(CASE STUDY) (NEW DATA) Bridging Potency Assays in Gene Therapy Clinical Development: Methods for Adjusting the Potency Matrix Between Clinical Phases
Time: 9:00 am
day: Day 1
Details:
- Presenting case-study examples of both, a protein expression and viral entry assay to determine their relative importance across developmental phases
- Highlighting the increasing expectations from regulators for potency assessment at all phases of clinical development to determine acceptable differences in assay readouts between clinical phases
- How should you adapt your potency matrix approach through the early to latestage transition?
