{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T06:26:10Z","timestamp":1792045570597,"version":"4.4.0"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"3","funder":[{"DOI":"10.13039\/100000038","name":"US Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,8,14]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Pressing challenges in the treatment of invasive fungal infections (IFIs) include emerging and rare pathogens, resistant\/refractory infections, and antifungal armamentarium limited by toxicity, drug-drug interactions, and lack of oral formulations. Development of new antifungal drugs is hampered by the limitations of the available diagnostics, clinical trial endpoints, prolonged trial duration, difficulties in patient recruitment, including subpopulations (eg, pediatrics), and heterogeneity of the IFIs. On 4 August 2020, the US Food and Drug Administration convened a workshop that included IFI experts from academia, industry, and other government agencies to discuss the IFI landscape, unmet need, and potential strategies to facilitate the development of antifungal drugs for treatment and prophylaxis. This article summarizes the key topics presented and discussed during the workshop, such as incentives and research support for drug developers, nonclinical development, clinical trial design challenges, lessons learned from industry, and potential collaborations to facilitate antifungal drug development.<\/jats:p>","DOI":"10.1093\/cid\/ciad195","type":"journal-article","created":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T09:51:52Z","timestamp":1680774712000},"page":"380-387","source":"Crossref","is-referenced-by-count":10,"title":["Food and Drug Administration Public Workshop Summary\u2014Development Considerations of Antifungal Drugs to Address Unmet Medical Need"],"prefix":"10.1093","volume":"77","author":[{"given":"Yuliya","family":"Yasinskaya","sequence":"first","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shukal","family":"Bala","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4517-6790","authenticated-orcid":false,"given":"Ursula","family":"Waack","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl","family":"Dixon","sequence":"additional","affiliation":[{"name":"Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Higgins","sequence":"additional","affiliation":[{"name":"Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason N","family":"Moore","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline J","family":"Jjingo","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"O'Shaughnessy","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Colangelo","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Radu","family":"Botgros","sequence":"additional","affiliation":[{"name":"Health Threats and Vaccines Strategy, European Medicines Agency , Amsterdam , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumathi","family":"Nambiar","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Angulo","sequence":"additional","affiliation":[{"name":"Scynexis , Jersey City, New Jersey , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron","family":"Dane","sequence":"additional","affiliation":[{"name":"DaneStat Consulting , Macclesfield , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Chiller","sequence":"additional","affiliation":[{"name":"Mycotic Diseases Branch, Centers for Disease Control and Prevention , Atlanta, Georgia , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael R","family":"Hodges","sequence":"additional","affiliation":[{"name":"RNA Medicines , San Diego, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taylor","family":"Sandison","sequence":"additional","affiliation":[{"name":"Cidara Therapeutics , San Diego, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Hope","sequence":"additional","affiliation":[{"name":"Centre for Excellence in Infectious Diseases Research, Department of Molecular and Clinical Pharmacology, University of Liverpool , Liverpool , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas J","family":"Walsh","sequence":"additional","affiliation":[{"name":"Transplantation-Oncology Infectious Diseases Program, Weill Cornell Medicine , New York, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Pappas","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, University of Alabama at Birmingham , Birmingham, Alabama , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aspasia","family":"Katragkou","sequence":"additional","affiliation":[{"name":"Transplantation-Oncology Infectious Disease Program, Weill Cornell Medicine , New York, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Kovanda","sequence":"additional","affiliation":[{"name":"Astellas Pharma Global Development , Northbrook, Illinois , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John H","family":"Rex","sequence":"additional","affiliation":[{"name":"F2G , Manchester , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kieren A","family":"Marr","sequence":"additional","affiliation":[{"name":"Department of Medicine, Johns Hopkins University , Baltimore, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4784-7589","authenticated-orcid":false,"given":"Luis","family":"Ostrosky-Zeichner","sequence":"additional","affiliation":[{"name":"Director of the Laboratory of Mycology Research, McGovern Medical School , Houston, Texas , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shohko","family":"Sekine","sequence":"additional","affiliation":[{"name":"Pharmaceuticals and Medical Devices Agency , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Deshpande","sequence":"additional","affiliation":[{"name":"DRT Strategies , Arlington, Virginia , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunita J","family":"Shukla","sequence":"additional","affiliation":[{"name":"Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Farley","sequence":"additional","affiliation":[{"name":"Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,4,6]]},"reference":[{"key":"2023081421081427000_ciad195-B1","author":"Food and Drug Administration"},{"key":"2023081421081427000_ciad195-B2","doi-asserted-by":"publisher","first-page":"760","DOI":"10.1016\/S0140-6736(15)01159-9","article-title":"Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial","volume":"387","author":"Maertens","year":"2016","journal-title":"Lancet"},{"key":"2023081421081427000_ciad195-B3","doi-asserted-by":"crossref","first-page":"1981","DOI":"10.1093\/cid\/ciy827","article-title":"Isavuconazole versus caspofungin in the treatment of candidemia and other invasive Candida infections: the ACTIVE trial","volume":"68","author":"Kullberg","year":"2018","journal-title":"Clin Infect Dis"},{"key":"2023081421081427000_ciad195-B4","author":"US Food and Drug Administration"},{"key":"2023081421081427000_ciad195-B5","author":"US Food and Drug Administration"},{"key":"2023081421081427000_ciad195-B6","author":"US Food and Drug Administration"},{"key":"2023081421081427000_ciad195-B7","author":"US Food and Drug Administration"},{"key":"2023081421081427000_ciad195-B8","author":"Communities EU"},{"key":"2023081421081427000_ciad195-B9","author":"National Institutes of Health"},{"key":"2023081421081427000_ciad195-B10","doi-asserted-by":"crossref","first-page":"2369","DOI":"10.1128\/JCM.38.6.2369-2373.2000","article-title":"Correlation between in vitro and in vivo antifungal activities in experimental fluconazole-resistant oropharyngeal and esophageal candidiasis","volume":"38","author":"Walsh","year":"2000","journal-title":"J Clin Microbiol"},{"key":"2023081421081427000_ciad195-B11","article-title":"Antifungal pharmacokinetics and pharmacodynamics","volume":"5","author":"Lepak","year":"2014","journal-title":"Cold Spring Harb Perspect Med"},{"key":"2023081421081427000_ciad195-B12","doi-asserted-by":"crossref","first-page":"21","DOI":"10.3390\/jof4010021","article-title":"Experimental in vivo models of candidiasis","volume":"4","author":"Segal","year":"2018","journal-title":"J Fungi (Basel)"},{"key":"2023081421081427000_ciad195-B13","author":"US Food and Drug Administration"},{"key":"2023081421081427000_ciad195-B14","doi-asserted-by":"crossref","first-page":"356","DOI":"10.1093\/infdis\/169.2.356","article-title":"Efficacy of unilamellar liposomal amphotericin B in treatment of pulmonary aspergillosis in persistently granulocytopenic rabbits: the potential role of bronchoalveolar D-mannitol and serum galactomannan as markers of infection","volume":"169","author":"Francis","year":"1994","journal-title":"J Infect Dis"},{"key":"2023081421081427000_ciad195-B15","doi-asserted-by":"crossref","first-page":"580","DOI":"10.1097\/INF.0000000000001957","article-title":"Exposure\u2013response analysis of micafungin in neonatal candidiasis: pooled analysis of two clinical trials","volume":"37","author":"Kovanda","year":"2018","journal-title":"Pediatr Infect Dis J"},{"key":"2023081421081427000_ciad195-B16","doi-asserted-by":"crossref","first-page":"2806","DOI":"10.1128\/AAC.05900-11","article-title":"Posaconazole exposure-response relationship: evaluating the utility of therapeutic drug monitoring","volume":"56","author":"Dolton","year":"2012","journal-title":"Antimicrob Agents Chemother"},{"key":"2023081421081427000_ciad195-B17","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1038\/clpt.2010.64","article-title":"Exposure-response of posaconazole used for prophylaxis against invasive fungal infections: evaluating the need to adjust doses based on drug concentrations in plasma","volume":"88","author":"Jang","year":"2010","journal-title":"Clin Pharmacol Ther"},{"key":"2023081421081427000_ciad195-B18","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1086\/508774","article-title":"Treatment of invasive aspergillosis with posaconazole in patients who are refractory to or intolerant of conventional therapy: an externally controlled trial","volume":"44","author":"Walsh","year":"2007","journal-title":"Clin Infect Dis"},{"key":"2023081421081427000_ciad195-B19","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1093\/cid\/ciw326","article-title":"Practice guidelines for the diagnosis and management of aspergillosis: 2016 update by the Infectious Diseases Society of America","volume":"63","author":"Patterson","year":"2016","journal-title":"Clin Infect Dis"},{"key":"2023081421081427000_ciad195-B20","doi-asserted-by":"crossref","DOI":"10.1128\/AAC.01244-19","article-title":"Therapeutic challenges of non-Aspergillus invasive mold infections in immunosuppressed patients","volume":"63","author":"Lamoth","year":"2019","journal-title":"Antimicrob Agents Chemother"},{"key":"2023081421081427000_ciad195-B21","doi-asserted-by":"crossref","first-page":"1379","DOI":"10.1093\/cid\/ciaa230","article-title":"Invasive aspergillosis due to Aspergillus section Usti: a multicenter retrospective study","volume":"72","author":"Glampedakis","year":"2021","journal-title":"Clin Infect Dis"},{"key":"2023081421081427000_ciad195-B22","doi-asserted-by":"crossref","first-page":"181","DOI":"10.3389\/fphar.2016.00181","article-title":"Measurements of deposition, lung surface area and lung fluid for simulation of inhaled compounds","volume":"7","author":"Frohlich","year":"2016","journal-title":"Front Pharmacol"},{"key":"2023081421081427000_ciad195-B23","doi-asserted-by":"crossref","DOI":"10.1111\/tid.13067","article-title":"Why do lung transplant patients discontinue triazole prophylaxis?","volume":"21","author":"Pennington","year":"2019","journal-title":"Transpl Infect Dis"},{"key":"2023081421081427000_ciad195-B24","doi-asserted-by":"crossref","first-page":"590","DOI":"10.1164\/rccm.201810-1919OC","article-title":"Changing prevalence of lower airway infections in young children with cystic fibrosis","volume":"200","author":"Breuer","year":"2019","journal-title":"Am J Respir Crit Care Med"},{"key":"2023081421081427000_ciad195-B25","doi-asserted-by":"crossref","first-page":"e3606","DOI":"10.1093\/cid\/ciaa1065","article-title":"Epidemiology of invasive pulmonary aspergillosis among intubated patients with COVID-19: a prospective study","volume":"73","author":"Bartoletti","year":"2021","journal-title":"Clin Infect Dis"},{"key":"2023081421081427000_ciad195-B26","doi-asserted-by":"publisher","DOI":"10.1016\/j.pulmoe.2022.04.010","article-title":"Infections in lung transplanted patients: a review","author":"Dettori","journal-title":"Pulmonology"},{"key":"2023081421081427000_ciad195-B27","doi-asserted-by":"crossref","first-page":"1367","DOI":"10.1093\/cid\/ciz1008","article-title":"Revision and update of the consensus definitions of invasive fungal disease from the European organization for research and treatment of cancer and the mycoses study group education and research consortium","volume":"71","author":"Donnelly","year":"2020","journal-title":"Clin Infect Dis"},{"key":"2023081421081427000_ciad195-B28","author":"US Food and Drug Administration"},{"issue":"suppl 1","key":"2023081421081427000_ciad195-B29","doi-asserted-by":"crossref","first-page":"S3","DOI":"10.1093\/jpids\/pix046","article-title":"Epidemiology of invasive fungal disease in children","volume":"6","author":"Pana","year":"2017","journal-title":"J Pediatric Infect Dis Soc"},{"key":"2023081421081427000_ciad195-B30","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1038\/clpt.2009.200","article-title":"Safety and pharmacokinetics of repeat-dose micafungin in young infants","volume":"87","author":"DK","year":"2010","journal-title":"Clin Pharmacol Ther"},{"key":"2023081421081427000_ciad195-B31","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1086\/524063","article-title":"The pharmacokinetics and pharmacodynamics of micafungin in experimental hematogenous Candida meningoencephalitis: implications for echinocandin therapy in neonates","volume":"197","author":"Hope","year":"2008","journal-title":"J Infect Dis"},{"key":"2023081421081427000_ciad195-B32","doi-asserted-by":"crossref","first-page":"635","DOI":"10.1097\/INF.0b013e31824f8426","article-title":"Commentary: pediatric antifungal drug development: lessons learned and recommendations for the future","volume":"31","author":"Watt","year":"2012","journal-title":"Pediatr Infect Dis J"},{"key":"2023081421081427000_ciad195-B33","doi-asserted-by":"crossref","first-page":"708","DOI":"10.1128\/AAC.05826-11","article-title":"Anidulafungin for neonatal hematogenous Candida meningoencephalitis: identification of candidate regimens for humans using a translational pharmacological approach","volume":"56","author":"Warn","year":"2012","journal-title":"Antimicrob Agents Chemother"},{"key":"2023081421081427000_ciad195-B34","doi-asserted-by":"crossref","first-page":"632","DOI":"10.1097\/INF.0b013e31824acc33","article-title":"Therapeutic monitoring of voriconazole in children less than three years of age: a case report and summary of voriconazole concentrations for ten children","volume":"31","author":"Doby","year":"2012","journal-title":"Pediatr Infect Dis J"},{"key":"2023081421081427000_ciad195-B35","doi-asserted-by":"crossref","first-page":"2166","DOI":"10.1128\/AAC.48.6.2166-2172.2004","article-title":"Pharmacokinetics and safety of intravenous voriconazole in children after single- or multiple-dose administration","volume":"48","author":"Walsh","year":"2004","journal-title":"Antimicrob Agents Chemother"},{"issue":"suppl 10","key":"2023081421081427000_ciad195-B36","doi-asserted-by":"crossref","first-page":"S58","DOI":"10.1002\/jcph.1053","article-title":"Innovative study designs optimizing clinical pharmacology research in infants and children","volume":"58","author":"Balevic","year":"2018","journal-title":"J Clin Pharmacol"},{"key":"2023081421081427000_ciad195-B37","doi-asserted-by":"crossref","first-page":"740","DOI":"10.1542\/peds.2009-3586","article-title":"Pediatric clinical research networks: current status, common challenges, and potential solutions","volume":"126","author":"Slora","year":"2010","journal-title":"Pediatrics"},{"key":"2023081421081427000_ciad195-B38","author":"Centers for Disease Control and Prevention"},{"key":"2023081421081427000_ciad195-B39","doi-asserted-by":"crossref","first-page":"6","DOI":"10.15585\/mmwr.mm6901a2","article-title":"Candida auris isolates resistant to three classes of antifungal medications\u2014New York, 2019","volume":"69","author":"Ostrowsky","year":"2020","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2023081421081427000_ciad195-B40","author":"Centers for Disease Control and Prevention"}],"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciad195\/50276504\/ciad195.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/77\/3\/380\/51111918\/ciad195.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/77\/3\/380\/51111918\/ciad195.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,14]],"date-time":"2023-08-14T21:09:21Z","timestamp":1692047361000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/article\/77\/3\/380\/7109297"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4,6]]},"references-count":40,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2023,4,6]]},"published-print":{"date-parts":[[2023,8,14]]}},"URL":"https:\/\/doi.org\/10.1093\/cid\/ciad195","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,8,1]]},"published":{"date-parts":[[2023,4,6]]}}}