{"title":"生物标记物监管接受要求","authors":"Hilke Zander, Jörg Engelbergs","doi":"10.1007/s15007-024-6397-8","DOIUrl":null,"url":null,"abstract":"<div><p>Generally, biomarkers could increase the success rate of medicinal product developments and as a consequence accelerate the availability of new therapeutics with an improved benefit-risk relationship. Therefore, patient identification based on predictive biomarkers is becoming increasingly important in all therapeutic areas [1]. The increasing use of predictive biomarker-guided-personalized (precision) medicine warrants the discovery of novel biomarkers as measurable indicators of physiopathological conditions [2]. Biomarkers can be used for diagnostics and prognostics, monitoring disease progression, but also to select the most effective therapy and to predict the treatment outcome [3, 4]. The current article provides a short focus on the regulatory definition of a biomarker and the biomarker qualification process of the European Medicines Agency (EMA). With the evolving landscape, the new Regulation (EU) 2017/746 on in vitro medical devices (IVD) [5] introduces important changes in the EU legal framework for IVDs especially by legally defining for the first time “companion diagnostic” devices (CDx). Challenges in the codevelopment of CDx and medicinal products are highlighted to provide scientific-regulatory considerations in this complex regulatory field.</p><p><b>Cite this as</b> Zander H, Engelbergs J. Requirements for regulatory acceptance of biomarkers. Allergo J Int 2024;33:309-12</p><p><b>https://doi.org/10.1007/s40629-024-00312-w</b></p></div>","PeriodicalId":7418,"journal":{"name":"Allergo Journal","volume":"33 8","pages":"54 - 57"},"PeriodicalIF":1.1000,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Requirements for regulatory acceptance of biomarkers\",\"authors\":\"Hilke Zander, Jörg Engelbergs\",\"doi\":\"10.1007/s15007-024-6397-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Generally, biomarkers could increase the success rate of medicinal product developments and as a consequence accelerate the availability of new therapeutics with an improved benefit-risk relationship. Therefore, patient identification based on predictive biomarkers is becoming increasingly important in all therapeutic areas [1]. The increasing use of predictive biomarker-guided-personalized (precision) medicine warrants the discovery of novel biomarkers as measurable indicators of physiopathological conditions [2]. Biomarkers can be used for diagnostics and prognostics, monitoring disease progression, but also to select the most effective therapy and to predict the treatment outcome [3, 4]. The current article provides a short focus on the regulatory definition of a biomarker and the biomarker qualification process of the European Medicines Agency (EMA). With the evolving landscape, the new Regulation (EU) 2017/746 on in vitro medical devices (IVD) [5] introduces important changes in the EU legal framework for IVDs especially by legally defining for the first time “companion diagnostic” devices (CDx). Challenges in the codevelopment of CDx and medicinal products are highlighted to provide scientific-regulatory considerations in this complex regulatory field.</p><p><b>Cite this as</b> Zander H, Engelbergs J. Requirements for regulatory acceptance of biomarkers. Allergo J Int 2024;33:309-12</p><p><b>https://doi.org/10.1007/s40629-024-00312-w</b></p></div>\",\"PeriodicalId\":7418,\"journal\":{\"name\":\"Allergo Journal\",\"volume\":\"33 8\",\"pages\":\"54 - 57\"},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2024-12-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Allergo Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s15007-024-6397-8\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Allergo Journal","FirstCategoryId":"1085","ListUrlMain":"https://link.springer.com/article/10.1007/s15007-024-6397-8","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ALLERGY","Score":null,"Total":0}
Requirements for regulatory acceptance of biomarkers
Generally, biomarkers could increase the success rate of medicinal product developments and as a consequence accelerate the availability of new therapeutics with an improved benefit-risk relationship. Therefore, patient identification based on predictive biomarkers is becoming increasingly important in all therapeutic areas [1]. The increasing use of predictive biomarker-guided-personalized (precision) medicine warrants the discovery of novel biomarkers as measurable indicators of physiopathological conditions [2]. Biomarkers can be used for diagnostics and prognostics, monitoring disease progression, but also to select the most effective therapy and to predict the treatment outcome [3, 4]. The current article provides a short focus on the regulatory definition of a biomarker and the biomarker qualification process of the European Medicines Agency (EMA). With the evolving landscape, the new Regulation (EU) 2017/746 on in vitro medical devices (IVD) [5] introduces important changes in the EU legal framework for IVDs especially by legally defining for the first time “companion diagnostic” devices (CDx). Challenges in the codevelopment of CDx and medicinal products are highlighted to provide scientific-regulatory considerations in this complex regulatory field.
Cite this as Zander H, Engelbergs J. Requirements for regulatory acceptance of biomarkers. Allergo J Int 2024;33:309-12
期刊介绍：
The Allergo Journal publishes original articles, reviews and case reports, guidelines and position papers in German and English. The topics concern allergological and immunological clinical pictures, current developments in diagnosis and therapy, research work concerning antigens and allergens and aspects related to occupational and environmental medicine. The quality of the contributions is guaranteed by an international board of editors; all contributions will be reviewed by at least two independent peers.
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