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

Project Summary The Long-Acting/Extended-Release Antiretroviral Research Resource Program (LEAP) supports academic, pharmaceutical, and community-based partners in order to accelerate the development of novel drugs, formulations, and technologies for the treatment and prevention of HIV, tuberculosis, and viral hepatitis. Through meetings, workshops, consultations, and publications, LEAP has identified barriers and knowledge gaps that stand in the way of developing a wider array of LA/ER products for these diseases. The Program's existing core services include 1) a Communications Core providing open access, web-based, tracking of the latest scientific advances and regulatory status of products in development, and 2) a Modeling and Simulation Core that uses cutting edge technologies to identify the most promising candidates and dosing predictions for drugs used in different clinical settings. LEAP’s seminal accomplishments include foundational input for regulatory guidance on LA/ER formulations for HIV; promoting development of the first candidate LA/ER formulations for tuberculosis and viral hepatitis; developing recommendations for using LA/ER formulations in infants, children, adolescents, and pregnant women; assisting first-in-human studies of novel nano- formulations for HIV; and supporting development of novel devices like anti-HIV implants and microneedles. During the next five years, we will expand our existing infrastructure based on stakeholder feedback to develop two additional core services: 3) a User Preferences Core to enlist biobehavioral expertise and provide community input into human-centered LA/ER product design; and 4) a Translation Accelerator Program to provide specialized expert advice that is product-specific for projects at earlier stages of development. Expected outcomes include an increased number of new LA/ER medicines in preclinical and clinical development, enhanced funding mechanisms to catalyze continued development of LA/ER products, greater access to these life-saving technologies for children, adolescents, and pregnant women including those in low- and middle-income countries, and accelerated pathways for more rapid translation of laboratory-based research into clinical testing and eventual regulatory approval with global implementation.