Regulatory Pathways & Post-BLA Flexibility
Time: 11:00 am
day: Conference Day Two
Details:
- An overview of considerations for demonstrating comparability of CAR T-cell therapy products and vectors following post-approval changes.
- A discussion of key challenges, such as the inherent variability in starting materials for autologous CAR T-cell therapies, will be addressed, highlighting the need for innovative approaches to ensure comparability.
- An exploration of strategies for designing effective comparability studies, with a particular focus on leveraging modelling techniques to supplement traditional exercises.
- Potentially a case study could be presented, showcasing a novel approach to demonstrating comparability for a complex vector change.
