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October 25-28, 2021
Delivered in a 100% Digital Format in EST Time Zone

Mikhail Ovanesov, CBER, OTAT, DPPT
Research Biologist, Principal Investigator at FDA CBER

Profile

Dr. Ovanesov is a biophysicist who joined CBER in 2009 as a regulatory scientist and principal investigator. Dr. Ovanesov conducts expert regulatory review of Investigational New Drug (IND) submissions and Biologics License Applications (BLA) for blood plasma-derived and recombinant plasma protein products, lyophilized human plasma, gene therapies for hemophilia, and related devices. He serves as the product reviewer and Committee Chair on original BLA submissions and participates in the inspections of manufacturing facilities. His laboratory at CBER develops biological reference standards and novel hemostasis assays, and investigates mechanisms of action of procoagulant therapeutics.

Agenda Sessions

  • FDA Address: Detection of Stability Change in Frozen Drug Substance and Efficient Stability Monitoring of Drug Product

    12:10pm
  • Regulatory Town Hall

    12:40pm