The human immune system is a complex cellular and molecular network unlike any other biological system. The complex interplay of multiple immune cells that rid the body of foreign invaders and diseased tissues is governed by a vast number of cell-to-cell communications. In this chapter we focus on the expanding utility of measuring these secreted protein messengers as biomark-ers for drug development and diagnostic efforts that are relevant to a variety of diseases. Herein we use a broad acronym, IB (immune-related biomarker), to represent protein biomarkers for a variety of immune- related disorders. The IBs most prominently monitored in drug development efforts are the cytokines and chemokines, but also include acute-phase reactants, tissue remodeling factors, vascular markers, and growth factors. This complexity has led to the rapid adoption of newer multiplexed measurement tools. Key features of these include the quantitation, sensitivity, and perhaps most important, precision of each measurement. Ecosanoids, prostaglandins, prostacyclins, the thromboxanes, and the leukotrienes are also key elements of immune processes but do not fit under the paradigm of protein biomarkers and are not addressed in this chapter.

Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy, Edited by Michael R. Bleavins, Claudio Carini, Malle Jurima-Romet, and Ramin Rahbari Copyright © 2010 John Wiley & Sons, Inc.

This ability to measure multiple IBs simultaneously from a small biological sample has ushered in an era of exploration known as biomarker patterning. It would be convenient if the single biomarker paradigm of the past were to continue unabated. However, the rate of introduction of new U.S. Food and Drug Administration (FDA)-approved diagnostic protein assays has fallen dramatically to an average of one or less per year [1]. This unfortunate trend does not suggest relying on a single biomarker but, rather, a group or set of biomarkers for drug development and diagnostic efforts. The theory of bio-marker stacking is that by combining the predictive power of each marker, the optimal sensitivity and specificity of the multiplexed test will be achieved [2]. Rather than a single biomarker to fit with a specific disease or drug effect, a pattern of multiple biomarkers provides stronger predictive value, due to their "stacking" effects. In this chapter we focus on the multiplexed immuno-assay measurement technologies as well as some recent and relevant examples of successful biomarker patterning. These approaches are rapidly bringing multiplexed biomarker assays into everyday use in drug development and diagnostics for personalized medicine.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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