Avoiding Late-stage Failure by Delivering Potency Assays That Meet Regulatory Expectations

• Prioritizing early development of functional potency assays to reduce late-stage risk and rework
• Demonstrating dose response and reproducibility to supporting smoother validation and approval
• Learning from case studies to improve assay robustness and reducing variability

Speakers:

Connie Tsai

Director, Cell & Gene Therapy Analytical Development

Novartis AG