The BioCentury Show

Leading biotech companies through the turbulence of the past few years and the uncertainty of the next ones takes not just resilience, but an ability to grapple with the CEO’s paradox, according to Climb Bio CEO Aoife Brennan. This paradox requires preparing for repeated setbacks while planning optimistically, a duality that has been the story of biotech since the outbreak of the pandemic, said Brennan. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Brennan discusses how CEOs are managing through uncertainty, and why "boring" naked mAbs are the smart move in one field. View full story: https://www.biocentury.com/article/654451 [https://www.biocentury.com/article/654451] #biotech #biopharma #pharma #lifescience 00:00 - Introduction 00:59 - State of Play for Biotech 04:34 - How to Choose a CEO Job 18:49 - New Era of Discipline 26:51 - Building a Team

With new governments both side of the pond, capital markets picking up, and some geopolitical overhang, there’s a mixed feast for biotech, with a net trend to the positive, says Sidley Austin’s Robert Darwin, who specializes in global M&A and private equity for life sciences and healthcare companies and investors. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Darwin, who is based in London, discussed the consequences for biotech of the changing forces as we enter 2025: the new Labour government’s recently announced budget, the incoming Trump administration, the improving outlook for the markets, and the ongoing — if not mounting — tensions between the U.S. and China. Across each of these is a considerable amount of uncertainty, but the pluses and minuses add up to net positive outlook, he believes. This episode of The BioCentury Show was sponsored by Cytiva [https://cytiva.com]. View full story: https://www.biocentury.com/article/654182 [https://www.biocentury.com/article/654182] #biotech #biopharma #pharma #lifescience #deals 00:00 – Introduction 01:49 – U.K.’s Place in Global Biotech 09:41 – Trump & Biotech 17:32 – Deals in 2025 31:57 – Private Equity in Biotech

Richard Pazdur, director of FDA’s Oncology Center of Excellence, joined FDA in 1999. Looking back on his 25th anniversary, he draws a line between unpopular decisions at the start of his tenure and a surge in cancer drug development over the last 20 years. He believes this and other lessons from the regulation of oncology can be applied broadly across FDA. The BioCentury Show discussed these lessons, as well as Pazdur’s views about advisory committees, pragmatic trials, dose optimization and more. This episode of The BioCentury Show was sponsored by Cytiva [https://cytiva.com]. View full story: https://www.biocentury.com/article/654032 [https://www.biocentury.com/article/654032] #biotech #biopharma #pharma #lifescience #RandD #drugapproval #regulation 00:00 - Introduction 01:55 - Rejecting the ineffective 10:56 - Creating Consensus 16:43 - Fire From the Dragon’s Mouth 24:30 - Three Reasons for Trial Equity 29:28 - Dose Optimization

With most of the highly attractive late-stage assets already scooped up, pharmas are turning their sights to Phase II companies, and lining up their case to make an attractive offer and move fast. About 40% of the M&A deals in 2023-24 were completed in less than six weeks, from approach to announcement, according to Lazard’s data. Michael Kingston and Dale Raine, global co-heads of biopharma at Lazard, joined The BioCentury Show this week to discuss the M&A outlook amid the still-precarious biotech financing landscape. View full story: https://www.biocentury.com/article/653858 [https://www.biocentury.com/article/653858] #biotech #biopharma #pharma #lifescience #IPO #capitalmarkets #deals 00:00 - Introduction 02:17 - Capital Markets Outlook 05:18 - M&A 14:37 - Breaking Down Deals 23:44 - Asia

CMS’s controversial decision to restrict access to Alzheimer’s mAb treatments, including Aduhelm, approved under FDA’s accelerated pathway was a unique case that is unlikely to set a precedent, former CMS CMO Lee Fleisher told BioCentury. “I do not think this will be repeated,” he said. In an interview with The BioCentury Show's Steve Usdin, Fleisher gives a behind-the-scenes account of the decision-making process, including the role of accelerated approval. He also discusses the opportunities and risks for healthcare posed by AI, and the scientific and legislative steps that will be needed to make real the promise of blood-based multicancer detection technologies. View full story: https://www.biocentury.com/article/653749 [https://www.biocentury.com/article/653749] #biotech #biopharma #pharma #lifescience #policy 00:00 - Introduction 01:31 - Behind the Aduhelm Decision 08:01 - Questioning CMS 17:19 - Accelerated Approval 26:34 - AI in Medicine