Are All My Assays Necessary? Rethinking the Conventional Potency Matrix Approach
Time: 9:05 am
day: Pre-conf day - Stream B
Details:
The potency matrix is the conventional approach to measuring product efficacy from the DNA through to the protein level. This workshop aims to critically analyze and redefine the conventional potency matrix approach in gene therapy and explore strategies for streamlining potency assays while meeting regulatory expectations.
Attend to Discuss:
- Brainstorming the necessity of performing all assays in the conventional potency matrix
- Evaluating the utility of the TCID50 to determine whether it is too variable for effective potency assessment
- Discussing regulatory perspectives on the inclusion of mRNA expression assays in the case of existing MoA potency assay platforms
- Balance the quantity of assays performed with the quality of regulatory submissions
