Samantha O’Hara
Director, Product Sciences Umoja Biopharma
Product Sciences group and Analytical Lead for multiple clinical and pre-clinical stage programs and Established Product Sciences group responsible for product understanding of In Vivo CAR T cell therapies. Her team develops characterization methods to link critical viral attributes to functional CAR T cell responses and supports multiple INDs and regulatory filings. She previously Led the mechanistic biology team developing in vitro and in vivo models for immunotherapy drug lead selection at Zoetis and held immunology roles at Merck. She holds a PhD from the University of Colorado Boulder and a BS from Florida State University.
Seminars
Wednesday 16th September 2026
Roundtable Discussion: Aligning Assay Strategy with Regulatory Expectations to Streamline Cell Therapy Testing
3:00 pm
- Exploring how to match functional and safety assays with regulatory requirements to ensure robust testing strategies
- Evaluating the use of quality testing for virus replication in cell therapy products despite minimal risk to balance regulatory compliance and assay costs
- Sharing insights on balancing regulatory compliance with scientific rationale to reduce unnecessary testing while maintaining patient safety
Thursday 17th September 2026
Characterizing CAR Function Across Disease Indications to Enable Clinical Expansion
12:25 pm
- Measuring CAR targeting and functional activity across diseases to understand indication-specific performance
- Comparing assay approaches assessing binding, functionality and cytotoxicity to ensure cross-indication characterization
