Translational Medicine in CNS Drug Development,
Edition 1
Edited by George G. Nomikos and Douglas E. Feltner

Publication Date: 19 Jun 2019

Translational Medicine in CNS Drug Development, Volume 29, 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 pharmacodynamic measures in both animals and humans.

Key Features

  • 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 indications, with particular attention to neuropsychiatric and neurocognitive disorders
  • Includes chapters written by international experts from industry and academia
About the author
Edited by George G. Nomikos, Global Medical Lead, Clinical Development, Biogen, Cambridge, MA, USA and Douglas E. Feltner, Vice President, Head of Clinical Development, at AveXis, a Novartis company.
Table of Contents

1. Translating animal models of obesity and diabetes to the clinic
B.M. Geiger and E.N. Pothos
2. Biomarker-guided drug development for better defined early patient studies and clinical trial efficiency
Aldemar Degroot
3. Modeling and simulation in the translational pharmacology of cns drugs
Elizabeth C. De Lange and Peter Bonate
4. Functional measurements of central nervous system drug effects in early human drug development
Joop van Gerven
5. Experimental medicine approaches in cns drug development
Jeffrey Paul
6. New approaches in translational medicine for phase i clinical trials of cns drugs
Matthew Macaluso, Michael Krams, Jonathan Savitz, Wayne C. Drevets and Sheldon H. Preskorn
7. Translational approaches for antidepressant drug development
Gerard J. Marek
8. Biomarker opportunities to enrich clinical trial populations for drug development in schizophrenia and depression
Bruce J. Kinon
9. Applications of neuroimaging biomarkers in cns drug development
Patricia E. Cole and Steven G. Einstein
10. Pet occupancy and competition in translational medicine and cns drug development
Paul Cumming and Gerhard Gründer
11. Stable isotope labeling kinetics in cns translational medicine: introduction to silk technology
Randall J. Bateman, Tim West, Kevin Yarasheski, Bruce W. Patterson, Brendan Lucey, John Cirrito, Sylvain Lehmann, Christophe Hirtz, Audrey Gabelle, Tim Miller, Nicolas Barthelemy, Chihiro Sato, James G. Bollinger, Paul Kotzbauer and Katrina Paumier
12. Applications of neurophysiological biomarkers in cns drug development: focus on psychoses
Yash B. Joshi, Melissa A. Tarasenko and Gregory A. Light
13. Heart rate variability as a translational biomarker for emotional and cognitive deficits
Bart A. Ellenbroek, Meyrick Kidwell, Joyce Colussi-Mas and Jiun Youn
14. Drug discovery in psychiatry: time for human genome-guided solutions
Andreas Papassotiropoulos and Dominique J.-F. De Quervain
15. Use of cognition to guide decisions about the safety and efficacy of drugs in early-phase clinical trials
Paul Maruff
16. Digital biomarkers in clinical drug development
Amir Kalali, Sarah Richerson, Emilia Ouzunova, Ryan Westphal and Bradley Miller
17. Lessons learned from public private partnerships and consortia: the adni paradigm
Enchi Liu
18. Regulatory perspectives on the use of biomarkers and personalized medicine in cns drug development: the fda viewpoint
Mathangi Gopalakrishnan and Jogarao V.S. Gobburu
19. Regulatory considerations for the use of biomarkers and personalized medicine in cns drug development: a european perspective
Eamon O’Loinsigh and Anjana Bose
20. Regulatory science objectives and biomarker qualification through public-private partnerships are critical to delivering innovative treatments for cns diseases
Diane T. Stephenson and Stephen P. Arneric
21. The assessment of cognition in translational medicine: a contrast between the approaches used in alzheimer’s disease and major depressive disorder
John E. Harrison and Suzanne Hendrix
22. Translational medicine strategies in drug development for neurodevelopmental disorders
Siddharth Srivastava, Mustafa Sahin and Lisa Prock
23. Translational medicine strategies in drug development for mood disorders
Zihang Pan, Radu C. Grovu and Roger S. Mcintyre
24. Translational medicine strategies in alzheimer’s disease drug development
Veronika Logovinsky
25. Experimental medicine models in generalized anxiety disorder and social anxiety disorder
David S. Baldwin and Ayman Abou-Aisha
26. Translational medicine strategies in ptsd drug development
Dan J. Stein, Willie Daniels and Brian H. Harvey
27. Unmet medical needs in the treatment of depression and the clinical development of a differentiated antidepressant: a translational line of evidence
George G. Nomikos
28. Translating neurobiology into practice in tobacco, alcohol, drug, and behavioral addictions
Benjamin Srivastava and Mark S. Gold
29. Translational medicine strategies for drug development for impulsive aggression
Emil F. Coccaro, Royce Lee And Neal G. Simon
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
Kenneth Blum, Mark S. Gold, Edward J. Modestino, Igor Elman, David Baron and Rajendra D. Badgaiyan
31. Traveling through the storm: leveraging virtual patient monitoring and artificial intelligence to observe, predict, and affect patient behavior in cns drug development
Adam Hanina and Laura Shafner

Book details
ISBN: 9780128031612
Page Count: 458
Retail Price : £115.00
  • Faingold, Neuronal Networks in Brain Function, CNS Disorders, and Therapeutics, 9780124158047, Jan 2014, 512pp, $150.00
  • Zigmond, Neurobiology of Brain Disorders, 9780123982704, Oct 2014, 824pp, $150.00
  • LeDoux, Movement Disorders 2e, 9780124051959, Sep 2014, 1280pp, $300.00
  • Wolfe, Progress and Challenges in Developing Therapeutics for Alzheimer’s Disease, 9780128021736, Jun 2016, 656pp, $200.00
  • Adejare, Drug Discovery for Neurodegenerative Disorders: Alzheimer’s Disease, Oct 2016, 208pp, $150.00

Clinicians, drug developers in industry and academia, and graduate students in behavioral neuroscience, neurobiology, translational neuroscience, clinical psychiatry, and pharmaceutical science