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

长效/缓释抗逆转录病毒资源计划 (LEAP)

• 批准号: 10431973
• 负责人: Charles W. Flexner
• 金额: $ 68.75万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-16 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10431973
• 关键词: AIDS prevention; Affect; Anti-Infective Agents; Anti-Retroviral Agents; Area; Award; Benchmarking; Capsid; Characteristics; Chemicals; Child; Clinical Trials; Communities; Consultations; Development; Devices; Disease; Dose; Drug Approval; Drug Combinations; Drug Delivery Systems; Drug Exposure; Drug Formulations; Drug Interactions; Drug Screening; Drug Targeting; Drug resistance; Ensure; Epidemic; Failure; Formulation; Foundations; Funding Mechanisms; Future; HIV; HIV/TB; Hepatitis B Virus; Hepatitis C; Hepatitis C virus; Human; Hydrogels; Implant; In Vitro; Infection; Infection prevention; Infrastructure; Injectable; Intramuscular Injections; Knowledge; Laboratories; Malaria; Modeling; Monoclonal Antibodies; Monoclonal Antibody R24; National Institute of Allergy and Infectious Disease; Oral; Outcome; Pathway interactions; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Phase; Physiological; Pregnant Women; Prevention; Process; Property; Regimen; Research; Resource-limited setting; Resources; Risk; Seminal; Services; Technology; Testing; Time; Toxic effect; Toxicology; Translations; Tuberculosis; Viral; Viral hepatitis; Vulnerable Populations; Work; animal data; base; biodegradable polymer; clinical development; drug development; improved; in silico; inhibitor; models and simulation; new technology; next generation; novel; novel strategies; novel therapeutics; open source; pharmacokinetic model; pill; preclinical development; predictive modeling; prevent; product development; programs; symposium; trait; web site; working group; young woman

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.

长效/扩展释放抗逆转录病毒研究资源计划（LEAP）提供了广泛的基础 科学支持以加速新的药物，配方和技术的发展 艾滋病毒和相关发作的治疗和预防。促进药物和配方的飞跃过程 发展始于景观分析，确定知识差距和障碍，模拟最佳 产品特征，传达潜在解决方案，然后跟踪产品结果。该程序 是有关LA/ER公式发展的全球对话的焦点，并带来了 世界上许多关键的利益相关者参与了这次对话。 Leap的半副标题包括 FDA开发艾滋病毒公式的基础投入；促进 开发第一个用于结核和疟疾的候选公式；组织第一个 关于在儿童，青少年和孕妇中使用LA/ER公式的艾滋病毒的大会；产生 首先专门访问抗感染产品和策略的网站；和支持 通过其建模和仿真开发新型设备，例如抗HIV玻璃和微针 核。 LEAP成立于2015年，现在被毒死，将其获得的专业知识应用于新的挑战。在 接下来的五年，我们将利用我们创建的基础设施来：1）将我们的科学资源应用于 确定并促进开发最有希望的新药和药物输送平台，以便 克服可用产品的局限性； 2）以我们现有的建模和模拟专业知识为基础 开发更好的方法来更快地识别具有最理想的药理学的方法 特性; 3）扩大飞跃的范围，包括与艾滋病毒流行重叠的疾病，其中 LA/ER药物和配方的可用性可能最深刻地影响治疗和预防 - 预期的结果包括 临床前和临床发育中新的长效药物和配方的数量增加，增强了 将更多此类产品带入测试的资金机制，并加速途径，以更快地 将基于实验室的研究转换为临床试验和最终药物批准。