Advancing the Development of Pediatric Drug Formulations: Planning and Implementation of a DAIDS-Industry Pediatric Formulation Partnership and Pediatric Drug Formulation Think Tank

推进儿科药物制剂的发展：DAIDS行业儿科制剂合作伙伴关系和儿科药物制剂智库的规划和实施

• 批准号: 10647608
• 负责人: PETER SILVERA
• 金额: $ 13.79万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10647608
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Advanced Development; Childhood; Clinical Trials; Development; Drug Formulations; Formulation; HIV; HIV Infections; Industry; Licensure; National Institute of Allergy and Infectious Disease; Persons; Play; Prevention; Prevention strategy; Preventive vaccine; Resources; Role; Technology; United States National Institutes of Health; Work; anti-HIV microbicide; meetings; microbicide; pediatric drug development; pre-clinical; pre-exposure prophylaxis; prevent; public-private partnership; 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. This project will support the planning and implementation of a DAIDS-Industry Pediatric Formulation Partnership and Pediatric Drug Formulation Think Tank.

HIV杀菌剂和生物医学预防的综合资源：发展高效的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，仍然是艾滋病（DAIDS）（daids）的最高优先事项之一（daids）和国家疾病研究所（Nationuial Diseases）（Niaiaide）（NIAIADITITITE）的最高优先事项之一。随着当前的全球艾滋病毒感染估计超过3,300万人，安全，有效且可接受的NBP产品以防止艾滋病毒的性传播的发展可能在世界上每天减少5000种新的HIV感染中发挥重要作用。随着有希望的NBP产品的出现（例如，微生物，暴露前预防（PREP）药物和预防预防技术（MPT），迫切需要快速有效地将这些候选者移动到临床测试中，从而将工作范围纳入临床活动。这些范围从最初的临床范围内进行了临床范围的临床范围，并支持临床范围或对临床培训进行试验或临床试验。实施妻子 - 行业配方伙伴关系和小儿药物配方智囊团的实施。