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Biomarkers in Drug Discovery and Development: A Handbook of Practice, Application, and Strategy, 2nd Edition





Biomarkers in Drug Discovery and Development: A Handbook of Practice, Application, and Strategy, 2nd Edition

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This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development.

•    Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine
•    Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory
•    Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring
•    Includes case studies of biomarkers that have helped and hindered decision making
•    Reviews of the first edition: “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) and “…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.” (ChemMedChem)

List of Contributors ix


Part I Biomarkers and Their Role in Drug Development x

1 Biomarkers Are Not New x
Ian Dews

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

3 Enabling Go/No Go Decisions x
J. Fred Pritchard and M. Lynn Pritchard

4 Developing a Clinical Biomarker Method with External Resources: A Case Study x
Ross A. Fredenburg

Part II Biomarker Technologies x

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

6 Imaging for Early Clinical Drug Development: Integrating Imaging Science With Drug Research x
Philip S. Murphy, Mats Bergstrom, Jonathan B. Moody, and Edward P. Ficaro

7 Circulating microRNAs as Biomarkers in Cardiovascular and Pulmonary Vascular Disease: Promises and Challenges x
Miranda K. Culley and Stephen Y. Chan

Part III Characterization, Validation, and Utilization x

8 Characterization and Validation Biomarkers in Drug Development: Regulatory Perspective x
Federico Goodsaid

9 Fit-for-Purpose Method Validation and Assays of Protein Biomarkers During Drug Development x
Jean W. Lee, Yuling Wu, and Jin Wang

10 Applying Statistics Appropriately for Your Biomarker Application x
Mary Zacour

Part IV Biomarkers in Discovery and Preclinical Safety x

11 Qualification of Safety Biomarkers for Application to Early Drug Development x
William B. Mattes and Frank D. Sistare

12 A Pathologist’s View of Drug and Biomarker Development x
Robert W. Dunstan

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

14 New Markers of Kidney Injury x
Sven A. Beushausen

Part V Translating from Preclinical to Clinical and Back x

15 Biomarkers from Bench to Bedside and Back – Back Translation of Clinical Studies to Pre-clinical Models x
Damian O’Connell, Zaki Shaikhibrahim, Frank Kramer, and Matthias Ocker

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

17 Clinical Validation and Biomarker Translation x
Ji-Young V. Kim, Raymond T. Ng, Robert Balshaw, Paul Keown, Robert McMaster, Bruce McManus, Karen Lam, and Scott J. Tebbutt

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

19 Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints x
Calvert Louden and Ruth A. Roberts

Part VI Biomarkers in Clinical Trials x

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

21 Integrating Molecular Testing into Clinical Applications x
Anthony A. Killeen

Part VII Big Data, Data Mining and Biomarkers x

22 IT Supporting Biomarker Enabled Drug Development x
Michael Hehenberger

23 Identifying Biomarker Profiles Through the Epidemiologic Analysis of Big Healthcare Data Implications for Clinical Management and Clinical Trial Design: A Case Study in Anemia of Chronic Kidney Disease x
Gregory P. Fusco

24 Computational Biology Approaches to Support Biomarker Discovery and Development xq
Bin Li, Hyunjin Shin, William L. Trepiccho, and Andrew Dorner

Part VIII Lessons Learned: Practical Aspects of Biomarker Implementation X

25 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork x
Lena King, Malle Jurima-Romet, and Nita Ichhpurani

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

Part IX Where Are We Heading and What Do We Really Need? x

27 Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection x
Sara Assadian, Michael Burgess, Breanne Crouch, Karen Lam, and Bruce McManus

28 Anti-Unicorn Principle: Appropriate Biomarkers Don’t Need to Be Rare or Hard to Find x
Michael R. Bleavins and Ramin Rahbari

29 Translational Biomarker Imaging: Applications, Trends and Successes Today and Tomorrow x
Patrick McConville and Deanne Lister

Index x