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.
A complete agenda will be posted at https://www.ibbr.umd.edu/NISTCART.
Keynote speaker:
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.