Dr. Gordon brings 30 years of experience in the pharmaceutical industry and FDA to her role at Amplex. Dr. Gordon has an in-depth understanding of the requirements for successful new drug registration, along with a first-hand knowledge of facilitating regulatory interactions. Dr. Gordon was the president and founder of EG Consulting Inc., where she provided expert regulatory advice on requirements for biological and pharmaceutical product development. Her responsibilities included oversight of U.S. and non-U.S. regulatory operations, preparation of all regulatory submissions, project and strategic planning from candidate selection through completion of clinical studies, oversight of product development information management systems and management of potential partners to support funding or other business transactions.
Dr. Gordon also acted as head of regulatory affairs while consulting for Lumena Pharmaceuticals Inc., a position that transitioned into full-time employment as vice president of regulatory affairs in early 2014. Under her leadership, Lumena initiated 10 clinical trials in eight countries. Its drug candidate ultimately gained orphan product designation in the United States and the European Union for the treatment of four rare cholestatic liver diseases. Dr. Gordon also previously served as senior director of regulatory affairs in the Medical and Regulatory Services Division of Quintiles Transnational, where she assisted clients in the development of efficient worldwide product development programs and provided strategic regulatory advice on all aspects of therapeutic development from discovery through post-marketing.
Prior to Quintiles, Dr. Gordon spent six years at the FDA serving in numerous positions in both the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.
Dr. Gordon holds a Ph.D. in microbiology from the University of Rhode Island and received a B.A. in microbiology from the University of New Hampshire. She also completed an Executive Master of Science in technology management at the University of Maryland.