Drug targets clinical biomarkers

Many diseases are characterized by the expression of specific proteins1 in some cases, malignant cells yield unique protein profiles when total cellular protein extracts are analyzed by proteomic methods such as two-dimensional gel electrophoresis or matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS).2 High-throughput proteomic studies may be useful to differentiate normal cells from cancer cells, to identify and define the use of biomarkers for specific cancers, and to characterize the clinical course of disease. Proteomics can also be used to isolate and characterize potential drug targets and to evaluate the efficacy of treatments. 

In this emerging era of molecular-targeted therapies, biomarkers are becoming more useful and perhaps even necessary for the success of new drugs. In this context, the two classes of biomarkers that are most relevant are pharmacodynamic biomarkers, which are used to confirm drug activity and mechanism of action, and predictive biomarkers, which are used to predict clinical response to targeted therapies. 

Question 34 A primary goal of clinical genomics, proteomics and metabolomics is the identihcation of early disease biomarkers and therapeutic drug targets. 

Several approaches for multiplexed detection of target analytes have been described by coupling of flow injection analysis (FIA) with different separation, sample pretreatment, and detection techniques (Hartwell and Grudpan, 2012). As will be illustrated by the examples selected, among different target analytes the flow-based analytical methods have been applied mainly to the detection of food additives, pesticides, clinical biomarkers, and drugs. 

The aim of this section is to cover approaches to assay selection, to provide an overview of the possible assay formats and to give a description of the most frequently used assay formats for potency determinations. Bioassays are developed and used for different purposes during drug discovery and development. Even though they can have the same assay format they have a different purpose in a product development cycle starting from target selection to clinical biomarkers. 

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