Post-Conference Comparability Day
Strategic Planning for Comparability Studies
Demonstrating comparability is one of the greatest challenges for gene therapy developers. With changing production sites, processes, and evolving analytical methods, comparability or bridging studies must be performed as these methods progress.
The post-conference comparability day will discuss the importance of:
- Encouraging an ongoing dialogue between a company’s regulatory affairs department and the respective health authorities
- Clarifying how many retains of samples were set aside to support clinical programs
- Encouraging ongoing negotiation between various departments, such as working with manufacturing to reserve quantities of early phase materials in advance with the anticipation that the health authorities are going to require retrospective testing
- Planning for the fixed volume required for analytical testing
- Analytical comparability vs clinical comparability: release and/or characterization methods
Thursday, December 3, 7am-12pm PST | 10am-3pm EST
Part 1: An Introduction to Comparability
Synopsis• What is comparability?
• What are bridging studies required for?
• Common challenges faced by gene therapy developers, such as limited materials and retrospective testing
Part 2: Comparability Strategies
• Increasing awareness for earlier phase developers and the different departments within them
• Designing bridging and comparability studies
• Submitting a comparability protocol: what is expected by health authorities?
• Suggestions for future programs
Part 3: Panel & Audience Discussion
• Hear from a panel of comparability experts as they discuss the most pressing comparability challenges facing gene therapy developers
• Participate in an audience discussion to share your insights and challenges with fellow analytical experts
Part 4: An Extra Degree of Comparability of Analytics: Between Different Companies
• Discussing the power of standardization of analytical techniques
• Setting standards for raw materials
With Expert Insight From:
Elizabeth Higgins, Director, Analytical Development, Voyager Therapeutics
David Malliaros, Independent Consultant
Jim Richardson, Senior Science & Standards Liaison, USP
Yuan Zhao, Principal Scientist, Leader of Gene Therapy Section, Advanced Therapy Division/ NIBSC, MHRA
Jasmine Lee, Consultant