With Dr. Marks’ (Director, Center for Biologics Evaluation and Research), recent perspective on FDA’s Effort to Advance the Development of Gene Therapy, he thoughtfully highlights the recent successes of approved gene therapies, highlights the expert resourcing within FDA, CBER and NIH being applied towards this therapeutic specialization and details the innovative programs and committees (Novel and Exceptional Technology and Research Advisory Committee (NExTRAC), Regenerative Medicine Advanced Therapy (RMAT) designation and the INTERACT program) being instituted and enacted by the FDA. In addition, he highlights the critical issue facing success of this scientific endeavor, is quality manufacturing capacity but attentively details FDA action of awarding grants dedicated to industry stakeholders for the advancement of manufacturing technologies.
