Biomarkers

The increase in the use of the term biomarker is a recent one.  When one looks back at the use of this term in the literature over the last fifty years, there was an explosive increase in its use in the 1980s and 1990s, and it continues to grow today.  However, biomarker research as we now know it has a much deeper history. Here we are going to focus on just one paper, published in 1965, twelve years before the term

Back in September the US Food and Drug Administration announced that it was going to delay its publication of draft guidance on the qualification of drug development tools, originally promised for the summer.  However, this draft guidance was finally published at the end of October.  While still in draft form, the Guidance substantially expands on the outline of the pilot qualification process given in an article written by two members of the Center for

It feels like every other day that another putative biomarker is identified that will predict presence or extent of some disease or another, usually with an absurdly low p value.  So, if these biomarkers are so common, why is the subsequent commercialisation and clinical use of these potential diagnostics so difficult to achieve? I believe that the biggest of the problems is in the design of the studies carried out, particularly in the early stages of biomarker research. The first stage in

In this kick-off article to the new Total Scientific biomarker blog series, we discuss the potential for biomarkers to improve the R&D productivity of the pharmaceutical industry. Please read the full article here.