The BioCentury Show

Simeon George, CEO and managing partner of SR One and biotech investor/founder, gives a candid take on adapting to a tougher capital market. He discusses valuation realism, prioritizing programs and when to pivot. He outlines proactive sourcing, China’s accelerating ecosystem, and building transatlantic companies. Practical strategy and capital discipline are central themes.

Clinical trials will be launched in the next year or two to test predictions about causal biology made by artificial intelligence models, Vik Bajaj, co-founder and CEO of Foresite Labs and managing director of Foresite Capital Management, believes. Foresite teamed up with Arch Venture Partners last year on a $1 billion venture round to fund Xaira Therapeutics, which aims to reinvent the R&D process via AI-driven protein design and biological discovery technologies.Bajaj, who serves as interim president of Xaira, discussed the potential for artificial intelligence to accelerate biomedical progress in an interview with Washington Editor Steve Usdin on The BioCentury Show.View full story: https://www.biocentury.com/article/654977#biotech #biopharma #pharma #lifescience #AI #RandD #drugdiscovery00:00 - Introduction01:18 - AI & Biotech12:19 - Getting the Data Right19:06 - Healthcare Delivery30:47 - Making It Real

All presidential transitions with a change of party come with disruption and threats as well as opportunities. But this one, in particular with regard to the implications for FDA, is different from all those Steve Usdin has been covering in his 30-year tenure as Washington editor at BioCentury.In particular, this is an inflection point for the agency that currently serves as the global gold standard for drug regulation, said Usdin on a special edition of The BioCentury Show covering the ramifications for the biopharma industry of the second Trump administration. Usdin has recently outlined the threats and opportunities that the new era presents, and he elaborated further on those in a discussion with Editor in Chief Simone Fishburn.View full story: https://www.biocentury.com/article/654798#biotech #biopharma #pharma #lifescience #politics #policy #fda #ftc #biosecure #ira00:00 - Introduction05:06 - Inflection Point at FDA14:10 - Changes at the FTC16:43 - China, Biosecure21:30 - The IRA

Rep. Jake Auchincloss (D-Mass.), an influential voice in Congress on life sciences issues, gained stature last week when he was appointed to serve on the Energy & Commerce Committee, giving him a seat at the table for debates over legislation affecting FDA, CMS and NIH and a host of issues of critical importance to the biopharma industry.In an interview with Washington Editor Steve Usdin on The BioCentury Show, Auchincloss outlined his priorities for the 119th Congress, from pushing “muscular” PBM reform over the congressional finish line to finding bipartisan support for refining the IRA's orphan drug exemption and advancing methods to evaluate the social value of medicines.View full story: https://www.biocentury.com/article/654659#biotech #biopharma #pharma #lifescience #politics #policy #law 00:00 - Introduction01:08 - New Congress & RFK Jr.10:09 - China & Biotech16:36 - Assessing Drugs’ Value

Specialist public investors are doing their best to hold up the sector, but biotech still has to wash out many of the lower quality companies that were funded during the boom and ended up driving the generalists away, said MPM Bioimpact's Chris Bardon on The BioCentury Show. Bardon said the market hasn’t yet found the footing that will see an opening of the IPO window and a swing of positive sentiment. But although markets aren’t yet out of the woods, she said M&A will remain robust for years, fueled by obesity drug revenues.View full story: https://www.biocentury.com/article/654649#biotech #biopharma #pharma #lifescience #financing #investing00:00 - Introduction01:30 - Market Sentiment06:19 - IPO Window12:04 - M&A Outlook19:51 - The Obesity Landscape

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#biotech #biopharma #pharma #lifescience00:00 - Introduction00:59 - State of Play for Biotech04:34 - How to Choose a CEO Job18:49 - New Era of Discipline26:51 - 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. View full story: https://www.biocentury.com/article/654182#biotech #biopharma #pharma #lifescience #deals00:00 – Introduction01:49 – U.K.’s Place in Global Biotech09:41 – Trump & Biotech17:32 – Deals in 202531:57 – 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.View full story: https://www.biocentury.com/article/654032#biotech #biopharma #pharma #lifescience #RandD #drugapproval #regulation00:00 - Introduction01:55 - Rejecting the ineffective10:56 - Creating Consensus16:43 - Fire From the Dragon’s Mouth24:30 - Three Reasons for Trial Equity29:28 - 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#biotech #biopharma #pharma #lifescience #IPO #capitalmarkets #deals00:00 - Introduction02:17 - Capital Markets Outlook05:18 - M&A14:37 - Breaking Down Deals23:44 - 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#biotech #biopharma #pharma #lifescience #policy00:00 - Introduction01:31 - Behind the Aduhelm Decision08:01 - Questioning CMS17:19 - Accelerated Approval26:34 - AI in Medicine