Michele Gargano, MS.c., has almost 30 years of industry experience in early-stage to BLA/NDA drug development. She brings extensive leadership experience having held positions of increasing responsibility throughout her career. Prior to joining HiberCell, Michele was the vice president of clinical development and program management at Biothera Pharmaceuticals, Inc., where she was responsible for managing clinical operations, cross-functional programming and regulatory affairs for multiple development programs. She has been responsible for 14 INDs for the treatment of cancer, various gastrointestinal, hepatic, and ophthalmic indications, and cystic fibrosis working closely with FDA’s CDER and CDRH divisions and select global health authorities. She has authored numerous clinical documents and regulatory submissions including clinical protocols, meeting briefing packages, breakthrough therapy and orphan drug applications, and has managed collaborative/ licensing relations furthering development.
Michele holds a B.A. in cultural anthropology and government from Sweet Briar College, and a general certificate and M.Sc. in social anthropology from the London School of Economics.