Sue Preston

Sue Preston is the Senior Vice President of Regulatory Affairs at Flame Biosciences. An experienced pharmaceutical executive, she has introduced successful development strategies for novel technologies for biopharmaceuticals, small molecules, drug delivery systems, and diagnostics.

Ms. Preston started her career with the NIH with a subsequent eight years at FDA/CBER responsible for review and approval of biologics and polymers including the first therapeutic, monoclonal antibody. After moving into the industry, she has 20+ years implementing innovative regulatory and quality strategies for timely product approval and life-cycle management for a variety of globally marketed products. Ms. Preston gained broad therapeutic and technology experience in oncology, respiratory, infectious diseases, autoimmune diseases, neurology, and critical care. Working in the industry, Ms. Preston was responsible for regulatory and quality strategies for over 60 products marketed in over 40 countries.

She has held positions of increasing responsibility at Baxter Healthcare, Medarex, Alpha Therapeutic Corporation, and Chiron Corporation. Ms. Preston has represented manufacturers and industry organizations in testimony before three Congressional Committees and the General Accounting Office.