Speaker

Cynthia Porter Riggins

HEAD OF CMC REGULATORY AFFAIRS, ELEVATEBIO
Cindy Riggins, Ph.D. is head of CMC Regulatory Affairs at ElevateBio. Cindy started her career in cell and gene therapies in 2001 at FDA/CBER as a post-doctoral fellow studying xenotransplantation and later transitioning to product reviewer for various cell therapy products. After leaving FDA in 2008, she has been involved in development of monoclonal, cell, and gene therapies through CMC Regulatory Affairs roles at AstraZeneca, Novartis, Autolus and ElevateBio. She was part of the regulatory team at Novartis responsible for submission and approval of Kymriah®, the first gene therapy product approved in the USA.
Speaking In
11:00 AM - 12:00 PM
Wednesday, June 7
The development of cell, gene therapy, and genome editing presents several challenges. While…