Ep. 92 - Reimagining FDA: Steve Usdin on Designing the Drug Regulator of the Future
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 - Introduction02:38 - Restructuring FDA18:04 - A Learning Regulatory Agency27:48 - Global View31:04 - Talent32:54 - User Fees
--------
38:43
--------
38:43
Ep. 91 – Annalisa Jenkins: How MHRA’s Reset Could Revive U.K. Biotech
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
--------
36:07
--------
36:07
Popular Episode - Vertex’s Winning Formula: Altshuler on Choosing the Next Breakthroughs
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
--------
32:44
--------
32:44
Ep. 90 – Inside Biopharma Dealmaking: ProFound CEO John Lepore on Knowing What Partners Want
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
--------
33:05
--------
33:05
Ep. 89 - Delivering on the biosimilars promise, a conversation with Gillian Woollett
Gillian Woollett, head of regulatory strategy and policy at Samsung Bioepis, discusses how FDA can deliver on its promise to “massively streamline” the regulation of biosimilars. Eliminating unnecessary clinical trial requirements could halve the time and cost of developing a biosimilar, according to Woollett.While regulators around the world are converging on ideas that will slash development times, commercial challenges, especially in the U.S., are far more challenging. The Medicare Drug Price Negotiation Program has undermined the economic rationale for investing in biosimilars. President Donald Trump’s proposals for most favored nation pricing would “kill” the industry, Woollett said.View full story: https://www.biocentury.com/article/656445#biotech #biopharma #pharma #lifescience #DrugDevelopment #FDA00:00 - Introduction02:50 - Halving the Time and Cost10:30 - Interchangeability15:50 - The Importance of Market Share22:08 - Most Favored Nation
Tune in to BioCentury’s in-depth conversations with global leaders who are advancing the future of medicine.Join our Senior Editors in face-to-face discussions with scientific KOLs, top executives, VCs, and key policymakers, dissecting the most urgent public health issues.The BioCentury Show is THE only place where BioCentury’s experts join top innovators and global influencers to show how science is being turned into medicine.Don't miss this event, every two weeks, now available as a video webcast or audio podcast.
France