- September 10, 2020
- Organized By:
About the Presentation:
The FDA continues to work around the clock to respond to the COVID-19 pandemic. As part of this effort, we recognize the potential for diverse, real-world data sources such as electronic health records, insurance claims, patient registries and lab results to further inform our science-based, all-of-America response to this unprecedented public health emergency.
In recent years, the agency has taken steps to leverage modern, rigorous analyses of real-world data—such as data from the health care setting—to inform our work. The COVID-19 pandemic has brought an urgency to these efforts and the FDA has worked quickly to advance collaborations with public and private partners to collect and analyze a variety of real-world data sources. Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity and understand available medical product supplies to help mitigate potential shortages. These data can also inform ongoing work to evaluate potential therapies, vaccines or diagnostics for COVID-19.
The FDA is applying data from diverse sources to inform its response to COVID-19, including sources that were already available to the agency, such as Sentinel, BEST, and NEST. The urgency of addressing the COVID-19 pandemic has demanded that we expand our work to identify, access and analyze new datasets to widen the breadth of the information available. This work is being done in collaboration with partners in the U.S. government, academia and industry.
About the Speaker:
Amy P. Abernethy, MD, PhD
Principal Deputy Commissioner
Acting Chief Information Officer
US Food and Drug Administration
As the Principal Deputy Commissioner of Food and Drugs, Dr. 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.
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 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 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.
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