Comprehensive Biomarker Discovery and Validation for Clinical Application

Comprehensive Biomarker Discovery and Validation for Clinical Application provides the reader with an extensive introduction into all aspects of proteomics biomarker discovery, validation and development. It discusses the current status of science and technology, its limitations, bottlenecks as well as future development trends to improve the success rate of translating biomarker discovery into useful clinical tests. The most important feature of the book is to provide an overview of current technologies and the challenges encountered during biomarker discovery and validation, such as patient selection, sample handling, data processing, statistical analysis and registration and approval of validated biomarkers through European and US regulatory authorities. The authors introduce the reader to each of these topics in significant detail and provide examples or guidelines for best practice. There are prominent chapters included on biomarkers in translational and personalised medicine; an introduction to regulatory affairs and bring biomarkers to the market; biomarker discovery and the use of mass spectrometry based profiling platforms; MALDI imaging techniques in tissue-based biomarkers discovery and a clinical application study on the use of diagnostic assays for early diagnosis of heart failure using various proteomic methods. The book concludes with a final chapter on future trends in biomarker discovery and validation. The book targets a readership of industrial and academic researchers that are involved in biomarker discovery and validation or that manage biobanks, develop sample preparation methods, analytical profiling systems and bioinformatics tools. Common pitfalls and success stories in biomarker discovery are highlighted and guidelines for best practice are provided for the different parts of the procedure. The book will be an essential information resource for scientists working in the field. Peter Horvatovich and Rainer Bischoff have worked at the University of Groningen Faculty of Mathematics and Natural Science for more than five years. Rainer Bischoff is professor in analytical biochemistry and has been studying protein analysis and proteomics for over 20 years. He obtained his PhD at the University of Gottingen before undertaking postdoctoral research at Purdue University in the USA. He also worked as a group and project leader at Transgene S. A. in Strasburg and a section manager at AstraZeneca R&D in Lund. Peter Horvatovich is an Assistant Professor. He has studied proteomics related bioinformatics for more than eight years and has an analytical chemistry background. Dr Horvatovich received his PhD at the University of Strasbourg for work related to the detection of irradiated food. He then worked at Sanofi-Synthelabo in Budapest and as a postdoctoral researcher at the Bundesinstitute fur Risikobewertung in Berlin before moving to the University of Groningen. Table of Contents Introduction to biomarker discovery and validation; Clinical context of proteomics biomarker discovery and validation, authority regulations; Biomarker discovery: Patient selection; Biomarker discovery: Experimental design and biobanking; Biomarker discovery: body fluids; Biomarker discovery: tissues; Biomarker discovery: mass spectrometry based profiling platforms; Biomarker discovery: array based profiling platforms; Biomarker discovery: data preprocessing for LC-MS data; Biomarker discovery: data preprocessing for Maldi imaging, and 2D electrophoresis and protein arrays data; Biomarker discovery: statistical analysis and validation; Biomarker validation: biomarker validation methods; Functional biomarker validation; Clinical application: case studies Clinical application: summary and future technology development trends