FDA guidance on the use of biomarkers as drug development tools

Back in September the US Food and Drug Administration announced that it was going to delay its publication of draft guidance on the qualification of drug development tools, originally promised for the summer.  However, this draft guidance was finally published at the end of October.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

Biomarkers: standing the test of time means good initial study design

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

Biomarkers: A Band-Aid for Bioscience

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

Total Scientific

Total Scientific Ltd. is a contract research organisation that specialises in biomarkers.

The use of biomarkers is playing an ever-increasing role in both the pre-clinical and clinical phases of drug discovery, as well as its more traditional role as a core activity for many diagnostic companies. From target identification and validation, through pre-clinical and early clinical phases, the ability to predict or follow drug effects in vivo can significantly reduce the cost and time taken to develop new drugs.