(CASE STUDY) (NEW DATA) Bridging Potency Assays in Gene Therapy Clinical Development: Methods for Adjusting the Potency Matrix Between Clinical Phases

Time: 10:00 am
day: Day 1


  • 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?