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Neuroscience Blueprint: Neurotherapeutics Grand Challenge

神经科学蓝图：神经治疗大挑战

基本信息

批准号：
8564645
负责人：
金额：
$ 9.12万
依托单位：
SRI INTERNATIONAL
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-13 至 2016-09-12
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8564645
关键词：
Address Award Basic Science Biological Biological Assay Biological Models Budgets Chemicals Clinical Communities Contract Services Development Disease Drug Formulations Drug Industry Drug Kinetics Funding Funding Opportunities Goals Hand Human Industry Institutes Institution Intellectual Property Laboratories Lead Nervous system structure Neurosciences Neurosciences Research Ownership Pharmaceutical Chemistry Pharmaceutical Preparations Phase Process Provider Research Research Contracts Research Infrastructure Research Institute Research Personnel Research Support Resources Structure Testing Toxicology U-Series Cooperative Agreements United States Food and Drug Administration United States National Institutes of Health Work analog cost drug development effective therapy experience improved meetings nervous system disorder novel pre-clinical programs research clinical testing response safety testing small molecule tool virtual

项目摘要

The NIH Blueprint for Neuroscience Research established the Grand Challenge for Neurotherapeutics in response to the paucity of effective treatments for disorders of the nervous system. 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 untreatable. Most promising compounds identified through basic research are not sufficiently drug-like for human testing. Before a new chemical entity can be tested in a clinical setting, it must undergo a process of chemical optimization to improve potency, activity and drug-likeness and pre-clinical safety testing to meet the standards set by the Food and Drug Administration (FDA) for clinical testing. These activities are largely the domain of the pharmaceutical industry and contract research organizations, and the necessary expertise and resources are not commonly available to basic researchers. To address this problem, the NIH Blueprint for Neuroscience Research 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. This Funding Opportunity Announcement (FOA) is soliciting applications for U01 cooperative agreement awards from investigators with small molecule compounds that have potential for development into clinical candidates within this network. This FOA and the Blueprint Neurotherapeutics ¿virtual pharma¿ network is an initiative of the NIH Blueprint for Neuroscience Research, which provides a framework for collaborative activities involving sixteen participating NIH Institutes, Centers, and Offices that support research on the nervous system (http://neuroscienceblueprint.nih.gov/blueprint_basics/about_blueprint.htm). By pooling resources and expertise, the NIH Blueprint for Neuroscience Research takes advantage of economies of scale, confronts challenges too large for any single Institute or Center, and develops research tools and infrastructure that serve the entire neuroscience community.

美国国立卫生研究院神经科学研究蓝图建立了神经治疗学的巨大挑战，以应对神经系统疾病缺乏有效治疗的情况。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无法治疗的神经系统疾病生产至少一种新颖有效的药物。通过基础研究发现的大多数有希望的化合物对于人体测试来说都不具有足够的药物样。在一个新的化学实体可以在临床环境中进行测试之前，它必须经过化学优化过程，以提高效力，活性和药物相似性，并进行临床前安全性测试，以满足美国食品药品监督管理局（FDA）为临床测试制定的标准。这些活动主要是制药业和合同研究组织的领域，基础研究人员通常无法获得必要的专门知识和资源。为了解决这个问题，NIH神经科学研究蓝图正在建立一个由具有丰富行业经验的合同服务提供商和顾问组成的虚拟制药网络，以实现NIH神经科学研究社区的药物开发。本资助机会公告（FOA）正在征求研究人员对U01合作协议奖励的申请，这些研究人员具有在该网络内开发成临床候选药物的潜力。这个FOA和Blueprint Neurotherapeutics虚拟制药网络是NIH神经科学研究蓝图的一个倡议，它为涉及16个参与NIH研究所、中心和办公室的支持神经系统研究的合作活动提供了一个框架（http：//neurosciencebluerprint.nih.gov/blueprint_basics/about_blueprint.htm）。通过汇集资源和专业知识，NIH神经科学研究蓝图利用规模经济，面对任何单一研究所或中心都无法应对的挑战，并开发服务于整个神经科学界的研究工具和基础设施。