Translational Medicine in CNS Drug Development

Translational Medicine in CNS Drug Development

1st Edition - June 18, 2019

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  • Editors: George Nomikos, Douglas Feltner
  • eBook ISBN: 9780128031643
  • Hardcover ISBN: 9780128031612

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Description

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

Readership

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

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. Arnerić
    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

Product details

  • No. of pages: 458
  • Language: English
  • Copyright: © Academic Press 2019
  • Published: June 18, 2019
  • Imprint: Academic Press
  • eBook ISBN: 9780128031643
  • Hardcover ISBN: 9780128031612

About the Editors

George Nomikos

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.

Affiliations and Expertise

Global Medical Lead, Clinical Development, Biogen, Cambridge, MA, USA

Douglas Feltner

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.

Affiliations and Expertise

Vice President, Head of Clinical Development, at AveXis, a Novartis company.

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