ABSTRACT

"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.

part 1|1 pages

What Is a Biomarker and Its Role in Drug Development?

part 2|1 pages

Biomarkers in Preclinical Sciences

chapter 2.1|8 pages

Lost in Translation

The Challenges with the Use of Animal Models in Translational Research

chapter 2.3|10 pages

The DIAMONDS Platform

Providing Decision Support for Toxicological Assessment Based on Integration of Structural, Toxicological, and Biomarker Information

part 3|1 pages

Biomarkers in Translational Medicine

chapter 3.1|9 pages

Lost in Translation

Bridging the Preclinical and Clinical Worlds Concepts, Examples, Successes, and Failures in Translational Medicine

part 4|1 pages

Biomarker-Informed Clinical Trials

chapter 4.4|4 pages

Outsourcing Biomarkers in Clinical Trials

Advantages and Disadvantages

part 5|1 pages

The Road Ahead

chapter 5.3|9 pages

Ectopic Gene Deregulations and Chromosome Conformations

Integrating Novel Molecular Testing into Clinical Applications, from Leukemias to Gliomas

chapter 5.6|14 pages

Publishing Biomedical Research Findings

What are the Odds?

chapter 5.7|8 pages

Computational Biology

Modeling from Molecule to Disease and Personalized Medicine

chapter 5.8|8 pages

Expectations for Quality Control

Challenges with Multiplex Assays

part 6|1 pages

Lessons from the Past and Pioneers of the Future

chapter 6.2|12 pages

Case Studies

Infertility and Anti-Müllerian Hormone

chapter 6.3|6 pages

Factor Xa

Case Study

chapter 6.4|14 pages

Delivering Companion Diagnostics for Complex Biomarkers

The BRCA Companion Diagnostic Story for LYNPARZA− (Olaparib)

chapter 6.5|7 pages

Delivering the Personalized Medicine Promise

Best Practice Recommendations for Designing Biomarker Development Processes

chapter 6.6|8 pages

Development, Launch, and Adoption of a Pharmacodiagnostic

Planning versus Reacting for Pharmaceutical Companies

part 7|1 pages

Paving a New Era of Personalized Medicine

chapter 7.1|8 pages

A New Era of Personalized Medicine

Emerging Technologies—Functional Proteomics, Companion Diagnostics, and Precision Cancer Medicine

chapter 7.5|11 pages

Predictive Cancer Biomarkers

Current Practice and Future Challenges

chapter 7.12|6 pages

Mass Spectrometry Imaging

Enabling Comprehensive Local Analysis of Molecular Biomarkers in Tissue for Personalized Medicine

chapter 7.13|7 pages

Insights of Personalized Medicine from the Gut Microbiome

Lessons Learned from Celiac Disease

part 8|1 pages

The Next Frontiers of Therapeutic Target Areas

chapter 8.4|13 pages

Advances in Cardiovascular Diagnostics

Use of Cardiac Biomarkers in Clinical Research and Care of the Patient

chapter 8.5|6 pages

Biomarkers for Psychiatric Disease

An Overview

chapter 8.6|9 pages

Progressing Towards Precision Psychiatry

Current Challenges in Applying Biomarkers in Psychiatry

part 9|1 pages

Lessons Learned

chapter 9.1|12 pages

Translational Science in Modern Pharmaceutical R&D

The Influence of Organizational Structures on Successes and Failures

chapter 9.2|6 pages

Biomarker Qualification and Companion Diagnostics

Failure and Success of Regulatory Processes

chapter 9.3|9 pages

Not All Biomarkers Are Worthwhile

An Unsuccessful Use and Pitfalls to Avoid

chapter 9.4|17 pages

Research Reproducibility

The Case for Standards