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Kathryn C. Zoon, Ph.D. (1949–present)

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“I believe that CBER’s tradition of integrating innovative science with innovative regulations has enhanced our ability to protect the public health, and has led to safer and more effective biological products.”

  • — Kathryn Zoon


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Kathryn C. Zoon was born in 1949 in Yonkers, New York. She received her bachelor’s degree with honors in chemistry from Rensselaer Polytechnic Institute (RPI) in 1970 and a Ph.D. in biochemistry from Johns Hopkins University in 1976. She was the only female in her chemistry classes at RPI in the 1960s

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FDA History Office

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From 1977 to 1980 she was a fellow at the NIH. She worked with Nobel Laurate Christian B. Anfinsen on the purification and characterization of interferon, a key player of the immune system’s first line of defense against viral infections. They were the first to sequence a human interferon alpha protein, which opened the door to genetic engineering of this interferon and many other important biological protein medicines. Dr. Zoon continued her research on interferon throughout her career.

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When she first joined the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) in 1980 she worked in the Division of Biochemistry and Biophysics. She was a crucial part of 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 then became the head of the Cytokine Biology Division (1988–1992) where she coordinated the reviews of further indications for the interferon products, including AIDS-related Kaposi’s sarcoma, genital warts and, more 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), which was approved in 1990 by Zoon’s group for the rare disorder of chronic granulomatous disease. In 1991, Zoon was in charge of the reviews of granulocyte and granulocyte-macrophage colony stimulating factors (Amgen’s Neupogen and Immunex/Hoechst’s Leukine/Prokine).

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