Biomarkers

This book provides an introduction to the field of biomarkers, how they have been and can be used, and how different approaches can be used to identify, characterize, and monitor biomarkers. The book has chapters on topics including HIV, Cancer, Parkinson’s, vascular injury, environmental exposure. A following section discusses the technologies (diagnostics and assays) to detect biomarkers and authors have emphasized the preclinical and clinical manifestation of the injury/disease process.

Preface xxii

Contributors xxv

1 Biomarkers: An Evolutionary Perspective 1
Michael Ferguson and Vishal Vaidya

Section I: Tools for Biomarker Discovery 5

2 Genomics 7
Weida Tong and Donna L. Mendrick

3 Proteomics for Biomarker Discovery 25
Timothy D. Veenstra

4 Metabolic Profiling for Biomarker Discovery 47
Hector C. Keun

5 The Bittersweet Promise of Glycobiology 75
Padmaparna Chaudhuri, Rania Harfouche, and Shiladitya Sengupta

Section II: Biomarkers of Injury/Disease 89

6 Biomarkers of Alzheimer's and Parkinson's Disease 91
Walter Maetzler and Daniela Berg

7 Biomarkers of Cardiac Injury 119
Anthony S. McLean and Stephen J. Huang

8 Lung Injury Biomarkers 157
Urmila P. Kodavanti

9 Translational Biomarkers of Acute Drug-Induced Liver Injury: The Current State, Gaps and Future Opportunities 203
Josef Ozer, William Reagan, Sheli Schomaker, Joe Palandra, Mike Baratta and Shashi Ramaiah

10 Biomarkers of Acute Kidney Injury 237
Frank Dieterle and Frank Sistare

11 In Search of Biomarkers for Drug-Induced Vascular Injury 281
James R. Turk

12 Biomarkers of Immunotoxicity 307
Rodney R. Dietert

13 Biomarkers in Obstetric Medicine 323
Manish Maski, Sarosh Rana and S. Ananth Karumanchi

14 Biomarkers in Cancer 355
Roopali Roy, Christine M. Coticchia, Jiang Yang and Marsha A. Moses

15 Biomarkers of HIV 381
Lewis Kaufman and Michael J Ross

16 Biomarkers of in Vitro Drug-Induced Mitochondrial Dysfunction 401
James A. Dykens and Yvonne Will

Section III: Technology for Biomarker Detection 423

17 Immunoassay-Based Technologies for the Measurement of Biological Materials Used for Biomarkers Discovery and Translational Research 425
Vincent Ricchiuti

18 Nanoscale Techniques for Biomarker Quantification 457
Madhukar Varshney, and Harold G. Craighead

19 Immunodiagnostics with a Focus on Lateral Flow Point-of-Care Devices 495
Roy R. Mondesire, Glen M. Ford, Hannie F. Ford, and Stephen C. Mefferd

Section IV: Hot Topics In Biomarker Research 517

20 Biomarkers for Environmental Exposure 519
Jane E. Gallagher, Elaine A. Cohen Hubal and Stephen W. Edwards

21 Clinical Study Design in Biomarker Research 549
Orfeas Liangos and Bertrand L. Jaber

22 Statistical Issues in Biomarker Research 561
Daniel Holder and Matthew Schipper

23 Regulatory Perspective for Biomarker Qualification from U.S. FDA 581
Federico Goodsaid

24 The European Medicines Agency Approach 589
Marisa Papaluca Amati and Spiros Vamvakas

Index 595

"In summary, this book provides an excellent introduction and overview of discovery and application of biomarkers in medicine and drug discovery and development. The chapters are well structured, with plenty of literature references for further reading, and supplemented with links to web-based resources." (ChemMedChem, 2011)

"They cover tools for discovering biomarkers, biomarkers for injury or disease, technology for detecting biomarkers, and hot topics in biomarker research." (SciTech Book News, December 2010)"This book provides an introduction to the field of biomarkers, how they have been and can be used, and how different approaches can be used to identify, characterize, and monitor biomarkers." (News Blaze, 1 November 2010)

VISHAL S. VAIDYA, PHD, is an Assistant Professor of Medicine at Harvard Medical School in the Renal Division of Brigham and Women's Hospital. He directs the Laboratory of Kidney Toxicology and Regeneration with a research emphasis on discovery and evaluation of biomarkers and biosensors for early detection of kidney injury and investigates the molecular mechanisms of kidney tissue repair. Dr. Vaidya has authored more than thirty-five original research articles and twelve chapters and reviews. He serves as a councilor for the northeast chapter of the Society of Toxicology and is an elected member of Harvard School of Public Health's Center for Environmental Health. He is the recipient of the Pathway to Independence grant by the National Institute of Environmental Health Sciences.

JOSEPH V. BONVENTRE, MD, PHD, is the Samuel A. Levine Professor of Medicine at Harvard Medical School. He is also Chief of the Renal Division and Director of the Biomedical Engineering Division of Brigham and Women's Hospital and is President-elect of the American Society of Nephrology. He has authored more than 250 original papers and 120 chapters and reviews. His research focuses primarily on the study of kidney injury and repair and signal transduction, with special emphasis on the role of inflammation, biomarkers, and stem cells. Bonventre has received a MERIT award from the National Institute of Diabetes and Digestive and Kidney Diseases.

The quintessential introductory guide to the study and application of biomarkers

Most commonly associated with medical diagnostics, biomarkers indicate the presence of disease as well as determine its stage of progression. However, in addition to their role in detecting illness, biomarkers have important roles to play in other important biological and biochemical functions that are directly relevant to health, including predicting a drug's toxicity or effectiveness, and providing a reliable parameter with which to measure one's exposure to hazards in the environment.

A robust introduction to these versatile tools, this book covers the basic fundamentals of biomarkers with discussion of their various uses, then explores the different approaches that can be applied in identifying, characterizing, and monitoring them. A solid foundation for examining the principles, advantages, disadvantages, and applications of methods for biomarker discovery techniques, this book:

• Describes classical and novel biomarkers for different organ damage and disease states including HIV, cancer, neurodegenerative disease, kidney and vascular injury
• Emphasizes the preclinical and clinical manifestations of injury and disease processes and how these can be predicted and monitored with biomarkers
• Covers the approaches, diagnostics, and assays for detecting biomarkers
• Provides information on the U.S. FDA's Critical Path Initiative, which has placed a high priority on the identification and qualification of additional biomarkers

Biomarkers offers a wealth of material that will aid researchers in choosing the correct biomarker for a given case, teach them how to accurately analyze and interpret their results, and guide them in making informed decisions concerning diagnoses and monitoring of tissue injury. For these reasons, students and professionals from many scientific fields will find Biomarkers a valuable addition to their reference library.