Richard Fisler's Biomarkers in Clinical Development: Implications for PDF

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Extra resources for Biomarkers in Clinical Development: Implications for Personalized Medicine and Streamlining R&D

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Classification of Biomarkers as Described by the FDA Exploratory Biomarker Probable Valid Biomarker Known Valid Biomarker “Regulatory Biomarker” A biomarker based on general exploratory or research information, such as broad gene expression screening, or collection of sera or tissue samples, and that has not reached the status of a probable valid biomarker. A biomarker that has not reached the status of a known valid biomarker because, for example, the supporting data has not been independently replicated or is not conclusive.

A biomarker that is not being used as a regulatory biomarker, but for which there is widespread agreement in the scientific community about its biological significance and which is measured in an analytical system with well-established performance characteristics. A biomarker being used to support scientific arguments made by the sponsor about drug dosing, safety, patient selection, or effectiveness; or that the sponsor proposes to describe in the drug label; or that are essential to achieve the dosing, safety, or effectiveness described in the drug label, or that will be used for decision making in any clinical trial or in an animal trial used to support safety.

They are going to be more and more the norm in the future and we need to ask how we proactively develop that data during the clinical development activities that surround the pharmaceutical and leverage that data later, as the drug approaches the marketplace. The FDA has this initiative,” states Michael Stocum, Managing Director of Personalized Medicine Partners LLC, and former Director Business Development and Alliance Management at GlaxoSmithKline’s Human Biomarkers Center. FDA has begun to consider whether a therapy already approved should require labeling As the guidelines are still under construction, the FDA has begun to consider whether new drug applications and therapies already approved should require labeling based on new pharmacogenomic information and testing associated with it (Wechsler, 2004).

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Biomarkers in Clinical Development: Implications for Personalized Medicine and Streamlining R&D by Richard Fisler

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