Gene & Cell Therapy Regulation

Comparability studies can be the biggest challenge in developing a cell or gene therapy product, but they are essential to maintain your product’s critical quality attributes (CQA). When the smallest changes to processes or analytical methods can derail a product’s approval, it’s essential to make sure you’ve covered every detail.

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.

Webinar Takeaways:

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

Understanding — and meeting — comparability requirements is crucial to developing gene and cell therapy products. This is your opportunity to ensure yours comply. Join us by registering now.

Scott R. Burger, MD
Principal
Advanced Cell & Gene Therapy

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. Burger has directed or consulted on process development, manufacturing and 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.

William E. Janssen, PhD
Principal
WEJ Cell and Gene Therapy Consulting Services

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. 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.

Webinar Takeaways:

Meet Your Presenters