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.
1. Chapter 1 : Introduction and definitions - p. Page ix 2. Chapter 2 : Problems, challenges, and initiatives in translation - p. Page 7 3. Chapter 3 : “Omics” translation: a challenge for laboratory medicine - p. Page 17 4. Chapter 4 : The power of genomics, metabolomics, and other omics for target identification and validation - p. Page 30 5. Chapter 5 : Potency analysis of cellular therapies: the role of molecular assays - p. Page 45 6. Chapter 6 : Translational pharmacogenetics: pharmacogenetically driven clinical decision making - p. Page 64 7. Chapter 7 : Tissue biobanks - p. Page 80 8. Chapter 8 : Animal models: value and translational potency - p. Page 91 9. Chapter 9 : Biomarkers in the context of health authorities and consortia - p. Page 101 10. Chapter 10 : Human studies as a source of target information - p. Page 113 11. Chapter 11 : Target profiling in terms of translatability and early translation planning - p. Page 121 12. Chapter 12 : Biomarkers - p. Page 132 13. Chapter 13 : Genetics, molecular biomarkers, and artificial intelligence to improve diagnostic and prognostic efficacy - p. Page 163 14. Chapter 14 : Cardiovascular translational biomarkers: translational aspects of hypertension, atherosclerosis, and heart failure in drug development in the digital era - p. Page 174 15. Chapter 15 : Biomarkers in oncology - p. Page 189 16. Chapter 16 : Translational medicine in psychiatry: challenges and imaging biomarkers - p. Page 201 17. Chapter 17 : Methodological studies - p. Page 216 18. Chapter 18 : The pharmaceutical research and development productivity crisis: can exploratory clinical studies be of any help? - p. Page 235 19. Chapter 19 : Adaptive trial design - p. Page 245 20. Chapter 20 : Combining regulatory and exploratory trials - p. Page 250 21. Chapter 21 : Accelerating proof of concept by smart early clinical trials - p. Page 255 22. Chapter 22 : Pharmaceutical toxicology - p. Page 260 23. Chapter 23 : Translational safety medicine - p. Page 278 24. Chapter 24 : Cancer vaccines: translational strategies - p. Page 302 25. Chapter 25 : Translational aspects of biologicals: monoclonal antibodies and antibody-drug conjugates as examples - p. Page 319 26. Chapter 26 : Orphan drugs: why is translation so successful? - p. Page 346 27. Chapter 27 : Translational science biostatistics - p. Page 355 28. Chapter 28 : Computational biology and model-based approaches in translational medicine - p. Page 371 29. Chapter 29 : Intellectual property and innovation in translational medicine - p. Page 385 30. Chapter 30 : Translational research in the fastest-growing population: older adults - p. Page 408 31. Chapter 31 : Translational medicine: the changing role of big pharma - p. Page 431 32. Chapter 32 : Translational science in medicine: putting the pieces together-biomarkers, early human trials, networking, and translatability assessment - p. Page 449 33. Chapter 33 : Learning by experience - p. Page 454 34. Index - p. Page 461
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.
1. Chapter 1 : Introduction and definitions - p. Page ix 2. Chapter 2 : Problems, challenges, and initiatives in translation - p. Page 7 3. Chapter 3 : “Omics” translation: a challenge for laboratory medicine - p. Page 17 4. Chapter 4 : The power of genomics, metabolomics, and other omics for target identification and validation - p. Page 30 5. Chapter 5 : Potency analysis of cellular therapies: the role of molecular assays - p. Page 45 6. Chapter 6 : Translational pharmacogenetics: pharmacogenetically driven clinical decision making - p. Page 64 7. Chapter 7 : Tissue biobanks - p. Page 80 8. Chapter 8 : Animal models: value and translational potency - p. Page 91 9. Chapter 9 : Biomarkers in the context of health authorities and consortia - p. Page 101 10. Chapter 10 : Human studies as a source of target information - p. Page 113 11. Chapter 11 : Target profiling in terms of translatability and early translation planning - p. Page 121 12. Chapter 12 : Biomarkers - p. Page 132 13. Chapter 13 : Genetics, molecular biomarkers, and artificial intelligence to improve diagnostic and prognostic efficacy - p. Page 163 14. Chapter 14 : Cardiovascular translational biomarkers: translational aspects of hypertension, atherosclerosis, and heart failure in drug development in the digital era - p. Page 174 15. Chapter 15 : Biomarkers in oncology - p. Page 189 16. Chapter 16 : Translational medicine in psychiatry: challenges and imaging biomarkers - p. Page 201 17. Chapter 17 : Methodological studies - p. Page 216 18. Chapter 18 : The pharmaceutical research and development productivity crisis: can exploratory clinical studies be of any help? - p. Page 235 19. Chapter 19 : Adaptive trial design - p. Page 245 20. Chapter 20 : Combining regulatory and exploratory trials - p. Page 250 21. Chapter 21 : Accelerating proof of concept by smart early clinical trials - p. Page 255 22. Chapter 22 : Pharmaceutical toxicology - p. Page 260 23. Chapter 23 : Translational safety medicine - p. Page 278 24. Chapter 24 : Cancer vaccines: translational strategies - p. Page 302 25. Chapter 25 : Translational aspects of biologicals: monoclonal antibodies and antibody-drug conjugates as examples - p. Page 319 26. Chapter 26 : Orphan drugs: why is translation so successful? - p. Page 346 27. Chapter 27 : Translational science biostatistics - p. Page 355 28. Chapter 28 : Computational biology and model-based approaches in translational medicine - p. Page 371 29. Chapter 29 : Intellectual property and innovation in translational medicine - p. Page 385 30. Chapter 30 : Translational research in the fastest-growing population: older adults - p. Page 408 31. Chapter 31 : Translational medicine: the changing role of big pharma - p. Page 431 32. Chapter 32 : Translational science in medicine: putting the pieces together-biomarkers, early human trials, networking, and translatability assessment - p. Page 449 33. Chapter 33 : Learning by experience - p. Page 454 34. Index - p. Page 461
