Gail McIntyre

Gail McIntyre

Opinion author

Gail McIntyre, Ph.D., is a partner at InnoDev Partners LLC. She is an accomplished biopharmaceutical executive with over 30 years of experience, including roles at Aravive, Meryx, Furiex Pharmaceuticals, Pharmaceutical Product Development (PPD) LLC and as founder of IntelliDev Consulting. She has led the development and licensing of multiple drugs, including Nesina, Priligy, and Viberzi. McIntyre played a pivotal role in the $1.1B acquisition of Furiex by Allergan in 2014 and successfully negotiated with Controlled Substances Staff on scheduling for Viberzi, which resulted in payment of a CVR. Most recently, McIntyre served as Aravive’s chief executive officer, chief scientific officer and head of R&D over a 7-year period and led the development of batiraxcept from discovery through the Phase 3 pivotal studies and negotiated, during which she engineered the licensing of batiraxcept to a company in China. McIntyre’s expertise spans various therapeutic areas and modalities, and she is board-certified in toxicology and clinical pathology. McIntyre earned a B.A. in biology from Merrimack College and M.S. and Ph.D. degrees in biochemistry and biophysics from the University of North Carolina at Chapel Hill.

The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.