The BioCentury Show

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

James Li, venture partner at Frazier Life Sciences with 30+ years in biotech and former JW Therapeutics CEO, talks about China’s booming biotech deal scene. He outlines regulatory reforms that sparked growth. He explains NewCo deal models, shifting from late-stage to earlier, broader partnerships. He compares China’s speed and capital efficiency with Japan, Korea and Singapore.

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

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 #AI00:00 - Introduction02:17 - Causal Biology08:54 - AI in R&D, at Vertex16:42 - Academia-Industry Interface22:08 - Cell Therapy for Diabetes25:44 - 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 #TargetDiscovery00:00 - Introduction01:17 - From GSK to Biotech CEO04:50 - Dealmaking15:26 - ProFound’s Platform24:13 - Building a Biotech: Team, AI

Gillian Woollett, head of regulatory strategy and policy at Samsung Bioepis, shares her expertise on biosimilars regulation. She argues that streamlining FDA processes could cut development time and costs significantly. Woollett highlights the commercial challenges in the U.S., particularly the impact of pricing policies on investment in biosimilars. She also addresses the complexities of interchangeability and emphasizes the need for improved incentives to bolster market entry and competition for biosimilars.