<p>Part I: Introduction<br>1. Introduction and definitions<br>2. Problems, challenges, and initiatives in translation<br>Part II. Target identification and validation<br>3. “Omics translation: a challenge for laboratory medicine<br>4. The power of genomics, metabolomics, and other omics for target identification and validation<br>5. Potency analysis of cellular therapies: the role of molecular assays<br>6. Translational pharmacogenetics: pharmacogenetically driven clinical decision making<br>7. Tissue biobanks<br>8. Animal models: value and translational potency<br>9. Biomarkers in the context of health authorities and consortia<br>10. Human studies as a source of target information<br>11. Target profiling in terms of translatability and early translation planning<br>Part III. Biomarkers as key elements of successful translation<br>12. Biomarkers<br>13. Genetics, molecular biomarkers, and artificial intelligence to improve diagnostic and prognostic efficacy<br>14. Cardiovascular translational biomarkers: translational aspects of hypertension, atherosclerosis, and heart failure in drug development in the digital era<br>15. Biomarkers in oncology<br>16. Translational medicine in psychiatry: challenges and imaging biomarkers<br>Part IV: Early clinical trial design<br>17. Methodological studies<br>18. The pharmaceutical research and development productivity crisis: can exploratory clinical studies be of any help?<br>19. Adaptive trial design<br>20. Combining regulatory and exploratory trials<br>21. Accelerating proof of concept by smart early clinical trials<br>Part V: Toxicology in translation<br>22. Pharmaceutical toxicology<br>23. Translational safety medicine<br>Part VI: Special topics in translation<br>24. Cancer vaccines: translational strategies<br>25. Translational aspects of biologicals: monoclonal antibodies and antibody-drug conjugates as examples<br>26. Orphan drugs: why is translation so successful?<br>Part VII: Biostatistics and modelling<br>27. Translational science biostatistics<br>28. Computational biology and model-based approaches in translational medicine<br>Part VIII. Legal aspects and special interest groups<br>29. Intellectual property and innovation in translational medicine<br>30. Translational research in the fastest-growing population: older adults<br>Part IX. Integration and application of translational guidance<br>31. Translational medicine: the changing role of big pharma<br>32. Translational science in medicine: putting the pieces together-biomarkers, early human trials, networking, and translatability assessment<br>33. Learning by experience</p>
