Gene Therapy Manufacturing: US FDA Wants Academics Brought ‘Into The Loop’

FDA’s Peter Marks once again emphasized the crucial need to improve manufacturing of gene therapies at a meeting on the future of regulatory science. He pointed to the need for industry collaboration and the involvement of academia to overcome hurdles and agree on best practices.

Marks, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, moderated a panel on CMC commercialization at the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) annual summit held in San Francisco on 7 January