Robert Keefe
Chief Technology Officer BlueSphere Bio
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
Designing Effective Neoantigen TCR Therapy
11:25 am
- Matching critical raw materials, characterization, and clinical response
- Balancing production and COGS
- Developing multi-modality approach to treat resistant cancers
