Jane Koo

Jane Koo

Opinion author

Jane Koo, PhD, head of regulatory at CTMC, is a regulatory expert with 20 years of experience in biologics and advanced therapies. At CTMC, she drives regulatory strategies to accelerate the development and industrialization of innovative cell and gene therapies, fueled by her commitment to transforming treatment options and advancing the fight against cancer. With a track record of securing first-to-market approvals, she specializes in translating complex technical data into actionable strategies. Her expertise spans monoclonal antibodies and cell-based therapies across all development stages, from preclinical to commercial.

The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing.