WILMINGTON, DE — A $30 million federal research initiative is taking aim at one of drug development’s most stubborn and costly blind spots: predicting how the human heart will respond to new medicines before patients are exposed.
InSilicoTrials is leading a multi-institution consortium known as CARDIOVERSE, a program funded by the Advanced Research Projects Agency for Health through its CATALYST initiative. The effort brings together The Jackson Laboratory, The New York Stem Cell Foundation, UConn Health, and the University of Michigan to build next-generation virtual heart models designed to reflect the genetic, physiological, and demographic diversity of the U.S. population.
The goal is to fundamentally change how cardiotoxicity is detected, moving safety evaluation upstream in the drug development process and reducing reliance on animal testing. Despite decades of progress, unexpected cardiac side effects remain a leading cause of late-stage drug failures, market withdrawals, and patient harm.
CARDIOVERSE will combine stem cell research, experimental cardiology, computational biology, and artificial intelligence to create digital heart simulations capable of forecasting cardiac risk with greater precision. The program is led scientifically by Dr. Matt Mahoney, principal computational scientist at The Jackson Laboratory, and supported through ARPA-H’s CATALYST program under the leadership of Dr. Andy Kilianski.
Mary Dickinson, executive vice president and chief scientific officer at The Jackson Laboratory, said InSilicoTrials brings proven computational models and regulatory-aligned digital tools already used across the life sciences industry. She said that capability adds rigor and practical relevance to a project aimed at improving how cardiac safety is assessed and how new medicines reach patients.
InSilicoTrials contributes its cloud-based modeling platform and a portfolio of established cardiotoxicity simulations that evaluate proarrhythmic risk and drug–heart interactions. The company has focused its work on producing regulatory-grade digital evidence aligned with expectations from agencies such as the FDA and the European Medicines Agency.
The project also advances a broader policy objective for ARPA-H, which is pushing early-stage drug safety testing away from traditional animal models toward human-relevant digital systems. CARDIOVERSE is positioned as one of the program’s flagship efforts, integrating living-cell data with high-fidelity simulations and virtual populations to surface risks earlier and more reliably.
By uniting biological data with advanced mathematics and AI-driven prediction, the consortium aims to give researchers a clearer view of cardiac risk before a drug ever reaches a clinical trial, potentially shortening development timelines while improving patient safety.
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