"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"--
"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"--
Part I: Introduction 1. Introduction and definitions 2. Problems, challenges, and initiatives in translation Part II. Target identification and validation 3. "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 translation 12. 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 design 17. 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 translation 22. Pharmaceutical toxicology 23. Translational safety medicine Part VI: Special topics in translation 24. 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 modelling 27. Translational science biostatistics 28. Computational biology and model-based approaches in translational medicine Part VIII. Legal aspects and special interest groups 29. Intellectual property and innovation in translational medicine 30. Translational research in the fastest-growing population: older adults Part IX. Integration and application of translational guidance 31. 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
Part I: Introduction 1. Introduction and definitions 2. Problems, challenges, and initiatives in translation Part II. Target identification and validation 3. "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 translation 12. 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 design 17. 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 translation 22. Pharmaceutical toxicology 23. Translational safety medicine Part VI: Special topics in translation 24. 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 modelling 27. Translational science biostatistics 28. Computational biology and model-based approaches in translational medicine Part VIII. Legal aspects and special interest groups 29. Intellectual property and innovation in translational medicine 30. Translational research in the fastest-growing population: older adults Part IX. Integration and application of translational guidance 31. 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
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