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The Long-Acting\/Extended Release Antiretroviral Research Resource Program (LEAP) was founded in 2015 with the support of the National Institutes of Health to encourage, promote, and accelerate the development of such products. Assessment methodology for any new proposal brought to this group is part of a framework\u2014the LEAP Process\u2014that includes a landscape analysis of what is currently available in the public domain. This is followed by in silico modeling and simulation offered as a service to the relevant scientific community. A variety of preclinical and clinical outcome metrics are applied to each new agent as part of a continuous feedback loop to improve product characteristics. This allows us to catalog knowledge gaps and barriers that can be addressed by engaged stakeholders. Results are communicated in scientific articles, reviews, and position papers. This undertaking serves to de-risk discovery, development, and implementation by bridging the gaps between academic, regulatory, and industrial investigators, and by engaging those in the community who will be the eventual users of these medicines. The LEAP Process has supported formulations now approved for human immunodeficiency virus, as well as products in clinical and preclinical development for tuberculosis and hepatitis viruses B and C.<\/jats:p>","DOI":"10.1093\/cid\/ciac750","type":"journal-article","created":{"date-parts":[[2022,11,21]],"date-time":"2022-11-21T21:43:49Z","timestamp":1669067029000},"page":"S502-S509","source":"Crossref","is-referenced-by-count":5,"title":["The LEAP Process: Streamlining the Development of Long-Acting Products and Formulations for Infectious Diseases"],"prefix":"10.1093","volume":"75","author":[{"given":"Charles","family":"Flexner","sequence":"first","affiliation":[{"name":"Divisions of Clinical Pharmacology and Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Johns Hopkins University , Baltimore, Maryland , USA"},{"name":"Department of Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, Johns Hopkins University , 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