In a Heartbeat

For pharmaceutical companies seeking to improve the productivity of their development pipelines, cardiac safety presents both an obstacle and an opportunity. Most drug developers are familiar with the difficulty of establishing a definitive cardiac safety profile for a compound in development. They may not know, however, that emerging technologies offer a way to significantly reduce uncertainty and curtail the time and cost associated with cardiac safety testing. By providing a solution for what has become a significant hurdle, these new technologies offer the opportunity to accelerate development, reduce false-positive and false-negative results and significantly reduce costs.

THE CARDIAC SAFETY CHALLENGE

That many drugs – whether in development or on the market – have the potential to cause a life-threatening arrhythmia, known as torsades de pointes (TdP), is a significant safety concern. It has been estimated that as many as 86 per cent of all new chemical entities tested in pharmaceutical development may show human ether-a-go-go related gene (hERG) inhibitory activity, and thus have a potential to affect the potassium ion channel (Ikr) and to prolong the heart’s ventricular repolarisation process – the brief period between two heart beats which is known to be a vulnerable point for arrhythmia induction. This prolongation can trigger TdP, which can lead to sudden cardiac death (1).