Jjingo CJ, Bala S, Waack U, Needles M, Bensman TJ, McMaster O, Smith T, Blakely B, Chan IZ, Puthawala K, Dixon C, Kim Y, Lim R, Colangelo P, St Clair C, Nambiar S, Moss RB, Botgros R, Bazaz R, Denning DW, Marr KA, Husain S, Berman L, Christensen DJ, Keywood C, Clayton RG, Walsh TJ, Song HSE, Shukla SJ, and Farley J
Allergic bronchopulmonary aspergillosis and invasive fungal diseases represent distinct infectious entities that cause significant morbidity and mortality. Currently, administered inhaled antifungal therapies are unapproved, have suboptimal efficacy, and are associated with considerable adverse reactions. The emergence of resistant pathogens is also a growing concern. Inhaled antifungal development programs are challenged by inadequate nonclinical infection models, highly heterogenous patient populations, low prevalence rates of fungal diseases, difficulties defining clinical trial enrollment criteria, and lack of robust clinical trial endpoints. On 25 September 2020, the US Food and Drug Administration (FDA) convened a workshop with experts in pulmonary medicine and infectious diseases from academia, industry, and other governmental agencies. Key discussion topics included regulatory incentives to facilitate development of inhaled antifungal drugs and combination inhalational devices, limitations of existing nonclinical models and clinical trial designs, patient perspectives, and industry insights., Competing Interests: Potential conflicts of interest. L. B. is a full-time employee of Pulmocide. As an employee, he receives reimbursements for conference- and travel-related costs to attend scientific conferences. He also owns Pulmocide stock options. D. J. C. serves as a consultant to TFF Pharmaceuticals, which covers his travel to conferences/meetings. He also owns TFF Pharmaceuticals stock options. R. G. C. is an interim executive and consultant for companies developing and commercializing pharmaceutical, biologic, and medical device products. He is currently working with Pulmatrix (has antifungal product in development), Larimar Therapeutics (not in antifungal space), and Respira, Inc (not in antifungal space). D. W. D. and family hold Founder shares in F2G Ltd, a University of Manchester spin-out antifungal discovery company, and share options in TFF Pharmaceuticals. He acts or has recently acted as a consultant to Pulmatrix, Pulmocide, Biosergen, TFF Pharmaceuticals, Pfizer, Omega, Novacyt, Rostra Therapeutics, MucPharm, Mundipharma, and Cipla, and reports grants from Pfizer. He chairs a Data Review Committee for Pulmocide and as Phase 1 Medical Monitor for Biosergen. In the last 3 years, he has been paid for talks on behalf of BioRad, Basilea, and Pfizer. He is a longstanding member of the Infectious Diseases Society of America Aspergillosis Guidelines group, the European Society for Clinical Microbiology and Infectious Diseases Aspergillosis Guidelines group, and recently joined the One World Guideline for Aspergillosis. He also reports issued and licensed patents for assays for fungal infection. S. H. has received grants from Pulmocide, Synerxis, Takeda, Merck, Avir Pharma, Inc, and Astellas. He also reports receiving consulting fees from Takeda. K. A. M. is the founder and chief executive officer of MycoMed Technologies. She is a consultant for Cidara Therapeutics and receives license revenue from Pearl Diagnostics. She also reports leadership or fiduciary roles at Pearl Diagnostics and Sfunga Therapeutics, and ownership of stocks or stock options of Pearl Diagnostics, Sfunga Therapeutics, and Cidara Therapeutics. R. B. M. is currently a consultant to 4D Molecular Therapeutics, Aridis Pharmaceuticals, Zambon Company SpA, and Nob Hill Therapeutics. He receives authorship and editorial royalties from UpToDate. He is on the Board of Directors of Cystic Fibrosis Research Institute. S.N.’s contributions occurred entirely while she worked at the Food and Drug Administration. She is currently employed by Johnson & Johnson and, as an employee, her travel to conferences/meetings is covered; she also owns Johnson & Johnson stock or stock options. S. N. is an unpaid member of the Scientific Advisory Committee for Global Antibiotic Research and Development Partnership. T. J. W. reports support for the workshop from the Henry Schueler Foundation. He has received grants for experimental and clinical antimicrobial pharmacology and therapeutics to his institution from Amplyx, Astellas, Leadiant, Gilead, Merck, and Shionogi. He reports payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Astellas, Leadiant, Scynexis, Shionogi, Statera, and T2 Biosystems. T. J. W. also reports a leadership or fiduciary role in the Medical Mycological Society of the Americas. J. F. reports being a US government employee. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)