Kevin Okimura is an experienced CMC leader with over 15 years of experience in the biotechnology industry spanning development phases from pre-clinical to post-commercial. He has expertise in biologics development strategy and execution, including cell line development, process development, CDMO selection/management, technology transfer, process characterization, process validation, regulatory affairs, and CMC project leadership. Kevin's background includes significant contributions to 4 BLAs (KEYTRUDA, ANDEXXA, Orca-T, undisclosed) and 15+ clinical program INDs. He has held key roles with progressively increasing scope and responsibility at Merck, Medivation, Portola Pharmaceuticals, Pionyr Immunotherapeutics, Orca Bio, and CARGO Therapeutics. Kevin has been a consultant since 2025 and holds a B.S. in Chemical Engineering from UC Berkeley.