Simplifying Global Compliance
Cell & Gene Therapy Strategies for Successful BLA Submissions - Webinar Recording/Transcript
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Cell & Gene Therapy Strategies for Successful BLA Submissions: Best Practices for Phase I to FDA Approval
“The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications. Based on this activity, we anticipate that the number of product approvals for cell and gene therapies will grow in the coming years, reflecting significant scientific advancement and the clinical promise of these new innovations.”
— Scott Gottlieb, FDA Commissioner, January 15, 2019 announcement
Gottlieb goes on to say that he predicts the FDA “will be approving 10-20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products.”
Sponsors need to prepare. The FDA is already getting ready by staffing up the review group for cell and gene therapy products and planning new guidance documents and policies to help sponsors.
Scott R. Burger, MD — Principal, Advanced Cell and Gene Therapy — discusses the FDA’s requirements for successful BLAs and how to comply and make you aware of the common mistakes and how to avoid them. He’ll help you understand:
- What the FDA requires for a successful cell therapy or gene therapy BLA
- What reviewers in the Office of Tissues and Advanced Therapies expect to see
- How a cell or gene therapy BLA fits into the framework of the CTD
- How the earlier stages in development affect the content of the BLA
- What the January 2019 announcement by FDA Commissioner Gottlieb about the surge of cell and gene therapy products entering early development means for you
It’s time to get prepared for the unique challenges of BLAs for cell and gene therapy products.
- Regulatory affairs
- Quality affairs
- Manufacturing, manufacturing process development, analytics
- R&D
- Senior management at smaller cell and gene therapy biotech companies
Scott R. Burger, MD, is the Principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, manufacturing, and regulatory affairs. Dr. Burger has over 25 years of experience developing cell and gene therapy products and has consulted for over 120 companies in North America, Europe, Asia, and Australia. He has directed or consulted on process development, manufacturing, and CMC regulatory aspects of a wide range of cell therapy and gene therapy products, including CAR T-cell, NK, and DC immunotherapies, gene-edited cell therapy products, as well as stem cell- and somatic cell-based regenerative medicine products.
