Optimizing Gene Therapy Comparability Study Design for Effective Development

Time: 8:30 am - 10:30 am
day: Pre-Conference Workshop Day


Ensuring successful gene therapy development and regulatory approval relies on well-designed comparability

studies. This session will delve into the significance of strategic study planning, enabling developers to make wellinformed

decisions at critical junctures.

Attend this session to:

  • Explore the importance of initiating comparability study design at the early stages of gene therapy development to establish robust process controls and ensure product stability
  • Understand how breaking down comparability studies into multiple parts can provide incremental data insights and enhance decision-making
  • Analyze study design adaptations to accommodate complex manufacturing processes involving multiple sites
  • Learn best practices for study design to align with international regulatory guidelines and facilitate successful approval of gene therapy products