Case Study: Navigating Regulatory Pathways & BLA Review for Ex Vivo Autologous Gene Therapies
Time: 10:00 am
day: Conference Day Two pt 1
Details:
- Insights into Abeona’s approach to addressing unique regulatory challenges specific to ex vivo autologous gene therapies, including patient-specific manufacturing
- Key takeaways from recent BLA reviews, focusing on how to align clinical endpoints and product characterization with FDA expectations for expedited timelines
- Best practices in quality control, manufacturing consistency, and data submission for maintaining compliance throughout the approval process
