Hoffmann, Peter (2014) TRANSLATION STRATEGY FOR DRUG-INDUCED VASCULAR INJURY BIOMARKERS. Toxicol Pathol. 2014 Jun;42(4):658-71. doi: 10.1177/0192623314527644. Epub 2014 Apr 24.

Abstract

Drug-induced vascular Injury (DIVI) is a common preclinical toxicity usually characterized by hemorrhage, vascular endothelial and smooth muscle
damage, and inflammation. DIVI findings can cause delays or termination of drug candidates due to low safety margins. The situation is complicated by
the absence of sensitive, noninvasive biomarkers for monitoring vascular injury and the uncertain relevance to humans. The Safer And Faster Evidencebased
Translation (SAFE-T) consortium is a public–private partnership funded within the European Commission’s InnovativeMedicines Initiative (IMI)
aiming to accelerate drug development by qualifying biomarkers for drug-induced organ injuries, including DIVI. The group is using patients with vascular
diseases that have key histomorphologic features (endothelial damage, smooth muscle damage, and inflammation) in common with those observed
in DIVI, and has selected candidate biomarkers associated with these features. Studied populations include healthy volunteers, patients with spontaneous
vasculitides and other vascular disorders. Initial results from studies with healthy volunteers and patients with vasculitides show that a panel of biomarkers
can successfully discriminate the population groups. The SAFE-T group plans to seek endorsement from health authorities (European Medicines
Agency and Food and Drug Administration) to qualify the biomarkers for use in regulatory decision-making processes.

Item Type:	Article
Keywords:	Vascular injury, arteritis, biomarker, inflammation, translation
Date Deposited:	03 May 2016 23:45
Last Modified:	03 May 2016 23:45
URI:	https://oak.novartis.com/id/eprint/10920