Director, Head of NBE DMPK Project Support Merck KGaA Darmstadt, Hessen, Germany
In 2012, the European Bioanalysis Forum published their first recommendation on biomarker assay development and the bioanalysis of biomarkers. From 2012 onwards, significant discussion on context of use of biomarker assays, the use of the data and the decisions taken with the data continued in industry. From 2018 to 2020, the EBF biomarker team re-engaged on the discussion and, in 2020, updated the 2012 EBF recommendation with focus on areas to consider when discussing context of use for biomarker assay development and validation, thus enabling the correct conversations to occur and the move away from the misapplication of PK assay validation criteria to biomarker assays. This presentation will focus on both the 2012 recommendation as well as the update.
Upon completion, participant will be able to understand Context of Use as foundation for science based Biomarker Assay validation
Upon completion, participant will be able to understand the importance of communication with stakeholders
Upon completion, participant will be able to understand the risk of generating poor or wrong data leading to wrong decision making
Upon completion, participant will be able to optimise resources in R&D when developing Biomarker assays
Upon completion, participant will be able to see the difference between PK-assays and Biomarker (PD) assays