Opportunities and Challenges of Biomarker Assays in Drug Development
Translational Medicine/Biomarkers
Francois Legay, Ph.D., Global Head of Marker Localization and Assay, Novartis, Inc.
Summary
The development of new drugs requires the understanding of the relationship between the dose, the exposure, the efficacy and the toxicity of the compound. In addition, it requires exploration of the pathway following the interaction of the drug to the target until the clinical/therapeutic effect. For all these steps the development of specific, sensitive and validated assays for soluble, cellular or tissue biomarkers are key. The measurement soluble biomarker in blood, plasma or other biological fluids need high sensitive and more specific assays. The assays to characterize blood cells are now sensitive enough to measure rare events, intracellular protein expression and protein phosphorylation. This paper summarizes the different areas where these technologies can play a role and, as well as what challenges they present.
This article was published in the October/November 2009 issue of International Drug Discovery, Volume 4, Issue 1, on pgs. 10-15.
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