Introduction: Biomarkers in Translational and Personalized Medicine
Introduction: Regulatory Development Hurdles for Biomarker Commercialization: The Steps Required to Get a Product to Market
Introduction: The Cardinal Role of Biobanks and Human Biospecimen Collections in Biomarker Validation: Issues Impeding Impact of Biomarker Research Outcomes
Sample Preparation and Profiling: Biomarker Discovery in Body Fluids by Proteomics
Sample Preparation and Profiling: Mass‐Spectrometry‐Based Profiling Strategies
Sample Preparation and Profiling: Probing the Kinome for Biomarkers and Therapeutic Targets: Peptide Arrays for Global Phosphorylation-Mediated Signal Transduction
Bioinformatics and Statistics: LC‐MS(/MS) Data Preprocessing for Biomarker Discovery
Bioinformatics and Statistics: Computational Discovery, Verification, and Validation of Functional Biomarkers
Discovery and Validation Case Studies, Recommendations: A Pipeline that Integrates the Discovery and Verification Studies of Urinary Protein Biomarkers Reveals Candidate Markers for Bladder Cancer
Discovery and Validation Case Studies, Recommendations: Discovery and Development of Multimarker Panels for Improved Prediction of Near‐Term Myocardial Infarction
Discovery and Validation Case Studies, Recommendations: Bottlenecks in Biomarker Discovery and Validation by Using Proteomic Technologies
About this book
This book focuses on proteomics biomarker discovery and validation procedures from the clinical perspective. It provides an overview of current technology and the challenges encountered throughout the process. This covers all key stages, from biomarker discovery and validation, through to registration with the European and US regulatory authorities (FDA and EMEA). All the important elements (such as patient selection, sample handling, data processing, and statistical analysis) are described in detail and the reader is introduced to each topic with well-described examples or guidelines for best practice. Case studies are also included to demonstrate clinical applications. Individual chapters explain the best performing techniques for profiling complex body fluids and biomarker discovery. This includes the application of mass spectrometry imaging combined with chromatography in profiling platforms and the use of laser micro dissection and MALDI imaging to study tissues in their natural environment. Future developments needed to improve the success rate of translating biomarker discovery into useful clinical tests are also discussed. Common pitfalls and success stories are described as are the limitations of the various technologies involved. Broad and interdisciplinary in approach, this book provides an excellent source of information for industrial and academic researchers, and those managing biobanks.
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.