Robert (Bob) Kumi has more than 20 years of experience as a pharmaceutical scientist, regulatory affairs professional, and FDA reviewer. Bob has served as a strategic leader in the pharmaceutical industry contributing to global drug development and marketing approval of small molecules and biologics in immunological diseases, oncology, dermatology, infectious disease, cardiovascular and renal disease with global experience in the US, Canada, Japan, Asia, Latin America, and Europe. At Halloran, he provides strategic development planning and support to emerging life science companies pursuing early to late stage development.
Prior to joining Halloran, Bob was a Senior Director of Regulatory Affairs at Insmed Incorporated leading the effort for global marketing applications as well as multiple investigational products across different therapeutic areas. Prior to that, he served as a Director of Regulatory Affairs at Regeneron Pharmaceuticals where he was the global lead for candidates in various diseases in Phase 3 and early development. In the past, he has also held senior Regulatory Affairs and Clinical Development positions at Boehringer Ingelheim and TOLMAR. He started his career as a Clinical Pharmacology Reviewer at the US FDA, reviewing investigational and marketing applications for antiviral, cardiovascular and renal, and neurology products involving various administration routes, formulations, study populations, and indications.