Exploring Different Approaches & Expectations in Proving Comparability in a Global Setting

Time: 10:00 am
day: Conference Day Two


  • Clarifying the FDA Expectations on Repeat Studies for Non-Clinical Studies Between and Before Phase 3
  • Exploring Different Global Approaches to Comparability between the FDA, EMA and other Regulatory Bodies
  • Understanding the Depth and Timelines Needed for Comparability Data as Gene Therapy Programs progress to phase 1 and 2 When Resource Burden Increases