Analytical & Translational Approaches Supporting Clinical Development of mRNA Based In Vivo CAR Products
- Leveraging preclinical drug product mechanism of action data to inform on FIH clinical pharmacology analytical strategy
- Fit-for-purpose qualification and validation strategies for FIH to support a recommended dose regimen for Phase 2/ 3 evaluation
- Refinement of analytical approaches and translational strategy in Phase 2/ 3 to support regulatory activities