NEW ASSAY DEVELOPMENT

新检测方法开发

• 批准号: 9543648
• 负责人: ROGER PTAK
• 金额: $ 14.68万
• 依托单位: SOUTHERN RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9543648
• 关键词: Academia; Biochemical; Biological Assay; Cells; Contracts; Data; Development; Funding; HIV; Intervention; Investigational New Drug Application; Local Microbicides; National Institute of Allergy and Infectious Disease; Private Sector; Public Health; Research Personnel; Services; Source; Therapeutic; Validation; assay development; base; high throughput screening; novel therapeutics; phase I trial; preclinical development; product development; prospective; public health priorities; service utilization

The development and introduction of new therapeutics and topical microbicides against HIV remains a high public health priority. To assist in filling these public health gaps, the NIAID supports preclinical development of promising therapeutic and topical microbicide candidates that emerge from academia, the private sector, or other sources. This contract provides product development services utilizing biochemical and cell-based assays in both standard and high throughput screening (HTS) formats. The services provided under this contract will assist a wide variety of investigators in obtaining critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I trials), and fulfill regulatory agency requirements for investigational new drug (IND) applications. Assay development and validation will be conducted in order to identify and evaluate the efficacy of anti-HIV therapeutics and topical microbicides. The primary activity is for the development and validation of cell-based assays as potential interventional agents including therapeutics and topical microbicides.

开发和引入针对艾滋病毒的新疗法和局部杀菌剂仍然是公共卫生的高度优先事项。为了帮助填补这些公共卫生空白，NIAID 支持来自学术界、私营部门或其他来源的有前景的治疗性和局部杀菌剂候选药物的临床前开发。该合同以标准和高通量筛选 (HTS) 形式提供利用生化和细胞检测的产品开发服务。根据该合同提供的服务将协助各类研究人员获得获得额外资金所需的关键数据、获得潜在的合作伙伴关系（用于进一步开发或支持第一阶段试验），并满足监管机构对研究性新药（IND）的要求。 ）应用程序。将进行检测开发和验证，以识别和评估抗艾滋病毒疗法和局部杀菌剂的功效。 主要活动是开发和验证基于细胞的检测作为潜在的介入药物，包括治疗剂和局部杀菌剂。