Operation Warp Speed for rare diseases: CBER leader says pilot is coming soon
The next generation of Operation Warp Speed is coming soon, and this time it’s going to take aim at rare diseases, Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told attendees of the Biopharma Congress in Washington, DC on Monday.
“We’re getting ready to pilot that program,” Marks said, making clear the goal is to help areas with high unmet needs.
I think the goal is to take a drug with some promise in the rare disease space for diseases that don’t have alternatives … and then take these products, maybe they have breakthrough or advanced therapy designation, they have promise and there is a product in development and not just a concept. And then give them the opportunity with not just chemistry, manufacturing and controls, which we have a pilot for, but allow the clinical development to happen in constant communication and sharing of potential results before a submission of an NDA or BLA. That’s the idea, is to move things as fast as possible.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.