Shrinking the Rate-Limiting Step: How Can We Streamline Potency Assay Parameters for Trial Efficiency while Maintaining Proof of Concept
Time: 11:00 am
day: Conference Day Two
Details:
- Understanding how and when to use potency assays within regulatory requirements to prove your product isn’t variable
- Evaluating the need for potency assays with associated quantification vs. simply proving gene function and delivery as a strategy to reduce the burden of a matrix of multiple assays
- Exploring current stances on flexibility towards demonstrating comparability with potency assays and potential next steps for simplifying this process
