Eurofins BioPharma Services will be attending the DIA Global Annual Meeting in San Diego, CA, June 23-27! Join us at Booth 1705 to discover how our dedicated BioPharma laboratories provide seamless, end-to-end solutions to help customers progress through the drug development cycle through a single, experienced provider!
Tags: Central Laboratory, Quality, Clinical Trial, Drug Development, Development, BioPharma, Gene Therapy
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.
Tags: FDA, Results, Drug Development, Cellular Response, Development, DNA, Gene Therapy