The post CPAP Therapy Reverses Low Testosterone in Men with Severe Obesity, Independent of Weight Loss appeared first on Endocrine News.

The General Dental Council (GDC) has announced plans to overhaul its Overseas Registration Exam (ORE) booking system following widespread technical issues experienced by candidates.

The regulator told Dentistry that the new portal would be in place for exams scheduled in 2027, as part of the new ORE contract with UCL Consultants.

This comes as dentists reported payment issues, errors and overloaded servers during the booking process for the next sitting of the ORE Part 1. The 30 June booking window was the first time candidates were able to book ORE sittings through their MyGDC accounts.

Unable to get in contact with the GDC in the aftermath of the crash, some applicants were left unsure if they had successfully secured a space, despite payment having been taken in many cases.

The GDC said it has now resolved the majority of the issues experienced by candidates. It has been working through bookings and payments individually to ensure each candidate’s record is accurate.

It said: ‘We’re confident this gives candidates the certainty they need ahead of the next booking window on 14 July.’

Acknowledging the 65% increase in the ORE Part 2 fee announced in May, the GDC clarified that the additional funds would not be used to reform the booking system, but instead recover ‘the cost of delivering a complex clinical exam at scale’.

Announcing the fee increase, the GDC said: ‘The new fee rates reflect the cost of the new contract, including the costs which come from expanding capacity. We expect them to remain broadly stable over the next five years.  

‘The increase in exam spaces is a positive step forward, but we are very conscious that the increased cost is a burden for candidates to bear.’

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A new study published in Nature Communications titled, “Astrocytic ankyrin-2 enables memory persistence in the mouse hippocampus,” suggests that astrocytes play a critical role in long-term memory through the regulatory protein ankyrin-2 (Ank2). 

Removing Ank2 function led to significantly impaired memory in mice after after two weeks. Under normal conditions, these mice showed standard locomotion, sociability, and recent memory immediately after learning.  

Astrocytes lacking Ank2 formed significantly less physical contacts with nearby engram neurons, the specialized neurons for memory storage. Additionally, the maintenance of long-term potentiation (LTP) was impaired while normal synaptic transmission remained intact. The findings suggest that astrocytes stabilize the neural circuits required for preserving memories long after they are formed. 

On the molecular level, researchers found that Ank2 is required for brain-derived neurotrophic factor (BDNF) signaling through the astrocytic TrkB.T1 receptor and IP3R2-mediated calcium signaling. In the absence of Ank2, calcium signaling weakened, astrocytes failed to undergo normal structural remodeling, and showed reduced ability to maintain contacts with memory-encoding neurons. 

The researchers further demonstrated that hippocampal BDNF infusion normally strengthens long-term memory persistence, but this effect disappeared when astrocytic Ank2 was deleted, showing that Ank2 is essential for BDNF-dependent memory stabilization. 

To determine whether astrocytic BDNF signaling alone is sufficient to enhance memory, the team developed an optogenetic tool called Opto-T1. Activation of this pathway promoted astrocyte remodeling, maintained long-term potentiation, and significantly enhanced remote memory without affecting recent memory.  

“Our findings show that astrocytes are not passive support cells, but active regulators that determine how long memories last,” said Wuhyun Koh, PhD, senior research fellow at Institute for Basic Science (IBS) and corresponding author of the study. “By identifying Ank2 as a key regulator of astrocyte remodeling and BDNF signaling, we have uncovered a new mechanism that helps stabilize long-term memories and opens new avenues for understanding and potentially treating memory disorders.” 

The researchers indicate the study provides a new framework for understanding how astrocytes contribute to neurological diseases. 

The post Astrocytes Preserve Memory Persistence Through Ankyrin-2 Protein in Mice appeared first on GEN - Genetic Engineering and Biotechnology News.

A JAMA research letter found that the number of messages sent through patient portals jumped from 0.99 per patient per year in 2020 to 2.50 in 2025. During that time, patients who used portals to communicate with clinicians went from sending 2.2 messages to 5.4 messages per year.

The authors of the report claim it’s the first scientific look at how many messages patients are sending health care providers through portals.

The research letter looked at data from more than 2,000 hospitals and nearly 50,000 clinics encompassing 1.34 billion messages from patients. Researchers also examined patterns in 1.59 billion phone calls and 146 million telehealth encounters between patients and clinicians.

A MedPage Today analysis on the study reported that telephone encounters during the same period fell slightly, from 2.33 per patient per year to 2.20. Researchers also found a 17% increase in patient visits, from 2.37 visits per patient per year to 2.77.

A separate study of digital communication in the inpatient setting didn’t look at the growth of secure chat, but it did look at differences in the amount of time physicians spend on secure messaging based on gender.

The study, published in the Journal of Hospital Medicine, found that while female hospitalists in an academic hospital worked similar hours as men, women spent more time in the hospital’s EHR: 248 minutes per day vs. 222 for male hospitalists. That’s a difference of about 12%.

Researchers found that female hospitalists spent more time on secure chat than their male colleagues (38 vs. 34 minutes per day). Women hospitalists also exchanged more messages, sending 62 vs. 53 messages per day and receiving 56 vs. 48 messages per day.

The study looked at activity from July 2023 to June 2024 of just over 200 hospitalists. The group included a mix of adult and pediatric hospitalists and attendings and residents.

Trends in digital communication were similar in residents and attendings. And even when a new scheduling model that had physicians work less hours was implemented, the researchers found that gender differences in digital communication remained.

The authors warned that while digital communication technology was supposed to increase efficiency, “these tools may contribute to unequal digital workloads.” They said their data “underscore the need for equity-informed strategies” to reduce the burden of digital communications in the inpatient setting.

The post Patient portal messages, EHR chat: How much time do docs spend? appeared first on Today's Hospitalist.

Leading a life sciences company comes with a unique level of responsibility. The decisions taken in boardrooms do not stop at business performance. They influence patient outcomes, regulatory trust, investor confidence, and in some cases, public health itself.

That responsibility also comes with a level of scrutiny that is materially different from most sectors.

Over the last several years, the regulatory landscape for life sciences companies has become more layered, more global, and far more unforgiving of oversight gaps. Expectations around governance, clinical integrity, disclosures, product safety, adverse event reporting, and data stewardship have evolved significantly. What may have been considered adequate governance a few years ago may no longer withstand scrutiny today.

For directors and officers, this is no longer only a corporate risk. Increasingly, it is a personal one.

When corporate issues become personal liability

Many directors understand, at least broadly, that they carry fiduciary responsibilities. What is often underestimated, however, is how quickly a regulatory issue can translate into personal legal and financial exposure.

An inquiry arising from a product issue, an allegation around inadequate disclosures, concerns over clinical or operational governance, or even a regulatory investigation into compliance failures can extend beyond the company itself. Directors and officers may find themselves personally named, drawn into lengthy investigations, defence proceedings, or reputational challenges — even where there has been no deliberate wrongdoing.

In life sciences, accountability is increasingly attached to named individuals, not merely institutions.

This is precisely where Directors & Officers (D&O) insurance is expected to respond. Yet, in my experience, one of the most common assumptions boards make is equating the existence of a D&O policy with adequate protection.

The more important question is this: Was the policy designed for the regulatory anatomy of your business?

Why generic D&O structures often fall short

Life sciences is not a conventional corporate environment. The sector operates under an intricate framework of approvals, compliance obligations, inspections, pharmacovigilance requirements, clinical governance, quality controls, and increasingly, cross-border regulatory expectations.

As companies scale — whether through international expansion, partnerships, fundraising, acquisitions, or product diversification — their liability profile evolves rapidly.

Yet, many D&O programmes continue to be structured as standard corporate placements.

This is where vulnerabilities often emerge.

For example, boards should evaluate whether their D&O framework adequately addresses:

• Regulatory investigation costs, particularly where individual directors may require legal representation early in proceedings
• Cross-border exposure, especially for organisations operating or raising capital across multiple jurisdictions
• Governance failures linked to clinical, product, or compliance oversight
• Data and disclosure-related liabilities, as healthcare and life sciences businesses become increasingly digitised and data-dependent

These are not theoretical risks. They are practical governance realities in a sector where regulatory expectations continue to rise.

D&O should evolve as the business evolves

One of the most overlooked aspects of D&O insurance is that it is often treated as an annual procurement exercise rather than a strategic governance tool.

A company that was primarily domestic two years ago but now exports, operates across regulated markets, or has institutional investors on its cap table is fundamentally different from a liability perspective.

Similarly, events such as:

• onboarding independent directors,
• entering regulated international markets,
• expanding into new therapeutic or healthcare categories, or
• preparing for fundraising or strategic transactions

should act as natural triggers to reassess whether the existing D&O structure still reflects the organisation’s actual exposure.

The policy that worked for yesterday’s business may not be sufficient for today’s board.

D&O as a governance signal

Increasingly, sophisticated investors, lenders, and independent directors view D&O insurance as more than a risk-transfer mechanism. Quietly, it has become an indicator of governance maturity.

Strong boards recognise that protection is not merely about insurance limits. It is about whether the wording, scope, and response mechanisms are aligned to the realities of the business they govern.

In a sector as regulated and consequential as life sciences, being underprepared is itself a risk.

The organisations that navigate this well are typically the ones that approach risk management not as a compliance obligation, but as an extension of responsible leadership. In life sciences, where trust is central to long-term success, that distinction matters.

The post Why life sciences leaders need D&O cover that keeps pace with regulation appeared first on Express Pharma.

For private practice physicians, particularly those in primary care and internal medicine, the structural constraints of the broader healthcare economy are less binding than they are for large health systems. Independent practices have the flexibility to differentiate and tailor their services, build direct relationships with patients, and create value that patients can actually perceive and act on. The practices that recognize and exploit this opportunity now are, in addition to improving near-term financial performance, building strategic positions that will be extraordinarily difficult for competitors to replicate.

To understand how to leverage this opportunity, it helps to first understand the distinction between two fundamentally different modes of competition: competing on price and competing on value.

Value Competition vs. Price Competition

Price competition is the most familiar form of market rivalry. When firms compete primarily on price, the competitive dynamic is straightforward: whoever can deliver an acceptable product or service wins business, and whoever does it the cheapest wins at the bottom line. Over time, pure price competition tends to compress margins, reward operational efficiency and scale, and push markets toward commoditization. Industries characterized by price competition (e.g., commodity manufacturing, certain retail categories, bulk logistics, etc.) are marked by thin margins, heavy consolidation, and relatively little differentiation between competitors. The product or service itself becomes largely interchangeable in the eyes of the buyer, and price becomes the primary basis of decision-making.

Value competition operates on a different logic entirely: firms compete to deliver what buyers are willing to pay a premium to access. The competitive dynamic here is about who can do it best, and more importantly, who can make “best” visible and credible to buyers. Value competition rewards differentiation, expertise, reputation, and innovation. For the service industry, professions like law, consulting, architecture, and medical specialties in cash-pay environments all exhibit value competition characteristics: the best practitioners command meaningfully higher prices than their peers, and clients actively seek them out rather than defaulting to whoever is cheapest or most convenient. For value to translate into price, buyers must be able to perceive the difference in quality among providers, have genuine options to choose between them, and be the ones making the purchasing decision. When any of these conditions break down, the value signal is severed from the price signal, and the market defaults toward something closer to cost competition, and high quality, even if desired, is not rewarded, or even disincentivized. This is what has happened in healthcare.

Barriers to Competition in the Healthcare Economy

Healthcare economics, particularly in the United States, are unusual in ways that systematically undermine the conditions for value competition. The most fundamental structural problem is what economists call the three-party system, where the party receiving the service is not the party paying for it. The insurer pays the provider, the patient pays the insurer through premiums, and the employer often pays the bulk of the premium, creating a web of misaligned incentives.

The insurer’s primary economic interest cannot be the quality of clinical care because their bottom line comes down to diversifying risk across a large patient population, hence why they pay higher rates to provider organizations with bigger footprints. In the aggregate, higher quality indirectly produces lower downstream costs in the future, but that association is too diluted and untraceable to have any impact at the transaction level. The patient, who experiences the quality of care directly, has no way of discerning quality they are paying for when choosing a health plan, and in most cases, is not even one making that choice.

Compounding this structural problem is pervasive information asymmetry. Patients can observe certain proxies of care quality (e.g., everything around a service), but they generally cannot reliably assess the quality of that service itself like how they can assess a financial advisor’s investment recommendations through their own performance or through the advisor’s historical performance. The dimensions that matter most are also the least visible. Physicians making referrals face a version of the same problem: even among clinicians, evaluating a peer’s clinical quality across institutional lines is genuinely difficult.

The result of these structural conditions is that the healthcare market defaults to cost competition rather than value competition, but in unique form. The competitive advantage that accrues to large health systems is negotiating leverage rather than clinical excellence, and it hits both the revenue side and the expense side, as size is what both an insurer and a vendor tend to value most. This dynamic explains one of the most counterintuitive findings in healthcare economics: consolidated health systems, on average, command higher prices than independent practices while delivering the same or lower quality of care. In a normally functioning market, a higher price for lower or equal value doesn’t make any sense; it would drive buyers to competitors.

Value-based care models have attempted to address this misalignment by creating financial incentives for insurers and large provider groups to improve clinical quality and reduce the aggregate cost of healthcare. The theory is sound in principle: if both insurers and providers can profit from keeping populations healthy versus volume alone, then the incentive structure should begin to approximate a value-competitive market. In practice, however, the results have been more modest than the theory would suggest. The causal chain between a clinical intervention today and a measurable cost outcome years later is long, indirect, and easily confounded by factors outside any single provider’s control. Measuring quality in ways that are both meaningful and resistant to gaming has proven exceedingly difficult. For individual practices, the administrative burden of participation often consumes a significant share of any financial benefit anyway.

Perhaps the aggregate system will eventually shift to a form with true economic mechanisms that drive prices down and quality up, but business owners seek success now, not eventually. This is the water you’re swimming in, and deliberate strategy is what it takes to stay afloat. And for private practice physicians willing to invest in that strategy, the opportunity is substantial.

The Opportunity For Private Practice

Healthcare economics are also unusual in a way that strengthens the ability to compete on value: geographical containment. A consultant, a software company, or a retailer competes nationally or globally and faces a market where every differentiation strategy has likely already been deployed somewhere by someone. By contrast, a physician practice competes in a radius where the number of direct competitors might be five to fifteen. The question then shifts from “what is everyone in the industry doing” to “what are the handful of practices and / or groups in my area doing, and what are they not doing.” That’s a much more manageable pool to differentiate from and doesn’t necessarily require complete originality.

The opportunities present are naturally more prominent in areas where the patient relationships are of a more recurring, longitudinal, rather than episodic, nature. The clearest evidence of how cash-pay value competition can function in healthcare comes from the specialties where it already operates. Dentistry, elective cosmetic surgery, dermatology, direct primary care, and concierge medicine have developed robust value-competitive markets in which people will pay meaningfully more for providers they believe are better in one way or another.

For private practices considering how to compete on value rather than on volume or cost, the starting point is a pair of diagnostic questions:

1. What inherent characteristics of the practice already exist and can be better leveraged?
2. What valuable capabilities do not currently exist but can be deliberately built?

Strategies for Enhancing Value… And The Bottom Line

Scope Differentiation

One of the most direct ways a private practice can distinguish itself from competitors is through the breadth and depth of services offered. The standard primary care visit, optimized for volume and insurance reimbursement, tends toward a narrow and reactive scope: address the presenting complaint and chronic conditions, order the appropriate preventive screenings, and move to the next patient. This model leaves significant unmet patient demand on the table.

Practices that essentially do more for each patient in their panel create a meaningfully different value proposition and contribute to continuity of care. This could take the form of services a patient might otherwise seek elsewhere or services addressing patient needs that the standard insurance-reimbursed model systematically underserves, the latter case typically lending itself to cash-pay pricing, which breaks the fixed-price constraint and allows the practice to price in proportion to the value delivered. A patient paying out of pocket for a comprehensive metabolic assessment, a personalized nutrition consultation, or a proactive longevity evaluation is making a direct purchasing decision based on perceived value

What does this signal to the patient population? It states, “this group operates differently from the rest; they’re built around comprehensive health.” Consistently reinforcement across the patient experience, in turn, contributes to durable competitive positioning.

Credibility

Professional credentials, training pedigree, and clinical expertise are among the most underutilized competitive assets in medicine. In virtually every other professional services industry (e.g., law, management consulting, investment banking, architecture, etc.), practitioners invest heavily in communicating their credentials and experience, and sophisticated clients use those signals when making selection decisions. Reducing the buyer’s uncertainty about the quality they are purchasing commands higher fees and / or attracts more volume. Therefore, a physician who trained at a nationally recognized program, who has clinical expertise in areas of genuine patient demand, or who has published research or received recognition in their field, has an inherent and meaningful competitive asset that is often underleveraged.

Making credentials legible to patients requires translation. Board certification, fellowship training, and academic affiliation mean relatively little to most patients in their raw form. The strategic task is to communicate what those credentials mean in practical terms: why a specific training background makes a physician better equipped to handle complex diagnostic challenges, or why a particular area of expertise or experience is relevant to the health concerns of the target patient population. Doing this well avoids self-promotion and reads as reassurance and specificity. That signals enhanced value.

Convenience

Convenience goes beyond geographic proximity, which is largely limited outside of startup practice territory, and encompasses the entire patient experience, from the initial phone call to the moment they walk out the door, and even intra-visit communication. Digital scheduling, same-day or next-day availability for acute issues, direct communication channels between patients and their care team, ease of payment, and streamlined administrative processes beat the standard model of weeks-long appointment lead times and phone trees.

Finding and maintaining the optimal balance between productivity and quality of experience can differentiate a private practice substantially from a competing organization built around throughput and cost-control. The signal: “this group respects patients’ time and values the relationship.” That kind of positioning can go a long way for reputation-building.

Reputation Compounding

Reputation is the most powerful competitive asset available to a private practice, and it is one of the few assets that compounds over time in ways that new entrants and large competitors cannot easily replicate.

Building reputation requires deliberate attention to dimensions that many practices allow to develop haphazardly. A few common examples: the physical environment, the aesthetic, the consistency of patient experience, the visual and tonal identity of communications and marketing materials, and the community presence. While often viewed as superficial, these qualities make a difference over the long term by creating an image in people’s minds. Once that image is established, it’s extremely “sticky,” so getting it right is crucial.

For practices with multiple physicians, this means being intentional about culture and ensuring that the experience a patient has with any member of the team reflects the standards and personality of the practice as a whole. For solo practitioners, the physician’s personal brand and the practice’s brand are largely synonymous, which concentrates both the opportunity and the risk. Either way, reputation must be actively cultivated, communicated, and protected.

If You Have It, Leverage It

A common strategic failure in private practice is the failure to communicate competitive advantage that already exists in ways that patients and referral sources can actually act on. A practice with excellent clinical outcomes, a great facility, a physician with exceptional training, and a genuinely differentiated service model is not competing effectively if none of these qualities are visible to the people making decisions about where to seek care. Competitive advantage that is not communicated is not, in any economically meaningful sense, an advantage at all.

The goal expands beyond marketing in the transactional sense of generating patient volume through promotion to the deliberate, long-term construction of a practice identity that is specific, coherent, and credible. The distinction is significant. Marketing aimed at volume tends to look and sound like everything else in the market: generic claims about compassionate care, convenient locations, and experienced physicians. Image-building aimed at positioning creates a distinct and recognizable practice identity that accumulates value over time and becomes progressively more difficult for competitors to replicate.

Every patient interaction, every piece of written communication, every visual element of the practice environment, and every presence in the community contributes either positively or negatively to this identity. Practices that approach these elements with intentionality build reputational assets that compound. Practices that treat these elements as afterthoughts leave value on the table and remain vulnerable to competitive displacement.

For specialty practices, the referral relationship is the primary channel through which both volume and reputation flow, and it deserves the same deliberate attention. Referring physicians make recommendations based on confidence. A specialist who communicates effectively with referring physicians and has a visible and specific clinical reputation in their area of expertise generates referral volume that is far more durable than volume generated by proximity or default. Building these relationships deliberately, and maintaining them with consistency, is among the highest-return activities available to a specialty practice.

Positioning For the Future of Private Practice

The structural barriers to value competition in healthcare are significant but not permanent. The past decade has seen the emergence and gradual expansion of direct primary care, concierge medicine, bundled payment systems, and increasing consumer demand for healthcare experiences that feel more like the rest of the professional services economy: transparent, responsive, and oriented toward the individual patient rather than the aggregate population. These trends are not yet dominant, but their direction is clear, and the practices that have already built value-competitive positioning are disproportionately well-prepared to benefit from a market that is slowly moving in their direction.

Building value-competitive positioning in private practice is an overall orientation: a commitment to delivering and communicating superior value across every dimension of the practice, consistently and deliberately, over time. For physicians with the clinical excellence, entrepreneurial instinct, and business acumen to pursue it, the opportunity is substantial.

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The post Competing on Value in Private Practice appeared first on DoctorsManagement.

Lactation experts Ashana Gupta and Sarah Oakley analyse the case of a dentist who was suspended for failing to gain adequate consent while treating an infant’s lip and tongue ties.

The terms tongue and lip tie refer to congenital conditions whereby the frenulum connecting the lip or tongue to the mouth is too tight. In newborn babies, they can cause challenges with latch, milk transfer, maternal discomfort during breastfeeding, or prolonged feeding times.

While accusations of overdiagnosis have led lip and tongue ties to be the subject of controversy in recent times, it was not the procedure itself that caused the issue in this case. Instead, the dentist was found to have failed to obtain informed consent for some aspects of the treatment.

We spoke to Sarah Oakley, a lactation specialist and tongue tie practitioner, and Ashana Gupta, an oral surgeon and lactation consultant, to gain some insight into what went wrong.

Communication and consent

Both experts stressed that the dentist in question was not criticised for their management of the patient’s tongue and lip tie. Ashana said: ‘The key themes from this case relate less to whether tongue tie release itself is an appropriate treatment, and more to the importance of transparent communication, informed consent and shared decision making throughout the entire patient journey.’

The dentist was also found to have obtained valid consent for the initial tongue tie procedure, informing the parents of the potential risks and even sending them an information pack that they had to sign prior to treatment.

However, the GDC concluded that they did not gain sufficient consent to reopen the wounds at a follow-up appointment.

For Sarah, this raises an important debate around what adequate consent is and how it is perceived by professionals and patients or their parents.

She said: ‘Parents frequently come to practitioners in a heightened state of stress, having experienced significant feeding difficulties for a sustained period of time. They are also often recovering from a traumatic birth experience. Most parents have little experience of surgical procedures, and many have accessed misleading information online and conflicting information and poor support from other healthcare professionals in relation to frenotomy and infant feeding.’

Addressing misconceptions can be very difficult, but is often key to managing expectations and ensuring patients fully understand their treatment.

What misconceptions surround tongue ties?

Sarah has found that many parents believe tongue tie treatment is a ‘quick snip’ which will result in instant improvement. In this case, reopening wounds caused the patient to bleed, which they and their parents found distressing.

She said: ‘Where practitioners are doing anything for which the evidence base is limited or conflicting, parents need to be made aware of that, along with the risks, benefits and alternatives prior to intervention.’

There is strong evidence that tongue tie can lead to reduced tongue mobility and feeding issues in young babies. However, Ashana notes that the evidence is less straightforward surrounding other possible effects of tongue ties such as speech impediments.

She continued: ‘Beyond infancy, a restricted tongue movement may, in some individuals, be associated with functional concerns such as difficulty producing certain speech sounds (for example, some “th” sounds), although the relationship between tongue tie and later speech difficulties is complex and not every child with a tongue tie will experience these problems.

‘This is why assessment should focus on function rather than appearance alone, and decisions should be made based on the individual child’s needs.’

How can consent for treatment of tongue ties be properly established?

Ashana believes that creating an environment that feels safe for the patient and their parents is crucial in tongue tie assessment and treatment. She said: ‘Parents should feel supported with clear, balanced information so they understand the diagnosis, the available options, the potential benefits and risks, and are able to make an informed decision at every stage of care.’

Checking that patients or parents have understood the information provided and keeping detailed records are both central to proving that consent has been established. Ashana advised a thorough explanation of what is being proposed, why it is being considered, the risks and the alternatives – ensuring these conversations are clearly documented.

The suspended dentist informed the patient’s parents that they were going to ‘apply some pressure to release the wound as it looked a bit tight’, and received a nod by way of agreement. This was not considered sufficient by the GDC.

Sarah said: ‘Practitioners offering division, or any surgical procedure, need to ascertain that the parents have fully understood the implications of proceeding with surgery, but this is not always straightforward and overwhelmed, sleep-deprived parents may not assimilate or recollect everything that is said to them.’

Ideally, parents would be given time to consider their options and do further research after an initial consultation. However, Sarah notes that many parents travel to access tongue tie treatment and may be reluctant to delay a procedure while coping with acute feeding issues.

Another crucial precursor to adequate consent is the practitioner’s own understanding of current professional discussions around lip and tongue ties.

What do dental professionals need to know about tongue ties?

Appropriate training is essential for any dental professional undertaking assessment and treatment of oral ties in newborns. According to Ashana, this might include:

• Understanding infant feeding
• A strong grounding in neonatal oral anatomy,
• Knowing the indications for intervention
• Appropriate consent processes
• Aftercare
• Recognising when referral or additional support is required.

There are a number of different techniques for treating tongue and lip ties, including sterile scissors and laser therapy. Ashana said: ‘Laser can provide a precise approach and may offer some haemostatic benefit by coagulating small blood vessels during treatment. As with any procedure, appropriate patient selection, clinical skill, consent and aftercare planning remain fundamental.’

The two experts agreed that the suspended dentist’s approach to treatment went against current thinking at times. While Ashana cited the Association of Tongue Tie Practitioners’ statement that releasing an upper lip tie is not supported for managing feeding difficulties to the same degree as with tongue ties, Sarah explained that reopening wounds after a tongue tie procedure is not a widespread practice as it could promote the formation of more scar tissue.

Sarah concluded: ‘I think all practitioners involved in tongue tie division – be they dentists, doctors, surgeons, nurses or midwives – can learn from this case and we can all take steps to improve our practice as a result.’

Overall, the specialists advised ‘careful assessment and appropriate discussion of the evidence base’ where tongue and lip tie management is concerned.

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CMT2S is a rare, inherited neurological condition that progressively causes muscle weakness and motor function loss.

VCA-894A is being investigated specifically for a patient who was diagnosed early in life with this rare subtype of Charcot-Marie-Tooth disease.

The therapy’s target is a specific genetic variant of CMT2S, which to date has not been observed in other patients.

As determined by the FDA, CMT2S predominantly impacts individuals from birth up to 18 years of age, meeting the established criteria for a rare paediatric disease.

The agency noted in its designation letter that severe disease symptoms largely affect paediatric patients.

Vanda Pharmaceuticals president, CEO and chairman Mihael Polymeropoulos said: “CMT2S is a devastating inherited neuropathy for which patients and families have limited treatment options.

“The FDA’s rare paediatric disease designation recognises the significant unmet medical need in this patient population and supports our efforts to develop a potentially transformative therapy for patients affected by this rare disease.”

The designation is designed to encourage development of new therapies for serious rare diseases mainly affecting children.

Through this, sponsors may qualify for a priority review voucher if their product achieves approval for a marketing application, although the FDA will determine final eligibility at the time of application review.

Vanda Pharmaceuticals is continuing to progress the development of VCA-894A and is coordinating with the FDA on its clinical programme.

The post FDA grants rare paediatric designation to Vanda’s CMT2S therapy appeared first on Pharmaceutical Business review.

Whitehawk Therapeutics will assess them in conjunction with its own ADC linker-payload platform.

Following the evaluation, Whitehawk can choose to further advance any resulting BsADC candidates as part of its pipeline.

Biocytogen’s RenLite platform uses a common light-chain design to support the discovery and optimisation of fully human bispecific antibodies across a wide range of target combinations.

This approach is intended to minimise the risk of light-chain mispairing during development and to support subsequent work on BsADCs.

The collaboration is structured to leverage Biocytogen’s antibody generation capabilities and Whitehawk’s expertise in ADC technologies, with the aim of identifying BsADCs that have differentiated targeting characteristics.

Biocytogen president and CEO Dr Yuelei Shen said: “Whitehawk has established strong expertise in ADC technology and oncology drug development. This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development.

“We look forward to supporting the efficient advancement of multiple programmes by contributing high-quality antibody molecules and integrated research capabilities to identify differentiated therapeutic candidates and ultimately bringing new treatment options to patients with cancer.”

Financial terms include an upfront payment to Biocytogen, with eligibility for additional payments tied to development, regulatory and commercial milestones, as well as low single-digit royalties on net sales.

Other financial details have not been disclosed. If Whitehawk opts to move forward with any BsADC candidates developed through the partnership, it will hold global rights and complete programme control over them.

In April 2026, Biocytogen entered a strategic partnership with Sihuan Pharmaceutical to advance new therapeutics across several disease areas, including weight loss.

The post Biocytogen and Whitehawk partner to develop ADCs appeared first on Pharmaceutical Business review.

The recent H5N1 avian influenza resurgence in poultry farms in certain districts of Maharashtra and Karnataka once again reminds us that human health is connected to animal health. How has animal health science and research evolved to meet these challenges? 

When we see outbreaks like H5N1, it is a very real reminder that animal health and human health are deeply connected. These are not abstract public health concepts. They affect farms, families, food systems, trade and livelihoods, often very quickly. 

Highly Pathogenic Avian Influenza (HPAI) remains one of the most serious threats to global animal health. India has had experience with H5N1 since its first poultry outbreak in Maharashtra in 2006, so the current resurgence builds on a history that has already shown why vigilance, rapid response and coordination matter. According to the World Organisation for Animal Health’s HPAI Situation Report 71 dated May 2025 (1), HPAI has led to the death or mass culling of more than 633 million poultry worldwide between 2005 and 2024, and the recent spread of H5N1 beyond poultry into other species, including mammals, reinforces why surveillance and scientific readiness matter.prediction, prevention, detection and rapid response – from biosecurity and genomic sequencing to faster diagnostics, better field-level.

What has changed is the speed and precision of animal health science. The response is no longer only reactive. It is increasingly built around surveillance and data sharing. 

At Zoetis, this aligns closely with how we think about innovation. With nearly 75 years of experience in animal health, our role is to support veterinarians, producers and public health systems with science that helps predict, prevent, detect and treat disease. 

But science only delivers when the systems around it are strong. That means robust biosecurity, surveillance, rapid diagnostics, transparent reporting and collaboration across government, industry and the veterinary community. Where appropriate and permitted by local policy, vaccination can also be part of that broader disease-control strategy. That is One Health in practice. 

What can be done to proactively detect and predict zoonotic spillover incidents, especially as industrial livestock farming intensifies? 

The shift we need is from waiting for disease to appear, to building systems that help us prevent disease and detect risk earlier. That means stronger biosecurity, surveillance, better field-level sampling, faster diagnostics, genomic sequencing, and the ability to connect data across animal health, human health and the environment. Biosecurity remains fundamental, but it cannot stand alone. It needs to be supported by surveillance, diagnostics, responsible vaccination strategies where appropriate, and clear channels for rapid reporting and response. 

The real opportunity is to make those systems more connected. If something is detected at farm level, that information should move quickly through veterinary, public health and government systems so that risk can be assessed and action taken earlier. Digital platforms, data analytics and AI can support this by helping identify patterns, prioritise risks and enable faster decisions. 

At Zoetis, we have a long history with avian influenza beginning in the early 2000s when we developed a vaccine in response to outbreaks in SE Asia. Since then, we continue to monitor avian influenza as well as many other zoonotic diseases so we can be ready with updated solutions if warranted. 

We are also investing in genomics, predictive analytics and digital tools, and our India Capability Centre is part of that global capability. As livestock systems become more complex, the most effective approach will be a connected One Health system: good farm practices, strong veterinary capacity, science-led surveillance and prevention and close collaboration across industry, government and public health authorities. 

How is India’s poultry sector evolving vis a vis other countries? Has it demonstrated the capability to tackle such public health challenges while balancing growth imperatives? 

India’s poultry sector is evolving quickly, and its importance goes well beyond agriculture. Poultry is one of the most accessible sources of animal protein, and India is now the world’s second-largest egg producer. India also ranks fourth globally in overall meat production, with poultry accounting for nearly half of the country’s meat output. 

The opportunity is significant, but so is the responsibility. As the sector grows, strong animal health systems become even more important. Among larger integrated producers, we are seeing greater focus on biosecurity, veterinary oversight, housing, hygiene and disease prevention. That is encouraging because animal health is not only a welfare issue. It is a productivity, food security and public health issue. India has demonstrated the ability to respond to animal disease threats through national and state-level surveillance, reporting and containment systems. At the same time, recent avian influenza outbreaks show that the next step is consistency: ensuring good biosecurity, veterinary access, rapid reporting and preventive health practices across the full poultry ecosystem. 

What is encouraging is India’s pace of modernisation, technical talent and growing recognition that prevention is far less costly than a serious outbreak. The poultry markets that will lead over the next decade will not simply be those that produce more, but those that grow responsibly and build resilience into the system. 

What are the latest technologies available in this space? 

There is a great deal of innovation happening across poultry health, and I would group it into three areas: prevention, production systems and decision-making. 

On prevention, vaccine science is becoming more precise and adaptable as disease threats evolve. Vector and recombinant vaccines are a fast-growing area, and approaches such as DIVA – Differentiating Infected from Vaccinated Animals – are increasingly important because they support surveillance, disease control and confidence in global trade.

The way vaccines are delivered is also changing. India has seen a remarkable shift from more conventional farmlevel vaccination and treatment-led protocols toward hatchery vaccination and prevention-led health programmes. For Zoetis, our in-ovo vaccination technologies, including Inovoject and Inovoject NXT, are strong examples. They support vaccine delivery during incubation, helping hatcheries automate and standardise vaccination at scale. India has adopted this technology quickly and is one of Zoetis’ strongest markets in Asia for in-ovo vaccination, reflecting how fast the sector is modernising. 

Beyond vaccines, environment-controlled farming is another important advancement. Better control of temperature, ventilation, humidity and housing conditions can improve predictability, productivity and flock health. 

On detection and decisionmaking, faster diagnostics, field-level sampling, genomic sequencing, environmental surveillance, digital platforms and AI are all changing what is possible. They can help identify risks, support faster decisions and strengthen the connection between farm-level signals and public health response. 

That is the direction poultry health innovation is moving in: stronger prevention, more consistent production systems, faster detection and more connected decision-making. 

How affordable and implementable are these technologies for India’s poultry sector, given that each country would have localised situations linked to capex, labour available at poultry farms etc? 

These are exactly the right questions, because technology only matters if it can be implemented in the system where it is needed. In a market like India, affordability and practicality are just as important as scientific sophistication. 

The answer will not be the same for every part of the poultry sector. For larger integrated producers, many technologies – from improved vaccination systems and stronger biosecurity to digital monitoring and diagnostics – are increasingly viable because the business case for prevention is clear. 

For smaller and mediumscale producers, the model has to be different. It cannot depend on every farmer making large capital investments. Shared infrastructure, veterinary extension services, practical farm-level training and partnership models become much more important. For smaller and mediumscale producers, the model has to be different. It cannot depend on every farmer making large capital investments. Shared infrastructure, veterinary extension services, practical farm-level training and partnership models become much more important. 

This is where Zoetis can bring value beyond products alone. We bring both products and services – including technical knowledge, training, field support and experience from different markets – which can help producers of different sizes adopt solutions in a way that is practical for their operations.India also has an implementation advantage: people on the ground. Farm workers can observe changes in flock health, follow biosecurity protocols and escalate concerns quickly, but only if they are trained, supported and given clear protocols. 

So the technologies are implementable, but not through a one-size-fits-all model. The right approach is tiered: advanced systems for larger integrated producers, shared access and support models for smaller producers, and strong basic biosecurity, surveillance and training across the sector. That is how we can partner in the industry’s transition to become more efficient, resilient and sustainable. 

A key feature of preventive strategies is vaccination, be it human or animal health. What are the latest offerings in this space for animal health and the advantages over traditional methods? 

Vaccines are one of the most important tools we have in preventive animal health. Across livestock, poultry and companion animals, they help protect animal welfare, support more reliable food production, and reduce the need to use antimicrobials to manage disease. That is why vaccines should be seen as part of core health infrastructure, not just as a response during an outbreak. 

What is changing is the precision of vaccine science and the consistency of delivery. Compared with more traditional approaches, newer vaccine technologies can be more targeted, more adaptable to changing disease threats, and easier to deliver consistently at scale. In areas such as avian influenza, they can also support surveillance through strategies like DIVA, which we discussed earlier.

Delivery is advancing too. Zoetis in-ovo vaccination technologies, including Inovoject and Inovoject NXT, help hatcheries automate and standardise vaccine delivery at scale, which is especially relevant for modern poultry systems.For India, the opportunity is to make prevention practical across different production systems. That means combining strong vaccine science with biosecurity, surveillance, training and technical support, so that innovation works not only in theory, but in the day-today reality of farms, hatcheries and veterinary practice. 

What is Zoetis’ annual spend on R&D as a percentage of overall revenues? Give us an idea of the projects in the animal health research pipeline to watch out for in this space. 

R&D is central to who we are as a company. Since our IPO, Zoetis has invested more than $6 billion in research and development, reflecting our sustained commitment to science-led innovation. 

What matters is not only the level of investment, but where it is focused. Our pipeline includes 12 potential blockbuster candidates across areas of significant unmet need, including chronic kidney disease, oncology, cardiology, anxiety and obesity in companion animals. We are also continuing to advance innovation in core areas such as osteoarthritis pain, dermatology, vaccines and livestock health. 

One area to watch is precision animal health. Zoetis has announced an agreement to acquire Neogen’s animal genomics business, which would strengthen our capabilities in genomic technologies and data-led insights for livestock producers, subject to closing and regulatory approvals. 

More broadly, the future of animal health will be increasingly integrated. It will not be medicines, vaccines, diagnostics or data in isolation, but these capabilities working together to help veterinarians and producers predict, prevent, detect and treat disease earlier and more effectively. That is where we see the next wave of innovation. 

Besides industrial livestock, the One Health philosophy includes the pet and companion animals. What is the current share of global revenues coming from India and what is predicted growth of the overall animal health market in India? 

India sits within our International segment, which remains an important growth driver for Zoetis. In our most recent quarter, our International segment delivered 10% organic operational growth, and India is an active part of that broader story. The market itself is very promising. Public estimates vary, but India is widely expected to be a high-growth animal health market, driven by the continued importance of livestock and poultry, as well as the rapid evolution of companion animal care. 

On the companion animal side, we are seeing a clear shift. Urbanisation, rising incomes, changing family structures and the growing role of pets in households are changing expectations of veterinary care. Pet owners are becoming more aware of prevention, diagnostics, parasite protection, dermatology and chronic disease management – not just treatment when something goes wrong. 

For Zoetis, the opportunity is to support that transition across both livestock and companion animals: helping producers improve health, productivity and disease prevention, while supporting veterinarians and pet owners with innovative solutions that improve quality of life for pets.

That is One Health in practice – stronger animal health, stronger veterinary capacity and better preventive care contributing to healthier animals, people and communities. 

What are Zoetis’ plans for India? Where does it fit into the company’s overall strategy, besides being a huge market? 

India is an important market for Zoetis, and not simply because of its size. What makes India distinctive is the combination of commercial opportunity, scientific capability and technology talent.We have a strong commercial presence in India, a Veterinary Medicine Research and Development presence in the Mumbai-Thane area, and our Zoetis India Capability Center in Hyderabad, which has become an important part of our global digital and technology capability. That gives India a role beyond local market growth – it contributes to how we innovate for customers globally. 

On the ground, our focus is to expand access to our portfolio across livestock and companion animals, while bringing global innovation to Indian veterinarians, producers and pet owners in a way that fits the market. That includes preventive care, productivity, diagnostics, dermatology, pain management and digital tools that support better decision-making.

More broadly, we want to be a long-term partner in strengthening India’s animal health ecosystem. As India’s ambitions in food production, productivity and companion animal care continue to grow, strong animal health infrastructure will be a critical enabler. What gives me confidence is the depth of talent we see in India – across our teams, our customers, and the veterinary and technology communities we work with. 

References: 1. High Pathogenicity Avian Influenza (Hpai) Situation Report 71 https://www.woah.org/app/uploa ds/2025/06/hpai-report-71.pdf 

viveka.r@expressindia.com
viveka.roy3@gmail.com 

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For a long time, pharma packaging was treated as a back-end function something that got done after the formulation work was complete. The focus was on cost, compliance, and timelines. That view is changing. As geopolitical tensions affect shipping routes, energy prices, and raw material supply, packaging has moved into sharper focus for procurement, supply chain, and leadership teams across the Indian pharmaceutical. 

The triggers are well known: Pritam Shimpi, General Manager-Supply Chain, ACG Packaging Materials explains, “Geopolitical risks are now directly influencing pharma packaging operations. Tensions in the Middle East, uncertainty around key trade routes, freight disruption, energy volatility, war risk and insurance premiums, currency movement, and potential trade restrictions, sanctions, or sudden regulatory changes are creating pressure across the packaging value chain. For Indian pharma packaging, the implications are significant because several packaging inputs are linked to global supply networks, crude derivatives, metals, polymers, films, additives, energy, and international logistics. Any disruption in raw material flow, port operations, shipping routes, container and vessel availability or insurance availability can affect lead times, landed costs, and production planning.” 

“Pharma packaging has therefore moved from being a cost focused support to a critical supply continuity enabler for pharma customers.” 

These are not new developments, but their combined effect on pharma packaging like a function that depends on polymers, aluminium, glass, specialty films, and stable logistics has been meaningful. 

Manish Jain, Director, Naprod Life Sciences, says the impact extends beyond logistics. “Escalating geopolitical tensions, including conflicts in the Middle East and disruptions to critical maritime chokepoints, are creating volatility in global freight, crude and petrochemical markets, directly affecting the availability and pricing of packaging raw materials, increasing transit times, and exposing supply chains to greater risk of delay or interruption. Geopolitical risk also intersects with trade policy shifts, tariffs and export restrictions that can complicate cross-border movement of packaging supplies while amplifying cost pressures and compliance burdens across global markets.” 

Jitendra Srivastava, CEO, Triton Logistics and Maritime, offers a view from the logistics side, “One of the biggest lessons from this year’s geopolitical disruptions is that the most critical risks in pharma are often invisible until they affect continuity. What appears to be a shipping issue quickly becomes a manufacturing issue. Extended transit times, rerouting through the Cape of Good Hope, and changing vessel schedules influence production planning, packaging availability, and inventory cycles.” 

What has changed on the ground 

Giving a market analysis, Ankush Kapoor, Founder, PharmNXT said, “While India’s pharma exports grew by over 5 per cent to $28.29 billion during April-February FY26, the industry’s $32 billion FY26 export target is considered challenging due to tariff uncertainties and geopolitical risks. Achieving this would require exports of nearly $3.7 billion in March 2026, compared to about $1.6 billion in March 2025. 

Dhananjay M. Chaudhari, DGM-Packaging Development(Formulations), Indoco Remedies notes, “India’s pharma exports is rising upto almost by 10 per cent year-onyear, showing the broader export momentum behind generics. More than 60 per cent of exports go to stringent regulatory markets, which strengthens India’s reputation as a reliable supplier of affordable medicines. The recent MiddleEast geopolitical crisis raises packaging material costs, tighten supply and increase logistics risk for India’s pharmaceutical packaging.” 

The industry’s ability to supply these markets reliably depends, in part, on a packaging supply chain that has historically been built around cost efficiency and singlesource procurement. That approach is now showing its limits. 

The most visible impact has been on input costs. Urvee Garg, Director, HAB Pharma, shares what the organisation has seen directly, “Prior to the conflict, PVC was being procured at approximately Rs 115 per kilo; currently, prices have increased to nearly Rs 150 per kilo, although we expect them to stabilise at around Rs 135 per kilo. Similarly, aluminium foil (Alu) prices have surged from around Rs 480 per kilo before the conflict to nearly Rs 650 per kilo now. These are just small examples highlighting the increase in tablet packaging material costs.” 

Rajendra Prasad A, AGMPackaging Development, Maiva Pharma provides a wider view of cost movement, “The Iran–US–Israel conflict and disruptions in the Hormuz have emerged as one of the most critical risks in 2026. This has impacted energy supplies (oil, gas), petrochemical feedstocks (critical for plastics and polymers) and global shipping routes. India imports a significant portion of crude oil via this region, and disruptions have caused raw material cost increases significantly in some cases and plastic resin prices from 50 per cent to 60 per cent. 

He also notes that, “Recent tariff escalations particularly from the US and EU have introduced higher input costs (metals, polymers, components), uncertainty in export markets and supply chain reconfiguration pressures. Tariffs of 20–40 per cent (potentially up to 200 per cent) on pharmaceutical-related goods are expected to increase cost burdens and force relocation strategies.” 

Since packaging materials from PVC and HDPE to aluminium and specialty films are tied to petrochemical and energy markets, any disruption in feedstock supply or energy pricing tends to move through the entire packaging value chain.

The feedstock connection 

To understand why pharma packaging is affected, it helps to look upstream. Many packaging materials are manufactured from petrochemical feedstocks such as naphtha, ethylene, and propylene. India imports a significant share of these from the Middle East region. 

Chaudhari explains, “Feedstocks such as naptha, ethylene, propylene and other derivatives which India is mainly exporting from Middle-East region is hampered due to Middle-East crisis. Many primary packaging materials such as bottles, blister films production is constrained due to reduced supply or shipping of feedstock causing tightened supply and price hike affects almost all pharmaceutical sector in India.” 

On the logistics side, route disruptions have added to the challenge. Shivaji Chakraborty, Head of Packaging Development, Fresenius Kabi Oncology notes, “Attacks in the Red Sea and tensions in the Strait of Hormuz force vessels to reroute around Africa, adding weeks to transit times and sharply increasing the freight costs forcing Indian farms to rethink sourcing strategies.” For temperature-sensitive products, longer transit times also raise questions around product integrity. Chaudhari points out, “Just-in-time inventories with only weeks’ cover are vulnerable — shortages are forcing production slowdowns, product reformulation, or use of inferior substitutes that may affect regulatory compliance or shelf-life.” Dr Sufi Roomi, Medical Spokesperson, Jolly Healthcare shares, “One of the main risks today is overdependence on limited geographies for all packaging inputs, well specialised materials, polymers and other allied suppliers. Any kind of disruption in shipping routes, customs movement, cost of energy and directly impact timelines of packaging and in turn product dispatches schedule. For all pharma companies, even a slight delay in availability of packaging can impact market commitments, and patient access.” 

Availability is as much a concern as cost 

Rising costs are one issue. The other and in some situations the more pressing one is availability. When supply is tight, materials can go to buyers who pay a premium or commit to advance payments, leaving others with longer lead times or gaps in supply. 

Jain says the current environment has exposed structural dependencies in packaging sourcing. “Packaging material availability is being stressed by supply chain dependencies on foreign petrochemical inputs and long logistics corridors, while shipping route disruptions cause lead time volatility and higher insurance and freight costs; this, combined with heavy reliance on imports of specialised materials such as polymers and barrier components, can impede operational continuity and force firms to reallocate inventory, change carriers, or resort to costly expedited shipping.” 

Garg describes a specific situation her organisation has faced, “We have one product that is an extremely important brand for us. To prevent counterfeiting, we use a holographic film on the PVC sheet for its packaging. We currently have two approved vendors for this material, both of whom are very large listed companies specialising in high-security packaging solutions. However, even these suppliers are facing difficulties in maintaining consistent supply during the current conflict situation. This, in turn, has a significant impact on our operational continuity.” 

The regulatory structure of the pharma industry means that supplier changes are not quick. An alternate source needs to go through qualification, documentation, and change control before it can be used. When even established, approved suppliers face supply issues, companies have limited immediate options. 

Shimpi frames the implication for how the industry needs to think about suppliers, “Supplier reliability is no longer measured only by price and quality; it must also include continuity capability, feedstock risk management, early communication, and compliance support.” 

Srivastava puts the same point in the context of logistics planning, “The challenge today is less about whether packaging materials are available and more about whether they arrive with the predictability that pharmaceutical operations require. Inputs that once moved through stable freight cycles are now exposed to disruptions that can alter timelines with little warning, creating uncertainty across production schedules and supplier commitments.” 

A different kind of risk: Compliance and serialisation 

tics, there is a dimension of the geopolitical impact that tends to get less attention: the effect on compliance and serialisation. As trade relations between countries shift, destination markets are introducing their own data and traceability requirements, and these are not always aligned with each other. 

Siddharth Reddy, CoFounder, AltiusHub mentions, “The risk most operators underestimate is not material scarcity but regulatory fragmentation. As trade blocs harden, every major destination market is mandating its own serialisation and reporting regime, and they are diverging rather than converging. India exports to over 50 regulated markets, each with its own data format, reporting cadence and national portal. A packaging line that was compliant for one corridor can be non-compliant for another overnight when a regulator updates a mandate. The geopolitical story for packaging is increasingly a data-sovereignty story, not just a logistics one.” 

Reddy also highlights an aspect of the hardware supply chain that many quality teams have not had to consider before, “The industry’s dependence on a narrow set of geographies for specialty films, foils, aluminium, and crucially the electronic components inside vision systems and printand-apply hardware, means a single export control or port disruption can idle a line even when the drug substance is available. We have seen lead times on serialisation-grade printers and cameras stretch precisely when shipping lanes get politicised. Packaging continuity now depends on hardware supply chains that most quality teams have never had to think about.” 

This points to a broader reality. The packaging function today has more dependencies on materials, logistics, hardware, and data infrastructure than it did even five years ago. Each of these can be affected by geopolitical developments, and they do not all respond to the same mitigation strategies. 

How companies are responding 

Across the industry, the response to these pressures has broadly moved in a few directions: building buffer stocks, qualifying more suppliers, diversifying sourcing geographies, and investing in supply chain visibility. 

Chakraborty outlines the near-term actions being taken: “Build safety stock of imported packaging materials, viz., aluminium foils, polymers, and inks to absorb shipping delays… use multimodal transport (air, sea and rail) and reroute via Europe or Central Asia to avoid Red Sea bottlenecks… Source packaging materials/raw materials from other countries including Europe to reduce dependency on China and Gulf countries.” 

Garg describes the broader pattern she has observed: “Pharma companies are increasingly adopting multi-vendor sourcing strategies and expanding partnerships with domestic packaging suppliers to reduce overdependence on single geographies or suppliers. Vendor qualification programs are also being strengthened to build flexibility and ensure continuity during disruptions. Many organisations are maintaining higher safety stocks for critical packaging materials and investing in better forecasting and supply chain visibility tools.” 

Kapoor identifies the shift in thinking this is prompting: “There is a shift away from the lowest cost supply chain philosophy to that of lowest risk qualified supply. This is evident in firms making safety stocks for critical components, qualifying alternative suppliers, regionising critical raw material supplies as well as getting packaging and process containment vendors involved early on in the manufacturing design.” 

Srivastava describes this same shift from the logistics side: “The most significant change we are witnessing is a move away from efficiencyonly models toward resilienceby-design. Pharma companies are no longer treating alternate routes as contingency plans; they are becoming part of the network architecture from the outset. Dual-route sourcing strategies, diversified ports of entry, and multimodal flexibility are increasingly standard expectations rather than exceptional measures.” 

He also highlights what visibility can do for companies during periods of disruption: “Real-time shipment intelligence allows disruptions to be identified early and responses to be activated before they escalate into operational challenges. The invisible journey of a resilient supply chain lies in its ability to adapt quietly in the background so that manufacturers, healthcare providers, and ultimately patients experience continuity rather than disruption.” 

An important context comes from Shimpi: “Alternate sourcing requires quality checks, documentation, validation, customer approval, qualification, change control, and regulatory discipline. For customers, resilience must not mean uncontrolled substitution. It must mean pre qualified, compliant, and approved alternatives.” 

The pharma supply chain operates within a regulatory framework that does not allow for quick substitutions, even under pressure. Companies that move too fast on alternate sourcing without following the required steps may create compliance problems that are harder to resolve than the original supply issue. 

Sustainability amid disruption 

The industry was already working through sustainability commitments when the geopolitical pressures intensified. For pharma packaging, the two objectives: supply continuity and reduced environmental impact do not always point in the same direction. 

Dr Roomi reflects, “The industry also needs to balance both sustainability and continuity. Eco friendly packaging is very significant, but it should be practical, compliance and scalable during the essential conditions of supply. Future ready pharma packaging also requires those material which are safe, cost efficient and adaptable to continuous changing regulations.” 

Garg is straightforward about the specific challenge pharma faces: “When it comes to sustainability goals, the answer is slightly more complex for the pharma industry. In many other sectors, it is comparatively easier to reduce or eliminate the use of single-use plastics. However, in pharma, where sterility and minimal exposure are critical requirements, it becomes far more difficult to completely move away from plastic-based packaging materials.” 

Srivastava notes that sustainability and logistics are now being looked at together rather than separately: “We are also seeing a meaningful shift in sustainability thinking. Packaging design, weight optimisation, emissions, and transport modes are no longer being evaluated independently. Companies are increasingly viewing them as interconnected decisions that influence both environmental performance and long-term supply chain resilience.” 

The longer-term picture 

The current disruptions have brought to the surface a structural issue: India’s domestic packaging material manufacturing capacity has not kept pace with the country’s pharmaceutical ambitions. This gap is something companies are now more directly aware of. 

Garg points to the plastics sector as a specific area that needs attention: “India needs to improve both the quality and availability of pharmaceutical-grade plastics. I believe this is one area where the industry is still lacking. At present, there is one major corporation manufacturing high-quality plastic materials, but even they are not always able to meet the volumes required by the market. Apart from them, very few players can consistently match the same quality standards. There is a strong need for greater investment in the plastics manufacturing sector, along with government support to encourage the growth of more companies in this space.” 

Shimpi points to the role of digital systems: “Digital tools and digital manufacturing will play a major role in building early risk visibility and faster response capability. Stronger systems for demand sensing, inventory visibility, supplier monitoring, logistics tracking, scenario planning, real time operational visibility, advanced quality systems, and data led decision making can help companies respond before disruption reaches the customer.” 

Kapoor frames the investment case in terms of India’s next growth opportunity: “Estimates show that 118 biologics will lose patent protection between 2025 and 2034, opening a $232 billion to $234 billion biosimilar opportunity. It has also been reported that biologic drugs with more than $300 billion in global sales are set to lose patent protection over the next decade. India has recognised this shift through Biopharma SHAKTI, a Rs 10,000 crore, five-year initiative to strengthen biologics and biosimilars, with an ambition to capture 5 per cent of the global biopharma market. To make this real, India must localise the critical enabling layer: specialty films, sterile bags, tubing, connectors, filters, cold-chain systems and traceable packaging formats. Future-proofing will come from validated localisation not basic import substitution.” 

Prasad highlights, “For Indian pharma companies, packaging functions must evolve from a transactional role to a strategic pillar of supply chain resilience. Proactive diversification, localisation, innovation, and long-term planning will be essential to ensure uninterrupted supply, regulatory compliance, and product integrity in an increasingly uncertain global environment.” 

The road ahead 

The geopolitical pressures affecting pharma packaging are unlikely to ease quickly. Supply chain dependencies built over many years will take time to reconfigure. Regulatory frameworks in destination markets will continue to evolve. Input costs will remain linked to global energy and commodity markets. 

Srivastava is clear about what the long-term response needs to look like: “Looking ahead, resilience must become a built-in capability rather than an emergency response mechanism. Diversifying sourcing geographies for critical packaging inputs, strengthening regional supply networks, and reducing dependency on single trade corridors will be essential for long-term stability. We are already seeing companies reassess traditional supply models and create greater redundancy across both procurement and logistics functions.” 

Chakraborty summarises where the industry stands: “Indian pharma is being squeezed by higher costs, shipping delays, and stricter compliance. Short-term resilience comes from buffer stocks, agile logistics, and supplier diversification, while long-term stability requires local manufacturing, smart packaging, and trade alliances.” 

Shimpi puts the collaboration agenda plainly: “Pharma companies and packaging partners must work more collaboratively. Early demand visibility, faster approvals for alternate sources, transparent cost discussions, and joint risk planning will be essential to protect medicine availability in an increasingly uncertain world.” 

Reddy makes the case for treating packaging as a strategic function: “Standardise internal master data so you are mandate-agnostic; insist on interoperable, exportable serialisation data so no single portal or vendor can strand you; wargame disruptions the way other industries run continuity drills; and elevate compliance from a cost centre to a board-level resilience function. India’s advantage as the world’s pharmacy will, over the next decade, be defended less at the chemistry bench and more in the packaging hall, where physical integrity and digital traceability meet.” 

The current situation has made clear that packaging is not just a downstream activity. It carries supply risk, cost risk, compliance risk, and in the longer run, competitive risk. How the industry responds to that reality including how much it invests in building domestic capacity and better supply chain structures will shape its ability to meet export commitments and grow in regulated markets over the years ahead. 

Kalyani.sharma@expressindia.com 

journokalyani@gmail.com

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Introduction: Moving beyond conventional QbD

Quality by Design (QbD) has become a cornerstone of pharmaceutical development by enabling a structured, science- and risk-based approach to formulation and process design. Regulatory frameworks such as ICH Q8 and ICH Q9 emphasize linking critical quality attributes (CQAs) to formulation and process variables to ensure consistent product performance.

However, as formulations become more complex, traditional QbD approaches—largely dependent on Design of Experiments (DoE)-face practical limitations. These include challenges in capturing non-linear interactions, increasing experimental burden, and limited ability to predict outcomes beyond defined experimental spaces.

Artificial intelligence (AI) tools, particularly artificial neural networks (ANN), offer a complementary approach by enabling predictive, data-driven modeling. Integrating ANN within QbD frameworks provides an opportunity to move from empirical development toward a more efficient and predictive paradigm.

“AI-enabled QbD is transforming pharmaceutical development from experimental optimization to predictive, data-driven design.”

Hybrid QbD–AI framework

A hybrid QbD–AI approach integrates structured experimentation with advanced modeling to improve formulation understanding and optimization. In this framework, initial DoE studies generate experimental data that are used to train ANN models. These models extend the design space, identify complex relationships, and support virtual optimization of formulation variables. Experimental confirmation then validates predictions, enabling robust and scalable formulation design.

“The integration of artificial neural networks within QbD enables the identification of complex, non-linear relationships that traditional models fail to capture.”

Hybrid QbD–AI workflow (practical view)

1. Define QTPP and CQAs

2. Run initial DoE screening to generate structured data

3. Train ANN on curated formulation/process datasets

4. Predict and refine the design space

5. Confirm with targeted validation runs

6. Establish control strategy and monitoring plan (PAT-enabled)

Figure 1. Hybrid QbD–AI framework for formulation development. Integration of traditional QbD elements with AI-driven modeling enables predictive design space expansion, optimized formulation selection, and robust control strategy development.

A comparative summary of traditional and AI-enabled QbD approaches is provided in Table 1

Table 1. Comparison of Traditional QbD vs AI-Enabled Hybrid QbD Approaches

“The integration of AI into QbD enables a shift from experimental optimization to predictive and knowledge-driven formulation development.”

Application example

In a representative application aligned with previously published work (Singh et al., 2026), artificial neural networks (ANN) were integrated within a QbD-guided formulation development strategy to optimize a multi-component modified release tablet system. Initial DoE studies were conducted to evaluate key formulation variables and their influence on CQAs. The resulting dataset was used to train ANN models capable of capturing non-linear relationships not fully described by conventional statistical approaches.

In the published study, the ANN model showed excellent predictive performance, with generalized R² values of 0.9989 (training), 0.9999 (validation), and 0.9988 (test), supporting reliable optimization of polymer ratios and modified-release performance.

These findings highlight the practical value of integrating AI within QbD frameworks to enhance formulation robustness, scalability, and development efficiency.

“Hybrid QbD–AI approaches significantly reduce experimental burden while improving formulation robustness and scalability.”

“AI models enable expansion of the design space beyond experimental boundaries, enhancing predictive confidence.”

Figure 2. Comparison of Traditional QbD and AI-enabled Hybrid QbD approaches.

Impact on manufacturing and scale-up

AI-guided models improve scale-up predictability by quantitatively linking critical material attributes (CMAs) and critical process parameters (CPPs) to CQAs across scales. By identifying process sensitivities and non-linear interactions, these models enable more robust design space definition and support control strategy optimization. Integration with process analytical technology (PAT) further allows data-driven monitoring and reduces variability during scale-up, technology transfer, and commercial manufacturing.

AI models should be managed under lifecycle governance (e.g., version control, retraining criteria, and audit trails) to support sustainable deployment within a pharmaceutical quality system.

“AI-guided formulation development improves scale-up predictability and reduces risk during commercialization.”

Practical adoption checklist (industry-ready)

• Use structured DoE to generate high-quality training data and avoid bias in factor coverage.

• Define CQAs and acceptance criteria before model training (QTPP-driven).

• Validate ANN predictions using an independent confirmation set before expanding the design space.

• Translate model outputs into a control strategy and monitoring plan (PAT where appropriate).

• Maintain model governance through documentation, change control, and periodic performance review.

Analytical procedures supporting PAT, release, and stability testing should follow science- and risk-based development and validation principles consistent with current ICH guidance (e.g., ICH Q14 and ICH Q2(R2)).

Conclusion

Hybrid QbD–AI approaches represent a significant advancement in pharmaceutical development, enabling more predictive, efficient, and robust formulation design. By integrating AI with established QbD principles, these approaches improve understanding of complex formulation–process relationships, enhance design space definition, and support robust control strategies across development and manufacturing. As pharmaceutical systems become increasingly complex, AI-enabled QbD frameworks offer a practical pathway toward more informed, efficient, and reliable product development.

“The future of pharmaceutical R&D lies in converging QbD principles with AI-driven predictive modeling.”

References

1. Singh, P.K., Kumar, V., Parihar, A., et al. AI-Powered Predictive Modeling to Optimize Pharmaceutical Formulation and Precise Drug Delivery in Modified Release Tablets. Journal of Pharmaceutical Innovation. 2026; 21:52. https://doi.org/10.1007/s12247-025-10283-2

2. International Council for Harmonisation (ICH). ICH Q8(R2): Pharmaceutical Development. Final version (Step 4), August 2009. https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf

3. International Council for Harmonisation (ICH). ICH Q9(R1): Quality Risk Management. Final version (Step 4), adopted 18 January 2023. https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2022_1219.pdf

4. International Council for Harmonisation (ICH). ICH Q10: Pharmaceutical Quality System. Final version (Step 4), 4 June 2008. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf

5. International Council for Harmonisation (ICH). ICH Q14: Analytical Procedure Development. Final version, adopted 1 November 2023. https://database.ich.org/sites/default/files/ICH_Q14_Guideline_2023_1116.pdf

6. International Council for Harmonisation (ICH). ICH Q2(R2): Validation of Analytical Procedures. Final version, adopted 1 November 2023. https://database.ich.org/sites/default/files/ICH_Q2%28R2%29_Guideline_2023_1130.pdf

(Paritosh Singh is a pharmaceutical R&D leader with extensive expertise in advanced drug delivery and AI-driven formulation development, leveraging Quality by Design (QbD), statistical modeling, and machine learning to develop robust and scalable pharmaceutical products. He is recognized for original and impactful contributions to the application of artificial intelligence in formulation science, with influence across multiple development programs. He has held critical scientific roles within global pharmaceutical organizations, including Jubilant, Johnson & Johnson, and Perrigo. He serves as a reviewer for leading scientific platforms, including AAPS and the Journal of Controlled Release, and as an international award judge, including AOAC scholarship panels, reflecting peer recognition of his expertise and contributions to the field.)

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A team led by scientists at La Jolla Institute for Immunology (LJI) and Scripps Research now reports a potential breakthrough. In a study published in Nature, the researchers demonstrated that a germline‑targeting HIV vaccine can elicit bnAbs in outbred nonhuman primates. The study is titled, “Vaccination elicits HIV broadly neutralizing antibodies in primates.”

Germline targeting represents a fundamentally different vaccine design philosophy. As the authors wrote, it is “a conceptually radical vaccine design approach to elicit bnAbs, aiming to prime rare bnAb‑precursor B cells possessing pre‑determined human genetic and structural features shared with template bnAbs, and then guide B cell affinity maturation to potent bnAb evolution with heterologous boosters.”

To test this strategy, the team engineered protein immunogens that mimic key HIV envelope structures known to initiate bnAb development. Rhesus macaques received a priming immunogen designed to activate naive B cells, followed by a sequence of booster shots that guided those cells through the necessary maturation steps. “This series of vaccinations will guide, or ‘walk,’ a B cell from its naive state to its broadly neutralizing state,” explained co-first author and LJI instructor Patrick Madden, PhD.

The researchers reported that bnAb‑class memory B cells emerged in at least half of the animals, and “serum bnAb activity developed in 44% of animals.” In the strongest responder, bnAb titers reached titers “expected to confer protection against diverse HIV isolates,” according to the authors.

Human translation is already underway. The priming immunogen used in this study has been evaluated in the HVTN 144 trial and is currently being tested in the Phase I IAVI G004 trial. Shane Crotty, PhD, LJI professor and CSO, noted that the approach may perform even better in humans due to immunogenetic factors.

The next challenge is optimization—refining booster sequences, improving response rates, and ultimately demonstrating protection. But this study provides long‑sought proof of principle, according to the authors: “Germline-targeting vaccines can reproducibly elicit prespecified classes of bnAbs to prespecified epitopes under endogenous conditions, supporting further optimization of this approach for HIV vaccine development.”

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Privately-held Myricx specializes in developing ADCs that use N-myristoyltransferase inhibitor (NMTi) payloads, an approach designed to deliver a differentiated cancer-killing payload directly to tumor cells. Myricx says its ADC approach holds the potential to address limitations of TOPO-1 inhibitors, tubulin inhibitors, and other commonly used ADC payload classes—ranging from toxicity to healthy cells, to tumor resistance, to dose-limiting adverse events.

The acquisition deal is designed to combine Myricx’s two lead ADC assets and next-generation first-in-class NMTi payload platform with Novartis’ expertise in developing cancer therapies.

According to Myricx Bio, preclinical data suggests that its NMTi payload may have broad activity across multiple solid tumors, including TOPO-1-resistant models, and may enable more effective use of ADCs in settings where existing payload classes have limitations. NMT is an enzyme responsible for the addition of myristic acid, a 14-carbon fatty acid, to the N-terminus of multiple proteins that are crucial for cancer cell survival.

“ADCs have become an important part of cancer treatment, but there remains a clear need for new payload mechanisms to overcome resistance and expand their impact for patients,” Fiona Marshall, PhD, Novartis’ president of biomedical research, said in a statement. “Myricx Bio has developed a promising NMTi payload platform with a differentiated mechanism that could broaden the use of ADCs across multiple tumor settings.”

Marshall added that the Myricx Bio acquisition “reflects our strategy to scale innovative platforms, as we have with radioligand therapies, to deliver more durable, transformative treatments for patients.” In February, Novartis announced plans to build a 46,000-square-foot radioligand therapy (RLT) manufacturing site in the Dallas-Fort Worth suburb of Denton, TX.

Novartis investors reacted by sending its shares traded on the SIX Swiss exchange down 2% Monday, from CHF 127.92 ($157.69) to CHF 125.10 ($154.22). Novartis’ American Depositary Shares (ADSs) traded on the New York Stock Exchange dipped 3%, from $159.90 to $155.08 as of 10:13 a.m. ET

Until now, Myricx has said little about its two lead NMTi-ADC candidates, except to disclose on its website that it is prioritizing one that targets B7-H3 and the other, HER2, “based on compelling preclinical efficacy and safety data across multiple solid tumor-associated antigens and cancer cell types.”

Novartis agreed to shell out $1.1 billion cash upfront plus up to $400 million tied to achieving milestones. The transaction is expected to close in the second half of this year, subject to satisfaction or waiver of customary closing conditions, including regulatory approvals.

“Transformative promise”

“We are delighted that Novartis recognizes the transformative promise of our NMTi-ADC platform to deliver this next-generation of potential first-in-class, highly differentiated ADC therapeutics,” stated Mohit Rawat, Myricx Bio’s CEO. “Together with Novartis, we look forward to building upon our work to transform the landscape of cancer treatment.”

Rawat joined Myricx last year with the goal of steering the company through preclinical development and its next stage of growth.

Founded in 2019, Myricx Bio was spun out from Imperial College London and the Francis Crick Institute by Ed Tate, PhD; Roberto Solari, PhD; and Andrew Bell, PhD, with support from Cancer Research UK, as well as seed investment from Brandon Capital and Sofinnova Partners.

Myricx’s co-founders and their collaborative teams discovered that NMT played a vital role in maintaining multiple critical, diverse cellular processes in cancer cells, including vesicle trafficking, growth factor signaling, cancer cell survival, mitochondrial biogenesis, and cancer cell metabolism.

Under CTO Robin Carr, PhD, Myricx Bio raised £90 million ($114 million) in a Series A financing in mid-2024 led by Novo Holdings and Abingworth, joined by British Business Bank, Cancer Research Horizons, Eli Lilly, and existing investors. This enabled the company to scale its operations and expand the team to rapidly advance its pipeline.

The planned acquisition of Myrocx Bio is Novartis’ third major deal this year focused on boosting its cancer pipeline.

On June 24, Antares Therapeutics announced it would receive $105 million upfront from Novartis through a strategic collaboration to discover, develop, and commercialize small molecule therapies against promising but historically undruggable oncology targets. Novartis also committed to paying Antares up to $1.8 billion tied to achieving additional option exercise, development, regulatory, and commercial milestones, as well as tiered royalties on global net sales.

And in March, Novartis committed up to $2 billion upfront toward acquiring Pikavation Therapeutics, a subsidiary of Synnovation Therapeutics that specializes in developing PI3Kα inhibitor programs designed to treat forms of cancer. Novartis also agreed to pay up to $1 billion in payments tied to achieving development, regulatory, and commercial milestones.

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Based in San Diego, Crinetics focuses on discovering, developing, and commercializing therapeutics for endocrine diseases. The company’s first marketed drug Palsonify^® (paltusotine), an oral SST2 agonist, was approved by the FDA in September as the first and to date only once-daily oral therapy for adults with acromegaly, a debilitating condition which affects an estimated 20,000 Americans. Palsonify won European Commission approval in April and is under review by regulators elsewhere in the world.

Palsonify has enjoyed rapid uptake among acromegaly patients, with Crinetics reporting the drug generated net product revenue of $10.3 million during the first quarter, with 232 patients enrolling for treatment. Approximately 70% of patients treated with Palsonify at the end of Q1 were on reimbursed therapy—reflecting payers increasingly agreeing to cover the treatment, according to the company.

Within the first two quarters of its U.S. launch, Palsonify was prescribed by 263 unique healthcare providers.

Under its generic name paltusotine, the drug is in Phase III study for a second indication of carcinoid syndrome, a rare condition resulting from neuroendocrine tumors.

‘Excellent strategic fit’

“Crinetics is an excellent strategic fit for Vertex, with its focus on serious diseases in specialty markets with significant unmet need, well-understood causal human biology, and potentially best-in-class medicines that could deliver transformative benefit to patients,” Reshma Kewalramani, MD, Vertex’s CEO and president, said in a statement. “We believe Vertex can build on the strong momentum of the Palsonify launch by applying our experience in commercializing medicines for rare genetic diseases.”

Crinetics investors agreed, roaring their approval of the pending acquisition as the company’s shares all but doubled in early trading Tuesday, zooming 99% to $83.54 as of 10:28 am ET from yesterday’s closing price of $42.03. Vertex shares dipped 2% to $516.48 from $529.59 at Monday’s closing bell.

Also in late-stage development is Crinetics’ lead pipeline candidate atumelnant, an oral adrenocorticotropic hormone (ACTH) antagonist now under development for congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing’s syndrome.

In classic CAH, a rare chronic genetic disease with 17,000 addressable patients in the U.S., atumelnant is in a pair of clinical trials. One is a Phase III study in adults with the most common cause of the disease, 21-hydroxylase deficiency (21-OHD). The study’s estimated primary completion date is May 2027 (NCT07144163). The other trial is a Phase II/III study in children ages one to <18, which has an estimated primary completion date of March 2030 (NCT07159841).

Earlier Phase II studies of atumelnant showed that patients treated with the therapy achieved near normalization of excess androgen levels on physiologic replacement doses of glucocorticoids—a therapeutic profile that Crinetics  has said positions atumelnant to become the leading treatment for people with CAH.

Atumelnant (formerly CRN04894) is also being developed for ACTH-dependent Cushing’s syndrome, and is under study in a Phase Ib/IIa open-label, multiple-ascending dose exploratory study (NCT05804669) designed to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with the treatment.

‘Significant potential’

“We are also excited by the significant potential of atumelnant to transform the treatment landscape for CAH, setting a new standard of care where patients do not have to choose between managing their excess adrenal androgens and enduring the side effects of high-dose steroids,” Kewalramani said.

One analyst said a Vertex buyout would be good news for Crinetics.

“This is a solid outcome for CRNX, given stock pressure from the near-term Palsonify launch (generally slow and steady launch but (+) [positive] progress by CRNX so far) and the fact that key Phase III catalyst for CAH isn’t until late 2027/28,” Jefferies equity analyst Dennis Ding wrote today in a research note.

In a regulatory filing yesterday, Crinetix shared an email it sent to employees, stating: “We have always been confident in the ability of Crinetics to achieve our plan and were not actively looking to sell the company when Vertex approached us. However, after careful consideration, our board unanimously determined that the transaction is in the best interests of our shareholders.”

Crinetics’ pipeline of more than 10 disclosed candidates includes:

• CRN09682, a Phase I nonpeptide drug conjugate candidate being developed to treat somatostatin receptor 2 (SST2) expressing neuroendocrine tumors and other SST2 expressing solid tumors.
• Discovery-phase preclinical programs focused on endocrine targets that include thyroid stimulating hormone (TSH), parathyroid hormone (PTH), somatostatin receptor 3 (SST3), growth hormone (GH), glucagon-like peptide 1 (GLP-1), and glucose-dependent insulinotropic polypeptide (GIP), as well as GPCR-targeted oncology indications.

Vertex said the deal was expected to contribute immediately to revenue growth via the ongoing launch of Palsonify, which the company says has blockbuster (greater than $1 billion in annual sales) potential in acromegaly. Longer term, Vertex says, atumelnant could also generate multiple billions of dollars in CAH, with additional revenue potential in Cushing’s syndrome.

$5B revenue forecast

At peak year, Palsonify and atumelnant could deliver more than $5 billion in combined annual revenue, Vertex said, and thus contribute toward its goal of delivering sustained double-digit revenue growth, plus industry leading operating margins. The transaction is expected to add to non-GAAP operating income as of 2029.

Jefferies analyst Ding commented that atumelnant in CAH is expected to generate the largest share of the projected $5 billion, as in $2 billion to $3 billion, plus another $1 billion to $2 billion for Cushing’s syndrome–with the remaining $1 billion to be generated by Palsonify in acromegaly.

Scotiabank analyst Louise Chen told Reuters: “The deal ​adds a fifth vertical, endocrinology, which helps diversify VRTX’s concentration in CF.”

That concentration has proven lucrative for Vertex: During Q1, CF treatments generated $2.915 billion in total revenues, 98% of the company’s total revenue of $2.987 billion.

Vertex has agreed to acquire all outstanding shares of Crinetics common stock for $85 per share cash, in a deal valued at $8.8 billion net of estimated cash acquired. Vertex said it expects to finance the acquisition using a combination of cash on hand and debt, supported by $4.5 billion of fully committed bridge financing from Bank of America and Morgan Stanley Senior Funding.

Vertex finished the first quarter with cash, cash equivalents, and total marketable securities of $13 billion, up from $12.3 billion as of December 31, 2025. The company attributed the increase primarily due to cash flows from operating activities, partially offset by repurchases of Vertex’s common stock.

The transaction is expected to close in the third quarter subject to customary closing conditions, including receipt of regulatory approvals and approval by Crinetics shareholders.

“Nearly 18 years ago, we founded Crinetics with a clear goal of transforming the lives of patients living with endocrine-related diseases. Today marks a historic milestone as we embark on this next chapter with Vertex,” stated R. Scott Struthers, PhD, Crinetics’ co-founder and CEO. “Vertex’s global infrastructure and commercial footprint will serve to amplify the reach of our science and allow us to maximize the impact of Palsonify, atumelnant and our pipeline.”

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The United States Pharmacopeia (USP) is proposing a new approach for its work to support the quality and availability of selected biologic medicines. Building on decades of experience in setting public standards for protein therapeutics, from insulins to growth hormones, USP is now advancing an evolved approach tailored to the complexity of biologics.

At the center of this evolution is the launch of emerging standards for biologics on USP’s Emerging Standards Platform. This platform enables an agile, iterative approach to shaping a potential standard and has grown in scope from focusing on analytical methods for small-molecule medicines to proposals for digital standards and now includes product-specific methods of analysis for biologics. This platform allows concepts in early development to be shared with the community prior to any compendial consideration in order to solicit feedback and stimulate a dialogue that contributes to its evolution.

The initial release includes methods for the analysis of Bevacizumab, Epoetin, Interferon beta 1-a, and Rituximab, spanning both glycosylated proteins and monoclonal antibodies. Together, these are intended to engage stakeholders and facilitate collaboration.

GEN sat down with Diane McCarthy, PhD, USP vice president of biologics, to discuss why USP published these tools, how industry can use these emerging standards, and what lies ahead.

GEN:  Last month, USP published “Emerging Standards for Bevacizumab, Epoetin,Interferon beta 1-a, and Rituximab.” What are these emerging standards?

Diane McCarthy: Emerging standards are concepts that USP shares with the scientific community to bring awareness and stimulate early discussion around a specific molecule, method, or attribute. Scientific experts may test or apply these emerging standards, submit comments, or propose additional test methods to be added. Emerging standards are developed outside of the normal compendial process to enable early stakeholder feedback. If an emerging standard evolves to the point of entering the official USP Documentary Standards process, it would go through USP’s formal notice and comment procedures through publication in the Pharmacopeial Forum.

The format of these emerging standards is different from current compendial standards and is intended to accommodate the natural heterogeneity of biologics that arise due to production in living cells and different manufacturing processes. The emerging standard focuses on quality attributes—such as biological activity, glycosylation, charge variants, and size variants—and establishing suitable test methods while providing greater flexibility in terms of analytical methods and acceptance criteria.

These emerging standards are also paired with reference standards that are intended to support system suitability testing and assay performance monitoring. These materials can help manufacturers ensure consistency in their analytical methods and generate reliable, consistent data over time.

Finally, it’s important to emphasize that emerging standards continue USP’s tradition of welcoming constructive feedback to advance the development of standards and tools that support the quality of medicines.

GEN: Why is USP publishing these emerging standards for biologics now?

McCarthy: USP’s release comes at a defining moment. Policymakers are seeking ways to broaden patient access to quality, affordable biological medicines, including biosimilars. The urgency of this work is underscored by what has been described as the “biosimilars void.”¹ Over the next decade, approximately 118 biologic drugs are expected to lose patent protection, yet only 12 currently have biosimilars in development. This gap represents a potential $230+ billion market opportunity for biosimilar competition in the U.S. alone and highlights a significant missed opportunity to reduce costs and expand patient access to more affordable biologic therapies.

Adding biologics to the emerging standard platform also advances a USP Convention resolution—adopted by 450+ organizations across 50+ countries—to expand availability of and access to quality-assured biologics products.

By taking this step to publish emerging standards, USP is responding to stakeholder requests and joining pharmacopeias around the world as they expand their portfolios of standards to support biologics. The publication of these emerging standards for comment reflects USP’s commitment to advancing public health worldwide through science-based, publicly accessible quality tools developed in a transparent and collaborative manner.

GEN:  How does USP envision the industry and regulatory authorities using an Emerging Standard?

McCarthy: These emerging standards are aligned with the evolving paradigm for biosimilar development, where analytical characterization plays a central role. Increasingly, regulators are recognizing that comparative analytical assessments, supported by pharmacokinetic and immunogenicity data, may be sufficient to demonstrate biosimilarity, reducing reliance on large, costly clinical studies.

We see several ways industry can leverage these emerging standards.

First, they provide a strong starting point for method development. Sponsors can use these publicly available analytical approaches in combination with reference products and in-house standards to assess product quality attributes and design robust analytical strategies early in development.

Second, the accompanying reference standards support system suitability testing and assay control. This is particularly important for helping ensure method performance, enabling data trending, and reducing variability across laboratories and over time.

Third, these emerging standards promote greater alignment between manufacturers and regulators. One of the challenges we’ve heard consistently from global regulators is the wide variability in analytical approaches submitted in biologics applications. By providing common tools and methods, we can help streamline review processes and improve regulatory predictability.

GEN: How are emerging standards different from official USP standards?

McCarthy: There are several important distinctions.

First, in contrast to current official USP standards, emerging standards are potential standards in their initial development phase and may never become official.

Second, emerging standards focus on quality attributes rather than prescribing market specifications. Instead of embedding fixed product specifications as in traditional monographs, they emphasize the critical attributes that define product quality, recognizing that specifications may be process-dependent. Manufacturers are expected to work with relevant regulatory authorities to define product-specific specifications.

Third, they are designed with flexibility in mind. Emerging standards provide multiple analytical methods to assess a given quality attribute and allow for the use of scientifically justified alternatives, including, where appropriate, compendial methods from other pharmacopeias. This approach supports innovation, keeps pace with evolving technologies, and can help improve the efficiency of development and manufacturing.

However, the emerging standards also leverage existing USP standards that help establish quality across an entire product class or multiple types of products. For example, emerging standards may cite cross-cutting standards such as USP General Chapter <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies or <509> Residual DNA Testing, as well as chapters related to assessment of microbial contamination and other broadly applicable compendial tests.

GEN:  You’ve highlighted that these are open for comment. What type of feedback are you seeking?

McCarthy: At a high level, we want feedback on the utility of the overall approach. At a technical level, we are interested in feedback on the methods themselves. Are they appropriate, sufficiently detailed, and representative of current best practices? Are there alternative methods that should be included? One of the key features of the emerging standards platform is the ability for stakeholders to submit their own methods for consideration.

We are also looking for feedback on gaps, whether additional quality attributes or orthogonal techniques should be incorporated, and on usability, including how easy the emerging standards are to interpret and apply.

GEN:  As USP looks forward, what will be the next steps for these emerging standards, as well as other potential biologics standards?

McCarthy: Now that we have published the first four emerging standards for comment, our immediate focus is on engagement. We will collect more stakeholder feedback during the comment period and use that to refine and potentially republish updated versions of these emerging standards.

In parallel, we will continue expanding the portfolio of emerging standards to additional biologics—particularly high-impact therapeutic proteins and monoclonal antibodies, while incorporating lessons learned from this initial release.

We also continue to build out our reference standards pipeline, ensuring a reliable supply and robust characterization to support these methods. Regulators have made it clear that product-specific reference standards are critical for establishing system suitability and controlling assay performance over time, and that remains a key focus.

Longer term, if we have sufficient stakeholder and regulatory support, we may consider evolving those emerging standards that show broad utility into official USP documentary standards, including monographs.

Ultimately, this initiative is about enabling global alignment on biologics quality, supporting efficient development, manufacturing, and regulatory review to increase the availability of biologic and biosimilar therapies for patients around the world.

Reference

1. IQVIA “Assessing the Biosimilar Void in the U.S.” Institute Report. Feb 3, 2025

The post A New Approach to Supporting Quality of Biologics appeared first on GEN - Genetic Engineering and Biotechnology News.

These offerings include a doctoral degree, thesis and non‑thesis master’s degrees, and two graduate certificates, all drawing on the university’s expertise in advanced biomedical technologies and biotechnology.

“The biotechnology and biomanufacturing sectors within the state of Alabama are growing quickly, and they need engineers who are prepared to contribute on day one,” said Mario Eden, PhD, dean of engineering. “These offerings position Auburn as a conduit for that workforce, producing graduates with the technical depth and hands‑on experience industry partners are asking for and enhancing the college’s capacity to support the state’s growing innovation economy.”

Biomedical engineering blends principles of engineering, biology, physics, and medicine to advance human health. It focuses on developing technologies and systems that improve how diseases and injuries are understood, diagnosed, monitored, and treated. This interdisciplinary field includes:

• Biomanufacturing, tissue engineering, and regenerative medicine
• Drug delivery and pharmaceutical engineering
• Computational modeling, data science, and artificial intelligence
• Biomechanics, biomaterials, and rehabilitation engineering
• Medical imaging, medical devices, wearable technologies, biosensors, and diagnostics

Auburn’s biomedical engineering lineup will involve more than 20 faculty members across the college.

“This effort gives us a clear framework for graduate study in a field where our faculty have already built real momentum,” said Selen Cremaschi, PhD, chair of the department of chemical engineering. “It brings that activity into a coordinated structure that supports rigorous graduate experiences and reflects our identity as a research driven college.

The biomedical engineering certificate program is expected to launch in Fall 2026 with a full program launch scheduled for Fall 2027.

The post Biotech and Biomed Engineering Grad and Certificate Programs to Debut at Auburn appeared first on GEN - Genetic Engineering and Biotechnology News.

A longstanding desire in the field is a one-and-done, mutation-agnostic cure for genetic diseases that result from numerous mutations in a gene or from large-scale chromosomal structural variations, including deletions, duplications, inversions, and translocations. Gene therapies for these genetic indications require large-scale DNA manipulation, presenting different technical and regulatory challenges than correcting single-nucleotide point mutations.

Scientists donned their Indiana Jones hats to search for this holy grail of genome editing. Promising approaches under exploration included bridge recombinases, large serine recombinases, and CRISPR-associated transposases (CASTs), as well as immune-evasive DNA cargoes like circular single-stranded DNA (cssDNA), which may address the innate toxicity of double-stranded DNA (dsDNA) payloads.

Still, delivery can remain a conundrum for large payloads. For the most part, current delivery mechanisms are size-limited in terms of payloads, as are the workarounds using mRNA formats and leveraging reverse transcriptase.

The thirst is there, and the quest will continue. New genome-editing tools applicable to large DNA cargoes and delivery mechanisms will be refined, putting potential cures in sight for some deplorable diseases.

Bridge recombinases

A new class of programmable genome-editing tools, bridge recombinases are the first RNA-guided DNA recombinases providing a distinct mechanism for manipulating DNA.^1,2

The system has two key components: the recombinase enzyme, which catalyzes the DNA rearrangement, and a bridge RNA guide with two independently programmable loops. The target-binding loop controls genomic locus targeting, and the donor-binding loop specifies the donor payload.

Reprogramming the bridge RNA to change the configuration and orientation of the target and donor sites allows the system to be redirected to perform excision of a desired sequence from the genome or inversion of a DNA segment in place. The modularity means a single two-component system can perform all three fundamental DNA rearrangements—insertion, excision, and inversion—through a single unified mechanism.

“The most immediate advantage is the scale of DNA that bridge recombinases can manipulate,” said Patrick Hsu, PhD, co-founder and core investigator of the Arc Institute and assistant professor of pathology at Stanford University. “A technology that can operate at the scale of whole-gene replacement or correct structural variants opens up a new class of genetic interventions.” Multi-kilobase insertions, inversions up to 0.93 Mb, and excisions up to 0.13 Mb have all been demonstrated in human cells.³

Bridge recombination also does not rely on dsDNA breaks. The recombinase catalyzes strand exchange directly through a covalent intermediate, making the outcome deterministic in a way that nuclease-dependent approaches are not. This indicates that the system may have advantages in post-mitotic cells for therapeutic applications. About a quarter of the size of Cas9, the system can be encoded in delivery vectors with limited capacity.

“The technology is still in development. While our current efficiency and specificity numbers (20% insertion efficiency with 82% on-target) represent a meaningful proof-of-concept in human cells, improving both metrics will be necessary for safe and effective therapeutic applications,” said Hsu. The diversity of bridge-recombinase systems found in nature continues to be explored.

Large serine recombinases

“For simpler cases where we want to insert a DNA payload into a fixed safe harbor site, we are working on large serine recombinases (LSRs),” said Hsu. While these enzymes lack the RNA programmability of bridge recombinases, they offer very high efficiency and specificity of insertion and are effectively unidirectional, leading to very stable insertions of large DNA cargoes into the human genome.

Stylus Medicine, a company Hsu co-founded, intends to advance LSRs for in vivo genetic therapies. “I am excited to see the new therapies that will emerge from combining recombinase technology with machine learning-assisted protein engineering and advances in DNA and effector delivery for challenging disease contexts,” said Hsu.

CRISPR-associated transposases

CASTs are naturally occurring bacterial systems that utilize nuclease-deficient CRISPR machinery to integrate DNA at genomic locations specified by guide RNAs (gRNA). “While CRISPR is often used to cut DNA, CASTs instead use CRISPR systems to guide site-specific DNA transposition,” said Isaac Witte, PhD, department of chemistry and chemical biology at Harvard University.

In 2019, two research groups—one at Columbia University led by Sam Sternberg, PhD, and the other at the Broad Institute of MIT and Harvard, headed by Feng Zhang, PhD—found that CASTs use CRISPR systems to target DNA transposition by a transposase complex. Further work demonstrated that CASTs were very efficient bacterial genome editors.

CASTs can mobilize multi-kilobase-scale DNA cargoes, and their naturally evolved transposition mechanism avoids forming dsDNA breaks in the genome. The problem was that the wild-type systems exhibited extremely low (often ≤0.1% of treated cells) or undetected integration activity in human cells.

Collaborating with the Sternberg lab, the lab of David Liu, PhD, from the Broad Institute of MIT and Harvard, used PACE (phage-assisted continuous evolution), a directed evolution platform developed by the Liu lab, to enhance the efficiency of CAST transposition.

In PACE, bacteriophages, which infect host bacteria, encode evolving genes in place of an essential gene for phage replication. This essential gene is instead encoded by host bacteria. “In PACE, you link the desired activity of the evolving biomolecule to the expression of this essential gene. In this case, we linked targeted DNA integration to the replication of phages encoding evolving CAST protein components,” said Witte.

A series of modifications ensured efficient enhancement of activity, resulting in the generation of an evolved variant of the CAST transposase protein TnsB that mediated over 200-fold improved integration activity in human cells. The TnsB protein contained ten individual mutations scattered throughout the predicted structure, which contributed to improved activity.

The evolved TnsB was combined with other PACE-evolved and rationally engineered CAST components to yield evoCAST, a system optimized for human-cell integration activity, published in Science.⁵

The evoCAST DNA integration does not require formation of dsDNA breaks in the genome, resulting in undetected levels of insertion and deletion mutations (indels) commonly found in traditional methods of gene insertion like nuclease-stimulated, homology-directed repair (HDR). In addition, evoCAST can be easily reprogrammed to genomic sites of interest by changing the gRNA sequence, and it supports a variety of DNA payload sizes, ranging from less than 1 kb to at least 15 kb.

A potential limitation, however, is that evoCAST is molecularly complex, containing seven distinct protein subunits, making the total coding size (~8.5kb) relatively large compared to around 5 kb for Cas9.

Big-picture limitations center on delivery, according to Witte, such as mitigating the cytotoxicity of foreign dsDNA in most therapeutically relevant cell types.  Additionally, reducing the size and the number of distinct components required for integration activity may facilitate evoCAST applications in vivo. Next steps include harnessing the naturally existing diversity of CAST systems to develop a more diverse repertoire of CASTs for genome editing in human cells.

Circular single stranded DNA

Full Circle Therapeutics’ genome writing technology centers on an immune evasive DNA modality, a mini-cssDNA, called C4DNA—circular, clean, concealed, and customizable up to 20 kb.

The company has commercialized over 350 research-grade cssDNA for primary sequences and is developing processes for GMP-grade products for clinical applications. According to Wu, initially, the company’s founder, Richard Shan, intended to supply linear cssDNA as a DNA commodity for researchers in the gene-integration field. The starting material was cssDNA that was cleaved into linear strands. A serendipitous benchmark experiment using cssDNA as a control demonstrated surprisingly better integration performance than its linear counterpart.⁶ The unexpected results led to a foundational patent describing the use of cssDNA for targeted genomic integration.

After benchmarking the different DNA formats, cssDNA appeared superior and compatible with various CRISPR-Cas systems, along with other meganuclease editing systems such as TALEN. Next, they evaluated the hypothesis that immunogenicity due to dsDNA could be eliminated if mobile genetic elements like transposase systems and LSRs could use cssDNA.

Collaborating with a team at Harvard Medical School led by Benjamin Kleinstiver, PhD, they demonstrated that naked unmodified cssDNA, combined with piggyback transposases or LSRs, enables kilobase writing, albeit inefficiently. One way to improve integration efficiency was to design an oligo that could fuse to the cssDNA with hydrogen bonding to form a partial duplex. A 30- to 60-mer partial duplex showed good integration efficiency when compared to dsDNA, while remaining immune silent.

In another approach, the team modified the nuclear editor and installed a peptide sequence identified from a bacterial genome with a strong binding affinity with cssDNA. In this case, the modified Cas9 became an engineered molecular chaperone to recruit the DNA molecule and form a complex, effectively loading and delivering the genome engineering complex into the nucleus and direct to the targeted genome.⁷

Continued collaboration with Kleinstiver’s lab aimed to improve integration efficiency. The approach, in this case, used a partial duplex cssDNA that reconstituted a recombinase recognition sequence. The scientists termed this integration through nucleus-synthesized template addition of large lengths (INSTALL). INSTALL is compatible with diverse genome engineering nucleases and RNA-guided recombinases for high-fidelity kilobase-scale human genome writing.⁸

“We welcome partners,” said Wu. “It is prime time to talk about DNA medicines.”

References

1. Hiraizumi, M, Perry NT, Durrant, MG, et al. Structural mechanism of bridge RNA-guided recombination. Nature2024; 630:994-1002. doi:10.1038/s41586-024-07570-2
2. Durrant, MG, Perry NT, Pai JJ, et al. Bridge RNAs direct programmable recombination of target and donor DNA. Nature2025:630:984-993. doi:10.1038/s41586-024-07552-4
3. Perry NT, Bartie LJ, Katrekar D, et al. Megabase-scale human genome rearrangement with programmable bridge recombinases. Science. 2026 Mar 12;391(6790):eadz0276. doi:10.1126/science.adz0276
4. Fanton, A, Bartie, LJ, Martins JQ, et al. Site-specific DNA insertion into the human genome with engineered recombinases. Nat Biotechnol. 2025 Nov 6. doi:10.1038/s41587-025-02895-3
5. Witte IP, Lampe GR, Eitzinger S, et al. Programmable gene insertion in human cells with a laboratory-evolved CRISPR-assoc iated transposase. Science. 2025 May 15;388(6748). doi:1126/science.adt5199
6. Xie K, Starzyk J, Majumdar I, et al. Efficient non-viral immune cell engineering using circular single-stranded DNA-mediated genomic integration. Nat Biotechnol. 2025 Nov;43(11):1821-1832. doi:10.1038/s41587-024-02504-9
7. Nam H, Xie K, Majumdar I, et al. Engineering tripartite gene editing machinery for highly efficient non-viral targeted genome integration. Nat Commun. 2025; 16:4569. doi:1038/s41467-025-59790-3
8. Tou CJ, Xie K, Ferreira da Silva J, et al. Immune evasive DNA donors and recombinases license kilobase-scale writing. Nature. 2026 Mar 11. doi:10.1038/s41586-026-10241-z

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A University at Buffalo (UB)-led team now reports that it has found a way to use artificial intelligence to reveal these otherwise invisible cortical lesions by reviewing existing MRI scans. The researchers say the significance of finally being able to see what has been known as one of the most important indicators in MS disease progression cannot be overstated.

“Detecting previously invisible cortical lesions on conventional legacy MRI scans has major implications for MS research and clinical care,” commented Robert Zivadinov, MD, PhD, SUNY distinguished professor in the Department of Neurology and director of the Buffalo Neuroimaging Analysis Center (BNAC) in the Jacobs School of Medicine and Biomedical Sciences at UB. “The ability to see for the first time these previously hidden indicators of MS disease progression, including cognitive impairment and disability, is an important advance.”

Added Michael G. Dwyer, PhD, associate professor of neurology and biomedical informatics in the Jacobs School and a researcher with BNAC, “What this collaboration has been able to accomplish is a real success story for applying AI in the medical arena. We now have access to these incredibly useful data on MRI scans that were there but you couldn’t see them without using AI to pull them out. The computational methods are finally at the point where we can do this.”

Zivadinov is senior author, Dwyer first and corresponding author of the team’s published paper in Communications Medicine, titled “Quantifying cortical lesions in multiple sclerosis MRI datasets using multi-contrast post- processing and deep learning.”

“Multiple sclerosis (MS) affects both the inner, connectivity-oriented portions of the brain (white matter) and the outer layer of the brain (the cortex),” the authors explained. While the involvement of cortical lesions in MS has been known almost since the identification of MS in the late 19^th century, they weren’t included on diagnostic criteria until the 21^st century. And even when they were included, it was noted that their use would be greatly limited due to the current capabilities of clinical MRI.

“Historically, research and clinical care in MS have focused on white matter, where focal demyelinating lesions are a hallmark of the disease,” they continued. And although there are now many therapies that can almost completely halt the incidence of new white-matter lesions in individuals with MS, they haven’t had the same impact on clinical progression, the team continued.

Over more recent decades it’s been found that gray matter is affected from the earliest MS disease stages, and it’s become evident that gray matter pathology is more than secondary to white matter damage. “From a clinical perspective, cortical lesions are strongly associated with clinical disability and cognitive impairment,” the authors stated. “They may also have more prognostic value than white matter lesions for disability and disease course.”

There’s an urgent need for in vivo imaging methods that can show gray matter lesions, they stressed. Dwyer added, “We have all been very frustrated, knowing that these cortical lesions were there but not being able to see them. There’s a lot of ongoing damage that continues to happen in MS that you won’t see with conventional MRI, but that histopathologists have been clearly demonstrating for decades on postmortem tissue.”

For their newly reported study the team applied advanced image processing techniques, including artificial intelligence, to standard MRI scans from a large MS clinical trial. “Recently, several post-processing methods, including synthetic contrasts and artificial intelligence (AI)-based approaches, have shown potential for enhancing cortical lesion detection on conventional MRI data,” they noted. “These methods have the potential to reanalyze existing clinical-trial data to answer key mechanistic questions about both MS development and about treatment effects.”

The AI approaches the researchers used, building on work from co-authors from the Netherlands, were designed to extrapolate vital information from the relationships between multiple images that can’t be seen on a single image.

The researchers combined multiple image-processing techniques, including a new one they developed called MMCLE, or multimodal cortical lesion enhancement. They then applied these techniques to MRI scans from the large, phase III FDA regulatory ORATORIO clinical trial, a study of the MS drug Ocrelizumab that included more than 700 participants.

They found that while individual images of a patient’s brain revealed mostly white matter lesions, once they applied the AI-based image processing methods to multiple different contrast images, they were able to see anywhere from 15 to 20 cortical lesions for each patient, more than 11,000 for the whole dataset. “We confirmed that cortical lesions can be clearly visualized and quantified with these methods,” they stated. “Using deep learning, we also confirmed that the simultaneous use of multiple contrasts improves quantification.”

Dwyer explained further, “If you look on the original scans, you generally can’t see the cortical lesions, but generative AI is very powerful because it can look between the scans and detect tiny differences between them. Because it sees those minor discrepancies, AI can reveal that there’s something going wrong there, that the tissue is not behaving like healthy tissue. The trained models can view multiple MRI images together and synthesize them and synthesize what had been missing.”

Zivadinov added “This work, which has revealed that there is so much invisible pathology in the brain, will have tremendous impact for reviewing data from past clinical trials and also for those going forward,” he says.

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• Sunnybrook Health Sciences Centre researchers are advancing personalized cardiac care through international clinical trials evaluating new minimally invasive procedures, medications and lifestyle interventions for heart disease. 

• Recent studies found that a device-based procedure to prevent stroke in patients with atrial fibrillation can provide an effective alternative to long-term blood thinners, while another trial challenged the belief that coffee worsens irregular heart rhythms. 

• Researchers say expanding treatment options and tailoring care to individual patient needs could improve outcomes, particularly for older adults and those with complex health conditions.

Heart disease is still the leading cause of death in North America. Healthy habits like eating well, staying active, and managing risk factors are important, and new tests and treatments are also helping people live longer and healthier lives.

In recent years, researchers at Sunnybrook’s Schulich Heart Program have been driving a shift toward more personalized and precise cardiac care, leading some of the largest randomized international clinical trials, and pioneering innovative approaches to treating heart disease and damaged blood vessels.

“There is no one-size-fits-all solution for treating heart conditions,” says Dr. Christopher Cheung, a cardiologist and director of the Schulich Heart Program’s clinical trials unit at Sunnybrook Research Institute (SRI).

“We need to personalize treatment options according to a patient’s health condition and also expand access to our treatments to those that may benefit. By expanding options for patients – including those traditionally considered higher risk due to age or other health conditions – we can better tailor care to each individual, helping them not only to live longer, but live better.”

Clinical trials testing interventional procedures

New waves of less-invasive and device-based cardiac procedures – being tested in clinical trials – are showing increasing promise as alternatives to open-heart surgery or long-term drug therapy, particularly for those with complex or multiple medical conditions, or elderly and frail patients that may not tolerate a traditional procedure or surgery.

Current and recent studies have spanned a number of cardiac procedures, addressing valve defects with minimally invasive techniques, to ablation of abnormal heart rhythms, to new treatments for heart attacks. One recent example, published in The New England Journal of Medicine in March 2026, adds to a growing body of innovation in cardiology research; with more advances on the horizon.

Led locally by Sunnybrook investigator Dr. Sheldon Singh, the CHAMPION-AF clinical trial enrolled patients across North America, Europe and beyond to evaluate whether a device-based procedure to prevent stroke in patients with irregular heart rhythm could perform as well as standard long-term blood-thinning therapy, while reducing bleeding risk.

The findings showed that left atrial appendage closure (LAAC) can offer comparable protection against serious cardiovascular events, while significantly lowering the risk of bleeding. This approach may provide an important alternative for patients who cannot tolerate blood-thinning medications, as well as for those with bleeding complications relating to blood thinners. The study authors emphasize treatment decisions should always consider individual patient risk factors and preferences.

CHAMPION-AF is one of many international clinical trials facilitated by the Schulich Heart Program clinical trials unit, many of which are focused on catheter-based interventions compared to standard care. These procedures involve guiding thin flexible tubes and wires (“catheters”) through blood vessels in the groin, arm or neck to the heart using real-time X-ray imaging.

Clinical trials studying the role and impact of lifestyle factors and modifications

In addition to a wide range of interventional therapies, the Schulich Heart Program’s Clinical Trials Unit also studies the role and impact of lifestyle factors and modifications one can make to improve their cardiac health.

The aptly-named DECAF study, for example, led by Dr. Cheung, sought out to test a long-standing belief that many doctors and patients have that coffee – especially caffeinated coffee – could trigger or worsen arrythmia (an abnormal heart rhythm), or atrial fibrillation (a specific, common type of irregular heart rhythm or arrythmia).

Presented at the American Heart Association Scientific Sessions in November 2025 and published in the Journal of the American Medical Association, the DECAF trial found that coffee drinkers who continued drinking coffee had less arrhythmias compared to those who stopped drinking coffee.

While the researchers outline the limitations of the study, the bottom line is that for most people with atrial fibrillation, the routine advice to completely avoid coffee may no longer make sense for many patients, say the authors. They do, however, stress there are always exceptions to the rule and individual reactions still matter, as some people may still notice caffeine triggers their atrial fibrillation and need to maintain close communication with their physician. 

“Whether it’s lifestyle and medication management, minimally invasive procedures, techniques to correct heart rhythms, or open-heart surgery—there has never been more choice in cardiology,” says Dr. Cheung, co-lead author of the DECAF study, and a cardiac electrophysiologist (a specialist in heart rhythms). “It represents a meaningful shift toward more tailored care and precision medicine, which has been the goal of our research.”  

“These newer options may be especially beneficial for select groups of patients—for example, older individuals in their seventies and beyond, or those with complex health conditions where surgery may be too risky or long-term therapies may pose challenges. In many cases, it ultimately comes down to patient preference—whether that’s a procedure, surgery, or drug therapy.”

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As proteolysis-targeting chimeras (PROTACs) mature from scientific breakthrough to clinical modality, a candidate’s degradation potency is no longer enough to justify its advancement. A strong degrader is not necessarily a strong drug candidate if liabilities in exposure, safety, selectivity, manufacturability, or dosing strategy emerge later. As the field advances, success will depend on whether sponsors can integrate chemistry, pharmacology, safety, manufacturability, and clinical strategy early enough to translate promising degraders into viable medicines.

PROTACs have helped redefine what may be possible in drug discovery. By harnessing the ubiquitin-proteasome system to eliminate disease-relevant proteins, rather than simply inhibiting their activity, they have expanded the scope of targets that may be therapeutically addressable. For the past several years, much of the excitement around PROTACs has centered on this breakthrough mechanism. The field has been driven by the promise of degrading previously “undruggable” proteins, improving selectivity, and potentially overcoming resistance mechanisms that limit traditional inhibitors. But as clinical programs progress and the modality moves closer to late-stage regulatory milestones, the central question is changing.

The issue is no longer whether targeted protein degradation works. It is whether promising degraders can be translated into clinically and commercially viable therapies.

That transition marks an important phase of maturity for PROTAC development. The next wave of progress will depend on translational discipline and the ability to balance potency with developability, pharmacology, safety, manufacturability, and clinical feasibility from the earliest stages of development.

Entering a new phase of maturity

Early PROTAC innovation was rightly focused on validating the modality itself. Demonstrating that a heterobifunctional molecule could recruit an E3 ligase, drive ubiquitination of a target protein, and induce selective degradation was a foundational scientific achievement. That early work established targeted protein degradation as part of a broader wave of transformational therapeutic modalities, alongside approaches such as RNA interference therapeutics and antibody–drug conjugates, that have expanded what drug developers can target and how they think about translation.

Today, however, the field is operating under a different set of expectations. As more candidates advance through clinical development, sponsors must show not just that a PROTAC can degrade a target, but that it can do so with an exposure profile, safety margin, formulation strategy, and manufacturing pathway appropriate for clinical applications. A potent degrader in vitro may still fail to become a viable development candidate if it cannot achieve sufficient intracellular exposure, is metabolically unstable, if its degradation profile extends beyond the intended target set, or if its chemistry introduces manufacturing and formulation complications that slow advancement.

In other words, the scientific novelty of a modality can carry a program only so far before technical feasibility must be addressed for a candidate to advance. For PROTACs, that moment has arrived.

Potency alone is an incomplete metric

Degradation potency remains important. Maximum degradation, degradation half-life, and related pharmacodynamic measures are essential for understanding whether a molecule is engaging its biology as intended. But potency on its own can be misleading, particularly when it becomes the dominant criterion for candidate selection.

PROTACs are not conventional inhibitors. Their event-driven, catalytic mechanism introduces complexities that make exposure-response relationships less intuitive than those seen with traditional small molecules. Biological effects may persist after plasma concentrations decline, while higher concentrations do not necessarily lead to greater activity. In some cases, excessive exposure may even reduce degradation efficiency because of saturation effects that limit productive ternary complex formation.

This means the “best degrader” in a screening cascade is not always the best drug candidate. A molecule may demonstrate impressive degradation in a cellular assay while carrying liabilities that emerge only later, such as poor permeability, limited oral bioavailability, rapid linker metabolism, high nonspecific binding, unstable analytical performance, or off-target degradation driven by ligase biology or ternary complex behavior. If those issues are not considered early, potency can create a false sense of confidence in a degrader’s potential for clinical use.

Development workflows fall short

One reason translational issues emerge so frequently in PROTAC programs is that many development workflows still reflect assumptions built around traditional small molecules. In those models, discovery, DMPK, bioanalysis, toxicology, and chemistry, manufacturing, and controls (CMC) often proceed in a staged or partially sequential manner, with each function evaluating modality-relevant properties within its own domain before handing it forward.

With targeted protein degraders, however, early chemistry decisions can directly influence permeability, intracellular exposure, metabolic clearance, assay reliability, biodistribution, and manufacturability. Linker design, ligand selection, and overall polarity are not simply medicinal chemistry concerns; they shape how the molecule behaves across the entire development continuum. Likewise, a bioanalytical challenge may obscure the interpretation of PK/PD relationships, complicate dose optimization, or delay confidence in candidate selection.

The same is true for safety. Because PROTACs eliminate proteins rather than transiently inhibiting them, the consequences of target engagement can differ meaningfully from those associated with conventional inhibitors. On-target toxicity may emerge when complete or prolonged degradation is not tolerated, even if partial functional inhibition is acceptable. Off-target effects may arise not only from target promiscuity, but also from E3 ligase recruitment and unintended ternary complex formation. These risks cannot be addressed effectively if safety is considered only after potency and exposure have been optimized.

Traditional workflows can also underweight manufacturability and CMC considerations. PROTACs are generally handled as small molecules, but their structural complexity can create multi-step synthesis challenges, impurity-control difficulties, and formulation constraints much earlier than teams may expect. When these issues are discovered late, promising programs can lose momentum for reasons that have little to do with biology.

The core issue is not organizational design alone. It is that PROTACs expose the limits of linear decision-making. They require earlier integration because the liabilities that determine success are tightly interconnected.

PROTAC-specific development

If PROTACs require a different development model, what would it look like?

First, a successful PROTAC development plan should begin with balanced optimization across parameters rather than sequential, single-parameter optimization. Candidate selection should account not only for degradation potency, but also for permeability, solubility, metabolic stability, intracellular exposure, selectivity, formulation feasibility, and synthetic tractability. Programs that rank candidates holistically are better positioned to recognize which molecules are genuinely translatable.

Second, the PK/PD strategy should be built around the biology of degradation. Because systemic exposure does not fully explain pharmacological effect, teams increasingly need direct measures of target degradation and recovery kinetics, not just plasma concentration data. Mechanistic PK/PD models can help connect degradation durability, protein resynthesis, and dosing schedule in a way that better reflects how PROTACs work in vivo.

Third, bioanalysis should be treated as a strategic enabler rather than a downstream technical function. PROTACs can introduce assay complications, including nonspecific binding, chromatographic artifacts, and instability across matrices. Robust analytical methods are essential not only for quantitation but for making reliable decisions about exposure, disposition, and translation across study systems.

Fourth, safety assessment must expand beyond conventional assumptions. Early proteomic profiling, tissue distribution analysis, and evaluation of degradation selectivity can help identify liabilities before they become entrenched in a program. For PROTACs, understanding where degradation occurs, how long it persists, and what unintended proteins may be affected is central to designing an acceptable therapeutic window.

Finally, CMC and manufacturability should be considered earlier than many teams may be accustomed to. A molecule with compelling pharmacology but limited synthetic scalability, poor solid-state properties, or unstable formulation behavior may not be a strong development candidate. Integrating these realities earlier supports smarter program prioritization and reduces late-stage surprises.

Taken together, these elements define a development playbook centered on translation. They signal a maturation of the field, in which the emphasis shifts from demonstrating biological power to establishing overall developability, recognizing that promising degraders must ultimately succeed as integrated therapeutic candidates, not just mechanistic innovations.

Sponsors can improve the odds

For sponsors advancing PROTAC programs, translation should be a design principle from the beginning. That starts with cross-functional alignment early in discovery. Chemistry, DMPK, bioanalysis, safety, and CMC teams should work together to shape candidate criteria, so that trade-offs are recognized early, and optimization reflects the realities of development rather than the priorities of any one function.

It also means adopting more realistic success metrics. Degradation data should remain central, but it should be interpreted alongside developability, not in isolation from it. Sponsors may also benefit from building translational assays and biomarkers earlier. The ability to directly measure target degradation and connect it to pharmacodynamic effect can strengthen decision-making throughout preclinical and clinical development. In a modality where traditional exposure markers may be incomplete, translational pharmacology can provide strategic direction.

Most importantly, teams should resist the temptation to force PROTACs into a conventional small-molecule framework. These candidates may be classified as small molecules for many regulatory purposes, but functionally, they behave as a distinct modality. Treating them as such allows the development strategy to evolve in step with biology.

The next phase of PROTAC success

PROTACs have already shifted the pharmacological landscape around drugability. Their next contribution may be just as important by forcing the industry to rethink what a good development strategy looks like for complex, mechanism-driven therapeutics. As the field matures, successful drug sponsors will be those who can translate degradation into a developable, manufacturable, safe, and clinically meaningful therapy. That requires a different playbook built on integration, balanced optimization, and translational discipline. For PROTACs, that is no longer a future concern. It is the central challenge of the present.

Shanghao Li, PhD, currently serves as international marketing associate director in the Laboratory Testing Division at WuXi AppTec.

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Knowing that the protein tissue kallikrein-1 (KLK1) is effective in treating ischemic diseases is one thing. Manufacturing it as a recombinant protein has been quite another. So, when DiaMedica Therapeutics cracked the manufacturing aspect, it was well on its way toward commercializing KLK1 therapeutics.

The manufacturing breakthrough came when researchers realized that protein activity (which is essential for therapeutic benefit) was linked to certain glycosylation patterns. DiaMedica engineered the molecule to reflect those glycosylations and also made two changes to the amino acid sequence to improve manufacturability. “Then we partnered with Catalent,” Rick Pauls, president and CEO, says. “We are using its GPEx^® technology with CHO cells,” which produces more cells within the same timeframe and thus lowers manufacturing costs.

Tenacity in action

This happened neither easily nor quickly. To understand the measure of this achievement, we need to look at DiaMedica’s history.

KLK1 came to DiaMedica’s attention because of liver research. “A liver physiologist cut the vagus nerve [which regulates liver metabolism] and discovered that the rats, effectively, became diabetic,” Pauls recounts. “We hypothesized that when a healthy person consumed a meal, the liver releases something that acts as an insulin sensitizer. We did some basic work and identified KLK1 as that insulin sensitizer.”

The company was founded in 2004 to develop a KLK1 therapeutic for complications related to Type II diabetes. Those trials failed. “It’s a long story,” says Pauls, that left the company “pretty close to bankrupt.”

DiaMedica, though, was tenacious. “We knew there was a human urine form of this protein that had been used for a few decades in Asia to treat acute ischemic stroke, and a porcine form treating hypertension for decades as well,” Pauls recalls. DiaMedica had the protein and the manufacturing know-how to produce active, recombinant proteins, and—with KLK1 levels low in stroke patients—a reason to pivot.

Ischemic stroke and preeclampsia

Its lead compound, DM199 (rinvecalinase alfa), is enrolling patients in Phase II/III trials for acute ischemic stroke. Called the ReMEDy2 trial, the company anticipates an interim readout near year’s end. Additionally, Phase I and II studies for preeclampsia and Phase II studies for fetal growth restriction are underway.

“This is protein restoration,” Pauls says. It targets ischemic stroke patients who have missed the three-to-four-hour post-stroke treatment window for tissue plasminogen activator (tPA) therapeutics or mechanical thrombectomy. Those patients constitute approximately 80% of acute ischemic strokes today, so “there is a huge unmet medical need,” Pauls says.

DM199 works by restoring normal levels of the KLK1 protein. KLK1, in turn, is thought to enhance the production of nitric oxide, prostacyclin, and endothelium-derived hyperpolarizing factor. Pouring through their own preclinical and clinical results, the DiaMedica team noticed that DM199 consistently enhanced blood circulation and lowered blood pressure.

That realization drove the team to also target preeclampsia, a hypertensive disease of pregnancy that Pauls says may be the company’s most exciting application for investors.

Unlike approved blood pressure therapeutics, DM199 does not cross the placental barrier, a critical safety feature that protects the fetus. After examining early clinical data, DiaMedica scientists also realized that increasing blood flow to the placenta could target the root cause of the disease and perhaps gain another few weeks of crucial time in utero for the fetus.

“Today, there are no approved treatments. Mothers are given labetalol and nifedipine to control blood pressure and to extend the baby’s time in utero for only a few days.” Results are less than ideal, and the consequences can be severe.

Pauls says, “Some 40% of babies born before 28 weeks could have long-term disabilities, and 10 to 15% will have problems with eyesight for life. There’s been a real lack of drugs in development because developers are worried about harming the baby.”

An investigator-led Phase II clinical trial is enrolling. Later this year, the company plans to initiate its own Phase II study focused on early-onset preeclampsia after recently receiving regulatory clearance to start the study in Canada.

If the molecule eventually is approved for preeclampsia, DM199 seems poised to become, perhaps, the first approved treatment that offers the potential to extend gestational days and possibly address a root cause of preeclampsia.

Leveraging the pivot

Unlike many biopharmaceutical companies, DiaMedica has been able to bypass some of the usual first steps by leveraging existing studies on KLK1, as well as existing clinical data for stroke and preeclampsia.

That allows researchers to focus on humans without the translational issues inherent in animal studies. It also helps the company identify the human subgroups most likely to benefit from these treatments and the most appropriate dosing regimen early. “Having that clinical data helps de-risk our program and gives a better possibility of success,” Pauls says, because, as he points out, “Animals are not the same as people.”

Once the company pivoted to its current indications six or seven years ago, the challenge shifted from getting and manufacturing the active form of the protein to selecting the best indications and assembling the right team members.

“In the early days, maybe we didn’t have the right level of experience with limited capital,” he admits. Today, “we’ve been able to bring people on board who have brought drugs to market.”

Readouts due in 2027

Currently, the company is focused tightly on its clinical trials. The next step for DiaMedica is to get readouts from many of those, with five readouts on various aspects of the programs expected between now and the end of 2027. Each of those readouts will report on about 30 patients and will be factors in the design of a subsequent pivotal trial.

Additionally, an interim analysis of the first 200 patients in its acute ischemic stroke trial is expected by the end of the year, Pauls says. “If we see a drug effect that’s comparable to our Phase II trial or the data with the urine form (of KLK1) from China—which treats close to a million patients per year—we’ll be looking at completing enrollment the following quarter for stroke and then for preeclampsia. DiaMedica is dedicated to offering second chances to acute ischemic stroke patients and others who haven’t had them before, all while pivoting to new opportunities itself. Now, as trials advance, Pauls says, “I think this should be a straightforward path.”

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In a new study published in Nature Microbiology titled, “Identification of chemical features for improved outer membrane permeation in mycobacteria using machine learning,” researchers from University of Massachusetts (UMass) Amherst have developed new methods to measure which chemical compounds can cross the outer bacterial membrane. 

“Mtb is unique,” said Sloan Siegrist, PhD, associate professor of microbiology at UMass Amherst. “Not only does it have two membranes that protect the cell from antimicrobial chemical compounds that we might use to kill it, its outer membrane is unlike any other biological barrier out there.” 

Siegrist’s lab specializes in finding vulnerabilities in the mycomembrane to develop drugs that can effectively treat tuberculosis. However, traditional drug discovery has relied on low throughput experimental screens. In 2023, Siegrist, in collaboration with Marcos Pires, PhD, professor of chemistry at the University of Virginia, published Peptidoglycan Accessibility Click-Mediated AssessmeNt (PAC-MAN), a method that can test many compounds in parallel. 

“Marcos and I wanted to harness measurements of known chemicals to predict compound uptake for unknown chemicals, so we brought in computational biologists and chemists, including my colleague Anna Green, PhD, from UMass Amherst’s Manning College of Information and Computer Sciences,” said Siegrist. 

Green uses computation to understand patterns in biological compounds. “Small molecules can be particularly difficult to analyze computationally,” she says. “Because they come in all different sizes with a wide range of molecular connections, you can’t describe them with a single measurement, by weight, say, or size.” 

Green and colleagues designed a machine learning model, the Mycobacterial Permeability neural Network (MycoPermeNet), trained on the PAC-MAN screening data. The model can predict how readily a compound permeates the mycomembrane from its chemical structure alone and points to the physical properties that help a compound penetrate Mtb’s defenses. 

“The mycomembrane lets some molecules through and keeps others out,” says Green. “There must be something about this membrane, and about the chemistry of each molecule, that decides which ones get in—and our combined tools help us figure out which ones can get through, and why.” 

The post AI Tackles Tuberculosis, Identifies Drugs that Penetrate Bacteria Membrane appeared first on GEN - Genetic Engineering and Biotechnology News.

“Intensified bioprocessing aims to improve the productivity and efficiency of biomanufacturing,” explains Julie Kozaili, PhD, principal scientist at Asahi Kasei Bioprocess. “This is often achieved by designing new processes or modifying existing ones to increase output per unit time or equipment volume.”

That deceptively simple definition captures a sweeping transformation. Instead of relying on traditional batch processes, intensification often involves running at higher cell densities, integrating multiple process steps, and transitioning toward continuous or semi-continuous operations.

The implications are significant. Intensified processes can reduce facility size, minimize resource consumption, and shorten development timelines—all while maintaining or even improving product quality. For an industry under constant pressure to deliver therapies faster, these advantages are hard to ignore.

The urgency behind intensification is driven by both scientific and economic realities. Many modern therapeutics—particularly viral vectors and gene therapies—face inherent production challenges. Low yields, complex manufacturing requirements, and stringent quality standards make scaling difficult and expensive.

In viral-vector development, one of the central bottlenecks is simply producing enough material. Clinical applications often require a minimum effective dose volume, yet production systems struggle to generate sufficient yield, forcing manufacturers to concentrate limited output into small delivery formats. Legacy adherent cell culture technologies compound the problem by relying on scale-out strategies—adding more units rather than increasing efficiency—making cost reductions difficult as production expands.

Intensified bioprocessing offers a different path. It “is important because it allows manufacturers to increase capacity without new facilities, reduce equipment footprint, reduce media, buffer, and utility usage per gram of product, and shorten scale-up, tech transfer, and time-to-clinic timelines,” Kozaili says.

For companies working with unstable or complex molecules, speed can be just as important as scale. Faster processing reduces the risk of degradation and accelerates the path from development to commercialization.

Beyond cost: speed and flexibility

Although cost savings are often cited as a benefit of intensification, industry leaders emphasize that its true value lies beyond the cost of goods. “Intensified bioprocessing is less about driving down cost and more about enabling speed, flexibility, and fit,” says Mark Schofield, PhD, director of science at Cytiva. “For monoclonal antibodies in particular, the industry’s priorities are getting to launch faster, making better use of existing facilities, and being able to respond to uncertain or fluctuating demand.”

This shift in perspective reflects broader changes in the biopharmaceutical landscape. Pipelines are increasingly diverse, with smaller patient populations and more specialized therapies. Manufacturing systems must be adaptable, capable of switching between products or scaling production up and down as needed. “Intensification helps companies do all three by rethinking how processes are designed and scaled,” Schofield adds.

Companies such as Repligen are advancing upstream intensification through perfusion-based systems designed to sustain high cell densities and continuous productivity. Perfusion cell culture, a cornerstone of many intensified strategies, continuously feeds fresh media while removing waste and product, allowing cells to remain in an optimal growth state over extended periods. This approach not only improves yield but also creates a more stable and controlled production environment compared to traditional fed-batch methods. Repligen’s filtration and analytical technologies further support this shift by enabling continuous clarification and real-time monitoring, helping bridge the gap between process development and scalable manufacturing.

Beyond large platform providers, a growing number of specialized innovators are helping push intensified bioprocessing forward, particularly in high-demand areas like viral-vector manufacturing and upstream control.

Meanwhile, Batavia Biosciences is tackling one of the most persistent challenges in gene therapy: low viral-vector yields. Traditional adherent cell culture systems often require scaling out—adding more equipment rather than increasing efficiency—which drives up costs without significantly improving productivity. Batavia’s intensified approach centers on integrated solutions that combine optimized cell lines, streamlined purification processes, and novel bioreactor designs to dramatically increase output. By enabling higher yields within a smaller footprint, these strategies effectively miniaturize manufacturing, making it possible to produce clinical and commercial quantities without the need for large-scale facilities.

Together, these efforts underscore a key theme in intensified bioprocessing: innovation is not confined to a single step or technology. Instead, it is emerging across the entire workflow, from upstream cell culture to downstream purification and process analytics.

Real-world applications

The promise of intensified bioprocessing is being realized through a growing ecosystem of technologies. Asahi Kasei Bioprocess, for example, has developed solutions that support intensification at multiple stages. “We support intensified bioprocessing across upstream and downstream operations,” Kozaili explains, pointing to innovations such as hollow-fiber microfilters for high-intensity cell culture clarification and advanced virus filtration systems designed for continuous processing.

These technologies are engineered to handle the increased throughput associated with intensified upstream processes. High-density cultures generate larger volumes of product, which must be efficiently clarified, purified, and stabilized without compromising quality.

Automation and integration are also key components. New ultrafiltration and diafiltration systems are being designed for flexibility, allowing them to be deployed upstream or downstream and enabling seamless process integration.

Designing for intensification

Though technology is a crucial enabler, successful intensification requires more than just new equipment. It demands a holistic approach to process and facility design. “At CRB, our role is to help clients translate emerging process concepts into facilities that are safe, operable, and scalable,” says John Rubero, senior fellow in purification bioprocessing.

One of the defining characteristics of today’s intensification efforts is that they are often partial or hybrid implementations. Fully continuous, end-to-end processes remain relatively rare. Instead, manufacturers are adopting elements of intensification—such as integrating continuous perfusion with multi-column capture chromatography—within otherwise traditional workflows. This incremental approach allows companies to realize benefits without fully overhauling their operations. It also provides a pathway for future evolution as technologies mature.

Despite its advantages, intensified bioprocessing is not without challenges. One of the most significant is bridging the gap between process development and commercial-scale implementation. “While the practice of linking unit operations together is largely accepted, real-time control of an end-to-end continuous process remains challenging,” Rubero explains.

In traditional batch processes, control strategies are relatively straightforward because lot traceability is easy to maintain. But intensified systems—especially continuous ones—require real-time monitoring and advanced control strategies to ensure process stability and product quality.

“It is not realistic or necessary to find and assign a sensor to monitor each critical process parameter or critical quality attribute,” Rubero says. “Instead, a combination of direct measurements, soft sensors, multivariate models, and process understanding is required for effective process control.”

So, the industry is moving toward integrated approaches that combine process analytical technology (PAT) with mechanistic and data-driven models. These systems enable more sophisticated monitoring and control but are still evolving in terms of reliability and adoption.

Operational barriers

Technical challenges are only part of the equation. Intensification also requires a shift in mindset—one that can be difficult for organizations accustomed to established manufacturing paradigms. “In many cases, the technologies are either new or have novel applications, creating a learning curve,” Kozaili acknowledges.

Training gaps, operational changes, and resistance to new approaches can slow adoption. Teams must adjust not only their processes but also their thinking, moving away from long-standing practices toward more dynamic, integrated systems.

As Schofield notes, “adopting new approaches inevitably comes with skepticism.” Externally, there can be hesitation to move away from established technologies. Internally, organizations might question how intensified solutions might impact existing product lines. Those discussions, however, are part of the transition.

Despite these challenges, momentum is building. As intensified technologies demonstrate their value in real-world applications, resistance is gradually diminishing. “Over time, evidence and adoption speak for themselves,” Schofield says.

Kozaili emphasizes the importance of organizational alignment. “We had to change the company’s established mindset by securing support to develop these technologies and clearly show the value of these approaches,” she explains.

Collaboration also plays a key role. For technology providers, working closely with customers to test and refine solutions helps build confidence and accelerate adoption. “For our customers, it’s about finding the right partners to test the technologies, while providing appropriate feedback for improvement,” Kozaili adds.

Looking ahead, the trajectory of intensified bioprocessing is clear. Purpose-built facilities designed specifically for intensified operations will become more common, replacing retrofitted batch plants that struggle to accommodate new workflows, because intensified bioprocessing is no longer a niche concept reserved for early adopters. It is rapidly becoming a central pillar of modern biomanufacturing strategy.

The post Bioprocessing at Full Throttle appeared first on GEN - Genetic Engineering and Biotechnology News.

Internal Medicine 

In 2025, the pass rate for first-time test takers remained level, with 86% of takers passing the exam.

Cardiovascular Disease 

In 2025, the pass rate for first-time test takers remained level, with 86% of takers passing the exam.  

Critical Care Medicine 

The Critical Care Medicine board exam saw a slight drop in pass rates from 2024 to 2025, with 86% passing the exam.

Gastroenterology 

The Gastroenterology board exam saw a slight decrease in pass rates, going from 97% in 2024 to 94% in 2025. 

Geriatric Medicine 

The Geriatric Medicine board exam saw a rise in pass rates from 2024 to 2025, going from 89% to 94%. 

Hematology 

The Hematology board exam pass rate was steady from 2024 to 2025, with 93% passing in 2025.

Infectious Disease 

The Infectious Disease board exam pass rate dropped slightly in 2025, with 93% of takers passing the exam.

Medical Oncology 

In 2025, the pass rate for first-time test takers remained the same, with 90% of takers passing the exam.

Nephrology 

The Nephrology board exam saw a slight increase in pass rates from 2024 to 2025, going from 82% to 83%. 

Pulmonary Disease 

The Pulmonary Disease board exam saw steady pass rates of 93% from 2024 to 2025.

Rheumatology  

The Rheumatology board exam saw a slight increase in pass rates, going from 90% in 2024 to 92% in 2025. 

Sleep Medicine 

The Sleep Medicine board exam saw the largest drop in pass rates of all ABIM exams, going from 90% in 2024 to 83% in 2025. 

Studying for one of the ABIM exams? BoardVitals offers top prep products targeted to 2026 ABIM blueprints.

What Do the Pass Rates Mean? 

While a high pass rate on the ABIM board exams may be encouraging, it’s crucial for aspiring candidates to recognize that higher pass rates do not negate the need for thorough preparation. A high overall pass rate reflects the overall average performance of candidates, but individual experiences may vary. Success in the exams is contingent on a comprehensive understanding of the material, critical thinking skills, and the ability to apply knowledge in diverse clinical scenarios. 

Don’t become complacent. Every candidate should approach the exams with a mindset of continuous improvement and a commitment to refining their understanding of internal medicine. Don’t put off studying – you don’t want to regret not being as prepared as possible. 

How Can I Prepare for the ABIM Board Exams? 

Effective preparation is key to passing ABIM board exams. Utilize reputable study resources and review courses that align with the exam’s requirements. The ABIM makes blueprints for all exams easily accessible. Familiarize yourself with these content specifications so you know exactly what to study for your exam. 

One of the most popular and effective study methods is incorporating practice questions into your study regimen. Practice questions not only assess your knowledge but also enhance your critical thinking and problem-solving skills, mirroring the challenges you may encounter in the actual exam. 

BoardVitals offers question banks for a number of ABIM exams. Each question bank is tailored to the most updated ABIM blueprint. All questions include explanations for correct and incorrect answers, letting you uncover problem areas before test day.  

Sign up for BoardVitals for practice ABIM questions in the following specialties: 

• Cardiovascular Disease Questions
• Gastroenterology Questions
• Geriatric Medicine Questions
• Hematology and Medical Oncology Questions
• Infectious Disease Questions
• Internal Medicine Questions
• Nephrology Questions
• Pulmonary and Critical Care Medicine Questions
• Rheumatology Questions
• Sleep Medicine Questions

The post 2025 ABIM Pass Rates: How Difficult are the ABIM Exams? appeared first on BoardVitals Blog.

How are the AOBIM Exam and ABIM Exam Similar? 

The AOBIM and ABIM exams share many similarities, including: 

• Both the AOBIM and ABIM internal medicine exams are designed to test the candidates’ ability to diagnose and treat various medical conditions, including acute and chronic illnesses. 
• Both exams are computer-based tests that consist of multiple-choice questions and case studies. 
• Both exams require candidates to have completed a residency program in Internal Medicine. 
• Both exams require candidates to complete continuing medical education (CME) credits to maintain their certification. 

How are the AOBIM Exam and ABIM Exam Different? 

Although the AOBIM and ABIM exams share many similarities, there are some notable differences that physicians should consider before choosing an exam: 

1. Osteopathic Approach: One of the main differences between the AOBIM and ABIM exams is the Osteopathic approach. The AOBIM exam emphasizes the Osteopathic principles and practices, which focus on treating the whole person and promoting wellness. In contrast, the ABIM exam is more focused on allopathic medicine, which is a traditional approach to medicine that emphasizes the use of drugs and surgery to treat illnesses. 

2. Accreditation: The AOBIM exam is accredited by the American Osteopathic Association (AOA), while the ABIM exam is accredited by the Accreditation Council for Graduate Medical Education (ACGME). 

3. Exam Length: The AOBIM exam has a slightly different format than the ABIM exam. The AOBIM exam is a single day exam consisting of 320 multiple choice questions, while the ABIM exam lasts approximately 10 hours and consists of a maximum of 240 multiple choice questions.  

Is AOBIM easier than ABIM? 

As both exams have their own unique requirements and content areas, it is difficult to say whether the AOBIM or ABIM is the more difficult exam. In 2025 the first-time pass rate for the ABIM exam was 86%. There is no publicly available pass rate data for the AOBIM. 

Should You take the AOBIM Exam, the ABIM Exam, or Both Internal Medicine Board Exams? 

The AOBIM and ABIM exams both offer unique benefits, but which test is more beneficial? In short, the decision depends on the physician’s personal preference and career objectives. The choice between the two exams will depend on the physician’s practice and career goals. Those who practice Osteopathic Medicine may find the AOBIM exam more aligned with their philosophy and approach, while those who practice allopathic medicine may prefer the ABIM exam. 

How do I review for the AOBIM or ABIM? 

No matter which exam you choose to take, having top board prep tools is essential to your success. The BoardVitals Internal Medicine board review question bank has been newly updated for 2025-2026. It now provides more than 1,650 Internal Medicine board questions targeted to the latest ABIM and AOBIM Content Blueprints.

Along with expertly written sample questions, the BoardVitals Internal Medicine Question Bank contains innovative technology to help you make the most of studying. Create quizzes with adaptive testing technology, which presents questions tailored to your current competency level. The Internal Medicine Question Bank also includes AI-powered risk assessment performance data, providing insight into your most at-risk subjects to optimize study efficiency. 

Both the AOBIM and ABIM exams are rigorous and comprehensive tests that evaluate the medical knowledge and clinical competence of physicians. Whether you sit for one or both exams, you will be prepared to practice in the field of Internal Medicine. 

The post Should You Prep for the AOBIM or ABIM Exam?   appeared first on BoardVitals Blog.

The post Growth Therapies Fall Short for Girls with Classical CAH appeared first on Endocrine News.

Leo Briggs explains how understanding both the ethical and legal duty of candour helps dental professionals respond appropriately and maintain patient trust.

Most patients accept that mistakes can happen but they won’t forgive any attempt to cover them up. The duty of candour is key to retaining their trust. 

The ethical duty of candour

The GDC says dental professionals have a duty of candour ‘when something goes wrong which causes, or has the potential to cause, harm or distress’ (GDC, 2019).

It expects Professional Conduct Committees to ‘take very seriously a finding that a dental professional took deliberate steps to avoid being candid with a patient or to prevent someone else from being so’.

The legal duty of candour

Alongside this individual duty is a legal duty of candour about ‘notifiable patient safety incidents’, which applies to NHS and private dental practices in England and Scotland and to practices providing NHS services in Wales (Northern Ireland plans similar legislation).

This requires practices to notify patients about patient safety incidents that meet the relevant threshold.

For example, in England, this is something unintended or unexpected which already has, or might lead to death, severe or moderate harm.

There is specific guidance about the legal duty of candour threshold and process for England, Scotland and Wales.

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

The Cedars-Sinai Center for Space Medicine Research has taken a special interest in biomanufacturing in space. It studies how microgravity aboard the International Space Station and other space platforms can be used to manufacture higher-quality biomedical products.

Researchers investigate the production of stem cells, organoids, engineered tissues, exosomes, and biopharmaceuticals, taking advantage of the reduced effects of gravity on cell growth and three-dimensional tissue formation.

The center collaborates with NASA, commercial space companies, and biotechnology partners to determine whether space-based manufacturing can yield therapies with improved quality, consistency, and function. Its long-term goal is to translate discoveries made in space into scalable manufacturing methods that advance regenerative medicine, drug development, and personalized healthcare on Earth.

At the upcoming ISSCR 2026 meeting, Arun Sharma, PhD, director of the Center for Space Medicine Research, will participate in a session co-sponsored by Cedars-Sinai on regenerative medicine in low Earth orbit. The focus of Sharma’s talk is accelerating development of organoid-based disease modeling and stem cell therapies due to increased access to microgravity, as well as in-space biomanufacturing.

Avinash Srivastava, PhD, a biomedical scientist in the Cedars-Sinai Biomanufacturing Center, is presenting information on the center’s proprietary integrated induced pluripotent stem cell biomanufacturing platform. The platform integrates standardized manufacturing with advanced bioprocessing to facilitate the scalable production of high-quality engineered cell therapies.

Dhruv Sareen, PhD, associate professor of Biomedical Sciences and founding director of the Cedars-Sinai Biomanufacturing Center, is presenting research on the integration of an in situ seed plating system into the center’s manufacturing workflow to streamline production of complex induced pluripotent stem cell lines for clinical-grade and research use.

The post Biomanufacturing in Space to Be Key Topic at ISSCR 2026 appeared first on GEN - Genetic Engineering and Biotechnology News.

It is expected to close in the third quarter (Q3) of 2026, pending regulatory approvals and shareholder consent from Crinetics.

The transaction adds two main endocrinology assets to Vertex’s portfolio.

Crinetics’ Palsonify (paltusotine), a once-daily oral therapy for adults with acromegaly, was approved by the US Food and Drug Administration (FDA) in September 2025 and also by the European Medicines Agency (EMA) in April 2026.

Acromegaly is a rare condition usually caused by a pituitary tumour that leads to excess growth hormone secretion.

The company’s pipeline also includes atumelnant, a once-daily oral adrenocorticotropic hormone receptor antagonist in Phase III development for congenital adrenal hyperplasia (CAH).

CAH is a chronic genetic disorder characterised by impaired cortisol synthesis and excess androgen production.

Vertex has stated that the acquisition is anticipated to contribute to its revenue growth from the ongoing launch of Palsonify, and that atumelnant, if approved, could also generate significant revenue in CAH and potentially in Cushing’s syndrome.

The two assets together are projected by the companies to have a combined annual peak sales potential exceeding $5bn.

Vertex intends to fund the acquisition with a mixture of cash on hand and debt, supported by a fully committed bridge financing of $4.5bn from Bank of America and Morgan Stanley Senior Funding.

Vertex CEO and president Reshma Kewalramani said: “Crinetics is an excellent strategic fit for Vertex, with its focus on serious diseases in speciality markets with significant unmet need, well-understood causal human biology, and potentially best-in-class medicines that could deliver transformative benefit to patients.

“We are also excited by the significant potential of atumelnant to transform the treatment landscape for CAH, setting a new standard of care where patients do not have to choose between managing their excess adrenal androgens and enduring the side effects of high-dose steroids.”

In April 2026, Halozyme Therapeutics’ subsidiary Halozyme Hypercon signed a global exclusive partnership and licence agreement with Vertex for the Hypercon technology.

The post Vertex signs agreement to acquire Crinetics for $10bn appeared first on Pharmaceutical Business review.

These results showed that the combination reduced the risk of disease progression or death by 79% versus R² alone. Patients treated with the Tepkinly-based therapy achieved an overall response rate of 96%, compared to 81% for those receiving R².

Complete response (CR) rates reached 74% for patients receiving the combination, with 181 out of 243 patients achieving this outcome. For those treated with R² alone, the CR rate was 43%, with 106 out of 245 patients achieving a CR.

The safety profile observed in the trial was consistent with the known characteristics of the individual treatments.

The most frequent adverse reactions, occurring in 20% or more of patients, included anaemia, constipation, Covid-19, cytokine release syndrome (CRS), diarrhoea, fever, hypogammaglobulinaemia, neutropenia, pneumonia and thrombocytopenia.

Serious adverse reactions were reported in 44% of patients receiving the combination. CRS, pneumonia, Covid-19, and febrile neutropenia were among the events affecting at least 5% of participants.

AbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar said: “This approval is important because it brings an effective treatment option to patients across Europe, representing meaningful progress for patients with follicular lymphoma.”

Epcoritamab is a subcutaneous IgG1-bispecific antibody developed using Genmab’s DuoBody technology.

It is being co-developed by AbbVie and Genmab and is approved for certain lymphoma indications in more than 65 territories, under the names Epkinly in Japan and the US, and Tepkinly in the European Union.

The companies are investigating further uses of epcoritamab, alone and in combination, for various haematological malignancies in clinical trials.

Last month, AbbVie agreed to acquire Apogee Therapeutics for $10.9bn, potentially further fortifying its legacy in the immunology space and marking another sizeable investment into the disease area as it garners notable big pharma interest.

The post EC approves AbbVie’s Tepkinly combination for follicular lymphoma appeared first on Pharmaceutical Business review.

Introduction

India is often described as the “pharmacy of the world.” Yet, the growing menace of counterfeit and substandard medicines poses a serious threat to public health, consumer safety and India’s pharmaceutical credibility.

Recent incidents involving adulterated cough syrups, oxytocin-related deaths, fake Mounjaro injections and large-scale counterfeit medicine seizures are not isolated violations. They point to a deeper systemic problem: counterfeit medicine is no longer merely a regulatory offence. It is an organised criminal enterprise involving illegal manufacturing, forged documentation, interstate supply chains, financial fraud, corruption and, increasingly, digital distribution.

Despite the seriousness of the offence, conviction rates in counterfeit drug cases remain extremely low. Investigations often stop at seizure and prosecution of retailers or wholesalers, while manufacturers, financiers, transporters and masterminds escape scrutiny. The Drugs and Cosmetics Act, 1940, by itself, is inadequate to address the scale and complexity of such organised networks.

The Delhi–Agra–Puducherry investigation, unfolding between 2025 and 2026, provides an important investigative model. It demonstrates how coordinated action by Drug Inspectors, police, Special Task Forces, CDSCO, State Drug Departments and the pharmaceutical industry can expose the full supply chain — from retail seizure to illegal manufacturing units.

Delhi: The value of police–drug inspector coordination

The Delhi investigation began with intelligence received by the Delhi Drugs Control Department. Acting with the assistance of Delhi Police, Drug Inspectors conducted a raid at a residential premises in Paschim Vihar, where counterfeit medicines worth crores were allegedly stocked and distributed.

The key significance of the Delhi case was its legal and investigative approach. The matter was not treated only as a violation under the Drugs and Cosmetics Act. Investigators also examined offences relating to cheating, forgery and criminal conspiracy.

This marked an important shift. When Drug Inspectors and police work together from the beginning, they are better placed to preserve documentary, digital, financial and forensic evidence. The Delhi investigation showed that an apparent local seizure could, through proper backward tracing, reveal links to illegal manufacturing units in Puducherry.

The lesson is clear: every counterfeit medicine seizure must trigger both backward and forward tracing. Investigators must identify the source of manufacture, distribution channels, transporters, financiers, beneficiaries and the larger criminal network.

Agra: Following the supply chain

The Agra investigation took the matter to a larger scale. In August 2025, Uttar Pradesh STF, FSDA and Agra Police uncovered a major counterfeit medicine syndicate. Counterfeit medicines worth more than ₹5 crore were reportedly recovered. Fake invoices, GST irregularities, cloned QR codes and interstate supply chains were also detected.

Unlike conventional enforcement actions, investigators did not stop with the seizure. They examined transport records, GST documents, warehouse operations, digital communications and movement of consignments across states. This approach led them to the same manufacturing source in Puducherry.

The Agra case also revealed the financial strength and audacity of such networks. During the enforcement action, one of the main accused allegedly offered ₹1 crore to investigating officials to stop the proceedings. Instead of derailing the investigation, this resulted in an additional case under the Prevention of Corruption Act.

This episode reinforces two important points. First, counterfeit medicine networks often possess substantial illicit financial power. Second, attempts to obstruct or influence investigations must be prosecuted firmly, as they form part of the organised crime ecosystem.

Puducherry: Reaching the manufacturing source

The most significant breakthrough came when evidence from Delhi and Agra led enforcement agencies to illegal manufacturing facilities in Puducherry.

Teams from Delhi Police, Drugs Control Department, Agra Police and FSDA travelled to Puducherry to pursue leads. Their efforts, along with joint operations by CDSCO and the Puducherry Drugs Control Department, uncovered clandestine units allegedly manufacturing counterfeit medicines in the names of reputed pharmaceutical companies.

Large quantities of counterfeit medicines, packaging material, holograms, empty capsules, manufacturing machinery, forged labels and other incriminating material were seized. The investigation also revealed the use of shell entities, fake invoices, forged QR codes and interstate logistics to move counterfeit products into North Indian markets.

This stage of the investigation confirmed that Delhi and Agra were not isolated cases. They were linked to a wider interstate manufacturing and distribution network. Several units were sealed, licences were cancelled and financial transactions came under scrutiny.

The Puducherry investigation shows that effective enforcement cannot end at the retail or wholesale level. To dismantle counterfeit medicine networks, investigators must reach the source of manufacture, disable production infrastructure, expose financial channels and identify all participants in the supply chain.

Multi-agency coordination changed the investigation

A defining feature of the investigation was coordinated action between Drug Regulatory Authorities, State Police, Special Task Forces, CDSCO and the pharmaceutical industry.

This coordination allowed agencies to connect cases that may otherwise have remained isolated. Industry support also played a crucial role. Pharmaceutical companies helped authenticate seized products, identify counterfeit packaging, verify QR codes, examine trademarks and establish whether the seized goods were genuine or fake.

Such cooperation transformed routine regulatory inspections into organised crime investigations.

Recognising the interstate ramifications of the case, the Hon’ble Lieutenant Governor of Puducherry directed that the matter be transferred to the Central Bureau of Investigation for a wider probe into the criminal conspiracy. This makes the case particularly significant in the context of counterfeit medicine enforcement in India as the first of its kind investigation handed over to the CBI.

From counterfeit medicines to corruption

The investigation also exposed the link between counterfeit medicine and corruption.

During the CBI probe, attempts were allegedly made to influence the investigation through illegal gratification. This led to the arrest of intermediaries, a Delhi Police Inspector and, subsequently, a senior IPS officer in connection with an alleged bribery conspiracy.

A similar attempt had earlier surfaced during the Agra investigation, where an accused allegedly offered ₹1 crore to investigating officers.

These developments show that organised pharmaceutical crime does not stop at illegal manufacturing. It can extend into bribery, obstruction of justice, financial crime and attempts to compromise enforcement agencies through their ill-gotten financial prowess.

Legal lesson: A drugs case alone is not enough

One of the strongest lessons from the Delhi–Agra–Puducherry investigation is that counterfeit medicine cases should not be investigated only under the Drugs and Cosmetics Act.

Every such case may also involve cheating, forgery, criminal conspiracy, trademark infringement, copyright violation and organised financial crime. Therefore, investigators should examine offences under:

• The Drugs and Cosmetics Act, 1940;
• The Bharatiya Nyaya Sanhita;
• The Trades Marks Act;
• The Copyright Act;
• The Information Technology Act;
• The Prevention of Corruption Act, where applicable;
• GST laws and financial statutes;
• The Income Tax violations;
• The Prevention of Money Laundering Act, where proceeds of crime are involved.

Counterfeit medicines are not merely illegal products. They are instruments of fraud. They deceive consumers, damage genuine brands, endanger public health and generate unlawful profits.

Financial investigation must therefore proceed in parallel. Investigators should examine bank accounts, GST records, ITRs, shell companies, benami assets, transport payments, digital wallets and suspected proceeds of crime. Where appropriate, the Enforcement Directorate should examine money-laundering dimensions.

Only an integrated legal strategy can ensure that the entire network — not merely the person in possession of counterfeit stock — is prosecuted.

The Mounjaro Case: The next stage of counterfeit crime

The fake Mounjaro case illustrates the changing nature of pharmaceutical crime.

Counterfeit medicine is no longer limited to conventional tablets and capsules. It now includes sophisticated biologics, injectable products, imported raw materials, forged labels, online marketing and digital supply chains having national and international ramifications.

In Avi Sharma v. State of Haryana, relating to the Mounjaro counterfeit case, the accused sought bail on the ground that he had cooperated with the investigation and that no direct recovery was made from his possession. It was also argued that the matter was merely a complaint under the Drugs and Cosmetics Act involving an experimental product. The defense did raise very many procedural lapses during the hearing which will cost the case heavily during the trial.

The Court, however, noted prima facie material indicating the manufacture and distribution of spurious medicines using forged labels and counterfeit branding of an international pharmaceutical company. Considering the public health risk, bail was declined.

The case reinforces the need for future investigations to combine cyber investigation, forensic examination, financial intelligence and pharmaceutical expertise.

The way forward

The Delhi, Agra and Puducherry investigations show that counterfeit medicine networks can be dismantled when enforcement is intelligence-led, evidence-based and coordinated.

India must move away from treating counterfeit medicine as a routine regulatory violation. It must be treated as organised crime affecting public health, market integrity and national credibility.

Future investigations must institutionalize joint operations between Drug Inspectors and police from the very beginning of the case. Every seizure should be followed by mandatory backward and forward supply-chain tracing so that investigators identify not only the person in possession of counterfeit medicines, but also the source of manufacture, transporters, distributors, financiers and end beneficiaries.

Investigations must also move beyond the Drugs and Cosmetics Act alone. Appropriate provisions relating to cheating, forgery, criminal conspiracy, trademark infringement, copyright violation, organised crime and corruption should be invoked wherever applicable. This wider legal approach is necessary because counterfeit medicine cases involve deception, brand misuse, public health risk and unlawful financial gain.

Forensic examination should become a routine part of such investigations. Packaging material, labels, QR codes, holograms, batch numbers, digital devices, transport records and financial documents must be scientifically examined to establish linkages between accused persons, locations, products and transactions.

A parallel financial investigation is equally essential. Bank accounts, GST records, shell entities, benami assets, logistics payments and proceeds of crime must be scrutinized. Where the proceeds of crime are identifiable, appropriate action under money-laundering laws should also be considered.

Data analytics must be used to identify repeat offenders, counterfeit medicine hotspots, targeted brands and recurring supply-chain patterns. Industry cooperation is also crucial, as pharmaceutical companies can assist enforcement agencies in product authentication, verification of packaging, identification of counterfeit labels and technical analysis of cloned QR codes or trademarks.

In cases involving interstate syndicates, central agency involvement should be considered at an early stage. Coordinated action between regulators, police, financial intelligence agencies and the pharmaceutical industry is necessary to dismantle the entire organized network rather than merely seize the counterfeit stock.

In this context, IPA’s proposed “Nautilus Counterfeit Medicine Databank” is a timely initiative. By collating information from FIRs, seizure reports, news articles and enforcement records, such a databank can help identify repeat offenders, map crime hotspots, detect targeted brands, track frequently counterfeited medicines and link persons, places, objects and events across cases.

The data already indicates that several accused have been involved in multiple offences across the country. Such repeat offenders must be investigated under appropriate provisions dealing with organised crime and criminal networks. BNS section 111 and 107 should be invoked.

The National Human Rights Commission’s recognition of counterfeit medicine as a human rights issue and the Bureau of Police Research and Development’s national-level training programmes further underline the urgency of the issue.

Conclusion

The Delhi–Agra–Puducherry investigation is a turning point in counterfeit medicine enforcement. It shows that when investigators go beyond seizure and follow the evidence, they can uncover the full criminal architecture behind fake medicines.

Counterfeit medicine is not a minor regulatory lapse. It is organised crime involving public health endangerment, forgery, cheating, financial fraud, corruption and interstate criminal networks.

The future of enforcement lies in coordinated investigation, data-driven intelligence, forensic support, financial scrutiny and strong industry–law enforcement cooperation. Only such a multidisciplinary approach can protect consumers, preserve public health and dismantle organised counterfeit medicine networks in India.

The post Lessons from the Delhi–Agra–Puducherry counterfeit medicine investigation appeared first on Express Pharma.

Joseph Sabbagh shares a practical application of root canal treatments using GenENDO instruments and BioRoot Flow in daily practice.

Root canal treatment (RCT) is a common endodontic procedure aiming to preserve a tooth through proper cleaning, shaping and obturation of the root canal system. When properly performed, root canal treatment has an estimated success rate of 90.3% (Ricucci et al, 2011). For retreatments, the success rate is between 65.5% and 77.6% (Stueland H et al, 2023).

Recent innovations in endodontics are revolutionising root canal therapy by integrating advanced imaging, precision instruments and enhanced disinfection methods, making the treatment easier and more predictable. Three-dimensional imaging – particularly cone-beam computed tomography (CBCT) – enables detailed visualisation of complex canal morphologies and guided access.

Cleaning and shaping of a root canal system relies on using flexible nickel-titanium (NiTi) files, simplified sequences, and improved alloys, together with apex locators and enhanced rotary motors, to facilitate efficient shaping of curved canals while minimising procedural errors. This enables subsequent steps, including coronal flaring, creating a reproducible glide path, determining the working length, and carrying out biomechanical preparation and disinfection of the root canal system.

Ultimately, the procedure aims to achieve effective obturation, ensure the longevity of the restoration, and preserve as much of the natural tooth structure as possible (Elmatary et al, 2025; ESE, 2006).

The gold standard in root canal treatments

The dental community has understood that an adequate endodontic treatment does not mean enlargement of the canals, but rather a proper disinfection of the root canal system combined with a three-dimensional seal. Several techniques using gutta-percha, delivered in different modes, are used for the obturation phase.

For several years, the warm vertical technique, described by Schilder in 1972, was considered the gold standard in endodontics. Although showing good clinical outcomes, this technique is complex and involves several steps. Recent development in biomaterials has led to a new category of products called bioceramics, based mostly on calcium silicate (CSCs). They can be used as cements in restorative dentistry for pulp vitality preservation, or as sealers in endodontics (Dong and Xu, 2023).

During the obturation step, the use of bioceramic sealer combined with a single gutta-percha cone makes this phase easier and more predictable.

The following clinical case report details a root canal treatment of an upper molar. The root canal preparation was completed with two NiTi files in continuous rotation (Revo-S+, GenENDO, Septodont). The obturation was done using a recent bioceramic sealer (BioRoot Flow, Septodont).

Clinical signs and symptoms

A 59-year-old male patient presented to the dental clinic to complete a root canal treatment after severe spontaneous pain localised at the upper right posterior quadrant. The pain had persisted for five days and intensified with hot stimuli. Consequently, the patient went to a hospital offering an emergency dental service. They created an access cavity in tooth #17 to relieve the pain, placed a temporary restoration, and asked him to continue the treatment with an endodontist.

A preoperative periapical radiograph revealed an apical lesion on the palatal root of tooth 17 (upper right second molar) with a widened periodontal ligament space around the mesial root. No swelling or sinus tract was visible.

Diagnosis

Based on the patient explanations, clinical and radiographic findings, the tooth was diagnosed with a necrosis following an acute irreversible pulpitis. A non-surgical root canal treatment was planned to complete the emergency procedure initiated at the hospital.

Procedure and treatment

Following administration of local anaesthesia (Septanest,1:200.000, Septodont, Saint-Maur-des-Fossés, France), the temporary cement was removed using a diamond bur and a carbide tungsten bur was used to finalise the access cavity. Three canal orifices were identified: mesiobuccal (MB), distobuccal (DB) and palatal (P). The working field was isolated using a latex rubber dam fixed with a Softclamp (Kerr, Orange, USA) to avoid any gingival fluid contamination or accidental instrument swallowing.

A manual stainless steel 010 K-File (GenENDO, Septodont) was used to scout the canals’ patency. Final working length was determined using an apex locator and confirmed radiographically.

Cleaning and shaping

Cleaning and shaping were initiated using a crown-down technique with rotary files GenENDO Revo-S+ (Septodont) SC2 and SU. There was no need for coronal flaring due to the size and the straight form of the canals.

The shaping of the canal was done with two NiTi Files: GenENDO Revo-S+ SC2 (25/0.4 symmetrical design) was used first, centered downward on the canal in two or three motions. Once the length was obtained with the SC2, a final shaping was done with the GenENDO Revo-S+ SU (25/.06 asymmetric  design)  for  a  uniform  taper  and optimal preparation following one centred downward and one upward movement with selective wall support, finishing at working length.

Copious irrigation with 3.5% sodium hypochlorite was performed throughout instrumentation, and canals were irrigated with EDTA on a final flush flow to remove the smear layer. Rechecking of canal patency was regularly ensured using a GenENDO K-File 010 between each instrument. Figure 5 shows the access cavity with the three cleaned and prepared canals.

Obturation

In the absence of swelling and after complete drying of the canals, contemporary endodontic strategy recommends the obturation of the canal system during the same session. After final irrigation, the canals were dried using one or two paper points to avoid over-drying. BioRoot Flow (Septodont), a recently introduced bioceramic sealer, was injected into each canal with low pressure.

Using a single-cone technique, one master cone of gutta-percha, previously calibrated and confirmed radiographically, was inserted into each of the canals. The gutta-percha points were then cut using a heat-cutting device and compacted with an endo plugger. A Teflon pellet was placed in the access cavity and covered by a temporary cement. Postoperative radiography of the canal system showed it was properly shaped, cleaned and homogenously filled to the radiographic apex.

Follow-up and outcome

At the one-month follow-up, the patient reported no pain or discomfort. Clinical testing showed no tenderness, and radiographic examination revealed resolution of the periodontal ligament widening and signs of periapical healing. The tooth remained functional and symptom-free.

Endodontic treatment of molars can be challenging due to variations and complexities in root canal morphology. Use of magnification, electronic apex location, and simplified rotary instrumentation enhanced the precision of canal shaping. The obturation phase was performed with a bioceramic sealer and a single gutta-percha cone, which is being used more and more in endodontics.

Successful root canal treatment depends on adequate diagnosis, canal disinfection, and hermetic obturation. Early intervention prevented the progression of periapical disease and preserved the natural tooth structure, avoiding extraction. This case highlights the importance of comprehensive diagnostic and clinical protocols in the endodontic treatment of maxillary molars. With proper technique and patient compliance, even complex molars can be predictably treated, resulting in long-term tooth retention and functional restoration.

References                                                                                                                                                     

1. Ricucci D, Rutberg M et al, 2011, A prospective cohort study of endodontic treatments of 1,369 root canals: results after 5 years. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 112(6) : 825-42.
2. Stueland H, Ørstavik D, Handal T. 2023 Treatment outcome of surgical and non-surgical endodontic retreatment of teeth with apical periodontitis. Int Endod J ; 56 (6) : 686-696.
3. Elmatary, A., Moawad, E., Heidarifar, O. et al. Endodontic access cavity preparation: challenges and recent advancements. Br Dent J 238, 469–475 (2025).
4. Dong X & Xu X. 2023 Bioceramics in Endodontics : Updates and future perspectives. Bioengineering: 10. 354.

This article is sponsored by Septodont.

• The University of Hawaiʻi Cancer Center opened the Hoʻōla Early Phase Clinical Research Center on July 6 in Kakaʻako. 
• UH says the center is the first dedicated facility in Hawaiʻi designed to conduct early-phase clinical trials for cancer. 
• The 7,500-square-foot center includes infusion bays, patient rooms, exam rooms, a pharmacy and clinical research space. 
• A pilot Phase I trial is already underway, and the center aims to support 30 active early-phase trials by 2031. 

HONOLULU — The University of Hawaiʻi (UH) Cancer Center has opened the Hoʻōla Early Phase Clinical Research Center, a new Kakaʻako facility intended to expand local access to early-phase cancer clinical trials. 

In a statement, UH said the center, which opened July 6, is the first dedicated early-phase clinical research center for cancer in Hawaiʻi. The project is designed to allow qualifying patients to participate in Phase I and Phase II studies without leaving the islands. 

The center opened during a private ceremony attended by more than 200 federal, state, university, healthcare and community leaders. The event included hula by Nā Wāhine Hula ʻĀkala, a hālau of cancer survivors, remarks from dignitaries, a maile-lei untying and a clinic tour. 

“The opening of the Hoʻōla Early Phase Clinical Research Center marks a major milestone for cancer care in Hawaiʻi,” according to an article from University of Hawaiʻi News. UH Cancer Center Director Dr. Naoto T. Ueno said the center will give qualifying patients access to investigational therapies in Hawaiʻi rather than requiring travel to mainland medical centers. 

UH said early-phase clinical trials, also known as Phase I and Phase II trials, are used to evaluate new cancer therapies for safety, dosage and potential effectiveness. Patients treated through Hoʻōla EPCRC will be able to remain close to home and ʻohana while contributing to the development of future cancer treatments. 

“These early-phase clinical trials through the Hoʻōla Early Phase Clinical Research Center are critical, because this is one of the ways that we develop new protocols and new treatments for cancer,” said U.S. Sen. Mazie Hirono during the opening event. 

The center includes dedicated patient treatment areas, clinical research space, a certified pharmacy and staff who will work with investigators, referring physicians and research sponsors. UH said a pilot Phase I clinical trial that began in 2025 has one patient enrolled and is being used to confirm that the center can safely provide treatment and conduct required clinical research operations. 

The facility spans 7,500 square feet on the first and second floors of the UH Cancer Center. Its features include six infusion bays, five patient rooms, two nurses’ stations, a pharmacy, two exam rooms, a clinical research laboratory, a patient lobby and reception area. 

Construction began in October 2022 and was completed in December 2025. UH said approximately $19.5 million in federal and state funding supported design and construction, with additional support from donors and organizations, including more than $1 million from The Leona M. and Harry B. Helmsley Charitable Trust. 

The center’s goal is to have 30 active early-phase clinical trials by 2031. UH said each Phase I or Phase II study will typically enroll no more than three participants from Hawaiʻi to ensure investigational therapies are closely monitored. 

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Over the last decade, the microbiome has shifted from a scientific curiosity to one of the most promising frontiers in biology and medicine. Whether it’s gut microbes that influence the host’s metabolism, an oral microbe that prevents cavities, or a microbial consortium that improves immunotherapy response in cancer—each discovery brings growing excitement.

As the excitement has grown, so too has the realization that identifying microbes is only part of the story. Preserving microbial viability and physiological relevance—particularly with regard to anaerobes and microaerophiles—throughout collection, transport, and cultivation is a critical prerequisite for accurately measuring microbial behavior.

The field is also shifting from descriptive microbiome research towards mechanistic understanding—using metabolic phenotyping, which directly measures microbial activity including nutrient and substrate utilization, cell growth, stress response, and more. Because only when we truly understand how microbes behave can we begin to shape them into powerful tools for healing.

Next generation sequencing (NGS) has transformed our ability to identify which species are present in a microbial community (“who’s there”) and what they may potentially be capable of. However, gene presence does not guarantee gene expression or necessarily reflect real-world activity (“what the microbes are doing”). Two strains may carry similar metabolic genes yet behave very differently under gutrelevant conditions.

These are some of the important functional questions sequencing alone can’t answer:

• What metabolic pathways are actually active?
• How do the microbes adapt to various environments and interact?
• What is the optimal environment to produce critical metabolites?

As the field pushes toward developing live biotherapeutic products, evidence-backed probiotics, and next-gen biomarkers, understanding these functional traits is essential.

This eBook explores how researchers can move beyond correlation and towards mechanism in microbiome research—from preserving physiologically relevant microbial communities to directly measuring microbial function through phenotyping.

The post Unlocking Microbiome Function with Anaerobic Workflows and Metabolic Phenotyping appeared first on GEN - Genetic Engineering and Biotechnology News.

Korea University College of Medicine has been selected to lead a government-supported initiative focused on developing next-generation hantavirus vaccines. The program will be conducted through the institution’s Vaccine Innovation Center.

Hantaviruses are carried primarily by rodents and can infect humans through exposure to contaminated urine, droppings, or saliva. Depending on the viral strain, infection can cause hantavirus pulmonary syndrome (HPS), a severe respiratory illness, or hemorrhagic fever with renal syndrome (HFRS), a disease characterized by kidney dysfunction and bleeding complications. Although relatively rare, hantavirus infections can carry high mortality rates and remain a public health concern in parts of Asia, Europe, and the Americas.

The renewed focus on vaccine development comes amid growing interest in preparedness for emerging and re-emerging infectious diseases. While mRNA technology gained worldwide recognition during the COVID-19 pandemic, researchers have increasingly explored its application against a broader range of viral threats.

According to Korea University, the newly funded program will leverage the rapid development potential of mRNA platforms to generate vaccine candidates targeting hantavirus infection.

“The Vaccine Innovation Center is the only private-sector vaccine research and development institute in Korea established to carry forward the scientific legacy of Dr. Ho-Wang Lee, who first discovered the hantavirus,” said Hee-Jin Cheong, MD, PhD, director of the Vaccine Innovation Center. “Beginning with hantavirus vaccine development, we aim to lead infectious disease research in Korea and contribute to improving public health.”

The initiative will draw on two domestically developed technologies: self-amplifying mRNA (sa-mRNA) and a next-generation lipid nanoparticle (LNP) delivery platform. Unlike conventional mRNA vaccines, sa-mRNA contains genetic instructions that enable replication of the RNA within cells, potentially generating stronger immune responses while requiring lower doses. The platform is intended to support rapid vaccine development and manufacturing while reducing dependence on overseas intellectual property.

The project builds on research conducted over the past two years at the Vaccine Innovation Center in collaboration with Moderna. The new program will seek to translate preclinical study findings into a next-generation vaccine candidate developed in partnership with biotechnology companies.

Under the two-year project timeline, researchers will spend the first year optimizing vaccine candidates and evaluating their efficacy. The second year will focus on Good Manufacturing Practice (GMP)-compliant production and safety testing.

Researchers have increasingly viewed mRNA platforms as particularly attractive because they can be rapidly redesigned when emerging threats arise. Lessons learned from COVID-19 vaccine development have helped establish manufacturing, regulatory, and clinical frameworks that may accelerate future vaccine programs.

As concern over emerging infectious diseases continues to shape global health priorities, programs such as this one may help expand the range of vaccine technologies available to combat pathogens that have historically received limited research attention.

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–Demis Hassabis, PhD, CEO of Google DeepMind and Isomorphic Labs, 2024 Nobel Laureate in Chemistry 

The infrastructure moment for AI-driven drug discovery continues to accelerate, with billion-dollar investments flowing into end-to-end platforms driven by models and compute, rather than single drug assets.

Underpinning this trend is the proliferation of AI reasoning workflows that accelerate biomedical research and large integrated datasets spanning genomics, transcriptomics, proteomics, metabolomics, and more. Together, these capabilities are enabling more powerful models of biological complexity for a new era of programmable therapeutics guided by prediction and rational design.

“This isn’t about developing therapeutics for a particular indication or target,” explained Max Jaderberg, PhD, president of Isomorphic Labs, on the Training Data podcast. Instead, the Google DeepMind spinout is building a general design engine applicable to any disease area.

Investors and pharma giants have rallied behind that vision. In May, Isomorphic announced a whopping $2.1 billion raise led by Thrive Capital. The AI drug developer has also secured major partnerships with Novartis, Eli Lilly, and Johnson & Johnson to embed AI-driven discovery workflows into pharma’s R&D pipeline.

While traditional drug discovery programs can be limited to known binding pockets revealed by structural biology, Isomorphic’s platform, known as IsoDD (Isomorphic Labs Drug Design Engine), expands the druggable landscape by probing previously inaccessible biology.

The platform’s capabilities include predicting induced-fit interactions, in which proteins change shape upon ligand binding, and identifying cryptic binding pockets that remain hidden in the absence of a ligand. IsoDD is also versatile across multiple drug modalities, including de novo antibodies and other large biologics.

Decoupled from clinical proof

The industry’s investment in AI extends well beyond Isomorphic Labs. In recent months, a wave of major partnerships has emerged to train biological foundation models with proprietary datasets from leading pharma companies.

In May, Genesis Molecular AI and Incyte announced an expanded collaboration with a potential payoff that exceeds $1 billion. The partnership will apply the GEMS (Genesis Exploration of Molecular Space) platform for protein-ligand structure and property prediction across a wider set of difficult targets in Incyte’s pipeline, while incorporating Incyte’s proprietary data to improve GEMS’s performance.

Just two weeks later, AI biologics company Chai Discovery unveiled a licensing agreement with Pfizer that provides the pharmaceutical giant with early access to Chai-3, the company’s AI model for de novo antibody design, as well as a custom model trained on Pfizer’s proprietary data.

Meanwhile, Lilly has emerged as one of the industry’s most aggressive adopters of AI. In addition to securing its own AI-focused partnership with Chai in January, Lilly recently selected Tamarind Bio to host the inference infrastructure for TuneLab 2.0, a federated AI/ML drug discovery platform that gives biotech partners access to models trained on Lilly’s proprietary data.

Observing this massive investment into AI-native biotechs, commentators on social media were quick to note that few AI-designed drugs have reached the clinic.

In Isomorphic’s case, biotech and AI analyst Andrii Buvailo, PhD, posits that Thrive and Google’s parent company, Alphabet, have deep conviction in the company’s platform, AlphaFold lineage, and pharma partnerships, and are locking in ownership before clinical data resets the company’s valuation.

The alternative scenario, writes Buvailo on LinkedIn, is that the AI drug discovery valuation cycle has fully decoupled from clinical proof, and “we are watching capital chase computational promise on its own terms.”

Previously unsolvable

As the AI biology ecosystem grows increasingly crowded, some investors are explaining how they make their bets.

For Rohan Ganesh, a partner at Obvious Ventures, differentiation comes from pursuing problems that others are unable to tackle. He points to Obvious portfolio company, Inceptive, which is developing foundation models for sequence-based medicines that generalize across programs, including RNA interference (RNAi) therapies that silence disease-causing genes.

Ganesh also argues that owning business outcomes may be the most important aspect of differentiation. As an example, another Obvious-backed company, Inductive Bio, builds virtual labs that combine AI chemistry assistants, predictive ADMET (absorption, distribution, metabolism, excretion, and toxicity) and PK (pharmacokinetics) models, and human-relevant digital organ technologies to surface key risks earlier and accelerate candidate nomination timelines by months.

The platform gained external validation in February, when Inductive placed first in the OpenADMET-ExpansionRx blind challenge, a benchmarking competition in which participants predict properties of previously unseen compounds from real-world drug programs.

“A model that’s accurate but doesn’t change the pace or probability of success in the clinic is meaningless,” Ganesh told GEN.

A key metric of AI’s success, according to Tananbaum, is whether the technology can unlock previously intractable problems, such as neurological disease. In this vein, Foresite-backed Insitro, founded by CEO Daphne Koller, PhD, announced an expanded collaboration with Bristol Myers Squibb to advance a broadened portfolio of therapeutic programs for amyotrophic lateral sclerosis (ALS) in March.

Foresite is also among the investors of closely watched AI unicorn, Xaira Therapeutics, which launched in 2024 with more than $1 billion in funding. Xaira has spent its initial years building virtual cell models trained on scalable single-cell perturbation datasets to advance target and mechanism-of-action discovery, patient stratification, and toxicity prediction.

“Genetic, biochemical, and multiomic data go hand-in-hand in untangling the biological relationships that will be fundamental for automating discovery,” Tananbaum told GEN.

Window for innovation

Jory Bell, general partner at Playground Global, concurs that “the special sauce” is in the data, not the model. He cites portfolio company Manifold Bio, which is building an AI-driven platform that scales in vivo measurements for biologics, such as PK and biodistribution, valuable for addressing challenges in tissue-specific delivery.

“Any biotech startup these days will be using AI as a core part of workflow, so the critical question is how you actually apply the AI,” Bell told GEN.

Simon Barnett, partner at Dimension, describes an investment thesis where small, focused groups effectively using machine learning will be wildly successful, regardless of whether they pursue therapeutic assets.

Notably, Dimension led Tamarind’s $13.6 million Series A in February, betting that as biology foundation models mature, the industry will move from piecemeal adoption to large-scale deployment of integrated model ecosystems.

“Platform companies need strong, informed views on whether frontier AI labs may eventually subsume their technology,” says Barnett. “Everyone needs something uniquely valuable that confers a durable advantage, whether it’s their team, cycle time, data assets, structural positioning, or something else.”

Dimension’s early bets paid off earlier this year, when portfolio company Coefficient Bio, a roughly 10-person AI drug discovery start-up founded by former Genentech scientists, was acquired by Anthropic for $400 million.

At SynBioBeta’s annual conference in May, Eric Kauderer-Abrams, PhD, head of biology and life sciences at Anthropic, said the team has focused primarily on the technical core, training AI assistant, Claude, in scientific fundamentals spanning chemistry, structural biology, and bioinformatics.

“Our thinking with the [Coefficient] acquisition was to accelerate the other side for biotech operators,” said Kauderer-Abrams. “How do we actually plan out and manage a biotech program from start to finish and make choices along the way?”

Taken together, Dov Gertz, PhD, co-founder and CEO of Converge Bio, reiterates that modern AI, particularly deep neural networks and their derivatives, has powered a dramatic transition from predictive modeling to generative design. However, the shift is still early, having only taken hold in the past decade. “Don’t expect a generatively designed molecule to reach patients for another seven years,” he tempered on LinkedIn.

Nevertheless, now is the time to invest.

“If you wait for that first FDA approval before engaging with the technology, you’ve likely already missed the most valuable window for innovation,” wrote Gertz. “Drug discovery rewards those who can see where the field is heading, not just where it is today.”

While time will tell how these bets translate in the clinic, one belief is deepening across the industry: that AI’s most important application is to improve human health.

The post Pharma Races to Scale AI as Billions Flow into Drug Discovery appeared first on GEN - Genetic Engineering and Biotechnology News.

“Our study provides proof-of-concept and preclinical evidence that CAlleR Tregs redirected against a birch pollen allergen can downmodulate birch pollen–induced allergic asthma,” said study lead Yannick D. Muller, MD, PhD, an associate professor at Lausanne University Hospital and the University of Lausanne.

Muller and colleagues reported on their study in Journal of Experimental Medicine (JEM) in a paper titled “Chimeric allergen receptor regulatory T cells suppress birch pollen allergic airway inflammation,” concluding “These findings unveil a novel mechanism for targeting soluble antigens and highlight the potential of CAlleR Tregs to prevent and treat severe allergies.”

Asthma affects over 300 million people worldwide, around 60% of whom suffer from allergic asthma. Allergens trigger an immune response in a patient’s airways, causing inflammation, excessive mucus production, and difficulty in breathing. “Allergic asthma is driven by an exacerbated type 2 immune response, characterized by the overproduction of IL-4, IL-5, and IL-13 by Th2 cells,” the authors explained. These cytokines trigger events that ultimately result in airway hyperresponsiveness, and airway mucus plugging, which is the primary cause of death in asthma.

Allergen immunotherapy (AIT), which involves the administration of gradually increasing doses of allergen, is the only treatment that addresses the underlying cause of asthma. Yet, it is not recommended for patients with severe asthma, representing the most vulnerable population at greatest risk of asthma-related morbidities and mortality. “This highlights the need for new, safe, and durable treatments for restoring allergen tolerance in severe allergic asthma,” Muller commented.

Regulatory T cells (Tregs) are immune cells that can dampen the body’s immune responses and prevent excessive inflammation. Tregs are being investigated as potential therapies for a variety of inflammatory and autoimmune disorders. “Importantly, Tregs can be expanded ex vivo and reinfused with multiple clinical trials evaluating their potential in autoimmune and inflammatory disorders,” the team continued. “However, Treg therapy has shown only limited efficacy, which has been mostly attributed to the lack of antigen specificity.”

Muller and colleagues wondered whether they could boost the therapeutic potential of Tregs by genetically engineering them to express receptor proteins that recognize specific allergens. This approach is analogous to the CAR T cell method that is now commonly used to treat cancers: cytotoxic T cells are engineered to express chimeric antigen receptors that specifically recognize proteins on the surface of cancer cells, directing the immune system to attack and kill the tumor cells.

A leading cause of allergic asthma is birch tree pollen, to which 8–16% of the European population are sensitive. The birch allergen Bet v1 is the most abundant allergenic protein, the authors commented. And while AIT for birch pollen–associated rhinitis and asthma has been shown to be effective, it is contraindicated for patients with severe and uncontrolled asthma. “This highlights the unmet need for new, safe, and durable treatments for restoring allergen tolerance in severe allergic asthma.”

Muller’s team constructed chimeric allergen receptors (CAlleRs) that specifically recognize the Bev v1 component of birch tree pollen. These CAlleRs were based on antibodies isolated from a birch-allergic patient, linked to protein signaling domains that can activate Treg cells. “We identified and characterized four novel anti–birch-specific antibodies and generated single-chain variable fragments (scFvs) fused to a CD28-ζ signaling domain,” the investigators noted.

Exposure to the birch pollen allergen, when stabilized by noncompetitive antibodies, boosted the suppressive activity of Tregs expressing these CAlleRs. The researchers found that simultaneous binding by a CAlleR and a non-competing antibody promotes receptor–allergen cross-linking underlying a novel mechanism to induce T cell activation by soluble antigens. “This mechanism opens new avenues not only for rewiring synthetic receptors against any soluble antigens including autoantigens for therapeutic intervention but also for delineating a more global pathway for antigen cross-presentation in allergies.”

Muller and colleagues injected these CAlleR-expressing Tregs into mice that were already allergic to birch pollen. When these treated animals were re-exposed to birch pollen, they showed decreased signs of allergic inflammation, reduced mucus production, and increased lung function. Next, the researchers injected CAlleR-expressing Tregs into mice that had never been exposed to birch pollen. When these animals were subsequently exposed to pollen, they failed to develop any asthma symptoms.

The team concluded, “These findings unveil a novel mechanism for targeting soluble antigens and highlight the potential of CAlleR Tregs to prevent and treat severe allergies.”  Muller added, “Future studies should evaluate the persistence and stability of CAlleR Tregs over time and define the optimal modalities for implementing such a therapeutic approach.” CAlleRs could also be developed that specifically suppress the immune response to other common allergens, including house dust mites or certain food allergens.” Future work should evaluate whether such approach could also be suitable to restore tolerance against food allergies,” the investigators said.

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Anna Najran shares her experience of navigating endometriosis and adenomyosis alongside a career in dentistry, plus her advice for others who are suffering.

As a general and cosmetic dentist, I have cared for thousands of patients, helping them through everything from routine examinations to smile makeovers. Behind the scenes, I was pushing through intense pain, living with an undiagnosed chronic illness while balancing the demands of life as a busy working mum.

Looking back, I had struggled with my menstrual health since my teenage years, but over the last decade my symptoms progressively worsened. I experienced a range of symptoms, from intense pelvic pain and back pain to bloating, chronic fatigue and migraines. Despite seeking medical advice, my symptoms were repeatedly dismissed.

Like many women, I accepted this for a time. But I knew something wasn’t right and I kept advocating for myself. Eventually I was referred for an MRI and then on to an endometriosis specialist.

It was only when I underwent complex surgery that I was finally diagnosed with stage 4 endometriosis and adenomyosis and truly understood just how much I had been living with.

I am sharing this because I know I am not the only dental professional living with this invisible condition.

What is endometriosis?

Endometriosis is a chronic inflammatory disease in which tissue similar to the lining of the uterus grows outside the uterus. It is increasingly recognised as a systemic disease with effects extending beyond the reproductive system. Adenomyosis, which often co-exists with endometriosis, occurs when similar tissue grows within the muscular wall of the uterus.

Around one in 10 women are affected, yet diagnosis still takes an average of eight years. Symptoms can vary widely and may include severe period pain, chronic pelvic pain, lower back pain, pain during or after sex, heavy menstrual bleeding, bloating, bowel and bladder symptoms, chronic fatigue, nausea and fertility struggles. Because many symptoms overlap with other conditions, diagnosis is often delayed.

When dentistry masks the disease

Dentistry is physically demanding at the best of times. We work in fixed positions for long periods, often leaning forward with a level of precision and concentration that leaves very little room for pain or discomfort. For someone living with endometriosis, where pelvic pain, lower back pain and fatigue are already part of daily life, those demands become even harder to bear.

My appointments range from routine examinations to smile makeovers lasting four or five hours. During those appointments there is little opportunity to move or relieve discomfort. Like many dentists, I assumed the headaches, back pain and exhaustion simply came with the busy clinics. It never occurred to me they could all be connected.

Dentistry can also be emotionally consuming. In a single day, we may see patients of all ages and backgrounds, each carrying their own anxieties, expectations and life circumstances. Some need reassurance, others empathy, while some simply need someone to listen. We instinctively adapt our communication, our tone and our approach to meet each patient’s individual needs before resetting and doing it all again for the next person.

When you are living with chronic fatigue, being fully present for every patient takes energy. Yet, as healthcare professionals, we become incredibly good at masking what we are experiencing so that every patient receives the same level of care, compassion and attention.

Managing GP and specialist appointments around a busy clinic diary is one of the less visible challenges of living with a chronic condition as a dentist. Moving or cancelling patients, even when necessary, carries its own weight of guilt, something many of us feel disproportionately.

What changed after my endometriosis diagnosis

Receiving my diagnosis did more than answer years of unanswered questions; it validated my symptoms and changed the way I think about health altogether. I threw myself into researching the disease and grew much more aware of my own triggers and flare-ups. The more I learnt about endometriosis and adenomyosis, the more empowered I felt to take an active role in my own health. Whilst my diagnosis gave me clarity, knowledge empowered me.

Endometriosis is complex. The causes of endometriosis are not fully understood, but hormones, inflammation, gut health, immune function and nervous system regulation can all play a role. That is why there is no single solution, and why managing it well often requires looking at the bigger picture.

Coping strategies

These are some of the things that have helped me:

• Adopting a more anti-inflammatory lifestyle, with a focus on nutrition, movement, sleep and recovery
• Focusing on gut healing, including high fibre foods and managing insulin resistance
• Using targeted supplementation to support my symptoms
• Reducing toxic load and switching to low toxin products where possible
• Optimising liver health to support hormone regulation and detoxification
• Tracking my symptoms to better understand my triggers, flare-ups and symptom patterns
• Being more intentional with my clinical diary, avoiding multiple long cases on consecutive days to allow adequate recovery
• Building short movement breaks into the day
• Using practical measures such as heat pads, a TENS machine and appropriate pain relief medication when needed
• Learning to adapt my exercise to how my body is feeling, recognising that recovery can be just as important as movement
• Incorporating mindfulness, meditation and complementary wellbeing practices, such as reflexology, into my routine
• Building a support network, whether that is a partner, close friends or a trusted member of your clinical team and leaning on them on the difficult days.

One of the biggest shifts has been learning to listen to my body rather than constantly pushing through. Having a well-trained clinical team around me has also made an enormous difference. When your nurse can independently handle tasks such as digital scanning, radiography, clinical photography and patient education, it meaningfully reduces both the physical and cognitive demands of a busy clinical day, and on the more difficult days, that support is invaluable.

Advice for colleagues living with endometriosis

If you are living with endometriosis or any chronic illness, the first thing I want you to know is that you are not alone.

Seek medical help and do not accept dismissal. If something feels wrong, advocate for yourself. Push for an MRI and ask for a referral to an endometriosis specialist. You deserve the same thoroughness of investigation that you would want for your patients.

Do your own research and explore what works for your body. Everyone’s experience of this condition is different and finding what helps you manage your symptoms is a personal journey.

Lean on the people around you, a partner, a close friend, a trusted colleague or your nurse. You do not have to carry this alone.

Final reflections

Living with endometriosis and adenomyosis has undoubtedly changed my life, but it has also changed the way I practise dentistry. It has made me more intentional with my health, more aware of the importance of recovery and even more empathetic towards the patients I care for every day. It has also reminded me what it feels like to sit on the other side of the consultation.

As dentists, we spend our careers educating and empowering our patients, encouraging them to understand their health and make informed decisions about their care. My diagnosis reminded me how powerful that knowledge can be. If sharing my experience helps just one dental professional feel seen, seek answers sooner or realise they are not alone, then telling my story will have been worthwhile.

Looking after ourselves is not a distraction from patient care; it is what allows us to continue providing it.

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“Current FDA-approved treatments for ALS provide only modest benefits. There is an urgent need for a real breakthrough,” said Xinglong Wang, PhD, corresponding author of the study a professor at the R. Ken Coit College of Pharmacy.  

ALS is difficult to treat because diagnosis occurs after substantial nerve cell damage. Causes of ALS are unclear. Fewer than one in 10 cases are inherited through a known genetic mutation. More than 90% of cases arise sporadically with no family history or clear genetic cause. However, nearly all cases demonstrate abnormal TDP-43 aggregation inside nerve cells, which often informs post-mortem diagnosis. 

“We asked a simple question that had never been tested: is there one specific part of TDP-43 that’s causing the harm, something a drug could switch off without disturbing the rest?” Wang said.  

The team found a region of TDP-43 were disease-causing mutations clustered. When this region was deleted in mice, the nerve cell death caused by TDP-43 dropped sharply while normal protein function remained intact. The researchers identified experimental drug, XL20, which could latch onto the target region in the TDP-43 protein. Notably, the drug could cross the blood-brain barrier. 

In mice, the XL20 extended median survival by approximately a week, protected nerve cells and reduced muscle weakness. When XL20 was tested on human motor neurons, the specialized nerve cells in the brain and spinal cord, the experimental drug reversed damage.

Wang says XL20 represents a promising candidate for future clinical development. As ALS typically develops over months to years after symptoms first appear, earlier treatment could provide greater opportunity to slow disease progression.  

Additionally, the study’s findings may have applications for other neurological diseases. The same TDP-43 pathology is central to limbic-predominant age-related TDP-43 encephalopathy (LATE), a common dementia which affects roughly one in three people over 80. TDP-43 pathology is also found in more than half of Alzheimer’s patients and is associated with faster cognitive decline. 

“The same TDP-43 pathology is implicated in several other neurodegenerative diseases,” Wang said. “If future studies show this approach works in those diseases as well, it could eventually benefit a much larger patient population.” 

The post ALS Drug Extends Survival in Mice, Targets TDP-43 Low-Complexity Domain appeared first on GEN - Genetic Engineering and Biotechnology News.

It is expected to close in the second half of 2026, pending customary closing conditions and regulatory approvals.

Myricx Bio is developing antibody-drug conjugates (ADCs) that target cancer cells using N-myristoyltransferase inhibitor (NMTi) payloads.

These next-generation payloads are designed to address limitations of commonly used ADC payload classes such as topoisomerase 1 (TOPO-1) inhibitors.

The company’s pipeline includes two lead candidates directed at the tumour-associated targets B7 homologue 3 (B7-H3) and human epidermal growth factor receptor 2 (HER2), indicating potential application across various solid tumour types.

Novartis biomedical research president Fiona Marshall said: “ADCs have become an important part of cancer treatment, but there remains a clear need for new payload mechanisms to overcome resistance and expand their impact for patients.

“Myricx Bio has developed a promising NMTi payload platform with a differentiated mechanism that could broaden the use of ADCs across multiple tumour settings.

“This proposed acquisition reflects our strategy to scale innovative platforms, as we have with radioligand therapies, to deliver more durable, transformative treatments for patients.”

Based on preclinical data, the NMTi payloads may display broad activity across solid tumours, including those resistant to existing therapies such as TOPO-1 inhibitors.

The agreement would enable Novartis to assist in establishing NMTi, pending clinical validation, as a new class of ADC payloads that could be used for a variety of targets and platforms.

Prior to this, the European Commission granted approval for Novartis’ Itvisma (onasemnogene abeparvovec) as a treatment for children two years and older, teenagers and adults who have 5q spinal muscular atrophy with a bi-allelic mutation in the survival motor neuron 1 gene.

The post Novartis to acquire Myricx Bio in up to $1.5bn deal appeared first on Pharmaceutical Business review.

Besins Healthcare will acquire UniD’s site in Seraing, Belgium. A total of 52 employees will also be transferred to the company.

The transaction will see UniD Manufacturing rebranded as Besins Healthcare PharmTech, which is intended to become a centre dedicated to future innovation and development projects.

Besins Healthcare has developed hormone therapies for both men’s and women’s health, including products such as Estrogel / Oestrogel (estradiol), Utrogestan (micronised progesterone) for women, and Androgel / Testogel (testosterone) for men.

UniD Manufacturing adds capabilities for developing drug delivery systems intended to enable less frequent administration of treatments.

Besins Healthcare co-CEOs Nicolas and Alexandre Besins said: “This acquisition unites two teams with deep and complementary expertise, and we couldn’t be more pleased to welcome UniD to Besins Healthcare. This is a natural partnership for both companies, and we are excited about what lies ahead.”

UniD Manufacturing executive chairman Marc Foidart said: “We are proud of what the UniD team has built over the past 20 years, and we are delighted to see those capabilities take on a new dimension as part of Besins Healthcare.

“The UniD team looks forward to innovating further with Besins Healthcare, as well as continuing to serve our existing clients with the same commitment they have always received.”

The companies have not disclosed the deal value.

In the immediate future, UniD Manufacturing will continue its current operations and service to existing clients.

Besins Healthcare operates in 114 countries through 22 subsidiaries.

The post Besins Healthcare boosts drug delivery portfolio with UniD deal appeared first on Pharmaceutical Business review.

The newly published Oral Health Index, which draws on data amassed by Hello Pearl, highlights significant differences in oral health outcomes between the UK and the US and reinforces the importance of identifying dental disease before symptoms develop.

Based on 737 million tooth observations from 26 million dental visits across both countries, the Index found that UK patients in the full-mouth radiograph cohort had an average of 6.36 missing teeth, compared with 2.16 in the US. Around 31% of affected teeth in the UK had been extracted, versus 14.5% in the US.

These findings should not be viewed as a criticism of clinicians. Rather, they reflect how access to care, funding models, appointment pressures and available treatment options can influence whether teeth are restored, monitored or extracted.

The data also highlights an important message: the absence of pain does not necessarily mean good oral health. Early carious lesions, periodontal disease and mineral loss frequently develop without symptoms and may remain undetected without radiographic assessment.

Interpreting radiographs can also be challenging for patients, who often rely solely on verbal explanations from clinicians. Hello Pearl’s Second Opinion platform aims to bridge this gap by analysing dental radiographs and highlighting findings such as suspected caries, periodontal bone loss and calculus deposits directly on the image. The technology is designed to support, not replace, clinical judgement by improving consistency and helping patients better understand their oral health.

Early detection can make a significant difference. Enamel demineralisation identified early may be managed with preventive measures, whereas disease detected later may require restorative treatment or even extraction.

Younger adults carrying a high burden of untreated disease

One of the most striking findings concerns younger adults. Among those aged 18-24, 52% of identified dental disease was untreated, the highest proportion of any age group. In adults aged 75 and over, the figure was 28%, despite a greater overall burden of dental disease. This suggests that older adults are more likely to have had previous treatment, including fillings, crowns and extractions, whereas younger adults may be accumulating untreated disease.

Several factors may contribute to this trend. Young adults often lose continuity of care when leaving home, fail to register with a new practice or deprioritise routine dental visits due to competing financial pressures. Without symptoms, disease progression can easily go unnoticed.

The Index also identified first permanent molars as particularly vulnerable. Although they represent only 14% of the dentition, they accounted for 24% of detected carious lesions and 31% of restorations. Evidence of decay in first molars appeared from around age 17, considerably earlier than in lower incisors, highlighting where preventive efforts may be most beneficial.

Access to care remains a key determinant

The findings suggest that oral health outcomes are influenced as much by access to care as by individual behaviours. Importantly, all individuals included in the dataset had attended a dental practice and undergone radiographic examination, meaning the true burden of undiagnosed disease among those who do not access care is likely to be even greater.

The Index ultimately reinforces a simple message: pain should not be the main reason for seeking dental care. The period between feeling well and being clinically well is often when preventable disease progresses. By helping clinicians identify and communicate pathology earlier, Hello Pearl aims to support interventions when conditions can still be monitored, managed or potentially reversed.

To request a demo, visit hellopearl.com/getdemo.

This article is sponsored by Hello Pearl.

Welcome to The Week in Dentistry, a regular round-up of dental sector updates from across the UK and Ireland.

This week’s edition includes the launch of an artificial intelligence receptionist for dental practices, the sale of a West Midlands practice, community support work in east London and a statement from a UK-based Venezuelan dentist following the earthquake in Venezuela.

Venezuelan dentists at LOC & ODL respond to earthquake

Venezuelan dentists at London Orthodontic Clinic (LOC) and ODL Dental Clinic have responded to the earthquake in Venezuela, highlighting the humanitarian impact on communities across the country.

Alex Seijas, founder of Mission Beyond Smiles and founder and clinical director of LOC and ODL, said many Venezuelans living abroad had spent recent days trying to contact family and friends.

He said: ‘At moments such as this, international solidarity and humanitarian support become more important than ever. My thoughts are with everyone affected by this disaster, particularly those who have lost loved ones, homes or livelihoods.’

Mission Beyond Smiles recently took a team of Venezuelan dental professionals from the UK to the Venezuelan Amazon to provide dental care and support to underserved Indigenous communities.

Dentally launches AI-powered Dentally Pulse

Dentally has unveiled Dentally Pulse, an artificial intelligence (AI) intelligence layer designed to reduce administration and support dental practice teams.

The platform is designed to sit across Dentally and turn conversations, clinical observations, patient interactions and operational data into practical outputs. Dentally said the first feature available through Dentally Pulse is an enhanced AI clinical notes tool, which can summarise appointment conversations into clinical records without storing the original audio.

Duncan Leslie, director of product and technology at Dentally, said: ‘Our approach to AI is simple: it should assist, not replace. Clinicians remain firmly in control, while technology works in the background to help practices work more efficiently and focus more time on patients.’

Dentally Pulse will be rolled out progressively throughout 2026, with additional capabilities expected during the third and fourth quarters. Practices can register interest through Dentally.

Savona Dental supports homeless community

Savona Dental partnered with SameDayDoctor and Nishkam SWAT to provide care packages for people experiencing homelessness in east London.

The Canary Wharf practice helped prepare and distribute bags containing toothbrushes, toothpaste and warm socks. SameDayDoctor also contributed feminine hygiene products, while Nishkam SWAT volunteers distributed the packages in Stratford.

AI dental receptionist Greeta launched

Conversico launched Greeta, an artificial intelligence (AI) dental receptionist designed to support practices with missed, overflow and out-of-hours calls.

The system answers calls, books directly into the practice management system and gives reception teams a clear next step. Greeta launched on 30 June 2026 and is now live, with a public demo available through Conversico.

Dudley dental practice sold after owner retires

Andrew Hargreaves Dental Practice in Dudley, West Midlands, was sold after its founding owner retired from clinical dentistry.

The three-surgery mixed-income practice was founded by Andrew Hargreaves in 1996. Christie & Co handled the sale, and the practice was purchased by Nazim Shah, an experienced dentist with previous practice ownership experience. The sale price was undisclosed.

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The General Dental Council (GDC) was challenged over the lack of formal quality assurance for Overseas Registration Examination (ORE) preparatory courses at a Dental Leaders Network event exploring how the growing number of internationally qualified dental professionals can be better supported in UK dentistry.

The event, held on 30 June, brought together regulators, educators, employers and professional support organisations to examine a workforce issue that is becoming increasingly central to NHS access, practice recruitment and patient care.

The informative and collaborative day opened with scenario modelling from Stefan Czerniawski, executive director of strategy at the GDC, showing how the make-up of the dental register could change if current and planned registration patterns continued. Under one scenario, fewer than a third of new dentists joining the register could be UK trained by 2029, with UK-trained dentists becoming a minority of the overall register by 2034.

Czerniawski stressed that the figures were scenarios rather than predictions, with future patterns dependent on factors including ORE and Licence in Dental Surgery (LDS) capacity, European registrations, retention and candidate behaviour.

He said this was not a negative trend, stressing that internationally qualified dental professionals made an ‘enormous and invaluable contribution’ to healthcare in the UK. However, the changing workforce raised questions about foundation training, supervised practice, support needs and how the UK remained attractive to internationally qualified dentists.

ORE preparation

One of the most noteworthy exchanges came towards the end of an afternoon panel discussion, when Fiona Sandom, senior lecturer and programme lead for dental hygiene and dental therapy at Bangor University, challenged Czerniawski and the GDC on oversight of ORE preparatory courses.

She asked whether the regulator quality assured ORE educational providers in the same way it quality assured other GDC-registered qualifications.

Czerniawski confirmed there was quality assurance of the ORE itself, but not of the courses candidates take to prepare for it. He said the ORE was structured as a self-contained assessment, with the regulator historically focused on the assessment rather than how candidates prepared for it.

However, he acknowledged that some form of accreditation or standard setting for preparatory courses could be valuable, adding that whether this should be done by the GDC, or under what powers, remained a separate question.

The exchange captured a wider theme running through the day: the ORE remained a central route into UK registration for many overseas-qualified dentists, but the journey around it was often fragmented, expensive and inconsistently supported.

Consistency and cost

Another panellist, Gauri Pradhan, honourable trustee of International Dental Organisation UK (IDO UK), said registration was often the first major hurdle for internationally qualified dentists, with some candidates unsure how to navigate the system despite recent improvements to the ORE booking process.

She said candidates could spend between £15,000 and £18,000 from the point they started the registration process to joining the register, with some paying thousands of pounds for preparatory support without clear validation or accreditation.

Kaushik Paul, clinical director at mydentist, used an earlier talk to discuss how course providers played an important role in preparing candidates, but argued that the profession needed more consistency. Given the cost of the ORE, he said more should be done to help candidates ‘get it right first time’.

Building support

The event, which featured a number of speakers who had come through the ORE pathway, also highlighted the scale of practical support needed after candidates pass the ORE, which has seen a significant rise in cost.

Sam James, overseas resourcing manager at mydentist, said more than 50% of clinicians working with the organisation had qualified outside the UK, and that 474 international dentists had started their journey with mydentist over the previous three years. This aligned with GDC figures released in May showing overseas registrants outnumbered those from the UK for the first time.

He said the company’s approach included overseas training partnerships, recruitment support, help with National Health Service (NHS) performer number applications, visa and relocation support, induction and mentoring.

But speakers were clear that support needed to go beyond formal onboarding. Paul said mentors often helped candidates with practical parts of settling into UK life, such as finding local shops, opening bank accounts, accessing accountants and settling families into new communities. He noted that you can’t just drop a dentist from Mumbai into Makerfield and expect it to work.

Mostafa Hassaan, deputy chief dental officer for Wales and an internationally qualified dentist, said passing the ORE was only the first stage of a longer journey. He argued, with specific examples from his own practice, that integration was fundamentally a leadership issue, with international dentists needing fair first opportunities, clear NHS pathways, mentoring, communication support and help understanding UK patient expectations.

NHS performer number

The NHS performer number process was repeatedly raised as a barrier. Hassaan described it as a major bottleneck, arguing that dentists could pass the ORE, join the register and still face delays before treating NHS patients.

Paul also called for a more consistent approach to NHS performer list systems, arguing that requirements varied between regions and nations.

The panel discussed whether a national induction programme could help internationally qualified dentists move into NHS practice more consistently. Pradhan suggested this could include structured training on NHS systems, local expectations and support from a buddy or supervisor.

However, panellists warned that a short induction alone would not be enough. Sandom said support needed to include tacit learning and mentorship, rather than becoming a tick-box exercise.

Culture and safety

The discussion also moved beyond dentists. Sandom said internationally qualified dental hygienists and dental therapists needed support, while questions were also raised about dental technicians and other registered titles.

She said integration was too often treated as something individual clinicians had to solve on their own, when many were entering complex systems where expectations were rarely spelled out. Clearer pathways, explicit expectations and consistent support, she argued, would allow internationally qualified professionals to contribute fully.

Speakers also raised concerns about exploitation. Neda Irani, restorative clinical teacher at King’s College London, used her lightning talk to highlight that many overseas dentists did not realise they were being exploited because they had not yet had time to learn UK workplace norms, contracts, regulation or professional support structures.

She said support needed to cover practical issues such as contracts, indemnity and professional expectations, as well as the emotional pressures of moving country and starting a career again.

Paul also warned that internationally qualified dentists could be treated as cheap labour, disrespected or discarded when they raised concerns about poor conditions.

Asked who should be responsible for regulating employers and tackling exploitation, Czerniawski said the GDC’s remit covered professional standards, but identifying and acting on exploitation was a wider responsibility shared across the profession.

He suggested that where leaders and colleagues were aware of exploitation, they needed to be prepared to act or provide enough detail for concerns to be followed up.

GDC ORE fee increase

Speakers also linked support for internationally qualified dentists directly to patient access and safety. They said overseas-qualified professionals brought much-needed capacity and clinical experience to areas struggling to recruit, but this needed to be matched with support around communication, consent, complaints handling and cultural expectations.

Biju Ramachandran, honorary secretary and immediate past president of the Indian Dental Association UK, said registration gave dentists permission to practise, while integration helped create belonging.

He also urged the GDC to reconsider its recent ORE fee increase, arguing many candidates were already stretched financially before they sat the exam.

Closing the event, Brid Hendron, postgraduate dental dean at the Northern Ireland Medical and Dental Training Agency, said the day’s central message was to ‘act now and act together’ in preparing for the incoming non-UK qualified workforce.

She said international dentists were an essential part of the workforce solution, with responsibility shared across regulators, employers, support organisations and practice teams.

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Immuneel Therapeutics, India’s pioneering cell and gene therapy  company, announced a strategic partnership with Arogya Finance to introduce India’s first  Zero Cost EMI program of up to ₹25 lakhs for eligible patients undergoing treatment with  Qartemi (Varnimcabtagene autoleucel), Immuneel’s CD19-directed autologous CAR-T cell  therapy.

The collaboration marks a significant milestone in improving patient access to advanced cancer  care by addressing one of the most critical barriers to treatment—timely affordability. The  partnership has been formalized through a collaboration agreement under which Arogya Finance  will independently provide financing to eligible patients, while Immuneel continues to focus on  delivering world-class CAR-T therapy.

For patients with relapsed or refractory B-cell malignancies, CAR-T cell therapy is often considered  after conventional treatment options have failed. While these patients are fighting against time,  families are frequently faced with another challenge—arranging substantial funds within a matter  of days. For many, this financial burden can delay treatment at a stage where every day is clinically  important.

Recognising this unmet need, Immuneel has introduced the Saksham Patient Access Program,  under which eligible patients can now avail Zero Cost EMI financing of up to ₹25 lakhs for a tenure  of up to 12 months, subject to credit assessment, lender approval and applicable terms and  conditions. The initiative has been designed to ensure that financial constraints do not become a  barrier to accessing potentially life-saving therapy.

Amit Mookim- Chief Executive Officer, Immuneel Therapeutics said “Innovation in healthcare is  meaningful only when patients can access it. While tremendous progress has been made in  developing advanced cellular therapies, affordability remains a significant challenge for many  families. Through this partnership with Arogya Finance, we are addressing a critical unmet need  by helping eligible patients access Qartemi without the burden of arranging the entire treatment  cost upfront. This is another important step towards making advanced cancer care more  accessible in India.”

Under the program, every patient first undergoes a comprehensive medical evaluation by  Immuneel’s Medical Affairs team to determine eligibility for CAR-T cell therapy. Eligible patients  are then supported through the Saksham Desk, which provides dedicated financial counselling  and facilitates the financing process. Upon submission of the required documentation, loan  applications are independently evaluated by Arogya Finance, enabling rapid processing so that treatment planning can proceed without unnecessary delays. The financing arrangement is  independently administered by Arogya Finance, which is solely responsible for loan approval,  disbursement and servicing.

Jose Peter, Co-founder & Chief Executive Officer, Arogya Finance added “At Arogya Finance, we  believe that access to quality healthcare should not be limited by immediate financial constraints.  We are proud to partner with Immuneel to introduce an innovative financing solution that enables  eligible patients to access one of the most advanced cancer therapies available today while easing  the financial burden on their families.”

Qartemi (Varnimcabtagene autoleucel) is Immuneel’s CD19-directed autologous CAR-T cell  therapy developed for eligible patients with relapsed or refractory B-cell malignancies. As India  continues to strengthen its capabilities in advanced cell and gene therapies, improving patient  access through innovative financing models will play an increasingly important role in ensuring  that medical innovation translates into meaningful patient outcomes.

The Zero Cost EMI initiative reinforces Immuneel’s commitment to democratizing access to  advanced cellular therapies through innovation, affordability and patient-centric care. By  combining scientific excellence with access solutions, the company continues to work towards  ensuring that eligible patients can receive timely treatment when they need it the most.

The post Immuneel and Arogya Finance launch India’s first zero cost EMI program for Qartemi CAR-T Cell Therapy  appeared first on Express Pharma.

Nigel Jones considers why a more trusted, collaborative GDC could shape not only regulation, but the future of the UK’s dental workforce.

The language surrounding the launch last November of the GDCs strategy to become viewed as a ‘trusted and effective’ regulator was encouraging, even if, for many years, the profession will have heard similar intent expressed at various intervals in various forums. This time, however, it feels different. 

I doubt anyone is under the illusion that the damage done to the relationship between the profession and its regulator will be repaired quickly. The mindset shift has to percolate right through the organisation itself and old habits die hard. Even after the operational changes are delivering a new approach consistently and reliably, it will be a while before the perception of the GDC as a body to be feared is shaken off.

But the early signs and feedback are good so there are definite grounds for optimism which is just as well given the key contribution the GDC may play in influencing dentistry over the coming years. As Dr Helen Phillips, chair of the GDC, put it in the foreword to the new strategy: ‘Collaboration is key. We have shared interests in making dentistry work across the UK and we all have a role to play.’

Why trust matters

Take, for example, the issue of the dental workforce planning and the part the GDC plays in the number of clinicians on the register. I’ve often expressed the view that the restricted supply of clinical services relative to demand from patients has been the main driver of change over the past. 

An inability to recruit or retain associate dentists has often been cited by the owners of NHS practices as the straw that broke the back of their hesitation about ‘going private’. Indeed, we are increasingly seeing it is associate dentists, having concluded that NHS contractual arrangements (old or new) are not for them, that are driving the decisions about a practice’s commitment to the NHS.

Resisting such requests is not easy, especially when there are so many vacancies in private practices offering better financial packages, career development opportunities and pace of work. The latter is of particular importance when private practice can offer the chance of longer appointments, leading to better communication and stronger relationships with patients as well as more time for note taking, all of which lessen the fear of getting on the GDC’s radar for the wrong reasons.

And while there are obviously significant regional variations, the drift to private practice exacerbates the lack of access to NHS dentistry, boosting the confidence of the remaining NHS dentists. With limited options available to patients, a move to purely private is feasible and so it goes on.

The wider consequences

In both NHS and private environments, the lack of clinicians can lead to downward pressure on practice income at the same time as the pressure on running costs is relentlessly upwards. The resulting financial pressure can bring in to play behavioral matters relevant to the tension between commercial and ethical considerations.

Indeed, the CMA’s look at private dentistry, while likely to pick up on the supply and demand imbalance in the dental market, is almost certain to be influenced by their work in the veterinary field. In a provisional report, issues such as price transparency and rising private treatment costs were called out as was the concentration of veterinary practice ownership in a few large companies. The BBC even ran a story in January about vets reporting being under corporate pressure to increase revenue.

The GDC has no remit to get directly involved in workforce planning, CMA recommendations, dental business models or NHS contractual arrangements.  However, the way in which it handles concerns about professional conduct is linked to the appeal of private dentistry. More significantly, the rate at which it opens or closes the tap on new dentists joining the register can have indirect impacts on many aspects of UK dentistry which in turn could lead to the kind of professional and ethical issues that are definitely within the GDC’s remit.

A regulator for the future

So, it is with all that in mind that the early signs of the GDC being true to the words of its strategy are to be highly welcomed. A regulator that is seen as supporting the profession it regulates and gives deeper consideration to the wider environment in which dental professionals work will be essential in the years ahead.

This article is sponsored by Practice Plan.

The Federation of Pharma Entrepreneurs (FOPE) has sought clarifications from the Central Drugs Standard Control Organization (CDSCO) on the implementation of pharmacovigilance (PV) requirements under the revised Schedule M, citing ambiguities that could lead to inconsistent interpretation and compliance across the pharmaceutical industry.

In a representation addressed to the Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, FOPE requested detailed guidance on the implementation of Paragraph 6.11 of the revised Schedule M following a CDSCO circular issued on June 3, 2026, directing stakeholders to establish and maintain an effective pharmacovigilance system in accordance with the Drugs and Cosmetics Act, 1940, the revised Schedule M and the New Drugs and Clinical Trials (NDCT) Rules, 2019.

The industry body, which represents pharmaceutical manufacturers with a strong focus on MSMEs, said regulatory clarity is essential to ensure uniform implementation by manufacturers, marketers and licensing authorities.

One of the key issues highlighted by FOPE relates to pharmacovigilance responsibilities in third-party or contract manufacturing arrangements. Under Paragraph 6.11 of the revised Schedule M, licence holders are required to maintain a pharmacovigilance system for collecting, processing and forwarding reports of adverse drug reactions arising from drugs “manufactured or marketed by the licensee.”

FOPE has requested CDSCO to clarify whether this responsibility should rest with the manufacturing licence holder or the marketing company whose name appears on the product label. The association argued that where products are manufactured under contract and marketed by another company, the marketer should be considered responsible for pharmacovigilance obligations, as marketers are already responsible for product quality under the Drugs Rules, 1945.

The representation also seeks clarification on the distinction between the general pharmacovigilance requirements prescribed under Schedule M and the Periodic Safety Update Report (PSUR) requirements under the NDCT Rules, 2019. FOPE noted that while Schedule M appears to mandate a pharmacovigilance system for all marketed products, PSUR submissions under the NDCT Rules are specifically linked to new drugs.

The association has therefore requested CDSCO to clarify whether Schedule M requires only a general pharmacovigilance system for marketed products, while PSUR submissions remain applicable exclusively to new drugs as defined under the NDCT Rules.

A third issue raised by FOPE concerns the applicability of the NDCT Rules, 2019 to products approved before the Rules came into force. The association has sought clarification on whether PSUR obligations apply only to new drugs approved after 2019 or whether they are intended to cover products that received regulatory approval prior to the commencement of the NDCT Rules.

FOPE said such clarifications would help manufacturers, marketers, State Licensing Authorities and CDSCO’s zonal offices adopt a consistent approach towards pharmacovigilance compliance. The association has urged the regulator to issue suitable guidance to facilitate uniform implementation of the revised Schedule M provisions across the pharmaceutical sector.

The post FOPE seeks CDSCO clarification on pharmacovigilance obligations under revised Schedule M appeared first on Express Pharma.

A couple of recent notifications, one a notified amendment and the second one, a proposed amendment, concerning medicines have good intentions, but could have quite the opposite outcomes. While regulators are playing their role to rationalise restrictions, with the mandate to improve Ease of Doing Business, they have to also balance patient safety and public good.

Let’s first take a recent instance of authorities stepping in to investigate and if necessary, enforce anti-dumping duties on specialised packaging material. A recent LKS International Trade Team update informs about the Directorate General of Trade Remedies (DGTR) acting on a complaint from JPFL Films and initiating an Anti-Dumping Duty investigation concerning imports of Biaxially Oriented Polyamide (BOPA) film originating in and exported from China PR and Thailand.

As per the LKS International Trade Team update, BOPA films are high-performance specialised flexible packaging films manufactured from polyamide resin through biaxial orientation technology, known for its high mechanical strength, isotropic properties, odour and aroma resistance, hot and cold forming resistance, moisture and oxygen barrier properties, and puncture resistance.

BOPA film is used as specialised packaging material for food, liquids and pharma products. If the DGTR’s investigation finds that the imports of BOPA film from China PR and Thailand are at dumped prices and impacting the business of the domestic industry/company, then it can recommend anti-dumping duty, to rectify the harm to JPFL Films’ business. This case ties in directly to the crisis looming around pharma packaging, the theme of the cover story of Express Pharma’s July edition. (Resilience by Design: The Packaging Imperative).

Let’s now consider how some regulations could backfire. For instance, the Union Health Ministry has expanded the QR code-based drug traceability framework to include all vaccines, antimicrobials, narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, and anti-cancer medicines. 

This notified amendment to the Drugs Rules, 1945 to expand the ambit of Schedule H2 is expected to “facilitate authentication of medicines at various stages of the supply chain and enable improved tracking and verification of drug products. The measure is expected to strengthen regulatory oversight and support efforts to curb the distribution of spurious medicines in the market.”

But industry experts have pointed out that QR codes can be counterfeited, leading to a false sense of security among patients. (https://www.expresspharma.in/how-counterfeiters-are-breaching-indiasqr-code-system/) 

Manufacturers of vaccines, narcotic and psychotropic drugs, and anti-cancer medicines have a year to comply with this mandate while the provisions relating to antimicrobials shall become effective a year later, from July 1, 2028.

One hopes that regulators use the interim period to ensure that they have the taskforce and systems in place to enforce these mandates. This would, at the very least, entail more frequent surprise inspections and raids of vulnerable touch points within the pharma supply chain to make this initiative as impactful as it needs to be.

Secondly, let’s consider the Union Ministry of Health and Family Welfare’s proposal to rationalise/reduce the required residual shelf-life for imported drugs. The draft amendment proposes to revise the current requirement of a minimum residual shelf life of more than 60 per cent for imported drugs to 12 months at the time of import. Biological products and radiopharmaceuticals are exempted from this revision “in view of their specialised nature and public health considerations.”

On the face of it, this amendment has many advantages. The amendment is “expected to optimise supply management, reduce costs, and strengthen the availability of essential medicines in the country.” Patients are expected to get improved access to imported medicines, while importers of such medicines will get more time to distribute such medicines before expiry.

The proposed amendment is open for comments from industry till July 22, 2026. Industry response has been positive so far, as it seems to address supply chain issues and gives more time to sell imported medicines. 

But from a patient safety point of view, how many patients in India are aware expired medicines could have health risks? How many patients check expiry dates? Are expired medicines indeed taken out of the pharma supply chain at all? Especially imported medicines, which would be more expensive? Would the Ease of Doing Business mandate result in compromised patient safety? Especially when it would be difficult to test the quality of such imported medicines as they near their expiry dates.

There have been many reports of expired medicines being re-sold to patients. In fact, the illegal sale and disposal of expired medicines was the topic of a Lok Sabha question in March 2026 (Unstarred Question no. 4641) from Jai Prakash of the Hardoi constituency of Uttar Pradesh, Bharatiya Janata Party.

His query was quite detailed and reveals the modus operandi of such scams: ‘whether the Government has taken or proposes to take strict action to curb the illegal and dangerous practice of reselling expired medicines, which involves altering expiry dates and reentering them into the supply chain’; whether the Central Drugs Standard Control Organization (CDSCO) has issued new guidelines on the safe disposal of expired/unused drugs to ensure that they are not diverted back into the market; and whether the Government has launched “Drug Take-Bank” programmes, where consumers can drop off expired medicine at designated locations.

In her reply, Anupriya Patel, Union Minister of State for Health and Family Welfare, informed that CDSCO, with the approval of the Drugs Technical Advisory Board (DTAB) had issued a guidance document (on May 26, 2025) on the disposal of expired/unused drugs. She also informed that State Licensing Authorities ‘are legally empowered and take stringent actions against violation of provisions of the Act and Rules including the instances of reselling the expired medicines.’

This exchange proves that there is enough awareness among legislators and regulators on the extent and serious harm to consumer health posed by expired medicines, imported or manufactured in India. Whether these rules are implemented and enforced enough is another question.

There is no doubt that regulatory oversight has had some wins. The recent CDSCO advisory against ‘promotional activities, including so-called “awareness campaigns,” that function as a surrogate advertisement for prescription drugs including Glucagonlike peptide-1 (GLP-1) receptor agonists,’ was a timely reminder that what may work in other markets, may not be aligned to Bharat’s realities.

These recent amendments and reforms underline the fine line between reform and risk. Regulators like the CDSCO, Ministry of Health & Family Welfare have a tough balancing act: to bring in business efficiencies without compromising public health. Converting good intentions into impactful benefits for all stakeholders will need stringent implementation and enforcement. 

VIVEKA ROYCHOWDHURY,
Editor
viveka.r@expressindia.com
viveka.roy3@gmail.com 

The post The fine line between reform and risk  appeared first on Express Pharma.

Abivax declared that obefazimod “delivered meaningful clinical benefit” to adults with moderately to severely active UC in the ABTECT Maintenance Part 2 supplemental portion of its Phase III UC maintenance program, with 37.2% of induction nonresponders achieving clinical remission and 34.5% achieving endoscopic remission at Week 44 following continued 50 mg treatment. Of those patients, 61.5% also showed clinical response, 48.0% endoscopic improvement, and 44.6% Histologic-Endoscopic Mucosal Improvement (HEMI).

In patients whose doses were escalated to 50 mg, clinical remission was recaptured in 45.5% of patients who relapsed during ABTECT Maintenance Part 1—a result Abivax said supported a practical dose-escalation strategy for regaining and sustaining disease control over time.

Of special interest to investors, no new safety signals were seen since earlier this month, when Abivax disclosed various malignancies in nine patients among the 580 enrolled in the study. The earlier disclosure triggered price plunges of 44% for both Abivax’s ordinary shares traded on Euronext Paris and the company’s American depositary shares (ADSs) traded on the Nasdaq Global Market.

Established risk factors

The latest data from ABTECT Maintenance Part 2 showed four total cases of non-melanoma skin cancer (NMSC)—two in the study’s 25 mg arm, two in the 50 mg arm: “All occurred in patients with established NMSC risk factors including advanced age, thiopurine use, prior skin cancer history, and failure of multiple prior advanced therapies,” Abivax stated.

Significantly, incidence rates of malignancies (including NMSCs) when adjusted for patient-year exposure were well within the pre-defined background reference ranges based on previous UC studies.

Exposure-adjusted incidence rates (EAIRs) for malignancies excluding NMSC were 0.48 and 0.69 events per 100 person-years (PYs) in the all-active combined (50 mg + 25 mg) and 50 mg cohorts, respectively, and for NMSC were 0.95 and 0.69 events per 100 PYs, in the all-active combined (50 mg + 25 mg) and 50 mg cohorts respectively, all consistent with expected UC background rates

EAIRs for malignancies excluding non-melanoma skin cancer (NMSC) were 0.48 per 100 PYs in the all-active combined (50 mg + 25 mg) cohort, and 0.69 events per 100 PYs in the 50 mg cohort. For NMSC, EAIRs were 0.95 in the all-active combined cohort and 0.69 in the 50 mg cohort. All those results were consistent, Abivax said, with expected UC background rates ranging from 0.30–0.70 for malignancies excluding NMSC, and 0.70–1.40 for NMSC.

“Paradigm-defining treatment”

“The expanded cumulative safety data further strengthens our confidence in the long-term safety profile of obefazimod and reinforces the favorable benefit-risk profile for our program as we prepare for our planned NDA [New Drug Application] submission later this year,” Abivax CEO Marc de Garidel stated. “We believe this growing body of evidence positions obefazimod, if approved, to become a paradigm-defining treatment option for patients living with ulcerative colitis.”

Investors appeared to share de Garidel’s optimism. The data sparked a buying surge among investors, who sent Abivax shares traded on Euronext Paris soaring 39% the day after the announcement, from €83.30 ($94.71) to €115.50 ($131.31) on Tuesday. The shares rose another 1.7% Wednesday, closing at €117.50 ($133.59), then climbed another 9% Thursday to €127.80 ($145.28) before finishing the week with a 6% increase, to €135.80 ($154.38) and a 63% one-week gain.

On Nasdaq, Abivax ADSs surged 50% for the week, consisting of a roughly 39% leap Tuesday from $96.15 to $133.26. From there, shares dipped 0.5% the following day to $132.56, before rebounding 9% Thursday, finishing the Independence Day holiday-shortened week at $144.65.

Wednesday was a shorter trading day than usual since the company requested a temporary, single-day halt. Abivax requested the halt to price an upsized offering of its U.S. American depositary shares (ADSs), which increased from the originally announced $600 million to $800 million—6.4 million ADSs at $125 per ADS, which the company expected would extend its cash runway into the second quarter of 2029.

The offering closed Thursday at $920 million, of which approximately $874.1 million consisted of net proceeds, after underwriters exercised in full their option to purchase 960,000 additional ADSs representing 15% of the total number initially sold in the offering.

The size of the offering appeared, based on investor chatter cited by Stocktwits, an effort to dampen speculation about Abivax being a prime candidate for a buyout; the company appears in GEN’s most recent A-List of Top 10 Takeover Targets of 2026. But the upsizing of the offering rekindled buyout speculation by individual or “retail” investors, the same outlet reported Thursday.

Abivax said it intends to use the net proceeds toward expenses relating to potential commercialization of obefazimod in the United States; clinical R&D expenses, primarily related to UC and Crohn’s disease; and the remainder, if any, for general corporate purposes.

Leerink Partners, Morgan Stanley, Piper Sandler, and Guggenheim Securities were joint bookrunning managers for the offering, while LifeSci Capital acted as a passive bookrunning manager and Van Lanschot Kempen as the lead manager.

“Response rates (clinical & endoscopic remission) in this portion also appear compelling, especially given the refractory nature of patients in this subset, reaffirming obe’s best-in-disease efficacy,” Thomas J. Smith, senior managing director, immunology and metabolism, and a senior research analyst with Leerink Partners, commented in a research note.

“Should allay investor concerns”

“We believe this update further de-risks obe’s profile in UC and Crohn’s and should allay investor concerns following Part 1 maintenance data released earlier this month,” Smith added.

Smith raised his firm’s 12-month price target on Abivax shares 6%, from $140 to $148.

Two other firms also raised their price targets on Abivax stock:

• BTIG (Julian Harrison)—Up 17%, from $150 to $175, maintaining “Buy” rating.
• Wedbush Securities (David Nierengarten)—Up 22% from $90 to $110, maintaining “Neutral” rating.

Even more positive feedback on the latest data came from Faisal Khurshid, a managing director and equity research analyst with Jefferies. Khurshid upgraded his firm’s rating on Abivax’s stock from “Hold” to “Buy,” and boosted Jefferies’ price target 46%, from $108 to $158.

On June 1, Khurshid downgraded Jefferies’ rating on Abivax from “Buy” to “Hold,” citing the safety concerns he said have since been addressed.

“Mgmt. did a nice job addressing investor concerns w/ how they presented the safety data [June 29] vs. the Part 1 update. On top of that, the efficacy profile strengthens w/ each add’l piece of data,” Khurshid observed.

He also cautioned: “There is still risk on cash runway, catalyst path, and commercial needs for a pot’l standalone launch. But ultimately, good data should generate value.”

The biggest outstanding risk for Abivax, Khurshid wrote, is the need for significant resources associated with a commercial launch for an indication in inflammatory bowel disease (IBD): “We still think pot’l of asset better realized w/ a strategic partner.”

Obefazimod is a small molecule upregulator of miR-124, an anti-inflammatory microRNA. It enhances the selective splicing of a single long noncoding RNA to generate miR-124, which downregulates cytokines and chemokines shown to promote inflammation, including tumor necrosis factor (TNF) alpha, IL-6, monocyte chemoattractant protein-1 (MCP-1), and IL-17, as well as Th17+ cells.

Under its former name ABX464, obefazimod was initially developed against HIV but was repurposed to fight inflammatory conditions based on its anti-inflammatory effect.

Leaders and laggards

• Elicio Therapeutics (Nasdaq: ELTX) shares tumbled 37% from $5.14 to $3.22 Thursday after the developer of immunotherapies for high-prevalence cancers said it entered into a definitive securities purchase agreement led by two new “fundamental institutional investors” with participation from a large existing shareholder—all undisclosed—to purchase 4,380,313 shares of Elicio common stock through a registered direct offering. The offering is expected to result in gross proceeds of approximately $15 million before deducting placement agents’ fees and other expenses, Elicio said. Titan Partners, a division of American Capital Partners, is acting as lead placement agent while B. Riley Securities is acting as co-placement agent.
• Takeda Pharmaceutical (Tokyo Stock Exchange: 4502) shares increased 2.4% from ¥5,150 ($31.91) to ¥5,274 ($32.68) Thursday and rose another 1.6% to ¥5,359 ($33.20) after the pharma announced an up to $600 million artificial intelligence (AI)-based drug discovery collaboration with Insilico Medicine (Hong Kong Exchange: 3696.HK). Insilico agreed to use its end-to-end platform in leading AI-driven discovery to identify molecules meeting predefined scientific and early development criteria, while Takeda agreed to apply its global development capabilities to advance selected candidates through clinical validation across its therapeutic areas. Takeda gained exclusive worldwide rights to develop, manufacture, and commercialize novel therapeutics selected through the collaboration. Takeda’s American depositary shares (NYSE: TAK) rose 5% from $15.95 to $16.77 Thursday (U.S. markets were closed Friday for the Independence Day holiday). Insilico shares fell 4.1% from HKD 39.62 ($4.97) to an even HKD 38 ($4.77) Thursday and slid 1.6% to HKD 37.38 ($4.66) Friday.

The post StockWatch: New UC Data Sparks Smoother Sailing for Abivax appeared first on GEN - Genetic Engineering and Biotechnology News.

Simran Bains reflects on the 19th annual Vaisakhi celebrations in Parliament and explains why faith leaders and healthcare professionals must unite to tackle oral health injustice.

I was honoured to be invited to mark Vaisakhi 2026 through my work with the British Academy of Cosmetic Dentistry (BACD) and the College of Dentistry, as the British Sikh Consultative Forum convened parliamentarians, faith leaders, health professionals and community organisations at the Speaker’s State Rooms, House of Commons. 

The 19th Annual Vaisakhi at Westminster united celebration with civic purpose, bringing together voices from across the UK to address one of the most pressing issues facing communities today – health inequalities.

Vaisakhi is one of the most significant dates in the Sikh calendar, marking renewal, gratitude, equality and the creation of the Khalsa in 1699.

It is a celebration of faith, service and community, values that continue to resonate far beyond religious observance. 

Central to Sikh teaching is seva; selfless service for the benefit of others.

For those working in dentistry, the theme should resonate strongly. Oral health inequalities remain among the clearest and most preventable examples of wider health injustice. 

Dentists see every day how deprivation and delayed access translate into pain, untreated disease and avoidable extractions.

The social gradient of oral disease

Too often, dentistry is discussed separately from mainstream healthcare policy.

Yet oral disease follows the same social gradient as many chronic conditions, with those who have the greatest need often facing the greatest barriers to care. 

Children in deprived communities continue to experience higher rates of decay, adults under financial pressure frequently delay treatment until symptoms become acute, and older patients can struggle with access, transport and affordability. 

These inequalities affect communities across the UK and are closely linked to wider health outcomes. 

Oral health does not exist in isolation; it is strongly connected to conditions such as type 2 diabetes, cardiovascular disease and respiratory illness. 

When prevention is limited and access to care is delayed, the cumulative impact on both oral and general health can be substantial. 

The discussions at Westminster also highlighted the important role dentistry can play in reducing wider health inequalities.

Dentists are not only treatment providers, but trusted healthcare professionals with an important voice in prevention and community wellbeing.

That means continuing to advocate for:

• Sustainable NHS dental access
• Prevention-led commissioning
• Targeted services for high-need communities
• Integration of oral health into wider healthcare pathways
• Partnerships with trusted community organisations.

Bridging the gap through faith

What made this year’s event especially notable was the recognition that faith institutions and community organisations are already helping to bridge healthcare gaps. 

Gurdwaras, charities and local community hubs across the UK frequently provide health awareness sessions, screening events, mental health support, food programmes and signposting into statutory services. 

They are trusted spaces with local reach, often engaging people who may not respond to traditional healthcare channels.

This year’s Vaisakhi at Westminster was therefore more than a cultural celebration.

It was a timely challenge to policymakers to recognise that fairer healthcare must include oral healthcare.

For dentists, the question is not whether we have a role in reducing inequalities. It is how we choose to lead it.

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

Welcome to The Week in Dentistry, a regular round-up of dental sector updates from across the UK and Ireland.

This week’s edition includes the launch of an artificial intelligence receptionist for dental practices, the sale of a West Midlands practice, community support work in east London and a statement from a UK-based Venezuelan dentist following the earthquake in Venezuela.

Venezuelan dentists at LOC & ODL respond to earthquake

Venezuelan dentists at London Orthodontic Clinic (LOC) and ODL Dental Clinic have responded to the earthquake in Venezuela, highlighting the humanitarian impact on communities across the country.

Alex Seijas, founder of Mission Beyond Smiles and founder and clinical director of LOC and ODL, said many Venezuelans living abroad had spent recent days trying to contact family and friends.

He said: ‘At moments such as this, international solidarity and humanitarian support become more important than ever. My thoughts are with everyone affected by this disaster, particularly those who have lost loved ones, homes or livelihoods.’

Mission Beyond Smiles recently took a team of Venezuelan dental professionals from the UK to the Venezuelan Amazon to provide dental care and support to underserved Indigenous communities.

AI dental receptionist Greeta launched

Conversico launched Greeta, an artificial intelligence (AI) dental receptionist designed to support practices with missed, overflow and out-of-hours calls.

The system answers calls, books directly into the practice management system and gives reception teams a clear next step. Greeta launched on 30 June 2026 and is now live, with a public demo available through Conversico.

Savona Dental supports homeless community

Savona Dental partnered with SameDayDoctor and Nishkam SWAT to provide care packages for people experiencing homelessness in east London.

The Canary Wharf practice helped prepare and distribute bags containing toothbrushes, toothpaste and warm socks. SameDayDoctor also contributed feminine hygiene products, while Nishkam SWAT volunteers distributed the packages in Stratford.

Dudley dental practice sold after owner retires

Andrew Hargreaves Dental Practice in Dudley, West Midlands, was sold after its founding owner retired from clinical dentistry.

The three-surgery mixed-income practice was founded by Andrew Hargreaves in 1996. Christie & Co handled the sale, and the practice was purchased by Nazim Shah, an experienced dentist with previous practice ownership experience. The sale price was undisclosed.

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

It’s not easy to transplant a whole human eye. The surgery is difficult. And the eyes themselves start to degenerate as soon as they’ve left the body. When surgeons attempted it a few years ago, the newly-transplanted eye wasn’t able to see.

But researchers believe they might have a solution: a device that maintains and revives freshly removed eyeballs using a technique called perfusion. Perfusion works by providing surgically-removed organs with some of the oxygen and nutrients they typically get when they’re inside a body. Treated eyes don’t degrade as quickly, and appear to retain the ability to transmit electrical signals, and potentially see. The device could one day make eye transplantations a viable possibility.

“It’s really cool,” says Shannon Tessier at Massachusetts General Hospital, who was not involved in the research but studies perfusion of other organs. “It could be a new frontier for retina preservation.”

Pia Cosma at the Centre for Genomic Regulation at the Barcelona Institute of Science and Technology in Spain and her colleagues have spent years developing their device. The Eye-in-a-Care-Box (ECaBox), as they call it, delivers an oxygen-rich supply of fluid through the artery that normally supplies the eye with blood.

The eye itself sits on a “bed,” and excess fluids are drained away. And while the device itself is sealed to maintain a specific temperature and pressure, a clear window on its side allows researchers to study and image the eye while it’s inside.

Cosma and her colleagues started experimenting with pig eyes, which are anatomically similar to human eyes but easier to get hold of (the team got theirs from a local slaughterhouse).

Pig eyes that are kept at room temperature outside of the device start to degenerate pretty quickly. The team found that cells in the eye shrank, and the eyes started to lose their structure. Cooling the organs didn’t help preserve them, either—the eyes degenerated within 24 hours even when they were kept at 4°C (39°F).

But eyes kept in the EcABox fared much better. 24 hours later, tests suggested the prefused eyes were “significantly more viable” than eyes that hadn’t been maintained in the device.

The perfused eyes also seemed to be able to respond to light, suggesting they might technically be able to see if they were transplanted. Untreated pig eyes lost this ability as soon as they were removed from the animal. But it came back after about 15 minutes of perfusion, according to the scientists behind the work. A few of the treated eyes kept going for 10 hours or more.

Cosma and her colleagues described the work in a preprint article that has not yet been peer reviewed, and did not want to comment on the work.

After success with the pig eyes, the team members then tested their device on human eyes. They first collected 12 eyes from six people who had died. In each case, one of each pair of eyes was put in the device, while the other was not. Again, the perfused eyes did better—and their retinas were preserved.

Cosma and her colleagues hope that their device could offer scientists a new way to study eye treatments—one that doesn’t involve experimenting on living animals. They also hope that, with some improvements, the ECaBox might provide a way to maintain and revive donated human eyes for whole-eye transplantation.

Whole-eye transplants have been attempted in the past, mostly in research animals, with limited success. In May 2023, a team at NYU Langone transplanted an eye along with part of a face to a man who had survived a high-voltage electrical accident that resulted in the loss of much of the left side of his face, including his left eye, two years earlier. Although the man recovered well, he wasn’t able to see out of the transplanted eye.

We won’t know whether eyes treated in the ECaBox could do any better until they have been transplanted, says Tessier. 

In the meantime, Cosma and her colleagues plan to use a newer version of their device to collect more human eyes for research. “We are planning to develop a portable, surgery-room ECaBox to minimize [degradation] in heart-beating donor eyes, when they become available,” they write.

By David Meek AIA, LEEP AP 

Conversations about the healthcare workforce crisis tend to focus on numbers. There are too many patients and not enough clinicians — and the gap just keeps widening. Less examined is what the daily work actually feels like for the people inside that gap and how much of that experience is shaped by the physical spaces where care is delivered.  

In specialty care settings, from cancer centers to neurological hospitals and pediatric facilities, the relationship between design and workforce sustainability is especially pronounced. These environments serve patients with complex, high-acuity needs, and the operational demands on staff reflect this level of care. With the global healthcare workforce shortage projected to widen over the next decade, health systems and healthcare design professionals are rethinking how design can improve staff experience, efficiency, and retention and recruitment in specialty care spaces. 

Staff Wellbeing as a Design Priority 

Across the industry, health systems investing in new specialty facilities are approaching the design process with a more holistic set of goals. While clinical performance remains the baseline for facility design, there is a growing focus on the lived experience of the people who will spend their careers in these buildings. Now, that intention materializes in how support spaces are planned. For instance, pharmacies and clinical laboratories have long been assigned to basements and interior corridors, but newer specialty facilities are exploring placement around the building’s perimeter, where daylight and openness are introduced to staff who might otherwise spend entire shifts without either. What may appear to be a simple planning decision is supported by evidence that demonstrates how natural light affects mood, alertness and the sustained focus that specialty care demands. 

Overall design response is also incorporated at a variety of scales. At the building level, this can be seen where staff entrances are located, how break areas are positioned relative to clinical zones and whether the building provides meaningful access to the outdoors. In terms of individual rooms and work areas, it appears in acoustic decisions, lighting controls, and the degree to which staff workstations account for the physical demands of long shifts. Furniture and casework decisions matter here as well, with movable, adaptable furnishings often better serving staff over time than fixed configurations, particularly as workflow shifts and new equipment is introduced without requiring costly renovation.  

Individually, each of these design decisions may seem modest. Collectively, however, they shape whether a building feels like it is working with its staff or quietly adding to their burden. In specialty care, where staff are routinely navigating some of the most demanding work in the health system, decisions around recovery spaces, acoustic control and spatial clarity have an outsized impact on overall well-being. 

Designing for the Emotional Weight of Specialty Care 

In specialty care, staff wellbeing is also shaped directly by the emotional intensity of the work. Clinicians in these environments often form relationships with patients managing chronic or terminal conditions, and the accumulation of that emotional weight over time is a meaningful driver of burnout and turnover. Designing for that reality requires ergonomic and wayfinding considerations, as well as attention to where staff go between difficult cases to meaningfully decompress and how the building allows them to step away from the demands of the floor. These spaces are no longer afterthoughts placed into leftover square footage but are instead programmed with the same rigor applied to clinical spaces. 

In pediatric-care environments, these dynamics become even more visible. Because children are typically accompanied by parents or caregivers throughout treatment, staff are operating alongside a consistent family presence that adds complexity to care delivery and communication, uncommon in traditional acute care settings. Longer treatment periods extend these interactions, and they require teams to regularly navigate care management and interpersonal engagement for staff. Both operational planning and spatial design play a critical role in reducing friction in daily workflows by supporting clearer interaction and accommodating families through enlarged patient rooms, family lounges and shared amenities. For staff, this creates an environment where emotional and operational demands are constantly correlated, ultimately reinforcing the importance of designing spaces that actively support recovery, focus and ease of movement throughout the day. 

The System Behind the Space 

Specialty care environments demonstrate how closely the success of healthcare delivery is tied to the relationship between the workforce and the built environment. As care becomes more complex and staffing conditions remain strained, outcomes increasingly depend on how effectively buildings support the realities of day-to-day clinical work. That now includes keeping pace with how the practice of medicine itself is changing. New technologies, including robotic systems and AI-assisted documentation, are shifting workflows and carrying spatial implications as much as clinical ones. Buildings change more slowly than medicine, and the gap between how care is practiced and how spaces are configured often shows up first in staff inefficiency. What ultimately defines performance is the alignment between operational demands and physical conditions over time. 

This connection influences how projects are framed from their earliest stages. Clinical requirements, staffing realities and spatial organization are developed as interdependent considerations rather than separate tracks. Within that framework, design structures the conditions of work itself through shaping how tasks are sequenced, how movement flows through the facilit, and how teams maintain focus across periods of care. 

The real measure of this approach is how these environments perform over time, and they’re defined by how reliably the system holds together under pressure: from the consistency of operations to the clarity of workflows and the endurance of the staff within them. Rather than functioning as finished products, specialty care facilities continue to evolve and adapt in real time to the needs of the teams who operate within them. The most effective specialty care environments will be those that quietly absorb and redirect pressure away from staff by allowing care to continue without exhausting the system behind it. The distinction lies in whether a facility ages well or begins catching up to itself the moment it opens. 

David Meek AIA, LEEP AP, is Principal at Shepley Bullfinch.

The post Designing Facilities That Support the Caregivers Behind Specialty Care appeared first on HCO News.

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“Luis has spent years influencing the FM industry in Latin America, raising awareness, growth and collaboration,” said IFMA President and CEO Michael V. Geary, CAE. “His global experiences will help IFMA continue to connect professionals and further our ability to guide our members to be positive forces for the organizations and people they serve.” 

Viña, a native of Madrid, has lived in Mexico City since 2013. He earned a Master of Business Administration as well as degrees in philosophy and theology. He has built his career around real estate, integrated facility management and workplace services for global portfolios. Viña has served on IFMA’s Global Board of Directors since 2022 and was the second vice chair in 2024-25 before becoming first vice chair in 2025-26. Since 2019, he has participated in IFMA’s development in Latin America through a variety of initiatives.  

 “I am very grateful to IFMA’s membership and Global Board of Directors for entrusting me with the leadership of the association for the 2026-27 term,” said Viña. “IFMA has come a long way since 1980. We want our association to continue being that North Star pointing the way for leaders and professionals in the built environment across the globe for the next 45 years. How do we lead in a fast-paced, AI-enhanced world? How do we serve as a global organization? These are questions I intend to address during this term with the support of our membership and board of directors.” 

The post Luis R. Viña Appointed Board Chair of International Facility Management Association appeared first on HCO News.

The post Luis R. Viña Appointed Board Chair of International Facility Management Association appeared first on HCO News.

River is made with a transparent 3D-printed polymer that creates a signature ridged body. Light and shadow naturally play with the textured surface, creating a distinctive effect. Inside, an LED tube provides continuous illumination of up to 400 lumens per foot. 

Thirteen eye-catching sizes and shapes may be selected, including linear, square, oblong, ring, lagoon, or freeform. Each mounting option brings a unique aesthetic. As a pendant, River’s aircraft cables carry both form and power, creating a floating effect. When surface-mounted, light moving through its transparent body casts an ambient glow onto the wall or ceiling. 

River’s metal brackets bring a deliberate hit of color, with 16 possible hues to create a specific mood or tone in a space. Potential applications include large retail areas, including food courts, shared amenity spaces, boardrooms or office receptions. 

Eureka Lighting

The post Decorative Lighting Solutions appeared first on HCO News.

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Dentists hoping to secure a spot to sit the Overseas Registration Exam (ORE) reported payment issues, errors and overloaded servers preventing them from completing the process.

Accessing a place in ORE examinations has previously been compared to buying Glastonbury Festival tickets, with applicants flooding the General Dental Council’s (GDC) MyGDC portal as new dates are released. International dentists must pass both parts of the exam to practise in the UK.

On 30 June, 600 places were released for the ORE Part 1 at 2:30pm. One dentist told Dentistry that they were unable to log in for 10 minutes, at which point they were met with a blank page. They were eventually taken to a payment page, though this refreshed and showed an error before they could enter their details. After two hours of refreshing, they regained access to the website which informed them that the exam slots were full.

Another ORE hopeful said they were able to enter their payment details but were told the payment had failed, despite the total fee being deducted from their bank account. Following several failed attempts, they tried to contact the GDC but were unable to get through.

Many applicants reported a similar difficulty in contacting the regulator since the website crash. With no confirmation email but payment taken, dental professionals have been left unsure if they were successful in booking an exam place. Others were unable to secure their spot despite correctly completing the booking process.

The GDC told Dentistry it was aware of the difficulties candidates had faced. It said: ‘We apologise for the uncertainty and inconvenience this has caused. We understand how much preparation goes into this exam, and candidates deserve confidence that their booking and payment have gone through correctly.’

Affected applicants are encouraged to contact examinations@gdc-uk.org.

‘The ORE booking process has become a lottery’

The booking process for the exam has long been criticised as a ‘lottery’. Speaking to Dentistry, dentist Mohammed Ghafoor said: ‘For many, that one-second difference between pressing the button before or after someone else decides the course of their entire professional life. Those with faster internet connections, quicker reflexes, or sheer good fortune secure a slot. Others, equally deserving and equally prepared, are locked out yet again.

‘This is not meritocracy. This is not fairness. This is chance masquerading as order. The ORE booking process has become a lottery.’

In March 2026, the GDC announced changes to the ORE which could allow five times more dentists to qualify each year through the exam. It estimated that Part 1 capacity would increase from 1,800 to 2,400 annually, and Part 2 from 720 to 944 initially – eventually increasing to 1,500 per year.

These changes follow a new contract with UCL Consultants announced last year, which the GDC said ‘allows the exams to run at a larger and more planned scale, increasing capacity in a controlled way rather than reacting to pressure year on year’.

The regulator stressed that capacity could only be increased to a level that maintains patient safety and candidate experience, saying it ‘will not compromise’.

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

Warning: This story contains comments of a racist nature and references to sexual violence

A High Court ruling has exposed conflicting positions within the GDC fitness to practise process after a dentist found to have made repeated sexualised and discriminatory comments to junior female colleagues and racist remarks was allowed to return to practice under conditions.

The dentist had been suspended for six months by an independent Professional Conduct Committee (PCC) in July 2025, but the GDC later supported a Professional Standards Authority (PSA) appeal arguing that the sanction was insufficient and that they should have been erased.

The PCC found that the dentist, between 2020 and 2023, had engaged in repeated inappropriate, sexualised and discriminatory behaviour towards junior female colleagues, alongside comments about female patients’ bodies and discourteous behaviour towards patients.

Staff at the practice reported having comments such as ‘I have my rape eye on you’ directed at them, and being told about a ranking system for women the dentist wanted to ‘shag’. They were asked in detail about their sex lives and threatened with ‘dick pictures’, with one colleague reporting that the registrant stroked their arms inappropriately on multiple occasions.

The clinician also commented on the bodies of female patients, including that it was a ‘shame’ that their patient had ‘a pretty face but such a small chest’. More generalised comments that women ‘belong in the kitchen’ were also reported.

Racist and homophobic remarks were also noted. For example, the dentist was quoted saying that they would ‘pour acid’ on their own daughter if she brought home a black man. They also told a colleague: ‘I hate gays, but I like you.’

What sanctions did the GDC impose?

Initially, the PCC imposed a six-month suspension after finding that erasure would be disproportionate. In reaching that decision, it took account of mitigation including previous good character, some evidence of reflection and remediation, and developing insight. However, it also found that the registrant’s insight and remediation remained limited, and did not treat some comments as sexual in nature.

Discussion of patients’ bodies, for example, was seen to be inappropriate but with ‘nothing to suggest that it was made in a sexual manner’.

In September 2025, following a review by the GDC’s Quality Assurance Group, the GDC wrote to the Professional Standards Authority (PSA) to alert it to concerns with the original decision. The PSA then began an appeal process in October, which the GDC confirmed it would not oppose.

Explaining the referral to the PSA, the GDC told Dentistry that it took the view that ‘the sanction imposed was insufficient to protect the public and maintain public confidence in the dental professions.’

At a review hearing in February 2026, a separate PCC found that the registrant’s fitness to practise remained impaired and that it could not be satisfied that a risk of repetition was highly unlikely. However, it revoked the suspension and imposed conditions for 18 months, allowing the registrant to return to practice under restrictions including workplace reporting and notifying the GDC of any disciplinary action. The PSA appeal was acknowledged during this process, though the committee said it did not affect its task or powers at that review hearing.

The result was a unique sequence in which the GDC argued that the dentist should have been erased, while a separate committee within its fitness to practise process allowed them back into practice under conditions despite finding that a risk of repetition remained.

The PSA argued that erasure was the only appropriate sanction, a position supported by the GDC.

The dentist argued before the High Court that the PCC was entitled to consider the steps they had taken since the concerns were raised, including relevant CPD, reflection and the fact that there had been no further incidents reported since referral.

However, Mr Justice Sweeting found that the original committee had placed too much weight on limited evidence of insight and remediation, despite its own findings that the registrant’s insight was partial, their understanding of the impact of their behaviour was incomplete and a risk of repetition remained.

Why has the decision been questioned?

Justice Sweeting found that the original committee had materially underestimated the seriousness of the dentist’s misconduct and failed to grapple with the cumulative gravity of the conduct it had found proved.

Although the High Court had the power to substitute erasure, Justice Sweeting said sanction in a case of this kind involved a ‘multifactorial evaluative exercise’ that was usually best carried out by a specialist tribunal. The case was therefore sent back to a newly constituted PCC to reconsider sanction.

The registrant has given an undertaking to continue practising under the same conditions until the Interim Orders Committee imposes any restrictions while they await a new hearing. 

The GDC said: ‘We were firmly of the view that the original sanction imposed in the case of [redacted] was insufficient to protect the public.

‘The GDC welcomes the decision of the High Court where the court has made clear the seriousness with which persistent sexual misconduct is taken in the context of fitness to practise proceedings for regulated professionals.

‘Where our standards are not met, we will ensure that we take appropriate and proportionate action.’

GDC back in the High Court

It is the second time in recent months that the High Court has been involved in an erasure case. In April, the High Court overturned the erasure of a dentist who had sent ‘racially-motivated’ emails. The dentist in question emailed their former employer asking for their name to be removed from the practice website as they did not want to be associated with ‘Indian dentistry’. As a result, they were erased from the GDC register with immediate suspension.

The judge felt that while the dentist’s actions were a ‘serious departure from the professional standards expected’, they did not show ‘an entrenched or enduring refusal to acknowledge wrongdoing’. 

The erasure was therefore overturned and replaced with a six-month suspension. The court suggested that the PCC’s approach to interpreting sanctions guidelines was ‘flawed’ and had been ‘misapplied’ in this case.

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

Every medical student knows that Step 1 or COMLEX Level 1 is a defining moment. Even though Step 1 has shifted to pass/fail, both exams still carry weight, and both require months of preparation. The good news is that the students who succeed aren’t necessarily the ones who know every detail, they’re the ones who start smart.

Step 1: Begin With the End in Mind

The smartest way to start is to pick a test date. It’s tempting to wait until you “feel ready,” but that usually leads to endless review without real progress. Once you have your date, schedule the exam so it feels real! Work backward to decide how many weeks you have for dedicated prep. Most students take 6-10 weeks of full-time (8-10 hours per day) studying, though part-time prep alongside rotations can work too if you’re strategic.

When you’re mapping out your schedule, set weekly goals that are specific and measurable. Instead of “study microbiology,” aim for “complete and review 200 UWorld questions this week.” Goals like that keep you accountable and help you see progress.

Step 2: Limit Your Resources

There are tons of Step 1/COMLEX resources. The trap is thinking you need them all. You don’t. You need two or three high-yield resources that cover the essentials, and you need to use them consistently in-depth.

The foundation for most students is UWorld, it’s not just practice, it’s a learning tool. Pair it with First Aid for a consolidated review, and then choose one supplemental resource like Boards & Beyond, Pathoma, or Sketchy for reviewing material at the level of detail you’re expected to know for the exam. Spaced repetition should absolutely be part of your preparation and Anki (especially the AnKing deck) is the best tool I’ve found to help cement the details. That’s it. Stick to your core set and resist the temptation to keep adding more.

Step 3: Don’t Delay Practice Questions

A common trap students fall into is thinking they need to finish “all” of content review before they can start practice questions. This is especially the case if students’ pre-clinical curriculum extends into the initial months they want to start preparing for their exam. It feels safer to highlight, re-read, and make notes because it feels like you have’t learned all the material you need to know yet. But here’s the problem: Step 1 and COMLEX are not pure memorization exams. They test whether you can integrate knowledge and reason your way through unfamiliar clinical vignettes. Further, the NBME-style questions are usually quite different from the questions you see on your medical school subject exams so you need to get used to this type of format. And the only way to get good at this is to practice.

That’s why UWorld (or another high-quality question bank like AMBOSS) should be part of your plan from the very beginning. Even if you feel unprepared, start with small sets, 10 or 20 questions at a time. Every explanation you read is a mini-lesson. Over time, those lessons add up to a far deeper understanding than passive review alone could ever give you.

The real power of practice isn’t in the number of questions you answer, but in how you review them. Don’t just note that you got something wrong and move on. Ask yourself:

• Was this a content gap? If yes, add the concept to Anki so you can continue to review it.
• Was this a test-taking mistake? Maybe you misread the question stem or ignored a key clue in the labs.
• Was this a reasoning issue? Did you struggle to connect multiple steps or eliminate distractors?

By categorizing your errors, you’ll start to see patterns. Maybe you’re consistently shaky on renal physiology, or maybe you rush through long stems and miss critical details. Once you recognize those trends, you can fix them deliberately.

Another strategy that works well is to slow down and treat each UWorld block as a learning opportunity, not just a score check. Read the full explanations for every answer, right and wrong. Ask yourself how you could have gotten to the correct answer faster. Could you have eliminated two distractors quickly? Was there a lab value or keyword that should’ve stood out? This is how you sharpen the clinical reasoning skills that Step 1 and COMLEX are built to test.

As you progress, gradually increase the size of your question blocks. Early on, untimed, shorter  blocks of certain subject questions can help you focus on understanding. Later, full-length mixed question blocks will build the pacing and endurance you’ll need for the real exam. And don’t underestimate that endurance piece, both Step 1 and COMLEX are long exams. You need to train your brain (and your focus) to handle hours of questions under pressure.

Practice exams also fit into this picture. NBMEs for Step 1 and COMSAEs for COMLEX are predictive, but they’re more than just diagnostic snapshots. They show you how ready you are, but they also reveal exactly where your weaknesses lie. After each practice test, spend time breaking down not just the score, but the story behind the score: which subjects dragged you down, which question types slowed you, and where you made careless mistakes.

Finally, create a “review ritual” that works for you. Some students keep a detailed error log spreadsheet; others create Anki cards out of every missed question. What matters is that you’re turning your mistakes into active learning. Over weeks, you’ll start to notice those once-frustrating topics becoming strengths.

The takeaway: practice is not something you tack on at the end of your prep. It is your prep. UWorld and practice exams are where the real growth happens, and reviewing them thoughtfully is what turns effort into results.

Step 4: Build Daily Structure

A good study day balances practice and review. Many students like to start with a timed UWorld block in the morning, spend the midday reviewing explanations and adding to Anki, and finish the afternoon or evening with targeted content review. This is just an example, figure out what works best for you. Study schedules will differ for everyone and that’s ok. There is not a “one size fits all” approach. The most important thing is that you stick to a routine that promotes consistency and that you’re seeing growth and progression in your practice scores. 

This routine helps you build both breadth and depth while keeping your days predictable. And just like with any other big exam, burnout is a real risk during dedicated prep, so build in breaks, exercise, and sleep to keep yourself sharp. If you don’t take care of yourself and manage your stress, you probably won’t see the progress that you’re capable of. 

Step 5: Extra Notes for COMLEX Takers

If you’re taking COMLEX specifically, don’t neglect OMM. It can be easy to focus only on “Step-style” questions, but osteopathic manipulative medicine is heavily tested on COMLEX. A concise, high-yield resource like Savarese’s OMT Review will give you what you need. Pair it with UWorld for general prep, and add a COMLEX-style question bank like COMBANK or TrueLearn.

Step 6: Use Practice Exams as Your Compass

NBMEs (for Step 1) and COMSAEs (for COMLEX) are the best predictors of how you’ll do on test day. Take them every 1-2 weeks to check your progress and make adjustments. They’re not just score reports, they’re diagnostic tools to help you fine-tune your plan. If you’re not seeing improvement in your scores, your study plan is not working for you and you need to figure out how to make an effective change. 

Takeaway

Step 1 and COMLEX Level 1 feel huge when you’re at the starting line. But success doesn’t come from memorizing every fact, it comes from starting smart. Schedule your test date, back into a realistic schedule, commit to a small set of resources, and begin practicing early. Take care of yourself along the way, and you’ll not only pass, you’ll build the foundation you need for the rest of your medical career.

The post Just Getting Started with the USMLE Step 1/COMLEX Level 1? This Beginner’s Guide Has You Covered appeared first on Elite Medical Prep.

As the parent of two little girls, I often think about how their childhood is different from mine. The seven-year-old is learning about AI at school. The five-year-old is given internet-based homework every week. And they are both absolutely repulsed by the idea of smoking.

That was not the prevailing sentiment when I was young. My parents smoked. The customers at our family’s restaurant smoked. Cartoon characters smoked. My friends and I would buy little cigarette-box-shaped packets of sugary white sticks and pretend to smoke in the playground. Smoking was a central part of our culture.

Which is why the UK’s recent passing of a generational sales ban on tobacco products feels like such a big deal. As part of the Tobacco and Vapes Act 2026, retailers are prohibited from selling tobacco products to anyone born after January 1, 2009, in perpetuity. It doesn’t matter when those people turn 18—or 38 or 68, for that matter. It will always be illegal to sell to anyone born after that date.

This is what’s described as an “endgame” approach. While many tobacco control strategies—such as taxation or gory imagery—aim to reduce consumption, policies like the UK’s are designed to eliminate it entirely. It’s a new approach, and no one knows whether it will work.

The Maldives was the first country to implement a generational smoking ban, in November last year. It’s too soon to say how that has panned out.

Nor do we know if these laws will even last. In 2022, New Zealand passed a similar generational sales ban as part of a broader anti-smoking law. But it was never enacted—the law was repealed by a new government in February 2024.

In the UK, both major parties support the ban. But Nigel Farage, whose right-wing party has seen a recent surge in support, has promised that “the generational smoking ban will not last long if Reform gets the chance to start rebuilding our mismanaged country.”

Chris Bostic, an attorney and former policy director for the advocacy group Action on Smoking and Health, says he and his colleagues began promoting the idea of a generational ban in the United States 11 years ago. Back then, they struggled to win support, even from major health charities. “People said we were crazy … [and] that this was impossible,” he says. Opponents argued that bans would infringe on personal freedoms.

“The public health argument is: Well, what about freedom from addiction?” says Britta Matthes, a tobacco control researcher at the University of Bath in the UK. Most people who smoke began when they were teenagers, want to quit, and wish they’d never started. Tobacco is arguably the most harmful consumer product of all time. It will kill half its users who don’t quit, according to the World Health Organization.

It also kills people who don’t smoke. Of the 7 million who die from tobacco every year, 1.6 million are nonsmokers who were exposed to secondhand smoke, according to the WHO.

Generational sales bans are a long-term strategy that will only protect future smokers. Most experts agree that people who already smoke should be a main consideration for any policy, and that a multipronged approach is probably the best way to go. Janet Hoek at the University of Otago, who has explored tobacco control policies in New Zealand, believes that enforcing very low limits on nicotine levels and banning filters—an environmental scourge that does not make smoking safer, as many people believe—might be a “powerful combination,” for example.

But preventing teenagers from starting to smoke in the first place is an enticing prospect, even among the majority of people who smoke. And it’s starting to look a lot less radical.

The US has quietly been making progress on a smaller scale. Since 2021, Brookline, a town in the Boston area, has banned the sale of tobacco products to anyone born after January 1, 2000. The idea has spread. Today there are 23 towns in Massachusetts with similar bans, says Bostic. Nine towns across Minnesota, New York, and California have implemented other endgame policies.

The UK law has normalized the idea more than ever, he adds. His colleagues are already fielding calls from health agencies around the world. “People [are] saying, Wow I can’t believe the UK just did this—can we do this here?” he says.

Norms change. Like many other millennials, I vividly remember my first night out after a ban on indoor smoking took effect. My clothes didn’t stink! My hair still felt clean! And my throat wasn’t scratchy the next morning! Now that’s just normal. I hope a tobacco-free world can be the new normal for my kids.

Itvisma works by providing a functional copy of the SMN1 gene, which is deficient in people with SMA.

The therapy involves a one-off, fixed-dose intrathecal injection and does not require adjustments based on age or body weight.

The approval is supported by data from the registrational STEER trial, alongside results from the Phase IIIb STRENGTH and Phase I/II STRONG studies.

In the STEER study, Itvisma led to a statistically significant improvement of 2.39 points in the Hammersmith Functional Motor Scale, with this benefit maintained over a 52-week period.

Both the STEER and STRENGTH studies reported clinically meaningful benefits for patients, regardless of whether they were previously treated or treatment-naïve.

Novartis International president Patrick Horber said: “This approval marks a major milestone for people living with SMA. With Itvisma, we are going further to expand access to a one-time gene replacement therapy for older children, teens and adults – potentially addressing long-standing unmet needs for patients.”

Common side effects reported for Itvisma include upper respiratory tract infection, raised temperature, vomiting, headache and increased hepatic enzymes.

Novartis holds exclusive global licences related to the intravenous and intrathecal delivery of AAV9-based gene therapies for SMA.

In March 2026, Novartis received US Food and Drug Administration approval for Cosentyx (secukinumab) to treat paediatric patients aged 12 years and above with moderate to severe hidradenitis suppurativa.

The post European Commission approves Novartis’ Itvisma to treat SMA appeared first on Pharmaceutical Business review.

The initiative seeks to create a platform that uses AI to analyse a wide range of scientific, immunogenicity and clinical datasets produced during vaccine research.

It aims to aid researchers in making evidence-based decisions, especially around advancing to costly and lengthy Phase III clinical trials, a step complicated in several vaccine areas, such as rotavirus, due to lack of validated immune correlates and inconsistent assay results.

The ROTOR platform will initially be developed and validated using rotavirus vaccine datasets and experience from SK bioscience and PATH.

Project leaders aim to build a scalable solution that could later be applied across various vaccine types and disease areas.

According to SK bioscience, reusable elements of the platform could facilitate broader adoption in the vaccine development sector, particularly helping researchers in low- and middle-income countries.

The company noted that pharmaceutical firms typically rely on Phase II data to decide about progressing to large-scale Phase III studies.

By applying AI to extensive research datasets and integrating diverse evidence sources, the ROTOR platform is intended to generate structured insights to support vaccine development strategy.

SK bioscience has previously worked with international health agencies, such as the World Health Organization (WHO), Gavi, the Vaccine Alliance, and the US Centers for Disease Control and Prevention (CDC).

SK bioscience CEO Jaeyong Ahn said: “This project represents a new approach to reducing uncertainty in vaccine development through AI and enabling more scientific and efficient decision-making. Through this consortium, we aim to drive innovation in vaccine R&D while contributing to improved vaccine access worldwide.”

In May 2026, SK bioscience signed a vaccine technology transfer and manufacturing agreement with Colombia’s state-owned pharmaceutical company VECOL, becoming part of the country’s $260m vaccine localisation initiative.

The post SK bioscience to lead Gates Foundation-funded ROTOR project appeared first on Pharmaceutical Business review.

Failure to diagnose or appropriately manage periodontitis remains one of the most common and highest value categories of dental negligence claims encountered in legal practice.

In this article, Sabrina Mahmood, associate at Keoghs LLP, explores the key legal issues that frequently arise in such claims and outlines practical risk management strategies for dental practitioners.

Why periodontitis claims?

The British Society of Periodontal Disease and Implant Dentistry (BSP) describes periodontitis as ‘one of the most widespread diseases in the world’. Against that backdrop, it is unsurprising that claims in this area are increasingly common. The condition often presents with subtle clinical signs, which may not be immediately apparent without a thorough periodontal assessment. This can create particular challenges in the busy, time-pressured environment of general practice, where many of these claims arise.

Common allegations include inadequate assessment and treatment planning, the provision of inappropriate or suboptimal therapy, insufficient patient communication regarding aetiology and risk factors (including smoking and oral hygiene), and a failure to make timely and appropriate referrals. Another level of complexity is that these claims often involve multiple practitioners as they can span extensive time periods, usually anywhere between five to 25 years.

Below we set out some of the key risk factors in more detail and consider practical steps that can be taken to mitigate these risks in everyday practice.

Risk factor one: assessment and treatment planning

Effective assessment and treatment planning can be a great way to ensure that many of the key risk areas are minimised. What we often see in legal claims are missing/regular BPE scores and where scores are three or higher, in-depth periodontal charting has been omitted, contravening the recommendations by the BSP (2019).

Another common issue is the failure to take radiographs at appropriate intervals. Radiographic assessment is often essential in identifying early bone loss and periodontal disease, particularly where clinical signs are not readily visible to the naked eye.

It is important to clearly document in the clinical records when radiographs are due, and to record any instances where a patient declines them, including the reasons for doing so. This provides important protection in the event of a later allegation that radiographs were not taken when clinically indicated. Patients may decline radiographs for a variety of reasons, including concerns relating to health or pregnancy, dental anxiety or phobia, concerns about radiation exposure, as well as general cost considerations given that they may incur an additional expense.

Finally, a clear discussion and documentation of the appropriate recall period will be important as patients with periodontal disease often need to be seen more frequently to help manage their disease, and allegations can arise where recall periods are too long.

Risk factor two: suitable treatment and onward referral

Many patients can be managed within the general dental setting with non-surgical therapy carried out by the dentist or hygienist at regular intervals. A common allegation is that appropriate therapy with non-surgical root surface debridement (RSD) has not been provided, and where treatment has been provided, it has been inadequate due to a failure to undertake subgingival debridement or supragingival plaque removal.

From experience, where a practitioner considers that a scale and polish is the most appropriate course of treatment, it is helpful for the clinical records to clearly set out both the decision taken and the reasoning behind it. In addition, where RSD has been carried out, this should be clearly documented including whether sub/supra gingival scaling has been undertaken.

An effective early treatment plan can help to ensure that appropriate therapy is provided, and where practitioners in the general dental practice setting feel that the patient’s needs are more complex or that surgical therapy is required, onward referral should be discussed and documented within the records. Failure to provide suitable referrals is another area where negligence allegations are common. Where periodontal disease is advanced, unresponsive to treatment, or beyond the practitioner’s scope, referral to a specialist should be discussed, offered and documented clearly in the records.

Risk factor three: oral hygiene and smoking

On nearly every periodontal claim, we see allegations that appropriate oral hygiene and tooth brushing advice was not provided, nor was smoking cessation discussed with the patient. Often, practitioners will notify us that they have discussed this but not documented it within the records.

Recent experience suggests that allegations in this area have become increasingly sophisticated. As patients have greater access to information, it is now commonly alleged that the aetiology of periodontal disease was not adequately explained, preventing patients from understanding how the condition develops and how factors such as poor oral hygiene and smoking may contribute to its progression.

Many smokers further allege that, had they been properly informed of the detrimental impact smoking can have on periodontal health and bone levels, they would have ceased smoking. In practice, we frequently see such allegations advanced even where smoking cessation advice has already been provided in primary care settings, often with limited evidence of patient engagement or compliance. In a number of cases, claimants have continued to smoke or use electronic cigarettes, even where they have subsequently received specialist periodontal input.

Financial implications

Legal costs in periodontal disease claims can escalate quickly. Independent expert evidence is often required, not only from a general dental perspective, but also from specialist periodontal and restorative experts. In addition, there is frequently a need for a detailed review of dental records, including both historic records and those from the index period. This is necessary to identify any pre‑existing disease, assess compliance with oral hygiene and smoking cessation advice over time, and consider whether gaps in attendance may have contributed to the outcome in question.

Claimants commonly allege that multiple teeth have been lost, or that tooth loss has been significantly accelerated, as a result of the alleged negligence. Claims often include the cost of extensive remedial treatment, including implants and complex restorative work, which can substantially increase the value of a claim. Defence experts will typically examine whether the proposed treatment is clinically appropriate and achievable, particularly where a patient’s oral hygiene remains poor.

In practice, many patients are not suitable candidates for the treatment claimed unless and until meaningful improvements in periodontal health are demonstrated, although there are cases where patients do engage positively and achieve sufficient improvement to proceed with restorative care.

Periodontitis treatment planning

From a risk management perspective, the most critical factor in limiting financial exposure is robust treatment planning supported by clear, documented discussions with the patient. Clinical records should demonstrate not only that an appropriate periodontal assessment was undertaken, but that the diagnosis, treatment options, risks, and prognosis were fully discussed and understood. Records should also reflect ongoing review and monitoring, including patient compliance or a lack of compliance with oral hygiene and smoking cessation advice. Where patients fail to attend, decline recommended treatment, or do not adhere to advice given, this must also be clearly and consistently documented.

From an indemnity perspective, early notification to insurers is critical where concerns arise regarding the management or progression of periodontal disease. Early involvement allows insurers to provide timely guidance, secure relevant records, and obtain early expert input which can support a robust defence of the allegations or otherwise inform an appropriate resolution strategy. This proactive approach can significantly reduce overall claims spend and improve prospects of a successful defence as well as preserving important evidence.

Summary and practical takeaways

Periodontal disease claims can involve scrutiny of many aspects of clinical care. However, practitioners can take reassurance from the fact that many of the associated risks can be mitigated through thorough assessment, clear and structured treatment planning, and well‑documented contemporaneous records of discussions and decision‑making.

While the financial exposure arising from periodontal disease claims can be significant, early notification to insurers plays a critical role in effective claims management. Prompt engagement allows for timely advice, early evidential review, and a more proactive approach to limiting both liability and overall claims costs.

If you have any questions or would like advice on dental negligence matters, please contact Louise Jackson, Keoghs partner and England and Wales regional lead for healthcare and sport, or Sabrina Mahmood, Keoghs senior associate and dental claims specialist in healthcare and sport.

For robust dental indemnity cover, contact Densura.

References

1. https://www.bsperio.org.uk/assets/downloads/Patient_Information_Leaflet.pdf
2. https://www.bsperio.org.uk/assets/downloads/BSP_BPE_Guidelines_2019.pdf

This article is sponsored by Densura.

The Central Government has amended the Drugs Rules, 1945 to bring cell or stem cell-derived products, gene therapeutic products and xenografts under the ambit of the Centrally Licence Approving Authority (CLAA) framework, marking a significant regulatory step towards strengthening oversight of advanced therapies and emerging medical technologies.

The amendment expands the list of products that require joint oversight by the Central and State licensing authorities, ensuring uniform regulatory standards for complex biological products across the country. Until now, the CLAA framework covered specified categories such as vaccines, recombinant DNA (r-DNA)-based medicines and large-volume parenterals exceeding 100 ml.

With the latest amendment, advanced therapies including stem cell-based regenerative treatments, gene therapies and xenografts will now also be subject to central licensing approval alongside state-level regulation.

According to the government, the move is aimed at enhancing regulatory scrutiny of rapidly evolving technologies that are increasingly being used in the treatment of complex diseases.

Cell or stem cell-derived products, including CAR-T cell therapies, have emerged as promising treatment options for blood cancers such as leukaemia and lymphoma. Gene therapeutic products, including gene replacement and gene-editing therapies, are being developed for the treatment of inherited genetic disorders and several types of cancers. Xenografts, which involve the transplantation of animal tissue-derived products such as heart valves into humans, have found applications in cardiology and orthopaedics.

Given the complexity and specialised nature of these therapies, the government said enhanced regulatory oversight is necessary to ensure patient safety while supporting the adoption of innovative treatment modalities.

The inclusion of these products under the CLAA framework is expected to facilitate coordinated regulation between the Central and State Licensing Authorities, leading to greater consistency in licensing decisions and regulatory compliance across the country. The government said the amendment would strengthen India’s regulatory framework for emerging healthcare technologies while aligning it with evolving scientific developments and global best practices.

The move comes as India witnesses growing research and clinical interest in advanced therapy medicinal products, particularly in areas such as regenerative medicine, cell and gene therapies, and precision medicine. By bringing these products under a centralised licensing mechanism, regulators aim to ensure that quality, safety and efficacy standards keep pace with technological advancements.

The amendment also underscores the government’s broader efforts to modernise the country’s regulatory ecosystem to support innovation without compromising patient safety. Officials said the initiative reflects the government’s commitment to fostering the development and adoption of advanced healthcare technologies while maintaining robust regulatory safeguards.

The post Centre amends Drugs Rules, 1945 to ensure uniform regulation of advanced cell and gene therapies appeared first on Express Pharma.

B&R, ABB’s Machine Automation division, announced the appointment of Pratip Samanta as new Regional Managing Director (RMD) for Southern and Eastern Asia, effective July 1, 2026. Pratip Samanta  succeeds Jhankar Dutta.  

Pratip brings over 21 years of leadership experience in Industrial Automation, IT Services, Digital Consulting, and Strategic Account Management. Most recently, he served as Global Client Partner at Tata  Consultancy Services (TCS) in Munich, where he drove strategic growth and large-scale digital transformation initiatives for global energy technology clients. He previously worked at ABB from 2008 to  2017 in several leadership roles across Sales, Consulting, and Operational Transformation, and brings  additional expertise from his tenure at Siemens in Automation & Drives, where he helped industrial  customers enhance operational efficiency and technological adoption. 

Pratip holds a Bachelor of Engineering from Vidyasagar University with focus on Electrical Engineering and attended TCS Emerging Leaders Program supported by Ohio State University and TATA Management Training Center.  

He succeeds Jhankar Dutta, who has decided to leave the company to pursue new career opportunities. 

The post ABB’s Machine Automation division appoints Pratip Samanta  as RMD for Southern and Eastern Asia   appeared first on Express Pharma.

DeNovo Dental Partners explains why its innovative partnership model is the best option for those who want to retain a sense of individuality when considering selling their practice.

In many areas of life, individuality is celebrated. People are encouraged to be themselves, while businesses are recognised for doing things differently, challenging convention and building something distinctive.

Keep what makes you, you

DeNovo Dental Partners believes dentistry should be no different. Practice principals should have the freedom to shape their businesses in ways that reflect their values, strengths and ambitions – building distinctive practices they are proud to lead. Individuality should be celebrated and actively encouraged, not standardised away.

DeNovo also believes that a practice’s identity should endure beyond a change in ownership. The success of your business is built on the legacy, relationships and reputation you have created over many years, and those qualities deserve to be protected as your practice enters its next chapter.

This belief is one of the reasons DeNovo created a different approach to practice ownership. It actively seeks out practices with strong identities and principals looking for a more collaborative, forward-thinking path for the next stage of their career.

The shared ownership model is designed to protect practice autonomy, enabling partners to retain control over day-to-day operations, their team, patient experience, community relationships and the future direction of the business. Rather than changing what made a practice successful, the team helps build on those foundations and support future growth.

Partners also have access to central support services, which are flexible and provided on your terms. You decide where support adds value, when you need it and how involved you want DeNovo to be.

You remain in control – DeNovo simply provides additional expertise, infrastructure and support to help you move the business forward.

Financial differentiators

The approach is different financially, too.

Traditional practice sales can often leave principals feeling disconnected from the future value of the business they spent years building. Complex structures, restrictive terms and uncertain future payments do not always reflect the contribution, commitment and legacy behind a successful practice.

DeNovo was designed to offer a different path.

The shared ownership model is built around alignment, long-term value creation and mutual benefit for both individual partners and the wider organisation. DeNovo pays full practice value upfront, with the majority delivered in cash and the remainder through equity in the parent company – enabling partners to continue participating in future group growth.

Importantly, tje model is designed to create opportunities beyond the initial transaction. Partners can benefit from ongoing value creation linked to practice and group performance, reflecting our continued investment in growth, innovation and the long-term success of the portfolio.

Delivering on promises

DeNovo is proud that its vision for a different kind of dental partnership model has already resonated with so many principals across the UK. A growing number of practices have joined the DeNovo community, embracing an approach centred around autonomy, shared ownership and long-term value creation.

For many partners, joining DeNovo is not about stepping away from the practice they have built, but about gaining the support, expertise and community needed to help take it further while protecting everything that made it successful in the first place.

Here’s what Dr Stephen Pitt from The Dental Studio had to say about his experience:

‘With DeNovo, it wasn’t about handing the practice off to a new owner, but rather introducing an extra pair of hands to help steer the practice on the next stage of its journey. I also appreciated that DeNovo sought practices with unique quirks and individuality. They embraced the things that we did a little differently. For example, I love teaching, and while other potential buyers were sceptical about the income this would continue to generate – despite its 10 years of success – DeNovo had a far more positive approach. They were honest, friendly, and transparent at every turn. From the moment I made the decision, the transaction moved rapidly and completed in just two to three months.

‘DeNovo is perfect for anyone who wants to continue working clinically for several years, but seeks expertise and support to unlock further practice growth. If you love the practice that you have built and wish to remain a part of its journey for a bit longer, DeNovo could be the answer you’re looking for.’

Find out more about how you could protect your practice’s individuality with DeNovo – arrange a confidential, no-obligation chat today!

This article is sponsored by DeNovo Dental Partners.

Shantha Biologics has entered into an outsourcing agreement with Novo Nordisk to provide cartridge fill-finish manufacturing services in India.

As per the press statement, the collaboration will be governed by the parties’ agreed contractual framework and carried out in accordance with applicable quality, compliance, and regulatory requirements. No financial terms or further details of the agreement were disclosed.

The agreement with Novo Nordisk reflects Hyderabad-based Shantha Biologics’ continued focus on high-quality manufacturing execution and its role as a trusted partner to global healthcare companies.  Shantha Biologics’ capabilities span vaccines, biologics, and specialised sterile manufacturing.

“We are pleased to enter into this collaboration, which reflects the confidence placed in Shantha Biologics’ capabilities and our commitment to reliable, high-quality cartridge fill-finish services,” said Dr. Vishy Chebrol, Director, Shantha Biologics. “We look forward to supporting this partnership through strong operational execution and a continued focus on quality and compliance.”

The post Shantha Biologics, Novo Nordisk collaborate for cartridge fill-finish services in India appeared first on Express Pharma.

Their advance makes the organoids more reliable models for studying disease and evaluating potential therapies, while supporting long-term efforts to generate transplantable kidney tissue. “It is important that we’re starting to get good reproducibility from organoid models that can lead to robust preclinical models of cell function and disease to benefit patients,” said Nils Lindström, PhD, assistant professor of stem cell biology and regenerative medicine at the Keck School of Medicine of USC. Lindström is co-corresponding author of the team’s published report in Science, titled “Patterning human kidney organoids with synthetic Wnt-secreting organizers.” In their paper, the researchers reported, “Our findings link a spatial organizing geometry in the developing human kidney to controllable engineering in vitro.”

“Stem cell–derived organoids have emerged as systems for modeling organ development and generating complex tissue structures in vitro,” the authors wrote. Over the past decade, organoid work has relied on cells’ ability to self-organize into tissue-like structures, often in response to adding chemicals and proteins that act broadly in the whole organoid. “Although this capacity enables organoids to recapitulate many developmental programs, it limits experimental control over tissue architecture, often producing structures that vary between cultures and are difficult to engineer reproducibly,” the team continued. “Understanding how to impose spatial patterning in organoid systems is therefore an important challenge.”

In embryos, spatial patterning is often organized by localized signalling centers, known as developmental organizers. But how organizing geometry is controlled in the developing kidney, and whether it can be recreated in vitro, hasn’t been known.

For their reported study, the team combined spatial transcriptomics of the developing human kidney with synthetic engineering. “We mapped this organizing geometry in developing human kidneys and tested whether a minimal cue of localized WNT signaling could restore spatial control of nephron patterning in organoids,” they explained.

The project began by making tools to copy developmental signals. Postdoctoral researcher Fokion Glykofrydis, PhD, in the Morsut lab, engineered a “synthetic organizer” cell that secreted a Wnt protein that their spatial transcriptomics and other analyses indicated was involved in spatial patterning during kidney development. Graduate student Connor Fausto from the Lindström lab proposed an experiment to test how this Wnt-secreting cell would affect organoid nephrons.

The experiments revealed that the synthetic organizer enabled two key processes essential for building organs: controlling the identity of cells and influencing the shape of developing structures. The synthetic organizer serves as a localized and targeted source that secretes controllable amounts of specific Wnt proteins within the organoid itself. These are key signals that help shape the developing kidney. This creates a signaling environment much more similar to a naturally developing kidney and gives researchers a way to control where and how kidney structures form.

Co-corresponding author Leonardo Morsut, PhD, associate professor of stem cell biology and regenerative medicine, and biomedical engineering at the Keck School of Medicine and USC Viterbi School of Engineering, said, “With our approach, we are trying to control self-organization, and work with it as opposed to try to completely override it.”

Lindström expected Wnt to trigger nephrons to change their identity into cells capable of forming connections with the urine drainage system. What surprised him was that the nephrons also changed shape and elongated toward the source of the Wnt signal, which doesn’t happen when signals are delivered uniformly to the whole organoid. Compared with the developmental process seen in traditional kidney organoids, this elongation toward the Wnt source is more similar to what happens in a naturally developing kidney.

“A single, localized signal did two things at once. It changed what the cells became and physically pulled the tubules toward the source,” Lindström said. “You would not see that with a uniform chemical bath of signals.” Engineered WNT-secreting cellular organizers introduced into kidney organoids restored organizing geometry, the authors noted, “… biasing distal nephron differentiation and orienting nephron morphogenesis toward the signal source, which demonstrates that developmental signaling geometry can be reconstructed synthetically to control tissue patterning.”

The team identified a previously unrecognized axis, a direction along which the developing kidney organizes itself. Developmental biologists have long known about the nephron’s classic “proximal-distal (PD) axis,” which runs from its blood-filtering end to its urine-drainage end. The new axis is defined instead by how close each part of the nephron sits to the collecting duct, the tube system that drains urine and releases Wnt signals during development. Those signals tell the nephron what shape to take and which way to point.

“The study shows that there’s an undiscovered axis that sets up how a nephron looks and forms,” said Lindström. “It’s not every day that you find something new in human development at that level.”

Most kidney organoids contain only nephrons and lack the collecting duct that supplies this local Wnt signal, so they have no such axis and organize in a radially symmetrical pattern. By mapping how kidney cells respond to Wnt at specific locations in the developing kidney, the team recreated that environment in organoids with the synthetic organizer, producing structures that are both more developmentally faithful and more reproducible.

“Introducing tunable WNT-secreting synthetic organizers (SOs) in organoids restored canonical WNT responses, biased distal nephron differentiation, and oriented nephron morphogenesis toward the WNT source,” the investigators stated in summary. The combined results, they suggested, “… demonstrate that the spatial geometry observed in vivo can be reconstructed synthetically to control early nephron patterning and morphogenesis … Synthetic organizers provide a modular way to restore missing spatial interactions without reconstructing the entire collecting duct lineage, complementing approaches that rebuild collecting duct–to–nephron cellular interactions.”

For Morsut, the synthetic organizer is one of several tools his lab is building to control how tissues form, and the one he is most excited about, because it steers development in a way that is powerful but not intrusive. “The synthetic organizer is just a little cluster of cells that don’t build anything themselves,” said Morsut. “But they produce a powerful field that aligns the stem cells and gives them a direction.”

Synthetic organizers offer a modular strategy to reintroduce spatial signaling interactions that are often absent in conventional organoid cultures, the team suggested. “This approach should be broadly applicable to other organoid systems in which spatial signaling environments play instructive roles during development, providing a framework for linking developmental biology with the rational engineering of tissue architecture.

Aligning cells is something embryos do repeatedly as they build themselves, Morsut noted, and the study shows it can now be put to work in an engineering setting, steering the process toward a desired outcome. “At the beginning of my talks, I always show a video of embryonic development,” said Morsut. “You start from a single cell, and you get to a complete organism, and that’s as close to magic as it gets. Now, we open a possibility of controlling this magic technology for building organs. This study shows that we can do that, and I’m excited to see what others will do in other contexts.”

The post Synthetic Organizers Aid Creation of Reproducible Kidney Organoids from Stem Cells appeared first on GEN - Genetic Engineering and Biotechnology News.

Do your toes cross or hurt with every step?

A bunion may start as a small bump near your big toe. Over time, it can make shoes harder to wear, walking less comfortable, and daily movement more frustrating.

If you're dealing with bunions, understanding your treatment options is the first step toward finding relief.

To help answer some of the most common questions about bunions, OrthoUnited foot and ankle specialist Dr. Daniel Charlick shares his insights on what causes them, when they become a problem, and the treatment options available.

What Is a Bunion?

A bunion forms when the bones around the big toe joint gradually shift out of alignment. As the big toe begins to lean toward the second toe, a bony prominence develops along the inside of the foot.

Many people assume a bunion is simply extra bone growth. In reality, a bunion is a structural change in the alignment of the foot and toe joint.

The bump is only part of the problem. Bunions can also cause:

• Pain near the big toe joint
• Redness or swelling around the bump
• Pressure and irritation from shoes
• Trouble walking comfortably
• Corns or calluses where toes rub together
• Stiffness in the big toe
• Changes in how your foot bears weight

Many patients notice symptoms improve when barefoot or wearing open-toed shoes and worsen when wearing tighter footwear.

Bunions often develop slowly over time. Some people notice mild pressure at first, while others experience soreness, burning, or pain after standing or walking for long periods.

Why Are Bunions More Common in Women?

Footwear plays a significant role in bunion development and symptoms.

According to Dr. Charlick, narrow toe boxes, pointed shoes, and high heels can increase pressure on the front of the foot and contribute to bunion progression. Research has also shown that many women regularly wear shoes that are too small for their feet, which may increase the risk of foot pain and deformity over time.

Family history, foot structure, arthritis, and how the foot functions can also contribute to bunion formation.

Why People Put Off Bunion Care

"Many patients with bunions assume the problem is painful and difficult to fix. But, there are often several options to treat these deformities, and even when surgery is the answer, it has come a long way from your Mother's bunion surgery."  —Dr. Daniel Charlick

Many patients try to manage bunions on their own before seeing a specialist. However, bunions can gradually worsen. As pain increases, people often change the way they walk without realizing it.

You may begin shifting weight to the outside of your foot, avoiding certain activities, or limiting how much you walk. Over time, this compensation can lead to discomfort in other areas, including the smaller toes, arch, ankle, knee, or hip.

You do not need to wait until your pain becomes severe. A visit with one of our foot and ankle specialists can help determine whether your bunion is mild, moderate, or more advanced.

How We Diagnose Bunions

A bunion evaluation typically begins with a conversation about your symptoms, activity level, footwear, and medical history.

Dr. Charlick will examine your foot to better understand how it functions and where it is painful. X-rays are used to evaluate the alignment of the bones, measure the severity of the deformity, and determine whether arthritis or other joint problems are present.

This information helps guide treatment recommendations and determine whether non-surgical care or surgery is the best option.

Non-Surgical Treatment Options

"Bunions that do not hurt do not require surgery, and the initial treatment for painful bunions is often non-operative."  —Dr. Daniel Charlick

Many bunions can be managed without surgery, especially when symptoms are mild or intermittent. While conservative treatment will not straighten the bunion, it can often reduce discomfort and improve daily function.

Non-surgical options may include:

• Shoes with a wider toe box
• Padding to reduce pressure and rubbing
• Custom or over-the-counter orthotics
• Ice to reduce swelling after activity
• Anti-inflammatory medications when appropriate
• Activity modifications during flare-ups
• Toe spacers or splints for comfort in select cases

If pain improves and you are able to remain active and comfortable, surgery may not be necessary.

Choosing Better Shoes for Foot Health

One of the simplest ways to reduce bunion pain is to choose footwear that fits properly.

Dr. Charlick recommends:

• Having your feet measured when purchasing new shoes
• Trying on shoes later in the day when feet are naturally more swollen
• Trying on both shoes before making a purchase
• Choosing shoes with a wide toe box
• Selecting lower heels whenever possible
• Leaving adequate room between the longest toe and the end of the shoe
• Making sure your toes can move freely

Comfort is often a better guide than the size printed on the shoe. If a shoe feels tight when you try it on, it is unlikely to become significantly more comfortable with wear.

When Surgery May Be Necessary

Bunion surgery may be considered when pain continues despite conservative treatment or when the bunion begins interfering with daily activities.

Surgery is typically recommended because of pain and loss of function, not simply because of appearance.

Many patients are surprised to learn that bunion surgery involves more than removing the visible bump. In many cases, the procedure requires realigning the bones and correcting instability within the joint to address the underlying cause of the deformity.

Because every bunion is different, there is no single procedure that works for every patient. Dr. Charlick carefully evaluates the structure of the foot, severity of the deformity, and patient goals before recommending a surgical approach.

What About Lapiplasty^®?

Dr. Charlick is also trained in the Lapiplasty^®? procedure.

Lapiplasty is a surgical technique designed to correct the bunion in three dimensions by addressing the underlying instability that contributes to the deformity. Rather than focusing solely on the visible bump, the procedure aims to restore alignment at the source of the problem.

Like all bunion procedures, Lapiplasty is not the right choice for every patient. A thorough evaluation and imaging help determine whether it is an appropriate option.

What Recovery Looks Like After Bunion Surgery

Recovery varies depending on the procedure performed, though many modern bunion surgeries allow patients to bear weight immediately in a specialized surgical shoe or after a short time using a walking boot.

Patients should understand that swelling often lasts longer than expected. Some swelling may persist for several months after surgery as the foot continues to heal.

Additional recovery considerations may include:

• Wearing a surgical shoe or boot during early healing
• Gradually returning to normal activities
• Waiting several months before returning to certain dress shoes
• Temporary or mild long-term stiffness in the big toe joint

Following post-operative instructions and footwear recommendations can help support the correction and reduce the risk of future problems.

Dealing With Bunions? Schedule an Appointment With Dr. Charlick

A bunion does not always mean surgery. It also does not have to be something you continue to ignore.

If your foot hurts, your shoes no longer fit comfortably, or walking has become more difficult, Dr. Charlick can help you understand what's causing your symptoms and what treatment options may be right for you.

With specialized training in foot and ankle care, Dr. Charlick takes a practical, individualized approach to bunion treatment. Together, you can determine the best path forward to help keep you moving comfortably.

Schedule an appointment online or contact your nearest OrthoUnited campus to learn more about your treatment options.

The post Bunions: Causes, Symptoms, and Treatment Options with Dr. Charlick appeared first on OrthoUnited.

But after several days of talks, posters, hallway conversations, and interviews with senior figures in mass spectrometry (MS)-based proteomics, the deeper story was not simply that instruments are getting better. The field is beginning to look past the instrument. The mass spectrometer is still central, but the question is shifting: what has to happen around it for proteomics to become clinically useful, scalable, trusted, and routine?

Beyond the instrument

Jennifer Van Eyk, PhD, professor of cardiology, biomedical sciences, pathology, and laboratory medicine, and director of the Advanced Clinical Biosystems Research Institute at Cedars-Sinai Health Science University, put it most directly: “I think mass spec is no longer the limitation. We have the sensitivity, the throughput, and the accuracy at discovery and targeted levels.”

Joshua Coon, PhD, professor of biomolecular chemistry at the University of Wisconsin-Madison and the Pyle Chair at the Morgridge Institute for Research, saw instrument speed as the force opening new applications. Faster scanning mass analyzers are allowing deeper proteome coverage, more post-translational modification (PTM) measurements, and shorter runs. Ryan Kelly, PhD, professor of chemistry and biochemistry at Brigham Young University, framed the same shift as a throughput problem. “Now the mass spec is so fast that we need to figure out how to feed it faster,” he said. In plasma proteomics, Coon said, faster instruments, nanoparticle-based enrichment, and improved chromatography are moving the field from hundreds

John R. Yates III, PhD, the John Lytton Young Endowed Chair in the department of integrative structural and computational biology at Scripps Research, highlighted electron activation dissociation methods and the possibility that high-throughput workflows could push MS deeper into plasma and population-level studies. He described targeted affinity platforms as powerful for “known knowns” because they measure targets defined in advance. “But with mass spectrometry,” he added, “you can look for unknown unknowns, which is where the gold lies.”

From depth to trust

If the first era of modern proteomics was about seeing more, the next may be about measuring better. Devin Schweppe, PhD, assistant professor in the Department of Genome Sciences at the University of Washington, described the current moment as a “duality.” Instruments can now deliver deep coverage, and computational tools are making interpretation faster. Together, he said, they are creating “a comfort level with trusting the data.”

This distinction matters across assay types. Targeted MS methods such as multiple reaction monitoring (MRM) and parallel reaction monitoring (PRM) can provide absolute quantification, but only for preselected proteins. Data-independent acquisition (DIA), meanwhile, has moved discovery proteomics closer to translation by improving reproducibility and scalability. DIA is still often used for relative quantification, but its ability to capture patterns across tens or hundreds of proteins may become important as clinical decision-making moves beyond single biomarkers and reference intervals.

The field is responding to these demands. David Kotol, PhD, R&D manager at ProteomEdge, discussed an independently validated nine-protein plasma panel designed to improve emergency department triage and imaging decisions for patients with suspected venous thromboembolism, compared with D-dimer alone.

The clinical gap

Mathieu Lavallée-Adam, PhD, associate professor in the department of biochemistry, microbiology and immunology and director of the specialization in bioinformatics at the University of Ottawa, gave the least glamorous answer to what still blocks clinical translation. “My answer is going to be boring,” he said. “It’s going to be education.”

Sasha Singh, PhD, assistant professor of medicine at Harvard Medical School, associate scientist at Brigham and Women’s Hospital, and director of proteomics research at the Center for Interdisciplinary Cardiovascular Sciences (CICS), described this translation role from inside a hospital environment. “That’s actually my role at the hospital,” Singh said. “I am a liaison between the technology and the application scientist.”

AI with guardrails

No 2026 conference escapes artificial intelligence (AI), and ASMS was no exception. But the mood among the researchers was cautious rather than breathless.

Lavallée-Adam said agent-based AI was dominating conversations in his part of the field. The dream is seductive: put a sample on an instrument, ask an AI agent to maximize protein identifications or optimize a method, and let it select the best protocol. But he drew a clear line between potential and reality. “Are such agents really driving change? It’s unclear at this point,” he said. “I think it’s unproven.”

Still, AI-assisted acquisition strategies are entering workflows. Lavallée-Adam’s group works on real-time MS data acquisition, where software analyzes data as it is acquired and adapts the run to the biological question. Instead of measuring the same abundant proteins repeatedly, the system can decide it has seen enough and move on to new targets. In that sense, AI becomes less a magical oracle than an instrument assistant.

Faster instruments are generating more data, and faster analysis is needed to keep up. Schweppe also argued that open-source tools remain essential because they let laboratories build on one another’s work rather than rebuild it.

More than abundance

Much of the clinical proteomics effort is focused on plasma because it is minimally invasive and suitable for screening, longitudinal sampling, and routine monitoring. But even in blood, researchers are learning that plasma is only part of the story.

Roman Fischer, PhD, associate professor and head of the Discovery Proteomics Facility at the Target Discovery Institute, University of Oxford, pushed the conversation back toward biology. Plasma alone does not capture the full circulating system, he noted. Peripheral blood mononuclear cells, extracellular vesicles, microvesicles, and other compartments may contain disease-relevant information that conventional workflows miss. “We have to be more sophisticated in addressing the compartments of the blood,” Fischer said.

Yates offered a clinical example. His group has been developing protein-footprinting approaches that can detect conformational changes in proteins in blood. In one transthyretin amyloid cardiomyopathy project, he said, abundance alone was not the answer. The important signal was how the protein folded or misfolded. That kind of assay moves proteomics beyond proteins going up or down, into structural disease biology.

Van Eyk’s work on remote sampling devices pointed to another future: patient-collected blood samples that make longitudinal cardiovascular studies easier, more inclusive, and better matched to real clinical questions.

In the background was a broader translational arc: discovery, verification, clinical validation, health economics, and access. Plasma proteomics highlights included Lekha Sleno, PhD, professor at Université du Québec à Montréal, who is combining nanoparticle enrichment with isotope-enabled targeted proteomics, and a CinderBio breakfast seminar featuring Fredrik Edfors, PhD, assistant professor at KTH Royal Institute of Technology and SciLifeLab, and Simion Kreimer, PhD, senior research project advisor in the Proteomics and Metabolomics Core at Cedars-Sinai Health Science University.

The seminar focused on accelerated plasma proteomics, rapid digestion workflows, stable isotope standards, Human Protein Atlas resources, and faster enzyme workflows that can reduce lead times. The common message was that sample preparation, quantification, and validation may become as decisive as instrument resolution.

The next bottleneck

ASMS 2026 was not short on technical spectacle. High-resolution instruments, electron-based fragmentation, narrow-window DIA, rapid acquisition, MS imaging, top-down workflows, and AI-enabled software all had their moment. But the most interesting conversations were less about spectacle than maturity.

Proteomics is no longer trying only to prove that it can see more. It is trying to prove that it can measure consistently, explain biology more deeply, support drug development, fit into clinical laboratories, and eventually improve patient decisions.

That means the next bottleneck is distributed across the ecosystem: sample preparation, standards, software, education, reimbursement, clinical menus, regulatory validation, open tools, and the ability to translate technical power into something a clinician can use.

Longer term, integrated proteomics, other omics, imaging, clinical data, and AI may support not only single biomarkers, but interpretable molecular patterns, longitudinal trajectories, and digital-twin-like models of patient biology.

The field spent decades making proteins visible. The next challenge is making proteomic measurements dependable enough to act on.

The post ASMS 2026: Solving Proteomics’ Next Bottleneck appeared first on GEN - Genetic Engineering and Biotechnology News.

Listed below are links to the GEN stories referenced in this episode of Touching Base:

Merck KGaA to Acquire Bio-Techne for $11.3B, Expanding Life Science Tools Presence

By Alex Philippidis, GEN Edge, June 25, 2026

Insilico, SK Launch Up-to-$2.5B Neuroimmune AI Drug Collaboration

By Alex Philippidis, GEN Edge, June 28, 2026

Claude Science Is Here, Antibiotics Designed by Text Prompt Among Applications

By Fay Lin, PhD, GEN Edge, June 30, 2026

Schistosomiasis Vaccine Shows Strong Immune Memory in Early Clinical Trials

GEN, June 29, 2026

Nipah and Hendra Viruses: Antibody Cocktail Provides Complete Protection in Hamster Model

GEN, June 26, 2026

Touching Base Podcast

Hosted by Corinna Singleman, PhD

Behind the Breakthroughs

Hosted by Jonathan D. Grinstein, PhD

The post Merck and Insilico Make Deals, Claude Science’s Debut, Vaccines for Neglected Diseases appeared first on GEN - Genetic Engineering and Biotechnology News.

Its therapy for addressing telomere biology disorders, based on its proprietary ZSCAN4 approach, is the furthest to the clinic. The biotech company will also target other aging-related diseases with the technology. Meanwhile, its efforts in the mRNA space are currently focused on Duchenne Muscular Dystrophy (DMD), although there are plans to pursue other targets there as well. 

Ko founded the company with CSO Minoru Ko, MD, PhD, in 2017. Elixirgen’s 15 employees are based in Baltimore in its office space in the Johns Hopkins Medical campus, although there is no affiliation with the university. This location offers some advantages to the company, according to Ko. Specifically, “we have a wet lab and an animal lab” that has “helped us go from in vivo to in vitro very quickly to test concepts or optimize formulations and things like that.” 

Recently, Elixirgen announced an option agreement with Japan’s Nippon Shinyaku focused on DMD. Under the terms of the agreement, Elixirgen will be responsible for the development of an asset dubbed EXG-7001, a locally administered, full-length dystrophin mRNA therapeutic that is currently in preclinical development for the treatment of DMD.

As part of the deal, Nippon Shinyaku will provide funding for the developmental costs of the therapy. Meanwhile, Elixirgen will receive an upfront payment and is eligible to receive additional development and sales-based milestone payments if the option were to be exercised. Also, Nippon Shinyaku may obtain exclusive worldwide rights to commercialize EXG-7001.

“Current approaches for treating DMD focus on delivering or restoring an incomplete dystrophin protein, and there still remains a significant unmet need for a therapy that can successfully deliver a full-length dystrophin protein,” Ko said in comments about the announcement. “By design, EXG-7001 has the potential to deliver the full-length, complete dystrophin protein that is missing in DMD patients, regardless of their genetic mutation.”

EXG-7001 leverages one of Elixirgen’s core technologies. The company has developed a platform for delivering mRNA-based therapies that it claims addresses the major delivery limitations of current methods. “The key features are that it is a lipid nanoparticle-free, localized mRNA therapeutics platform,” Ko explained to GEN. With this approach, “we’re avoiding some of the complications of gene therapies and delivering genes systemically by going local” and avoiding liver accumulation, which remains “a big issue” for mRNA therapeutics. 

The system has two components. The first component, called RNA tether, is designed to ensure that the RNA stays in the tissue that is injected without migrating to the liver. The second component is the mRNA cargo itself, which the company calls Bobcat® mRNA. Though the lead indication for this technology is DMD, there are other diseases involving large genes that the company could target. 

“We’re able to express the full length protein as mRNA as a single strand” and “it stays where you administer it, which is kind of unusual,” Ko said. Combining RNA tether and Bobcat makes it possible to express large genes and localize them to target tissues even without accumulation in the liver. Preclinical data has demonstrated its effectiveness in mice with no safety concerns associated with administration or treatment. “A full length dystrophin being given to kind of key muscles could potentially change quality of life,” particularly for the non-ambulatory population, Ko said. 

Beyond EXG-7001, Elixigen has other candidates in its pipeline that are much closer to the clinic. Its lead candidate is currently in Phase I/II testing at Cincinnati Children’s Hospital Medical Center. This is an ex vivo cell therapy based on the company’s ZSCAN4 technology, which is designed to extend the telomeres of stem cells in “a controlled way” using a telomerase-independent mechanism. EXG-34217 is comprised of autologous CD34+ hematopoietic stem cells that have been treated ex vivo with EXG-001, a non-integrating, non-transmissible, temperature-sensitive Sendai virus vector encoding human ZSCAN4.

The features of that technology were identified by the company’s CSO and his team while he worked at the National Institutes of Health’s National Institute on Aging. In 2024, the U.S. Food and Drug Administration granted Rare Pediatric Disease Designation to the treatment, dubbed EXG-34217, for the treatment of patients with dyskeratosis congenita and related telomere biology disorders. 

“Telomeres obviously have a relationship with aging, and there are in fact genetic diseases associated with short telomeres and telomerase mutations,” CEO Ko told GEN at BIO. People with TBDs are “born with shorter telomeres typically, but also have a mutation in their telomerase so they are not necessarily maintaining them either.” The result is a type of premature aging, so conditions like bone marrow failure and cytopenia happen earlier in the life of the patient. In fact, “bone marrow failure is one of the largest issues” affecting both adults and young children, CEO Ko said. 

One treatment option in these cases is allogeneic hematopoietic stem cell transplantation (HSCT), he continued. However, people with short telomeres have more fragile genomes that are less resistant to chemotherapy and radiotherapy and are at greater risk of cancer even after HSCT treatment. In an ideal scenario, it would be possible to postpone or avoid HSCT for these patients, and the company’s ZSCAN4-based therapy could make it possible to do that. 

The treatment is currently being tested in adult and pediatric patients in Cincinnati. “We started in adults because this is first-in-human,” but the disease is also very severe in children, Ko said. “Our target ultimately is to make sure as many people with TBDs can get this if they need it.” Early clinical results published in 2025 in a paper in NEJM Evidence show durable telomere extension overall with no treatment-related safety concerns observed over a 24-month and 5-month period after infusion. The trial has been going on for some time, and “we have a lot of longer-term data now” and are “looking toward potential accelerated approval.”

But targeting TBDs is just one indication. “Short telomeres manifest in many different ways,” Ko said. Other potential targets for the company’s technology are aging-related diseases, including things like idiopathic pulmonary fibrosis. 

To date, Elixirgen has raised roughly $34 million from existing investors.

The post Elixirgen Builds Rare Disease Pipeline Around Telomere Biology Disorders and DMD appeared first on GEN - Genetic Engineering and Biotechnology News.

Every second, cells throughout the body are sending signals that help regulate hunger, energy use, and blood sugar. Understanding those hidden conversations has become the life’s work of Katrin Svensson, PhD, whose research is opening new doors in the fight against obesity and diabetes.

The Endocrine Society recognized Svensson as one of its 2026 Laureates, honoring her with the Richard E. Weitzman Outstanding Early-Career Investigator Award. The annual award recognizes an exceptionally promising young clinical or basic investigator whose work is poised to make a lasting impact on the field.

Svensson is an associate professor in the Department of Pathology at Stanford University, as well as the Metabolic Core Director and Affinity Group Leader at the Stanford Diabetes Research Center. She earned both her MS and PhD from Sweden’s Lund University and completed her postdoctoral training at Harvard Medical School, before joining the Stanford faculty in 2018.

Her research focuses on how cells communicate to maintain metabolic homeostasis. Svensson’s laboratory discovered Isthmin-1, a secreted protein that regulates glucose uptake and lipid metabolism independently of insulin, as well as the non-incretin anti-obesity BRINP2-related peptide (BRP). Her group has also developed computational methods to predict new peptides and ligand-receptor pairs, advancing the discovery of novel endocrine pathways. She has two patents licensed to Merrifield Therapeutics, a biotech startup company she co-founded that focuses on translating biological endocrinology discoveries into therapeutic targets for obesity and diabetes.

Svensson recently spoke with Endocrine News about the promise of intercellular communication research and what continues to drive her scientific curiosity.

Endocrine News: What did hearing the news of winning the Early Investigator Award mean to you?

Svensson: It’s really a tremendous honor because I’ve been working with the Endocrine Society for a long time and this award really recognizes the overall body of work rather than a single study. Since I started at Stanford, much of my work has focused on identifying endocrine signaling systems that were not previously identified, which requires pursuing biology that is poorly understood. It’s hard to get funding and it’s hard to get traction for this kind of work because of that. So, receiving this award is quite meaningful for me because it reflects the efforts of many trainees and collaborators, and it’s encouraging to see that the field really values curiosity-driven discovery and fundamental mechanistic science.

EN: Your research program is built around understanding how cells communicate with one another. What first sparked your fascination with the intercellular communication and metabolism?

Svensson: I have been studying cell communication in a tumor microenvironment since I started my PhD in 2007. So, I looked at angiogenesis and how cells are communicating within a tumor. That led me to be more interested in how these molecules are regulated physiologically within the body. Different organs are communicating with each other all the time and while much is known about the classic hormones, biology is full of secreted peptides, signaling molecules, and metabolites, where we know extremely little about their functions.

When I moved to my postdoc in 2013 at Harvard with Bruce Spiegelman, PhD, I was interested in understanding how these peptides and hormones regulate physiology across the entire body. So, I became interested in the idea that there are “hidden” endocrine systems that can regulate metabolism and feed inter-organ communication. Finding these pathways could fundamentally change how we think about disease and therapy and physiology in general.

EN: Looking back on your career so far, who has been the biggest influence on you as a scientist and a leader?

Svensson: I’ve been very supported by many, many people in my field as an early-career scientist, but I would say the biggest influence has been Bruce Spiegelman, my mentor as a postdoctoral fellow at Harvard. He really inspired me in thinking about novel biology and discovering something new. That is what I learned in his lab and that’s what I’ve continued to build on since then. I don’t think I could have done it if I hadn’t been in his lab.

EN: Now that you’ve received this Early Career Investigator Award, what do you think is the biggest scientific question that you’re hoping to answer in the next 10 years?

Svensson: I think that there’s a lot still to be discovered in endocrine signaling pathways. There are many peptides, not just the ones that we have identified. But the field, in general, has recognized peptide therapeutics with the GLPs and the different variants that are coming along now. It is now generally understood that peptides are useful for regulating many different types of physiological functions.

“You can organize, not just practically, but in your thinking. What is the most interesting and critical biological question? What are the critical experiments to answer those questions? Is this really what you need to do, or are you just doing it because you can? If you’re organized in your thinking, everything else will follow.” – Katrin Svensson, PhD, associate professor, Department of Pathology, Stanford University; Metabolic Core Director and Affinity Group Leader, Stanford Diabetes Research Center, Stanford, Calif.

We are really on a good path to understanding how they are physiologically regulated and how we can try to use them therapeutically to target various diseases. I think that there are many other types of endocrine system issues where these peptides could prove to be therapeutically useful.

EN: Looking at your lab website, I see you lead a very diverse team of postdocs, graduate students, and undergrads. What keeps you motivated when experiments fail or when progress comes more slowly than expected, and what do you impart to your team about this to keep them motivated as well?

Svensson: I talk with them a lot about this because our projects are so exploratory, and I think it’s important to be excited about discovering something genuinely new and be willing to pursue questions that are not fully validated by the field, and not being too focused on working on safe or already validated problems, although you know it’s going to work out.

People have different interests, so the people who are joining my lab are very aware of this and they know that pursuing this exploratory project can really open new directions. I’ve been very fortunate to work with trainees and collaborators who are very dedicated, and we talk a lot about persistence, which is super important to keep following the path that you believe in without being stubborn.

Sometimes it works differently than you expect. So, follow the data honestly and be willing to adapt when the biology tells you something unexpected, which often happens, and just keep going. You know, there’s a lot of things to be found and if you follow the science, it’s going to be fun! It’s very fun and that is what I’m trying to instill in my trainees.

EN: Is there any advice you give your team that you wish someone had told you when you first started your lab?

Svensson: I’ve been very lucky to work with great trainees, and I would say there are pretty much two things. First, find people who are interested in the science and are dedicated and want to do this. You don’t need to have a huge lab, necessarily, in the beginning. You need a few trainees who are really dedicated in trying to solve the problems.

“Receiving this award is quite meaningful for me because it reflects the efforts of many trainees and collaborators, and it’s encouraging to see that the field really values curiosity-driven discovery and fundamental mechanistic science.” – Katrin Svensson, PhD, associate professor, Department of Pathology, Stanford University; Metabolic Core Director and Affinity Group Leader, Stanford Diabetes Research Center, Stanford, Calif.

The second thing, I think, is very boring, but it’s being organized. I think all these other things about what you need to do in your career and publishing and getting grants, all these things will follow if you have good ideas. You can design great experiments and then being organized is really the key to pretty much everything. We talk about this in the lab. You can organize, not just practically, but in your thinking. What is the most interesting and critical biological question? What are the critical experiments to answer those questions? Is this really what you need to do, or are you just doing it because you can? If you’re organized in your thinking, everything else will follow.

—Shaw is a freelance writer based in Carmel, Ind. She is a regular contributor to Endocrine News and writes the monthly Laboratory Notes column.

The post Endocrine Pathway Trailblazer: Q&A with Katrin Svensson, PhD appeared first on Endocrine News.

Asahi Kasei announced in 2018 the development of a system that dehydrates and concentrates liquids without the application of heat or pressure. This reduces the number of freeze-drying batches and the amount of time required for freeze-drying, thereby shortening API manufacturing time. Peptistar has begun operation of the system at manufacturing scale as part of its evaluation toward GMP production.

Some of the next-generation APIs such as peptides and oligonucleotides are heat sensitive. Their manufacturing processes have thus relied on the costly, time-consuming, and energy-intensive freeze-drying method, which can remove solvents without heating, to obtain APIs with high quality explains an Asahi spokesperson.

Although the freeze-drying process can be shortened by concentrating the raw material solution to reduce the volume of liquid feed prior to the freeze-drying step, conventional concentration technologies such as vacuum distillation carry the risk of quality degradation due to heating, and the formation of precipitates caused by changes in solvent composition during the concentration step, adds the spokesperson.

Asahi Kasei says it looks forward to studying the prospects for future commercialization of the FO–MD system.

The post Peptistar Began Operation of the Asahi Kasei FO-MD System at Manufacturing Scale appeared first on GEN - Genetic Engineering and Biotechnology News.

Protecting Your Hair and Scalp This Summer at the Pool, Beach, and Under the Sun

We’re back with another Derm Deep Dive, where we provide expert advice from our board-certified dermatologists about common skin conditions or treatments.

Using sunscreen daily, especially in the summer is widespread advice for protecting the skin from UV rays. But your skin isn’t the only thing that needs protection in the summer.

The sun, chlorine, and saltwater can do a number on your hair and scalp, but we often don’t consider proper protection before or after spending time at the pool or on the beach.

To help you prepare, and to alleviate any unexpected challenges this summer, we have 4 tips for taking care of your hair and scalp that will leave you sun and fun ready.

1. The Sun & Your Scalp: Use an SPF on Your Part Line

One of the easiest places to get a sunburn is your scalp. It’s also one of the easiest places to protect by applying an SPF directly to your part line and hairline, or wearing a wide-brimmed or UPF-rated hat.

Even individuals with thick hair are susceptible to UV rays, which can carry multiple risks:

• Skin cancer from repeated UV exposure  

• Sun damage and severe sunburn 

• Drying out the scalp and causing flakiness or irritation 

Not a fan of putting sunscreen on your scalp? Consider trying a broad-spectrum powder sunscreen, scalp spray, or lightweight mist, all of which are easy to use and won’t leave the hair feeling or looking greasy. Choose an SPF 30 or higher and remember to reapply every two hours if you’re swimming or sweating heavily.

2. The Sun & Your Hair: Use a Heat Protectant Before Heading Outside

While heat protectants are helpful as styling products for blow drying, straightening, or curling hair, they can also help minimize damage from prolonged UV exposure. Some leave-in conditioners and heat protectants contain ingredients that help coat the hair shaft, lock in moisture, and prevent color fade from the sun’s rays.

Armor your hair with a lightweight leave-in conditioner or UV-protectant spray. These products can also reduce dryness, breakage, or frizziness caused by the sun.

3. Saltwater & Your Hair: Rinse With Clean Water Before Jumping In 

Wet hair absorbs less saltwater than dry hair, so if you can, rinse with clean water before dunking in the ocean. Even better – rinse again as soon as possible after swimming and use a hydrating conditioner or hair mask to restore moisture.  

If you swim in saltwater a lot and want a summer-long solution for the effects of saltwater on your hair and scalp, try these tips: 

• Use sulfate-free shampoos to cleanse hair without stripping its natural moisture 

• Apply leave-in conditioner before swimming, which creates a hydrophobic barrier around the hair shaft 

• Limit excessive heat styling right after beach days to prevent additional damage  

• Use moisturizing scalp treatments if irritation develops 

You may experience softer hair or “beachy waves” after swimming in the ocean, but saltwater can also suck moisture out of your hair, leaving strands feeling brittle or more susceptible to damage. It can also lighten color-treated hair and increase photosensitivity, which can cause breakage. 

4. Chlorine & Your Hair: Wear a Swim Cap When Possible 

Chlorine is a chemical designed to kill bacteria and keep pools safe for swimming, but when it’s absorbed by hair, it can strip away natural oils, leaving hair feeling dry, brittle, and more prone to breakage.  

Frequent chlorine exposure can also affect hair color, and blonde hair is particularly vulnerable because chlorine can react with metals like copper in pool water, sometimes causing lighter hair to develop a greenish tint. Color-treated hair may also fade faster with repeated exposure.  

The best option for protecting your hair from chlorine is to wear a swim cap, but you can also follow these tips to reduce chlorine absorption: 

• Wet your hair with fresh water before entering the pool  

• Apply a leave-in conditioner or protective hair oil before entering the pool 

• Shampoo and condition with hydrating products as soon as possible after swimming 

Clarifying shampoos are popular for removing chlorine buildup but should be used only when necessary; overuse can further dry out the hair.  

Signs of Sun Damage and the Risks of Skin Cancer  

The scalp is one of the most overlooked areas for sun protection, especially for people with thinning hair, wider parts, or hairstyles that expose the scalp. Repeated UV exposure increases the risk of developing skin cancer or sun damage.  

It’s never too late to start protecting your scalp from UV rays, but it’s also important to be aware of the signs of sun damage, as chronic sun damage can contribute to precancerous lesions and skin cancers over time.  

Watch for: 

• Scalp tenderness or redness 

• Peeling along the part line 

• Increased scalp dryness or flaking 

• Brittle or rough hair texture that doesn’t return to normal 

• Faded hair color 

• Increased breakage or split ends 

If you notice persistent rough patches, sores that don’t heal, or scalp irritation, schedule an appointment with your board-certified dermatologist for a full evaluation.  

Healthy Hair and Scalp, Happy Summer! 

You don’t have to avoid the outdoors or going for a refreshing swim in the ocean or pool. With the right protection, you can enjoy the summer while maintaining your healthy hair and scalp – and staying safe from sun damage.  

Treat your scalp with the same care you give the rest of your skin. If you experience any hair or scalp challenges during the summer, especially flaky skin or increased hair damage, get an expert opinion from your dermatologist.  

Schedule an appointment with our team if you’d like some extra help preparing for or managing your summer hair and skin health.  

FAQs About Protecting Your Hair and Scalp from Sun, Saltwater, and Chlorine 

Should I put sunscreen on my scalp? 

Yes. The scalp is highly susceptible to sunburn and UV damage, especially along the hair part, hairline, or thinning areas. Dermatologists recommend using broad-spectrum SPF 30 or higher on exposed scalp areas. 

Does chlorine permanently damage hair? 

Chlorine does not usually cause permanent damage after occasional exposure, but repeated exposure can dry out the hair shaft, weaken hair, strip natural oils, and contribute to breakage or color fading over time. 

Why does blonde hair turn green in pools? 

The green tint often comes from copper and other metals in pool water reacting with chlorine and binding to the hair shaft. Blonde and lighter-colored hair tends to show the discoloration more visibly. 

Is saltwater bad for your scalp? 

Saltwater can dry out the scalp and worsen irritation or flaking in some individuals. Rinsing with fresh water after swimming and using moisturizing scalp products can help restore hydration. 

What is the best way to protect hair from sun damage? 

The best approach combines multiple strategies: wearing hats, applying SPF to exposed scalp areas, using UV-protective or heat-protectant hair products, limiting prolonged sun exposure, and restoring moisture after swimming or sun exposure

The post Derm Deep Dive: Sun, Saltwater & Chlorine Tips for This Summer appeared first on Optima Dermatology.

The Department of Pharmaceuticals (DoP) has notified the Drugs (Prices Control) Amendment Order, 2026, introducing a series of amendments to the Drugs (Prices Control) Order (DPCO), 2013 aimed at improving regulatory clarity, easing compliance for pharmaceutical manufacturers and strengthening monitoring under the price control regime. The amendments came into effect on June 30, 2026.

Among the key changes is a provision allowing the government to notify separate ceiling or retail prices for the same scheduled drug based on pack size, packaging type, dosage compliance or formulation characteristics.

The notification also provides significant relief to manufacturers in cases involving overcharging. Under the amended Paragraph 14, a manufacturer’s liability will now be restricted to the stock traded through the specific distributor or retailer found to have overcharged, provided the manufacturer demonstrates compliance with the requirements under Paragraph 24 and other government guidelines.

In another important amendment, the DoP has simplified the pricing requirements for follow-on manufacturers launching an already approved new drug. Existing manufacturers introducing the same new drug within 12 months of the retail price fixation will no longer be required to seek fresh retail price approval. Instead, they must intimate the launch to the government in the newly introduced Form IA within one month of commercialisation. However, manufacturers launching products above the notified retail price will continue to be liable to deposit the overcharged amount along with applicable interest and penalties.

The amendments also introduce additional safeguards relating to price revisions. Manufacturers seeking protection from wider overcharging liability will be required to demonstrate that revised prices have been effectively communicated to dealers, retailers and consumers through multiple channels. These include circulating revised price lists within two weeks of notification, publishing advertisements in at least two national newspapers, issuing revised Forms V or VI, displaying updated prices on the company’s website and submitting batch-wise production and stock details at the time of price revision. In such cases, overcharging liability will be calculated only on the stock handled by the retailer, distributor or stockist found selling above the notified price.

Another notable amendment relates to record retention. Manufacturers will now be required to maintain records relating to active pharmaceutical ingredients, bulk drugs, formulations and sales for a minimum of seven financial years immediately preceding the current financial year. The records must also be preserved until the conclusion of any proceedings initiated under the DPCO, if applicable. The government will retain the authority to inspect these records whenever required.

The amendment further mandates manufacturers to furnish price lists and supplementary price lists to State Drug Controllers and the government with references to the relevant price fixation or revision notifications issued under the DPCO. It also formally introduces Form IA to facilitate mandatory reporting of new drug launches, including information on formulation details, launch price, pack size and the latest government-notified retail price.

The latest amendments are expected to improve operational clarity for manufacturers while reinforcing transparency and compliance within the country’s drug pricing framework.

The post DoP amends DPCO 2013 to ease compliance, clarify overcharging liability appeared first on Express Pharma.

The post From packaging to patient outcomes: Why India’s latest DPCO amendment signals a new direction for pharmaceutical care appeared first on Express Pharma.

The healthcare industry has become increasingly competitive. Patients today have more choices than ever before, and their expectations continue to evolve. Whether you are a primary care practice, specialty clinic, surgical group, or independent physician practice, relying solely on referrals is no longer enough to sustain growth.

Successful medical practices understand that marketing is not simply advertising, it is about building trust, enhancing patient experiences, and creating a strong presence in the communities they serve. At our consulting firm, we work with practices across the country to develop strategic marketing plans that increase patient volume, strengthen brand recognition, and improve long-term profitability.

Here are the most effective ways medical practices can market themselves in today’s competitive environment.

1. Build a Strong Online Presence

For many prospective patients, your website serves as their first impression of your practice. A modern, professional website should clearly communicate who you are, what services you provide, and why patients should choose your practice.

An effective medical practice website should include:

• Mobile-friendly design
• Easy online appointment scheduling
• Provider biographies
• Patient testimonials
• Service descriptions
• Contact information and directions
• Search engine optimization (SEO)

A website that loads slowly, looks outdated, or lacks important information can drive potential patients directly to a competitor.

2. Invest in Search Engine Optimization (SEO)

Search engine optimization remains one of the most cost-effective medical practice marketing strategies available. When patients search for terms such as “dermatologist near me,” “primary care physician,” or “orthopedic surgeon,” your practice should appear prominently in search results.

Medical practice SEO focuses on:

• Optimizing website content
• Improving local search rankings
• Creating service-specific pages
• Managing online reviews
• Developing educational blog content
• Maintaining accurate business listings

The goal is simple: make it easier for patients to find your practice when they need care.

Practices that consistently invest in SEO often experience sustained growth because they attract patients who are actively searching for healthcare services.

3. Manage Your Online Reputation

Online reviews significantly influence patient decisions. Studies consistently show that patients trust online reviews almost as much as personal recommendations.

Medical practices should actively monitor platforms such as:

• Google Business Profile
• Healthgrades
• Vitals
• Facebook
• Yelp

Encourage satisfied patients to leave reviews while ensuring all efforts comply with HIPAA and applicable regulations.

Responding professionally to reviews demonstrates that your practice values patient feedback and is committed to providing excellent care.

A strong online reputation can become one of your most valuable marketing assets.

4. Leverage Social Media Strategically

Many healthcare providers underestimate the impact social media can have on patient engagement and brand awareness.

The most successful practices use platforms such as Facebook, Instagram, LinkedIn, and YouTube to:

• Share educational content
• Highlight providers and staff
• Promote community involvement
• Announce new services
• Showcase patient success stories (with proper consent)
• Provide healthcare tips

The key is consistency. Posting valuable content regularly helps establish your providers as trusted experts within their specialties.

Patients are more likely to choose a provider they recognize and trust before they ever schedule an appointment.

5. Create Valuable Educational Content

Content marketing has become one of the most effective ways to attract new patients.

Educational content helps answer common patient questions while improving search engine rankings. Examples include:

• Blog articles
• Videos
• FAQs
• Downloadable guides
• Webinars
• Infographics

For example, a dermatology practice might publish articles about skin cancer prevention, acne treatment options, or Mohs surgery. An internal medicine practice could create content about diabetes management, hypertension, or preventive care.

High-quality educational content positions your providers as experts while helping prospective patients feel more comfortable choosing your practice.

6. Strengthen Referral Relationships

While digital marketing is essential, physician referrals remain a critical source of patient volume for many medical practices.

Practices should actively cultivate relationships with:

• Referring physicians
• Urgent care centers
• Hospitals
• Physical therapists
• Community healthcare providers

Regular communication, educational events, provider meet-and-greets, and timely referral reporting can help strengthen these relationships.

Many practices lose referral opportunities simply because they fail to maintain ongoing communication with their referral sources.

7. Focus on Patient Experience

One of the most powerful marketing tools is delivering exceptional patient experience.

Patients who have positive experiences are more likely to:

• Return for future care
• Refer friends and family
• Leave positive online reviews
• Become long-term advocates for your practice

Evaluate every touchpoint in the patient journey, including:

• Phone interactions
• Appointment scheduling
• Wait times
• Clinical encounters
• Billing processes
• Follow-up communication

Marketing can attract patients, but a superior patient experience helps retain them.

8. Utilize Targeted Digital Advertising

Digital advertising allows medical practices to reach highly targeted patient populations.

Effective advertising channels include:

• Google Ads
• Facebook Ads
• Instagram Ads
• YouTube Advertising
• Retargeting Campaigns

Targeted advertising can be particularly effective when promoting:

• New providers
• New locations
• Specialty services
• Seasonal healthcare needs
• Elective procedures

A properly managed advertising campaign can generate measurable patient acquisition while providing valuable insights into marketing performance.

9. Engage with Your Local Community

Healthcare remains a relationship-driven industry. Community involvement can significantly strengthen brand awareness and trust.

Consider participating in:

• Health fairs
• Community events
• School programs
• Charity initiatives
• Employer wellness programs
• Educational seminars

These activities position your practice as a trusted healthcare resource and create opportunities to connect directly with potential patients.

Community engagement often generates goodwill that translates into patient growth over time.

10. Measure Results and Adjust Your Strategy

One of the biggest mistakes medical practices make is investing in marketing without tracking performance.

Successful practices monitor key metrics such as:

• New patient volume
• Website traffic
• Conversion rates
• Referral sources
• Cost per acquisition
• Online review growth
• Advertising ROI

Data-driven decision-making allows practices to allocate resources effectively and maximize marketing results.

Healthcare marketing should be viewed as an ongoing process rather than a one-time initiative.

Final Thoughts

Marketing a medical practice in today’s competitive environment requires a combination of digital strategy, reputation management, patient engagement, and community involvement. Practices that proactively invest in marketing are often better positioned to attract new patients, retain existing ones, and achieve sustainable growth.

At our consulting firm, we frequently find that the most successful organizations are not necessarily the largest; they are the ones that consistently communicate their value, deliver exceptional patient experiences, and adapt to changing patient expectations.

A well-executed marketing strategy can help your practice stand out in a crowded marketplace and create a foundation for long-term success.

Contact Us

The post How to Market Your Medical Practice in a Competitive Industry appeared first on DoctorsManagement.

DoctorsManagement’s Consultants specialize in Medical Practice Management and can offer a myriad of solutions to effectively and efficiently manage administrative and operational tasks by performing a practice assessment, however, this article would like to focus specifically on the area of credentialing.

Credentialing inefficiencies can cause thousands of dollars in lost revenue per physician. It is estimated that inefficient credentialing costs the healthcare industry over $2 billion annually, with delays causing approximately $9,000 in lost revenue per provider, per day. A 3-month delay in credentialing a new physician can result in over $100,000 of lost revenue. A single provider missing 12 weeks of patient visits can cost a practice, while specialists or surgeons may lose over a 120-day delay. Those losses add up quickly.

Common Results of Credentialing Inefficiencies

• Revenue loss due to services that cannot be billed
• Higher claim denial rates
• Cash flow disruption
• Costs of administrative rework

Common Reasons for Credentialing Inefficiency

Manual Processes

While we recognize that most credentialing software systems may not be in the budget for many small practices and have limitations, there may be other ways available to streamline the process. Something as simple as using MS Forms and MS 365 Agents to help collect and organize credentialing onboarding information can assist in reducing data entry error mistakes as well as improving data collection times.

Fragmented Systems or Processes

Many health systems rely on four or more systems to manage provider onboarding workflows, leading to duplicative effort, lost time, and limited visibility (Kaufman Hall).

Having multiple systems in place in a small practice is probably not typical, however, it is still important that credentialing processes be streamlined and consolidated. Creating a list of standard credentialing onboarding processes and procedures can improve workflows and reduce duplicative efforts.

Some top suggestions to get started would be:

• Use a standardized onboarding application for every provider
• Standardize onboarding task tracking and management
• Create a standardized filing system for storage of credentialing onboarding information, documentation, applications, contracts and correspondence
• Create a standardized follow up schedule for status updates

Payor Complexity

Requirements differ for each payor and a lack of knowledge regarding each payor’s unique requirements and timelines can lead to delays and application rejection. Evolving requirements and processes from payors often slow down the process. In an effort to stay abreast of technological advances and reducing credentialing administrative burdens often caused by staffing shortages, healthcare payors often update their credentialing processes and it is important for credentialing experts to stay abreast of various payor updates.

Provider Credentialing and Enrollment is an ever-changing process that challenges even the best credentialing teams. Medical credentialing services can institute organization, accountability and knowledge to a complex process. Outsourcing credentialing services to an organization with the tools, skills and knowledge to complete the credentialing process correctly can reduce the burden placed on the practice caused by inefficient practices. DoctorsManagement’s credentialing staff have extensive knowledge, experience and tools to successfully complete the credentialing process. If your organization needs assistance with credentialing and onboarding, whether it be with new practice startups, existing practices adding new providers, or credentialing maintenance, DoctorsManagement is here to assist.

Contact Us

The post Is Credentialing Software the Right Fit For Your Practice? appeared first on DoctorsManagement.

Takeda will take the lead in advancing selected candidates through clinical validation, using its global development capabilities.

The partnership aims to identify drug candidates with the potential for clinical differentiation across Takeda’s main therapeutic areas.

By applying advanced AI models in early-stage drug design, both companies aim to enhance the selection process for candidate molecules and focus on achieving criteria related to efficacy and safety.

Insilico will receive about $60m in fees, near-term payments, and milestones upon project initiation.

The deal also includes the possibility of further preclinical, clinical, commercial, and sales milestone payments, which could bring the total value up to approximately $600m.

Insilico is also set to receive tiered royalties on any future sales resulting from the collaboration.

The agreement gives Takeda exclusive global rights to develop, manufacture, and commercialise new therapeutics that emerge from the drug discovery programme.

Insilico Medicine founder, CEO and CBO Alex Zhavoronkov said: “I am excited to partner with one of the top leaders in the biopharmaceutical industry with massive competence in generative AI.

“As we deepen the integration of generative AI into every stage of the pharma value chain, I believe the future of pharmaceutical superintelligence has the potential to deliver the highest quality and differentiated drugs. This is a fundamental step on our journey toward extension of healthy productive life.”

Earlier this year, Insilico Medicine announced several AI drug discovery collaborations with China Medical System (CMS) across several projects in central nervous system (CNS) and autoimmune diseases.

The post Insilico Medicine, Takeda partner on AI-driven drug discovery appeared first on Pharmaceutical Business review.

Additionally, the whole genome sequencing (WGS) capabilities of Inocras will be integrated into AimedBio’s antibody-drug conjugate (ADC) clinical programmes.

The post Inocras, AimedBio team up for cancer treatments appeared first on Pharmaceutical Business review.

The Ministry of Health and Family Welfare has released the draft National Pharmacy Commission (NPC) Bill, 2026 for public consultation, proposing a comprehensive overhaul of India’s pharmacy education and professional regulatory framework by replacing the nearly eight-decade-old Pharmacy Act, 1948.

The proposed bill seeks to modernise pharmacy education, strengthen professional standards, improve institutional oversight and create a transparent, technology-driven regulatory ecosystem aligned with evolving healthcare and industry needs.

The draft bill proposes the establishment of the National Pharmacy Commission as the apex regulatory body for pharmacy education and practice. It envisages competency-based education, a National Exit Test (Pharmacy) for registration, a live digital National Register of Pharmacy Professionals, periodic assessment and rating of pharmacy institutions, and stronger ethical and professional standards. It also proposes dedicated boards for pharmacy education, institutional assessment and registration to streamline governance and improve accountability. Stakeholders have been invited to submit comments on the draft within one month.

The proposed reforms have received an encouraging initial response from industry.

The Federation of Pharma Entrepreneurs (FOPE) has welcomed the government’s move, describing it as a landmark reform that could significantly strengthen India’s pharmacy ecosystem.

Harish Jain, National President, FOPE, said, “FOPE welcomes the Government of India’s initiative to modernize the pharmacy regulatory framework through the proposed National Pharmacy Commission Bill, 2026, replacing the Pharmacy Act, 1948. This is a landmark reform that has the potential to align pharmacy education and professional regulation with the evolving needs of the healthcare system and the pharmaceutical industry.

“The emphasis on competency-based education, a National Exit Test, digital registration, transparent assessment of pharmacy institutions, and stronger ethical standards are progressive measures that can enhance the quality and global competitiveness of India’s pharmacy profession.”

While endorsing the overall direction of the reforms, FOPE has urged the government to ensure that the final legislation adequately reflects the perspective of the pharmaceutical manufacturing sector.

Jain said, “However, FOPE believes that the final legislation should also ensure meaningful representation of the pharmaceutical manufacturing sector, particularly MSMEs, in policy formulation and implementation. The practical experience of industry is critical in shaping pharmacy education, industrial pharmacy, skill development, regulatory compliance, and research.”

FOPE has also called for a smooth transition from the existing regulatory framework, highlighting the need to safeguard the interests of currently registered pharmacists and promote stronger collaboration between academia and industry.

“We also urge the Government to provide a smooth transition from the existing regulatory framework, protect the interests of currently registered pharmacists, strengthen industry-academia collaboration, and ensure that implementation is phased, practical, and consultative,” Jain added.

The industry body said it will undertake a detailed review of the draft legislation before submitting its recommendations to the Ministry during the consultation period.

“FOPE will study the draft Bill in detail and submit comprehensive recommendations to the Ministry within the consultation period. We remain committed to working with the Government to build a modern pharmacy ecosystem that promotes patient safety, quality education, innovation, and the sustainable growth of India’s pharmaceutical sector,” Jain said.

The Ministry is expected to finalise the legislation after examining stakeholder feedback received during the consultation process.

The post Draft National Pharmacy Commission Bill proposes sweeping overhaul of pharmacy education and regulation  appeared first on Express Pharma.

Periodontitis remains a major global health challenge, says Varkha Rattu, but better outcomes depend on consensus in diagnosis, collaboration around referral and clear communication with patients.

Periodontitis is the sixth most prevalent health condition globally. According to the Global Burden of Disease study (2017), severe periodontitis affects approximately 11% of the world’s population – around 743 million people – while milder forms affect more than half of all adults (The Economist Intelligence Unit, 2021). The global prevalence of severe periodontitis exceeds that of cardiovascular disease (7%), making it a public health challenge that demands serious clinical attention.

Bridging the gap between evidence and practice requires three things: Consensus on how we diagnose and classify disease; Collaboration in recognising when cases need specialist input; and Co-operation in communicating effectively with patients and colleagues.

Part one: consensus

Diagnosing and classifying periodontitis

In periodontology, consensus takes the form of internationally agreed classification systems and clinical practice guidelines – the foundation of good clinical decision-making.

Diagnosis is underpinned by criteria established by the European Federation of Periodontology (EFP, 2019).

Once confirmed, staging and grading characterises severity, complexity, and rate of progression. The 2017 World Workshop Classification (WWC) introduced complexity factors that shift a case to a higher stage (Papapanou et al, 2019). For example, furcation involvement Class II or III, probing depths ≥6 mm, and vertical bone loss ≥3 mm escalate from Stage II to Stage III.

These complexity factors are especially useful because they identify which clinical features are most likely to make treatment more demanding, and therefore more likely to warrant specialist input.

Part two: collaboration

Complexity factors as a framework for referral

From clinical experience, the following complexity factors should prompt serious consideration of referral following initial non-surgical periodontal therapy (NSPT):

1. Residual probing depths ≥6 mm

Subgingival instrumentation is the cornerstone of active periodontal treatment. Where residual pockets of ≥6 mm persist following NSPT, this signals the need for more advanced intervention. The EFP S3 guideline confirmed that hand and powered instruments can be utilised effectively, and adjunctive measures such as systemic antibiotics may be considered in specific categories such as generalised Stage III/IV periodontitis in younger adults (Sanz et al, 2020).

2. Vertical/Infrabony Defects ≥3 mm

Angular bony defects carry significant prognostic weight. Papapanou and Wennström (1991) found that deep intrabony defects were associated with 68% tooth loss at 10 years, compared with 13% for horizontal bone loss (Papapanou, 1991). The EFP S3 guideline gives a strong recommendation for periodontal regenerative surgery at residual deep pockets with intrabony defects ≥3 mm, supported by 22 RCTs in 1,182 teeth (Sanz et al, 2020). Techniques include barrier membranes and enamel matrix derivative, with papilla preservation flaps strongly recommended.

3. Furcation Involvement Class II and III

Furcation involvement is not, in itself, a reason for extraction (Sanz et al, 2020). For mandibular Class II furcation, regenerative surgery carries a strong recommendation supported by 17 RCTs in 493 patients. For maxillary buccal Class II, regeneration is suggested. While for Class III presentations, tunnelling, root separation, or root resection may be considered.

4. Complex rehabilitation requirements (masticatory dysfunction, secondary occlusal trauma, severe ridge defects, bite collapse, drifting or flaring, fewer than 20 remaining teeth)

Secondary occlusal trauma – occlusal overload in the context of reduced periodontal support – is a Stage IV complexity factor. Temporary splinting and/or selective occlusal adjustment may be considered throughout therapy (Sanz et al, 2020), and cases of Grade 2 mobility with fremitus can be successfully stabilised through targeted occlusal adjustment, avoiding extraction.

Ridge defects (Siebert Class I–III) represent a further indication for specialist involvement, particularly where implant rehabilitation is planned. Horizontal augmentation options include GBR, ridge splitting, and onlay grafts (Naenni et al, 2019). Vertical augmentation encompasses GBR, distraction osteogenesis, onlay block grafts, and sinus floor augmentation (Urban et al, 2019).

Part three: co-operation

The final pillar concerns communication: with patients and with colleagues. Evidence-based care is only effective if patients understand and accept the pathway offered.

When explaining the need for referral, language matters, and helping patients understand the systemic dimension is equally valuable. Periodontitis is an immune-inflammatory condition – the body’s response to persistent bacterial challenge. The inflammatory mediators generated in the periodontium can travel systemically, with established associations between periodontitis and diabetes, cardiovascular disease, rheumatoid arthritis, and Alzheimer’s disease. Framing the mouth as the gateway to the body – and periodontal treatment as an investment in overall health – can meaningfully shift patient engagement.

Taking these factors into consideration, managing periodontitis effectively demands:

• Consensus: applying internationally agreed diagnostic criteria and classification systems rigorously in every patient encounter
• Collaboration: recognising the complexity factors most likely to warrant referral, and acting on them decisively
• Co-operation: communicating openly with patients, framing advanced care as an investment in their long-term health.

Periodontitis remains a disease of significant global public health impact. With the right clinical framework, dental professionals at every level are better placed to improve outcomes for this patient group.

References

1. The Economist Intelligence Unit. Time to take gum disease seriously: The societal and economic impact of periodontitis. Report commissioned by the European Federation of Periodontology, 2021.

2. Guidance for clinicians: Periodontitis: clinical decision tree for staging and grading, European Federation of Periodontology (2019).

3. Papapanou, P. N., Sanz, M., Buduneli, N., et al. (2018). Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Journal of clinical periodontology, 45 Suppl 20, S162–S170. https://doi.org/10.1111/jcpe.12946

4. Sanz, M., Herrera, D., Kebschull, M., Chapple, I., Jepsen, S., Berglundh, T., Sculean, A., Tonetti, M. S., & EFP Workshop Participants and Methodological Consultants (2020). Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. Journal of clinical periodontology, 47 Suppl 22(Suppl 22), 4–60. https://doi.org/10.1111/jcpe.13290

5. Papapanou PN, Wennström JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x. PMID: 2066446.

6. Naenni, N., Lim, H. C., Papageorgiou, S. N., & Hämmerle, C. H. F. (2019). Efficacy of lateral bone augmentation prior to implant placement: A systematic review and meta-analysis. Journal of clinical periodontology, 46 Suppl 21, 287–306. https://doi.org/10.1111/jcpe.13052

7. Urban, I. A., Montero, E., Monje, A., & Sanz-Sánchez, I. (2019). Effectiveness of vertical ridge augmentation interventions: A systematic review and meta-analysis. Journal of clinical periodontology, 46 Suppl 21, 319–339. https://doi.org/10.1111/jcpe.13061

This article is sponsored by NSK.

Glenmark Specialty S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals (Glenmark) announced the advancement of its multi-country Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811), a HER2-targeted antibody drug conjugate (ADC), for patients with platinum-resistant ovarian cancer (PROC).

India will serve as the first country in Glenmark’s licensed markets to initiate patient enrollment for the Phase 3 clinical trial, following the approval of Drugs Controller General of India (DCGI). Glenmark also plans to enroll patients in Australia and South Korea, subject to regulatory approvals.

The study is aligned with Jiangsu Hengrui Pharmaceuticals’ ongoing parent Phase 3 trial in China. Glenmark aims to generate clinically relevant data across broader and more diverse patient populations, supporting the development of Trastuzumab rezetecan across Glenmark’s licensed markets. The randomized, controlled, multi-centre, Phase 3 trial is designed to evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab rezetecan in patients with HER2-expressing platinum-resistant ovarian cancer, a difficult-to-treat disease where treatment options remain limited, and outcomes continue to be poor. Conducting the trial across multiple geographies is expected to support the generation of evidence from diverse patient groups and strengthen the clinical data package for the therapy across Glenmark’s licensed markets.

Commenting on the announcement, Dr Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals Limited, said, “Advancing this pivotal Phase 3 trial marks an important step in Glenmark’s journey to build a differentiated oncology pipeline for global markets. Platinum-resistant ovarian cancer remains an area of significant unmet need, and the initiation of patient enrollment in India, with additional countries planned, reflects our commitment to developing novel targeted therapies for patients with hard-to-treat cancers and limited treatment options. This study also strengthens our ability to generate clinically relevant evidence across diverse populations.”

Ovarian cancer remains one of the most challenging gynecologic malignancies globally. It is the eighth1 most common cancer among women worldwide. India carries a significant burden, ranking among the countries with the highest number of ovarian cancer cases and deaths globally. Many patients with advanced ovarian cancer treated with available platinum-based therapies develop recurrence and subsequently platinum resistance. This underscores the need for continued clinical development of targeted therapies that may improve treatment options for patients with advanced and resistant disease.

In September 2025, Glenmark entered into an exclusive collaboration and license agreement with Jiangsu Hengrui Pharmaceuticals (“Hengrui Pharma”) for Trastuzumab rezetecan (SHR-A1811), securing rights to develop and commercialize the asset across multiple markets. Under the agreement, Glenmark holds exclusive rights worldwide excluding Mainland China, the Hong Kong SAR, the Macao SAR, Taiwan Region, USA, Canada, Europe, Japan, Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan and Uzbekistan.

The post Glenmark advances multi-country phase 3 clinical trial of Trastuzumab rezetecan in PROC appeared first on Express Pharma.

Resilience By Design – The Packaging Imperative
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Click to download: July 2026 Digital Magazine

A team at Columbia University has now finally caught the moving junction in the act. By freezing parasites at the onset of invasion and lifting the intact complex straight out of the cell, the researchers obtained the first high-resolution view of its three-dimensional structure. What they saw overturned a decades-old assumption about how the parasite gets in. Rather than a passive doorway, the moving junction turns out to be a molecular machine that actively remodels the host cell’s membrane to help the parasite force its way inside.

The findings detail how the team obtained the structure and then used it as a blueprint to design a mini-protein, from scratch, that blocks invasion—a proof of concept for a new kind of antimalarial drug.

“We’ve known for decades that this structure is essential for the parasite to get into a cell, but not how it actually works,” said Chi-Min Ho, PhD, an assistant professor in the Department of Microbiology and Immunology at Columbia University Vagelos College of Physicians and Surgeons and the study’s senior author. “Pulling it directly out of the parasite intact let us finally ask that question directly.”

Ho is senior author of the team’s published paper in Cell, titled “Structural basis for host membrane binding and remodeling by invading malaria parasites.” In their paper, the team stated in summary, “This work represents a major step toward resolving the decades-long mystery surrounding the structure and function of the malarial MJ, underscoring the power of pursuing native structures and laying the foundation for structure-guided design of next-generation antimalarials.”

Malaria still kills roughly 600,000 people a year, the overwhelming majority of them young children in sub-Saharan Africa, and the parasite is steadily becoming resistant to frontline drugs. “Malaria morbidity and mortality are directly linked to the invasion and replication of the malaria parasite Plasmodium falciparum in human red blood cells (RBCs),” the authors wrote. The malaria parasite life cycle involves two hosts, humans and Anopheles mosquitoes, and infecting human RBCs and hepatocytes, as well as mosquito salivary glands.

The disease starts with a single event: a parasite breaking into a red blood cell. “Parasites establish infection by invading host cells in a rapid and precisely choreographed process …” the team continued. In an infected person, trillions of parasites are released and invade every 48 hours in synchronized waves. This rhythmic cycle of rupture and reinvasion drives the periodic fevers malaria is known for. “After gliding, reorientation, and initial attachment, parasite internalization is initiated by the formation of a ring-shaped ultrastructure called the moving junction (MJ), which anchors the parasite to the host cell,” the researchers explained.

The same moving junction machinery is used across every species and every stage of the parasite’s life cycle, which has made it one of the most sought-after targets in malaria research. For antimalarial drug and vaccine development, block it, and you stop infection at its source.

The moving junction has been a puzzle since 1978, when scientists first observed in electron microscopy images a mysterious thickening of the membrane where parasite meets cell. Researchers eventually identified the four parasite proteins—AMA1, RON2, RON4, and RON5—that assemble into the junction’s basic building block, and confirmed that all were essential for invasion. But what the structure actually did remained unknown, because it survives for a minute or so and refuses to reassemble in a test tube. “Efforts to address this critical gap in understanding have been thwarted by the short-lived (60–90s) nature of the complex, as well as by the difficulty of recapitulating it in heterologous systems for detailed biochemical and structural study,” the researchers stated.

The Columbia team got around this by stopping invasion mid-stride. Using a compound that halts the parasite’s internal motor without preventing the junction from forming, they stalled parasites partway into red blood cells, then extracted the fully assembled AMA1-RON complex—the building block from which the whole junction is constructed—and imaged it with cryo-electron microscopy (cryo-EM), a technique where molecules are flash-frozen and imaged with an electron beam at extremely high magnifications to reveal their shape in atomic detail. The result was a sharp, three-dimensional view of that building block. The researchers noted that it was quite strikingly shaped like a sailboat, with the AMA1 protein forming a “sail” above the cell surface and the three RON proteins forming a broad “hull” pressed against the membrane below.

The biggest surprise was in the hull, where the team found clues that finally hinted at the moving junction’s role in invasion. The face of the structure pressed against the host membrane is blanketed with positively charged anchors, and the surface is studded with short helices that drive deep into the membrane like wedges. “These short helices insert asymmetrically into one leaflet of the membrane, displacing lipid headgroups and applying lateral pressure to generate local membrane deformations.”

Both features are widely recognized hallmarks of a well-known family of cellular machines that bend and reshape membranes. Their structural findings, they noted in their report, reveal “a highly unusual molecular staple that exhibits the hallmarks of a powerful membrane-remodelling machine.”

To test whether the structure could indeed deform a membrane, the researchers synthesized the parasite’s wedge-like helices and added them to artificial membrane bubbles. The membranes thinned and punctured. Meanwhile, weakened versions of the helices left the bubbles intact. The team concluded that the moving junction appears to pull the host membrane into shape, likely working in concert with the parasite’s motor to lever the parasite inside.

“It had been pictured as a kind of series of staples or spot-welds, making up a passive ring the parasite hauls itself through,” said Meseret Haile, the study’s first author and a PhD candidate in Ho’s lab. “What we see instead is a machine built to reshape the host cell’s own membrane. That changes how we think about the whole event.” In their paper, the team added, “Our work reveals that, although visually suggestive of canonical tight junctions, the MJ differs fundamentally in function, serving as a dynamic portal that orchestrates parasite internalization, rather than a static adhesion molecule.”

Beyond finally revealing how the moving junction allows the parasite to invade, the structure also gave the team a precise map of where and how AMA1 grips its partner protein, the contact that holds the entire junction together. Using a machine learning-powered protein-design tool together with their structural information, the researchers designed a mini-protein to break that grip. Their best candidate blocked parasites from invading red blood cells in a dose-dependent way and left already-infected cells unaffected, confirming that it works specifically by stopping entry rather than through general toxicity.

The designed mini-protein is a first proof of concept, not a drug, and will need considerable refinement before it could be tested in people. But it demonstrates an exciting new strategy: using near-native structures to design invasion-blocking mini-proteins against a target that has long frustrated conventional approaches. The same structure also clarifies how several leading anti-malaria antibodies work, information that could feed back into vaccine design. “Our successful proof of principle demonstrates the potential power of context-driven binder design for challenging systems, offering a previously unexplored avenue for therapeutic intervention,” they wrote. “In addition to their therapeutic potential, these binders may also serve as powerful tools for probing the functional relevance of specific protein interactions.”

Daphne Kaxiras, an MD-PhD student in Ho’s lab who led the inhibitor design, said, “Once we could see the target in its real setting, designing something to block it became a tractable problem. That’s the part we’re most eager to build on.”

The team’s approach, imaging fragile complexes captured directly from the organism and using them to guide design, may apply to many other parasites and pathogens that are notoriously difficult to study.

The post First 3D Structure of Malaria’s “Moving Junction” Solves Infection Mystery appeared first on GEN - Genetic Engineering and Biotechnology News.

In an early-stage mouse embryo, cells of the epiblast are polarized and give rise to all major tissues. The team investigated the fundamental principles governing the behavior of polarized cells that are present in bulk and the impact of physical constraints at tissue borders. By focusing on how cellular orientations influence each other and their environment, the researchers built a minimal model that predicts how organization changes when interactions are altered.

“For me, as a physicist, I may know why something works, but it’s still kind of magic to see that it’s all true in messy biological systems,” said Pamela Guruciaga, PhD, postdoctoral researcher at EMBL and co-first author of the study. “It was also super interesting coming from a pure physics perspective to come up with a common language to work with biologists.” 

In the cup-shaped epiblast, results showed different boundaries led to varying orientations for epiblast cells. When the boundary was lined with the extracellular matrix, the cells oriented perpendicularly. In contrast, when the epiblast was in direct contact with a neighboring tissue without a matrix, the cells aligned parallel to the boundary. The researchers found that the combination of these two orientations result in the appearance of structures, known as “topological defects.” 

“These are points in space where it is undefined in which direction an object should point,” explained Guruciaga. “For example, if a set of arrows is arranged in a starburst pattern, the center is a point where all directions are equivalent. These points are super relevant because they are very robust; you cannot easily destroy them.” 

To directly test whether the boundary shape controls the number of defects, the authors  altered the geometry of the epiblast. Perturbing embryo shape induced the formation of additional lumina at the predicted positions.  

“What I find most exciting is that these results identify a very general physical principle,” said Anna Erzberger, PhD, group leader at EMBL and co-corresponding author of the study. “We show that geometry alone can determine orientation patterns in three dimensions, independent of the microscopic details of the system. That means shape itself can act as a robust control parameter—not just in embryos, but across a wide range of biological and physical systems.” 

The post Biological Order Emerges from Tissue Boundaries, Drives Embryo Development appeared first on GEN - Genetic Engineering and Biotechnology News.

The study is published in Nature in the paper, “Restoring cortical disinhibition improves Huntington’s disease phenotypes.”

“This work shows that correcting specific imbalances in brain circuits can restore function, even in a complex neurodegenerative condition, and highlights the potential of targeting defined cell types to promote recovery,” said Takaki Komiyama, PhD, professor in the UC San Diego Departments of Neurobiology (School of Biological Sciences) and Neurosciences (School of Medicine).

Huntington’s disease is caused by a trinucleotide repeat mutation in the Huntingtin (HTT) gene. While the mutation is well known, the neural networks connected with the disease progression have been more elusive.

This work aimed to map the neural circuits that expose the networks involved at the onset and spread of the disease’s debilitating symptoms. In transgenic mice carrying the same mutation as human patients, the researchers evaluated how different types of brain cells in the motor cortex are affected in Huntington’s disease. Advanced imaging techniques allowed the researchers to track the activity of these cortical neurons as the disorder progressed.

The researchers found that the disease disrupts the balance of activity across different cell types, including cortical inhibitory neurons.

“Cortical inhibitory cells have received little attention in Huntington’s disease, as for a long time they were considered to be spared from neurodegeneration,” said Irina Dudanova, PhD, previously based at the Max Planck Institute for Biological Intelligence, now at the University of Würzburg in Germany. “Surprisingly, we detected profound changes in their activity, with some cell types being overactive and some nearly silent.”

In particular, a class of inhibitory neurons known as vasoactive intestinal peptide (VIP) neurons, exhibited significantly reduced activity. VIP neuron activity is essential for normal learning, as these cells enable the brain to adapt and refine brain circuits during learning.

Reduced VIP neuron activity, the researchers reasoned, could be impairing the brain’s ability to function and learn properly. They sought to activate these cells to re-engage brain states that support learning. They tested this idea using optogenetics to stimulate VIP neurons.

“By activating the VIP inhibitory cell type, we gradually restored more normal activity patterns, and, very importantly, we also saw an improvement in the ability of the mouse to learn a motor task,” said Sonja Blumenstock, PhD, assistant project scientist at UC San Diego.

The results confirm VIP neurons as a key point of vulnerability in Huntington’s disease as well as a promising target for therapy. As to how this process works, the results suggest that modulating VIP neurons opens a “gate” that enables learning-related brain plasticity.

“This intervention restored more normal patterns of activity in the brain and improved movement in affected mice,” said Komiyama. “Importantly, the improvements persisted for days after stimulation ended, suggesting that the treatment triggered lasting beneficial changes in brain circuits rather than only temporary effects.”

The study provides important indications of where research could focus to normalize human brain function and facilitate brain recovery. Komiyama envisions a future scenario in which scientists could non-invasively activate the brain from outside the skull using novel approaches.

“Our study shows that despite the genetic defect, a precise intervention into the brain circuitry can lead to significant improvements in motor symptoms,” said Dudanova. “If we know which cells to target, we can retune the brain’s abnormal activity patterns. This gives hope for future therapies.”

The research also shows that corrections to specific brain circuit imbalances can restore function in a highly complex neurodegenerative condition, with similar potential in other disorders.

“We have come up with a way to allow the diseased brain to learn better,” said Komiyama. “The approach can improve behavior in diseased mice, and our hope is that a related approach will help people with impairment in their learning abilities.”

The post In Huntington’s Mouse, Optogenetic Activation of VIP Neurons Restores Brain Function appeared first on GEN - Genetic Engineering and Biotechnology News.

• Why sometimes resting isn’t an effective injury prevention strategy
• The science behind substitutions in football
• The mysterious green whistle at the World Cup

Why sometimes resting isn’t an effective injury prevention strategy

A recent study on load management has revealed some fascinating insights. It investigated whether NBA players who missed games for rest or load management were less prone to injuries later in the season. The study utilised nine seasons of audited NBA medical records—from 2014–15 to 2022–23—covering 1,233 player-seasons and over 1.5 million player-minutes.

On a positive note, the data showed that the number of games missed for rest and load management had surged by 125% over the nine years. This trend reflects a significant shift among medical and support staff, indicating they are more informed and proactive about managing player workloads, feeling empowered to rest players in favour of prioritising their welfare.

However, the study found that despite the increase in games missed, injury rates did not drop. One of the most compelling discussions in the paper revolves around the concept of the workload–injury paradox. The authors suggest that while rest can reduce fatigue, it might also reduce the chronic exposure needed for athletes to build resilience. In essence, while too much load can increase injury risk, too little load may reduce physical preparedness. Therefore, resting alone isn’t an effective injury prevention strategy.

If you would like to learn more about load management, you should definitely check out our relevant blogs:

• How load management can help reduce injury risk in youth athletes
• Training load monitoring: How coaches can effectively monitor multiple variables
• 4 Ways to Monitor an Athlete’s Load on a Budget
• A multi-dimensional approach to training load and performance monitoring
• Is there a relationship between workload, the athlete’s state of recovery, and injury?

The science behind substitutions in football

While many of us are likely absorbed in the ongoing FIFA World Cup, a recently published study has shed light on an important aspect of the game. Researchers examined over 250 substitutions made in top division male professional football matches.

Their findings revealed that substitute players covered up to 75% more relative distance and exerted 90% more relative high-intensity efforts than those who played the full match or were replaced. Additionally, substitutes were 3 to 4 times more likely to improve the match score than to worsen it.

This research clearly indicates that substitutions are playing an increasingly crucial role in elite football, demonstrating that they are essential for sustaining or enhancing physical performance throughout the course of a match.

The mysterious green whistle at the World Cup

In an earlier World Cup match between Canada and Qatar, Canadian midfielder Ismaël Koné caught the spotlight when he was stretchered off the field with a broken leg while inhaling from a small green tube that resembled a whistle. This incident sparked widespread speculation on social media about the nature of the device.

The device in question is called Penthrox, a handheld inhaler designed for quick pain relief. It contains methoxyflurane, a non-opioid pain reliever that works swiftly. One of the key advantages of Penthrox is that it provides immediate pain relief while keeping the athlete awake and alert. However, it’s crucial to note that the device should only be used for short-term relief under medical supervision due to potential side effects, including drowsiness, dizziness, and nausea.

If you would like to learn more about pain management, check out our excellent course, The Science of Pain Management.

From us this week:

>> New course: Female Physiology
>> New podcast: Creatine’s Next Chapter with Steve Jennings
>> New infographic: Wingate Anaerobic Test
>> New article: Hydrotherapy

Access to a growing library of sports science courses

SFS Academy is an all-access membership to premium sports science education.

With SFS Academy, you’ll learn from some of the best coaches around the world as they teach you how to apply the latest research and practice with your athletes.

The post Is Resting An Effective Injury Prevention Strategy? appeared first on Science for Sport.

By Eric Galipo 

Across the United States, decades of development have greatly lessened people’s direct access to nature; however, a growing understanding of the benefits of access to even small outdoor space outdoors has encouraged designers exploring ways of subtly weaving green space into unexpected places. As cities expand, “pocket gardens” have emerged as a scalable response to introduce green interventions into densely built streetscapes. One surprisingly purposeful place that pocket gardens have taken root is in areas close to hospitals and healthcare facilities.  

Pocket gardens are small, strategically implemented areas that feature plants and greenery, and provide respite from densely built environments. Many repurpose underutilized spaces to provide patients, staff, and residents with greater access to nature while softening the boundary between a campus and adjacent streets. When thoughtfully designed, these gardens enhance walkability, advance urban sustainability goals, and reconnect neighborhoods with nature without requiring large-scale redevelopment. 

Improving Healthcare Campuses Through the Landscape  

At the Newark Beth Israel Medical Center (NBI) in Newark, N.J., FCA worked with healthcare leaders to update and expand the 11-acre campus with the goal of reshaping how it connects to the surrounding neighborhood. NBI’s leadership emphasized the need for an improved sense of place and safety, ensuring that visitors would feel welcomed and reassured by the quality of the facility’s neighborhood and surroundings. Deliberately located pocket gardens were a specific urban design response to this effort create a more legible entry experience, showing that small green interventions can soften boundaries and create easily accessible natural moments day-to-day.  

The project involved adding more than 50 new trees across NBI’s urban campus, along with strategic planting beds and mini plazas within expanded sidewalks and the transitional spaces between buildings. Equal parts aesthetic and functional, these pocket gardens reshaped the building’s relationship with its neighborhood and reinforced its broader goals of encouraging healing through intentional exterior urban design.  

Historically, many medical centers contain hard boundaries that make them feel disconnected from their neighborhoods. The redesign of NBI softens its edges that abut historic residential neighborhoods, giving way to human-centered spaces that support interaction and connection to nature. They offer accessible moments of respite along city blocks, and the sense of a healthy campus that is tailored for both patients seeking comfort and neighborhood residents seeking leisure.  

Whether someone is coming to or from NBI, or lives in the community, any pedestrian can make use of these restorative green pockets to pause, reset, linger, or support their physical and emotional well-being.  

Enhancing Environmental Performance and Human Experience 

NBI’s pocket gardens play an essential role in catalyzing interaction within the campus’s streetscapes. They also serve as open space and green infrastructure for the surrounding community, contributing to rainwater absorption that reduces stormwater runoff. Shaded areas with understory plantings also support cooling and mitigate urban heat island (UHI) effects that are characteristics of urban environments.  

With cities working to address aging infrastructure and climate resiliency amidst population growth and development, pocket gardens provide an achievable, flexible, and minimally disruptive tool for enhancing environmental comfort and ecosystem services. They are particularly transformative for large-scale institutional campuses that are unable to accommodate more significant, green-focused changes or additions.  

These areas also improve public health outcomes by encouraging the quality of pedestrian environments and access to comfortable outdoor spaces. Urban areas are typically automobile oriented, but these spaces refocus usability around the pedestrian. Thoughtfully integrated lighting, seating, and greenery around bus stops and key pedestrian routes also work to enhance visibility and safety of the campus while ensuring that these outdoor spaces can be enjoyed by anyone at any time.   

Working together, these strategies elevate pocket gardens from a quaint feature to high-performing elements that merge environment, community and social infrastructure seamlessly. 

Scalable Models for Other Campuses  

One of the most significant advantages of pocket gardens is their capacity to effect incremental change at a reasonable cost. The inherent flexibility associated with these green spaces allows for gradual introduction, providing a scalable model that can be adjusted to the needs of different campuses, contexts and implementation phasing. At NBl, this flexibility allowed the FCA team to embed green infrastructure directly into the design process, making sustainability and community integration core tenets of the overall campus plan.  

As healthcare systems look to expand in urban areas and attempt to bridge the gap between interior and exterior, the need for human-centric environments is only growing. Pocket gardens present an effective and impactful opportunity to enhance well-being and community connectivity while prioritizing environmental responsibility.  

The lessons from our work at NBI demonstrate an opportunity: even the smallest green interventions can have an impact when envisioned and implemented strategically.  

Eric Galipo is the Director of Strategic Planning and Design and an Associate at FCA. 

The post Pocket Gardens Provide Sustainability at Scale Across Healthcare Campuses appeared first on HCO News.

The post Pocket Gardens Provide Sustainability at Scale Across Healthcare Campuses appeared first on HCO News.

Join Mark Topley and Gagan Kumar on 8 July at 7pm as they discuss how to step back with confidence for a practice that runs without you.

This webinar will show practice owners and principals what it actually takes to build a practice that doesn’t depend on them sitting in the middle of every decision, standard and patient conversation. The session covers two halves of the same picture: the team structure that gets people taking real responsibility, and the mindset, communication and revenue thinking that lets the principal step out of the middle without the numbers slipping. The aim is to give attendees a clear, honest read of where their own practice sits today, and a sensible first step if they want to change it.

Learning outcomes

• Understand why most ‘team problems’ are really clarity, structure or confidence problems – and what to do about each
• Learn the three things that turn a busy practice into one that runs without the principal in the middle: purpose, clarity and rhythm
• Discover where revenue quietly leaks when the principal is the only person who can hold a high-stakes patient conversation
• Build communication, conversion and ownership across the whole team, so the numbers aren’t carried on one set of shoulders
• Consider what the shift from doing to leading actually asks of the principal – and how to make it stick.

The speakers

Mark Topley

Mark Topley is a leadership and team performance consultant who works with dental practice owners and their teams on the structures that get people taking responsibility, delivering to a consistent standard, and being a pleasure to work with. He has more than 25 years in the dental industry, has been a judge for the Private Dentistry Awards for over a decade, and speaks regularly for organisations including Portman Dentex, the BDIA, the BDA, the Dentistry Show and FDI World Dental. He writes and consults under the brand Exceptional Team Performance.

Gagan Kumar

Gagan Kumar is an international business coach and the founder of Limitless Coach, where he works with principal dentists, aesthetic clinics and other service-based businesses on the shift from operator to leader. He has more than 20 years of experience advising established businesses across healthcare, hospitality and education, and built his own companies from the ground up before moving into coaching. His work combines practical strategy, operations and ethical sales with the mindset and identity work that makes those changes stick – helping clients build the kind of revenue, freedom and leadership that doesn’t depend on them being in the middle of everything.

Catch up on previous on-demand webinars:

• ‘I need an implant mentor!’ Everything you need to know
• Your waiting list isn’t the problem. Your triage is
• Finishing your orthodontic cases: essential tips for anterior composites
• Advancing vital pulp therapy: clinical applications and predictable outcomes using MTA vpt
• From enquiry to treatment start: the patient journey most practices have never mapped.

You can sign up for the webinar here.

The study, by a team at University College Dublin and services firm APC, examined the manufacturing systems used to make the recombinant adeno-associated viruses (rAAVs) on which many gene therapies rely.

And the key finding is that not one of the eight commercial cell lines used to date—including the most widely-used line, HEK293—is ideal.

Lead author, James Conheady, from APC, tells GEN, “Current rAAV production methods using existing cell lines struggle to meet clinical demands, contributing to the expensive price-tag associated with rAAV-based gene therapies.

“Novel cell lines may be able to produce rAAVs at higher yields and/or with improved quality, which ultimately could help make these therapies more accessible to the people who need them.”

Shortcomings

To date, eight different host cell systems have been used to produce rAAVs, with each having strengths and weaknesses.

For example, some cell lines generate rAAV capsids that do not contain the desired genetic material. These empty vectors are a problem because they generate an immune response without providing a therapeutic effect.

Other cell lines struggle to make enough capsids. For example, the recommended dose for systemically delivered gene therapies is upwards of 1 × 10¹⁴ vg/kg of a patient’s bodyweight. The yield per production run for HEK293 cells is only around 10¹⁰.

Cost is another issue.

According to Conheady and co-authors, the GMP-grade plasmids and transfection reagents used to modify cell lines such that the vectors they produce contain the genes of interest account for a significant proportion of the price of the resulting therapies.

Alternative systems

Given these shortcomings, it is no surprise that the search for more effective alternative hosts is already underway.

Conheady says, “At the end of the day, rAAV manufacturers are all looking for the same things from their upstream process—high titers, improved full/empty ratios, and transduction rates.”

Current cell line development efforts are focused on combining desirable traits, Conheady adds, with characteristics such as resistance to apoptosis, diminished antiviral immune response, and secretion profiles being among the most sought after.

“Many of the traits identified in this review are aligned with modifications that have been shown to be beneficial in the context of rAAV production in HEK293 cells. For example, secretion of vector particles from the cell into the production medium can greatly simplify downstream operations and can be influenced by knocking out genes involved in endosomal trafficking.

“The ideal cell line should also be resistant to transfection and virus-induced apoptosis, to produce significant vector quantities. Knockout of the pro-apoptotic BAX and BAK1 genes has been shown to improve vector yields,” he says.

Whether industry will ever see these efforts pay off and agree on the “ideal” cell line remains to be seen, according to Conheady.

“Manufacturers will require significant grounds to agree on a standardized approach, a novel cell line may need to vastly outperform all others in relation to yield and quality characteristics—as the saying goes, ‘you stick with what you have until you have better’.”

The post Trait Combining Key to More Effective Vector Production Hosts appeared first on GEN - Genetic Engineering and Biotechnology News.

To close the gap, Manus, a next-gen industrial biotechnology company, and BioMADE have developed an apprenticeship program that can become a blueprint for other companies to develop their own training. “The program can be scaled so development for other [companies] can be faster, down the road,” says Maren Wehrs, PhD, program manager at BioMADE.

“We are trying to build a fairly comprehensive training program that spans fermentation operations as well as downstream purification,” Christine Santos, PhD, CTO, Manus, tells GEN.

Focus: Hands-on learning

“It’s focused on hands-on experiential learning,” Santos continues, “with an extensive curriculum that will include deep dives on the practical aspects of running the equipment, such as so sterilization, safety, contamination control, process monitoring, and analytics. It will also delve into some of the technical aspects, like scale-up principles, as well as decision-making, problem-solving, teamwork, and communications.”

The work occurs at a Manus pilot facility in Augusta, GA. The first cohort starts in July and completes at year’s end, with another cohort beginning in January. After 18 months, “We hope to have a blueprint for an apprenticeship program that could be deployed at any other facility,” Santos says, including new BioMADE pilot facilities or those of other companies.

“We would offer access to the curriculum and the blueprint for [others] to deploy. We’ve spent the past few months formalizing the curriculum,” Santos says. It was developed with input from the University of Georgia, but apprentices needn’t be enrolled in a university program to participate.

Manus’ interest in apprenticeships stems from its 2018 acquisition of a decommissioned NutraSweet manufacturing facility in Augusta for its cell factories and bioprocesses.

“We had the task of recommissioning the facility and rebuilding the workforce to operate it,” Santos recounts. “We were able to rehire some of the NutraSweet employees [and regain their institutional knowledge], but to build out further, we had a huge challenge finding workers who were trained for biomanufacturing operations. We had to invest in a lot of hands-on training.”

This program is one of a few offered directly by a biomanufacturer. More commonly, companies participate in workforce training consortia to develop potential manufacturing workers.

The post Blueprint to Fill the Manufacturing Talent Gap appeared first on GEN - Genetic Engineering and Biotechnology News.

That’s the topic of a talk by Kok-Seong Lim, PhD, a pharmaceutical leader in CMC development, at the Bioprocessing Summit in Boston.

“Baby KJ was the first proof that individualized gene editing therapy was doable, and, at the same time, in the background, there are manufacturing platforms now being set up that maybe we’re not hearing so much about in the media,” he says.

According to Lim, manufacturers seeking to develop standardized platforms for personalized CRISPR gene-editing therapies using liquid nanoparticles (LNP), the same technology used for Baby KJ, will need to “lock in” their lipid formulation they’re going to use for future manufacturing, which may vary depending on the target organ and therapeutic indication.

After selecting their raw materials, they will also need to lock in their manufacturing process parameters, such as the microfluidic mixing conditions and lipid compositions. Likewise, he says, although the target gene may need to be customized for different patients, certain core components, such as the mRNA encoding the CRISPR-Cas enzyme, could remain unchanged across multiple patients.

This type of standardization may help establish a more scalable and reproducible manufacturing platform for personalized gene-editing therapies, he believes.

Going forward, Lim says, eventually companies may need to look at standardizing their regulatory CMC data package for regulatory filing, such as determining the appropriate extent of their impurity profiling and the overall scope of stability studies.

“Impurity profiling may not need to be as extensive for individualized and personalized treatments because they’re manufactured for a single patient only and the stability requirements may only need to support the timeframe needed for the patient’s treatment,” he says.

Lim adds that the Innovative Genomics Institute (IGI), Penn Medicine, and their collaborators, who treated Baby KJ, are currently working toward clinical trials to treat the next group of patients, but details of the specific LNP configurations for each future patient have not been disclosed.

As well as talking about LNPs, Lim will also discuss AAV technology for personalized CRISPR gene-editing therapies. The technology, he explains, is less popular within the industry than LNPs, due to concerns about potential toxicity, side effects, and manufacturing complexity, but it still merits consideration as a platform technology when it delivers patient benefits.

The post Standardizing Personalized CRISPR Gene-Editing Therapies appeared first on GEN - Genetic Engineering and Biotechnology News.

Speaking about the industry’s biggest challenges, Seyf describes poor data management as the “elephant in the room,” arguing that too much crucial information remains trapped in paper records, spreadsheets, and isolated systems.

“Everybody wants to have AI,” Seyf says. “But where do you have your data? If it’s in binders, there’s not much you can do.”

According to Seyf, the path toward more efficient manufacturing, stronger clinical outcomes, and meaningful AI applications begins with digitizing information from the earliest stages of research. He believes many organizations make the mistake of waiting until their science is mature before investing in digital infrastructure. “The sooner you start, the better it is,” he says. “Pen and paper do not prevail, and pen and paper do not transfer.”

Seyf argues that the consequences extend far beyond operational inefficiencies. When data remain inaccessible or fragmented, researchers lose opportunities to learn from past experiments, identify patterns, and accelerate scientific discovery. He stresses that the industry must become more willing to share non-commercially sensitive knowledge, particularly in areas such as rare diseases and advanced therapies, where patient populations are limited. “We are all here to serve patients,” he says. “Protect your intellectual property, but also share the learnings.”

One of his strongest criticisms is directed at the scientific community’s tendency to focus almost exclusively on successful outcomes. Seyf believes failed studies and unsuccessful trials often contain lessons that could prevent others from repeating the same mistakes. “A lot of publications want to publicize only the good news,” he says. “That’s fundamentally wrong. We need to learn from failures.”

To illustrate his point, Seyf compares the biotechnology sector with the aviation industry. Modern airlines routinely share information about incidents and technical problems to prevent future accidents, creating a culture of collective learning and safety. “If something goes wrong, everybody in the world knows about it and knows how it was managed,” he says. “We are also dealing with people’s lives. The only way for us to improve is to share.”

Seyf also highlights the growing role of AI in healthcare. Although consumer AI systems have benefited from vast amounts of publicly available information, healthcare still operates with a relatively small pool of accessible data, he says. Expanding that foundation, he argues, could unlock major advances in diagnosis, drug development, and personalized medicine. “Imagine what we could do,” he says. “The progression of science is unlimited.”

For commercial bioprocessors, his recommendation is straightforward: digitize from day one. Capturing research, development, manufacturing, and clinical data in digital formats not only improves collaboration but also preserves institutional knowledge when employees move on. “Every time a scientist leaves, the knowledge goes with them,” Seyf says. “But when it is digital, the knowledge stays with the company.”

As cell and gene therapies continue to evolve, Seyf believes the industry faces a choice. It can continue operating in silos, or it can embrace transparency, digitalization, and collaboration to speed innovation and deliver better outcomes for patients. “The reason humanity has progressed,” he says, “is because we shared.”

The post Digitize or Fall Behind appeared first on GEN - Genetic Engineering and Biotechnology News.

On May 29, the Office of Management and Budget (OMB) proposed sweeping changes to the rules governing all federal grant funding.

If finalized, this rule would fundamentally reshape how biomedical research, including endocrine science, is funded in the U.S. The proposed rule would give political appointees the power to block grant awards that do not align with current administration priorities, allow federal agencies to terminate grants at any time without a formal appeals process, and impose restrictions on publication costs and international collaborations, among other disruptions. Taken together, the proposed rule directly threatens the foundational principles of merit-based science.

The OMB is seeking to implement its proposed changes this year, and the Endocrine Society is opposing the rule, calling for its withdrawal, and urging Congress to intervene.

The proposed rule would give political appointees the power to block grant awards that do not align with current administration priorities, allow federal agencies to terminate grants at any time without a formal appeals process, and impose restrictions on publication costs and international collaborations, among other disruptions.

There are three ways you can make a difference:

• Contact Congress: Your representative and senators need to hear from you about the threat to research posed by the proposed rule. The Endocrine Society has created a new advocacy campaign where you can send a message to your elected representatives urging them to intervene and protect federal research funding. This is the quickest and most effective way to make an impact now.
   
• Submit Comments to Regulations.gov: Comments submitted to regulations.gov will have an impact as part of the public record. Substantive, original, and specific comments carry real weight in the rulemaking process, but it is critical that you personalize your submission. The Endocrine Society has prepared detailed guidance to help you submit a comment before the Monday, July 13 deadline.
   
• Join Our Virtual Hill Day this Summer: We are organizing virtual meetings for our members and their Representative & Senators to give you the opportunity to share how federal research funding has advanced endocrine health and patient care—and what is at stake if this rule is finalized. Training and talking points will be provided. If you are interested in participating, please contact advocacy@endocrine.org.

We have developed comments on behalf of the Society urging the withdrawal of the rule but it is also essential that policymakers hear from you — the scientific and medical professional community.

INSULIN Act Gains Momentum; Society Leads Effort to Urge Senate HELP Committee to Advance the Legislation

Increasing access to affordable insulin is a top policy priority of the Endocrine Society and we continue to urge Congress to pass the INSULIN Act, bipartisan legislation that would cap out-of-pocket costs for insulin at $35 a month for people with private insurance and create a pilot program for the uninsured in 10 states. Although the likelihood for passing the INSULIN Act this year originally was small, our advocacy is helping build momentum for the legislation in the Senate and now there are 28 bipartisan senators supporting the legislation introduced by Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME).

The Society will continue working with the bipartisan co-chairs of the Senate Diabetes Caucus to pass the legislation out of the HELP Committee this summer.

Last week, the Senate Health, Education, Labor, and Pensions (HELP) Committee considered several pieces of health-related legislation. Prior to the markup, the Endocrine Society sent a letter to the HELP Committee urging the committee to consider and pass the INSULIN Act. The Society developed the letter and invited other diabetes advocacy organizations to sign. As a result of increasing interest in insulin affordability, Senator Bernie Sanders (I-VT) introduced an amendment that would have added the INSULIN Act to another bill under consideration. Although the Sanders amendment was approved by the HELP Committee in a bipartisan vote, Senator Bill Cassidy (R-LA), Chairman of the Senate HELP Committee, canceled a final vote on the overall bill, saying he needed more information about the cost of the legislation. Chairman Cassidy indicated that he is open to considering the legislation at a future markup in July.

The Society will continue working with the bipartisan co-chairs of the Senate Diabetes Caucus to pass the legislation out of the HELP Committee this summer. We urge all Endocrine Society members to take action through our online advocacy campaign and ask your Senators to cosponsor and pass the INSULIN Act. 

Medicare Bridge Program To Expand Access to GLP-1 Medications Launches July 1

On July 1, the Centers for Medicare and Medicaid Services (CMS) will launch the Medicare Bridge Program to provide eligible Medicare Part D beneficiaries with access to certain GLP-1 medications for weight loss for a $50 co-pay. To qualify for the program, Medicare beneficiaries must meet certain clinical criteria, and the provider must submit a prior authorization request attesting that the beneficiary has met these criteria. More information about the Bridge Program, including the clinical criteria, information on submitting a prior authorization request, and other FAQs for providers can be found on the CMS website. 

The Endocrine Society has urged Congress and the Administration to expand access to GLP-1 medications for people living with obesity, and we are pleased that CMS is initiating this program. We will continue to provide information as the Bridge Program is implemented in the coming months. We will also share additional educational information about the Bridge Program during our advocacy session to be held at the Clinical Endocrinology Update (CEU) meeting later this year.

The post Advocacy Update: July 2026 appeared first on Endocrine News.

I’m grateful the Endocrine Society provides many different communications channels to generate useful and practical knowledge on every aspect of endocrine science and care. I’d like to highlight some of them.

Endocrine News

The Society’s longstanding magazine has been a pilar of our field, not only for sharing the latest research and best clinical practices, but for highlighting the achievements of our members and featuring our organization’s many products and services. The publication is marking a milestone this summer as it fully transitions to online-only. As the Executive Editor Mark A. Newman notes, the greatest strength of the magazine “is its access to amazing Endocrine Society members.”

EndoForum

This unique communications and networking platform is designed exclusively for our members. In EndoForum, you can find the latest information and alerts on upcoming Society meetings and events, as well as connect with members from around the world. This networking is achieved through several online discussion channels, including the “Discussions” section, where members regularly pose clinical questions to their peers, and the “Groups” section, where our 12 Special Interest Groups (SIGs) gather. By joining a SIG, you can communicate with colleagues who share your same interests and passions.

Endocrine eNews

Delivered to your inbox each week, Endocrine eNews provides a quick-read, executive summary of the Society’s many activities, including awards, webinars, meetings, advocacy, podcasts, and featured research. The newsletter also provides timely reminders about such things as membership renewal deadlines, and store offerings.

Endocrine Briefing

Our unique e-newsletter uses artificial intelligence (AI) to bring you the latest endocrine research and practice headlines in a way that’s personalized for your specific interests. As you click on stories that interest you, the platform uses that data to select related content for future issues tailored specifically for you.

Endocrine Signals

Our Society blog takes a monthly deep dive into the inner workings of the organization. Here you will find stories from Society team members who head up advocacy, education, meetings, publications, clinical practice guidelines, membership, awards, and more.

Society Website

Certainly not to be overlooked is the Society’s website itself. I invite you to visit this site often, where you’ll find the full breadth and depth of our organization’s activities and programs. The homepage and Latest sections offer a quick view of the latest happenings. Our Society Calendar provides a view of Society events, as well as events throughout our field. The Our Community tab provides a pathway to member-oriented content, including more on the SIGs and career development programs. The Advancing Research tab allows scientists to quickly pursue our offerings, including fellowship programs, research grant opportunities, and scientific statements. The Improving Practice tab leads to sections on our Clinical Practice Guidelines, education, and training. And our Advocacy tab features a wealth of information on campaigns, letters, testimony, and position statements. This is just the tip of the iceberg.

But not every communications channel involves words on paper or screen. The Society in recent years has taken major steps to boost its presence in podcasting and video.

Endocrine Feedback Loop Podcast

This monthly journal club podcast is a must-listen for members who want to hear an in-depth discussion on recently published research. Each episode features an expert educator and a topical specialist dissecting recently published journal articles and discussing implications for clinical practice. Recent episodes included topics on infrequent zoledronate in low fracture risk, taste changes with semaglutide, and dosing strategies for remission in Graves’ disease.

Endocrine News Podcast 

Our membership podcast casts a similarly wide net, focusing on the latest research and clinical advances from experts in the field. Recent episodes include discussions on the SABRE Project and its significant impact on osteoporosis clinical trials and addressing the endocrine workforce shortage.

Endocrine Society’s YouTube Channel

This is another excellent communications vehicle for members who prefer to consume visual media. On the YouTube channel, you can hear — and see — our members discuss a wide range of topics, including previews of upcoming meetings and summaries of published research.

Social Media

The Society curates a lively conversation about endocrine topics on major social media platforms. Here you can get the latest information about the organization’s programs, initiatives, and members, and weigh in with your own thoughts. Our platforms are:

• X (formerly Twitter)
• Facebook
• Instagram
• LinkedIn
• BlueSky

Through these channels and more, the Society aims to keep you armed with the latest knowledge that will help you achieve your professional and personal goals. What you’re reading now, in fact, is a perfect example of the Society’s aim to keep you well informed. I look forward to sharing more knowledge in this letter over the coming 12 months.

The post Society Offers Many Ways for Members to Stay Informed and Make Connections appeared first on Endocrine News.

For dentists getting started in implant dentistry, supervised clinical experience can teach what textbooks cannot – Patric Aria Saraby shares his insights.

When I enrolled on my implant master’s programme, I knew there would be a steep learning curve. However, nothing prepares you for placing multiple implants over consecutive days in a busy setting.

Earlier this year, I joined a dental mission in Fortaleza, Brazil, at ICEO, where I had the opportunity to place 20 implants under the supervision of experienced implant surgeons. Although I had spent countless hours studying CBCTs, drilling protocols and prosthetic principles, the clinical experience taught me lessons that textbooks simply cannot.

These are the five lessons that changed the way I think about implant dentistry.

1. Implant placement is far more about soft tissue than drilling bone

Before my first case, I was focused almost entirely on the osteotomy.

• Implant diameter
• Implant length
• Insertion torque
• Primary stability.

What surprised me was how much of the procedure depended on flap management.

A poorly reflected flap immediately reduces visibility, increases tension and makes every subsequent step more difficult. Conversely, a well-designed full-thickness flap with careful tissue handling transforms the surgery.

I quickly realised that experienced implant surgeons often appear ‘fast’ not because they drill quickly, but because they manage soft tissue exceptionally well.

The implant is only one part of the surgery, the flap determines how smoothly everything else proceeds.

2. Bone has a personality

On paper, drilling protocols look identical. In reality, every patient feels completely different.

Some osteotomies almost guide the drill naturally. Others require constant tactile feedback.

The difference between dense cortical bone and softer cancellous bone becomes obvious within seconds.

One of the biggest surprises was learning to trust tactile sensation rather than relying solely on depth markings or drilling sequences.

Primary stability isn’t simply measured by insertion torque, it’s something you begin to feel. That tactile confidence only develops through repeated clinical exposure.

3. Guided surgery cannot replace surgical judgement

Planning software is remarkable. CBCT planning allows accurate implant positioning before the patient even enters the surgery.

However, once the flap is reflected, reality doesn’t always match the virtual plan.

Bone contours vary. Extraction sockets appear different. Soft tissue thickness changes perception.

The surgical guide remains valuable, but it is exactly that – a guide.

Clinical judgement is still essential for deciding whether small adjustments are necessary while maintaining restorative principles.

The digital workflow enhances decision-making; it doesn’t replace it.

4. Grafting is not the difficult part – knowing when to graft is

Before the mission, bone grafting seemed intimidating.

Mixing particulate graft, placing collagen membranes and stabilising the material looked technically demanding.

In practice, the mechanics are relatively straightforward.

The real challenge is recognising when grafting is required and understanding what outcome you’re trying to achieve.

Sometimes the objective is contour preservation. Sometimes it’s filling a dehiscence. While sometimes it’s simply protecting exposed implant threads.

The indication is far more important than the technique itself.

5. Implant dentistry is a team sport

One of the biggest lessons had nothing to do with implants.

Watching experienced surgeons work alongside assistants, nurses and mentors highlighted how much good implant dentistry depends on teamwork.

The assistant anticipates every instrument, the supervisor notices details you have missed, and the nursing team maintains efficiency throughout the procedure.

As the operator, you remain responsible for every decision, but successful implant surgery is rarely an individual achievement.

Learning from clinicians with decades of experience accelerated my own learning far more than practising in isolation ever could.

Final thoughts

Leaving Fortaleza, I realised I hadn’t simply placed 20 implants.

I had learned to respect the complexity of implant surgery.

The experience reinforced that implant dentistry is not about placing fixtures into bone, it is about careful planning, precise execution, biological understanding and continual learning.

Perhaps the biggest lesson was also the simplest.

The more implants I placed, the more I appreciated how much there is still to learn.

That, in my view, is exactly what makes implant dentistry such a rewarding career.

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

For many IMGs, the idea sounds almost too good to be true. After years of hearing that repeating residency in the United States was essentially unavoidable, several states have now introduced alternative licensing pathways that appear to allow some internationally trained physicians to practice medicine without completing a traditional U.S. residency program.

Naturally, this has created excitement, confusion, misinformation, and a lot of unrealistic expectations.

The short answer is yes, some states are now creating pathways that may allow certain experienced international physicians to practice without repeating U.S. residency training. But the longer answer is much more complicated, and that nuance is where many applicants misunderstand what these laws actually mean. (Niskanen Center)

What Has Recently Changed?

In response to worsening physician shortages, especially in rural and underserved areas, more than a third of U.S. states have either enacted or explored alternative licensure pathways for internationally trained physicians (ITPs) and IMGs. (Niskanen Center)

Traditionally, the pathway for IMGs in the United States has been extremely rigid. Regardless of prior experience abroad, physicians generally needed to complete the following steps:

• ECFMG certification
• USMLE exams
• Matching into a U.S. residency
• Completing residency training in the U.S. or Canada
• Obtaining board certification and full licensure afterward

The residency bottleneck has long been one of the biggest barriers. In 2025 alone, over 47,000 applicants competed for approximately 37,000 first-year residency positions. Match rates for IMGs remained significantly lower than those for U.S. MD and DO seniors. (Niskanen Center)

As a result, states facing physician shortages began exploring whether experienced doctors trained abroad could safely practice under supervised or provisional pathways instead of repeating years of residency training they may have already completed overseas.

What These New Laws Actually Allow

This is where the biggest misconception happens.

These laws generally do not mean that anyone with a foreign medical degree can suddenly start independently practicing medicine in the United States next month.

Most of the newer pathways are designed for physicians who already completed residency training abroad, practiced independently in another country for several years, passed licensing exams, and can demonstrate recent clinical experience. (Niskanen Center)

In many states, applicants still need:

• ECFMG certification
• USMLE Step completion (often all three step exams)
• Proof of postgraduate training abroad
• Active or recent clinical practice
• Sponsorship from a healthcare employer
• Supervised or provisional practice periods

In other words, these laws are usually not bypassing physician competency standards. They are mainly bypassing the requirement to repeat an entire U.S. residency program from the beginning. (Niskanen Center)

That distinction matters enormously. The Biggest Misunderstanding: These Are Often Provisional Pathways One of the biggest pitfalls IMGs fall into is assuming these are immediate full-license opportunities.

In reality, many states use a provisional or supervised licensing model first. Physicians may initially work under supervision at approved healthcare systems or sponsoring employers before becoming eligible for unrestricted licensure later. (Niskanen Center)

Some states also limit practice settings to underserved communities, rural hospitals, academic systems, or specific facilities. This means these pathways often function more like a monitored transition period rather than an instant independent attending role. For some physicians, that may still be an excellent opportunity. But it is important to understand that the details vary significantly by state.

State Requirements Are Not Uniform

Another major source of confusion is that there is no single national IMG alternative pathway. Every state has different eligibility rules, timelines, supervision requirements, and definitions of acceptable foreign training. (Niskanen Center)

Some states require several years of independent practice abroad. Others focus more heavily on residency equivalency. Some allow eventual conversion to unrestricted licensure, while others only offer temporary or limited licenses.

For example, some states emphasize recent clinical practice, while others are stricter about how similar foreign residency programs must be compared to U.S. training standards. (Niskanen Center). This means that a physician who qualifies in one state may not qualify in another. 

One of the biggest mistakes IMGs make is reading headlines or social media summaries without reviewing the actual medical board requirements for the state they are interested in. It’s important to do the research and find out the important details. 

These Laws Mainly Target Experienced Physicians

Another important reality is that these pathways were largely designed for experienced international physicians, not necessarily newly graduated IMGs who have never practiced independently.

Many laws specifically focus on doctors who:

• Already completed residency abroad
• Have active licensure overseas
• Have recent years of clinical practice
• Can demonstrate ongoing competency

This is a critical distinction because many students or recent graduates interpret these laws as alternatives to residency matching altogether.

For newer graduates without significant independent clinical experience, traditional residency training may still remain the most realistic and stable path into U.S. medicine. And it’s important not to forget that this is an option. 

Physician Shortages Are Driving These Changes

The driving force behind these reforms is the growing physician shortage in the United States. Policymakers, hospitals, and advocacy groups increasingly argue that experienced international physicians are being underutilized while many communities struggle to access care. (Niskanen Center)

Some internationally trained physicians living in the U.S. currently work in research, administration, medical assistance, or non-clinical jobs despite years of prior physician experience abroad. Reform advocates argue that forcing all experienced foreign-trained doctors to repeat residency from scratch may unnecessarily waste medical talent. (Niskanen Center)

At the same time, critics raise concerns about standardization, patient safety, physician compensation, supervision quality, and long-term implementation challenges. (Reddit)

That debate is still evolving.

What IMGs Should Be Careful About

One of the biggest mistakes IMGs make right now is assuming these pathways are already fully functional and widely available.

In reality, implementation has been slower than many people expected. Some state medical boards are still developing regulations, reviewing credentialing systems, and determining how supervision and sponsorship structures will work. (Niskanen Center)

Just because a law was passed does not necessarily mean hospitals are already hiring large numbers of physicians through these pathways.

Another major issue is sponsorship. Many pathways require healthcare systems or employers willing to supervise and sponsor internationally trained physicians. Even if the law exists, finding an employer prepared to navigate the process may still be difficult. (Niskanen Center)

Visa issues also remain complicated. These laws do not automatically solve immigration barriers, work authorization issues, or sponsorship logistics. Some IMGs online have pointed out that visa sponsorship may still remain one of the biggest practical hurdles. (Reddit)

Does This Mean Residency Is Becoming “Optional”?

For most IMGs, the answer is still no. Traditional residency training remains the standard and most universally accepted pathway into U.S. medical practice. Completing residency in the United States still provides:

• Board eligibility
• Stronger employment flexibility
• Easier credentialing
• Fellowship access
• Greater geographic mobility
• More predictable long-term career options

Many of the newer pathways are still evolving, and long-term outcomes are not fully established yet. Some employers, insurers, and credentialing bodies may also treat these alternative pathways differently from traditional residency-trained physicians.

That does not mean these laws are unimportant. They absolutely represent one of the biggest changes in IMG policy discussions in years. But they are not replacing residency overnight.

Why So Much Misinformation Exists Online

Part of the confusion comes from how these laws are discussed online. Headlines often simplify the story into phrases like “practice medicine without residency,” which leaves out the important details about supervision, licensing restrictions, exams, sponsorship, and eligibility.

On forums and social media, some physicians are optimistic and see these laws as long-overdue reform. Others remain skeptical about whether hospitals, boards, insurers, and employers will fully embrace the pathways. (Reddit)

The truth likely falls somewhere in the middle. These laws are real, and they are expanding. But they are also new, variable, and still being implemented differently across states.

What IMGs Should Focus on Right Now

For most IMGs, the smartest approach right now is to stay informed without abandoning traditional planning.

Students and physicians should still prioritize:

• Passing USMLE exams
• Obtaining ECFMG certification
• Building strong clinical experience
• Understanding state-specific licensing rules
• Monitoring medical board updates directly
• Keeping residency applications as an option whenever possible

One of the biggest mistakes applicants make is assuming these pathways eliminate the need for preparation or competitiveness. In reality, many states still require strong credentials and documented clinical competence.

At the same time, experienced physicians who previously felt permanently locked out of U.S. medicine may now have additional opportunities worth exploring carefully.

The Bottom Line

The new 2025–2026 state laws do not mean residency suddenly disappeared in the United States. What they do mean is that some states are beginning to recognize that experienced international physicians may not always need to completely restart their training from the beginning.

Fill out the form below to receive your free Residency Application Timeline via email!



These pathways are best understood as carefully supervised alternative licensure models, not shortcuts into unrestricted medical practice for inexperienced physicians.

For some internationally trained physicians, especially those with extensive prior experience abroad, these laws could become meaningful opportunities over the next several years. For others, traditional residency will likely remain the ideal and most stable route.

Either way, one thing is clear: the conversation around IMG licensing in the United States is changing rapidly, and these laws represent one of the most significant shifts in physician workforce policy in recent times.

The post Can You Practice Medicine in the U.S. Without Residency? What the New 2026 State Laws Actually Mean appeared first on Elite Medical Prep.

Three individuals allegedly bought expired medicines at scrap prices, relabelled them with professionally printed stickers, repackaged them, and pumped them back into the pharmaceutical supply chain. This incident is a stark reminder that expired medicines are not merely a regulatory concern—they are a patient safety hazard. Yet, barely a week later, the Ministry of Health and Family Welfare (MoHFW) proposed making it easier to import medicines much closer to their expiry dates.

The timing could not have posed a more uncomfortable question: can a pharmaceutical supply chain already struggling to keep expired medicines off pharmacy shelves safely accommodate medicines entering the country with substantially less shelf life remaining?

Parsing the proposal

On 22 June 2026, the MoHFW published draft amendments to Rule 31 of the Drugs Rules, 1945,(1) replacing the existing requirement that imported drugs retain at least 60 per cent of their total shelf life with a flat requirement of 12 months’ residual shelf life. Under the current regime, a medicine with a total shelf life of 36 months can be imported only if approximately 21.6 months remain before expiry. The government argues that the proposed change would reduce wastage, improve the availability of medicines, simplify customs compliance, and promote ease of doing business by aligning India more closely with international supply chains.(2)

Those objectives are legitimate. But they rest on an assumption that India’s pharmaceutical supply chain functions efficiently enough for medicines with shorter remaining shelf lives to safely reach patients. That assumption merits closer examination.

One size does not fit all

The draft notification identifies reduced wastage and improved availability as its objectives but does not quantify the extent to which the existing 60 per cent rule has constrained imports or affected medicine availability.

The amendment exempts biological products and radiopharmaceuticals, and rightly so. Biologicals are temperature-sensitive and have variable shelf lives, while radiopharmaceuticals are susceptible to radioactive decay and may have shelf lives ranging from only a few hours to a few days.

Notably, many medicines with similarly short or unstable shelf lives are conspicuously absent from the list of exceptions. These include allergen extracts used for diagnostic testing and immunotherapy, which may have total shelf lives of only 9–18 months;(3) certain enzyme preparations with comparatively short stability periods;(4) and other biologically derived products that may lose potency much earlier than conventional medicines.

The proposed change also overlooks the slow turnover of inventory movement in India. Transportation of imported medicines from foreign manufacturers typically takes 3–15 days by air and up to 2–4 weeks by sea. Customs clearance and regulatory verification by drug control authorities may take another week. Thereafter, medicines are stored in warehouses and distributed through wholesalers over a period of six to eight weeks before finally reaching hospitals or retail pharmacies, where dispensing depends on patient demand. A medicine imported with only twelve months of residual shelf life may therefore reach a patient with less than eight months remaining before expiry. In slower-moving supply chains, particularly in smaller towns, rural markets, or low-demand therapeutic categories, medicines may reach consumers when they are already close to expiry—or even after becoming expired.

Perils of post-dated pills

Twenty-six years ago, the People’s Union for Civil Liberties filed a complaint against the Gobind Ballabh Pant Hospital, alleging that doctors administered expired medicines to patients, resulting in 26 deaths.(5) An expert committee subsequently found serious lapses on the part of the hospital administration.

This is not merely a story of the past. In June this year, an 11-year-old girl in Talabaruda village in Odisha’s Banspal block allegedly died after consuming an expired medicine obtained from an Auxiliary Nurse Midwifery Centre to treat fever. In another reported case from February 2026, a six-month-old infant died in Hyderabad suspectedly after consuming an expired medicine.

These incidents reflect a broader reality. Medicine users are often not vigilant about checking expiry dates. An empirical study conducted in rural Tamil Nadu found that approximately 30–60 per cent of consumers did not check the expiry dates of medicines before use.(6)

Time to regulate based on realities

Expired medicines may not merely result in reduced therapeutic efficacy. Many undergo significant degradation and changes in chemical composition over time. In time-sensitive conditions or among vulnerable patients, diminished efficacy alone can have serious clinical consequences. In other critical therapies, the use of expired medicines may also result in serious adverse health outcomes.

Ease of doing business is an important regulatory objective. But medicines are not ordinary consumer goods. Patients consume them with the expectation that they will be safe, effective and capable of treating illness. They must therefore retain their therapeutic quality throughout the supply chain.

India cannot afford to facilitate the circulation of near-expiry medicines when supply chains remain lengthy, consumer awareness of expiry dates is limited, and unscrupulous actors continue to exploit expired medicines for profit.

A more balanced regulatory approach would classify medicines according to their stability profiles, therapeutic risks and supply-chain realities rather than replacing one uniform rule with another.

While regulators deliberate on the proposed amendments and stakeholders submit their comments, the central question remains: what deserves pride of place on India’s pharmaceutical policy shelf—ease of doing business or patient safety?

Endnotes

1. Ministry of Health and Family Welfare, Government of India. Draft Notification: Amendment to Rule 31 of the Drugs Rules, 1945. Gazette of India (Extraordinary), 22 June 2026. Available at: https://egazette.gov.in/WriteReadData/2026/273833.pdf.

2. Press Information Bureau, Government of India. “Draft Amendment to Rule 31 of the Drugs Rules, 1945.” Ministry of Health and Family Welfare. Available at: https://www.pib.gov.in/PressReleasePage.aspx?PRID=2278097®=48&lang=1.

3. Cox LS, et al. “Allergen Immunotherapy: A Practice Parameter Third Update.” Journal of Allergy and Clinical Immunology, 2011. Available at: https://www.jacionline.org/article/S0091-6749(10)01566-6/fulltext.

4. Feller G. “Stability and Stabilization of Enzymes.” Advances in Enzymology and Related Areas of Molecular Biology, Vol. 67, 1993. Available at: https://www.sciencedirect.com/science/article/pii/000326709385082U.

5. Ferner RE. “Expired Medicines.” BMJ. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC1118495/.

6. Suresh K., et al. “Consumer Awareness Regarding Expiry Dates of Medicines: A Rural Tamil Nadu Study.” Journal of Family Medicine and Primary Care. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11512748/.

The post What stays on the top of pharma shelf—ease of doing business or patient safety? appeared first on Express Pharma.

Mankind Pharma has announced a strategic collaboration with Denovo Sciences to launch an AI-led drug discovery programme, marking an important step in the company’s focus on innovation-driven and technology-enabled research and development.

The partnership will bring together Mankind Pharma’s strong R&D capabilities, experimental validation infrastructure, and clinical development expertise with Denovo Sciences’ proprietary platform for AI-driven molecular generation and prioritization. Together, both organisations will work under a human-in-the-loop model, where AI generates and evaluates molecular candidates while scientific experts guide, validate, and refine the results at every stage.

The collaboration is focused on three key goals: reducing early drug discovery timelines, improving the quality of lead candidates, and ensuring that only candidates with the strongest development potential move ahead. By using computational precision in the early stages of discovery, both partners aim to reduce the time and resources spent on candidates that may not succeed later. The long-term goal, as highlighted by both organisations, is to benefit patients. Faster discovery cycles and better candidate selection can help bring differentiated, effective, and accessible therapies to patients sooner.

“Drug discovery has always been a long and uncertain journey, and that uncertainty has real consequences for patients. Our collaboration with Denovo Sciences is about using the best available technology to make this journey faster and more precise. AI gives us the ability to explore a much larger molecular space than traditional methods, while the human-in-the-loop model ensures that scientific rigour remains central to every decision. This is the kind of R&D investment we believe will shape Mankind Pharma’s next chapter,” said Arjun Juneja, COO, Mankind Pharma.

“Artificial intelligence is significantly accelerating drug discovery timelines, particularly through emerging tools in generative chemistry, modular antibody design, and process optimization across the preclinical as well as clinical development value chain. Our entry into AI-driven drug discovery will position Mankind as one of India’s leading innovations-focused pharmaceutical companies,” said Dr Anil Koul, who leads innovation as company Group CSO.

“Partnering with Mankind Pharma is a natural fit for what we have built at Denovo Sciences. Our platform is designed to work alongside experienced drug discovery experts to generate better candidates, faster. Mankind Pharma brings deep R&D expertise and a strong commitment to making medicines more accessible. Together, we are using our proprietary AI technologies where they can create the greatest impact at the earliest stage of the discovery process, where the right decisions save the most time,” said Hovakim Zakaryan, CEO, Denovo Sciences.

For Mankind Pharma, this collaboration reflects a clear move beyond traditional drug discovery methods. The company has been expanding its R&D ambitions in recent years, and the partnership with Denovo Sciences represents its strongest step yet towards using AI as a core tool in the drug development process.

For Denovo Sciences, this collaboration represents a significant step in applying its proprietary technologies at scale with a leading pharmaceutical partner. It also supports Denovo Sciences’ broader goal of translating AI technologies into better drug candidates that can ultimately benefit patients.

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Cadila Pharmaceuticals, one of India’s leading integrated pharmaceutical companies, and Wellesta Holdings, Singapore, have signed a Memorandum of Understanding (MoU) to establish a strategic Joint Venture aimed at expanding access to high-quality healthcare solutions across South-East Asia and selected international markets. The partnership brings together the complementary strengths of both organisations. 

Cadila Pharmaceuticals contributes its extensive capabilities in research & development, manufacturing, regulatory compliance, and a diversified portfolio spanning prescription medicines, consumer healthcare products, and specialty therapies. With decades of pharmaceutical expertise and a strong vertically integrated business model, Cadila has established itself as a trusted healthcare partner across multiple global markets. 

Wellesta Holdings, headquartered in Singapore, is a fast-growing healthcare and pharmaceutical commercialization company with a strong presence across South-East Asia and other international markets. Through its established front-end infrastructure, market access capabilities, regulatory expertise, distribution network, and experienced commercial teams, Wellesta has successfully built and managed numerous healthcare partnerships across the region.

The proposed Joint Venture will focus on identifying and commercializing high-potential pharmaceutical and healthcare products, leveraging Cadila’s innovation and manufacturing excellence together with Wellesta’s market reach and commercialization strengths. The collaboration is expected to strengthen Cadila’s presence in key growth markets while enhancing Wellesta’s portfolio with differentiated and high-quality healthcare solutions.

The Joint Venture is envisioned as a strategic growth engine to expand business across South-East Asia, the Middle East, Africa, and other emerging markets. By combining Cadila’s product development and supply capabilities with Wellesta’s strong regional commercial footprint, the partnership aims to build a significant healthcare business over the coming years.

This collaboration reflects the shared commitment of both companies to improving healthcare outcomes through innovation, quality, and market excellence, while creating lasting value for patients, healthcare professionals, partners, and stakeholders.

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Roche today announced its second Digital Tech Hub in India, expanding its global Technology Hub network to Hyderabad alongside its existing site in Pune.  The new Tech Hub will be going live in the first quarter of 2027 and plans to scale up over the next few years.

“Hyderabad is a destination for an exceptional talent pool, especially for the Pharmaceutical and Life Sciences domain,” said Ramesh Durvasula,  Chief Data Officer and Chief AI Officer a.i.. “By tapping into India’s vibrant healthcare and technology  ecosystem,  we are creating scalable data-driven innovations to advance our core purpose of improving patient care.’’

On the development, Raja Jamalamadaka, Vice-President & Site Head, Roche Pune & Hyderabad Sites, shared; “Our investment in Hyderabad – a rapidly growing destination for research, technology and high-end innovations – reflects our long-term commitment to India and its ecosystem.” He further added: ”By scaling our footprint, we are enhancing our capability to orchestrate seamless, next-generation digital and technology solutions.”

The two Digital Technology Hubs in India will house teams delivering IT services and digital applications in areas such as Biostatistics, ERP, and Medical Safety. Hyderabad adds depth and capacity to the Life Sciences domain knowledge specifically tailored to accelerating the development of our digital solutions.

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The Dentistry Top 50 has returned once again – now we need you to nominate the best and brightest in the profession to help us compile the list.

Each year, the Top 50 highlights the individuals making the biggest impact across UK dentistry – from influential leaders and innovators to those driving meaningful change within the profession.

As in previous years, the Dentistry team will curate a list recognising the people who are shaping the dental profession in 2026. More than simply a ranking of influence, the Top 50 is intended to celebrate dedication, progress and the lasting contributions being made across the profession.

As part of this process, we encourage you to nominate anyone you feel deserves recognition. Using the form below, submit their name along with details of how they have made a difference to dentistry and why they should be considered for this year’s list.

This year, Denplan has offered its support to help the Dentistry Top 50 achieve its mission of celebrating dentistry’s brightest stars.

Matthew Nolan, head dental officer at Denplan, said: ‘I’m incredibly proud to support the Dentistry Top 50 because I’ve seen firsthand the passion, dedication and kindness that exists throughout our profession. Every day, dentists and their teams go above and beyond for their patients, support one another, mentor future colleagues and continually strive to improve the standard of care we provide. Taking the time to recognise these individuals is so important, not only to celebrate their achievements but also to inspire others and showcase the very best of dentistry.’

When will the Dentistry Top 50 be announced?

The final Top 50 for 2026 will be revealed in July, with a more interactive online celebration than ever before.

Guy Hiscott, content director at FMC, said: ‘As we relaunch the Top 50 for another year, it feels more important than ever to recognise the breadth, resilience and diversity of talent across UK dentistry.

‘Even as the government begins its long-promised process of NHS contract reform – while navigating its own political and economic turbulence – dentistry refuses to wait passively for salvation. Up and down the country, the profession is busy forging its own path: rethinking access, embracing new technologies, building stronger teams, improving the patient experience and finding more sustainable ways to deliver care.

‘The profession has never had such a range of different perspectives on how to move things forward, and that’s what makes the Top 50 so compelling. It’s not designed to recognise one type of career, one model of success or one narrow definition of influence. Rather, it reflects the profession as it really is: varied, ambitious, inventive and full of people finding different ways to push dentistry forwards.’

The 2025 Top 50 list can be found here.

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

Verzenios is a cyclin-dependent kinase 4 (CDK4) and 6 inhibitor that has received approval in China for several indications related to breast cancer.

Originally developed by Eli Lilly, it is approved in the country for use in combination with endocrine therapy as an adjuvant treatment for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence.

It is also indicated for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer.

In these settings, the therapy may be delivered in combination with an aromatase inhibitor, fulvestrant or imlunestrant.

Since 2021, Verzenios has been included in China’s National Reimbursement Drug List (NRDL) Class B, making it the first CDK4 and 6 inhibitor covered by national reimbursement.

Its renewal in the NRDL for 2025 provides continued coverage for both early and advanced breast cancer indications.

Innovent founder, board chairman and CEO Dr Michael Yu said: “Leveraging our established commercial infrastructure and strong market presence in China, we remain focused on addressing critical unmet needs in major oncology indications. Breast cancer, one of the most prevalent and life-threatening malignancies among women, is a strategic priority within Innovent’s oncology portfolio.

“Through this commercial collaboration with Lilly on Verzenios (abemaciclib) – backed by its robust clinical efficacy, comprehensive labelled indications and national reimbursement coverage – we are expanding our presence in this area, laying a solid foundation for our pipeline development and market expansion [to] deliver lasting benefits to patients in breast cancer.”

Last month, Eli Lilly entered a licensing agreement worth up to $1.26bn with Hanmi Pharm to develop, manufacture and commercialise Hanmi’s biologic drug candidate, sonefpeglutide (a LAPS GLP-2 analogue), worldwide, excluding Korea.

The post Eli Lilly and Innovent agree Verzenios commercialisation deal in China appeared first on Pharmaceutical Business review.

The FDA did not raise concerns related to the clinical efficacy or safety data provided for the therapy, nor did it request new data from Unicycive.

Unicycive noted that the latest CRL is based on the same manufacturing issues identified in a previous CRL issued in June 2025.

As part of the current review process, the FDA has not yet conducted an inspection of the third-party manufacturer.

The NDA was resubmitted after Unicycive believed its manufacturer had made progress towards resolving previously cited deficiencies and demonstrating readiness for FDA inspection.

A Type A meeting between Unicycive and the FDA in September 2025 was held to discuss the status of the manufacturing vendor and to seek feedback on the company’s approach to addressing compliance concerns.

Unicycive reported that at that meeting, the FDA did not raise further issues or concerns regarding the third-party manufacturer’s remediation progress.

The NDA for OLC is supported by three clinical studies: a Phase I trial and a bioequivalence study in healthy subjects, and a tolerability study in patients with chronic kidney disease on dialysis, in addition to multiple preclinical studies and chemistry, manufacturing and controls data.

Unicycive CEO Shalabh Gupta said: “We remain confident in the efficacy and safety of OLC. We are in active and ongoing discussion with the FDA regarding label and packaging, and we are optimistic that there will be a successful inspection of the third-party manufacturing vendor and that we will be able to expeditiously resubmit the NDA.”

Unicycive is seeking approval for OLC via the 505(b)(2) pathway.

The therapy, which is described as an investigational oral phosphate binder, remains under FDA review and is currently protected by a global patent portfolio extending until 2031.

The post US FDA rejects approval of Unicycive’s kidney disease therapy appeared first on Pharmaceutical Business review.

The litigation team at Medical Protection Society (MPS) – which Dental Protection is part of – has won the gold award for team of the year (operational excellence) at the 2026 Industry Eagles Awards.

The MPS cases team also won the bronze award for team of the year (innovation and transformation).

The International Industry Eagles Awards honour outstanding achievements and innovation across diverse sectors, including legal services. The specialised Legal Services Eagles Awards specifically celebrate past achievements and future innovations by law firms, legal departments, and technology providers in the legal sector.

The judges recognised the MPS teams for demonstrating outstanding teamwork, dedication, and innovation in achieving their goals, as well as their significant contributions to the success and advancement of MPS and the legal services industry.

Karen Miller, chief executive of Medical Protection Society, said: ‘The focus, determination and expertise of our legal services teams are invaluable in our commitment to defending our members with confidence and protecting them at moments when their professional standing matters most.’

Dr George Wright, dental director at Dental Protection, said: ‘These awards are a great recognition of the exceptional support that Dental Protection members receive. We are proud of how our legal services department has reimagined how they work across the organisation and with members to provide a gold standard service.’

The Industry Eagles Awards were hosted by Andy Hodgson on Thursday, 4 June 2026 at The Bentley Hotel, London. MPS was nominated for team of the year (operational excellence) alongside Sodexo Live! and Frenkel Topping Limited, and for team of the year (innovation and transformation) alongside Swanborough House Care Home and Frenkel Topping Limited.

This article is sponsored by Dental Protection.

Empowering dental practice managers: Lisa Bainham explores the benefits of the Association of Dental Administrators and Managers (ADAM) and why you should join.

The role of a dental practice manager (PM) is complex and varied, demanding a unique blend of skills to ensure smooth operations, compliance, and exceptional patient care. Recognising these challenges, the Association of Dental Administrators and Managers (ADAM) is dedicated to providing comprehensive support and resources tailored specifically for dental practice managers and those involved in dental practice management.

Understanding the challenges of dental practice management

Dental Practice Managers often find themselves at the intersection of clinical and administrative responsibilities. The team expects them to have answers to all questions, while practice owners rely on them to keep the practice running seamlessly. This dual pressure can lead to feelings of isolation and overwhelm, especially when faced with unique challenges that vary from one practice to another. Whether it’s managing staff, ensuring regulatory compliance, or improving patient satisfaction, the PM’s role is indispensable yet demanding.

ADAM: your partner in practice management

ADAM understands these pressures and is committed to supporting dental practice managers every step of the way. With a wealth of resources from industry experts and a supportive community, ADAM offers an array of benefits designed to make your role more manageable and rewarding:

Expert support and advice

Gain access to industry experts who provide practical advice and solutions tailored to the unique challenges of dental practice management. Whether you need guidance on compliance issues or strategies for enhancing practice efficiency, ADAM’s experts are here to help.

Exclusive members-only website

Our members-only website is a treasure trove of resources, including templates, guides, and industry updates. This centralised hub helps ensure you have the tools and information you need to excel in your role.

Closed Facebook group

Connect with fellow PMs in a supportive, private environment. Share experiences, seek advice, and build a network of peers who understand the intricacies of your role.

Member magazines

Stay informed with our regular publications, featuring articles on the latest trends, best practices, and insights from leading professionals in the dental industry.

Monthly compliance clinics and webinars

Stay ahead of regulatory changes and enhance your skills with our monthly compliance clinics and webinars. These sessions are designed to keep you informed and equipped to handle the evolving landscape of dental practice management.

Industry discounts

Enjoy a wide range of industry discounts that far outweigh the cost of membership. From supplies to services, our partnerships with leading companies mean you save money on essentials for your practice.

In-person events

Attend exclusive in-person events free of charge. These events provide opportunities for networking, professional development, and staying abreast of industry innovations.

Affordable membership options

We believe that every dental practice manager should have access to the support and resources they need. That’s why we’ve made ADAM membership as affordable as possible. For just £120 per year, or convenient monthly payments of £10, you can access all the benefits of ADAM membership. This modest investment in your professional development can yield significant returns in terms of efficiency, compliance, and job satisfaction.

Join a community that understands you

One of the most significant benefits of ADAM membership is the sense of community it fosters. As a dental practice manager, you are not alone. ADAM brings together professionals who understand the unique pressures and responsibilities you face. Our community is here to support you, share insights, and help you navigate the complexities of your role.

Supported by industry leaders

ADAM is proud to be supported by a range of industry companies that appreciate the critical role of the dental practice manager. This support allows us to offer valuable resources and services to our members, ensuring you have everything you need to succeed.

Dental practice managers play a crucial role in the success of dental practices, but the challenges of the job can often lead to feelings of isolation. ADAM is here to provide the support, resources, and community you need to thrive in your role. Join us today and discover how ADAM can make a difference in your professional life.

Visit www.adam-aspire.co.uk to learn more about our membership options and how we can support you in your journey as a dental practice manager. Together, we can navigate the complexities of dental practice management and achieve excellence in all aspects of your role.

This article is sponsored by the Association of Dental Administrators and Managers (ADAM).

Akums Drugs & Pharmaceuticals, India’s leading contract development and manufacturing organization (CDMO), has announced the launch of its DCGI-approved Pregabalin, Methylcobalamin and Duloxetine (Delayed Release) Capsules, a novel triple-action therapy for the management of diabetic peripheral neuropathic pain associated with Vitamin B12 deficiency.

Neuropathy is emerging as a significant public health concern in India, driven by the growing prevalence of diabetes and nutritional deficiencies. India is home to more than 100 million people living with diabetes, and studies suggest that nearly 25–50% of diabetic patients may develop neuropathy during the course of their disease. Vitamin B12 deficiency, reported in a large proportion of urban Indians, further contributes to symptoms such as tingling, numbness, fatigue, and cognitive changes, making effective management increasingly important.

Peripheral neuropathy is a progressive neurological disorder characterised by burning sensations, tingling, numbness, shooting pain, and loss of nerve function. If left unmanaged, it can lead to irreversible nerve damage, impaired mobility, sleep disturbances, and reduced quality of life. Early intervention and comprehensive treatment are therefore critical.

The newly launched formulation combines Pregabalin 75 mg, Methylcobalamin 1500 mcg, and Duloxetine 20 mg/30 mg (Delayed Release), bringing together three complementary therapeutic mechanisms. Pregabalin helps reduce abnormal nerve firing and provides relief from neuropathic pain symptoms. Duloxetine modulates central pain pathways by inhibiting serotonin and norepinephrine reuptake, while also supporting improvements in associated anxiety and sleep disturbances. Methylcobalamin, the neurologically active form of Vitamin B12, supports myelin sheath repair, improves nerve conduction, and aids in the regeneration of damaged nerve fibres.

A key differentiator of the therapy is its advanced dual-delivery technology, which enables the immediate and consistent release of Pregabalin and Methylcobalamin while ensuring targeted intestinal delivery of Duloxetine. This innovative design helps optimize the absorption profile of each active ingredient, supporting enhanced therapeutic effectiveness and patient comfort. The formulation is designed to promote therapeutic consistency, improve convenience, and encourage long-term treatment adherence.

Commenting on the launch, Sandeep Jain, Managing Director, Akums Drugs & Pharmaceuticals said, “India is witnessing a sharp rise in neuropathy cases driven by diabetes, nutritional deficiencies, and lifestyle disorders. Managing this condition requires more than symptomatic relief—it demands a holistic approach that supports nerve repair and long-term neurological health. Our triple-action formulation is a science-led innovation that combines multiple mechanisms into a single, patient-friendly dosage form to improve outcomes and adherence.”

He added, “As disease patterns evolve, there is a growing need for therapies that address multiple dimensions of patient care within a single treatment approach. This formulation combines pain management with nerve health support, offering clinicians a comprehensive option for neuropathy management while reinforcing our focus on developing differentiated and clinically relevant therapies for India’s healthcare needs.”

The CNS and neuropathy treatment market in India is expanding steadily, driven by increasing disease prevalence, improved diagnosis rates, and growing awareness among healthcare professionals and patients. Combination therapies are gaining prominence as they address multiple disease pathways while simplifying treatment regimens.

Indicated for diabetic peripheral neuropathic pain with co-existing Vitamin B12 deficiency, the formulation offers a differentiated option within the neuroscience segment. With this launch, Akums continues to strengthen its neuro-care portfolio and commitment to developing innovative, clinically relevant, and patient-centric therapies for India’s evolving healthcare landscape.

The post Akums launches novel triple-action therapy for comprehensive neuropathy management appeared first on Express Pharma.

Single-use bioprocessing has evolved from a tactical choice for speed and flexibility into a strategic pillar of modern biologics manufacturing. Yet one anxiety endures across process engineers, QA leaders, and supply chain executives alike: bag failures. Whether they occur at receiving, during gamma-aged storage, in a cold-chain handover, or mid-campaign at 2 a.m., the practical and financial consequences can be severe—lost batches, deviation cascades, contamination risk, and reputational damage. As titers rise, scales increase, and modality diversity explodes (mAbs, vaccines, CGT, RNA, and next-gen recombinant proteins), the reliability expectations placed on single-use bags are reaching parity with stainless systems—without compromising agility.

This article examines how the industry can engineer reliability into the next generation of single-use bags, focusing on seven critical levers: film selection, failure modes, seal integrity, mechanical stress, transportation studies, gamma aging, and bag qualification strategies. It closes with the strategic implications for both manufacturers and end users, and points to a set of core references for deeper study.

Why bag failures remain a major concern

Economic impact: A single drug-substance (DS) bag failure at 1,000 to 2,000 L—especially for high-value biologics—can translate to seven-figure losses and weeks of schedule slippage. Beyond direct material costs, the deviation investigation, CAPA, potential requalification, and regulatory exposure magnify the impact.

Complexity and variability: Bags are composite systems – polymer films, tie layers, EVOH or PVDC barriers, UV stabilizers, antioxidants, gamma stabilizers, fluid-contacting layers, ports, gaskets, and heat seals, assembled with process-specific hardware. Any weak link can become the initiating site for failure.

Scale and cumulative risk: Large DS fills (500 to 5,000 L) increase hydrostatic load, weld length, and handling complexity. The probability of an excursion somewhere across storage, shipping, staging, and processing grows with the number of touchpoints.

Regulatory and quality expectations: Agencies expect robust supplier oversight, material traceability, extractable/leachable control, contamination risk management, and change control. Bag integrity failures can trigger broader questions about supply chain robustness and patient safety.

Operating envelope expansion: Bags now see more extremes, i.e.,  -80 to -196 oC cold chains (frozen bulk, cryogenic hold), aggressive CIP-like detergents for pre-flush, long-term gamma-aged storage, elevated hold times, intensified mixing, and shipping under vacuum or pressure differentials.

Reliability, then, is not a single attribute—it is the emergent property of disciplined material science, manufacturing process control, mechanical design, logistics engineering, and lifecycle qualification.

Film selection: the foundation of reliability

Film architecture is the single most consequential determinant of bag performance. A modern film is a multilayer stack balancing five priorities: chemical compatibility, barrier performance, mechanical toughness, thermal behaviour, and radiation resistance.

The following are the important considerations while selecting single use.

Contact layer chemistry: Common choices for SU material is ULDPE/LLDPE for biocompatibility and weldability, sometimes metallocene-catalyzed grades for toughness. For solvents or surfactants (e.g., PS-80), the contact layer must resist swelling, environmental stress cracking, and additive extraction. Medical master batches and gamma stabilizers must be compatible; antioxidants (e.g., hindered phenols) mitigate oxidative embrittlement but can increase extractable if not controlled.

Barrier layer strategy: EVOH provides excellent oxygen barrier but is moisture-sensitive; humidity cycles during shipping can impact barrier properties and stiffness. PVDC has strong barrier properties but regulatory and sustainability headwinds; careful change control is essential if migrating away. Some “barrier-less” architectures lean on thicker polyolefins plus process controls; trade-offs include O2 ingress and CO2 retention in cell culture.

Mechanical reinforcement: Tie layers and outer layers define puncture and tear propagation resistance. Toughness must be maintained down to lowest-use temperatures (e.g., -80 C), where ductile-to-brittle transitions can occur. Notch sensitivity is crucial: slight cuts from hose barbs or handling fixtures can propagate under cyclic loading.

Thermal behaviour: Films must tolerate gamma-induced heat during sterilization and temperature excursions in transit. Glass transition and crystallinity profiles dictate low-temperature brittleness. For cryogenic applications, specialty elastomer-modified polyolefins or EVA blends can improve impact resistance.

Radiation stability: Gamma (25–50 kGy typical) drives chain scission and crosslinking. Formulation must target minimized embrittlement and controlled yellowing without raising leachable. Alternative sterilization (X-ray, e-beam) is emerging; however, cross-vendor comparability requires new validation as dose distribution and radical chemistry differ.

Supply continuity and change control: Dual-source resin strategies and pre-qualified alternates protect against upstream disruptions. Detailed resin lot traceability, certificate harmonization, and lock-step change notifications are essential to prevent “silent” film shifts.

For end users, the practical approach is a film selection rubric aligning the film to the application’s chemical, thermal, mechanical, and lifespan stressors; matched with supplier transparency on resin formulation, additive packages, sterilization dose mapping, and historical change logs.

Failure modes: know them to prevent them

Understanding failure mechanisms enables targeted design and qualification. High-frequency modes include:

1.     Incomplete fusion, cold seals, over-welded brittle zones, particulate occlusion in the weld, and misaligned multilayer stacks cause seal failure. These may pass low-pressure leak tests yet fail under thermal cycling or dynamic agitation.
2. Rigid port inserts create stiffness discontinuities, stress concentrates at the weld toe under bending, torsion, and impact during handling or mixing, hence special attention is required for port and weld interface.
3. Film stress cracking and brittle fracture is well known in SU. Low-temperature handling, gamma-aged embrittlement, or solvent exposure can initiate micro-cracks that accelerate under pressure cycles.
4. Abrasion from tubing clamps, transport vibration against pallet edges, trapped sharp particulates, or ice crystals in frozen storage can cause pinhole leaks.
5. Adhesion failures in multilayer structures due to poor tie-layer compatibility, humidity cycles (EVOH), or excessive thermal gradients during sealing cause delamination.
6. Silicone or TPE gasket set under compression creep; reconnect cycles erode sealing force. Mismatched connectors exacerbate. All these cause connector and gasket leakage.
7. Particulate ingress/foreign matter also a concern. Not a “leak” per se, but functionally a batch risk; sourced from film slitting, cutting, or outgassing residues adhering electrostatically.
8. Bioburden breach or sterile barrier compromise the bag integrity. Micro-channel defects that pass gross leak testing but fail sterile hold over time, especially under thermal/humidity cycling.

Failure is often multifactorial. A marginal seal plus gamma aging plus an unvalidated shipment profile is a disaster in combination. Robustness means stacking safety margins across multiple stressors simultaneously.

Seal integrity: where quality meets physics

Seals are typically the weakest structural feature because they alter polymer morphology, introduce geometric stress risers, and depend on process capability. It is important to engineering priorities, specifically process windows and controls. Seal need full characterization w.r.t. time-temperature-pressure windows using designed experiments. It is also essential to include film thickness tolerance extremes and study impact of humidity conditions.

It is essential to control and monitor real-time energy delivery in impulse sealing. Platen temperature uniformity and jaw pressure mapping is also essential. SPC on surrogate metrics (e.g., peel strength) guards against drift need precision control.

Seal geometry is critical. Wider seals distribute stress and stepped or multi-lane seals can localize and arrest tear propagation. It is known that smooth radii at corners reduce stress concentration. It is critical to avoid “knife edges” near port transitions.

Inline vision to detect inclusions/voids; HEPA-filtered sealing stations; anti-static controls to prevent particulate attraction require control and monitoring to assure cleanliness and occlusions.

To assure peel and burst, it is essential to use standardized peel tests (180°/T-peel) with acceptance criteria correlated to end-use loads. Burst tests should mimic realistic constraints (clamp points, temperature), and validation need to happen at initial and end-of-shelf-life after worst-case gamma and environmental aging. Moreover, port-to-film material compatibility (e.g., PP port with PE-based film) must ensure co-weldability without weak boundary layers.

For end users, supplier seal qualification data should be part of technical files, including histograms of seal strength, not just point estimates. On-receipt AQL sampling with statistically defensible plans (e.g., c=0, tightened inspection when supplier CPk drifts) adds assurance.

Mechanical stress: design for the real, messy world

Bags do not live in ideal test rigs. They are dragged across floors, overfilled, under-supported, and palletized next to heavier components.

Table 1: Mechanical reliability checks

Operational controls matter as much as design: SOPs for max stack height, corner protection, minimum support radius, and clamp placement reduce real-world excursions that formal testing may not fully capture.

Transportation studies: closing the gap between lab and logistics

Transit is a crucible for bag reliability. Temperature excursions, vibration spectra, shocks, altitude pressure changes, and handling practices vary widely across lanes and forwarders. When logistics are designed and qualified as deliberately as process steps, bag failure in transit becomes rare rather than routine for biopharma manufacturers.

Table 2: Where to pay attention for single-use shipping logistics

Gamma aging: the slow, invisible stressor

Irradiation is essential for sterility assurance, yet it initiates long-tail chemical changes in polymers that continue during storage. Gamma aging is manageable when treated as a design variable, not an afterthought.

During gamma exposure, chain scission reduces molecular weight and elongation-at-break, crosslinking become embrittle and radicals drive oxidative reactions if oxygen is present post-sterilization, additives (antioxidants, HALS, UV absorbers) quench radicals but can be consumed or transform into extractable species over time.

Industrial gamma cells produce dose gradients across pallets. Hence it is essential to validate performance at minimum and maximum mapped doses—both can be worst-case depending on mechanism. X-ray and e-beam can also present different dose-rate effects, hence do not assume interchangeability without data.

It is well know that elevated temperature and oxygen accelerate post-irradiation oxidation. Barrier packaging (e.g., aluminium over-pouch with oxygen scavenger) and cool, dark storage can extend mechanical life. It is essential to establish aging curves (e.g., Arrhenius-based accelerated aging) correlating to end-of-life properties: tensile, puncture, seal strength, and leak rate.

Gamma can increase low-MW species. Comprehensive extractable profiles at T0 and end-of-shelf-life, under relevant solvents (WFI, acids/bases, ethanol, PS-80), are table stakes. For high-risk modalities (cell/gene therapy), adopt science-based safety evaluations and clinically relevant leachable studies.

Manufacturers need to define sterilization dose range in the material specification, include acceptance criteria for mechanical properties at both dose extremes, initial and aged, and implement change control triggers for sterilization modality or supplier site moves; require requalification of both mechanicals and E/L.

Bag qualification strategies: from component to system

A robust qualification framework integrates material science with application-specific stressors. This lifecycle approach shifts reliability from reactive firefighting to proactive assurance.

Table 3: SU bag qualification strategy

Strategic value: why this matters to manufacturers and end users

For manufacturers (SU suppliers), publishing detailed film architectures, sterilization dose maps, and end-of-life mechanical curves builds trust and shortens customer qualification cycles, and offers differentiation through science and transparency. Investing in SPC on seal processes, advanced NDT leak screening, and route-specific packaging engineering reduces warranty claims and brand risk, which offers advantages related to cost of quality vs. cost of failure. Dual-resin strategies, second-source sterilization, and mirrored production cells in different regions de-risk geopolitical and logistics shocks, offering supply chain resilience. The future is about co-innovation with end users, where joint FEA, lane fingerprinting, and shared E/L toxicology models become sticky partnerships that outlast price cycles.

For end users (biopharma and CDMOs), reliable bags de-risk campaign schedules, increase OEE, and support intensified or continuous operations without buffer overstocking “just in case” offers significant advantage in terms of  operational continuity. Traceable, well-qualified single-use systems strengthen filings, reduce pre-approval inspection findings, and simplify post-approval changes offers regulatory confidence. Avoiding one DS batch loss can pay for multi-year reliability programs. Fewer excursions mean leaner deviation management and faster tech transfers, ultimately translating to financial resilience.  Standardized, qualified bag families enable global site harmonization, multi-modality flexibility, and faster on boarding of new processes offering platform scalability.

Reliability is not only a technical goal—it is a strategic enabler of speed, quality, and cost competitiveness.

Putting it together: a practical roadmap

It is important to define the operating envelope, to map fluids, temperatures, contact times, shear/mixing, fill heights, and logistics routes. This need to include future-state scenarios (e.g., scale-up, colder chains).

Always select film and design for context. Choose films aligned to chemistry and temperature; confirm gamma aging curves and E/L acceptability. Most importantly, engineer ports, seals, and geometries with FEA-informed stress diffusion that leads to a seal and port integrity control plan. Consider DOE for the sealing process; lock process windows with real-time controls; and validate peel/burst at T0 and end-of-life; include particulate controls.

Consider engineering logistics. It is important to qualify packaging via ISTA/ASTM plus lane-specific profiles, add corner protection, rigid containment, and shock/vibration damping as needed, validating altitude effects. Qualify it as a system – MQ/DQ the design and materials, IQ/OQ the hardware interfaces and process loads, and PQ at scale with worst-case conditions, including integrity testing.

Also monitor and improve. Implement incoming inspection AQL plans, defect taxonomy tracking, and CAPA loops. Requalify upon supplier or lane changes. Share data with your partner to prevent recurrence. It is also important to institutionalize change control where you need to pre-negotiate notice periods, comparability protocols, and parallel-lot strategies with suppliers. Maintain a living risk register tied to bag SKUs and uses.

Last but not least, the culture and training. Engineer-proof designs help, but trained operators prevent the majority of handling-induced defects. Consider using visual aids, do-not-bend zones, and hands-on practice with damaged exemplars.

Thoughtful advances on the horizon

Next-gen radiation sterilization is under consideration where in X-ray and advanced e-beam promise tighter dose control and less collateral polymer damage. It may result in new qualification paradigms and potential shelf-life gains.

Smarter films are under development where in formulations being tailored for cryogenic ductility without raising extractable; or oxygen-scavenging over-pouches; or embedded strain or breach-indicating inks.

Inline non-destructive integrity tests is are in near term horizon. High-sensitivity vacuum decay, acoustic resonance, or laser interferometry are being evaluated by the SU suppliers that could move QC from sampling to 100% screening for critical SKUs.

Digital twins are being considered for logistics. Predictive models fusing bag mechanics with real lane telemetry to recommend packaging configurations and even carrier selections seasonally are being developed.

Standardized data are being packed. Cross-supplier, regulator-endorsed templates for E/L, gamma aging, mechanicals, and seal capability that accelerate cross-qualification and reduce redundant testing packages are under development.

These innovations will raise the reliability floor while enabling even more ambitious process intensification and decentralized manufacturing models.

Conclusion

Single-use bags will remain central to bioprocessing’s agility and scalability, but the expectations have changed. Reliability must be engineered deliberately across film science, mechanical design, sealing processes, logistics, radiation effects, and comprehensive qualification. When suppliers and end users treat bag integrity as a shared, data-driven discipline—rather than a procurement line item—the risk of catastrophic failures diminishes, regulatory confidence grows, and manufacturing strategies become more resilient.

The future of single-use bags is not just tougher plastics or thicker films; it is a system-level commitment to quality by design, validated in the real world, and continuously improved through transparent partnerships. That future is within reach—and it is a strategic advantage waiting to be seized.

(Author: Priyabrata Pattnaik;  pattnaik.p@amipolymer.com)

References

• PDA Technical Report 66: Single-Use Systems for Pharmaceutical Manufacturing. PDA
• ASTM D4169-22: Standard Practice for Performance Testing of Shipping Containers and Systems. ASTM International
• ISPE Good Practice Guide: Single-Use Technology. ISPE
• BioPhorum (BPOG) Best Practices for Extractables Testing of Single-Use Systems in Biomanufacturing. BioPhorum
• PDA Technical Report 76: Consensus Method for Extractables and Leachables Risk Management in Biomanufacturing. PDA
• USP General Chapter <1665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. USP
• ISTA 3A: Packaged-Products for Parcel Delivery System Shipment 70 kg or Less. ISTA
• ISO 11137: Sterilization of Health Care Products—Radiation

The post The future of single-use bags: Engineering reliability for large-scale bioprocessing appeared first on Express Pharma.

Morepen Laboratories issued an update on its recently announced Rs. 825 crore CDMO mandate. The first commercial dispatch, valued at approximately Rs. 50 crore, has already been completed by the company under the program during Q1FY2026-27. This marks the successful transition of the mandate from validation and qualification stage to commercial execution stage.

Commenting on the development, Sanjay Suri, Managing Director, Morepen Laboratories said, “This is an important milestone in Morepen’s transition toward long-duration global manufacturing partnerships. Our teams have worked closely with the customer through validation, manufacturing readiness and supply-chain planning. Having started execution of commercial supplies, we are focused on scaling up, expanding capacity and building a stronger CDMO platform across additional customer and product opportunities.” 

Having dispatched the first batch under the CDMO mandate, Morepen expects to scale the program further in the coming quarter, with additional supplies of approximately Rs. 225 crore expected during Q2FY2026-27, subject to customer schedules and regulatory/commercial requirements.

The Company continues to strengthen its manufacturing infrastructure to support larger CDMO opportunities. Total reactor capacity is expected to reach approximately 600 KL by the end of Q2, followed by further expansion toward 800 KL and 1,000 KL in subsequent phases.

The commencement of commercial supplies under this mandate reinforces Morepen’s strategy to build a scalable CDMO platform, deepen customer partnerships and participate in long-duration global manufacturing opportunities.

The post Morepen dispatches its first batch under CDMO mandate appeared first on Express Pharma.

• Ascension Saint Thomas has broken ground on a $148.5 million full-service hospital and integrated health campus in Clarksville, Tenn. 
• The 96-acre campus will be located near Highway 76 and Interstate 24 and will open with 44 inpatient beds, with planned capacity for 132 beds. 
• Initial services will include emergency care, inpatient surgery, cardiology, neurosciences, women’s health, neonatal intensive care, oncology and orthopedics. 
• The project is expected to create about 250 hospital jobs and support an estimated $316 million in annual economic impact. 

CLARKSVILLE, Tenn. — Ascension Saint Thomas has started work on a new full-service hospital and integrated health campus in Clarksville, Tenn., a $148.5 million project aimed at expanding care access in Montgomery County and the surrounding region. 

Health system leaders, public officials, physicians and healthcare partners gathered Tuesday for the groundbreaking. The campus is planned for 96 acres near Highway 76 and Interstate 24 and is designed to serve a community Ascension described as one of Tennessee’s fastest-growing. 

The hospital is expected to open with 44 inpatient beds and be designed for future expansion to 132 beds as local needs increase. Ascension said initial services will include emergency care, inpatient surgery, cardiology, neurosciences, women’s health, neonatal intensive care, oncology and orthopedics. 

The broader campus is planned to include physician and subspecialty services, an inpatient rehabilitation hospital, outpatient surgery, advanced imaging and specialty ambulatory care. Ascension said the campus is intended to support coordinated care closer to home across different stages of life. 

Healthcare partners expected to be part of the campus include Tennessee Oncology, Tennessee Orthopaedic Alliance, Ascension Saint Thomas Heart, Howell Allen Clinic and Lifepoint Health, which is planned to be involved with a new inpatient rehabilitation hospital. Montgomery County also is partnering on a new ambulance and EMS station on the campus. 

“This groundbreaking is a direct response to community leaders and physicians who championed a bolder future for local healthcare,” said Fahad Tahir, president and CEO of Ascension Saint Thomas, according to an article from Ascension. Tahir said the campus is being built to anticipate and evolve with the region’s growth. 

Clarksville Mayor Joe Pitts also connected the project to the city’s growth. “This new hospital will enhance access to healthcare services and strengthen the overall well-being of families throughout our community,” Pitts said, according to an article from Ascension. 

Montgomery County Mayor Wes Golden said the project will help address ongoing care needs for residents. “By expanding access to care close to home, we continue to meet the healthcare needs of the people and families who live and work in our community every day,” Golden said, according to an article from Ascension. 

Ascension said the project is expected to create about 250 hospital jobs and generate an estimated annual economic impact of $316 million while supporting more than 1,300 direct and indirect jobs in the region. 

Ascension Saint Thomas opened its first Clarksville-area location in 2005 and now operates 17 care locations in Montgomery County. Construction is expected to begin immediately after the groundbreaking, with additional updates on construction timelines and future services to be announced as the project advances. 

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Billions of dollars are flooding into efforts to reverse aging as scientists explore ways to return cells to a younger state. But how far off are these experimental treatments? Will they really work? Watch a conversation exploring longevity’s new focus.

Speakers: Mary Beth Griggs, science editor and Jessica Hamzelou, senior biotechnology reporter

Recorded on June 30, 2026

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The company has completed its animal-derived component-free (ADCF) liquid media expansion facility (A1X), Pierre-Alain Ruffieux, Cytiva group executive, bioprocess, told GEN in an interview conducted from the company’s booth during the Biotechnology Innovation Organization (BIO) International Convention recently held in San Diego. He said the completion was celebrated with a ceremony on the site.

Cytiva detailed the expansion project in a May 12 post on its website: The ADCF liquid media expansion facility (A1X) has larger mixing tanks than the existing facility, supporting batch sizes from 700 L up to 13,000 L—compared with batch sizes of 100 L to 10,000 L supported by Cytiva’s existing facility.

Also, the A1X facility uses mixing tanks and liquid media transfer lines comprised of AL6XN and 316 L stainless steel. This differs from the existing facility equipment, which is comprised solely of 316 L stainless steel. AL6XN is a low-carbon, high-purity stainless-steel alloy that is more resistant to wear and corrosion than 316 L, representing an upgrade to the product contact layer versus the existing facility equipment.

The expanded site’s added liquid capacity comes from the addition of three manifold fill lines, three filling manifolds, six mixing tanks, six formulation booths, and a utility building to support large volume liquid media production. Housed in the utility building are a 45,000 L tank and process water system, a 55,000 L tank and water for injection system, a clean steam generator, and additional supporting utilities.

“In addition to the added capacity, Cytiva has updated several aspects of the manufacturing floor layout and equipment, improvements designed to shorten production cycle time, improve safety, and minimize product risk,” the company explained. “The updates also establish closed systems for cleaning and a controlled environment for the transport and handling of raw materials and finished goods.”

Previously, Cytiva completed expanding its dry powder and liquid media manufacturing capacity for large-volume customers and added high-speed bottle filling for smaller-volume users. The company also opened an expanded staging area for finished goods, as well as a new centralized 10,000-square-foot quality control lab to support increased manufacturing.

AI’s “two major impacts”

During a wide-ranging interview, Ruffieux discussed Cytiva’s approach to AI and several recent Cytiva announcements.

“We see two major impacts from AI on what we are doing,” Ruffieux explained. “The first one, and I always like to start with the customers because it’s really our focus: We see our customers accelerating and increasing the number of targets they are doing. AI is helping them to have more targets and in a faster time,” Ruffieux said. “It’s putting pressure on the CMC folks, and I think it’s where we play: They ask us to provide innovative solutions to go faster.”

Cytiva’s focus on AI is two-fold, he continued.

“One, we are developing intelligent equipment which is using AI to be easier for customers to use and which are more functional; that is one aspect. It’s also delivering more experience in a shorter time frame,” Ruffieux said. “It’s a kind of next level of DoE [design of experiments], but it’s also delivering a productivity aspect because the goal is to have equipment which requires either fewer people or fewer people with less specific knowledge of the equipment.”

Like a growing number of companies in and outside biopharma, Ruffieux said, Cytiva has fully embraced AI “to make our product better, to make the customer experience better, but also to improve our internal processes.”

“Faster and better”

“We see AI helping us to develop software, writing new software to go faster and better. AI is very powerful for reviewing documents and doing things,” he explained. “It’s amazing what we can do both in writing code, but also perhaps as importantly, as we validate the code and we test everything, the use of AI is allowing our people to work in a much more comprehensive way, in a much faster way.”

AI also adds a layer, he said, to the continuous improvement ethos that Cytiva and other Danaher-owned companies practice through the Danaher Business System (DBS). Since the mid-1980s, Danaher has carried out an ongoing company-wide Kaizen or continuous improvement effort based on lean manufacturing and anchored on DBS, a common culture and operating system focused on people, plans, processes, and performance.

“AI is an additional pillar to this system, really helping the company to be more efficient and to drive business,” Ruffieux said.

Cytiva’s customers, he continued, have not specifically asked about AI. So what are customers telling the company that they want?

“What customers want is Cytiva delivering solutions which help them to innovate, produce drugs, and accelerate these processes. And AI is one of the attributes, but they don’t have a specific task on AI,” Ruffieux replied. “In discussing with senior customers, people are interested in the outcome, not in the product itself. So it’s not AI for AI, it’s AI for a business outcome. And in life science, the business outcome is quality. It’s reliability. It’s speed. It’s customers asking, can we help them to be better?”

AMT designation

Last month, Cytiva hailed the FDA’s granting its Advanced Manufacturing Technology (AMT) designation to the company for its Elevecta transient cell line for adeno-associated virus (AAV) manufacturing, one of the first gene therapy manufacturing technologies to receive the designation. Customers using the Elevecta transient cell line will benefit, according to Cytiva, from a clear, predictable regulatory and quality framework for gene therapy development.

Through its AMT designation, the FDA recognizes drug manufacturing technologies that it deems to have elevated the reliability, quality, and robustness of advanced therapeutics manufacturing. By enabling a streamlined Chemistry, Manufacturing, and Controls (CMC) review and frequent communication with the FDA, designees count on the AMT designation to help accelerate their manufacturing-related development timelines and create a meaningful advantage through faster time to market.

“This recognition by the FDA is giving confidence and trust for our customers: If they use this cell line to produce AAV, they know that the agency has seen the technical advantage and it’s confidence on the regulatory pathway,” Ruffieux said. “This recognition by that regulatory body is giving trust to the work of the company in helping customers develop drugs, which is really where we position ourselves as true partners.”

Elevecta is designed to significantly reduce the formation and encapsidation of host cell DNA (hcDNA).

“What is beautiful with that is, we get a reduction of 99% of the host cell DNA. You don’t have to worry any more about the host cell DNA which is coming with your product. Again, that is a huge advantage for the customer using that,” Ruffieux said. “This is the kind of innovation we are really proud to bring to our customers.”

Operating from hubs in Marlborough, MA, Amersham, U.K., Uppsala, Sweden, and Shanghai, Cytiva is a unit of Danaher that was re-launched in 2020 after Danaher spent $21.4 billion for the former biopharma business of GE Healthcare Life Sciences. Danaher oversees a global family of more than 20 operating companies focused on biotech and life sciences, as well as diagnostics, water quality, and product identification.

Bringing “the entire workflow”

Earlier this month, the company said that eight of its 2,000 L single-use Xcellerex bioreactors were among equipment contained in the new GMP-2 manufacturing facility inaugurated in Wuhan, China, by Chime Biologics, a decade-long customer that has used equipment made by Cytiva and its predecessor company.

“I want to put that in a larger context: At Cytiva, we really bring to the customers the entire workflow, which is really exciting for small to mid-sized customers. Coming to us, they really get a full facility that is working, really, from A−Z,” Ruffieux said. “It’s starting from an expansion of the cell line, to freezing the drug substance. It’s about a fully integrated solution that helps the customer to have that. And we have multiple facilities like that, that we are building every year for customers across the world.”

“We make significant investments to be able to supply our customers with what they need into different regions, in-region-for-region,” Ruffieux said.

In-region-for-region refers to Cytiva’s ongoing effort to satisfy customer demand for manufacturing tools and services usable within their regions of the world.

“This is really helping us and the customer to secure supply independent of any disruption,” he added. “Since COVID-19, we have seen multiple disruptions worldwide. And really, our original presence is giving confidence to customers that they will get what they need, independent of whatever crisis is happening across the world.”

Worldwide, the United States and European Union have championed “reshoring” efforts by drug developers and tools/technology providers across biopharma to manufacture more of their products within their regions rather than in China or elsewhere in Asia.

“When there is investment, it’s definitely always a tailwind,” Ruffieux said. “We welcome investment, and we are happy to support all customers to put up new facilities, and for the opportunity these facilities offer to position our equipment.”

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Designed specifically for the end-to-end research workflow, LeapSpace was created to accelerate discovery, help researchers calibrate the strength of the evidence, and support critical thinking. LeapSpace draws on 20+ million full-text peer-reviewed articles and books from Elsevier and over 1,000 new content licensing partners, including Sage Publishing, Emerald Publishing, IOP Publishing, and NEJM Group. as well as 100+ million scientific records from 7,000+ publishers on Scopus.

Results are grounded in peer-reviewed literature, citations are traceable to sources, Trust Cards help researchers calibrate the strength of evidence, and the researcher remains in control, with every recommended change requiring approval, notes an Elsevier spokesperson.

General-purpose AI tools can generate text, summarize articles and automate some tasks. But researchers require something more demanding: the latest trusted peer-reviewed content, verifiable citations, transparent reasoning, research integrity safeguards, and enterprise-grade security and privacy, according to Stuart Whayman, president, corporate markets, Elsevier, adding that this is what LeapSpace is built for.

Built with research-grade AI, LeapSpace is already delivering results for thousands of researchers around the world: 97% report time savings, with more than half saving over 50% of their research time, points out Whayman, LeapSpace is now extending support to writing—the task researchers most want AI to help with: more than half find writing clearly and concisely to convey complex ideas a challenge, rising to 60% among students and early-career researchers.

The post New Agentic Capabilities for Tasks Across the Complete Research Workflow appeared first on GEN - Genetic Engineering and Biotechnology News.

When injected into mouse models of retinal disease, these “retinal endothelial cells” (iRECs) integrated into the damaged tissue to regenerate blood vessels and restore retinal function. The team also demonstrated these cells’ ability to form functional retinal vascular tissue in a lab-grown environment, providing a pathway to model and research various eye diseases.

The results point toward the potential of using these retinal cells and models to develop new methods of impactful vision loss treatments and eye disorder research. “Retinal vascular diseases affect millions of people in the U.S., but our understanding remains limited, hindering our ability to discover and develop new therapeutics,” said Sharon Gerecht, PhD, the Paul M. Gross Distinguished professor and chair of Biomedical Engineering at Duke. “Using human stem cells, we generated the cells found in retinal blood vessels, paving the way for new therapeutic approaches.”

Gerecht is senior and corresponding author of the researchers’ published paper in Nature Biomedical Engineering, titled “Derivation of functional retinal endothelial cells from human pluripotent stem cells for therapeutics and modeling.” In their report the authors suggested that their iREC differentiation strategy will “… advance cell therapy and disease modeling, accelerating the discovery of treatments for retinal microvascular diseases.”

The old saying that the eyes are windows into the soul is more accurate than one might think. Neurons from the retina—the back part of the eye that detects light—extend directly to the brain, technically making the eyes part of the central nervous system.

Also like the brain, the retina has a blood barrier that strictly controls what gets in and out including oxygen, nutrients, water and pharmaceuticals. While this barrier keeps the retina healthy and relatively protected from disease-causing agents, it also makes treating the retina difficult. “Retinal tissue has the highest energy and oxygen usage in the body due to the retina’s intense and continuous neuronal activity,” the authors further explained. “This demand leads to a crucial reliance on the inner blood–retina barrier (iBRB) to maintain ocular homeostasis.”

The barrier is formed by blood vessel tissue comprising a tight network of retinal endothelial cells, which form the inner layer of blood vessels, in concert with other specialized cells called pericytes and astrocytes. “Retinal endothelial cells (RECs) in the iBRB are continuous endothelial cells (ECs) that form tight junctions to regulate the diffusion of small molecules, such as ions and water, across their cell–cell interface,” the investigators continued. The specificity of these cells and the fact that they do not form in other areas of the body make the complex tissue difficult to heal or to grow from scratch.

These retinal endothelial cells are currently collected and grown from real patients, making them relatively expensive with a limited supply. “A renewable source of human iBRB endothelium is thus vital for advancing eye research and treatment development,” the team noted in their paper.

To expand access, reduce cost and control variability, the Gerecht lab wanted to see if they could grow them from iPSCs. These are essentially mature adult cells reprogrammed to become primal versions of themselves that can then grow into a wide variety of other cell types.

To do this, Esswein and Ying-Yu Lin, PhD, a former PhD student in Gerecht’s lab, took commercial iPSCs and used a well-established procedure to get them to grow into common endothelial cells that form the inner layer of most of the body’s blood vessels. The researchers then used a specialized cocktail of growth factors to coax the cells into becoming the specific type of endothelial cells found in the retina. “… we differentiated human induced pluripotent stem cells into retinal endothelial cells (iRECs) via the Wnt–β-catenin pathway, namely Norrin–Frizzled4 signaling,” they explained.

Once successful, the researchers put their development to the test. In benchtop experiments, the team was able to get the iRECs to form the same networks and structures that they do within the body. The team then subjected these lab-grown tissues to low oxygen and high glucose levels, which are detrimental conditions often seen within real people. These conditions are fundamental causes of diabetic retinopathy (DR), the leading cause of vision loss in working-age people in the United States, and caused the tissue barrier to break down just like it does in patients. They wrote in summary, “Overall, we were able to robustly recapitulate the DR phenotype in 2D and 3D with our iRECs, exemplifying their ability to be utilized for in vitro disease modeling and to elucidate aberrant pathways and therapeutic targets.”

The researchers then tried their lab-grown cells as a therapy for mouse models with weak, unstructured retinal blood vessels. When injected into the mice before any actual vision loss occurred, these cells successfully integrated into the existing tissue and helped develop strong blood vessels with strong barriers. “When injected into oxygen-induced retinopathy mice, iRECs integrated into the host vascular network and revascularized the ischemic eye, rescuing the tissue,” they stated.

“The tests showed that these lab-grown cells have promise for preventative treatments, especially since they should be easier and cheaper to obtain using our technique,” Esswein said. “And while our benchtop experiments did not attempt to model a wide variety of specific eye diseases in these studies, we’re confident we can create excellent human tissue models in the lab to help better understand these diseases and uncover therapies.”

Moving forward, the researchers are planning to explore these potential uses for their retinal endothelial cells both in their laboratory and through emerging industry partnerships. The group also has a patent pending that covers both the stem cell-based therapeutics and in vitro modeling for drug discovery and testing. In their paper they concluded “Our study establishes functional human iRECs and microphysiological iBRB models that facilitate mechanistic studies aimed at identifying therapeutic targets and promoting the revascularization of injured retinas, thereby supporting treatment advancement.”

The post iPSC-Derived Retinal Endothelial Cells Offer Platform for Studying Diseases appeared first on GEN - Genetic Engineering and Biotechnology News.

Anthropic’s life science partners are delivering applications. Basecamp Research is targeting global public health, where drug-resistant infections play a role in nearly five million deaths per year. The London-based team has announced that its antibiotic design and vaccine target prediction EDEN models will now be available through Claude Science.

A metagenomic foundation model, EDEN demonstrated a 97% success rate when designing functional peptides with high potency against World Health Organization (WHO) critical-priority and multidrug-resistant pathogens. The work was done in collaboration with César de la Fuente, PhD, presidential associate professor at the University of Pennsylvania.

In a Claude Science demo, Oliver Vince, PhD, co-founder at Basecamp, uploaded a sample patient microbiology report. When given a simple natural language prompt, the platform designed peptides, predicted their efficacy, and provided a shortlist of candidates most likely to succeed in experiments in minutes.

While generating human-ready antibiotics at the click of a button is still a step away, Vince said democratizing these tools is a powerful first step, particularly for researchers in regions where accelerated computing infrastructure is not readily accessible.

“Most models require you to be a computational scientist,” Vince told GEN Edge. “Now, potentially any clinician in the world can chat with Claude and design an antibiotic that may work.”

“From a strategic perspective, you want the people with the most agency to solve the problem,” added Phil Lorenz, PhD, CTO at Basecamp. “Not the model builders who are two or three steps removed.”

Full stack

Founded in 2019, Basecamp has spent its initial years building a full computational stack spanning data, models, and therapeutic assets.

In addition to antibiotics and vaccines, the company’s U.S. office, based in Cambridge and led by Jonathan Finn, PhD, Basecamp CSO and former CSO of Tome Biosciences, has fine-tuned EDEN for programmable gene insertion. The approach places large therapeutic DNA sequences at precise locations in the human genome, expanding upon CRISPR-based approaches that use small edits to address a limited number of indications.

EDEN’s generalizability is enabled by training on BaseData, the company’s proprietary dataset composed of 9.8 billion protein sequences collected over 200 diverse and extreme locations, including thermal springs, polar ice, and high-altitude plateaus, across more than 30 countries. The database provides a 10-fold expansion of known protein diversity when compared to all public databases combined.

In March, the team published the compounding advantages of BaseData on model performance in a technical report on scaling laws for metagenomics. Basecamp is steadily pushing forward that data diversity through the Trillion Gene Atlas, a partnership with Anthropic, NVIDIA, PacBio, and Ultima Genomics that aims to scale BaseData 100-fold over the next two years.

Vince emphasizes that model deployment and integration into real-world workflows will be critical for these models to reach their full potential. Basecamp anticipates releasing more applications over the next year.

“I think it will surprise people what these models can do,” he said.

The post Claude Science is Here, Antibiotics Designed by Text Prompt Among Applications appeared first on GEN - Genetic Engineering and Biotechnology News.

HN Summary

• AI is improving healthcare efficiency by reducing physician burnout, streamlining documentation and enhancing patient care through tools such as medical scribes and AI-assisted treatment planning. 

• Healthcare organizations across Canada are using AI to improve system performance, including reducing long-term care wait times, enhancing mental health monitoring and streamlining patient referrals. 

• Speakers emphasized that AI investments must deliver measurable clinical and financial value to help healthcare systems maximize limited resources.

s healthcare leaders from across Canada and abroad gathered in Halifax, Nova Scotia, for the 2026 e-Health Conference, one topic dominated the conversation: the rapidly expanding role of artificial intelligence (AI) in healthcare.

Throughout the conference, speakers shared compelling examples of how AI is improving efficiency across the healthcare system while emphasizing that successful implementation requires careful planning, evaluation and strategic investment.

During the opening plenary session, three healthcare leaders discussed what they described as the “low-hanging fruit” of AI—solutions that are relatively easy to implement while delivering significant benefits. Among the most promising are AI medical scribes and documentation tools that listen to or analyze patient consultations and automatically generate structured clinical notes, referral letters and treatment plans.

“The evidence is no longer refutable that this is a technology that should be in every clinician’s hands,” said Tej Shah, Managing Director at Accenture.

Shah shared data showing that, at some organizations, AI scribes have reduced physician burnout by 20 per cent while decreasing time spent on documentation by approximately 10 per cent. That additional time, he said, allows clinicians to focus on what matters most—caring for patients.

AI is also transforming patient care in other ways. Dr. Andy Smith, President and CEO of Sunnybrook Health Sciences Centre, highlighted how AI integrated with radiation therapy systems is reducing the number of treatments many cancer patients require.

“If instead of coming in [for treatment] 30 times, you only have to come five times, that is a profound leap forward in terms of the positive patient experience,” said Smith.

Despite its potential, AI adoption presents challenges. With countless new technologies entering the market, choosing the right solutions can be overwhelming. At the same time, healthcare organizations continue to operate under significant financial pressures and must carefully prioritize investments.

Karen Oldfield, President and CEO of Nova Scotia Health, stressed that return on investment must remain a key consideration.

“The bottom line for any healthcare system is that the benefits of AI also need to deliver monetary value,” she told attendees, noting that every dollar saved through greater efficiency can be reinvested into patient care.

Throughout the remainder of the conference, presenters explored real-world examples demonstrating how AI is improving efficiency while generating measurable savings.

Increasing long-term care capacity in Nova Scotia

During one session, Glenda Keenan, Senior Director of Continuing Care at Nova Scotia Health, described the province’s partnership with Strata Health to implement real-time scheduling software for long-term care beds.

The platform tracks every long-term care bed across Nova Scotia, identifies the types of patients each bed can accommodate and continuously analyzes waitlists to prioritize placements.

Peter Smith, President of Strata Health VitalHub Corp., said the software has significantly improved system capacity.

“You’re literally creating thousands of days of capacity in the system,” said Smith.

Keenan explained that Continuing Care Nova Scotia coordinated more than 3,400 long-term care beds last year. Before implementing the platform, staff managed placements manually using phone calls, fax machines and email.

“We had no line of sight on what was happening at the provincial, local or zone level, so it was imperative that we move forward with a better solution,” she said.

Since introducing the system in 2022, the median time required to fill a vacant bed has dropped from 10.7 days to six days—a 43 per cent improvement. Keenan estimates the economic value of the initiative at approximately $845,000.

She added that the system has improved not only coordination, but also strategic planning by providing better access to data.

“It has supported our ability, as well as the government’s, to make informed decisions because we now have much better insight,” she said.

Real-time mental health monitoring at CAMH

Another presentation highlighted how the Centre for Addiction and Mental Health (CAMH) has implemented Oracle Fusion Cloud Applications to create a centralized operations management system.

David Rotenberg, Chief Analytics Officer and Operations Director at the Krembil Centre for Neuroinformatics at CAMH, said the platform enables clinicians to monitor patient progress with unprecedented precision.

“We have dashboards embedded directly into patient charts that show whether people are getting better or not,” he said.

The dashboards support approximately 50 different care pathways, including psychosis, dementia and depression.

“You name it, we have a pathway for it.”

Rotenberg said the real-time insights help clinicians identify when patients require additional support and allow for earlier, more timely interventions.

Reducing wait times and improving patient experience in British Columbia

Natasha Kumari, Growth and Marketing Specialist at Thrive Health, described how her company has helped streamline referral and intake processes for healthcare organizations across British Columbia.

Through interviews and workflow assessments, Thrive identified several common challenges, including incomplete referrals, missing patient information and time-consuming follow-up calls.

“Some of the things we found were that there are a lot of incomplete referrals and information coming into the clinic, which leads to follow-up calls, chasing information and spending valuable appointment time collecting medical history that could have been provided beforehand,” Kumari said.

To address these challenges, Thrive implemented its Thrive Clinical platform at an ENT clinic in British Columbia.

The platform automates much of the information traditionally entered manually. Patients complete their medical history before arriving for their appointment, and the system generates additional questions based on individual responses while automatically sending reminders for incomplete forms.

“Because patients present with different diagnoses and conditions, the system can trigger additional follow-up questions depending on the patient’s responses,” Kumari explained.

Previously, clinicians spent an hour with every new patient simply reviewing medical history. According to Kumari, those sessions have now been virtually eliminated.

The platform also supports patients while they wait for specialist appointments by providing referral updates, personalized recommendations for managing their condition and opportunities to report changes in their health status.

Rather than relying on a static waitlist, Thrive Clinical creates a dynamic triage system that keeps information current for both patients and care providers.

“The idea is to automate the small, manual tasks that take up so much time, provide the right information to the right person at the right time, and help patients move through care faster,” Kumari said.

The post Where AI is making the biggest impacts in healthcare appeared first on Hospital News.

The Royal Society, one of the world’s oldest and most prestigious scientific institutions, includes some of the most influential scientists in history, such as Isaac Newton, Charles Darwin and Albert Einstein. APS is the the oldest learned society in the United States, founded in 1743 by Benjamin Franklin.

Woodruff served as president of the Endocrine Society from 2013 to 2014, and as editor-in-chief of Endocrinology. In 2021, Woodruff received the Endocrine Society’s Gerald D. Aurbach Laureate Award for Outstanding Translational Research for “seminal discoveries about gonadal structure, function, and hormones, as well as female fertility and its regulation.”

Currently, Woodruff is an MSU Research Foundation Distinguished Professor at Michigan State University in the Department of Obstetrics, Gynecology and Reproductive Biology in the College of Human Medicine and the Department of Biomedical Engineering in the College of Engineering. She served as MSU provost beginning in August 2020 and is currently president emerita of the university.

“Today, young cancer patients can expect a consult from an oncofertility specialist, and I am honored to have worked with so many caring scientists and clinicians to make these real-world outcomes a reality.”

 Reflecting on her election to the Royal Society and to the APS, Woodruff said she was “surprised and humbled,” adding that it reflects the work of her lab and colleagues over many years, as well as the urgent need that led to her founding the field of oncofertility. She coined the phrase to describe the merging of cancer and fertility research and translating that work into an internationally recognized medical discipline. The field helps cancer patients preserve their ability to have a family after fertility-threatening treatments.

“This is the 20th anniversary since I coined the term ‘oncofertility,’” she says. “Today, young cancer patients can expect a consult from an oncofertility specialist, and I am honored to have worked with so many caring scientists and clinicians to make these real-world outcomes a reality.”

In this work, she leads the global Oncofertility Consortium, an international network dedicated to advancing fertility preservation worldwide.

Her research has produced landmark discoveries in reproductive biology, including the identification of the “zinc spark” at fertilization with MSU Research Foundation Distinguished Professor Tom O’Halloran and breakthroughs in maturing ovarian follicles outside the body, contributing to new fertility preservation strategies.

Woodruff has received numerous honors for her scientific leadership, including the National Medal of Science, the Presidential Award for Excellence in Science Mentoring, election to the National Academy of Medicine, the American Academy of Arts and Sciences and the National Academy of Inventors.

For Woodruff, the impact on patients remains the most significant measure of her work. “I believe the promise of fundamental science in medicine is that tomorrow’s patient is treated better than today’s,” she says. “That is the distinction that matters most.”

Looking ahead, Woodruff continues to lead active research at MSU. Her lab is focused on uncovering the mechanisms behind zinc’s role in egg development, building on the discovery of the zinc spark. She adds, “There is tremendous excitement around where this work can lead.”

The post Teresa K. Woodruff, PhD, Elected to Fellowship of the Royal Society, American Philosophical Society appeared first on Endocrine News.

Join Pat Langley and Bobby Bhandal on 7 July at 7pm as they discuss what dental practices need to know about changes to CQC registration.

This webinar will provide guidance on the recent updates to the CQC process for registering as a new provider.

Attendees will learn how to comply with the new requirements.

Learning outcomes

• Understand what the changes involve and why the new guidance matters
• Understand the financial implications of the new CQC registration process
• Learn the requirements for registration applications to be considered urgent
• Avoid the pitfalls of the new process.

The speakers

Pat Langley

Since qualifying from Manchester University, Pat’s career has included more thqn 30 years in general practice, oral surgery teaching positions at Guy’s and Manchester, deputy chief dental officer at Denplan, group clinical director at Oasis Dental Care, course director at the FGDP(UK), and chief dental officer at Dentex.

In 2010, Pat founded Apolline to provide compliance and regulatory support to dental practices and groups. She is passionate about compliance and has lectured widely on all compliance-based subjects. In 2023, Apolline partnered with FMC to form an integral part of the Dentistry Practice Services division.

Bobby Bhandal

With his unrelenting passion for dentistry, Bobby wanted to find a way to bring pioneering dental services within the reach of his local community. It all started with a dream and a burning desire to make a positive impact on people’s lives through exceptional healthcare.

Following on from this, he has extended this reach further in teaching and mentoring dentists all over the UK in building their own successful dental practices.

Catch up on previous on-demand webinars:

• Finishing your orthodontic cases: essential tips for anterior composites
• Advancing vital pulp therapy: clinical applications and predictable outcomes using MTA vpt
• From enquiry to treatment start: the patient journey most practices have never mapped
• Dealing with patient complaints: real cases, real solutions
• The first 100 days of marketing for a new practice owner.

You can sign up for the webinar here.

How to Match into a Pediatrics Residency Program

Residency application season is here and today we are looking at what it takes to match into a Pediatrics Residency Program! The NRMP conducts annual surveys to determine what factors Program Directors consider when deciding which candidates to interview and rank for their pediatric residency program. The results were compiled into a “at a glance” tool, which is extremely helpful in gauging where your application packet stands compared to the applicant pool, and whether adding additional components, like a letter of recommendation (LOR) in the specialty, could give you a leg up as programs review your application. Many students who are researching, “how competitive is pediatric residency” use NRMP data to evaluate pediatric residency competitiveness and improve their pediatric residency match chances.

The most recent program director’s survey was conducted following the 2024 residency match cycle. We recommend taking a look at the specialty you’ll be applying to before submitting your ERAS application packet. The information below can also help you better understand the application process and make informed decisions throughout medical school.

Selection Criteria for an Interview for Pediatrics Residency

A passing Step 1 score and your MSPE/Dean’s Letter rank highly among the most important residency matching factors pediatric program directors cite when granting interview invitations. Step 1 pass was cited as most important, and notably any USMLE/COMLEX failure was ranked as the #5 most important factor.

Step 2 Scores

Interestingly, 17% of program directors said that they do not consider Step 2 scores at all, and an additional 36% said they prefer, but do not require a score. An additional 32% said they require a pass, and only 15% said they require a target score.

The Step 2 score does seem to be more important for IMG applicants, but still only 26% of directors require a target score.

It should be noted that while Step 2 scores don’t seem to be a major concern for directors when selecting whom to interview, 59% of directors still cite them as an important factor for ranking. This still falls behind other aspects such as interactions during the interview and interpersonal skills, but should be kept in mind.

Students interested in competitive pediatrics residency programs often ask about the average Step 2 score for pediatrics residency, though most programs still evaluate applicants holistically. For students aiming for a 90th percentile score, strong shelf exam performance can help strengthen an application.

Step 2CK – Timing of Taking the Exam

Only 47% of programs required applicants to have passed Step 2 CK at the time of application. This means that for many programs, though certainly not all, you may wait to take Step 2 CK until after you have submitted ERAS.

Failing Step 1 or 2 will hurt you, but won’t sink your chances:

Failing any step of the USMLE is a BIG deal in ANY specialty, and pediatrics is no exception. So, if you’ve failed an exam, you can still apply, but you should consider applying to MANY (40+) programs. 79% of programs reported that a Step 1 failure was seldom an important factor when considering whom to interview.

Types of Applicants Considered:

International Grads (U.S. and non-U.S.) have more difficulty matching in pediatrics than domestic applicants, but it’s not impossible: Approximately one-third (31%) of programs consider interviewing U.S. IMGs on a routine basis, and approximately half (53%) seldom do; only 16% never do. For non-U.S. IMGs, chances are worse, but still possible: 21% routinely interview and rank non-U.S. IMGs, 49% seldom interview and rank them, while 30% never do.

We recommend doing your homework to determine which programs may be more likely to consider IMGs to maximize your chances of success. IMGs who have completed their training and residencies abroad may consider applying to work in Tennessee under the new HB1312 law to bypass the need for redundant residencies. Applicants should also research IMG friendly pediatrics residency programs to identify institutions with a history of interviewing international graduates.

Osteopathic graduates have a good chance of matching: 71% of programs will routinely interview DO applicants, while only 7% never do. This still pales in comparison with U.S. Seniors (91%), so it is still important to do your research to identify these programs so that you can best increase your chances of matching. This is encouraging for applicants pursuing pediatrics residency for DO students.

Pediatrics Residency Interviews

Understanding what program directors look for in pediatrics applicants can help you prepare more effectively for interview season.

• Interviewees Get Ranked!: If you receive an interview invitation, you are likely to be placed on a program’s rank list if you complete the interview. In 2024, the likelihood of matching for applicants who ranked just one program was 80%. Additionally, out of 206 applicants interviewed, 194 were ranked in the 2024 cycle. That likelihood approached 100% for applicants who ranked four contiguous programs. We recommend ranking at least 8-10 programs to be safe, so once you receive 10 residency interview invitations, you can feel okay with starting to prioritize and cancel as more come in given you are likely to get ranked.
• Expect to receive interview invitations in September and October: If you have not heard from programs within several weeks of submitting your application, it may indicate that your application is less competitive for some pediatrics programs.
• Expect to interview in October-December: Few interviews will occur in January or later, which means you should plan to have free time in October-December to maximize your chances of being off during peak interview season. For further discussion on how to prep for your interview, see our blog post on how to crush your residency interview:  https://elitemedicalprep.com/preparing-for-your-residency-interview/

Certain factors less important for Pediatrics than for other programs:

• Research isn’t particularly important for Pediatrics — again, it can strengthen an application, but was not in the top 10 most important factors listed by all PDs.
• AOA status isn’t as important in Pediatrics as it is in other specialties. Again, it can certainly strengthen an application, and is likely important at more competitive programs, but is not expected or required to match.
• Having an LOR from a pediatrician is definitely important, but is not quite as important as some other fields (e.g., neurosurgery, dermatology). This likely means that a strong application could easily feature LORs from 1-2 pediatricians with additional letters of recommendation for pediatrics residency from practitioners outside of the field.
• Achieving awards or honoring clinical rotations in the desired specialty is not as important.

Summary for Pediatrics Residency Applications:

• A solid pediatrics application would include a passing score on Step 1, a strong MSPE or Dean’s letter, at least one LOR from a pediatrician, and demonstrating strong interpersonal skills during your interview. A strong pediatric residency personal statement can further support your application to a pediatric residency training program.

• Pediatrics is somewhat more IMG friendly, than other fields, but matching as an IMG is far from certain. Be sure to do your research to identify programs with active IMG residents and establish proper connections. Students frequently ask, “how hard is pediatric residency to match into,” but the overall pediatric residency match rate remains favorable compared to many specialties.

• If you’ve failed an exam, you can still apply in Pediatrics, but you should apply very broadly and consider applying for a back-up specialty.

• Expect Interviews in October-December. Reach out to programs you have high interest in if you haven’t heard from them by mid-November. Once you have about 10 interview invitations, you can consider being a bit more selective about which ones you actually take (but not before).

Good Luck! ☺ 

Be sure to review individual pediatrics residency requirements as you build your application strategy and evaluate the competitiveness of your application. If you need further or specialized assistance understanding which residency specialties you are best suited to apply to, you can contact us or visit our residency advising page to learn more about our pediatrics shelf exam tutoring services and other Elite Medical Prep residency advising services. 

The post How Competitive Is Pediatric Residency? Match Rates & Acceptance Factors appeared first on Elite Medical Prep.

Looking for a more in-depth Step 1 testing day guide? See our USMLE Step 1 6-week and 10-week study calendars if you’re just getting started!

What Should I Do to Prepare in the Days Leading Up to My Step 1 Exam?

Preparation for Step 1 begins long before test day and following these Step 1 exam day tips and tricks can greatly help mitigate any anxiety about approaching test day.

Drive to the USMLE Step 1 Test Center 3 Days Before Your Test

Visit the Prometric test center three days prior to your scheduled test. Familiarize yourself with the transportation mode you plan to use on the actual exam day. If someone is providing transportation for you, kindly request their assistance. If you’re using a family member’s car, ensure you are comfortable with driving it. In the case of public transportation, utilize the same mode for your practice visit. This USMLE exam day preparation will help ensure a smoother experience on the day of your test. This will allow you to 1) prepare for any uncertainties – is there construction? Is the car low on gas? 2) have a clear idea of how long it will take you to get to the center on test day, and plan accordingly.

The Day Before Your Step 1 Exam

Stop studying by noon and take the afternoon to relax. Doing a short workout (nothing too intense!) can help tire your body out a little bit and make it easy to fall asleep. Also consider doing something relaxing or fun the evening before your test day to help unwind.

Charge Your Electronics

Even though you can use your phone between blocks during the break, I recommend keeping your phone off the whole time you’re in the center. However still bring it with you so that you can make calls in case of emergencies or coordinate your pick up after Step 1 exam.

Make a Packing List

Using the Step 1 exam day packing guide below, make a list of Step 1 exam day essentials to pack before your test a few days before and pack them the evening before!

What Should You Wear on Test Day?

One of the most common questions is what should I wear on my Step 1 test day? Comfort, comfort, comfort! The most important thing on test day is dress in a way that will allow you to focus on your test. Whatever outfit you are most comfortable in is the best outfit. We recommend that in the week leading up to your test day that you take a practice test in your “test day outfit” to make sure that it’s comfortable during the test.

For what you should wear to your Step 1 exam:

Shirt and Pants

we recommend a shirt without a collar and pants without pockets. Remember that every time you enter and leave the room you have to turn your pockets inside and out and collars have to be flipped up and down. Wearing clothes without collars or pockets will save you time on your breaks.

A Sweater

We also recommend wearing layers. Prometric test centers are often kept cool so having a light jacket will allow you to adjust between blocks if you find yourself getting cold or overheating. Remember however that this layer cannot be taken off while in your exam room, but it might be handy to have in your locker.

Socks/ Shoes

For shoes, wear something comfortable. If you might want to slip your shoes during the test you may want to consider wearing slippers you can slip off during testing.

Accessories

Skip them! Don’t wear any jewelry, watches, etc. on test day.

What Should I Bring to Prometric for Step 1?

It’s really essential to have a list of what to bring with you on your Step 1 test day and just as important to know what not to bring. Here is a list of USMLE test day requirements you should pack with you:

Your Scheduling Permit

You must have your scheduling permit from registration with you on test day. If you forget your scheduling permit you won’t be allowed to test

Government Issued Form of ID

Bring two forms of ID, such as a passport and driver’s license. Remember that the required ID for Step 1 must be government issued and have your photo and signature. Although you only need one, having a backup never hurts if you have one that you can bring.

Bring Snacks and Drinks to Your Step 1 Exam

You are allowed to bring snacks and drinks to Prometric. Bring your snacks in a clear plastic bag and your drink in a clear bottle. They will be stored in a locker during testing. For your snacks for the Step 1 exam, make sure to pack plenty of high nutrition snacks with you! Some of my favorites included: yogurt, granola bars, and hummus! Make sure to pack sweet and salty snacks – you’ll never know what you’ll be craving between blocks.

Medications

If you’re on any prescription medications make sure to take them with you and take them as prescribed. In addition, if you are prone to upset stomach, headaches, allergies and know you may need to take a medication during the test make sure to pack those too.

Other Things to Consider

Depending on Covid 19 guidelines and testing center policies, you may need to show your vaccine card, a negative test, or wear a mask during your USMLE Step 1 exam. Make sure you call your Prometric center or look online to see what the current guidelines are as well as any other Prometric Step 1 rules.

Although you are allowed to bring notes, I strongly recommend against bringing any notes to test day. This often causes more stress for students. You can never predict what question will be next and it is often tempting to look up answers to questions you were uncertain on. However, this may just shake your confidence and is not worth it!

What to Expect at Prometric?

• They will give you headphones if you want them:Yes, Prometric provides headphones for test takers. The headphones are noise-canceling and cover your entire ear. They are provided to block out external noise and distractions.

• Check in can take time: An important part of our Step 1 arrival instructions is to get to your prometric testing center at least 30 minutes early to ensure you start your test on time

• Watch the prometric preparation video: On Prometric’s website you can find a video that walks you through some of the basics of Prometric testing centers. Click this link (link: https://www.prometric.com/test-takers/what-expect ) to learn more about what to expect on test day and the items allowed at Prometric. This will also let you know about any prohibited items that you can’t bring to test day.

Preparing for the USMLE Step 1 can be a daunting experience. But with proper planning and organization, you can make the test day experience more manageable. With these tips on how to prepare and what to bring to USMLE Step 1 test day – you can cross one more thing off your list! Remember – make sure you dress comfortably, bring only necessary items, and review the Prometric testing center rules beforehand.

Good luck on your USMLE Step 1 test! If you’re looking for help preparing for your USMLE exams, consider enlisting the help of an Elite Medical Prep USMLE Step 1 tutor! Schedule a complimentary consultation today to learn more about how we can help you succeed!

The post What to Bring to Step 1: Your USMLE Exam Day Checklist appeared first on Elite Medical Prep.

This study plan can serve as a perfect template and jumping-off point for you to customize based on your specific needs while studying for COMLEX Level 2. It can be used as a COMLEX Level 2 study schedule alone, or to combine studying for the COMLEX Level 2 and the USMLE Step 2 at the same time.

We recommend taking osteopathic principles and practice before the COMLEX exam, though some students may prefer a different testing order. For more information on which exam you should take first, read our post on the topic.

Edit the organ system you review on different days based on the weak areas discovered during your self-assessment or customize with your favorite resources. For instance, if you performed well in OB/GYN and pediatrics on your second self-assessment but are still having trouble with cardiology, consider doing just one block of pediatrics and OB/GYN on the following day in favor of another cardiology block.

Make sure you keep track of your COMLEX Level 2 practice exams and are seeing a steady trend of improvement throughout your dedicated study period. Suppose after your third practice exam on week 3 you still are not close to passing and have been plateauing or seeing irregular practice exam scores. In that case, it may be time to consider delaying your COMLEX Level 2 exam until you are better prepared.

Tips for Success Using the COMLEX Level 2 Study Planner

Embarking on the path to ace the COMLEX Level 2 exam requires dedication, strategic planning, and a little insight into what works best. Here are some essential tips for making the most out of the COMLEX Level 2 Study Planner:

1. Customize Based on Your Needs: While the Ultimate COMLEX Level 2 Study Plan provides an excellent foundation, ensure you adapt it to highlight your weak points and strengths.
2. Diversify Your Resources: The COMLEX Level 2 exam is comprehensive. Lean into a variety of study materials, QBank questions, and practice tests. Not only does this provide a more rounded understanding, but it also exposes you to different question formats and presentations. Read our blog post dedicated to this topic to help you select a good variety of resources, without getting too overwhelmed.
3. Schedule Regular Self-Assessments: Recognizing areas that need additional attention is crucial. Periodic self-assessments not only highlight these areas, but also give you a sense of progress and a boost in confidence.
4. Stay Consistent: The key to retaining information and staying on track is consistency. Set aside dedicated study hours each day and stick to your plan, adjusting as necessary based on your self-assessments.
5. Seek External Guidance: Engage with COMLEX Level 2 resources like Elite Medical Prep tutoring for personalized study strategies, effective time management techniques, and expert advice. Our tailored approach can be invaluable in ensuring that you cover all necessary content effectively.
6. Review Foundational Concepts: COMLEX Level 2 doesn’t only test advanced knowledge. It’s crucial to bridge any gaps from Level 1 and reinforce foundational concepts to ensure you have a holistic understanding.
7. Practice, Practice, Practice: The more questions you tackle, the more comfortable you’ll be on exam day. Use the planner to allocate time for mock tests and practice questions, honing your skills and understanding your mistakes.
8. Stay Updated and Informed: Keep abreast of any changes in the exam scoring or syllabus. Elite Medical Prep and other resources often provide insights and updates that can be beneficial.
9. Mind Your Well-being: Remember that it’s not just about hitting the books. Ensure you’re getting enough sleep, maintaining a balanced diet, and incorporating stress-relieving activities into your routine.
10. Stay Positive and Trust the Process: Lastly, believe in your preparation and the study plan. While challenges are part of the journey, staying motivated and positive can significantly impact your performance.

By integrating these tips into your study routine and making the most of the COMLEX Level 2 Study Planner, you’ll be well-positioned for success on exam day.

How to Balance COMLEX Level 2 and Step 2 CK Preparation

Many osteopathic students choose to take both COMLEX Level 2 CE and Step 2 CK during the same study period. Fortunately, there is significant overlap between the two exams, so much of your clinical knowledge review will benefit both tests.

We generally recommend taking Step 2 CK first and then using the remaining days in your COMLEX Level 2 study timeline to focus on osteopathic principles and OMM-specific content. While the core clinical material is similar, COMLEX includes additional emphasis on osteopathic diagnosis, treatment concepts, and patient scenarios that require a dedicated osteopathic principles review.

If you’re wondering how to study for Level 2 CE while also preparing for Step 2 CK, it’s best to keep your resources focused. A solid question bank, targeted OMM review materials, and a few high-yield COMLEX Level 2 prep resources are often enough. Many students find that too many resources create confusion rather than improvement.

One effective strategy for dual board exam preparation is to dedicate separate study blocks to OMM topics such as viscerosomatics, Chapman points, autonomics, and counterstrain while continuing your broader high yield clinical review.

If you need additional guidance with your study plan or osteopathic board exam prep, consider reaching out to work with one of our COMLEX Level 2 tutoring experts.

How to Analyze Practice Exam Performance During COMLEX Level 2 Preparation

Practice exams are one of the most valuable tools available during clinical rotation exam prep, but it’s important to look past the score report. Take the time to review missed questions and identify why you missed them. Were there content gaps? Did you misread the question? Were you rushing? These patterns often reveal the common mistakes during board prep that can hold students back.

As you continue studying, use practice exam results to adjust your schedule. If you’re struggling with a specific subject area, dedicate more time to it during your daily review sessions. Students frequently ask how to study multiple subjects in one day, and practice exam data can help determine where their time is best spent.

Practice tests also help answer questions such as how long to study for osteopathic board exams by showing whether your scores are improving consistently. If scores fluctuate dramatically between assessments, it may point to issues with stamina, retention, or test-taking strategy rather than knowledge alone.

Finally, remember that learning how to avoid burnout during dedicated study is just as important as improving your score. Be sure to leave enough time between your final practice exam and test day to review weak areas, build confidence, and avoid last-minute cramming.

Crafting Your Ideal COMLEX Level 2 Study Schedule with Elite Medical Prep

Making the most of your preparation time for the COMLEX Level 2-CE can feel overwhelming. With Elite Medical Prep, you’re not alone in this journey. Our team is equipped to help you strategize and optimize your study plan for maximum success.

Why Choose Elite Medical Prep for Your COMLEX Level 2 Preparation?

• Personalized Approach: Every medical student has their strengths and weaknesses. We analyze where you stand and tailor a COMLEX or dedicated board study schedule specifically to your needs.
• Time Management Guidance: Confused about how long to study for COMLEX Level 2? Our expert team will help you allocate your time effectively, ensuring every topic gets the right attention.
• Resource Recommendations: We don’t just help you with a Level 2 COMLEX study plan; we also recommend the best resources to complement your preparation.
• Practice Questions Review: Hone your skills with focused practice questions. Understand your mistakes and refine your approach for the real deal.
• Holistic Preparation: It’s not just about rote learning. Learn how to approach challenging material, assess yourself periodically, and stay on track with our guidance.

A Few Tips from Our Experts for COMLEX Level 2-CE:

• Self-Assessment: Always start your COMLEX Level 2 preparation by understanding where you stand. Recognize your strong and weak areas to allocate study time efficiently.
• Diverse Resources: Don’t rely solely on one resource. Diversify your materials and practice questions for more rounded preparation.
• Consistent Practice: Consistency is key. Regularly solve practice questions and periodically take mock tests to measure your progress.
• Mind the Gaps: While preparing for COMLEX Level 2, ensure you bridge the knowledge gaps from Level 1, reinforcing foundational concepts.

Navigating Medical Milestones with Elite Medical Prep

Embarking on a medical journey is filled with both challenges and rewarding milestones. Elite Medical Prep stands ready to illuminate your path, ensuring you excel at every significant turn, whether in medical school or transitioning into specialized domains. Here’s how we make a difference:

1. USMLE Step 1 Support: Establish a robust foundation in your medical school curriculum and step into the 3rd year with unmatched expertise, courtesy of our USMLE Step 1 preparation.
2. USMLE Step 2 CK (Step 2) Excellence: Transitioning from foundational knowledge to clinical applications is seamless with our focused strategies for USMLE Step 2CK.
3. USMLE Step 3 Strategy: We aid in refining your clinical decision-making skills, ensuring your USMLE Step 3 performance is top-notch.
4. COMLEX Level Suite:
   1. Level 1: Build your foundation with the first of the COMLEX level examinations.
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Having a COMLEX Level 2 study plan is important to keeping yourself organized and on track while studying for your exam. For more help customizing your study plan, reviewing your incorrect questions on practice tests or QBank questions, or talking through challenging material, consider enlisting the help of a 1-on-1 COMLEX Level 2 tutor!

Your success in COMLEX Level 2-CE is our goal. To learn more about how we can help you in preparing for COMLEX Level 2 and get deeper insights tailored to you, contact Elite Medical Prep today!

The post The Ultimate 4-Week COMLEX Level 2 Study Plan appeared first on Elite Medical Prep.

The finding points to a broader health care transformation grounded in medical excellence: using advanced tools and richer data to personalize disease detection. It also helps move medicine closer to the goals of value-based care: delivering the right care to the right patient at the right time.

“Breast cancer risk tools can help identify high-risk women who are most likely to benefit from more frequent breast cancer screening or risk reduction with medications,” said lead author Vignesh Arasu, MD, PhD, a research scientist at the Kaiser Permanente Division of Research and a radiologist with The Permanente Medical Group. “Our study shows that each of the 3 tests identifies a unique group of women, and that when all 3 risk tests are used we increase our ability to differentiate high-risk and low-risk women and provide more personalized screening recommendations.”

Related health care innovation story: Why health care innovation is essential during uncertain times

Combining risk scores strengthens breast cancer risk prediction

Published in the Journal of the National Cancer Institute, the study is one of the largest and most diverse to evaluate how well 3 scores predict breast cancer risk. Those scores included:

• Mammography AI algorithm, which predicts 5-year breast cancer risk based on the presence of imaging biomarkers. The technology assists radiologists by scanning mammography images in seconds to identify tiny, subtle lesions or calcifications that might be missed by the human eye.
• Polygenic risk score, which is determined by the presence or absence of 313 single nucleotide polymorphisms (SNPs) that prior studies have found to be associated with breast cancer.
• Clinical risk score, which considered factors such as age, race or ethnicity, family history of breast cancer, breast density, and body mass index.

The study included 82,957 women enrolled between 2003 and 2020 in the Kaiser Permanente Research Bank, a national biobank that includes medical records, survey, and genetic data from more than 400,000 Kaiser Permanente members. All study participants had a recent mammogram with no signs of breast cancer and no known genetic mutation or prior diagnosis that increased their risk.

Over a decade, 2,471 or 3% of the women in the study were diagnosed with invasive breast cancer or abnormal, cancerous cells in the lining of the milk ducts, but that had not spread to surrounding breast tissue. The model that combined all 3 risk scores was the most accurate, with a Concordance Index score of .70, indicating the predictive model has good accuracy. A score of .5 is equivalent to a coin flip, while 1.0 represents perfect accuracy. By comparison, the clinical risk tool scored .62, the polygenic test scored .61, and the combined clinical and polygenic risk scores reached .66.

Among women at the highest risk of developing breast cancer, the clinical risk score alone identified 19% of the women who developed breast cancer over a decade while the combined model identified 26% of these women.

Related value-based care story: How value-based care improves breast cancer survival rates

Personalized screening advances health care transformation

That ability to better match screening intensity to individual risk reflects a meaningful shift in health care transformation — one that brings together new tools, prevention, evidence-based medicine, and a commitment to improving care quality. It is also central to value-based care, where innovation is used to make care more precise, proactive, and personal.

The new research builds on prior research led by Dr. Arasu showing that AI-based mammography risk assessment more accurately predicted a woman’s future breast cancer risk than a clinical risk model.

“Our previous study showed that an AI risk score was slightly more accurate than a clinical risk score,” said Dr. Arasu. “This new study shows that by combining them, and by adding a polygenic risk score, we make a substantial improvement in accurately assessing risk.”

Read the full story on the Kaiser Permanente Division of Research website.

The post Study: AI, genetics, and clinical data improve breast cancer risk prediction appeared first on Permanente Medicine.

The era of “make and hope” is dead. For decades, pharmaceutical manufacturing has been shackled to a retrospective model—a legacy system where quality is a post-mortem exercise conducted after a batch is already finished. This “old-fashioned” reliance on manual science and slow, physical trials creates a dangerous bottleneck. While patients wait for life-saving therapies, medicine sits in a state of regulatory limbo. We are now witnessing a paradigm shift: the transition from reactive testing to molecular precision. The futurist’s mandate is clear: we must stop checking for quality and start building it digitally before a single molecule is ever processed.

From manual science to digital design (QbDD)

We are evolving beyond traditional Quality by Design (QbD). While QbD was a noble attempt to define a Quality Target Product Profile (QTPP), it remained tethered to labor-intensive experiments. The future belongs to Quality by Digital Design (QbDD).

This shift represents a fundamental rewriting of the manufacturing roadmap:

• Process understanding: We are moving from physical experiments and risk assessments to a world of molecular modeling and predictive analytics.

• Data usage: The reliance on historical batch data and limited “designed experiments” is being rendered obsolete by massive volumes of real-time data from IoT sensors and AI-driven insights.

• Control strategy: We are replacing predefined rules and end-product “batch testing” with Process Analytical Technology (PAT) that allows for constant, adaptive adjustments.

By moving the lab into a virtual environment, AI simulations allow us to explore thousands of scenarios in seconds, ensuring that Critical Quality Attributes (CQAs)—such as purity and dissolution—are locked in with mathematical certainty.

The “virtual mirror” of the factory floor

The centrepiece of this revolution is the Digital Twin (DT). To understand its power, one must recognise that a static 3D model is merely a map—a snapshot of a moment in time. A Digital Twin, however, is the GPS: a living, breathing replica that accounts for real-time traffic, weather, and road conditions.

“A Digital Twin is a virtual replica of a physical system or process… constantly updated with real-time data from its physical counterpart, allowing for simulation, analysis, and optimisation throughout the product’s lifecycle.”

This “virtual mirror” provides a temporal advantage legacy systems cannot match:

• Predictive maintenance: The twin identifies machinery fatigue before the physical part even fails, eradicating unplanned downtime.

• Process optimisation: It simulates “what-if” scenarios for Critical Process Parameters (CPPs)—like mixing speed and reaction kinetics—to find the “Golden Batch” without wasting a milligram of raw material.

• Quality assurance: It ensures the process stays within its “Design Space” continuously, providing a lifetime of data rather than a single point of failure.

A nervous system of molecular “eyes and ears”

A Digital Twin is only as smart as its senses. This is where Process Analytical Technology (PAT) serves as the factory’s nervous system. Utilising high-tech observers like Near-Infrared (NIR) and Raman spectroscopy, the system monitors chemical and physical changes at the molecular level in real-time.

When the sensors detect a microscopic deviation, the system doesn’t trigger a shutdown; it initiates a “Sense-Analyse-Adjust” cycle. If moisture levels shift, the AI calculates the impact on the final dissolution rate and automatically adjusts the granulation temperature. This invisible calibration is the vital bridge to the ultimate goal: the end of the waiting period.

Killing the wait with real-time release testing (RTRT)

Traditional batch testing is a relic of an era that accepted inefficiency. In the old way, finished medicine sits in a warehouse for 14 days while scientists perform manual lab tests. For a patient waiting for a Narrow Therapeutic Index (NTI) drug, where minor deviations in concentration can mean the difference between therapy and toxicity, this delay is a clinical risk.

Real-Time Release Testing (RTRT) turns the manufacturing process itself into the final test. Because the system “knows” the quality is perfect the moment the process ends, the medicine can be shipped immediately. This is not just an efficiency gain; it is a clinical breakthrough that ensures life-saving Biopharmaceuticals reach the bedside the moment they leave the line.

Solving the sustainability paradox

The transition to AI is often criticised for its high energy cost, but digital twins are the key to “Green Manufacturing.” We are mitigating the carbon footprint of AI through Green Simulations—a process of reusing previously processed data rather than starting every simulation from scratch.

This digital integration addresses the sustainability paradox with hard data:

• 15–25 per cent increase in energy efficiency: Achieved through optimised, AI-driven production cycles.

• Up to 25 per cent reduction in material waste: Early detection by AI prevents defective batches from being fully processed.

• Decarbonising the supply chain: Advanced analytics optimise logistics and prevent overproduction, significantly lowering greenhouse gas emissions.

Conclusion: Building quality at the molecular level

The Digital Twin revolution is more than a technological upgrade; it is a moral imperative. We are moving from a world where we “check” for quality to a world where we build quality digitally at the molecular level.

By creating virtual mirrors of our factories, we ensure that medicine is of higher quality, kinder to our planet, and—most importantly—ready when the patient needs it. We must ask ourselves: How many patients are we willing to let wait while a perfect batch of medicine sits in a two-week quarantine, tethered to the “old-fashioned” rules of a pre-digital age? The future of medicine is virtual, and the time to build it is now.

The post Beyond the batch: How digital twins are rewriting the rules of medicine appeared first on Express Pharma.

BOSTON, June 30, 2026 — The Physicians Foundation today announced findings from its 2026 Survey of America’s Physicians: Impact of Healthy Food on Chronic Disease Care and Prevention, revealing a critical disconnect in U.S. healthcare: while physicians recognize nutrition as foundational to preventing and managing chronic disease, the healthcare system is not fully equipped to enable its use – leaving many patients unable to follow clinical guidance.

Chronic disease may be diagnosed in the exam room, but too often it is shaped by whether patients can access nutritious food and make healthy lifestyle choices. At a moment when national attention is increasingly focused on nutrition as a core tool for improving health, a survey of more than 1,000 U.S. physicians, conducted in collaboration with Medscape, finds that gaps in access to key drivers of health – particularly healthy food – are contributing to worsening control of chronic conditions and limiting physicians’ ability to deliver effective care.

Key findings point to widespread challenges affecting both patients and physicians – and potential solutions to address these issues:

• More than three quarters of physicians (78%) encounter patients at least monthly whose chronic disease care is compromised by a lack of access to healthy food.
• Nearly half of physicians (45%) report that patients with chronic diseases frequently or almost always experience worsening control of symptoms primarily due to drivers of health, rather than clinical factors alone.
• 68% of physicians support insurance coverage for healthy food benefits to make it easier for patients with chronic conditions to make healthier lifestyle or diet choices.

“Physicians understand that nutrition is a critical clinical intervention to prevent and manage chronic disease,” said Dr. Gary Price, President of The Physicians Foundation. “When patients lack access to the healthy foods they need and therefore cannot follow clinical recommendations, it undermines care and leads to worse outcomes. As our survey makes clear, insurance coverage for nutritious food benefits is a crucial tool in enabling patients to follow their doctors’ guidance to eat real food.”

The Physicians Foundation’s findings reinforce the growing recognition across the country – including by leadership at the federal and state level – that improving access to nutritious food is essential to addressing diet-related and other chronic diseases and reducing healthcare costs. Aligning healthcare coverage, policy frameworks, and community resources to support nutrition-based care will be critical to improving outcomes and supporting both patients and physicians.

The Physicians Foundation is advancing research to better integrate drivers of health into care delivery and improve chronic disease outcomes.

Read the full survey results and methodology here.

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 The Physicians Foundation Survey Finds Lack of Access to Nutritious Food is Undermining Chronic Disease Care and Prevention appeared first on The Physicians Foundation.

Could shade matching be simpler than ever? This article uncovers why shade selection remains one of the biggest challenges in restorative dentistry – and how advances in digital workflows and simplified restorative systems may finally be making the process easier, more predictable and more efficient for clinicians.

Sometimes it’s getting the patient to say ‘yes’ to life-changing treatment, or it may be crafting the perfect tooth shape. For many, shade selection is the most challenging stage when crafting a perfect restoration (Hardan et al, 2022).

Perception depends on a light source, the object and the detector, which could be the human eye or new pieces of technology (Adebayo et al, 2022).

Understanding what can affect the shade matching process, and how modern solutions optimise restorative routines for more predictable, successful outcomes, is key for every dental professional. It can lead to greater confidence in their workflows, and seamless restorations that blend into their patients’ existing smiles.

Can we trust our eyes?

Shade matching for dental restorations has traditionally been completed with the naked eye, but this is a subjective process. It is therefore up to the clinician’s eyesight, past training, and lighting conditions within the practice when making an appropriate decision.

Complications can include colour vision problems or colour blindness, the changing of eyesight in tandem with ageing, fatigue, the influence of medications, binocular difference (the contrast of visual quality between the left and right eye), and the backgrounds or surroundings of a tooth influencing perception (Alayed et al, 2021).

To mitigate issues with the last complication, patients are often advised to not wear makeup or colourful eyewear, and a grey background is typically preferred.

Achieving accurate shade selection

Between clinicians, accurate shade selection can vary greatly. One study brought together a dental surgery technician, a specialist restorative dentist and a dental surgery intern to assess 26 teeth across 24 patients, comparing their assessments for shade selection. The VITA classical shade guide was used.

It found that inter-examiner reliability was very low for conventional shade selection, with all three professionals agreeing on a tooth shade unanimously on just one occasion – and there was complete disagreement in 42.3% of cases (Adebayo et al, 2022).

This isn’t an indictment on clinicians being inaccurate; rather, it displays the clear subjectivity of the process. Minimising this effect can lead to a more predictable, uniform aesthetic outcome that best suits a patient.

It’s therefore important to understand how modern solutions have changed the shade selection routine to achieve this.

When shade selection went digital

Modern shade selection routines may include contact-based instruments and non-proximity devices to aid the process. The former includes spectrophotometers and colorimeters, which are thought to be a gold standard in some approaches to care (Rashid, Farook and Dudley, 2023).

A 2024 study compared the use of dental guides to a spectrophotometer for shade selection and found a reduced variance with the digital solution, creating more reliable and reproducible results (Alvarado-Lorenzo et al, 2024).

Non-proximity devices will include professional digital cameras, intraoral cameras, and smartphone cameras. They have been found to produce more reliable clinical outcomes due to shade-matching results than conventional shade selection methods, but this is notable in that this is under controlled environments (Rashid, Farook and Dudley, 2023).

These have grown in popularity due to the increased acceptance of digitalisation and, in particular, automated diagnostic tools in dentistry. Intraoral scanners have been a leading aspect of this trend (Rashid, Farook and Dudley, 2023).

The latest stage of development is the use of digital imaging systems alongside artificial intelligence, which can create efficient, streamlined analysis of high-quality images.

Even the use of mobile phones as a shade selection aid is rising, in part due to their quality, and also the difficulties facing accessibility and handling of alternative adjuncts (Zilpilwar et al, 2025).

But what if the most optimal change, which would lead to enhanced aesthetics while balancing treatment efficiency and cost, lies in the restoratives used?

Clinical case

In the following clinical case, Dr Chris O’Connor restores form and function in extensive root caries with Solventum Filtek Easy Match Flowable Restorative.