Biomarkers' double edge

In the current capital-scarce environment, toxicity biomarkers could prove more important for the biotech industry than for pharma, experts in the field say. At a workshop on biomarkers convened by the Forum on Drug Discovery, Development, and Translation of the Institute of Medicine in Washington, participants predicted that some biotech companies may start relying on biomarkers to decide whether to continue pursuing candidate products or terminate programs at ever-earlier stages. The slightest hint of unsatisfactory safety signals could prompt biotech firms to drop otherwise promising projects. Pharma, with deeper pockets, may be better placed to follow the drug and see if early ambiguous findings turn out to be bona fide or misleading. But if biomarker test results routinely overstate toxicities of promising drug candidates then “we haven't succeeded,” says workshop participant Alastair Wood, a managing director of Symphony Capital in New York City, as this would undermine discovery efforts and deprive society of potentially valuable products. At the same time, a company could save huge sums in development costs if a biomarker flags toxicity issues early on, allowing it to terminate the project. Despite the ambiguities, Wood urges companies to fully embrace biomarkers and not to hold out for special incentives from the federal government. “If we all agree that having biomarkers will accelerate drug development, then we don't need incentives [and] don't want to be paralyzed by insisting on tax rebates or some other incentives,” says Wood.

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Fox, J. Biomarkers' double edge. Nat Biotechnol 26, 1322 (2008). https://doi.org/10.1038/nbt1208-1322b

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