Back to Basics: What Do Potency Assays Actually Tell Us, Beyond Being a Checkpoint for the FDA?
Time: 10:00 am
day: Workshop A
- Analyzing how potency assays are being interpreted and why
- How do potency assays affect the rest of the clinical process development?
- Do potency assays bias a trial? Are they helpful in predicting clinical efficacy?
- Outlining how to utilize your potency assay as a valuable tool in determining safety, efficacy, and comparability within your own process development, rather than developing them solely for regulatory purposes