Biomarkers in Drug Development : A Handbook of Practice, Application, and Strategy

by Bleavins, Michael R.; Carini, Claudio; Jurima-Romet, Mallé; ; Rahbari, Ramin

• ISBN13: 9780470169278
• ISBN10: 0470169273
• Format: Hardcover
• Copyright: 2010-02-15
• Publisher: Wiley

Summary

By focusing on how to identify, develop, and integrate biomarkers into drug development, this book will improve biomarker use and enhance pharmaceutical decision making. The coverage includes case studies showing how biomarkers can substantively impact drug development timelines and costs, enable better compound selection and reduce late stage attrition, and facilitate personalized medicine. It describes biomarker technologies, characterization and validation, and applications including in discovery, preclinical safety assessment, clinical trials, and translational medicine. The text, a useful resource for the pharmaceutical industry, also looks at practical issues and intellectual property concerns.

Author Biography

Michael R. Bleavins, PhD, is cofounder of Michigan Technology and Research Institute. He retired from Pfizer/Warner-Lambert/Parke-Davis in 2006 and has twenty-three years of experience in pharmaceutical research, development, and biomarkers with more than sixty-five peer-reviewed publications. Claudio Carini, MD, PhD, FRCPATH, is Chief Medical Officer and Vice President for Clinical Research at Fresenius. Previously, Claudio served as Global Head of Translational Medicine at MDS and Global Head of Biomarkers at Hoffmann-La Roche. Claudio has more than twenty years of experience in the field of immunology and biomarkers and has authored more than 200 publications in international and domestic peer-reviewed journals. Mall Jurima-Romet, PhD, is Senior Director for Development and Regulatory Services and MDS Pharma Services, where she provides strategic and scientific consulting to pharmaceutical and biotech sponsors, and leads drug development program teams. Mall has authored over forty peer-reviewed publications and is an adjunct professor at the University of Montreal. Ramin Rahbari, MS, is cofounder and Senior Consultant at Innovative Scientific Management. Previously, Ramin has held positions at Pfizer, Synaptic, and Parke-Davis pharmaceutical companies, leading cross-functional biomarker teams.

Table of Contents

Contributors	p. ix
Preface	p. xv
Biomarkers and Their Role in Drug Development	p. 1
Biomarkers Are Not New	p. 3
Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care	p. 15
Enabling Go/No Go Decisions	p. 31
Identifying New Biomarkers: Technology Approaches	p. 41
Imaging as a Localized Biomarker: Opportunities and Challenges	p. 43
Protein Biomarker Discovery Using Mass Spectrometry-Based Proteomics	p. 101
Quantitative Multiplexed Patterning of Immune-Related Biomarkers	p. 121
Gene Expression Profiles as Preclinical and Clinical Cancer Biomarkers of Prognosis, Drug Response, and Drug Toxicity	p. 135
Use of High-Throughput Proteomic Arrays for the Discovery of Disease-Associated Molecules	p. 155
Characterization and Validation	p. 177
Characterization and Validation Biomarkers in Drug Development: Regulatory Perspective	p. 179
Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development	p. 187
Molecular Biomarkers from a Diagnostic Perspective	p. 215
Strategies for the Co-Development of Drugs and Diagnostics: FDA Perspective on Diagnostics Regulation	p. 231
Importance of Statistics in the Qualification and Application of Biomarkers	p. 247
Biomarkers in Discovery and Preclinical Safety	p. 287
Qualification of Safety Biomarkers for Application to Early Drug Development	p. 289
Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor	p. 301
Biomarkers for the Immunogenicity of Therapeutic Proteins and Its Clinical Consequences	p. 323
New Markers of Kidney Injury	p. 335
Translating from Preclinical Results to Clinical and Back	p. 359
Translation Medicine-A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers	p. 361
Clinical Validation and Biomarker Translation	p. 375
Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis	p. 399
Pharmacokinetic and Pharmacodynamic Biomarker Correlations	p. 413
Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints	p. 433
Biomarkers in Clinical Trials	p. 443
Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: Case Study in Anticoagulant Development	p. 445
Integrating Molecular Testing Into Clinical Applications	p. 463
Biomarkers for Lysosomal Storage Disorders	p. 475
Value Chain in the Development of Biomarkers for Disease Targets	p. 485
Lessons Learned: Practical Aspects of Biomarker Implementation	p. 493
Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork	p. 495
Integrating Academic Laboratories into Pharmaceutical Development	p. 515
Funding Biomarker Research and Development Through the Small Business Innovative Research Program	p. 527
Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices	p. 541
Anti-Unicorn Principle: Appropriate Biomarkers Don't Need to Be Rare or Hard to Find	p. 551
Biomarker Patent Strategies: Opportunities and Risks	p. 565
Where Are We Heading and What Do We Really Need?	p. 575
IT Supporting Biomarker-Enabled Drug Development	p. 377
Redefining Disease and Pharmaceutical Targets Through Molecular Definitions and Personalized Medicine	p. 593
Ethics of Biomarkers: The Borders of Investigative Research, informed Consent, and Patient Protection	p. 625
Pathodynamics: Improving Biomarker Selection by Getting More Information from Changes Over Time	p. 643
Optimizing the Use of Biomarkers for Drug Development: A Clinician's Perspective	p. 693
Nanotechnology-Based Biomarker Detection	p. 709
Index	p. 731
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