One of the most frequent debates in the scientific community today regards how to reduce the risk of drug-induced cardiac safety issues in drugs. CardiacSafety is crucial in the development of new molecules, since drugs can sometimes interfere with the heart’s ionic currents system and cause arrhythmias.
In 2005 the regulatory issued two specific guidelines on drug-induced cardiac safety with recommendations to the pharmaceutical companies when developing a new drug: ICH S7B (at preclinical level) and ICH E14 (at clinical level). Today these guidelines show some limitations with respect to the great technological development that has taken place in the last 15 years.
In recent years, the regulatory has been working to establish a new guideline that is expected by the end of 2020. This single guideline (that will substitute ICH S7B and ICH E14) will include preclinical as well as clinical recommendations in line with FDA’s Comprehensive In Vitro Proarrhythmia Assay (CiPA) Paradigm. In 2004 FDA published a white paper on the need to reduce R&D costs and attrition rate through the introduction of new technologies such as Modeling & Simulation.
New technologies can raise the level of safety screening in ways that are cost-effective while reducing development timelines. Among these new technologies, Modeling and Simulation – that has been widely used in safety-critical sectors like Aviation and Automotive in the last decades but in Medicine does not reach by far the same level of implementation – has a key role. In silico tests can not only simulate the effects of a molecule on the human heart, based on in vitro data, but also the effects of different drug concentrations.
At InSilicoTrials we are currently working to expand with new models the so-called Drug Safety Suite, a new series of products to reduce the risk of drug-induced cardiac safety issues in drugs that is already available on our platform.