In a landmark move, the US Food and Drug Administration (FDA) has initiated the Collaboration on Gene Therapies Global Pilot (CoGenT), signaling a significant leap toward worldwide collaboration in the field of gene therapy.

Spearheaded by Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), this pilot aims to enable concurrent collaborative reviews of new gene therapy applications with global regulators, including the EU, US, Japan, Canada, and Switzerland.

The primary objective is to streamline regulatory processes, enhance efficiency, and reduce time and costs for both regulatory agencies and sponsors, with a focus on expediting the availability of gene therapies in the market.

The CoGenT pilot reflects a groundbreaking approach to regulatory cooperation and underscores the shared responsibility of global agencies in addressing challenges and fostering collaboration for the benefit of patients worldwide.

Marks detailed the pilot, at the Alliance for Regenerative Medicine’s Cell & Gene State of the Industry Briefing. He emphasized the importance of harmonizing requirements globally, particularly in addressing rare diseases with small patient populations, illustrating a collective commitment to advancing the development and accessibility of gene therapies on a global scale.

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