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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.

McClellan is director of the healthcare innovation and value initiative at the Brookings Institution.He was FDA commissioner from 2002 to 2004 and Centers for Medicare & Medicaid Services administrator from 2004 to 2006.

Briggs Morrison, CMO and EVP of global medicine development at AstraZeneca plc, said, "The goal is to speed up drug development. Biomarkers are an important tool, but up to this point we have done a poor job of developing, qualifying and using biomarkers

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