FDA NEWS RELEASE

Dr. Janet Woodcock Honored for Scientific Leadership

Dr. Janet Woodcock, the U.S. Food and Drug Administration's Deputy Commissioner for Operations, has been chosen as the first recipient of a prestigious award 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 Dr. 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 Dr. Andrew von Eschenbach, Acting Commissioner of Food and Drugs. "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. Her vision, drive, and scientific expertise are helping move medical progress forward, and make all of us at the FDA proud."

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 Dr. Woodcock, the group singled out two FDA innovating programs under her leadership.

One of them is the Critical Path initiative, an ongoing nation-wide project designed to modernize the techniques, tools, and methods for evaluating the safety and effectiveness of candidate drugs during their development. The other innovation is the FDA's Guidance on Pharmacogenomic Data Submissions, which was issued last March. The Guidance 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, Dr. 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.

A prominent FDA scientist and executive, Dr. Woodcock has received numerous awards, including a Presidential Rank Meritorious Executive Award, the American Medical Association's Nathan Davis Award, and six Special Citations from FDA Commissioners. She will be presented her PMC award during today's conference of the Harvard-Partners Center for Genetics and Genomics in Boston.

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