Panel Discussion: Overcoming Challenges in Validation & Clinical Relevance of Potency Assays to Demonstrate Efficacy
Time: 2:10 pm
day: Day Two
Details:
- Potency Assay Validation Challenges: Validating potency assays, especially cell-based ones, is difficult due to their product-specific nature and the need to establish reliable biomarkers or functional outputs to demonstrate efficacy
- Unique Assays for Unique Products: Potency assays are often unique to each gene therapy product, requiring adaptation of academic or preliminary assays for use in clinical development while ensuring reproducibility and reliability
- Linking Potency to Clinical Response: The critical challenge lies in correlating in vitro potency measurements with actual clinical outcomes, ensuring that the assay’s predictive power aligns with therapeutic efficacy and safety in patients
