Pharmacology and Toxicology for Neurotherapeutics Program (PTNP)

神经治疗药理学和毒理学计划（PTNP）

• 批准号: 8340440
• 负责人: CAROL E GREEN
• 金额: $ 15.54万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-13 至 2012-09-12
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8340440
• 关键词: Accounting; Acute; Address; Award; Biochemistry; Biological; Biological Assay; Chemicals; Clinical; Communities; Consultations; Contract Services; Contractor; Contracts; Cytochrome P450; Data; Data Reporting; Databases; Dependence; Development; Dose; Drug Compounding; Drug Formulations; Drug Kinetics; Evaluation; Feedback; Goals; Hepatotoxicity; In Vitro; Industry; Information Systems; Institutes; Investigational Drugs; Investigational New Drug Application; Lead; Liquid substance; Metabolic; Nervous system structure; Neurosciences; Neurosciences Research; Participant; Permeability; Pharmaceutical Chemistry; Pharmaceutical Preparations; Pharmacology and Toxicology; Phase; Phase I Clinical Trials; Plasma Proteins; Process; Protein Binding; Protocols documentation; Provider; Research; Research Design; Research Infrastructure; Research Personnel; Research Support; Resources; Rodent; Route; Schedule; Services; Solutions; Suggestion; Testing; Tissues; Toxic effect; Training; United States National Institutes of Health; Validation; analytical method; base; design; drug development; effective therapy; experience; genotoxicity; in vitro activity; in vivo; indexing; nervous system disorder; novel; pre-clinical; programs; research clinical testing; small molecule; tool; user-friendly; virtual; web-accessible

To address the paucity of effective treatments for disorders of the nervous system, the NIH is establishing 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 untreatable. To address this problem, 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 goal of the Blueprint is to advance compounds successfully from chemical optimization through Phase 1 clinical testing. The Pharmacology and Toxicology for Neurotherapeutics Program (PTNP) contract award will 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. The NIH Blueprint Neurotherapeutics network is an initiative of the NIH Blueprint for Neuroscience Research, a collaborative framework of 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. The Blueprint Neurotherapeutics Network will include the following components: 1. Pharmacology and toxicology facilities (PTNPs). As detailed in this SOW, the PTNP Contractor(s) will provide all preclinical pharmacology and toxicology testing needed to inform lead optimization and the selection of a clinical candidate, and testing required for an Investigational New Drug (IND) application for the FDA to support clinical evaluation of the compound. 2. Contractors for all other aspects of the drug development process, including medicinal chemistry, GMP manufacture, formulation, regulatory consultancy and IND preparation, and Phase 1 clinical trials. 3. Neuroscience researchers (Contributors) with bioactive small molecule compounds and bioactivity assays. The Contributors¿ compounds will serve as starting points for optimization and development within the Blueprint Neurotherapeutics network. 4. NIH staff. The NIH Contracting Officer (CO) and Contracting Officer Technical Representative (COTR) will oversee the PTNP contract. The COTR will offer suggestions and provide feedback to the Contractor on preclinical development strategies and protocol design, in consultation with the Contributors and NIH-hired consultants (see below). 5. Drug development consultants. The NIH will hire expert consultants to assist the COTR in reviewing proposals, reports, and data produced by the network Contractors and contributors. 6. Information Technology (IT) system. The NIH will establish a database and user-friendly, web-accessible interface for entering, searching, downloading, and visualizing development project data. At the direction of NIH, the PTNP Contractor(s) will be responsible for entering the data that they generate into this database. All network participants will receive training on how to use the IT system and technical support.

为了解决神经系统疾病有效治疗的缺乏，NIH正在建立蓝图神经疗法网络（http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm）。该计划旨在通过I期临床成功开发药物，并促进行业伙伴关系的全面发展。这一巨大挑战的长期目标是为神经系统的疾病至少生产一种新型且有效的药物，该疾病目前接受治疗不佳或无法治疗。 为了解决这个问题，NIH蓝图神经疗法网络正在建立一个具有丰富行业经验的合同服务提供商和顾问的虚拟制药网络，以使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了各种行业风格的药物开发服务和专业知识的访问，包括医学化学，辅助研究和第一阶段临床试验基础设施。蓝图的目的是从化学优化到1阶段临床测试成功推进化合物。神经疗法计划的药理学和毒理学（PTNP）合同奖将支持所有临床前药理学和毒理学测试，以告知铅优化和选择临床候选者，以及用于FDA的研究新药（IND）所需的全面研究，以允许对新化学实体进行临床评估。 NIH蓝图神经疗法网络是NIH NIH蓝图的倡议，这是NIH机构，中心和办公室的协作框架，该框架支持神经系统研究（http://neuroscienceblueprint.nih.nih.gblueprint_basiprint_basics/abasics/abbasics/abbasics/abbasics/abbasout_bluicprrint-basout_bluicprrint-basoprint_bluicprrint.hhttp：http://neuroscienceblueprint.nih.nih.nih.nih.nih.nih.nih.nih.nih.nih.nih blueprint。通过汇集资源和专业知识，NIH神经科学研究的蓝图利用规模经济，面对任何单一研究所或中心的挑战，并开发了为整个神经科学社区服务的研究工具和基础设施。 蓝图神经疗法网络将包括以下组件： 1。药理学和毒理学设施（PTNP）。如本母猪所详细介绍的那样，PTNP承包商将提供所有临床前药理学和毒理学测试，以告知铅优化和选择临床候选者，以及研究新药（IND）申请FDA所需的测试，以支持该化合物的临床评估。 2。药物开发过程所有其他方面的承包商，包括药物化学，GMP制造，配方，调节方便和IND制备以及1阶段临床试验。 3。具有生物活性小分子化合物和生物活性测定的神经科学研究人员（贡献者）。贡献者将作为蓝图神经疗法网络中优化和开发的起点。 4。NIH员工。 NIH承包官（CO）和承包官技术代表（COTR）将监督PTNP合同。 COTR将在与贡献者和NIH雇用的顾问协商时向承包商提供建议，并向承包商提供有关临床前开发策略和协议设计的反馈（见下文）。 5。药物开发顾问。 NIH将聘请专家顾问来协助COTR审查网络承包商和贡献者产生的建议，报告和数据。 6。信息技术（IT）系统。 NIH将建立一个数据库和用户友好，可访问的界面，用于输入，搜索，下载和可视化开发项目数据。在NIH的方向上，PTNP承包商将负责输入它们在此数据库中生成的数据。所有网络参与者将接受有关如何使用IT系统和技术支持的培训。