The BioCentury Show

Najat Khan, CEO and President of Recursion Pharmaceuticals and former Johnson & Johnson R&D leader, explains how AI must prove itself by delivering real medicines. She discusses where AI is already adding value across biology, chemistry and clinical work. Topics include agentic AI for lab workflows, out-of-domain prediction, virtual cells and precompetitive consortia to build stronger shared data foundations.

There is a real opportunity for artificial intelligence to dramatically transform the speed, cost and efficiency of drug development over the long term, but the uptake of AI tools across biopharma has been much slower relative to the broader healthcare environment, SoftBank’s Jacqueline Fok said on The BioCentury Show.In conversation with BioCentury's Stephen Hansen, Fok, who is investment director, Life Sciences & Health Tech at SoftBank Investment Advisers, also detailed SoftBank’s investment strategy in life sciences and the opportunity the U.K. has to stand out as a globally competitive player, with SoftBank’s obesity portfolio company Metsera as a recent example of success.View full story: https://www.biocentury.com/article/658661#ArtificialIntelligence #DrugDevelopment #BiotechInvestment #UKBiotech #ObesityDrugDevelopment00:00 - Introduction01:30 - SoftBank Strategy08:40 - Metsera14:48 - U.K. Biotech21:38 - AI28:20 - Women in Leadership32:03 - Fok’s Catalysts

Peter Kolchinsky, managing partner and co-founder of RA Capital and outspoken biotech investor and policy advocate. He warns that FDA staffing and conservatism are slowing U.S. trials and pushing early-stage work overseas. He dives into MFN and drug pricing risks, offers a targeted MFN pilot idea, and urges stronger industry advocacy and international R&D collaboration while protecting manufacturing.

With disease biology still murky and trials notoriously noisy, psychiatry R&D is advancing fastest where teams can solve engineering problems. Delivery, selectivity and tolerability fixes are turning long-standing hypotheses into usable medicines, says veteran CNS drug developer Steven Paul. Few drug developers have had a closer view of the field’s false starts — and occasional breakthroughs — than Paul, who has moved from NIH to pharma R&D leadership and now to company building at Karuna, acquired by BMS for $14 billion, and Seaport.In conversation with The BioCentury Show's Selina Koch, Paul explains why serendipity still plays a disproportionate role in psychiatric drug development and how critical it is for teams to engineer and execute their way from an unexpected signal to a usable medicine. He also discusses psychedelics, brain shuttles, Karuna’s muscarinic approach in schizophrenia, and the delivery and trial-design choices Seaport is using to revisit neuroactive steroid biology in depression.View full story: https://www.biocentury.com/article/658314#PsychiatryTherapeutics #CNSDrugDevelopment #BiotechEngineering #Psychedelics #NeuroScience00:00 - Introduction01:32 - Psychiatric Drug Discovery06:56 - The Karuna Story22:09 - What’s New in Depression32:06 - Gene Therapies, Brain Shuttles33:53 - Psychedelics

Why does great science so often stall before it becomes a medicine? Astellas Pharma CEO Naoki Okamura argues the bottleneck isn’t capital — it’s translation: a shortage of people, processes and platforms that can move ideas across the boundaries of biology, manufacturing, regulation and commercialization. That theme threaded through his conversation on The BioCentury Show with Executive Editor Selina Koch, surfacing most clearly in his diagnosis of what Japan’s biotech ecosystem lacks — and in his rationale for why Astellas is doubling down on cell and gene therapy as other multinational pharmas pull back. The discussion also touches on Astellas’ journey in commercializing a women’s health product, the company’s China strategy, and its plans for life after Xtandi’s patent cliff.View full story: https://www.biocentury.com/article/658141#BiotechTranslation #CellAndGeneTherapy #JapanBiotech #PharmaStrategy #DrugDevelopment00:00 - Introduction00:39 - Cell & Gene Therapy07:22 - Women’s Health13:00 - Japan’s Biotech Ecosystem19:00 - Astellas’ China Strategy22:45 - Astellas’ Near-Term Strategy

Adam Koppel, a Partner at Bain Capital Life Sciences, dives into the evolving landscape of private equity in biopharma. He outlines why traditional PE shied away from biotech and how the sector has matured to require large-scale investments. Koppel shares Bain’s unique approach to prioritizing deals and maintaining capital discipline, even as average check sizes soar. He discusses the sustainability of this trend, raising concerns over development costs and company proliferation, while remaining optimistic about private financings and IPO readiness.

In historical terms, this is not a bear market, says Stelios Papadopoulos. There’s volatility, which is unnerving, and major issues to reckon with, but the level of anxiety in biotech doesn’t reflect the “extraordinary science, the likes of which we’ve never seen — and it’s getting better,” said Papadopoulos on The BioCentury Show.Papadopoulos is one of the long-term leading voices of biopharma, recognized for his influence in shaping the industry. Former chair of Biogen and current chair of Exelixis, with roles on several boards, and a background of nearly two decades as an investment banker, he brings a long view to how the industry has grown and the forces driving where it is headed. Tune in to hear his take on the financing environment for biotechs, company building, pricing pressure, innovation from China, and the future of big pharmas, in conversation with Editor in Chief Simone Fishburn.View full story: https://www.biocentury.com/article/657910#BiotechOutlook #DrugPricing #ChinaBiotech #BigPharma #BiopharmaStrategy00:00 - Introduction02:00 - Financing Environment10:18 - Company Building20:47 - Women in Biotech25:38 - China, Korea & Europe30:00 - Is Biotech Too Insular?

When Bill Hinshaw looks back across the arc of his career — from his early days helping to commercialize Gleevec to his present role leading Fore Biotherapeutics — he sees a precision oncology field transformed by technological ambition, yet still grappling with many of the structural challenges that defined its beginnings, now compounded by the difficulty of positioning therapies within an ever more complex treatment landscape.Gleevec proved the power of targeting a genomic driver, but the healthcare system around it was far from ready. “We weren’t able to fulfill the promise as fast as we wanted to until that scaling happened,” Hinshaw told The BioCentury Show — a reminder that even today, precision medicines succeed or fail based not only on their biology but on the infrastructure that enables patients to access them.Hinshaw sat down with Executive Editor Selina Koch on The BioCentury Show to discuss what’s changed in precision oncology, what’s stayed the same, and how he’s applying those lessons to steer Fore’s BRAF-focused program.View full story: https://www.biocentury.com/article/657768#PrecisionOncology #BRAFAlterations #NGSTesting #MasterProtocol #TargetedTherapies00:00 – Introduction00:47 – Precision Medicine’s Evolution09:22 – Zeroing in on Subtypes17:59 – Fore’s BRAF Inhibitor26:38 – Fore’s Development Approach32:01 – Moving from Pharma to Biotech

This is a previously recorded episode of The BioCentury Show from September 5, 2025. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.If you could redesign FDA from the ground up, what would it look like? That’s the fundamental question underlying the 2025 BioCentury Back to School essay, authored by BioCentury Washington Editor Steve Usdin, who has been a leading voice on regulation and policy for over two decades. The topic is especially meaningful in this era of FDA turmoil, when regulatory risk has piled on top of the market pullback, making biotech appear an unusually hazardous domain for investors. But while the current landscape has underscored the need, FDA reform has been on the table long before this administration came into power. On this edition of The BioCentury Show, Usdin and Editor in Chief Simone Fishburn discuss the key arguments, and some specific concepts, within Back To School, which reimagines the U.S. drugs regulator.View full story: https://www.biocentury.com/article/656928#FDA #DrugRegulation #Biopharma #LifeSciences #Biotech #PublicTrust00:00 - Introduction02:39 - Restructuring FDA18:08 - A Learning Regulatory Agency27:54 - Global View31:09 - Talent32:59 - User Fees

Elias Zerhouni personifies the American dream. He arrived in the U.S. from Algeria as a young man with a couple of hundred dollars in his pocket. Talent, ambition and hard work propelled him into a successful academic career. In 2002, he was nominated and confirmed as NIH director, and later he served in senior positions in the biopharma industry. That trajectory “would be almost impossible” today, he told BioCentury Washington Editor Steve Usdin on The BioCentury Show.Anti-immigration policies, underfunding of basic research, and attacks on philanthropy have made the U.S. an unattractive destination for anyone hoping to follow his path, Zerhouni said.Zerhouni also discussed reasons for optimism about life sciences in the U.S., the difficulty of fixing drug pricing, and his time at Sanofi.View full story: https://www.biocentury.com/article/657591#NIH #BiomedicalInnovation #ImmigrationPolicy #Biopharma #LifeSciences #HealthcareReform #MedicalResearch01:09 - The American Dream & Science05:51 - Zerhouni at NIH09:40 - Loss of Trust16:53 - Vaccine Policy20:12 - Zerhouni in Industry23:20 - Drug Pricing