NEW ASSAY DEVELOPMENT

新检测方法开发

基本信息

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
项目类别：
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

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

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项目摘要

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.

针对艾滋病毒的新疗法和局部杀菌剂的开发和引入仍然是高公共卫生的重中之重。为了帮助填补这些公共卫生差距，NIAID支持从学术界，私营部门或其他来源出现的有前途的治疗和局部菌心候选者的临床前开发。该合同提供了使用标准和高吞吐量筛选（HTS）格式的生化和基于细胞的测定的产品开发服务。根据本合同提供的服务将有助于各种各样的调查人员获得获得额外资金，获得潜在合作伙伴关系（用于进一步开发或支持I期试验）所需的关键数据，并满足调查公司新药（IND）应用的监管机构要求。将进行测定开发和验证，以识别和评估抗HIV治疗剂和局部杀菌剂的功效。主要活性是为了开发和验证基于细胞的测定，作为包括治疗剂和局部杀菌剂在内的潜在介入剂。