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: 8356081
• 负责人: DONNA ROMERO
• 金额: $ 4万
• 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 2012-06-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356081
• 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机构和中心的NIH神经科学研究蓝图宣布了神经疗法学家的巨大挑战，即解决神经系统疾病的有效药物的匮乏。为了应对这一巨大的挑战，NIH蓝图正在开创一种用于药物开发的新模型。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资助的研究的实力。蓝图神经疗法网络将以虚拟药物为单位（http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm）。神经科学研究人员（主要研究人员）具有引人注目的治疗原理和药物开发项目的起始材料，将与高级，行业调查的顾问相匹配，他们将设计和指导药物开发计划。首席研究人员将进行生物活性评估和生物学工作，并签约研究组织（CRO）将通过NIH通过单独的合同来确定和资助，将实施所有其他药物开发活动。从事一个项目的主要调查员，顾问，NIH工作人员和CRO员工将构成领先开发团队（LDT）。