Cell & Gene Therapies: A Regulatory Update

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.