David Morse, PhD
Chief Regulatory Officer and Senior Vice President
David Morse, PhD has over 35 years of experience in pharmaceutical development and Regulatory Affairs. Prior to working for BioVie, he served as the Vice President of Global Regulatory Affairs and Vice President of Regulatory Strategy for multiple top-tier contract research organization (CRO) services industry corporations. Dr. Morse has also worked as an independent consultant, Associate Director at the U.S. Food and Drug Administration (FDA), and Laboratory Director in translational medicine research settings.
His Regulatory Affairs and product development background includes extensive experience in neurology, anti-infectives, oncology, gastro-intestinal, dermatology, and radiological injury therapeutics. His background includes successful application strategy development for multinational submissions to the U.S. FDA, EMA, HC and other worldwide authorities, including market applications for small molecular entity products, therapeutic proteins, antibodies, immunoglobulins, and vaccines, resulting in over a dozen successful regulatory authority filings and market application approvals.
Dr. Morse is a graduate of the Uniformed Services University of the Health Sciences, Bethesda, Maryland.
His Regulatory Affairs and product development background includes extensive experience in neurology, anti-infectives, oncology, gastro-intestinal, dermatology, and radiological injury therapeutics. His background includes successful application strategy development for multinational submissions to the U.S. FDA, EMA, HC and other worldwide authorities, including market applications for small molecular entity products, therapeutic proteins, antibodies, immunoglobulins, and vaccines, resulting in over a dozen successful regulatory authority filings and market application approvals.
Dr. Morse is a graduate of the Uniformed Services University of the Health Sciences, Bethesda, Maryland.