PANEL: When Should We Start Measuring Potency? Navigating Potency Measurement & Assay Setup Considerations
Time: 9:00 am
day: Regulatory Focus Day
Details:
- Understanding the implications of the new FDA draft potency guidance on the necessity and implications of potency assays in phase 1 trials
- Determining best practice for optimizing controls, reference standards, and AAV serotype selection to establish robust potency assays that satisfy regulatory demands
- Overcoming limited batch size to develop appropriate documentation and address gaps in CMC packages for potency assays
