Ronald L Rabin, Matthew C Altman, S Hasan Arshad, Richard D Beger, Pamela A Frischmeyer-Guerrerio, Elena Goleva, Robert G Hamilton, Gurjit K Khurana Hershey, Mohamed H Shamji, Hugh A Sampson, Alexandra F Santos, Wayne G Shreffler, Alkis Togias, Stefan Vieths, Erik Wambre, Sally E Wenzel, Kathleen Hise, Joohee Lee, Anubha Tripathi, Jay E Slater
{"title":"生物标志物驱动的过敏性疾病和哮喘药物开发- FDA公开研讨会。","authors":"Ronald L Rabin, Matthew C Altman, S Hasan Arshad, Richard D Beger, Pamela A Frischmeyer-Guerrerio, Elena Goleva, Robert G Hamilton, Gurjit K Khurana Hershey, Mohamed H Shamji, Hugh A Sampson, Alexandra F Santos, Wayne G Shreffler, Alkis Togias, Stefan Vieths, Erik Wambre, Sally E Wenzel, Kathleen Hise, Joohee Lee, Anubha Tripathi, Jay E Slater","doi":"10.1016/j.jaci.2025.03.014","DOIUrl":null,"url":null,"abstract":"<p><p>The US Food and Drug Administration (FDA) hosted a workshop on February 22, 2024, to discuss the status of biomarkers in drug development for allergic asthma and food allergy. The workshop provided a forum for open discussion among regulators, academicians, NIH staff and industry to inform stakeholders of the requirements for the FDA to adopt a biomarker as a surrogate endpoint for a clinical trial, and to inform FDA of the status of various biomarkers in development. The workshop was divided into three sessions: 1) FDA and EU regulators discussing regulatory perspectives on use of biomarkers in drug development programs; 2) investigators discussing biomarkers for pediatric and adult asthma; and 3) investigators discussing biomarkers for food allergy. In this report, we review the information presented at the workshop and summarize the current status of potential biomarkers for these allergic diseases.</p>","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":" ","pages":""},"PeriodicalIF":11.4000,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Biomarker-driven drug development for Allergic Diseases and Asthma-An FDA public workshop.\",\"authors\":\"Ronald L Rabin, Matthew C Altman, S Hasan Arshad, Richard D Beger, Pamela A Frischmeyer-Guerrerio, Elena Goleva, Robert G Hamilton, Gurjit K Khurana Hershey, Mohamed H Shamji, Hugh A Sampson, Alexandra F Santos, Wayne G Shreffler, Alkis Togias, Stefan Vieths, Erik Wambre, Sally E Wenzel, Kathleen Hise, Joohee Lee, Anubha Tripathi, Jay E Slater\",\"doi\":\"10.1016/j.jaci.2025.03.014\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The US Food and Drug Administration (FDA) hosted a workshop on February 22, 2024, to discuss the status of biomarkers in drug development for allergic asthma and food allergy. The workshop provided a forum for open discussion among regulators, academicians, NIH staff and industry to inform stakeholders of the requirements for the FDA to adopt a biomarker as a surrogate endpoint for a clinical trial, and to inform FDA of the status of various biomarkers in development. The workshop was divided into three sessions: 1) FDA and EU regulators discussing regulatory perspectives on use of biomarkers in drug development programs; 2) investigators discussing biomarkers for pediatric and adult asthma; and 3) investigators discussing biomarkers for food allergy. In this report, we review the information presented at the workshop and summarize the current status of potential biomarkers for these allergic diseases.</p>\",\"PeriodicalId\":14936,\"journal\":{\"name\":\"Journal of Allergy and Clinical Immunology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":11.4000,\"publicationDate\":\"2025-03-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Allergy and Clinical Immunology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jaci.2025.03.014\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Allergy and Clinical Immunology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jaci.2025.03.014","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ALLERGY","Score":null,"Total":0}
Biomarker-driven drug development for Allergic Diseases and Asthma-An FDA public workshop.
The US Food and Drug Administration (FDA) hosted a workshop on February 22, 2024, to discuss the status of biomarkers in drug development for allergic asthma and food allergy. The workshop provided a forum for open discussion among regulators, academicians, NIH staff and industry to inform stakeholders of the requirements for the FDA to adopt a biomarker as a surrogate endpoint for a clinical trial, and to inform FDA of the status of various biomarkers in development. The workshop was divided into three sessions: 1) FDA and EU regulators discussing regulatory perspectives on use of biomarkers in drug development programs; 2) investigators discussing biomarkers for pediatric and adult asthma; and 3) investigators discussing biomarkers for food allergy. In this report, we review the information presented at the workshop and summarize the current status of potential biomarkers for these allergic diseases.
期刊介绍：
The Journal of Allergy and Clinical Immunology is a prestigious publication that features groundbreaking research in the fields of Allergy, Asthma, and Immunology. This influential journal publishes high-impact research papers that explore various topics, including asthma, food allergy, allergic rhinitis, atopic dermatitis, primary immune deficiencies, occupational and environmental allergy, and other allergic and immunologic diseases. The articles not only report on clinical trials and mechanistic studies but also provide insights into novel therapies, underlying mechanisms, and important discoveries that contribute to our understanding of these diseases. By sharing this valuable information, the journal aims to enhance the diagnosis and management of patients in the future.
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