Food and Drug Administration Public Workshop Summary-Development Considerations of Antifungal Drugs to Address Unmet Medical Need.

Autor:	Yasinskaya Y; 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., Bala S; 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., Waack U; 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., Dixon C; 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., Higgins K; 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., Moore JN; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland, USA., Jjingo CJ; 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., O'Shaughnessy E; 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., Colangelo P; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland, USA., Botgros R; Health Threats and Vaccines Strategy, European Medicines Agency, Amsterdam, the Netherlands., Nambiar S; 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., Angulo D; Scynexis, Jersey City, New Jersey, USA., Dane A; DaneStat Consulting, Macclesfield, United Kingdom., Chiller T; Mycotic Diseases Branch, Centers for Disease Control and Prevention, Atlanta, Georgia, USA., Hodges MR; RNA Medicines, San Diego, California, USA., Sandison T; Cidara Therapeutics, San Diego, California, USA., Hope W; Centre for Excellence in Infectious Diseases Research, Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom., Walsh TJ; Transplantation-Oncology Infectious Diseases Program, Weill Cornell Medicine, New York, New York, USA., Pappas P; Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA., Katragkou A; Transplantation-Oncology Infectious Disease Program, Weill Cornell Medicine, New York, New York, USA., Kovanda L; Astellas Pharma Global Development, Northbrook, Illinois, USA., Rex JH; F2G, Manchester, United Kingdom., Marr KA; Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA., Ostrosky-Zeichner L; Director of the Laboratory of Mycology Research, McGovern Medical School, Houston, Texas, USA., Sekine S; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Deshpande M; DRT Strategies, Arlington, Virginia, USA., Shukla SJ; Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Farley J; Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Jazyk:	angličtina
Zdroj:	Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2023 Aug 14; Vol. 77 (3), pp. 380-387.
DOI:	10.1093/cid/ciad195
Abstrakt:	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. Competing Interests: Potential conflicts of interest. P. C. was employed at the Food and Drug Administration until 31 December 2020. 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. D. A. is an employee and own shares of Scynexis. A. D. of DaneStat Consulting is a statistical consultant for the Pharmaceutical and Biotechnology Industry; he has acted as a consultant for Adaigo, AN2, Achaogen, Allecra, Amicrobe, Amplyx, Artizan, Bioscript, Bugworks, CARBX, Cidara, Closed Loop Medicine, Correvio, ContraFect, DaVolterra, Destiny, F2G, Entasis, Gates, Geom, GSK, Gyroscope, Humanigen, Kymab, Liverpool University, Melinta, Mironid, Modis, Nabriva, Orca, Pfizer, Phico, Pled, Quince, Roche, SFunga, Scynexis, Spero, Sinovent, SNIPR Biome, TenNor, Transcrip, VenatoRx, and Zavante (payments to DaneStat Consulting). He also reports as the independent statistician on data safety monitoring boards for a number of companies, including Aridis, ContraFect Midatech, Pfizer, Pled, Rare Thyroid, Sanofi, and Transcrip. M. R. H. reports support as a full-time employee of Amplyx Pharmaceuticals, a biotech company that was developing fosmanogepix, and received stock potions and a salary. T. S. is a full-time employee of and owns stock or stock options in Cidara Therapeutics. W. H. reports grants or contracts from F2G and Pfizer; personal consulting fees from F2G, Amplyx, Pfizer, Mundipharma, and Gilead (payments to DaneStat Consulting); participation on F2G's advisory board; a role as National Institutes of Health Research Specialty Co-lead for Infection; and a data sharing agreement with Astellas without any financial commitment. T. J. W. has received grants for experimental and clinical antimicrobial pharmacology and therapeutics to his institution from Allergan, Amplyx, Astellas, Lediant, Medicines Company, Merck, Scynexis, and Tetraphase; has served as consultant to Amplyx, Astellas, Allergan, ContraFect, Gilead, Leadiant, Medicines Company, Merck, Methylgene, Pfizer, and Scynexis; reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Astellas, Leadiant, Scynexis, Shinogi, Statera, and T2 Biosystems; and reports a leadership or fiduciary role in the Medical Mycological Society of the Americas. P. P. reports grants from Merck, Astellas, Scynexis, Cidara, and F2G and consulting fees from F2G and Cidara. L. K. reports support as a full-time employee of Astellas Pharma Global Development. J. H. R. is chief medical officer and director of F2G, operating partner and consultant for Advent Life Sciences, and expert in residence for Wellcome Trust. He sits on the scientific advisory boards of Bugworks Research, Basilea Pharmaceutica, Forge Therapeutics, Novo Holdings, and Roche Pharma Research & Early Development and is a shareholder in AstraZeneca Pharmaceuticals, F2G, Advent Life Sciences, Macrolide Pharmaceuticals, and Bugworks Research. He has also received consulting fees from Phico Therapeutics, ABAC Therapeutics, Polyphor, Heptares Therapeutics, Gangagen, Meiji Seika Pharma, Basilea Pharmaceutica International, Allecra Therapeutics, Forge Therapeutics, SinSa Labs, AtoxBio, Peptilogics, F. Hoffmann-LaRoche, Novo Holdings, Innocoll, Vedanta, Progenity, Nosopharm, Roivant Sciences, and Shionogi. K. A. M. is founder and chief executive officer of MycoMed Technologies and a consultant and advisory board member for Cidara Therapeutics and Sfunga Therapeutics. She has consulted for Amplyx Pharmaceuticals, Astellas Pharma, Advaxis, Chimerix, F2G, Genentech, Incyte, Merck & Co, OncoSec, RTI Surgical, Scynexis. and Vical. She receives authorship and editorial royalties from UpToDate and a grant from Merck, owns shares in Pearl Diagnostics and Sfunga Therapeutics, and is an employee of Sfunga Therapeutics. L. O. Z. has received research funding and/or personal honoraria for consulting or speaking from Pulmocide, Pfizer, Merck, Astellas, Cidara, Scynexis, F2G, Amplyx, Gilead, Therapeutics, Viracor, Octapharma, Biotoscana, Stendhal, Mayne, Takeda, RealTime Labs, and Viracor. L. O. Z. also reports honoraria from F2G, Pfizer, and Gilead; participation on a data safety monitoring board or advisory board for Octapharma, Cidara, F2G, and Pfizer; and leadership roles as president for the Mycoses Study Group and Education Consortium, president-elect for the Immunocompromised Host Society, senior editor for Journal of Antimicrobial Chemotherapy, and an associate editor for Clinical Infectious Diseases. 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. (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)
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