"The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings's College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

The Future of Clinical Research and Health Care: From Empirical to Precision MedicineClinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease TreatmentThe first four chapters discuss biomarker development from a clinical perspective. Coverage ranges from an introduction to biomarkers to advances in RNAi screens, epigenetics, and rare diseases as targets for personalized medicine approaches. Subsequent chapters examine the statistical considerations in applying a personalized medicine approach, including multiplicity in pharmacogenomics. The last chapter assesses the regulatory issues involved in using biomarkers. Improve Patient Care and Reduce Costs and Side EffectsDespite the vast amount of literature on biomarkers, there is no comprehensive book that integrates the clinical and statistical components. This book is one of the first to incorporate both the clinical and statistical aspects of biomarkers in the personalized medicine paradigm. Covering a wide spectrum of personalized medicine-related topics, it presents state-of-the-art techniques for advancing the application of biomarkers in drug discovery and development.

"The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings's College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

The Future of Clinical Research and Health Care: From Empirical to Precision Medicine Clinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease Treatment The first four chapters discuss biomarker development from a clinical perspective. Coverage ranges from an introduction to biomarkers to advances in RNAi screens, epigenetics, and rare diseases as targets for personalized medicine approaches. Subsequent chapters examine the statistical considerations in applying a personalized medicine approach, including multiplicity in pharmacogenomics. The last chapter assesses the regulatory issues involved in using biomarkers.Improve Patient Care and Reduce Costs and Side Effects Despite the vast amount of literature on biomarkers, there is no comprehensive book that integrates the clinical and statistical components. This book is one of the first to incorporate both the clinical and statistical aspects of biomarkers in the personalized medicine paradigm. Covering a wide spectrum of personalized medicine-related topics, it presents state-of-the-art techniques for advancing the application of biomarkers in drug discovery and development.