Deploying Assays to Demonstrate Effective Cell Depletion & Immunosuppression
Time: 9:00 am
day: Pre-Conference Workshop Day Pink Track P1
Details:
Assays are critical for demonstrating early efficacy prior to clinical entry. With uncertainty of requirements across cell therapies and how best to measure cell depletion and immune suppression, this workshop will explore the use of cytokine release profiles and targeted biomarker assays, offering insights into selecting the right approach and outlining requirements for approval.
- Discuss contrasting evidentiary hurdles for immunosuppression and cell depletion to streamline preclinical data packages ahead of approval
- Highlight strategies to demonstrate Treg functionality, considering optimized release assays or assay combinations
- Explore suppression assays and cytokine release profiles to evaluate their role as translational efficacy markers
- Utilize targeted biomarker assays to effectively detect cell depletion and immunosuppression signatures
