Breakthrough in drug safety testing thanks to computer simulation

Currently, whether a drug is safe for the heart has been assessed by a set of laboratory tests, with a tightly limited range of acceptable outcomes.  But there is broad agreement within the drug development community that these tests are not as sensitive or accurate as they should be. The challenge has been how to find a credible alternative.

Now researchers at Oxford, working with European universities and businesses as part of the preDiCT project, have developed computer models and tools to simulate drug effects on the heart. This offers the possibility of a better way to predict drug safety. 

Modelling and simulation technology could help establish whether a drug is safe, or too risky, for specific groups of patients. It could also predict a drug’s likely safety performance at an earlier stage in its development, and possibly resurrect drugs which failed under the old test regime but which prove effective under the new and more sensitive tests.

In February 2011, following this breakthrough, drug regulators and pharmaceutical industry researchers met researchers from Oxford and Valencia Polytechnic Universities, to discuss the next steps to integrate computerised modelling and simulation in drug safety assessment.

As a result of this meeting, the project will now energetically pursue further discussions with regulators and pharmaceutical representatives, to agree criteria for the acceptance of models in the drug development process.

Members of the preDiCT team and Scientific Advisory Board, the European Medicines Agency, Health Canada and the US Food and Drug Administration, along with representatives from AstraZeneca, GSK, Notocord, Fujitsu Laboratories of Europe, and clinicians participated in the discussions.