IGF::OT::IGF

IGF::OT::IGF

• 批准号: 9163233
• 负责人: DONNA ROMERO
• 金额: $ 1.95万
• 依托单位: DONNA L ROMERO
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-06-20 至 2016-06-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9163233
• 关键词: Biological Assay; Chemistry; Clinical Pharmacology; Contracts; Development; Drug Kinetics; Funding; Industry; Institutes; Lead; Leadership; Maps; Medical; Neurosciences; Neurosciences Research; Pharmaceutical Chemistry; Pharmacologic Substance; Phase; Phase I Clinical Trials; Principal Investigator; Regulatory Affairs; Research; Research Contracts; Research Personnel; Services; Toxicology; United States National Institutes of Health; Writing; drug development; drug discovery; drug metabolism; experience; programs

The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through phase I clinical trials. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants contracted by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. The NIH possesses senior-level, industry-experienced drug discovery and development consultants with expertise in medicinal chemistry, pharmaceutical development, chemistry manufacturing and controls (CMC), drug metabolism and pharmacokinetics (DMPK), toxicology, bioassay development, regulatory affairs, medical writing, and phase I clinical pharmacology to provide leadership and technical guidance on drug discovery and development projects in the BPN and possibly other NIH drug discovery and development programs and projects.

NIH神经科学研究的NIH蓝图是支持神经科学研究的8个NIH机构和中心的财团，建立了蓝图神经疗法网络（BPN），作为NIH资助的研究的典型终点与行业药物开发的开始之间的典型终点。 BPN为神经科学研究人员提供了资金，并获得了各种行业风格的药物开发服务和专业知识。该计划旨在通过I期临床试验进行药物化学优化和合同研究组织（CRO）支持的项目。每个项目都是由由首席研究员（PI），NIH签约的行业顾问和NIH员工组成的领先开发团队（LDT）指导的。该团队绘制了包括里程碑在内的研究策略，并监督CRO的实施。 NIH拥有高级，行业经验的药物发现和开发顾问，在药物化学，药物开发，化学制造和控制方面具有专业知识，（CMC），药物代谢和药代动力学（DMPK）（DMPK），毒理学，生物测定事务，医学培训和技术指南，医学和技术指南，医学，医学和技术指南，以及临床研究，以及临床研究指南，以及阶段INDICENT，医学和技术指南其他NIH药物发现与开发计划和项目。