The BioCentury Show

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

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 #PharmaInnovation00:00 - Introduction01:15 - Becoming a Biotech CEO11:40 - MASH18:15 - First v. Best in Class24:10 - 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 #BiotechInnovation00:00 - Introduction01:07 - Degraders' Appeal07:22 - Glue vs. Heterobifunctional16:12 - Translating a New Modality24:14 - 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 #BiotechInvesting00:00 - 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 #InnovationVsAccess00:00 - Introduction00:48 - MFN Drug Pricing11:06 - Tariffs18:27 - China Policy23:58 - Vaccines27:03 - IRA

In this engaging conversation, Steve Usdin, Washington Editor at BioCentury with over twenty years of experience in FDA reporting, explores the future of drug regulation. He discusses ideas for restructuring the FDA, including a dedicated agency model and independent oversight. Usdin highlights the Oncology Center of Excellence as a potential blueprint for innovation. He also advocates for learning-driven approaches to regulatory failures and new funding alternatives to restore public trust in the system.

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 #TalentAttraction00:00 - Introduction02:52 - State of U.K. Biotech13:15 - Improving U.K.’s Path to Clinic18:50 - What’s Next for MHRA24:53 - Changes at FDA29:58 - Working with China