Woodcock steps away from CDER for Operation Warp Speed; Marks back to CBER

Leadership shuffle at FDA to support government and company programs against COVID-19

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In a major reorganization intended to better align FDA’s activities with the national effort to develop COVID-19 countermeasures, Janet Woodcock is temporarily stepping away from her position as director of FDA’s Center for Drug Evaluation and Research, and Peter Marks is stepping away from his role as lead of vaccines at Operation Warp Speed.

Woodcock will be detailed to FDA’s Office of the Commissioner.

“While Dr. Woodcock focuses on the therapeutics aspect of Operation Warp Speed, CDER Deputy Director Patrizia Cavazzoni, M.D., will serve as CDER’s acting director,” FDA Commissioner Stephen Hahn told BioCentury in a statement. “Woodcock’s work will complement the FDA’s Coronavirus Treatment Acceleration Program, which is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate these medical countermeasures.”

Prior to joining CDER as deputy director for operations, Cavazzoni was SVP for worldwide safety strategy at Pfizer Inc. (NYSE:PFE), and head of global pharmacovigilance and epidemiology at Sanofi (Euronext:SAN; NASDAQ:SNY).

When Operation Warp Speed was announced on May 15, Marks and Woodcock were listed as the heads of its vaccines and therapeutics teams, respectively.

Two days later, Hahn announced in an email to FDA staff that Woodcock and Marks would not participate in reviews of COVID-19 products. The move seemed to be a response to concerns that individuals involved in developing products should not pass judgment on those products as regulators (see “Woodcock, Marks to Recuse Themselves”).

Marks “will focus on leading the entire spectrum of important work of taking place within CBER related to the COVID-19 response -- in both the vaccine and therapeutics space,” Hahn told BioCentury on Friday.

Marks helped organize the U.S. government’s COVID-19 vaccine initiatives, including formation of Operation Warp Speed.

Marks played an “instrumental role in helping stand-up” the Operation Warp Speed vaccine project, HHS Assistant Secretary for Public Affairs Michael Caputo told BioCentury.

“I’m very grateful to have been able to help stand-up the basic structure of Operation Warp Speed over the past few months,” Marks told BioCentury. “I’m confident that this endeavor is now in great hands with a team of experts in vaccine development and program execution.”

Operation Warp Speed’s leadership includes two vaccine development veterans. The initiative is led by Moncef Slaoui, a partner at venture firm Medicxi who was chairman of the vaccines division at GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and head of its pharmaceutical R&D. Warp Speed’s vaccines team is supported by Matt Hepburn, an infectious diseases physician with 24 years of Department of Defense experience in vaccines and public health (see “With AZ Deal, Operation Warp Speed Takes First Step”).

Marks said FDA “will continue to work collaboratively with industry, government partners and other researchers to expedite the development and availability of vaccines to combat COVID-19.”

Hahn also stressed FDA’s collaboration with government agencies and industry to speed the development and deployment of COVID-19 vaccines.

“We all recognize the urgent need to develop a vaccine to prevent COVID-19 and the FDA will ultimately play an integral role in reviewing applications related to candidates supported through Operation Warp Speed,” Hahn said. “With Dr. Marks’ leadership in CBER, the FDA will continue to work collaboratively as a regulator with industry, federal, domestic, and international partners, and other researchers to accelerate these efforts."

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