1. Edition - March 2010
142.- Euro
2010. 784 Pages, Hardcover
ISBN-10: 0-470-16927-3
ISBN-13: 978-0-470-16927-8 - John Wiley & Sons






Sample Chapter

Short description
By focusing on how to identify, develop, and integrate biomarkers into drug development, this book will improve biomarker use and enhance pharmaceutical decision making. The coverage includes case studies showing how biomarkers can substantively impact drug development timelines and costs, enable better compound selection and reduce late stage attrition, and facilitate personalized medicine. It describes biomarker technologies, characterization and validation, and applications including in discovery, preclinical safety assessment, clinical trials, and translational medicine. The text, a useful resource for the pharmaceutical industry, also looks at practical issues and intellectual property concerns.

From the contents
Part 1 - What is a Biomarker and Role in Drug Development.

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).

Part 2 - Identifying New Biomarkers: Technology Approaches .

4. Imaging as a Localized Biomarker: Opportunities and Challenges (Jonathan 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. The Use of High Through-Put Proteomic Arrays for the Discovery of Disease-Associated Molecules (Douglas M. Molina, W. John W. Morrow, and Xiaowu Liang).

Part 3 - Characterization and Validation.

9. Characterization and Validation Biomarkers in Drug Development: A 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 - An FDA Perspective on Diagnostics Regulation (Francis Kalush and Steven Gutman).

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

Part 4 - Biomarkers in Discovery and Pre-Clinical Safety.

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 Beushausen).

Part 5 - Translating From Pre-Clinical Results to Clinical and Back.

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, 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 - An Example from Rheumatoid Arthritis (Christina Trollmo and Lars Klareskog).

21. Pharmacokinetic and Pharmacodynamic Biomarker Correlations (Jean-Francois Marier and Keith Gallicano).

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

Part 6 - Biomarkers in Clinical Trials.

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).

Part 7 - Lessons Learned: Practical Aspects of Biomarker Implementation.

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

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 (SBIR) 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. The 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).

Part 8 - Where Are We Heading/What Do We Really Need.

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

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: Where are the Borders of Investigative Research, Informed Consent, and Patient Protection (Heather Walmsley, Michael Burgess, Jacqui Brinkman, Richard Hegele, Janet Wilson-McManus, 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 Perspective (Alberto Gimona).

38. Nanotechnology-Based Biomarker Detection (Joshua Reinke).