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CBER’s NEW DIRECTOR IS KATHRYN ZOON, FORMER CYTOKINE DIVISION HEAD; ACTING DIRECTOR GERALD QUINNAN IS EXPECTED TO RESUME BIOLOGICS DEPUTY DIRECTORSHIP

Executive Summary

FDA Center for Biologics Evaluation and Research has a new director, Kathryn Zoon, PhD, the former head of the agency's Cytokine Biology Division. Zoon, 43, is expected to assume the top position March 4. Gerald Quinnan, MD, who has served as acting director since the departure of Paul Parkman, MD, is expected to resume his previous post as deputy director. Janet Woodcock, MD, has been CBER's acting deputy director since September 1990 when she joined center management from the Division of Biological INDs. The center has been without a permanent director since the retirement of Parkman in July 1990. A large group of candidates were considered for the post, including: National Cancer Institute Director Daniel Hoth, MD; University of Cincinnati infectious diseases researcher Martin Meyer, MD; Center for Drug Evaluation and Research Deputy Director of Scientific and Medical Affairs Bruce Burlington, MD; CBER's Quinnan, and Pharmaceutical Manufacturers Association VP-Medical and Regulatory Affairs John Petricciani, MD. Zoon, among regulators and industry alike, is considered a keen manager and inspiring leader with strong research credentials. Foreshadowing her present appointment, Zoon represented CBER before the Edward's Committee Subcommittee on Drugs and Biologics in November 1990. At that time, she promoted the preservation of intramural research programs in CBER despite an anticipated influx of biotech applications, saying that CBER had the capacity to shift people from research to regulation when needed. Zoon suggested that active researchers would be better able to understand issues surrounding biotech products and thereby more effectively convey FDA's ideas to industry. Zoon has risen in the last 10 years from FDA senior staff fellow in the Division of Biochemistry and Biophysics to director of one of the most important divisions reviewing biotechnology products today. Zoon earned a bachelor's in science from Rensselaer Polytechnic Institute and a PhD in biochemistry from Johns Hopkins University. From 1977 to 1980 she was a fellow at the National Institutes of Health. During her early years at FDA, Zoon was instrumental in the development of quality control standards for alpha interferon and participated in the reviews of the first alpha interferon products (Schering-Plough's Intron A and Hoffmann-La Roche's Roferon). Zoon takes charge of CBER at a time when the center faces a major influx of new applications from biotechnology companies and the first signs of a building review backlog ("The Pink Sheet" Jan. 20, p. 9). As director of the cytokine division, she coordinated the reviews of further indications for the interferon products, including AIDS-related Kaposi's sarcoma, genital warts and, most recently, hepatitis C. Zoon was also involved in the licensing of a third alpha interferon product, Interferon Sciences' Alferon N. Genentech's Actimmune (interferon gamma-1b) was approved in 1990 by Zoon's group for the rare disorder of chronic granulomatous disease. In 1991, she presided over PLA reviews of granulocyte and granulocyte-macrophage colony stimulating factors (Amgen's Neupogen and Immunex/Hoechst's Leukine/Prokine).
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