Alan Dove, contributing editor to Drug Discovery & Development, reports on efforts to break the barriers that separate laboratory successes in identifying biomarkers to actual validation and qualification in the clinic. Dove begins by pointing out the many successes in identifying potential biomarkers. The trouble is bringing those research successes into a formalized process of analytic validation "to demonstrate that it provides reliable data and is suitable for the intended purpose," said Ronald Bowsher of EMD Millipore Biopharma Services. Then, take the biomarkers further into clinical qualification, which "demonstrate that the data that are generated analytically are...indicative or predictive of the disease or some endpoint," Bowsher tells DD&D.
What makes achieving these goals a problem, Dove writes, is that while there are well-established guidelines for approving new drugs and devices, "neither the U.S. Food and Drug Administration (FDA) nor the European Medical Association (EMEA) had indicated how companies should qualify new markers for disease progression or clinical trial endpoints. It was a chicken-and-egg problem: with no applications to evaluate, regulators didn't know what standards would make sense, and without standards, companies were loathe to submit applications."
Fortunately, he writes, the Critical Path Institute (C-Path), an independent nonprofit group, took up the biomarker qualification problem beginning in 2005. "Agreeing upon the utility and the non-utility of some biomarkers that have been floating around for a long time is really a valuable tool. Industry can come together to develop a dataset, get FDA and global regulatory agencies to give their agreement in terms of how to adopt new safety testing methods and safety biomarkers, and that really benefits everybody and preserves competitiveness in the marketplace," Elizabeth Gribble Walker, director of C-Path's Predictive Safety Testing Consortium, tells DD&D.
- read the article in Drug Discovery & Development