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Reaching consensus on biomarker use
DOI: 10.1038/nbt.1622
DOI: 10.1038/nbt.1623
DOI: 10.1038/nbt.1624
DOI: 10.1038/nbt.1625
DOI: 10.1038/nbt.1627
DOI: 10.1038/nbt.1634
A collaboration to define how biomarkers can be used in preclinical drug trials to the satisfaction of health authorities is discussed in this month’s special focus issue of Nature Biotechnology. Seventeen drug companies, the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and several non-profit institutions have come together to form the collaborative Predictive Safety Testing Consortium (PSTC).
Drug-induced organ toxicity accounts for the loss of at least a third of all compounds that enter the drug-development pipeline. However, there is little consensus about how safety biomarkers—molecules that indicate organ damage caused as a side effect of drugs—can be used to decide which candidate drugs to move forward in development. For example, the kidney is an important site of drug-induced toxicity; yet, only two biomarkers are currently approved for detecting kidney injury, and their levels only start to increase after considerable damage has already occurred.
The PSTC has rigorously evaluated the reliability of seven previously described biomarkers found in urine, which specifically detect injury at particular sites in the kidney of rats exposed to a range of nephrotoxic drugs. The work presented in the special issue is one of the first examples of an open collaboration between drug developers and regulatory bodies that has yielded findings of importance to improving human health.
A perspective by Frank Sistare and colleagues outlines the standard procedures and analyses used by the participating groups. A second perspective, by Frank Dieterle and colleagues, explains how the guidelines that emerge from this project provide a template for future efforts to define the use of different biomarkers to reliably discern early toxicity affecting other organs, such as the heart or liver.
Three research articles, with lead authors Frank Dieterle, Yan Yu and Vishal Vaidya, show that seven urinary biomarkers either outperform or add value to the previous two biomarkers used to detect and monitor kidney injury. The studies have formed the bases for the FDA and EMA decisions to approve the use of these new biomarkers in preclinical trials. The ultimate goal of these efforts, as discussed in a perspective, is to evaluate additional data that may support the use of these biomarkers in humans, potentially reducing the many thousands of deaths from kidney injury that occur due to drug toxicity today.
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Author paper – DOI 10.1038/nbt.1622; 10.1038/nbt.1625
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Frank Sistare (Merck, West Point, PA, USA)
Author paper – DOI 10.1038/nbt.1634
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Vishal Vaidya (Brigham and Women's Hospital, Boston, MA, USA)
Author paper – DOI 10.1038/nbt.1623
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Yan Yu (Merck, West Point, PA, USA)
Author paper – DOI 10.1038/nbt.1624
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Carl Peck (Center for Drug Development Science, Washington DC, USA)
News & Views author
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