Peter Marks, director of Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), attributes an increase in the amount of regenerative medicine advanced therapy (RMAT) requests approved for cell and gene therapies to sponsors “getting the hang” of the agency’s expectations for designation requests.
Marks spoke at the California Separation Science Society’s (CASSS) meeting on 8 June on cell and gene therapies. The meeting was held both in-person in Arlington, VA and virtually.
Marks also expressed interest in starting a gene therapy pilot program where sponsors would get real-time feedback from FDA reviewers on their development programs. The pilot would test which approaches work best and which do not in developing these products. This would help to avoid setting regulatory policies for approaches that are impractical…
