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"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"--
List of contents
Part I: Introduction1. Introduction and definitions
2. Problems, challenges, and initiatives in translation
Part II. Target identification and validation3. "Omics? translation: a challenge for laboratory medicine
4. The power of genomics, metabolomics, and other omics for target identification and validation
5. Potency analysis of cellular therapies: the role of molecular assays
6. Translational pharmacogenetics: pharmacogenetically driven clinical decision making
7. Tissue biobanks
8. Animal models: value and translational potency
9. Biomarkers in the context of health authorities and consortia
10. Human studies as a source of target information
11. Target profiling in terms of translatability and early translation planning
Part III. Biomarkers as key elements of successful translation12. Biomarkers
13. Genetics, molecular biomarkers, and artificial intelligence to improve diagnostic and prognostic efficacy
14. Cardiovascular translational biomarkers: translational aspects of hypertension, atherosclerosis, and heart failure in drug development in the digital era
15. Biomarkers in oncology
16. Translational medicine in psychiatry: challenges and imaging biomarkers
Part IV: Early clinical trial design17. Methodological studies
18. The pharmaceutical research and development productivity crisis: can exploratory clinical studies be of any help?
19. Adaptive trial design
20. Combining regulatory and exploratory trials
21. Accelerating proof of concept by smart early clinical trials
Part V: Toxicology in translation22. Pharmaceutical toxicology
23. Translational safety medicine
Part VI: Special topics in translation24. Cancer vaccines: translational strategies
25. Translational aspects of biologicals: monoclonal antibodies and antibody-drug conjugates as examples
26. Orphan drugs: why is translation so successful?
Part VII: Biostatistics and modelling27. Translational science biostatistics
28. Computational biology and model-based approaches in translational medicine
Part VIII. Legal aspects and special interest groups29. Intellectual property and innovation in translational medicine
30. Translational research in the fastest-growing population: older adults
Part IX. Integration and application of translational guidance31. Translational medicine: the changing role of big pharma
32. Translational science in medicine: putting the pieces together-biomarkers, early human trials, networking, and translatability assessment
33. Learning by experience
About the author
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.
