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Gene Therapy Platforms May Require Less Preclinical Data, Gottlieb Says

 
• By Brenda Sandburg

US FDA's preclinical policies should be 'more closely matched to the complexion of modern technologies,' commissioner explains.

FDA entrance sign 2016

US FDA Commissioner Scott Gottlieb said the agency is developing new policies for preclinical development of products involving new technology platforms, whereby certain second entry therapies could require less pre-clinical data.

"We're going to be taking other new steps to make sure that our policies governing early, pre-clinical science are more closely matched to the complexion of modern technologies," Gottlieb said in a Sept. 7 speech to Research America's National Health Research Forum in Washington, DC. "One is evidenced in how clinical trials are initially designed. In certain cases, there are a lot of common features across the same platform, even as it's used to target different genes or proteins

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