Scientific and Quality/Regulatory Support Services: Data Integrity Consultation

科学和质量/监管支持服务：数据完整性咨询

• 批准号: 10244791
• 负责人: MARIA FERRARI
• 金额: $ 6.17万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10244791
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Clinical Trials; Consultations; Development; HIV Infections; Licensure; National Institute of Allergy and Infectious Disease; Pharmacologic Substance; Play; Prevention; Prevention strategy; Preventive vaccine; Resources; Role; Services; Technology; United States National Institutes of Health; Work; anti-HIV microbicide; data integrity; microbicide; pre-clinical; pre-exposure prophylaxis; prevent; research clinical testing; sexual HIV transmission

Comprehensive Resources for HIV Microbicides and Biomedical Prevention: The development of highly effective HIV prevention strategies, including a preventive vaccine and other non-vaccine biomedical prevention (nBP) products, remains one of the highest priorities for the Division of AIDS (DAIDS) and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). With current global HIV infection estimates exceeding 33 million people, the development of safe, effective, and acceptable nBP products to prevent the sexual transmission of HIV could play a major role in the worldwide reduction of the estimated 5000 new HIV infections per day. As promising nBP products emerge (e.g., microbicides, pre-exposure prophylaxis (PrEP) agents, and Multipurpose Prevention Technologies (MPT’s), there is a critical need to rapidly and efficiently move these candidates into clinical testing. The scope of work encompasses preclinical activities that range from initial product discovery to those required to support clinical trials and/or product licensure.

HIV 杀菌剂和生物医学预防的综合资源：开发高效的 HIV 预防策略，包括预防性疫苗和其他非疫苗生物医学预防 (nBP) 产品，仍然是美国国立卫生研究院 (NIH) 艾滋病司 (DAIDS) 和国家过敏和传染病研究所 (NIAID) 的最高优先事项之一。目前全球艾滋病毒感染人数估计超过 3300 万人，开发安全、有效和可接受的 nBP 产品来预防艾滋病毒性传播可能会在全球范围内每天减少估计 5000 例新增艾滋病毒感染方面发挥重要作用。随着有前途的 nBP 产品（例如杀微生物剂、暴露前预防 (PrEP) 剂和多用途预防技术 (MPT)）的出现，迫切需要快速有效地将这些候选产品投入临床测试。工作范围涵盖从初始产品发现到支持临床试验和/或产品许可所需的临床前活动。