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The Resource Improving and accelerating therapeutic development for nervous system disorders : workshop summary, Forum on Neuroscience and Nervous System Disorders ; Board on Health Sciences Policy ; Institute of Medicine ; Sheena M. Posey Norris, Diana E. Pankevich, Miriam Davis, Bruce M. Altevogt, rapporteurs, (electronic resource)

Improving and accelerating therapeutic development for nervous system disorders : workshop summary, Forum on Neuroscience and Nervous System Disorders ; Board on Health Sciences Policy ; Institute of Medicine ; Sheena M. Posey Norris, Diana E. Pankevich, Miriam Davis, Bruce M. Altevogt, rapporteurs, (electronic resource)

Label
Improving and accelerating therapeutic development for nervous system disorders : workshop summary
Title
Improving and accelerating therapeutic development for nervous system disorders
Title remainder
workshop summary
Statement of responsibility
Forum on Neuroscience and Nervous System Disorders ; Board on Health Sciences Policy ; Institute of Medicine ; Sheena M. Posey Norris, Diana E. Pankevich, Miriam Davis, Bruce M. Altevogt, rapporteurs
Creator
Contributor
Subject
Language
eng
Summary
  • Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials
  • Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials
  • Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials
  • "Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials."--
Assigning source
Publisher's website
Cataloging source
DNLM
http://library.link/vocab/creatorName
Norris, Sheena M. Posey
Funding information
This project was supported by contracts between the National Academy of Sciences and the Alzheimer's Association; CeNeRx Biopharma; the Department of Health and Human Services' National Institutes of Health (NIH, Contract No. HHSN26300026 [Under Master Base # DHHS-10001018]) through the National Eye Institute, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and NIH Blueprint for Neuroscience Research; Department of Veterans Affairs (101-D27015); Eli Lilly and Company; Fast Forward, LLC; Foundation for the National Institutes of Health; GE Healthcare, Inc. (2580261187); GlaxoSmithKline, Inc.; Johnson & Johnson Pharmaceutical Research and Development, LLC; Lundbeck Research USA; Merck Research Laboratories; The Michael J. Fox Foundation for Parkinson's Research; the National Science Foundation (Contract No. OIA-0753701); One Mind for Research; Pfizer Inc.; the Society for Neuroscience; and Wellcome Trust. The views presented in this publication are those of the editors and attributing authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
NLM call number
  • 2014 H-222
  • WL 140
http://library.link/vocab/relatedWorkOrContributorDate
  • 1975-
  • 2013
http://library.link/vocab/relatedWorkOrContributorName
  • Pankevich, Diana E.
  • Davis, Miriam
  • Altevogt, Bruce M
  • Institute of Medicine (U.S.)
  • Accelerating Therapeutic Development for Nervous System Disorders Toward First-in-Human Trials (Workshop)
http://library.link/vocab/subjectName
  • Nervous System Diseases
  • Clinical Trials as Topic
  • Drug Delivery Systems
  • Drug Discovery
  • Models, Animal
  • Translational Medical Research
  • United States
Label
Improving and accelerating therapeutic development for nervous system disorders : workshop summary, Forum on Neuroscience and Nervous System Disorders ; Board on Health Sciences Policy ; Institute of Medicine ; Sheena M. Posey Norris, Diana E. Pankevich, Miriam Davis, Bruce M. Altevogt, rapporteurs, (electronic resource)
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Publication
Note
Title from PDF title page
Bibliography note
Includes bibliographical references
Control code
OCM1bookssj0001191230
Dimensions
unknown
Isbn
9780309292467
Specific material designation
remote
System control number
(WaSeSS)bookssj0001191230
Label
Improving and accelerating therapeutic development for nervous system disorders : workshop summary, Forum on Neuroscience and Nervous System Disorders ; Board on Health Sciences Policy ; Institute of Medicine ; Sheena M. Posey Norris, Diana E. Pankevich, Miriam Davis, Bruce M. Altevogt, rapporteurs, (electronic resource)
Publication
Note
Title from PDF title page
Bibliography note
Includes bibliographical references
Control code
OCM1bookssj0001191230
Dimensions
unknown
Isbn
9780309292467
Specific material designation
remote
System control number
(WaSeSS)bookssj0001191230

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