Demonstrating Comparability: Are Potency Assays Necessary?
Wednesday, May 29, 2024 09:15 AM - 10:15 AM
Room 212-214
Regulation & Policy
Roundtable
Organized by: ISCT Global Regulatory Task Force
Moderator
While a shared-platform approach can simplify and accelerate product development, demonstrating comparability across CGT products remains challenging. This session addresses key design considerations for studies assessing the comparability of CGT products manufactured using the same platform.
Key Learning Objectives
1. To understand the regulatory ramifications of platform strategies for cell and gene therapy product development.
2. To understand considerations for the design of comparability studies in the setting of multiple CGT products manufactured using the same platform process.
Moderator
- Scott R. Burger, MD, Advanced Cell & Gene Therapy, LLC, United States
- ​Kathleen Francissen, PhD, Genentech, A Member of the Roche Group, United States
- Lee Lee Ong, PhD, Health Sciences Authority (HSA), Singapore
- Pille Säälik, PhD, Estonian State Agency of Medicines (SAM), Estonia
- Rhianna Thompson, Therapeutic Goods Administration (TGA), Australia
While a shared-platform approach can simplify and accelerate product development, demonstrating comparability across CGT products remains challenging. This session addresses key design considerations for studies assessing the comparability of CGT products manufactured using the same platform.
Key Learning Objectives
1. To understand the regulatory ramifications of platform strategies for cell and gene therapy product development.
2. To understand considerations for the design of comparability studies in the setting of multiple CGT products manufactured using the same platform process.
