The BioCentury Show

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.

Mounting clinical evidence suggests amylin agonists could supplant GLP-1 molecules as the foundational backbone of future obesity therapy, says Zealand Pharma CEO Adam Steensberg on The BioCentury Show.One of the leading cardiometabolic biotechs, Zealand received the largest-ever upfront payment in a biotech licensing deal when it partnered its petrelintide with Roche for nearly $2 billion. The deal helped make amylin arguably the hottest target in obesity.In conversation with BioCentury’s Stephen Hansen, Steensberg goes behind the scenes of Zealand’s deal with Roche and also shares his vision for how the obesity treatment paradigm will evolve over the next five years. This episode of The BioCentury Show was sponsored by Faron.View full story: https://www.biocentury.com/article/656295#biotech #biopharma #pharma #lifescience #DrugDevelopment #Amylin #GLP100:00 - Introduction02:18 - The Case for Amylin16:44 - Roche Deal21:04 - What’s Next for Obesity Therapies

In this captivating discussion, SJ Lee, Founder and CEO of Orum Therapeutics, shares insights from his experience leading a biopharmaceutical company specializing in novel therapies. He emphasizes South Korea’s rapid globalization and unique strategies to compete worldwide. Lee elaborates on the importance of innovative collaborations and the evolving funding landscape for startups. He also reveals Orum's promising work on degrader-antibody conjugates, particularly targeting CD33, for treating acute myeloid leukemia, positioning Korea as a rising star in biotech.

The macrophage field has seen its share of setbacks, but Faron believes bexmarilimab, its humanized mAb that binds to immune checkpoint target Clever-1, has what it takes to get across the goal line at FDA.On a special sponsored edition of The BioCentury Show, Juho Jalkanen, founder and CEO of Faron Pharmaceuticals, explains how the Finnish biotech landed on Clever-1, and why the target might more effectively repolarize macrophages than therapies against other macrophage checkpoints.Jalkanen also discusses the Phase I/II data Faron presented for bexmarilimab in myelodysplastic syndrome at the American Society of Clinical Oncology (ASCO) in Chicago, and what’s next for the immunotherapy. This episode of The BioCentury Show was sponsored by Faron.View full story: https://www.biocentury.com/article/656099#biotech #biopharma #pharma #lifescience #ASCO #RandD #DrugDevelopment

Notwithstanding the bad start that the Trump administration got off to on FDA, Tim Opler is optimistic that the agency will serve drug developers well, and sees enough good signals that the direction the agency is headed will not bring the difficult regulatory era that many in the industry feared.Opler, a managing director at Stifel, spoke to Editor in Chief Simone Fishburn on The BioCentury Show about why he’s optimistic about FDA, what he sees ahead for capital markets, competition in China, and three areas of innovation he’s focused on -- aging, women's health and the brain.View full story: https://www.biocentury.com/article/656040#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment #FDA00:00 - Introduction01:30 FDA under Trump 2.008:07 State of Capital Markets13:13 China Competition17:09 Innovation: Aging, Women’s Health & the Brain

As CEO of a vintage 2021 biotech, Jorge Santos Da Silva has had his leadership mettle tested by a pandemic, rising interest rates, a bear market, and a tumultuous U.S. policy environment — all while building the case for Moonlake’s lead program to become a top therapy for hidradenitis suppurativa and, eventually, a “pipeline-in-a-product.”The key for Santos Da Silva as founder and CEO of  Moonlake Immunotherapeutics is to dial down the noise and focus on the key choices in front of you. “Moonlake has always existed in times of turmoil,” Santos Da Silva told Executive Editor Jeff Cranmer on The BioCentury Show, citing the recent M&A drought, high interest rates and political turmoil. “Understanding the situation from a cool perspective, being able to explain that to your people first, and then try to explain that to the Street and place the company in the right moment so that you have all the game in front of you" is his recipe for success as a CEO in biotech. Moonlake’s sonelokimab is expected to enter Phase III testing this year for HS; it's one of the most advanced multispecifics in the clinic for inflammation and immunology diseases.View full story: https://www.biocentury.com/article/655903#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment00:00 - Introduction01:48 - Landscape for HS Therapies09:03 - Market Opportunity19:40 - Next Steps for Moonlake

Europe did not ask for this opportunity, says VIB’s Jérôme van Biervliet, but with FDA and the U.S. research funding situation headed into uncertain territory, it needs to use this moment to capitalize on its strengths in research, and address the shortcomings of its business and regulatory systems that have made it hard for biotech to fulfill its potential there. Van Biervliet is managing director of Flanders Institute for Biotechnology (VIB), a key player in the Belgian biotech landscape that has both a research arm and an investment unit.  Ahead of BioCentury’s Bio€quity Europe conference in Bruges, which will discuss how Europe can meet the complexity of this moment, he talked to BioCentury Editor in Chief Simone Fishburn on The BioCentury Show about the landscape unfolding in Europe, as well as where he sees innovation headed.View full story: https://www.biocentury.com/article/655818#biotech #biopharma #pharma #LifeScience #ResearchFunding #EuropeanInnovation00:00 - Introduction02:03 - VIB’s Mission07:52 - Europe’s Funding Opportunity17:37 - Belgium’s Biotech Ecosystem25:27 - Nanobodies’ Potential

The U.S. will cede its preeminence in biotechnology to China within three years unless the government acts urgently, an independent commission chartered by Congress warns. “Our window to act is closing,” the National Security Commission on Emerging Biotechnology said in a newly released report. “We need a two-track strategy: make America innovate faster, and slow China down.” BioCentury Washington Editor Steve Usdin discusses the report's recommendations and warnings with the commission’s vice chair, Michelle Rozo, on The BioCentury Show.View full story: https://www.biocentury.com/article/655654#biotech #biopharma #pharma #lifescience #politics #policy #law 00:00 - Introduction03:56 - China Closing the Innovation Gap09:20 - Slowing China Down17:20 - Bolstering U.S. Biotech