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

Author:

Yasinskaya Yuliya1,Bala Shukal1,Waack Ursula1ORCID,Dixon Cheryl2,Higgins Karen2,Moore Jason N3,Jjingo Caroline J1,O'Shaughnessy Elizabeth1,Colangelo Philip3,Botgros Radu4,Nambiar Sumathi1,Angulo David5,Dane Aaron6,Chiller Tom7,Hodges Michael R8,Sandison Taylor9,Hope William10,Walsh Thomas J11,Pappas Peter12,Katragkou Aspasia13,Kovanda Laura14,Rex John H15,Marr Kieren A16,Ostrosky-Zeichner Luis17ORCID,Sekine Shohko18,Deshpande Monika19,Shukla Sunita J20,Farley John20

Affiliation:

1. 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

2. 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

3. Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland , USA

4. Health Threats and Vaccines Strategy, European Medicines Agency , Amsterdam , the Netherlands

5. Scynexis , Jersey City, New Jersey , USA

6. DaneStat Consulting , Macclesfield , United Kingdom

7. Mycotic Diseases Branch, Centers for Disease Control and Prevention , Atlanta, Georgia , USA

8. RNA Medicines , San Diego, California , USA

9. Cidara Therapeutics , San Diego, California , USA

10. Centre for Excellence in Infectious Diseases Research, Department of Molecular and Clinical Pharmacology, University of Liverpool , Liverpool , United Kingdom

11. Transplantation-Oncology Infectious Diseases Program, Weill Cornell Medicine , New York, New York , USA

12. Division of Infectious Diseases, University of Alabama at Birmingham , Birmingham, Alabama , USA

13. Transplantation-Oncology Infectious Disease Program, Weill Cornell Medicine , New York, New York , USA

14. Astellas Pharma Global Development , Northbrook, Illinois , USA

15. F2G , Manchester , United Kingdom

16. Department of Medicine, Johns Hopkins University , Baltimore, Maryland , USA

17. Director of the Laboratory of Mycology Research, McGovern Medical School , Houston, Texas , USA

18. Pharmaceuticals and Medical Devices Agency , Tokyo , Japan

19. DRT Strategies , Arlington, Virginia , USA

20. Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA

Abstract

Abstract 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.

Funder

US Food and Drug Administration

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3