Full Description
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 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.
Contents
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
