavet, 2022). The clinical lesson is simple: do not just check whether the wire is still there, check what the teeth are doing.

At review appointments, inspect individual composite pads, wire integrity, anterior alignment, torque, periodontal health and occlusion.

There is also emerging evidence that technique matters. A 2026 systematic review and meta-analysis involving 1,481 patients found a significantly greater first-failure risk for directly bonded mandibular retainers compared with indirectly bonded retainers (HR 1.41) (Marei et al, 2026). For clinicians experiencing repeated mandibular retainer failures, laboratory- or digitally assisted indirect placement is therefore worth considering.

A practical post-Invisalign retention protocol

For most clear-aligner patients, the following provides a sensible, evidence-informed starting point:

1. Provide removable retention in both arches. A full-coverage vacuum-formed retainer (VFR), such as Vivera, is a straightforward choice after aligner treatment and is familiar to the patient for six months full time and then night-time wear for life
2. Add a bonded retainer when greater anterior security is desirable, particularly following closure of spacing or a diastema, significant rotations, substantial anterior tooth movement, or where even minor relapse would be problematic
3. Use the removable retainer even when a fixed retainer is present. The bonded wire is additional security, not a replacement for the removable retainer
4. Review retention early. A review during the first few months and again at approximately six to 12 months allows problems to be intercepted before significant movement occurs
5. Teach patients that retention is lifelong. If they want their teeth to remain where treatment placed them, some form of retention needs to continue indefinitely.

This is deliberately simple. A retention protocol that patients understand and follow is more useful than an elaborate protocol that disappears into a drawer.

Here is a useful video guide by Aligner Dental Academy on Retention after Invisalign treatment.

Retention has no real finishing date

A patient’s teeth can move throughout life. The retainer is how you protect the result we have created.

The British Orthodontic Society advises long-term retention and explains that patients wishing to maintain tooth position may require retention for life (BOS, 2013). That discussion should occur at the start of Invisalign treatment, be reinforced at completion, and form part of written consent.

The Invisalign journey therefore does not finish with the last aligner. Active treatment creates the result; retention protects it. And perhaps the most practical rule of all is this: if a patient wants straight teeth for life, they should expect to retain them for life.

References

1. Littlewood SJ, Kandasamy S, Huang G. Retention and relapse in clinical practice. Aust Dent J. 2017;62(Suppl 1):51–57.
2. Martin C, Littlewood SJ, Millett DT, et al. Retention procedures for stabilising tooth position after treatment with orthodontic braces. Cochrane Database Syst Rev. 2023;5:CD002283. doi:10.1002/14651858.CD002283.pub5.
3. British Orthodontic Society. Clinical Guidelines: Orthodontic Retention. British Orthodontic Society.
4. Krämer A, Sjöström M, Apelthun C, Hallman M, Feldmann I. Post-treatment stability after 5 years of retention with vacuum-formed and bonded retainers—a randomized controlled trial. Eur J Orthod. 2023;45(1):68–78. doi:10.1093/ejo/cjac043.
5. Aye ST, Liu S, Byrne E, El-Angbawi A. The prevalence of the failure of fixed orthodontic bonded retainers: a systematic review and meta-analysis. Eur J Orthod. 2023;45(6):645–661. doi:10.1093/ejo/cjad047.
6. Iliadi A, Kloukos D, Gkantidis N, Katsaros C, Pandis N. Performance of clear vacuum-formed thermoplastic retainers depending on retention protocol: a systematic review. Odontology. 2016;104:237–247.
7. Krämer A, Sjöström M, Hallman M, Feldmann I. Vacuum-formed retainer versus bonded retainer for dental stabilization in the mandible—a randomized controlled trial. Part I: retentive capacity 6 and 18 months after orthodontic treatment. Eur J Orthod. 2020;42(5):551–558. doi:10.1093/ejo/cjz072.
8. Charavet C, Vives F, Aroca S, Dridi SM. “Wire Syndrome” following bonded orthodontic retainers: a systematic review of the literature. Healthcare (Basel). 2022;10(2):379. doi:10.3390/healthcare10020379.
9. Marei MA, Failakawi LE, Alhouti FY, Alshamly MY, Mostafa OY. Effect of direct versus indirect bonding techniques on fixed retainer failure rates: a systematic review and meta-analysis. Cureus. 2026;18(2):e102821. doi:10.7759/cureus.102821.
10. Fleming PS, Pandis N. Orthodontic retention: rationale and periodontal implications. Periodontol 2000. 2024. doi:10.1111/prd.12560.
11. Regalado-Bazán CF, Espichan-Salazar AC, Arriola-Guillén LE. Comparison of relapse of orthodontic treatment following aligner versus conventional fixed appliance treatment: a systematic review. J Clin Exp Dent. 2024;16(5):e586–e594. doi:10.4317/jced.61520.

This article is sponsored by the Aligner Dental Academy.

With a famous biotech cluster in Research Triangle Park (RTP) established almost 70 years ago, North Carolina is already a powerhouse of pharmaceutical R&D and manufacturing, and recent expansion plans worth billions of dollars will continue growth into the future.

A delegation from the Biotechnology Innovation Organization (BIO), led by BIO President & CEO John F. Crowley, learned about North Carolina’s biotech industry on an Oct. 2 visit to RTP, a 7,000-acre complex spread across the three cities of Raleigh, Durham, and Chapel Hill, N.C. It was the latest stop of the BIO on the American Road learning and networking tour of America’s biotech ecosystems.

BIO’s delegation met local members of industry, patient advocates, and Rep. Deborah Ross (D-NC), a champion of IP rights and biotech (pictured at top, with Crowley). The BIO delegation also toured the RTP facilities of Biogen, which are currently undergoing a $2 billion expansion.

“Companies come to North Carolina and RTP because of the investments, talent, partnerships and strong support from elected leaders, like Rep. Ross, that make innovation possible,” said Crowley. “RTP has built an ecosystem where biotechnology companies can develop medical breakthroughs and manufacture them right here in America. The U.S. must continue to lead in biotechnology, and that requires building a stronger American biotech industry. North Carolina and RTP are demonstrating the power of bringing innovation, investment and manufacturing together.”

Biotech R&D, manufacturing, and distribution are all well represented in North Carolina, where the life sciences employed 103,107 as of 2024, according to a TEConomy NCBiotech report. These workers belonged to nearly 6,700 state businesses working in biotech, the report said.

BIO’s delegation met with several innovation leaders at an industry roundtable hosted at the offices of the North Carolina Biotech Center (NCBiotech). Founded in 1984, NCBiotech was the first state-sponsored initiative of its kind to support the biotech industry. They seek to “create North Carolina’s competitive advantage in the life sciences by engaging partners, maximizing opportunities, and delivering solutions to accelerate innovation, investment, and job creation.”

BIO also hosted a luncheon with patient advocates from across the state and met with  Rep. Ross, who represents the RTP area, at Biogen’s impressive manufacturing campus, which has roots dating back 30 years in the area.

Rep. Ross sits on the  House Judiciary Committee and has authored and supported several bills promoting IP and biotech.

Ross recently cosponsored H.R. 6089, the Biomanufacturing Excellence Act of 2025 which would establish a public-private partnership to allow innovators to scale their products in the U.S. with smarter, faster, more efficient manufacturing practices. The bill was inspired by recommendations from the National Security Commission on Emerging Biotechnology’s April 2025 Action Plan for Congress.

“I’m proud to represent North Carolina’s Research Triangle, where universities, startups, and major institutions are constantly pushing the boundaries of what’s possible,” Rep. Ross said. “That’s why I was grateful to visit Biogen’s RTP campus in Morrisville for an important discussion about the future of biomanufacturing in North Carolina. Biomanufacturing is a pillar of our economy and workforce, creating good-paying jobs and attracting some of the brightest minds to our community. It’s more important than ever that we develop new medications here at home that are accessible and affordable.”

‘Bipartisan support for biotech’

“Given the high level of biotech employment, the importance of the industry’s supply chain and research activities around the state, we see a lot of good bipartisan support for biotech from our federal delegation,” said Gunter.

She said NCLifeSci receives assistance and guidance from BIO when addressing federal issues that matter for North Carolina. These include: federal funding for the state’s top-tier research (R1) universities; SBIR federal seed funding for early-stage research; and national security priorities outlined by the NSCEB, Gunter said.

Founded in the early 1990s, NCLifeSci has focused on state policy affecting biotech.

“We’ve been able to have a real impact on the industry overall on the state level,” said Gunter. This has included “being one of the first states to really incorporate a matching fund for federal SBIR dollars,” getting state support for workforce development training programs, and tax incentives.

NCLifeSci was instrumental in establishing the NC Life Sciences Caucus, made up of lawmakers from both parties in both the state House and state Senate. Among its pro-biotech efforts, the Life Sciences Caucus supported the introduction of the first omnibus life sciences appropriation bill for inclusion in the state budget, NCLifeSci helped write the bill.

“Measures that matter to the industry were grouped in an omnibus package with the goal of saying, here’s a number of areas where the state can contribute to North Carolina’s life sciences,” Gunter said.

The pro-biotech policy environment and the existence of institutions like NCBiotech help North Carolina build one of the country’s leading biotech ecosystems, according to Gunter. Other attributes of that ecosystem include five R1 research universities, a broad range of small biotechs, a large concentration of clinical research organizations, and manufacturers—from major pharma firms to contract development manufacturing organizations.

“So we have the full soup-to-nuts of the biotech ecosystem, and it really works well together,” Gunter said.

Biogen’s growth

BIO’s team joined Rep. Ross for a tour of the RTP facilities of BIO member Biogen, a leading biotech company developing innovative treatments in neurology, immunology, and rare diseases. With more than 1,500 manufacturing and technical employees and more than 400 skilled contractors, Biogen is the largest biotech employer in North Carolina, and they’re still growing.

“Biogen announced a $2 billion investment in our existing Research Triangle Park (RTP), North Carolina manufacturing footprint in July 2025, and we’ve continued to progress this multi-project strategic investment plan since our announcement,” said Nicole Murphy, Biogen Executive Vice President and Head of Pharmaceutical Operations and Technology. “This year, Biogen’s facility in RTP has executed approximately $200 million year-to-date, supporting progress across multiple modality expansions, including a new ASO (antisense oligonucleotide) purification factory and additional synthesis capabilities.”

The expansion will also add new clinical product assembly and packaging capabilities, utility, environmental, and infrastructure improvements, continued digitalization and AI-enabled roadmap deployment, and initial engineering work for future biologics, fill-finish, lyophilization, and oral solid dose capabilities.

“The work happening here is helping Biogen reliably produce medicines for patients today while also building the capabilities we will need for the future,” Murphy said. “Given recent acquisitions, we are also evaluating additional potential investment opportunities based on our late-stage portfolio.”

While Biogen is headquartered in Kendall Square in Cambridge, MA, and has a new facility in San Francisco, it mainly conducts its U.S. manufacturing in North Carolina.

“RTP has become our largest manufacturing footprint because it offers the right environment for advanced biomanufacturing,” Murphy said. “You have leading universities, research institutions, life sciences companies and a deep technical workforce all in one region.”

Biogen is not just a beneficiary of the biotech expertise in RTP, it is also a major contributor to the ecosystem, Murphy noted.

“Biogen brings a large, established, and advanced manufacturing presence to RTP, along with continued investment in high-quality jobs, technical capabilities, and infrastructure. Our presence helps strengthen the broader life sciences ecosystem by creating opportunities for collaboration, training, and workforce development,” Murphy said. “We also work with local institutions and programs to help build pathways into biotech manufacturing careers, which is important both for Biogen and for the region’s long-term growth.”

Biogen’s North Carolina expansion is just one of several announced recently. Others include:

•  BIO member Genentech said it is planning to invest $2 billion in its first East Coast manufacturing facility in Holly Springs, NC.
• BIO member Novartis said in November it will build a flagship manufacturing hub in North Carolina, which will create an additional 700 jobs.
• AbbVie announced plans for a $1.4 billion manufacturing facility in North Carolina in April.

“North Carolina’s biotech sector is rooted in a long tradition of innovation, and its momentum continues to grow,” Crowley observed.

The post BIO on the American Road visits pioneering NC biotech hub appeared first on Bio.News.

Tariffs of up to 100% on patented pharmaceuticals and their ingredients that went into effect Sept. 29 are expected to increase costs for innovators, discourage drug development and investment, and potentially reduce patient access to drugs they need. They also weaken U.S. competitiveness at a time when China is seeking to replace America as the world leader in biotech, experts say.

Meanwhile, the lack of information on how to comply with the Administration’s guidance on tariff implementation is creating chaos that complicates day-to-day operations of drug makers, according to the biotech industry. Innovators of all sizes have questions, ranging from types of patents that will be considered to the process and criteria for seeking an exemption to the tariffs.

“With these tariffs, the United States has reversed decades of sound trade policy, creating new uncertainty for biotech innovators, and increasing the burden on the small- and mid-sized companies responsible for many of tomorrow’s breakthrough medicines,” according to a statement from the Biotechnology Innovation Organization (BIO).

As BIO research shows, small- to medium-sized biotechs are responsible for 71% of the industry’s output and 54% of the new drug applications. The smaller innovative companies generally have less available capital to adjust to shocks like tariffs or to take moves that could reduce the tariff burden, experts noted.

The tariffs are being implemented after a Department of Commerce Section 232 investigation determined that global supply chains are risky, and concluded that onshoring drug production bolsters national security. Yet, experts argue that the additional obstacles to global networks posed by the tariffs will weaken the supply chain and reduce our access to medicines we need.

Companies that agree to move their production to the U.S. can apply for reductions in tariffs, but this relief is out of reach for most small biotechs, which must outsource all of their production. Suddenly shifting their complex manufacturing processes from overseas contractors may be impossible, says Marta Wosińska, a senior fellow at the Brookings Institution, according to Axios.

These smaller firms also generally lack in-house capacity to adjust to new tariff reporting burdens for compliance, experts say.

Insufficient guidance

But even those firms seeking to comply do not have adequate guidance to do so, experts say.

As Bio.News reported on Sept. 14, with two weeks until implementation, much of the necessary federal guidance was still missing, including information on how to qualify for exemptions based on the type of drug being imported, the country of origin, and engagement in Most Favored Nation (MFN) pricing agreements or onshoring commitments.

On Sept. 23, days before the tariff went into effect, the Department of Commerce did issue new guidance, but “its guidance has created more confusion,” according to a Sept. 27 Wall Street Journal editorial.

“Biotech companies will have to apply for exemptions for each individual product, regardless of whether it meets one of the specified categories, and explain ‘why the import meets an urgent U.S. health need.’ Urgent will be in the eyes of the bureaucrats who rarely act with urgency,” says the editorial.

Indeed, the Commerce Department’s guidance does not seem to offer hard, fast rules on the definition of “urgent U.S. health need”, nor provide clarity on the criteria that Commerce will use to make case-by-case determinations.

“The rationale can include information such as the type of disease the product treats and an assessment of alternative therapies or lack of alternative therapies for the type of disease the product treats, the number of U.S. patients that use the product, and whether or not the product is available in other jurisdictions,” the Commerce department’s guidance says. While the guidance notes. “Commerce will make an individual, fact-specific, company-specific decision for each request.”

There is no set time frame for these decisions, and companies still don’t know if those that are ultimately granted exemptions will have to pay full tariffs first and ask for refunds later.

The challenge to competition

Experts expressed concerns that both tariffs and the cost of compliance will eat away at funding that could be used for research, harming America’s competitiveness and the future of innovative therapies for the American people.

“One small company says tariff compliance could consume 2% to 4% of its working capital before it commercializes its first medicine,” says The Wall Street Journal’s editorial. “That means less money for research. It’s hard enough developing a new drug. Tariffs add more uncertainty that will discourage investment in U.S. biotech.”

While the justification given for the tariffs is strengthening national security, experts worry that by harming America’s ability to invest in biotech research, it will have the opposite effect.

“At a time when the United States should strengthen its biotechnology leadership to compete aggressively with China, these tariffs move us in the wrong direction,” says BIO’s statement.

The post Tariffs’ drag on innovation compounded by lack of guidance, experts say appeared first on Bio.News.

Fixderma has grown from its 2010 launch into a company exporting to over 35 countries with a 130-plus product portfolio. Looking back, which single decision or pivot do you think had the biggest impact on that trajectory?

I don’t think there is one single decision in business that brings a larger impact on the overall performance of a company. It is a cumulative effect of many decisions, including wrong decisions, decisions taken at the right time and some decisions that you did not take at the right time.

If I look back, I think it was the persistence and resilience to keep going. That is why we are here today. For a company like ours, particularly in such a competitive category, continuing to move forward is not easy.

When we started, we were not an online or D2C company. We were a pure-play business selling through dermatologists. That was one of the more difficult routes to take, but we stayed with it. So, putting it in one line, it is difficult to point to one decision. It has been a collective and cumulative effect of several decisions over the years.

You’ve positioned FCL as a premium range alongside the core Fixderma brand. What was the strategic thinking behind running two brand identities rather than just expanding one?

I saw a need for a premium skincare range that was completely dedicated to specific skin problems. We are taking baby steps towards that.

FCL Skincare was launched about 10 years ago by Dr Raj to give dermatologists and aware users products with a strong focus on ingredients. Even the names of the products reflect this approach. Eye Refining Matrix is our under-eye cream, Intensive Eye Serum contains peptides, and we have a Skin Brightening Complex. We have also recently launched a Exosomes range that penetrates 20X deeper into the skin & Neck Firming Cream.

The formulations are quite complex, with multiple ingredients being used for specific purposes. So, the idea was to create a range that is focused on the problem, the formulation and the quality of ingredients.

The line between cosmetic and pharmaceutical skincare has been getting blurrier, with the rise of what’s now called the dermaceutical or cosmeceutical category. How do you see this segment evolving over the next five years, and what’s driving that shift?

We have seen a significant shift in the last two to three years. Users have become much more aware of ingredients and what they are putting on their skin.

Earlier, people were following different spokespeople and recommendations about what they should use. Now there is greater awareness about what ingredients are actually doing and whether using too many actives could affect the skin barrier.

I think this has created an opportunity for brands that are ingredient-focused and have the right documentation to support the claims they make. Consumers are becoming more informed, and they are looking for products where there is a clear connection between the ingredients, the formulation and the claims.

India’s cosmeceutical exports have grown steadily, but so has competition from established global skincare majors. What do Indian dermaceutical companies need to get right to compete internationally rather than just domestically?

I think the key is to understand the market and develop products accordingly. Indian skin, climate and lifestyle have their own characteristics, and these factors need to be considered while developing formulations.

We are a very diverse population, and skin characteristics can vary across populations. Climate and daily routines also influence how products perform. So formulations cannot simply be developed by looking at what works in another country and assuming the same approach will work in India or other markets.

At the same time, Indian companies need to have strong R&D capabilities and be able to build formulations around a clear understanding of the consumer and the market.

Skincare innovation has increasingly leaned on newer actives and delivery technologies, from peptides to encapsulation methods. In your view, is the Indian dermaceutical industry keeping pace with that R&D curve, or is it still largely dependent on formulations developed elsewhere?

There has to be a strong R&D curve, particularly when you are developing products for Indian skin and Indian conditions.

For us, the focus has been on formulations and ingredients rather than simply creating products around marketing claims. Some of our formulations are quite complex and use multiple ingredients for specific purposes.

I think understanding the ingredient, the formulation and how it works for the intended skin concern is important. The industry needs to keep building that capability rather than simply replicating what is being developed elsewhere.

Regulatory frameworks for cosmeceuticals in India sit somewhere between cosmetics and drugs, and enforcement can be inconsistent. What changes, if any, would you like to see in how this category is regulated?

I would simply say: be honest with your combinations and your claims.

There are products in the market where brands make claims around specific concentrations of ingredients. For example, they may claim three per cent Redensyl or two per cent Capixyl.

These are meaningful ingredients, but when such products are being sold at a very low price while making claims that suggest a particular level of active ingredients, consumers have a right to question whether those claims are realistic.

We cannot expect to get everything at an extremely low price and still assume that the formulation contains the claimed ingredients and concentrations. Something is wrong somewhere.

I think the industry needs greater honesty and transparency in how products are formulated, what they contain and what claims are made about them.

The post The changing face of dermaceutical skincare appeared first on Express Pharma.

Aesthetic treatments were generally used for correction purposes until recently. The usual practice was to smooth out wrinkles, lessen pigmentation, resurface scars, and treat hair loss. All these things have changed as a new approach in this field has developed.

This innovative method moves further than just improving the appearance of skin and hair. It deals with supporting the body’s self-regeneration process. The new approach is called regenerative aesthetics, which combines different fields such as dermatology, the hair restoration industry, modern technology, and regenerative medicine.

The main objective is more than just changing somebody’s looks. The point lies in assisting the skin in becoming healthier, the scalp in functioning better, and the process of hair restoration being as natural as possible.

What is regenerative aesthetics?

Regenerative aesthetics refers to methods that stimulate the body’s own natural systems responsible for healing, forming collagen and carrying out their activity at the cellular level. Unlike conventional aesthetic treatments that deal with outer correction only, regenerative aesthetics focuses more on the body’s biological processes occurring in the skin, hair follicles and the surrounding tissues.

This trend is especially pertinent to individuals suffering from hair loss, the first signs of ageing, acne scars, skin unevenness, pigmentation and loss of skin elasticity.

The principle is pretty simple: healthy-looking skin and hair cannot be only a result of surface preservation; a lot depends on what happens beneath the skin surface. Therefore, not only does the modern cosmetic industry intend to focus on one specific aspect while treating patients, but it is constantly combining various procedures, which allows certain positive outcomes.

From surface correction to skin renewal

Take skin that’s ageing. It may have fine wrinkles on the surface, but what really occurs is a drop in collagen and elastin levels, skin structure modification and lagging regeneration.

Treatments that aim for regeneration are different in focus from the preceding techniques. Microneedling, RF microneedling, skin boosters and particular injectable or energy forms can help with a tailored regeneration programme.

Microneedling, for instance, produces small injuries that cause the skin to heal itself. RF microneedling enhances the procedure by using the energy of radio frequencies to solve the problems of skin firmness due to thermal stimulation.

The aim is not to change the person’s face. Rather, the requirement that is expected from the process is a gentler result: good texture, enhanced firmness and a younger appearance.

Regenerative approaches in hair restoration

In terms of hair loss, regenerative aesthetics is making its way into the limelight. Hair thinning can be caused by several factors. Genetic factors, hormonal changes, lack of nutrition, stress and some medical reasons can all be involved in hair loss. This tells us that treatment should start by addressing the cause of hair loss rather than choosing treatment based on its popularity.

Modern hair restoration has many advanced techniques, including GFC hair therapy, exosome therapy, autologous micrograft treatment, and other procedures that can support hair growth. However, effectiveness will depend on the reason or severity of hair loss.

In the most severe hair loss cases, regenerative types of methods will be examined together with surgical methods of hair restoration. For instance, FUE hair transplant is aimed at transferring healthy follicles to the bald area and creating a natural hairline. The trend nowadays is that combinations of therapies are used. That is, a person may use an approach for the scalp and another approach for the hairline, and later on, the strategy may be altered over time.

Why personalisation matters

There is no one-size-fits-all remedy for aged skin or hair thinning. Two people who visit the same clinic may have similar problems but will require two completely different treatment plans. While one patient may suffer from pigmentation and texture issues, the other may need help with collagen loss. Likewise, while one hair thinning case could be attributed to hereditary reasons, another one may be due to a temporary shedding cycle or a disease. This is why it is so important to have a consultation. An aesthetic-regenerative treatment plan must take into consideration one’s age, skin type, medical history, and lifestyle, as well as the condition to be treated and the person’s expectations. That is why it is the problem that should determine the treatment options rather than the other way around. This is how aesthetic medicine remains a part of healthcare.

Combining technology with medical expertise

Regenerative aesthetics does not refer to a single revolutionary treatment. Rather, it refers to the practice of combining different practices and technologies smartly. For skin treatments, different methods might include peels, laser procedures, RF microneedling, skin boosters, resurfacing treatments, and other rejuvenation therapies. For hair treatments, regenerative options might include non-surgical methods of hair growth and hair transplant techniques. The actual needs of the skin or hair will determine which treatments will be applied. This is why modern aesthetic clinics employ a wider range of practitioners. Dermatologists, aesthetic physicians, plastic surgeons and other specialists are involved in the treatment process if the problem requires both medical and cosmetic approaches.

Natural results are becoming the new definition of beauty

The ongoing shift in aesthetics brings about the idea of simplicity in beauty techniques. More and more people prefer looking natural and not twisted or artificially done. For those who face problems of hair loss, they expect their hairline to suit their face and not make them look transplanted.

The practice of regenerative aesthetics totally embodies the above-mentioned trends. It suggests that instead of just altering tissue structures, work on improving tissue quality is undertaken.

In sum, aesthetics goes from the question “What can we change?” to the question “How can we help skin and hair to look and function better?”

The future of skin and hair care

Regenerative aesthetics is still an evolving field. Not every treatment marketed as regenerative has the same level of scientific evidence, and outcomes can differ considerably between individuals. Claims surrounding newer therapies should therefore be considered carefully, with attention to clinical evidence, regulatory status, practitioner qualifications and realistic expectations.

For patients, this means asking questions matters. What exactly is being used? What evidence supports the treatment? Is it appropriate for the specific condition? How many sessions may be required? What are the risks and alternatives?

The future of aesthetics is unlikely to be about choosing between beauty and medicine. It is increasingly about bringing the two together.

Skin health, hair health and appearance are deeply connected. As regenerative approaches continue to develop, aesthetic care is moving toward a more personalised model, where prevention, restoration and appearance can be considered as parts of the same conversation.

The new frontier is therefore not simply about looking younger or growing more hair. It is about healthier-looking skin, stronger approaches to hair restoration and results that respect the person underneath.

That may ultimately be the most meaningful promise of regenerative aesthetics: not changing who you are, but helping your skin and hair look closer to their healthiest potential.

The post Regenerative aesthetics: The new frontier of skin and hair health appeared first on Express Pharma.

Aurigene has announced plans to invest around $100 million. What are the key areas where this investment will be deployed, and where do you expect it to have the greatest impact on the company’s growth and capabilities?

The investment is aimed at the areas where we see the most customer demand and where the industry has the least capacity: 

• Peptide research and manufacturing
• Capacity expansion for our core platforms
• Digital and AI platforms
• Biologics infrastructure

The impact will be greatest where these areas connect, for example peptides and biologics that move from our discovery labs into development and manufacturing without a tech-transfer gap. The aim is to take on larger, more complex programmes and support them through to commercial supply.

Aurigene, together with its parent company Dr Reddy’s, recently signed a long-term agreement with a leading global pharmaceutical company for technology transfer and commercial drug-product manufacturing and supply of a diversified portfolio. How significant is this agreement for Aurigene, and are you seeing similar interest from other pharmaceutical and biotech companies?

This is one of the most important agreements in Aurigene’s journey. It is a 10-year master agreement covering technology transfer and commercial manufacturing of products across sterile injectables, biologics and topicals. The products will be made across five Aurigene / Dr Reddy’s sites in India, with revenue expected from calendar year 2028 . It gives us long-term visibility, and it shows that a global innovator trusts our drug-product capabilities, particularly in sterile injectables and biologics.

We are seeing growing interest of the same kind. Large pharma companies are cutting down their external manufacturing networks and moving from product-by-product outsourcing to fewer, strategic partners. That trend suits an integrated player like us. We already have multi-year commercial contracts with three of the top five innovator pharma companies. We are in active discussions with several global pharma and biotech companies. We will share more when those agreements are signed.

How is Aurigene leveraging AI and other emerging technologies across the drug discovery process—from target identification and validation to molecule design, optimisation and candidate selection?

AI is built into how we run discovery. Aurigene.AI combines generative design, predictive modelling and computational chemistry, and it is directly integrated with our wet chemistry and biology labs. The models suggest molecules; our chemists make and test them quickly.

 This lets us run our integrated drug discovery (IDD) programmes more efficiently: we need fewer cycles, make better choices about which compounds to synthesise, and reach candidates faster. All programme data is used only for that programme and that customer.  A good example is our collaboration with Alveus Therapeutics, a biotech company developing next-generation therapies for obesity and metabolic disease. We combined Aurigene.AI with our medicinal chemistry and integrated biology platforms to support their discovery programmes. Together, we nominated ALV-200, a highly selective AMYR3 peptide candidate, as the first development candidate. Other discovery programmes under the collaboration are still ongoing. Across our integrated discovery work, we have delivered

around 75 projects, and six are now in the clinic.

What are the biggest challenges currently facing the drug discovery and development ecosystem, from target identification and validation to clinical development, and how is Aurigene addressing these challenges?

First, capital efficiency. Biotech funding has become more selective, and innovators have to show more data with less money and in less time. Every experiment and every month has to count. This is where India has a real advantage. We have a large pool of experienced chemists and biologists, and the cost of running discovery and development here is competitive. At Aurigene, we combine that talent with Aurigene.AI and our integrated wet

labs. Partners get more work done for every dollar they spend, and they reach decision points sooner.

Second, supply-chain risk. Recent years have shown the danger of relying too much on a few countries or single suppliers. Innovators are now reviewing where their molecules are developed and made, and they want partners they can trust over the long term. India is increasingly the natural choice. We add to that with R&D in India and the UK and manufacturing in India, the UK and Mexico, so we can offer customers geographic flexibility

and supply security.

Third, quality and trust at scale. Indian CDMOs have often had to prove that they can deliver innovator-grade quality, not only cost advantage. Our track record answers that. We have 16 USFDA-inspected facilities and have taken 20 NCEs to commercialisation.

Across all three, our answer is integration. Discovery, development and manufacturing sit under one roof, so innovators avoid the delays and risks of moving a programme between vendors. For our partners, that means lower cost, less risk and faster timelines, delivered from Aurigene to global standards.

Which therapeutic areas have the strongest demand?

CNS, oncology, immunology and metabolic disorders remain our strongest areas. Metabolic disease, especially obesity, has grown sharply, and it is pushing demand for both peptides and small molecules. Our discovery collaboration with Alveus Therapeutics is a good example. Working together, we nominated ALV-200, a selective AMYR3 peptide candidate for metabolic disorders. We also see strong growth in targeted therapies and in modalities

such as bispecifics, peptide conjugates and complex injectables. In these areas, customers need a partner that can handle both the science and the scale-up Q3. Use of AI and emerging technologies AI is built into how we run discovery. Aurigene.AI combines generative design, predictive modelling and computational chemistry, and it is directly integrated with our wet chemistry and biology labs. The models suggest molecules; our chemists make and test them quickly.

This lets us run our integrated drug discovery (IDD) programmes more efficiently: we need fewer cycles, make better choices about which compounds to synthesise, and reach candidates faster. All programme data is used only for that programme and that customer.  

A good example is our collaboration with Alveus Therapeutics, a biotech company developing next-generation therapies for obesity and metabolic disease. We combined Aurigene.AI with our medicinal chemistry and integrated biology platforms to support their discovery programmes. Together, we nominated ALV-200, a highly selective AMYR3 peptide candidate, as the first development candidate. Other discovery programmes under the collaboration are still ongoing. Across our integrated discovery work, we have delivered around 75 projects, and six are now in the clinic.

What will be your key priorities over the next three to five years?

We aim to be a truly integrated partner across modalities, taking a programme from discovery through development to commercial supply. We have taken 20 NCEs through to commercialisation and have 4 R&D centres with 16 USFDA-inspected facilities. We work across small molecules, peptides and biologics, and our next priority is to scale this integration. Our global presence is a big part of this, especially in today’s complex and fast-

changing geopolitical environment. We have R&D centres in India and the UK, and manufacturing in India, the UK and Mexico. This gives our partners geographic flexibility and supply security.

Over the next three to five years, we will focus on:

• Converting our relationships with large pharma into long-term, multi-product/platforms partnerships
• Building a full stack peptide CRDMO
• Scaling AI-led integrated drug discovery
• Expanding into newer modalities such as ADC, biologics and complex drug products

Sanjiv.das@expressindia.com

sanjivdas1@gmail.com

The post We aim to be a truly integrated partner across modalities appeared first on Express Pharma.

CERVAVAC, India’s first indigenously developed gender-neutral Quadrivalent Human Papillomavirus vaccine (qHPV) developed by Serum Institute of India, has received prequalification by the World Health Organization (WHO).

This is the 32nd WHO prequalification for products/biologicals received by Serum Institute of India. Inclusion on the WHO List of Prequalified Vaccines allows CERVAVAC to be procured by United Nations agencies.

The recombinant quadrivalent HPV vaccine targets HPV types 6, 11, 16 and 18. It is indicated for girls and boys aged 9 through 26 years.

Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said, “WHO prequalification of CERVAVAC is an important step in strengthening the global response to HPV. This milestone reflects the effectiveness of the vaccine and creates the opportunity for countries to prevent HPV-related risks. We are pleased to see this indigenously developed vaccine reach this achievement, and look forward to contributing to immunisation coverage, advancing global healthcare”

CERVAVAC was previously approved for use in India by the Drugs Controller General of India (DCGI). It is administered for the prevention of diseases caused by the four HPV types.

This includes the prevention of anal cancer in boys and young men, and cervical, vulvar, vaginal, and anal cancers in girls and young women. It is also indicated for preventing genital warts, as applicable to the indicated population.

The post CERVAVAC receives WHO prequalification appeared first on Express Pharma.

“We all believe that there is a shared risk factor of aging for many, many chronic diseases. But to me, it’s interesting: Is there a way of beginning to start quantifying that, really working a lot on the biological side but also on the clinical side, what that looks like?” FDA Chief Scientist Steven Kozlowski, MD, told attendees at the 13^th Aging Research & Drug Discovery Meeting (ARDD 2026), held at the David Rubinstein Treehouse at Harvard University.

Kozlowski said the updated FARS would come out early in FY 2027 but offered no further specifics on timing.

“It would be really good to have a shared endpoint [that was] pre-competitive, qualified, and shared broadly so that everybody can use that can serve as a bridge,” Kozlowski elaborated. “Attributes of that endpoint would be regulatory acceptance, right? You buy into that endpoint and it’s really useful, that it allows feasible clinical trial designs that it’s worth doing, that it serves as a standard for all the other novel things that come after it, and that to some extent helps with accessibility [to other researchers].”

Kozlowski spoke during “Matching Clinical Trials of Therapeutics & Regulatory Mandates,” a panel of four current FDA officials.

“Steve and his team have been working really hard to develop these key areas where I’ve been speaking to all of our stakeholders where there is a need for more regulatory science,” said Lowell M. Zeta, JD, Acting Chief of Staff in the FDA’s Office of the Commissioner. “To the extent that we can be and should be evolving our programs to help you all solve the challenges, that’s what we want to hear.”

Zeta called longevity and healthspan—the number of years a person lives free from long-term disease or disability—“an important topic for the agency and HHS [U.S. Department of Health and Human Services].

‘A defining moment’

“It’s really a defining moment, an inflection point for the future,” Zeta added. “It’s a test for the future of FDA and how to adapt to the rapidly evolving science in this space.”

Zeta was the highest ranking FDA official on the panel, which included Justin Penzenstadler, PharmD, acting associate director of the FDA’s Office of Cardiology, Hematology, Endocrinology, and Nephrology; and Jeffrey Siegel, MD, director of the FDA’s Office of Drug Evaluation Sciences.

Panel moderator was Andrew Brack, PhD, program manager, proactive health with ARPA-H. Brack oversees PROSPR (PROactive Solutions for Prolonging Resilience), a $144 million research initiative designed to extend American healthspan by redefining how aging and functional decline are measured and treated.

Brack began the panel session by asking a question to the four FDA officials: What do you see as the most realistic regulatory path to date response of trying to develop a therapy that targets aging biology rather than a single disease?

Siegel replied that aging could be considered for approval of new therapies in two ways. One is taking into account that aging increases the prevalence of numerous chronic diseases, including types of cancer, Parkinson’s disease, Alzheimer’s disease, and cardiovascular disease.

“Once you get to two or three that the same mechanism impacts, you begin to think that maybe this general mechanism is having an effect overall on aging-related disorders. And maybe you would be able to generalize from that,” Siegel said

Impact on people

But there is another approach, Siegel continued, which entails looking at the ways that aging impacts people, such as increasing the risks of cognitive decline and frailty, and causes loss of senses such as hearing and vision.

“If you have a way to evaluate those general aspects of aging, and you can define a patient population who’s subject to that aging-related deterioration, then you have to make use of a clinical trial that could demonstrate an effect on aging more broadly,” he explained.

The trial would need to measure aging-related domains, showing that the progression of these domains is less in treated patients than in an untreated control group, Siegel said: “That would be an indication that this is impacting the way that patients function and feel and survive, and potentially could be a way towards demonstrating efficacy for a drug impacting aging.”

Basic science research in recent decades has identified general mechanisms that underlie the aging process. Experimental models blocking some of these mechanisms has been demonstrated to increase lifespan, sometimes by as much as 30%, Siegel explained.

‘Amazing implications’

Some newer studies, he added, have suggested that treatments that block these aging processes could potentially reverse aging.

“If this can be applied in therapeutics for people, this has amazing implications, potentially increasing lifespan, but also decreasing the adverse effects that aging has on people, including aging-related diseases.”

Officials and researchers have long ascribed economic as well as health benefits to lengthening healthspans: An economic analysis published in 2021 concluded that a slowdown in aging that increased life expectancy by one year would generate $38 trillion in economic gains—a figure that ballooned to $367 trillion for 10 years of increased life expectancy.

Siegel said earlier trials will look at prevention of age-related comorbidities or mortality as an endpoint, but will also collect measures of clinical outcome assessments. He cited drug development history: The first trial of insulin evaluated a single patient—a 14-year-old boy with type 1 diabetes—using a single endpoint, mortality.

“I see geroscience following a similar arc, where you start with enriched patients, you’re looking at the hard endpoints, right? And then as the field, the body of evidence builds, you’ll be able to say, hey, here’s some measures that track with mortality. And maybe we ought not run trials as long,” Penzenstadler said. “You might be able to start validating some other endpoints or biomarkers that predict mortality, and that could shorten your trials.”

The FARS focus on aging and longevity sparked a question from a panelist in the panel that followed.

“Let’s say aging will be designated as a disease, how do we define it? And suddenly we come to a decade-long question, what is aging?” asked Steve Horvath, PhD, professor, human genetics and biostatistics at University of California, Los Angeles (UCLA).

Huge progress

“I would say we’ve made huge progress in defining that. And in short, it’s complicated, but you will not—in my opinion, you will not be able to get there unless you also have molecular biomarkers of aging,” Horvath asserted. “Assessing function in 10 different ways and disease indication, that’s really easy and very well defined. But what can we, the scientists in the field, contribute to physiologic markers, molecular markers of aging, so that they can be folded into future clinical trials that target aging per se?”

The 2022 FARS report—completed within the tenure of then-FDA commissioner Robert M. Califf, MD, who served under Democratic presidents Joe Biden and Barack Obama—was written with the COVID-19 pandemic still fresh in recent memory. That explains why the first priority highlighted by that report was “Public Health Preparedness and Response.” Also identified were:

• Increasing Choice and Competition through Innovation.
• Understanding the Power of Data.
• Empowering Patients and Consumers.

The terms “aging research” and “longevity medicine” do not appear in the 2022 FARS.

According to the FDA, a key purpose of FARS reports is to communicate the importance and impact of its ongoing regulatory science research activities that cut across its numerous centers, offices, and laboratories. The FDA defines regulatory science as the science of developing tools, standards and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

The FDA is now helmed by Acting Commissioner Kyle Diamantas, JD, who previously served as the agency’s deputy commissioner for food. President Donald Trump has nominated Heidi N. Overton, MD, PhD, as permanent commissioner. Overton’s nomination has yet to be voted by the U.S. Senate, whose Committee on Health, Education, Labor, and Pensions heard testimony from her on September 24.

Urging disease prevention

Before the FDA panel Admiral Brian Christine, MD, HHS assistant secretary for health, urged longevity drug developers and researchers to focus on modifying biological processes associated with aging over time and intervening to prevent disease before it occurs, rather than managing illness once someone gets sick.

Christine—who was appointed by President Donald Trump, confirmed by the U.S. Senate, and serves under HHS Secretary Robert F. Kennedy Jr.—aligned the push toward longevity medicine articulated by panelists at ARDD 2026 with Kennedy’s “Make America Healthy Again” (MAHA) policy framework. Kennedy has led an overhaul of federal policy on nutrition and disease prevention including vaccination schedules, prompting backlash from medical groups and researchers. David Robert Grimes, PhD, a professor of biostatistics at Trinity College Dublin and advocate, last year characterized MAHA as a movement that “thrives on science denialism.”

Not so, according to Christine.

“At its core, our MAHA movement is about confronting chronic disease,” Christine contended. “It begins with a very simple question, deceptively simple: Why are so many Americans sick, and what are we willing to do differently about it?”

“For decades, we have too often responded to chronic disease one condition at a time, and frequently, unfortunately, measure the rate and course of the disease,” said Christine, who also leads the U.S. Public Health Service Commissioned Corps, which consists of about 5,300 public health professionals. “Good science must be willing to ask questions even when the answers challenge longstanding assumptions. That matters enormously in healthy aging because patients are already moving faster than many traditional institutions.”

He cited as examples growing interest by women in menopausal hormone replacement therapy, by men in testosterone replacement therapy, and by both in improving their health through peptides, dietary supplements, continuous glucose monitors, wearables, biological AIDS tests, and emerging diagnostic technologies.

“Increasingly, people are learning about these interventions from podcasts, from social media, from wellness clinics, and direct to consumer companies before they ever walk into a physician’s or a nurse’s office,” Christine said.

Christine and the FDA officials spoke during ARDD 2026’s initial series of sessions. Before they spoke, George Q. Daley, MD, PhD, dean of Harvard Medical School, opened the conference with a plea for caution when it comes to promoting the benefits of drugs designed to fight the effects of aging.

“I’m concerned that the optimistic claims being made by some in the aging community far exceed what one can responsibly conclude from our current understanding of the biology,” Daley told ARDD 2026 attendees. “I implore you all to listen attentively to the many compelling presentations scheduled over the next few days, but also skeptically and critically, so that we will emerge with a greater respect for the science, but proper restraint in forward-looking claims of life extension.”

The post FDA to Highlight Aging, Longevity Medicine in Planned FARS Updates appeared first on GEN - Genetic Engineering and Biotechnology News.

Scientists exposed mice to a predator odor after giving them a placebo or a cannabinoid drug. Animals given the cannabinoid froze more and spent less time investigating the odor. Using small microscopes, scientists identified neurons activated by the drug that helped drive anxious behaviors. When those neurons were silenced the cannabinoid no longer triggered the same level of anxious behaviors.

The findings could help scientists better understand how cannabis exerts its psychoactive effects, and potentially point to strategies for holding back anxiety in affected individuals. The results could provide insights into strategies for reducing anxiety symptoms in other contexts, outside of cannabis use.

“The results of this study could explain why a good trip can turn bad pretty quickly if people consume too much cannabis or the situation they are in turns stressful or scary,” said Sachin Patel, MD, PhD, chair of psychiatry and behavioral sciences at Northwestern University Feinberg School of Medicine.

Patel is senior and corresponding author of the team’s published paper in Nature Communications, titled “Cannabinoid modulation of central amygdala population dynamics during threat investigation.” In their paper the team concluded that their results “… could ultimately provide important insights into how cannabinoids augment threat reactivity and the interactions between cannabis use and anxiety disorders.”

Plant-derived cannabinoids are widely used for medicinal and recreational purposes, and exert broad-ranging behavioral and physiological effects on mood, anxiety, memory, appetite, and sleep, the authors noted. But they can also precipitate anxiety and panic reactions in people, and increase threat-related defensive responses in rodents. “Specifically, while tension and anxiety relief represent major reasons for cannabis use, paradoxical dose- and context-dependent increases in anxiety and panic are also well-documented, and some studies have suggested associations between cannabis use and the development and worsening of anxiety disorders, especially in heavy cannabis users.” However, they continued, Despite well-established research findings, “… how cannabinoids affect in vivo neural dynamics associated with threat-related behavior has not been examined.”

For their newly reported study the scientists exposed mice to a threatening odor. Before being exposed to the scent, derived from fox urine, the mice either received a placebo or a synthetic cannabinoid drug. Patel and colleagues tested several doses of the synthetic cannabinoid on mice and tracked how much time they spent near the predator odor, and whether they froze or fled from the scent.

To simultaneously record brain activity, the team implanted a small microscope into the mice’s brain. The results showed that mice receiving the cannabinoid drug froze more often and spent less time investigating the predator odor. These anxious behaviors were linked to the drug’s activation of a small group of somatostatin neurons (SOM) in the brain’s central amygdala (CeA), a region that processes fear and stress.

Importantly, when the scientists genetically silenced the somatostatin neurons, mice given the cannabinoid drug did not avoid the predator scent as much. The researchers also conducted brain tissue experiments to analyze how the cannabinoids affected interactions between neurons. They found that the drug weakened the brain’s natural “brake” on the somatostatin neurons, allowing them to become more active. “Our data suggest suppression of GABA release from local afferents onto CeA SOM neurons underlies cannabinoid effects on CeA SOM neurons,” they wrote.

“Higher doses of cannabinoids and environmental stress worked together to synergistically release the ‘brake’ on the central amygdala, which in turn drove excessive anxiety,” Patel noted. “Understanding how cannabis affects brain function to generate its psychoactive effects could ultimately reveal new ways to counteract negative consequences should they arise in some people,” Patel said, also noting that the findings could have implications beyond cannabis. “Suppressing the activity of somatostatin neurons in the central amygdala could represent a final pathway for reducing anxiety symptoms, not just in the context of cannabis side effects,” he explained.

Cannabis use in the U.S. has steadily increased in recent years and so have emergency department visits related to adverse effects from the drug. Previous studies have also found an association between cannabis use and increased risk of anxiety in the long term. What’s more, anxiety and mood disorders are also on the rise globally.

Commenting that their newly reported data begin to shed light on neural mechanisms subserving the “dark-side” adverse effects of cannabinoids, the authors concluded, “… we suggest cannabinoids could trigger context-dependent adverse anxiety and panic reactions, in part, via activation of CeA-related circuits and that cannabis-induced long-term adaptations in these circuits could contribute to observed associations between cannabis use and anxiety disorders.”

The post Neurons Involved in Generating Anxiety After Cannabinoid Drug Exposure Identified in Mice appeared first on GEN - Genetic Engineering and Biotechnology News.

But the tool that delivered it matters just as much: an upconverting nanoparticle (UCNP) probe, doped with heavy rare earth elements, that simply doesn’t photobleach.

In one corner of Sam Peng’s lab, the imaging rig looks almost improvised. Cameras, lenses, and lasers are bolted directly onto a metal breadboard, like an enormous sheet of Legos built by hand rather than bought off a shelf.

Peng’s team engineered UCNPs doped with ytterbium, erbium, and thulium to track EGFR, HER2, and HER3 at the single-molecule level on live cells simultaneously, in three colors. The new imaging platform holds 100-millisecond resolution and runs for over 16 minutes straight. Conventional dyes lose signal within seconds. These UCNP probes do not photobleach.

Peng compares short-duration imaging to eavesdropping on a conversation that gets cut short: “If you’re trying to understand a conversation between two people… if all of a sudden I just cut off this conversation, then you have to guess my answer based on our previous two-minute interaction, which is often impossible to do.”

The real advantage isn’t a fixed window. Peng said the probe can run for hours. His team stopped at 16 minutes because they’d already captured the long EGFR homodimers they were after.

HER3’s stable pairing

The surprising finding was the unexpected stability of HER3 homodimers and the effects of cancer-associated mutations on these pairings.

“The first time we saw HER3 homodimers, we were really puzzled,” Peng told GEN. “We thought that maybe this was some experimental artifact.”

HER3’s kinase domain is too weak to signal on its own, so the prevailing model treated it as a heterodimer partner—something that pairs with other receptors. This does not rule out its forming homodimers. Peng’s team expected HER3 to serve as a negative control for dimer detection. It should have come back empty.

The team reran the experiment with different labels and probes. The result held every time: wild-type HER3 homodimers proved remarkably stable, far outlasting unstimulated EGFR homodimers.

The group’s working model is that these homodimers form a signaling-inactive pool. In this model, they sequester HER3, limiting its availability to pair with other receptors and trigger cancer signaling.

Cancer mutations support the model, but EGFR and HER3 moved in opposite directions. Mutations like the exon-19 deletion make EGFR homodimers more stable, driving signaling that tracks with clinical aggressiveness. The more stable the dimer, Peng said, the more signaling it triggers. The HER3 mutations studied do the opposite, destabilizing the homodimer, potentially freeing HER3 to form signaling-active heterodimers.

HER2 rounds out a third pattern. The HER2 mutations studied only modestly enhance the stability of its homodimers. That tracks with the clinic: HER2 cancers are typically driven by gene amplification.

Sourcing the materials 

Ytterbium and erbium are heavy rare earth elements. Unlike light rare earth elements such as neodymium, mined at industrial scale for electric vehicle (EV) motors and consumer electronics, heavy rare earth elements are produced in far smaller volumes, for a narrow set of high-performance uses where few substitutes exist. Peng’s imaging platform is one of them.

The supply chain for these materials is highly concentrated. China dominates global rare-earth separation and refining, and its share of the heavy subset is larger still. According to Benchmark Mineral Intelligence, China controlled 85% of total rare earth oxide production in 2025, including an estimated 99% of dysprosium oxide and terbium oxide. That concentration has shown up in prices for those magnet metals: in 2025, dysprosium oxide in North America on average cost 4.4 times the Chinese price.

China introduced export controls on seven rare earth elements in April 2025: samarium, gadolinium, terbium, dysprosium, lutetium, scandium, and yttrium. An October 2025 expansion added ytterbium, erbium, holmium, thulium, and europium, including the elements used in Peng’s probes. That expansion is currently suspended under a U.S.–China trade truce.

At bench scale, Peng’s lab works in milligrams to grams, small enough that global supply pressure doesn’t immediately register. His lab buys rare earth salts in vials from a U.S. distributor. “They come in as a form of powder, like salt, just like your kitchen salt,” he said. Erbium salts arrive in pink. “Pretty beautiful,” he noted.

An expertise gap, not a supply gap

Heavy rare earth elements aren’t especially scarce in the earth’s crust. They’re just rarely found in concentrations worth mining—and separating them is difficult. While Peng’s lab doesn’t track where the material was mined, it likely comes from China.

Peng’s lab buys these salts the way other labs buy antibodies. Rare earth elements are used in TR-FRET, some forms of NIR-II imaging, mass cytometry, and UCNP tracking, although these methods use different elements and probe chemistries.

As Xi Jinping was recently in Washington for his first state visit in more than a decade, U.S. officials said the two sides had agreed to extend their trade truce, and with it the pause on China’s expanded rare earth controls, from November to January.

Currently, the bottleneck is expertise, not supply. Peng estimates roughly a dozen groups worldwide work at this intersection of UCNP imaging and single-molecule biology. It’s a small overlap, since the work demands nanomaterial chemistry, molecular labeling, advanced optics, and computation, all in one lab. “It’s the integration of this entire pipeline that makes it challenging,” Peng said.

The research of nanoparticle optics has lasted for years. For now, the rare earth salts are the easy part. The optics, and the people who can build them, are what’s scarce.

References

1. Broad Institute. Single-molecule tracker illuminates workings of cancer-related proteins. Broad Institute of MIT and Harvard. Published May 1, 2026. Accessed September 24, 2026. https://www.broadinstitute.org/news/single-molecule-tracker-illuminates-workings-cancer-related-proteins

2. Shida JF, Ma K, Toll HW, et al. Multicolor long-term single-particle tracking using 10 nm upconverting nanoparticles. Nano Lett. 2024;24(14):4194-4201. doi:10.1021/acs.nanolett.4c00207

3. Peng Lab, Broad Institute of MIT and Harvard. Accessed September 24, 2026. https://www.sampenglab.org/publications

4. Ingall G, Mukherjee N. Ex-China rare earths premium to grow, especially for heavies. Benchmark Mineral Intelligence. Published March 24, 2026. Accessed September 24, 2026. https://source.benchmarkminerals.com/article/ex-china-rare-earths-premium-to-grow-especially-for-heavies

5. Shalal A. US, China agree to extend trade truce by two months, work on bigger deal, Bessent says. Reuters. Published September 23, 2026. Accessed September 24, 2026. https://www.reuters.com/world/asia-pacific/us-treasurys-bessent-chinas-he-meet-unfinished-business-before-trump-xi-summit-2026-09-23/

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Chiorazzo will lead AP’s finance and accounting operations, working closely with leaders across the organization to strengthen project controls and forecasting while improving the financial information teams use to make business decisions.  

Chiorazzo brings more than 20 years of financial and operational leadership experience. She most recently served as CFO of Conti Federal, a federal construction and design-build company. Before joining Conti Federal, she was vice president of finance, shared services at PAE, where she supported finance processes for more than 15,000 employees and a $3 billion business portfolio.  

Throughout her career, Chiorazzo has strengthened project controls, improved working capital and modernized financial systems. She has also built reporting and forecasting processes that give operational leaders clearer insight into business performance.  

Chiorazzo is a certified public accountant and holds an MBA in finance from Drexel University. 

The post Carla Chiorazzo Named CFO at Adolfson & Peterson Construction appeared first on HCO News.

The post Carla Chiorazzo Named CFO at Adolfson & Peterson Construction appeared first on HCO News.

Verkada’s unified physical security platform combines video security, access control, alarms, intercoms, air quality sensors and visitor management through a cloud-based management platform. The system is designed to provide centralized visibility across multiple facilities, allowing users to manage devices, sites, users and security events through Verkada Command. Security cameras can provide video context for door and alarm events, while access control can be integrated with intrusion alarms and other security functions. Verkada’s alarm platform supports wired and wireless intrusion sensors, including door contacts, motion, panic and water-leak sensors and can pair sensors with cameras for video verification. The platform also supports remote management and configuration. For healthcare organizations operating multiple campuses or facilities, the approach provides a single interface for coordinating physical security systems.

The post Verkada Unified Physical Security Platform appeared first on HCO News.

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Southern Albertans are set to gain greater access to advanced diagnostic imaging and specialized treatments with the development of Calgary’s first cyclotron facility.

The Calgary Radiopharmaceutical Centre is being built at the Foothills Medical Centre and will house Calgary’s first cyclotron and Alberta’s third. The facility is intended to strengthen the supply of radiopharmaceuticals used in diagnostic imaging and treatments for cancer, cardiac and neurological conditions.

The project is supported by a combined $71-million investment from the Alberta government and donors. The province is providing $64 million over three years toward completion of the centre, while the Alberta Cancer Foundation is contributing an additional $7 million for specialized equipment and research laboratories, with support from donors.

Bringing production closer to patients

Cyclotrons produce radioactive isotopes that can be incorporated into radiopharmaceuticals used for medical imaging and treatment.

At present, Alberta’s two existing cyclotrons are located in Edmonton – one at the University of Alberta’s South Campus and another at the Cross Cancer Institute. The new Calgary facility will add capacity and provide a more local source of radiopharmaceuticals for patients in southern Alberta.

Location is particularly important because some radioisotopes decay quickly after they are produced. Producing them in Calgary rather than transporting all supplies from Edmonton is expected to reduce transportation time and strengthen the reliability of supply for southern Alberta.

The Calgary cyclotron is expected to produce isotopes including fluorine-18, carbon-11 and gallium-68. These can be used in diagnostic imaging, including PET and SPECT scans, to support the diagnosis and treatment of cancer as well as cardiac and neurological conditions.

Preparing for growing imaging demand

The investment comes as Alberta anticipates significant growth in demand for advanced diagnostic imaging. Demand for PET scans is expected to more than triple by 2040, according to information released about the project. The new centre is expected to more than triple Alberta’s capacity to produce medicines for PET scans and almost double production capacity supporting SPECT imaging. Medicine Hat News

Beyond clinical care, the centre is also expected to support research and clinical trials and the development of new radiopharmaceuticals, potentially giving patients access to emerging diagnostic and treatment options.

Construction of the Calgary Radiopharmaceutical Centre is underway at the Foothills Medical Centre campus, near the Arthur J.E. Child Comprehensive Cancer Centre and University of Calgary Foothills Campus. Alberta.ca

Once operational, the centre will provide another link in Alberta’s radiopharmaceutical supply network while expanding specialized imaging capacity for patients across southern Alberta.

Source: Government of Alberta / Alberta Health Services

The post Calgary’s first cyclotron to expand access to advanced diagnostic imaging and cancer care appeared first on Hospital News.

Newfoundland and Labrador is expanding addiction treatment and recovery services in Corner Brook, with plans to introduce community-based detox beds and increase inpatient capacity at the Humberwood Treatment Centre.

The multi-year project represents an investment of $8.25 million, including $3.75 million allocated through Budget 2026. The expansion will be completed in two phases and is intended to provide faster access to withdrawal management and residential addiction treatment in western Newfoundland.

New short-stay detox beds

During the first phase, four dedicated short-stay beds will be established for people requiring community-based detox services.

The beds are intended to accommodate individuals requiring same-day or next-day admission, providing more timely access to withdrawal management and helping patients transition to inpatient treatment when clinically appropriate.

NL Health Services has engaged CORE Engineering to complete detailed design work for the first phase, which is expected to begin this fall. The company is also developing a preliminary scope of work for the second phase.

The addition of community-based detox services on Newfoundland’s west coast is part of the province’s effort to make addiction recovery services available closer to where patients live.

Inpatient capacity to increase

The second phase will add six inpatient beds to Humberwood.

The centre currently operates 12 inpatient beds and provides a 28-day treatment program for adults living with substance use disorders and addictions. Once the expansion is complete, Humberwood will have 18 inpatient treatment beds in addition to the four community-based detox beds.

The expansion is also intended to improve continuity between different levels of addiction care. Patients who begin with withdrawal management could transition more smoothly to inpatient treatment and ultimately to community-based recovery supports.

According to NL Health Services’ most recent annual reporting, the province had already increased Humberwood’s capacity from 11 to 12 beds and introduced measures aimed at reducing treatment wait times. NL Health Services reported a 34 per cent reduction in provincial wait times for adult inpatient addiction treatment during 2024-25.

The new expansion aligns with recommendations from Newfoundland and Labrador’s All-Party Committee on Mental Health, Substance Use and Addictions to improve access to detoxification and inpatient treatment services. It is also identified as a priority under the province’s Alcohol Action Plan.

Source: Government of Newfoundland and Labrador / Newfoundland and Labrador Health Services

Original Government of Newfoundland and Labrador announcement

The post Newfoundland and Labrador expands addiction treatment and detox capacity in Corner Brook appeared first on Hospital News.

The USMLE Step 1 exam is an important early step in the career of any aspiring US-licensed doctor. In this blog post we will review some frequently asked questions about the exam. This includes USMLE Step 1 2026 exam dates and costs, the scope and length of the exam and more!

What is the USMLE Step 1 Exam?

The USMLE Step 1 exam is a standardized examination administered by the National Board of Medical Examiners (NBME). It assesses the medical knowledge, concepts, and principles of students who are in the process of completing their medical education and preparing to enter clinical practice.

The USMLE Step 1 is the first in a series of three exams that are required for medical licensure in the United States. It covers a broad range of topics, including anatomy, physiology, biochemistry , pharmacology, microbiology, pathology, and behavioral sciences.

The NBME website provides comprehensive content outlines for the exam. This provides more information on what could be on the test. There you can see the proportional representation of topics on the exam by systems, disciplines, and testable physician competencies. The USMLE Step 1 exam is designed to evaluate the student’s ability to apply scientific principles to the practice of medicine. It also tests their knowledge of the diagnosis and management of common medical conditions.

Medical students typically take the Step 1 exam at the end of their second year of medical school. Passing the exam is an important factor in successfully progressing through medical school and the residency matching process. 

For more information on the effects that the pass/fail system is having on medical students, see what the experts are saying.

When Do Students Take Step 1?

Usually, students take Step 1 in between their second and third years of medical school because there is often built-in study time, known as the dedicated study period, that schools allow for prior to the start of clerkship rotations. However, unless schools have their own rules/expectations for when students have Step 1 done, there is no requirement to take Step 1 at this time and there is even no requirement to take the USMLE Step 1 before Step 2. However, for students still in medical school, we recommend taking the USMLE Step 1 first. 

Step 1 does not have fixed test dates. You register for the exam through the NBME website, procure a registration permit to select a 3-month eligibility window, and then book your exam appointment at a Prometric test center. You may schedule your Step 1 exam anytime within your assigned eligibility window. Available exam dates for USMLE Step 1 depend on each testing center’s availability. 

When Should You Schedule Your Step 1 Eligibility Window?

The USMLE Step 1 eligibility window is one of the first logistical steps medical students encounter in the Step 1 preparation process. This three-month block determines when you are permitted to sit for the exam at a Prometric location. Once you complete registration and receive your scheduling permit, you gain access to Prometric’s system, where you can select a specific date and time that works within your chosen eligibility period. Understanding how this window works – and planning around it – is critical for a successful experience.

For many students, the question of when to take Step 1 is not just about the logistics of scheduling but also about the logic of predicting your readiness.  The answer depends heavily on your academic progress and personal readiness. Most students target the end of the second year of medical school, once their core pre-clinical curriculum is complete. At this point, the foundational sciences are still fresh, and students often have a built-in study block to prepare exclusively for the exam. My recommendation is that you think about these factors, select an exam date and secure it, and then focus on creating a study schedule around this date to have you prepared in time. 

Strategically choosing your window requires looking beyond academics alone. School calendars, family obligations, and even health should factor into your decision. It’s wise to allow room for unexpected challenges such as illness, burnout, or administrative delays in receiving your permit. Building flexibility into your plan makes a difference, particularly since some Prometric sites fill up fast. Limited availability at certain locations means last-minute scheduling can leave you stuck with inconvenient dates or long travel requirements. Plan ahead and consider that those hoping to test early may face higher competition for spring and summer dates, while later testers must balance preparation with the transition into clinical rotations. Adjusting your approach to match your academic goals is key.

Step 1 Rescheduling & Cancellation Fees Explained

Once you’ve secured a date, life events may still require changes. Prometric applies a tiered structure for rescheduling and cancellations:

• No fee if changed more than 30+ days before your appointment.
• A moderate fee if changed 5–29 days in advance.
• The highest fee if changed 4 days or fewer before your exam.

Students may reschedule within the same eligibility period but cannot move an appointment outside of that block unless they request an extension through NBME. Extensions usually involve additional charges and paperwork.

In emergency situations – such as sudden illness or a family issue – students can submit documentation for review. Missing your exam entirely risks being marked as a “no-show,” which could forfeit fees under the test cancellation policy.

What to wear for the USMLE?

We recommend you dress comfortably. You should wear comfortable clothes that are appropriate for a prolonged period of testing. Note that each testing center may have specific recommendations on attire. Call the testing center in advance and request answers to your questions around clothing. Note that wearing some clothing like hoodies might increase the time needed to enter and exit the testing room so plan accordingly.

It is important to avoid wearing anything that may cause discomfort or distraction during the exam. You should also consider the weather and dress accordingly. For example, you may want to dress in layers in case the temperature of the exam room fluctuates. 

What to Bring (and Not Bring) to Your Step 1 Exam

Preparing for Step 1 doesn’t end with studying – it also involves knowing what you can and cannot bring to the exam. The rules are strict, and failing to follow them could jeopardize your ability to sit for the test.

On test day, two items are absolutely mandatory: a valid government-issued photo ID that exactly matches the name on your registration, and your scheduling permit. These documents are checked carefully at the Prometric check-in desk. If the name on your ID doesn’t match the one used during USMLE Step 1 registration, you may be denied entry and forced to reschedule.

Once checked in, all personal belongings must be stored in lockers provided at the test center. This includes phones, wallets, outerwear, snacks, and water bottles. During scheduled breaks, you may return to your locker to eat, drink, or take medications.

Strict bans apply to prohibited items. Notes, books, calculators, electronic devices, and even accessories like smartwatches are not allowed inside the testing room. These restrictions exist to maintain the integrity of the exam and prevent distractions for both you and other students.

To feel confident, review Prometric’s online tutorial and rules in advance so you know exactly what to bring to Prometric center locations.

More USMLE Step 1 Help

If you’re navigating the challenges of the USMLE Step 1 exam, you’re not alone. Our subreddit, r/ask_a_usmle_tutor, is a community of experienced MD tutors and aspiring doctors discussing everything related to the USMLE. Whether you have questions about USMLE exam dates, study tips, a USMLE Step 1 cost breakdown to budget effectively, or need personalized advice, this is the place to be.

Join us now at r/ask_a_usmle_tutor and connect with peers and experts who can help you on your journey towards USMLE success.

For more resources, check out our 10-week or 6-week Step 1 study schedule , our blog post on the best predictor for passing Step 1 , and more Step 1 content.

If you are looking for more customized USMLE Step 1 help, consider enlisting the help of a 1-on-1 Step 1 tutor. Schedule a complimentary consultation today to hear more about what we can do to help you succeed!

The post When Do You Take USMLE Step 1? 2026 Exam Dates & Costs appeared first on Elite Medical Prep.

This week, I officially signed up for an unusual competition. One that rewards competitors for getting younger.

I recently turned 40, and I don’t need reminding that both time and my chronological age only tick forward. But this game is focused on competitors’ biological ages—figures that are meant to provide a better way to measure the age-related health of our organs and bodies.

Over a six-month period, around 500 of us will try to reverse our biological age as measured in a bunch of different ways. There’s even a leaderboard! The winners will include the person who shows the greatest difference between their chronological and biological age, as well as the person who manages to reverse their biological age the most.

The competition is the brainchild of the neuroscientist and physician Christin Glorioso, who is also founder and CEO of NeuroAge Therapeutics. The company offers tools to track brain health and aging and is running a trial to find out if biological brain age can predict the onset of Alzheimer’s disease.

Glorioso says she has several goals for the Younger contest. The first, she tells me, is to “explain to the world what aging clocks are.” Regular Checkup readers will be familiar with these tools, but for the uninitiated, they are basically designed to measure biological age.

Many measure chemical signatures that form a layer on top of our DNA and seem to change with age. But others might involve looking at proteins or lipids in blood. Some are designed to measure functional health, while others predict when a person will die. There are more than a hundred clocks out there, and they probably each capture a specific aspect of the biological process of aging.

These clocks are proving very useful for scientists, who use them to study aging and development in humans and many other species. But using them to estimate the biological age of an individual person is more controversial. They’re just not good enough for that yet.

Part of the problem is that we don’t really understand what each clock is capturing. Glorioso hopes that data collected through the Younger contest might help answer that question. She’s hoping to generate “the world’s most comprehensive clock dataset.”

Some longevity clinics try to get around the limits of biological age testing by using multiple clocks. That’s this competition’s approach too. As a standard competitor, I’ll be sending a blood spot sample to TruDiagnostic, a company that measures epigenetic chemical groups on DNA and offers to reveal an overall biological age as well as a person’s pace of aging and the biological ages of each of 11 organ systems, including the heart and brain.

I’ll get a brain age score from NeuroAge once I complete the cognitive tasks on offer. I’ll also submit some physical measures like grip strength. And I’ll upload a series of selfies to an app developed by a team at Harvard that promises to tell me my face age. That’s exactly what it sounds like—an estimate of how old my face looks.

I’m intrigued to see my scores, even though I know I shouldn’t put too much stock in them. The first time I took a test, four years ago, the company I used gave me a biological age that matched my chronological age, which was a little disappointing and, if I’m honest, a bit underwhelming. A year later, the same company told me I had a young heart but a relatively old brain, liver, and hormonal system. My lifestyle hasn’t changed much since then. Will the years have made much difference?

(Ultra competitors—who pay $4,499 rather than the $999 cost of regular entry—are also offered a range of other blood tests and clocks, as well as MRI and DEXA scans. I’ve got complimentary press access to the standard package.)

Glorioso is also hoping to gather information about the effects of some purported longevity approaches. During the competition, some participants will be offered red-light masks, access to a sauna, or other low-risk offerings that partner companies who are sponsoring the event to varying degrees might want to collect data on. “A lot of these companies just can’t afford to run [clinical] trials,” says Glorioso.

She also sees the event as a public health initiative. A couple of years ago, David Sinclair, who studies aging at Harvard Medical School, and his colleagues estimated that if we could slow down aging in the general population and increase life expectancy by one year, it would save the US economy $38 trillion.

The event officially kicks off in January, but around 120 people have already signed up, says Glorioso. Ultimately, she expects 500 participants. Each person’s six-month run starts as soon as they take their baseline measurements, whenever that may be. A handful of people have already started. “I think the majority of people are going to want to sign up after the holidays,” says Glorioso. “They’re not going to want to be trying to win an aging contest over Christmas and Hanukkah.”

Glorioso took her own baseline measurements back in August. Those initial tests suggested that her biological age was around 10 years below her chronological age. That sounded pretty impressive to me until I looked at the leaderboard and saw that competitor @Fred had a biological age 28.8 years below his chronological age.

The leaderboard is pretty sparse at the moment, as only seven people have logged their baseline measurements so far. Six of them have biological ages tracking low, but one 47-year-old has been given a biological age of 68.1. She’s competing publicly, so I can see the breakdown of her scores. The worst is for the speed at which she can stand from sitting in a chair—by that measure, she’s been given a biological age of 100.

Hillary Lin, a longevity-focused physician in New York, has just started logging her baseline measurements for the competition. She tells me she’s taken biological age tests in the past and that they’ve tended to give scores below her chronological age, which is currently 37. Last year, the TruDiagnostic test put her pace of aging at 0.75—suggesting she’s only doing nine months’ worth of aging in a typical year. “That’s supposed to be quite good,” she says.

If it had been up to her, Lin says, she would have incorporated more blood tests into the competition, to build a fuller picture of a person’s health. And she’s worried that a six-month period might not be long enough to see changes in biological measures of aging. Still, she’s excited, and is already making plans to improve her sleep, diet, and exercise.

But she already follows a high-protein, low-carb diet and works out at the gym every day. She also visits a sauna every few days (sauna use has been linked to improved heart health). Glorioso’s efforts are impressive too. She tells me she’s started drinking a smoothie made from a pond plant that has been linked to health improvements, and that she’s cut added sugar and deep-fried foods from her diet. She’s also bought “a bunch of fancy Korean sunscreens” in an attempt to lower her face age.

I haven’t received my kit or logged my baseline measurements yet, and I’ll wait until then to start setting health goals. I don’t fancy my chances against these two competitors. But at the very least, I hope I can stand up faster than a 100-year-old.

This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

A reliable handpiece is essential to safe and efficient dentistry – but knowing when to repair or replace it is not always straightforward, says Gavin Knight. Take our quick quiz to find out what your handpiece may need next.

Dental handpieces are an essential piece of equipment in any dental practice, so keeping them performing safely and reliably is critical. Like any precision instrument, however, even a well-maintained handpiece will eventually require servicing, repair or replacement. The challenge for practices is knowing when a repair is the sensible option and when continued investment is no longer worthwhile.

A useful starting point is to consider the total lifecycle cost of a handpiece rather than simply its original purchase price. Regular servicing should form part of that calculation from the outset. Preventative maintenance helps ensure equipment continues to operate as the manufacturer intended, while also identifying smaller problems before they develop into more serious and expensive failures.

Common signs your handpiece needs attention

A handpiece rarely fails completely without giving some warning. Changes in performance can be early indicators that servicing is required. These may include unusual or increased noise, vibration, reduced cutting performance, inconsistent speed, overheating, water or air-flow problems, or difficulty operating the chuck or bur retention mechanism.

Visible damage should also be taken seriously. Cracks, corrosion, worn components or damage caused by repeated handling and sterilisation can affect both performance and safety. If a handpiece is taking longer to perform routine procedures, or clinicians notice that it no longer feels or sounds as it normally does, it should be inspected rather than simply returned to service.

Regular inspection is particularly important because minor faults can cause damage to other components if they are left unattended. Addressing a relatively small issue early can prevent a much larger repair later – a case where the old saying, ‘a stitch in time saves nine,’ remains very relevant.

Take the quiz!

Create your own user feedback survey

Repair or replace?

When a handpiece requires attention, the decision should not automatically be based on the repair quotation alone. Several factors need to be considered.

Age is an important consideration. An older handpiece may have provided many years of reliable service, but if several major components are approaching the end of their useful life, repeated repairs may become increasingly difficult to justify. By contrast, a relatively new handpiece with a straightforward fault may be an excellent candidate for repair.

Condition and repair history are equally important. A handpiece that has been regularly maintained and is otherwise in good condition may have plenty of useful life remaining. One that has suffered repeated failures, significant wear or accidental damage may represent a different proposition.

Cost should also be viewed in the context of future reliability. A lower-cost repair is not necessarily the most economical option if further failures are likely. Conversely, replacing equipment that could be restored reliably and economically is unlikely to provide the best return on investment. The decision should therefore consider the expected future service life, not simply today’s repair bill.

Technological developments can also influence the decision. Newer handpieces may offer improved ergonomics, performance, efficiency or compatibility with other equipment in the practice. In some circumstances, replacing an older model may therefore be a commercial decision as much as a technical one.

Maintenance matters

Preventative maintenance can significantly influence the lifespan of a dental handpiece. Service intervals may be determined by time, usage or the number of cycles completed, depending on the product and manufacturer’s recommendations. At W&H UK, annual safety inspections and function checks are recommended for applicable devices as good practice, helping practices confirm that instruments remain safe and operational.

Keeping accurate service records can make this process easier. Recording the handpiece’s model and serial number, service history and future inspection requirements supports effective equipment management and helps practices make informed replacement decisions. For larger equipment estates, a dedicated service-management system can provide an additional level of traceability.

The quality of replacement components also matters. Using genuine manufacturer-approved parts helps preserve the handpiece’s intended performance, reliability and safety. Generic components can alter the original specification of a precision instrument and may affect its reliability and longevity.

Making the right decision

Ultimately, there is no universal point at which every dental handpiece should be replaced. The right decision depends on the individual instrument, its age, condition, service history, repair requirements and the investment needed to keep it operational.

The best approach is to view repair and replacement as part of the handpiece’s whole lifecycle, rather than treating each repair as an isolated expense. Regular servicing, professional inspection and accurate records provide the information needed to make that decision confidently.

A reputable manufacturer or authorised service centre can also help assess whether a handpiece is worth repairing or whether replacement would provide better long-term value. For a busy dental practice, the objective is not simply to keep an old instrument running for as long as possible. It is to ensure that every investment delivers the right balance of safety, performance, reliability, longevity and cost.