STAT+: Pharmalittle: We’re reading about Trump’s drug tariffs, a U.S.-U.K. pharma trade deal, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest so far. We plan to tidy up around the castle, promenade with the official mascots, and catch up on our reading. We also plan another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The change of seasons opens up all sorts of possibilities, from long walks through woods to strolling along city streets to drives through the countryside. Of course, if the weather fails to cooperate, you could open a book, watch the telly, or spin a platter and dance about. Or maybe it is an opportunity to connect with someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The Trump administration announced 100% tariffs on imported brand-name drugs — but with significant caveats, STAT explains. Many large drugmakers will not have to pay the tax because they struck deals with the U.S. to build manufacturing facilities here and lower the prices of their medications. Drugmakers that have not struck such deals but pledge to bring production to the U.S. can have tariffs reduced to 20% for the remainder of Trump’s term. The tariffs open a new front in the Trump administration’s efforts to rein in the pharmaceutical industry and in its push to bring manufacturing back to the U.S. The announcement comes as Trump has looked to emphasize his administration’s work to make prices — especially for medicines — more affordable ahead of the midterm elections.

Meanwhile, the Trump administration is negotiating more drug-pricing deals, now with smaller companies, according to STAT. The new talks offer a pathway for smaller pharmaceutical companies — those not included in the first round of deals — to pledge lower prices and potentially avoid tariffs or new pricing policies through Medicare. The negotiations suggest the administration is looking to replicate the strategy it used with larger drugmakers: extract voluntary, confidential agreements in pursuit of lower prices and more domestic manufacturing. They also offer smaller players in the sector the chance to cut a deal and gain more certainty about how they might be affected by federal policies. But the number of companies in talks with the administration remains unclear, as does whether or when the sides will reach agreement.

Continue to STAT+ to read the full story…

Hydrogel-Based Axon Model Improves Early Testing for MS Remyelination Therapies

Axons—the long, cable‑like projections that relay electrical signals across the nervous system—depend on tightly wrapped layers of myelin to keep those messages fast and reliable. When this insulation is damaged, as in multiple sclerosis (MS) and other neurodegenerative diseases, signal transmission slows and neurons eventually degenerate. Although oligodendrocytes can repair myelin early on in the process, this capacity declines with age and repeated inflammatory attacks, leaving researchers searching for therapies that can restore myelin more effectively.

A team at University College London (UCL) has now developed a more physiologically realistic way to study how myelin forms—and how potential drugs might influence that process. Their new hydrogel‑based axon model, described in Nature Methods in a paper titled “Tunable hydrogel‑based micropillar arrays for myelination studies,” recreates both the geometry and softness of real axons. The platform is designed to address a longstanding problem in the field: many drug candidates that appear promising in rigid, plastic‑based lab models ultimately fail in human trials.

“To stop MS, we need therapies that repair myelin,” said senior author Emad Moeendarbary, PhD, professor of cell mechanics and mechanobiology at UCL and CEO of BioRecode. “Promising drug candidates in the past have failed when tested in human patients. One factor might be that laboratory models do not replicate the basic physical properties of the human brain.”

The UCL team engineered vertical micropillars—each tens of times thinner than a human hair—using a microfabrication process called photolithography that allowed them to precisely tune diameter, spacing, and stiffness. Unlike earlier artificial axons made from hard polymers, these pillars are composed of polyacrylamide hydrogel, a material whose elasticity can be adjusted to match the ~5 kPa softness of native axons. As the authors noted in the paper, the system “mimics the three‑dimensional architecture and softness of axons,” enabling oligodendrocytes to form “multilayered compact myelin” around the pillars.

The researchers seeded the hydrogel pillars with human and rodent oligodendrocytes and tested several candidate remyelination drugs. When the pillars were tuned to realistic softness, drug performance dropped—suggesting that overly rigid models may have produced misleading hits in the past. “Our work suggests that commonly used rigid models, hundreds of times stiffer than real axons, can generate misleading drug hits,” Moeendarbary said. “We believe that our more life-like model can be used as a more robust early test of drug candidates and as a platform to discover new drugs.”

The study also marks the first demonstration of compact, multilayered myelin grown from human oligodendrocytes in a fully hydrogel‑based system. The platform’s design allows high‑content imaging, transcriptomic profiling, and systematic variation of mechanical cues—capabilities that could help researchers dissect how myelin forms and why it fails in disease.

Building such a soft, microscale structure was not trivial. “Hydrogel is a close mimic of living cells… but to fabricate a soft hydrogel at such a small scale is not an easy task,” Moeendarbary noted, crediting the five years of work led by PhD student Soufian Lasli and Claire Vinel, PhD.

By more faithfully recreating the physical environment of the brain, the UCL team hopes their model will provide a more reliable proving ground for remyelination therapies before they reach clinical trials.

The post Hydrogel-Based Axon Model Improves Early Testing for MS Remyelination Therapies appeared first on GEN – Genetic Engineering and Biotechnology News.

AI In Silico Multi-Omics Technique Cuts Therapeutic Development Costs

Bringing a drug from discovery through clinical trials takes too long and is too expensive, with preclinical costs alone estimated at $15 to $100 million. Employing artificial intelligence (AI) early in the process can lower those costs dramatically.

AI itself isn’t a panacea, though, Jayson Uffens, CTO and chairman of GATC Health, tells GEN. Instead, “Smart computing makes smart people smarter. There’s still a lot of expertise from people on the ground who bring a lot of value—maybe the ultimate value—to the mix.”

GATC Health, an AI-driven therapeutic discovery company, uses AI to raise the floor on opportunities to get high-potential compounds into human studies faster and thereby drive success.

Its proprietary approach to hit and lead identification and program derisking can cut preclinical development costs, according to Uffens, who maintains that the earlier AI is used in a program, the more dramatic the results.

The success GATC Health touts is based on deploying Operon™, the company’s proprietary AI platform. Operon deploys in silico models to simulate human biology and takes a multi-omics approach to analysis. That approach has allowed GATC to deliver three to five optimized compounds within six months, claims Uffens, versus the up to 48 months associated with traditional high-throughput screening methods.

Such acceleration occurs by using advanced in silico models to circumvent the “hundreds of thousands of dollars’ worth of experiments performed to get a hit and, ultimately, a lead,” Uffens says.

Rather than relying upon one huge model, he elaborates, “We attack the problem from multiple facets, looking at individual problems with various models and different architectures…and coordinate hundreds of AI models to answer different questions. That’s the starting point. There’s a lot of value in how we curate and parameterize our data in those specific contexts.”

The company also launched the Derisq™ AI Report, an in-depth analysis of drug candidates that highlights safety concerns, efficacy, and non-obvious risks early, while decision-makers can still modulate those risks.

This predictive intelligence layer is, in fact, a key element of GATC’s clinical trial insurance product. Underwritten by Medical and Commercial International (MCI) under the Lloyd’s of London framework, this insurance product leverages GATC’s predictive capabilities to identify risk. It reimburses the full cost of the trial if safety or efficacy endpoints aren’t met.

Typically, MCI’s preclinical trial insurance clients would provide that company with the relevant trial information, which would be run through the Derisq tool as part of their risk analysis.

Buyers for this insurance tend to be biopharma companies that aren’t large enough to self-insure their own trials. “Capital is expensive for them,” Uffens points out. “The insurance product is there to help them lower the cost of capital and open capital doors that may not be open otherwise.”

Multiomics to Discovery

What’s different about GATC’s approach to AI, Uffens says, is that “We come in, generally, as outsiders.” The founding team includes computer scientists as well as those with strong biology and genetics backgrounds, but not necessarily industry experience.

“We built our technology originally as a genetics interpretation platform,” he recalls, “and expanded it to find additional value.” The company was formed officially in 2020.

The turning point came when GATC became involved in a failed, big pharma program for addiction research.

“(The big pharma company) hadn’t found a solution, but had really valuable data and samples. A partner of ours was working with it to identify biomarkers and thought we could validate them. We discovered that not only could we validate the biomarkers, but we could also identify the therapeutic targets. That’s how we moved from multi-omics analysis into discovery,” Uffens recalls.

Moving forward, “We want to empower researchers,” he says. This means not only helping clients advance existing programs but also by identifying potentially more valuable targets.

Working with GATC

GATC’s key partners most likely will be biotech rather than big pharma, Uffens predicts. And, he notes, “We’re fairly agnostic to therapeutic area.”

“Most of our customers have called us because they want to realize the benefits of AI sooner rather than later,” Uffens says. “There is a lot of risk in the space. Folks who are willing to adopt AI at this stage…are looking for additional help before they risk more capital…” to solve particular challenges.

For a company to begin working with GATC, he explains, “The data we’re looking for is very similar to what they would include in an Investigational New Drug (IND) package. The earlier they are in the process, the less data they will have, but, at a minimum, we need some particulars on their therapeutic’s chemistry and the intended mechanism of action.”

Challenges

Drug development is a difficult space with plentiful challenges, he admits. Therefore, “We approach things as a tech company. We iterate through a problem and find where we can succeed or fail as quickly as we can to develop a solution. We’ve gone through multiple generations of architectures, finding ways that work best.”

The next milestone is to accumulate multiple successes with Operon and Derisq in human trials. “‘Wins in humans’ is our [next] frontier,” he says. That includes wins for its insurance underwriting partners as well as for companies working directly with GATC to advance therapeutics to human trials.

As part of that goal, GATC and BioAtla are closing a deal for a Phase III trial of ozuriftamab vedotin for oropharyngeal squamous cell carcinoma and to further develop conditionally active biologic senolytic therapies. Termed a special purpose vehicle transaction—a financial entity designed to hold specific assets that last for the life of the project—the $40 million deal formed Inversagen AI, LLC, to leverage the strengths of the founding companies.

“GATC and BioAtla are equal partners in Inversagen,” Uffens says. “GATC will own a percentage of ozuriftamab vedotin and a larger stake in future joint discoveries,” thus potentially discovering new therapeutic combinations that may be effective as conditionally active biologics.

Currently, the GATC is fine-tuning its own project prioritization. “The AI landscape is both beneficial and challenging,” Uffens acknowledges. “People have certain expectations about what AI can and should do, how it works, and how they might adopt it. Getting them to hear our unique perspective comes back to our focus on wins in humans.”

The post AI <i>In Silico</i> Multi-Omics Technique Cuts Therapeutic Development Costs appeared first on GEN – Genetic Engineering and Biotechnology News.

Commercial or industrial use of mental health data for research: primer and best-practice guidelines from the DATAMIND patient/public Lived Experience Advisory Group

BackgroundRoutinely collected health data, such as that held by United Kingdom (UK) national health services (NHS), has important research uses. However, its use requires public trust and transparency. Access by commercial/industrial organisations is especially sensitive for the public, as is mental health (MH) data. Although existing MH data science guidelines emphasise patient/public involvement (PPI), they do not cover commercial uses specifically.ObjectivesTo develop patient- and public-led guidelines for the commercial and industrial use of MH data for research. Though UK-focused, their principles may apply internationally.MethodsA PPI Lived Experience Advisory Group (LEAG) was created within DATAMIND, a UK data hub for MH informatics. Initial discussion yielded a requirement for definitions and explanations of concepts relating to MH data research, developed iteratively. Subsequently, the LEAG developed guidelines via a qualitative quasi-Delphi approach. The agreed scope excluded data provided for research with informed consent, data processing arrangements (e.g. companies hosting electronic systems on the instruction of health services), and compliance with legal minimum requirements. The scope included the use of routinely collected MH data for research by commercial/industrial organisations without explicit consent, and aspects of industry-led MH data collection conducted with consent.ResultsAlongside the primer in MH data research concepts, the LEAG provide best-practice guidelines relating to commercial/industrial research use of MH data, for organisations controlling MH data (such as NHS bodies) and for commercial applicants seeking access. Core principles include transparency, patient rights, meaningful PPI, stringent governance, and statistical disclosure control. The guidelines recommend a risk–benefit approach to assessing data access applications, within limits that include avoiding the export of unconsented patient-level data outside NHS-controlled secure data environments, and not providing commercial applicants with access to unconsented free-text MH data. Further recommendations for NHS executive and regulatory bodies relate to public choice and transparency, clarity of guidance to research-active NHS organisations, and support for de-identification.ConclusionsMH data research requires patient/public involvement and understanding. These guidelines reflect the views of people with personal or family experience of mental ill health. We hope they are useful to the MH research community and increase public transparency and trust.

The Performance of Wearable Device–Based Artificial Intelligence in Detecting Depression: Systematic Review and Meta-Analysis

Background: In recent years, advances in wearable sensor technology and artificial intelligence (AI) have provided new possibilities for detecting and monitoring depression. Objective: This study systematically reviewed and meta-analyzed the diagnostic and predictive performance of wearable device–based AI models for detecting depression and predicting depressive episodes and explored factors influencing outcomes. Methods: Following PRISMA-DTA (Preferred Reporting Items for a Systematic Review and Meta-Analysis of Diagnostic Test Accuracy) guidelines, the PubMed, Embase, Web of Science, and PsycINFO databases were searched from inception to May 27, 2025. Eligible studies used AI algorithms on wearable device data for depression detection or episode prediction. Sensitivity, specificity, diagnostic odds ratio, and area under the curve (AUC) were pooled using a bivariate random effects model. Risk of bias was assessed using Prediction Model Risk of Bias Assessment Tool plus artificial intelligence (PROBAST+ AI), and certainty of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool. Results: We included 16 studies (32 datasets) with 1189 patients and 13,593 samples. For depression detection, pooled sensitivity and specificity were 0.89 (95% CI 0.83‐0.93) and 0.93 (95% CI 0.87‐0.96), with a diagnostic odds ratio of 110.47 (95% CI 33.33‐366.17) and AUC of 0.96 (95% CI 0.94‐0.98). Random forest models showed the best performance (sensitivity=0.89, specificity=0.91, AUC=0.97). Subgroup analyses indicated that study design, AI method, reference standard, and input type significantly affected diagnostic accuracy (<.05). For depressive episode prediction (3 datasets), pooled sensitivity was 0.86 (95% CI 0.80‐0.91), and pooled specificity was 0.65 (95% CI 0.59‐0.71). The overall risk of bias was low to moderate, with no evidence of publication bias. Conclusions: Wearable device–based AI models achieved high accuracy for detecting depression and moderate utility in predicting episodes. However, heterogeneity, reliance on retrospective and public datasets, and lack of standardized methods limited generalizability. Trial Registration: PROSPERO CRD420251070778; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251070778

[Comment] Lived experience perspectives on the development of a Psychosis Metabolic Risk Calculator (PsyMetRiC)

In this issue of The Lancet Psychiatry, Benjamin Perry and colleagues1 present a collaboratively developed, refined, and externally validated risk prediction tool (the Psychosis Metabolic Risk Calculator [PsyMetRiC]) that is clinically available, and that can separately predict the risk of clinically significant weight gain, metabolic syndrome, and type 2 diabetes in young people with psychosis. Key to the collaborative development of PsyMetRiC has been the involvement of young people with a lived experience of psychosis, supported by the McPin Foundation and Equally Well UK.

ARIA funding

We’re proud to share that Relatix Bio has applied for funding from the UK’s Advanced Research and Invention Agency (ARIA) under their Trust Everything, Everywhere programme. This initiative explores how trust can be built across the digital and physical worlds, and we believe this conversation must include those whose minds work differently.

Our proposal focuses on one of the most pressing and least understood challenges of the digital age: how people with neurodevelopmental and neurodiverse conditions — including autism, ADHD, schizophrenia, borderline traits, and psychopathy — experience, interact with, and build trust in AI systems. In a world increasingly mediated by algorithms, the ways these systems interpret, respond to, and store our most personal thoughts and data matter profoundly.

Throughout history, individuals living with stigmatised neurocognitive conditions have been marginalised or misrepresented — by institutions, by society, and now, potentially, by AI. Some may over-trust technology that feels neutral or supportive; others may under-trust it due to past harm or bias. We want to ensure that digital systems meet people where they are — building trust rather than eroding it. Protecting privacy, and supporting quality of life, health and wellbeing.

Through our work, Relatix Bio aims to lead the way in ethical and inclusive neuro-AI design: protecting privacy, removing stigma, and defining standards for responsible data handling in the era of AI. Our goal is to make sure that the next generation of AI-driven tools — from chatbots to diagnostics — truly serve everyone, regardless of how their brain is wired.

We know how often in the past things have gone wrong — from chatbots unintentionally encouraging depressive or paranoid thoughts, to credit and gambling platforms optimising for addiction or impulsive behaviour. These systems were built without safeguarding those with neurodevelopmental conditions, who may react differently to AI optimised interactions. Many respond by disengaging digitally, and may be feeling that an AI-driven world is a minefield — because it wasn’t built for them.

Join us in shaping a radically different future where cognitive diversity and digital trust can coexist, and AI tools are built to truly support and facilitate. To learn more about our mission or to collaborate contact our team.