Amy Abernethy, current chief medical officer, CSO, and senior VP of oncology at Flatiron Health, will join the US Food and Drug Administration as principal deputy commissioner, second to the agency's commissioner Scott Gottlieb. She is slated to join the agency in early 2019, pending ethics clearances, and will replace Rachel Sherman, who is retiring as the FDA's current principal deputy commissioner. Patrizia Cavazzoni, who is deputy director for operations at the FDA's drug center, will step in as interim principal deputy commissioner till Abernethy joins.
Abernethy became an executive at cancer-focused health technology firm Flatiron more than four years ago. She currently serves as a member of the board for CareDx, and will step down from that post effective Jan. 31, 2019. She has served as a director on the company's board since July 2018 as chairman of the scientific committee. Abernethy has also worked at Athenahealth and directed the Duke Center for Learning Health Care. In an internal email about Abernethy's hire, the FDA highlighted that she is an internationally recognized expert in clinical trials, cancer outcomes research, health policy, patient-reported outcomes, and patient-centered care, and has authored more than 400 peer-reviewed articles.
The non-profit advocacy organization Personalized Medicine Coalition, where Abernethy serves as a board member, noted in a statement that the agency's decision to hire her reflects its increasing focus on personalized medicine. While Abernethy was at Flatiron, the company struck up a research alliance with the FDA to explore how real-world data, derived from sources outside of the traditional clinical trial setting, could be used to gather evidence on the safety and efficacy of cancer treatments.