SUPPORT FOR REGULATORY EXPERTISE IN THE DEVELOPMENT OF LIVE BIOTHERAPEUTIC AGENTS

开发高效的艾滋病毒预防策略，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HIV感染估计超过3300万人，开发安全、有效和可接受的nBP产品来预防HIV的性传播，可以在全球范围内减少每天约5000例新的HIV感染方面发挥重要作用。随着有前途的nBP产品的出现（例如，杀微生物剂、暴露前预防（PrEP）药剂和多用途预防技术（MPT），迫切需要快速有效地将这些候选药物投入临床测试。工作范围包括临床前活动，从最初的产品发现到支持临床试验和/或产品许可所需的活动。 这项活动将为生物制剂开发的监管专业知识提供支持，并协助向美国食品药品监督管理局（FDA）提交申请。

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 activity will provide support for regulatory expertise in the development biotherapeutic agents and assist with filings with the U.S. Food and Drug Administration (FDA).