Top US FDA Official Says New ‘Playbook’ Needed For CMC Reviews Of Gene Therapy Products
BY JOANNE S. EGLOVITCH Executive Summary CBER director says lack of a clear regulatory structure is holding back the development and acceleration of gene therapy products, while industry says regulations should be flexible to keep up with changing technology for these products.
26 / August 2020
A “new playbook” is needed to ensure consistent chemistry, manufacturing, and controls (CMC) reviews for gene therapy products, the lack of which is hindering the development of these products, asserted a top official at the US Food and Drug Administration . “Now is the time to get things right” asserted Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, who spoke at a 15 June virtual Drug Information Association annual meeting session on how innovation can help overcome hurdles for these products. The session’s moderator, Nancy Myers, president of Catalyst Healthcare Consultants, asked the panelists to describe some of their main CMC “constriction” points in developing gene therapy products, and to identify potential solutions. The other panelists were Karen Walker, the senior advisor for cell and gene therapy at Genentech Inc., who formerly was at Novartis AG and worked on the development of
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