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Principles of Translational Science in Medicine

From Bench to Bedside

2nd Edition - April 2, 2015

Editor: Martin Wehling

Hardback ISBN:

9 7 8 - 0 - 1 2 - 8 0 0 6 8 7 - 0

eBook ISBN:

9 7 8 - 0 - 1 2 - 8 0 0 7 2 1 - 1

Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically… Read more

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Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics.

The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics.

The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine.

List of Contributors
Preface
Chapter 1. Introduction and Definitions
- What is Translational Medicine?
- Primary Translation versus Secondary Translation
- The History of Translational Medicine, Obstacles, and Remits
- What Translational Medicine Can and Cannot Do
- The Present Status of Translational Medicine (Initiatives and Deficiencies)
- Translational Science in Medicine: The Current Challenge
Chapter 2. Target Identification and Validation
- Chapter 2.1.1. “Omics” Translation: A Challenge for Laboratory Medicine
  - Introduction
  - “Omics”: What does it mean?
  - Proteomics as a Paradigm of Problems in Translational Medicine
  - Development of Biomarkers: From Discovery to Clinical Application
  - Discovery
  - Identification/Characterization
  - Validation
  - Standardization/Harmonization
  - Clinical Association and Clinical Benefit
  - Translating Omics into Clinical Practice
  - Continuum of Translation Research and Omics
  - Conclusions
- Chapter 2.1.2. “Omics” Technologies: Promises and Benefits for Molecular Medicine
  - Introduction
  - Genomics
  - Metabolomics
  - Conclusion
- Chapter 2.1.3. Potency Analysis of Cellular Therapies: The Role of Molecular Assays
  - Potency Testing
  - Complexities Associated with Potency Testing of Cellular Therapies
  - Factors Affecting the Potency of Cellular Therapies
  - Measuring Potency of Cellular Therapies
  - Gene Expression Arrays for Potency Testing
  - Potential Applications of Gene Expression Profiling for Potency Testing
  - MicroRNAs as Potency Assays
  - Conclusions
- Chapter 2.1.4. Translational Pharmacogenetics to Support Pharmacogenetically Driven Clinical Decision Making
  - Introduction
  - Pharmacogenetics as a Tool for Improving Individual Drug Therapy
  - Types of Drug Therapies that Might Profit from Pharmacogenetic Diagnostics
  - The Status of Translational Pharmacogenetics in Various Drug Therapy Fields
  - Translational Pharmacogenetics and the Need for Clinical Studies to Support Pharmacogenetically Driven Prescribing
- Chapter 2.1.5. Tissue Biobanks
  - Introduction
  - Principles and Types of Tissue Biobanks: Pros and Cons
  - Developments in Vascular Biobanking Research and Clinical Relevance
  - Challenges for Future Biobanks
  - Summary
- Chapter 2.1.6. Animal Models: Value and Translational Potency
  - What is the Value of Animal Models? Pathophysiological Concepts
  - What is a Good Animal Model for Translational Research?
  - What is the Translational Value of Animal Models?
  - Remedies for Failed Translation: Improving Preclinical Research
  - Summary
- Chapter 2.1.7. Localization Technologies and Immunoassays: Promises and Benefits for Molecular Medicine
  - Introduction
  - Localization Technologies
  - Immunoassays
  - Case Study: Screening of a Biomarker for Kidney Injury Using Localization and Immunoassays
- Chapter 2.1.8. Biomarkers in the Context of Health Authorities and Consortia
  - The Critical Path Initiative
  - New Technologies, Health Authorities, and Regulatory Decision Making
  - Private–Public Partnerships (Cooperative R&D Agreements)
  - Consortia
- Chapter 2.1.9. Human Studies as a Source of Target Information
  - Using Old Drugs for New Purposes: Baclofen
  - Serendipity: Sildenafil
  - Reverse Pharmacology
- Chapter 2.2. Target Profiling in Terms of Translatability and Early Translation Planning
  - Essential Dimensions of Early Translational Assessment
  - A Novel Translatability Scoring Instrument: Risk Balancing of Portfolios and Project Improvement
  - Case Studies: Applying the Novel Translatability Scoring Instrument to Real-Life Experiences
Chapter 3. Biomarkers
- Chapter 3.1. Defining Biomarkers as Very Important Contributors to Translational Science
- Chapter 3.2. Classes of Biomarkers
- Chapter 3.3. Development of Biomarkers
- Chapter 3.4. Predictivity Classification of Biomarkers and Scores
- Chapter 3.5. Case Studies
- Chapter 3.6. Biomarker Panels and Multiple Readouts
  - Introduction
  - Source of Errors in Proteomics Studies
  - Statistical and Computational Methods in Clinical Proteomics
  - Multiparameter Approach
  - Conclusions
- Chapter 3.7.1. Cardiovascular Biomarkers: Translational Aspects of Hypertension, Atherosclerosis, and Heart Failure in Drug Development
  - Hypertension
  - Atherosclerosis
  - Heart Failure
- Chapter 3.7.2. Biomarkers in Oncology
  - Other Pathways That May Be Suitable for Biomarker-Assisted Development
  - Tissue Biopsies
- Chapter 3.7.3. Translational Imaging Research
  - Why Imaging?
  - Differences between Translational Imaging and Conventional Imaging
  - Validation of Imaging and Back-Translation
  - Imaging Modalities
  - Characteristics of Various Imaging Modalities
  - Examples of Translational Imaging in Various Disease Areas
  - Conclusion
- Chapter 3.7.4. Translational Medicine in Psychiatry: Challenges and Imaging Biomarkers
  - Biological Treatment of Psychiatric Disorders
  - Specific Challenges of Translation in Psychiatry
  - New Biomarkers for Translation in Psychiatry
  - Imaging Biomarkers in Schizophrenia
  - Imaging of Genetic Susceptibility Factors
  - Characterization of Antipsychotic Drug Effects
  - Conclusions and Future Directions
Chapter 4. Early Clinical Trial Design
- Chapter 4.1. Methodological Studies
  - Conventional Phase I Trial Methodology
  - Measuring Endpoints
  - Mechanism-Oriented Trial Design
  - Can We Make Go-or-No-Go Decisions at the End of Phase I?
  - Phase II Trials
  - Personalized Medicine
  - Open Access Clinical Trials
- Chapter 4.2. The Pharmaceutical R&D Productivity Crisis: Can Exploratory Clinical Studies Be of Any Help?
  - Traditional Drug Development
  - IND Application
  - Opportunities for Earlier Decision Making
- Chapter 4.3. Exploratory Clinical Studies (“Phase 0 Trials”)
  - Types of Studies
  - Microdosing
  - Repeated Dosing
  - Should Exploratory Clinical Studies Be Performed in All Projects?
  - Practical Applications
- Chapter 4.4. Adaptive Trial Design
- Chapter 4.5. Combining Regulatory and Exploratory Trials
- Chapter 4.6. Accelerating Proof-of-Concept by Smart Early Clinical Trials
Chapter 5. Pharmaceutical Toxicology
- Introduction
- Basic Principles of Toxicology
- Regulatory Toxicology
- Biomarkers
- Links
- The Practice of Discovery Safety Assessment
- Summary
- Preclinical Safety from a Translational Perspective
Chapter 6. Translational Science Biostatistics
- Statistical Problems in Translational Science
- Statistical Models and Statistical Inference
- Design and Interpretation of an Experiment
- Multiplicity
- Biomarkers
- Biological Modeling
- Statistical Models
Chapter 7. Intellectual Property and Innovation in Translational Medicine
- Introduction
- Context
- Trends in Translational Intellectual Property
- Discussion
- Conclusion
Chapter 8. Translational Research in the Fastest-Growing Population: Older Adults
- Introduction
- Gerontology Versus Geriatrics
- Animal Models of Aging
- Human Approaches to Translational Aging Research
- Testing Treatments to Extend Health- and Lifespan
- Limitations for Both Animal and Human Models
- Example of Translational Research in Aging: Calorie Restriction
- Translational Aging Resources
- Conclusion
Chapter 9. Translational Medicine: The Changing Role of Big Pharma
- Introduction
- History: How Did We Get Here?
- Translational Solutions
- Public–Private Partnerships: The New Mantra
- Precompetitive Consortia: The Road Ahead
- Summary
Chapter 10. Translational Science in Medicine: Putting the Pieces Together
Chapter 11. Learning by Experience
- Example of a Smart, Successful Translational Process
- Example of a Failed Translational Process
Index