James Kanter
SVP, CMC

Mr. Kanter brings over 30 years of CMC experience in the development and commercialization of small molecule, peptide, natural product and ADC conjugate compounds covering a range of therapeutic areas including oncology, cardiovascular, pain, antiviral, antibiotic, immunologic, diagnostic and orphan/rare diseases. Mr. Kanter has held scientific and management roles at various biotech companies, including COR Therapeutics/Millenium, Exelixis, Gilead Sciences, Portola Therapeutics, Ardelyx, and most recently BridgeBio where he was VP of CMC/Pharmaceutical Development. In this role, Mr. Kanter managed the CMC portfolios, which include drug substance development and manufacturing, formulation development and drug product manufacturing, analytics to support DS and DP, labeling, packaging and kitting and supply chain and logistics from early development through commercialization. This included regulatory/CMC strategy and the drafting and review of CMC regulatory documents; BBs, INDs, IMPDs, NDAs, and CTAs, as well as interactions with relevant regulatory agencies worldwide (FDA, EMA, MHRA, KFDA, NMPA, PMDA, ANVISA, AIFA, Health Canada and Swiss Medic). He has contributed to more than 60 NCE INDs/IMPDs, as well as six successful NDA/EMA submissions and subsequent drug approvals resulting in multiple commercial launches.