Back to School: How biopharma can reboot drug development. Access exclusive analysis here

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Politics, Policy & Law

FDA’s credibility on the line, plus biotech’s venture wave and a Back to School preview: a BioCentury podcast

Sep 1, 2020 | 1:54 AM GMT

With FDA’s independence in question, how the agency handles emergency use authorization of COVID-19 vaccines is becoming ever-more pressing. On the latest edition of the BioCentury This Week podcast, BioCentury’s Editors discuss the implications of granting an EUA based on Phase II data. They also check in on the state of venture financing for biotech, including the role of crossover investors and the evolving landscape in Europe, and preview BioCentury’s annual Back to School issue.

This year, BioCentury’s Back to School will address biopharma’s once-in-a-generation opportunity to reboot how drug development is done. Editor in Chief Simone Fishburn previews the week-long multimedia event, which will begin Monday Sept. 7 with essays and data analyses produced daily, as well as audio interviews with industry leaders such as Vas Narasimhan of Novartis AG (NYSE:NVS; SIX:NOVN), U.K. Vaccine Taskforce Chair Kate Bingham and former FDA Commissioner Mark McClellan, who is director of the Duke-Margolis Center for Health Policy.

Also on this week’s podcast, Washington Editor Steve Usdin argues that FDA Commissioner Stephen Hahn’s failure to maintain “social distance” from President Donald Trump is imperiling the ability of the U.S. — and other countries that are looking to the U.S. for leadership — to respond to COVID-19. He addresses the issue in detail, including how the FDA should approach the EUA process for vaccines, in an Editor’s Commentary posted Monday (see “FDA Should Maintain ‘Social Distance’ from the White House”).

Biopharma companies have raised more than $21 billion across at least 450 venture rounds so far this year, outpacing 2019’s venture raise over the same period. Associate Editor Virginia Li says that’s been driven in part by large mezzanine rounds supported by crossover investors with an appetite for life sciences IPOs.

Li, Executive Editor Jeff Cranmer and Fishburn discuss the evolving venture ecosystem in continental Europe, where VC firms focused on investing in European companies, such as Andera Partners, Gilde Healthcare Partners and LSP, have been raising record funds. Li spoke with Andera’s Olivier Litzka in early August (see “Andera Looks to Deploy Record €450M Fund”)

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