Today, I wanted to provide an update on the FDA’s involvement in efforts to expedite the development and availability of therapeutics and vaccines to combat #COVID19 under Operation #WarpSpeed.

In order to devote efforts full-time to the start-up of Operation Warp Speed’s therapeutics initiative, @DrWoodcockFDA will go on detail to the Office of the Commissioner. While she focuses on this work, CDER Deputy Director Dr. Patrizia Cavazzoni will serve as acting director.

. @DrWoodcockFDA’s work will complement FDA’s Coronavirus Treatment Acceleration Program, which is using every tool our disposal to bring new therapies to sick patients as quickly as possible, while also supporting research to further evaluate these medical countermeasures.

Additionally, given the team of tremendous experts in vaccine development that’s been assembled to pursue Operation Warp Speed, CBER Director Dr. Peter Marks will be stepping away from the project he helped to stand up over the past few months.

Dr. Marks will focus on leading the entire spectrum of important work of taking place within CBER related to the #COVID19 response – in both the vaccine and therapeutics space.

We all recognize the urgent need to develop a vaccine to prevent #COVID19 and FDA will ultimately play an integral role in reviewing applications related to candidates supported through Operation Warp Speed.

With Dr. Marks’ leadership in CBER, FDA will continue to work collaboratively as a regulator with industry, federal, domestic, and international partners, and other researchers to accelerate these efforts.

Thank you to @DrWoodcockFDA for her ongoing work on Operation Warp Speed, Dr. Marks for his efforts to stand up this project and continued leadership in CBER, as well as Dr. Cavazzoni and others for ensuring critical activities taking place across CDER are supported.