Approaching Institutional Biosafety Committee Approval for CAR T-cell Therapy

EP: 1.The Mission Behind CAR T-cell Clinical Trials

EP: 2.Key Challenges within CAR T-cell Clinical Trials

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EP: 3.Approaching Institutional Biosafety Committee Approval for CAR T-cell Therapy

EP: 4.FDA Regulations for CAR T-cell Therapy

EP: 5.The Future of Regulatory Processes in Cell and Gene Therapy

EP: 6.Site Selection for CAR T-cell Trials

EP: 7.Collaboration with Clinical Trial Sites

EP: 8.Patient Selection and Recruitment for Clinical Trials

EP: 9.Looking Towards the Future of CAR T-cell Trials

EP: 10.Final Thoughts

IBC approval has become a larger hurdle when conducting clinical research. This review process often adds two to three months to the timeline that must be accounted for in order for CAR T-cell sites to be IBC certified. It requires training from both the sponsor and CRO perspective. Our panelists highlight how to work through this process and what extra thought is needed behind planning for clinical trials.