Dr. Arifa Khan is a principal investigator and supervisory microbiologist in the Division of Viral Products, Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration (FDA). She joined the FDA in 1991, after working at the National Institute for Allergy and Infectious Diseases, National Institutes of Health, where she contributed significantly to recombinant pathogenic retroviruses and functional analysis of endogenous retroviruses. An important component of Dr. Khan’s current research program in CBER is focused on developing next generation sequencing for detection of adventitious viruses for cell substrate and vaccine safety. Additionally, her program is investigating host and viral interactions involved in latent infections. Her regulatory responsibilities include review of Investigational New Drugs and Biological License Applications for a variety of candidate vaccines, including influenza and HIV, and novel cell substrates across different product categories.
Dr. Khan has been involved in licensure of several viral vaccines and development of various guidance documents from FDA, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Public Health Service, and the World Health Organization related to cell substrates, vaccines, therapeutics, and xenotransplantation. She is a lead in various FDA and external working groups related to next generation sequencing, adventitious viruses, and cell substrate safety. Dr. Khan received her doctorate in microbiology from the George Washington University, Washington, DC.