James Kanter

Mr. James Kanter has extensive experience in all areas of small molecule CMC development gathered during his 27 years in the biotech/pharmaceutical industry. This includes the development of over 35 compounds in the areas of oncology, antivirals, antibiotics, immunology, cardiovascular and pain management. James has been an integral member in the successful approval of more than 30 IND’s, 6 NDA’s and 4 IMPD’s.

James previously served as the Vice President of Pharmaceutical Development at several subsidiary companies of Bridgebio, where he spearheaded the CMC activities for several early stage small molecule assets as well as the recent NDA filing for fosdenopterin, a breakthrough designated compound for the treatment of MoCD-Type A, a rare neurological disorder in newborns that can lead to severe brain toxicity, developmental delays, and death. Before Bridgebio, James worked at various biotech companies including Ardelyx as Senior Director of Pharmaceutical Development where he was part of the team responsible for the successful approval of Tenapanor. Before that James was the CMC lead at Portola that led to the approval of Betrixaban, spent five years in increasing leadership roles at Gilead Sciences where he was part of multiple IND and NDA approvals, as well as managing the commercial drug substance supply for both Tenofovir and Emtricitabine as part of the HIV franchise.

James received his MSc and BSc from the University of Toronto and is a coauthor of more than twenty-five papers and patents.