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The BioCentury Show

BioCentury

49 episodes

2 weeks ago

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 decade...

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All content for The BioCentury Show is the property of BioCentury and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.

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 decade...

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Episodes (20/49)

The BioCentury Show

Ep. 98 - Inside Precision Oncology’s Next Chapter with Fore’s Bill Hinshaw

When Bill Hinshaw looks back across the arc of his career — from his early days helping to commercialize Gleevec to his present role leading Fore Biotherapeutics — he sees a precision oncology field transformed by technological ambition, yet still grappling with many of the structural challenges that defined its beginnings, now compounded by the difficulty of positioning therapies within an ever more complex treatment landscape. Gleevec proved the power of targeting a genomic driver, but the ...

1 week ago

37 minutes

The BioCentury Show

Popular Episode - Reimagining FDA: Steve Usdin on Designing the Drug Regulator of the Future

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 decade...

2 weeks ago

38 minutes

The BioCentury Show

Ep. 97 – From NIH to Industry: Zerhouni Warns Policy & Rhetoric Threaten U.S. Science

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 polic...

4 weeks ago

34 minutes

The BioCentury Show

Ep. 96 – From Pharma Partnering to Biotech CEO: Sophie Kornowski on Boston Pharma’s Playbook

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...

1 month ago

32 minutes

The BioCentury Show

Ep. 95 - Kymera CEO Nello Mainolfi: Matching Degrader Chemistry to the Problem

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...

1 month ago

31 minutes

The BioCentury Show

Ep. 94 - Frazier's James Li on China’s Rapidly Evolving Biotech Deal Landscape

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, wh...

2 months ago

29 minutes

The BioCentury Show

Ep. 93 – BIO’s Fritz Bittenbender on Trump 2.0, MFN Threats & Pharma’s Concessions

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 ...

2 months ago

34 minutes

The BioCentury Show

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 curre...

3 months ago

38 minutes

The BioCentury Show

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 Therapeut...

3 months ago

36 minutes

The BioCentury Show

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 com...

4 months ago

32 minutes

The BioCentury Show

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 Fish...

4 months ago

33 minutes

The BioCentury Show

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 P...

5 months ago

31 minutes

The BioCentury Show

Ep. 88 – From Satiety to Muscle: Zealand CEO Steensberg on Amylin’s Edge in Obesity

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 ...

5 months ago

30 minutes

The BioCentury Show

Ep. 87 – Korea’s Biotech Playbook: Orum CEO SJ Lee on Going Global and Creating Novel 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 k...

6 months ago

27 minutes

The BioCentury Show

Ep. 86 – Macrophages, ASCO & Clever-1: Faron CEO Juho Jalkanen on Bexmarilimab’s Promise

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. Jalkane...

6 months ago

10 minutes

The BioCentury Show

Ep. 85 - Stifel’s Opler on Trump 2.0's FDA & the Capital Markets

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 Chin...

6 months ago

32 minutes

The BioCentury Show

Ep. 84 – Leadership Amid Turmoil: Moonlake CEO Jorge Santos Da Silva

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....

6 months ago

29 minutes

The BioCentury Show

Ep. 83 – Europe’s Biotech Moment: Jérôme van Biervliet on Turning Uncertainty into Opportunity

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 th...

7 months ago

31 minutes

The BioCentury Show

Ep. 82 – Act Now or Fall Behind: Michelle Rozo on Biotech’s National Security Stakes

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 vic...

8 months ago

31 minutes

The BioCentury Show

Ep. 81 - Data-Driven Growth: Immunocore CEO Bahija Jallal on Expanding TCR Therapies

On the latest episode of The BioCentury Show, Editor in Chief Simone Fishburn speaks with Bahija Jallal, CEO of Immunocore and the former president of Medimmune. While some biotechs are circumspect about gathering data during clinical trials that might not support the product in question, Jallal sees it as part of the obligation to patients and the field to learn as much as possible, as efficiently as possible. And that strategy has informed how the company will take its TCR technology into e...

8 months ago

30 minutes