Debra Gessner

  • Regulatory Consultant; Therapeutics

Debra Gessner has over 25 years of hands-on submissions and management experience in Regulatory Affairs and compliance, including building and heading regulatory, QA Quality and publishing teams, project team leadership, corporate partner management, and due diligence activities. Debra’s regulatory experience encompasses Pre-IND through approval and launch of 5 marketed products. Most recently, Debra spent nearly over four years at Tocagen Inc. as Vice President of Regulatory and Quality Assurance. Her 26 years of drug and biologics development experience comprise VP, Director and Manager-level roles at seven other biotechnology companies in Southern California, including Sirion Therapeutics, Bruin Pharma, Santarus, Collateral Therapeutics, La Jolla Pharmaceutical Co., Viagene, and Gensia. Debra is also actively involved in regulatory teaching and mentoring, having served on the faculty of DIA for over 10 years, as well as speaking and participating in numerous conferences sponsored by UCSD, USD, ASCRP and other professional associations. Debra received an M.Sc. in Regulatory Affairs from San Diego State University, and a B.S. in Medical Technology from the University of Texas Medical Branch in Galveston.