Mehrshid Alai-Safar

Mehrshid Alai is the Vice President of Regulatory Affairs, CMC at Kite, a Gilead Company, and is involved with new product development and life cycle management of genetically modified cell therapy products. Prior to joining Kite, she was the head of Regulatory CMC at Baxter/Baxalta/Shire. Dr. Alai has extensive experience in biological product development, quality requirements and regulatory approval and management of post-approval changes. Prior to her regulatory affairs experience, she was part of quality organization with extensive experience in different areas such as quality control, quality assurance of new products, stability and device and combo product development. Dr. Alai also worked in research and development as a protein characterization scientist and managed a group of scientists in that area. She has 30 years of experience in biologics development, biological product life cycle, quality and regulatory affairs. Prior to joining Baxter, she was an assistant professor at Simon Fraser University. She holds a Ph.D. from Johns Hopkins School of Medicine.