Translational Medicine in CNS Drug Development - 1st Edition - ISBN: 9780128031612

Translational Medicine in CNS Drug Development, Volume 29

1st Edition

Editors: George Nomikos Douglas Feltner
Hardcover ISBN: 9780128031612
Imprint: Academic Press
Published Date: 28th June 2019
Page Count: 592
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Table of Contents

1. Experimental medicine approaches in CNS drug development

Jeffrey Paul

2. Modeling and Simulation in the Translational Pharmacology of CNS Drugs

Peter Bonate and Elizabeth Cunera maria de Lange

3. Proof-of-mechanism and proof-of-principle trials in early clinical drug development: Applications of biomarkers and experimental medicine

Gerard Marek

4. Phase I Trials: From Traditional to Newer Approaches

Sheldon Prescorn and Matthew Macaluso

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?

Douglas Eric Feltner

6. Biomarker Opportunities to Enrich Clinical Trial Populations for Drug Development in Schizophrenia and Depression

Bruce Kinon

7. Applications of translational neuroimaging research in CNS drug development

Pat Cole and Steve Einstein

8. Assessments of neurotransmitter function by molecular imaging: A translational medicine approach for CNS drug development

Paul Cumming

9. Applications of neurochemical biomarkers in CNS drug development

Holly Soares

10. Applications of neurophysiological biomarkers in CNS drug

Gregory Light and Yash Joshi

11. Applications of pharmacogenetic and pharmacogenomic biomarkers in CNS drug development

Andreas Papassotiropoulos and Dominique De Quervain

12. Applications of clinical biomarkers in CNS drug development

Paul Maruff

13. Uses of Stable Isotope Labeling Kinetics in CNS Translational Medicine

Randall Bateman, Tim West, Kevin Yarasheski, Bruce Patterson, Brendan Lucey, John Cirrito, Sylvain Lehmann, Christophe Hirtz, Audrey Gabelle, Timothy Miller, Nicolas Barthelemy, Chihiro Sato, James Bollinger, Paul Kotzbauer and Katrina Paumier

14. Multiparameter PKPD Assessment to Quantify Target Engagement in CNS Translational Medicine

Joop van Gerven and Geert van Groeneveld

15. The Use of Small Exploratory POC Trials to Identify Indications for CNS Drugs

Nick DeMartinis

16. Lessons learned from public private partnerships and consortia: The ADNI paradigm

Enchi Liu

17. Regulatory perspectives on the use of biomarkers and personalized medicine in CNS drug development: The FDA viewpoint

Jogarao Gobburu and Mathangi Gopalakrishnan

18. Regulatory perspectives on the use of biomarkers and personalized medicine in CNS drug development: The EMA viewpoint

Eamon O’Loinsigh

19. Regulatory Qualification of Biomarkers: Learnings from Critical Path Institute

Diane Stephenson Jr. and Stephen Arneric

20. Uptake and utilization of biomarkers and personalized medicine by prescribers, payers and patients: Emerging trends

Susan DeSanti and David Wang

21. Digital health-based biomarkers for use in clinical drug development

Amir Kalali

22. Translational medicine strategies in drug development for neurocognitive disorders

John Edward Harrison and Suzanne Hendrix

23. Translational medicine strategies in drug development for neurodegenerative disorders

Beth Hoffman

24. Translational medicine strategies in drug development for neurodevelopmental disorders

Mustafa Sahin and Siddharth Srivastava

25. Translational medicine strategies in drug development for impulse control disorders

Emil Coccaro

26. Translational medicine strategies in drug development for affective disorders

Roger S. McIntyre

27. Translational medicine strategies in drug development for movement disorders

Aaron Ellenbogen

28. Translational medicine strategies in Alzheimer’s disease drug development

Veronika Logovisnky

29. Translational medicine strategies in schizophrenia drug development

Tom Macek

30. Translational medicine strategies in major depressive disorder drug development

Connie Sanchez and Corey Puryear

31. Experimental medicine approaches to drug development in anxiety disorders

David Stewart Baldwin and Abou-Aisha Ayman

32. Experimental medicine approaches to drug development in PTSD

Dan Joseph Stein

33. Translating Neurobiology into Practice in Tobacco, Alcohol, Drug, and Behavioral Addictions

Mark S. Gold and A. Benjamin Srivastava

34. Translational medicine strategies in neuropathic pain and chronic pain drug development

Smriti Iyengar and Märta Segerdahl Storck

35. Use of translational medicine approaches across neuropsychiatric indications: Are we there yet?

Douglas Eric Feltner and George Nomikos

36. Hypothesizing Major Depression as a Subset of Reward Deficiency Syndrome (RDS) linked to Polymorphic Reward Genes

Kenneth Blum

37. Translating nonclinical models of disease and drug action to the clinic

Brenda M. Geiger and Emmanuel Pothos

38. Heart Rate Variability as a Translational Biomarker for Emotional and Cognitive Deficits

Bart Ellenbroek


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 pharmcodynamic 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 issues, from neuropsychiatric disorders, to movement disorders
  • Includes chapters written by international experts from industry and academia


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


No. of pages:
© Academic Press 2019
Academic Press
Hardcover ISBN:

Ratings and Reviews

About the Editors

George Nomikos Editor

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

Affiliations and Expertise

Senior Medical Director, CNS Global Clinical Lead, Takeda Pharmaceuticals, Deerfield, IL, USA

Douglas Feltner Editor

Affiliations and Expertise

LLC, Novi, MI, USA