Arifa Khan

Dr. Arifa S. Khan received her Ph.D. in Microbiology from the George Washington University, Washington, D.C. She is currently a Supervisory Microbiologist and Senior Investigator in the Division of Viral Products, Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. Dr. Khan joined FDA in 1991, after working in Dr. Malcolm Martin’s laboratory at NIAID/NIH since 1979, where she contributed significantly to field on murine leukemia retroviruses, endogenous retroviruses, and SIV. In CBER, Dr. Khan established and maintains a rigorous research program on development of sensitive, state-of-the art assays for adventitious virus detection, with focus on safety of novel cell substrates and vaccines. Dr. Khan’s current research efforts include development of standards and next generation sequencing pipelines for adventitious virus detection by in biologics. Her regulatory responsibilities include review of candidate viral vaccines, including SARS-COV-2, HIV, influenza, and to provide expert consultation on novel cell substrates and adventitious viruses in CBER and CDER. Dr. Khan has been involved in licensure of several viral vaccines and development of FDA, ICH, PHS, USP, and WHO guidance documents related to cell substrates and viral safety. She is the FDA lead on adventitious viruses and next generation sequencing for cell substrates and product safety.