Gene & Cell Therapy Regulation: Comparability and Other New Developments – Webinar Recording/Transcript
Complying with the FDA’s gene and cell therapy regulations — particularly conducting comparability studies — is a huge challenge. But when the smallest changes to processes or analytical methods can derail a product’s approval, it’s time to make sure you’ve covered every detail.
Compliance starts with this webinar: learn to understand and follow the FDA’s requirements and avoid common errors so you can maintain your products’ critical quality attributes (CQA) and bring them to market.
Scott R. Burger, MD, the principal of Advanced Cell & Gene Therapy, and William E. Janssen, PhD, the principal of WEJ Cell and Gene Therapy Consulting Services, will explain exactly what you need to know about comparability so you can meet all requirements and obtain approvals.
- FDA requirements for comparability studies for gene and cell therapy products
- Best practices for risk analysis and mitigation using comparability studies
- How to design an effective comparability protocol for a gene or cell therapy product
- How to construct a statistical approach to comparability
- How to assemble the comparability package to comply with FDA requirements
- An update on FDA regulatory announcements that include forming a consortium to deal with rare diseases and potential guidance about intermediate pathways
Understanding — and meeting — comparability requirements is crucial to developing gene and cell therapy products. This is your opportunity to ensure yours comply.
Meet Your Presenters
Scott R. Burger, MD, is the principal of Advanced Cell & Gene Therapy, a consulting firm specializing in cell and gene therapy product development, manufacturing and regulatory affairs. He has more than 25 years of experience developing cell and gene therapy products and has consulted for more than 140 companies in North America, Europe, Asia and Australia. Dr. Burger 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; and stem cell- and somatic cell-based regenerative medicine products. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was vice president for R&D at Merix Bioscience and director of the University of Minnesota Cell Therapy Clinical Laboratory. His regulatory background includes numerous IND and IDE submissions and productive interactions with the FDA’s Office of Tissues and Advanced Therapies (formerly the Office of Cellular, Tissue and Gene Therapies).
William E. Janssen, PhD, is the principal of WEJ Cell and Gene Therapy Consulting Services. He has worked for more than 30 years in academic institutions translating lab bench models into cell and gene therapy products for administration to patients in early-phase clinical trials. In the course of these efforts, he has developed and refined methodologies for all aspects of cell-based therapy, from collection through manufacturing and administration. Throughout, Dr. Janssen has also been engaged in the regulatory process and has prepared numerous applications for INDs, IDEs and for RAC approval of recombinant DNA use in clinical trials. He has been responsible for shepherding these regulatory applications through the approval process and through the entirety of their lifecycle management. Dr. Janssen has also been responsible for facility design; drug master file creation; development of staff training programs; process engineering; SOP development; process validation; and integration of processes, equipment and raw materials.
Who Will Benefit
- Quality professionals
- Regulatory affairs professionals
- Manufacturing process development professionals
- Analytics professionals
- Research and development personnel
- Senior management at cell and gene therapy (pharma/biotech) companies
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Aug. 10, 2022