Mehrshid Alai is VP of Global Regulatory CMC for Kite, a Gilead Company, where she is responsible for all aspects of Regulatory CMC, including development and life cycle management. Mehrshid has her Ph.D. in Biochemistry, Cell, and Molecular Biology from The Johns Hopkins University School of Medicine. Prior to Kite, Mehrshid was Interim Head of Global Regulatory CMC for Baxalta/Shire. She had the responsibility to oversee CMC aspects of all products including small molecules, biologics, complex biologics and devices. Previous to that she held various roles in R&D, Quality and Regulatory in Baxter. She is a member of Gene Therapy Working party and USP Complex Biologics Expert Committee.