We met Javier Saiz – Professor of Biomedical Engineering at the Polytechnic University of Valencia, Spain – who led the research group that created the computational model which is at the core of our QT/TdP Risk Screen product, available on our cloud-based platform. Our objective was to let him share his wide experience in Modeling and Simulation applied to the healthcare sector.
Let’s try to understand first of all how the idea for this model was born. “One of my passions has always been to solve problems, maybe that’s why I became an engineer. I started to work in the field of biomedical engineering more than 30 years ago. At the beginning, I developed different medical devices to register medical signals. But very quickly, I had the curiosity of understanding how these signals detected in the body surface are developed. And I started modeling the electrical behavior of heart cells. Later I moved to develop multiscale and multi–physics specialized models of the heart – also called in silico models – to improve the development of medical devices and drugs, thus helping clinicians and the industry in the decision-making process”.
One of the big problems that the pharmaceutical industry faces every day is related to drug-induced cardiac safety problems. Drugs can be good antibiotics or anti-malaria, for example, but can affect at the same time the heart provoking cardiac arrhythmias. One of these arrhythmias, called Torsades de Pointes, is related to the prolongation of the QT interval, causes death and is responsible for the withdrawal of many drugs from the market. “The challenge for pharma companies is the early detection of these problems in a new drug”, continues Saiz. “This can avoid wasting time and huge amounts of money to develop a drug that, in the end, can cause cardiac safety problems and be withdrawn. In this field, cardiac models can play an important role by providing pharma companies with new biomarkers that help them take better decisions in the development of new molecules”.
Here comes the QT/TdP Risk Screen model: “We started to study the effect of different drugs on the electrical activity of the heart more than 10 years ago. However, to develop the decisive algorithms that classify a drug as safe or not safe, we have been working for about five years. First of all, we simulated the effect of more than 100 well-known drugs on the heart cells. After, analyzing the different changes in the electrical activity of the cells due to the action of this drugs, we finally developed a new classifier of drug-induced arrhythmias based on different in silico biomarkers”.
This unique tool classifies more than 100 drugs as safe or not safe – based on more than 450,000 simulations – with a 95% accuracy. In other words, it can be used to quickly assess the proarrhythmic risk of a new molecule. Another advantage of this product available on the InSilicoTrials platform is that it is not necessary to have any knowledge of computer modelling to use it. This in silico–based tool helps pharma companies detect early pro-arrhythmic progress in new compounds. And this information is provided in an easy and cost-effective way.
About the partnership with InSilicoTrials, Prof. Saiz comments: “As a researcher, my mission is to develop new models and tools. However, to deploy these tools to clinicians and the industry, it is necessary the role of a company such as InSilicoTrials, mainly for two reasons. First of all, to build a bridge between our research lab and the industry. The industry has to propose the right questions, that the model can answer. The second reason is related to the development of user-friendly interfaces that can help the industry use our models. We have spent much more time on developing and validating our in silico models than on creating software tools for facilitating their daily use. It is also important to underline that research centers are not keen on the exploitation and commercialization of the in silico technology, and cannot give an adequate support to the end users. In a few words, InSilicoTrials is playing a key role in the deployment of our models and tools to the pharmaceutical industry”.
Last question we want to ask Prof. Saiz is about simulation and whether or not it can be a game changer for the healthcare industry today. “There is a general consensus that the predictive capability of in silico models is starting to change the biomedical industry. This methodology is helping optimize the research and development phases of new medical devices and drugs, reducing at the same time the use of animals in the preclinical phase and of humans for clinical trials. Regulatory bodies all over the world are starting to ask companies for scientific evidence on the efficacy and safety of new medical products based on in silico simulations. In my opinion, in the next years we will see a big expansion of the use of in silico modeling tools for medical device and drug development”.
See the whole interview here: