As the Principal Deputy Commissioner of Food and Drugs, Amy P. Abernethy, M.D., Ph.D., helps oversee the agency’s day-to-day functioning and directs special and high-priority initiatives that cut across offices overseeing FDA’s regulation of drugs, medical devices, tobacco and food. As acting Chief Information Officer, she oversees FDA’s data and technical vision, and its execution.
Dr. Abernethy, a hematologist/oncologist and palliative medicine physician, is an internationally recognized clinical data expert and clinical researcher. Her areas of expertise include cancer data, real world evidence, clinical trials, health services research, patient reported outcomes (PROs), clinical informatics, and patient-centered care.
Before coming to FDA, Dr. Abernethy served as chief medical officer, chief scientific officer, and senior vice president for oncology at Flatiron Health (a member of the Roche Group), where she led the research oncology, clinical operations and data science teams, and contributed to the overall strategic vision of the company, including directing their research vision on real world evidence.
Prior to that, Dr. Abernethy was professor of medicine at Duke University School of Medicine, where she ran the Center for Learning Health Care in the Duke Clinical Research Institute and the Duke Cancer Care Research Program in the Duke Cancer Institute. At Duke, she pioneered the development of technology platforms to spur novel advancements in the care of people with cancer and other serious life-limiting illnesses.
Dr. Abernethy was formerly an appointed member of the National Academy of Medicine’s National Cancer Policy Forum, an elected member of the American Society for Clinical Investigation, and Past President of the American Academy of Hospice & Palliative Medicine.
Dr. Abernethy received her M.D. at Duke University, where she also did her internal medicine residency, served as chief resident, and completed her hematology/oncology fellowship. She received her Ph.D. from Flinders University in Australia, with a focus on evidence-based medicine and clinical informatics, and her bachelor’s degree from the University of Pennsylvania.