Cell & Gene Therapies: A Regulatory Update

4:15 PM - 5:15 PM (PDT), Wednesday, June 15, 2022 ・ Upper Level, Session Room 2

The number of cell and gene therapies entering clinical trials is growing at an increased rate. With FDA providing new guidance on AAV-based gene therapies, early engagements with a strong regulatory strategist can help navigate the complexities of an evolving regulatory environment and give insights to the different ways to enhance the efficiency of CGT development programs. Come join this fireside chat and learn about recent FDA Guidance documents, including PDUFA VII Commitment letter and their implications on CGT programs. 

Sponsored By
Moderator
photo
Vice President, Regulatory Affairs
BlueRock Therapeutics
Speakers
photo
Vice President, Regulatory Affairs
BlueRock Therapeutics
photo
Mr
PAREXEL International