Bolstering regulatory expertise in low- and middle-income countries could help prevent a safety-related disaster that chills enthusiasm for the field, while greater regulatory convergence could help tamp down the proliferation of stem cell clinics, the FDA’s Peter Marks says.
Regulatory strengthening in middle- and lower-income countries is critical to ensuring public confidence in gene and cell therapies on an international scale, the US Food and Drug Administration’s Peter Marks believes.
Marks, director of the Center for Biologics Evaluation and Research, also said increased international convergence on cell and gene therapy...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.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.
