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Biomarker Work Needs To Start Early In Drug Development Programs, US FDA Says

 
• By Sue Sutter

Companies often do not focus on biomarker development and validation until too late in the game, FDA officials said at a recent Duke-Margolis meeting; experts cited the need for precompetitive work and public-private collaborations with an emphasis on early engagement, data sharing and transparency.

Budding tree
The earlier the better when it comes to biomarker work in a drug development program. • Source: Shutterstock

When it comes to biomarker and surrogate endpoint development, the US Food and Drug Administration has a plea for industry: “think early.”

Work on establishing biomarkers and surrogate endpoints needs to start early in a drug development program and requires planning and a substantial resource investment. However, companies often do not focus...

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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
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• By Eliza Slawther

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