FALLS CHURCH, Va. (PRWEB) March 14, 2019
Cell & Gene Therapy Strategies for Successful BLA Submissions
Best Practices for Phase I to FDA Approval
**An FDAnews Webinar**
Thursday, March 28, 2019, 1:30 p.m. - 3:00 p.m. EDT
The FDA predicts that by 2025 it will be approving 10 to 20 cell and gene therapy products a year.
That will only come true if sponsors are ready for the unique challenges of BLAs for cell and gene therapy products.
Scott R. Burger, MD — Principal, Advanced Cell and Gene Therapy — will discuss 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 attendees 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 companies
It’s time to get prepared for the unique challenges of BLAs for cell and gene therapy products.
Meet Your Presenter:
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.
Who Will Benefit
- Regulatory affairs
- Quality affairs
- Manufacturing, manufacturing process development, analytics
- Senior management at smaller cell and gene therapy biotech companies
Latest Regulatory, Compliance & Approval Developments
**An FDAnews Webinar**
Thursday, Feb. 14, 2019, 1:30 p.m. - 3:00 p.m.EST
$287 per site
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.