Original Publication Date: 17 April, 2019
Publication / Source: Bioanalysis 11(7)
Authors: Islam R, Kar S, Ritzén H et al.
Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Contract research organizations regularly use commercially available immunoassay kits to validate biomarker methods. However, adaptation of such kits in a regulated environment presents significant challenges and was one of the key topics discussed during the 12th Global Contract Research Organization Council for Bioanalysis (GCC) meeting. This White Paper reports the GCC members’ opinion on the challenges facing the industry and the GCC recommendations on the classification of commercial kits that can be a win-win for commercial kit vendors and end users.
The Global Contract Research Organization Council (GCC) for Bioanalysis was formed in 2010 to bring together many senior-level contract research organization (CRO) representatives to openly discuss bioanalysis and the regulatory challenges