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FDA's Marks Sees 'Two Or Three Year Window' To Transform Gene Therapy Environment

 
• By Brenda Sandburg

Agency has to ‘think creatively’ to make gene therapies commercially viable, CBER director says, suggesting greater use of accelerated approval endpoints and advancing manufacturing technologies. Center is focused on recruiting mid-level career people with manufacturing experience.

Gene therapy
FDA is focusing on ways to accelerate development of gene therapies • Source: Shutterstock

Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, says he hears from foundations every week who are trying to develop a gene therapy but find the cost is in the $250,000 cost per dose range or higher.

“That essentially puts it out of reach,” he said. “So we’ve got to do something here. That may mean in...

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