Karen Midthun

Karen Midthun is an American infectious disease internist and physician-scientist. She worked at the Food and Drug Administration from 1993 to 2016, ultimately holding the position of director of the Center for Biologics Evaluation and Research.

Education Midthun received a bachelor's degree from the Massachusetts Institute of Technology and a M.D. from the George Washington University School of Medicine & Health Sciences. She trained as a resident in internal medicine at Johns Hopkins Hospital and as a fellow in infectious diseases at Johns Hopkins Hospital and the National Institute of Allergy and Infectious Diseases. She later became director of the Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review. During her tenure at the FDA, Midthun oversaw the approval of biologics, including influenza vaccines using novel technologies, vaccines for pneumococcal and meningococcal diseases, human papillomavirus, and treatments for rare blood disorders. She also contributed to the development of regulatory frameworks for human cell and tissue products and collaborated with other FDA centers on biosimilar policy.

Midthun is a fellow of the Infectious Diseases Society of America and a member of the American College of Physicians and the American Society for Virology.