Dr Janet Woodcock, FDA, Gives Her Vision for the Integration of Clinical Research and Care

Laura J Esserman, MD, MBA, is Professor of Surgery and Radiology at UCSF, where she is also Director of the multi-disciplinary UCSF Carol Franc Buck Breast Care Center. She is Co-Leader of the Breast Oncology Program for the Comprehensive Cancer Center.Dr Esserman’s breast cancer work spans a spectrum from basic science to public policy issues and the impact of both on the delivery of clinical care. She has published more than 300 articles in peer-reviewed journals. She led efforts to address harms of screening including over-diagnosis, and proposed tools including the development of molecular diagnostics to help reclassify tumors as IDLE or ultra-low risk.She leads the I-SPY TRIALS, a ground-breaking national public-private collaboration among 20 cancer research centers, pharma and biotech companies, FDA, and NCI, designed to reduce the time and cost for drug development, find the right drug for the right patient earlier in the disease course when cure is possible.In addition, Dr Esserman led the creation of the University of California-wide, and now national Athena Breast Health Network, a learning system designed to integrate clinical care and research and follow 150,000 women from screening through treatment and outcomes. This spawned the PCORI funded WISDOM study to determine if personalized screening has higher health care value than the standard of annual screening.Dr Esserman was included as one of TIME Magazine’s 100 Most Influential People of 2016, was the recipient of the 2016 Stanford Business School Ernest C Arbuckle Award and the 2016 Personalized Medicine World Conference Luminary Award.

Dr Janet Woodcock began her long and distinguished FDA career in 1986 with the agency’s Center for Biologics Evaluation and Research (CBER) as Director of the Division of Biological Investigational New Drugs. She also served as CBER’s Acting Deputy Director, and later as Director of the Office of Therapeutics Research and Review.In 1994, Dr Woodcock was named Director of the FDA’s Center for Drug Evaluation and Research (CDER), overseeing the center’s work that is the world’s gold standard for drug approval and safety. In that position, she has led many of the FDA’s groundbreaking drug initiatives.  She has also served in other leadership roles at the FDA, including as Deputy Commissioner and Chief Medical Officer.With the onset of the COVID-19 public health emergency last year, Dr Woodcock was asked to lend her expertise to “Operation Warp Speed” the initiative to develop therapeutics in response to the pandemic. Dr Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021. Dr Woodcock has received numerous honors during her distinguished public health career, including: a Lifetime Achievement Award in 2015 from the Institute for Safe Medication Practices; the Ellen V Sigal Advocacy Leadership Award in 2016 from Friends of Cancer Research; the Florence Kelley Consumer Leadership Award in 2017 from the National Consumers League; the 2019 Biotechnology Heritage Award from the Biotechnology Innovation Organization and Science History Institute; and the 2020 Lifetime Achievement Award from NORD.  She is also an avid and accomplished gardener.