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