CAR-T cell therapies are demonstrating tantalizing clinical efficacy in early trials against blood cancers, and are changing the paradigm for standard of care. However, for CAR-T therapies to move into routine clinical use, their manufacture must become robust, reliable, and cost-efficient. The regulatory framework for approval of these CAR-T therapies must also accommodate more flexible, 'right-sized' manufacturing processes. On Friday, January 29, 2016, NIST will convene industry, government and academic stakeholders to address industry-wide challenges to the production of CAR-T therapies. Join thought-leaders and policy-makers as we develop strategies to break down the barriers for manufacture of these exciting new therapies.
Dr. Bruce Levine
Abramson Cancer Center
University of Pennsylvania
Speakers to include representatives from the FDA, MedImmune, bluebird bio, National Cancer Institute, MaxCyte, and Novartis.