Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy / Edition 1

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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 thedrug 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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Editorial Reviews

From the Publisher
"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)

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Product Details

  • ISBN-13: 9780470169278
  • Publisher: Wiley
  • Publication date: 2/15/2010
  • Edition number: 1
  • Pages: 800
  • Product dimensions: 6.46 (w) x 9.25 (h) x 1.62 (d)

Meet the Author

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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Table of Contents

Contributors ix

Preface xv

Part I Biomarkers and Their Role in Drug Development 1

1 Biomarkers Are Not New Ian Dews 3

2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care Gregory J. Downing 15

3 Enabling Go/No Go Decisions J. Fred Pritchard Mallé Jurima-Romet 31

Part II Identifying New Biomarkers: Technology Approaches 41

4 Imaging as a Localized Biomarker: Opportunities and Challenges Jonathan B. Moody Philip S. Murphy Edward P. Ficaro 43

5 Protein Biomarker Discovery Using Mass Spectrometry-Based Proteomics Joanna M. Hunter Daniel Chelsky 101

6 Quantitative Multiplexed Patterning of Immune-Related Biomarkers Dominic Eisinger Ralph McDade Thomas Joos 121

7 Gene Expression Profiles as Preclinical and Clinical Cancer Biomarkers of Prognosis, Drug Response, and Drug Toxicity Jason A. Sprowl Amadeo M. Parissenti 135

8 Use of High-Throughput Proteomic Arrays for the Discovery of Disease-Associated Molecules Douglas M. Molina W John W. Morrow Xiaowu Liang 155

Part III Characterization and Validation 177

9 Characterization and Validation Biomarkers in Drug Development: Regulatory Perspective Federico Goodsaid 179

10 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development Jean W. Lee Yuling Wu Jin Wang 187

11 Molecular Biomarkers from a Diagnostic Perspective Klaus Lindpaintner 215

12 Strategies for the Co-Development of Drugs and Diagnostics: FDA Perspective on Diagnostics Regulation Francis Kalush Steven Gutman 231

13 Importance of Statistics in the Qualification and Application of Biomarkers Mary Zacour 247

Part IV Biomarkers in Discovery and Preclinical Safety 287

14 Qualification of Safety Biomarkers for Application to Early Drug Development William B. Mattes Frank D. Sistare 289

15 Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor Alan P. Brown 301

16 Biomarkers for the Immunogenicity of Therapeutic Proteins and Its Clinical Consequences Claire Cornips Huub Schellekens 323

17 New Markers of Kidney Injury Sven A. Beushausen 335

Part V Translating from Preclinical Results to Clinical and Back 359

18 Translation 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 Robert R. Ruffolo, Jr. 361

19 Clinical Validation and Biomarker Translation David Lin Andreas Scherer Raymond Ng Robert Balshaw Shawna Flynn Paul Keown Robert McMaster Bruce McManus 375

20 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis Christina Trollmo Lars Klareskog 399

21 Pharmacokinetic and Pharmacodynamic Biomarker Correlations J.F. Marier Keith Gallicano 413

22 Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints Calvert Louden Ruth A. Roberts 433

Part VI Biomarkers in Clinical Trials 443

23 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: Case Study in Anticoagulant Development Kay A. Criswell 445

24 Integrating Molecular Testing Into Clinical Applications Anthony A. Killeen 463

25 Biomarkers for Lysosomal Storage Disorders Ari Zimran Candida Fratazzi Deborah Elstein 475

26 Value Chain in the Development of Biomarkers for Disease Targets Charles W. Richard, III Arthur O. Tzianabos Whaijen Soo 485

Part VII Lessons Learned: Practical Aspects of Biomarker Implementation 493

27 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork Lena King Mallé Jurima-Romet Nita Ichhpurani 495

28 Integrating Academic Laboratories into Pharmaceutical Development Peter A. Ward Kent J. Johnson 515

29 Funding Biomarker Research and Development Through the Small Business Innovative Research Program James Varani 527

30 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices Bruce D. Car Brian Gemzik William R. Foster 541

31 Anti-Unicorn Principle: Appropriate Biomarkers Don't Need to Be Rare or Hard to Find Michael R. Bleavins Ramin Rahbari 551

32 Biomarker Patent Strategies: Opportunities and Risks Cynthia M. Bott Eric I Baude 565

Part VIII Where Are We Heading and What Do We Really Need? 575

33 IT Supporting Biomarker-Enabled Drug Development Michael Hehenberger 377

34 Redefining Disease and Pharmaceutical Targets Through Molecular Definitions and Personalized Medicine Craig P. Webb John F. Thompson Bruce H. Littman 593

35 Ethics of Biomarkers: The Borders of Investigative Research, informed Consent, and Patient Protection Heather Walmsley Michael Burgess Jacquelyn Brinkman Richard Hegele Janet Wilson-McManus Bruce McManus 625

36 Pathodynamics: Improving Biomarker Selection by Getting More Information from Changes Over Time Donald C. Trost 643

37 Optimizing the Use of Biomarkers for Drug Development: A Clinician's Perspective Alberto Gimnona 693

38 Nanotechnology-Based Biomarker Detection Joshua Reineke 709

Index 731

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