Welcome to the Gene Therapy Comparability Summit
Virtually uniting leading CMC, Regulatory, QC, Analytical and Process Development experts, the Gene Comparability Summit is the industry’s definitive and only digital meeting focused on tackling the greatest challenges associated with comparability in the context of gene therapy drug development.
Hear from the likes of Biogen, Pfizer, Takeda and the Italian Medicine Agency across 3 days of in-depth online case studies, interactive panel discussions, dedicated Q&A time and highly appraised virtual networking opportunities to meet and learn from the leaders of this pioneering field.
Join your peers online and discover:
- How Biogen defined a robust comparability strategy for late phase gene therapy products
- Gain insights into the planning and considerations for a comparability study and risk assessment and understand what defines process comparability vs analytical comparability with Amicus Therapeutics
- Hear from the National Institute of Biology and discover if results of non-related analytical methods can be directly compared
- Learn from the Italian Medical Agency and take a deep dive into regulatory expectations for ATMP comparability and comparability exercises
- Explore next generation sequencing (NGS) and how its application can be utilized for comprehensive rAAV genome characterization with Biogen
- Better understand the challenges associated with limited batch retention and sample availability in the context of comparability and learn best practices for mitigating such challenges with Gyroscope Therapeutics