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Impact of biomarker development on drug safety assessment

Marrer, Estelle and Dieterle, Frank (2010) Impact of biomarker development on drug safety assessment. Toxicology and Applied Pharmacology, 243 (2). pp. 167-179. ISSN 0041-008X


Drug safety has always be a key aspect of drug development. Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on biomarker development. A illustrative and “door opening” safety biomarker success story is the recent endorsement of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the “know how” acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e. molecular pathology as a complement to the classical toolbox allow promising discoveries in the safety biomarker field. This review will focuse on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.

Item Type: Article
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Keywords: Biomarker, Safety, Drug Development
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Date Deposited: 13 Oct 2015 13:16
Last Modified: 13 Oct 2015 13:16


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