Principles of Translational Science in Medicine
From Bench to Bedside
- 3rd Edition - July 15, 2021
- Imprint: Academic Press
- Editor: Martin Wehling
- Language: English
- Hardback ISBN:9 7 8 - 0 - 1 2 - 8 2 0 4 9 3 - 1
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 2 0 4 9 6 - 2
- eBook ISBN:9 7 8 - 0 - 3 2 3 - 9 9 9 6 2 - 5
Principles of Translational Science in Medicine: From Bench to Bedside, Third Edition, provides an update on major achievements in the translation of research into medically… Read more
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Request a sales quotePrinciples of Translational Science in Medicine: From Bench to Bedside, Third 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 number of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics.
New chapters include: Translation in Oncology, Biologicals, and Orphan Drugs. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine and is written by worldwide experts in their respective fields.
- Includes state-of-the-art principles, tools such as biomarkers and early clinical trials, algorithms of translational science in medicine
- Provides in-depth description of special translational aspects in the currently most successful areas of clinical translation, namely oncology and immunology
- Covers status of institutionalization of translational medicine, networking structures and outcomes at the level of marketing authorization
All biomedical researchers from preclinical to clinical scientists need to understand and apply translational science in medicine, which applies to scientists in pharmaceutical industry though almost all principles are applicable to device development. Additionally, academic researchers will need the book, as well.
Most major universities offer courses, programs (e.g. master programs) in translational medicine for which the book is ideal as the basic teaching material. It is currently used in courses on pharmaceutical medicine e.g. at Basle University.
Most major universities offer courses, programs (e.g. master programs) in translational medicine for which the book is ideal as the basic teaching material. It is currently used in courses on pharmaceutical medicine e.g. at Basle University.
- Cover image
- Title page
- Table of Contents
- Copyright
- List of contributors
- Part I: Introduction
- Chapter 1. Introduction and definitions
- Abstract
- What is translational medicine?
- Primary translation versus secondary translation
- The history of translational medicine, obstacles, and remits
- References
- Chapter 2. Problems, challenges, and initiatives in translation
- Abstract
- Attrition
- What translational medicine can and cannot do
- The present status of translational medicine (initiatives and deficiencies)
- Translational science in medicine: the current challenge
- References
- Part II: Target identification and validation
- Chapter 3. “Omics” translation: a challenge for laboratory medicine
- Abstract
- 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
- References
- Chapter 4. The power of genomics, metabolomics, and other omics for target identification and validation
- Abstract
- Introduction
- Genomics
- Metabolomics
- Conclusion
- References
- Chapter 5. Potency analysis of cellular therapies: the role of molecular assays
- Abstract
- Introduction
- 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
- References
- Chapter 6. Translational pharmacogenetics: pharmacogenetically driven clinical decision making
- Abstract
- 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
- References
- Chapter 7. Tissue biobanks
- Abstract
- Introduction
- The concept of biobanking
- Types of biospecimens
- Biobanking in the era of precision medicine
- Ethical issues
- References
- Chapter 8. Animal models: value and translational potency
- Abstract
- 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
- References
- Chapter 9. Biomarkers in the context of health authorities and consortia
- Abstract
- Introduction
- From biomarkers to diagnostic tests to improve patient care
- In vitro diagnostic tests
- Companion diagnostics
- Lab tests (CLIA test or lab-developed test)
- Drug development tools
- Collaborations for biomarkers and drug development tools
- References
- Chapter 10. Human studies as a source of target information
- Abstract
- Using old drugs for new purposes: baclofen
- Serendipity: sildenafil
- Reverse pharmacology
- References
- Chapter 11. Target profiling in terms of translatability and early translation planning
- Abstract
- Essential dimensions of early translational assessment
- A translatability scoring instrument: risk balancing of portfolios and project improvement
- Case studies: applying the translatability scoring instrument to real-life experiences
- References
- Part III: Biomarkers as key elements of successful translation
- Chapter 12. Biomarkers
- Abstract
- Defining biomarkers as very important contributors to translational science
- Classes of biomarkers
- Development of biomarkers
- Predictivity classification of biomarkers and scores
- Case studies
- References
- Chapter 13. Genetics, molecular biomarkers, and artificial intelligence to improve diagnostic and prognostic efficacy
- Abstract
- Introduction
- Source of errors in clinical proteomics studies
- Source of errors in next-generation sequencing
- Bioinformatics and computational tools for clinical proteomic studies
- Bioinformatics and computational tools for next-generation sequencing
- Examples of the applications of genetics and molecular markers for diagnostic or prognostic purposes
- Conclusions
- References
- Chapter 14. Cardiovascular translational biomarkers: translational aspects of hypertension, atherosclerosis, and heart failure in drug development in the digital era
- Abstract
- What is new?
- Hypertension
- Digital biomarkers of hypertension
- Atherosclerosis
- Animal models of atherosclerosis
- Imaging (digital) biomarkers in atherosclerosis conditions
- Continuously measured digital biomarkers in atherosclerosis conditions
- Heart failure
- Animal models in heart failure
- Traditional biomarkers of heart failure
- Soluble markers for cardiac remodeling and fibrosis
- Soluble markers for myocardial stretch
- Markers of inflammation
- Digital biomarkers of heart failure
- Cardiovascular biomarkers: Quo Vadis?
- Case study: atrial fibrillation
- Conclusion
- References
- Chapter 15. Biomarkers in oncology
- Abstract
- Circulating biomarkers
- Pharmacodynamic markers: target inhibition
- Focus on lung cancer
- The PD-1/PD-L1 axis
- Conclusion
- References
- Chapter 16. Translational medicine in psychiatry: challenges and imaging biomarkers
- Abstract
- 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
- Multiomics and transdiagnostic biomarker discovery
- Conclusions and future directions
- References
- Part IV: Early clinical trial design
- Chapter 17. Methodological studies
- Abstract
- 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
- The contribution of modern imaging to early-phase trials
- Anatomical and molecular imaging evaluation
- Metabolic measurements using positron emission tomography ligands
- Choice of imaging modality
- Radiomics
- Quantification imaging methods
- The role of imaging in phase I trials
- Challenges for novel imaging methodologies and clinical trials
- Conclusion
- Open access clinical trials
- References
- Chapter 18. The pharmaceutical research and development productivity crisis: can exploratory clinical studies be of any help?
- Abstract
- Traditional drug development
- Definition of exploratory clinical studies
- Decision making: regulatory perspective versus company internal perspective in phase I and phase IIa
- The problem at hand: attrition versus opportunity focus
- From phase thinking to question-based development
- High risk and variable costs: how to address the risk-cost combination in development?
- Real options in translational development
- Exploratory studies: the scorn perspective
- Exploratory studies: the value perspective
- Summary: challenges and outlook
- References
- Chapter 19. Adaptive trial design
- Abstract
- References
- Chapter 20. Combining regulatory and exploratory trials
- Abstract
- References
- Chapter 21. Accelerating proof of concept by smart early clinical trials
- Abstract
- References
- Part V: Toxicology in translation
- Chapter 22. Pharmaceutical toxicology
- Abstract
- Introduction
- Discovery toxicology
- Regulatory toxicology
- References
- Chapter 23. Translational safety medicine
- Abstract
- Introduction
- State of affairs of translational safety medicine
- Constraints to effective translational safety medicine
- Practicing translational safety medicine
- In summary
- References
- Part VI: Special topics in translation
- Chapter 24. Cancer vaccines: translational strategies
- Abstract
- Introduction
- Historic perspective of immune system involvement in the biology of cancer
- Microbes: the first cancer vaccine platform in the history of modern medicine
- Discovery of cytokines and the first usage in cancer treatment
- Discovery of white blood cell subtypes and translation from bench to bed
- Nucleic acid–based cancer vaccines
- Synthetic peptides as a cancer vaccine
- Medical advances with monoclonal antibodies in clinical fields
- Virus-based cancer vaccine platforms
- Neoepitope vaccines
- Combination strategies
- Cancer vaccines with broader goals
- Challenges and future directions
- Conclusion
- References
- Chapter 25. Translational aspects of biologicals: monoclonal antibodies and antibody-drug conjugates as examples
- Abstract
- Overview of monoclonal antibodies for cancer therapy
- Structure and functions of antibodies
- Generation of monoclonal antibodies for cancer therapy
- Mechanisms of action of antibodies for cancer therapy
- Antibody-drug conjugates
- Conclusion
- Acknowledgments
- References
- Chapter 26. Orphan drugs: why is translation so successful?
- Abstract
- Introduction
- Special characteristics of translational processes for orphan drugs
- References
- Part VII: Biostatistics and modelling
- Chapter 27. Translational science biostatistics
- Abstract
- Statistical problems in translational science
- Statistical models and statistical inference
- Design and interpretation of an experiment
- Multiplicity
- Biomarkers
- Biological modeling
- Statistical models
- References
- Chapter 28. Computational biology and model-based approaches in translational medicine
- Abstract
- Introduction: Model building in sciences
- Model-informed drug development and discovery (MID3)
- References
- Part VIII: Legal aspects and special interest groups
- Chapter 29. Intellectual property and innovation in translational medicine
- Abstract
- Introduction
- Context
- Trends in translational intellectual property
- Discussion
- Conclusion
- Acknowledgments
- References
- Chapter 30. Translational research in the fastest-growing population: older adults
- Abstract
- Introduction
- Translational aging research
- Testing treatments to extend healthspan and lifespan
- Examples of experimental therapies in aging research
- Translational aging resources
- Conclusion
- References
- Part IX: Integration and application of translational guidance
- Chapter 31. Translational medicine: the changing role of big pharma
- Abstract
- Introduction
- History: how did we get here?
- Academia and integrated discovery nexuses
- Pharma meets academia: models of external innovation
- Precompetitive consortia
- Attitudes, ethics, and standards
- Coronavirus and the road ahead
- References
- Chapter 32. Translational science in medicine: putting the pieces together-biomarkers, early human trials, networking, and translatability assessment
- Abstract
- References
- Chapter 33. Learning by experience
- Abstract
- Example of a smart, successful translational process
- Example of a failed translational process
- References
- Index
- Edition: 3
- Published: July 15, 2021
- Imprint: Academic Press
- No. of pages: 494
- Language: English
- Hardback ISBN: 9780128204931
- eBook ISBN: 9780128204962
- eBook ISBN: 9780323999625
MW
Martin Wehling
Martin Wehling is the Managing Director at the Institute of Experimental and Clinical Pharmacology and Toxicology. Martin Wehling is Director in Clinical Pharmacology at Mannheim Medical Faculty, Mannheim University of Heidelberg, Mannheim, Germany.
Affiliations and expertise
Managing Director, Institute of Experimental and Clinical Pharmacology and Toxicology, Director, Clinical Pharmacology, Mannheim Medical Faculty, Mannheim University of Heidelberg, Mannheim, GermanyRead Principles of Translational Science in Medicine on ScienceDirect