Robert Keefe
Chief Technology Officer BlueSphere Bio
Robert Keefe is Chief Technology Officer at Bluesphere and a T-cell biologist and process engineer with over 20 years of experience in cell and gene therapy product development. He earned a PhD in Immunology at the University of California, Davis and completed postdoctoral training at Fox Chase Cancer Center. He previously served as Head of CMC for cell and gene therapies at AstraZeneca, leading global development of autologous and allogeneic therapies. His expertise focuses on process and analytical development, GMP vector production, and advancing innovative cancer therapies from research through clinical development and commercialization.
Seminars
- 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
- Matching critical raw materials, characterization, and clinical response
- Balancing production and COGS
- Developing multi-modality approach to treat resistant cancers