Recorded: June 2023

This webinar discusses the considerations when designing your gene therapy preclinical and CMC development strategies.  We shared our experience to help build successful strategies that carefully balance time and cost while ensuring quality to meet regulatory needs.

Agenda

  • Regulatory, Budgetary, and Scientific Considerations for
    • designing preclinical studies for AAV-based gene therapy products
    • developing and validating a phase-appropriate potency assay
  • Designing the CMC development plan for viral vectors for successful IND submission