FDA taps Flatiron’s Abernethy for oversight post

Commissioner Gottlieb described Flatiron's Abernethy as helping to lead the vision for real-world evidence research. (Andrew Harnik/Associated Press)

The FDA has named Flatiron Health’s Amy Abernethy to succeed Rachel Sherman as principal deputy commissioner of food and drugs, which oversees a wide range of the agency’s regulatory, clinical and scientific programs.

At Flatiron, the cancer and real-world data software developer acquired by Roche earlier this year for $1.9 billion, Abernethy served as chief medical and scientific officer, as well as senior VP of oncology.

In a letter to his agency colleagues this week announcing the choice, FDA Commissioner Scott Gottlieb described Abernethy as a “highly regarded thought leader” in evidence generation and clinical trial efficiency, and that she has helped lead the vision for real-world evidence-based research.

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“For more than a decade, she has pioneered the development of technology platforms to accelerate clinical evidence development, including the development of systems by which aggregated clinical data can support personalized medicine, outcomes research, cancer care quality monitoring, and scientific discovery,” Gottlieb wrote in the letter obtained by FierceMedtech.

RELATED: FDA teams with Flatiron for real-world cancer data analytics project

Sherman previously announced that she will retire from the agency in January, after holding a variety of roles at the FDA since 1989. Following a brief retirement in 2015, Sherman was asked to come back and lead the Office of Medical Products and Tobacco.

With Abernethy starting in the coming months, CDER’s deputy center director for operations, Patrizia Cavazzoni, will serve as acting principal deputy commissioner in the interim.

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