Kathy Lee

Ms. Lee works for Eli Lilly and Company in Global Regulatory, CMC. Responsible for the post-approval E. coli drug substance platform global change agenda and responsible for both early and late phase projects. Additionally, Ms. Lee is the CMC regulatory lead for biosimilar products and policy for Eli Lilly and Company.

Prior to joining Lilly, Ms. Lee was with the FDA where she supervised the review of the product quality, manufacturing process and control, pharmaceutical development information submitted in Investigational New Drug applications (IND), Investigational Device Exemptions (IDE), Pre-Marketing Approvals (PMA), New Drug Applications (NDA), supplemental NDAs, Biological License Applications (BLA), and supplemental BLAs. Early in her career Ms. Lee work at a contract research organization for ten years performing a large variety of in vitro and protein characterization assays.

She holds a M.S. degree from Johns Hopkins in biotechnology and a B.A. degree from St. Mary’s College of Maryland in biology.