The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a “playbook” or platform approach for developing multiple cell and gene therapy products and a globally harmonized template would facilitate the development of such products at a 17 May meeting of the American Society of Gene and Cell Therapy (ASGCT).
Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research (CBER) and Ana Hidalgo-Simon, head of advanced therapies at the European Medicines Agency (EMA), also agreed that manufacturing and reimbursement challenges are impeding the development of these products.
At the meeting, the regulators were asked to address why there have not been more approvals of these products, and their suggestions for ushering more of these therapies to market…
