NINDS BPN MEDICAL WRITING CONSULTANT IGF::CL::IGF

NINDS BPN 医学写作顾问 IGF::CL::IGF

• 批准号: 9915614
• 负责人: KAREN HANSEN
• 金额: $ 6.99万
• 依托单位: CCS ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-14 至 2019-09-13
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9915614
• 关键词: Biological Assay; Chemistry; Clinical Pharmacology; Contracts; Development; Drug Industry; Drug Kinetics; Funding; Industry; Institutes; Lead; Leadership; Maps; Medical; National Institute of Neurological Disorders and Stroke; Neurosciences; Neurosciences Research; Pharmaceutical Chemistry; Pharmacologic Substance; Phase; Phase I Clinical Trials; Principal Investigator; Program Development; 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.

美国国立卫生研究院神经科学研究蓝图是一个由8个支持神经科学研究的美国国立卫生研究院研究所和中心组成的联盟，它建立了蓝图神经治疗网络（BPN），作为连接美国国立卫生研究院资助研究的典型终点和工业药物开发起点的管道。BPN为神经科学研究人员提供资金，并提供全面的行业式药物开发服务和专业知识。该计划旨在为通过I期临床试验需要药物化学优化和合同研究组织（CRO）支持的项目提供支持。每个项目由首席研究员（PI）、NIH签约的行业顾问和NIH工作人员组成的领导开发团队（LDT）指导。该团队制定研究策略，包括里程碑，并监督cro的实施。NIH拥有在药物化学、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、法规事务、医学写作、以及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药物发现和开发项目提供领导和技术指导。