Title Improving and Accelerating Therapeutic Development for Nervous System Disorders : Workshop Summary

Published Washington : National Academies Press, 2014

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Description 1 online resource (119 pages) Contents FrontMatter -- 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 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 Bibliography Includes bibliographical references Notes English Print version record Subject Drug development -- Research Neuropharmacology -- Testing Drugs -- Research. Clinical trials. Neurosciences. Pharmaceutical chemistry. Chemotherapy. Diseases. Therapeutics. Chemistry. Pharmacology. Physical sciences. Public health. Life sciences. Medical care. Nervous system -- Diseases. Chemistry, Pharmaceutical Epidemiologic Study Characteristics as Topic Investigative Techniques Drug Therapy Disease Evaluation Studies as Topic Therapeutics Epidemiologic Methods Health Care Evaluation Mechanisms Chemistry Pharmacology Analytical, Diagnostic and Therapeutic Techniques and Equipment Natural Science Disciplines Public Health Biological Science Disciplines Quality of Health Care Health Care Quality, Access, and Evaluation Disciplines and Occupations Environment and Public Health Delivery of Health Care Models, Animal Clinical Trials as Topic Drug Delivery Systems Nervous System Diseases Drug Discovery Neurosciences Patient Care illness. disease. chemistry. pharmacology. physical sciences. public health. biological sciences. treating (health care function) Therapeutics Public health Physical sciences Pharmacology Pharmaceutical chemistry Nervous system -- Diseases Medical care Life sciences Diseases Chemotherapy Chemistry Clinical trials Drugs -- Research Neurosciences Form Electronic book Author Policy, Board on Health Sciences Disorders, Forum on Neuroscience and Nervous System ISBN 9780309292474 0309292476 0309292468 9780309292467

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