Planning For Commercial Success – Best Practices For Designing Cell & Gene Therapy Clinical Trials
Cell and gene therapy applications have, in the last three years, made the jump from pure research products to commercialized products with high clinical efficacy, particularly for hematologic malignancies. In order to facilitate further development of cell and gene therapies for other diseases, such as solid cancers and inherited diseases, it will be important to define a framework for such undertakings, and choose the right path for eventual commercialization of successful products. In this webinar, Siofradh McMahon, Senior Manager, Clinical translation regulatory affairs at CCRM, elaborates on how to design early development programmes and clinical trials for CGTs to ensure that the product can be commercialized successfully in all target markets i.e. can be reimbursed and adopted successfully despite small patient numbers, rare diseases, complex administration etc.
(Presented as part of ISCT Webinar 2019: Planning for Commercial Success – Best Practices for Designing Cell & Gene Therapy Clinical Trials)
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