Kathryn C. Zoon, Ph.D. (1949–present)
“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
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 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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FDA History Office
Known for her strong research skills, inspiring leadership abilities, and intelligent management style, Dr. Zoon became the first female director of CBER in 1992, a position she held through 2002. She took the helm at CBER during a time 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.
In 2003 she returned to the NIH where she worked at the National Cancer Institute (NCI) as principal Deputy Director. She became the first female Scientific Director at NIH’s National Institute of Allergy and Infectious Disease (NIAID) Division of Intramural Research in 2006. In this role led staff in virology, immunology, product development and clinical research, returning and training new scientists, and providing future director 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.
Dr. Zoon has won numerous awards during her career including the BioPharm Person of the Year Award in 1992, a Genetic Engineering News Award in 1994, the 2001 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, and a 2003 HHS award for counter-bioterrorism. She also received the 2014 William Hancock Award for Outstanding Achievement in CMC Regulatory Science from non-profit science society, CASSS, and was inducted into the Rensselaer Polytechnic Institute’s Alumni Hall of Fame in 2020.
She worked in Building 29, Room 130 and Building 29A, second floor.