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

Format:

Book

Author/Creator:

Institute of Medicine (U.S.) Forum on Neuroscience and Nervous System Disorders, Corporate Author.

Contributor:

Norris, Sheena M. Posey, speaker.

Institute of Medicine (U.S.)

Language:

English

Subjects (All):

Drug development--Congresses.

Drug development.

Drug approval--Congresses.

Drug approval.

Clinical trials--Congresses.

Clinical trials.

Physical Description:

1 online resource (119 p.)

Edition:

1st ed.

Place of Publication:

Washington, District of Columbia : National Academies Press, 2014.

Language Note:

English

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."-- Publisher's website.

Contents:

""Front Matter""; ""Reviewers""; ""Contents""; ""1 Introduction and Overview""; ""2 Drug Development Challenges""; ""3 Target Identification""; ""4 Target Validation""; ""5 Opportunities to Improve and Accelerate the Drug Development Pipeline""; ""6 Perspectives on Next Steps""; ""Appendix A: References""; ""Appendix B: Workshop Agenda""; ""Appendix C: Registered Attendees""

Notes:

Description based upon print version of record.

Includes bibliographical references.

Description based on online resource; title from PDF title page (ebrary, viewed May 4, 2014).

ISBN:

0-309-29249-2

0-309-29247-6

OCLC:

923289754