Currently, six FDA-approved CAR-T cell therapies are available to patients, and at least two gene therapies for the treatment of rare and prevalent conditions. There are more than 2000 Cell & Gene Therapy (CGT) clinical trials worldwide, with 200 in Phase III, of which as many as 20 could be approved by 2025. For now, manufacturing most CGT drugs depends on the support of qualified academic medical centers, from collecting starting material by apheresis programs to handling, storing, and dispensing by specialized cell processing facilities. As manufacturing of new CGT grows exponentially, clinical centers are being asked, on top of already limited resources, to handle numerous protocols from multiple providers with different processes, documentation, data management systems, and requirements. Moving this number of new CGT drugs from clinical trials to commercialization is beyond the current capability of academic medical programs. This session will review the role of medical centers in the manufacturing of advanced CGT. It will describe the specific challenges faced by cell therapy collection and processing facilities with the increased number of available therapies. Practical solutions, such as using uniform procedures for onboarding and centralization of the oversight of CGT will be presented. We will discuss the need for collaboration with manufacturers and regulatory agencies for the standardization and harmonization of CGT manufacturing and the need for the clinical community to prepare for the approaching CGT tsunami.
All relevant financial relationships have been mitigated.
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AM23-SN-10-O: Clinical Centers as Partners in Advanced Cell and Gene Therapy Manufacturing – Roles, Challenges & Future Considerations (Enduring) Evaluation