Translational Medicine and Drug Discovery

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.

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.

Rajesh Krishna, PhD, FCP, is an area lead director in early stage development at Merck Research Laboratories. Dr Krishna is the editor of three books on new drug development besides publishing over 120 articles and oral/poster presentations. He has served as a section editor for the Journal of Clinical Pharmacology, associate editor for BMC Clinical Pharmacology and an editorial board member for BMC Medicine. He is a Fellow of the American College of Clinical Pharmacology and the American Association of Pharmaceutical Scientists, where he is the current Chair of the Clinical Pharmacology and Translational Research section. He is an affiliate member of the Institute of Translational Medicine and Therapeutics at the University of Pennsylvania.
Bruce Littman, MD, is the founder of Translational Medicine Associates, LLC, as well as former co-chair and current member of the Inflammation and Immunity Steering Committee of the Biomarker Consortium. Prior to starting his own company, Dr Littman was the Vice President and Global Head of Translation Medicine at Pfizer Inc. where he worked for nineteen years, first in experimental medicine and then translational medicine. He was also a faculty member of Virginia Commonwealth University School of Medicine for thirteen years. He is a Founding Fellow of the American College of Rheumatology, former President of the Virginia Society of Rheumatologists and a Fellow of the American College of Physicians.