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; [...]opean 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.