Ep.89 - Delivering on the biosimilars promise, a conversation with Gillian Wollett
Gillian Wollett, head of regulatory strategy and policy at Samsung Bioepis Co. Ltd., 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 Wollett.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, Wollett said.View full story: https://www.biocentury.com/article/656445#biotech #biopharma #pharma #lifescience #DrugDevelopment #FDA
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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 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
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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 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 #DrugDevelopment02:11 - Korea's Biotech Ecosystem09:57 - Evolution of Korean Biotech16:08 - Orum's Degrader Antibody Conjugates
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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.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
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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 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
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