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Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders - Proceedings of a Workshop (Paperback)
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Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders - Proceedings of a Workshop (Paperback)
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Compared with other disease areas, central nervous system (CNS)
disorders have had the highest failure rate for new compounds in
advanced clinical trials. Most CNS drugs fail because of efficacy,
and the core issue underlying these problems is a poor
understanding of disease biology. Concern about the poor
productivity in neuroscience drug development has gained intensity
over the past decade, amplified by a retraction in investment from
the pharmaceutical industry. This retreat by industry has been
fueled by the high failure rate of compounds in advanced clinical
trials for nervous system disorders. In response to the de-emphasis
of CNS disorders in therapeutic development relative to other
disease areas such as cancer, metabolism, and autoimmunity, the
National Academies of Sciences, Engineering, and Medicine initiated
a series of workshops in 2012 to address the challenges that have
slowed drug development for nervous system disorders. Motivated by
the notion that advances in genetics and other new technologies are
beginning to bring forth new molecular targets and identify new
biomarkers, the Academies hosted the third workshop in this series
in September 2016. Participants discussed opportunities to
accelerate early stages of drug development for nervous system
disorders in the absence of animal models that reflect disease and
predict efficacy. This publication summarizes the presentations and
discussions from the workshop. Table of Contents Front Matter 1
Introduction and Overview 2 Drug Development for Nervous System
Disorders: Overview of Challenges and Potential Opportunities 3
Case Studies: Therapeutic Development for Parkinson's Disease and
Schizophrenia in the Absence of Predictive Animal Models of Disease
4 New Modeling Approaches for Nervous System Disorders 5
Private-Sector Thresholds for Investment in Neuroscience Clinical
Trials 6 Ethical Considerations 7 Regulatory Perspectives Appendix
A: References Appendix B: Workshop Agenda Appendix C: Registered
Attendees
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