Briti Saha

Company: Century Therapeutics

Job title: Senior Scientist

Seminars:

Panel Discussion: Regulatory Considerations on Potency Assays for Decision-Making During Development 4:30 pm

Early phase vs. late phase regulatory expectations for cell-based products Challenges in the regulatory frameworks for CGT potency assays Potency assurance considerations with respect to cell therapies Moderator: Diana ColleluoriRead more

day: Conference Day One

Navigating Regulatory Expectations for Demonstrating Potency of a Phase 1 Allogeneic Product 4:00 pm

FDA recommendations and approaches for potency/functional assessments of investigational cell therapy products Differences in FDA and EMA regulatory expectations  Considerations for surrogate assays and cell-based potency/functional assay development Read more

day: Conference Day One