Handbook of Biomarkers and Precision Medicine

Description

Content: Cover -- Half Title -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Preface -- About the Editors -- Contributors -- 1: What Is a Biomarker and Its Role in Drug Development? -- 1.1 Definitions and Conceptual Framework of Biomarkers in Precision Medicine -- 1.2 In Search of Predictive Biomarkers in Cancer Immunotherapy: Establishment of Collaborative Networks for the Validation Process -- 1.3 Integrating Personalized Medicine in the Health Care: Payers and Reimbursements -- 1.4 Regulatory Strategies to Accelerate the Implementation of Biomarkers and Companion Diagnostics -- 2: Biomarkers in Preclinical Sciences -- 2.1 Lost in Translation: The Challenges with the Use of Animal Models in Translational Research -- 2.2 Application of Pharmacokinetic and Pharmacodynamic Modeling of Biomarkers of Efficacy in Translational Research -- 2.3 The DIAMONDS Platform: Providing Decision Support for Toxicological Assessment Based on Integration of Structural, Toxicological and Biomarker Information -- 2.4 Predicting the Safety of Drug Targets: An In Silico Perspective -- 2.5 Unwanted Immunogenicity Responses to Biotherapeutics -- 2.6 Biomarker Use for Advanced Screening of Drug-Induced Kidney Injury -- 2.7 Soluble Biomarkers for Drug-Induced Cardiotoxicity -- 3: Biomarkers in Translational Medicine -- 3.1 Lost in Translation: Bridging the Preclinical and Clinical Worlds Concepts, Examples, Successes, and Failures in Translational Medicine -- 3.2 Necessary Characterization of Biomarkers to Be "Fit for Purpose" -- 3.3 Crucial Role of High Quality Biosamples in Biomarker Development -- 3.4 Informatics Solutions for Biomarker Discovery and Personalized Medicine in Clinical Care -- 3.5 Systems Biology Approaches to Identify New Biomarkers -- 3.6 The Need for Global Collaboration in Translational Medicine -- 4: Biomarker-Informed Clinical Trials. 4.1 Overview of Biomarker Discovery and Statistical Considerations -- 4.2 Overview of Classical Design in Biomarker-Informed Clinical Trials -- 4.3 Novel Biomarker Guided Clinical Trial Designs: A Practical Review -- 4.4 Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages -- 4.5 Case Studies for Biomarker-Based Clinical Trials -- 4.6 Informational Designs and Potential Applications to Rare Disease -- 5: The Road Ahead: Identification of the Hurdles and Solutions to the Implementation of Precision Medicine in Healthcare -- 5.1 Paving a New Era in Patient Centric Care through Innovations in Precision Medicine -- 5.2 Integrating Molecular Testing into Early Stage Clinical Applications -- 5.3 Ectopic Gene Deregulations and Chromosome Conformations: Integrating Novel Molecular Testing into Clinical Applications, from Leukemias to Gliomas -- 5.4 Challenges and Opportunities of Next Generation Sequencing Companion Diagnostics -- 5.5 Implementing Companion Diagnostics -- 5.6 Publishing Biomedical Research Findings: What are the Odds? -- 5.7 Computational Biology: Modeling from Molecule to Disease and Personalized Medicine -- 5.8 Expectations for Quality Control: Challenges with Multiplex Assays -- 6: Lessons from the Past and Pioneers of the Future -- 6.1 Development of Maraviroc and the Companion Diagnostic HIV Tropism Assay -- 6.2 Case Studies: Infertility and Anti-Müllerian Hormone -- 6.3 Factor Xa: Case Study -- 6.4 Delivering Companion Diagnostics for Complex Biomarkers: The BRCA Companion Diagnostic Story for LYNPARZATM (Olaparib) -- 6.5 Delivering the Personalized Medicine Promise: Best Practice Recommendations for Designing Biomarker Development Processes -- 6.6 Development, Launch, and Adoption of a Pharmacodiagnostic: Planning versus Reacting for Pharmaceutical Companies. 6.7 Biomarker Consortia to Drive BM Discovery and Clinical Applications in the UK: Lessons Learned from RA-MAP -- 6.8 Measuring the Success of U.S. Biomarker Consortia -- 6.9 The Value of Public-Private Partnerships in the Netherlands -- 7: Paving a New Era of Personalized Medicine: Emerging Technologies -- 7.1 A New Era of Personalized Medicine: Emerging Technologies-Functional Proteomics, Companion Diagnostics and Precision Cancer Medicine -- 7.2 The Impact of Epigenetics on the Future of Personalized Medicine -- 7.3 Incorporating Predictive Imaging Biomarkers in Clinical Trials for Personalised Healthcare -- 7.4 Innovation in Metabonomics to Improve Personalized Health Care -- 7.5 Predictive Cancer Biomarkers: Current Practice and Future Challenges -- 7.6 Glycomics as an Innovative Approach for Personalized Medicine -- 7.7 miRNAs as Novel Biomarkers for Health and Disease -- 7.8 Targeted Proteomics for Absolute Quantification of Protein Biomarkers in Serum and Tissues -- 7.9 Integrated Omics for Tissue-Based Mapping of the Human Proteome -- 7.10 Proteogenomics and Multi-omics Data Integration for Personalized Medicine -- 7.11 Sequencing Approaches for Personalized Cancer Therapy Selection in Pathology -- 7.12 Mass Spectrometry Imaging: Enabling Comprehensive Local Analysis of Molecular Biomarkers in Tissue for Personalized Medicine -- 7.13 Insights of Personalized Medicine from the Gut Microbiome: Lessons Learned from Celiac Disease -- 8: The Next Frontiers of Therapeutic Target Areas: Autoimmunity, Inflammation, Respiratory, Metabolic, Cardiovascular and Neurological Diseases -- 8.1 Precision Mucosal Sampling and Biomarkers in Allergic Rhinitis and Asthma -- 8.2 Stratified Medicine in Autoimmune Diseases -- 8.3 Biomarkers of Systemic Lupus Erythematosus. 8.4 Advances in Cardiovascular Diagnostics: Use of Cardiac Biomarkers in Clinical Research and Care of the Patient -- 8.5 Biomarkers for Psychiatric Disease: An Overview -- 8.6 Progressing Towards Precision Psychiatry: Current Challenges in Applying Biomarkers in Psychiatry -- 8.7 Identification of Biomarkers for the Diagnosis, Prediction and Progression of Alzheimer's Disease -- 8.8 Biomarkers in Lung Cancer -- 9: Lessons Learned: What Have We Learned and What Is the Next Challenge? -- 9.1 Translational Science in Modern Pharmaceutical R&D: The Influence of Organizational Structures on Successes and Failures -- 9.2 Biomarker Qualification and Companion Diagnostics: Failure and Success of Regulatory Processes -- 9.3 Not All Biomarkers Are Worthwhile: An Unsuccessful Use and Pitfalls to Avoid -- 9.4 Research Reproducibility: The Case for Standards -- 9.5 Can Big Data Analytics Recapitulate Biology? A Survey of Multi-omics Data Integration Approaches -- 9.6 Can Health Care Be Made More Affordable by the Use of Biomarkers? -- 9.7 Omics Driven Medicine for Democratizing Health Care Delivery and Health Economics -- Index.