Speaker

Angela Whatley, PhD

SENIOR DIRECTOR REGULATORY AFFAIRS, BRIDGEBIO
Dr. Angela Whatley is Director of Regulatory Affairs at PTC Therapeutics. From 2016 to 2021, Dr. Whatley worked as a CMC Reviewer for Gene Therapies at the US FDA. During this period, she served on the Biologics License Application (BLA) review team for all AAV gene therapy products submitted to the FDA with increasing responsibilities including serving as the BLA Chair and CMC lead for a BLA for which she directed the regulatory review. Angela is also a member of the American Society for Gene and Cell Therapy’s CMC Committee. Following her time at FDA Dr. Whatley has worked with biotech companies as both a Global Regulatory Lead and subject matter expert for CMC. Dr. Whatley is passionate about expediting the drug development process to ensure promising therapies reach the patients who need them. Dr. Whatley received a PhD in Microbiology from the University of Missouri and a B.S. in Biology from Rockhurst University.
Speaking In
11:00 AM - 12:00 PM
Wednesday, June 7
The development of cell, gene therapy, and genome editing presents several challenges. While…