Handbook of Biomarkers and Precision Medicine 1st Edition by Claudio Carini,Mark Fidock,Alain van Gool 9780429574627 0429574622

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 LYNPARZA– (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