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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 #NeuroScience 00:00 - Introduction 01:32 - Psychiatric Drug Discovery 06:56 - The Karuna Story 22:09 - What’s New in Depression 32:06 - Gene Therapies, Brain Shuttles 33:53 - 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 #DrugDevelopment 00:00 - Introduction 00:39 - Cell & Gene Therapy 07:22 - Women’s Health 13:00 - Japan’s Biotech Ecosystem 19:00 - Astellas’ China Strategy 22:45 - Astellas’ Near-Term Strategy

Private equity’s expanding role in biopharma as a growth equity investor reflects both the maturation of the life sciences sector and the rising need for large-scale capital, alongside PE firms’ increasing ability to conduct the technical diligence required for investments once considered too risky for their models. In conversation with The BioCentury Show's Stephen Hansen, Bain Capital’s Adam Koppel discussed the evolution of private equity's interest in biotech, Bain’s prioritization scheme for scaled investments and his outlook for the capital markets in the year ahead. View full story: https://www.biocentury.com/article/657997 #PrivateEquity #BiotechDeals #LifeSciencesInvesting #GrowthEquity #BiopharmaMarkets 00:00 - Introduction 01:57 - PE's Evolution in Biotech 06:58 - Bain's Priorities 11:24 - Structuring Deals 18:23 - Capital Market Conditions 24:03 - Environment for Private Companies 27:08 - IPO Outlook

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 #BiopharmaStrategy 00:00 - Introduction 02:00 - Financing Environment 10:18 - Company Building 20:47 - Women in Biotech 25:38 - China, Korea & Europe 30:00 - 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 #TargetedTherapies 00:00 – Introduction 00:47 – Precision Medicine’s Evolution 09:22 – Zeroing in on Subtypes 17:59 – Fore’s BRAF Inhibitor 26:38 – Fore’s Development Approach 32:01 – 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 #PublicTrust 00:00 - Introduction 02:39 - Restructuring FDA 18:08 - A Learning Regulatory Agency 27:54 - Global View 31:09 - Talent 32:59 - 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 #MedicalResearch 01:09 - The American Dream & Science 05:51 - Zerhouni at NIH 09:40 - Loss of Trust 16:53 - Vaccine Policy 20:12 - Zerhouni in Industry 23:20 - Drug Pricing

It took Sophie Kornowski under four years as CEO of Boston Pharma to bring it from a pipeline full of in-licensed assets to an acquisition by GSK for about $2 billion in total deal value for a single MASH program. Though her first gig as a biotech CEO, Kornowski’s success was built on her years of experience as head of partnering at Roche. She discussed that pivot and the value of rolling your sleeves up on the latest episode of The BioCentury Show. View full story: https://www.biocentury.com/article/657446 #BiotechLeadership #DrugDevelopment #PharmaDeals #BiotechCEO #StartupSuccess #LifeSciences #MetabolicDisease #PharmaInnovation 00:00 - Introduction 01:15 - Becoming a Biotech CEO 11:40 - MASH 18:15 - First v. Best in Class 24:10 - GSK Deal

Kymera Therapeutics has a clear mission: to transform immunology with targeted protein degraders that enable “oral drugs with biologics-like activity,” CEO Nello Mainolfi told The BioCentury Show. A pioneer in one of biopharma’s most closely watched new therapeutic modalities, Kymera is now over nine years into its story, with multiple pharma partnerships and a wholly owned pipeline, including a STAT6 degrader that produced promising data in June. In conversation with BioCentury’s Selina Koch, Mainolfi discusses the appeal of degraders, the rationale for choosing glues or heterobifunctional degraders and how to prove a new modality on a new target without incurring biology risk. View full story: https://www.biocentury.com/article/657297 #ProteinDegradation #DrugDiscovery #MolecularGlues #HeterobifunctionalDegraders #Immunology #RationalDrugDesign #BiotechInnovation 00:00 - Introduction 01:07 - Degraders' Appeal 07:22 - Glue vs. Heterobifunctional 16:12 - Translating a New Modality 24:14 - Partnerships

The frenzy among Western companies to access China’s biotechnology innovation is remaking the landscape for cross-border dealmaking, with assets becoming more expensive and partnerships earlier and broader than ever before. That’s being driven by exceptional capital efficiency, access to patients and speed of development, said Frazier Life Sciences’ James Li on The BioCentury Show podcast. Among multinational companies, “every company has an army on the ground hunting for assets,” said Li, who has more than 30 years of biotech experience, as an investor, company builder and executive at an MNC and a biotech. View full story: https://www.biocentury.com/article/657156 #ChinaBiotech #Biopharma #CrossBorderDeals #LifeSciences #DrugDevelopment #HealthcareInnovation #BiotechInvesting 00:00 - Introduction  02:18 - Evolution of an Ecosystem  04:31 - NewCo Deals  10:30 - Japan, Korea  15:30 - Dealmaking

President Donald Trump’s demands for “most favored nation” drug pricing presents the biopharma industry with an immense public policy challenge. Drug companies are convinced that meeting the president’s demand to reduce U.S. prices to levels below those of other industrialized countries would decimate the industry. On this episode of The BioCentury Show, Fritz Bittenbender, SVP of Roche's Genentech unit and chairman of BIO, discusses the industry’s responses to the MFN challenge, and some of the under-appreciated nuances of policy options. He notes that reducing or eliminating payments to PBMs would lead to higher insurance premiums. While drug companies are scrambling to meet Trump’s Sept. 29 deadline to make voluntary pricing concessions, Bittenbender says a more comprehensive deal should be made that reduces out-of-pocket costs, preserves patient access and supports biomedical innovation. The interview touches on other hot button public policy issues, presenting the biotech industry’s views on reforming the Medicare drug pricing negotiation program, tariffs, and prospects for reviving the Biosecure Act. View full story: https://www.biocentury.com/article/657021 #DrugPricing #HealthPolicy #MFN #BIO #DrugPolicy #MedicarePartD #MedicarePartB #PBMs #Tariffs #InnovationVsAccess 00:00 - Introduction 00:48 - MFN Drug Pricing 11:06 - Tariffs 18:27 - China Policy 23:58 - Vaccines 27:03 - IRA

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 #PublicTrust 00:00 - Introduction 02:38 - Restructuring FDA 18:04 - A Learning Regulatory Agency 27:48 - Global View 31:04 - Talent 32:54 - User Fees

A new head at MHRA, a streamlined government life sciences strategy, and a more sophisticated innovation ecosystem have Annalisa Jenkins optimistic about the future of U.K. biotech — and its potential to carve out a stronger global role. On The BioCentury Show, Annalisa Jenkins, chair of Gemma Biotherapeutics, discussed the evolving landscape of biotech in the U.K. and the critical hurdles it faces as it implements the latest strategy. Jenkins, who was president and CEO of Dimension Therapeutics, is a committee member on the Science Board to FDA, a board member of Genomics England and Faster Cures, and chair of the court at the London School of Hygiene and Tropical Medicine. View full story: https://www.biocentury.com/article/656787 #UKBiotech #MHRA #BiotechStrategy #GrowthCapital #RegulatoryScience #TalentAttraction 00:00 - Introduction 02:52 - State of U.K. Biotech 13:15 - Improving U.K.’s Path to Clinic 18:50 - What’s Next for MHRA 24:53 - Changes at FDA 29:58 - Working with China

This is a previously recorded episode of The BioCentury Show from March 19, 2025. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes. Vertex’s approach to research, defined over a decade ago to beat the dismal odds of success in biotech, remains core to its strategy, even as the industry evolves and technologies expand. While that strategy, which EVP and CSO David Altshuler calls “serial innovation,” has seen the company launch eight drugs since 2011 and jump market cap tiers on the success of its cystic fibrosis portfolio, it’s now being tested in other areas as Vertex expands to pain, renal disease, Type I diabetes, and more. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Altshuler discussed the rising interest in causal biology and the role of AI, noting that the fundamentals of picking targets and programs have not changed. View full story: https://www.biocentury.com/article/655408 #biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment #AI 00:00 - Introduction 02:17 - Causal Biology 08:54 - AI in R&D, at Vertex 16:42 - Academia-Industry Interface 22:08 - Cell Therapy for Diabetes 25:44 - Gene Therapy for DMD

In an environment where everybody hurts, it helps for biotech CEOs to understand the pressures driving pharmas, investors and other key players if they want to secure deals and financings that will help them succeed. That’s how John Lepore, CEO of Profound Therapeutics and former head of research at GSK, is navigating his early stage company through this capital-constrained era as he builds it from the ground up. Speaking on The BioCentury Show in conversation with Editor in Chief Simone Fishburn, Lepore discussed how he approaches partnering, how he manages the need to both build a platform and generate products, and the science driving the company’s technology. View full story: https://www.biocentury.com/article/656568 #biotech #biopharma #pharma #lifescience #BiotechLeadership #PartneringStrategy #TargetDiscovery 00:00 - Introduction 01:17 - From GSK to Biotech CEO 04:50 - Dealmaking 15:26 - ProFound’s Platform 24:13 - Building a Biotech: Team, AI