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Improving and accelerating therapeutic development for nervous system disorders workshop summary [electronic resource]
Norris, Sheena M. Posey
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| 자료유형 | E-BOOK |
|---|---|
| 서명/저자사항 | Improving and accelerating therapeutic development for nervous system disorders [electronic resource]: 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. |
| 개인저자 | Norris, Sheena M. Posey, Pankevich, Diana E.,1975-, Davis, Miriam(Medical writer), Altevogt, Bruce M, |
| 단체저자명 | Institute of Medicine (U.S.). Forum on Neuroscience and Nervous System Disorders,sponsoring body. |
| 발행사항 | Washington, D.C.: National Academies Press, [2014]. |
| 형태사항 | 1 online resource (1 PDF file (xi, 105 pages)): illustrations. |
| 기타형태 저록 | Print version: Institute of Medicine (U.S.). Forum on Neuroscience and Nervous System Disorders. Improving and accelerating therapeutic development for nervous system disorders. Washington, D.C. : National Academies Press, [2014] 0309292468 |
| ISBN | 9780309292467 0309292468 9780309292474 0309292476 |
| 일반주기 |
Title from PDF title page.
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| 서지주기 | Includes bibliographical references. |
| 내용주기 | Introduction and overview -- Drug development challenges -- Target identification -- Target validation -- Opportunities to improve and accelerate the drug development pipeline -- Perspectives on next steps. |
| 요약 | 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. |
| 기금정보주기 | 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. |
| 회의명 | Accelerating Therapeutic Development for Nervous System Disorders Toward First-in-Human Trials (Workshop) (2013 : Washington, D.C.) |
| 일반주제명 | Nervous System Diseases --drug therapy --United States --Congresses. Clinical Trials as Topic --United States --Congresses. Drug Delivery Systems --United States --Congresses. Drug Discovery --United States --Congresses. Models, Animal --United States --Congresses. Translational Medical Research --United States --Congresses. Nervous system --Diseases --Chemotherapy --Congresses. Drug development --Congresses. Drug approval --Congresses. Clinical trials --Congresses. Clinical trials. Drug approval. Drug development. Nervous system --Diseases --Chemotherapy. MEDICAL / Pharmacology |
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