NIH DRUG DEVELOPMENT CONSULTING SERVICES

美国国立卫生研究院药物开发咨询服务

• 批准号: 8429010
• 负责人: DONNA ROMERO
• 金额: $ 9.8万
• 依托单位: DONNA L ROMERO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-20 至 2013-06-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8429010
• 关键词: Address; Biological Assay; Biology; Consult; Contracts; Development; Development Plans; Disease; Funding; Future; Industry; Institutes; Lead; Leadership; Modeling; Neurosciences; Neurosciences Research; Peer Review; Pharmaceutical Preparations; Principal Investigator; Process; Research; Research Contracts; Research Personnel; Seasons; Services; Shapes; Therapeutic; United States National Institutes of Health; Work; design; drug development; experience; indexing; innovation; meetings; nervous system disorder; programs; virtual

In 2010, the NIH Blueprint for Neuroscience Research, representing sixteen NIH Institutes and Centers, announced a Grand Challenge for Neurotherapeutics to address the paucity of effective drugs for disorders of the nervous system. To meet this Grand Challenge, the NIH Blueprint is pioneering a new model for drug development¿a network that integrates industry drug development expertise with the innovative disease biology that is the strength of NIH-funded research. The Blueprint Neurotherapeutics Network will operate as a ¿virtual pharma¿ (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm). Neuroscience researchers (principal investigators) with a compelling therapeutic rationale and starting materials for a drug development project will be matched with senior-level, industry-seasoned consultants who will design and direct the drug development plan. The principal investigators will conduct the bioactivity assays and biological work, and Contracted Research Organizations (CROs), which will be identified and funded by NIH through separate contracts, will implement all other drug development activities. The principal investigator, consultants, NIH staff, and CRO staff engaged in a project will constitute a Lead Development Team (LDT).

2010 年，代表 16 个 NIH 研究所和中心的 NIH 神经科学研究蓝图宣布了一项神经治疗大挑战，以解决治疗神经系统疾病的有效药物的匮乏问题。为了迎接这一大挑战，NIH 蓝图正在开创一项新的挑战。药物开发模型¿一个将行业药物开发专业知识与创新疾病生物学相结合的网络，这是 NIH 资助的研究的优势，蓝图神经治疗网络将作为 ¿虚拟制药?? (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm) 拥有令人信服的治疗原理和药物开发项目起始材料的神经科学研究人员（主要研究人员）将与资深的、行业经验丰富的顾问相匹配。主要研究人员将设计和指导药物开发计划，并由 NIH 通过单独合同确定和资助的合同分析研究组织 (CRO) 将实施所有其他工作。参与项目的主要研究者、顾问、NIH 工作人员和 CRO 工作人员将组成先导开发团队 (LDT)。