Tag: Non-Clinical

Biomarkers in early drug development

The EMA glossary defines a biological marker, or biomarker, as ‘an objective and quantifiable measure of a physiological process, pathological process or response to a treatment (excluding measurements of how an individual feels or functions)’. Similarly, the FDA defines a biomarker as ‘a defined characteristic that is measured as an indicator of normal biological processes, continue reading…

Evaluation of drug safety does not start at candidate nomination: Create value by de-risking early

Photo of Ruud Bueters. Evaluation of drug safety does not start at candidate nomination

  Drug development is a daunting and difficult task where all the puzzle pieces need to click to result in an efficacious and safe treatment for patients. It is a high-risk endeavor involving many different scientific and non-scientific disciplines over a long period of time. The current estimates to develop a drug are about 2.3 continue reading…