Key Challenges within CAR T-cell Clinical Trials

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

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

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

CAR T-cell therapies involve genetically modifying a patient’s T cells which requires careful oversight by regulatory agencies to maximize safety and efficacy. This in turn often leads to complex regulatory challenges. The panelists explain some of these challenges and what they do to face them.