Translational Medicine and Drug Discovery

doi:10.1017/CBO9780511976087

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.

'This is an important book in a relatively new and growing field. Anyone engaged in advanced research designed to bring new drugs and biologics to market will find it valuable.'

Source: Drug Information Journal

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Contents

Frontmatter
pp i-iv
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Contents
pp v-xiv
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Contributors
pp xv-xviii
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Preface
pp xix-xx
- By Bruce H. Littman, Translational Medicine Associates, LLC, Rajesh Krishna
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Translational Medicine and Drug Discovery
pp xxi-xxii
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SECTION I - TRANSLATIONAL MEDICINE: HISTORY, PRINCIPLES, AND APPLICATION IN DRUG DEVELOPMENT
pp 1-2
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1 - TRANSLATIONAL MEDICINE: DEFINITION, HISTORY, AND STRATEGIES
pp 3-34
- By Bruce H. Littman, Translational Medicine Associates, LLC
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2 - TRANSLATIONAL MEDICINE AND ITS IMPACT ON DIABETES DRUG DEVELOPMENT
pp 35-61
- By Roberto A. Calle, Pfizer Pharmatherapeutics Research and Development, Ann E. Taylor, Novartis
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3 - CHALLENGES IN ATHEROSCLEROSIS
pp 62-88
- By John S. Millar, University of Pennsylvania
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4 - OBESITY: NEW MECHANISMS AND TRANSLATIONAL PARADIGMS
pp 89-114
- By Gregory Gaich, Eli Lilly & Co., David E. Moller, Eli Lilly & Co.
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5 - BONE DISORDERS: TRANSLATIONAL MEDICINE CASE STUDIES
pp 115-167
- By S. Aubrey Stoch, Merck Research Laboratories
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6 - CASE STUDIES IN NEUROSCIENCE: UNIQUE CHALLENGES AND EXAMPLES
pp 168-179
- By Gerard J. Marek, Abbott Laboratories
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7 - TRANSLATIONAL MEDICINE IN ONCOLOGY
pp 180-192
- By Dominic G. Spinella, Pfizer, Inc.
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SECTION II - BIOMARKERS AND PUBLIC–PRIVATE PARTNERSHIPS
pp 193-194
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8 - BIOMARKER VALIDATION AND APPLICATION IN EARLY DRUG DEVELOPMENT: IDEA TO PROOF OF CONCEPT
pp 195-221
- By Pfizer Global
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9 - IMAGING BIOMARKERS IN DRUG DEVELOPMENT: CASE STUDIES
pp 222-264
- By Johannes T. Tauscher, Lilly Research Laboratories, Adam J. Schwarz, Lilly Research Laboratories
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10 - EUROPEAN NEW SAFE AND INNOVATIVE MEDICINES INITIATIVES: HISTORY AND PROGRESS (THROUGH DECEMBER 2009)
pp 265-288
- By Ole J. Bjerrum, University of Copenhagen, Hans H. Linden, European Federation of Pharmaceutical Sciences
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11 - CRITICAL PATH INSTITUTE AND THE PREDICTIVE SAFETY TESTING CONSORTIUM
pp 289-294
- By Elizabeth Gribble Walker, Critical Path Institute
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12 - THE BIOMARKERS CONSORTIUM: FACILITATING THE DEVELOPMENT AND QUALIFICATION OF NOVEL BIOMARKERS THROUGH A PRECOMPETITIVE PUBLIC–PRIVATE PARTNERSHIP
pp 295-300
- By David Wholley, Foundation for the National Institutes of Health, David B. Lee, Foundation for the National Institutes of Health
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SECTION III - FUTURE DIRECTIONS
pp 301-302
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13 - IMPROVING THE QUALITY AND PRODUCTIVITY OF PHARMACOMETRIC MODELING AND SIMULATION ACTIVITIES: THE FOUNDATION FOR MODEL-BASED DRUG DEVELOPMENT
pp 303-327
- By Thaddeus H. Grasela, Cognigen Corporation, Jill Fiedler-Kelly, Cognigen Corporation, Robert Slusser, Pfizer Pharmatherapeutics Research and Development
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14 - EMBRACING CHANGE: A PHARMACEUTICAL INDUSTRY GUIDE TO THE 21ST CENTURY
pp 328-344
- By Mervyn Turner, Merck & Co.
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Index
pp 345-361
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Translational Medicine and Drug Discovery

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Contents

Frontmatter
pp i-iv

Contents
pp v-xiv

Contributors
pp xv-xviii

Preface
pp xix-xx

Translational Medicine and Drug Discovery
pp xxi-xxii

SECTION I - TRANSLATIONAL MEDICINE: HISTORY, PRINCIPLES, AND APPLICATION IN DRUG DEVELOPMENT
pp 1-2

1 - TRANSLATIONAL MEDICINE: DEFINITION, HISTORY, AND STRATEGIES
pp 3-34

2 - TRANSLATIONAL MEDICINE AND ITS IMPACT ON DIABETES DRUG DEVELOPMENT
pp 35-61

3 - CHALLENGES IN ATHEROSCLEROSIS
pp 62-88

4 - OBESITY: NEW MECHANISMS AND TRANSLATIONAL PARADIGMS
pp 89-114

5 - BONE DISORDERS: TRANSLATIONAL MEDICINE CASE STUDIES
pp 115-167

6 - CASE STUDIES IN NEUROSCIENCE: UNIQUE CHALLENGES AND EXAMPLES
pp 168-179

7 - TRANSLATIONAL MEDICINE IN ONCOLOGY
pp 180-192

SECTION II - BIOMARKERS AND PUBLIC–PRIVATE PARTNERSHIPS
pp 193-194

8 - BIOMARKER VALIDATION AND APPLICATION IN EARLY DRUG DEVELOPMENT: IDEA TO PROOF OF CONCEPT
pp 195-221

9 - IMAGING BIOMARKERS IN DRUG DEVELOPMENT: CASE STUDIES
pp 222-264

10 - EUROPEAN NEW SAFE AND INNOVATIVE MEDICINES INITIATIVES: HISTORY AND PROGRESS (THROUGH DECEMBER 2009)
pp 265-288

11 - CRITICAL PATH INSTITUTE AND THE PREDICTIVE SAFETY TESTING CONSORTIUM
pp 289-294

12 - THE BIOMARKERS CONSORTIUM: FACILITATING THE DEVELOPMENT AND QUALIFICATION OF NOVEL BIOMARKERS THROUGH A PRECOMPETITIVE PUBLIC–PRIVATE PARTNERSHIP
pp 295-300

SECTION III - FUTURE DIRECTIONS
pp 301-302

13 - IMPROVING THE QUALITY AND PRODUCTIVITY OF PHARMACOMETRIC MODELING AND SIMULATION ACTIVITIES: THE FOUNDATION FOR MODEL-BASED DRUG DEVELOPMENT
pp 303-327

14 - EMBRACING CHANGE: A PHARMACEUTICAL INDUSTRY GUIDE TO THE 21ST CENTURY
pp 328-344

Index
pp 345-361

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