Timing & Challenges of Potency Assessment in Cell Therapy Development
Time: 1:00 pm
day: Track A - Cell Based Assay (Day One - Morning)
Details:
- Learn how to effectively balance the need for robust and validated potency assays with the practicalities of clinical trial timelines and resource allocation, optimizing both development speed and product quality.
- Explore strategies for meeting regulatory expectations on potency assays early in development while maintaining flexibility for product optimization, ensuring compliance without stifling innovation.
- Discuss the impact of the evolving understanding of mechanisms of action on potency assays, and how to adapt these assays to capture critical therapeutic attributes throughout the product lifecycle.
