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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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