Management Bios

Dr. King C. Lee is a senior regulatory and clinical affairs executive with more than 30 years of experience guiding pharmaceutical and biotechnology products from early development through FDA approval. His career spans therapeutic immunomodulators, oncology agents, vaccines, metabolic pathway–directed therapies, and advanced biologics, with deep expertise in translating complex science into successful regulatory outcomes.

Prior to joining CaroGen, Dr. Lee held senior leadership roles at Cornerstone Pharmaceuticals, Acorda Therapeutics, ATON Pharma, Vion Pharmaceuticals, and IBEX Technologies, where he led regulatory strategy, IND submissions, clinical development planning, and quality oversight across multiple therapeutic areas.

Dr. Lee played key roles in the FDA approvals of Zolinza (vorinostat) for leukemia, Primacor (milrinone) for congestive heart failure, and Omniscan (gadodiamide) as an MRI contrast agent—demonstrating his ability to navigate diverse regulatory pathways from oncology to cardiovascular and diagnostic products.

Over the course of his career, Dr. Lee has contributed to more than 50 successful IND applications and three NDA approvals, and has authored or co-authored over 40 scientific publications, book chapters, and professional papers. He is widely respected for his practical regulatory insight, meticulous documentation standards, and ability to align clinical strategy with regulatory expectations.

Dr. Lee earned his PhD in Pharmacology from the College of Medicine at the University of Kentucky College of Medicine and is a Regulatory Affairs Certified (RAC) professional.

At CaroGen and NewCo, Dr. Lee provides critical leadership in IND strategy, FDA engagement, CMC compliance, and quality systems—ensuring that the AVIDIO™ VLV platform and CARG-2020 program advance to the clinic on a sound and efficient regulatory foundation.