MGT SVCS/CONTRACT & PROCUREMENT SUP

MGT SVCS/合同

• 批准号: 8739910
• 负责人: ROSE HOOD
• 金额: $ 83.19万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-10 至 2014-04-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8739910
• 关键词: Acute; Address; Biological; Biological Assay; Chemicals; Clinical; Communities; Contract Services; Contracts; Cytochrome P450; Development; Dose; Drug Kinetics; Evaluation; Goals; Hepatotoxicity; In Vitro; Industry; Investigational Drugs; Investigational New Drug Application; Lead; Liquid substance; Metabolic; Neurosciences; Neurosciences Research; Permeability; Pharmaceutical Chemistry; Pharmaceutical Preparations; Pharmacology and Toxicology; Phase; Phase I Clinical Trials; Plasma Proteins; Protein Binding; Provider; Research Infrastructure; Research Personnel; Rodent; Route; Services; Solutions; Support Contracts; Testing; Tissues; Toxic effect; United States National Institutes of Health; Validation; analytical method; drug development; effective therapy; experience; genotoxicity; in vivo; indexing; nervous system disorder; novel; pre-clinical; programs; research clinical testing; virtual

To address the paucity of effective treatments for disorders of the nervous system, the NIH has established the Blueprint Neurotherapeutics Network (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm). This program intends to develop drugs successfully through clinical Phase I and facilitate industry partnerships for their full development. The long-term goal of this grand challenge is to produce at least one novel and effective medication for a disorder of the nervous system that is currently poorly treated or untreated. The NIH Blueprint Neurotherapeutics Network is establishing a ¿virtual pharma¿ network of contract service providers and consultants with extensive industry experience to enable drug development in the NIH neuroscience research community. The Network offers neuroscience researchers access to a full range of industry-style drug development services and expertise, including medicinal chemistry, IND-enabling studies, and Phase 1 clinical trial infrastructure. The Pharmacology and Toxicology for Neurotherapeutics Program (PTNP) contracts support all preclinical pharmacology and toxicology testing needed to inform lead optimization and the selection of a clinical candidate, and comprehensive studies needed for an Investigational New Drug (IND) application for the FDA to allow for clinical evaluation of New Chemical Entities.

为了解决神经系统疾病缺乏有效治疗的问题，NIH建立了蓝图神经治疗网络（http：//neuroscienceblueprint.nih.gov/bpdrugs/index.htm）。该计划旨在通过临床I期成功开发药物，并促进行业合作伙伴关系，以促进其全面发展。这项重大挑战的长期目标是为目前治疗不力或未治疗的神经系统疾病生产至少一种新颖有效的药物。NIH Blueprint Neurotherapeutics Network正在建立一个虚拟制药网络，由具有丰富行业经验的合同服务提供商和顾问组成，以实现NIH神经科学研究社区的药物开发。该网络为神经科学研究人员提供全方位的行业风格药物开发服务和专业知识，包括药物化学，IND使能研究和1期临床试验基础设施。神经治疗学药理学和毒理学项目（PTNP）合同支持所有临床前药理学和毒理学测试，这些测试需要为电极导线优化和临床候选药物的选择提供信息，以及FDA研究性新药（IND）申请所需的综合研究，以允许对新化学实体进行临床评价。