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

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...