Regulators Talk Up Plans for Drug Biomarkers ...

摘要

New methods of predicting clinical outcomes are getting serious consideration at the U.S. Food and Drag Administration (FDA). Last week the agency invited members of one of its advisory committees to a meeting in Washington, D.C., where attendees explored the use of biomarkers to monitor everything from protein levels to bone density, to gauge a drug's effectiveness, or possibly to measure the progression of a disease. FDA officials at the meeting said they're launching a multiyear effort to bring biomarkers into the mainstream of drag discovery. "There are some significant payoffs if this is successful," such as speedier drug trials, says Lawrence Lesko, FDA's director of clinical pharmacology and biopharmaceutics. Still, Lesko has encountered hesitancy: "People are sensitive to past failures" of biomarker use, he says.