Roundtable: Discussing Strategies to Design Potency Assays Earlier in The Pipeline to De-risk IND & Clinical Trial Readiness
- Discussing how to integrate potency assay design into early R&D so that assays are relevant, reproducible, and fit for regulatory expectations at IND stage
- Evaluating how early potency assay choices reduce risk of late-stage delays, bridging studies, or regulatory feedback loops
- Reviewing emerging tools, including ddPCR-based functional assays, FACS, in vitro surrogate models, that allow faster and more reliable potency readouts