Translational Medicine in CNS Drug Development, Volume 27, is the first book of its kind to offer a comprehensive overview of the latest developments in translational medicine and biomarker techniques. With extensive coverage on all aspects of biomarkers and personalized medicine, and numerous chapters devoted to the best strategies for developing drugs that target specific disorders, this book presents an essential reference for researchers in neuroscience and pharmacology who need the most up-to-date techniques for the successful development of drugs to treat central nervous system disorders.
Despite increases in the number of individuals suffering from CNS-related disorders, the development and approval of drugs for their treatment have been hampered by inefficiencies in advancing compounds from preclinical discovery to the clinic. However, in the past decades, game-changing strides have been made in our understanding of the pathophysiology of CNS disorders and the relationship of drug exposure in plasma and CNS to pharmcodynamic measures in both animals and humans.
- Includes comprehensive coverage of biomarker tools and the role of personalized medicine in CNS drug development
- Discusses strategies for drug development for a full range of CNS issues, from neuropsychiatric disorders, to movement disorders
- Includes chapters written by international experts from industry and academia
1. Experimental medicine approaches in CNS drug development 2. Modeling and Simulation in the Translational Pharmacology of CNS Drugs 3. Proof-of-mechanism and proof-of-principle trials in early clinical drug development: Applications of biomarkers and experimental medicine 4. Phase I Trials: From Traditional to Newer Approaches 5. De-risking proof-of-concept CNS clinical trials based on translational medicine approaches: What is needed, what we do and what we do not do 6. Biomarker Opportunities to Enrich Clinical Trial Populations for Drug Development in Schizophrenia and Depression 7. Applications of translational neuroimaging research in CNS drug development 8. Assessments of neurotransmitter function by molecular imaging: A translational medicine approach for CNS drug development 9. Applications of neurochemical biomarkers in CNS drug development 10. Applications of neurophysiological biomarkers in CNS drugs 11. Applications of pharmacogenetic and pharmacogenomic biomarkers in CNS drug development 12. Applications of clinical biomarkers in CNS drug development 13. Uses of Stable Isotope Labeling Kinetics in CNS Translational Medicine 14. Multiparameter PKPD Assessment to Quantify Target Engagement in CNS Translational Medicine 15. The Use of Small Exploratory POC Trials to Identify Indications for CNS Drugs 16. Lessons learned from public private partnerships and consortia: The ADNI paradigm 17. Regulatory perspectives on the use of biomarkers and personalized medicine in CNS drug development: The FDA viewpoint 18. Regulatory perspectives on the use of biomarkers and personalized medicine in CNS drug development: The EMA viewpoint 19. Regulatory Qualification of Biomarkers: Learnings from Critical Path Institute 20. Uptake and utilization of biomarkers and personalized medicine by prescribers, payers and patients: Emerging trends 21. Digital health-based biomarkers for use in clinical drug development 22. Translational medicine strategies in drug development for neurocognitive disorders 23. Translational medicine strategies in drug development for neurodegenerative disorders 24. Translational medicine strategies in drug development for neurodevelopmental disorders 25. Translational medicine strategies in drug development for impulse control disorders 26. Translational medicine strategies in drug development for affective disorders 27. Translational medicine strategies in drug development for movement disorders 28. Translational medicine strategies in Alzheimer's disease drug development 29. Translational medicine strategies in schizophrenia drug development 30. Translational medicine strategies in major depressive disorder drug development 31. Experimental medicine approaches to drug development in anxiety disorders 32. Experimental medicine approaches to drug development in PTSD 33. Translating Neurobiology into Practice in Tobacco, Alcohol, Drug, and Behavioral Addictions 34. Translational medicine strategies in neuropathic pain and chronic pain drug development 35. Use of translational medicine approaches across neuropsychiatric indications: Are we there yet? 36. Hypothesizing Major Depression as a Subset of Reward Deficiency Syndrome (RDS) linked to Polymorphic Reward Genes 37. Translating nonclinical models of disease and drug action to the clinic 38. Heart Rate Variability as a Translational Biomarker for Emotional and Cognitive Deficits
Dr. Nomikos has more than 25 years of experience investigating neuropharmacology and CNS therapeutics in both academia and the pharmaceutical industry, specializing in CNS translational and experimental medicine. He is the author of more than 150 research articles
Feltner, Douglas E.