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This book, edited by two innovative leaders in the field, focuses on the new discipline of translational medicine as it pertains to drug development within the pharmaceutical and biotechnology industry. Translational medicine seeks to translate biological and molecular knowledge of disease and how drugs work into innovative development strategies that reduce the cost and increase the speed of delivering new medicines for patients. This book outlines general strategies, biomarker development, imaging tools, translational human models and examples of their application to real drug development. The latest thinking is presented by researchers from many of the world's leading drug development companies, including Pfizer, Merck, Eli Lilly, Abbott and Novartis, as well as academic institutions and public-private partnerships that support translational research. This book is essential for anyone interested in translational medicine from a variety of backgrounds: university institutes, medical schools, pharmaceutical companies and drug development researchers and decision-makers.

Table of Contents

 

Part I. Translational Medicine:

History, Principles and Application in Drug Development: 1. Overview of translational medicine and drug development Bruce H. Littman

2. Concepts and case studies: diabetes Ann Taylor and Roberto Calle

3. Challenges in atherosclerosis John Millar

4. Obesity: new mechanisms and translational paradigms Gregory Gaich and David E. Moller

5. Bone disorders: case studies of translational research S. Aubrey Stoch

6. Case studies in neuroscience: unique challenges and examples Gerard J. Marek

7. Translational medicine in oncology Dominic G. Spinella

Part II. Biomarkers and Public-Private Partnerships:

8. Biomarker validation and application in drug development Pfizer Global Research and Development

9. Application of imaging methods in translational medicine Johannes T. Tauscher and Adam Schwarz

10. European innovative medicines initiative Ole J. Bjerrum and Hans H. Linden

11. Critical path institute and the predictive safety consortium Elizabeth Gribble Walker

12. The biomarker consortium David B. Lee

Part III. Future Directions:

13. Improving the quality and productivity of pharmacometric modeling and simulation activities - the foundation for model-based drug development Thaddeus H. Grasela, Jill Fiedler-Kelly and Robert Slusser

14. Embracing change: a pharmaceutical industry guide to the 21st century Mervyn Turner.