Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape.

ABSTRACT: Biomarkers are widely used at every stage of drug discovery and development. Utilisation of biomarkers has a potential to make drug discovery, development and approval processes more efficient. An overview of the current global regulatory landscape is presented in this article with particular emphasis on the validation and qualification of biomarkers, as well as legal framework for companion diagnostics. Furthermore, this article shows how the number of approved drugs with at least 1 biomarker used during development (biomarker acceptance) is affected by the recent advances in the biomarker regulations. More than half of analysed approvals were supported by biomarker data and there has been a slight increase in acceptance of biomarkers in recent years, even though the growth is not continu

SUBMITTER: Gromova M 

PROVIDER: S-EPMC7727038 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature