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

ISBN: 978-0-470-16927-8
800 pages
February 2010
Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy (0470169273) cover image


Discover how biomarkers can boost the success rate of drug development efforts

As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine.

Biomarkers in Drug Development is divided into eight parts:

  • Part One offers an overview of biomarkers and their role in drug development.

  • Part Two highlights important technologies to help researchers identify new biomarkers.

  • Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose.

  • Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine.

  • Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs.

  • Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns.

Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.

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Table of Contents




1 Biomarkers Are Not New (Ian Dews).

2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care (Gregory J. Downing).

3 Enabling Go/No Go Decisions (J. Fred Pritchard and Mallé Jurima-Romet).


4 Imaging as a Localized Biomarker: Opportunities and Challenges (Jonathan B. Moody, Philip S. Murphy, Edward P. Ficaro).

5 Protein Biomarker Discovery Using Mass Spectrometry-Based Proteomics (Joanna M. Hunter and Daniel Chelsky).

6 Quantitative Multiplexed Patterning of Immune-Related Biomarkers (Dominic Eisinger, Ralph McDade, and Thomas Joos).

7 Gene Expression Profiles as Preclinical and Clinical Cancer Biomarkers of Prognosis, Drug Response, and Drug Toxicity (Jason A. Sprowl and Amadeo M. Parissenti).

8 Use of High-Throughput Proteomic Arrays for the Discovery of Disease-Associated Molecules (Douglas M. Molina, W. John W. Morrow, and Xiaowu Liang).


9 Characterization and Validation Biomarkers in Drug Development: Regulatory Perspective (Federico Goodsaid).

10 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development (Jean W. Lee, Yuling Wu, and Jin Wang).

11 Molecular Biomarkers from a Diagnostic Perspective (Klaus Lindpaintner).

12 Strategies for the Co-Development of Drugs and Diagnostics: FDA Perspective on Diagnostics Regulation (Francis Kalush and Steven Gutman).

13 Importance of Statistics in the Qualification and Application of Biomarkers (Mary Zacour).


14 Qualification of Safety Biomarkers for Application to Early Drug Development (William B. Mattes and Frank D. Sistare).

15 Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor (Alan P. Brown).

16 Biomarkers for the Immunogenicity of Therapeutic Proteins and its Clinical Consequences (Claire Cornips and Huub Shellekens).

17 New Markers of Kidney Injury (Sven A. Beushausen).


18 Translational Medicine-A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers (Giora Z. Feuerstein, Salvatore Alesci, Frank L. Walsh, J. Lynn Rutkowski, and Robert R. Ruffolo, Jr.).

19 Clinical Validation and Biomarker Translation (David Lin, Andreas Scherer, Raymond Ng, Robert Balshaw, Shawna Flynn, Paul Keown, Rob McMaster, and Bruce McManus).

20 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis (Christina Trollmo and Lars Klareskog).

21 Pharmacokinetic and Pharmacodynamic Biomarker Correlations (J.F. Marier and Keith Gallicano).

22. Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints (Calvert Louden and Ruth A. Roberts).


23 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: A Case Study in Anticoagulant Development (Kay A. Criswell).

24 Integrating Molecular Testing into Clinical Applications (Anthony A. Killeen).

25 Biomarkers for Lysosomal Storage Disorders (Ari Zimran, Candida Fratazzi, and Deborah Elstein).

26 The Value Chain in the Development of Biomarkers for Disease Targets (Charles W. Richard III, Arthur O. Tzianabos, Whaijen Soo).


27 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork (Lena King, Mall‚ Jurima-Romet, and Nita Ichhpurani).

28 Integrating Academic Laboratories Into Pharmaceutical Development (Peter A. Ward and Kent J. Johnson).

29 Funding Biomarker Research and Development Through the Small Business Innovative Research Program (James Varani).

30 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices (Bruce D. Car, Brian Gemzik, and William R. Foster).

31 Anti-Unicorn Principle: Appropriate Biomarkers Don’t Need to be Rare or Hard to Find (Michael R. Bleavins and Ramin Rahbari).

32 Biomarker Patent Strategies: Opportunities and Risks (Cynthia M. Bott and Eric J. Baude).


33 IT Supporting Biomarker-Enabling Drug Development (Michael Hehenberger).

34 Redefining Disease and Pharmaceutical Targets Through Molecular Definitions and Personalized Medicine (Craig P. Webb, John F. Thompson and Bruce H. Littman).

35 Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection (Heather Walmsley, Michael Burgess, Jacqui Brinkman, Richard Hegele, Janet Wilson-McManus, and Bruce McManus).

36 Pathodynamics: Improving Biomarker Selection By Getting More Information From Changes Over Time (Donald C. Trost).

37 Optimizing the Use of Biomarkers for Drug Development: A Clinician's Perspective (Alberto Gimona).

38 Nanotechnology-Based Biomarker Detection (Joshua Reinke).


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Author Information

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.

MALLÉ JURIMA-ROMET, PhD, is Senior Director for Development and Regulatory Services at MDS Pharma Services, where she provides strategic and scientific consulting to pharmaceutical and biotech sponsors, and leads drug development program teams. Mallé 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.

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"The content is laid out systematically so that it provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation. It has a fine collection of papers detailing both practical approaches and case studies". (ChemMedChem, 1 May 2011)

"An extensive index (an estimated 1000 entries), tables, schemes, flow diagrams and color plates (16 pages), as well as good quality paper and a stout binding make this an excellent offering. If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn't be, then this book is for you." (ISSX, 2010)

"I really enjoyed reviewing this book as it is a gem. " (BTS Newsletter, Summer 2010)

"[This book] is unquestionably the best available and most updated source of information on the use of biomarkers in Translational Medicine available today. The Editors superbly crafted an excellent resource and straightforward read. ... Aptly described by the editors, biomarkers have emerged as a useful and valuable tool for anyone working in the research and development of novel pharmaceuticals. Replete with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. ... This book is absolutely crucial for drug-development scientists and researchers. Each of the winning chapters has been penned by an official in the relevant field. This is a book that should not be missed by anyone working with biomarkers in the challenging and changing market of today."
Raffaele Baffa, MD, Translational Sciences, MedImmune, LLC

"The book by Bleavins, et al. is a real tour de force on the topic of biomarkers, and attacks the subject in a well balanced and very holistic way. This is by far the most comprehensive treatise on the topic of biomarkers that has been published to date. The chapters are extremely well written, and it was great fun to read the historical aspects that reminds every reader that biomarkers are not a new invention. Chapters that dwell on the qualification, analytical, and regulatory considerations are very sobering as they show that the use of biomarkers sound easy in theory but considerably more difficult in practice.... The ability of this book to address issues from the scientific to the investment attests to the holistic nature that the editors chose to address in a topic deceptively named with one word…biomarkers. Overall the chapters are evenly informative and consistently well written and organized, which is tribute to the editors.... [A] remarkable aspect of this book is the breadth of experience and diversity of the authors. Rather than maintaining an uniform view from one fraction of the biomarker user world , the editors were broadly inclusive of a wide set of disciplines from academia, pharma industry, and regulatory but also from commercial and laboratory organizations. This diversity brings a richness of experience and knowledge that propels the book to a level of insight that is atypical for a topic of this nature. Another area for which the editors should receive great credit is in the breath of biomarker considerations. The landscape is large and ranges from the more traditional serum analytical assay to the complexities of imaging and genetic biomarkers and the unique issues associated with these fields. Another strength of the book is highlighting examples of the applications of biomarkers in a couple of diseases.... Overall this is an excellent book and will serve as a superb reference for anyone in the field of drug development and translational medicine. It is highly informative, rich in detail and extensive in breath. It deserves to be on the shelf of anyone involved in the discipline of biomarker application. The editors should be commended for having delivered an exceptional piece of work on a very topical issue."
--Diane K. Jorkasky, M.D., Aileron Therapeutics, Inc.

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