Improving and accelerating therapeutic development for nervous system disorders workshop summary / Forum on Neuroscience and Nervous System Disorders ; Board on Health Sciences Policy ; Sheena M. Posey Norris [and 3 others], Rapporteurs.

Author/creator Institute of Medicine (U.S.).
Other author Norris, Sheena M. Posey.
Format Electronic
Publication InfoWashington, D.C. : The National Academies Press, [2014]
Descriptionxi, 105 pages : illustrations (some color) ; 23 cm.
Supplemental ContentFull text available from Ebook Central - Academic Complete
Subjects
Drug development.
Neuropharmacology--Research.
Drugs--Testing.
Clinical trials.
Neurosciences--Research.

Abstract "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."-- Publisher's website.
Bibliography noteIncludes bibliographic references (pages 79-86).
Access restrictionAvailable only to authorized users.
Other formsAlso available via the World Wide Web.
Technical detailsMode of access: World Wide Web
Genre/formElectronic books.
LCCN 2014451411
ISBN9780309292467 (pbk.)
ISBN0309292468 (pbk.)

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