Dr. Dominique Gouty

Dr. Dominique Gouty brings over 25 years of business leadership experience in multi-national Pharmaceutical / Healthcare and Services industries, spanning, clinical operations, diagnostics, manufacturing of Biologics and Bioanalytical testing of Protein Drugs, Cell Therapies and Gene Therapies.

Dr. Gouty most recently served as the Chief Scientific Officer at BioAgilytix, a contract research laboratory. Over her tenure she participated in successfully bringing half of all the biologic drugs (including gene and cell therapies) to final approval by the FDA. Before this she led an international pharma division of a contract research laboratory specializing in small and large molecule services. Her strategic leadership role led to the building of several market-leading services companies in different locations around the world. Dr. Gouty also has 15 years of prior industry experience with Eli Lilly and smaller biotech companies.

Dr. Gouty is a leading expert in novel therapeutic biologics, gene therapy, cell therapy, and biosimilars. She has written several eBooks and over 150 published scientific papers covering areas of new drug development / healthcare, and she holds patents on drugs and technologies which have contributed to bringing multiple drugs to market. Dr. Gouty has a deep and expert knowledge on the evolving regulations of the FDA, EMA, and other regulatory agencies.