The biomarker is not the end

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In this article Michael Nohaile discusses several areas of expertise that need to be considered for drug discovery and translational scientists to use stratification with biomarkers to improve the chances of getting medicines to patients.

Michael Nohaile discusses analytical validation, clinical validation, regulatory affairs and intellectual property. He also discusses how enlisting the appropriate experts at the right stages in this process can make or break an effort to bring a biomarker-based companion diagnostic successfully into clinical practice.

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