GoingToMeet

The rapid development of Cardiac Safety standards in clinical and drug development practices, coupled with the increased regulatory scrutiny, has resulted in a momentous evolution of the cardiac drug safety field. The ICH-E14 guidance has been at the centre of the public and industry interest since its inception in 2003. After its finalization in 2005, focus has shifted to regional interpretation and implementation of the guidance and the development of cardiac safety compliance strategies by biopharmaceutical and other organisations.

The implementation of the E14 guidance has recently also been broadened to cover oncology drugs and biologics, with associated challenges in terms of e.g. finding alternatives to the ‘thorough QT study’ in healthy volunteers. Concomitantly, the field of Cardiac Drug Safety has expanded beyond the repolarisation and arrhythmia issues and is now involving wider areas of drug induced cardiotoxicity, including vascular and tissue related toxicities. These topics and other will be discussed at the forthcoming DIA Cardiac Safety meeting, alongside presentations of new technologies and novel biomarkers for early detection and risk management of drug related cardiac toxicity.