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Regulation

Abernethy and the obvious at FDA; plus CEPI and EpimAb: a BioCentury podcast

Mar 30, 2021 | 2:00 AM GMT

Amy Abernethy set out to tackle “the blooming obvious” issues faced by FDA when she joined the agency two years ago. In the latest BioCentury This Week podcast, BioCentury’s editors discuss the key takeaways from the principal deputy commissioner’s exit interview with Washington Editor Steve Usdin, as well as CEPI’s initiative to develop a vaccine in 100 days and the investors behind EpimAb’s latest venture round.

Abernethy told BioCentury that the two key issues she set out to solve at FDA was an incoming wave of regulatory submissions, including for cell and gene therapies, that threatened to overwhelm FDA’s reviewers, and the fact that the agency would not be able to hire its way out of the situation. The result, Associate Editor Virginia Li says: Abernethy modernized FDA’s technology and data, addressing an urgent need for the agency and producing results that will motivate its leadership to continue to invest in technology.

The Coalition for Epidemic Preparedness Innovations is not waiting for this pandemic to be over before preparing for the next one, Editor in Chief Simone Fishburn says. The 100-day goal is based on a vision of a library of partially prepared vaccines, plug-and-play manufacturing with a global footprint, and international cohesion on regulatory policies that can cut time and uncertainty from the process of vaccine development.

For this week’s Deal in Focus, Li and Executive Editor Jeff Cranmer break down what the syndicate backing last week’s series C round by EpimAb Biotherapeutics Inc. says about the state of crossover investing for biotechs and what’s next for the Shanghai cancer play.

Sponsorship and underwriting packages are available for BioCentury’s webinars, podcasts and surveys. For more information, please contact Eric Pierce and Josh Berlin at conferences@biocentury.com.

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