Our Pharmaceutical Director, Dr Gerry Kenna, recently presented a virtual seminar on “In vitro models for assessment of drug-induced liver injury (DILI): a personal perspective” to the Liver Toxicity Working Group of the US regulator, the FDA. The illustrated talk is 45 minutes long and gives a valuable insight, from an expert with decades of experience, into the state of the art of drug safety testing to avoid the risk of DILI. DILI is an important cause of drug-related ill health, which can be serious and even fatal, and is a leading reason for failed development and use of many otherwise promising new drugs.
The talk is technical, so you may wish to focus just on the Summary in the final 7 minutes. Here, Gerry explains that numerous methods which use human-derived cells are available, and provide data that are much more useful than animal safety studies. Because DILI is complicated, no single method can be used and multiple endpoints need to be analysed. Gerry highlights that there is an urgent need for scientists to reach consensus on which assays to use and how best to analyse and interpret the data that they provide. There is also a need for strong regulatory guidance that requires in vitro methods be used to assess the risk of DILI, thus reducing the incidence of this serious but often avoidable adverse drug reaction.