Master the Regulatory Pathway for Cell & Gene Therapy Submissions
Strategies for Successful BLAs

Monday, Dec. 16, 2019 • 1:30 – 3:00 p.m. EST

Attend the webinar to prepare.

Over the past two decades, FDA has approved a dozen of cell and gene therapy (CGT) products. The agency predicts it will be approving 10 to 20 CGTs every year by 2025. In fact, it’s already getting ready by staffing up the review group for CGT products and planning new guidance documents and policies to help sponsors.

Scott R. Burger, MD, Principal of Advanced Cell and Gene Therapy, will lay out for you the FDA’s requirements for successful BLAs. You’ll understand how to avoid the most common mistakes and guarantee compliance with strategies he’ll provide to ensure your BLA submissions’ success.

Webinar Takeaways:

• FDA’s requirements for a successful cell therapy or gene therapy BLA
• What Office of Tissues and Advanced Therapies (OTAT) reviewers expect to see
• How a cell or gene therapy BLA fits into the framework of the CTD 
• How the earlier stages in development affects the content of the BLA

Marketing approvals for your CGTs are within reach. You must submit successful BLAs — and avoid the common mistakes — or risk being left behind. Join us by registering today.

Who Will Benefit

• Regulatory Affairs Personnel
• Quality Assurance Personnel
• Manufacturing Professionals
• Manufacturing Process Developers
• Manufacturing Analytics Professionals
• Clinical Personnel
• R&D Specialists
• Senior Managers of Cell and Gene Therapy Biotech Companies