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 神经科学研究蓝图是由 8 个支持神经科学研究的 NIH 研究所和中心组成的联盟，建立了蓝图神经治疗网络 (BPN)，作为 NIH 资助的研究的典型终点和行业药物开发开始之间的管道。 BPN 为神经科学研究人员提供资金并让他们获得全方位的行业式药物开发服务和专业知识。该计划适用于需要药物化学优化和合同研究组织 (CRO) 通过 I 期临床试验支持的项目。每个项目均由首席开发团队 (LDT) 指导，该团队由首席研究员 (PI)、NIH 签约的行业顾问和 NIH 工作人员组成。该团队制定研究策略，包括里程碑，并监督 CRO 的实施。 NIH 拥有资深、行业经验丰富的药物发现和开发顾问，他们在药物化学、药物开发、化学制造和控制（CMC）、药物代谢和药代动力学（DMPK）、毒理学、生物测定开发、监管事务、医学写作等方面拥有专业知识和 I 期临床药理学，为 BPN 的药物发现和开发项目以及可能的其他 NIH 药物发现和开发计划和项目提供领导和技术指导。