Innovation Incentives and Biomarkers

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Regulators are likely to use biomarkers in many ways and it is therefore unsurprising that the US Food and Drug Administration (FDA) has been actively involved in the harmonization of terminology related to biomarkers. Acknowledging that “effective, unambiguous communication is essential for efficient translation of promising scientific discoveries into approved medical products,” the FDA‐NIH Joint Leadership Council has defined categories that are likely to be of use to “multiple communities of users and stakeholders”—both in regulation, clinical practice, and new product innovation.2 Regulators are unlikely to finance the establishment of biomarkers themselves, although they do sanction their use in drug development, for example, through the FDA's Biomarker Qualification Program.
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