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

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 #FDA

00:00 - Introduction
02:50 - Halving the Time and Cost
10:30 - Interchangeability
15:50 - The Importance of Market Share
22:08 - Most Favored Nation

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 #GLP1

00:00 - Introduction
02:18 - The Case for Amylin
16:44 - Roche Deal
21:04 - What’s Next for Obesity Therapies

Globalizing quickly and gaining a first-mover advantage are the winning strategies for South Korean biotechs as they look to compete on the world stage, says Orum Therapeutics founder and CEO SJ Lee in conversation with BioCentury Executive Editor Jeff Cranmer on The BioCentury Show.
Lee’s company, a leader in degrader-antibody conjugates, provides an example of how to run that playbook. Lee also spoke about where Korea fits in East Asia’s life sciences scene, how Western players can get to know the Korean biopharma industry, and what’s next for Orum’s pipeline. This episode of The BioCentury Show was sponsored by Faron.

View full story: https://www.biocentury.com/article/656147

#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment

02:11 - Korea's Biotech Ecosystem
09:57 - Evolution of Korean Biotech
16:08 - Orum's Degrader Antibody Conjugates

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 #FDA

00:00 - Introduction
01:30 FDA under Trump 2.0
08:07 State of Capital Markets
13:13 China Competition
17:09 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 #DrugDevelopment

00:00 - Introduction
01:48 - Landscape for HS Therapies
09:03 - Market Opportunity
19:40 - Next Steps for Moonlake