JESSE GOODMAN, M.D., MPH, NAMED DIRECTOR OF CBER;
KATHRYN ZOON, Ph.D., MOVES TO NIH

Commissioner of Food and Drugs Dr. Mark McClellan today announced that he has appointed Jesse Goodman, M.D., MPH, to replace Kathryn Zoon, Ph.D., as director of FDA's Center for Biologics Evaluation and Research (CBER). He also announced that he expects improvements in making effective new cancer treatments available as a result of Dr. Zoon's new appointment at the National Cancer Institute (NCI).

Dr. Zoon, who joined FDA in 1980 and has served as director of CBER since 1992, announced her pending resignation on Friday in order to return to the National Institutes of Health, as Principal Deputy Director for Research, in the Center for Cancer Research, at NCI.

"As head of FDA's biologics center, Kathy Zoon has skillfully presided over a decade of dramatic change in the world of biotech, cellular, and gene therapies," said Dr. McClellan. "She has helped forge CBER into the world's premier biologic regulatory agency, the global leader in the development of vaccine, blood, and novel therapeutics. NCI Director Andrew von Eschenbach and I are convinced that the close FDA ties Dr. Zoon brings to her new post at NIH will enhance FDA's efforts to collaborate closely with NIH to bring safe and effective products to the market - one of my top priorities as FDA Commissioner."

Dr. Goodman, currently CBER's Deputy Director (Medicine), is a virologist who is board certified in internal medicine, oncology, and infectious diseases. Educated at Harvard, he earned an M.D. from Albert Einstein, and did residency and fellowship training at the University of Pennsylvania and UCLA.

Dr. Goodman joined FDA's Office of the Commissioner in 1998, where he directed the U.S. government's Interagency Task Force on Antimicrobial Resistance. He later moved to CBER, where he has been active in a wide variety of clinical and public health issues including bioterrorism preparedness and response, product development, human subject protection, and blood and vaccine safety.

"Jesse Goodman possesses the ideal credentials and experience to serve the American public as an empowered director of FDA's biologics center," said Dr. McClellan. "This is a critical time for biologics, with technologies like cellular and gene therapies holding the promise of transforming medical care in the 21st century, and with new challenges including countering terrorism and protecting the blood supply from new threats. Dr. Goodman is absolutely committed, as am I, to meeting these challenges through sound regulation based on the best science and risk assessment models."

During Dr. Zoon's tenure at the helm, CBER licensed approximately 320 products, implemented the prescription drug user fee program for biological products, and met all performance goals under that program. The first woman to serve as director of an FDA center, she has served as an outspoken advocate for strong science, both in CBER and throughout the FDA.

Dr. Goodman will work closely with Dr. McClellan and the senior leadership of CBER in the coming days and weeks to seek new ideas and approaches to carrying out the FDA's public health mission. They will also work quickly to complete the transfer of certain product reviews formerly conducted in CBER to FDA's Center for Drug Evaluation and Research.

Dr. Goodman is expected to assume his new duties as center director by mid-January.

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