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Biologics Regulation and ResearchThe People and Work of Buildings 29 & 29A

Kathryn C. Zoon, Ph.D. (1949–still living)

“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

Dr. 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.

From 1977 to 1980, Zoon was a fellow at the National Institutes of Health (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. Zoon continued her research on interferon throughout her career.

Kathryn Zoon sitting at a table, smiling for the photo

FDA History Office
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).

Known for her strong research skills, inspiring leadership abilities, and intelligent management style, Zoon became the first female director of CBER in 1992, a position she held through 2002. She took the helm at CBER when they were receiving a remarkable number of new biotechnology product applications.

In 2002, she was elected to the National Academy of Medicine based on her contributions to public health and biotechnology.

Zoon returned to the NIH in 2003 where she worked at the National Cancer Institute as principal deputy director. She became the first female scientific director at NIH’s National Institute of Allergy and Infectious Disease's Division of Intramural Research in 2006. In this role she led staff in virology, immunology, product development, and clinical research, retaining and training new scientists, and providing future directors for programs.

Since 2017 she has served on the board of directors for Emergent BioSolutions, Inc., whose mission is to protect and save lives from public health threats.

Zoon has won numerous awards during her career including: the BioPharm Person of the Year Award (1992); a Genetic Engineering News Award (1994); the Department of Health and Human Services (HHS) Secretary’s Award for Distinguished Service for outstanding leadership in positioning the FDA as an important contributor to the nation’s ability to respond to bioterrorism (2001): and an HHS award for counter-bioterrorism (2003). She also received the 2014 William Hancock Award for Outstanding Achievement in CMC Regulatory Science from the non-profit science society, CASSS, and was inducted into RPI's Alumni Hall of Fame in 2020.

Dr. Zoon worked in Building 29, Room 130 and Building 29A, second floor.


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