Predicting how a person’s heart will react to a new drug remains one of the most persistent blind spots in drug development. Despite decades of scientific progress, cardiotoxicity can still occur unexpectedly, resulting in enormous financial costs and, more importantly, real consequences for human health. Today, this challenge is being addressed with a new vision.
InSilicoTrials, an innovative Italian company, together with The Jackson Laboratory (JAX) under the leadership of Matt Mahoney, chief computational scientist, at the New York Stem Cell Foundation, UConn Health and the University of Michigan, is the reference point for the Cardioverse project, an initiative funded with a contribution of up to $30 million from the Advanced Research Projects Agency for Health (ARPA-H) through its Catalyst programme, led by Andy Kilianski. Together, this consortium will create the next generation of virtual heart models capable of representing the genetic, physiological and demographic diversity of the population, initially the American population, radically transforming the prediction of cardiac safety.
“It is fantastic to have InSilicoTrials as a partner in the Cardioverse team. Their validated computational models, including cardiotoxicity tools already valued across the industry, add valuable scientific and technical value to this initiative. Their ability to translate complex biology into practical, regulatory-compliant digital trials brings essential rigour. Thanks to their experience and the expertise of our wider team, we can take important steps towards cardiac safety assessments that better reflect human physiology and improve the way new drugs are developed,” said Mary Dickinson, executive vice president and chief scientific officer at The Jackson Laboratory, in a statement.
“Being a company that is able to receive so much international recognition for its scientific validity and business model is definitely a source of pride that rewards the commitment of an excellent team. We are changing the pharmaceutical development sector and, after years of investment, the market is taking notice,” Luca Emili, CEO of InSilicoTrials, tells Startupbusiness.
Cardioverse is more than a scientific project: it is a multidisciplinary effort combining innovation in the fields of stem cells, experimental cardiology, computational biology and artificial intelligence. InSilicoTrials brings to this collaboration its cloud-based technology platform, built on years of work in developing regulatory-compliant simulation tools, supporting studies in line with the FDA (Food and Drug Administration, US regulatory body) and EMA (European Medicines Agency, EU regulatory body), and providing cloud-based models to pharmaceutical and biotechnology companies globally. In addition to these capabilities, InSilicoTrials has already developed established cardiotoxicity models used by the life sciences industry to assess proarrhythmic risk and drug-heart interactions, expertise that directly strengthens its role in Cardioverse and elevates the scientific impact of the consortium.
This project builds on InSilicoTrials’ mission to make in silico testing accessible, reliable and impactful at every stage of development. Cardioverse enables the company to expand that mission to cardiotoxicity with unprecedented depth, integrating data on living cells, high-fidelity simulations, and virtual populations to help researchers identify risks that were previously invisible.
Cardioverse is one of the flagship initiatives of the Catalyst programme, ARPA-H’s visionary effort to shift early-stage drug safety from traditional animal models to human-relevant digital systems. Contributing advanced mathematical models, artificial intelligence-based predictions, and proven expertise in regulatory pathways, the project will help transform how cardiac safety is assessed before a drug reaches the human heart. (photo by Robina Weermeijer on Unsplash)
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