Caution: This episode of The BioCentury Show contains strong language.

In a candid interview with BioCentury, RA Capital Managing Partner Peter Kolchinsky warns that staffing losses and growing conservatism at FDA are slowing drug development and pushing companies to launch early-stage trials outside the U.S.
In conversation with BioCentury Washington Editor Steve Usdin, Kolchinsky also discusses U.S. policy headwinds, including most-favored-nation (MFN) pricing proposals and the Inflation Reduction Act’s “pill penalty,” and why he’s concerned that the biopharma sector is too “genteel” in its advocacy. Kolchinsky explains his decision to speak publicly about regulatory and political issues, including immigration, and reflected on China’s expanding role in the global life sciences innovation ecosystem.

View full story: https://www.biocentury.com/article/658433

#BiotechPolicy #FDALeadership #DrugPricingPolicy #LifeSciencesInnovation #CapitalMarkets

00:00 - Introduction
00:37 - Impact of FDA Policy Changes
06:17 - MFN & Drug Pricing in Europe
20:16 - The Importance of Speaking Up
34:26 - China & Innovation

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