{"title":"Requirements for regulatory acceptance of biomarkers","authors":"Hilke Zander, Jörg Engelbergs","doi":"10.1007/s40629-024-00312-w","DOIUrl":null,"url":null,"abstract":"<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 (IVDR) [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>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 8","pages":"309 - 312"},"PeriodicalIF":0.0000,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00312-w.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Allergo Journal International","FirstCategoryId":"1085","ListUrlMain":"https://link.springer.com/article/10.1007/s40629-024-00312-w","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
Abstract
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 (IVDR) [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.
期刊介绍:
Allergo Journal International is the official Journal of the German Society for Applied Allergology (AeDA) and the Austrian Society for Allergology and Immunology (ÖGAI). The journal is a forum for the communication and exchange of ideas concerning the various aspects of allergy (including related fields such as clinical immunology and environmental medicine) and promotes German allergy research in an international context. The aim of Allergo Journal International is to provide state of the art information for all medical and scientific disciplines that deal with allergic, immunological and environmental diseases. Allergo Journal International publishes original articles, reviews, short communications, case reports, and letters to the editor. The articles cover topics such as allergic, immunological and environmental diseases, the latest developments in diagnosis and therapy as well as current research work concerning antigens and allergens and aspects related to occupational and environmental medicine. In addition, it publishes clinical guidelines and position papers approved by expert panels of the German, Austrian and Swiss Allergy Societies.
All submissions are reviewed in single-blind fashion by at least two reviewers.
Originally, the journal started as a German journal called Allergo Journal back in 1992. Throughout the years, English articles amounted to a considerable portion in Allergo Journal. This was one of the reasons to extract the scientific content and publish it in a separate journal. Hence, Allergo Journal International was born and now is the international continuation of the original German journal. Nowadays, all original content is published in Allergo Journal International first. Later, selected manuscripts will be translated and published in German and included in Allergo Journal.