The Long-Acting/Extended Release Antiretroviral Resource Program (LEAP)

长效/缓释抗逆转录病毒研究资源计划(LEAP)提供了广泛的基础 为加快新药、制剂和技术的开发提供科学支持 艾滋病毒及相关流行病的治疗和预防。促进药物和制剂的LEAP过程 开发从环境分析开始，找出知识差距和障碍，模拟最佳 产品特征，沟通潜在的解决方案，然后跟踪产品结果。该计划 作为关于LA/ER配方开发的全球对话的联络人，并带来了 世界上许多关键的利益相关者都加入了这场对话。Leap的开创性成就包括 为FDA关于开发艾滋病毒LA/ER配方的指导草案提供基本意见；促进 开发用于结核病和疟疾的第一个候选LA/ER配方；组织第一个 关于在儿童、青少年和孕妇中使用艾滋病毒的LA/ER配方的会议；制作 第一个公开可访问的网站，专门介绍LA/ER抗感染产品和策略；以及支持 通过建模和仿真开发抗HIV植入物和微针等新型设备 核心。Leap成立于2015年，现在准备将其获得的专业知识应用于新的挑战。在.期间 未来五年，我们将利用我们创建的基础设施：1)将我们的科学资源应用于 确定和促进最有前景的新药和药物输送平台的开发，以便 克服现有产品的限制；2)以我们现有的建模和仿真专业知识为基础 开发更好的方法来更快地识别那些具有最理想药理作用的方法 属性；以及3)扩大LEAP的范围，以包括与艾滋病毒流行重叠的疾病，其中 LA/ER药物和制剂的可获得性可能对治疗和预防产生最深远的影响。 具体地说，结核病、乙肝病毒和丙型肝炎病毒感染。预期结果包括 在临床前和临床开发中增加长效新药和制剂的数量，增强 资金机制，使更多的此类产品进入测试，并加快实现更快的途径 将基于实验室的研究转化为临床试验和最终的药物批准。

The Long-Acting/Extended Release Antiretroviral Research Resource Program (LEAP) provides broadly based scientific support to accelerate the development of novel drugs, formulations, and technologies for the treatment and prevention of HIV and related epidemics. The LEAP Process to facilitate drug and formulation development begins with a landscape analysis, identifying knowledge gaps and barriers, simulating best product characteristics, communicating potential solutions, and then tracking product outcomes. The Program serves as a focal point for the global conversation on the development of LA/ER formulations, and has brought many of the world's key stakeholders into this conversation. LEAP's seminal accomplishments include foundational input for FDA draft guidance on the development of LA/ER formulations for HIV; promoting development of the first candidate LA/ER formulations for tuberculosis and malaria; organizing the first conference on use of LA/ER formulations for HIV in children, adolescents, and pregnant women; producing the first publically accessible website devoted to LA/ER anti-infective products and strategies; and supporting development of novel devices like anti-HIV implants and microneedles through its Modeling and Simulation Core. Established in 2015, LEAP is now poised to apply its acquired expertise to new challenges. During the next five years, we will leverage the infrastructure we have created to: 1) apply our scientific resources to identify and facilitate development of the most promising new drugs and drug delivery platforms in order to overcome the limitations of available products; 2) build upon our existing modeling and simulation expertise to develop better ways to more rapidly identify those approaches with the most desirable pharmacologic properties; and 3) expand the scope of LEAP to include diseases that overlap the HIV epidemic, where the availability of LA/ER drugs and formulations could most profoundly affect treatment and prevention – specifically, tuberculosis, hepatitis B virus, and hepatitis C virus infections. Expected outcomes include an increased number of new long-acting drugs and formulations in preclinical and clinical development, enhanced funding mechanisms to bring more such products into testing, and accelerated pathways for more rapid translation of laboratory-based research into clinical trials and eventual drug approvals.