Current Practices and Future Outlook on The Integration of Biomarkers in The Drug Development Process

Abstract

Over the last decade, there has been broad incorporation of translational biomarkers into the early drug development process to predict safety concerns, measure target engagement and monitor disease progression. One goal of translational biomarkers is to create a cycle whereby preclinical readouts influence candidate selection and subsequent clinical data are fed back into research to facilitate better decision making. Successes have been limited and not as broad in scope as desired. Collaborations between industry and regulators have increased the number of qualified biomarkers; but the process is lengthy and expensive. A high level overview of translational biomarkers as well as a discussion of some of the successes and failures encountered in development is discussed here.

Keywords::

• animal model
• assay validation
• biomarker
• biomarker qualification
• biomarker specificity
• context of use
• sensitivity
• translational biomarker

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.