FDA’s Peter Marks says educating academics about CMC would help them understand why it is necessary to do things in a standardized way. He predicts the field will move away from individual manufacturing platforms in the next five to 10 years.
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...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
