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US FDA’s START Program Might See Expanded Funding If Pilot Meets Speed Goals

 
• By Derrick Gingery

The program bringing Operation Warp Speed-like treatment to rare disease product development could expand if successful, but will require more employees and thus funding commitments from Congress and industry, CBER Director Peter Marks said.

net present value
Peter Marks thinks the net present value of the START pilot program will support expansion. • Source: Shutterstock

An expansion of the Support for clinical Trials Advancing Rare disease Therapeutics (START) program beyond the pilot stage will require dozens of new employees for the US Food and Drug Administration, but Peter Marks believes the additional funding needed would be well-invested.

The START program is intended to provide Operation Warp Speed-like treatment to rare disease therapies. Instead of using the formal meeting process that can take weeks or months, sponsors will...

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