Cynthia Riggins

Cynthia Riggins, Ph.D. is Vice President and Head of CMC Regulatory Affairs at ElevateBio. Cindy joined FDA/CBER as a post-doctoral researcher studying the cellular rejection response to xenotransplantation in 2001 and later performing regulatory review of investigational new drug applications for various cell therapy products in CBER. After making the jump to industry in 2008, Cindy has been in numerous CMC Regulatory Affairs roles spanning Manager to Vice President and Head of CMC Regulatory at companies including AstraZeneca, Novartis, Autolus and ElevateBio. Cindy has more than 15 years of experience working in global CMC regulatory affairs, primarily in Cell and Gene Therapy and Monoclonal Antibody product development. She has experience in building and leading CMC teams to support early to late stage development of Cell and Gene Therapy Products, including submission of Kymriah (CD19 CAR T gene-modified cellular therapy) marketing applications in multiple regions and life cycle management.