The FDA's push for better biomarkers

Despite the huge output of preclinical papers on new biomarkers, few result in validated agents that contribute to clinical trials. The FDA turned to stakeholders from industry and academia last week to discuss the challenges in the space and hear proposals for how to address them. Meeting attendees agreed that clarity and standardization of the regulatory process involving biomarkers is critical for advancing the use of biomarkers.

"Our goal with biomarkers is to know exactly the right way to treat each patient," said meeting moderator Mark McClellan. He added that although there have been scientific advances in targeted therapeutics and biomarkers, that progress has not accelerated drug development...