Mikhail V. Ovanesov, PhD U.S. FDA

Mikhail V. Ovanesov, PhD

Mikhail V. Ovanesov, PhD U.S. FDA

Dr. Mikhail Ovanesov is a Branch Chief and Principal Investigator in the Office of Therapeutic Products of the Center for Biologics Evaluation and Research, US Food and Drug Administration. Dr. Ovanesov is a biophysicist who joined the Agency in 2009 after postdoctoral fellowships with the American Red Cross, Johns Hopkins University and Howard Hughes Medical Institute. He oversees regulatory reviews and conducts manufacturing site inspections for a variety of biological products, including plasma derived and recombinant protein therapeutics, dried plasma and platelets for transfusion, and gene therapies for hemophilia. His research laboratory is investigating safety and efficacy of hemostasis products and represents Agency in international collaborative laboratory studies on biological standards for the World Health Organization. Dr. Ovanesov also serves as Government Liaison to standards development organizations European Pharmacopeia, US Pharmacopeia and International Society for Thrombosis and Haemostasis.