Life Sciences Sector Skill Development Council (LSSSDC) recently hosted “SkillVerse 2026 – A National Skill Summit for the Life Sciences Sector” at Le Méridien, Gachibowli, Hyderabad, bringing together more than 100 senior leaders and key stakeholders from the life sciences ecosystem. The summit focused on addressing skill gaps, strengthening training ecosystems, building industry-aligned talent and preparing India’s workforce for the future needs of the rapidly evolving life sciences sector.

Organised around the theme “Shaping the Skilled Future of Life Sciences,” the national summit brought together representatives from the Central and State Governments, pharma and life sciences industries, academia, skill development organisations, policymakers and other ecosystem partners. Express Pharma was the media partner for this event.

The summit commenced with the welcome of dignitaries, followed by the ceremonial lighting of the lamp and the National Anthem. Shri Gautam Bhattacharya, Chief Executive Officer, LSSSDC, delivered the welcome address. Shri Anil Matai, Chairman, LSSSDC and Director General, OPPI, shared his perspectives through a video message.

Special addresses were delivered by Shri Aman Sharma, IAS, Department of Pharmaceuticals; Shri Chakravarthi AVPS, LSSSDC Board Member; Ms. Nidhi Satiija, ISS, Director, Ministry of Skill Development & Entrepreneurship (MSDE); Dr. K. Narendran, Deputy Drugs Controller, CDSCO; Dr. Sarvesh Singh, CEO, Telangana Life Sciences; and Prof. Shailendra Saraf, Director, NIPER Hyderabad, among other distinguished speakers.

More than 100 senior industry leaders participate

A major highlight of SkillVerse 2026 was the participation of more than 100 senior leaders, CXOs, industry experts and decision-makers from the life sciences sector. The summit provided a high-level platform for meaningful dialogue between industry, government, academia and the skill development ecosystem.

The industry ecosystem represented at the summit included leading pharmaceutical, biotechnology and life sciences organisations such as Dr. Reddy’s Laboratories, Sun Pharma, Cadila, Biological E, Aurobindo Pharma, Hetero Labs, Granules India, Natco Pharma, MSN Laboratories, Eisai Pharmaceuticals India, Sahajanand Medical Technologies, Alkem Laboratories, Sekhmet Pharmaventures, Cohance Life Sciences, Agappe Diagnostics, Sandoz, Aragen Life Sciences , Bharath Biotech, Biozeen, Sai Life Sciences, Gland Pharma, Vimta Labs, Sai Parenterals.

Strong representation across government, academia and industry associations

The summit witnessed strong representation and participation from key Government Departments and organisations, including the Ministry of Skill Development & Entrepreneurship (MSDE), National Skill Development Corporation (NSDC), Central Drugs Standard Control Organisation (CDSCO), Telangana Life Sciences, Telangana Academy for Skill and Knowledge (TASK), Department of Employment and Training, Government of Andhra Pradesh, Department of Technical Education, Government of Andhra Pradesh, Regional Directorate of Skill Development & Entrepreneurship (RDSDE), Andhra Pradesh Pharmacy Council, Department of Pharmaceuticals and TICEL Bio Park.

The academic and knowledge ecosystem was represented by institutions and organisations including IIT Hyderabad, National Institute of Pharmaceutical Education and Research (NIPER), CSIR, GITAM, SRM, Punjab Biotech Incubator, PAGE and VIPER, reflecting the strong commitment of academia and knowledge partners towards building a future-ready life sciences workforce.

Industry associations and ecosystem bodies, including FOPE, BDMAI, MDP TG and FABA, also participated in the summit, contributing to discussions on industry requirements, skill development priorities and collaborative models for strengthening the life sciences skill ecosystem.

Key discussions on skill gaps and industry needs

The first panel discussion, “Identifying Skill Gaps in Life Sciences Sector,” examined the current skill requirements of the industry, changing demands in the employment market and the need to build a workforce that is industry-ready from day one.

The second panel, “NeeV Initiatives – Industry-led Models for Strengthening Skill Development Centres (SDCs),” explored practical models for strengthening Skill Development Centres through deeper industry participation, infrastructure support and outcome-oriented training.

Government initiatives and industry partnership

The third panel discussion on “Government Initiatives for Skilling” focused on aligning government-led skill development programmes with industry requirements, improving training quality and expanding employment opportunities for young talent.

The fourth panel, “Future-Ready Workforce for Life Sciences – Preparing for Industry 5.0,” brought together industry experts to discuss emerging skills, advanced technologies, innovation, digital transformation and the human capabilities required to prepare the life sciences workforce for the Industry 5.0 era.

Key partnerships to strengthen skill development

The summit also witnessed important partnership initiatives aimed at strengthening the skill development ecosystem. An MoU exchange took place between LSSSDC and Biological E Limited for a new Corporate Social Responsibility (CSR)-supported Skill Development Initiative for FY 2026–27.

LSSSDC also entered into an understanding with Medical Devices Park to strengthen industry collaboration for multiple skill development initiatives. In addition, Oxygen Pharmatech Private Limited was associated as a Knowledge Partner for various skill development initiatives.

Building a future-ready life sciences workforce

Speakers and participants unanimously emphasised that as India’s life sciences and pharmaceutical sectors continue to grow rapidly, sustained investment in industry-aligned skilling, industry–academia collaboration, government support and awareness of emerging technologies will be critical.

The discussions highlighted that bridging skill gaps can not only improve employment opportunities for young talent but also strengthen India’s ability to compete globally by building a highly skilled, adaptable and future-ready workforce.

A strong national platform for collaboration

In his concluding remarks, Gautam Bhattacharya, CEO, LSSSDC, outlined key recommendations and the way forward, while thanking the distinguished guests, industry leaders, government representatives, academic institutions, partners and other stakeholders for their valuable participation and support.

All participating stakeholders appreciated the LSSSDC team for successfully organising this useful and timely national event for the Life Sciences Sector Skill Ecosystem. Participants acknowledged the summit as a valuable platform for meaningful dialogue, knowledge sharing, collaboration and collective action towards addressing skill gaps and strengthening India’s life sciences talent pipeline.

With the shared objectives of “Bridging Skill Gaps – Strengthening Training Ecosystems – Driving Innovation & Future-Ready Talent – Building a Competitive Global Workforce,” SkillVerse 2026 emerged as a significant national platform that brought together industry, government, academia and the wider skill ecosystem to collectively shape the future of talent development in India’s life sciences sector.

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Merck and Moderna made both Wall Street and biotech news by trumpeting positive topline results from the Phase III INTerpath-001 trial (NCT05933577) showing that patients treated with intismeran plus Merck’s blockbuster cancer immunotherapy Keytruda^® (pembrolizumab) showed greater improvement than patients treated with Keytruda alone. The cancer INT surpassed Keytruda on both the trial’s primary endpoint of recurrence-free survival (RFS) and the study’s key secondary endpoint of distant metastasis-free survival (DMFS).

While Merck and Moderna saw their shares jump far above normal increases, several sequencing companies caught the proverbial tailwind and surged as well. That happened because intismeran is a personalized cancer therapy made for each patient based on the individual genetic mutations of their tumors.

As a result, the Merck-Moderna surge extended to sequencing giants such as Illumina (Nasdaq: ILMN), Pacific Biosciences of California (Nasdaq: PACB), and, to a degree Oxford Nanopore Technologies (London Stock Exchange: ONT), though a strong first-half earnings report and other positive announcements propelled Oxford Nanopore’s climb.

Between Wednesday’s announcement and Friday, Illumina shares jumped 16%, from $188.29 to $219.40, while PacBio climbed 18%, from $1.14 to $1.35. Oxford Nanopore rocketed 39% from £122.20 ($166.68) to an even £170 ($231.97), for reasons that go beyond Merck-Moderna.

In addition to the cancer INT, those reasons include an announced 10.5% revenue jump from £105.6 million ($144 million) to £116.7 million ($159.2 million) during the first half of this year, a restated commitment by new CEO Francis Van Parys to grow annual revenue to £700 million+ ($955 million+) by 2030, plus an intellectual property cross-licensing agreement with an undisclosed diagnostics developer that agreed to pay Oxford Nanopore $20 million in fees to be included in H2 2026 results, plus $15 million in committed purchases in 2027–2028, and low- to mid-single digit royalties.

Data to be presented

Merck and Moderna saw their shares surge despite not sharing any specific data for either the intismeran-plus-Keytruda arm or the Keytruda-alone arm of their trial.

That data, the companies said, will be presented at an “upcoming international medical meeting”—which analysts speculated could be either the European Society for Medical Oncology (ESMO) or the Society for Immunotherapy of Cancer (SITC) conferences—and shared with regulators.

Yet the absence of specific data did not stop analysts from sharing mostly very positive vibes about Moderna, whose shares had already more than doubled, soaring 124% in the year preceding the cancer INT announcement, from $28.09 to $62.96. The announcement sent Moderna’s shares into the stratosphere, catapulting them 177% to $174.38 and adding $45 billion to the company’s market capitalization (share price times the number of outstanding shares).

Moderna shares tumbled nearly 24% the following day to $133.32 on a combination of profit-taking plus expectations of a longer Iran war that sank most of the markets. But Moderna’s stock resumed its upward climb Friday, jumping 9% to finish the week at $145.13 and a 130.5% three-day gain. That’s a far cry from the 10% rise Moderna saw in December 2023 when it joined Merck to report positive Phase IIb data in stage III/IV melanoma.

“We see [Wednes]day’s update as a clear positive for shares and Moderna’s fundamental business,” Myles R. Minter, PhD, a partner and biotechnology analyst with William Blair, declared in a research note.

“Watershed moment” and “landmark win”

Minter also upgraded Moderna shares from “Market Perform” to “Outperform.” He was one of two analysts who raised their ratings on the company’s shares. Alec Stranahan, PhD, BofA Securities vp, equity research covering U.S. small- to mid-cap biotechnology companies, upgraded his firm’s rating from “Underperform” to “Neutral” and set a 12-month price target of $170, calling the positive data announcement “a watershed moment for Moderna,” as reported by Forbes. At Needham & Co., senior analyst Joseph Stringer, PhD, declared the results a “landmark win,” according to Investors Business Daily.

Behind the upbeat assessments of analysts is a view, shared by a consensus, that the cancer INT will significantly broaden Moderna’s sales beyond its two marketed mRNA-based COVID-19 vaccines.

Spikevax^® and mNexspike^® accounted for 97% ($91 million) of the company’s $94 million in second-quarter net product sales, down 17.5% from $114 million in Q2 2025, all of that from Spikevax (mNexspike did not reach the market until the third quarter of last year). The remaining $3 million in Q2 2026 sales came from respiratory syncytial virus (RSV) vaccine mResvia^®. A fourth FDA-approved vaccine, mCombriax^®, is an influenza/COVID-19 combination jab that has yet to be commercialized.

“We believe Moderna has a clear line of sight to revenue diversification from the COVID-19 business,” Minter added.

Andrew Tsai, equity analyst with Jefferies, wrote in a research note that market watchers were “likely to ascribe multibillion peak sales pot’l to melanoma,” as well as to conclude that those strong sales will read across intismeran’s numerous Phase II and Phase III programs in various solid tumor indications.

As for what the positive data is likely to show, Tsai continued, “We can infer RFS (and DMFS) could imply at least an HR [hazard ratio of between] 0.5–0.8, which seems clinically meaningful, especially if OS [overall survival] trends are favorable. Tsai noted that an earlier Phase IIb trial of the cancer INT in Stage III/IV melanoma showed a durable HR=0.51 on RFS stretching as far as year 5 after treatment, including an HR of 0.561 (p=0.0266) on two years of follow-up data presented at the American Association for Cancer Research (AACR) Annual Meeting 2023.

The Merck-Moderna announcement led to gains for the stocks of two leading rivals in cancer INT vaccine development: BioNTech (Nasdaq: BNTX) is partnering with Roche (SIX Swiss: RO and ROP)-owned Genentech on an mRNA-based individualized cancer vaccine, autogene cevumeran (BNT122/ RO7198457), that is in Phase II trials for advanced colorectal cancer and adjuvant pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer.

BioNTech shares jumped 26% this week from $92.75 to $116.59, while Roche’s RO bearer shares rose 3.5%, from CHF 366.80 ($457.93) to CHF 379.60 ($473.91), while its ROP participation certificates increased 4% from CHF 360.90 ($450.57) to CHF 375.60 ($468.96).

“Overly optimistic”

Daina M. Graybosch, PhD, senior managing director, immuno-oncology, and a senior research analyst with Leerink Partners, took a more cautious view on the Merck-Moderna announcement: “While we were thrilled to see a positive market reaction for the definitive success of the therapeutic cancer vaccine intismeran autogene (INT), the reception was overly optimistic and creates expectations that we believe will be difficult to meet.”

Graybosch said her caution reflected her views that:

• There will be less read-across to other cancer indications since melanoma is a tumor that is most immune-sensitive and has the highest tumor mutational burden (TMB).
• Rosy multi-billion-dollar sales forecasts won’t materialize for the cancer INT since its per-patient manufacturing cost as a personalized therapy will result in a lower gross margin of ~50–75% compared with the ~90% of monoclonal antibodies.
• HR will be no worse than 0.76 to 0.79, and could be much better.

Despite those cautions, Graybosch and colleagues at Leerink raised their projected 2032 sales forecast for intismeran 17%, from $1.2 billion to $1.4 billion. Karen Andersen, a director with Morningstar, went much further, projecting $16.8 billion in sales by 2035, more than double its previous projection of $7.2 billion. Morningstar also doubled its “fair value” or long-term, intrinsic value estimates on Moderna shares from $79 to $163, and on Merck shares by 29%, from $111 to $143.

INTerpath-001 is one of nine Phase II and Phase III trials within the INTerpath clinical development program assessing intismeran as a monotherapy and in combination with Keytruda and other anti-cancer therapies. In addition to melanoma, intismeran is being studied in non-small cell lung cancer (NSCLC), bladder cancer, and renal cell carcinoma.

The cancer INT is also under study in the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial (NCT03897881) in adjuvant melanoma, and a Phase I study evaluating intismeran in adjuvant pancreatic ductal adenocarcinoma, perioperative gastric carcinoma, and perioperative NSCLC.

In NSCLC, Merck and Moderna are studying intismeran in two Phase III trials, INTerpath-009 (NCT06623422) in patients with resectable Stage II to IIIB (N2) NSCLC; and INTerpath-014 (NCT07513376), in patients with completely resected high-risk Stage I NSCLC.

“Critical” read-across

“We see the read-across to other indications as critical, and even more important, to thinking about value from here” for Moderna stock, J.P. Morgan analyst Jessica Fye and four colleagues wrote in a research note.

While viewing a launch of intismeran in adjuvant melanoma as key to Moderna returning to profitability, Fye and colleagues said the positive results announced Wednesday were less a driver of value for Moderna shares than the other cancer indications since the cancer INT is a partnered product in a relatively small indication by immuno-oncology standards whose probability of success in adjuvant melanoma was pegged at 85% and already priced into the company’s shares before the announcement.

A day later, Fye and colleagues nearly doubled her firm’s price target on Moderna shares, raising it 92.5% from $40 per share as of December to $77 per share as of December 2027. The J.P. Morgan analysts also stopped risk-adjusting Moderna’s economic prospects in adjuvant melanoma. And they raised their probability of success forecasts for Moderna generating future profits in three other cancer indications—adjuvant lung cancer, adjuvant kidney cancer, and adjuvant bladder cancer—from 55% to 70%.

“While we have the most questions around whether this efficacy in adjuvant melanoma can read across to the metastatic setting, we are adding more heavily risk-adjusted credit for the possibility of activity in metastatic disease,” Fye and colleagues wrote.

As with Moderna, Merck enjoyed a mostly positive week that started with its shares jumping nearly 13% from $135.17 to $152.20 on Wednesday—an all-time high closing price and an unusual one-day double-digit leap for a pharma giant.

“These first Phase III findings for intismeran in combination with Keytruda as adjuvant therapy reinforce the promise of a more personalized approach to cancer treatment,” Dean Y. Li, MD, PhD, president, Merck Research Laboratories, said in a statement. “We believe individualized neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated.”

Merck shares slid 2% Thursday to $148.99 before bouncing back 2% Friday, finishing the week at a new all-time high close of $152.52 and a 13% three-day gain.

Merck needs a new blockbuster to help it recoup sales it will lose when Keytruda loses exclusivity for key U.S. patents in 2028—the most successful drug facing the proverbial patent cliff over the remainder of this decade. Keytruda racked up $15.81 billion in Q1–Q2 2026 sales in addition to the $31.641 billion it generated last year. Keytruda Qlex, a subcutaneous injection form of Keytruda, generated $590 million in the first half of this year and $40 million in 2025, since Qlex didn’t win FDA approval till September of last year.

“We expect positive investor reaction that will help sustain momentum for MRK into the fall,” Graybosch wrote. “Whether INT will be a large contributor to Merck’s bottom line is still uncertain, as we await pricing, COGS [cost of goods sold], and whether this success in the most immune-sensitive tumor will translate to non-small cell lung cancer.”

Leaders and laggards

• Capricor Therapeutics (Nasdaq: CAPR) shares yo-yoed in recent days, soaring 77% over two days from $4.21 to $7.45 on August 17 after the company told analysts on its second quarter earnings call that the FDA had agreed to review an amendment to its Biologics License Application (BLA) with additional 24-month data showing improved upper limb function following treatment with its drug candidate deramiocel. Capricor shares rose further to $7.98 by Wednesday, then nosedived 21% over two days to $6.29 at Friday’s close, on speculation that the FDA will reject deramiocel a second time.
• Tenax Therapeutics (Nasdaq: TENX) shares cratered 90% from $13.44 to $1.38 on August 10 after the cardiopulmonary drug developer said its lead candidate TNX-103 (oral levosimendan), a first-in-class K-ATP channel activator/calcium sensitizer developed to treat pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), failed the Phase III LEVEL trial (NCT05983250). TNX-103 missed the study’s primary endpoint of improvement in the six-minute walk distance vs. placebo, and the key secondary endpoint of improvement in Kansas City Cardiomyopathy Questionnaire total symptom score. Tenax said it will request a Type C meeting with the FDA to present the complete LEVEL dataset together with the company’s recommendations and will seek scientific consultation from the European Medicines Agency. Tenax said it intends to enrich the study population of its ongoing Phase III LEVEL-2 trial (NCT07288398), citing subgroup data from LEVEL that identified a substantial beneficial treatment effect in patients with greater disease burden, supported by clinically meaningful changes in predefined cardiac biomarker and pulmonary hemodynamic measures across the overall trial population.

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For some physicians, these changes feel long overdue. Many internationally trained doctors already completed years of residency and independent practice abroad and question why they must completely restart training in the United States despite physician shortages across the country. Others worry that creating alternative pathways could unintentionally create confusion, inconsistent standards, or even a “two-tier” physician system.

The reality is that both perspectives contain valid points. These new pathways may create meaningful opportunities for some physicians while also introducing important risks and unanswered questions. Understanding both sides of the discussion is essential, especially as more IMGs begin considering these routes as possible alternatives to traditional residency.

Why Alternative Pathways Exist in the First Place

The push for alternative IMG licensure emerged largely because of growing physician shortages in the United States, particularly in rural and underserved communities. At the same time, thousands of internationally trained physicians living in the U.S. have found themselves unable to practice clinically despite years of prior experience abroad.

For years, the traditional pathway into U.S. medicine for IMGs has remained narrow and highly competitive. Even highly qualified IMGs often struggle to secure residency positions because residency slots themselves are limited. Every residency Match cycle leaves behind thousands of unmatched applicants despite ongoing workforce shortages.

Supporters of alternative pathways argue that the system may be overlooking experienced physicians who could help address patient care gaps safely and effectively. They believe requiring all foreign-trained doctors to repeat residency from the beginning may not always make sense, especially for physicians who have already practiced independently for years.

From that perspective, alternative licensure pathways are not about lowering standards. They are about reassessing whether residency repetition is always necessary for every experienced physician entering the U.S. healthcare system.

The Potential Opportunities for IMGs

For many internationally trained physicians, these pathways represent something that previously felt almost impossible: a realistic chance to practice medicine in the United States without restarting their careers from scratch.

One of the biggest opportunities is preserving professional momentum. Many experienced physicians who immigrate to the U.S. spend years working in research, healthcare administration, medical assistance, or entirely unrelated jobs while attempting to navigate residency applications. Many of them will unfortunately not end up matching despite all this time, effort, and sacrifice. Some eventually abandon clinical medicine altogether.

Alternative pathways could allow at least some of these physicians to return to patient care more efficiently. For doctors who already completed residency abroad and maintained active clinical practice, this may feel like long-overdue recognition of prior experience.

Another potential benefit is reducing some of the emotional and financial strain associated with the traditional Match process. Residency applications are expensive, time-consuming, and highly uncertain, particularly for IMGs. Many physicians spend years reapplying, completing observerships, studying for exams, and relocating repeatedly without guaranteed outcomes.

These pathways may also create opportunities for care for underserved communities. Many states implementing these laws are specifically targeting physician shortages in rural or lower-access regions. International physicians have historically played a major role in caring for underserved populations, and policymakers hope these pathways may help strengthen healthcare access where shortages are most severe.

Why Some Physicians Are Still Cautious

One major challenge is the lack of standardization between states. Because each state creates its own licensing rules, requirements can vary significantly. Some pathways involve close supervision and extensive review processes, while others may operate differently. Critics worry that inconsistent standards could create confusion for physicians, employers, hospitals, and even patients.

Another concern involves long-term career flexibility. Residency training in the United States does more than provide clinical education—it also establishes board eligibility, credentialing pathways, fellowship access, and portability between states. Physicians entering alternative pathways may eventually discover limitations that are not immediately obvious early in the process.

For example, some employers or credentialing organizations may still strongly prefer traditionally residency-trained physicians. Certain fellowships, hospital privileges, or insurance panels could potentially become more difficult to access depending on how these pathways evolve over time.

In other words, even if alternative licensure becomes legally possible, it may not automatically carry identical professional mobility or recognition everywhere.

The Risk of Misinformation

One of the biggest problems regarding this topic right now is misinformation.

Social media discussions often oversimplify the issue into headlines like “You no longer need residency in America,” which can create unrealistic expectations. In reality, most alternative pathways still involve extensive requirements, including USMLE exams and ECFMG certification, credential verification, supervision, and employer sponsorship, with more limited future career mobility.

Some physicians may mistakenly assume these pathways are easier than residency when, in practice, they may still be highly selective and difficult to access.

Another issue is that implementation is still evolving. In many states, laws were passed before systems were fully operational. Hospitals, licensing boards, insurers, and employers are still figuring out how these pathways will work in practice. Some physicians may expect immediate opportunities only to discover that actual hiring infrastructure remains limited.

This uncertainty creates risk for applicants who abandon traditional residency plans prematurely based on incomplete information.

Could This Create a “Two-Tier” Physician System?

One of the most debated concerns is whether alternative pathways could unintentionally create separate categories of physicians.

Some critics worry that internationally trained physicians entering through alternative licensure routes could face stigma or reduced opportunities compared to traditionally residency-trained doctors. Even if these physicians are highly skilled, the perception of “nontraditional” training may affect hiring decisions, workplace dynamics, or patient trust in certain settings.

Others worry that underserved communities could become disproportionately staffed by physicians working under alternative or provisional licensing structures while more affluent healthcare systems continue favoring traditional pathways.

Supporters of reform argue that these concerns should not automatically invalidate alternative pathways, especially if physicians demonstrate competency and patient outcomes remain strong. However, the concern about unequal professional treatment remains part of the larger discussion.

Why Residency Still Matters

Even as alternative pathways expand, residency training in the United States continues to offer major advantages.

Residency provides standardized clinical exposure, familiarity with U.S. healthcare systems, multidisciplinary teamwork experience, and structured evaluation within the American medical environment. It also creates long-term professional security in ways that newer pathways may not yet fully guarantee.

For many IMGs, especially recent graduates without extensive independent practice abroad, traditional residency will likely remain the most reliable and widely accepted path forward. In reality, residency remains the gold standard in U.S. physician training and likely will for the foreseeable future.

The Emotional Side of the Debate

Part of why this topic generates such strong reactions is because it touches on fairness, identity, and sacrifice.

Many IMGs spent years working toward residency positions, completing observerships, passing multiple licensing exams, and enduring repeated Match cycles. For some, the idea of bypassing residency can feel emotionally complicated, especially after personally enduring the traditional pathway.

At the same time, experienced international physicians who already completed rigorous training abroad may understandably feel frustrated by a system that often requires them to repeat years of education despite prior independent practice.

Both perspectives are understandable, which is part of what makes this conversation so nuanced.

What IMGs Should Focus on Right Now

For now, the smartest approach is balance.

IMGs should absolutely stay informed about changing state laws and evolving licensure pathways. These reforms may create valuable opportunities for certain physicians over the next several years. Ignoring them entirely would likely be shortsighted.

At the same time, applicants should avoid making major career decisions based solely on online discussions or headlines. State requirements are changing rapidly, implementation remains uneven, and long-term outcomes are still largely unknown.

For most physicians, maintaining flexibility remains important. Continuing to strengthen traditional residency applications while also considering alternative pathways may provide the best balance of stability and opportunity.

Applicants who decide to continue pursuing the traditional Match can also consider personalized residency advising for support with application strategy, personal statements, interviews, and overall Match preparation.

It is also essential for IMGs to research individual state medical board requirements carefully rather than relying on generalized summaries online. Small details about supervision, eligibility, portability, or credentialing can make enormous differences in long-term career planning.

So, Opportunity or Risk?

The honest answer is that these pathways are both.

For some internationally trained physicians, especially those with extensive prior practice experience, alternative licensure pathways may become meaningful opportunities to re-enter clinical medicine in the United States without completely restarting their careers.

At the same time, these pathways still carry uncertainty. Questions about implementation, portability, professional recognition, employer acceptance, and long-term career flexibility are still evolving and remain unanswered.

The most important thing IMGs can do right now is approach these opportunities thoughtfully rather than emotionally. The laws are real. The opportunities may be significant. But the system is still developing, and careful planning matters more than ever.

What is clear, however, is that the conversation around IMG licensing in America is changing rapidly. Whether these pathways ultimately become mainstream alternatives or remain limited to exceptions, they are already reshaping how the medical community thinks about international physician training, workforce shortages, and the future of medical licensing in the United States.

The post Alternative IMG Licensing Pathways: Opportunity or Risk? appeared first on Elite Medical Prep.

Available models include cabinets with two doors and one or two drawers, five-drawer configurations, and Cart-Mate carts with varying drawer and door configurations. Specific models are offered in Clinton Classic Laminate, with select models also available in Fashion Finish or with molded tops. 

Clinton Industries Inc.

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DeepCyte launched the DeeTox Atlas, a single-cell metabolomic reference atlas of drug toxicity mechanisms. Enterprise pilot programs with global pharmaceutical companies are expected to begin in the coming months.

DeeTox Atlas is described as a foundation dataset built from two independent single-cell metabolomics perturbation studies, spanning approximately 100 toxicant compounds, 300,000 cells, and ~500 metabolites per cell—over 3,000 single-cell measurements per compound across six biological replicates. Each compound is mapped to a curated four-level hierarchy of toxicity mechanisms anchored to established Adverse Outcome Pathways (AOPs), according to the company.

Rather than generating new wet-lab data for every compound, DeepCyte trains a foundation model capable of predicting toxicity mechanisms for compounds it has never measured, said Theodore Alexandrov, co-founder and CEO of DeepCyte, adding that as the atlas expands, the platform becomes increasingly scalable, reducing laboratory dependence while improving predictive performance.

“AI in toxicology is only as good as the biological data it learns from. DeeTox Atlas lets us find subtle molecular patterns tied to key toxicity mechanisms—patterns our validation studies show are expressed in small subpopulations of cells and are effectively invisible to methods lacking single-cell resolution—and turn them into predictive models,” explained Alexandrov. “Our vision is to move toxicology from reactive laboratory testing toward predictive, mechanism-based AI that surfaces and explains safety liabilities earlier in drug discovery.”

The Atlas will expand with more compounds, mechanisms, and biochemical and clinical data, making predictions more actionable for toxicologists, medicinal chemists, and safety scientists, noted Alexandrov.

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For the biotech and pharmaceutical industry, AI’s impact has also been profound. Researchers can now identify potential drug targets faster, predict protein structures with remarkable accuracy (thanks to advances like AlphaFold and RoseTTAFold), analyze vast scientific literature in seconds, and generate molecular insights that would previously have taken months to uncover.

Yet despite these advances, AI applications in scientific research have not experienced their “Claude Code” moment. A scientist investigating a drug target for a specific disease may consult multiple databases, retrieve scientific papers, run molecular analyses, compare outputs from different AI models, and move a protein structure prediction from one platform into a docking tool on another, and then wonder whether a different model would have given a better answer.

The compute power exists. The models exist. What’s missing is a system that coordinates them.

Why Agentic AI Matters

For all the excitement surrounding AI, much of the infrastructure required to apply it effectively in scientific research remains out of reach for many organizations. Access to frontier AI models, large-scale computing resources, molecular simulation platforms, scientific retrieval systems, and workflow orchestration tools often requires substantial investment and technical expertise. This creates a growing divide between organizations that can afford to assemble sophisticated AI-driven discovery environments and those that cannot.

Unlike traditional AI systems that generate outputs in response to prompts, agentic AI systems are designed to function more like a coordinated research team. They understand objectives, plan tasks, retrieve context, coordinate tools, evaluate results, and recommend next actions. In other words, agentic AI offers a potential path to democratize drug discovery by bridging the gap between generating an insight and acting on it.

Even with AI, scientific discovery rarely occurs in a single step. New therapies often emerge through a chain of interconnected discoveries. By handling the iterative workflows necessary for drug discovery, agentic systems free up researchers to pursue breakthroughs that depend on creativity, intuition, and the ability to ask questions nobody has thought to ask before.

How Agentic AI Actually Works

The preclinical drug discovery process flows across distinct phases, from target identification and hit screening through lead optimization, preclinical validation, and ultimately translational readiness. Across all of them, a central challenge repeats: knowing which model to use, and when.

We encountered this challenge firsthand when building Vecura, NYB.AI’s agentic AI platform for molecular discovery, to support our own internal drug discovery operations. As our work expanded across molecular screening, docking, protein structure prediction, bioactivity scoring, ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) profiling, and molecular design, we managed a fragmented collection of specialized tools including:

• AlphaFold for structure prediction
• DiffDock for blind docking
• EquiBind for binding pose estimation
• ESMFold for sequence-based folding
• Drug-Target Interaction Graph Neural Network (DTIGN) and
• LigoSPACE models for drug-target interaction scoring.

Each tool generated useful outputs but we needed a system that could integrate these into a single workflow, reduce manual hand-offs, and help our team move faster from hypothesis to candidate prioritization. That need drove us to add an agentic AI layer, moving beyond tool access toward workflow execution.

A recent peer-reviewed paper from our team, published in Briefings in Bioinformatics, examined this “which model to use, and when” problem further in the field of graph-based drug-target interaction modeling.¹ The field has produced a wealth of powerful models, but they operate at fundamentally different levels.² Some work at the network level, capturing broad associations between drugs and targets. Others work at the sequence level, representing proteins as strings of amino acids. Still others require full 3D structural data, modeling interactions at the resolution of individual atoms and binding pockets. And a fourth category focuses specifically on interaction mechanisms. Each level answers a different kind of question; using the wrong one wastes time and compute.

This paper¹ proposes a practical framework: before selecting any model, clarify what decision you actually need to make. Is your task association discovery, interaction classification, affinity estimation, candidate ranking, pocket identification, pose assessment, or mechanistic hypothesis generation? Only then do you examine inputs, choose the right resolution, scrutinize how candidate models were evaluated, and plan experimental validation.

This is precisely the kind of reasoning an agentic layer can encode, and it’s the philosophy around which we built Vecura. Throughout every phase, agentic workflows automatically route tasks and generate decision support. Model interaction likelihood ensures the right AI models are engaged at the right moments, operationalizing the output-driven logic. When a project shifts from target identification to lead optimization, the required model resolution moves from network-level associations toward pocket geometry and pose-ranking, where the agentic layer recommends for researchers to accept rather than through manual tool reconfiguration. And iterative scoring continuously refines predictions based on real-world validation data, so each cycle gets smarter.

Agentic AI fundamentally differs from traditional tools. It doesn’t just process your request and hand you an answer. It understands the scientific journey you’re on, anticipates what comes next, and coordinates the entire apparatus to get you there faster. A lead that might have taken months to optimize with scattered tools and manual hand-offs can now be systematically enhanced in weeks.

What Industry Leaders Should Be Thinking About Now

For executives across biotechnology, pharmaceuticals, healthcare, and scientific research, the strategic opportunity is orchestration, not automation, which remains largely limited to single tasks. The organizations most likely to benefit from the next wave of AI adoption may not be those deploying the latest or best-performing models but those who can most effectively integrate models, data, expertise, and workflows into a coherent research process.

If executed thoughtfully, agentic approaches could help organizations:

• Accelerate research cycles by reducing workflow bottlenecks
• Improve utilization of scientific knowledge across teams and projects
• Scale expertise beyond individual researchers or departments
• Enable scientists to spend more time on high-value decision-making

The next phase of AI adoption is about leveraging agentic AI to integrate fit-for-purpose AI models and the supporting technology ecosystem around them, available to more skilled and passionate research teams worldwide. That’s how breakthroughs get democratized. For research-driven industries, such increased access may prove to be the most important breakthrough of all.

Giang Nguyen is the CEO of NYB.AI, a Singapore-based company developing agentic AI infrastructure for molecular discovery and life science research. He is also the CTO of Nanyang Biologics. In June 2026, NYB.AI was featured in the opening showcase video at NVIDIA GTC Taiwan 2026, highlighting agentic AI designed to coordinate actions to speed up molecular discovery. Vecura is currently in early access mode.

References

1. Nguyen T, To HM, Nguyen DA, et al. Graph-based drug-target interaction modeling: from representation learning to output-driven drug discovery. Briefings Bioinformatics. 2026;27(4):bbag392. doi: 10.1093/bib/bbag392
2. Ahmad B, Quahada K, Hamam H. Machine learning for drug-target interaction prediction: A comprehensive review of models, challenges, and computational strategies. Comp. Struct. Biotech. J. 2026;31:316-345. doi: 10.1016/j.csbj.2025.12.033

FIGURE LEGEND

Vecura, an agentic AI platform for molecular discovery.

The post From Models to Agents: The Next Phase of AI Adoption in Molecular Discovery appeared first on GEN - Genetic Engineering and Biotechnology News.

To date, this type of organization has been difficult to reproduce in lab-grown models of the human brain. But now, scientists at the University of California (UC), Irvine, have developed a new approach that lets them engineer lab-grown human brain tissue with a defined regional identity. The result is brain organoids with characteristics of either the front or back of the developing cerebral cortex that could be used in studies of how neurodevelopmental disorders develop. Full details are provided in a Cell Stem Cell paper titled “Morphogen-guided neocortical organoids with anteroposterior areal identity.”

According to the paper, the UC Irvine team used the approach to generate neocortical organoids from human stem cells that copy important features of the developing cerebral cortex. Each organoid was steered to take on the identity of either a front or back region using carefully selected chemical signals. It is an important step, one that ordinary organoids lack. Without this step, organoids end up with a patchwork of random regions rather than a clear front or back. 

In this study, after exposing the organoids to the chemical signals, the scientists examined the individual cells to determine whether those differences resembled actual human development. Their analysis of more than 200,000 cells showed that the organoids reproduced molecular characteristics that were associated with different regions of the prenatal human context. 

As an example of how these organoids can be used, the scientists used their new model to investigate fragile X syndrome. They wanted to know whether this genetic condition might affect both individual brain cells and broader developmental patterns that help organize those cells across the cortex.

Specifically, they looked at two proteins important to brain development, SOX4 and SOX11, that normally appear at different levels in front and back tissue. That difference showed up reliably in organoids grown from donors without the condition. In organoids modeling fragile X syndrome, it largely disappeared. The broad front-to-back patterning was still there, but this particular difference had flattened out.

This finding is supported by other research in donated tissue from people with autism. Importantly, the findings do not show that disrupted brain patterning causes autism. Instead, they highlight a potential developmental process that researchers can now investigate in a human tissue model with greater spatial detail.

These more fine-grained models could also be used in other types of studies, according to the scientists. Neurological and neurodevelopmental disorders do not necessarily affect every part of the brain in the same way. So by giving organoids defined regional characteristics, researchers can begin studying not only what changes in a disorder but also where those changes emerge during development.

Furthermore, the platform contributes to growing efforts to develop human tissue-based research models that can complement animal studies. The scientists believe that the approach could be used to examine how genetic and environmental factors affect different regions of the developing cortex and, over time.

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An interdisciplinary research team headed by scientists at University of Chicago and at Columbia University has now developed a computational tool that could make the challenge of finding genes most directly related to disease much easier. Their newly reported study in Cell showed how the tool, called DANDELION, was able to identify 21 genes related to asthma, most of which hadn’t been discovered by other methods. The researchers used both CRISPR gene-editing screens and mouse models to validate that these genes lead to asthma phenotypes and demonstrated that two of the genes are in the same pathway involved in fatty acid metabolism and protein palmitoylation, which hasn’t yet been studied for asthma.

In their paper (“Trans-regulatory gene mapping prioritizes disease drivers in asthma,”) co-senior author Xuanyao Liu, PhD, assistant professor of medicine and human genetics at the University of Chicago, and colleagues, wrote, “DANDELION identifies genes that are not detected by existing approaches or gene prioritization methods, such as GWAS and polygenic priority score (PoPS) … Our study establishes DANDELION as a powerful framework for prioritizing novel, therapeutically actionable genes and pathways underlying disease pathogenesis.”

One of the most important goals of studying genetics is to find the genes that are important for specific diseases. The problem is that most diseases aren’t caused by a single gene or mutation. They’re the result of complex interactions among dozens, if not hundreds or thousands of genes, plus environmental factors, lifestyle, and a host of other variables. That flood of genes creates a needle-in-a-haystack problem. The authors wrote, “Deciphering which genes are most important to disease etiology is a central challenge in human genetics … However, the highly polygenic nature of complex disease makes it challenging to distinguish central disease drivers from many, sometimes hundreds, of genetic associations.”

The DANDELION tool focuses on a process known as trans-gene regulation. In complex diseases like asthma, many genetic variants may contribute to disease by changing the expression of other genes. This has a cascading effect where one variant changes the expression of a nearby gene, and then that gene changes the expression of another, and so on. This creates what’s called a gene regulatory network that ultimately drives the development of disease. “Here, we define disease-proximal genes (DPGs) as those that centrally mediate the effects of other, more distal disease-associated genes within trans-regulatory networks,” they explained.

Existing approaches like genome-wide association studies (GWAS) instead focus on genes that are often in the periphery of the gene regulatory network, however, and only indirectly affect disease. “All these existing tools assume that the actual disease genes are always going to be very close to the disease variants, but when you search for clues around that variant, you don’t always find much,” said Liu, PhD, who developed DANDELION. The authors further commented, “Genome-wide association studies (GWASs) are not suited for DPG identification because they are inherently weighted toward discovery of common variants, which generally have small effect sizes and, due to the pressure of selection, are less likely to impact genes involved in critical biological pathways.”

“What’s unique about our method is that we believe the disease genes are not just next to the genetic variants. They’re embedded in this gene regulatory network, and the actual disease-driving gene is downstream of those associated variants, maybe on different chromosomes. So, they’re on the receiving end of a genetic effect that is very far away,” Liu said. Liu named the tool DANDELION in reference to the puffy heads of dandelion flowers once they go to seed. The puffball resembles an interconnected, branching network of genes, ultimately pointing to the center of the core disease genes, the DPGs.

For the reported study, Liu analyzed a large set of data from the human transcriptome and the UK Biobank, a repository of health and genetic data from more than 500,000 volunteers. She used DANDELION to search for DPGs for asthma and found 21 candidates, 19 of which have not been discovered before using tools like GWAS. Liu showed the data to Marcelo Nóbrega, MD, PhD, chair of the department of human genetics at the University of Chicago, who has developed experimental platforms to manipulate the expression of genes in human cell types that are relevant to asthma, such as epithelial cells from the lining of the airways, inflammatory cells, and immune T cells.

At first, he was skeptical. “Xuanyao showed me a list of genes, and we didn’t recognize almost any of them,” Nóbrega said. “I thought that either this is going to be really cool and groundbreaking or it’s going to be wrong. But we had the experimental validation system running, so I thought, ‘Let’s test them all.”

Nóbrega’s team, led by postdoctoral scholar Isabella Salamone, PhD, conducted a series of experiments to test the effects of the genes predicted by DANDELION. Surprisingly, most of the genes Liu identified had a direct, measurable impact on the function of asthma-related cell types, producing phenotypes that model those seen in asthma at a much higher rate than the distal genes, or any other genes in the genome that they also tested. Looking more closely, Salamone saw that two genes had opposite effects. Knocking out one gene called SLC27A3 protected against the effects of asthma in both epithelial and T cells, while knocking out another gene, SCD, contributed to disease.

Looking at the effects of mutations of these genes in a large human cohort of almost half a million people, the researchers found that mutations in SLC27A3 are protective of asthma, supporting their findings in the cell-based phenotyping screens. “We saw this really striking pattern,” Salamone said. “Knocking out SLC27A3 had the strongest protective effect of all the genes we tested, and knocking out SCD was very detrimental to whatever cellular function we assayed. When we dug into patient data that had been collected by other labs, we saw the same pattern repeat itself—expression of SLC27A3 is increased in lung cells of patients with severe asthma, and SCD expression is decreased.”

Intriguingly, both SLC27A3 and SCD are involved in the same biochemical pathway for fatty acid metabolism. To understand how this might be linked to asthma, the investigators turned to chemical biologist Hening Lin, PhD, the James and Karen Frank Family Professor of Medicine and Professor of Chemistry at the Univereity of Chicago, who is a world-leading expert on the process, especially its role in protein palmitoylation, the addition of a long-chain fatty acyl group to proteins that regulate protein activity. Lin helped them confirm that both genes are involved in palmitoylation, and that reducing palmitoylation by knocking out SLC27A3 causes lung epithelial cells to dampen several immune-related and inflammatory processes.

“My lab has been working on the role of protein palmitoylation in immune signaling. We know many immune signaling pathways are regulated by palmitoylation, but I am still amazed by the finding that disrupting a lipid metabolic protein, SLC27A3, could offer protection in asthma models at least in part via affecting protein palmitoylation,” Lin said.

Finally, to test whether these genetic, biochemical, and cellular findings ultimately translate into asthma susceptibility, Salamone developed mice in which SLC27A3 or SCD were inactivated. They found that SLC27A3 knock-out mice are protected against allergy-induced lung inflammation, while SCD knock-out mice are more prone to lung inflammation compared to control mice, demonstrating that the new pathway the team uncovered is indeed capable of changing susceptibility to asthma.

“…our results show that loss of two enzymes with opposing effects on protein palmitoylation also has opposing CD4+ effects on cellular phenotypes in human epithelial and T cells and a mouse model of allergic sensitization,” the team wrote in summary. In their paper, the investigators suggested, “Our findings represent a new direction for understanding mediators of asthma pathogenesis and a new potential therapeutic intervention in the treatment of asthma, either by targeting SLC27A3 specifically or palmitoylation more broadly.”

Encouraged by this initial success Liu looks forward to testing it with other diseases, such as inflammatory bowel disease or type 2 diabetes. Historically, one of the limitations of drug development has been finding the true protein targets for treatment. DANDELION has the potential to overcome this challenge by identifying new and more effective drug targets.

“We’re really excited about this direction because for these diseases, GWAS has identified tons of signal, but we still don’t know the actual disease-driving genes that we can target for therapies,” Liu said. “I think our collaboration has been really powerful because we closed the gap at both the computational level and the experimental level.”

The authors further concluded, “We expect that the deployment of DANDELION to new traits and diseases will reveal a wealth of DPGs, with high drug development potential while also facilitating a deeper understanding of the roles these genes play in disease etiology.”

Nóbrega emphasized the importance of this collaboration as well, especially the advantage of being able to confirm their findings with a leading expert like Lin. “None of this would have come to fruition if any one of us were working on this alone,” he said. “We would have three papers buried in separate journals and virtually nobody would know how to put these stories back together. So, the power of having this complementary expertise across the division is really important.”

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Despite their increasing utility, organoids have proven challenging to maintain over long periods. Now, researchers have successfully maintained brain organoids for longer than ever before. For over five years, the tissue continued to mature in ways that closely resemble human brain development. By extending the lifespan of these organoids, the researchers create new opportunities to investigate neurodevelopment, model brain disorders, and test potential drugs.

This work is published in Nature in the paper, “Human brain organoids record the passage of time over multiple years.”

Brain organoids have become increasingly important for studying human brain development. “These models allow us to track development over time and examine how different brain cell types emerge,” said Noelia Antón-Bolaños, PhD, assistant professor at UMC Utrecht. So far, most studies have focused on the earliest stages of development because researchers could not maintain brain organoids in culture for extended periods.

Antón-Bolaños and her colleagues investigated how far human brain organoids can continue to mature. However, standard culture conditions did not adequately support neuronal activity over extended periods.

“During human brain development, neurons display spontaneous activity,” Antón-Bolaños explained. “By adapting the composition of the culture medium, we supported that activity, kept the neurons active, and maintained the neuronal populations for much longer.”

Using this approach, the team maintained organoids for over five years. At defined time points, the researchers profiled the cell types present, gene-expression patterns, epigenetic changes, and neuronal activity.

The researchers then examined whether the organoids simply stayed alive or continued to develop. Different brain cell types appeared in the same order as during human brain development, neurons formed increasingly complex connections, and genes became active or inactive at the expected times.

Some of the strongest evidence came from epigenetic changes. “In the human brain, these epigenetic changes accumulate according to a characteristic developmental pattern,” Antón-Bolaños said. “We observed the same pattern in the brain organoids.”

After approximately one year, the organoids displayed features that normally emerge only after birth. “The cells are outside the body, yet they still follow approximately the same developmental timeline as we do—and even more closely than we had anticipated.”

The team also found that mature cells retained a memory of developmental time. “When we dissociated an older organoid and allowed the cells to grow again, they produced the cell types associated with a late developmental stage,” Antón-Bolaños said. “Yet when we combined older cells with younger cells, the older cells regained the ability to produce neurons—but only the types associated with later stages of development.”

The organoids are still developing in the laboratory. The researchers now want to determine how environmental cues, such as stimulation with light, improve further maturation. The field also aims to improve features that remain incomplete, including vascularization and the layered organization of the cerebral cortex.

“We now know that these models have the capacity to continue developing for years,” Antón-Bolaños said. “The next step is to understand how to provide optimal conditions for that capacity to unfold. That will bring us closer to more faithful models of the human brain.”

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The first month of MCAT preparation often sets the tone for everything that follows. Students usually begin studying highly motivated, armed with color-coded schedules, new resources, and ambitious goal scores. But despite good intentions, many students unknowingly build ineffective habits during those early weeks that later become difficult to fix.

One of the biggest misconceptions about the MCAT is that success comes purely from working harder or studying longer hours. In reality, the students who improve the most are usually the ones who learn how to study strategically early on. The first month is less about mastering every biochemical pathway or memorizing every psychology term and more about developing the right systems, habits, and mindset.

Unfortunately, this is also the phase where students commonly waste time, burn themselves out, or create unrealistic expectations for themselves. Understanding these early mistakes can save students months of frustration down the line.

Trying to Study Everything at Once

One of the most common first-month mistakes is attempting to master all the material simultaneously. Students often start by creating massive study schedules that include every subject, every Anki deck, multiple prep books, question banks, YouTube videos, and full-length exams all at once. On paper, it seems productive. In reality, it quickly becomes overwhelming.

The MCAT covers an enormous amount of material, and students sometimes panic when they realize how much content exists. The first month should focus on building consistency and identifying weaknesses, not trying to complete every resource available online.

Students who succeed long-term often simplify their study plan early. Instead of asking, “How can I cover everything immediately?” they ask, “What study system can I realistically sustain for the next several months?”

Spending Too Much Time on Passive Content Review

Another major mistake is using passive studying approaches. During the first month, students often spend hours highlighting textbooks, rewatching lectures, or reading chapters repeatedly without actively testing themselves. While this can feel comforting, it creates the illusion of learning more than yielding actual retention.

The MCAT is not just a memorization exam, it is a logic and reasoning exam. Students are expected to apply concepts, analyze unfamiliar passages, and think critically under time pressure. Passive review alone rarely prepares students for this.

Many high-scoring students wish they had started active learning earlier. Practice questions, recall-based studying, flashcards, passage analysis, and teaching concepts out loud are usually far more effective than endlessly rereading notes. Content review matters, especially early on, but it’s important not to wait too long before incorporating active problem-solving into their routine.

Saving CARS for Later

One of the biggest traps students fall into is postponing CARS practice because it feels uncomfortable, difficult to improve, or totally different from the rest of the test. Many students focus heavily on science review during the first month while telling themselves they will “work on CARS later”.

Unfortunately, CARS improvement tends to happen gradually over time. Unlike memorization-heavy subjects, reading comprehension and passage strategy usually improve through repeated exposure and consistent practice. Advisors and tutors frequently see students regret waiting too long to build these habits.

Even completing a few passages regularly during the first month can make a meaningful difference later. The goal early on is not perfection, it is developing familiarity with the pacing, logic, and mental endurance required for the section.

Taking Too Many Notes

Students often assume that more notes equal more learning. During the first month, many spend hours creating elaborate notebooks filled with rewritten textbook chapters, color-coded diagrams, and perfectly organized summaries.

While organization can be helpful, excessive note-taking can become a major time sink. Some students spend so much energy making beautiful study materials that they leave little time for actual application or to actually review their notes in a meaningful way.

One of the most important realizations during MCAT prep is that recognition is not the same as mastery. Being able to recognize information in your notes is very different from retrieving it independently during a timed exam. Students who shift earlier toward active recall and spaced repetition often improve more efficiently.

Obsessing Over Diagnostic Scores

Another common first-month mistake is placing too much emotional weight on an initial diagnostic score. Many students take their first practice exam and immediately panic if the number is lower than expected.

The reality is that diagnostic exams are meant to serve as a benchmark and identify strengths and weaknesses, not predict final outcomes. Some students interpret a low starting score as evidence that they are “bad at standardized tests” or incapable of reaching their goal. Others become discouraged and completely overhaul their study plans after every practice test.

The first month should focus more on learning patterns than chasing numbers. The diagnostic score is simply a baseline data point. Students benefit much more from asking, “Why did I miss these questions?” than obsessing over a single score report. Improvement on the MCAT is usually gradual and nonlinear.

Using Too Many Resources

The internet has made MCAT prep resources almost endless, which can ironically become part of the problem. Students often spend the first month constantly switching between prep books, tutors, apps, YouTube channels, Reddit study plans, Anki decks, and question banks. Students feel pressure to go through every single resource for fear they’ll miss something important if they don’t. 

This usually creates fragmented studying rather than efficient learning. Many students mistake resource collection for productivity. Most successful students eventually realize that mastery of a few high-quality resources is far more valuable than superficial exposure to dozens of them. 

Comparing Yourself to Other Students

The first month of MCAT studying can quickly become emotionally draining when students constantly compare themselves to others online. Social media and Reddit are filled with study schedules, score updates, and stories from students studying 12+ hours a day.

This comparison often creates unrealistic expectations. Students begin feeling behind even when they are making reasonable progress. Some assume that everyone else understands physics immediately or remembers every amino acid after one review session.

In reality, most students struggle far more than they admit publicly. MCAT preparation is rarely linear, and confidence fluctuates constantly. Students who focus too much on others often lose sight of what actually works for them individually. The only standard of comparison should be your own progress and improvement over time. 

Avoiding Practice Questions Because “I’m Not Ready Yet”

One of the most damaging first-month habits is delaying practice questions until content review feels “complete.” Many students believe they need to fully memorize every topic before beginning practice passages.

The problem is that the MCAT rarely tests isolated facts in the way students expect. Passage interpretation, reasoning, and test-taking strategy are skills that require practice over time. Students who avoid questions early often struggle later when transitioning into application-based studying.

Getting questions wrong during the first month is normal and expected. In fact, some of the best learning happens through reviewing mistakes carefully. Students who embrace early discomfort tend to build stronger long-term reasoning skills.

Studying Without Reviewing Mistakes Properly

Another major issue is rushing through questions without analyzing errors deeply. Students sometimes focus only on completing large quantities of questions instead of understanding why they missed them.

The review process is often where the most meaningful improvement occurs. Simply seeing the correct answer is not enough. Students should understand whether the issue came from content gaps, passage misinterpretation, timing problems, or careless reading.

Many experienced MCAT tutors emphasize that thoughtful review is often more important than the number of questions completed. Students who develop strong review habits early tend to improve much more steadily over time.

Burning Out Too Early

Perhaps one of the most common first-month mistakes is starting too intensely. Motivated students sometimes attempt to study 12+ hours every day immediately, thinking that maximum effort from the start guarantees success.

Unfortunately, this often leads to exhaustion within a few weeks. Students become mentally drained, frustrated, and unable to maintain consistency. Burnout is especially common among perfectionistic pre-med students who feel guilty whenever they are not studying.

Sustainable studying almost always outperforms unsustainable intensity. The MCAT is more like a marathon than a sprint. Students who build balanced routines with adequate sleep, exercise, and breaks often perform better than those who try to “grind” nonstop from day one.

Forgetting That the MCAT Is a Skills Exam

One subtle but important mistake is viewing the MCAT purely as a content exam instead of a reasoning exam. Students sometimes assume that if they memorize enough facts, high scores will automatically follow.

While strong content knowledge absolutely matters, the exam is heavily focused on interpretation, critical thinking, pattern recognition, and decision-making under pressure. Students who focus only on memorization during the first month may later struggle when faced with unfamiliar passages.

The best early study plans include both content review and skill development. Learning how the MCAT asks questions is just as important as learning the material itself.

Building Good Habits Early Makes Everything Easier Later

The good news is that first-month mistakes are incredibly common, and fixable. Nearly every successful MCAT student can look back and identify habits they wish they had changed earlier. The key is recognizing these patterns before they become deeply ingrained.

Students who perform well over time are usually not the ones who study perfectly from day one. They are the ones who adapt, simplify, stay consistent, and learn from mistakes without panicking. The first month of MCAT prep is ultimately less about perfection and more about building a foundation that can realistically carry you through the long months ahead.

At the end of the day, successful MCAT preparation is not about finding a magical resource or studying more hours than everyone else. It is about developing sustainable habits, studying actively, reviewing thoughtfully, and trusting that progress takes time. For students who would benefit from additional structure and personalized guidance, MCAT tutoring can help them develop an effective study plan, strengthen weaker areas, and stay accountable throughout their preparation. Students who understand this early often save themselves unnecessary stress and position themselves for long-term success.

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When the biotech company Insilico Medicine used its computer models to propose a promising drug for pulmonary fibrosis, it enthusiastically claimed in a press release that the molecule had been “discovered by” its generative AI platform.

Insilico leads a pack of companies using AI to rapidly come up with drug ideas humans might never think of, potentially speeding the race to new cures. AI models are now able to generate atomic designs for drugs almost as easily as ChatGPT can write a thank-you note.

However, when it came time to file for an all-important patent to protect that new chemical structure, the company made no mention of AI. Instead the patent names five humans, including CEO Alex Zhavoronkov, as the drug’s “inventors.”

The discrepancy points to a fascinating wrinkle in intellectual-property law. No matter how fundamental an AI is to a discovery, when it comes to winning rights to an invention, it’s humans—and only humans—who can take the credit.

US courts reached that conclusion after Ryan Abbott, a partner at the LA law firm Brown, Neri, Smith & Khan, brought a pro bono test case naming an AI called DABUS as an inventor of a better food container, whose intricate geometric surface lets it transfer heat well and stack easily. Because no human contributed to the design, Abbott argued that the AI should be named the inventor.

The case might have raised philosophical questions, like whether AIs deserve legal rights or what the true nature is of that eureka moment that leads to a better mousetrap. But in 2022, an appeals court in Washington, DC, said these “metaphysical matters” were beside the point. Instead, it noted that US statutes describe an inventor as an “individual,” the plain meaning of which is a human being.

Since machines aren’t people, they can’t be inventors. Case closed.

“There needs to be a human inventor or there’s no invention and no patent,” says Sarah Korman, a patent attorney who is now chief business officer and legal officer of Isomorphic Labs, an Alphabet spinout with big ambitions for AI cures. Korman, who made her remarks at MIT Technology Review’s EmTech event last year, added that there is “no doubt” our laws will need to evolve to keep pace with AI.

That’s partly because no one is denying that AIs can invent things. In the future, they may do so with less and less human intervention. As the US Patent and Trademark Office has itself acknowledged, “an AI system—like other tools—may perform acts that, if performed by a human, could constitute inventorship under our laws.”

Instead, the key question going forward may actually be whether or not any human contributed enough to be named as an inventor. Abbott believes there could be legal challenges to AI-generated drugs, since one way to invalidate a patent is to show it has the wrong inventors listed.

Abbott’s worry is that if US policy excludes AI-generated outputs from protection, that could put a damper on future drug development. Already, the US Copyright Office is refusing to grant copyrights to images and text generated by AI, raising concerns from organizations like the Motion Picture Association of America, whose members are using those tools. 

The point of our intellectual-property laws is to encourage innovation, Abbott says. It’s right there in Article 1 of the US Constitution, which says inventors and authors need to be given exclusive rights to their ideas, for a limited time, in order “to promote the Progress of Science and the Useful Arts.”

Currently, the US patent office seems to be taking a don’t-ask-don’t-tell approach to the use of AI. Under the Biden administration, the agency published guidance to help applicants determine whether and when humans would truly qualify as co-inventors of an AI discovery. But after Trump arrived in office, it reversed course. Now the patent office says AI is merely a tool, like a calculator. No need to even mention it.

You can bet that pioneering AI drug companies are keeping humans in the loop, at least for now, and documenting everything carefully. At Insilico, Zhavoronkov says, human chemists still have to synthesize the drugs, create variants, and test them on animals. “That’s the person who is going to be named on the patent,” he says. “And even if you decided to completely roboticize this process, including the experiments, someone will still push the button and give the budget.”

Should pushing a button count as being an inventor? Abbott says that’s a question for future legal cases. “What if I asked Claude to cure cancer, and it did?” he says. “I think it would be inappropriate to claim that I invented that.” 

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.

Zydus Lifesciences announces the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP, 25,000 mg/50 mL (500 mg/mL) and 5,000 mg/10 mL (500 mg/mL). The product is primarily used for the short-term treatment of scurvy in adult and paediatric patients aged 5 months and older for whom oral administration is not possible, insufficient or contraindicated.

Zydus’ Ascorbic Acid Injection is the generic equivalent of the reference listed drug (RLD), Ascor Injection, 25,000 mg/50 mL (500 mg/mL). The USFDA has designated the ANDA for the product as a Competitive Generic Therapy (CGT). Eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the USFDA and, where applicable, the period runs from the date of first commercial marketing of the product.

The product will be manufactured at the group’s USFDA-approved injectable manufacturing plant at Jarod, near Vadodara in Gujarat, and will be marketed in the US market by Zydus Pharmaceuticals (US) Inc.

The brand product had annual sales of approximately $11.6 million in the US (IQVIA MAT June-2026).

The Group now has 448 approvals and has so far filed 513* ANDA with the USFDA. (*As on 30-June-2026)

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The agreement aims to accelerate the progression of the new enterovirus vaccine.

It seeks to leverage the global expertise that Charles River provides in areas, including biologics testing, virology, non-clinical development, and regulatory science.

The collaboration is intended to align development with global regulatory expectations and advance the vaccine programme.

Medigen Vaccine Biologics has previously secured approval for its Envacgen Enterovirus 71 Vaccine in Taiwan and Vietnam.

Based on this prior regulatory experience, the company is moving forward with the development of a next-generation vaccine to address broader enterovirus strains.

As part of this process, Charles River has been selected to supply the necessary analytical, testing, and regulatory support.

Charles River global manufacturing corporate senior vice-president Kerstin Dolph said: “We are excited to collaborate with MVC and apply our testing and NGS expertise for vaccine development.

“By leveraging our experience in biologics, analytics, and safety, we are proud to partner with companies like MVC to achieve key milestones and drive innovation in the industry.”

The two companies plan to integrate Charles River’s biologics testing and non-clinical development capabilities with Medigen’s research in order to accelerate development and support investigational new drug (IND)-enabling non-clinical studies.

The partnership also seeks to generate data for global IND applications and future clinical pathways. They have indicated a shared interest in exploring further vaccine development opportunities in response to global infectious diseases.

Charles River has recently enhanced its NGS testing capabilities through the acquisition of Pathoquest. The company’s biologics testing solutions offer expertise and regulatory support across the entire developmental life cycle for clients worldwide.

The post Charles River and MVC to develop enterovirus vaccine appeared first on Pharmaceutical Business review.

Over the last five years, more than 1,300 WellSpan patients at 12 cancer sub-specialties have received support from the partnership, which includes physician consultations, multidisciplinary tumour conferences, and access to subspecialty expertise.

Around 500 WellSpan patients have enrolled in clinical trials that are being by Johns Hopkins Medicine.

WellSpan Health president and CEO Roxanna Gapstur said: “When we expanded this collaboration five years ago, we shared a vision of bringing together the strengths of a leading academic medical centre and a nationally recognised community-based cancer programme to better serve patients across our region.

“Today, that vision continues to deliver meaningful benefits for our patients and it reflects our shared commitment to ensure more people can access world-class cancer care while remaining close to home and surrounded by their support systems.”

Johns Hopkins Health System president and Johns Hopkins Medicine executive vice-president Kevin Sowers said: “Our collaboration with WellSpan Health reflects a shared belief that every patient deserves access to the highest level of cancer expertise, regardless of where they live.

“Over the years, we have built strong clinical and research relationships that support healthcare professionals, advance innovation and improve patient experience.”

The extended collaboration will reach patients in areas, including the Central Susquehanna Valley, where WellSpan is investing in a programme for oncology at WellSpan Evangelical Community Hospital.

Starting this autumn, phased improvements will introduce local oncology, infusion, and eventually radiation oncology and advanced cancer services.

Earlier this year, WellSpan collaborated with Cancer Care Associates of York to support cancer care efforts in York County.

The post WellSpan and Johns Hopkins renew partnership for advanced cancer care access appeared first on Pharmaceutical Business review.

Dr Chinwe Akuonu explores fluoride misinformation, personalised preventive care and how a patient-friendly approach can improve the compliance with and effectiveness of fluoride treatment.

In this episode of Dentistry Connected, Solventum clinical advisor Karen Toole speaks with general dentist Dr Chinwe Akuonu about the changing role of fluoride therapy. Their conversation explores misinformation around fluoride, the importance of personalised preventive care and how factors such as taste, texture and treatment time can influence patient compliance.

They also discuss Clinpro Clear fluoride treatment and how a clearer, simpler and more patient-friendly application could help bring professional fluoride treatment into the modern dental practice.

Have patients become more prevention-aware, or are they more confused?

Chinwe: I would say both. They are definitely more prevention-aware, thanks to social media. We all have access to the internet on our phones, so if you are ever confused about something, you can look it up.

We know how expensive it can be to treat disease, especially dental disease, and we are aware of the NHS crisis and people who do not have access to dentistry.

At the same time, there is still a lot of confusion. There is a lot of information out there, but sometimes that information can be untrue. Patients come into practice and say, ‘I read about this’ or ‘I saw this video on TikTok. What do you think?’

Fluoride is particularly relevant. Patients ask: ‘Is it toxic? Is it not toxic?’ When we are about to put fluoride varnish on children, parents can sometimes be worried.

When we talk about fluoride, it is about understanding that many things are good for us but can be harmful in very high doses. Fluoride is one of those things where we weigh the benefits against the possible damage. When it is used within the recommended doses, we know that it works really well.

How do sensory sensitivities such as texture, taste and smell affect compliance?

Chinwe: They definitely affect compliance, especially with children. If a child does not like the smell or taste of something, they are not going to let you put it in their mouth. They will spit it out straight away.

After fluoride application, we tell patients not to eat or rinse. Imagine having a taste you do not like in your mouth. As soon as you step out of the practice, you are going to spit it out and rinse.

For a patient at high risk of dental disease, that protection is then gone. If there is no compliance, we are wasting our time, money and resources.

The consistency and texture are also important, particularly for neurodiverse patients. After the application of some fluoride products, patients can experience a sticky feeling. Children sometimes sit with their mouths open because they do not know what to do. They are thinking: ‘Should I stay open? Should I stay closed? Can I swallow?’

These factors can seem like small details, but they can make a significant difference to whether the treatment is accepted and ultimately effective.

Why is toothpaste not enough for some patients?

Chinwe: Because we are not all the same. Some people are more predisposed to developing disease.

Patients may be neurodiverse, have impaired mobility, gum recession, hard-to-reach areas or deep pits and fissures. These factors increase their risk, and the amount of fluoride in a regular toothpaste may not be enough.

That is when extra professional care and the application of a high-fluoride treatment become important.

Sometimes patients try their best to do everything correctly, but every time they come in, there is another cavity. They are brushing, flossing and using interdental brushes, but they still need extra help.

It is not one size fits all. It is about understanding the patient’s risk of dental disease and creating a care plan specifically for them.

How is Clinpro Clear different from traditional fluoride varnishes?

Chinwe: From my point of view as the dental professional applying the product, it is very easy to use. It has a single-use applicator, and it is simple to press, activate and apply.

I have found that it sticks to the tooth rather than the brush. It is also clear and transparent, so the patient does not get up from the chair with a coloured varnish visible on their teeth.

Having that clear, smooth feeling on the teeth is important for patients. There are also different flavour options for different kinds of patients. There is a flavourless option, which can be useful for neurodiverse patients, as well as mint and watermelon.

We are all different in terms of flavour and sensory preferences. Giving patients options can help make the experience easier and improve their acceptance of the treatment.

Listen to the full conversation on YouTube or Spotify.

Click here to find out more about Solventum.

This article is sponsored by Solventum. Solventum, the S logo and Filtek are trademarks of Solventum or its affiliates. 3M is a trademark of 3M company.

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Every industry is racing to optimize AI in their operations. For many biotech research teams and investors that means “generative genomics.”

Generative genomics is an emerging field of study using AI to analyze genetic sequences. Researchers hope that, with AI, they can efficiently assess the world’s collected stores of DNA/RNA data, discovering overlooked patterns that lead to new treatments. 

Experts believe this technology will lead to faster results and increase the success rate of clinical trials. The possibilities were discussed during a panel at the BIO International Convention (BIO 2026) entitled “How Can Generative Genomics Help Us Design Biology Better, Not Just Faster.”  

Cause for excitement

When it comes to reducing time and costs of developing medicine, there is potential for major efficiency gains. It can take more than a decade for a new product to go from the planning stage to rollout, and according to Genentech CEO Ashley Margagee, the cost of developing a drug is $2 billion on average.

The most optimistic proponents of generative genomics say AI could shorten drug development time from years to months, creating money savings too.

Accuracy could also improve. Currently, 90% of clinical trials fail, a figure that has remained stubbornly stable despite decades of advancements in the industry. Any change in that situation could be impactful.

“Just increasing success by five percent is a massive deal,” said John Androsavich, General Manager of Ginkgo Datapoints at Ginkgo Bioworks. “Investments that move the success rate by small increments would be huge.” 

Generative genomics could be the technology that finally moves the needle, according to experts. AI categorizes and processes data at a speed never seen before. As the global biotech industry continues producing more data, AI can recognize patterns from across different sources and present its own conclusions. It will become easier than ever before for scientists to learn from research conducted by others. 

Ensuring trust and quality

Biotech is a high-stakes industry: a literal matter of life and death. For biotech researchers to engage with generative genomics to its full potential, their model must be able to earn their trust.

“If the most beautiful, accurate model doesn’t change a decision, it’s not useful,” said Julie Rytlewski, a Senior Director at Bristol Myers Squibb. 

She explained the real proof of success will not come from generating accurate hypotheses, but instead when those hypotheses start changing researchers’ decisions. 

“There has to be trust in what these models are doing, especially when it comes to treating people,” Rytlewski said. “As we build trust, people value the output of the models more. It won’t be a switch overnight.”

The panelists agreed that developers cannot—and should not—rush the process in which AI wins over its skeptics. 

“There is no single modality that can unlock biology,” said Justin Guinney, Senior Vice President of Cancer Genomics at Tempus AI. “It requires a multimodal perspective.”

‘We’re seed-planters, not tree-buyers’

It is no secret that AI is a darling of investors, and their enthusiasm extends to generative genomics’ potential. But with so many options to choose from, companies have to be strategic about which platforms they rely upon.

Danjuma Quarless, Senior Director of AI Innovation at Lilly Ventures gave the BIO 2026 panel insight on the industry’s decision-making process. Lilly Ventures, as the investment branch of biotech titan Eli Lilly, is tasked with “intersecting with the next great generation of biotechs” ahead of their rise to prominence. His strategy is to partner with as many promising developers as possible, a process which involves much speculation.

“I like to say that we are seed-planters, not tree buyers. We foster many small options without fear of redundancy.” 

Rytlewski agreed, and explained why large companies are taking chances with early-stage models.

“One of key ideas is blended innovation: it’s not ‘build’ or ‘buy’ but partnering. It’s not uncommon for us to place multiple bets. It’s all about finding the right tool for the right ambition.”

This tactic of backing several developers at once is indicative of the optimism that established biotech companies have in generative genomics. It reflects the confidence that the industry will prove incredibly lucrative, and that it is better to pick the eventual winning companies early on.

“Most foundation models are in the ‘preclinical stage,’” said Jeff Leek, Co-CEO of Synthesize BIO, which is developing its own generative genomics model. “We are at the very beginning of the game.”

Much has been said about the ways AI will reshape the world, but its introduction into biotech could lead to unprecedented streamlining of the discovery to approval pipeline. And in biotech, time saved means lives saved.

The post BIO 2026: Generative genomics helps biotechs design better, not just faster appeared first on Bio.News.

Glenmark Pharmaceuticals, USA (Glenmark) has announced the launch of Calcium Gluconate Injection USP in the US in 1,000 mg/10 mL (100 mg/mL) Single-Dose Vials, 5,000 mg/50 mL (100 mg/mL) Single-Dose Vials and 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package.

Glenmark’s Calcium Gluconate Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug, Calcium Gluconate Injection, 1,000 mg/10 mL (100 mg/mL), 5,000 mg/50 mL (100 mg/mL) and 10,000 mg/100 mL (100 mg/mL), of Fresenius Kabi USA, LLC [NDA 208418].

According to IQVIA sales data for the 12-month period ending June 2026, the Calcium Gluconate Injection, 1,000 mg/10 mL (100 mg/mL), 5,000 mg/50 mL (100 mg/mL) and 10,000 mg/100 mL (100 mg/mL) market achieved annual sales of approximately $69.9 million*.

Commenting on the launch, Marc Kikuchi, President & Business Head, North America, said, “The launch of Calcium Gluconate Injection USP marks another important step in strengthening Glenmark’s U.S. injectables business and expanding our hospital portfolio. It reflects the disciplined execution of our strategy to build a differentiated and sustainable injectables business – one that addresses institutional needs, supports greater supply resilience and deepens Glenmark’s relevance across the U.S. healthcare system,” he added.

The post Glenmark launches Calcium Gluconate Injection USP in US appeared first on Express Pharma.

Lupin has announced that VISUfarma B.V. (VISUfarma), a wholly owned subsidiary of Lupin, has entered into an exclusive licensing agreement with Visus Therapeutics Inc., U.S.A., a wholly owned subsidiary of Tenpoint Therapeutics Holding Limited (Tenpoint).

Under the agreement, VISUfarma will hold exclusive rights to undertake regulatory activities, commercialisation, marketing, promotion, distribution and sale of YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution) 2.75 per cent/0.1 per cent for the treatment of presbyopia in adults across the European Union, the United Kingdom, Switzerland, Norway and Iceland (Licensed Territories).

VISUfarma will make a strategic investment in Visus under the agreement. Tenpoint and Visus, individually or collectively, will also be eligible to receive regulatory and commercial milestone payments, as well as tiered royalties based on net sales.

Vinita Gupta, Chief Executive Officer, Lupin, said, “We are delighted to partner with Tenpoint Therapeutics to bring a novel ophthalmic therapy that advances our Specialty Care strategy. Building on the strategic acquisition of VISUfarma, this partnership further strengthens our vision care franchise and expands our presence across key European markets. The addition of YUVEZZI underscores our commitment to broadening access to differentiated therapies, improving patient outcomes, and reinforcing our leadership in eye care across the Licensed Territories.”

“This exciting partnership marks an important step for Tenpoint as we continue our work to make YUVEZZI available for the millions of patients with presbyopia and eye care professionals around the world,” said Henric Bjarke, Chief Executive Officer, Tenpoint. “Lupin’s strong commercial operations span major European markets, and its specialty ophthalmology company VISUfarma’s longstanding presence in eyecare makes them an excellent partner. We look forward to working together as we bring YUVEZZI to Europe.”

YUVEZZI is the first and only approved once-daily, dual-agent eye drop for presbyopia. The addition of YUVEZZI expands Lupin’s ophthalmology portfolio and supports its strategy to expand its specialty care business through therapies addressing patient needs.

Tenpoint is advancing the commercialisation of YUVEZZI in the United States following its U.S. FDA approval. Tenpoint has submitted an MMA in the UK through the MHRA’s International Recognition Procedure and will continue its plans for regulatory applications for YUVEZZI in other regions. 

The post Lupin signs exclusive licensing agreement for YUVEZZI in Europe appeared first on Express Pharma.

Regardless of your age, you are never too old for orthodontic treatment. Age is rarely a deciding factor for orthodontic treatment. While your orthodontist will consider many variables when developing your customized treatment plan, it can be as successful for adults as it is for adolescents. In fact, one in three orthodontic patients is an adult, proving that you don’t have to let your age keep you from the smile you’ve always wanted.

Adults Can Get Braces, Too

Although adults have greater bone density than children, the same principles for creating a beautiful smile apply to the young at heart. Check out this short clip from an AAO orthodontist and start your smile journey today.

Age and Tooth Movement: Is There an Impact?

Whether you’re 8 or 80, the physiological process that moves teeth through bone remains the same. Teeth move in response to forces being placed on them over time, regardless of how old you are. Many orthodontic problems can be corrected as easily for adults as for children and teens. While you may not be an adolescent anymore, your teeth can still be moved and adjusted to create a beautiful smile and a healthy bite.

How is Adult Treatment Different from Child Orthodontics?

The biggest difference in orthodontics for adults vs. children/teens is that adults are no longer growing. While this won’t impact the success of orthodontics, adult treatment may take slightly longer than that of a child with a similar problem, due to the maturity and density of adult bone tissue.

Additional factors your orthodontist will consider when determining the optimal treatment include the presence of fillings, missing teeth, misshapen or worn teeth, or dental diseases. Some medications and habits, like smoking, clenching or grinding teeth, or tongue thrusting, can affect the outcome of treatment. It’s common for orthodontists to work with a child’s family dentist to coordinate care, and the same applies to adult orthodontics. For some adults to reach optimal dental health, the dentist and orthodontist may need to call in other dental specialists such as oral surgeons, periodontists, and endodontists.

How Does the Adult Treatment Process Work?

To move your teeth to their ideal positions, your orthodontist will use an “appliance” to deliver controlled forces that gently and predictably reposition teeth. The most common appliances used in adult orthodontics are braces and clear aligners.

For those worried about aesthetics, advances in orthodontics have made treatment more comfortable and less noticeable than ever. Many of today’s treatment options are designed to minimize the appearance of the appliance to fit any lifestyle better. This includes clear aligners or different braces treatment options like ceramic braces, which blend into the color of your teeth; self-ligating braces, which can also be ceramic, making them more discreet; or lingual braces, which are mounted on the back sides of the teeth, making them virtually invisible but just as effective.

However, it is important to note that not every type of appliance is suitable for every kind of orthodontic problem, making it essential to be treated by a licensed orthodontist. By working with an orthodontic specialist, you ensure that the right appliance is selected to correct your unique orthodontic issue. Orthodontists have access to the full range of appliance options, and more than anyone else in the dental profession, orthodontists know which appliance is right for an individual patient’s care.

How Long Does Adult Orthodontic Treatment Take?

Adult orthodontic treatment varies depending on the severity and complexity of issues, and each patient will have a unique plan customized for their needs. Your orthodontist will be able to give you a more accurate timeline for your specific treatment during your initial consultation.

However, it is safe to assume that patients with mildly misaligned teeth will take around eight to twelve months, while more complex cases may take a few years to complete treatment. During that time, orthodontist visits are scheduled every six to eight weeks to monitor your progress. It’s a comparatively small investment of time that pays big dividends in improved dental health, jaw function, biting, chewing, dental hygiene, and overall self-confidence.

Just because you’re no longer a child doesn’t mean the opportunity for a healthy, beautiful smile has passed you by. You don’t have to spend the rest of your life hiding your smile. When considering orthodontic treatment, your age doesn’t matter. You can have the smile you’ve always wanted, and it starts with consulting an AAO orthodontist.

Achieve Your Best Smile with an AAO Orthodontist

You can work with an AAO orthodontist to achieve a healthy, beautiful smile at any age. Orthodontists are experts in orthodontics and dentofacial orthopedics – properly aligned teeth and jaws – and possess the skills and experience to achieve your best smile. Find an orthodontist near you and transform your smile.

The post How Old Is Too Old For Braces? Rediscover Your Smile At Any Age appeared first on American Association of Orthodontists.

The big question is how much oversight is needed and whether—or the extent to which—AI interactions should be documented and reported in regulatory filings.

Although the lab of the future may be envisioned as a self-driving lab, that’s actually a bad idea, noted Le Cong, PhD, associate professor, Stanford University, and co-founder of LabOS and MedOS. Instead, he and leaders in the AI and biopharmaceutical industries see the future of scientific AI as agentic, with humans in charge.

“We think there is a positive trend toward using AI in a way that’s human, rather than as a self-driving lab,” he said. In that environment, AI is simply a tool—albeit a powerful, adaptive one—that can be managed as long as scientists use the right prompts.

Humans in the lead

“Today, much of the scientific research process remains inaccessible to machines,” Cong and colleagues wrote in a recent paper. Despite automation and some use of AI, “Scientific discovery remains fragmented.” Specifically, AIs lack the tacit knowledge, evolving experimental context, human observations, and adaptive decision-making inherent in human scientists.

Human involvement is needed, therefore, not just to oversee AI-based activities and check the output, but to ask the right questions and to ensure that analyses make sense in context. Specifically, he describes a scientific setting in which an AI would handle an experiment’s execution, and the scientists would be responsible for:

• Framing objectives
• Interpreting results
• Setting constraints
• Governing risks

“If AI can interpret everything, then it will start to generate fake stuff, right?” Cong asks. “We’ve seen this when AIs begin guessing in an effort to return results and supply citations that don’t exist. There are certain things that are useful for AI to do in the lab.”

But, as last summer’s sandbox breakouts illustrated, an AI needs firm guidelines as to what it can do, where it can access information, and the degree of autonomy it has in meeting a request.

For example, he recommends adding this phrase to instructions: “Any actions not explicitly stated in the protocol need human approval.” That default to human judgment also should apply to determining the risks associated with certain actions, such as editing a human gene, Cong said. With those guardrails, the paper points out, agentic AIs can freely handle “routine execution and coordination across models, instruments, protocols, and laboratory states.”

Cong equates the scientific use of AI to autonomous vehicles, which, according to the Insurance Institute for Highway Safety, have a 68% lower crash rate per mile traveled than human drivers in the same environment. Given those statistics, he added, “My thought is to elevate humans to setting destinations. We do not need humans to always execute the driving.”

In a university scientific lab, that equates to staffing a principal investigator and trainees, without much of the hierarchy that exists today. In a corporate environment, the hierarchy flattens to scientists who propose, design, execute, and interpret experiments, and a lab manager. The distinctions between senior and junior scientists blur because much of the hands-on work is automated.

The combination of AI and lab automation is expected to reduce human errors. Cong cited a 2016 Nature study of 1,500 scientists. When asked, “’Can you replicate other people’s experiments, and can you replicate your own after a few months?’ approximately 70% could not replicate others’ experiments, and half could not replicate their own!” Cong said. “AI can improve that.”

AI risks minimal

As yet, it’s unclear how AI involvement in experiments should be preserved and reported in regulatory submissions, Cong continued. “We’re still early in this journey.”

That said, the risk that AI will escape its constraints and cause physical harm—like designing and developing a physical virus—appears relatively low, according to Cong. That’s because a rogue AI still needs a human accomplice to allow a virus, for example, to be manufactured and released. “In areas where there is a physical execution step, I think AI is still incapable,” he said, “although we are seeing progress in connecting AI to biomedical labs and applications, and the physical execution layer.”

That’s due to the fact that there are multiple layers of human intervention needed to actually manufacture a product. Aside from logistics, he cites good manufacturing practices, safety and efficacy regulations, and digital safeguards like track and trace and the FDA’s 21 CFR Part 11, as well as real-time monitoring, periodic inspections, and quality control activities. Those regulations and checkpoints should also be sufficient to manage variations that occur during manufacturing as real-time conditions drift from specifications.

The catch, as last summer’s breakouts of frontier AIs underscore, is that sometimes AIs exceed their parameters. Whether there is sufficient appreciation of this among AI users remains to be seen, Cong said.

“A lot of people are connecting AI systems, which have access to more and more information and key decision-making systems,” Cong pointed out, without deeply understanding the risks and establishing appropriate guardrails. “People might be overly trusting of AI, perhaps.

“The more powerful the AI, the more capable it is of doing something. Are people keeping pace [with the technology and its risks]?”

Sometimes, small, highly specific AIs may be a better choice than always leveraging the large frontier models, Cong suggested. The reason, Cong, senior corresponding author Mengdi Wang, PhD, professor, Princeton University, and a dozen colleagues, noted in a 2025 paper in Nature Biomedical Engineering, is that “Large language models often lack domain-specific knowledge and struggle to accurately solve biological design problems.”

Whatever level of AI is used, however, “Humans need to be in the lead throughout the process,” Cong stressed.

The post Protecting Scientific Intent in AI-Enabled Labs by Not Letting AI Set the Mission appeared first on GEN - Genetic Engineering and Biotechnology News.

Cells constantly control the fate of their proteins. They remove proteins that are worn out or no longer needed, but can also alter their activity, localization, or interactions with other molecules. The ubiquitin–proteasome system plays a key role in this process. Its enzymes tag selected proteins with ubiquitin, which acts as a molecular label. Depending on the type of tag, a protein may be directed for degradation by the proteasome—the cell’s molecular “shredder”—or subjected to another form of regulation.

Cullin–RING ligases belong to the largest family of E3 enzymes responsible for attaching these tags. Their precision depends on substrate receptors, which recognize the specific proteins that the ligase acts upon. The IIMCB scientists focused their work on the role of these receptors in genetic diseases.

The authors combined data on receptors’ function, tissue expression, and associations with different types of disease. They found that neurodevelopmental and neuromuscular symptoms are particularly common in diseases linked to these receptors, even though most of the receptors do not clearly show tissue-specific expression.

Their analyses therefore indicate that the clinical presentation cannot be explained solely by the sites of protein expression. Instead, other important factors may include the substrates they recognize, gene activity at different stages of development, the vulnerability of particular cell types, gene dosage, and the effect of a specific variant on the function of the entire cullin–RING ligase complex.

267 receptors, 93 linked to genetic diseases 

“We created the first systematic catalog of 267 cullin–RING ligase substrate receptors, 93 of which have already been linked to genetic diseases. This resource can serve as a reference point for research into rare diseases and the ubiquitin–proteasome system,” noted Natalia Szulc, a PhD student in the laboratory of protein metabolism at IIMCB and the first author of the article.

“It can help identify further potential disease genes and interpret variants detected in patients. It also facilitates studies into why different mutations in the same gene can produce different symptoms and disease courses. The catalog may also help reconstruct networks of relationships between receptors, their substrates, and other ligases, which is important for understanding why cells can sometimes compensate for the effects of a mutation, while in other cases disease develops.”

Targeted protein degradation is now an important direction in the development of new therapies, Pokrzywa added.

“Rare diseases show how precisely the ubiquitin–proteasome system must operate: altering a single component can have serious consequences that emerge only in particular tissues or at specific stages of development,” Szulc said.

“By analyzing variants found in patients, we can better understand which features of substrate receptors determine the function of cullin–RING complexes, which substrate interactions might be amenable to modulation, and where the limitations of therapies based on targeted protein degradation may lie. This provides valuable guidance for designing safer and more precise therapeutic strategies,” said Pokrzywa.

The post Scientists Analyze 267 Receptors That Control Protein Fate in Rare Diseases appeared first on GEN - Genetic Engineering and Biotechnology News.

The team discovered lymph node-like structures in the skull bone marrow of mice for the first time and demonstrated that they act as rapid first responders against brain cancer before distant lymph nodes get the signal that abnormal cells are present. The researchers also found evidence of similar immune cells in human skull bone marrow. The study is the first to find such immune hubs in bone.

“This study reveals that the skull bone marrow is far more than just a structural framework—it harbors previously unrecognized hubs for brain-specific immune responses,” said Jonathan Kipnis, PhD, the Alan A. and Edith L. Wolff Distinguished Professor of Pathology & Immunology and a BJC Investigator at WashU Medicine. “Uncovering this localized immune niche changes how we view neuroimmune interactions and opens exciting new avenues for treating brain tumors and other neurological diseases.”

Kipnis is senior author of the researchers’ published paper in Nature, titled “Functional role of skull lymphoid structures in CNS immunosurveillance.”

The Kipnis lab challenged the once widely accepted idea that the brain is shielded from the immune system when they discovered lymphatic vessels running through the dura mater, the outer tissue layer enveloping the brain underneath the skull. More recently, the team identified tiny physical channels bridging the skull, dura, and brain tissue, revealing a direct conduit for immune cells and cellular waste to move between the brain and local skull bone marrow. “Recent findings reveal that channels between the skull and the dura mater facilitate the exchange of cerebrospinal fluid and immune cells between the CNS and skull bone marrow of mice under both homeostatic and disease conditions,” the authors wrote in their newly published paper in Nature.

However, they pointed out, while accumulating evidence demonstrates that the CNS is not disconnected from the peripheral immune system, “… precisely how the adaptive immune system surveils the CNS remains a critical question … Skull bone marrow functions as a source of immune cells for the CNS5, yet its role in CNS antigen-specific adaptive immune responses remains unclear.”

For their newly reported research in mice, the team tracked the movement of proteins from the brain through the channels directly into the skull’s bone marrow, where they uncovered immune-system structures typically found in the lymph nodes. These act as the immune system’s training hub where T follicular helper (T_FH) immune cells assist B cells in creating large amounts of antibodies that help fight disease and infection. “…we demonstrate that the skull BM of mice contains cellular components that are characteristic of peripheral lymphoid organs,” they wrote. “We have never seen such structures in healthy bone marrow before,” said Jang Hyun Park, PhD, the study’s first author and a postdoctoral research fellow in the Kipnis lab who is starting his own lab at the Korea Advanced Institute of Science and Technology this year. “It is an exciting discovery that points out that a complex brain requires its own specialized immune structures to defend it.”

The researchers also developed a targeted therapy designed to supercharge antibody production inside the skull marrow. By delivering the mixture of the three immune-boosting proteins using a gel applied directly under the scalp, the researchers prompted a wave of tumor-fighting immune responses to attack the cancer. These responses, the research found, occurred first in the immune hubs in the skull bone marrow, then later in nearby lymph nodes outside the skull. Mice given the gel experienced better tumor rejection and lived longer compared with control mice. The collective data, the team wrote, “… indicate that skull-targeting CD40 agonism combined with administration of the IL-21 and IFNγ supports IgG responses in the skull BM and subsequently enhances intratumoural microglial, NK and CD8+ T cell anti-tumor responses while attenuating suppressive immune cells.”

Kipnis said, “The finding fundamentally changes our current understanding of neuroimmunology. Knowing that the brain relies on first responders in the surrounding skull for defense has the potential to change how we think about developing therapies for many neurological conditions, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, long COVID, and many others that have an immune component to them. Such therapies could access these immune hubs directly through the skull, without major peripheral side effects.”

The post Skull Immune Structures May Provide First Response Against Brain Cancer appeared first on GEN - Genetic Engineering and Biotechnology News.

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Angela M. Cacace, PhD

Chief Scientific Officer
Arvinas

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Angela M. Cacace, PhD

Dr. Angela Cacace serves as Chief Scientific Officer (CSO) at Arvinas. Prior to her role as CSO, Dr. Cacace most recently served as our Senior Vice President, Neuroscience and Platform Biology. Dr. Cacace has three decades of drug discovery experience in neuroscience and oncology research across modalities. During her time at Arvinas, Dr. Cacace has led the continuous evolution of our PROTAC Discovery Engine to employ new E3 ligases and cross the blood-brain barrier for multiple neurologic disease targets.

Previously, Dr. Cacace served as the Vice President of Biology at Fulcrum Therapeutics, where she built the biology platform, grew talented scientific teams, delivered the first development candidates, and guided the development of translational biomarkers to enable clinical development programs.

Additionally, Dr. Cacace served in positions of increasing responsibility at Bristol Myers Squibb, including as the Director of Neuroscience and Genetically Defined Diseases, where she spearheaded alternative therapeutic modalities and was a co-inventor on several development candidates. Throughout her time at Bristol Myers Squibb, she was responsible for building research-wide teams and initiatives, including the Lead Discovery and Optimization functions. While serving as a Sr. Principal Scientist in Cancer Biology at Pfizer, together with her team, she discovered a novel anti-angiogenic antibody development candidate. Dr. Cacace currently serves on the Board of Directors for BioCT.

Dr. Cacace received her B.S. in Biology from Fairfield University, Ph.D. in Pharmacology from Columbia University and completed her postdoctoral research in Oncology at Bristol Myers Squibb and the National Cancer Institute.

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Neurodegenerative diseases have long challenged researchers developing treatments for Alzheimer’s, Parkinson’s, and other neurodegenerative conditions. Small‑molecule inhibitors have shown limited clinical benefit, amyloid‑beta–focused approaches address only one of many underlying disease drivers, and repeated late‑stage failures have underscored the biological complexity of these disorders.

Within this landscape, the emergence of LRRK2 protein degraders and early data to date have reignited optimism—particularly as biomarker science begins to clarify which patients may benefit most. Learn more about the increasing rationale for targeting LRRK2 with PROTAC degraders and how protein degradation may enable deeper, more precise modulation of disease biology and open new avenues across neurodegenerative diseases.

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

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The post Is Targeted Protein Degradation the “Break” Neurology Needs? appeared first on GEN - Genetic Engineering and Biotechnology News.

The researchers then used artificial intelligence to analyze antibody patterns in samples collected before and after COVID-19 vaccination, identifying antibody signatures that helped distinguish strong vaccine responders from weak ones. In particular, they found that pre-existing antibodies to common microbes consistently predicted post-vaccination antibody responses in both healthy and immunosuppressed individuals.

These “sentinel antibodies,” the researchers suggest, may represent biomarkers of immune responsiveness to vaccination. “What our study found is that certain biomarkers, when analyzed with AI, can predict who is likely to respond well to a vaccine, even before they receive it,” said study lead Joshua LaBaer, PhD, executive director of the Biodesign Institute at ASU and director of the Virginia G. Piper Center for Personalized Diagnostics. “This suggests that some people may be more immune-ready than others.”

The team’s approach is one of the first to use a broad, pre-vaccine antibody “fingerprint” to assess immune readiness. Unlike some prediction methods that rely on genetic analyses, this strategy uses antibody patterns in blood, which may be easier to adapt for clinical use.

LaBaer and colleagues reported their findings in Cell Press Blue, in a paper titled “Pre-vaccine sentinel antibodies predict blunted vaccine responses,” stating that their results “… identify pre-existing antimicrobial antibody profiles as scalable biomarkers of humoral immune responsiveness and provide a framework for predicting vaccine responses before immunization.”

Vaccines protect most people from serious illness, but the strength of that protection can vary considerably from one person to another. Before a vaccine ever enters the body, the immune system may already hold clues to how strongly it will respond. Age, sex, genetics, prior illnesses, and underlying health conditions have all been linked to how strongly people respond to vaccines. People with immune-compromising conditions are often at higher risk of weaker responses. But even within these groups, outcomes can differ sharply.

Usually, scientists evaluate vaccine response after the shot has been given by measuring whether the immune system has produced antibodies against the target. For their newly reported study, LaBaer and team asked whether antibody patterns already present in the blood might predict an individual’s immune readiness and response to vaccination.

The team looked at antibody responses to 185 antigens, including SARS-CoV-2 antigens, other common viral and bacterial antigens, and targets associated with autoimmune diseases. To do this, the researchers analyzed 8,687 samples from 4,089 participants, including 2,445 healthy volunteers and 1,644 people with conditions or treatments linked to immune suppression, such as HIV, multiple myeloma, solid organ malignancy, autoimmune disease, inflammatory bowel disease, and solid organ transplantation.

They found that several immunosuppressed groups were more likely to have blunted responses to COVID-19 vaccination. But those categories were imperfect predictors. Some immunosuppressed participants mounted strong responses, while about 5% to 6% of healthy participants demonstrated weak responses. The results did find that higher levels of certain preexisting antibodies, including antibodies to common bacteria and viruses, such as Staphylococcus aureus, respiratory syncytial virus, and human respirovirus 3, were associated with stronger COVID-19 vaccine responses.

The researchers describe these as “sentinel” antibodies because they may indicate a person’s baseline immune readiness. They are not necessarily fighting the vaccine target directly. Instead, they may reflect how responsive the antibody-producing arm of the immune system is likely to be. “These broadly prevalent antimicrobial antibodies represent sentinel antibodies that may serve as biomarkers of system-level humoral immune competence,” the team stated.

The researchers then asked whether the full antibody fingerprint, not just a few individual markers, could help identify people likely to have weak vaccine responses. A deep-learning model analyzed patterns across the antibody panel, combining measurements into a broader immune profile. “Using global antimicrobial antibody profiles, we developed a deep-learning predictive model that stratified individuals according to their likelihood of mounting blunted vaccine responses,” they explained.

The study highlights a key strength of AI in health research: its ability to find subtle, predictive patterns in millions of biological data points that might otherwise remain hidden. The approach suggests that vaccine readiness may be better understood by looking at the immune system as a whole, rather than focusing only on a single disease or a single antibody.

The work also highlights the value of newer technologies that can measure large numbers of antibody responses at once. Instead of asking whether someone has antibodies to one pathogen, the method can scan a wider immune landscape, capturing patterns formed by many previous encounters with viruses, bacteria, and other immune targets.

The researchers say the findings could have implications beyond COVID-19 if they are validated in additional studies and with other vaccines. Sentinel antibody profiling could help guide vaccine testing, vaccine development, and clinical care for people at risk of weak immune responses. “Together, these findings identify pre-existing antimicrobial antibody profiles as scalable biomarkers of humoral immune responsiveness and provide a framework for predicting vaccine responses before immunization,” the authors wrote in summary.

The approach might eventually help doctors identify patients who need additional vaccine doses, closer follow-up, or alternative protective measures. It could also help researchers better understand why some people respond well to vaccination while others do not. The work points toward a future in which vaccine decisions could be guided by a person’s own immune readiness.

The post AI Identifies Pre-existing Antimicrobial Antibody Profile That May Predict Immune Response to Vaccination appeared first on GEN - Genetic Engineering and Biotechnology News.

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A dedicated dentist, teacher, mentor and public servant, John Chope made a lasting contribution to the profession over a remarkable 50-year career.

Dr John Chope passed away peacefully in his sleep at home on 1 August 2026, after a five-month illness with pancreatic cancer.

He graduated from Bristol University Dental School in 1972 after six years of study, which included an intercalating physiology degree. During this period, he studied taste receptors, reflecting an early interest in the scientific foundations of dentistry and medicine.

In 1973, he was employed by the University of Khartoum, where he worked as a senior lecturer in physiology in the Faculty of Medicine. His role involved both teaching and examining medical students.

During his time in Sudan, John also became a co-founder of Khartoum Dental School. He assisted with the establishment and design of the first dental course in Sudan and contributed to its teaching, combining his academic work in physiology with the development of dental education.

On returning to Bristol, John became a senior house officer (SHO) in the oral surgery department. He subsequently worked in general practice in Bristol and Shepton Mallet before opening his own practice in Holsworthy, a small market town in Devon.

Running his own practice required skills that went far beyond clinical dentistry. Out of necessity, John developed not only as a dentist and employer, but also as an engineer, electrician, plumber and builder. These practical abilities became another important part of a working life characterised by wide-ranging interests and skills.

He remained an enthusiastic and dedicated dentist for 50 years, working in his own practices in Holsworthy, Okehampton and Hartland in Devon, and Bude in Cornwall.

Beyond the practice

John’s commitment to dentistry extended well beyond his own practices and communities. Teaching and supporting other members of the profession remained a significant part of his life.

His involvement in education, which had begun during his time in Khartoum, continued throughout much of his professional career, establishing postgraduate teaching for young dentists and mentoring right up until his retirement in 2024.

John also gave many years of service to the wider dental profession. He served on the General Dental Council (GDC) for 17 years and worked for 15 years as an independent medicolegal expert.

He was a National Council member for 16 years, including nine years as chair of the Confederation of Dental Employers (CODE). He was also a National Council member of the Dental Practitioners’ Association (DPA) for six years.

His professional responsibilities extended beyond these organisations. John was an expert professional panel member of the Family Health Services Appeal Authority and the Health, Education and Social Care Chamber of the First-tier Tribunal of the Ministry of Justice for 18 years.

Alongside this extensive professional service, he also served as a magistrate for 25 years, adding another long-standing commitment to public life.

In 2005, John became a member of the external advisory board for the successful Peninsula Medical School dental school bid in national competition, contributing once again to the development of dental education.

His commitment to dentistry also took him overseas later in his career. In 2018, John volunteered as a dentist and dental team leader with a small multidisciplinary clinical team working for the International Health Service charity in remote Honduras.

As well as providing dental care, he took on responsibility as the dental team leader. The majority of the treatment provided during the trip was oral surgery.

Sharing wisdom

John was committed to sharing the knowledge and experience he had accumulated throughout his career.

He gave more than 50 professional talks to dental groups on a wide variety of subjects, with titles ranging from ‘Hypnosis in dentistry’ to ‘That’s a fine mess you got us in! Understanding current GDS crisis’. The breadth of these subjects reflected the wide range of issues that interested him within dentistry.

Writing was another important part of John’s contribution to the profession. Over the years, he wrote more than 150 dental articles, the majority of them for Dentistry magazine and CODE. Together with his lectures and professional talks, his writing provided another means through which he shared his knowledge and views with colleagues.

John’s interests, however, went far beyond dentistry. They included farming, architecture, building, structural design, inventing and sketching.

These interests often had a distinctly practical and creative dimension. He produced his own technical drawings, designed dental and agricultural equipment, and even illustrated his professional talks himself.

John will be remembered for his remarkable contribution to dentistry, his commitment to teaching and mentoring, his many years of professional and public service, and the breadth of interests that accompanied his working life.

Across five decades in dentistry, he remained closely involved with the profession through clinical practice, education, writing, mentoring and service.

Follow Dentistry.co.uk on Instagram to keep up with all the latest dental news and trends.

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Matthew D. Youngblut, PhD

Co-founder and Chief Scientific Officer
Flock Bio

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Panelist

Matthew D. Youngblut, PhD

Matthew Youngblut, PhD, is the co-founder and CSO of Flock Bio, where he leads the development of high-quality DNA library technologies for protein engineering, genetic medicines, crop science, and synthetic biology. His work focuses on solving the practical challenges that sit between library design and useful experimental data, including DNA synthesis, cloning bias, barcoding, library assembly, and NGS-based quality control. Prior to Flock Bio, Matthew worked across synthetic biology and DNA technology at companies including Ginkgo Bioworks and Twist Bioscience.

Matthew holds a PhD in chemistry from the University of Wisconsin-Milwaukee and has spent his career developing and applying high-throughput molecular biology technologies to make biological experimentation more scalable and quantitative.

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Divya Vijay Pratheek

Vice President of Product
Ribbon Bio

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Panelist

Divya Vijay Pratheek

Divya Vijay Pratheek is the Vice President of Product at Ribbon Bio. She played a pivotal part leading the launch of the MiroMine product to ensure laboratories can access cell-free DNA synthesis at their bench. She previously had impactful roles at QIAGEN and various startups, where she led cross-functional teams and managed product portfolios and growth strategies for large portfolios across automation, reagents, and software.

Divya holds a BS degree in microbiology, zoology, and chemistry from Mount Carmel College, Bangalore, and an MS in Communications Science from North Carolina State University.

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Complex DNA workflows are often slowed by bacterial cloning, challenging genome sequences, and lengthy production cycles. A technology that brings cell-free DNA synthesis directly to the bench would give researchers an accessible, on-demand way to build high-fidelity DNA sequences without bacteria. Such an approach is now offered by Ribbon Bio’s MiroMine^TM: this helps avoid bacterial contaminants such as endotoxins and host-cell DNA, while supporting complex or sensitive sequences that can be difficult to produce through conventional cloning.

In this GEN webinar, speakers from Flock Bio and Ribbon Bio will explore how bench-based, cell-free DNA production can complement expertise in custom DNA design and manufacturing. Drawing on applications including CRISPR screening, enzyme evolution, lineage tracing, and massively parallel reporter assays (MPRAs), they will discuss how MiroMine^TM can reduce dependence on conventional cloning, shorten production cycles, and give researchers greater control and confidentiality. Attendees will learn how accessible cell-free synthesis can accelerate the path from design to experiment and enable cleaner, faster, and more flexible research workflows.

A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.

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The post Built Without Bacteria: Bringing Cell-Free Synthesis to the Bench appeared first on GEN - Genetic Engineering and Biotechnology News.

GSDIa is a rare genetic metabolic disorder caused by a deficiency in the enzyme required for releasing glucose from the liver into the bloodstream.

This deficiency impairs the liver’s ability to manage glucose levels, leading to a risk of severe hypoglycaemia and requiring continuous nutritional monitoring, often involving frequent intake of raw cornstarch as oral glucose replacement.

The FDA granted accelerated approval for Genglycos, also known as DTX401, based on data from a 48-week double-blind, randomised, placebo-controlled Phase III study involving 46 participants who were treated with either DTX401 or a placebo.

The GlucoGene study demonstrated a statistically significant reduction in cornstarch requirements among those who received the gene therapy.

According to the trial’s protocol, participants who completed 48 weeks were able to cross over to the alternate treatment, and follow-up analyses are planned at weeks 96 and 144.

As part of the approval, Ultragenyx will provide two years of efficacy and safety data from an open-label commercial treatment group comprising 50 patients.

This will be conducted alongside 20 control patients who are unable to receive Genglycos due to anti–adeno-associated virus serotype 8 (AAV8) antibodies.

Data collection will occur via the GSDIa Disease Monitoring Program, which will track both new commercial patients and previous trial participants for up to ten years.

Ultragenyx chief medical officer Dr Eric Crombez said: “The approval of Genglycos fulfills our commitment to provide the first therapy that directly targets the root cause of GSDIa.

“The reduced reliance on cornstarch, experienced by patients in our clinical studies, demonstrates this gene therapy’s ability to establish the normal breakdown of glycogen to produce glucose during fasting or episodes of metabolic stress.

“This ability to regulate glucose has alleviated the disease burden and has the potential to mitigate the risk of severe or life-threatening hypoglycaemia for these patients.”

Genglycos is set to be distributed through a network of Qualified Treatment Centers and manufactured at the company’s facility in Bedford, Massachusetts.

In July 2025, Ultragenyx received a complete response letter from the FDA concerning its biologics licence application for UX111 (ABO-102), an adeno-associated virus gene therapy aimed at treating Sanfilippo syndrome type A (MPS IIIA).

The post FDA grants accelerated approval to Ultragenyx’s Genglycos gene therapy appeared first on Pharmaceutical Business review.

ISHRAE Thane Chapter, along with ISHRAE Mumbai Chapter, successfully hosted PharmaConnect 2026 – Cleanroom Conclave, a knowledge-sharing and networking platform bringing together professionals from the pharma, biopharma, cleanroom, HVAC, engineering, consultancy and allied industries.

Held at Hotel Ramada, Navi Mumbai, the conclave was organised around the theme “Transcending Frontiers in Pharma: Evolution of Biologics & Facility Adaptation for Next-Gen Sustainable Manufacturing.”

The programme served as a platform for industry leaders, pharma professionals, consultants, technology providers, HVAC experts and facility specialists to discuss the rapidly evolving requirements of the pharma manufacturing ecosystem. The pharmaceutical industry is undergoing significant transformation with the growth of biologics, advanced therapies and next-generation manufacturing technologies — developments that are creating new challenges and opportunities in facility design, cleanroom technology, HVAC systems, contamination control, energy efficiency, sustainability and regulatory compliance.

The gathering was addressed by Tejas Gawde, President, ISHRAE Thane Chapter; Mukesh Suthar, President, ISHRAE Mumbai Chapter; and Manoj Khati, Convener, PharmaConnect 2026, whose remarks set the tone for the event.

PharmaConnect 2026 addressed these emerging requirements through a combination of technical presentations, keynote sessions, expert discussions and a panel discussion, enabling participants to exchange experiences and perspectives.

The event featured eminent industry professionals, including Shyam Khante, President, Shyam Khante & Associates; Ajit Kadam, Director, Spectrum Pharmatech Consultant; and Bhupeshkumar Patil, Associate Vice President, Knexir Consultant, along with other experts from the pharma and engineering ecosystem.

A key highlight of the programme was a panel discussion moderated by Gautam Baliga, which brought together industry experts including Prashant Kavale, Shyam Khante, RV Kulkarni, Adnan Khan and Ajit Kadam. The panel discussed the challenges associated with evolving pharma facilities, sustainability, technology adoption and the changing needs of next-generation manufacturing. The discussion underscored the need for future pharma facilities to balance product quality, patient safety, regulatory compliance, operational reliability, energy efficiency and environmental sustainability.

Speaking on the occasion, the organisers highlighted the need for stronger collaboration between pharmaceutical manufacturers, consultants, technology providers and HVAC professionals to develop facilities that are not only compliant but also energy-efficient, resilient, sustainable and future-ready.

Recognising industry excellence

PharmaConnect 2026 also provided an opportunity to recognise and acknowledge the contribution of professionals and organisations supporting the growth and advancement of the pharmaceutical industry. The event witnessed strong participation from professionals across the pharma and allied sectors, creating opportunities for knowledge exchange, professional networking and collaboration.

The success of PharmaConnect 2026 reflects the commitment of ISHRAE Thane Chapter to promoting technical excellence and creating meaningful platforms for interaction between the HVAC&R and pharma industries.

Looking ahead

With the pharma industry moving towards biologics, advanced manufacturing technologies and increasingly sustainable operations, the role of cleanroom engineering, HVAC, contamination control and energy-efficient facility design will become even more critical. PharmaConnect 2026 highlighted the importance of bringing stakeholders together to share knowledge, address emerging challenges and explore solutions for the pharma facilities of tomorrow.

ISHRAE Thane Chapter extended its appreciation to all speakers, panelists, sponsors, supporting organisations, delegates and volunteers whose contribution helped make the conclave a successful industry gathering

The post ISHRAE successfully hosts PharmaConnect 2026 – Cleanroom Conclave in Mumbai appeared first on Express Pharma.

It enables drug discovery teams to computationally assess and rank how strongly candidate molecules are likely to interact with specific disease targets.

Unlike established computer methods that require detailed structural data about the target molecule, AQPotency does not rely on existing structural maps.

This capability allows researchers to evaluate potential drug compounds even for targets that lack structural information, which has typically limited access to traditional computational screening.

SandboxAQ stated that early-stage drug discovery often involves selecting which molecules to assess experimentally, a process that can be both costly and time-consuming if unsuitable candidates are chosen.

Existing computational narrowing techniques are described as slow and expensive, and restricted to cases where a detailed structure is available.

AQPotency addresses these shortcomings by providing rapid ranking of molecule-target pairs and delivering results in seconds using standard computing resources.

The model reports both the predicted activity and a confidence assessment, indicating whether a target falls within its reliable performance range.

The tool is also designed to support analysis in the opposite direction.

Researchers can input a molecule and receive a prioritised list of proteins that the compound may interact with, which could be useful when a molecule demonstrates effects whose mechanisms are not yet clear.

SandboxAQ drug discovery vice-president Andrea Bortolato said: “AQPotency has given us and our customers a faster, scalable and reliable way to prioritise compounds in the workflows we already run, without needing a 3D crystal structure of the target. This opens up programmes that structure-based methods simply couldn’t reach.

“The confidence intervals make the output actionable for biopharma companies, and the model has already been successfully used in eight customer programmes with experimentally validated impact.”

The post SandboxAQ introduces AQPotency for virtual drug screening appeared first on Pharmaceutical Business review.

Mankind Pharma has entered into an exclusive in-licensing and marketing agreement with Chongqing Chenan Biopharmaceutical Co., Ltd., China, for the commercialisation of two insulin analogues, Insulin Degludec and Insulin Degludec + Aspart Combination, in India.

The partnership marks a step in Mankind Pharma’s strategy to strengthen its presence in diabetes care and broaden its portfolio of injectable therapies. The addition of these products will further enhance Mankind Pharma’s position in the injectable diabetes segment, contributing to a more comprehensive portfolio and reinforcing its commitment to addressing the evolving needs of patients.

The partnership further reinforces the company’s commitment to expanding its diabetes portfolio and bringing a broader range of treatment options to patients in India.

Commenting on the partnership, Atish Majumdar, Senior President – Sales and Marketing, Mankind Pharma, said, “China is rapidly emerging as a hub for innovative biopharmaceutical assets. Building on our partnerships for Insulin Aspart and Insulin Degludec, we remain focused on expanding our in-licensing pipeline from China. This partnership reinforces our commitment to expanding access to advanced therapies for patients in India while further strengthening our presence in the injectable diabetes segment.”

The partnership with Chongqing Chenan Biopharmaceutical is also aligned with Mankind Pharma’s broader strategy of leveraging global innovation through strategic partnerships and in-licensing opportunities. China’s developing biopharmaceutical ecosystem presents opportunities for Indian pharmaceutical companies to access differentiated and innovative assets that can complement their existing portfolios.

The post Mankind Pharma inks agreement for two insulin analogues in India appeared first on Express Pharma.

Strides Pharma Science has announced that its flagship manufacturing facility in Bengaluru, India, has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA), indicating the closure of the inspection conducted at the facility.

The USFDA conducted a current Good Manufacturing Practices (cGMP) inspection of the facility from May 12 to May 20, 2026. As previously disclosed to the stock exchanges on May 20, 2026, the inspection concluded with the issuance of a Form 483 containing five observations. The company submitted a response addressing all observations within the stipulated timeline.

Based on the company’s response and the corrective and preventive actions implemented, the USFDA classified the inspection outcome as Voluntary Action Indicated (VAI) and issued the Establishment Inspection Report (EIR), thereby concluding the inspection.

The facility is Strides’ flagship manufacturing site and serves regulated and other international markets. The facility manufactures pharmaceutical dosage forms, including tablets, capsules and oral liquids, supporting existing commercial products and future growth opportunities.

The closure of the inspection further strengthens Strides’ regulatory track record and reinforces the company’s commitment to supplying pharmaceutical products to patients across global markets.

The post Strides Pharma receives USFDA EIR for Bengaluru facility appeared first on Express Pharma.

Glenmark Pharmaceuticals has announced the receipt of U.S. FDA approval for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray. Glenmark’s Fluticasone Propionate Nasal Spray USP is bioequivalent and therapeutically equivalent to the reference listed drug, Flonase Nasal Spray, 0.05 mg/spray of Haleon US Holdings LLC [NDA 020121], and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIA sales data for the 12-month period ending June 2026, the Flonase Nasal Spray market achieved annual sales of approximately $295.2 million.

Commenting on the approval, Marc Kikuchi, President & Business Head, North America, said, “The approval of Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area. We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.”

The post Glenmark receives USFDA approval for Fluticasone Propionate Nasal Spray appeared first on Express Pharma.

Ahead of her Dentistry Show London 2026 presentation, Emily Lu discusses the growing role of platelet-rich fibrin (PRF) in everyday clinical practice.

Platelet-rich fibrin (PRF) has attracted considerable interest in recent years. What has driven that momentum, and why is it becoming increasingly relevant in everyday clinical practice?

I think it has been driven by a combination of biological appeal, clinical practicality and a growing evidence base. PRF is prepared chairside from the patient’s own blood and provides a fibrin scaffold containing platelets, immune cells and signalling molecules that can support the natural wound-healing process.

It is also relatively straightforward and cost-effective to prepare, which makes it more accessible for everyday practice. However, its growing popularity should not lead us to overstate what it can achieve. PRF is most valuable when used as a biological adjunct in carefully selected cases, alongside sound treatment planning and meticulous surgical technique.

The evidence base for PRF continues to evolve. Where do you think the evidence is strongest today, and where is more research still needed?

Our understanding has become more nuanced. Earlier discussions often focused on the presence of growth factors, whereas we now appreciate that PRF is a three-dimensional fibrin matrix that can support cell migration, angiogenesis and the gradual release of biological mediators.

Clinically, some of the most consistent evidence relates to improved early soft tissue healing and reduced postoperative discomfort, particularly following extractions. There is also encouraging evidence for its adjunctive use in periodontal intrabony defects, ridge preservation and ridge reconstruction procedures, where it may support wound healing and be combined with grafting materials to enhance their handling and biological environment.

However, the evidence is less consistent for some implant-related applications, peri-implantitis and predictable long-term hard tissue gains following ridge preservation or reconstruction. Protocol heterogeneity also remains an important limitation.

We therefore need to distinguish between promising biological mechanisms, improved early healing and evidence of predictable long-term regeneration.

Which patients and clinical situations are most likely to benefit from PRF, and how do you decide when it is the right option?

I tend to think about the clinical indication before thinking about the material. PRF may be particularly helpful when supporting soft tissue healing is a priority, for example following extraction or oral surgery, and as an adjunct in appropriately selected periodontal intrabony defects and regenerative procedures.

The decision depends on the defect anatomy, the patient’s plaque control, smoking status, systemic health, healing capacity and ability to maintain the result. I would also consider whether the patient is comfortable with venepuncture and whether there are relevant medical or haematological considerations.

Most importantly, PRF cannot overcome uncontrolled disease, poor plaque control, unsuitable defect anatomy or inadequate surgical technique. Patient and site selection remain fundamental.

What practical advice would you give clinicians who are considering introducing PRF into practice?

Start with a clearly defined clinical indication rather than purchasing a centrifuge and then looking for situations in which to use it. Undertake appropriate training in venepuncture, preparation and handling, and use a validated protocol consistently.

The whole dental team should understand the workflow. Blood collection, centrifugation, preparation of the clot or membrane and delivery to the surgical site are all time-sensitive. It is helpful to establish a written protocol covering equipment checks, infection control, consent, documentation and the management of complications.

I would begin with straightforward, well-selected cases, record outcomes carefully and avoid changing several protocol variables at once. Consistency is essential if clinicians want PRF to become a predictable part of their workflow.

Your session at Dentistry Show London is titled ‘PRF chairside: translating biology into everyday practice’. Without giving too much away, what practical insights can delegates expect to take back to practice?

The practical message is simple: start with the patient and the clinical problem, ensure the fundamentals of disease control and surgical technique are in place, and then ask whether PRF offers a biological and evidence-based benefit in that particular situation. If delegates can apply that reasoning the next day, rather than seeing PRF as a universal solution, the session will have achieved its purpose.

Want to learn more?

Dr Emily Lu will be joined by Dr Triantafyllio Zafeiri and Dr Aiste Volkyte for ‘PRF chairside: translating biology into everyday practice’ in the Specialty Interest Theatre at 11:15 on Saturday 10 October during Dentistry Show London 2026. Register free of charge at london.dentistryshow.co.uk.

This article is sponsored by Closerstill.

Eppendorf has introduced a new addition to its Eppendorf Research 3 neo single-channel pipette line, launched in 2025. From today, laboratories worldwide can order 3-pack and 6-pack bundles at a special rate, making it easier and more cost-effective to upgrade to the latest Eppendorf pipetting technology.

The 3-pack bundles are available in three sets, each designed for common laboratory needs. Option 1 includes 10 µL, 100 µL and 1000 µL pipettes. Option 2 includes 20 µL, 200 µL and 1000 µL pipettes, while Option 3 includes 1000 µL, 5 mL and 10 mL pipettes.

The 6-pack bundle includes 2.5 µL, 10 µL, 20 µL, 100 µL, 200 µL and 1000 µL pipettes, along with a Pipette Carousel 2 for convenient and safe storage.

Eppendorf said all multi-packs include an original Eppendorf pipette pen as a bonus item.

The Research 3 neo pipettes address key pain points for scientists, including faster and easier volume adjustment with a lock to prevent accidental volume changes during pipetting, improved ergonomics with a shorter pipetting button, flexible labelling options, and the reliability and ergonomics Eppendorf is known for.

Further information about the Eppendorf Research 3 neo pipettes and value packs is available at www.eppendorf.link/research3neo.

The post Eppendorf introduces Research 3 neo pipette value packs appeared first on Express Pharma.

Invesco Mutual Fund has announced the launch of the Invesco India Pharma and Healthcare Fund, an open-ended equity scheme investing in pharma, healthcare and allied sectors.

The fund seeks to capitalise on India’s evolving healthcare ecosystem, which is being shaped by favourable demographics, expanding healthcare access, rising insurance penetration, growing global pharmaceutical leadership and emerging innovation-driven opportunities across healthcare and life sciences. The scheme will invest across pharmaceutical companies, hospitals, diagnostics, contract development and manufacturing organisations (CDMOs), contract research organisations (CROs), medical devices, healthcare services, insurance and other allied healthcare segments.

India today occupies a position in the global healthcare ecosystem, supported by its scale, talent pool, manufacturing capabilities and growing innovation footprint. Structural drivers such as increasing healthcare expenditure, ageing demographics, rising lifestyle diseases, expanding health insurance coverage, infrastructure development and growing global outsourcing trends are expected to create long-term opportunities across the healthcare value chain.

The fund will be managed by Aditya Khemani and will be benchmarked against the BSE Healthcare TRI.

Speaking at the launch, Aditya Khemani, Head of Equity & Fund Manager, Invesco Mutual Fund, said “India’s healthcare sector is undergoing a structural transformation. The country is not only witnessing rising healthcare consumption driven by favourable demographics and increasing affordability but is also strengthening its position as a global pharmaceutical and healthcare innovation hub. We see attractive opportunities across domestic pharma, hospitals, diagnostics, CDMOs and emerging healthcare segments that can potentially benefit from this multi-year growth cycle. Our investment approach will focus on identifying quality businesses with sustainable competitive advantages and strong growth visibility across the healthcare ecosystem.”

The minimum lumpsum investment amount during the NFO is ₹1,000 and in multiples of ₹1 thereafter. For SIP investments, the minimum application amount is ₹100 and in multiples of ₹1 thereafter. The fund will charge an exit load of 0.50 per cent for units redeemed or switched out on or before three months from the date of allotment. No exit load will be charged if units are redeemed or switched out after three months.

The New Fund Offer (NFO) is open for subscription from August 18, 2026 and will close on September 1, 2026.

The post Invesco Mutual Fund launches India Pharma and Healthcare Fund appeared first on Express Pharma.

For physicians and health care leaders, the anniversary offers more than a retrospective. It highlights how a medical journal can help translate clinical experience and health system learnings into evidence that is easier to find, cite, and apply.

“Over the course of [the journal’s] existence, so many professionals have been instrumental in its growth and development, and its contributions to health care can be attributed to all who have participated,” wrote G. Richard Holt, MD, the journal’s editor-in-chief, in his latest editorial.

Holt’s message included reflections from others who helped shape the journal, among them Scott Young, MD, of The Permanente Federation and Kaiser Permanente’s Care Management Institute. “The journal’s growth is evident not only in the breadth and rigor of its scholarship, but also in its embrace of digital dissemination,” Young said, pointing to the journal’s numerous advances in indexing, branding, and workflow enhancement.

Milestones in visibility and reach

The journal is indexed in several major medical and scientific databases including PubMed, PubMed Central, Scopus, ResearchGate, and EBSCO. Inclusion in leading indexes is a significant achievement, given the rigorous criteria for acceptance. Further indexing expansions are anticipated. “Where a journal is indexed matters,” said Stephen Parodi, MD, vice president of The Permanente Federation, which publishes the journal. “Indexing status is not only a mark of prestige for a journal, but an important aspect of discoverability for busy clinicians and researchers.”

Related story: What’s causing the physician shortage and how to fix it: The Permanente Journal panel

The Journal, reimagined

In 2021, The Permanente Journal undertook a rebranding effort that included revising its aims and scope, refreshing its visual identity and updating its website. This work positioned the journal as an important venue for scholarly content in value-based care, health care delivery research, and integrated delivery systems, while maintaining its broader role as a platform for clinical research across medical disciplines.

The rebrand — guided by an interdisciplinary steering committee comprised of leaders from all Permanente Medical Groups — was followed by a publishing model change aimed at reducing barriers to participating in scholarship.

Related quality care story: Self-described ‘knowledge-seeker’ leads relaunch of The Permanente Journal

Expanding participation by open access

Although the journal has always been free to read, The Permanente Journal became fully diamond open access in 2023. Under this model, authors retain copyright to their accepted articles and publish under an exclusive license rather than transferring ownership. Importantly, authors pay no publication fees, and accepted articles are published without embargo and are immediately citable from online-first publication.

Recent high-interest articles include “Why Have All the Doctors Gone? Insights Into Early Clinical Departure Among Physicians in the United States: A National Survey” by authors Sea Chen, MD, PhD, and colleagues out of the American Medical Association, and Comparing Kaiser Permanente Members to the General Population: Implications for Generalizability of Research by authors Anna C. Davis et al. Both are among the journal’s most accessed, impactful articles.

The journal has also published expert panel discussions on current challenges in health care and clinical practice, including “Strengthening the Physician Workforce: An Expert Panel Discussion” moderated by Ted O’Connell, MD, and “Moving the Needle Toward True Value-Based Care: An Expert Panel Discussion” led by Nancy Gin, MD, FACP. These and other panels bring together a diverse range of voices to discuss some of today’s most-pressing topics in health care and clinical practice.

Readers have found value in the journal’s release of special sections, such as Improving Health Care Access (2026) and Trauma-Informed Health Care (2024), while those in research communities have cited “Comparing Kaiser Permanente Members to the General Population: Implications for Generalizability of Research” by Elizabeth McGlynn and colleagues over 350 times.

Get all the articles included for the 30th anniversary acknowledgment sent straight to your inbox. Sign up to receive journal alerts from The Permanente Journal.

The post The Permanente Journal at 30: A look at its role in care delivery research appeared first on Permanente Medicine.

Bio.News sat down with Katie Southwick, Vice President of Marketing & Communications at NPF to discuss their research on unreached patient populations and the lived experiences shaping their decisions.

Tell us more about your research on unreached patient populations. What inspired it? Why is there such a great need for this research?

There has been tremendous progress in psoriatic disease treatments. Today, patients are surrounded by messaging about the disease and new treatment options, whether on television, social media, or online. Despite that visibility, a significant portion of people living with psoriatic diseases remain undiagnosed or are still not taking advantage of modern treatment options. That disconnect led us to ask a simple question: Why?

As we dug deeper, we found that out-of-pocket cost and concerns about side effects were certainly a big driver. Importantly, we found that patients’ lived experiences often have a great impact on whether they continue engaging with the healthcare system. Negative encounters with healthcare providers, feeling dismissed, feeling unheard, or becoming discouraged after unsuccessful treatments can all influence future decisions about seeking care.

The need for this research is substantial. There are approximately 8 million people living with psoriatic disease in the United States, and another roughly 600,000 remain undiagnosed. Not managing psoriasis often leads to soaring health care expenses, productivity losses, and expensive long-term medical comorbidities such as cardiovascular disease or diabetes. Yet, many patients have no formal care plan or lack access to specialist care, particularly in rural communities. Understanding why patients disengage is essential if we want advances in treatment to translate into better outcomes for patients.

Your research suggests that the biggest barrier to care is “patient momentum.” Can you explain what this means?

Our research showed that many patients become stuck in what we call a “doom loop.”

Living with a psoriatic disease can be exhausting. Symptoms affect physical health, mental health, confidence, relationships, and daily routines. Over time, patients may experience frustration with the healthcare system, disappointment with not immediately finding the right treatment option that works best for them, or feelings of hopelessness. All of those factors build on one another and make it harder to take the next step toward care.

“Patient momentum” is really about helping people move forward again. Effective engagement is not simply telling someone there is a new treatment available. It is helping them believe that things can improve, that support exists, and that they do not have to continue struggling alone.

The study found that patients often settle into a “good enough” mindset, managing symptoms without seeking better outcomes. What are the risks of this approach?

Psoriasis is not just a skin condition. It is a chronic, systemic immune-mediated disease that can have serious long-term consequences when left inadequately managed.

When patients settle for “good enough,” they may not realize they are still at risk for disease progression and related health complications. For some individuals, that can mean the development or worsening of psoriatic arthritis, which can cause irreversible joint damage if not treated appropriately. Psoriatic disease is also associated with several comorbid conditions that can affect overall health and quality of life.

That is why one of our key messages is that good enough is not actually good enough. We want patients to understand that better outcomes are possible, and that staying engaged in care can help reduce the risk of more serious issues down the road.

What role does trust play in keeping patients engaged in care?

Trust is everything.

Patients are navigating an overwhelming amount of information today, and it is often difficult to determine what is evidence-based and what is not.

Organizations like NPF play an important role because patients need trusted sources of information and guidance. We work alongside leading clinicians, researchers, and patient advocates to help connect people with credible resources and support.

Trust also means recognizing that every patient’s journey is different. The same treatment approach does not work for everyone. Patients want to be seen, heard, and respected in their decision-making. Building that trust is critical to helping people move toward optimal care.

What needs to happen next to ensure that advances in treatment translate into action for the patients who remain disengaged from care?

Patients need to be met where they are. Disengaged patients are not necessarily choosing to ignore their disease. Many have experienced setbacks that have slowed their momentum. By listening to patients, validating their experiences, and demonstrating that better outcomes are possible, we can help more people move beyond the doom loop and toward a healthier future. The encouraging reality is that today’s treatments, combined with trusted support and education, can make a meaningful difference.

August is Psoriasis Action Month. NPF has launched our Is This a Thing campaign, which has the goal of empowering patients through education on psoriasis and validation that: “No matter what this disease does to make you ask: Is this a thing? The answer is typically: Yes, this is psoriasis.

NPF has also recently launched our Milestones to a Cure initiative. As part of this initiative, NPF is investing in innovative research designed to accelerate progress toward a cure for psoriatic disease. This funding opportunity will support researchers pursuing transformative, high-impact projects aimed at advancing our understanding of disease mechanisms, improving treatment approaches, and ultimately bringing us closer to a cure.

If you are interested in learning more about NPF and Psoriasis Action Month, visit https://www.psoriasis.org/psoriasis-action-month. Letters of intent for Milestones to a Cure are due Aug. 31. You can learn more here: https://www.psoriasis.org/milestones-to-a-cure-rfp/

Additionally, if you are a patient advocate, consider registering for the Biotechnology Innovation Organization’s Patient Advocacy Changemakers Event (PACE): an empowering and inspiring event focused on breaking barriers to access and ensuring that innovative medicines reach the patients who need them.

The post Connecting more patients with psoriasis to the care they need appeared first on Bio.News.

The results of research by a team at Osaka University studying Japanese supercentenarians aged 110 years and older, now suggest that a rare type of immune cell known as CD4 cytotoxic T lymphocytes, or CD4 CTLs, becomes increasingly abundant with extreme age. These rare cells have the ability to both recognize threats and destroy dangerous cells.

“Immune aging is not simply a process of decline,” said Kosuke Hashimoto, PhD, an associate professor at the University of Osaka in Japan. “The selective expansion of certain T cells suggests that, even in extreme old age, the immune system may continue to adapt to age-related challenges … CD4 CTLs are an atypical and relatively rare T cell population. So their marked increase in supercentenarians may provide important clues as to how the immune system is maintained in extreme old age.”

Hashimoto is first author of the researchers’ published paper in Cell Reports, titled “CD4 CTLs in supercentenarians: Signs of adaptive expansion in healthy aging,” in which they say that their collective findings “… suggest that CD4 CTLs expand and diversify as an adaptation to persistent antigens, potentially contributing to longevity through cancer suppression.”

While maintaining good health as we age is important, it is also difficult, considering that the risk of certain diseases increases with age, alongside weakened immunity to some illnesses. “Aging is an inevitable biological process, characterized by gradual declines in physical and cognitive functions. This process is driven by the accumulation of molecular and cellular alterations, including DNA mutations, mitochondrial dysfunction, and cellular senescence,” the authors wrote.

Among the various changes that occur at the cellular and molecular level, the team continued, “… aging of the immune system compromises its ability to defend against external pathogens and eliminate internal abnormal cells such as precancerous or senescent cells, increasing the risk of various diseases.”

This has raised an important question for researchers: why do some people live to a very old age while avoiding major diseases? Aging itself is not a disease, they commented, nor does it necessarily lead to the failure of essential physiological systems.

“Supercentenarians—individuals who live to or beyond 110 years—provide a model of healthy aging, achieving longevity while avoiding or delaying major age-related diseases such as cardiovascular disorders and cancer,” the investigators commented. “They maintain immune, cardiovascular, and epigenomic profiles that appear younger than expected for their chronological age.”

One class of immune cells, T cells, is traditionally divided into two groups: helper cells that coordinate immune responses and killer cells that destroy infected or cancerous cells. However, supercentenarians accumulate an unusual hybrid known as CD4 cytotoxic T lymphocytes, or CD4 CTLs. “Our previous study identified CD4 cytotoxic T lymphocytes (CD4 CTLs) as a hallmark of supercentenarians,” the team stated. These rare cells have the ability to both recognize threats and destroy dangerous cells. “CD4 CTLs are an atypical and relatively rare T cell population,” Hashimoto said. “So, their marked increase in supercentenarians may provide important clues as to how the immune system is maintained in extreme old age.”

To understand exactly how rare these hybrid cells are, the scientists analyzed blood samples of 28 adults who had been divided into three age groups: 70–99 years, 100–109 years, and 110 years and older. “In this study, we conducted integrated single-cell profiling of T cells, combining transcriptome, surface protein, and TCR sequence data across different age groups, including rare cohorts of centenarians and supercentenarians,” the investigators explained.

They found that the proportion of CD4 CTLs increased with age, with median percentages of 4%, 9.6%, and 17.6%, respectively. The hybrid cells remained uncommon throughout most of life, but were found to expand dramatically around the age of 100. In supercentenarians, these cells made up nearly one-fifth of all T cells in the blood, whereas they only comprised about 4% of total cells in the younger study participants. “We analyzed a rare cell population that is enriched in supercentenarians and found signs of immune remodeling in extreme old age,” said Hashimoto. “Rather than showing signs of exhaustion, they remain highly active and may help the body cope with persistent threats that increase with age.”

While the study findings suggest CD4 CTL expansion begins around 100, this phenomenon was not unique to centenarians and supercentenarians; one participant younger than 100 had the highest proportion of these cells. The team then looked at participants’ T cell receptors and determined that clonal expansion helps drive this increase. CD4 CTLs clone themselves when the immune system is under attack. The newly reported study found that the most prominent clone accounted for an average of 33.3% of CD4 CTLs, indicating that older adults may be responding to persistent immune threats. In one centenarian’s blood sample, a single clone accounted for 53.8% of their CD4 CTLs.

Next, the researchers matched the receptor sequences of each participant’s top CD4 CTL clone to those in a public database. Nearly three dozen matches belonged to people with cancer—namely lung, breast, and liver cancers. Because none of the centenarians or supercentenarians studied had been diagnosed with these cancers, the researchers theorized that their CD4 CTL expansion may reflect early immune responses. “Some CD4 CTLs may recognize cancer-related targets, although their exact targets remain unknown,” Hashimoto said. “The similarity between these receptor sequences and those found in T cells from tumors suggests that these cells may help recognize tumors before they become clinically detectable. It may be that immune changes in extreme old age are better understood as the immune system reorganizing itself rather than just wearing out.”

The study, which focused on T cells circulating in the blood, does not prove that having an abundance of CD4 CTLs prevents cancer or causes a person to live longer. However, the findings provide one of the clearest pictures yet of how the immune system adapts in people who achieve exceptional lifespans, offering insight into healthy aging and potentially contributing to protection against disease in supercentenarians.

“Our results revealed that CD4 CTLs expand with age and exhibit plasticity in cytokine production,” the team wrote in summary. “This suggests that CD4 CTLs may contribute to cancer suppression and longevity through adaptive responses to persistent antigens, emphasizing their role in immune resilience and healthy aging.”

Hashimoto noted that the team’s next step is to research how these cells behave in human tissues. “As we age, abnormal cells, including senescent and cancerous cells, become more common,” Hashimoto stated. “Our findings suggest that immune adaptation to these changes may contribute to exceptional longevity.”

The post Rare Immune Cell Type in Supercentenarians May Help Maintain Healthy Aging appeared first on GEN - Genetic Engineering and Biotechnology News.

Now, new work reports the development of a multi-organ chip that mimics how cancer cells spread from vascular flow to distant organs—the first model of cancer metastasis of its kind. The chip includes compartments with millimeter-sized engineered human bone and lung tissues, and the vascular flow that contains circulating breast cancer cells and allows the dynamic cross-talk of the tissues being colonized.

“The key advantages of this advanced model of metastasis are that it is human and can be patient-specific,” said Gordana Vunjak-Novakovic, PhD, university professor and professor of biomedical engineering and professor of medical sciences at Columbia University. “It faithfully mimics some of the key aspects of human metastasis that are otherwise largely inaccessible for direct study.”

This work is published in Science Translational Medicine in the paper, “Organ-specific colonization and niche remodeling in a human tissue model of metastasis.”

“The pressing need for developing human tissue models of metastasis has been a key motivation for our study,” said Vunjak-Novakovic. “Our objective was to probe the ability of cancer cells to adhere to and traverse across endothelium [inner lining of blood vessels], and to determine their capacity to survive in the tissues they are colonizing through cell reprogramming and niche remodeling.”

The study sheds light on a critical phase of metastasis, known as organ colonization, which is difficult to study using animal models. The process is highly complex, requiring the cancer cells to evade tissue defense and adapt to the specific organs they invade.

The multi-organ chip allows scientists to investigate, in detail, metastatic progression with patient cells and tissues. The platform enables controlled experimentation of cancer cell-tissue interactions within organ-specific microenvironments, toward revealing molecular pathways and therapeutic targets for metastasis.

To demonstrate the chip’s capabilities, the team examined the colonization of circulating human breast cancer cells in bone and lung. Bone and lung, common sites of metastasis for breast cancer, and the vascular endothelium were engineered from induced pluripotent stem cells (iPSCs) using tissue-specific scaffold-bioreactor culture systems. The engineered tissues were maintained in individual compartments of the chip, which were each optimized for tissue maturation and long-term maintenance of functionality, and linked to each other by vascular circulation.

A selectively permeable endothelial barrier separates tissue compartments from the vascular channel, as in the human body. Once the platform was established, the researchers introduced breast cancer cells into the vascular circulation to observe patterns of organ-specific colonization. In line with what happens inside the human body, cancer cells that typically gravitate toward the bone showed stronger bone colonization and induced more pronounced bone degeneration. In contrast, cancer cells that typically gravitate toward the lung caused greater disruption in the lung tissue and only modest colonization of bone. Distinct patterns of tissue colonization and secreted factors demonstrate that this device mimics key features of organ-specific metastasis observed in the human body.

In addition, a post-analysis of the engineered tissue revealed that cancer cells condition the distant organs to be more receptive to colonization. The team saw signs of this process—called pre-metastatic niche formation—across both tissue compartments.

“Cancer is very smart, unfortunately. We learned how the cells cross barriers to get from blood circulation into the tissues,” said Vunjak-Novakovic. “We were also able to reproduce something that happens in patients, where cancer cells condition the target tissues, even before they colonize them, to make them more receptive.”

The work is aligned with the trend of more preclinical research in the future, including engineered human tissues that can complement what is learned from animal models. “As the FDA and NIH place growing emphasis on new approach methodologies, this study is a concrete example of what that shift can look like in practice, applied to one of cancer’s most challenging hallmarks: metastasis,” noted Ilaria Baldassarri, a PhD student at Columbia University.

The post Human Multi-Organ Chip Offers New Insight Into Cancer Metastasis appeared first on GEN - Genetic Engineering and Biotechnology News.

Bio.News sat down with Katie Southwick, Vice President of Marketing & Communications at NPF to discuss their research on unreached patient populations and the lived experiences shaping their decisions.

Tell us more about your research on unreached patient populations. What inspired it? Why is there such a great need for this research?

There has been tremendous progress in psoriatic disease treatments. Today, patients are surrounded by messaging about the disease and new treatment options, whether on television, social media, or online. Despite that visibility, a significant portion of people living with psoriatic diseases remain undiagnosed or are still not taking advantage of modern treatment options. That disconnect led us to ask a simple question: Why?

As we dug deeper, we found that out-of-pocket cost and concerns about side effects were certainly a big driver. Importantly, we found that patients’ lived experiences often have a great impact on whether they continue engaging with the healthcare system. Negative encounters with healthcare providers, feeling dismissed, feeling unheard, or becoming discouraged after unsuccessful treatments can all influence future decisions about seeking care.

The need for this research is substantial. There are approximately 8 million people living with psoriatic disease in the United States, and another roughly 600,000 remain undiagnosed. Not managing psoriasis often leads to soaring health care expenses, productivity losses, and expensive long-term medical comorbidities such as cardiovascular disease or diabetes. Yet, many patients have no formal care plan or lack access to specialist care, particularly in rural communities. Understanding why patients disengage is essential if we want advances in treatment to translate into better outcomes for patients.

Your research suggests that the biggest barrier to care is “patient momentum.” Can you explain what this means?

Our research showed that many patients become stuck in what we call a “doom loop.”

Living with a psoriatic disease can be exhausting. Symptoms affect physical health, mental health, confidence, relationships, and daily routines. Over time, patients may experience frustration with the healthcare system, disappointment with not immediately finding the right treatment option that works best for them, or feelings of hopelessness. All of those factors build on one another and make it harder to take the next step toward care.

“Patient momentum” is really about helping people move forward again. Effective engagement is not simply telling someone there is a new treatment available. It is helping them believe that things can improve, that support exists, and that they do not have to continue struggling alone.

The study found that patients often settle into a “good enough” mindset, managing symptoms without seeking better outcomes. What are the risks of this approach?

Psoriasis is not just a skin condition. It is a chronic, systemic immune-mediated disease that can have serious long-term consequences when left inadequately managed.

When patients settle for “good enough,” they may not realize they are still at risk for disease progression and related health complications. For some individuals, that can mean the development or worsening of psoriatic arthritis, which can cause irreversible joint damage if not treated appropriately. Psoriatic disease is also associated with several comorbid conditions that can affect overall health and quality of life.

That is why one of our key messages is that good enough is not actually good enough. We want patients to understand that better outcomes are possible, and that staying engaged in care can help reduce the risk of more serious issues down the road.

What role does trust play in keeping patients engaged in care?

Trust is everything.

Patients are navigating an overwhelming amount of information today, and it is often difficult to determine what is evidence-based and what is not.

Organizations like NPF play an important role because patients need trusted sources of information and guidance. We work alongside leading clinicians, researchers, and patient advocates to help connect people with credible resources and support.

Trust also means recognizing that every patient’s journey is different. The same treatment approach does not work for everyone. Patients want to be seen, heard, and respected in their decision-making. Building that trust is critical to helping people move toward optimal care.

What needs to happen next to ensure that advances in treatment translate into action for the patients who remain disengaged from care?

Patients need to be met where they are. Disengaged patients are not necessarily choosing to ignore their disease. Many have experienced setbacks that have slowed their momentum. By listening to patients, validating their experiences, and demonstrating that better outcomes are possible, we can help more people move beyond the doom loop and toward a healthier future. The encouraging reality is that today’s treatments, combined with trusted support and education, can make a meaningful difference.

August is Psoriasis Action Month. NPF has launched our Is This a Thing campaign, which has the goal of empowering patients through education on psoriasis and validation that: “No matter what this disease does to make you ask: Is this a thing? The answer is typically: Yes, this is psoriasis.

NPF has also recently launched our Milestones to a Cure initiative. As part of this initiative, NPF is investing in innovative research designed to accelerate progress toward a cure for psoriatic disease. This funding opportunity will support researchers pursuing transformative, high-impact projects aimed at advancing our understanding of disease mechanisms, improving treatment approaches, and ultimately bringing us closer to a cure.

If you are interested in learning more about NPF and Psoriasis Action Month, visit https://www.psoriasis.org/psoriasis-action-month. Letters of intent for Milestones to a Cure are due Aug. 31. You can learn more here: https://www.psoriasis.org/milestones-to-a-cure-rfp/

Additionally, if you are a patient advocate, consider registering for the Biotechnology Innovation Organization’s Patient Advocacy Changemakers Event (PACE): an empowering and inspiring event focused on breaking barriers to access and ensuring that innovative medicines reach the patients who need them.

The post Not all patients benefit from progress against psoriasis appeared first on Bio.News.

The scientific team from Dongguk University in South Korea believes this represents a powerful non-invasive tool for understanding gene expression and for gene therapy.

DNA contains regulatory elements that control when, where, and to what extent specific genes are turned on or off. They can be co-opted to create “gene switches” that hold significant potential for understanding gene expression and for therapeutic applications, particularly for the non-invasive treatment or management of genetic disorders.

In recent years, researchers have developed several gene switches that enable the remote control of gene expression in living organisms using stimuli such as drugs, light, heat, ultrasound, and electrical signals. However, current versions are limited in offering precise control over the timing and duration of gene expression, according to the Dongguk University investigators. Additionally, drug-based gene switches can have undesirable adverse effects, while some stimuli, such as light, can make penetrating deeper tissues challenging.

Addressing these limitations, Jongpil Kim, PhD, and doctoral student Yerim Hwang from the Institute for Stem Cells and Regenerative Medicine at Dongguk led a group that developed a novel electromagnetic field (EMF)-responsive gene switch.

To identify EMF-responsive genes, the researchers performed single-cell RNA sequencing (scRNA-seq) on mouse brain tissue following exposure to an EMF of 2.0 millitesla at 60 hertz. The team found exclusive upregulation of Lgr4 expression. Through a series of validation experiments, the team found that the promoter of Lgr4 was well suited for constructing an EMF-inducible (Ei) gene switch, exhibiting precise activation with no detectable adverse effects during the study.

To evaluate the system in living animals, the researchers linked the Ei element to a reporter that produces green fluorescent protein (GFP), allowing gene activity to be visualized. They then generated transgenic mice carrying this reporter. Following EMF exposure, the mice showed strong GFP expression throughout the body, while targeted EMF exposure produced localized gene expression in specific organs.

When EMF stimulation was discontinued, gene expression returned to baseline within 24 hours, demonstrating that the Ei gene switch is highly tunable, reversible, and capable of precise remote control of gene expression.

Using a genome-wide CRISPR-Cas9 knockout screen, the researchers identified cytochrome b5 type B (Cyb5b), a membrane-associated protein, as the biological sensor for EMF. “This may be the first reported molecular sensor for electromagnetic fields,” noted Kim. Further tests revealed that due to EMF exposure, Cyb5b produces rhythmic calcium influx oscillations in cells, functioning as a specific code for activating the target gene.

The researchers also demonstrated several applications of the Ei gene switch, e.g., they established an AD mouse model that decouples brain aging from amyloid β plaque deposition. In addition, cyclic EMF exposure was used to achieve partial cellular reprogramming in aged and progeroid mice, improving several aging-associated markers without detectable adverse effects. The team also restored serotonin levels and reduced depression-like behaviors in mice by controlling expression of the Tph2 gene.

“This technology could move gene therapy away from a single, irreversible dose and toward simpler, real-time treatments administered by physicians or even wearable devices,” said Hwang.

Although further validation and testing are required, the Ei gene switch represents a promising platform for developing non-invasive, remotely controlled gene therapies, she added.

The post Gene Switch Uses Electromagnetic Fields to Control Genes Remotely appeared first on GEN - Genetic Engineering and Biotechnology News.

The call came from Stefano Menegatti, PhD, professor, Department of Chemical and Biomolecular Engineering at North Carolina State University, who says the limited availability of viral vectors has become a major bottleneck.

“Gene therapy is one of the most transformative frontiers in modern medicine. It holds the promise of curing devastating diseases with a single treatment. Adeno-associated viruses (AAVs) are the leading delivery vehicles for these therapies.

“Yet for all the excitement in the field, manufacturing remains a critical bottleneck: producing AAVs at the purity, potency, and scale needed for clinical use is enormously challenging,” he tells GEN.

A key obstacle is that current purification materials—usually resin-based affinity adsorbents—cannot distinguish between full AAV capsids that carry genetic material and empty capsids that have no payload.

Another issue with current purification technologies is the need to use low flow rates, which increases processing costs and, ultimately, gene therapy prices, Menegatti says.

“Purification technologies operate at slow flow rates, require harsh chemical conditions that can damage the product, and wear out quickly, all of which drive up manufacturing time and cost.

“For patients waiting on life-saving treatments, these are not abstract engineering problems. They translate directly into delayed access and higher prices,” he says.

Purification materials research

In May, Menegatti and colleague Michael Daniele, PhD, were awarded a NIIMBL grant to further develop a purification method with novel materials that they claim can differentiate between full and empty capsids.

“At the heart of it are AvXcel affinity adsorbents—developed by ChromaGenix—which substantially accelerate purification. More importantly, they selectively enrich full, gene-loaded AAV capsids directly at the capture step.

“Our preliminary data show that the fraction of full capsids increases from roughly 20−30% in the raw material to 34−48% in the affinity eluate, far outperforming the industry benchmark,” he says.

In addition, the membranes can also withstand harsh cleaning processes—up to 50 cycles with caustic solutions—which is in line with industry needs, Menegatti adds.

“The combination of speed, selectivity, and durability is genuinely unprecedented. We are not making incremental improvements; we are redesigning the purification step from the ground up, with the goal of transforming a months-long process development campaign into one that takes weeks.”

Machine learning

The NIIMBL grant will also support the ongoing development of a machine learning-based analytical software platform, called Beacon, designed to help manufacturers optimize vaccine purification.

Daniele tells GEN, “Even with next-generation purification materials, optimizing the process for each new AAV target remains a major challenge.

“Today, the standard approach is a trial-and-error methodology that requires dozens to hundreds of experiments to map out the right operating conditions for each new product. This must be repeated essentially from scratch for every new AAV serotype and transgene combination, which is both time-consuming and expensive.”

Beacon, or Bayesian-Enhanced AAV Chromatography Optimization Network, is a machine learning platform designed to help process developers avoid such repetition.

“It uses a Gaussian Process algorithm, a type of Bayesian AI that learns from each experiment and predicts the next most informative one to run. Rather than blindly sweeping through conditions, Beacon intelligently navigates the optimization landscape, reducing the experimental burden by 30−50% compared to conventional DOE while simultaneously optimizing multiple performance criteria: yield, full capsid enrichment, impurity clearance and productivity,” Daniele continues.

Another key Beacon feature is the use of North Carolina’s VVIRAL database, which comprises thousands of AAV purification experiments, to “warm-start” new campaigns.

Danielle tells GEN, “In other words, it doesn’t start from zero for each new product; it leverages everything we’ve already learned. And unlike a black-box AI, Beacon provides interpretable, quantitative outputs through SHAP analysis, so scientists understand why a particular protocol works, enabling smarter decisions and better risk management.

“Beacon will be released as an open-access, cloud-hosted platform to the broader biomanufacturing community, democratizing access to cutting-edge AI tools that were previously available only to a handful of computational specialists,” he adds.

The post Vector Production a Bottleneck for Gene Therapy Sector appeared first on GEN - Genetic Engineering and Biotechnology News.

“In modalities like small molecules, platforms are more or less plug-and-play and so are the systems used for automation, but there’s been a gap as people have moved to this new modality,” explains Ronnie Lum, PhD, director of analytical and quality control.

To contribute to the growing cell therapy ecosystem, Lum and his team have adapted readily available tools and systems to the smaller batch volumes produced in cell therapies.

“This field is new,” he says. “We want to be a pioneer and really push the envelope of where we can go with automation. Specifically in the analytical audit space, there aren’t many solutions out there, so we’ve really put the effort in.”

The customized system has been designed and built in collaboration with Hamilton Robotics and involves adapting the company’s existing analytical systems to liquid handling and, they hope, high-throughput automation with the aim of scaling up to commercial volumes in this new field.

The company hopes their new system will help them reach the market faster with their own pipeline of therapies and can be adapted easily afterward to the processes involved with their new products.

In general, they hope these technologies will drive down the cost of analytics across the cell therapy industry by reducing the sample volumes needed for testing and, thus, the cost of reagents used in complex assays.

Going forward, BlueRock Therapeutics urges other companies to join them in developing systems to address technological gaps. “We’re willing to push the boundaries by investing in these technologies and trying to innovate.”

The post Cell Therapy Company Aims to Pioneer Analytics Automation appeared first on GEN - Genetic Engineering and Biotechnology News.

“This project establishes a high-value circular manufacturing framework by capturing nutrient-rich spent media side-streams generated during biopharmaceutical cell culture and repurposing them as low-cost feedstock for precision microbial fermentation,” Dave Ow, PhD, a principal scientist and group leader, microbial cell bioprocessing at Bioprocessing Technology Institute (BTI), A*STAR, tells GEN.

The Singaporean team led by Ow and Prashant Mainali, PhD, a bioprocess scientist and researcher at the BTI, A*STAR, chose L. lactis as the production cell because it has a doubling time of 35−60 minutes and can secrete recombinant proteins, thus minimizing downstream purification steps. Because the spent fermentation media still contains nutrients, reusing and fortifying it lowers the cost of formulating fresh media, thereby enhancing productivity and lowering FGF2’s cost per gram.

For further gains, the team adapted this approach for a continuing manufacturing process for both intracellular production and secretion of FGF2, optimizing process conditions and integrating that model with downstream purification. Using it, they achieved 16 mg/L titers for intracellular forms and 396 µg/L titers for secreted forms of FGF2. Optimal conditions, they report, are 10 g/L glucose, 35°C cultivation temperature, and 100 ng/mL nisin.

Optimization focused around glucose concentration, temperature, and nisin concentration. “The interaction between glucose concentration and temperature was statistically significant,” they note. The glucose/nisin interaction was not. Increasing dilution rates increased FGF2 production to a point, after which washout occurred. Therefore, balancing the tradeoffs—for example, minimizing nutrient loss or maximizing FGF2 concentration or total output—is critical.

The scientists used a chemostat process, which enables continuous bioprocessing under steady-state culture conditions, to simulate process outcomes under varying conditions. The results, they report, “captured overall trends…[and] accurately predict the final concentrations of cells, glucose, lactate, and total intracellular FGF2 at the end of the chemostat run.” It underpredicts FGF2 concentrations, however.

Then they added depth filtration and crossflow filtration to the chemostat process, mimicking typical purification steps used in Escherichia coli, showing that such integration and streamlining is feasible. The FGF2 from this process was used without further purification to supplement cell cultures. When applied to a culture of Anguilla japonica (Japanese eel) cells, “Their growth was comparable to cells cultured with commercially available FGF2 and FBS-supplemented media,” Mainali and colleagues note.

“Our findings demonstrate that fortified spent cell culture media can support the growth of L. lactis and the secretion of FGF2,” Ow, Mainali, and colleagues conclude. Secretion simplified downstream purification, and the reuse of spent media is both cost-effective and environmentally sound, “potentially lower[ing] the cost of FGF2”…and “helping to overcome one of the principal economic barriers to serum-free media.”

Already, Ow says, “There is interest from biopharma manufacturers to potentially use this approach to upcycle spent media for their cell culture production processes to reduce media waste toward a more sustainable biomanufacturing future.”

The post Cutting Costs in Serum-Free FGF2 Processing With Recycled Media appeared first on GEN - Genetic Engineering and Biotechnology News.

Speaking to GEN, experts from VIVEbiotech, Terumo Blood and Cell Technologies, and Bracco describe an industry transitioning from demonstrating scientific feasibility to building robust manufacturing systems capable of delivering life-changing therapies to many more patients.

Parallel paths for CAR T innovation

“Ex vivo CAR T therapies will continue to play a critical role, while in vivo approaches are rapidly advancing and have the potential to broaden patient access by simplifying treatment pathways,” Natalia Elizalde, PhD, chief business development officer at VIVEbiotech, says.

Rather than viewing the two technologies as competitors, she expects them to develop side by side, each serving different clinical and operational needs. According to Elizalde, the industry’s priorities are shifting beyond proof-of-concept toward making therapies more widely available and economically sustainable.

She identifies advances in lentiviral vector engineering and targeted delivery technologies as major drivers of future progress. Improvements in manufacturing scalability and process robustness will also be crucial as commercial demand grows.

“The future of CAR T will not be defined by a single technological approach,” Elizalde says. “It will be defined by the ability of different platforms to address unmet patient needs while improving scalability, accessibility, and sustainability.”

Automation tackles manufacturing variability

While scientific innovation continues, manufacturing remains one of the biggest barriers to broader adoption. According to Wenyan Leong, PhD, director, APAC commercial, cell and gene therapies at Terumo Blood and Cell Technologies, the greatest challenge in ex vivo CAR T production is not any individual manufacturing step but the cumulative variability created throughout the workflow.

“Every manual intervention, open manipulation, operator-dependent activity, and process handoff introduces opportunities for variability, deviation, and operational complexity,” Leong says.

That variability extends from cell collection through processing, expansion, quality control, and final-product release. As manufacturers scale production, maintaining consistent product quality becomes increasingly difficult and expensive.

Leong believes automation offers a practical solution, although implementation should be tailored to each developer’s manufacturing strategy rather than applied universally.

“A useful framework is to automate where risk is highest, where variability has the greatest impact on product quality, and where scaling creates the most operational burden,” she explains.

For many manufacturers, cell expansion represents the most logical place to automate because it is labor-intensive, highly dependent on operator expertise, and difficult to reproduce consistently across multiple sites. By reducing manual processes and simplifying operations, manufacturers can lower costs while improving reproducibility and expanding patient access, Leong says.

Integrated manufacturing supports industrialization

Sophie He, PhD, vice president, cell therapy at Bracco, points to additional manufacturing bottlenecks that continue to slow commercialization. For example, she says ex vivo CAR T manufacturing must overcome complex supply chains, logistical challenges, and significant analytical demands that increase both timelines and production costs.

“In autologous manufacturing, patient-to-patient variability and poor starting-cell quality lead to inconsistent transfection and expansion,” He says. “In allogeneic approaches, the priority is obtaining highly pure starting material before stem cell differentiation into T cells.”

He also highlights fragmented cell selection and activation workflows as major contributors to cellular stress, inconsistent yields, and reduced product quality across both therapy modalities.

“Integrating multiple processing steps, such as cell selection and activation, into a single closed, continuous workflow reduces handling, washing, production time, and cost while improving cell viability and consistency,” He says.

According to He, combining workflow integration with automation and flexible manufacturing models, including point-of-care production, will enable reliable, high-throughput, and cost-effective CAR T manufacturing.

Taken together, these experts see the future of CAR T therapies resting on a combination of scientific advances and manufacturing innovation. As vector technologies mature and automated production becomes more sophisticated, both ex vivo and in vivo approaches are expected to complement one another, creating a more scalable and accessible ecosystem capable of bringing advanced cell therapies to far more patients.

The post CAR T Manufacturing Innovation Expands Patient Access appeared first on GEN - Genetic Engineering and Biotechnology News.

Device History Record (DHR)

A Device History Record (DHR) is a collection of records demonstrating that an individual medical device was manufactured, tested, inspected, and released in accordance with approved procedures and specifications. The DHR provides complete traceability for a specific device and serves as objective evidence that manufacturing activities were performed as required.

DHRs are most commonly used for devices that are individually identified and traceable through a unique serial number. Since each device can be distinguished from every other device, manufacturing and quality records are maintained at the individual device level rather than at a batch level.

A typical DHR may include:

• Device serial number
• Manufacturing date
• Components and material lots used
• Assembly records
• Inspection and test results
• Calibration verification records
• Nonconformance and rework records
• Final release authorization

Examples of Devices Commonly Managed Through DHRs

• Infusion Pumps
• Ventilators
• Patient Monitors
• Dialysis Machines
• Surgical Navigation Systems
• Medical Lasers
• Imaging Equipment
• ECG Machines

For example, an infusion pump with Serial Number IP-2026-000145 would have its own manufacturing, testing, and release records maintained within a dedicated DHR specific to that device.

Batch Production Record (BPR)

A Batch Production Record (BPR) documents the manufacturing activities performed for a defined batch or lot of medical devices produced under the same manufacturing conditions. Rather than maintaining records for each individual unit, the BPR captures information applicable to all devices within the batch.

BPRs are typically used when large quantities of identical devices are manufactured together and assigned a common batch number or lot number. In such cases, production controls, inspections, testing, and material usage are recorded at the batch level.

A typical BPR may include:

• Batch or lot number
• Manufacturing dates
• Raw material lot numbers
• Equipment used
• Process parameters
• In-process inspection results
• Final inspection results
• Yield calculations
• Scrap and reject quantities
• Batch release authorization

Examples of Devices Commonly Managed Through BPRs

• Syringes
• IV Administration Sets
• Blood Collection Tubes
• Catheters
• Surgical Gloves
• Wound Dressings
• Extruded Medical Tubing
• Diagnostic Test Strips

For example, a manufacturer may produce 10,000 PVC catheters under Batch Number CT-250801. Material consumption, yield calculations, scrap quantities, inspection results, and release activities for all 10,000 units would be documented within a single BPR associated with that batch.

DHR vs BPR: Are They Different?

Although the terms Device History Record (DHR) and Batch Production Record (BPR) are sometimes used interchangeably, they are often applied to different manufacturing scenarios. The primary distinction lies in the level of traceability required for the product being manufactured.

Why Yield Calculations Are Required

Yield calculations are used to demonstrate material accountability throughout the manufacturing process. Every component, raw material, subassembly, or consumable issued to production should be traceable to a documented outcome, such as acceptable finished product, scrap, rejects, samples, rework, or returned inventory.

Without yield calculations, manufacturers may be unable to explain differences between the quantity of materials issued to production and the quantity of finished devices produced. Such discrepancies can indicate process inefficiencies, material losses, documentation errors, inventory inaccuracies, equipment problems, or other manufacturing issues that require investigation.

Yield analysis also provides an objective measure of manufacturing performance. By comparing expected and actual production outputs, organizations can identify trends, monitor process efficiency, evaluate manufacturing controls, and detect unusual losses that may affect product quality or operational performance.

From a quality and regulatory perspective, yield calculations help demonstrate that:

• Materials issued to production have been appropriately accounted for.
• Manufacturing losses are identified and documented.
• Scrap, rejects, samples, and rework activities are traceable.
• Production processes remain within expected operating limits.
• Significant deviations are investigated and addressed when necessary.

For batch-manufactured medical devices, yield calculations are often performed as part of the Batch Production Record (BPR) and become an important element of production review and batch release activities. The resulting calculations provide evidence that manufacturing outputs are consistent with the quantities of materials introduced into the process and that all material dispositions have been properly documented.

Fundamental Material Accountability Terms

Understanding Overage

Overage refers to the additional quantity of materials intentionally issued to production above the theoretical quantity required to manufacture a planned number of devices. Overage is a planned and controlled manufacturing practice used to compensate for expected material losses that occur during routine production operations.

In an ideal manufacturing process, the exact quantity of materials required would be sufficient to produce the planned output. In reality, however, manufacturing activities frequently involve setup losses, process waste, inspection sampling, trimming operations, machine adjustments, and other unavoidable material consumption. To ensure that sufficient materials are available to achieve the intended production quantity, manufacturers often issue an additional quantity known as the overage.

Why Overage is Required

Overages may be established to compensate for:

• Equipment setup and start-up losses
• Process-related material waste
• Cutting and trimming losses
• Extrusion start-up scrap
• Inspection and testing samples
• Expected reject rates
• Validation or qualification samples
• Historical manufacturing losses

The amount of overage is typically determined using historical production data, process capability studies, engineering evaluations, or established manufacturing procedures.

Practical Example

A manufacturer plans to produce:

10,000 PVC Catheters

Historical production data indicates:

To ensure that 10,000 acceptable catheters can be produced, the manufacturer issues:

10,400 Catheter Components

The additional 400 components represent the planned overage.

Key Principle

An overage is not a manufacturing loss. It is an intentionally planned quantity issued to production to accommodate anticipated losses and ensure that the required production target can be achieved.

However, all overage quantities must ultimately be accounted for through documented outcomes such as:

• Finished goods
• Scrap
• Rughage
• Rejects
• Samples
• Rework
• Returned inventory

Any unexplained differences between issued quantities and recorded dispositions should be investigated through the organization's quality management system.

Relationship Between Overage and Yield

Although overage does not directly reduce yield, it influences the quantity of materials issued to production and therefore affects how manufacturing efficiency is evaluated. Excessive overages may indicate poor process capability, unstable manufacturing operations, or inadequate process controls, while well-controlled processes generally require smaller overage allowances.

Consequently, overage planning and yield analysis are closely related activities within Batch Production Records (BPRs) and play an important role in material accountability and production reconciliation. Once materials have been issued to production, manufacturers must determine how efficiently those materials were converted into acceptable finished devices. This assessment is performed through yield calculations, which compare production outputs against the quantities of materials introduced into the manufacturing process.

Understanding Yield

Yield is a measure of manufacturing efficiency that indicates how effectively materials issued to production are converted into acceptable finished products. It is one of the most important metrics documented within Batch Production Records (BPRs) because it provides objective evidence of material utilization and process performance.

In simple terms, yield answers the following question:

A high yield generally indicates an efficient manufacturing process with minimal losses, whereas a low yield may indicate excessive scrap, rejects, process waste, equipment issues, operator errors, or other manufacturing inefficiencies.

Why Yield is Important

Yield calculations help manufacturers:

• Evaluate manufacturing efficiency.
• Monitor process performance.
• Identify excessive material losses.
• Detect abnormal production trends.
• Support material accountability.
• Investigate unexpected process deviations.
• Improve production planning and overage estimates.

Practical Example

A manufacturer issues:

At the end of production, the following quantities are recorded:

All materials issued to production have been accounted for through documented dispositions. The quantity of acceptable finished products produced from the materials issued forms the basis of the yield calculation.

Basic Yield Formula

Example Yield Calculation

This means that approximately 95.24% of the materials issued to production were successfully converted into acceptable finished catheters.

Interpreting Yield Results

The yield formula presented above represents the most basic approach to yield calculation. In practice, organizations may use different methodologies depending on how they treat approved samples, reworked units, returned inventory, or planned process losses. Understanding these variations is important when comparing yield values across products, manufacturing sites, or production processes.

Gross Yield vs Net Yield

Although yield is often expressed as a single percentage, manufacturers may calculate yield using different methodologies depending on their procedures and reporting requirements. The two most common approaches are Gross Yield and Net Yield (Adjusted Yield).

The difference between these calculations lies in how certain material dispositions, such as approved samples, are treated during the yield calculation.

Gross Yield

Gross Yield considers only the quantity of acceptable finished product released from the manufacturing process. Any units consumed during testing, validation activities, or other approved uses are excluded from the acceptable output.

Net Yield (Adjusted Yield)

Net Yield recognizes that some units are intentionally removed from production for approved quality control activities, validation testing, sterility testing, retention programs, or other authorized purposes. Because these units were successfully manufactured and did not fail the process, some organizations include them when evaluating overall manufacturing performance.

Example Calculation

Assume the following production results:

Gross Yield Calculation

Net Yield Calculation

Comparison

Yield Reconciliation

Yield calculations provide an indication of manufacturing efficiency, but they do not by themselves demonstrate complete material accountability. To verify that all materials issued to production have been properly tracked and documented, manufacturers perform a process known as yield reconciliation or material reconciliation.

Yield reconciliation is the process of accounting for every unit, component, or quantity of material introduced into the manufacturing process by assigning it to a documented disposition category. The objective is to ensure that no material remains unexplained at the completion of production.

Fundamental Reconciliation Principle

For a batch to be considered fully reconciled, the total quantity issued to production should equal the total quantity accounted for through documented outcomes.

Common Material Disposition Categories

Practical Reconciliation Example

Assume a production batch receives:

Reconciliation Verification

Special Considerations for Moulding Operations

In injection moulding, compression moulding, and blow moulding processes, rughage often represents a significant proportion of total material consumption. Common examples include runners, sprues, gates, purging material, setup waste, color change material, and flash removal.

In some moulding operations, rughage may exceed the quantity of actual rejects. Consequently, manufacturers frequently track rughage separately from scrap and rejects to better understand process efficiency and material utilization.

• Could virtual reality be the future of agility training and injury prevention?
• Is creatine safe for young athletes?
• When to return to driving following a concussion

Could virtual reality be the future of agility training and injury prevention?

A fascinating new study has produced some very promising findings on the potential of virtual reality (VR) training. The researchers recruited 70 university-level basketball players and divided them equally into two groups: a virtual reality-assisted neuromuscular training group and a conventional neuromuscular training group. Both groups then completed a 12-week training intervention.

The basketball players in the VR-assisted group wore HTC Vive Pro headsets alongside Xsens motion sensors, and their training focused on dynamic balance, reactive agility, plyometrics, and basketball-specific movements. The results were impressive. When agility was assessed following the intervention, the VR-assisted group achieved substantially greater improvements on both the T-Test and Hexagon Test than the conventional training group. The neuromuscular findings were equally encouraging, with the VR-assisted group demonstrating notably greater improvements in reactive strength index (RSI), proprioceptive accuracy, and dynamic knee valgus.

One particularly interesting advantage of VR training is its ability to provide athletes with immediate feedback while they are actually performing a movement. By detecting changes in joint positioning, the technology can provide instant visual and aural feedback, allowing athletes to identify and correct movement issues in real time.

So, could virtual reality become part of the future of agility training and injury prevention? Based on the findings of this study, that possibility no longer seems particularly far-fetched. However, while the improvements in agility and several injury-related biomechanical measures are certainly promising, the study did not measure actual injury rates. Therefore, considerably more research is needed before VR training can be considered an effective injury-prevention strategy.

If you would like to learn more about VR training, check out our blogs Virtual reality for sports training: How VR can help pro and amateur athletes (and fans) and  Virtual reality for sports training: Can VR help athletes?

Is creatine safe for young athletes?

Leading sports and exercise scientist Paul Hough published an insightful post on LinkedIn regarding young athletes and their use of creatine. He reviews the current evidence surrounding creatine supplementation in this population based on existing literature.

Hough notes that while evidence on creatine use in children and adolescents is limited, the available research suggests that it is generally safe. According to the studies, a dosage of 0.1 to 0.3 grams of creatine per kilogram of body mass per day is considered safe. However, there is very little research on the effectiveness and safety of higher doses. Some individuals may employ a rapid loading phase, taking 0.3 g/kg four times daily for a week to quickly increase muscle creatine stores. Hough warns that this approach may lead to a higher risk of gastrointestinal discomfort.

Worryingly, Hough highlights research indicating that only 11% of young athletes could answer questions about creatine use correctly. This finding raises concerns about the potential misuse of creatine among young athletes and underscores the need for proper education and adult supervision if young athletes are taking creatine.

While more concrete evidence is needed on the effectiveness of creatine and appropriate supplementation guidelines for young athletes, Hough concludes his post by emphasising that young athletes should prioritise consistent training, sound nutrition, and adequate sleep before even considering taking creatine. This is undoubtedly the most important message.

When to return to driving following a concussion

A highly practical new study has shed light on the often-overlooked issue of driving after a concussion. The research involved 49 young adults who had been diagnosed with a concussion within the past 12 days. Each participant took part in a simulated driving assessment.

The findings revealed a clear trend: the closer the participants were to the day they suffered the concussion, the poorer their driving performance was. Interestingly, driving skills improved as more days passed since the injury, indicating that recovery happens gradually during the first couple of weeks post-concussion.

While return-to-play protocols for athletes have improved, protocols for returning to driving are often neglected. Based on this study’s results, it’s advisable to limit driving for at least the first 24 to 72 hours following a concussion. After that initial period, individuals should follow a gradual return-to-driving approach rather than jumping back in immediately.

From us this week:

>> New course: Micronutrients for Athletes
>> New podcast: Why Athletes Keep Breaking Down
>> New infographic: Sleep Hygiene Protocol
>> New article: Hydrotherapy

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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.

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Improving patient access to new treatments requires policy that supports America’s innovation ecosystem—not price setting that discourages investment, BIO tells a Senate working group.

Written comments by the Biotechnology Innovation Organization (BIO) advise against importing foreign pricing or increasing government setting of prescription drug prices.

Instead, BIO recommends reducing patient out-of-pocket costs, through measures like pharmacy benefit manager (PBM) reform, as well as policy to encourage investment in innovation and address aggressive biotech competition from China.

BIO’s 46-page policy analysis is a response to a “Request for Information: Commonsense Policy Options to Lower Drug Prices for Patients,” issued by the Drug Price Working Group led by Senate Finance Committee Ranking Member Ron Wyden (D-OR) with Sens. Catherine Cortez Masto (D-NV), Peter Welch (D-VT), Ruben Gallego (D-AZ), Mark Kelley (D-AZ), Tammy Baldwin (D-WI), Maggie Hassan (D-NH), Jeff Merkley (D-OR), Chris Van Hollen (D-MD), Tammy Duckworth (D-IL), and Richard Blumenthal (D-CT).

The goal of the RFI is to provide detail that can shape proposals from the Democratic working group.

“Sustaining America’s world-leading biotechnology pipeline will require policymakers to ensure that policies intended to improve affordability strengthen, rather than weaken, the ecosystem that makes continued innovation possible,” BIO’s Aug. 17 comments say.

BIO addresses various areas for action suggested by the Working Group’s RFI.

Price setting

The current drug-price negotiation program (DPNP), which will set prices on 100 drugs within the next five years, is already a drag on investment, and there is no need to increase its reach, BIO says. In particular, proposals to use international reference pricing ignore the realities of the U.S. market, which provides quicker and more robust access to medicines, the comments note.

To ensure investment in needed innovation, it is recommended that certain protections from DPNP are added or extended. Biologics and small molecule drugs should both have 13 years of protection from the DPNP, and there should be additional exemptions to promote development of orphan drugs for rare diseases, BIO says. Furthermore, the IRA Small Biotech Exception should not be allowed to expire in 2028:

“Protections for small biotech companies from the DPNP should be extended to support small and emerging companies that drive early-stage innovation,” say BIO’s comments. 

Across the more than 2,000 biotech companies in the U.S., approximately 300 are publicly listed, and most are small or mid-sized companies, according to a BIO fact sheet. Today, these small and mid-sized companies account for 71% of the industry’s total employment, originate 49% of all new drugs launched globally, and account for 54% of Food and Drug Administration (FDA) filings. 

BIO’s comments to the RFI also recommend policies to enable value-based pricing: “A holistic consideration of a treatment’s value to patients, families, and society should be the overarching principle when developing policies to provide sustainable access to novel, innovative, and transformative therapies.”

Increasing patient access

BIO’s recommendations for reducing the amount patients pay for drugs include reforming PBM practices and a range of other steps to ensure patients have access to needed medicines.

For example, automatic enrollment in the Medicare Prescription Payment Plan (MPPP) would make sure all patients have help in “smoothing” out payments over the course of a year.

Regarding “step therapy,” in which patients are expected to “fail first” on a cheaper medicine before receiving coverage for the drug their doctor prescribes, BIO calls for establishing clear exemption standards for patients in all types of coverage and eliminating step therapy for Part B drugs in Medicare Advantage.

BIO also encourages Congress to address other insurer practices that can restrict access, including eliminating copay accumulator programs, “so all forms of copay assistance count toward patient deductibles.” Furthermore, alternative funding programs (AFPs) that delay or prevent access by diverting insured patients to charitable assistance programs should be prohibited, BIO says.

Regarding PBMs, which use their market power to profit by driving up the cost of prescription drugs, BIO recommends several reforms, including:

• “Requiring fees to be transparent, delinked from medicine prices and formulary placement, consistent with fair market value, and not contingent on business conducted with PBM affiliates.”
• Insulating clinical decision-making from rebate and fee incentives.
• “Addressing vertical integration and associated value extraction enabled by self-dealing.”
• Expanding PBM transparency requirements.
• “Removing contractual barriers that prevent plans, employers, manufacturers, and patients from pursuing lower-cost options.”

Encouraging innovation to maintain U.S. biotech leadership

BIO notes the remarkable advances achieved through biotech innovation.

“Continued progress depends on a research ecosystem that supports scientific discovery, rewards risk-taking, and enables innovators to efficiently translate breakthrough science into therapies that reach patients,” BIO says.

BIO’s comments urge expansion of federal programs supporting translational research, such as the National Institutes of Health (NIH) and ARPA-H, as well as addition of new types of support for acceleration and commercialization.

Along with providing new treatments, innovation in the U.S. allows America to maintain its global biotech leadership in the face of China’s concerted efforts at competition, which can pose supply chain and security threats, BIO says.

“Investments in clinical trial infrastructure, regulatory modernization, workforce development, and manufacturing capacity can make the United States more competitive, while maintaining the scientific standards that distinguish FDA and the broader American system,” according to BIO.

China has become particularly competitive in conducting first-in-human clinical trials by enabling these trials to take place more rapidly there than in the U.S. BIO recommends several clinical trial reforms, including: streamlining regulatory processes, reducing operational burdens, improving patient participation and site activation, and modernizing Investigational New Drug (IND) requirements and review processes.

Overall, BIO recommends leaning into the natural strengths of the U.S. biotech ecosystem. “America’s advantage has always been its ability to innovate,” say BIO’s comments. Policies that drive innovation by enabling investment are therefore encouraged.

Read BIO’s full comments on the RFI.

The post Build patient access by strengthening innovation, BIO tells senators appeared first on Bio.News.

Physician optimism: three-year outlook

When asked about the future, 16 of the 29 specialties surveyed said they were optimistic about the next three years.

Radiologists were the most hopeful about their specialty, with 69% expressing optimism. Oncologists were close behind, with 67% saying they were optimistic about the next three years.

Internal medicine ranked the third-lowest, with only 27% expressing optimism about their specialty’s future over the next three years. Among nephrologists, only 22% said they were optimistic about the future.

Medscape’s analysis noted that between the most and the least optimistic specialties, there was a 47% gap.

Here’s a look at optimism by specialties over the next three years.

Physician optimism over the next three years: top seven specialties

Radiology: 69%.

Oncology: 67%.

Otolaryngology: 66%.

Psychiatry: 63%.

Pathology: 60%.

Cardiology: 59%.

Gastroenterology: 58%.

Seven most pessimistic specialties: short-term view

Public Health/Preventive Medicine: 46%.

Nephrology: 43%.

Infectious Diseases: 37%.

Ob/Gyn: 37%.

Pediatrics: 37%.

Family Medicine: 33%.

Internal Medicine: 35%.

Long-term pessimism by physicians

When asked about the long-term future for the Medscape survey, ob/gyns were the most pessimistic, with 50% saying they were worried about the future of their specialty three years out. Internal medicine was the second most pessimistic specialty, with 47% worried about the long-term future.

Physicians gave various reasons for their pessimism. One pediatrician, for example, noted that being part of one of the lowest-paying specialties in American medicine leaves “a very bleak outlook for the future.” Another physician predicted that “primary care will be taken over by AI in a year or two.”

Seven most pessimistic physician specialties about the long-term

Ob/Gyn: 50%.

Internal Medicine: 47%.

Family Medicine: 44%.

Emergency Medicine: 44%.

Nephrology: 43%.

Pediatrics: 42%.

General Surgery: 40%.

Which specialties will appeal to younger generations?

When asked which specialties, not just their own, will appeal to medical students and residents over the next three years, more than half of physicians identified dermatology and orthopedics.

Most physicians (71%) considered factors like “potential compensation” key in attracting the next generation of physicians. Work-life balance was identified by 57% by physicians as key to attracting new physicians. Reimbursement was identified by 53% and career prospects/job security was identified by 45%.

One physician responding to the survey said that nephrology could be attractive to new physicians because the field is data-driven and incorporating technology like AI and telehealth for conditions like CKD.

Interestingly, most physicians in the survey (60%) said that new physicians likely don’t have the information they need to choose a specialty while they’re still in medical school or training.

Which specialties will appeal to new physicians in the next three years?

Dermatology: 54%.

Orthopedics: 54%.

Cardiology: 34%.

Anesthesiology: 34%.

Plastic Surgery: 31%.

Radiology: 27%.

Emergency Medicine: 27%.

Would you go into medicine again?

Despite the pessimism expressed by many physicians in the survey, 73% said they would choose to become a physician again and 76% said they would choose the same specialty again.

In this part of the survey, the biggest regret was practice setting. Only 30% of physicians said they would choose the same practice setting, and 18% said they wouldn’t choose medicine at all.

For more data on how physicians view the future of their specialties, see Medscape’s analysis of its survey data. 

The post Physician optimism: What do you think about your specialty? appeared first on Today's Hospitalist.

Buying Medical Equipment

Pros

• You own the equipment which becomes an asset of the practice.
• Once it’s paid off you can continue to utilize the equipment without payment.
• You will have more freedom to move, modify, or dispose of the equipment.
• If you decide to upgrade to a different piece of equipment, you might retain better resale value.
• Depending on your business structure and current tax rules, you might qualify for deductions and depreciation.

Cons

• Upfront cash most likely will be required and might impact your working capital.
• Without purchasing a service contract, maintenance and repairs will become your responsibility.
• Technology might become outdated while you still own the equipment.
• If your practice grows, changes specialties, or moves locations you will have less flexibility.
• Capital might not be available in other areas such as payroll, marketing, inventory if it’s tied up in the purchase of equipment.

Leasing Medical Equipment

Pros

• You will be able to preserve your cash flow without making a large initial investment.
• Will free up money to make other purchases that the practice might need.
• Monthly budgeting will be more predictable.
• May become easier to upgrade if technology changes rapidly.
• Maintenance and service contracts might be included depending on the type of lease.

Cons

• Cost of the life of the equipment can cost more.
• Contract terms can be complicated.
• You will have committed to monthly payments even if the equipment isn’t being used as initially anticipated.
• You don’t necessarily own the equipment.
• Return/upgrade fees might be impactful depending on the terms of the lease.
• Tax impact can vary depending on your lease, so a CPA would need to review.

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The post Should You Purchase or Lease Equipment in Your Medical Practice? appeared first on DoctorsManagement.

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Tim Doswell reflects on the stark financial reality of supply-cost drift, explaining how unexamined overhead compounds into a devastating penalty when a buyer calculates your EBITDA.

Practice valuation is a function of earnings before interest, taxes, depreciation, and amortisation (EBITDA), and EBITDA is a function of overhead. Most of us focus on the wrong end of that equation for 15 years, and then a buyer’s accountant gets a closer look at our cost base than we ever did.

There is a moment that most principals experience only once, and almost always in retrospect. It is the moment you realise that a buyer has formed a clearer view of your practice’s cost base than you ever did, and has priced that view into their offer, without you ever seeing their workings.

The practice sale process

Earlier in the process, your accountant will have pulled together calculations of past and forecast EBITDA for the information memorandum that goes out to market.

By that stage, the cost base is what it is. There is not much remedial action you can take at that point that would meaningfully change the multiple.

And in many cases, the timeline to sell is not yours to decide. It is dictated by health, family circumstances, partnership issues, or simply the year you have settled on for personal reasons. The luxury of saying, ‘I will sell when my consumable costs are optimised’ is one most principals never have.

What I want to share is what I now wish I had understood about that ordinary, unremarkable corner of the business in the years before any of this became relevant.

Not because anyone is doing anything wrong, but because the maths of how supply costs translate into practice value is much less forgiving than most of us realise, and the window for doing something about it is much longer and earlier than I appreciated.

The number that quietly compounds

Industry analysis suggests that supplies and lab fees account for six to nine percent of gross revenue at a typical UK practice, depending on size and treatment mix.

For a practice collecting £800,000 a year, that is somewhere between £48,000 and £72,000 annually, before lab work is even considered.

Within that figure sits something that I now think of as the silent line item. It is the gap between what you are actually paying for your supplies and what comparable practices are paying for the same things.

Some of that gap is genuine market movement. Some of it is drift, which is what happens to prices in any market where buyers have no comparison data.

Drift is not dramatic. It is a few per cent on a composite syringe one year, a product code that gets quietly replaced the next, a promotional rate that expired 18 months ago and that nobody noticed reverting. Each change is too small to challenge.

The cumulative effect, across a few hundred regularly ordered line items, is a different matter.

Research from dental procurement analysts has found price variations of up to 30% for identical products between practices, depending on the supplier relationship and the timing of the last negotiation. Most of that variation is invisible to the practices experiencing it.

Why this is a valuation issue, not just a margin issue

Here is the part I genuinely did not appreciate while I was running my practice.

Dental practices in the UK trade on EBITDA multiples that vary by buyer, structure, and circumstance, but generally sit somewhere in the region of six to nine times. The exact number depends on factors specific to each transaction.

The principle, however, is constant. Every pound of recurring overhead in your practice is not just a pound off this year’s profit. It is several pounds off your eventual sale value.

The arithmetic is straightforward but worth pausing on. A practice spending £4,000 a month on consumables, with 15% of that figure sitting above market rate, is overspending by roughly £7,000 a year. At a seven times multiple, that is nearly £50,000 removed from the practice’s eventual sale value.

At a higher multiple, the figure is larger. And that is for one category of overhead, on a relatively modest spend, with a drift figure I would describe as middle of the road, based on what is now becoming visible across the industry.

The number is not the point. Multiples vary, drift varies, and every practice differs. The point is the structural relationship between cost discipline and valuation.

Every pound of unnecessary overhead you carry is multiplied into the price you eventually receive, in the wrong direction.

The hard lesson is that this multiplier works whether you know about it or not. The practices being acquired today are being valued by buyers who do know about it, and whose accountants are perfectly capable of doing this analysis themselves.

By the time it surfaces in due diligence, the principal has lost the chance to do anything about it.

Why careful people miss this

Nothing about price drift is the fault of the principals it happens to. The way prices move in this market is specifically designed to sit below the threshold of attention.

A composite syringe goes from £18.50 to £19.80 to £21.40 over three years. Each step looks like inflation. None of them is large enough on its own to question.

But the cumulative move is around 16%, which is roughly double what general dental inflation has been doing over the same period. You would only know that if you had a benchmark, and most of us never have.

There are several mechanisms involved, none of them sinister. Products get discontinued and replaced by new models with a different code at a higher price, so no like-for-like comparison is possible. Promotional rates quietly expire when you open an account, and the standard rate applies.

A box of 200 gloves becomes a box of 180, and the unit cost rises, even though the invoice never shows a price change.

Or, most commonly, your supplier gradually edges your price up because the longer you have been a customer, the less likely you are to switch.

None of this is dishonest. It is rational commercial behaviour in a market without price transparency. Every industry without price transparency works the same way.

Energy did, before comparison sites. Insurance did. Telecoms did. Dentistry, until very recently, has had no equivalent.

What I would do differently

The point of what follows is not that every principal should be preparing for sale. Most of the principals reading this will not be selling for years, and some never plan to.

The exercise is worth doing regardless, because the same cost discipline that protects your valuation also protects your monthly margin, your associate pay pool, and your capacity to invest in the practice.

The valuation argument is one of several reasons. It just happens to be the one with the largest number attached to it.

If I were earlier in my career as a principal and looking at this fresh, I would spend a focused afternoon on the exercise below. It does not require software, although software now exists that does this continuously rather than as a one-off.

This exercise will not give you a complete picture, because true benchmarking requires comparing your prices against what other practices actually pay across a sample large enough to be statistically meaningful. But it will tell you whether the problem is real and roughly how much you are dealing with.

A note on suppliers

It’s worth being direct about this, because it matters.

Drift is not evidence that suppliers are doing something wrong. It is evidence that any market without transparency produces the same outcome over time. Prices trend upward when nobody is checking.

The vast majority of dental suppliers operate in good faith, with their own rising input costs and their own competitive pressures to manage. Greater transparency works in their favour, too.

Suppliers who price fairly and consistently have nothing to fear from comparison. The only people disadvantaged by visibility are those who depend on its absence, and in my experience, that is rarely the kind of relationship that serves a practice well in the long run.

The takeaway

If there is one thing I want a principal reading this to take away, it is the multiplier and the timeline. Every pound of unnecessary overhead in your practice is not a pound.

It is six to nine pounds, depending on what your buyer pays for EBITDA. And the time to act on that figure is years before any sale becomes a live conversation, because by the time it is a live conversation, your accountant is already preparing the information memorandum, and your options have narrowed.

Supply costs are one of the few overhead categories where you have meaningful room to optimise. The market largely sets staffing. Premises are what they are. But what you pay for supplies is variable, negotiable, and historically rarely audited.

The dental profession has been operating without the kind of pricing transparency that consumer markets have taken for granted for years.

That is starting to change, partly through tools that benchmark anonymised invoice data across practices, and partly through principals deciding that this is overdue attention. Either way, the question is not whether drift is present in your practice.

Statistically, it almost certainly is. The question is whether you would prefer to address it on your own timeline or face its consequences in an offer letter priced by someone who saw what you did not.

Follow Dentistry.co.uk on Instagram to keep up with all the latest dental news and trends. 

This partnership, which began in 2023, has so far provided Brukinsa to more than 300 CLL patients in Armenia, Ethiopia, and Nepal. The figure surpassed the programme’s initial goal by around 150 patients.

The initiative is aimed at improving access to CLL therapy in regions where advanced treatments have previously been limited or unavailable.

Support for the project involves donated Brukinsa from BeOne Medicines and a $1m BeOne Care Foundation grant, which together help underpin patient care, physician involvement, and operational needs for the next two years.

The Max Foundation leads implementation efforts based on its experience with oncology access programmes.

BeOne Medicines co-founder, chairman and CEO John Oyler said: “From the beginning, our goal has been to ensure that where a person lives does not determine whether they can access high-quality cancer care.

“Renewing this partnership with The Max Foundation reflects both the impact we have already achieved together and our commitment to reaching many more patients who otherwise may have limited treatment options.”

The agreement will maintain support in Armenia, Ethiopia, and Nepal, and may include additional countries such as Côte d’Ivoire, Malawi, Mongolia, Mozambique, Togo, and Zambia, depending on future capacity and priorities.

The model includes provisions for ongoing treatment for enrolled patients beyond 2028 if clinically required.

Earlier this month, BeOne Medicines signed a multi-part collaboration with Revolution Medicines to develop and commercialise targeted oncology therapies.

The post BeOne Medicines and partners renew Brukinsa access programme for CLL appeared first on Pharmaceutical Business review.

GM2 gangliosidosis is a rare genetic disorder that leads to the progressive loss of nerve cells in the brain and spinal cord. The most common form begins during infancy, although other forms can appear later in life.

The condition belongs to the group of lysosomal storage disorders and results from genetic mutations that impair lysosomal function, leading to harmful accumulation within cells and severe neurological symptoms.

Andelyn Biosciences will implement a multi-phase programme using its Curator Platform, which features a cell line and a modular approach intended to adapt manufacturing processes to specific programme needs.

Andelyn Biosciences chief commercial officer Matt Niloff said: “We are proud to partner with Queen’s University to advance this gene therapy candidate for the benefit of patients and families facing the challenges of GM2 gangliosidoses.

“Our deep expertise in AAV development and production allows us to support Queen’s University with the scale and quality rigour necessary to bring this life-changing therapy one step closer to reality.”

Queen’s University medical geneticist and department of paediatrics professor Dr Jagdeep Walia said: “This partnership with Andelyn is very strategic as they have the established expertise of producing vectors for many gene therapy programmes.

“Their track record and ability to manufacture the viral vector for the upcoming GM2 programme gives us confidence that the participants in the clinical trial will be receiving the highest quality, safe product.”

In August 2025, Andelyn Biosciences entered a collaboration with Amplo Biotechnology to manufacture adeno-associated virus (AAV) gene therapies to address conditions affecting the neuromuscular junction.

The post Andelyn Biosciences to develop GM2 gangliosidosis therapy appeared first on Pharmaceutical Business review.

The number of dental technicians on the UK register has fallen for the sixth consecutive year, despite the overall dental care professional register growing by almost 5%.

Annual renewal statistics from the General Dental Council (GDC) showed that 84,746 dental care professionals (DCPs) were registered in 2026, an increase of 3,746 compared with the equivalent point last year.

However, dental technician numbers fell from 4,895 to 4,824, continuing a decline that has prompted concerns about training and the future capacity of UK dental laboratories.

Laboratory editor-in-chief Matt Everatt has suggested that the decline in the dental technology workforce was due to a number of factors including training programmes under financial pressure, unregulated manufacturing, and the impact of new technology.

A total of 3,769 DCPs were removed from the register following the annual renewal period. Due to ongoing problems with the MyGDC portal during this renewal period, the GDC said that DCPs who were having technical issues would not be removed from the register provided they contacted the regulator before the deadline.

Dental workforce demographics

Dental nurses remain by far the largest DCP group, with 69,824 registered – up from 65,797 in 2025. Additionally, the number of dental hygienists increased to 11,407 from 11,065 in 2025.

The dental therapy profession has seen significant growth since 2023. In three years, the number of dental therapists has increased from 5,558 to 8,824. Many of these were from internationally qualified dentists who joined the register with DCP titles, a route that the GDC has now closed. 

Since 2025, the government has called for greater use of the wider team in NHS dentistry, particularly by helping dental therapists work to the ‘top of their clinical potential’.

Training capacity for dental therapists is also being significantly expanded through new courses and facilities.

Follow Dentistry.co.uk on Instagram to keep up with all the latest dental news and trends. 

“Given the majority of state legislatures are adjourned and the fact we have a major election in November, which includes 39 gubernatorial elections, I think we’ve pretty much seen what we’re going to see from the states this year, says Patrick Plues, Senior Vice President, State Government Affairs and Affiliate Relations at the Biotechnology Innovation Organization (BIO).

So what were some of the major policy areas this year, and how are they affecting patients?

340B, PDABs, and PBMs

“The issues we saw this year on prescription drug affordabihlity boards (PDABs), Most Favored Nation (MFN) and Maximum Fair Price (MFP) reference pricing, continued scrutiny of vaccines—we’ll anticipate seeing those again next year,” says Plues.

When it comes to PDABs, there was legislation happening in a number of states, including Colorado, Hawaii, Illinois, Louisiana, Minnesota, Virginia, Vermont, and West Virginia. However, these boards are having trouble proving their financial viability and usefulness when established.

“No new PDABs were introduced this year, and I think that is because of a better understanding of the many actors within the supply chain who impact prescription drug prices,” explains Plues. “There is also the question: Do PDABs actually work? These boards are expensive, and to date, we have not seen them successfully bring down drug prices for patients, and legislators see that.”

BIO has also tracked 63 340B-related bills across 20 states and Puerto Rico.

“340B is a perennial issue in the US,” says Plues. “There needs to be more transparency and accountability from the entities that are receiving 340B dollars on where those dollars are going, and there needs to be better tracking of how 340B products are being dispensed.”

In particular, advocates and biotech leaders are calling out the issue of duplicate discounts, a prohibited practice where a 340B hospital might receive a 340B upfront discount and the state would also receive a Medicaid rebate.

If a hospital provides medication to a Medicaid patient, Plues explains, then that product needs to be reimbursed either through the Medicaid program with the State claiming a rebate, or the state forgoes the rebate and reimburses the providers at the 340B discount rate—often because it may be lower. However, what ends up happening is that manufacturers often end up paying both the Medicaid rebate and discount, with hospitals being the ultimate beneficiary because they get 340B revenue that they are not entitled to.

“Those duplicate discounts are prohibited in the federal statute that governs the 340B program,” Plues says. “Hospitals must work to protect against duplicate discounts, but their current practices only obfuscate and make it harder to identify them. There needs to be legislation to address that because it costs the state and patients more money in the long run.”

And that is not the only 340B-related issue either. In Arkansas, the Attorney General has moved to file a complaint in federal court against manufacturers who are not complying with Arkansas Act 1103 enacted in 2021. This is significant because Arkansas Act 1103 was one of the earliest state laws to address certain 340B-related practices between contract pharmacies, manufacturers, pharmacy benefit managers (PBMs), and payers.

“This is the first court case we’re seeing of a state trying to sue manufacturers for non-compliance of a state 340B law,” explains Plues. “That’s pretty significant, and it is something we are watching closely.”

Lastly, there have been a number of bills aimed at addressing PBM transparency and pharmacy vertical integration in the states.

While BIO currently remains neutral on vertical integration bills, it does agree that comprehensive structural reforms addressing PBM vertical integration and practices are best overseen through coordinated federal and state action.

The vaccine battle

“One trend that began popping up in a number of states are bills aimed at holding manufacturers liable for any injury caused by a vaccine,” says Plues. “Really it is just another attempt by the anti-vaccine movement to curb vaccine usage in their states.”

The federal Vaccine Injury Compensation Program (VICP), formed by bipartisan legislation in 1986, is a program, funded by a tax on manufacturers, that has ensured people injured by certain vaccines are provided with a fair and efficient process for compensation. People who have been injured have their cases heard by dedicated judges with experience in vaccine injury, making the process oftentimes faster and more efficient than civil litigation.

BIO maintains the VICP program is the most effective and efficient mechanism to address vaccine-related injuries. BIO counters state-level vaccine-injury bills with a focus on educating state policymakers on why the VICP program is a better alternative for people seeking relief and restitution than developing state liability bills. Learn more about VICP with this BIO resource.

Thankfully, there is also some positive vaccine legislation on the state level.

“We just saw Pennsylvania become the first state to make immunization rates public for all of their school districts, and that’s something we think is a good idea—no other state has done that yet,” says Plues. Learn more with the Pennsylvania School Immunization Rates Interactive Data Tool.

Artificial Intelligence

“There is great interest among state legislators to regulate AI, particularly given that we don’t have a federal law in place yet,” says Plues. “So the states are taking it upon themselves to regulate it.”

In particular, AI’s potential to help drug manufacturers research and develop newer and more effective medicines could change the healthcare landscape as we know it. AI’s use, BIO notes, should be facilitated and protected.

Yet, there is another area of the healthcare world where the use of AI has already caused some concern: insurance coverage. BIO supports legislation that would implement safeguards around insurers’ use of AI in coverage and reimbursement decisions. State and federal guardrails need to be in place to ensure that AI is not being used to systematically deny or restrict access to care.

As we round out 2026 and head into 2027, BIO will continue to work on the ground in the states to ensure that patients of all kinds not only have access to the drugs and treatments they need, but that biotech can continue to innovate and develop breakthroughs.

The post Mid-year review: State-level legislative action impacting biotech appeared first on Bio.News.

Dr Ashok Kumar Mittal, Rajya Sabha MP and Founder-Chancellor of Lovely Professional University, has been elected by 245 Members of Parliament from the Rajya Sabha as a member of the governing body of the All India Institute of Medical Sciences (AIIMS), Bathinda.

Dr Mittal is among the Rajya Sabha members recently elected to the governing bodies of various AIIMS institutions across the country. His election to AIIMS Bathinda adds an institutional responsibility to his parliamentary role and places him within the governance framework of a public healthcare and medical education institution in Punjab.

AIIMS Bathinda combines patient care, medical education and research. Its development is relevant to healthcare capacity and access to medical services in Punjab and the wider region.

Institutional governance supports healthcare institutions in advancing their academic, clinical and research objectives. In Punjab, medical education, healthcare capacity, research and innovation are areas of focus for developing public healthcare infrastructure.

Speaking on his election, Dr Ashok Kumar Mittal said, “ I am honoured to have been entrusted with this responsibility, having been elected by 245 Members of the Rajya Sabha. This appointment holds special significance for me: I was previously nominated by the Vice President of India as a member of the School of Planning and Architecture, and of the Jawaharlal Nehru University (JNU) Court — both central institutions located in Delhi. AIIMS Bathinda, though also a central institution, is located in Bathinda, in my own home state of Punjab. ”

He added, “ The Bathinda region faces a significant health burden linked to water table issues, with cancer being the most serious of these challenges. AIIMS Bathinda, with its clinical experience, its team of doctors, and the infrastructure it is building, can make a major contribution towards addressing the cancer burden faced by the people of Punjab, and particularly by those in the Bathinda region. I am especially glad that, as a member of AIIMS Bathinda, I may be able to contribute meaningfully to the health and well-being of the people of Punjab, and I look forward to strengthening Punjab’s healthcare ecosystem. ”

He further said, “ Healthcare and education are fundamental pillars of social and economic development. As we work towards a healthier and more developed Punjab, we must continue to strengthen institutions that can deliver quality healthcare while also creating the knowledge, talent and research capabilities needed for the future. My endeavour will be to bring a constructive and public-interest-oriented perspective to this responsibility. ”

The election comes as healthcare institutions are expected to integrate patient care with medical education, research, technology and innovation. AIIMS Bathinda can contribute to this ecosystem in Punjab.

Dr Mittal’s participation in the governing body provides an opportunity to contribute his perspective on institution-building and capacity development while supporting objectives related to medical education, healthcare accessibility, research and innovation. No specific initiatives or policy measures have been announced by Dr Mittal in connection with his new role at this stage.

As Punjab continues to strengthen its healthcare infrastructure and human-resource capabilities, institutions such as AIIMS Bathinda will remain relevant to healthcare access and the development of medical professionals and researchers. Institutional systems, academic excellence and public-oriented healthcare remain areas of focus for the state’s long-term development.

The post Dr Ashok Kumar Mittal elected to AIIMS Bathinda governing body appeared first on Express Pharma.

India-US pharma ties are entering a new phase. The two countries already have a strong pharma relationship, India supplies 40 per cent of US generic pharma. Now, both sides are looking at what comes next.

The message came through at the Indo-American Chamber of Commerce (IACC) National Convention 2026 in Mumbai. Sergio Gor, US Ambassador to India and Devendra Fadnavis, Chief Minister, Government of Maharashtra spoke about taking the wider India-US partnership deeper.

The timing is significant. Gor said trade in goods and services between the two countries has grown 12-fold to $240 billion. The two countries are targeting $500 billion in bilateral trade by 2030.

“The reason we get 40 per cent of our generic pharma from India, that’s an incredible number, is because we trust India,” said Gor.

He sees scope to take that trust further. “Simply put, when the US and India work together, we integrate value chains, accelerate breakthroughs in critical technologies, and strengthen supply chain resilience,” he said.

The bigger opportunity

Fadnavis wants Maharashtra to play a central role.

“The next chapter of the India-US partnership must move from strategic convergence to economic execution. And when that happens, Maharashtra wants to be at the center of that story.”

His message to industry is simple. Do more together.

He said, “It means moving towards co-investment, co-innovation, co-development and co-creation. It means American technology meeting Indian scale. American capital meeting Indian entrepreneurship. American research meeting Indian talent.”

For pharma, this could open up new areas of collaboration. Fadnavis pointed to joint research, technology transfer, global capability centres and manufacturing partnerships.

He also described a bigger ambition for India-US manufacturing.

“Not merely made in India but increasingly designed together, developed together, manufactured together and taken to the world together.”

That is a clear step beyond the traditional generics model.

Gor also made a direct pitch to Indian companies.

“So here’s my ask of every company in this room. If you’re weighing your next overseas investment, choose the US. Bring your regional project, your R&D center, your manufacturing lines to American soil.

If you’ve already invested in America, deepen that commitment further. This is the moment.”

He cited Natco Pharma and Aurobindo Pharma among Indian pharma companies that have expanded their operations in the US.

He also highlighted Mumbai-based LMAC Packages. The company has partnered with North Carolina-based Aylward to build high-speed pharma packaging equipment.

So, what will it take?

Deeper partnerships will need a supportive business environment, Gor said.

“We need predictable taxation and regulatory frameworks that allow business to thrive. We need candid, trust-based engagement on export controls and technology flows. And we need rock-solid intellectual property protections, giving every innovator in this room the confidence to invest, create and scale without fear.”

Maharashtra is making its own pitch to US companies.

“Look at Maharashtra as a platform for your India and global growth. Partner with Maharashtra for your manufacturing. Partner with Mumbai for your financial operations. Utilise our talent for your global capability centers. Utilise our technology ecosystem for innovation. Utilise our healthcare ecosystem for research and medical innovation.”

Thus, the IACC National Convention brought larger ambition into focus. Anup Acharya, National President, IACC, and Raghavendra Ponkshe, Regional Director–West, IACC, highlighted, the India-US relationship has grown beyond traditional trade and investment.

IACC has spent decades building bridges between the two business communities. The next chapter, its leadership said, will be about ideas, investment and partnerships.

lakshmipriya.nair@expressindia.com 

laxmipriyanair@gmail.com 

The post India-US pharma ties look beyond generics appeared first on Express Pharma.

Previous research has linked sugar-sweetened beverages with an increased risk of colorectal, breast, and liver cancers, but evidence on gastric cancer has been limited. The study analyzed data from 112,284 participants in the Nurses’ Health Study and Health Professionals Follow-Up Study. Both studies gathered detailed diet, lifestyle, and health information on U.S. adults over many decades. During the follow-up period, which spanned decades, 278 participants developed gastric cancer.

“This is the first study to demonstrate an association between sugar-sweetened beverage intake and gastric cancer in a U.S. population,” said senior author Andrew T. Chang, MD, a gastroenterologist and epidemiologist with the Mass General Brigham Cancer Institute. Gastric cancer is the fifth leading cause of cancer death worldwide, but we’ve known little about how diet might contribute to this cancer.

After accounting for other potential risk factors, participants who consumed at least one serving of a sugar-sweetened beverage per day had a 2.45 times higher risk of gastric cancer compared with those who consumed less than one serving per month. The association was observed in both women and men. Higher total fructose intake (fructose is the main sweetener in these drinks) was also associated with greater gastric cancer incidence.

For instance, among women in the Nurses’ Health Study, consuming more than one such beverage per day was associated with a 3.04-fold higher risk of gastric cancer, compared to those who rarely consumed sugar-sweetened beverages. In contrast, after controlling for other factors, higher consumption of artificially sweetened beverages wasn’t associated with a higher incidence of gastric cancer.

Researchers defined sugar-sweetened beverages as carbonated beverages, punch, lemonade, and sports drinks, while artificially sweetened beverages were defined as low-calorie carbonated beverages.

Because Helicobacter pylori infection increases the risk of gastric cancer, researchers also assessed H. pylori status in a subset of 940 participants. While just over one-third of these participants had evidence of H. pylori infection, there was no association between sugar-sweetened beverage consumption and infection.

Limitations of the study include its observational design. It is possible that higher rates of gastric cancer in people who consumed more sugar-sweetened beverages were related to other factors. The study had limited information on H. pylori status and family history of gastric cancer. In addition, participants were predominantly white, limiting the researchers’ ability to examine differences across racial and ethnic groups.

However, the large study population and detailed health and lifestyle information gathered over many years allowed the researchers to control for many other possible potential risk factors for gastric cancer.

The researchers say further studies are needed to confirm the findings and investigate why these beverages might increase gastric cancer risk.

The post Sugar-Sweetened Beverages Daily Can Lead to Higher Stomach Cancer Risk appeared first on GEN - Genetic Engineering and Biotechnology News.

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Jeffrey Mocny, PhD

VP Scientific Leadership
Rose BioSolutions

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Panelist

Jeffrey Mocny, PhD

Jeffrey Mocny, PhD, VP Scientific Leadership for Rose BioSolutions translates client needs into actionable development and manufacturing programs that help clients achieve their therapeutic development goals. Mocny leads a team of scientists with expertise in cell and molecular biology, virology, immunology, immunotherapy, T-cell biology, and viral vector transduction techniques. Central to the Scientific Leadership team’s approach is developing phase-appropriate strategies that ensure regulatory compliance and provide the scientific rationale for the manufacturing approaches employed by Rose’s clients. A product strategy and development executive leader, he leverages experience in quality management, strategic planning, and risk mitigation to guide programs from conceptualization to completion. Mocny has a PhD from the State University of New York at Buffalo (SUNY at Buffalo), an MS and BS from Gannon University, and has completed postdoctoral fellowships at the University of North Carolina at Chapel Hill and Duke University. As an innovator in the CDMO and CRO sectors for more than 20 years, his experience in product development spans analytical, manufacturing, market entry/positioning, and regulatory strategy.

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Felicia Irons, BS, CSSGB

Global CDMO Regulatory Affairs & Compliance Lead
Rose BioSolutions

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Panelist

Felicia Irons, BS, CSSGB

Felicia Irons, global CDMO regulatory affairs & compliance lead for Rose BioSolutions, ensures the highest level of quality, regulatory compliance and safety are adhered to for cell and gene therapy programs across Rose BioSolutions CDMO business unit. An expert in Quality Management Systems (QMS), Felicia is a member of the Regulatory Affairs Professionals Society (RAPS), American Society of Quality (ASQ), and Parenteral Drug Association (PDA). Prior to her position at Rose BioSolutions, Felicia served as the global CDMO regulatory affairs & compliance lead for Charles River Laboratories’ CDMO business unit, head of quality at Natureplex, quality manager and regulatory liaison for PharMEDium Services (an AmerisourceBergen company), and corporate quality manager with Drexel Chemical. Felicia has a BS in chemistry and biochemistry from the University of Memphis, certification in Six Sigma Green Belt from Villanova University and certificate in quality culture and investigations from PDA. Active in her community with many organizations involving healthcare, education and youth, Felicia founded the JusLuv Community Foundation in 2006 to assist youth and young adults in career mentorship.

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For cell and gene therapy programs, early development decisions can have a significant impact on regulatory success, development timelines, and overall program risk. Embedding regulatory strategy from the outset helps developers identify critical challenges early, align development activities with product-specific requirements, and build a stronger foundation for future clinical and commercial milestones.

In this GEN webinar, experts from Rose BioSolutions, a CDMO and Cell Solutions organization formed from Charles River Laboratories’ businesses, will discuss how integrating regulatory strategy at the earliest stages of development can reduce overall risk and improve program outcomes. Attendees will learn how a well-defined Target Product Profile (TPP) can guide decision-making across the drug development lifecycle, and help teams prioritize activities, anticipate regulatory expectations, and develop a fit-for-purpose CGT manufacturing and testing strategy. Presenters will use real-world case studies to highlight common cell and gene therapy product development challenges and practical approaches to addressing issues such as sterility testing, interim product release, and device compatibility at patient infusion.

Key Takeaways

• How to implement a regulatory strategy during program scoping to align development activities with product-specific risks and compliance expectations
• Why a Target Product Profile (TPP) should be established at the beginning of development and how it guides strategy, critical quality requirements, and risk mitigation plans
• How early identification of product-specific challenges can help minimize unnecessary regulatory information requests, avoid manufacturing delays, and support timely patient treatment
• Practical strategies for developing a more efficient, inspection-ready path from early development through clinical manufacturing and commercialization

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

Produced with support from:

The post Embedding Regulatory Strategy in Cell and Gene Therapy Development appeared first on GEN - Genetic Engineering and Biotechnology News.

Meeting provincial documentation standards while managing full caseloads leaves little room for shortcuts, making the right supporting technology a practical necessity.

The Documentation Burden Facing Today’s Therapists

Clinical documentation is one of the most time-intensive aspects of mental health practice, and the demands rarely end when the session does. Therapists spend hours each week translating session observations into structured notes that meet regulatory standards, insurance requirements and continuity-of-care expectations. For many practitioners, this administrative weight extends far beyond office hours and contributes directly to professional burnout.

A 2025 study found that 26% of surveyed physicians at a Canadian mental health organization met burnout criteria, and most of those who were burned out attributed it to electronic health record use.

The DAP format itself is a major driver of that time commitment. Each entry requires practitioners to work through three distinct components before a note is complete:

• Data: observable, session-specific details, including what the client said, presented or reported
• Assessment: the practitioner’s clinical interpretation of that data, tied to treatment goals
• Plan: next steps for treatment, including interventions and follow-up actions

Working through all three sections with care takes real time and focus, especially across a full caseload. Mental health AI documentation tools for DAP notes have emerged as one response to this challenge.

More broadly, roughly one in three working-age Canadians are reported to experience burnout. Administrative burden is a recurring theme in burnout research across professions, and AI-powered documentation tools are increasingly positioned as one way to reduce time spent on note-taking.

Three Best AI Tools for Generating DAP Notes for Therapists

For therapists weighing their options, finding the best therapy note AI for DAP notes often comes down to a handful of platforms built specifically for mental health documentation, each taking a somewhat different approach to the same underlying problem.

1. Owl Practice

As AI clinical notes software for therapists, Owl Practice offers a practice management platform that pairs day-to-day mental health workflows with built-in documentation support. Its Smart Notes feature generates DAP-formatted notes from session details, cutting down the time practitioners spend translating clinical observations into written records.

Key Features

• Smart Notes generates DAP-formatted documentation directly from session details
• Purpose-built for mental health professionals rather than adapted from general healthcare software
• Integrates practice management tools alongside documentation support
• Reduces administrative time so practitioners can focus on client connection

2. Mentalyc

For practices wanting broad modality coverage, Mentalyc offers purpose-built documentation support with a template library spanning DAP, SOAP, BIRP, GIRP and EMDR formats, drawing on more than 100 therapy-specific templates.

Key Features

• Offers more than 100 therapy-specific note templates
• Supports DAP, SOAP, BIRP, GIRP and EMDR formats
• Built specifically for behavioural health documentation
• Works alongside existing EHR systems rather than replacing them

3. Upheal

Alongside note generation, Upheal integrates session analytics and maintains compliance with PIPEDA and HIPAA standards, making it a relevant option for Canadian practitioners tracking session-level insights over time.

Key features

• Generates DAP, SOAP, BIRP and GIRP notes
• Meets PIPEDA and HIPAA compliance standards
• Includes built-in session analytics alongside documentation
• Offers customizable note sections for practitioner-specific workflows

Comparing Options at a Glance

Each platform brings distinct strengths to the documentation process, summarized below for quick comparison.

Criteria for Selecting the Top Tools

Each featured company offers mental health AI documentation tools for DAP notes, Canadian privacy compliance and integration pathways that fit into existing clinical workflows without demanding extensive technical expertise.

Choosing the Right Fit

With the right AI tool, DAP note documentation does not have to consume the majority of a therapist’s non-clinical hours. The best tool depends on practice size, budget and whether Canadian privacy compliance through PIPEDA or PHIPA matters most. These technologies offer a path toward lighter administrative loads, leaving more time for the client relationships that drew practitioners to the field in the first place.

The post Advancing Therapist Workflows: Evaluating AI Technologies for DAP Notes appeared first on Hospital News.

Research lead Lee Roberts, PhD, professor of molecular physiology and metabolism at the University of Leeds, said, “Our research identifies L-BAIBA as an exercise-induced signal that helps muscles adapt, improve their metabolic capacity and ability to contract, and ultimately enhances physical performance. This gives us exciting new insight into how exercise benefits the body and highlights a promising target for future therapies aimed at preserving muscle function in chronic conditions such as diabetes.”

Roberts is senior and corresponding author of the team’s published paper in Nature Communications, titled “The metabokine β-aminoisobutyric acid mediates exercise performance and skeletal muscle adaptation through a PGC1α-BAIBA-PPARδ axis.” In their paper, the team noted, “It may be that BAIBA can offer a novel therapy for other diseases with a skeletal muscle atrophy or dysfunction component, such as chronic heart failure, cancer cachexia, or sarcopenia. Conducting intervention studies using BAIBA to target muscle function, exercise capacity, and quality of life in these clinical populations will be important for future translation.”

Exercise training involves multiple bouts of activity that challenge whole-body physiology, driving adaptations across cells, tissues, and organs, the author wrote. “Exercise is also an effective intervention for the prevention or treatment of a range of diseases and pathological risk factors, including obesity, type 2 diabetes (T2D), and cardiovascular disease, and may facilitate improvements in age-related reduction in quality of life.”

But how exercise impacts the body’s ability to respond to challenges is not fully understood. The team continued, “Elucidating the fundamental molecular mechanisms and intra- and inter-organ signals through which exercise mediates systemic adaptations, driving beneficial effects, holds potential for the identification of both therapeutic targets and new strategies to treat a range of diseases, including T2D.”

Given the health benefits of exercise, Roberts and colleagues set out to discover whether this mechanism could hold the potential for treatment for chronic conditions such as type 2 diabetes. L-BAIBA has been studied in the past, and Roberts carried out research in 2014, which showed that it had beneficial effects on metabolism, boosting the fat-burning effects of exercise. It can now be purchased as a nutritional supplement.

The newly reported study has found that it triggers muscles to respond and change, linking exercise to beneficial alterations in muscle structure and metabolism. “Circulating L-BAIBA associated with aerobic fitness in humans,” the team noted in summary. “The current study identified that in mice, BAIBA supplementation in drinking water increases skeletal muscle mitochondrial number and functional capacity, improves muscle contractile function, and drives phenotypic remodelling similar to aerobic exercise training. We find that BAIBA supplementation in mice, when combined with exercise training through wheel running, leads to an increased adaptive response in skeletal muscle.”

L-BAIBA also protected muscle from damage that occurs in type 2 diabetes, which can limit a person’s quality of life, such as loss of muscle and strength, and impaired metabolism. Improving muscle resistance to fatigue could be transformative, as exercise can help to manage diabetes. The discovery that BAIBA not only mimics the adaptive response of muscle to exercise but can also contribute to translating the benefits of exercise to improved muscle and systemic function may have important clinical implications, the investigators continued. “In our study, BAIBA treatment exhibited therapeutic potential by improving the free-wheel running capacity and skeletal muscle molecular, metabolic, and functional phenotype in a mouse model of obesity and T2D-induced skeletal muscle dysfunction.”

Anna Morris, assistant director of research strategy and partnership at Diabetes UK, said, “Exercise plays an important role in managing type 2 diabetes, but for many people, muscle weakness and fatigue can make staying active a real challenge. This research helps us better understand how muscles adapt to exercise and identifies a potential new target for improving muscle health. While these findings are still at an early stage, they could help shape future approaches that support people with type 2 diabetes to remain active and live healthier, longer lives.”

The post Exercise-Boosting Molecule May Help Improve Muscle Health in Type 2 Diabetes appeared first on GEN - Genetic Engineering and Biotechnology News.

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A planned Phase IIa trial of an experimental tooth-regeneration drug will involve 24 children with severe congenital tooth agenesis, Toregem BioPharma has said.

The Japanese biotechnology company said the Pharmaceuticals and Medical Devices Agency (PMDA) had completed its investigation of the clinical trial notification for a tooth regrowth medicine called TRG035.

Toregem said the study must now undergo institutional review board assessment before it can begin enrolling participants and administering the investigational drug. Toregem did not announce a proposed start date for the Phase IIa study.

The open-label, non-comparative, multicentre study will investigate dosing in children with severe congenital tooth agenesis. It would move testing of TRG035 from healthy adults into patients with the condition the drug is intended to treat.

TRG035 already tested in adults

TRG035 has already undergone human testing in a Phase I study at Kyoto University Hospital, which began in October 2024.

The registered study had a target sample of 30 healthy adult men aged between 30 and 64 who were missing at least one molar. It was a randomised, double-blind, placebo-controlled dose-escalation study designed primarily to assess safety.

Toregem said Phase I confirmed the drug’s safety, although detailed results have not been made publicly available.

In June, Toregem BioPharma announced it had raised US$5.3 million to support the next stage of development.

The study forms part of wider research into whether tooth regrowth could eventually become possible in adults, although Toregem’s current clinical programme is focused on congenital tooth agenesis in children.

How is TRG035 intended to work?

TRG035 is an antibody treatment designed to block USAG-1, a protein involved in suppressing tooth development. Toregem hopes this will allow dormant tooth buds to develop and form new teeth.

The company has reported positive findings in animal models, but TRG035 has not yet been shown to regenerate teeth in humans.

Toregem said: ‘If administration of TRG035 enables tooth formation, patients will be able to eat using their own teeth throughout their lives.’

Its initial development is focused on severe congenital tooth agenesis. The company ultimately hopes to investigate whether the treatment could address teeth lost through dental decay and periodontal disease, but this remains a longer-term ambition.

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Consultant orthodontist and researcher Dr Farnaz Parvizi explores how a formal patient complaint can impact clinicians, from wellbeing to professional identity, and the role workplace culture can play in helping them cope.

Consultant orthodontist and researcher Dr Farnaz Parvizi has spent the last few years studying one of the most universal yet least discussed experiences in clinical practice: what really happens to a clinician when they receive a formal patient complaint? Her session at BOC 2026 in Brighton promises to be one of the most honest and personally relevant discussions at this year’s conference.

Ask any orthodontist about patient complaints and you will not have to wait long for a story. Almost everyone in clinical practice has been through one, or knows someone who has, and most will tell you it was one of the most difficult experiences of their professional life. Yet, for all its familiarity, the formal complaint remains one of the least studied areas in dentistry. Very little rigorous work has been done to define it, measure it or understand how it impacts clinicians’ wellbeing.

Dr Farnaz Parvizi is trying to change that.

How do orthodontists experience a formal complaint?

Now in the fourth year of a PhD funded by the British Orthodontic Society Foundation, Dr Parvizi is developing a theoretical framework for understanding how UK orthodontic clinicians experience formal complaints and what role workplace factors play in shaping those experiences. The research grew out of her own career, her work with trainees, and a conviction that the profession deserves something more substantive than the acknowledgement that complaints are simply stressful.

‘Like many of my colleagues, I have been subject to formal complaints,’ she says. ‘I knew how it made me feel; the emotional impact; the responses; the behaviours. I was interested to find out how it was for everyone else. It is one thing knowing it about yourself, yet we do not really know the impact it has on us as a collective.’

Turning experience into research

Dr Parvizi qualified from the University of Bristol, completed her orthodontic training in Birmingham and spent eight years in specialist practice, including a year in Australia. On her return, she pursued further training, secured a consultant post and has remained closely involved in teaching and education ever since. She is currently a consultant orthodontist at the Royal United Hospitals Bath and an honorary senior lecturer at the University of Bristol. A master’s degree in education, completed in 2019, gave her the appetite for a PhD. BOS Foundation funding has allowed her to have protected research time away from her clinical responsibilities. She is keen to highlight that support because she suspects many colleagues do not know it exists.

‘A lot of people have ideas but think they cannot access the funding, or that it is not for them,’ she says. ‘It absolutely is. If you have a question you want to answer, find out what support is available. You might be surprised.’

More than just stressful

At the heart of Dr Parvizi’s research is a distinction that will feel familiar to anyone who has been through the process: the difference between stress and threat.

‘In a regulated profession, a formal complaint is never just an uncomfortable experience. It challenges our professional credibility, how others see us, and our professional identity, how we see ourselves. In addition, there is always the risk of escalation and loss of one’s ability to practise. The possibility of losing your registration to practise means that formal patient complaints are no longer just a stress but a threat – and that is a very different thing.’

Having completed the qualitative phase of her study, involving in-depth interviews with orthodontic clinicians, Dr Parvizi has identified six domains that together define the complaint experience, including the cognitive burden of carrying a complaint, regardless of its severity, the way its effects can extend into other parts of life, and challenges to professional identity and moral values. All of these outcomes are influenced by workplace factors that either exacerbate or buffer the impact of formal complaints.

‘If the clinicians’ basic psychological needs are frustrated in the workplace, formal complaints will have a more pronounced impact on their wellbeing. People begin to doubt their own abilities. They withdraw. They become more cynical. Their productivity falls. Absenteeism increases. These are the downstream markers I will be looking at in the survey.’

What your workplace has to do with it

Dr Parvizi’s research focuses on workplace factors that she believes are especially important. The first is psychological safety: whether clinicians feel safe enough within their teams to acknowledge mistakes and ask for support without fear or blame. The second is organisational justice: when a complaint process begins, do clinicians feel it is handled fairly? Are they respected, involved and kept informed, or does the process feel opaque and out of their hands?

‘In aviation and in nuclear industries, psychological safety is well understood,’ she says. ‘But we have never actually looked at it in our own workplaces. Safe teams are teams that learn from mistakes. That is the culture we should be building.’

She is also clear that seniority offers no immunity. If anything, she suggests, the stakes can be even higher for those further along in their careers. ‘When that complaint comes through, you will experience the same dimensions as your trainees would,’ she says. ‘It does not matter who you are or where you sit in the hierarchy.’

A chance to take part

The next phase of Dr Parvizi’s research will build on her interview findings through a large-scale survey, extending the project to a broader group of orthodontic clinicians. Dr Parvizi hopes that delegates at BOC 2026 will be able to take part directly and plans to provide a QR code to direct them to find out how after the session. It is an exciting stage in a study that has the potential to shape how the profession understands and supports clinicians facing formal complaints.

For those wondering whether a session on complaints is really worth their time at a conference full of clinical content, Dr Parvizi’s view is straightforward. ‘It does not matter what technique you use, what grade you are, or how long you have been qualified,’ she says. ‘If you have ever received a complaint and wondered why it hit you as hard as it did, this session is for you. For the first time, someone is trying to properly understand what that experience involves. And that work starts with you being in the room.’

The British Orthodontic Conference takes place from 24 to 26 September 2026 at the Brighton Centre. Dr Parvizi’s presentation, ‘How do UK orthodontic clinicians experience formal patient complaints and what roles do workplace factors play in shaping their experiences?’ will offer delegates the chance to engage with an issue that cuts across every stage of clinical practice.

Book your place and see the full programme here.

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Following completion of the merger, the new entity will focus on developing Slate’s pipeline of migraine treatments, with SLTE-1009 as its lead candidate.

This clinical-stage subcutaneous anti- pituitary adenylate cyclase-activating peptide / vasoactive intestinal peptide (PACAP/VIP) monoclonal antibody is intended for the prevention of migraine and other headache disorders.

The financing is expected to support operations through 2029, enabling progress of SLTE-1009 through Phase I studies in healthy volunteers and a Phase II dose-range finding study in patients with migraine.

Also in development is SLTE-2100, a bispecific antibody targeting PACAP/VIP and calcitonin gene-related peptide (CGRP), which remains in the lead optimisation stage.

SLTE-2100 is scheduled to enter clinical trials in the second half of 2027 and has secured funding for a Phase IIa study in migraine.

The transaction, unanimously supported by the boards of both companies, is targeted to close in the fourth quarter of 2026, pending regulatory and shareholder approvals, as well as satisfaction or waiver of customary closing conditions.

Upon completion, pre-merger Fulcrum stockholders are expected to own 5% of the new company while pre-merger Slate stockholders and pre-closing financing investors are expected to hold 95%.

Fulcrum is anticipated to contribute net cash of nearly $20.3m and issue a cash dividend estimated at $270m, to be paid immediately prior to closing, to Fulcrum stockholders.

Slate Medicines CEO Gregory Oakes will lead the merged entity.

Oakes said: “Migraine remains one of the most prevalent and disabling neurological diseases, yet millions of patients continue to be underserved by existing therapies.

“This merger and the related financing are expected to provide the resources to advance SLTE-1009, along with the rest of our pipeline, through potentially meaningful clinical milestones.”

Slate’s management team includes president and chief operating officer Neil Buckley, chief medical officer Dr Roger Cady, and chief financial officer John Umstead.

The new company’s board of directors will include representatives from RA Capital Management, Forbion, Foresite Capital, and a former executive of Verona Pharma.

The post Fulcrum and Slate Medicines sign merger agreement appeared first on Pharmaceutical Business review.

It also applies to those who have previously undergone platinum-based chemotherapy and an immune checkpoint inhibitor.

Faeth Therapeutics is currently conducting a Phase II trial of this treatment approach, known as Study FTH-PIK-201, in second-line advanced endometrial cancer.

The company anticipates releasing top line results from this trial by the end of this year.

Faeth Therapeutics CEO Anand Parikh said: “Fast track designation for PIKTOR reflects the significant unmet need in advanced endometrial cancer for patients whose disease has progressed despite platinum-based chemotherapy and an immune checkpoint inhibitor.

“We believe PIKTOR’s multi-node approach to the PI3K/AKT/mTOR pathway is well suited to this population as our preclinical data suggests that PIKTOR can resensitise patients to chemotherapy.”

PIKTOR is described as an investigational, all-oral combination therapy and is designed to inhibit several nodes of the PI3K/AKT/mTOR pathway, which, according to published literature, is altered in up to half of all solid tumours.

In addition to the endometrial cancer trial, PIKTOR is being tested in a Phase Ib/II study for hormone receptor positive / human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer, referred to as Study FTH-PIK-101.

The first patient in this study was dosed in April, with interim results expected in 2027.

Faeth Therapeutics focuses on multi-node therapies for cancer, with PIKTOR as its leading development programme.

The post Faeth’s PIKTOR plus paclitaxel combo gains FDA fast track status appeared first on Pharmaceutical Business review.

Godavari Biorefineries has secured a patent from the European Patent Office for its invention, “Pharmaceutical Composition and a Process to Prepare the Same”. The patent covers a pharmaceutical composition that combines anti-cancer compounds with a solubilising agent, along with the process to prepare it.

The composition is designed to enhance the solubility and bioavailability of the active compounds, thereby improving their therapeutic potential. It has applications in the treatment of various cancers, including breast and prostate cancers, particularly through oral administration.

The patent adds to Godavari Biorefineries Limited’s oncology-focused intellectual property portfolio.

“In oncology research, identifying a promising compound is only one part of the challenge. How that compound is formulated can determine how effectively it can be developed for therapeutic use. Our research has focused on improving the solubility and bioavailability of these compounds, and the grant of this European patent is an important recognition of that work,” said Dr Sangeeta Srivastava, Executive Director, Godavari Biorefineries Limited.

Commenting on the achievement, Samir Somaiya, Chairman and Managing Director, Godavari Biorefineries Limited said, “Our approach to innovation has always been guided by a larger purpose, to advance health, wellbeing and sustainability while creating lasting value for all. The Sanskrit mantra ‘सर्वे सन्तु निरामयाः’, meaning ‘Health for All’, reflects this purpose and reminds us that the true value of innovation lies in its ability to improve lives. As we look beyond our traditional businesses, our investments in R&D are enabling us to build capabilities in areas where science and technology can address meaningful societal needs. This European patent is an important milestone in that journey, strengthening our intellectual property and opening possibilities for developing solutions with potential applications in healthcare. For us, innovation is meaningful when it creates sustainable opportunities for the business while also contributing to a healthier and more sustainable future for society.”

The European grant further expands Godavari Biorefineries’ international intellectual property footprint as the company continues to protect its research across major markets worldwide.

The post Godavari Biorefineries secures European patent for pharma composition appeared first on Express Pharma.

This article draws on peer-reviewed research conducted at SP Jain School of Global Management and published in Bioengineering (2025, 12, 35). The study develops a novel machine learning methodology for diabetes prediction that outperforms existing algorithms when clinical data suffer from class imbalance.

The clinical stakes of getting prediction right

Diabetes remains one of the most consequential public health challenges worldwide. According to the International Diabetes Federation’s Diabetes Atlas (11th edition, 2025), an estimated 589 million adults aged 20–79 are living with diabetes, and that figure is projected to reach 853 million by 2050. 

Early detection is critical: when clinicians can identify at-risk individuals before the disease takes hold, lifestyle interventions and targeted treatment can slow or even reverse its progression. Machine learning offers a powerful tool for this purpose, sifting through biological and social indicators to flag patients who might otherwise be missed.

Yet a persistent technical obstacle undermines many predictive models. Real-world clinical datasets are frequently imbalanced: healthy patients vastly outnumber diabetic ones. In the widely used PIMA Indians Diabetes Dataset, for example, roughly two thirds of observations are non-diabetic. A classifier trained on such data can achieve deceptively high overall accuracy simply by predicting the majority class, while failing to identify the very patients who most need attention. The consequences in a clinical setting are serious: missed diagnoses, delayed treatment, and poorer health outcomes for the most vulnerable.

A simpler path to better predictions

Our research, conducted at SP Jain School of Global Management in collaboration with Sofia University, set out to address this class imbalance problem without resorting to computationally expensive deep learning architectures or elaborate feature selection procedures. The methodology we propose introduces two straightforward preprocessing steps—resampling and random shuffling—before applying a standard support vector machine classifier with balanced class weights and k-fold cross validation.

Resampling supplements the minority class so that both classes are represented more evenly in the training data. Random shuffling then rearranges the order of observations, preventing the model from learning spurious patterns tied to the sequence of the data rather than the genuine relationships among variables. These steps are combined with Python’s built-in balanced class weighting and tested under both standard k-fold and stratified k-fold cross validation. The entire pipeline is simple to implement, fast to execute, and requires no specialist hardware.

Results that rival deep learning

The results are striking. Our proposed methodology achieved a classification accuracy of 95.5 per cent on the PIMA dataset, with 100 per cent specificity and over 91 per cent sensitivity. By comparison, the classical approach—shuffling and balanced class weights alone, without resampling—yielded accuracies between 83 and 85 per cent and notably lower sensitivity scores. The proposed methodology also outperformed published results from several other research groups using Random Forest, Naive Bayes, Adaboost, and SHAP-based ensemble methods on the same dataset.

Perhaps most remarkably, our simple machine learning pipeline came within roughly 2.5 percentage points of the best reported deep neural network accuracies, while achieving a perfect specificity of 100 per cent—a result none of the deep learning benchmarks matched. This means our model correctly identified every non-diabetic patient in the test set, producing zero false positives. In clinical terms, that translates to fewer unnecessary follow-up procedures and reduced patient anxiety, while still detecting over 91 per cent of diabetic cases.

Why it matters for healthcare

The practical implications extend well beyond a single dataset. The methodology avoids feature selection, which eliminates an entire source of researcher bias and saves considerable analytical time. It is agnostic to the type of cross validation, performing comparably under both k-fold and stratified k-fold approaches, which suggests robustness across datasets of different sizes and structures. And because it relies on standard Python libraries rather than bespoke deep learning frameworks, it can be deployed in resource-constrained clinical environments where computational infrastructure is limited.

For public health professionals and policymakers, this work offers an accessible, evidence-based tool for diabetes prescreening. By improving the identification of at-risk individuals, clinicians can allocate preventive resources more effectively, tailor interventions to individual risk profiles, and ultimately reduce the burden of a disease that exacts an enormous toll on patients, families, and health systems.

Looking ahead

Future work at SP Jain School of Global Management will extend this methodology to larger diabetes datasets, multiclass classification problems, and datasets with high-dimensional feature spaces. We also plan to incorporate additional evaluation metrics such as the Matthews Correlation Coefficient and nested stratified cross validation to further strengthen model reliability. As artificial intelligence becomes increasingly embedded in healthcare decision-making, ensuring that predictive models are not only accurate but also simple, interpretable, and ethically sound is an imperative that this research directly serves.

This research was conducted at SP Jain School of Global Management, Dubai.

Reference: Toleva, B.; Atanasov, I.; Ivanov, I.; Hooper, V. An Effective Methodology for Diabetes Prediction in the Case of Class Imbalance. Bioengineering 2025, 12, 35.

https://doi.org/10.3390/bioengineering12010035

https://idf.org/news-and-resources/news/idf-diabetes-atlas-11th-edition/

The post An effective methodology for diabetes prediction in the case of class imbalance appeared first on Express Pharma.

ACG has appointed Lalit Kasliwal as Group Chief Financial Officer, with responsibility for the company’s global finance function across its pharmaceutical and nutraceutical manufacturing businesses.

In his new role, Kasliwal will lead financial strategy, treasury, governance, capital allocation and risk management to support ACG’s long-term ambitions.

Kasliwal brings more than 27 years of global leadership experience across financial strategy, treasury, capital allocation and structuring, governance, enterprise transformation and risk management in the pharmaceutical, manufacturing and international trading sectors.

He joins ACG from Tata International Limited, where he served as Chief Financial Officer and Company Secretary, leading the global finance function for operations across more than 29 countries. Before this, he served as CFO – Group Manufacturing and Head of Group Insurance at Reliance Industries Limited. Earlier in his career, he held senior finance leadership positions with Vedanta Group, including Hindustan Zinc Limited and Sterlite Technologies Limited, Ruia Group and IPCA Laboratories Limited.

Karan Singh, Managing Director at ACG, commented; “We are delighted to welcome Lalit to ACG. He brings a wealth of global experience, a strong track record of financial leadership and a deep understanding of complex international businesses. His expertise will be invaluable as we continue to strengthen our operations and pursue the next phase of our growth strategy.”

Lalit Kasliwal added; “I am delighted to be joining ACG at an exciting stage of its global growth journey. I look forward to partnering with colleagues across the organisation to strengthen financial performance, enhance governance and support sustainable long-term value creation for our customers, partners and stakeholders.”

The appointment comes as ACG continues to expand its global presence and invest in technologies and solutions that support pharmaceutical and nutraceutical manufacturers worldwide.

The post ACG appoints Lalit Kasliwal as Group Chief Financial Officer appeared first on Express Pharma.

The Aligner Dental Academy presents a five-step guide to getting the most of your Invisalign cases and building clinical confidence.

Many Invisalign clinicians find that one of the biggest hurdles to treating more complex cases isn’t the treatment itself, it’s having the confidence to critically review and optimise the ClinCheck before treatment begins.

ClinCheck should not be regarded as a polished animation that simply requires approval. It is a clinical prescription and must reflect the patient’s diagnosis, facial aesthetics, periodontal health, restorative objectives, and functional requirements.

A reliable review process begins by defining the intended final tooth positions before assessing the digital setup. Each ClinCheck should then be evaluated systematically against these predetermined treatment goals.

Begin with a comprehensive assessment and clear treatment objectives

Before reviewing the first ClinCheck, complete a thorough clinical assessment using photographs, radiographs, intraoral scans, and appropriate occlusal records. Identify the patient’s primary concern and translate it into specific, clinically achievable treatment objectives.

These objectives provide a benchmark against which the digital treatment plan can be assessed. They also support clear communication with the patient and contribute to a robust consent process.

The Aligner Dental Academy’s Five-Step ClinCheck Review provides a structured framework for assessing ClinCheck plans.

Step one: product and feature selection

Whether you are a GO or Comprehensive provider, the first thing to do is to check that the product type you have selected is able to meet your patients treatment goals. For example if your patient speficially wants to have a wide smile, then ensuring the plan is on GO plus can help deliver that as you can expand to the first molar.

Step two: review bite and technicians comments

Verify the accuracy of the starting occlusion

Even the most sophisticated digital setup has limited value if it begins from an inaccurate representation of the patient’s bite.

Compare the initial digital occlusion with the clinical photographs, intraoral scan, and occlusal records. Pay particular attention to: occlusal cant, mandibular deviation, facial asymmetry, dental midlines, posterior intercuspation, arch relationships, overjet and overbite.

Orientate the ClinCheck model to correspond with the clinical photographs so that the comparison is meaningful and consistent.

Review the technician’s comments before proceeding. These may highlight incomplete records, unclear instructions, or limitations associated with the requested movements. Confirm that an adequate proportion of the occlusal surface of the most posterior teeth has been captured, as incomplete scan data may compromise the accuracy of the digital occlusion.

Step three: assess the proposed final position against the prescription

Evaluate the proposed endpoint before becoming absorbed in the animation. The final setup should resolve the patient’s presenting concern while remaining consistent with the agreed aesthetic, periodontal, restorative, and functional objectives.

A useful framework is the four-sentence prescription, which defines four key reference points:

1. The patient’s presenting complaint
2. The desired position of the upper anterior teeth
3. The intended upper posterior position and arch form
4. The desired lower incisor position, overjet, and overbite.

This approach describes the intended endpoint in clear, familiar, and facially driven language before the automated setup is reviewed.

Begin with the upper central incisors. Their inclination, vertical position, and relationship to the smile line influence the overall aesthetic result. Assess whether the planned intrusion or extrusion will improve tooth display and the smile arc, and confirm that the upper dental midline has not shifted unintentionally.

Next, evaluate the upper posterior reference point and proposed arch form. Expansion should be purposeful and supported by the diagnosis rather than accepted as an automatic feature of treatment.

Finally, assess the lower incisors carefully, particularly in patients with a thin gingival phenotype, reduced periodontal support, or pre-existing recession. Excessive proclination or buccal movement may create avoidable periodontal risk.

The Aligner Dental Academy’s guide to the four-sentence treatment plan provides a practical framework for modifying ClinCheck plans.

Use the available visual assessment tools

Superimposition is particularly valuable for identifying the magnitude and direction of planned tooth movement. Compare the initial and final positions from both occlusal and lateral perspectives.

Grid tools can assist in estimating movement, while in-face smile visualisation may support assessment of: incisor position, smile arc, tooth display, dental midlines and facial integration.

These tools are important because a final digital model may appear well aligned while still containing undesirable expansion, unnecessary round-tripping, or unfavourable changes in incisor inclination.

Step four: review the complete sequence of tooth movement

Once the proposed endpoint is acceptable, examine how the software intends to achieve it.

Play the animation from beginning to end and look to ensure the final position is meeting the upper and lower anterior reference point and the posterior reference point. In addition look for the following movements:

• Round-tripping
• Excessive simultaneous movement
• Loss of anchorage
• Unfavourable sequencing
• Unnecessary expansion or proclination
• Potential occlusal interferences.

Consider whether additional auxiliaries, such as elastics, bite ramps, or attachments, may be required.

Review the tooth movement table and identify movements that may be biologically demanding or less predictable. ClinCheck displays prescribed movement; it does not guarantee biological expression. Difficult rotations, extrusion, intrusion, torque, and root movement therefore require particular scrutiny.

A common error is to assess only the final position without reviewing the sequence through which that position is intended to be achieved.

Audit interproximal reduction carefully

Do not accept prescribed interproximal reduction automatically. Review the amount, location, distribution, and timing of all planned IPR.

The Aligner Dental Academy recommends limiting IPR to approximately 0.3 mm per anterior contact and up to 0.5 mm per posterior contact. These values should nevertheless be adapted to the patient’s dental anatomy, enamel availability, periodontal condition, and clinical access.

IPR may also be used strategically. For example, lower-arch IPR may facilitate lower incisor retraction and increase overjet, whereas upper-arch IPR may assist in reducing excessive overjet.

Consider tooth morphology, contact-point position, and the risk of black triangles. Space creation and distribution should support the intended aesthetic, restorative, and occlusal outcome rather than merely resolve crowding numerically.

Protect the final occlusion

Confirm that the proposed overjet and overbite are functional, atraumatic, and compatible with any planned or existing restorations.

Maintain adequate overjet, commonly at least 2 mm, to reduce the risk of an unfavourable anterior relationship.

Remain alert to the risk of posterior open bite. Excessive anterior contact, poor arch coordination, unsuitable staging, and inappropriate single-arch treatment may all compromise the final occlusion.

Single-arch treatment should be considered only when arch coordination, function, overjet, and overbite can be maintained predictably. Where these relationships cannot be preserved, dual-arch treatment may offer a safer and more reliable approach.

Step five: conclude with informed consent and precise communication

Before approving the plan, revisit all case-specific consent considerations, including: gingival recession, black triangles, IPR, tooth-shape limitations, difficult or less predictable movements, potential occlusal changes, treatment duration, retention requirements, additional costs, the possible need for refinement, treatment costs etc.

Where modifications are required, use 3D Controls alongside concise and specific written instructions. The four-sentence prescription can be included within the modification request to provide the technician with a clear description of the intended endpoint.

The following Aligner Dental Academy webinar discusses effective communication with the ClinCheck technician.

When the revised setup is returned, verify each requested change individually. Do not assume that all instructions have been interpreted or incorporated correctly.

Conclusion

A consistent ClinCheck review is an extension of diagnosis and treatment planning, not a separate administrative step. By combining a facially driven prescription with a structured review process, clinicians can identify errors earlier, communicate more effectively, and deliver treatment that is safer, more efficient, and better aligned with the patient’s clinical needs and expectations.

This article is sponsored by the Aligner Dental Academy.

Led by Jan Terje Andersen, PhD, at the University of Oslo and Oslo University Hospital, the team’s studies in mice and in ex vivo human tissues found that the placenta distinguishes between antibodies and albumin. The scientists showed that although the neonatal Fc receptor binds both immunoglobulin G (IgG) antibodies and albumin, FcRn expressed in the placenta selectively transports IgG to the fetus, while largely excluding albumin. Their experiments demonstrated that fusing IgG antibodies to albumin minimized their transport across the placenta and prevented adverse effects in offspring in mice.

The findings address a rapidly growing unmet need. While monoclonal IgG antibodies are increasingly used to treat chronic diseases that affect women during their reproductive years, decisions concerning treatment during pregnancy often involve balancing the benefits of disease control against risks to the developing fetus.

Andersen said, “Rather than asking whether existing biologic medicines are safe to use during pregnancy, our findings show that we can now design them differently. The placenta selectively transfers protective IgG antibodies while preventing albumin from crossing. By understanding this, we now have the opportunity to develop a new generation of biologic medicines that combine long-lasting efficacy with improved safety during pregnancy. This study shows how fundamental discoveries in biology can directly inspire the design of better medicines.”

Andersen is corresponding author of the team’s published paper in Science Immunology, titled “Fusion of IgG antibodies to albumin inhibits transport across the placenta,” in which they concluded, “These findings identify albumin as an attractive fusion partner for biologics intended to minimize fetal exposure during pregnancy.”

Albumin and IgG antibodies are the most prevalent soluble proteins in blood, the team explained. “Whereas IgG is pivotal in the fight against infectious diseases, albumin transports a plethora of insoluble ligands, such as fatty acids, hormones, and waste products, for delivery to tissues and organs.”

IgG-based monoclonal antibodies are among the fastest-growing class of biologics that are being used to treat a range of acute and chronic diseases, the team noted, and are effective therapies for cancer, autoimmune diseases, and migraine. “However, they are actively transported across the placenta by the neonatal Fc receptor (FcRn), limiting their use during pregnancy.” Evidence that supports safe use of such therapeutics during pregnancy remains limited.

For their studies, the team focused on albumin, a transport protein that also has a long half-life and binds FcRn at a different site to IgG. The researchers showed that FcRn transferred maternal IgG, but not albumin, across the placenta and into fetal pups in mice. To uncover the mechanism, the researchers combined studies in conventional and genetically humanized mouse models with an advanced ex vivo human placental perfusion system using placentas donated immediately after childbirth. Across all models, the findings were strikingly consistent: IgG antibodies were transferred efficiently, whereas albumin was not.

The researchers then took advantage of the discovery to make a platform for engineering next-generation biologics. They found that fusion of albumin to therapeutic IgG antibodies produced biologics with both FcRn-mediated long plasma half-life and substantially reduced placental transport. An even greater effect was achieved by fusing antibody fragments to an engineered albumin variant (QMP) with optimized human FcRn binding, demonstrating that both reduced placental transfer and long plasma half-life can be tuned through rational protein design.

The concept was validated in human placental tissue and disease models. In a mouse model of fetal and neonatal alloimmune thrombocytopenia (FNAIT)—a potentially life-threatening pregnancy complication in which maternal antibodies attack fetal platelets—the engineered antibodies resulted in substantially reduced fetal exposure and associated adverse effects in the offspring.

“This is first and foremost a discovery of how the placenta works,” Andersen said. “For decades, we have known that FcRn binds both IgG and albumin, yet only IgG reaches the fetus by an FcRn-dependent mechanism. We show that the placenta has a remarkable ability to distinguish between these two soluble proteins, revealing a level of biological selectivity that was previously unrecognized.”

The findings address a rapidly growing unmet need. While monoclonal IgG antibodies are increasingly used to treat chronic diseases that affect women during their reproductive years, decisions concerning treatment during pregnancy often involve balancing the benefits of disease control against risks to the developing fetus. The authors propose that further research is needed to understand the mechanisms that restrict albumin transport, which could inform more tailored therapeutics with varied fetal exposure profiles.

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This year, the group celebrated its 10-year anniversary, at the annual meeting in June, held in Boston. The first day was focused on the successes of the past decade. The second day looked ahead to the future, and the impact the HCA will make on research and drug discovery. GEN spoke with Holger Heyn, PhD, ICREA professor at the Centro Nacional de Análisis Genómico (CNAG) and co-founder of Omniscope about the meeting and what the next 10 years may bring. Heyn has been with the HCA since (almost) the beginning and currently serves as the co-chair of the Standards and Technologies working group, co-chair of the Industry Partnership Program, an organizing committee member, and a member of the task force to design HCA 2.0.

LeMieux: Let’s start with the meeting, which covered a lot of ground. Can you share what the main takeaways were?

Heyn: The first day was about the past—the last 10 years. The second day was about the future. And the third day was reserved for working group meetings.

Talking about the past, the first day celebrated the completion of most organ and tissue atlases of the HCA. The HCA activities are broken down into 18 different biological networks (or bionetworks): lung, liver, heart, etc. All of those will have either published or submitted their atlases in 2026.

After 10 years, we have come a long way and we delivered what we set out to do, which was the generation of the HCA, single-cell resolved, for all main tissue and organ systems. That is exactly the mission of the HCA: completely grassroots—to deliver representative atlases of tissues and organs with openly available data. In total, we have already 450 publications, that have been cited 100,000 times, and a global representation with almost 4,000 members from a hundred countries. Recently, the representation from Africa and South America has grown a lot. The HCA is now a really global effort.

LeMieux: On the point of increasing the globalization of the HCA, how is the technology being democratized to reach more areas of the world?

Heyn: This has been approached in two separate ways. One was when my group published a method to cryopreserve cells, about eight years ago. It allowed researchers to put cells in the freezer and then thaw them to run them anywhere. The idea was to centralize data processing, so each hospital or each center does not need to have a single-cell instrument. More recently, we have been able to use formalin fixation, which allows researchers to fix and sequence later. Both technologies offer flexibility in terms of where the data is generated and to disconnect the sampling from the processing time. Being able to collect and store, then process later, makes single-cell analysis much more accessible.

In addition, there has been a drop of cost per cell. Although the assay is still costly, over the years, people get more cells per dollar, allowing the generation of scalable atlases. Now, most of these atlases are represented by millions of cells. Ten years ago, there was no way to afford that.

LeMieux: Now let’s move into the future. The first day of the meeting was called HCA 1.0. But now let’s talk about day two, or HCA 2.0.

Heyn: Day two was all about the future roadmap and where the project is going. Aviv Regev highlighted this in her talk. Even though the HCA is now split into phase one and phase two, the that was published 10 years ago in eLife laid everything out clearly. There are the two pillars, single-cell and spatial, to build atlases. Single-cell technology was available earlier and only now is spatial becoming scalable. The initial plan was always to do a single-cell and the spatial cell atlas—to profile cells in their tissue context. But technology had to catch up.

For HCA 2.0, we now have a five-year time frame where we scale the atlas in multiple different directions. One is the already mentioned spatially resolved atlases: we will use spatial methods, very advanced capture-based sequencing methods, and full transcriptome imaging-based methods. The focus of HCA 2.0 is to move away from cells in dissociation and toward generating spatial data at scale. With this, we can use the single cell references that we have generated in the past and map cells back into their natural context.

The second focus is the global representation. One area where this goal has been very nicely implemented is in Asia. HCA Asia is one of the largest, most active communities. In HCA 2.0, we aim at better diversity, representing not only blood, which is the best represented sample type right now, but also other major tissue types.

The third, and very important one, is opening from a healthy reference atlas to include a disease focus. We had a discussion with the HCA community at the meeting where to focus first. We asked, what are global disease burdens, what are local efforts we want to support, and what samples are available?

Disease also brings us closer to collaborating with pharma partners. We are in discussion with multiple partners to make our atlas generation efforts useful for diagnostics and drug development. For increasing impact, you eventually need commercialization and innovation on top of that. Pharma partners are already developing drugs using our healthy atlases. Now it will be crucial to align with these collaborators for diseased atlas efforts as well.

Fourth, imagine a Venn diagram with the single-cell atlases, spatial, disease, and genetic diversity. And now picture in the middle a small circle as a union: these are the foundation models. The HCA is generating a unique resource to build foundation models. Most foundation models to date are already built on single cells from our atlases. However, many recent initiatives are also building foundation models based on spatial data, in order to have the tissue context represented. To make these foundation models useful, you have to train them on a specific task. And this is where the disease context becomes important. With the healthy atlases, you have the representation of cellular biology of the human system. Fine tuning models can then be based on predictive tasks, such as drug target identification, prediction of therapy outcome, and patient stratification. This brings out the real value of those models, to make them actionable and to use them for predictive tasks.

LeMieux: It seems like every time I turn around there is a new virtual cell project, whether it’s being done by CZI or Tahoe or another group. So how do all of these come together with HCA?

Heyn: We are a virtual cell community. HCA is in active discussion with all of the stakeholders. We all have the same goal to build a virtual cell that is representative of biology and diseases. We all have very different approaches. The approach that the HCA is offering is that we use spatial technology to put cells back in their natural context and then to use such data to train models on the natural perturbation of interacting cells. But everyone has their own niche. There is no right or wrong for now. We are following strategies that will be complementary and synergistic in the future.

LeMieux: Moving toward disease, where do you think that the HCA will start to make inroads?

Heyn: Today it is still hard to say. We did some analysis, asking what our community chooses as diseases of interest? We also talked to the main stakeholders to make those atlases impactful. We are basically in the landscaping phase to see what disease areas are suitable for pilot flagship projects on specific tissues and diseases. But we already want to connect this initial phase to the end goal. Therefore, we need the different stakeholders on board to make informed decisions together with all parties.

There are two main objectives for a pharma company when using the atlases. One is to find new drug targets. The second is to predict toxicity to have on target and not off target effects. To do that, they need both a healthy reference and a disease cohort. Traditionally, you would have done a differential expression analysis to find something in the disease cohort that is missing in the healthy reference. Now you can actually map that out spatially at cellular resolution.

LeMieux: How much of a spatial focus do you think there will be in a decade from now? 

Heyn: Over the next five years, there will be a heavy focus on spatial data generation. There will be large-scale, flagship projects using spatial technologies. Single-cell will not go away though. For immune related references, diversity, and certain diseases, you still need single-cell analysis. Spatial will be the driver though toward more clinical applications. Spatial is the way forward to really look at clinical cohorts and diseased tissue at scale and for digital pathology implementations.

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Built from short, synthetic strands of DNA or RNA, oligonucleotides offer a fundamentally different way to influence disease biology. Rather than targeting proteins after they are produced, these molecules act upstream, engaging RNA and gene-regulatory pathways to alter protein expression with remarkable precision and duration. Their growing success has transformed them from a niche modality into one of the most promising frontiers in therapeutic discovery.

Today, advances in artificial intelligence (AI), multiomics analysis, human genetics, and disease modeling are accelerating the identification of new oligonucleotide targets. Across neurodegeneration, fibrosis, metabolic disease, and rare genetic disorders, companies are using these technologies to uncover biological mechanisms that were previously hidden. The result is a rapidly expanding therapeutic landscape where researchers are no longer limited by conventional notions of druggability.

A new class of precision medicines

Oligonucleotides are engineered sequences of nucleic acids, typically ranging from 10 to 50 nucleotides in length. Because they can be designed to recognize specific genetic sequences, they provide highly selective control over biological processes. Chemical modifications give sustained effects with patients receiving maintenance doses every three to 12 months.

As explained by Evotec: “Unlike gene therapy, oligonucleotide drugs targeting RNA, such as small interfering RNA (siRNA) and antisense oligonucleotides (ASOs) have a transient effect in the body, and do not permanently modify the patients’ genome. Sequence-based targeting of RNA uses synthetically produced, matching stretches of oligonucleotides to bind with exquisite precision to a specific RNA target, causing subsequent changes in protein expression, either by altering splicing of the immature RNA or causing rapid turnover of that RNA before a protein can be made.” This temporary and programmable nature has made oligonucleotides an attractive therapeutic platform.

The field has expanded far beyond simple gene silencing. Modern oligonucleotide approaches can redirect RNA splicing, edit RNA transcripts, enhance protein expression, block RNA-binding proteins, and even target proteins directly through aptamers, which are structured nucleic acid molecules capable of binding proteins with antibody-like affinity.

Overall, oligonucleotides are increasingly viewed not merely as another therapeutic modality, but as a platform capable of unlocking entirely new classes of targets.

Guiding drug discovery with microRNA

One area generating significant excitement involves microRNAs, which David Salzman, PhD, CEO of Gatehouse Bio, describes as “master regulators of biological pathways.” Rather than targeting a single gene, a microRNA can control entire biological programs, including cellular stress responses, inflammation, fibrosis, and protein production. Because these pathways are often disrupted across multiple diseases, microRNAs offer an opportunity to intervene at key regulatory nodes, particularly in central nervous system (CNS) disorders where distinct diseases frequently share underlying mechanisms.

Beyond their regulatory functions, microRNAs offer another advantage as druggable targets, Salzman explained. “They have dual roles as both biomarkers and drug targets.”

Researchers can inhibit harmful microRNAs using ASOs or restore beneficial microRNAs with synthetic mimetics, creating a direct bridge between diagnosis and therapeutic intervention.

The approach reflects growing recognition that many diseases are more heterogeneous than clinical diagnoses suggest. In neurodegenerative diseases such as Alzheimer’s, Parkinson’s, and vascular dementia, patients with similar symptoms might have different molecular drivers. By analyzing thousands of microRNA measurements alongside clinical outcomes, pathology, imaging, and other molecular datasets, AI can uncover patterns that traditional methods often miss.

“Ultimately, our goal is not simply to identify biomarkers,” Salzman said. “We use AI to connect microRNAs to disease biology, patient subgroups, and therapeutic opportunities.” The strategy moves researchers beyond correlation and toward causal, mechanistic understandings, a crucial step in validating therapeutic targets.

Multiomics and biomarkers

Although AI can identify disease-associated signals, determining whether those signals drive disease requires additional biological context. This is where multiomics approaches have become indispensable.

By integrating microRNA sequencing with transcriptomics, proteomics, genomics, pathology information, and clinical-outcome data, researchers can reconstruct disease networks. If a microRNA appears altered in patients with a specific outcome or pathology, investigators can assess whether related genes and proteins change in a coordinated manner. This helps distinguish passengers from drivers when prioritizing therapeutic targets.

“The power of multiomics is that it allows us to connect microRNAs to disease biology, patient subgroups, and therapeutic opportunities with much greater confidence than any single data type alone,” Salzman noted.

Gatehouse Bio’s fibrosis program illustrates how oligonucleotide discovery combines AI, multiomics, patient stratification, and experimental validation. In fibrotic tissues and blood samples from patients with idiopathic pulmonary fibrosis, the company identified reduced levels of a microRNA called miR-92.

Initially, the finding appeared to be only a biomarker. However, integrated analyses revealed something more significant. Reduced miR-92 activity mapped to fibrosis-related pathways involving TGF-beta signaling, WNT signaling, extracellular matrix remodeling, and integrin biology. Patients with lower circulating miR-92 levels experienced worse outcomes, and experiments showed that reducing miR-92 activity worsened fibrosis, whereas restoring it produced anti-fibrotic effects. The result was GHB1589, an miR-92 mimetic.

For Gatehouse Bio, the program represents a blueprint for target discovery: identify disease-associated RNA signatures, connect them to biological mechanisms, stratify patients, validate causality, and translate the findings into therapeutics.

Recreating disease in human neurons

Another major challenge in oligonucleotide discovery involves generating disease models that accurately reflect human pathology. AcuraStem has addressed this problem by using patient-derived induced pluripotent stem cells (iPSCs) that are directly converted into induced motor neurons. Unlike many traditional laboratory models, these neurons preserve aging characteristics and disease-specific pathology from the original donor.

According to AcuraStem’s CEO Sam Alworth these patient-derived models have been instrumental in uncovering novel therapeutic targets. “AcuraStem uses transcription factor-mediated lineage conversion to reprogram patient-derived iPSCs into induced motor neurons that retain the aging and pathological markers of the donor,” Alworth explained. The company’s iNeuroRx platform integrates these disease models with ASO design, screening, and pharmacology tools, creating a comprehensive discovery engine.

AcuraStem’s disease models reproduce TDP-43 pathology without requiring artificial stressors or genetic manipulation—a capability the company believes is unique. This platform has enabled the discovery of several therapeutic targets, including the gene SYF2, which appears capable of restoring TDP-43 localization and function.

The work highlights a broader trend within oligonucleotide discovery: targeting upstream molecular mechanisms rather than downstream symptoms. “RNA dysregulation, as a direct and measurable consequence of TDP-43 dysfunction, is a target that can be modulated by technologies such as antisense oligonucleotides,” Alworth said.

An expanding oligonucleotide toolbox

While some companies begin with disease biology, others start with genetics. Aperture Therapeutics, for example, is building its discovery strategy around naturally occurring protective human genetic variants. The company’s platform analyzes large-scale genomic and clinical datasets to identify resilience mechanisms that protect individuals from neurodegenerative disease. These insights are then translated into oligonucleotide strategies, including gene-expression modulation and splice-switching approaches. By focusing on genetically validated targets, Aperture aims to reduce development risk and improve the probability of clinical success. The strategy reflects a growing industry consensus: human genetics provides one of the strongest forms of biological validation available.

The oligonucleotide field is also expanding beyond traditional antisense and RNA interference approaches. As an example, Opprtna Therapeutics is developing aptamer-based therapeutics for CNS diseases. Unlike many aptamers that primarily serve delivery functions, the company is designing molecules that directly influence disease biology. Using structured DNA molecules capable of binding proteins associated with RNA and DNA regulation, Opprtna hopes to target pathways that have traditionally been inaccessible to conventional drug modalities. The approach underscores how oligonucleotide chemistry itself continues to evolve, creating entirely new therapeutic opportunities.

Meanwhile, Riboway Therapeutics is pursuing RNA-targeting technologies capable of increasing, decreasing, activating, or inhibiting protein expression depending on the therapeutic need. The company’s AI-driven platform focuses on decoding RNA regulation to identify previously inaccessible intervention points.

In many ways, oligonucleotides are redefining what drug discovery can be. Rather than asking whether a target is druggable, researchers are increasingly asking how RNA biology can be leveraged to reach it. That shift may ultimately prove to be one of the most important developments in modern therapeutics.

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When scientists at Bac³Gel hear from potential customers, they typically express a mixture of frustration, curiosity, and skepticism, Sebastião van Uden, PhD, the company’s CEO, tells GEN. Usually, they approach the company after their own culture efforts have failed to produce consistent results, or they are on the hunt for a solution for bacteria “that is hard to grow,” or they are concerned about the costs and duration of current bioreactor experiments.

These are issues that the company believes it can address with its proprietary biomaterial platform, which uses a synthetic, organic gel, made from food-grade ingredients, to reproduce the structural and chemical properties of human mucus. The gel is designed to support the growth of highly complex microbial communities in the laboratory setting and is used for applications in academia, biotech, and pharma research and nutrition. Importantly, the gel can be customized to grow microbial communities that are found in different environments including the gut, lung, skin, and vagina.

The company claims that its technology addresses key industry pain points, including hard-to-culture bacteria as well as the high cost and low throughput of existing bioreactors. According to numbers shared with GEN, the company’s gel can enable growth of up to 92% of a microbiome sample’s species, which is a significant improvement over the 2–3% that is achievable with standard methods.

Bac³Gel is adopting a three-step market strategy that starts with research tools, moving into the food supplement space in partnership with existing corporations, and finally developing live biotherapeutics. It is the most prudent path for the early-stage startup, van Uden says. “Our business strategy lies in [moving] step-by-step, increasing risk while we expand in markets.”

Like most biotech companies, Bac³Gel is exploring ways to deploy artificial intelligence (AI) that make sense for its portfolio. One avenue is to leverage the large datasets that it has generated to create digital twins of the human body that allow it to test how particular strains affect the existing microbiome population or how particular probiotics impact people in different geographies with unique diets. “This is something very interesting, and we started working on it,” van Uden says. “I think AI has a place here in the microbiome.”

Prebiotic substrates for phenotyping

As consumables product manager at Biolog, Juan Sanchez, has a good overview of the company’s microbiome portfolio. In fact, “I actually introduced our first microbiome target product,” he tells GEN. “We had other products that could be used for this type of research, but this one is really for the gut microbiome.” Specifically, these are three different plates with prebiotic substrates that at their core are designed to help scientists who are studying human or animal gut microbiomes simplify their work.

The so-called PreBioM line of microplates is designed for phenotyping gut microbiomes by testing their ability to metabolize various prebiotic substrates. Plates come pre-loaded with 90 different prebiotic substrates, removing the need for scientists to handle the plate formulation and testing on their own. And though the product was designed for the gut microbiome initially, it is applicable to other mammalian microbiomes such as oral and skin. “We remove all of the trouble from the researcher having to guess which substrates are relevant, what concentrations should these substrates be at,” Sanchez says. “We did all of that work for them.”

Primary customers for PreBioM plates are scientists in universities, university hospitals, and pharmaceutical companies that are developing live biotherapeutics. “The live biotherapeutic space is really one direction where the microbiome research has been evolving to,” Sanchez says. “Before it was just making probiotic pills, but now they are a lot more specialized.”

And that brings up a new challenge: the need to standardize not just the final product but also what goes into producing the product. This is another area where Biolog stands out. “We’ve actually been making media for growing the bacteria that will be used for the live biotherapeutic in bioprocess bags,” he tells GEN. This product, TruPRAS, is the only commercial media manufactured under true pre-reduced, anaerobically sterilized conditions, according to Biolog.

The evolving live biotherapeutics market is also driving greater interest in customized media offerings, Sanchez notes. In fact, it is “one of the bigger trends for live biotherapeutics that I’ve seen coming up,” he says.

Building immune tolerance

“The big bold vision that we’ve always had at Siolta Therapeutics is that we can actually stop diseases before they start,” Nikole Kimes, PhD, tells GEN. Kimes co-founded the company with Susan Lynch, PhD, a professor in the department of medicine and director of the Colitis and Crohn’s Disease Microbiome Research Core at the University of California, San Francisco (UCSF).

Kimes, who serves as the company’s CEO, joined Lynch’s lab at UCSF back in 2014 at a time when scientists were learning a lot about how allergic disease develops. “What we kept seeing was that early life risk factors were the most highly associated with disease development downstream,” she says. “We started to look into the gut microbiome early in life” for “signatures that were consistent across kids who went on to develop either atopic dermatitis, food allergy, asthma [or] any of the IgE-mediated atopic diseases.” Their idea was to create a cocktail of beneficial microbes that could be used to treat infants whose signatures suggested they were at greater risk of disease. In theory, by replenishing the gut microbiome, they would be able to support immune tolerance rather than immune inflammation.

Their research led them to examine the microbial communities of infants in different cohort studies globally, looking for signals that indicated they lacked beneficial microbes. “What we’re really interested in is the functionality, what role are they playing?” Kimes explains. This is an important point because two people might have drastically different strains in their microbiomes that have functionally similar roles. They also looked at the functional capacity of the microbes that conferred healthy benefits to their hosts. This way, they identified a subset of potential candidates for the cocktail that would have the greatest efficacy and be easy to manufacture.

The company has now completed a Phase II proof-of-concept clinical trial of its live biotherapeutic in 238 newborn infants with a familial history of allergic disease. “We have great data showing that this cocktail of organisms, when given over the first year of life, is reducing atopic dermatitis and food allergy at one year of age.” By age two, “we actually see reductions across atopic dermatitis, food allergy, and even asthma.”

An edge in the obesity market

For years, the ketogenic diet has been effectively used to treat drug-resistant epilepsy and other metabolic conditions by pushing the body to burn fat as an energy source. Bloom Science is turning to the microbiome to develop therapeutics for neurological and metabolic disorders that work in much the same way without dietary changes. “Our core technology and program is actually based on what we like to say is reverse engineering the ketogenic diet,” says Chris Reyes, the company’s CEO and founder. “We looked at the ketogenic diet as our reference point” and asked, “How does it work? What are the key bioactive molecules that have been shown or are being focused on to explain this effect?”

Underpinning the company’s therapeutic pipeline is a proprietary platform dubbed IrisRx. Leveraging this platform, it has developed live biotherapeutics that treat obesity, Dravet syndrome, Alzheimer’s disease, and amyotrophic lateral sclerosis. Its lead candidate, BL-001, is currently in Phase Ib testing for obesity. Early signals indicate that the biotherapeutic is well tolerated with no serious adverse events, and patients with overweight had statistically significant placebo-adjusted weight loss.

“We took a very traditional drug discovery and development approach,” Reyes explains to GEN. After identifying strains of bacteria that could replicate the diet, “we created a library of strains within these species and other species, and we screened them like we would an antibody library or a small molecule library looking for optimal functional fit.” The company is also working on engineering specific improvements to some strains to further optimize them for different indications.

If Bloom’s first candidate is successful, BL-001 could become an alternative to GLP-1s. In fact, Reyes believes that even with the success of GLP-1s, the population of people with obesity in the United States is still underserved. “Maybe about a third of the obese population is actually on or has been on GLP-1s,” meaning “two-thirds are not.” He attributes this partly to hesitation among this population due to factors like drug cost and tolerability.

Macrophages to aid immunotherapies

The constant interaction between the microbiome and the immune system is of particular interest to scientists at Exeliom Biosciences. As Benjamin Hadida, the company’s co-founder and CEO, explains it, “we are trying to modulate the immune system by using some components that come from the microbiome.”

The French biotech company is developing a single asset, dubbed EXL01, that is delivered orally and is currently in Phase II testing in six different clinical studies across three therapeutic areas, Hadida tells GEN. EXL01, the company’s immunomodulator, is a strain of the bacterium Faecalibacterium prausnitzii, which is prevalent in healthy human guts. It is also one of the first to be impacted in systemic inflammation seen with conditions like inflammatory bowel disease or in patients undergoing chemotherapy.

Four of their studies are focused on oncology where the asset is being evaluated in combination with several approved checkpoint inhibitors in gastric cancer, renal cell carcinoma, hepatocellular carcinoma, and non-small cell lung cancer. Essentially, “we’re developing an immunomodulator that acts on the innate part of the immune system,” he explains. “We activate macrophages so that we can make patients more able to respond to immunotherapies.”

The company is positioning EXL01 as an add-on to existing immunotherapies since it targets a different type of immune cell. For patients on these treatments, whether that is in oncology or immune disease, “one of the key issues is the durability of the effect. We work on macrophages so that we keep the response to these treatments sustainable,” he says.

“We took it to the lab and tested it in some models trying to identify the mechanism at play,” he continues. It turns out that this bacterium has a unique component on its membrane that makes it a specific agonist of a key receptor in macrophages. Upon binding, it activates the NOD₂-CARD₉ pathway that reprograms the macrophages to resist the immunosuppressive tumor environment and keep the T cell pool in shape.

Industry skepticism toward microbiome therapeutics in the last several years has created both challenges and opportunities for companies like Exeliom. “In the oncology world, [there have been a] number of Phase III failures that we’ve seen when [pharmas] try to combine things with checkpoint inhibitors to increase the efficacy,” Hadida says. “Some of them were able to increase the response rate, but they all failed in terms of progression-free survival. What’s interesting is when you look at all these strategies, they are all focusing on the adaptive immune system. None of them tried to act on the innate immune system.” It is a common blind spot that Exeliom is targeting. “People are maybe a bit more open [to] new strategies that look somewhere else,” Hadida says.

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CAA is characterized by the abnormal buildup of amyloid-beta protein in the walls of the brain’s blood vessels. Over time, vascular amyloid accumulation can damage and ultimately weaken the vessels, increasing a person’s risk for brain bleeds, hemorrhagic stroke, and contributing to cognitive decline. The condition is difficult to accurately diagnose and lacks targeted treatment options.

“Despite the prevalence of the disease, there are no reliable early-stage biomarkers, and disease-modifying therapies currently do not exist,” said William Van Nostrand, PhD, co-executive director of the George & Anne Ryan Institute for Neuroscience at URI.

The grant is part of a $9 million five-year Transatlantic Networks of Excellence grant from the Leducq Foundation. The initiative is known as TRAFFIC (Translational Framework For Innovation in Cerebral Amyloid Angiopathy).

The goals of the TRAFFIC study are to find and clarify disease mechanisms, identify early-stage biomarkers, and reveal potential targets for disease intervention.

“Our role at URI will be to perform studies to address why CAA develops in people and how certain risk factors for disease can increase the chance for bleeding in the brain,” explained Van Nostrand. “This will be done using an animal model developed here at URI that mimics CAA found in humans.”

The project will begin in January 2027, and Van Nostrand will collaborate with scientists from Harvard Medical School, Vanderbilt University Medical Center, Vall d’Hebron Research Institute (Spain), and Otto von Guericke University Magdeburg (Germany).

Since 2024, Van Nostrand has been working on another project funded by the Leducq Foundation that focuses on the disruption of brain waste clearance mechanisms that contribute to the biological processes by which CAA develops.

“Support from these highly competitive and prestigious transatlantic networks will reveal new insights into the disease, paving the way for better diagnosis and development of disease-modifying therapies,” said Van Nostrand.

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Plasmodium parasites multiply and mature in the liver before exiting the tissue and infecting red blood cells, triggering the symptoms of malaria. Vaccines that arrest infection during the liver stage of Plasmodium infection can induce potent immunity; however, they have challenges such as complex production and repeated rounds of IV delivery in field settings. With drug resistance continuing to undermine malaria control, there is an urgent need for new strategies to stop infections.

Now, researchers developed a novel immunization strategy, chemovaccination, that paired mosquito-delivered malaria parasites with an investigational class of antimalarial drug compounds. The compounds blocked the parasite’s development at a critical stage of the malaria lifecycle, preventing disease and triggering a robust immune response that provided durable protection against malaria. Subsequent mosquito bites then reinforced this immunity and protection.

In chemovaccination, exposure to live parasites is accompanied by the administration of antimalarial drugs that arrest the parasite life cycle, preventing illness and allowing the immune system to respond to the attenuated parasite.

Now, researchers from WEHI (Melbourne, Australia) have demonstrated that chemovaccination can prime the immune system to fight malaria parasites before they cause disease, with subsequent mosquito bites acting as boosters to strengthen immunity over time—turning mosquito bites into ongoing immune boosters

This approach protected mice against malaria for the study period—a rare outcome that could inform the development of next-generation prevention strategies for one of the world’s deadliest infectious diseases. The study is the first to target malaria parasites at the late liver stage using an antimalarial drug candidate discovered by WEHI and the global biopharmaceutical company MSD (tradename of Merck & Co., Inc., Rahway, NJ).

The research is published in Science in the paper, “Chemovaccination with a late-liver-stage antimalarial induces durable immunity against malaria.”

“Using this new drug compound, we’ve found a way to turn mosquito bites—the very thing that spreads malaria—into vaccination events in mice,” said Justin Boddey, PhD, associate professor at WEHI. “This represents a shift in the way drugs could be employed to prevent malaria.”

The antimalarial drug candidates used in the study, WM382 and MK-7602, are both dual inhibitors of plasmepsin IX and X—two “master regulators” that are crucial for parasite survival. The drug candidates are the result of a decade-long research collaboration between WEHI and MSD.

John A. McCauley, senior director, discovery chemistry at MSD, said: “Current approaches often rely on genetically attenuated parasites, which can provide strong protection but require high doses and are difficult to produce, scale, and administer in real‑world settings. By using a drug to arrest parasites at the late liver stage, we’ve enabled the immune system to recognize a broader range of malaria antigens using a smaller parasite dose. This approach may provide a broader response against the diversity of malaria parasites seen in the real-world and go beyond what genetically attenuated laboratory strains can achieve.”

As WM382 and MK-7602 target enzymes that are highly conserved across malaria species, researchers hope this will enable their approach to provide protection against a wide range of malaria “variants” in the future—potentially allowing people in endemic areas to build immunity from natural mosquito bites over time. A long-acting injectable based on the compounds is in preclinical development.

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To capture the human impact of UM practices and to empower patients to effectively advocate for themselves, CancerCare, a national non-profit organization that provides emotional, practical and financial support for anyone affected by cancer, recently launched the Micro Insights, Macro Impact project.

The resources developed in conjunction with the project include the Focus Group Report, “Behind the Barriers: Patient Voices on Access to Treatment,” an Advocacy Toolkit, and three videos.

‘Fail first’ policies fail cancer patients

“My insurance company asked me to try and fail one treatment before I can get the actual treatment that I needed, and I was devastated by that,” said Maria, a patient living in New Jersey, with stage 3b uterine cancer. In a video testimony for Micro Insights, Macro Impact, Maria details her experience with step therapy, a utilization management practice where health insurance companies require patients to try other, often less effective, treatments first before they provide access to the treatment the patient was actually prescribed by their healthcare provider.

Maria’s case demonstrates the devastating impacts of step therapy on patients: only after experiencing harmful effects from the insurance-required treatment did Maria become eligible for the treatment her doctors prescribed. “I was then informed by doctors, Oh, you had the rash, so now you’re actually eligible for the better chemo. And I was like, What do you mean, better chemo? You have to have a side effect first before we allow you to advance to the better chemo. I was shocked,” explained Maria.

‘Prior authorization’ prioritizes insurers, not patients

Maria also experienced barriers from prior authorization, a process most patients know all too well. Prior authorization is a strategy used by health insurance plans that requires providers to obtain approval from the health insurance plan for a medicine before insurance will cover it.  Oftentimes, prior authorization increases administrative burden on patients and providers and delays access to medically necessary treatments.

“It was really hard to get anything filled,” said Maria. “I had to wait until I got an authorization. I had a waiting period of about a month and a half. No treatment, no medication, just waiting for the new coverage.”

Maria’s experience is all too common, and costs patients and caregivers valuable time. As CancerCare’s 2025 Insurance Red Tape report found, among patients directly impacted by prior authorization protocols, 51% lost up to a full business day, 27% lost up to 2–3 business days, and 12% lost a full business week or more dealing with a single authorization incident. The Red Tape report labeled this issue as “time toxicity,” where a patient or caregiver spent substantial time communicating with insurers, gathering documentation, and appealing decisions. And patients are not just losing time out of their day, they are losing valuable treatment days. The report also found 29% of participants reported diagnosis delays, and 40% reported treatment delays due to authorizations. Additionally, 14% experienced abrupt coverage stoppages in the past year and 64% of those experienced treatment interruption.

The Micro Insights, Macro Impact project conducted a series of patient focus groups which captured poignant, real-life examples of the UM challenges and barriers documented in the Red Tape Report. These stories culminated in a telling report titled, “Behind the Barriers: Patient Voices on Access to Treatment.”

Like Maria, Steven, a patient from the suburbs of New York with stage four colorectal cancer, provided additional context to the focus group report through his video testimony about his UM challenges and how they affected his life. “They don’t know who you are. They don’t care who you are. You’re just a number,” said Steven. “When you have cancer, it’s stressful enough. And when you’re dealing with insurance companies, it’s a double whammy, right? From prior authorizations to delays to denials, they throw a bunch of terms at you, but you know no one bothers to translate what it actually means. How do I navigate through this?”

“This isn’t a game. This is my health,” said Steven, “Why is this so difficult? It can be a bit dehumanizing. I think it’s important for the decision makers to really think about it from a more humane perspective. The system’s broken, and I think we could do a better job in making people’s lives easier.”

In a third video, “What It Feels Like When Insurance Stands Between You and Your Care,” three cancer patients succinctly and boldly speak about the unacceptable consequences of UM on their lives and what they would say to the people who denied their coverage.

Improving access and affordability

Individuals living with cancer deserve better. Utilization management practices are causing real harm to patients for whom time is of the essence.

“It is a nightmare waking up every day wondering if some people halfway across the country will approve what my doctors have said is my only chance,” said a patient in the Micro Insights, Macro Impact report.

Ultimately, many of the barriers imposed by utilization management are wholly unnecessary. “Among the 1,201 respondents who experienced prior authorization,” the Red Tape report states, “95% ultimately had their most recent request approved—89% after initial review and 6% after appeals—yet delays still frequently occurred, even when the initial request was approved.” These findings put in question the premise behind utilization management – WHY the initial treatment was denied at all in the first place, which jeopardizes the health of cancer patients who cannot afford to wait.

Empowering patients

Another key takeaway of the Micro Insights, Macro Impact project is the importance of empowering patients and caregivers to engage in policy advocacy by sharing their personal stories with decision makers. To help facilitate this goal, the project’s Advocacy Toolkit helps familiarize patients with UM health policy terms and provides an easy-to-understand framework for people to reach out to policy makers via letter writing, social media posts, and meetings. The Toolkit provides “how-to” examples of the different policy advocacy methods to help demystify the process and boost the confidence of patients and caregivers.

Micro Insights, Macro Impact marks a critical step forward in moving the needle toward meaningful utilization management reform, showcasing the people and stories behind the numbers.

“Utilization management practices are being implemented in ways that harm patients. Micro Insights, Macro Impact spotlights the shared challenges that disrupt patients’ daily lives from diagnosis and beyond. These stories put a human face to the data, point to where policy change is needed most, and empower patients and caregivers to help drive necessary change” said Kim Czubaruk, JD, Vice President of Policy, CancerCare.

If you are interested in learning more, you can visit https://www.cancercare.org/, where you can read Micro Insights, Macro Impact, the 2025 Red Tape Report, and other CancerCare resources.

Additionally, if you are a patient advocate, consider registering for the Biotechnology Innovation Organization’s Patient Advocacy Changemakers Event (PACE): an empowering and inspiring event focused on breaking barriers to access and ensuring that innovative medicines reach the patients that need them.

The post CancerCare project highlights barriers to patient access appeared first on Bio.News.

Lab leaders are under pressure to adopt AI and automation, and most of that pressure is well-founded. When properly implemented, AI and robotic systems, including automated polymerase chain reaction (PCR) workflows, can reduce manual variability, ease workflow bottlenecks, and produce high-quality data. When integration runs ahead of the science underneath it, new tools can introduce errors and slow down the work they were meant to accelerate.

In genetic analysis, credibility is built on reproducibility. New instruments and software continue to enter the market with the promise of faster and higher-quality results. However, the variable that is most often overlooked is also the most consequential: the reagents and consumables that influence every reaction. Real-time PCR (qPCR) assays, master mixes, primers, probes, plates, seals, and tips quietly determine whether a workflow can be trusted, especially as new platforms enter the market with the promise of faster, cleaner results.

When labs chase speed without stabilizing the basics, they risk building sophisticated workflows on unstable foundations. AI and automation cannot reduce variability on their own. They depend on consistent consumables, robust chemistry, and strong traceability. Without that foundation, small issues can scale into batch-level failures. Labs that want to succeed with new technology must first invest in analytically validated reagents that make that technology trustworthy.

Automation amplifies everything

Automation can generate more data faster, but it can also scale small problems into larger ones when inputs from genetic analysis experiments, such as assay design, reagent chemistry, and consumables, are inconsistent. For example, a master mix that performs well in a manual benchtop workflow may behave differently after sitting on an automated deck for an extended period. If evaporation, temperature exposure, or incomplete mixing shifts reaction concentration in only a subset of wells, the result may not appear as a complete run failure. Instead, the lab may see subtle threshold cycle (Ct) shifts, increased well-to-well variation, or edge effects that are difficult to trace after the run is complete. In high-throughput qPCR, reproducibility often depends less on the thermal cycler than on reagent performance and reaction assembly.

Automation without consumable consistency across assays and master mixes does not always save time. Rather, it shifts time from pipetting to troubleshooting. Before scaling, labs should evaluate whether assays, master mixes, and consumables can perform under real automated conditions (e.g., hold times, ambient exposure, and mixing steps); not just under ideal bench conditions.

Consumable quality is critical

Multiplex qPCR leaves almost no margin for uncontrolled variability, which makes consumable consistency across qPCR assay design and chemistries an especially important consideration in genetic analysis labs. When several targets are amplified in a single reaction, noise sources, such as baseline instability, spectral bleed, and inconsistent fluorescence transmission, can compete with the real signal. The result is curves that are difficult to interpret and translate into action.

Consumables that perform consistently lot-to-lot, with low-binding surfaces, robust sealing, and low-background optics, paired with multiplex-stable master mixes, give labs fewer reruns and cleaner target differentiation. The practical step is to qualify every new lot under the conditions where it will actually run, including hold times, mixing steps, and full multiplex panels, before releasing it into production. That requires evaluating plates, seals, and tips for autofluorescence, adsorption, and lot-to-lot optical consistency, not just for sterility or general compatibility.

What your controls aren’t saying 

Common assumptions about consumable quality create blind spots that can become dangerous at scale. Three are worth calling out. First, “sterile” does not automatically mean nuclease-free or DNA-free. These certifications cover different things, and a label that satisfies a procurement specification may not satisfy a sensitive amplification reaction. Second, passing controls does not guarantee an entire plate is unaffected. Controls can miss edge effects; low-input loss and mild inhibition can still distort results in target wells. Third, master mixes are not interchangeable. Formulation and lot variation change efficiency, inhibitor tolerance, and multiplex behavior, sometimes in ways that only surface after a method transfer.

A practical step that genetic analysis labs can take is to test consumables under worst-case conditions: low input, edge wells, and extended hold times. That is closer to how an automated workflow actually behaves.

AI is not a guarantee 

AI has the potential to add real value in genetic analysis workflows, but only when it sits on top of consistent physical inputs and good metadata. It does not replace the need for widely used consumables and traceability.

AI has the potential to flag issues early, including Ct drift, edge effects, and unusual amplification curves. It tracks trends over time and links problems to reagent lots, instruments, or staging conditions. However, the dependency runs in both directions. AI-driven quality monitoring is only as good as the data it receives. If consumables introduce uncontrolled variability through inconsistent optics, adsorption losses, or leachables, AI may detect symptoms without identifying root causes. Even worse, it may normalize drift if the baseline itself is unstable. The difference between a useful flag and a misleading one usually comes down to whether the lab can trace what changed.

Consider this scenario: A lab uses AI to monitor plate-to-plate performance, and the system flags a subtle upward Ct trend. With appropriate traceability, meaning lot numbers for plates, seals, master mix, and tips linked to each run, the team traces the issue to a new consumable lot with higher autofluorescence. Without that metadata, the trend is visible but unexplainable. The model can flag that something is wrong, but it cannot explain it.

The implication: traceability is a workflow discipline problem, not a software problem. Scientists need to build traceability into every run (e.g., link reagent lots, consumable lots, staging conditions, and instrument IDs to results). Without this metadata for AI to consume, there is no AI-driven quality monitoring.

Get the foundation, then scale 

The real innovation ahead is not just smarter software or technology. It is robust assay design, reagent chemistry, and consumables designed for automated workflows: stable at room temperature, tolerant to inhibitors, and consistent in multiplex performance. Better traceability, with reagents and labware tracked by lot and linked to QC data, supports more unattended runs, fewer failures, and faster troubleshooting when something does go wrong.

AI and automation can move genetic analysis forward, but only when the underlying workflow is already controlled. The lab of the future will not be defined by how much human judgment it removes. It will be defined by how well it preserves that judgment with better data, better context, and fewer avoidable sources of variation. That starts with unglamorous work: qualifying consumable lots, documenting reagent and labware changes, stress-testing chemistries on automated decks, and making traceability part of every run. These are not side details. They are the foundation that determines whether AI-enabled genetic analysis produces insight or simply scales uncertainty.

The post Your AI Is Only as Good as Your Inputs appeared first on GEN - Genetic Engineering and Biotechnology News.

Agilent Technologies

Effective impurity removal in biomanufacturing requires strategically integrated separation and analytics across both upstream and downstream workflows. Early-stage control focuses on removing process-related impurities, such as host cell proteins (HCPs), DNA, and media components, where affinity chromatography remains foundational for bulk clearance and process robustness

As molecules increase in complexity, orthogonal analytical approaches become critical. High-resolution multidimensional separations enable deeper interrogation of complex mixtures and reduce the risk of co-eluting impurities. Agilent Bio-inert LC platforms are developed to minimize metal interactions that can compromise protein integrity or mask low-level impurities, improving sensitivity and reproducibility for biologics and metal-sensitive analytes.

Downstream purification strategies are increasingly tailored to modality. LC solutions paired with integrated software workflows, support efficient peptide purification with yield and purity tradeoffs. For oligonucleotides, impurity removal often relies on orthogonal ion-pairing reverse phase (IP-RP) and anion exchange (AEX) chromatography to resolve sequence failures and closely related variants.

Ultimately, combining robust purification technologies with advanced analytical workflows ensures not only effective impurity clearance, but also comprehensive characterization critical to maintaining product stability, regulatory compliance, and patient safety.

Lonza

Driving effective impurity control in biomanufacturing requires orthogonal diversity coupled with capacity redundancy and holistic process stewardship.

Bioinformatics can inform liabilities before even picking up a pipette. Cell line stability, clone selection and high-throughput upstream optimization reduce host cell protein (HCP) accumulation by preventing upregulation of lipases and proteases that cause oxidation and unfolding but serve to protect cellular function under prolonged stress.

Often overlooked, effective primary harvest depth filtration combined with charged media is the first line of defense, separating impurities based on size and electrostatic, hydrophobic, and hydrogen bonding mechanisms. This focus is central as upstream processes intensify.

Downstream processing should leverage heterogeneous product characteristics: selection of specialized affinity resins, enhanced washes that disrupt “hitchhiking” HCP-target molecule-histone complexes, and reduced proteases that contribute to ligand leachate. Viral inactivation precipitates impurities to aid physical removal when followed by charged depth filtration, which should be optimized for pH and conductivity conditions. Multimodal resins combining IEX, HIC and hydrogen bonding provide powerful synergistic polishing for removing aggregates, fragments, stubborn HCPs, endotoxins, viruses, and residual affinity ligand to provide representatively pure product, essential for successful liquid formulation studies. Changes to regulatory guidance mandate future HCP characterization using LC-MS informed early process development, to ensure patient safety, product stability, and promote the maximum possible shelf life.

MilliporeSigma

Effective impurity control is enabled through a combination of advanced analytics, targeted purification technologies, and upstream material design. Upstream, MilliporeSigma minimizes impurity introduction through stringent raw material qualification, trace element (TE) control strategies, and high-sensitivity analytical platforms such as ICP-MS for multi-element profiling. These capabilities allow precise characterization and specification of low-level metal impurities that can catalyze oxidation or destabilize proteins. Engineered cell culture media further reduce variability by controlling impurity ingress at the source, supported by supplier qualification and risk-based raw material selection. In-process controls and real-time monitoring ensure consistency throughout bioreactor operations.

A recent supply chain disruption involving ferric ammonium citrate (FAC) put these capabilities to the test. When alternative sourcing introduced material with markedly different TE impurity profiles, MilliporeSigma leveraged its integrated chemical manufacturing expertise and ICP-MS analytical platforms to engineer an FAC solution aligned with historically established TE baselines. Defined impurity targets preserved process comparability and avoided customer reformulation, demonstrating how analytical comparability and change management frameworks keep impurity profiles within defined limits when supply or process adjustments are required.

In summary, MilliporeSigma integrates analytical rigor, engineered impurity control, and robust purification technologies across upstream processes, providing a scalable, supply-resilient foundation that safeguards product quality, process consistency, and patient safety while reinforcing leadership in differentiated bioprocessing solutions.

Repligen

Effective impurity control begins with a well-designed purification strategy. Across downstream processing, the objective is straightforward: remove process- and product-related impurities while preserving the quality, potency, and stability of the therapeutic.

Repligen has built a comprehensive portfolio of purification and analytical technologies designed to address impurity challenges across a wide range of biologics. Affinity chromatography remains one of the most powerful tools available, routinely removing more than 95% of process-related impurities in a single step while maintaining yields above 90%. Our portfolio includes both catalog affinity resins and industry-leading capabilities for the rapid development and commercialization of custom affinity ligands. These custom solutions can address particularly challenging separations, including product-related impurities that are difficult to resolve using conventional polishing techniques.

Filtration plays an equally important role throughout the purification workflow. Tangential flow filtration, using either flat-sheet or hollow-fiber formats, supports impurity clearance, enhances chromatography performance, and enables efficient formulation of the final drug product. Together, chromatography and filtration create a highly effective platform for delivering consistent product quality and process robustness.

What differentiates Repligen is the integration of purification technologies with advanced process analytical technologies (PAT). We believe effective impurity control requires not only removing contaminants but also measuring and understanding them in real time. Our portfolio spans at-line, on-line, and real-time analytical solutions that provide actionable process insight directly to operators and manufacturing teams.

Because no single analytical technology can address every challenge, we have deliberately built a broad PAT portfolio that enables customers to apply the right tool to the right problem. Repligen provides solutions that provide real-time UV-Vis and Raman analytics for upstream and downstream process monitoring, while platforms enable deeper characterization of media components, proteins, and critical impurities.

Ultimately, successful impurity control requires the seamless integration of purification, filtration, and analytics. By combining these capabilities into a connected bioprocessing ecosystem, Repligen helps customers accelerate development, strengthen process understanding, and consistently manufacture safe, high-quality biologics.

Sartorius Stedim Biotech

Effective impurity control is essential in biomanufacturing, with strategies tailored to the target molecule and process. Downstream processes for monoclonal antibodies (mAbs) have demonstrated a direct impact on product quality and patient safety. Key impurities—host cell proteins (HCPs), residual DNA, endotoxins, aggregates, and process-related chemicals—originate from the expression system or manufacturing steps. If not adequately removed, HCPs and DNA can trigger immune responses or toxicity in patients, aggregates may induce immunogenicity or reduce efficacy, and endotoxins can cause severe inflammation. Process chemicals, like Protein A leachates or buffer residues, further contribute to safety risks.

Industry-leading technologies are applied in downstream processing to ensure impurity removal. Protein A affinity chromatography captures mAbs and eliminates bulk HCPs and DNA, mostly followed by a prolonged hold step at low pH to facilitate virus inactivation. Polishing steps with ion exchange as well as hydrophobic interaction chromatography remove charged contaminants, viruses, and aggregates. Sartorius membrane chromatography enables a complete membrane-based workflow for efficient impurity removal and high productivity, while bioburden, sterile, and virus filters ensure reliable removal of particulates, bacteria, and viruses, maintaining the critical quality attributes before final formulation. All process steps are usually complemented by several ultrafiltration and diafiltration steps, which facilitate further impurity removal, buffer exchange, as well as concentration of the molecule of interest.

Regulatory entities rigorously assess these purification steps during drug approval, ensuring impurity removal meets stringent safety standards to protect patient health, as demonstrated in many commercial processes.

Veranova

For antibody-drug conjugates (ADCs), it is critical to tightly control reaction stoichiometry, buffer composition, temperature, and reaction time. Hold times during antibody modification and conjugation should also be assessed, as delays in processing the antibody-linker intermediate may alter reaction stoichiometry or increase product-related impurities that complicate downstream purification.

Tangential flow filtration (TFF) is widely used with minimal yield loss to remove small-molecule stabilizers from antibody storage buffers prior to conjugation, as well as for ADC concentration, buffer exchange, and clearance of process-related impurities such as free payload, linker, and organic solvents. Compared to chromatography, TFF is typically more scalable, cost-effective, and higher yielding, largely due to the significant size difference between the ADC (~150 kDa) and payload (<2 kDa).

In some cases, carbon filtration is applied after TFF as an orthogonal step to remove residual linker-payload species. Depending on antibody subtype, conjugation method, and payload, product-related impurities may include aggregates and undesired isoforms. In these situations, size exclusion chromatography or hydrophobic interaction chromatography may be necessary, although they can reduce yield and increase manufacturing cost.

As novel conjugation technology evolves using bispecific mAbs, Fc-fusion proteins, and chemical site-specific conjugation, traditional TFF systems will be sufficient for purification alone or in combination with chromatographic separation techniques to deliver homogeneous ADCs with uniform drug-to-antibody ratios.

WuXi Biologics

Residual impurities are primarily process-related, including DNA, host cell proteins (HCPs), leached Protein A, and upstream additives. Effective control of these impurities requires an integrated strategy across both upstream and downstream processes. While cell line and process development help define and minimize the initial impurity burden, downstream purification takes the main responsibility for their removal.

Among the residual impurities, lipases and metal ions can be particularly detrimental due to their roles in protein degradation and instability. In downstream processing, Protein A affinity chromatography is one of the most effective unit operations for removing such impurities, owing to its high selectivity for antibodies/Fc-fusions. However, certain HCPs and other impurities may interact with the target molecule and copurify.

To address this, it is critical to disrupt these interactions. Therefore, we extensively optimize Protein A wash conditions using additives such as amino acids, chaotropic salts, organic solvents, or detergents to enhance HCP clearance. In one case, we successfully removed cathepsin B, a CHO endogenous protease that chops the target antibody, by adding sodium caprylate into the wash buffer.¹ Similarly, EDTA is used in the wash buffer to remove metal ions. High-pH eluting Protein A resins and Protein A membranes have also demonstrated advantages for HCP clearance, reducing HCP levels to below those achieved with regular Protein A resins.^2,3

Beyond the affinity step, intermediate depth filtration following low-pH inactivation/ neutralization and subsequent polishing steps are further optimized to reduce residual impurities. Among polishing techniques, hydrophobic interaction chromatography (HIC) has shown particular effectiveness in removing lipases, and ongoing evaluations focus on resins with varying hydrophobicity to enhance performance.

References

1. Hu L, Tang J, Zhang X, Li Y. Sodium caprylate wash during Protein A chromatography as an effective means for removing protease(s) responsible for target antibody fragmentation. Protein Expr Purif. 2021, 186: 105907.

2. Li Z, Hu L, Li Y. The advantage of high pH eluting Protein A resins over their regular counterparts in aggregate and host cell protein clearance. Protein Expr Purif. 2026, 239: 106859.

3. Yang Y, Zhang X, Li Y. Deciphering the inconsistent performance of Protein A membrane on host cell protein clearance. Protein Expr Purif. 2026, 240: 106891.

The post Roundup: Removing Impurities from Biomanufacturing appeared first on GEN - Genetic Engineering and Biotechnology News.

Patients in the Macedonia and Rocky River Area Can Now See Tiffany Wu, MD For Expert Dermatology Care 

Dermatologist Dr. Tiffany Wu has joined Optima Dermatology’s Macedonia and Rocky River, OH practices, expanding patient access to treatments for a variety of skin conditions including acne, eczema, psoriasis, skin cancer, and more. 

Dr. Wu completed her residency in dermatology at the Cleveland Clinic Foundation and was selected to serve as Chief Resident during her final year of training. She gained valuable experience during an additional year performing dermatology clinical trials at the Icahn School of Medicine at Mount Sinai, where she evaluated emerging therapies in atopic dermatitis, psoriasis, hidradenitis suppurativa, acne, and dermatomyositis.  

She earned her Bachelor of Arts in Molecular and Cell Biology at the University of California, Berkeley, and her Doctor of Medicine at Case Western Reserve University School of Medicine. During an additional year of medical school, she attended Stanford University to study translational research, examining datasets of patients with dermatomyositis, pachyonychia congenita, and Gorlin syndrome to bridge basic science and clinical application in dermatology.  

She has been featured in numerous dermatology-focused medical publications and readily takes on community service and leadership roles.  

Dedicated Dermatology Care Rooted in Experience and Passion 

Dr. Wu is excited to deliver personalized and comprehensive dermatology care to patients in the Macedonia and Rocky River areas. She provides a comfortable patient experience and customized treatments for even the most complex skin issues. 

Optima Dermatology’s mission is to treat every patient how we would treat our friends and family, and Dr. Wu embodies this commitment in every patient interaction.  

We recently had the opportunity to learn more about Dr. Wu, her approach, and the path that led her to become a dermatologist. 

What made you decide to pursue a career in dermatology? What did the path to get there look like for you? 

When I was in college, I worked as a scribe at a dermatology clinic. This was my first exposure to the field, and I was inspired by the wide variety of conditions dermatologists treat, as well as the long-term relationships they build with their patients. That early experience sparked my interest in dermatology and led me to pursue additional opportunities throughout my training. During medical school, I dedicated a year to translational dermatology research, where I gained a deeper appreciation for the complexity of skin disease and the field’s collaborative nature. After medical school, I spent another year working in dermatology clinical trials, bringing promising new therapies to patients. Looking back, I feel incredibly fortunate to care for patients in a field that combines science, problem-solving, and compassionate care with helping patients feel healthier and more confident in their skin. 

What is your favorite aspect of being a dermatologist? 

I love being able to help patients achieve healthier skin and greater confidence. Skin conditions often impact more than appearance, such as self-esteem and overall quality of life, and can cause physical discomfort such as itching. I enjoy partnering with each patient to develop a personalized treatment plan and seeing the positive change healthier skin can make in their lives. 

What is your approach to treating your patients? 

I believe the best care starts with listening. My approach is centered on building a partnership with each patient and taking the time to ensure patients feel empowered to share their concerns, ask questions, and participate in decisions about their care. 

What is your number one tip when it comes to taking care of your skin? 

Sun protection! In addition to reducing skin cancer risk, daily sun protection is important in preventing premature skin aging. 

What is one thing you want your patients to know about you? 

I want my patients to know that we are partners in your healthcare! My goal is to provide compassionate, individualized care so every patient feels heard, supported, and confident. 

What do you like to do when you are not in the office treating patients? 

Outside of the office, I enjoy lifting weights, doing yoga, and taking aerial classes. I also enjoy exploring local cafes and new restaurants. 

What to Expect From Dr. Wu and Her Team 

Patients visiting Dr. Wu and her team at Optima Dermatology’s Macedonia and Rocky River practices will receive quality care backed by advanced training and experience. 

Dr. Wu is currently accepting new patients at our Macedonia and Rocky River, OH locations. To schedule an appointment at our Macedonia practice, call 330-306-9844 or visit https://s.odoro.com/optimaderm/. To schedule at our Rocky River practice, call 234-702-1244 or visit https://s.odoro.com/optimaderm/

The post Dr. Tiffany Wu is Treating Patients at Two Cleveland Practices   appeared first on Optima Dermatology.

BOSTON, August 17, 2026 — Today, The Physicians Foundation announced a new request for proposals (RFP) to support medical associations working to strengthen physicians’ ability to identify and address drivers of health (DOH) as part of regular patient care. The Foundation will select five organizations to receive grants of up to $75,000 for projects implemented over a period of up to two years.

Drivers of health, including access to nutritious food, safe housing, transportation, physical activity and primary care, can have a profound impact on a patient’s ability to prevent and manage disease. A 2026 survey of America’s physicians underscores the consequences physicians are seeing in their practices: more than half of physicians (55%) encounter patients at least weekly whose chronic disease care is compromised by a lack of access to healthy food, while nearly one in four (23%) encounter these patients every day.

“Physicians see every day how the conditions surrounding a patient’s life can determine whether even the best clinical care succeeds,” said Gary Price, MD, president of The Physicians Foundation. “Addressing drivers of health cannot fall on physicians alone. Through this grant program, we are investing in the infrastructure, resources and partnerships physicians need to connect patients with meaningful support and translate what they identify in the exam room into better health.”

Through the 2026 Drivers of Health Grant Program, the Foundation is seeking proposals from medical associations interested in developing capacity, resources and data collection to support physicians in integrating DOH screening and resource navigation into their practices. Selected grantees will recruit cohorts of physicians to implement or enhance these approaches and provide feedback and data on the integration process.

The RFP encourages proposals addressing areas including nutrition, physical activity, and access to primary care, while welcoming innovative approaches to other drivers of health. Projects may help physicians build stronger referral pathways to community resources, make screening and resource navigation more actionable within clinical workflows, or address structural barriers that prevent patients from accessing the resources they need to be healthy.

The need for these solutions extends beyond individual patient encounters. The Foundation’s Food as Medicine survey found that 45% of physicians report that patients with chronic diseases frequently or almost always experience worsening symptom control primarily because of drivers of health rather than clinical factors alone. 63% of physicians also report experiencing stress, frustration or moral distress at least weekly when they are unable to stabilize a patient’s chronic disease because of drivers of health outside their control.

Applicants should demonstrate their ability to support physicians with practice-level change, their existing resources or expertise related to drivers of health, the DOH landscape within their state or region and their organizational capacity to work directly with practicing physicians. The Foundation will prioritize proposals that are rooted in physician needs, responsive to urgent challenges within their communities and positioned to create meaningful impact from the practice level to the policy level.

To apply, organizations should register and log in to The Physicians Foundation’s online application system and use the access code DOH26.

Proposals are due September 9, 2026, at midnight ET. Funding decisions are expected by October 31, 2026, with projects beginning January 4, 2027.

About The Physicians Foundation 

The Physicians Foundation is a public charity seeking to advance the work of practicing physicians and help them facilitate the delivery of high-quality health care to patients. As the U.S. health care system continues to evolve, The Physicians Foundation is steadfast in strengthening the physician-patient relationship, supporting medical practices’ sustainability and helping physicians navigate the changing health care system. The Physicians Foundation pursues its mission through research, education and innovative grant making that improves physician wellbeing, strengthens physician leadership, addresses drivers of health and lifts physician perspectives. For more information, visit www.physiciansfoundation.org.

The post 2026 Drivers of Health Grant Opportunity to Strengthen Physician-Led Solutions, Open Now appeared first on The Physicians Foundation.

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ACG has appointed Rajesh Bhogavalli as Group Chief Commercial Officer as the company continues its international growth, operational excellence and commercial transformation across its pharmaceutical and nutraceutical manufacturing businesses.

As Group Chief Commercial Officer, Bhogavalli will lead the Group’s global commercial strategy, strengthen strategic partnerships, drive cost-optimisation initiatives and support market expansion.

Bhogavalli brings more than 30 years’ experience in commercial strategy, global supply chain and business transformation. Before joining ACG, he spent almost 12 years with EPL Limited, formerly Essel Propack Ltd., most recently as President – Supply Chain & Sustainability (Global), leading operations across 11 countries. He has also held senior leadership positions with BASF India and Asian Paints.

Bhogavalli holds an MBA in Operations Management from IGNOU and an MSc in Physical Chemistry from Andhra University.

Karan Singh, Managing Director at ACG, said: “We are delighted to welcome Rajesh to ACG. He brings a wealth of global experience, a strong track record in commercial strategy and operations, and a deep understanding of complex international businesses. His expertise will be invaluable as we continue to strengthen our operations and pursue the next phase of our growth strategy.”

Rajesh Bhogavalli said: “ACG has built an outstanding reputation across the pharmaceutical manufacturing ecosystem, and I’m excited to join the business at such an important stage of its growth. I look forward to further strengthening our commercial strategy, deepening customer relationships and supporting the company’s continued global expansion.”

The appointment comes as ACG continues to expand its global presence and invest in technologies and solutions that support pharmaceutical and nutraceutical manufacturers worldwide.

The post ACG appoints Rajesh Bhogavalli as Group Chief Commercial Officer appeared first on Express Pharma.

Optimus Pharma, a subsidiary of Sekhmet Pharmaventures, has become the first company in India to receive permission from the Drugs Controller General of India (DCGI) to manufacture and market Tapinarof Cream 1 per cent w/w and the tapinarof bulk drug.

Tapinarof Cream 1 per cent w/w is a non-steroidal topical treatment for plaque psoriasis in adults.

Psoriasis is a chronic, non-communicable skin condition that the World Health Organization estimates affects at least 100 million people worldwide. Indian studies place prevalence in the country between 0.44 and 2.8 percent, with plaque psoriasis the most common presentation. Many patients depend on long-term topical therapy, where options beyond corticosteroids have remained limited. Tapinarof, a topical aryl hydrocarbon receptor agonist, provides a non-steroidal option for the management of plaque psoriasis in adults.

Optimus’ clinical study in India enrolled 213 patients with moderate-to-severe plaque psoriasis. Tapinarof Cream 1 per cent w/w demonstrated statistically significant superiority over placebo in achieving Physician Global Assessment (PGA) success at Week 12.

Significant improvements compared with placebo were also observed in the Psoriasis Area and Severity Index (PASI ≥50), percentage reduction in Body Surface Area (%BSA) involvement, the Peak Pruritus Numeric Rating Scale (PP-NRS) and Psoriasis Symptom Diary (PSD) scores. Numerical improvements were observed in higher PASI response rates (PASI ≥75 and PASI ≥90). Additionally, significant improvements were seen in Dermatology Life Quality Index (DLQI) scores.

Tapinarof Cream 1 per cent w/w was well tolerated in Indian patients, and no immunogenicity concerns were identified during the study.

Tapinarof Cream 1% w/w and its bulk drug are manufactured at facilities operating cGMP-compliant quality systems. These facilities have undergone inspections by regulatory agencies including the US FDA and European authorities, and are designed to ensure product quality, reliability and patient safety through controls across manufacturing, testing and supply operations.

With both the bulk drug and the finished formulation produced in-house, Optimus maintains control across the end-to-end manufacturing journey, from drug substance to finished dosage form, supporting consistency, traceability and quality at every stage.

The approval reflects the company’s capabilities in the development and manufacture of complex and differentiated formulations, enabling early launch through its strategic partners and making products available to Indian patients.

Sumit Kumar, Chief Commercial Officer, Sekhmet Pharmaventures, said: “The approval for Tapinarof Cream 1 per cent w/w and its bulk drug is a significant milestone for Sekhmet and a testament to the strength of our R&D, regulatory, quality and manufacturing capabilities. The group is backed by more than 250 scientists, reinvests over 12 percent of revenue into R&D, and has filed more than 300 patents and secured over 170 grants. Being the first company in India to receive this permission reflects our commitment to bringing differentiated pharmaceutical products to patients while maintaining the highest standards of quality and compliance.”

Optimus’ Tapinarof Cream 1 per cent w/w is a prescription-based drug. Patients are advised to consult their doctors for more details.

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Complex care pathways could improve care for patients with high levels of disease, says Ian Gordon, but questions remain over prevention, remuneration, clinical complexity, patient disengagement and the financial risk transferred to NHS dental practices.

In a previous article, I explored the clinical rationale, operational reality and practical risk underpinning the decision to use or not implement clinical care pathways. I’d now like to consider the wider practical limitations of complex care pathways: clinical complexity, financial sustainability, professional judgement and risk transfer to providers.

The concerns about complex care pathways are not limited to Compass reporting, declarations and patient charging. There are wider questions about whether the model properly reflects the clinical complexity, time, cost and risk involved in treating high-need patients in NHS general dental practice.

Prevention must remain central, whatever the payment model

One important risk is that the debate becomes too focused on whether care is delivered through a complex care pathway or a conventional banded course of treatment. Preventive care and risk factor management must remain integral to both.

If a patient is treated through a banded course rather than a pathway, that should not be interpreted as reducing the need to address diet, oral hygiene, fluoride use, smoking, alcohol, plaque control, diabetes control, xerostomia or other relevant modifiable risk factors. Prevention is not optional simply because the payment mechanism changes.

This is clinically and medico-legally important. If a patient later deteriorates, or complains that disease progression was not properly addressed, the question will not only be whether the correct NHS claim was made. It will also be whether the clinician assessed risk, gave appropriate preventive advice, delivered relevant interventions and recorded those discussions.

The remuneration may not reflect the service requirements

The service requirements for CCPs are extensive. They require assessment, diagnosis, staging and grading, risk factor identification, personalised care planning, preventive advice, ongoing review, documentation, declarations, and completion or exit management. That is before considering the operative treatment itself.

There is a legitimate concern that the current remuneration does not adequately reflect the level of work required. The pathway tariff may look more substantial than a conventional banded claim, but the clinical and administrative requirements are also much greater. For some practices, particularly where high-need patients require multiple visits, DCP input, extended review and close monitoring, the pathway may be difficult to deliver sustainably.

That matters because an underfunded pathway can create perverse incentives. If the model is not economically viable, practices may be reluctant to use it, clinicians may disengage, or the pathway may be delivered in a way that technically satisfies the claim but does not fully realise the intended clinical benefit.

Very high treatment need is not sufficiently recognised

The pathways are intended for patients with more complex disease, but they do not appear to scale adequately with the extent of disease burden. A patient with five carious teeth may meet the entry threshold for a caries pathway, but so might a patient with seven, ten or more carious teeth. Those patients may require substantially different levels of clinical time, treatment planning, operative care, prevention, stabilisation and review.

The same point applies to periodontal and combined caries/periodontal cases. There is a significant difference between meeting an eligibility threshold and presenting with very extensive disease requiring prolonged, staged intervention.

This creates a practical limitation in the design. A fixed pathway tariff may not adequately recognise the upper end of complexity. The risk is that patients with the greatest need may be the least financially viable to treat under the pathway model, even though they are precisely the cohort the reform is intended to support.

Non-carious treatment need is under-recognised

The guidance necessarily focuses on caries and periodontal disease because these are the main clinical entry routes into the pathways. However, many patients in this cohort also present with significant non-carious treatment needs: fractured teeth, heavily restored teeth, failing restorations, tooth wear, broken cusps, defective margins, compromised occlusion and complex restorative decision-making.

These issues are not incidental. In real practice, stabilising a high-need patient often involves managing both active disease and the consequences of previous restorative history. Broken or heavily restored teeth can be time-consuming, technically challenging and costly to restore, even where they are not simply ‘carious teeth into dentine’ for pathway-entry purposes.

If the pathway design does not properly recognise this broader restorative complexity, it risks underestimating the work required. It may also create disagreement about what is included within the pathway, what should be claimed separately, and what the patient should reasonably expect to receive.

Financial risk is disproportionately transferred to practices

A further concern is that pathways may be clinically front-loaded. In many cases, the assessment, diagnosis, urgent stabilisation, prevention planning and much of the operative intervention will take place early in the pathway. If the patient then disengages, fails to attend or becomes unable to continue, the practice may already have incurred a substantial proportion of the clinical time and cost.

The pathway cannot simply be unwound. If the patient does not complete the pathway, the practice still has to manage the declarations, incomplete pathway rules, patient communication, any complaint risk and the clinical consequences of partially completed care.

This transfers a significant element of risk to providers for factors that may be outside their control. High-need patients may be more likely to have irregular attendance, social barriers, anxiety, competing health problems or difficulty engaging over six or twelve months. These are precisely the patients the model is designed to help, but they are also the patients most likely to create completion and financial risk.

A fair model needs to recognise that risk. Otherwise, practices may reasonably hesitate before commencing pathways for the very patients who could benefit most, particularly where early treatment costs are high and later patient engagement is uncertain.

Prescriptive requirements may affect clinical flexibility

Standardisation can be helpful. It can support consistency, reduce inappropriate variation and give practices a clearer structure for managing complex disease. However, there is a balance to be struck.

If service requirements become too prescriptive, there is a risk that clinicians feel they are delivering a contractual pathway rather than exercising professional judgement for the individual patient. Patients do not always respond predictably. Their attendance, motivation, disease activity, social circumstances and treatment preferences may change over time. A pathway model needs enough flexibility to accommodate that reality.

The concern is not that clinicians should be free from accountability. It is that contractual requirements should support clinical judgement, not replace it. The records should show why decisions were made, how the patient responded, and why care was adapted. That is preferable to a rigid process in which compliance with the pathway becomes the dominant objective.

Summary of additional risks

Overall conclusion

The success of complex care pathways will depend not only on whether the clinical rationale is sound, but on whether the model is practical to deliver in NHS general dental practice.

A workable system must preserve prevention across all courses of treatment, recognise the full range of clinical complexity, fund the time and documentation required, allow appropriate clinical flexibility, and avoid transferring disproportionate financial risk to practices where patients disengage.

It is therefore reasonable for the profession to support the ambition of better care for high-need patients while remaining critical of the current mechanics. The question is not whether prevention, stabilisation and risk management matter. They clearly do. The question is whether the pathway structure, reporting systems and remuneration model are sufficiently robust to deliver those aims safely, fairly and sustainably in real practice.

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Now, researchers have identified new mutations associated with the parasite’s decreased susceptibility to current treatments. By sequencing the whole genomes of Plasmodium falciparum from the blood of hundreds of infected people in Uganda, the team found that a cluster of genetic variants showed significantly decreased susceptibilities to the drugs most commonly used to treat malaria in Africa and the United States.

The findings were published in Nature Medicine in the paper, “Emergence and spread of Plasmodium falciparum PX1 polymorphisms associated with decreased susceptibility to antimalarials in Uganda.”

“It’s very concerning that these new mutations are spreading so rapidly—it tells us they are important to the parasite’s survival,” said Jeffrey Bailey, MD, PhD, associate professor of translational research and of pathology and laboratory medicine at Brown University. “Malaria still is a major killer, particularly in sub-Saharan Africa. As drug resistance continues to emerge, we worry it will undermine control of its spread and result in even more deaths for a large number of people there and beyond.”

Because of growing drug resistance, surveillance systems are being built to track known mutations in the pathogen as well as drug performance over time and identify biological markers of drug resistance.

“We knew that the parasites were changing so that over time, their susceptibility to malaria treatments was decreasing, and we wanted to know the exact genetic determinants of this shift,” said Karamoko Niaré, PhD, formerly a postdoctoral researcher in Bailey’s lab and now an adjunct assistant professor of pathology and laboratory medicine at Brown. “We decided to sequence the entire genome to get a better sense of what was going on.”

For the last two decades or so, the primary treatment for uncomplicated malaria in Uganda has been artemether-lumefantrine (AL), the most used artemisinin-based combination therapy (ACT) across sub-Saharan Africa. As of 2026, the Centers for Disease Control and Prevention has been recommending a longer course of therapy because standard doses failed to cure several travelers returning home, suggesting that the parasites are becoming less susceptible to treatment.

The researchers identified an area in the genome with 69 genes. More specifically, three specific mutations and two deletions were associated with decreased susceptibilities to the drugs artemisinin and lumefantrine (both components of AL) as well as the malaria drug mefloquine. The mutations most likely to drive this selection were found in a gene that encodes phosphoinositide-binding protein (PX1 protein) which is often found near another gene known to cause moderate resistance to the drug artemisinin.

This is the first time researchers have correlated a gene mutation with reduced susceptibility to multiple drugs used in the combination therapy for malaria.

“We didn’t have any validated molecular marker of lumefantrine resistance—we knew that there was a gene involved in partial resistance to artemisinin but couldn’t explain changes observed for lumefantrine,” Niaré said. “Our work identifies a molecular marker that could be used by surveillance studies to track the emergence and spread of reduced susceptibility to front-line malaria treatments across Africa. That’s a very important tool for public health.”

Since this effect was studied in the lab in parasites that had been collected from malaria patients, Bailey said future research should investigate how these mutant parasites impact clinical outcomes of malaria treatment with ACTs. While the authors found that the mutation was spreading rapidly in Uganda, how far it has spread beyond Uganda’s borders is unknown and needs to be examined.

The finding has major implications for sustaining an effective malaria treatment program, Bailey said. “It underscores the need to develop prediction models for when the drug will stop working altogether and also highlights the urgency to develop new drugs to treat malaria.”

The post Malaria-Causing Plasmodium in Uganda Show Rapid Spread of Drug Resistance Mutations appeared first on GEN - Genetic Engineering and Biotechnology News.

Spevatamig is a bispecific antibody targeting claudin 18.2 and cluster of differentiation 47 (CD47), designed to function as an innate immunity enhancer (I₂E).

The fast track designation for BTC follows other recent regulatory milestones for spevatamig.

In 2024, the antibody received the designation for metastatic claudin 18.2-positive pancreatic adenocarcinoma, and orphan drug status for metastatic pancreatic cancer in 2022.

Phanes Therapeutics expanded a clinical trial partnership with Merck & Co (MSD) last month to examine spevatamig in combination with pembrolizumab as a first-line treatment for BTC.

The companies began their collaboration in 2023 to study this combination therapy.

Phanes Therapeutics CEO Ming Wang said: “Spevatamig has the potential to be a transformational treatment option for patients with BTC.

“Following the successful completion of enrolment in our Phase II clinical trial of spevatamig in combination with chemotherapy for the front-line treatment of metastatic pancreatic ductal adenocarcinoma, we are making significant progress in the Phase II study of the molecule in BTC.”

The company is conducting three separate Phase II studies of its pipeline assets, notably spevatamig, peluntamig, and mavrostobart.

Both spevatamig and peluntamig are described as first-in-class bispecific antibodies and secured fast track and orphan drug status from the FDA.

The company’s pipeline is built using its PACbody, SPECpair and ATACCbody technology platforms, with the aim of addressing significant unmet needs in cancer treatment.

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The submission is supported by efficacy and safety data from the Phase III VALOR clinical trial, which enrolled 9,437 participants aged five years and above across the US, Canada, and Europe.

In the study, PF-07307405 showed efficacy of more than 70% in preventing Lyme disease. The vaccine candidate was found to be well tolerated with no identified safety concerns, according to the companies.

Pfizer senior vice-president and chief vaccines officer Annaliesa Anderson said: “I’m proud of the progress we have made with our Lyme disease vaccine candidate and excited about the opportunity to potentially bring the first vaccine of its kind to Europe. I look forward to collaborating with the EMA as this vaccine candidate advances through the review cycle.”

“Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year. When left untreated, it can lead to serious and potentially long-lasting complications involving the skin, joints, nervous system, and heart.

“We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease and help people continue to enjoy the outdoors with greater confidence.”

Pfizer and Valneva began collaborating on PF-07307405 in April 2020, with the former holding exclusive manufacturing and commercialisation rights if regulatory approval is achieved.

The vaccine is a 6-valent outer surface protein A (OspA)-based protein subunit, targeting six Borrelia OspA serotypes found in North America and Europe.

Currently, no approved human vaccines exist for Lyme disease.

In June 2026, Pfizer received approval from the US Food and Drug Administration for an expanded indication of Hympavzi (marstacimab-hncq) to treat haemophilia A or B.

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The 75th Indian Pharmaceutical Congress (IPC) will be held from 18-20 December 2026 at the Yashobhoomi Convention Centre, Sector 25, Dwarka, New Delhi. The Platinum Jubilee edition is being organised by the Indian Pharmaceutical Congress Association (IPCA) and the Indian Pharmacy Graduates’ Association (IPGA).

The theme of IPC 2026 is “Transforming India from Pharmacy of the World to Pharma Powerhouse @2047”, aligned with the national vision of Viksit Bharat – Viksit Pharmacy.

According to the event documents, the Congress will bring together scientists, academicians, industry leaders, regulators, healthcare professionals, researchers, policymakers, entrepreneurs and students from India and other countries to exchange knowledge, foster collaborations and discuss the future of pharmaceutical science and the profession.

The programme will include plenary lectures, keynote addresses, scientific sessions, symposia, workshops, Continuing Professional Development (CPD) programmes, panel discussions and a CEO Conclave. It will also include a pharmaceutical expo, oral and poster presentations, student competitions, innovation challenges, a job fair and career development opportunities.

The Congress will focus on pharma education, research, industry, healthcare and professional practice. The event documents also identify innovation, advanced research, artificial intelligence, biotechnology, precision medicine, sustainable manufacturing, resilient supply chains and globally harmonised regulatory systems as areas relevant to the sector’s development towards 2047.

The 75th IPC will also include discussions involving industry, academia, research institutions, government and healthcare professionals. The documents state that the Congress will provide a platform for scientific deliberations, technology exchange, business networking and collaborative partnerships.

The event will feature PharmaExpo 2026. The documents also list Pharma PowderTech Expo 2026, covering powder processing, particle engineering and pharmaceutical manufacturing technologies. The expo will include areas covering filling, blending, granulation and drying; nutraceutical powder supplement systems; laboratory testing and quality-control equipment; stainless steel equipment and process components; plant engineering and turnkey project solutions; contract manufacturing and processing services; excipients, pharmaceutical ingredients and specialty materials; research, consultancy, validation and regulatory services; and research laboratories, academic institutions, government departments, regulatory organisations, trade organisations, investors, innovators and start-ups.

The event documents also outline sponsorship opportunities for the 75th IPC. The listed sponsorship categories are Principal Sponsor at Rs 100 lakh, Platinum Sponsor at Rs 75 lakh, Gold Sponsor at Rs 50 lakh and Silver Sponsor at Rs 25 lakh.

Sponsorship opportunities also include hospitality, scientific sessions, resource persons from abroad, entertainment programmes, delegate kit bags, uniforms and caps for student volunteers, gifts in kit bags, mementos, scientific schedule booklets, stationery for delegates and cosmetics items in kit bags.

The documents state that the Congress has been held since 1948, with the first Indian Pharmaceutical Congress held at Kota, West Bengal, in December 1948. The IPGA was established in 1971 and has branches across more than 20 states and 10 local chapters, according to the event material.

The event will be held at Yashobhoomi Convention Centre, Sector 25, Dwarka, New Delhi, from Friday, 18 December to Sunday, 20 December 2026.

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Tata Consultancy Services (TCS) has launched TCS ADD AgentHub, a role-based, enterprise-ready and trusted AI platform that enables the use of agentic AI in drug development at scale. The platform is designed to transform clinical trials and pharmacovigilance services while maintaining regulatory and audit requirements.

Pharmaceutical companies operate in regulated environments and face challenges related to trust, governance and scalability when applying AI across functions. Growing data volumes, fragmented systems and increasing regulatory expectations across clinical development and pharmacovigilance are adding complexities across the R&D value chain.

TCS ADD AgentHub provides a framework to address these challenges. Within the framework, AI agents can operate with clear roles, defined oversight and built-in auditability. Pharmaceutical companies can custom build their AI agent hub and deploy it across clinical workflows. The platform enables integration with minimal effort to accelerate adoption while maintaining regulatory compliance.

Built on the TCS ADD framework, TCS ADD AgentHub delivers operational benefits across drug development and drug safety functions. Solutions powered by the platform have demonstrated up to 40 per cent efficiency gains in clinical data management activities, up to 30 per cent reduction in clinical study build effort through metadata-driven automation and up to 30 per cent cost savings in end-to-end safety case processing. AI-powered safety agents can also reduce quality control effort by as much as 50 per cent.

Built on the TCS ADD agentic AI architecture, TCS ADD AgentHub enables pharmaceutical companies to deploy a Human + AI Operating Model in which AI agents are embedded into enterprise workflows, with humans retaining responsibility for governing and decision-making.

Debashis Ghosh, President, Lifesciences and Healthcare, TCS, said, “TCS ADD AgentHub, is a role-based, enterprise-ready, and trusted AI platform that will enable our customers to accelerate drug development using agentic AI at scale. It enables a shift from reactive to proactive, scalable, and audit-ready operations amidst an ever-changing regulatory environment. TCS’ strategy is to move towards autonomous enterprise functions where AI agentic workforce operates alongside humans driving innovation in drug development and improving patient safety.”

TCS ADD AgentHub supports workflows across clinical development and pharmacovigilance through AI workers for ICSR intake, data entry, coding, review and literature analysis; study design, protocol digitisation and clinical data review; SDTM (Study Data Tabulation Model) transformation; and medical monitoring assistance, among others.

The platform has an evolving catalogue of AI agents that can be deployed based on specific requirements and the existing landscape. These agents can be deployed progressively with minimal integration and implementation effort. By standardising how AI agents are deployed across these processes, the platform helps organisations improve productivity and enables scientific teams to focus on higher-value work.

TCS said its “AI-first” culture, exemplified by TCS ADD AgentHub, supports its aspiration to become the world’s largest AI-led technology services company. By leveraging the proprietary cognitive intelligence of the TCS ADD suite, TCS enables tangible, predictive and secure digital ecosystems for its customers.

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Aurobindo Pharma said the United States Food and Drug Administration (USFDA) has classified its Raleigh plant in North Carolina, USA, as “Voluntary Action Indicated” (VAI) following an inspection conducted in 2025.

Pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, the company said the USFDA inspected the Raleigh plant from March 24, 2025, to April 10, 2025. The facility is owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the company, and is established for manufacturing inhalers, dermatology and transdermal products.

At the end of the inspection, Form 483 was issued with a total of 11 observations.

The unit has now received the Establishment Inspection Report (EIR), which classifies the facility as “Voluntary Action Indicated” (VAI). The USFDA has concluded that the inspection is now closed.

The company said that as the unit is classified as VAI, pending applications for multiple inhalers and other dosage forms filed from the facility can now progress through the USFDA’s review process.

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Lupin has received final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45 mg and 17.8 mg.

The U.S. FDA has approved Lupin’s Pitolisant Tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix for the indications in the approved labelling.

The post Lupin receives USFDA approval for Pitolisant Tablets appeared first on Express Pharma.

Christian Darnell explores the often-overlooked financial implications of moving from NHS to private dentistry, and why dentists should prioritise replacing pensions and protection benefits from day one.

Given the changing landscape of primary care dentistry in recent years, many practices across the UK have moved away from NHS contracts and transitioned into fully private models.

For many dentists, this shift is driven by greater autonomy, improved financial sustainability and more lifestyle flexibility. But practice revenue is only part of the picture.

Transitioning from NHS to private practice also means giving up a range of benefits that are often overlooked in the early stages of the process. Financial advisers commonly refer to these collectively as the ‘basket of benefits’ – and replacing them should be treated as a priority, not an afterthought.

What dentists often miss when leaving the NHS

For dentists moving into private practice, the emphasis is understandably on business cashflow and clinical continuity. Yet a common behavioural risk can emerge at this point – pension contributions are often delayed.

The reasoning is familiar: ‘I’ll restart my pension once things settle.’ In practice, those delays can become prolonged and financially significant.

The issue isn’t simply lost contributions. It’s lost time in the market. And time, once gone, cannot be recovered.

Even if contributions are increased later, the compounding growth that would have occurred in the intervening years cannot be retrospectively recreated.

That distinction is often underestimated. Two dentists can end up with very different retirement outcomes despite contributing similar amounts overall, simply because one started earlier.

Additionally, protection planning often takes a back seat during the transition to private practice. Income protection, life cover and critical illness insurance are frequently postponed until the business feels more established.

Yet periods of change can also be when financial resilience matters most, making it important to review existing arrangements and ensure cover remains appropriate.

The compounding effect of delay

Private pensions operate differently from the NHS Pension Scheme (NHSPS). While NHS benefits are defined and linked to career earnings, private pension provision relies on investment growth in underlying assets, typically diversified funds.

This introduces a critical factor: compounding.

Growth is generated not only on contributions, but also on previously accumulated growth. For example, if a portfolio grows by 5% in one year and 10% the next, the second year’s return is applied to a higher base (including the gains from year one).

Over time, this creates a snowball effect. But equally, it means that even short delays in starting or restarting pension contributions can increase the monthly cost required to achieve the same retirement outcome.

In practical terms, a contribution level that might have required £300 per month at the point of transition could increase significantly if deferred for even a couple of years.

The most effective approach is consistency from day one of private practice. If the transition occurs on 1 January, pension saving should ideally begin in that same month. This ensures continuity of long-term planning and preserves the full benefit of compounding over time.

Replacing the wider NHS ‘basket of benefits‘

A key misunderstanding among many dentists is that the NHS pension is solely a retirement savings vehicle. In reality, it also includes a suite of embedded protections that are often underestimated until they’re lost.

These typically include:

Spouse’s and dependants’ pensions

The NHSPS provides ongoing income for a spouse or civil partner after death, alongside dependants’ pensions for eligible children (typically up to age 23 if financially dependent). These benefits provide long-term income security that extends beyond the individual member.

Death in service benefits

In many cases, a lump sum is payable on death in service, broadly calculated as a multiple of pensionable earnings, alongside ongoing survivor benefits.

Ill health retirement provisions

The NHS scheme includes tiered ill health retirement benefits, which may provide early access to accrued pension benefits if a dentist is permanently unable to continue working. In more severe cases, enhanced benefits may apply based on projected service to retirement age.

Sick pay arrangements

NHS dentists typically benefit from structured sick pay, including full pay for an initial period followed by reduced pay for a defined duration, subject to service terms. This creates a material income safety net during periods of short to medium-term illness.

Taken together, these form a significant protection framework – one that doesn’t automatically exist in private practice unless it is actively replaced.

Importantly, what often changes aren’t just the benefits themselves, but the responsibility for securing them. In the NHS, much of this framework exists as part of the employment structure.

In private practice, dentists must actively decide what to put in place, when to do it and how it integrates with their broader financial planning. That shift in decision-making responsibility is often underestimated during the transition.

How private arrangements can replicate NHS protections

The good news is that these benefits are not lost permanently when leaving the NHS. But they do need to be deliberately rebuilt.

A direct pension replacement is one route. However, many dentists also combine pension saving with dedicated protection policies to replicate the broader safety net.

For example, life cover can replace death-in-service lump sums, while Family Income Benefit policies can mirror the structure of spouse and dependants’ pensions by providing regular monthly income rather than a single lump sum payment.

This distinction is important. While lump sums can be useful, many households are more naturally structured around income flow. A monthly benefit (such as £5,000 per month for a defined period) can be easier to integrate into ongoing living costs, mortgage commitments and education planning.

Similarly, income protection insurance can be designed to align with expected NHS sick pay run-on periods, with deferred periods structured so that cover begins only once NHS benefits cease. This can improve cost efficiency while continuing to protect income.

The importance of timing

One of the most critical planning considerations isn’t just what is replaced, but when it’s replaced.

Delaying pension contributions or protection planning doesn’t simply pause progress. It reduces the number of years available for compounding, and it can increase the monthly cost required to reach the same target outcome.

Crucially, while contribution levels can often be increased later, the lost growth potential from earlier years cannot be recovered. Time is, therefore, one of the most valuable inputs in any long-term plan.

It also creates a protection gap during the early phase of private practice, when financial stability is often most sensitive to disruption.

From a planning perspective, the goal should be straightforward. Ensure that the transition from NHS to private practice is matched by an immediate and structured transition in personal financial arrangements.

A structured approach to transition

Moving from NHS to private dentistry is a significant professional milestone. It’s also a shift in responsibility as much as it is a shift in income. Decisions around pensions, protection and long-term planning move from being largely embedded within employment structures to being actively managed by the individual.

A structured approach typically considers:

• Pension continuity from day one of private practice
• Replacement of spouse and dependants’ pensions
• Rebuilding death in service protection via life cover
• Reviewing ill health and long-term protection needs
• Aligning income protection with existing sick pay gaps.

The aim is not to replicate the NHS scheme exactly, but to ensure that no critical protection is unintentionally left behind.

Final thoughts

The shift from NHS to private practice is often framed around opportunity, and rightly so. But the financial implications extend beyond practice income and into long-term personal security.

As specialist financial advisers at Wesleyan Financial Services regularly highlight, the key risk is not the transition itself, but the pause that sometimes follows it.

Because when it comes to pensions and protection, time is not neutral. It’s a contributing factor in its own right.

To book a conversation with a dental specialist financial adviser from Wesleyan Financial Services, visit wesleyan.co.uk/dental or call 0808 149 9416.

Please note: charges may apply. You will not be charged until you have agreed to the services you require and the associated costs. Learn more at www.wesleyan.co.uk/charges.

This article is sponsored by Wesleyan Financial Services.

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Government of India, has directed all State and Union Territory (UT) Drugs Controllers to take action against the manufacture and marketing of drug products containing Enclomiphene and its combinations without approval from the Central Licensing Authority (CLA).

In a letter dated 10 August 2026, issued by the Enforcement & Intelligence Cell of CDSCO, the Directorate said it had been brought to its notice that certain manufacturers were manufacturing and/or marketing drug products containing Enclomiphene and its combinations without obtaining the requisite permission from the CLA, despite such products falling within the definition of a “New Drug” under the New Drugs and Clinical Trials Rules, 2019.

As per Rule 2(1)(w) read with Rule 19 of the New Drugs and Clinical Trials Rules, 2019, no new drug shall be manufactured for sale or distribution unless it has been granted permission by the CLA.

Further, under Rule 80 of the Rules, any person intending to manufacture a new drug, whether as an Active Pharmaceutical Ingredient (API) or as a pharmaceutical formulation for sale or distribution, is required to obtain prior permission from the CLA by submitting an application in Form CT-21, along with the prescribed fee specified in the Sixth Schedule.

The Directorate said it had observed that Enclomiphene and its combinations had not been approved by the CLA for manufacture and marketing in the country.

Accordingly, it stated that any manufacture, sale, distribution or marketing of such products without prior approval from the CLA would be treated as non-compliance with the provisions of the New Drugs and Clinical Trials Rules, 2019, and the Drugs and Cosmetics Act, 1940.

The State and UT Drugs Controllers have been requested to immediately identify manufacturers, marketers, distributors and retailers dealing with drug products containing Enclomiphene and its combinations without the requisite approval from the CLA.

They have also been directed to initiate appropriate regulatory action under the provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder, including cancellation or suspension of manufacturing permissions, wherever applicable.

The Controllers have further been asked to ensure that such unapproved products are not manufactured, sold, distributed or marketed within their respective jurisdictions.

CDSCO has also sought an action taken report, including details of manufacturers identified, regulatory action initiated and the present status of compliance, at the earliest.

The post CDSCO directs action against unapproved Enclomiphene drug products appeared first on Express Pharma.

The Life Sciences Sector Skill Development Council (LSSSDC), operating under the aegis of the Ministry of Skill Development & Entrepreneurship (MSDE), Government of India, will organise ‘LSSSDC Skillverse 2026’, a National Skill Summit for the Life Sciences sector, on 21st August 2026 at Hotel Le Méridien, Hyderabad.

The summit will bring together CXOs, Managing Directors, CEOs, HR Leaders, Manufacturing Heads, R&D Leaders, CSR Heads, academia, government officials, policymakers, industry associations and skill development experts to deliberate on building a future-ready workforce for India’s Life Sciences ecosystem.

As India’s Life Sciences industry expands across Pharmaceuticals, Biotechnology, Medical Devices, Clinical Research and Allied Healthcare, the demand for industry-ready talent has become more critical. LSSSDC Skillverse 2026 has been conceptualised as a platform to bridge the gap between industry expectations and workforce capabilities while promoting collaborative solutions for skill development.

The summit will feature keynote addresses, panel discussions, industry presentations and networking opportunities focused on workforce challenges and emerging opportunities in the sector.

The key themes of Skillverse 2026 will include identifying skill gaps and workforce requirements in the Life Sciences sector; NeeV initiatives and industry-led models for strengthening Skill Development Centres (SDCs); preparing a future-ready workforce for Industry 5.0; strengthening talent, innovation and global operations in Life Sciences through Global Capability Centres (GCCs); and government initiatives for skill development and workforce transformation.

The event will provide a platform for industry leaders to share best practices, discuss emerging trends and contribute towards shaping India’s national skilling agenda for the Life Sciences sector.

Skillverse 2026 reflects LSSSDC’s commitment to creating a skilled, globally competitive workforce by fostering collaboration between industry, academia, government and training institutions. The summit is expected to generate actionable insights and strategic partnerships that will accelerate talent development across the Life Sciences value chain.

LSSSDC has invited organisations, industry leaders, training institutions and stakeholders from the Life Sciences ecosystem to participate in Skillverse 2026 and contribute towards building a skilled, future-ready workforce for India.

The event, titled LSSSDC Skillverse 2026 – National Skill Summit for the Life Sciences Sector, will be held on Friday, 21st August 2026 at Hotel Le Méridien, Hyderabad. It is being organised by the Life Sciences Sector Skill Development Council (LSSSDC) under the Ministry of Skill Development & Entrepreneurship (MSDE), Government of India.

The post LSSSDC to organise Skillverse 2026 National Skill Summit in Hyderabad appeared first on Express Pharma.

From AI-assisted paediatric dentistry to tackling the clinical record-keeping burden, this week’s updates highlight how technology, workforce investment and changing models of care are reshaping dentistry across the UK.

Dental Protection and the British Dental Association (BDA) have welcomed NHS England’s new standard operating procedures (SOPs) for clinical record keeping, describing them as a step towards a more proportionate and efficient approach to documentation.

Published on 3 August 2026, the guidance aims to reduce repetitive recording by allowing clinicians to reference agreed procedures rather than documenting routine treatment steps in full at every appointment. This could make appointment-specific information easier to identify while reducing the administrative burden on dental teams.

Dental Protection’s Raj Rattan said the guidance could help dentistry move away from ‘defensive documentation’ towards records that are clear, accurate and focused on clinical judgement and patient care.

BDA Indemnity’s head, Len D’Cruz, said dentists frequently struggle to complete contemporaneous records while working against the clock. He warned that pre-populated templates can cause problems if they fail to reflect what actually happened, adding that ‘copious notes do not necessarily mean more accurate notes’.

NHS England has published four example SOPs covering extractions, root canal treatment, crowns and onlays, and anterior composite restorations. The protocols are not intended to standardise clinical practice or restrict clinical judgement, with practices encouraged to develop procedures suited to their own workflows.

Denplan appoints new managing director to lead next phase of growth and innovation

Denplan, part of Simplyhealth, has appointed Nick Tait as managing director to lead its next phase of growth and innovation.

Tait said he was excited to return to the dental sector, adding that his wife is a dental hygienist and therapist and that dentistry has ‘long had a connection’ to his life.

Smile Together expands NHS dental access across the south west

Smile Together Community Interest Company (CIC) has expanded NHS dental provision across the south west of England with the opening of a new Dental Access Centre in Gloucester, while continuing investment in services across Cornwall.

The Quayside Dental Centre opened on 1 July 2026 following a partnership with NHS Gloucestershire Integrated Care Board and Gloucestershire County Council. The centre provides urgent NHS dental care and stabilisation services, with daytime, evening and limited weekend appointments accessed through NHS 111 or directly.

The seven-room facility is also an approved NHS Dental Foundation Training Practice, supporting newly qualified dentists and contributing to the future NHS dental workforce.

The Gloucester centre marks Smile Together’s first expansion beyond Cornwall and the Isles of Scilly, where it has continued to strengthen access. The organisation opened a new practice in Falmouth in January 2026 and another in Camborne in July, improving access to NHS care and urgent treatment.

Chief executive Jasem Greval said the Gloucester opening was an ‘exciting milestone’, adding that the organisation aims to share its community-focused approach while continuing to strengthen services across Cornwall and the Isles of Scilly.

Hello Pearl launches AI tool to tackle paediatric dental anxiety

Hello Pearl has introduced Second Opinion for Kids, an AI-assisted dental diagnostic tool designed to support communication, reduce anxiety and encourage earlier intervention among young patients.

The paediatric-focused platform analyses dental radiographs in real time to identify findings associated with dental pathology, including early carious lesions. It builds on Hello Pearl’s existing AI diagnostic technology, with child-friendly visual overlays featuring animated ‘Sugar Bug’ characters to help clinicians explain findings to children and their parents or carers.

The company said the technology aims to address key challenges in paediatric dentistry, including communicating clinical findings to young patients and building trust and cooperation during examinations and treatment planning.

Second Opinion for Kids can support clinicians in identifying and monitoring developing pathology in children from as young as four, potentially enabling earlier preventive intervention and minimally invasive treatment.

Ophir Tanz, CEO of Hello Pearl, said positive dental experiences early in life can influence attitudes towards oral healthcare, adding that the technology supports both the clinical and behavioural aspects of paediatric dentistry.

Dr Kunal Patel, founder of Love Teeth Kids in Surrey, said the visual tool helps children understand the earliest signs of dental disease, while giving parents a clearer understanding of clinical findings. He added that this shared understanding can improve engagement, reduce anxiety and encourage positive oral health behaviours.

Follow Dentistry.co.uk on Instagram to keep up with all the latest dental news and trends.

Fujifilm Biotechnologies

Fujifilm Biotechnologies has celebrated the selection of its commercial-scale cell culture manufacturing facility in Holly Springs, NC, among seven facilities chosen by the FDA for its PreCheck Pilot Program, designed to strengthen the nation’s pharmaceutical manufacturing capabilities.

Last year, Fujifilm Biotechnologies opened the first phase of its $3.2 billion end-to-end biomanufacturing facility in Holly Springs. The company initially committed $2 billion to a facility consisting of eight 20,000 L mammalian cell culture bioreactors, then in 2024 announced plans to invest an additional $1.2 billion by building eight additional 20,000 L bioreactors at the site by 2028. About 800 people are based at Holly Springs, a figure set to grow to 1,400 when the second phase is completed.

One biopharma customer has been announced for the second phase—the immunology drug developer argenx, which has agreed to manufacture drug substance for efgartigimod alfa-fcab marketed as intravenous Vyvgart^® and combined with hyaluronidase-qvfc as injectable Vyvgart Hytrulo^®, both indicated for adults with generalized myasthenia gravis or chronic inflammatory demyelinating polyneuropathy.

Holly Springs is one of Fujifilm Biotechnologies’ two large-scale biomanufacturing facilities. The other is Hillerød, Denmark, where in April the company cut a ceremonial ribbon to mark the opening of a 2,000‑square‑meter (21,528-square-foot) quality control (QC) laboratory at its commercial‑scale manufacturing site.

Approximately 100 members of the company’s Quality team are based at the lab, where they conduct viral safety testing for drug substance/product release, scale capacity for complex cell‑based potency and ELISA methods, and perform raw material and critical total organic carbon cleanability studies. The QC lab also includes robotics and supports the implementation of an ongoing laboratory information management system (LIMS) across company sites to enable digital harmonization and data integrity.

Operations began in May at the QC lab, which is housed within a new 7,600-square-meter (81,806-square-foot) building with employee amenities, office and collaboration space, utility services, and an emergency generator to ensure uninterrupted operations and timely delivery of test results. The Hillerød site—which parent company Fujifilm Corp. acquired from Biogen in 2019 for $890 million—was expanded in 2024 from 6 to 12 x 20,000 L mammalian cell culture bioreactors, increasing the complexity and volume for QC testing.

“Simply, we needed more QC analytical capacities to support all the increased number of batches and the increased number of testing programs,” Toshihisa Iida, director, corporate vice president, general manager of Life Sciences Strategy Headquarters and the Bio CDMO Division of Fujifilm, told GEN.

“Our current focus is to get all our facilities online, go live, and focus on operational excellence because we already have big contracts with big clients. Our mission is to deliver as promised,” Iida said. “Before we decide on any next-phase investment, we will really focus on investing more in our people, investing more in our quality system, getting first-class operations, then delivering to our clients.”

Fujifilm Biotechnologies is part of the Fujifilm Life Sciences Group along with Fujifilm Biosciences (formerly Fujifilm Irvine Scientific), a provider of products and services from discovery research through large-scale production—and three other companies, one of which is Fujifilm Cellular Dynamics, a developer and manufacturer of human induced pluripotent stem cells (iPSCs) used in drug discovery, toxicity testing, stem cell banking, and cell therapy development.

In May, Fujifilm Cellular Dynamics celebrated the opening of its new 175,000-square-foot headquarters and iPSC development and manufacturing facility in Madison, WI, which features cell culture manufacturing laboratories, process development laboratories, and a center of excellence for gene editing—all designed to support both research-grade iPSC products and development services for partners developing next-generation cell therapies. The nearly 200-employee facility is part of a previously announced $200 million strategic investment by Fujifilm.

Lonza Group

As AI reshapes how drugs are discovered, developed, clinically studied, and commercialized, Lonza Group says its operations are evolving to reflect that change. Lonza is in the process of building a team of 20 to 30 AI-focused professionals that tap into the CDMO’s experience stretching back to the early 1980s of helping customers launch more than 80 drugs.

“There is retained expertise that customers come to us for, and what I’m excited about is that we should use AI to enhance that,” Matthew Moorcroft, PhD, Lonza’s chief intelligence and analytics officer and head of the CEO office, told GEN. “What we’ve learned over the last nearly 45 years is in our DNA, and it’s in our people. Using AI to further enhance that further empowers us to do better product launches, to serve customers quicker, and to interact with them in better ways. That’s our ambition.”

Customers have shown interest, he said, in incorporating AI into molecule discovery and designing molecules, as well as into their clinical trial processes.

In addition to strengthening its AI capabilities, Lonza is enhancing its two major operational facilities in Switzerland. The company announced plans to expand its aseptic drug product capacity in Stein by adding another commercial-scale multi-purpose filling line for antibody-drug conjugates (ADCs), expected to be operational in 2030. The Stein expansion is supported by a long-term collaboration agreement with an undisclosed “major pharmaceutical” company for clinical and commercial ADC supply. Also at Stein, Lonza is expanding its commercial capabilities to high-value small molecule drug products, with those operations expected to start in 2028.

In June, Lonza also revealed plans to expand its Visp site to establish new commercial-scale capabilities for manufacturing highly potent active pharmaceutical ingredients (HPAPI) and ADC payload-linkers, reinforcing Lonza’s position as a fully integrated CDMO partner in ADC development. Lonza says the expanded Visp facility—set to be fully operational in 2028—will be able to offer additional payload-linker production and purification alongside dedicated analytical and process development labs.

Beyond facilities, Lonza Group is transforming into a pure-play CDMO, announcing plans in March to sell its Capsules & Health Ingredients (CHI) business to Lone Star Funds for CHF 2.3 billion (2.836 billion), a sale expected to close before year’s end. The deal—set to close in the second half—will give Lonza CHF 1.7 billion ($2.2 billion) upfront, and a 40% stake in CHI—which finished the first half of 2026 with core earnings before interest, taxes, depreciation, and amortization (EBITDA) of CHF 1.152 billion ($1.42 billion) on revenue of CHF 3.374 billion ($4.16 billion), up 11% year-over-year.

Once the deal closes, Lonza says it plans to invest its upfront proceeds into growth-focused activity reflecting its “One Lonza” strategy, which simplified operations from three divisions and nine business units into three integrated CDMO business platforms (Integrated Biologics, Advanced Synthesis, and Specialized Modalities), as well as fund acquisitions of smaller complementary or “bolt-on” businesses. Through a share buyback program, Lonza plans to return CHF 500 million ($616 million) to shareholders.

“What we’ve agreed and what we’ve decided is to be purely focused on delivering value to our CDMO customers. That’s where Lonza’s experience is; that’s what we do,” Moorcroft explained. “When we did our organizational review two years ago, we asked, ‘What is non-core to that vision, in terms of our vision, purpose, and values?’ And being a contract manufacturer for our customers—not making our own products, not competing with them—was actually core to what we believed in. And we believe that pure play focus is really important to keep winning business and to convince our customers to stay with us. There’s no distraction.”

MilliporeSigma (Merck KGaA, Darmstadt, Germany)

Merck KGaA, Darmstadt, Germany, whose Life Sciences business in the United States and Canada is known as MilliporeSigma, is completing construction of a €300 million ($346.5 million) Bioprocessing Production Center in Daejeon, South Korea, that is set to open by year’s end.

“Since COVID-19, we have implemented a global manufacturing region-for-region strategy where we are building manufacturing capacity in every geography, on every continent. And we continue to do that,” Sebastián Arana, the head of Process Solutions for the Life Science business of Merck KGaA, Darmstadt, Germany, told GEN.

Over the past four to five years, Arana added, Merck KGaA’s Life Sciences business has deployed more than €3 billion ($3.465 billion) in capital expenditures (capex) toward building out capacity to meet customer demand.

In Daejeon, Arana said Merck KGaA aims to be closer to customers in Korea and the rest of the Asia-Pacific region. He cited growth momentum in South Korea, fueled by business activity as well as President Lee Jae Myung committing his government last year to easing regulation of biotech R&D, and catapulting the nation into a top-five biotech industry powerhouse by 2030.

“Korea has intentionally invested in creating a life science ecosystem in the last few years,” Arana said, “with wonderful government support for life science being a critical area to invest in the economy, that’s number one. Korea is an easy country to do business with, so a lot of the Western pharma companies feel very safe working with Korean suppliers. All of the supply chain is very reliable, very, very quick. Plus, they have a history of very good manufacturing capabilities and have now expanded to bioprocessing. They are very flexible and super quick—things that pharma is looking for. They can do technology transfers in months.”

Another portion of capex investment for expansion of manufacturing came in Cork, Ireland, where Merck KGaA last year opened a €150 million ($173.25 million) filtration manufacturing facility in Blarney Business Park. The 3,000-square-meter (32,292-square-foot) cleanroom facility was designed to support global demand for filtration products used in the manufacturing of vaccines and therapies, including monoclonal antibodies, and emerging modalities such as cell and gene therapies.

“More and more, customers are asking for supply chain resiliency, redundancy, to make sure that if something happens with their supply chain, they’re ready to jump from one side to the other. That’s the fundamental strategy we’re executing,” Arana said. “Ideally, they want the closest site for them, but also, we try to have a second or even a third site qualified in case something happens.”

Another factor driving increased business for Merck KGaA is ongoing reshoring efforts by U.S.-based biopharmas that are shifting more production to the United States, whether to meet growing Stateside customer demand, or to avoid tariffs from the administration of President Donald J. Trump, or both.

“We see some good traction in our U.S. business with customers feeling pretty good about the next two years,” Arana said. “It’s not modality-driven. It’s more just global expansion-driven, and you see some of the large molecules continue to grow and be manufactured in the United States. And on top of that, you need to think that the biopharma space is growing. So, there’s a natural investment that should come every year just to keep up the global demand.”

Merck KGaA expects that demand to continue to grow: “We see the market growing in the 8 to 10% range in the coming years,” Arana said, citing what he called an extremely healthy market for bioproduction of pipeline molecules by drug developers. “MilliporeSigma is very well positioned to continue to grow above market or in the upper side of the range.”

Samsung Biologics

Samsung Biologics expanded into the United States earlier this year when it completed its $353 million acquisition of a former GlaxoSmithKline (GSK) manufacturing site in Rockville, MD. The Rockville site adds two cGMP plants totaling 60,000 L of drug substance capacity, capable of supporting both clinical and commercial biologics production across multiple manufacturing scales, to Samsung Biologics’ total global capacity, which now stands at 845,000 L.

Samsung Biologics retained the workforce of more than 500 that had worked for GSK, which took over the site when it completed its $3.6 billion acquisition of Human Genome Sciences in 2012.

“The Rockville facility gives us our first U.S. footprint and allows us to move into a strategic area within the United States East Coast that is closer to clients, allowing for some additional flexibility with supply from U.S. soil,” John Gagliardi, sales director, key account management with Samsung Biologics, told GEN in a recent interview. “We also wanted to be in a major life science hub, which we have within the DMV [District of Columbia-Maryland-Virginia] area.”

The region, which brands itself BioHealth Capital Region, ranks No. 3 in GEN’s A-List of “Top 10 U.S. Biopharma Clusters.”

The remainder of Samsung Biologics’ capacity is the 785,000 liters available at its Bio Campus I and II in Songdo, Incheon, South Korea, where the company is headquartered. Within Bio Campus II, Samsung Biologics will be collaborating with Lilly Gateway Labs (LGL) to establish an open innovation center, a hub designed to support early-stage and emerging biotechnology companies. The center will have capacity for up to 30 companies to be jointly selected by Lilly and Samsung Biologics, and will occupy a five-story, 125,000-square-foot facility set to be completed in July 2027.

Samsung Biologics has also secured land for BioCampus III, laying the groundwork for future capacity expansion to support next-generation therapies and emerging modalities.

“BioCampus III is meant to house additional complex modalities or new modalities that we would get into outside of mAbs [monoclonal antibodies],” Gagliardi explained. “This is meant for cell and gene therapies or peptides, depending on how the market needs shape up. We will bring that capacity to the market to help as the biopharma industry grows.”

Most recently, on July 19, Samsung Biologics signaled its intent to expand further in the United States, as well as across Europe and India, by announcing plans to acquire publicly traded PolyPeptide Group, a CDMO specializing in the production of peptide-based active pharmaceutical ingredients (APIs), for CHF 1.46 billion (about $1.8 billion).

Samsung Biologics said the purchase of PolyPeptide will enable it to expand its capabilities beyond antibodies and antibody-drug conjugates (ADCs) to include peptide therapeutics, whose fast growth has been fueled by a surge in global demand for obesity treatments and continued expansion of peptide-based therapies into new disease areas.

Headquartered in Baar, Switzerland, PolyPeptide has manufactured APIs for some 70 years and has produced more than 1,000 therapeutic peptides to date.

At CHF44.31 ($54.63) a share, Samsung Biologics’ offer represents a 40% premium to PolyPeptide’s closing price of CHF31.65 ($39.02) on the SIX Swiss Exchange as of April 10, before the company’s acquisition became the subject of market speculation.

Samsung Biologics says its buyout of PolyPeptide is expected to be completed “toward the end of 2026,” subject to customary conditions that include owners of at least 66⅔% of PolyPeptide shares accepting the deal, regulatory approvals, publication of the offer prospectus in accordance with Swiss takeover law, and other conditions.

PolyPeptide’s largest shareholder, representing approximately 55.65% of outstanding shares (excluding treasury shares), supports the deal through an irrevocable tender offer, while the company’s independent and non-conflicted board members have unanimously endorsed the planned acquisition.

Thermo Fisher Scientific

Thermo Fisher Scientific says its two-year-old  Accelerator Drug Development platform, a suite of expanded contract research organization (CRO) and CDMO services, has attracted customers seeking an end-to-end partner for services ranging from drug substance development and manufacturing, no matter the modality, to packaging, labeling, distribution, and carrying out clinical trials through the company’s Clinical Research group.

“All of these services within the same company help reduce the time and complexity and bring all the things required for a robust CMC package that our sponsors would then submit for approval and get these effective medicines to patients faster,” Anil Kane, PhD, executive director, global head of technical and scientific affairs at Thermo Fisher Scientific, told GEN.

The company enhanced its ability to glean insights from clinical trial data in March, when it completed its acquisition of Clario Holdings, a provider of endpoint data solutions for clinical trials, for $8.875 billion cash, plus potential additional milestone and other payments.

Thermo Fisher launched Accelerator in 2024, three years after acquiring the CRO PPD for $17.4 billion, and seven years after expanding into the CDMO market by buying Patheon for $7.2 billion. At its Investor Day in May, Mike Shafer, Thermo Fisher’s executive vice president and president of biopharma services, offered examples of how two undisclosed customers benefited from Accelerator.

For a large U.S.-based biopharma seeking a fast commercial launch for its respiratory drug candidate for competitive reasons. Thermo Fisher ramped up a Phase III trial by activating over 160 sites in less than eight weeks, reducing enrollment time and the dosage timeline by more than 50%. The other was a South Korean drug developer that saved 12 months of activity by using Accelerator to eliminate bottlenecks that included formulation issues, trial design issues, and regulatory alignment requirements.

“We took something that was delayed to accelerating it by almost a year,” Shafer said.

In April, Thermo Fisher opened its flagship U.S. Bioprocess Design Center (BDC) at the company’s Plainville, MA, site, expanding the facility to support customers in developing and scaling biologics. The new center brings together advanced bioproduction capabilities and hands-on collaboration, with the aim of helping customers accelerate process development and bring therapies to patients faster.

“Our customers have been asking about opportunities to develop on a small scale, within a U.S. site,” Kane said. “Our Plainville site was ideally located for our customers based in North America to perform experimentation in the development center. We also have sterile fill-finish capability at the Plainville site. By combining the capabilities of bioprocessing as well as sterile fill-finish, our customers could develop their molecule and the product, then decide the next steps of a clinical product that they can take to Phase I and beyond.”

Thermo Fisher agreed in January to integrate into its lab instruments the AI technology of Nvidia, with the aim of developing intelligent and increasingly autonomous laboratories. The Nvidia announcement came three months after Thermo Fisher agreed to embed OpenAI application programming interfaces into areas ranging from product development, service delivery, customer engagement, and operational efficiency.

“We have applied AI tools in quality management, quality operations, and manufacturing. The idea here is to bring efficiencies and reduce that turnaround time of quality deviations, CAPA [Corrective and Preventive Action] management, to bring efficiencies in planning, scheduling of operations, and reduce the downtime of equipment,” Kane said.

Thermo Fisher has yet to publicly quantify the savings in time and cost from AI applications, though it says it has seen promising results: “We will continue to monitor those and quantify those as we generate more case studies, as we generate more data, because this is certainly of importance to us and our partners.”

The post CDMOs Expand and Build for Future Growth appeared first on GEN - Genetic Engineering and Biotechnology News.

For Kelly, being a mom is everything. So, when she broke her wrist, she went to the OSMS Walk-In Clinic for quick and direct access to an orthopedic specialist, giving her the care she needed to confidently return to the role she loves most.

While Kelly was playing in the driveway with her children, she decided to put on her rollerblades while her boys rode around on their scooters and her two-year-old napped. At the end of her driveway, Kelly ended up hitting a bump and fell. The moment she hit the ground, she heard a crack and immediately knew in the back of her mind that something wasn’t right.

Kelly called her parents and when they arrive, her dad told her to get in the truck. While they were driving, Kelly asked her father where he was taking her – she assumed they were going to the ER – when her dad responded, “No, we’re going to go to the walk-in clinic at OSMS. You can probably get in much quicker than visiting in the ER waiting room for however many hours.”

Kelly go x-rays taken and she was seen by an OSMS orthopedic physician, they confirmed what Kelly feared. Kelly had fractured her wrist and the best path to recovery was going to be surgery.

Kelly wanted the path of whatever was going to happen the fastest. It wasn’t an ideal situation, but after being walked through the timeline of events, Kelly understood that the recovery option for surgery was much quicker than possibly casting it and seeing how long that was going to be. Kelly was comfortable with the plan, which was set the same day she walked in – on a Wednesday – and had surgery that following evening.

“I feel like I couldn’t really do hardly anything ’cause it was of course on my right hand and I’m right-handed,” Kelly explained. “I couldn’t cook, I couldn’t fold laundry like normally. Everything just took so much longer. Just normal things or just playing with my kids, strapping them into their car seat, just doing the day-to-day things.”

Kelly explained that her OSMS physician communicated with her that it would take approximately six weeks for the bone to heal, but not necessarily for her wrist to be fully recovered with full mobility. It would likely take the full year to heal.

So, when Kelly felt like there was nothing that she couldn’t do anymore than she could do before her injury, five weeks after surgery, she was pleasantly surprised. Her wrist healed much quicker than even anticipated.

Kelly described that she is back to “doing all the mom things laundry, cooking, cleaning, taking care of her kids, getting her two-year-old out of her crib, lifting her kids, and playing soccer and football.

“I 100% would recommend OSMS to anyone,” Kelly stated. “I would 100% take them to OSMS, especially just the fact that they have the walk-in clinic that you can be seen quickly. I feel like they care about you as a person, they care about your goals and just getting you back to what you want to be doing.”

Thanks to OSMS, Kelly’s back!

The post Kelly’s I’m Back Story: Broken Wrist appeared first on Orthopedic Sports Medicine Specialists (OSMS).

The field in 2015

When GEN first covered our work in single-cell functional assays in 2015,¹ immunology was entering a new era of molecular resolution. Researchers were gaining deeper insight into immune-cell heterogeneity through rapidly advancing single-cell technologies, reshaping how disease biology could be studied.

Yet an important challenge remained unresolved: molecular measurements could describe what immune cells appeared to be, but they did not always predict what immune cells would actually do over time.

Immune cells with activated molecular profiles sometimes failed to sustain durable antitumor activity, while cells that expanded efficiently during manufacturing did not necessarily maintain persistence or therapeutic efficacy. The biological processes that determine therapeutic outcome unfold dynamically through behavior, adaptation, persistence, and dysfunction over time, requiring approaches capable of observing immune behavior directly alongside molecular state.

At Northeastern University, our laboratory focused on developing technologies designed to study immune function in a more dynamic and biologically relevant way. Much of this work centered on creating single-cell systems capable of observing immune-cell behavior in real time while preserving the biological context required for meaningful downstream molecular analysis.

Over the following decade, advances in microfluidics, live-cell imaging, computational analysis, and single-cell biology made it possible to connect directly observed immune behavior with downstream molecular and clinical information at scales that were previously unattainable. What began as an effort to observe immune-cell behavior more faithfully evolved into integrated functional-immunomics systems capable of supporting translational analysis, therapeutic characterization, and more sophisticated computational modeling.

These efforts contributed to the emergence of functional immunomics—an approach centered on understanding immune behavior and its relationship to disease and therapeutic outcome.

A shift toward functional immunomics

One of the major transitions in immunology over the past decade has been the recognition that immune-cell behavior represents a critical biological variable.

Traditional molecular approaches continue to provide essential insight into gene expression, signaling state, and cellular composition. Functional approaches extend those modalities, adding behavioral context to molecular information.

Persistence, resistance to dysfunction, therapeutic durability, and effective immune response are fundamentally functional properties. Behaviors such as serial killing, sustained cytotoxicity, and resistance to exhaustion cannot be fully captured through static measurements alone because they emerge over time.

Advances in microfluidics, live-cell imaging, and single-cell analysis made it increasingly possible to observe these processes directly. In our own work, controlled single-cell pairing systems enabled immune cells to be placed into defined microenvironments with tumor targets, allowing functional behavior to be observed before downstream molecular analysis was performed.^2,3

This sequence—observing what a cell does before analyzing what it contains—represented an important conceptual shift. Rather than inferring function from molecular correlation alone, functional approaches make it possible to anchor molecular interpretation to directly observed biological behavior.⁴

In our early single-cell experiments, what struck me most was how often immune cells with strong activation signatures failed to sustain functional killing over time, and how often cells that appeared less remarkable molecularly turned out to be the ones driving effective cytotoxic responses. After seeing that pattern repeatedly across experiments, it became increasingly difficult to think about immune behavior as something a molecular state alone could fully explain. That observation gradually shifted my own perspective from focusing primarily on what immune cells contained to focusing on what they actually did.

A growing number of academic and industry groups are now contributing to this growing emphasis on function-linked immune analysis. Over time, our own work evolved into what we described internally as “Function-to-Omics”—a conceptual framework in which immune behavior serves as a foundational reference point for understanding disease and therapeutic response.

Much of the foundational intellectual property underlying this work originated through my research at Northeastern University and was later advanced translationally through Feromics, a functional immunomics company focused on AI-enabled immune analysis. The broader goal has been to establish function as a key framework for immune analysis, therapeutic development, and predictive modeling.

The AI inflection point

The rise of AI in biology has amplified the importance of this transition.

Machine-learning systems are fundamentally shaped by the biological quality and structure of the data used to train them. Bulk population-averaged datasets introduce biological noise by averaging across heterogeneous cell states, whereas function-linked analyses resolve this heterogeneity and yield cleaner, more therapeutically informative immune signatures.

A mixture of cells in different states—some highly cytotoxic, some exhausted, some transitional—may produce a population-level signal that reflects none of those states precisely. In practice, this means that cells expressing canonical activation markers may still fail to demonstrate sustained cytotoxic activity when observed functionally over time. Functional analysis makes it possible to separate those behaviors rather than averaging them into a single composite measurement.

As functional single-cell datasets mature, they create opportunities for computational systems capable of linking immune behavior more directly to therapeutic outcome.

More importantly, they change the structure of the learning problem itself.

Rather than training models primarily on correlative molecular associations, function-linked datasets allow computational systems to learn from experimentally observed biological outcomes at the level of individual cells.

This represents an important conceptual shift for the field: moving from systems built primarily on correlation toward approaches informed by experimentally observed biology.

At Feromics, this convergence between functional biology and AI is now being advanced through the development of large functional immunomics datasets linking immune behavior with downstream molecular and clinical information.⁵ Supported in part through a contract with the Advanced Research Projects Agency for Health (ARPA-H)⁶, these efforts have shown potential to predict response to immune-based therapies using function-labeled immune datasets linked to clinical outcome.

In these systems, models are trained on datasets in which observed immune-cell behavior—including cytotoxic activity, persistence, and resistance to dysfunction—is connected directly to downstream molecular and clinical data. The goal is to generate biologically meaningful datasets capable of supporting more predictive and clinically relevant computational models.

The long-term implication is the possibility of improved biological analysis and computational systems that better represent patient-specific immune behavior and therapeutic response.

Clinical translation

The clinical implications of functional immunomics are beginning to emerge across multiple areas of immunotherapy and translational medicine.

In cell therapy, conventional metrics alone often do not fully capture therapeutic potential. Functional approaches create opportunities to improve therapy characterization, donor evaluation, patient stratification, and response prediction through a deeper understanding of immune behavior.

This is already becoming visible in donor-derived immune-cell studies, including work in acute myeloid leukemia (AML) and lymphoma, where functional stratification prior to molecular analysis has begun to reveal distinct transcriptomic programs associated with antitumor activity. These types of approaches create opportunities to identify high-performing immune subsets based on directly observed function rather than molecular inference alone.

Therapy-response prediction represents another important area of development. Profiling patient immune cells based on how they behave in the presence of disease-relevant targets creates the possibility of predicting therapeutic response before treatment begins.

Functional approaches may also influence target discovery and biomarker development by connecting biological activity more directly with therapeutic outcome. In this context, molecular information becomes most powerful when interpreted alongside observed behavior rather than independently from it.

Several of these concepts are now transitioning from academic research into translational development. Through Feromics, technologies originating from my research at Northeastern University are being advanced toward applications in immunotherapy development, precision immune profiling, AI-enabled therapeutic prediction, and next-generation engineered immune-cell therapies.

Over time, functional immunomics may support more individualized therapeutic strategies and more predictive models of immune response across oncology, autoimmune disease, and broader immune-mediated disorders.

Looking ahead

The next decade will likely focus less on proving the value of functional biology and more on integrating it into scalable research and clinical frameworks.

Reproducibility, standardization, data integration, and clinical translation remain major challenges for the field. Functional biology is inherently complex and capturing immune-cell behavior in ways that faithfully reflect human disease remains an ongoing scientific challenge.

For much of modern immunology, the central challenge was describing the immune state with increasing molecular precision. The next phase of the field may be defined not only by molecular description, but also by the ability to measure how immune systems behave dynamically over time—functionally, adaptively, and in ways directly connected to therapeutic outcome.

The question that motivated much of our work in 2015—what is the immune system actually doing?—is now becoming possible to answer at single-cell resolution, at a meaningful scale, and in ways increasingly connected to clinical decision-making.

The convergence of functional biology, AI, and translational medicine is beginning to reshape how immune systems are studied, modeled, and therapeutically engineered.

References

1. Marusina K. Single Cell Is No Longer a Limit. Genetic Engineering & Biotechnology News. March 15, 2015;35(6).
2. Sharkey C, Akligoh H, Finocchiaro M, et al. High-throughput 3D matrigel-based droplet microfluidics for single-cell function-to-omics analysis of cytotoxic immune cells in solid tumor interactions. Adv Mater Technol. 2026;202501801.
3. Sullivan MR, White RP, Dashnamoorthy Ravi, et al. Characterizing influence of rCHOP treatment on diffuse large B-cell lymphoma microenvironment through in vitro microfluidic spheroid model. Cell Death Dis. 2024;15(1):18.
4. Sharkey C, White R, Finocchiaro M, Thomas J, Estevam J, Konry T. Advancing point-of-care applications with droplet microfluidics: from single-cell to multicellular analysis. Annu Rev Biomed Eng. 2024;26(1):119-139.
5. White R, Sharkey C, Vyas J, et al. Transcriptomic profiling of T cell immune states before and after donor lymphocyte infusion in a patient with acute myeloid leukemia. Blood. 2025;146(Suppl 1):2566.
6. ARPA-H Contract No. 75N91024C00036. Advanced Research Projects Agency for Health. (Contract awarded to Feromics Inc., $4.1 million; publicly disclosed.)

Tania Konry, PhD, is the cofounder of Feromics and associate professor at Northeastern University.

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The pharmaceutical and biotechnology sectors are experiencing a historic wave of investment. Across the United States and around the world, companies are expanding manufacturing capacity, establishing new facilities, and accelerating development of innovative medicines ranging from monoclonal antibodies and antibody-drug conjugates to mRNA vaccines, gene therapies, and other advanced modalities.

Recent announcements show the scale of this momentum. In Virginia, AstraZeneca committed $4.5 billion near Charlottesville, Merck broke ground on a $3 billion manufacturing center in Elkton, and Eli Lilly announced a $5 billion facility in Goochland County. Lilly also announced a separate $3.5 billion Pennsylvania investment to support advanced therapies and injectable medicines. Together, these projects represent thousands of new jobs and more than $16 billion in capital investment.^1,2,3,4.

Yet facilities, technologies, and equipment are only part of the equation. Realizing the full value of these investments depends on something equally important: a skilled workforce capable of developing, manufacturing, testing, and regulating high-quality medicines.

This need has become a central theme across industry. At the BIO International Convention in June, workforce readiness featured prominently in discussions such as Future-Ready Solutions to the Global Biomanufacturing Talent Challenge. The message was consistent: maintaining growth in life sciences requires parallel investments in education, training, and talent development.

In many ways, the industry is already responding. In Virginia, AstraZeneca, Eli Lilly, and Merck have committed up to $120 million toward development of the Virginia Center for Advanced Pharmaceutical Manufacturing, a workforce initiative expected to support thousands of future workers through credentialing and education pathways.⁵ Similarly, Eli Lilly has partnered with Lehigh Carbon Community College in Pennsylvania to help establish a pharmaceutical workforce development hub aligned with regional manufacturing growth.

Importantly, this trend extends far beyond the United States. In Australia, the State of Victoria partnered with Monash University to establish the Monash Centre for Advanced mRNA Medicines Manufacturing and Workforce Training, supporting the growing ecosystem surrounding Moderna and BioNTech investments.⁶ In South Korea, Yonsei University’s K-NIBRT Education Center, developed in collaboration with Ireland’s National Institute for Bioprocessing Research and Training (NIBRT), was created to address anticipated shortages in biopharmaceutical manufacturing talent and provide hands-on training at scale.⁷

These examples illustrate a broader reality: successful pharmaceutical ecosystems require sustained investment not only in manufacturing infrastructure, but also in people.

Workforce development for quality

For USP, workforce development is closely tied to medicine quality and accessibility. As an independent scientific organization whose standards are used in more than 150 countries, USP has long viewed education as a critical enabler of quality across the pharmaceutical lifecycle.

The importance of training grows as technologies evolve. Analytical methods become more sophisticated, regulatory expectations expand, and novel therapeutic modalities introduce new scientific considerations. The ability to consistently produce quality medicines increasingly depends on access to current knowledge and practical training.

USP’s approach reflects a simple principle: workforce development should not be limited to a single audience or delivery model. Instead, it should serve the broader ecosystem responsible for bringing medicines to patients.

USP pursues this mission through three complementary lenses: broad-based professional education, regulatory capacity building, and practical training solutions.

Global manufacturing workforce support

The first lens focuses on providing education that can support professionals regardless of geography, employer, or therapeutic modality.

USP Education was established to help pharmaceutical scientists, quality professionals, manufacturers, regulators, and laboratory personnel effectively understand and apply public quality standards. The mission is straightforward: ensuring that the education required to interpret and apply USP quality standards remains accessible to those who need it. The program currently reaches more than 25,000 learners annually across thirty-eight countries.

Because a pharmacopeia’s primary role centers on quality standards and analytical science, much of USP’s educational portfolio focuses on analytical methodologies, quality systems, and the practical application of standards. Courses cover topics spanning compendial methods, microbiology, biologics characterization, pharmaceutical manufacturing, and regulatory science.

A distinguishing feature of the program is its connection to the standards development process itself. USP courses are developed by subject matter experts, either Expert Volunteers or USP staff, who are involved in creating USP standards. Course instructors are separately selected and qualified using a formal framework designed to assess both subject matter expertise and teaching capabilities.

Developing effective education, however, requires more than subject matter expertise. USP has invested considerable effort into the pedagogy behind its training programs. In a 2022 LTEN Focus article, USP Education leader Tim Greiner described a structured methodology for evaluating instructor qualifications that emphasizes both technical expertise and teaching effectiveness.⁹ The framework includes standardized instructor assessments, defined content ownership, feedback mechanisms, and continuous qualification processes designed to ensure consistency and instructional quality. This approach reflects a broader philosophy that educational excellence requires the same rigor applied to scientific and operational processes.

As the pharmaceutical and biotechnology industry’s workforce evolves, scalable training approaches such as online learning, virtual instruction, and blended educational models increasingly allow organizations to develop talent independent of location or facility-specific investments.

Strengthening regulatory capacity

Workforce development extends beyond manufacturers: medicine quality also depends on regulators who review applications, evaluate manufacturing processes, interpret analytical data, and oversee product quality throughout the lifecycle. For this reason, USP places significant emphasis on regulatory education and capacity building.

One recent example is USP’s growing collaboration with the African Medicines Agency (AMA). In April 2026, USP and AMA signed a Memorandum of Understanding establishing a framework for cooperation in regulatory science, pharmacopeial standards, capacity building, product quality monitoring, and regulatory harmonization across Africa.⁸ The partnership aims to strengthen regulatory systems and advance access to quality-assured medical products throughout the continent.

The agreement builds upon decades of USP engagement with national and regional regulatory authorities across Africa and complements broader efforts focused on local manufacturing, regulatory convergence, and post-market quality systems.

Strong science-based regulatory systems are increasingly important for advancing local manufacturing, enabling regulatory harmonization, and supporting access to innovative technologies. These activities help ensure that growing pharmaceutical manufacturing capacity is matched by corresponding regulatory readiness.

In the Asia-Pacific region, USP likewise supports regulator education through participation in the Asia-Pacific Economic Cooperation’s APEC regulatory training initiatives and centers of excellence. Training programs have included educational activities focused on advanced therapy products, including gene therapies. For example, USP recently conducted specialized training on qualification of raw and starting materials for gene therapies, helping regulators and industry professionals navigate evolving quality expectations associated with emerging therapeutic modalities.

By investing in regulator education alongside manufacturer training, USP seeks to strengthen the broader quality ecosystem that supports medicine availability and patient confidence.

Training beyond the classroom

As pharmaceutical manufacturing expands, workforce development increasingly requires more than traditional classroom-based instruction. Employers need personnel who can enter manufacturing environments with practical familiarity and direct experience relevant to current production technologies.

One example is the Maryland Tech Council’s BioHub Maryland program, which recently celebrated its first group of graduates. The program was designed in collaboration with regional life science employers and prioritizes curriculum development based on feedback from an industry advisory panel. This model helps to align workforce preparation with the skills most needed by local manufacturers.

Importantly, the curriculum adapts as the industry evolves. With companies such as Kite Pharma expanding cell therapy manufacturing capabilities in the region and AstraZeneca announcing significant investments in advanced therapeutics, BioHub has incorporated training focused on cell therapy production and microbial contamination control. By connecting educators directly with employers, programs such as BioHub help ensure that workforce development efforts remain relevant to emerging manufacturing needs.

These initiatives illustrate an important principle: workforce development is most effective when educational institutions, industry, regulators, and scientific organizations work together to align training with evolving technologies and quality expectations.

While hands-on programs provide valuable experiential learning, organizations may also seek objective ways to measure competency as personnel begin performing critical activities. In high-growth manufacturing environments where employee turnover and rapid hiring may occur, objective competency assessment tools can provide additional confidence that critical techniques are being performed correctly and consistently.

Importantly, these tools do not replace training. Instead, they complement educational programs by helping organizations measure practical performance and reinforce quality-focused behaviors.

A holistic model

The pharmaceutical sector’s expansion presents an extraordinary opportunity. Billions of dollars are flowing into new manufacturing facilities, advanced technologies are progressing across biologics, mRNA therapeutics, cell and gene therapies, and precision medicines, and regional life sciences ecosystems continue to grow around the world.

Realizing the long-term value of these investments will require a workforce prepared to sustain them.

Examples from the United States, Australia, South Korea, and many other regions show that workforce development is increasingly recognized as a strategic necessity, not a supporting activity.

USP’s experience points to a holistic model: accessible education for industry professionals, support for regulators who shape medicine quality ecosystems, and practical tools that reinforce competency and continuous improvement.

As students return to classrooms and professionals continue building new skills, the life sciences industry is entering its own global back-to-school season. Facilities may be new, and technologies may evolve, but the objective remains constant: ensuring that high-quality medicines reach patients everywhere.

And that objective starts with people.

References 

1. Eli Lilly Pennsylvania manufacturing investment announcement (January 2026)
2. Eli Lilly Virginia manufacturing facility announcement (September 2025)
3. AstraZeneca Virginia manufacturing investment announcement (October 2025)
4. Merck Elkton, Virginia manufacturing center announcement (October 2025)
5. Virginia Center for Advanced Pharmaceutical Manufacturing MOU announcements (October–November 2025)
6. Monash University and Victoria Government mRNA workforce training initiative
7. Yonsei University K-NIBRT Education Center and NIBRT partnership
8. African Medicines Agency–USP Memorandum of Understanding (April 2026)
9. Tim Greiner, “The Who, How and When of Instructor Qualification,” LTEN Focus Magazine (Fall 2022)
10. AMA–USP Regulators Forum educational program materials

Brian McNally, PhD, Director of Global Biologics Marketing & Strategic Collaborations at USP

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Characterizing the RNA and ligands in nanoparticle-based therapeutics has, historically, been a cumbersome process. The lipid nanoparticles (LNPs) that encase RNA and payloads are cloudy by nature, which means analysis can’t be accomplished using the UV/Vis spectrometers that are ubiquitous throughout the life sciences industry.

Marama Labs has developed a technology that eliminates the light scatter in cloudy samples—even in samples as cloudy as milk—thereby “unlocking a huge capability for complex particle analysis,” Brendan Darby, PhD, co-founder and CEO of Marama Labs, tells GEN.

The technology, CloudSpec, employs scatter-free absorbance to remove the signal interference caused by a solution’s cloudiness, in effect, chasing away the clouds. To do this, Darby and colleagues created a highly reflective spherical chamber called an integrating sphere, which harnesses the properties of physics—specifically, the Beer-Lambert Law regarding light attenuation—and an algorithm to precisely measure analyte concentrations. This enables clean measurements similar to those of a standard spectrometer. Using this device, LNP lysing and fluorescent dyes are unnecessary for payload quantification.

Research from Victoria University of Wellington (New Zealand), University College Cork (Ireland), and Marama Labs indicates this analysis method outperforms fluorescence-based quantification assays in terms of precision and agreement with expected RNA concentrations.

CloudSpec delivers results across the 240 to 850-nm spectral range that are “within 10% of the nominal value expected for RNA concentration,” Darby says. And, he adds, “The technique is very precise.” It’s also fast and simple. Sample dilution is the only preparation needed, and the measurement itself takes only 15 seconds.
Alternative technologies, in contrast, he says, can involve eight to 10 steps and between 30 minutes and two hours to analyze each sample, with significant variability between samples and also between operators.

Physics, wine, and RNA

The idea for this novel quantification technology emerged during Darby’s doctoral work in the RAMAN Lab of Eric Le Ru, PhD, professor at Victoria University of Wellington, now Marama Labs’ CSO.

“We were trying to understand how light interacts with nanoparticles from a very fundamental physics point of view,” Darby recalls. “We were looking at the fundamental optics of scattering and light absorbance with nanoparticles and found that what we were trying to measure was impossible with the existing instruments at our university. We realized that light scattering was causing a major source of error in measurements.”

“Most liquids are cloudy by nature, unless they are purified in a lab or filtered. When we (produced) the same quality and repeatability as UV/Vis, but in unprocessed samples, we immediately understood that this technology could potentially become the gold standard for characterization of complex samples,” Darby says. UV/Vis, he explains, measures extinction—both scatter and absorption. CloudSpec, however, measures extinction and absorption directly and uses those measurements to determine scattering.

At that point, Darby, Le Ru, and Matthias Meyer, PhD, CTO and co-founder, began the process of forming Marama Labs, which was incorporated in 2019.

In his thesis research, Darby measured molecules on the surface of metallic nanoparticles at ultra-low, previously unmeasurable, concentrations accurately. That finding was extended to RNA therapeutics and validated in collaboration with CureVac researchers.

From the beginning, though, the team understood that CloudSpec’s greatest contributions would be in the life sciences, but its first applications were in the New Zealand wine industry.

“Winemakers in New Zealand are very technology-centric and innovative,” he says. At the time, “There was no easy method to measure color and tannin at the very earliest stage of winemaking. They used their palettes and their eyes.” CloudSpec’s advanced analytics provided the data that those winemakers needed to better control their processes and thus craft the style of wine they needed for their market needs, while, he says, “being respectful of the grape.”

To transition to life sciences, the challenge was how to evolve the technology and apply learnings from the wine industry to the pharmaceutical industry. “Our primary focus is in life sciences and RNA therapeutics,” he reiterates.

Formulations to QA

Currently, most of CloudSpec’s applications are in therapeutic formulation development. There, this technology helps companies optimize formulations to provide both effective nanoparticle delivery and effective therapeutic response. Additional applications include manufacturing and quality assurance.

CloudSpec technology is currently single-parameter focused, measuring RNA and targeting-ligand concentrations. While these are quite important, they are only one of several chemical and physical parameters that must be measured. The size of the nanoparticles, their distribution, and surface charge, for instance, are among the critical quality parameters that biomanufacturers must measure.

With that in mind, Darby hints that an additional measurement capability “for one of the most widely-used attributes in the LNP formulation space” may be added to the CloudSpec soon. “It’s been demonstrated and validated internally that CloudSpec can do this measurement, and do it faster and more repeatably than the existing method. We don’t just add on capability for the sake of adding,” he stresses. What that new measurement is couldn’t be released at the time of the interview.

In addition to expanding its technology, Marama Labs is also growing its global presence. Its core research and development team and manufacturing facilities are based in Wellington, NZ. Darby heads the company’s commercial and strategic development from his office in Dublin. The company also recently opened an office in Boston to support its growing customer base there.

That combination provides access to the major European and North American markets while maintaining close ties to its innovation team, effectively chasing away the clouds wherever LNP analysis is performed.

The post SFA Spectroscopy Chases Away Cloudy Samples appeared first on GEN - Genetic Engineering and Biotechnology News.

Researcher headed by a team at the Whitehead Institute have now discovered that cells rely on small molecules called polyamines as an unexpected protector against this threat. The newly reported study by White Institute member Ankur Jain, PhD, together with former postdoc Whitney Henry, PhD, and graduate student Pushkal Sharma, and colleagues, revealed that polyamines act like storage lockers for iron, safely holding the metal in a non-reactive state until cells need it. As part of their research the team developed a genetically encoded fluorescent reporter allowing them to quantitatively measure redox-active iron in living cells.

The collective findings solve a decades-old mystery about why cells maintain such extraordinarily high levels of polyamines and also uncover a previously unknown defense mechanism that protects cells from toxic iron overload. The discovery could potentially help scientists develop better cancer treatments, by allowing iron overload to trigger cancer cell death. The study results could also offer up new clues about disorders such as early-onset Parkinson’s disease, in which mutations affect polyamine levels within neurons.

Jain and Henry are co-senior and co-corresponding authors of the team’s published paper in Cell titled “Polyamines buffer labile iron to suppress ferroptosis,” in which they stated that the findings “… reposition polyamines as key regulators of iron homeostasis, with implications for ferroptosis-linked disease states and cellular redox balance.”

The Jain Lab studies RNA and is particularly interested in how RNA folds, misfolds, and sometimes clumps inside cells. Jain and Sharma first began studying polyamines because these molecules bind to RNA and help to shape its structure. However, they suspected that polyamines must be playing other roles inside cells. Polyamines are among the most abundant small molecules within cells, present at levels comparable to ATP, the molecule that cells use as their energy currency.

“We’ve known that without polyamines, cells stop growing and dividing,” explained Jain, who is also an associate professor of biology at the Massachusetts Institute of Technology (MIT). “But their best-known function only requires a small fraction of the polyamine levels cells actually have.”

To uncover the hidden function of polyamines inside cells the researchers used a large-scale genetic approach that allows them to screen the entire genome at once, rather than testing genes one-by-one, in order to find out which cellular processes are impacted when polyamine levels are changed within cells. “To identify cellular dependencies that emerge during polyamine stress, we performed a genome-wide CRISPR-Cas9 screen in human cells under polyamine-depleted conditions,” they noted.

The screen revealed that when cells have reduced levels of polyamines, a protein called GPX4 becomes essential for survival. GPX4 is known to prevent harmful chemical reactions that damage the fatty molecules that make up cell membranes. “This synthetic lethal screen revealed a surprising link between polyamines and iron homeostasis: polyamine depletion rendered cells highly dependent on glutathione peroxidase 4 (GPX4), an antioxidant enzyme that protects membranes from lethal lipid peroxidation and ferroptotic cell death,” the team added.

The team also found that cells with lower polyamine levels have higher amounts of another protein that acts as an iron sponge and keeps the metal in a mineralized form. Together, these findings led the researchers to hypothesize that polyamines might be helping keep iron in a safe, non-reactive state within cells.

To test this idea, they developed a new fluorescent sensor that would allow them to measure chemically reactive iron inside living cells. The new sensor causes living cells to glow based on the amount of chemically reactive iron they contain, allowing researchers to track any changes under a microscope in real time.

The team paired the new iron sensor with another sensor they had previously developed that measures polyamine levels within cells. By employing them simultaneously, they observed a striking pattern: as polyamine levels dropped within cells, the amount of chemically reactive iron went up, offering new evidence that polyamines play a key role in preventing toxic iron build up inside cells. “Single-cell analysis revealed that labile iron levels increase as polyamines decline,” the team wrote in summary. They suggest that their collective findings “… support a model in which millimolar polyamines help restrain labile iron availability, linking polyamine metabolism to redox balance and ferroptosis sensitivity … Altogether, these data demonstrate a tight, inverse coupling between polyamine and labile iron levels at the single-cell level and establish our genetically encoded reporter as a robust tool for the quantitative dissection of iron biology.”

Beyond answering a fundamental biological question, these findings could have implications for cancer treatment. Cancer cells often rely on high polyamine levels to support their rapid growth and division. However, cancer drugs designed to lower polyamine levels to stop cell division have had limited success.

“We saw that when polyamine levels fall, cells rely on GPX4 to protect themselves from iron toxicity,” said first author Sharma. “This could mean that combining drugs that lower polyamine levels with those that block GPX4 might be more effective for killing cancer cells than targeting either pathway alone.”

The discovery may also have implications beyond cancer. Mutations in genes that help move polyamines around cells are linked to a rare form of early-onset Parkinson’s disease, and scientists have long observed unusually high levels of iron in the brains of Parkinson’s patients.

While it is still unclear whether excess iron directly contributes to neuron death in Parkinson’s, the discovery that polyamines help buffer reactive iron inside cells offers a possible explanation for this link and opens new directions for future investigation.

In addition, the researchers expect the new iron sensor to be a valuable tool for other scientists. By allowing them to track chemically reactive iron inside living cells, it could power new discoveries in aging, cancer, and neurodegeneration. “We anticipate that this reporter will provide a powerful platform to facilitate future discoveries into iron biology, ferroptosis, and disease mechanisms,” they stated.

“There are a lot of promising future directions for this work,” Jain noted. “It’s exciting to think about how these tools and findings could help answer further questions about disease pathways and potentially help design better therapies.”

The post Newly Discovered Role for Polyamines Could Point to Potential Anticancer Strategies appeared first on GEN - Genetic Engineering and Biotechnology News.

Listed below are links to the GEN stories referenced in this episode of Touching Base:

Next 10 U.S. Biopharma Clusters
By Alex Philippidis, GEN, Aug 12, 2026

Recursion Partners with Genentech to Advance First Validated Neuro Target Discovered Through AI Map
By Alex Philippidis, GEN Edge, Aug 5, 2026

COVID-19 Reactivates Dormant Viruses, Offering New Clues to Long COVID
GEN, Aug 5, 2026

Trump’s Treatments: Regeneron’s Antibodies and Gilead’s Remdesivir Explained
By Alex Philippidis, GEN, Oct 5, 2020

Lessons from the COVID Crisis: An Interview with Peter Hotez
By Alex Philippidis, GEN Edge, Oct 19, 2022

Candida auris Persists in Hair Follicles, Hijacks Immune Signaling
GEN, August 10, 2026

The State of Biotech Summit
September 23, 2026

Touching Base Podcast
Hosted by Corinna Singleman, PhD

Behind the Breakthroughs
Hosted by Jonathan D. Grinstein, PhD

The State of Biologics Testing 2026

Charles River Laboratories and GEN, June 10, 2026

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The post BMS’s New Facility, Recursion–Genentech Partnership, Long-COVID and Persistent C. auris appeared first on GEN - Genetic Engineering and Biotechnology News.

The post Pharma Friday – August 14, 2026 appeared first on Endocrine News.

Rana Al-Falaki explains how changing from suppression to management of stress could transform your performance, your practice, and your life.

Ask any dental clinician how they manage stress, and most will give you some version of the same answer: ‘I just get on with it.’ It is, in many ways, the default setting of the profession. We are trained to perform under pressure, to hold composure in the surgery whatever is happening internally, and to keep moving regardless of how the day feels. In dentistry, pushing through is not just accepted – it is quietly admired.

But here is what that stoicism is costing you. And it is more than you might think.

Dentistry consistently ranks among the most stressful professions in the UK. Figures from the British Dental Association suggest that stress-related issues affect up to three quarters of the profession. Burnout has become a quiet epidemic sitting at the heart of dentistry, yet the dominant cultural response remains the same: keep going, and do not show it.

The question worth exploring is not whether dentistry is stressful – it clearly is – but whether the way most of us have been taught to think about stress is actually making things worse. Because the latest evidence suggests it might be.

‘Stress is part of the job – you just have to push through’

When I first met Dr HC, he was, by every external measure, doing exceptionally well. A high-performing associate in a busy mixed practice, he was technically accomplished, reliable, and popular with his patients. His principal was happy. His diary was full. There was nothing obviously wrong.

Spend any time with Dr HC, however, and a different picture emerged. He described his working days as being on speed – moving from patient to patient with barely a pause, eating at the desk, answering messages between appointments, always just ahead of the next task because falling behind was not an option. The output was impressive. The cost was invisible. Until it was not.

The early signs were subtle. He forgot a patient’s name mid-consultation – someone he had been treating for three years. He missed a follow-up call he had promised. Then, he snapped at his dental nurse over something trivial and felt awful about it for the rest of the day. At home, he was physically present but mentally still in the surgery, running through the day’s cases while his family tried to talk to him.

These are the hallmark signs of early burnout, and they rarely announce themselves dramatically. Burnout tends to arrive quietly: as heightened irritability, difficulty concentrating, a growing sense of detachment from patients, disrupted sleep despite exhaustion, and a creeping feeling that however much you do, it is never quite enough. The most troubling aspect is that the people most at risk are frequently also the most productive,  right up until the point they are not.

When we explored what was underpinning all of this for Dr HC, one belief came through clearly: ‘Dentistry is stressful; it always has been and always will be. You just have to get on with it.’

It is a belief born of training, culture, and professional pride. It feels rational. Stoic, even. But it contains a fundamental misunderstanding about the nature of stress, and is quietly doing enormous damage.

Why pushing through is not resilience – it is suppression

Stress is a biological response to a real or perceived threat. When a stressor hits, a difficult patient, a clinical complication, a General Dental Council concern, a staffing crisis, the body responds predictably: cortisol and adrenaline flood the system, heart rate increases, breathing sharpens, awareness heightens. This is not the enemy. This is your biology doing precisely what it was designed to do: preparing you to meet a challenge with focus and energy.

The problem is not stress – it is what happens when stress becomes chronic. When pressure is relentless and there is no recovery, the very same hormones that help in a short burst begin to erode performance over time. Constantly elevated cortisol impairs the ability to focus, make decisions, retain information, and communicate clearly. People become irritable, fatigued, and emotionally flat, and increasingly vulnerable to conditions including heart disease, high blood pressure, and compromised immunity.

Pushing through, without ever processing or releasing the stress, is not resilience. It is suppression. This suppression has a cost that accumulates invisibly – until the moment it does not.

The truth: your mindset about stress matters as much as the stress itself

Here is where the science becomes genuinely fascinating, and genuinely useful.

If you think of stress as a form of energy, and physics tells us that energy cannot be created or destroyed, only transformed, then the question is not how to eliminate it, but how to work with it. The same stress response that feels overwhelming when you are fighting it can become a source of focus and drive when you understand what it actually is.

Research by Dr Alia Crum, assistant professor of psychology at Stanford University, demonstrated something that ought to be on every dental school curriculum. She found that people who viewed stress as harmful experienced the full negative cascade of chronic stress. Those who understood stress as a physiological response that could be channelled showed measurably better health, higher productivity, and greater emotional wellbeing,  even during periods of intense pressure. The difference was not the amount of stress. It was the relationship with it.

A separate study found that actively trying to avoid stress increased the long-term risk of depression, relationship breakdown, and job loss, because avoidance led people toward unhelpful coping strategies such as procrastinating, withdrawing, and imagining worst-case scenarios.

Where attention goes, energy flows: keeping your focus on eliminating stress keeps you locked in a losing battle with it.

Working with Dr HC: from pushing through to working with

We introduced Dr HC to three mindset shifts:

1. Viewing the body’s stress response as helpful rather than debilitating
2. Recognising your own capacity to grow through difficulty
3. Understanding that stress is a universal human experience, not evidence that you are uniquely failing.

His initial response was familiar. He did not see himself as someone struggling with stress. He was someone who handled it. A pusher-through. That, we explained gently, was precisely the problem.

Through the NAIL-IT in Dentistry Titanium training programme, Dr HC started to shift. The first shift was awareness: becoming conscious of the internal narrative running beneath the surface of his days. Not just the workload itself, but the constant accompanying commentary.

• ‘I cannot drop anything’
• ‘I cannot let anyone down’
• ‘I have to stay ahead.’

These were not neutral observations. They were stress amplifiers, keeping his nervous system in a state of sustained alert long after individual stressors had passed.

The second shift was reframing the stress response itself. Instead of interpreting the physical signs of pressure – the heightened alertness, the racing thoughts – as warning signals to be alarmed by, he began recognising them as his body preparing him to perform. The language changed.

‘I am overwhelmed’ became ‘I am activated’.

This shifted the emotional register entirely, and with it, the physiological response.

The third shift was accepting that stress as energy requires an outlet. Suppressing it does not make it disappear; it redirects into the body, the mood, the snapped remark, the dropped ball, the missed detail.

Within the NAIL-IT programme, Dr HC was introduced to a range of practical regulation tools: structured breathing between patients as a micro-reset, genuine lunch breaks away from the screen, and a brief end-of-day journal – not to catalogue problems, but to note what had gone well. Small practices, consistent habits. The shift in his nervous system within weeks was marked.

The true shift

Six months later, Dr HC describes his experience of work as fundamentally different. Not because the demands have reduced, the diary is just as full, but because his relationship with those demands has shifted.

His treatment conversion rate increased by more than 20%. Not through any change in clinical skill, but through the quality of his presence in the room. Patients respond powerfully to a clinician who is genuinely calm and attentive. When you are running on adrenaline, patients feel it, even when they cannot name it. When you are regulated, they feel that too. Trust builds faster. Consultations feel more natural. Treatment acceptance follows.

His clinical notes are no longer the last thing standing between him and home. With improved concentration and reduced cognitive load, he returned to completing records in real time – a habit he had long since abandoned as impractical. It turned out it was not impractical. It was simply incompatible with a mind running at perpetual high alert.

He started sleeping better, being present at the dinner table, and took up running again. He described, with some surprise, looking forward to Monday mornings for the first time in years.

Most significantly, he told us he had stopped viewing stress as a sign that something was going wrong and started viewing it as a signal that something mattered. That reframe, small in words, significant in impact, is at the heart of what the NAIL-IT leadership model teaches about stress mindset.

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But here’s the part that’s less often talked about: once you meet that baseline, those traditional metrics start to blur together. Many applicants look very similar on paper. That’s when program directors begin asking a different question, not just “Is this applicant capable?” but “Who is this person, really?” and “Will they thrive here?”

This blog is about both sides of that equation: what you need to demonstrate to be taken seriously, and how you can go beyond the checklist to stand out in a meaningful, authentic way.

Let’s start with the basics.

Grades and Board Scores: The Initial Filter

Whether your school uses graded systems or pass/fail, your academic performance still plays a role. Program directors are trying to assess your ability to handle the cognitive demands of residency, and historically, grades and board scores have served as proxies for that.

As Step 1 is now pass/fail, Step 2 CK has taken on more importance. A strong score reassures PDs that you have a solid clinical knowledge base and can perform under pressure. But it’s important to recognize that scores are rarely the deciding factor once you’re above a certain threshold. They open doors, but they don’t carry you through them.

For students from pass/fail schools, narrative evaluations and clerkship comments become even more critical. Program directors read these closely. They’re looking for patterns: Are you consistently described as hardworking? Reliable? Curious? Do you show growth over time? A single strong comment is nice, but consistent themes across rotations are what build confidence.

Clinical Evaluations: Who You Are on the Wards

If there’s one part of your application that carries a lot of weight, it’s your clinical evaluations. These give program directors insight into how you function in real patient care settings, which is ultimately what residency is all about.

Strong evaluations tend to highlight a few key traits: ownership of patients, teamwork, communication skills, and work ethic. It’s not just about being smart, it’s about being dependable. Can your team trust you? Do you follow through? Are you proactive without being overbearing? Do you have a good bedside manner? Are you a team player?

Many PDs will tell you they are far more concerned about red flags here than perfection. Comments suggesting poor professionalism, difficulty working with others, or lack of accountability can be significant concerns. On the flip side, even average academic performance can be offset by consistently excellent clinical feedback. 

Letters of Recommendation: The Power of Advocacy

Letters of recommendation are one of the few parts of your application where someone else speaks on your behalf. And program directors can tell the difference between a generic letter and one that truly advocates for you.

Strong letters are specific. They include concrete examples of your performance, your interactions with patients, and your contributions to the team. They also provide context, how you compare to other students the writer has worked with.

A common misconception is that the “big name” matters most. In reality, the strength of the relationship often matters more. A detailed, enthusiastic letter from someone who knows you well is far more valuable than a vague letter from a well-known figure who barely worked with you.

Program directors are also paying attention to tone. Does the letter sound genuinely excited about you? Would the writer trust you to take care of their own patients or family members? Those subtle cues matter.

Research: More Than Just a Line on Your CV

Research can be a significant asset, particularly in more competitive specialties, but its value isn’t just about quantity. Program directors are less interested in how many abstracts you’ve submitted and more interested in what your research says about you.

Did you demonstrate persistence? Did you take ownership of a project? Do you understand the work you were involved in, or are you simply listed as a co-author? Are you passionate about the projects you’ve worked on?

For some applicants, research is a true passion and a central part of their career goals. For others, it’s a smaller component. Both are okay. What matters is authenticity. If you’ve done research, be prepared to talk about it and answer questions about it in a thoughtful and engaged way. Program directors often use research discussions during interviews to gauge intellectual curiosity and depth of understanding.

The Personal Statement: Your Narrative Matters

The personal statement is often underestimated. Many applicants treat it as a formality, but for program directors, it can be a window into your motivations and values.

A strong personal statement answers a simple but important question: Why this specialty, and why you?

It doesn’t need to be dramatic or filled with life-altering moments. In fact, overly polished or cliché narratives can feel less genuine. What resonates more is clarity, reflection, and sincerity. Tell your story. What experiences shaped your interest? What have you learned along the way? How do you think about patient care? Tie in some of your patient experiences to tell a story that is unique to you. 

Program directors aren’t expecting perfection—they’re looking for insight into how you think and what drives you. This is your chance to share some unique experiences about you and paint the picture of your goals and aspirations in your career as a physician. 

Now let’s shift to what really differentiates applicants.

The Intangibles: What Sets You Apart

Once you’ve demonstrated that you can handle the academic and clinical demands of residency, program directors start looking for qualities that are harder to quantify.

They’re asking questions like: Will this person be a good teammate? Do they have resilience? Are they reliable? Are they someone we’d want to work with at 2 a.m.?

These qualities often come through indirectly, in your evaluations, your letters, and your interview, but they’re also shaped by the experiences you choose to pursue. This is where passion projects come in.

Passion Projects: Showing Who You Are Beyond Medicine

One of the most effective ways to stand out is through something that genuinely matters to you. Not something you think will look good, but something you actually care about.

Maybe you started a mentorship program for underrepresented students. Maybe you created educational content, worked with a community organization, or pursued a creative interest like writing, art, or advocacy. Maybe you worked on a quality improvement project that improved the care patients receive. These experiences add dimension to your application.

Program directors remember applicants who have a story, something that makes them distinct and relatable. Passion projects signal initiative, creativity, and commitment. They also make for much more engaging conversations during interviews.

Importantly, these projects don’t need to be massive or highly formal. What matters is authenticity and follow-through. A small, meaningful project you’ve sustained over time often speaks louder than a long list of short-lived activities.

Consistency and Cohesion: The Hidden Advantage

One subtle but powerful way to strengthen your application is through cohesion. When different parts of your application reinforce each other, it creates a clear and compelling narrative.

For example, if your personal statement emphasizes a commitment to underserved populations, and your experiences, research, and letters all reflect that, it builds credibility. It shows that your interests are genuine and sustained.

On the other hand, a scattered application with no clear thread can make it harder for program directors to understand who you are and what you’re aiming for. Cohesion doesn’t mean limiting yourself, it means being intentional about how your experiences fit together.

Professionalism and Reliability: The Non-Negotiables

There are certain qualities that program directors consistently emphasize as essential: professionalism, reliability, and integrity.

These may sound basic, but they’re critical. Residency is demanding, and programs need residents they can depend on. Someone who shows up prepared, communicates clearly, and handles challenges with maturity is incredibly valuable.

Even small signals can matter, how you communicate in emails, how you interact during rotations, how you respond to feedback. These details contribute to the overall impression you leave.

The Interview: Bringing It All Together

By the time you reach the interview stage, your application has already demonstrated your qualifications. The interview is about fit.

Program directors are assessing how you communicate, how you think on your feet, and how you interact with others. They’re imagining what it would be like to have you as a colleague.

Preparation helps, but authenticity is key. Over-rehearsed or memorized answers can feel impersonal, while thoughtful, genuine responses tend to resonate more.

Interviews are also an opportunity for you to evaluate the program. Fit goes both ways. The goal isn’t just to impress, it’s to find an environment where you’ll thrive.

Final Thoughts: Building an Application That Feels Like You

At the end of the day, program directors are not looking for a single “perfect” type of applicant. They’re building a team of individuals who are capable, collaborative, and committed.

Strong grades, solid evaluations, meaningful letters, and relevant experiences will get your foot in the door. But what makes you memorable is how those pieces come together to tell your story. The most compelling applications are not the most polished or the most decorated, they’re the most authentic. They reflect a person who has taken the time to understand their own motivations, pursued their interests with intention, and grown through their experiences.

Bringing all those pieces together into a clear, authentic application can be challenging. If you’d like personalized guidance, Elite Medical Prep’s residency advising can help you develop your application strategy, strengthen your materials, and present your story with confidence.

If there’s one takeaway, it’s this: don’t just focus on checking boxes. Focus on becoming the kind of person you’d want as your own colleague. And pursue opportunities that you’re passionate about along the way. That’s ultimately what program directors are looking for, and it’s what will carry you not just through the application process, but through residency and beyond.

The post What Program Directors Really Want to See in Residency Applications: An Insider’s Perspective appeared first on Elite Medical Prep.

Since joining the Children’s Hospital of Philadelphia (CHOP) as the director of bioinformatics three years earlier, Taylor had been disappointed by the lack of investment in medical research focused on children. The dominant view, she says, was that children are exactly like small adults. They’re not. Children’s cells are different from grownups’ cells in the way they express genes—switching them on and off or turning them up or down. Those variations can cause drastically different and even deadly responses to drugs that adults tolerate well. 

The 2017 talk was the moment Taylor didn’t know she’d been waiting for. She quickly channeled her concern into a campaign, joining the Human Cell Atlas’s volunteer team and helping write a section on children for a white paper outlining the group’s goals and plans. She then rallied a cross-hospital coalition of pediatric researchers to contribute to the project and spearheaded a 2019 paper that outlined the case for studying children—a bid to attract more interest and funding to the field. “It put a flag in the ground,” she says. “Why don’t we have healthy models of children’s development?”

So far, the push has paid off. In 2021 the NIH awarded a $38.5 million grant to the Developmental Genotype-Tissue Expression Project (dGTEx), a major initiative aimed at establishing the first comprehensive database of healthy pediatric tissue. The project banks samples collected from otherwise healthy children who have died and whose parents agreed to donate their bodies, and maps how genes across all the major organ systems are expressed. Taylor and her team curate and standardize the information associated with each tissue donation, including family history and details about the samples. A separate group does analysis on the samples themselves, and then all the information is combined to create a database­—a baseline of what gene expression looks like in children. It’s the first step to enabling research that could advance our knowledge of normal development, disease, drug effectiveness, and other phenomena. 

The dGTEx team will eventually feed its data into the Human Cell Atlas, which, thanks to Taylor and many of the coauthors of the 2019 paper, now includes a pediatric section.

Taylor’s primary responsibility may be collecting and organizing data for dGTEx, but colleagues say she’s also the glue holding diverse research projects together. That’s especially important for the Human Cell Atlas, which depends on contributions from a loose coalition of researchers, all pursuing their own objectives. “Deanne took a big-picture view and said, We don’t just need to understand the pediatric kidney or the pediatric brain or the pediatric immune system. We need a holistic view of pediatric development,” says Sarah Teichmann, a cofounder of the Human Cell Atlas. “She embodies that interdisciplinary spirit.” 

A healthy baseline

Taylor describes her career as a “random walk,” driven by a singular intensity she now attributes to undiagnosed autism and ADHD. At five, she began reading her mom’s medical texts. By 12, she was checking out physics books from the library. Physics provided mysteries to solve, and she wanted to understand how things worked. 

Taylor got her PhD in biophysics, in 2001, but was inspired by the then-active Human Genome Project to change gears and take on a postdoc at Pfizer, writing code to handle complex data in rare-disease research. Then she moved to reproductive medicine, where she worked on some of the first computer programs to screen embryos for chromosomal abnormalities—many of which are still in use today.

HANNAH YOON

Despite this seemingly winding road, Taylor says her focus has always been on understanding why the same illness hits people differently. How can two people carry the same disease-­associated gene variant, but only one get sick? 

The Human Cell Atlas—including all the data feeding into it from dGTEx and other projects—could at last help researchers find answers. The effort is a natural extension of the Human Genome Project. That initiative, which wrapped up in 2003, helped researchers link specific genes to specific diseases. But a map of the genome is a bit like a DIY kit with all the parts and no assembly manual. It doesn’t tell you where and how cells use each gene throughout the body.

After all, “we’re just older kids,” Taylor says. “By ignoring the pediatric side of things, I think people are missing a window of intervention in human disease.”

For that, you need to know how the genes are expressed. Gene expression generally involves making a protein that does a specific job in the body, like building tissue or sending signals. Unlike DNA, which largely remains the same throughout our lives, the way the genes in DNA are expressed changes as we develop. 

Differences in gene expression can determine whether a therapy will work—or could harm more than it helps. Because of the way cardiac genes are expressed in children, chemotherapy drugs can attack not only tumors but also children’s developing hearts, potentially causing lifelong damage. Other treatments can affect the entire body, sometimes triggering a reversible but potentially fatal immune-system reaction called cytokine release syndrome.

The dGTEx database aims to create a baseline for gene expression in children—a molecular map of how the body’s roughly 20,000 genes do their work in healthy tissue cells. It is only one of the collaborations Taylor manages. She’s a principal investigator for the Kids First Data Resource Center, which sequences diseased tissues collected from children enrolled in other studies nationwide. And she has been collaborating with researchers on HubMAP, an effort that’s building a resource complementary to the Human Cell Atlas, to secure funding to create 3D maps of children’s cells like the ones it’s already made for adults.

Extending such initiatives to children is important, Teichmann argues. Much of human development happens in childhood; key brain cells called astrocytes form in the first five years, for instance, and the immune system matures in puberty. “Those changes are really important to understand from a disease point of view,” she says. A granular view of how individual cells work “will change pediatric medicine, for sure.” 

Herding cats

Taylor helps the dGTEx machine run, coordinating researchers across multiple organizations that each contribute different pieces to the puzzle. These include a nonprofit group that secures tissue samples from deceased children soon after death and CHOP pathologists who assess each sample’s quality and type. Tissues are frozen and stored for future researchers to use with the group’s permission, while samples are sent to organizations including the nonprofit Broad Institute, which analyze gene expression. Data streams in at all these steps—information that the Human Cell Atlas effort can eventually draw on.

This coordination is “like herding cats,” says Rebecca Linn, a pediatric pathologist at CHOP. “So many individuals with different goals.” Taylor says an important part of her role is mediating among participants. That means, for example, explaining to researchers who want to use dGTEx’s tissues that it’s impossible to divide a one-month-old’s tiny testes 20 ways. 

Colleagues describe Taylor as a well-connected collaborator who unites people across diverse specialties—essential qualities for a multidisciplinary, international effort like the Human Cell Atlas. It also helps that Taylor is full of surprises. She has tattoos of Schrödinger’s and Boltzmann’s equations and dabbles in painting and photography; a non­descript rock from Burning Man, where she volunteered in the kitchen, sits on her desk. “She can make friends and be memorable through her interests and knowledge and questions about all these different subjects. It really draws you in,” says Linn. 

Taylor, however, believes the life-changing potential of the work itself is enough to motivate colleagues. Comparing a sick person’s cells with the healthy, age-matched baseline the Human Cell Atlas provides could yield biomarkers of health and disease that could serve as drug targets or diagnostic markers. A pediatric chapter in that atlas could produce similar insights for children—and strengthen our understanding of how our genetics and environments affect health and disease at various stages of development. 

Extending the atlas to children may even help reveal how adult diseases trace back to distinct signals in childhood, raising the possibility that we could screen for and treat chronic conditions years or even decades before they surface. That could not only improve outcomes but help people prevent debilitating symptoms before they ever develop. After all, “we’re just older kids,” Taylor says. “By ignoring the pediatric side of things, I think people are missing a window of intervention in human disease.” 

Taylor hopes the project will shift how research views pediatrics. It’s a big goal, one that will require big data—and forces like her to help pull everything together. 

Colleen de Bellefonds is a science journalist based in Paris.

This week I spoke to scientists who have found a way to turn male mouse embryos female. They’ve developed a CRISPR-based approach to essentially cut out the Y chromosome. It allowed them to create female clones of male mice.

That’s right: female animals that are genetically identical to males, except for the missing Y chromosome. Takashi Ishiuchi, a reproductive biologist at the University of Yamanashi who co-led the work, told me it felt a bit like sci-fi.

Ishiuchi and his colleague Shogo Matoba of the Riken BioResource Research Center hope their approach could be helpful in conservation efforts, especially in cases where we might have only a few individuals of a species left. But cloning has multiple uses, ranging from the cool to the outright creepy.

We can’t talk about cloning without mentioning Dolly, the celebrity sheep born in 1996 and the first mammal successfully cloned from an adult cell. In that case, scientists took the DNA-containing nucleus of an adult mammary cell from one sheep and transferred it into an egg cell that had had its own nucleus removed. The resulting embryo was transferred to a surrogate sheep, which gave birth to Dolly—an animal genetically identical to the DNA donor.

The scientists behind that work were interested in genetically modifying livestock. Farmers have essentially been doing this for thousands of years through selective breeding, but cloning allows scientists to create genetic replicas of animals with desirable traits.

Cloning is also being used to replicate deceased pets, including, famously, those of Barbra Streisand and Tom Brady, among others. For a price somewhere in the tens of thousands of dollars, a company can take cells from your pet and turn them into a living, breathing clone.

Considering that cloning also requires egg cells from another animal, and a surrogate animal to carry the pregnancy, not everyone is on board with this, especially since there is no medical or environmental need for the procedures. One bioethicist, Jessica Pierce, has described this aspect of dog cloning as “the exploitation of the canine underclass.”

The case for cloning is stronger when it comes to conservation—where some argue there is environmental value.

Scientists have been preserving animal tissues for years. Some of these tissues are cryopreserved at low temperatures in “frozen zoos.” The facility at the San Diego Zoo, for example, currently has cells from over 1,300 species. Some of these samples were taken decades ago.

Preserved tissues like these have enabled scientists to create clones of animals considered close to extinction, including black-footed ferrets and Przewalski’s horse. But they might also help us bring back extinct animals.

In 2009, researchers in Spain described how they’d cloned an extinct wild goat, the Pyrenean ibex, using skin cells that had been cryopreserved a decade earlier. In that research, the team used egg cells from domestic goats to create a total of 439 embryos. Ultimately, only one goat—a female—was born. She died minutes later because of a defect in her lungs.

Poor Pyrenean ibex. It’s the only animal we know of that has gone extinct twice.

The biotech company Colossal Biosciences is hoping to use old—and potentially ancient—genetic material to bring back long-extinct species like the thylacine and woolly mammoth. So far, the company’s efforts have largely involved modifying the genomes of modern-day animals.

Technically, it’s also possible to clone humans. As far as we know, no one has done it. But some have played with the idea. One biotech startup founder has pitched an idea for “brainless clones”—human clones that lack a brain but contain all the organs people might need to replace their own in future. My colleague Antonio Regalado described that pitch in March. (I had to pause eating my lunch while rereading it.)

Scientists have done a hell of a lot with cloning over the last few decades. I’m excited—but also slightly nervous—about what the coming decades will bring.

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.

Dr Kalim Sadiq explores how the VAT ruling on clear aligners could affect orthodontic practices, treatment costs and patient preferences – plus, why affordability should never outweigh clinical suitability.

I have been practising orthodontics for over 20 years and have seen many changes during that time, including the increasing use of clear aligners in preference to fixed appliances, advances in digital orthodontics and the introduction of AI with remote monitoring. Over the past decade, clear aligners have become an increasingly popular treatment option in the UK (BOS, 2023).

In a recent tribunal, it was ruled that Invisalign clear aligners do not qualify as exempt from VAT as dental prostheses and are subject to the standard rate.

Alongside rising laboratory costs, increasing dental material costs and higher staffing costs following increases in the national living wage, the VAT ruling is bound to create additional financial pressures for dental practices.

It is unlikely that every practice will be able to absorb these additional costs indefinitely. Some practices may absorb part of the increase, while others may need to reflect some of those costs in their treatment fees. Ultimately, this will depend on each practice’s business model and financial position. 

The financial impact of VAT on clear aligners

Recent British Orthodontic Society data shows that 77.3% of responding orthodontists now provide clear aligner therapy, while more than 70% have reported an increase in adults seeking orthodontic treatment in recent years.

While patients clearly continue to value aesthetic dental treatment, affordability is becoming an increasingly important consideration when choosing treatment options.

With direct to consumer aligners now widely available and fixed appliances generally carrying lower laboratory costs, patients may become increasingly willing to consider fixed braces where they are clinically appropriate. We believe the VAT ruling may accelerate a trend that we had already begun to observe in practice. 

Since the ruling, we have had patients asking whether it will affect the cost of treatment and whether fixed braces now represent better value. One patient asked during a consultation whether the increase would affect their overall treatment costs. Another patient undergoing aligner treatment asked whether their agreed treatment costs would change following the ruling. 

We also spoke to the mother of a patient who did not qualify for NHS orthodontic treatment. She expressed concern that Invisalign may no longer be financially achievable for her son and that fixed braces may now represent the more affordable option. 

How are patient attitudes changing?

Orchard Orthodontics conducted a survey of more than 100 current patients to better understand their perceptions of orthodontic appliances and the factors influencing their treatment choices. 

Our findings demonstrate that attitudes are changing. Around 91% of respondents believed adult braces are more socially acceptable today than they were five years ago. For appliance preference, 61% selected fixed braces compared with 39% selecting clear aligners. Convenience was the most commonly cited reason for appliance choice, followed by treatment time, cost, aesthetics and discreet appearance. 

These results suggest that appearance is no longer the only factor influencing adult orthodontic treatment decisions. Affordability, convenience, clinical suitability and expected treatment outcomes are all becoming increasingly important considerations. 

Ethics before cost

However, cost should never become the determining factor when choosing orthodontic treatment. The General Dental Council requires dental professionals to put patients’ interests first and ensure that treatment decisions are based on the patient’s individual needs, taking into account their circumstances, preferences and the most appropriate clinical outcome.

Patients should be informed of all clinically appropriate treatment options available to them. A clinician’s inability to provide a particular appliance should never limit what is presented to the patient. In accordance with GDC guidance: ‘If a task, type of treatment or decision is outside your scope of practice or you do not feel that you are trained and competent to do it, you must refer the patient to an appropriately trained colleague.’ (GDC, 2013)

Fixed braces and clear aligners each have advantages depending on the clinical objectives. Fixed appliances often provide superior control for significant tooth rotations, extrusive movements, impacted teeth and complex bite correction. Clear aligners may be more appropriate where maintaining camouflage, aesthetics or patient lifestyle are priorities. We must also consider the behavioural aspect of treatment, as some patients struggle to wear removable appliances consistently, making fixed appliances a more predictable option in those cases. 

Patients should therefore receive clear information about how the VAT ruling may affect treatment costs, together with an explanation of all clinically appropriate appliance options, including fixed appliances where suitable, which tend to have lower laboratory costs and may offer a more affordable alternative for some patients. 

My advice is that patients should always speak to their orthodontist and choose the treatment that is clinically right for them, rather than simply going for the cheapest option. 

References

1. BOS Survey, available at: https://journals.sagepub.com/doi/10.1177/14653125231204889 
2. BOS Survey, available at: https://www.nature.com/articles/s41415-025-8300-8? 
3. Orchard Orthodontics, 2026
4. HM Revenue & Customs v Align Technology Switzerland GmbH [2026] UKUT 00256 (TCC), Upper Tribunal Tax and Chancery Chamber, available at: https://www.gov.uk/tax-and-chancery-tribunal-decisions/2026-ukut-00256-tcc-hm-revenue-and-customs-v-align-technology-switzerland-gmbh? 
5. Office for National Statistics (ONS), released 2 May 2025, available at: https://www.ons.gov.uk/peoplepopulationandcommunity/personalandhouseholdfinances/incomeandwealth/bulletins/householddisposableincomeandinequality/financialyearending2024? 
6. British Dental Association (2025), page 3. Available at: https://www.bda.org/media/vexpfw1b/ddrb-25-26-round-bda-submission.pdf? 
7. https://www.gov.uk/government/news/national-living-wage-increases-to-1271-per-hour? 
8. General Dental Council, Standards for the Dental Team, Principle 1. Available at: https://standards.gdc-uk.org/? 
9. General Dental Council, Standards for the Dental Team, Principle 6 and General Dental Council, Scope of Practice guidance. Available at: https://www.gdc-uk.org/standards-guidance/standards-and-guidance/scope-of-practice? 

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Industries based on intellectual property, including biotech, are responsible for $11.4 trillion in U.S. gross domestic product, or 44% of total private sector GDP, according to a report released by the U.S. Patent and Trademark Office (USPTO) on Aug. 3. Out of this total, pharmaceuticals contributed $247 billion to the U.S. GDP in 2024, the report says.

When looking at the broader societal value of biotech, the impact is much greater, according to a recent analysis produced by a University of Chicago economist for the U.S. Chamber of Commerce.

“Medical innovations in four disease areas: HIV, heart disease, breast cancer, and obesity generated $167.5 trillion in societal value over a 30-year horizon across all four disease areas,” the U.S. Chamber report finds.

The importance of patents to biotech

The USPTO report highlights the importance of patents to the overall U.S. economy, with patent-reliant industries providing 65.8 million jobs, or 44% of total private sector jobs. These are also better-paying jobs, “with average weekly earnings 53% higher than those received by workers in other industries,” USPTO says.

Pharmaceuticals rely on several types of IP, according to the report, including utility patents, design patents, and trademarks.

The biopharma sector is one of the most research-intensive industries, which means IP provides its value. When a biotech firm sells investors on the promise of an innovative new drug, what they are really selling is IP developed through research. That’s why biotech firms need a strong patent system to safeguard their IP. Research has shown that venture capital funding for life sciences startups plummeted after legal changes weakened the patent system.

Given the importance of IP to biotech, the Biotechnology Innovation Organization (BIO) advocates policy to strengthen patent protections. BIO continues to expand its efforts in this area, working on Capitol Hill, through courts, and in international fora, with initiatives like BIO’s IP Task Force.

The importance of biotech to society

Beyond providing jobs, biotech provides treatments that patients need. The U.S. Chamber of Commerce report looks at the social benefits of medical innovation and assesses the monetary value of “saving lives, extending lifespans, and driving economic growth through increased productivity and tax revenue.”

The study analyzes the period 30 years after the introduction of breakthrough therapies for HIV (1995–2024), heart disease (1986–2024), and breast cancer (1991–2020), and projects the benefits of obesity drugs (2021–2050).

“HIV patients who would have died within two years in 1995 now live full lifespans—an average of 40 additional years,” says a summary of the report. It notes that heart disease and breast cancer patients are living years longer. It projects that “new obesity treatments are poised to add nearly a year of life while dramatically reducing the chronic disease burden that has plagued millions of Americans.”

Based on these findings, “every dollar invested in medical R&D has returned 27 dollars in societal value—demonstrating that innovation is an investment, not a cost,” according to the U.S. Chamber.

As these studies underline, biotech’s productive output, job creation, and additional years of healthy living provide huge benefits for America’s economy and society.

The post Studies show value of biotech IP for the economy and society appeared first on Bio.News.

The project combines Xanadu’s algorithms team and the University of Alberta chemistry professor Alex Brown.

They will work jointly to create a quantum computing framework that addresses the challenges involved in the discovery of novel photosensitisers.

Existing approaches to identifying effective photosensitisers rely on experimental methods or classical simulations, which the partners say are either slow, costly, or limited in their capacity to account for critical molecular interactions.

Recent results released by Xanadu have used quantum computers to simulate light-matter interactions in photosensitiser compounds, focusing on characteristics such as sensitivity to specific wavelengths and the efficiency of triggering cancer cell death.

Xanadu founder and CEO Dr Christian Weedbrook said: “Current methodologies for developing effective photosensitisers are hampered by a variety of hurdles.

“By leveraging early fault-tolerant quantum computers to model critical light-matter interactions within photosensitisers, we are positioning quantum computing as a highly competitive method for accelerating photodynamic drug discovery.”

Brown said: “Photosensitisers are challenging systems because their performance depends on excited-state processes that are difficult to capture accurately with standard computational methods.

“By combining Xanadu’s quantum algorithm expertise with our experience in modelling photodynamic therapy systems, we’re excited to explore how fault-tolerant quantum computing could provide new tools for understanding and designing more effective light-activated cancer treatments.”

The collaboration is intended to strengthen Xanadu’s quantum-based drug design workflow, with the goal of expanding its use to more complex problems in photosensitiser development.

Brown’s role will include identifying mechanisms that influence therapeutic effectiveness in photodynamic therapy.

The post Xanadu and University of Alberta to develop quantum algorithms for cancer appeared first on Pharmaceutical Business review.

Zenbexus is said to be the first cereblon E3 ligase modulator (CELMoD) therapy approved by the FDA for MM treatment. Continued approval for this indication may depend on confirmation of clinical benefit in ongoing trials.

In combination with ZDd, Zenbexus received the agency’s decision following results from the Phase III EXCALIBER-RRMM trial.

The study compared Zenbexus, ZDd (n=207) with daratumumab, bortezomib and dexamethasone (n=213) in patients with relapsed or refractory MM.

After a median follow-up of 16 months, 41% of patients treated with ZDd achieved minimal residual disease (MRD)-negative complete response compared to 21% receiving the comparator regimen.

Safety data indicated that 7.8% of patients discontinued ZDd because of adverse reactions.

Serious infections and severe neutropenia were observed, with neutropenia and infections occurring in 90.2% and 78.9% of patients, respectively.

Fatal adverse reactions occurred in 4.9% of patients treated with Zenbexus, with sepsis as the only event affecting more than one individual. Other observed reactions included upper respiratory tract infection, pneumonia, diarrhoea and fatigue.

Bristol Myers Squibb chief medical officer and development head Cristian Massacesi said: “Today’s approval of Zenbexus represents meaningful progress for patients living with multiple myeloma and underscores the power of our targeted protein degradation platform, particularly our CELMoD programmes.

“As the first approved CELMoD, Zenbexus marks the arrival of a new treatment class and is an important milestone in our efforts to expand what is possible for patients with multiple myeloma. And we believe this is only the beginning.

“This approval validates years of scientific research and strengthens our confidence in the potential of this approach as we continue to advance our innovative pipeline on behalf of patients with significant unmet needs.”

This review was conducted under the FDA’s Project Orbis, enabling concurrent regulatory assessment in several other countries.

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Gulfstream Intelligence has announced the launch of a regulatory intelligence and execution platform for pharmaceutical, biotechnology and life science organisations.

Developed by Gulfstream Life Science, the platform was created by regulatory professionals with more than 25 years of experience in the pharmaceutical and biotechnology industry. Gulfstream Intelligence was developed from experience managing global development programmes, health authority interactions, submissions, labelling, regulatory strategy and regulatory team activities.

Gulfstream Intelligence said regulatory teams have access to information and technology, but their work can remain disconnected across systems, documents, spreadsheets, email and presentations. Regulatory intelligence may be maintained in one system, submission plans in another and labelling in separate documents and spreadsheets, while health authority preparation, gap assessments and programme decisions may be managed through email, presentations and individual files.

Gulfstream Intelligence was built to bring these activities together and help regulatory professionals move from finding information to understanding its implications for a programme and determining the actions required.

The platform brings together global regulatory intelligence and policy, global labelling, global regulatory gap assessments, health authority preparation and simulation, submission planning and critical path management, regulatory document intelligence and decision-ready deliverables.

The global regulatory intelligence and policy function enables teams to monitor guidance, legislation, policy changes and health authority developments across global markets and assess how these changes may affect development programmes.

The global labelling function supports the development and lifecycle management of product labelling, including Core Data Sheets and regional labels such as US Prescribing Information, EU Summary of Product Characteristics and Canadian Product Monograph. Teams can compare regional labelling, identify differences, evaluate new safety and efficacy information and maintain consistency between global and local labelling positions.

The global regulatory gap assessment function enables teams to evaluate programmes and regulatory documentation against regional health authority expectations to identify gaps, risks and actions that may be required before an interaction or submission.

The health authority preparation and simulation function supports preparation for meetings and interactions with the FDA, EMA, MHRA, PMDA, Health Canada and other global authorities by identifying likely questions, areas of concern and issues that may require additional justification.

The submission planning and critical path management function enables teams to develop submission plans, timelines, dependencies and deliverables for INDs, BLAs, NDAs, MAAs and other regulatory milestones, while maintaining visibility into activities that may affect submission timelines.

The regulatory document intelligence function reviews regulatory documents to identify inconsistencies, missing information, potential risks and areas requiring attention. The platform also converts regulatory analysis into structured reports, summaries and editable presentations that can be shared with regulatory teams, development teams and leadership.

“The problem is not simply finding regulatory information. It is what happens after the information is found,” said Scott Morvay, Founder of Gulfstream Intelligence. “After more than 25 years working in regulatory affairs, we have seen how quickly important context can become disconnected as information moves between systems, documents and teams. We built Gulfstream around the way regulatory professionals actually work, from understanding an issue to deciding what it means for the program and ultimately doing something about it.”

Gulfstream Intelligence aims to maintain the connection between the regulatory source, professional interpretation of that information, its impact on the development programme, the resulting actions and the final regulatory deliverable.

For larger pharmaceutical organisations, Gulfstream Intelligence provides a way to maintain continuity across programmes, functions, regions and health authorities. Regulatory intelligence, labelling, health authority preparation, submission planning and document review can remain connected rather than being managed as separate workstreams across multiple systems.

For emerging and mid-sized biotechnology companies, Gulfstream provides the same capabilities in one environment. The company said this can support regulatory teams managing broad responsibilities with limited internal resources.

Gulfstream Intelligence was built from the experience of regulatory professionals rather than by adapting a general technology platform to regulatory affairs. The company said this experience informed the platform and how its capabilities work together.

Gulfstream uses artificial intelligence to assist with research, comparison, analysis, planning and drafting, while qualified regulatory professionals remain responsible for reviewing information, interpreting regulatory requirements and making regulatory decisions.

“AI can help us work faster, but regulatory affairs is not simply an information problem,” Morvay said. “Experience matters. Judgment matters. Understanding the development program matters. Gulfstream was built to give regulatory professionals better tools to apply that experience.”

The platform does not replace professional judgment, provide legal advice or independently submit materials to health authorities.

Gulfstream Intelligence is designed to support regulatory teams throughout development, from monitoring changes in the global regulatory environment and assessing programme readiness to preparing for health authority interactions, developing global labelling and planning submissions.

As programmes progress, information generated through these activities can remain connected rather than becoming isolated across separate systems and documents. The platform is designed to provide teams with visibility into what has changed, what it means for their programme, what requires attention and what needs to happen next.

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What is the extent of counterfeiting in India’s pharma supply chain? 

Counterfeit medicines continue to pose a significant risk to patient safety and the integrity of India’s pharmaceutical supply chain. According to the CRISILASPA State of Counterfeiting in India 2025 Report, 28 per cent of consumers reported encountering a counterfeit healthcare product at least once during the last 12 months. The report uses the broader category “healthcare products,” which includes pharmaceuticals, OTC medicines, nutraceuticals, and medical devices following a nomenclature update. 

ASPA believes the threat extends beyond economic losses. Counterfeit medicines directly endanger patient safety, undermine treatment outcomes, erode consumer confidence, and damage the reputation of legitimate pharmaceutical manufacturers.

What are the common modus operandi of such counterfeit operations? 

ASPA observes that counterfeiters have become increasingly sophisticated. Rather than producing obvious imitations, they now: 

• Closely replicate genuine packaging and labels. 
• Attempt to imitate certain security features. 
• Exploit fragmented distribution networks. 
• Use online marketplaces and e-pharmacies to reach consumers. 
• Introduce products containing incorrect ingredients, substandard formulations, harmful substances, or sometimes no active pharmaceutical ingredient at all. 

These evolving tactics make visual inspection alone insufficient and reinforce the need for authentication combined with end-to-end traceability.

What has been the reaction of pharma companies to such incidents? Has it been adequately addressed to prevent future incidents? 

Pharma companies are increasingly strengthening their anti-counterfeiting efforts. ASPA cites examples such as Mankind Pharma, which has adopted authentication and traceability solutions to enhance product security and consumer trust. 

Manufacturers are increasingly viewing authentication not merely as a compliance requirement but as a strategic investment in patient safety and brand protection. 

That said, ASPA’s position is that more needs to be done. Counterfeiters continue to evolve, making isolated security measures insufficient. The association advocates integrated authentication ecosystems combining serialisation, traceability, physical security features, digital verification, and stakeholder collaboration. 

What has been the reaction from policymakers like the CDSCO? 

ASPA welcomes the Government of India’s efforts to strengthen oversight within the pharma packaging ecosystem, including initiatives aimed at improving accountability and traceability. This is a step in the right direction and reflects growing regulatory recognition of the problem. 

At the same time, ASPA believes oversight measures need to evolve into enforceable standards. The association is advocating for the next phase of policy to include mandatory adoption of multi-layered Authentication and Traceability Solutions (ATS) for high-risk drug categories, stricter penal action against counterfeiters and those enabling them, and a national track-and-trace mandate that gives visibility across the entire supply chain, not just at the point of packaging.

The CDSCO has mandated expansion of QR codes to vaccines. What are ASPA’s views, given that QR codes have proven unsuccessful in preventing counterfeiting? 

ASPA welcomes this as a step in the right direction. Extending QR code requirements to vaccines shows the regulator’s intent to improve traceability in a high stakes category. 

However, the solution is complete only when QR codes are combined with other visible and invisible security features. A standard QR code, on its own, carries the risk of being copied or reprinted by counterfeiters just as easily as the genuine one, since it does not by itself authenticate the product. Layering it with tamper-evident features, holograms, and covert or nonclonable markers is what actually closes that gap and gives both regulators and consumers a way to verify authenticity with confidence.

At the 69th Drugs Consultative Committee (DCC) meeting, held virtually on last month on June 24, it was recommended to constitute a subcommittee to evaluate the feasibility of the proposal to introduce an online registration framework for manufacturers/suppliers of printed pharma packaging materials used for drugs. Why does ASPA feel that the printer registration initiative is a meaningful first step, but insufficient on its own? 

ASPA sees printer registration as a welcome and meaningful first step. It strengthens oversight, accountability, and transparency at the packaging stage of the supply chain, an area that has traditionally seen limited scrutiny. However, registration of printers does not, by itself, authenticate a product or track it once it leaves the printing facility. Counterfeiters operating outside registered networks can still replicate packaging design. ASPA’s ask is for this initiative to be paired with clear enforcement mechanisms, such as periodic audits of registered printers and a defined compliance timeline, alongside a broader push for product-level authentication so that oversight extends beyond who printed the packaging to whether the product itself can be verified as genuine. 

Where are the gaps even after printer registration is in place? 

The real gap lies beyond the printing stage. Once a product moves through manufacturing, warehousing, distribution, and retail, visibility drops sharply. There is currently no reliable way to confirm that the medicine reaching a patient at the last mile is the same one that left the manufacturing facility. 

This is a supply chain visibility problem as much as a packaging problem. Diverted stock, parallel distribution channels, and unregulated online sellers can all introduce counterfeit or tampered products at any point after packaging, well outside the reach of printer oversight. Closing this gap requires giving every product a verifiable identity that can be checked at each handoff, not just at the point of origin. 

What kind of authentication technology is essential to close those gaps? 

ASPA’s position is that no single technology can eliminate pharma counterfeiting on its own. 

What is needed is a multilayered Authentication and Traceability Solution (ATS): serialisation for unique product identity, secure or non-clonable QR codes, tamper-evident packaging, holograms and covert security features, RFID/NFC for automated tracking, cloud based verification, and AI-enabled monitoring for anomaly detection. 

This “phygital” approach, combining physical security with digital verification, is what allows a product to be authenticated and tracked through its entire lifecycle, rather than relying on any single checkpoint. 

What do such counterfeiting operations mean for India’s credibility as a global pharma exporter? 

Counterfeiting poses a serious threat to India’s reputation as one of the world’s largest pharmaceutical manufacturers and exporters. Even isolated incidents can undermine confidence among international regulators, healthcare providers, and global buyers, leading to increased scrutiny and affecting trust in the country’s pharmaceutical supply chain. 

As the Pharmacy of the World, India must continue strengthening supply chain integrity through robust product authentication, end -to-end traceability, and advanced anti-counterfeiting technologies. These measures will not only safeguard patient safety but also reinforce India’s credibility as a trusted global supplier of high-quality medicines and support seamless international trade. 

viveka.r@expressindia.com 

viveka.roy3@gmail.com 

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Treeline Dental Group has once again demonstrated its commitment to community spirit, teamwork and social responsibility through its BIG Community Challenge in support of Dentaid, held on 27 June 2026.

The initiative brought together colleagues from across the organisation for a demanding 12‑mile coastal walk, a challenge that perfectly reflects Treeline’s ethos of stepping up, showing up and making a meaningful difference beyond the dental clinic.

A coastal challenge with purpose

The team set off from Mablethorpe Queen’s Park, heading south along the coastline towards Anderby Creek. The route offered sweeping views, bright sunshine and, on this day, exceptionally warm weather. Despite the heat, spirits stayed high. The group paused at Anderby Creek for refreshments and food before making the return journey back to Mablethorpe, completing the full 12 miles with determination and camaraderie.

Around 20 people took part, representing every corner of Treeline Dental Group: practice managers, team leads, dental nurses, receptionists, administrators, head office colleagues and both directors, Jimmey and Nav Palahey. The turnout reflects Treeline’s culture, one where every individual, regardless of role, is encouraged to contribute to the wider community and celebrate shared achievements.

Supporting Dentaid’s mission

The challenge raised £1,000 for Dentaid, a charity Treeline has proudly supported through multiple initiatives. Dentaid’s work, delivering oral healthcare to vulnerable communities in the UK and internationally, aligns closely with Treeline’s belief that dentistry should be accessible, preventive and rooted in compassion.

Treeline’s ongoing support for charitable organisations, community events and local partnerships has become a defining feature of the group’s identity. From sponsorship activities to volunteering days and large-scale staff events, Treeline consistently demonstrates that dentistry can be a force for good far beyond the clinic doors.

A culture built on people, purpose and pride

The BIG Community Challenge is the latest example of Treeline’s growing portfolio of community-focused initiatives. With practices across the East Midlands and South Yorkshire, the group has built a reputation for investing in its people, celebrating teamwork and championing local engagement. Whether through charity walks, company away days, sponsorships or collaborative events, Treeline’s teams show up with energy, enthusiasm and a shared sense of mission.

Dr Jimmey Palahey, founder and CEO, said: ‘When our teams come together for something bigger than ourselves, it reminds us of what Treeline is about – people, purpose and making a positive impact. I’m incredibly proud of everyone who took part. Their commitment, even in the heat, shows the strength of our culture and the heart of our organisation.’

A day that captured Treeline at its best

The walk wasn’t just a fundraiser; it was a celebration of Treeline’s values in action. Colleagues encouraged one another, shared stories along the route, and enjoyed the rare chance to connect outside their usual practice environments. The challenge strengthened relationships, boosted morale and reinforced the Group’s belief that meaningful experiences build stronger teams.

Raising £1,000 for Dentaid is a fantastic achievement, but the day’s impact goes far beyond the final total. It showcased Treeline’s commitment to community wellbeing, its passion for supporting national dental charities, and its dedication to creating opportunities for staff to grow, bond and give back.

Treeline Dental Group’s BIG Community Challenge stands as another proud milestone in the organisation’s ongoing journey – one defined by teamwork, generosity and a deep-rooted belief that dentistry can change lives both inside and outside the clinic.

Discover more about Treeline Dental Care here.

This article is sponsored by Treeline Dental Care.

The study, “Pangenome-guided breeding restores high-altitude adaptation and improves yield in Tartary buckwheat,” was published in Cell. The international team was led by the Chinese Academy of Agricultural Sciences and included researchers from 22 institutions across 10 countries, including scientists at Murdoch University’s Centre for Crop and Food Innovation (CCFI). Tartary buckwheat (Fagopyrum tataricum), a nutrient-dense grain grown in the Himalayan highlands, was selected as a model because its wild relatives tolerate harsh conditions such as cold and intense UV-B radiation.

Most genomics-assisted breeding compares crop lines with a single reference genome and focuses heavily on single-nucleotide polymorphisms. But that approach can miss larger structural variants, including gene copy-number changes, that influence agriculturally important traits. To capture that hidden variation, the team generated a telomere-to-telomere reference genome and assembled a graph-based pangenome from 16 accessions spanning Himalayan wild populations and globally distributed landraces. They also integrated genomic data from 994 accessions across 15 countries and cataloged 123,131 nonredundant structural variants.

“Most modern breeding compares a crop’s genome against a single reference, which is like judging a language by a single dictionary,” said Rajeev Varshney, FRS, FAA, CCFI director, and co-corresponding author of the study. “A pangenome captures the whole vocabulary, including the words a crop lost along the way. And that’s where a lot of the useful genetics for resilience is hiding.”

Using marker-assisted selection, the team crossed these superior FtRNH and FtPLATZ alleles into candidate breeding lines, effectively stacking high-altitude adaptation with larger seed size. In high-altitude field trials, the resulting lines showed improved growth, larger seeds, and significantly higher yields compared with the standard variety.

“Resilience and yield are usually a trade-off, meaning that when you increase one, you lose the other,” Varshney said. “What the pangenome lets us do is identify the specific DNA segments underlying each trait and deliberately stack them. That’s a template other breeding programs can follow.”

Whether the approach will translate broadly remains to be tested, but the study provides a framework for looking beyond elite crop genomes. By capturing variation in wild relatives and landraces, pangenomes may give breeders a clearer view of alleles that could be combined to improve adaptation without sacrificing yield.

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The project creates a large-scale proteomics resource designed to help researchers study Parkinson’s disease at the protein level and investigate biological signals associated with disease progression, patient heterogeneity, and potential biomarker development. By applying Olink technology to deeply characterized PPMI samples, Thermo Fisher officials said the company is expanding access to MJFF’s dataset that may help advance precision medicine approaches to Parkinson’s research.

Deep proteomic insights

An estimated 10 million people worldwide are living with Parkinson’s disease, and that number is expected to rise as populations age. Although the disease is still diagnosed and monitored largely through clinical symptoms, research increasingly shows Parkinson’s disease involves multiple biological pathways and distinct patient subtypes. That complexity has made it difficult to develop biomarkers that reliably identify patient groups, track disease progression, and support more targeted therapeutic development.

As the field shifts toward biology-driven precision medicine, large-scale proteomic datasets are helping researchers better understand disease biology and generate hypotheses that can be tested across cohorts and methods.

Olink, part of Thermo Fisher, was designed to enable high-throughput, affinity-based proteomic analysis using Proximity Extension Assay (PEA) technology. Olink’s PEA-based platform is a scalable solution for protein biomarker analysis, supporting applications from discovery through translation and population-scale proteogenomics, according to Thermo.

Proteomics can help researchers identify patient subtypes, characterize disease progression, uncover biological pathways linked to inflammation, lysosomal function, and neuronal stress, and discover candidate biomarkers for future validation. Combining proteomic insights with longitudinal clinical, genetic, imaging, and other molecular data can further enrich understanding of health and disease.

Defining Parkinson’s by its underlying biology

PPMI, sponsored by the Michael J. Fox Foundation, launched in 2010 and was recently renamed the Parkinson’s Precision Medicine Initiative to reflect the field’s shift toward defining Parkinson’s by its underlying biology rather than clinical symptoms alone. PPMI’s open-access data are available to researchers worldwide and have been downloaded more than 50 million times.

The analysis was completed as proteomics and multi-omics approaches gain broader use in neurodegenerative disease research. These methods can reveal dynamic biological changes that may not be captured through genomics or clinical assessment alone. Biobanks and large population studies are also adopting proteomic analysis to build richer molecular datasets that support biomarker discovery and precision medicine.

“Discovery is only the beginning in Parkinson’s research,” said Yan Zhang, PhD, president of proteomic sciences at Thermo Fisher. “The next challenge is determining which molecular signals are reproducible, clinically meaningful, and useful for advancing Parkinson’s precision medicine. Making these data available to the research community helps put that validation work into motion.”

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By Lindsey Coulter

• $252 million investment: The new St. Luke’s Heart Hospital represents the largest construction project in St. Luke’s University Health Network’s history.
• 355,000 square feet of space: The five-story facility will significantly expand the St. Luke’s Anderson Campus in Bethlehem, Pennsylvania, adding 140 beds.
• Purpose-built for cardiovascular care: The hospital will include four heart operating rooms, a hybrid operating room, 10 interventional suites, a dedicated cardiac intensive care unit and advanced imaging and life-support capabilities.
• Designed around clinical operations: The facility incorporates dedicated staff circulation routes, expanded support spaces and a rooftop helipad to facilitate efficient patient care and emergency access.
• Opening in October 2026: The Heart Hospital is scheduled to open this fall, expanding St. Luke’s cardiovascular services while adding educational and research opportunities, including a cardiac fellowship program.

BETHLEHEM, Pa. — St. Luke’s University Health Network is preparing to open a new heart hospital at its Anderson Campus in October, adding 140 beds and nearly doubling the size of the campus.

The $252 million St. Luke’s Heart Hospital represents the largest construction project in the health system’s more than 150-year history, both by investment and square footage. The five-story facility encompasses approximately 355,000 square feet and was constructed entirely with American steel. Construction began in 2024 and employed hundreds of skilled workers.

The project expands the Anderson Campus’ capacity for cardiovascular care while consolidating a broad range of specialized services within a purpose-built facility. The hospital will include four dedicated heart operating rooms, one hybrid operating room and 10 advanced interventional suites supporting cardiac catheterization, electrophysiology and interventional radiology.

A dedicated cardiac intensive care unit will provide specialized care for high-acuity cardiac patients. The facility also will feature advanced imaging equipment, heart-lung machines used during open-heart surgery and extracorporeal membrane oxygenation, or ECMO, equipment for patients requiring extended cardiopulmonary support.

Designed Around Clinical Workflow

The Heart Hospital was designed with operational efficiency and patient care in mind. A central corridor on each of the upper floors extends approximately 330 feet, while internal service corridors give staff access to supplies and support areas without relying on primary patient circulation routes.

The facility also includes a rooftop helipad and a larger cafeteria, improvements intended to support both the new hospital and the broader Anderson Campus.

The hospital’s design also supports St. Luke’s educational and research mission. Expanded teaching space and a new cardiac fellowship program are intended to strengthen clinical education while providing additional opportunities for learning and innovation.

The project is part of St. Luke’s broader expansion of cardiovascular services. The health system has built five full-service acute care hospitals in recent years, which it says is more than any other health system in Pennsylvania.

Expanding the Anderson Campus

Located on a 500-acre site overlooking the Lehigh River, St. Luke’s Anderson Campus opened 15 years ago as Pennsylvania’s first new full-service acute care hospital in four decades. The campus has subsequently expanded through several major projects.

A $26 million Specialty Pavilion opened in 2017, adding specialty services and an ambulatory surgery center. In 2020, a $90 million Women & Babies Pavilion added labor and delivery services, a neonatal intensive care unit, graduate medical education space and a simulation teaching center.

The new Heart Hospital will again substantially increase the campus footprint and capabilities. Once fully operational, the facility also is expected to support hundreds of permanent health care jobs.

For St. Luke’s, the project represents a significant investment in both cardiovascular care and the physical infrastructure needed to support a growing regional health system. The Heart Hospital is scheduled to open in October 2026.

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Since acquiring Bassetti Architects in 2025, HMC has been building upon the Portland and Seattle studios’ longstanding strengths in education, civic, and community-focused design. The addition of Brooks and Kruse establishes dedicated healthcare leadership in the region, pairing their local relationships and experience with HMC’s decades of expertise in designing hospitals, outpatient facilities, specialty care, and other complex healthcare environments.

Brooks brings more than 20 years of experience designing healthcare, research, workplace, and civic environments. His portfolio includes Legacy Health Randall Children’s Hospital in Portland, Oregon; the UCSF Nancy Friend Pritzker Psychiatry Building; and the Stanford University Biomedical Innovation Building. His work is grounded in a human-centered design approach that supports healing while balancing patient and staff needs, operational performance, environmental responsibility, and a strong response to place. His experience with mass timber and other high-performance design strategies also complements Bassetti’s longstanding commitment to architecture that is both enduring and sustainable.

As principal-in-charge, Brooks will guide the strategic growth of HMC’s Pacific Northwest healthcare practice, cultivate client relationships, and connect regional opportunities with the firm’s healthcare leaders and resources across the organization.

“The Pacific Northwest’s healthcare organizations are navigating tremendous change, from evolving models of care and workforce pressures to aging infrastructure and growing community needs,” Brooks said. “HMC brings the depth and specialized knowledge to help address those challenges, while our Portland-based team brings an understanding of the region and the people who call it home. We are building a practice that combines firmwide healthcare expertise with deep regional knowledge, a focus on long-term relationships, and design that genuinely improves the human experience.”

Kruse brings 28 years of architectural experience, with extensive work in healthcare planning, design, technical documentation, and project delivery. Throughout her career, she has led projects for hospitals, clinics, behavioral health facilities, emergency departments, pharmacies, imaging suites, and other technically demanding care environments across Oregon, Washington, and beyond.

Her recent work includes projects for Legacy Silverton Medical Center, Samaritan Health Services, Mercy Medical Center, and Snoqualmie Valley Hospital. She has also been an active member of regional healthcare organizations, including the Oregon Society for Healthcare Engineering, Washington State Society for Healthcare Engineering, Women in Healthcare, and The Center for Health Design.

“Advancing health and healing through architecture is more than a professional philosophy for me; it is what motivates me every day,” Kruse said. “The work begins with careful listening and grows through close collaboration and trust. I am excited to bring HMC’s healthcare expertise to the Pacific Northwest and help create environments where patients, families, care teams, and communities can flourish.”

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Momentum

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For most of modern medicine, we have treated disease as a static condition. A patient has cancer. A patient has rheumatoid arthritis. A patient has inflammatory bowel disease. Diagnosis has largely meant identifying the condition, assigning a label, and selecting a treatment based on the standard of care.

But disease is not static, it is a dynamic biological process that evolves over time. Biology operates through change, and what we call a disease is often just the name we assign to a single point along a continuous biological journey, shaped by interactions among cells, tissues, and the immune system, by environmental exposures, and by the selective pressures of therapy itself. The lines we draw between health and disease, response and progression, are snapshots of a process that never stops moving.

Seen this way, the most consequential questions in healthcare are not about presence but about direction. Where is the patient today? Where are they heading? Which future states remain possible, and how can we change the path? The next era of medicine will be defined not by earlier detection alone, but by the ability to measure biological trajectories and ultimately intervene to change them.

A state-transition problem

Consider the decisions that actually determine patient outcomes. Diagnosis asks what biological state a patient is in. Therapy selection asks which intervention is most likely to move them toward a better one. Treatment monitoring asks whether they are moving in the expected direction. Drug development asks how an intervention alters biological trajectories across an entire population.

These look like distinct challenges, but at their core they are the same problem: understanding how biological systems move from one state to another. Yet most of our measurement tools were never designed to answer that question. They were built to detect the presence of something—a mutation, a protein, a lesion, a biomarker. Those measurements have transformed medicine, but they are static snapshots. They tell us what is present at a given moment far better than they reveal what is changing, why, or where the biology is headed next.

The challenge facing medicine is no longer detection alone. It is understanding dynamics.

A larger transformation

The evolution of liquid biopsy mirrors this broader shift. In 1997, Dennis Lo, DM, DPhil, and colleagues showed that cell-free fetal DNA circulates in maternal plasma, establishing that biological information could be read non-invasively from blood. The first generation of tests asked a simple question: Can disease-associated DNA be detected non-invasively?

The second generation moved from detection to sequence. Circulating tumor DNA assays identified cancer-associated mutations, monitored molecular residual disease, and flagged emerging resistance. The third generation went further still, using methylation and fragmentomic patterns to infer tissue of origin—which organs or cell types had contributed DNA to circulation.

Each advance extracted more information from a single blood draw. But all three generations remained focused on what was present and where it came from. A more fundamental question is now emerging: What was happening inside the cell before that DNA entered circulation? Not which tissue released it, nor which mutations it carried, but the functional state that generated the signal in the first place. Answering that question moves liquid biopsy beyond measuring static signals and toward measuring the biological processes that produced them.

Tissue of origin to biological state

The field has already begun to move past the question of where DNA comes from. The harder question is what those tissues were doing. Disease is rarely the work of isolated cells acting alone. Cancer emerges through interactions among tumor, stromal, and immune compartments. Autoimmune disease arises from cross-talk between infiltrating immune cells and tissue-resident populations. Fibrosis develops through coordinated remodeling across multiple cell types. These processes are not defined by single genes or mutations, but by regulatory programs, cell-to-cell communication, and transitions between biological states. And traces of that functional information appear to persist in circulation: A growing body of work indicates that cell-free DNA can carry signals of immune activation, fibroblast activity, and tissue remodeling, making aspects of gene regulation and cellular state readable directly from plasma.

This shifts liquid biopsy from identifying tissue of origin toward measuring tissue and disease states. Across a range of immune-mediated diseases, circulating signals increasingly reflect the stromal and immune programs seen in tissue and single-cell studies—not isolated molecular changes, but coordinated states of matrix remodeling, immune activation, and tissue stress. Just as important, repeated measurements turn these signals from snapshots into longitudinal trajectories, letting clinicians watch how biology evolves and responds to treatment over time. The critical question is no longer only what state a patient is in today, but where that state is heading next.

The emergence of trajectory medicine

Once biological states become measurable, a different model of care becomes possible. Many diseases are still managed by observation and iteration. In rheumatoid arthritis, for example, patients often cycle through therapies until one happens to work. The problem is not a shortage of options, but limited visibility into the biology driving disease in a given patient. The same constraint runs through oncology, inflammatory bowel disease, fibrosis, neurodegeneration, and transplantation.

This is no longer purely theoretical. In a peer-reviewed study led by investigators at Princess Margaret Cancer Center,¹ a single blood-based assay simultaneously measured immune, stromal, and tumor-associated biology in leiomyosarcoma—a cancer where low tumor mutation burden limits conventional circulating tumor DNA approaches and repeat biopsies are rarely feasible. Plasma-derived promoter activity showed strong concordance with matched tumor RNA sequencing, and longitudinal sampling captured shifts in immune and stromal biology tied to immunotherapy response and resistance.

Similar observations are beginning to appear beyond oncology. In immune-

mediated diseases such as rheumatoid arthritis² plasma-derived signals have recovered distinct, tissue-anchored stromal and immune programs consistent with the biology of the affected tissue. These findings are still early—generated in relatively small cohorts and in need of validation in larger, independent studies—but together they suggest that functional biological state, across both cancer and chronic inflammatory disease, can be measured from blood and followed over time.

When biological state becomes measurable, treatment shifts from reacting to symptoms toward managing trajectories. The questions change: not where a patient is today, but which path they are on, which intervention is most likely to change course, and how early a divergence from the expected response can be caught. Answering them requires a measurement framework built to capture biological change, not just biological presence.

The next platform layer in medicine

Every major advance in medicine has been unlocked by a new layer of measurement. Clinical chemistry enabled laboratory medicine. Imaging-enabled anatomical medicine. Genomics enabled precision medicine. The next layer will come from the ability to measure functional biological states and how they change over time.

The implications reach well beyond diagnostics. Therapy selection becomes a question of which intervention is most likely to alter a patient’s course. Drug development becomes a question of mapping how interventions reshape biology across populations. Disease interception becomes a question of recognizing an unfavorable path before symptoms appear. Healthcare itself becomes organized around how biological systems evolve, respond, adapt, and recover.

The organizations that define this future will not simply identify biomarkers. They will build the technologies and analytical frameworks that make biological change measurable, predictable, and ultimately actionable. The next era of medicine will be defined not by detecting disease earlier, but by understanding where biology is headed and learning how to change its course.

Problems that will define the field

None of this will come easily, and the challenges are worth stating plainly. Reading regulatory signal from cell-free DNA demands sophisticated computational methods and large, well-annotated datasets that account for variation across individuals, disease states, and platforms. Without rigorous analytical and technical standardization, such measurements will be hard to compare, reproduce, and interpret at scale.

The challenges of clinical translation are greater still. Prospective studies must show that measuring biological state from plasma improves clinical decisions and patient outcomes, especially where treatment selection remains largely empirical. Regulatory and reimbursement frameworks, built for mutation- and burden-based tests, may be a further hurdle. Functional biomarkers will need to prove that they can reliably characterize biological state, predict clinically meaningful change, and shift management in ways that improve outcomes.

These are not reasons for doubt. They are the next set of problems that will define the field and the test any serious platform will have to pass.

Where biology is going next

Twenty-five years of liquid biopsy trace a steady expansion of what blood can tell us: from detecting DNA fragments, to identifying their tissue of origin, to understanding the functional states that produced them. The patients who stand to benefit reach far beyond oncology, into the many chronic diseases whose underlying biology is increasingly understood but still hard to measure in routine care.

The shift from detection to function is already underway. How much it ultimately changes medicine will depend on how well we translate biological insight into clinical decisions. The question is no longer whether disease can be detected from blood, but whether we can see where biology is going next and intervene before the outcome is set.

References

1. Lopes, C.D.H., Wu, HT., Dilger, K. et al. Predicting immunotherapy benefit in leiomyosarcoma through active chromatin cfDNA profiling. npj Precis. Onc. (2026). doi: 10.1038/s41698-026-01451-9.
2. Taylor P., Antonova J., Geis J. et al. Detection of Synovial Signatures in Peripheral Blood of Patients with Rheumatoid Arthritis via a Novel Blood-Based DNA Capture Assay [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9).

Diana Abdueva, PhD, is the founder and CEO of Aqtual.

The post The Coming Shift from Biomarkers to Biological Trajectories appeared first on GEN - Genetic Engineering and Biotechnology News.

Antibody reagent variability is a leading but frequently underappreciated source of irreproducible preclinical data. For in vivo studies, the problem is multidimensional: supply must simultaneously meet specifications for yield, purity, endotoxin control, and lot-to-lot consistency, and standard production approaches commonly treat at least one of these as a flexible trade-off. Higher yield at the expense of purity, or rigorous quality control at volumes too small to support multi-cohort designs, are the familiar compromises. Specifying all four attributes together as non-negotiable engineering targets, rather than aspirational outcomes, changes what study designs can responsibly assume and what data can be trusted.

This article examines what that specification looks like in practice, using recombinant antibody production and analytical data across multiple formats to illustrate how yield, purity, endotoxin performance, and lot-to-lot consistency can each be controlled simultaneously. Bispecific antibodies are the most technically demanding format in this analysis and serve as a useful reference point for understanding the production architecture required across all formats.

Why platform design matters

A standard Immunoglobulin G (IgG) is a symmetric homodimer, and its production, while technically demanding, benefits from that symmetry at every stage from expression through purification. Bispecific formats deliberately break that symmetry by pairing two distinct heavy chains, two distinct light chains, or both simultaneously, and every stage of production is harder as a result.¹

A common challenge in bispecific antibody production is chain mispairing and the correct assembly of complex antibody formats. Compared with conventional IgG molecules, bispecific antibodies require coordinated expression and pairing of multiple antibody components, increasing production complexity and placing greater demands on expression, purification, and analytical workflows.^1–3

As a result, achieving strong yield, high purity, low endotoxin, and lot-to-lot consistency simultaneously is substantially more challenging for bispecific formats than for conventional monoclonal antibodies.

This is why platform design matters. The combination of attributes that preclinical researchers need, sufficient yield to supply multi-cohort studies, purity adequate for in vivo use, endotoxin control across independent lots, and analytical consistency that makes lots interchangeable, is harder to deliver simultaneously for bispecific formats than for any other. A platform that can consistently produce bispecific antibodies at high yield and quality demonstrates the ability to maintain consistent production performance across recombinant antibody formats.

Yield across formats

Transient transfection of mammalian cells, principally HEK293 and CHO systems, is the standard expression approach for research-grade recombinant antibody production. One advantage of transient mammalian expression systems is rapid material generation, enabling recombinant antibody production within weeks rather than the months often required for stable cell line development. These systems are also compatible with the co-transfection strategies used for complex antibody formats such as bispecifics.

When expression workflows are properly optimized across DNA mass ratios, transfection reagent formulations, culture media composition, and harvest timing, yields well above historical benchmarks are achievable across formats. Data from this platform demonstrate conventional murine IgG production averaging 633 mg/L, compared to previously published transient murine expression examples averaging approximately 114 mg/L, a more than five-fold improvement. For murine bispecific formats, the same platform averaged 180.5 mg/L versus previously reported transient murine bispecific examples averaging 35.5 mg/L. The proportional improvement is comparable across both format classes. Gram-scale preclinical production is achievable even for the most structurally demanding formats without requiring stable cell line development.

Purity and endotoxin control

Yield at the expense of purity is not a viable tradeoff for in vivo applications. Recombinant antibodies intended for in vivo use must meet quality standards across multiple dimensions simultaneously: product-related impurities, including aggregates, fragments, and endotoxin, must be controlled within defined specifications at every lot.

Endotoxin is a particular concern for studies measuring immune activation, cytokine biology, or tumor microenvironment dynamics, where uncontrolled endotoxin burden can introduce signals that are indistinguishable from treatment effects. Endotoxin control is therefore not a release formality but a scientific requirement for study interpretability.

Across 300 released custom service lots spanning multiple antibody formats, endotoxin levels were consistently maintained within defined internal release specifications. Ninety-one percent of lots measured ≤0.4 EU/mg, well within the 0.5 EU/mg threshold commonly referenced for in vivo study readiness.⁴ That distribution reflects process consistency rather than occasional good performance: the same controlled purification conditions and quality checkpoints applied across every lot produce a predictable endotoxin outcome, independent of format or production scale.

Lot-to-lot consistency

Purity and endotoxin performance on a single lot are necessary but not sufficient for multi-cohort in vivo research. The question that governs longitudinal and multi-site study design is whether lot three will be analytically interchangeable with lot one. Lot-to-lot antibody variability is among the most common and most underappreciated contributors to irreproducible preclinical data, and it is a confounder that experimental design cannot correct for retrospectively.

Treating lot-to-lot consistency as a built-in specification rather than a hoped-for outcome requires that the same analytical release package be applied to every lot, and that the production process be controlled tightly enough to make the results of that package predictable. High-performance SEC (HP-SEC) provides the most sensitive window into that consistency, resolving monomer from high-molecular-weight aggregate species and capturing subtle process drift through retention time and peak shape metrics.

HP-SEC data from four independently produced lots of two representative antibodies, MAR1-5A3-CP056 and 29F.1A12-CP005 (n=8 total), demonstrate what that consistency looks like in practice. Monomer purity exceeded 98.7% in every lot across both antibodies, with a combined range of 98.57 to 99.35% and within-antibody RSD of ≤0.05%. HMW pre-peak area remained ≤1.43% across all eight lots (range 0.65 to 1.43%), with within-antibody variability of ≤0.78 percentage points. Monomer retention time was stable within each antibody to ≤0.05% RSD, and peak width at half maximum, a sensitive indicator of column performance and process consistency, remained stable within each antibody across all lots. Together, these metrics demonstrate that the production and analytical processes are sufficiently controlled to deliver interchangeable lots across independent production runs.

Translating analytical requirements

Treating antibody reagent quality as a study design variable, rather than a procurement decision, changes how specifications should be set before work begins. For endotoxin, the relevant question is not whether a lot passes a generic release threshold but whether that threshold is appropriate for the biology being measured. Studies interrogating immune activation, cytokine signaling, or tumor microenvironment dynamics require more stringent endotoxin limits than studies where immune readouts are not the primary endpoint; the specification should follow the assay, not the other way around.

For lot-to-lot consistency, the practical requirement is that the same analytical release package, minimally, SEC purity profile, monomer retention time, and HMW aggregate content, be obtained for every lot used in a study, and that acceptable ranges be pre-specified rather than assessed retrospectively. When those ranges are defined in advance, an out-of-specification lot can be identified before animals are dosed rather than after results are in hand.

Yield determines whether these specifications are enforceable at the scale a study actually requires. A consistency specification that cannot be met at the multi-gram scale is not a specification; it is an estimate. The data presented here illustrate that strong yield is achievable for both conventional and bispecific formats, while analytical consistency can be maintained across independent recombinant antibody lots. For researchers designing studies where the antibody must behave the same way every time, that combination is the starting point for a defensible experimental design.

References

1. Chen S, et al. Immunoglobulin gamma-like therapeutic bispecific antibody formats for tumor therapy. J Immunol Res. 2019 Feb 11; 2019:4516041. doi:10.1155/2019/4516041.
2. Wei H, et al. Structural basis of a novel heterodimeric Fc for bispecific antibody production. Oncotarget. 2017 May 2;8(31):51037-51049. doi: 10.18632/oncotarget.17558.
3. Schaefer W, et al. Immunoglobulin domain crossover as a generic approach for the production of bispecific IgG antibodies. Proc Natl Acad Sci USA. 2011;108(27):11187–11192. doi:10.1073/pnas.1019002108.
4. Malyala P, Singh M. Endotoxin limits in formulations for preclinical research. J Pharm Sci. 2008;97(6):2041–2044. doi: 10.1002/jps.21152.

Christina Bouwens is a marketing manager at Bio X Cell.

The post Producing Recombinant Antibodies for In Vivo Research appeared first on GEN - Genetic Engineering and Biotechnology News.

Their findings indicate that memory may be preserved not through individual synapses, but through resilient patterns of neural architecture, including specific clusters of connected synapses that remain protected during widespread hibernation-associated brain remodeling. These preserved structural motifs could act as a “core memory trace,” allowing the brain to rebuild functional networks after major disruptions.

Research lead Kazumasa Tanaka, PhD, head of OIST’s Memory Research Unit, said, “Previously, synaptic strengthening was thought to be key to memory recall, and that stronger synapses with larger dendritic spines were fundamental to long-term memory retention. Here, we show that not every synapse matters, and demonstrate instead the vital importance of engram architecture. The study indicates that small clusters of engram-engram synapses are preserved to enable accurate recall even after hibernation.”

Tanaka is senior and corresponding author of the team’s published paper in Science, titled “Artificial hibernation reveals synaptic engram architecture associated with memory retention.”

Understanding how memories are stored in the brain is one of the central challenges in neuroscience, the authors wrote. For decades, scientists have believed synaptic potentiation—the adaptive strengthening of our brain’s cellular connections—to be the key to memory retention. The newly reported research by Tanaka and colleagues now demonstrates the importance of higher-order synaptic architecture, suggesting that specific clustered patterns of connections between brain cells may be key to retaining long term memory.

“The structural underpinning of memory has been one of the most fundamental topics in neuroscience for decades,” the authors wrote. Much like computer storage, we humans require a physical memory trace to be stored in the brain. This physical trace, known as an engram, is encoded through a dedicated network of brain cells undergoing changes at their synapses, the junctions where they meet. When connecting brain cells repeatedly fire together, their synapses strengthen, increasing neurotransmitter release and triggering structural changes, such as larger dendritic spines, which expand the contact area between the two cells. Conversely, when a particular connection isn’t very active, the synaptic bonds between the cells weaken, and may eventually disappear altogether.

The synapses with larger, more stable dendritic spines have traditionally been seen as key for memory. While we might expect these connections to stay consistent over the course of a memory, recent studies have found that the structures and numbers of cells involved in a particular engram can change over time, without affecting recall. “… recent studies have revealed that synapses can be highly dynamic, with dendritic spines frequently appearing and disappearing, neuronal representations drifting over time, and memories remaining retrievable even after previously strengthened synaptic connections are disrupted,” the team continued. These observations raise a fundamental question, they noted. “How can memories remain stable despite extensive structural remodeling of neuronal networks?”

To investigate, the researchers turned to an artificial model of hibernation, as an experimental model for studying memory stability. In a hibernation state, decreased metabolism enables creatures to survive harsh, wintery conditions with little food, and can also causes brain activity to dramatically reduce.

In 2020, a team led by coauthor Takeshi Sakurai, PhD, at the International Institute for Integrative Sleep Medicine (WPI-IIIS), Tsukuba Institute for Advanced Research (TIAR), University of Tsukuba, induced artificial hibernation for the first time in mice. Their research uncovered the brain circuitry necessary for inducing hibernation, unlocking a new tool for neuroscience research. They later reached out to Tanaka to collaborate. “Our brains are incredibly complex. If hibernation can reduce and simplify brain activity and structure, it could make studying these convoluted systems a bit easier. That’s why I wanted to use artificial hibernation techniques to study memories,” he said.

By imaging mouse brains before, during and after artificial hibernation, the researchers found that more than half of synapses in the hippocampus region of the brain disappeared in hibernation, and neuronal firing rate, a measure of brain activity, reduced by roughly 70%. Synapse elimination didn’t seem to be influenced by dendritic spine size, with synapses involving both large and small spines equally likely to be removed.

“Artificial hibernation caused a profound reduction in neuronal activity and eliminated more than half of hippocampal synapses,” the investigators noted.

The surprise came in behavioral tests after artificial hibernation, which showed that the animals’ memory recall remained the same, or even improved in some instances. “Despite these large-scale structural changes, mice retained previously acquired memories and preserved neuronal representations of experience,” they stated.

To investigate why memory retention may have stayed intact or improved, the researchers used a technique called CLEM—correlative light and electron microscopy. “CLEM combines fluorescence microscopy with high-resolution electron microscopy, explained co-author and technician Ai Takahashi. “By labelling samples with fluorescent tags, we can see different parts of the cell or organism in different colors. This can, for example, help us to pinpoint important proteins. Then using electron microscopy, we can zoom in on those same areas, to examine substructures in much higher detail.”

The team’s study is the first to use CLEM to observe engrams, a significant achievement given how small and sparse engram synapses are. “Successfully correlating the light microscopy and electron microscopy datasets to image engrams is a very technically challenging feat,” added Tanaka. “We hope our contributions to developing this method may provide new platforms for studying other important neuroscientific questions in future.”

The team fluorescently labelled the synapses thought to be involved in a particular memory trace and examined these before and after artificial hibernation. They found a significant decrease in synapses. However, certain clusters of synapses seemed to be spared. “Dendritic spines were eliminated regardless of their size, but many reappeared at the same dendritic locations after recovery,” they wrote. “Notably, synaptic connections between neurons encoding the memory were organized into spatially clustered groups.” Tanaka said, “This suggests that for long-term memory, only particular clusters of synapses matter—the rest may be dispensable. Interestingly, dendritic spine size, which has been shown to increase in initial memory encoding, doesn’t seem to play a factor in memory retention.”

Lin added, “We’ve observed this interesting correlation between clusters and memory retention, but not yet proven a causal link. As technology develops, it will be interesting to study these clusters in more detail, to answer these remaining questions.”

Looking forward, the researchers hope to continue their studies on memories, with the aim of understanding the mechanisms by which these core clusters are protected. “A deeper understanding of the mechanism by which hibernation protects the core memory trace and maintains the network integrity would reveal more comprehensive principles of memory,” the investigators concluded. “

Tanaka noted, “We’ve unlocked some insights into the architecture needed for memory retention. But there are many more questions to explore. How does the brain maintain this structure over time? How do different memories interplay? We have so much left to learn.”

The researchers also plan to study other aspects of artificial hibernation. “This work focused on mice, but the same neuronal circuitry for hibernation is well-conserved across many mammals, including humans,” Tanaka pointed out. “Therefore, through artificial hibernation studies, we may be able to discover new insights or applications that can translate to human health and neuroscience.”

The post Long-Term Memory Loss Secrets Revealed with Artificial Hibernation appeared first on GEN - Genetic Engineering and Biotechnology News.

The findings are based on benchmarked oncology program and clinical trial data from Tufts CSDD and contract value data from Medable, which provides a cloud-based software platform designed to modernize and accelerate clinical trials for the pharma and life sciences industries.

• Expected net present value: The agent showed expected net present value (eNPV) gains of approximately $7.5 million (Phase II trial), $11.3 million (combined Phase II and Phase III) development, and $21 million (Phase III trial).
• Overall return on investment: The study found an estimated ROI of 64x for Phase II and 82x for Phase III clinical trials.
• Direct operating cost savings: Tufts CSDD estimated direct operating cost reductions in on-site monitoring per clinical trial of approximately $4.4 million per Phase II and $5.6 million per Phase III study.

“To our knowledge, this is the first time that eNPV modeling based on actual use and benchmark data has been applied to quantify the net financial impact of an agentic AI solution deployed to support a drug development program,” said Ken Getz, Tufts CSDD executive director. “The financial value created by the investment and deployment of the monitoring agent was driven by operational efficiencies such as the reduction in the number of on-site visits and reduced travel costs as well as accelerated enrollment and database lock timelines.”

Additional analysis identified and valued administrative off-site monitoring task efficiencies of approximately $600,000 (Phase II) and $1.7 million (Phase III). These savings reflect clinical research associate time that could be reallocated to other studies and were not included in the eNPV calculations.

The analysis also found that agentic AI can accelerate clinical development by approximately 10 weeks. By shortening activities on the critical path of development, agents help sponsors complete studies sooner, advancing regulatory submission and potential commercialization while increasing the expected financial value, according to the study.

Key contributors include faster patient enrollment, reducing enrollment timelines by approximately 109–119 days, earlier database lock, shortening closeout activities by about two weeks, and earlier realization of future revenue and lower development costs.

“The potential impact is magnified when applied across a large oncology portfolio,” said Pamela Tenaerts, MD, chief medical officer at Medable. “For a sponsor with 20 active indications, deploying a clinical monitoring agent across Phase II and III studies could generate as much as $226 million in incremental portfolio eNPV.

“For a sponsor with 50 active indications, that figure could jump to as much as $565 million. Bottom line? We now have evidence demonstrating sizable value creation of agents in clinical research, helping break longstanding barriers.”

In addition to these high-level findings, Tufts and Medable will publish a more detailed peer-reviewed paper later this year. Sign-up to be the first to receive the final published paper here.

The post Financial Value of AI Agents in Drug Development appeared first on GEN - Genetic Engineering and Biotechnology News.

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Sam Zhang, PhD

Vice President, Head of Microbial and Viral Platforms (MVP)
WuXi Biologics

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Panelist

Sam Zhang, PhD

Sam Zhang, PhD, has more than 18 years of experience in the biopharmaceutical industry, with extensive expertise in CMC management, cell line development, process development, and clinical manufacturing. In his current role as vice president and head of the MVP site at WuXi Biologics, Sam leads innovative efforts across microbial, in vivo CAR, and HEK293 platforms to provide end-to-end CRDMO solutions. His career spans key technical leadership roles at Pfizer, Amgen, and AbbVie, where he specialized in recombinant protein expression, bioprocess development, and CMC management.

Sam holds a PhD in cell biology from the University of California, San Diego, an MS in microbiology from the National University of Singapore, and a BS in biology from Nanjing University. His areas of expertise include rProtein expression, cell culture process development, business development, and regulatory filings.

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In biomanufacturing, there are complex demands around fermentation scale-up, process consistency, technology transfer, and manufacturing capacity that must be addressed for microbial-derived biologics to complete commercialization. Meeting those demands depends on specialized infrastructure and an integrated strategy for process validation, process performance qualification (PPQ), and long-term operational readiness.

In this GEN webinar, our expert speaker, Sam Zhang, PhD, will discuss emerging trends and capacity needs across the global late-stage microbial pipeline and CDMO landscape. He will introduce WuXi Biologics’ integrated late-stage microbial capabilities including the newly constructed commercial facility in Chengdu, China, designed for microbial-derived biologics. He will demonstrate features of the comprehensive tech transfer and scale-up platform, as well as PPQ and commercial readiness strategies. He will also share a case study featuring a peptide program that will elucidate WuXi Biologics’ tailored solutions for microbial-derived biologics. Key takeaways will include:

• Critical success factors for technology transfer, process scale-up, PPQ readiness and commercial manufacturing
• Large-scale microbial manufacturing capabilities at the Chengdu site, with fermentation scales of up to 15,000 L
• Practical learnings from a complex peptide program, with broader relevance to recombinant proteins and other microbial-derived modalities

A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.

Produced with support from:

The post Advancing Microbial-Derived Biologics from Scale-Up to Commercial Production appeared first on GEN - Genetic Engineering and Biotechnology News.

In August, the Centre hospitalier de l’Université de Montréal (CHUM) reported what it described as the first North American liver transplant using an organ treated with its new regeneration approach. The recipient was a 64-year-old Quebec man who had lived with liver disease for approximately 15 years and later developed cirrhosis and liver cancer.

The technology uses a machine called Liver Assist to keep a donated liver functioning outside the body while doctors evaluate and treat it before transplantation.

Rather than relying only on traditional cold preservation, the system circulates oxygenated fluid through the liver. This process can allow an organ affected by oxygen deprivation during donation and transport to recover. Doctors can then use a blood-based solution to assess how well the liver functions under conditions designed to more closely resemble those inside the human body.

The potential benefit is significant because some donated livers that might previously have been considered unsuitable for transplantation could potentially be reassessed and used.

CHUM performs approximately 70 liver transplants annually. According to the hospital team, an analysis conducted with Transplant Québec suggests the technology could potentially make an additional 20 to 24 donated livers available for transplantation during its first year of use.

The technology may offer benefits beyond increasing the organ supply. The CHUM transplant team says research indicates this type of organ-preservation technology may help reduce complications, repeat operations and hospital stays in appropriate patients.

The Quebec recipient reportedly showed encouraging signs soon after his operation, including better-than-expected blood test results the following day. He continues to recover while receiving regular follow-up care.

While technologies such as machine perfusion could improve how donated organs are preserved, assessed and ultimately used, they cannot address the shortage of donor organs by themselves.

The development highlights two increasingly important areas of transplant medicine: finding ways to safely use more donated organs and encouraging people to consider and discuss organ donation with their families.

The post New Technology Could Expand the Supply of Donor Livers appeared first on Hospital News.

The post In Pursuit of Precision: New Lab Tech appeared first on Endocrine News.

Around 12,550 candidates have been accepted onto dentistry and medicine courses this A-level results day (13 August), a 28% increase since 2019.

Today’s A-level results release saw more students than ever receive top A* grades, outside of the COVID-19 pandemic when predicted grades were used.

The combined figure for students accepted into competitive dental and medical schools rose by 2.2% on the previous cohort.

Jo Saxton, UCAS chief executive, said: ‘Today’s school leavers were just starting secondary school when the pandemic interrupted their education. Given the significant disruption they faced at such a formative stage of their learning, it is wonderful to see so many young people getting a place at university or college. I’m delighted to see them backing themselves and choosing to invest in their education.’

Can dentistry be accessed through clearing?

Many students who did not achieve the grades to progress onto the courses they had applied to will now be going through the clearing process to search for a university place elsewhere.

Jo continued: ‘For those who haven’t got the grades they need, are reconsidering their plans, or haven’t applied yet but are thinking of doing so, I’d encourage them to explore the wide range of choices on offer in clearing – with over 26,000 courses available there are plenty of options.’

While it is unusual for dentistry courses to be accessed through clearing, the University of Liverpool has announced that places on its BDS are available via its clearing process. Multiple courses in related disciplines such as dental nursing and dental technology are also available for applications on the UCAS clearing site.

Dental school applications soar

In June, UCAS data revealed that applications to medicine and dentistry courses had risen by 12% since the previous year. There were 134,210 applications recorded for 2026 entry, the highest level since 2019.

International interest also increased. Applications from outside the European Union rose by 14%, from 16,660 to 18,990, while applications from the European Union excluding the UK increased from 3,460 to 3,900. Combined, international applications to medicine and dentistry reached 22,890 in 2026.

Jo said: ‘It’s fantastic to see so many UK 18-year-olds holding an offer this year, putting them in a strong position as we head into the critical summer results period.

‘It’s clear that young people remain as keen as ever to invest in their futures, and I’m delighted that UK universities and colleges are responding to that demand.’

Follow Dentistry.co.uk on Instagram to keep up with all the latest dental news and trends.

A conversation with Jonathan Williamson, digital workflow specialist, on the advantages of in-house model and aligner production.

As orthodontic practices and laboratories continue to embrace digital workflows, one question keeps coming up: how can we produce more in-house without adding complexity, staffing pressures, or longer working hours?

Jonathan Williamson, one of the digital workflow specialists at DB Orthodontics and DB Lab Supplies, explains why the Formlabs Form 4B is generating so much interest among orthodontists and dental technicians. Having worked closely with practices, laboratories, and our own in-house production team, Jonathan has seen first-hand how the latest generation of dental 3D printing is changing what is possible.

Jonathan, what makes the Form 4B different from other dental 3D printers?

‘The first thing people are impressed with is the speed,’ says Jonathan. ‘Printing up to 11 orthodontic models in just nine minutes is a genuine game-changer. That’s not just a nice specification for a brochure – it completely changes how practices and laboratories can work.’

Traditionally, many orthodontic teams have relied on overnight printing. Models are queued up at the end of the day and staff return the next morning hoping everything has printed successfully.

‘The Form 4B removes that mindset,’ Jonathan explains. ‘You can print during normal working hours. If you need aligner models, retainer models, or diagnostic models, you can produce them throughout the day rather than waiting until tomorrow. That has a huge impact on workflow efficiency.’

Is speed the main reason people are investing?

‘Speed gets people’s attention, but accuracy and reliability are what convince them,’ says Jonathan.

Orthodontic appliances depend on accurate models. Any variation can affect appliance fit, create additional adjustments, and ultimately impact treatment efficiency.

The Form 4B delivers exceptional precision, with 95% of surfaces within 50 microns of the CAD model and 99% within 100 microns. That’s the level of consistency orthodontic professionals need when they’re producing aligner models, retainers, indirect bonding trays, and other appliances.

Just as importantly, that accuracy is maintained across the entire build platform, allowing multiple models to be printed simultaneously without compromising quality.

What about reliability?

‘Ask anyone who has experienced failed prints. Reliability suddenly becomes your number one priority.’

The Form 4B has been designed to minimise production interruptions through intelligent monitoring systems that track resin levels, temperature, print forces, and overall build conditions throughout the printing process.

‘The reported print success rate is over 98%, which is incredibly important for busy practices and laboratories. Failed prints don’t just waste resin. They waste time, delay cases, and create frustration. Reliability is often where the real return on investment comes from.’

Is the Form 4B suitable for practices that are new to digital manufacturing?

‘Absolutely,’ says Jonathan. ‘One of the biggest misconceptions about digital workflows is that they’re difficult to learn. Formlabs has done a fantastic job of making the process incredibly intuitive.’

Most users can learn the workflow in around 15 minutes. From importing scans and preparing models through to washing, curing, and finishing, the process has been designed to be simple and repeatable.

‘You don’t need a dedicated 3D printing expert in your practice to make this work. That’s one of the reasons adoption has accelerated so quickly.’

What types of orthodontic applications are customers using it for?

According to Jonathan, the majority of interest currently centres around clear aligner production and retainer workflows, but the possibilities extend much further.

‘We regularly see customers producing clear aligner models, retainer models, indirect bonding trays, occlusal splints, diagnostic models, and surgical guides. The open material capability also gives laboratories and advanced users additional flexibility when choosing materials.’

With Open Material Mode, users can work with validated Formlabs materials as well as selected third-party options, helping future-proof their investment as workflows evolve.

DB Orthodontics uses the Form 4B internally in its on-site lab. How important is that?

‘For me, it’s probably one of the biggest advantages we offer,’ says Jonathan. ‘At DB Orthodontics and DB Lab Supplies, we don’t just sell the equipment. Our own laboratory team uses the Form 4B every day. We’re producing models, testing workflows, solving challenges, and continually learning how to get the very best from the technology.’

That practical experience means conversations go beyond specifications and sales literature.

‘When customers ask questions, we’re answering from experience. We understand how the printer fits into an orthodontic workflow because we’re doing it ourselves.’

What would you say to someone considering a move to in-house production?

Jonathan’s answer is straightforward. ‘Come and see it. We actively encourage orthodontists, dental technicians, and laboratory teams to visit us and see the Form 4B running in a real orthodontic environment. You can speak to our laboratory team, ask questions, look at printed models, and understand exactly how the workflow operates from start to finish.’

He adds: ‘The technology is impressive, but what really helps people make decisions is seeing it working in practice and discussing their specific challenges with people who genuinely understand orthodontics.’

Final thoughts

The Form 4B is more than just another dental 3D printer. With the ability to print up to 11 models in nine minutes, accuracy of 95% of surfaces within 50 microns, and a reported print success rate of over 98%, it represents a significant step forward for orthodontic manufacturing.

Perhaps most importantly, it allows practices and laboratories to bring more production in-house without increasing complexity. Faster turnaround times, reduced outsourcing, predictable results, and a workflow that fits comfortably within the working day are compelling benefits for any modern orthodontic business.

And if you’re wondering whether it could work for your practice, Jonathan’s advice is simple: visit our DB headquarters, see it in action, and talk to the people using it every day.

Ready to see the Form 4B in action?

Book a call or visit our in-house laboratory and discover how digital workflows could transform your practice.

This article is sponsored by DB Orthodontics.

Damian Whitlam explores how generative AI is making it easier for patients to pursue dental complaints and negligence claims, while creating new risks and resource pressures for practices, insurers and regulators.

Generative AI is increasingly being used by patients to bring complaints and negligence claims against dental providers. The AI model makes it easier for patients to pursue disputes because the barriers to adoption are low and the technology is simple to access and use. Put simply, it has never been easier for patients to complain.

What is generative AI?

Both patients and practices are now using generative AI to bring and respond to complaints and claims. This type of AI can create new, complex content including text and images. Large language models learn patterns, relationships and structures from large datasets and then generate new content that reflects those patterns in response to user prompts.

Generative AI is a probabilistic technology. This means it predicts the most likely response based on patterns in its training data rather than retrieving facts in the way a database does. As a result, the AI can sometimes ‘hallucinate’, generating content that is inaccurate, misleading or unsupported by reliable sources, while presenting it as though it were correct.

Dental practices and their insurers therefore need to be ready to respond as efficiently as possible to this new breed of complaints and claims which present emerging risks.

Increased complexity of dental complaints and claims

Freely available generative AI tools can be used to produce lengthy letters of complaint and letters of claim running to hundreds of pages in a matter of minutes. At Weightmans, anecdotally we have seen complaints received by our dentistry clients becoming longer, more detailed and increasingly opaque as AI uses legal jargon in allegations.

What was once a short email outlining concerns can now be difficult to unpick and understand because generative AI can confidently generate incorrect legal analysis, misstate facts and even invent case law at a speed and volume that we have not previously had to deal with.

Impact on dental practices

The knock-on effect is that responding to complaints and letters of claim requires significant additional time and resource, regardless of the merits of the case.

While documents may appear polished and persuasive, they are not always accurate. The challenge for defendants is that AI-generated documents from claimants cannot simply be dismissed because they appear implausible. Practices must carefully review patient records and consult clinicians to prepare thorough responses to often confusing allegations to tight deadlines.

Where documents created using generative AI contain legal arguments that ultimately prove to be incorrect, each allegation must still be considered and addressed. That places additional pressure on practices and insurers while also raising important questions about proportionality in litigation.

Practices face growing pressure on resources as a result of the increased use of generative AI to create documentation, but failure to spot, properly investigate and acknowledge genuine concerns at an early stage can lead to protracted and expensive legal proceedings.

The risks of generative AI for defendants

Practices may consider it quicker and cheaper to use generative AI to respond to complaints and claims, but this can be risky for defendants.

Generative AI can support the response to claims process, but it cannot replace professional judgement. Every factual assertion, legal reference and clinical opinion must still be verified.

Getting the response to a claim wrong can potentially result in criticism by the court and adverse costs consequences for dental practices.

It is therefore important to seek early legal advice to mitigate these risks. Using publicly available generative AI can also cause issues around confidentiality as the materials are likely to contain health data and some models retain and uses the information for training.

Similar issues are arising in inquests and investigations by professional regulators. Complaints to regulators using generative AI are often more complex and raise wider issues which, even if often tangential, irrelevant or sometimes not even reflective of what has actually occurred, require investigation by the regulator and a response from the registrant.

As with claims, this leads to increased cost, but also higher levels of concern on the part of the individual under investigation. The use of generative AI by registrants to formulate reflections to regulators addressing alleged misconduct is also becoming more prevalent. Different regulators are adopting different approaches to its use in that context.

What the courts are saying about generative AI

The courts are already taking steps to combat the misuse of generative AI when used in legal proceedings. Judicial guidance was released in October 2025 which encouraged the court to inquire about the use of AI chatbots, and to remind litigants that they are responsible for the material they put to the court or tribunal.

This followed a number of significant court decisions from the spring of 2025 where the court put the use of AI chatbots, by lawyers and individuals, under the microscope, outlining the sanctions that could apply if misused. And in the recent case of Cork versus Smith, three solicitors were publicly admonished by the court and referred to the Solicitors Regulatory Authority after submitting misleading material containing fabricated statutory text as a result of using generative AI.

The Crown Prosecution Service also recently apologised after court documents contained non-existent legal authorities that were likely created by generative AI. While the court accepted there was no intention to mislead, it made clear that there had been a failure to verify the accuracy of authorities before the documents were filed.

The Civil Justice Council has recently published an interim position update in relation to the consultation on the use of AI for the preparation of court documents by lawyers.

The direction of travel confirms that the Working Group will continue looking at ‘maintaining the current position for AI use in professional legal drafting [namely, that existing professional responsibility frameworks are considered largely sufficient to govern appropriate use]; introducing proportionate transparency in relation to expert evidence, and recognising the distinct and evolving challenges posed by litigants in person’.

Preparing for what’s next

For the dental sector, the question is no longer whether generative AI is impacting complaints and claim. The question is now: how can practices and insurers respond most effectively to this evolution?

Those that embrace AI responsibly and maintain robust professional and legal oversight of the use of it will be best placed to benefit from the technology while managing its risks.

As generative AI continues to remove barriers to bringing complaints and legal claims, the demands on defendants are only likely to grow. It is therefore important for dental practices and their insurers to seek early legal advice to minimise the risks and significant avoidable costs that can arise.

Follow Dentistry.co.uk on Instagram to keep up with all the latest dental news and trends.

The latest funding brings the total capital raised by the company to $62m.

The Series A round was led by OG Venture Partners and M Ventures, Merck KGaA, Darmstadt, Germany’s corporate strategic venture arm.

Other new and existing backers include NFX, Qumra Capital, Tadmor Group, TechAviv, and Vine Ventures.

Remepy develops Hybrid Drugs through partnerships with pharmaceutical companies.

These drugs combine prescription medicines with personalised, AI-driven therapeutic applications, aiming to integrate pharmacology with adaptive physical, cognitive, and behavioural interventions into a single treatment regimen.

The company stated that the Hybrid Drug model has gained traction, supported by evolving US regulatory frameworks for drug-software combination products.

Remepy recently disclosed a strategic partnership with Merck KGaA, Darmstadt, Germany to develop hybrid drugs for multiple indications, beginning with rare tumours.

Hybridopa, it’s lead programme for Parkinson’s disease, has reported positive Phase IIa clinical data regarding both motor and non-motor symptom improvement.

It remains an investigational product and has not received approval from the US Food and Drug Administration.

Remepy co-CEOs Michal Tsur and Or Shoval said: “We believe medicine is entering a new era, where every breakthrough drug will be paired with personalised intelligence to maximise its impact for every patient.

“Over the past year, we’ve demonstrated that this vision is achievable through clinical validation, peer-reviewed science, regulatory alignment, and partnerships with leading pharmaceutical companies.

“This financing allows us to advance Phase III of Hybridopa for Parkinson’s disease, and expand the hybrid drug model across multiple therapeutic areas.”

The post Remepy secures $36m funding for hybrid drug pipeline expansion appeared first on Pharmaceutical Business review.

Ivonescimab is described as an investigational bispecific antibody. The latest marketing authorisation is based on data from the HARMONi-6 multi-centre Phase III study that was conducted in China.

Data for the study were generated, managed, and analysed solely by Akeso.

The HARMONi-6 trial compared ivonescimab in combination with platinum-based chemotherapy against a regimen of the programmed cell death protein 1 (PD-1) inhibitor tislelizumab with platinum-based chemotherapy.

It included patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression.

The study showed that the combination with ivonescimab produced statistically significant and clinically meaningful improvements in both progression-free survival and overall survival when compared to the PD-1 inhibitor-based regimen.

The safety profile observed was said to be consistent with earlier studies of ivonescimab combined with chemotherapy.

Summit Therapeutics chairman and co-CEO Bob Duggan said: “Today’s approval in China marks another extraordinary milestone for ivonescimab and reinforces the strength of the clinical evidence generated to date.

“HARMONi-6 is the first known Phase III study in NSCLC — or any tumour type — to demonstrate a statistically significant and clinically meaningful overall survival benefit over an anti-PD-(L)1 antibody plus chemotherapy regimen in a head-to-head setting.”

Ivonescimab, which is also referred to as SMT112 in Summit Therapeutics’ licence regions, remains an investigational therapy and is not approved by regulatory authorities in the US or Europe.

As noted by Akeso, more than 4,000 patients have been treated with ivonescimab in clinical studies worldwide, and over 70,000 in a commercial setting in China.

The post Akeso secures China NMPA authorisation for ivonescimab combo appeared first on Pharmaceutical Business review.

BASF’s Personal Care business has introduced Floragenist, a range of floral active ingredients developed to address consumer demand for natural beauty with performance supported by scientific studies. Floragenist Rose and Floragenist Blossom are derived from Damask Rose (Rosa damascena) and Bitter Orange blossom (Citrus aurantium var. amara), respectively, and are sourced from Morocco.

BASF said the ingredients are designed to enhance skin radiance and support the skin’s ability to adapt to daily stress. The botanicals are sourced with traceability and responsible sourcing practices.

BASF said the development of Floragenist combines its AquaGenesis extraction technology with epigenetic science. AquaGenesis uses coconut water as a natural solvent to extract bioactive compounds without aggressive solvents. According to BASF, the technology preserves phytochemicals while increasing the concentration of key active molecules. Compared with conventional extraction methods, it delivers enhanced levels of flavonoids for skin care applications.

BASF researchers combined the extraction technology with epigenetic science to develop flower extracts that support the epidermis.

Floragenist Rose is designed to enhance skin radiance by supporting the skin’s expression of “surface optics” proteins. BASF said these proteins are involved in maintaining skin structure and light-reflecting properties, supporting skin cohesion and visible luminosity. Floragenist Rose also addresses the effects of oxidative stress and supports an even-looking complexion. Clinical studies using VISIA imaging reported a 2.7-fold improvement in the appearance of skin luminosity and a 22 per cent decrease in redness at a concentration of 0.4 per cent of the ingredient compared with the placebo group.

Floragenist Blossom is designed to support the skin’s adaptive capacity in response to environmental and lifestyle-related stress. BASF said it supports skin resilience by helping the skin express key skin integrity proteins. This contributes to maintaining the skin’s natural barrier function, improving the appearance of epidermal cohesion and helping the skin cope with external stressors such as mechanical stress, over-cleansing and microbial imbalance. An in vivo study found that harsh cleansing of skin pre-treated with 0.1 per cent Floragenist Blossom for 28 days resulted in 52 per cent lower variation in transepidermal water loss (TEWL) than placebo.

BASF said the development of the Floragenist range is guided by the principles of its Responsibly Active programme for cosmetic bioactives, which focuses on transparency, ethical conduct and environmental responsibility. The ingredients are derived from certified organically cultivated Damask Rose and Bitter Orange, hand harvested in Morocco and traceable to the source. BASF said the Damask Rose originates from a supply chain verified against a sustainable sourcing standard, supporting agricultural practices and creating impacts for local communities.

The post BASF introduces Floragenist floral active ingredients for skin care appeared first on Express Pharma.

The Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Enterprise of the Department of Biotechnology (DBT), Government of India, is showcasing its innovation and start-up ecosystem at a pavilion during the Bharatiya Vyapar Mahotsav (BVM) 2026, being held from August 12–15 at Bharat Mandapam, Pragati Maidan, New Delhi.

Organised jointly by the Confederation of All India Traders (CAIT) and India Trade Promotion Organisation (ITPO), BVM 2026 brings together traders, MSMEs, manufacturers, institutions, investors and policymakers under the theme “Made in India, Made for India, Made for the World”.

The BIRAC pavilion allows visitors, investors, industry leaders and the public to engage with biotech and medtech innovators and understand BIRAC’s schemes, funding instruments and infrastructure supporting the development of laboratory research into market-ready products.

Since its establishment, BIRAC has worked as an interface between India’s scientific research base and industry, supporting the conversion of research into enterprises and products. As an industry–academia interface agency under DBT, BIRAC has developed a network of incubators, bioclusters, accelerators and funding schemes supporting entrepreneurs from proof-of-concept to commercialisation.

BIRAC’s support includes seed and early-stage funding for validating ideas and developing prototypes, access to risk capital through venture funds and co-investment mechanisms, technology transfer and intellectual property (IP) support, bioincubation infrastructure, and regulatory and market-access support.

Its bioincubation network provides lab space, mentorship and technical support, including in tier 2 and tier 3 regions. BIRAC also runs social innovation programmes supporting technologies for affordable healthcare, assistive devices, and solutions for underserved and marginalised communities.

According to BIRAC, these programmes have supported start-ups and MSMEs across therapeutics, diagnostics, medical devices, agri-biotech, industrial biotechnology and clean energy.

A share of the start-ups featured at the BIRAC pavilion are working on medical technology and social impact, including prosthetics, robotic rehabilitation systems and assistive devices for persons with disabilities.

“BIRAC’s role has always gone beyond funding — to de-risk the innovation journey for India’s biotech entrepreneurs, connecting them to capital, infrastructure, mentorship and markets at every stage. The start-ups showcased at our pavilion this year, many of them working on assistive technologies and rehabilitation solutions, are a powerful example of how Indian innovation can be both cutting-edge and deeply inclusive. Platforms like the Bharatiya Vyapar Mahotsav allow us to bring these home-grown solutions closer to industry, investors and the public, and to reaffirm BIRAC’s commitment to building a self-reliant, globally competitive Indian bio-economy.” Stated Dr. Dhananjay Kumar Tiwary, Managing Director, BIRAC.

Reconstructive Healthcare Solutions  (RHS), founded in 2018 by a maxillofacial surgeon, is an ISO 13485-certified medtech company specialising in virtual surgical planning and 3D-printed anatomical models, surgical guides, splints, and dental and orthopaedic implants. Operating from a GMP facility at IMT Faridabad, Haryana, RHS combines imaging, software integration and manufacturing for patient-specific surgical care and healthcare education.

GenElek Technologies, an IIT Delhi-incubated medical robotics company, develops robotic exoskeletons for gait training and mobility rehabilitation. Its Sencibel Robotic Gait Trainer is a lower-limb robotic exoskeleton with multiple training modes, real-time monitoring and analytics for individuals with neurological and musculoskeletal impairments.

Exobot Dynamics Pvt. Ltd., incubated at IIT Delhi and backed by BIRAC, AIC, IHFC, SACC, NCPEDP, DST and FICCI-Mercedes Benz, develops upper-limb prosthetics and wearable robotic systems. Its GripX product is a myoelectric prosthetic hand designed for Indian clinical workflows. The company is also developing X1, a bionic hand, as part of its “Human Physical AI” vision.

Rymo Technologies Pvt. Ltd., founded in 2020, has developed a neuro-rehabilitation ecosystem combining robotics, VR, AI and electrical stimulation. Its product suite includes Mobi-L, Mend, Nudge, Aura XR and Pulse FES. The company said its products have been installed at 779 sites across 612 clinics and hospitals, including AIIMS, Apollo, Sakra and Manipal.

Translead Medtech Pvt. Ltd., a Bengaluru-based medical device company, has developed Stand at Eaze, an unpowered assistive chair that helps users sit and stand using a compliant hinge mechanism licensed exclusively from biomechanics research at the Indian Institute of Science. The device is CDSCO-registered as a Class A medical device, with clinical evaluation underway at partner hospitals.

Torchit, a social technology company, develops assistive technologies including the Saarthi Smart Mobility Aid, the Jyoti AI ecosystem, AI Vision Glasses and AI Reader, braille technologies and the Saksharta Inclusive Education Kit. The company works with government bodies, NGOs, hospitals and CSR partners and has impacted over 2 million lives across India and other emerging markets.

Visitors, media representatives, investors and potential industry partners can connect with BIRAC and the participating start-ups at the BIRAC pavilion at Bharat Mandapam through August 15, 2026, for information on BIRAC’s funding schemes and eligibility for start-ups and SMEs, bioincubation and infrastructure support, technology transfer, licensing and IP-related assistance, regulatory and market-access guidance, and partnership, collaboration and investment opportunities with the participating start-ups.

The post BIRAC showcases biotech and medtech start-ups at Bharatiya Vyapar Mahotsav 2026 appeared first on Express Pharma.

In pharmaceutical manufacturing, contamination control begins long before products reach final packaging. Raw materials are blended, milled and granulated before being compressed into tablets or filled into capsules. At each stage, there is potential for metal contamination arising from broken sieves, worn equipment, magnets or foreign material introduced with ingredients.

Metal detection forms part of the control strategy applied during these processes. By identifying and removing metal contaminated products while they are still in production, it aids compliance with regulations plus supports quality management within validated and documented systems. 

Why are metal detectors used in pharmaceutical production?

As medications are used directly by individuals, even a small metal contaminant within a tablet, capsule or powder can present a risk to patient safety and product quality. Applicable Good Manufacturing Practice (GMP) requirements, including 21 CFR Parts 210 and 211, require manufacturers to establish appropriate controls to prevent contamination and deliver product quality. Where automated systems are used, GAMP 5 (Good Automated Manufacturing Practice) provides guidance on validation and lifecycle management.

Metal detection provides an automated inspection method capable of identifying stainless steel, ferrous and non-ferrous metal contaminants, including very small particles. In pharmaceutical applications, stainless steel detection sensitivity can reach down to 0.3 mm test spheres, depending on the product and configuration. At this level of sensitivity, inspection plays a vital role in physical contamination control.

Inspection before compression: powders and granules

Active Pharmaceutical Ingredients (APIs) and excipients are handled as powders or granules before tableting or encapsulation. During blending, milling or granulation, metal contaminants may be introduced through equipment wear or raw material handling.

Pharma Gravity Fall (GF-PRO) metal detection systems are designed specifically to inspect these free-flowing materials at vertical transfer points. As powders move by gravity through an enclosed chute, they pass through the detector aperture. If metal contamination is identified, a fast-acting reject mechanism diverts only the affected material from the product stream.

By positioning inspection before compression, metal contaminated material can be removed early in the process, reducing the likelihood of a full batch being affected.

Inspection after compression: tablets and capsules

Once powders have been compressed into tablets or filled into capsules, inspection shifts to the finished dosage form before packaging.

Tablex-PRO is a pharmaceutical metal detection system from Mettler-Toledo designed specifically for solid-dose applications. It integrates directly with tablet presses or encapsulators and de-dusters, to inspect products immediately after formation. As tablets discharge from these machines, they pass through the metal detector and are automatically separated into accepted and rejected streams.

Inspection can take place at speeds of up to 300,000 tablets per hour, depending on the application. If a metal contaminant is detected, a minimal number of tablets or capsules are diverted into the reject container by the fast-acting reject device. This rejection approach helps minimise product loss while maintaining tight process control. A lift flap diverter reject mechanism offers straight-line product flow for delicate products; a side diverter reject mechanism is ideal when inspection height space is restricted.

Blister packs are not typically inspected using conventional metal detectors at this stage because aluminium foil interferes with the detection field. For that reason, inspection is generally focused on unpackaged powders, tablets and capsules.

How do pharmaceutical metal detectors work?

Pharmaceutical metal detectors operate using balanced coil technology. A high-frequency electromagnetic field is generated within the inspection aperture. When metal passes through this field, it disturbs the signal and is detected by the system electronics.

Ultra-high tuned frequency operation, combined with an optimised aperture size, enhances sensitivity particularly for non-magnetic stainless steel contaminants, which can be more difficult to detect. 

When contamination is identified, visual alarms are activated and the reject mechanism diverts the affected product. These events are recorded to provide documented evidence of removal.

Compliance, validation and lifecycle control

In pharmaceutical environments, detection capability alone is not sufficient. Inspection systems must operate within validated frameworks and be supported by documented performance. Metal detection equipment is supplied with documentation to support Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) as part of the wider Equipment Qualification (EQ) process. Ultimately, the EQPac documentation from Mettler-Toledo allows the manufacturer to have a traceable procedure for implementing the metal detection system into their production line. 

Validation and verification activities continue throughout the system lifecycle. Regular sensitivity checks, including Performance Monitoring Routine (PMR) testing, annual performance verification and scheduled revalidation form part of standard site procedures. Systems also maintain controlled records of user access, configuration changes and test results, with reports available via Ethernet or USB to support audit readiness and traceability.

Trained service engineers can also support installation, validation and ongoing maintenance, helping manufacturers maintain consistent inspection performance over time.

Design considerations in pharmaceutical environments

Pharmaceutical production areas are tightly controlled and often space is constrained. Metal detection systems must combine compact design with flexibility to integrate with different tablet presses, de-dusters and transfer points. Adjustable configurations allow the system to accommodate varying tablet sizes and product formats. Flexibility is enhanced with adjustable aperture / reject device height and castors which allow the system to be easily repositioned to integrate with other in-process equipment.

Hygienic design in pharmaceutical environments focuses on cleanability. Mirror-polished, stainless steel construction, smooth surfaces and simplified strip-down procedures support controlled cleaning processes. Touchscreen interfaces and password-protected access contribute to ease of use and controlled operation.

Conclusion

Metal detection remains a core inspection technology within pharmaceutical manufacturing. By inspecting APIs, excipients, tablets and capsules at critical stages, manufacturers can detect and remove metallic contamination before products progress further through production.

In an industry defined by compliance, documentation and patient protection, metal detection supports reliable inspection, validated performance and controlled process management across the system lifecycle.

For more information view: www.mt.com/md-pharma-basics-pr