Biomarker assay validation for clinical trials: a questionnaire survey to pharmaceutical companies in Japan

While some biomarker assays use the same methodologies (e.g.,ligand-binding assays and chromatographic assays) as pharmacokinetics (PK) assays, there are some differences in points to consider in assay validation between biomarker assays and PK assays. [...]biomarker assay validation has been a hot topic in bioanalysis conferences and communities. The only survey was conducted within European and North American CROs by Global CRO Council for Bioanalysis (GCC) in 2012 (9).To investigate the current situation in the pharmaceutical companies, the biomarker working group (WG) in the bioanalytical assay validation study group, which was subsidized by the Japan Agency for Medical Research and Development, decided to conduct a questionnaire survey in Japan (10). According to the present survey, the same biological matrix as study samples was used in 39.0% of the assays, whereas the surrogate matrix (such as water, buffer, solution included in commercial kits, protein solution, stripped matrix) was used in 37.8% of the assays. According to the survey results, the majority of biomarker assays consisted of three types as follows: chromatographic assays to be developed de novo,ligand-binding assays to be developed de novoand ligand-binding assays using commercial kits.