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Janet Woodcock, M.D., deputy commissioner for operations for the U.S. Food and Drug Administration (FDA), has been awarded for significant contribution to the advancement of state-of-the-art medical science. The Personalized Medicine Coalition's (PMC's) award for Leadership in Personalized Medicine honors Woodcock for her pioneering initiatives to stimulate and guide the development of novel therapies.
"I am thrilled to congratulate Janet on this richly deserved distinction," said Andrew von Eschenbach, M.D., acting commissioner of Food and Drugs, in a press statement. "I've had the pleasure of working with Janet at the National Cancer Institute, and I've learned to appreciate her creative ideas and her dedication to getting them implemented.”
PMC is a non-profit group of academic, industrial, government, patient and health care provider organizations dedicated to advancing the understanding and adoption of personalized medicine concepts and products. In honoring Woodcock, the group singled out two FDA innovating programs under her leadership.
The Critical Path initiative is an ongoing nationwide project designed to modernize the techniques, tools and methods for evaluating the safety and effectiveness of candidate drugs during their development. Her other innovation, the FDA's Guidance on Pharmacogenomic Data Submissions, was issued last March and established a framework for voluntary submission of genomic and other data and their use in evaluating new drug and biologic license applications.
Before becoming FDA's deputy commissioner and chief operating officer, Woodcock was the acting deputy director of the Center for Biologics Evaluation and Research and, from 1994 until 2005, the director of the Center for Drug Evaluation and Research.