Translational Medicine in CNS Drug Development. Handbook of Behavioral Neuroscience Volume 29

Table of Contents

1. Translating animal models of obesity and diabetes to the clinic 2. Biomarker-guided drug development for better defined early patient studies and clinical trial efficiency 3. Modeling and simulation in the translational pharmacology of cns drugs 4. Functional measurements of central nervous system drug effects in early human drug development 5. Experimental medicine approaches in cns drug development 6. New approaches in translational medicine for phase i clinical trials of cns drugs 7. Translational approaches for antidepressant drug development 8. Biomarker opportunities to enrich clinical trial populations for drug development in schizophrenia and depression 9. Applications of neuroimaging biomarkers in cns drug development 10. Pet occupancy and competition in translational medicine and cns drug development 11. Stable isotope labeling kinetics in cns translational medicine: introduction to silk technology 12. Applications of neurophysiological biomarkers in cns drug development: focus on psychoses 13. Heart rate variability as a translational biomarker for emotional and cognitive deficits 14. Drug discovery in psychiatry: time for human genome-guided solutions 15. Use of cognition to guide decisions about the safety and efficacy of drugs in early-phase clinical trials 16. Digital biomarkers in clinical drug development 17. Lessons learned from public private partnerships and consortia: the adni paradigm 18. Regulatory perspectives on the use of biomarkers and personalized medicine in cns drug development: the fda viewpoint 19. Regulatory considerations for the use of biomarkers and personalized medicine in cns drug development: a european perspective 20. Regulatory science objectives and biomarker qualification through public-private partnerships are critical to delivering innovative treatments for cns diseases 21. The assessment of cognition in translational medicine: a contrast between the approaches used in alzheimer's disease and major depressive disorder 22. Translational medicine strategies in drug development for neurodevelopmental disorders 23. Translational medicine strategies in drug development for mood disorders 24. Translational medicine strategies in alzheimer's disease drug development 25. Experimental medicine models in generalized anxiety disorder and social anxiety disorder 26. Translational medicine strategies in ptsd drug development 27. Unmet medical needs in the treatment of depression and the clinical development of a differentiated antidepressant: a translational line of evidence 28. Translating neurobiology into practice in tobacco, alcohol, drug, and behavioral addictions 29. Translational medicine strategies for drug development for impulsive aggression 30. Hypothesizing major depression as a subset of reward deficiency syndrome (rds) linked to polymorphic reward genes: considerations for translational medicine approaches for future drug development 31. Traveling through the storm: leveraging virtual patient monitoring and artificial intelligence to observe, predict, and affect patient behavior in cns drug development

Authors

George G. Nomikos Global Medical Lead, Clinical Development, Biogen, Cambridge, MA, USA. Dr. Nomikos has more than 30 years of experience in neuropsychopharmacology and CNS therapeutics in both academia and the pharmaceutical/biotechnology industry, focusing on CNS translational and experimental medicine and clinical drug development in psychiatry and neurology. Douglas E. Feltner Vice President, Head of Clinical Development, at AveXis, a Novartis company.. Dr. Feltner has more than 20 years of experience in drug development and translational medicine. He has held previous positions leading neuroscience development at Abbvie and leading Translational Medicine at Pfizer.