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Cell/Gene Therapies: US FDA Wants ‘Quantitative Correlation' Between Surrogate And Clinical Outcome, Former Reviewer Says

 
• By Sue Sutter

When weighing accelerated approval, the FDA wants to see that ‘X change in the surrogate translates into Y change in the clinically meaningful outcome,’ Parexel’s Steve Winitsky says. CBER Director Peter Marks opines on the types of therapeutic settings where accelerated approval is best suited, and what happens when a confirmatory trial disappoints.

Rubber bands
When it comes to accelerated approval, CBER's Peter Marks wants to stretch the rubber band but not snap it. • Source: Shutterstock

The US Food and Drug Administration wants to see a “quantitative correlation” between a surrogate endpoint and a clinically meaningful outcome for accelerated approval of cell and gene therapies, a former agency reviewer said.

In a presentation at the recent World Orphan Drug Congress USA, Steve Winitsky, VP-technical at Parexel International Corp., discussed some “regulatory myths” for cell and gene therapy development.

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