King C. Lee
Senior Regulatory
pharmaceutical
Pars Esta
United States of America
Biography
Dr. Lee has extensive pharmaceutical experience in regulatory, quality, and clinical affairs. He has been involved in small molecule and biologics research and development from pre-IND through post-NDA, including products for cancers, metabolic, neurological and hematological disorders. Dr. Lee has served as Vice President, Regulatory and Clinical Affairs at Cornerstone Pharmaceuticals since 2005 where he has global clinical and regulatory responsibility for all phases of drug development. Prior to Cornerstone, he was the Vice President of Regulatory Affairs at Acorda Therapeutics and Executive Director of Regulatory Affairs/Quality Assurance for ATON Pharmaceuticals (purchased by Merck in 2003). Previously, Dr. Lee was the Director of Regulatory Affairs/Quality Assurance for Vion Pharmaceuticals, Inc. from 1996 through 2001, and was the Manager of Regulatory Affairs/Clinical Affairs for IBEX Technologies from 1993 to 1996. In addition, Dr. Lee has authored and co-authored over 40 publications (scientific and professional papers, books and review articles) and numerous scientific abstracts. He received his Ph.D. in Pharmacology from the College of Medicine, University of Kentucky in 1983 and was certified by the Regulatory Affairs Professionals Board in 1994.
Research Interest
cancers, metabolic, neurological and hematological disorders