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Demonstrating drug potency early in cell therapy development

October 07, 2019 / DEBRA AUB WEBSTER

With traditional drug development, the FDA typically focuses the majority of its attention on clinical aspects of a drug. With advanced cell and gene therapies, the agency places far more focus on chemistry manufacturing and controls (CMC) much earlier in development. Due in part to the fact that these medications are manufactured in patient-specific doses, the far more challenging questions relate to product manufacturing and quality. Additionally, because of the potential for initial clinical efficacy of advanced therapies to be established in early clinical trials, sometimes in a small series of patients, CMC should drive the pace of development.