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US FDA appoints Flatiron chief medical officer Amy Abernethy deputy commissioner

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Incoming U.S. Food and Drug Administration Principal Deputy Commissioner Amy Abernethy.
Source: Flatiron Health Inc.

U.S. Food and Drug Administration Commissioner Scott Gottlieb said Dec. 17 that the agency had appointed Amy Abernethy as principal deputy commissioner, a position she will fill early in 2019.

Abernethy will replace Rachel Sherman, who announced her retirement in early December.

Abernethy is currently the chief medical officer, chief scientific officer and senior vice president at New York City-based Flatiron Health Inc., where she specializes in real-world evidence, a stated "top strategic priority" at the FDA. Roche Holding AG completed its $1.9 billion acquisition of Flatiron in April.

In medicine, Abernethy is an oncologist and former Duke University professor, as well as head of the Center for Learning Health Care and the Duke Cancer Care Research Program, both at the university.

"Dr. Abernethy brings to the FDA deep experience in evidence generation and clinical trial efficiency and innovation, which will help us advance our clinical policy and programs and continue to drive scientific excellence in support of FDA's public health mission," Gottlieb said.

Upon taking the FDA position, Abernethy will step down from her seat on the board of directors at California diagnostics company CareDx Inc.

Before Abernethy assumes the FDA role, the agency's Center for Drug Evaluation and Research deputy director of operations Patrizia Cavazzoni will serve as interim acting deputy commissioner.