Goodbye Guinea Pigs: How Computer Models Are Revolutionizing Heart Medicine

Drug testing is a complex process, with heart toxicity assessment being a crucial step. Traditionally, this involved animal testing, which was time-consuming and not always accurate for human hearts. However, a new method called in silico trials has emerged, using computer models to create virtual human hearts for testing.

South Korean company Meta Heart is at the forefront of this technology with their product CardioSIM. This system conducts in silico trials for new drugs using data from earlier testing stages. CardioSIM applies the drug to a virtual average, healthy human heart to observe potential harmful side effects.

The concept of in silico trials comes from the CiPA (Comprehensive in vitro Proarrhythmia Assay) working group, which set about updating heart toxicity testing guidelines in 2012, recognizing that many promising drugs were being held up by slow and inefficient testing methods. Their work culminated in new guidelines that were approved by the FDA just a few years ago.

Here’s the high level version: Meta Heart’s core product, CardioSIM, provides in silico trials for new drugs, using data that researchers or pharmaceutical companies glean from their drugs in an earlier stage of testing. CardioSIM will plug in the data and administer the drug to a virtual heart – an average, healthy human heart – to see what effects that drug might have. If all goes well, the drug moves forward – if not, it’s back to research.

All phases of testing, including in silico trials that Meta Heart performs, are governed by guidelines that the FDA has already set out, and the data and models that build virtual hearts and guide these trials are provided by the FDA, sourced from research from the 1950s to today.

Meta Heart’s CardioSIM testing has met FDA guidelines, and the company is now working with researchers on drug testing. Meta Heart CEO Kimoo Lim hopes that Meta Heart will soon be working with pharmaceutical companies, providing testing as well as consultation services about the new CiPA testing guidelines that have been implemented.

Lim’s interest in virtual human hearts began in 2005, when he started researching treatments for arrhythmia. When the CiPA working group was formed to tackle updating heart toxicity testing, Lim started to look into how someone would use virtual hearts – when the FDA approved those new CiPA guidelines just a few years ago, he was ready to go.

As a result, Meta Heart quickly had a testing model that matched FDA guidelines. But, the company hasn’t stopped there. According to Lim, while most researchers will just use the standard model of a virtual heart, CardioSIM is flexible enough to be used with other models, based on the needs of individual researchers or pharmaceutical companies. That could include models of hearts that have specific defects, to check if the drug may interact particularly poorly with heart conditions or diseases.

CardioSIM can also help researchers establish causality – if there’s some negative reaction within the virtual heart, researchers can figure out what in the drug caused the reaction, pointing the way forward for future research. Meta Heart is also working on an AI-based model that Lim hopes, in time, will become even better than the standard model at establishing causality.

Meta Heart plans to be at CES 2025 this coming January, hoping to meet with other researchers and pharmaceutical companies to advance in silico trials using their CardioSIM testing. If all goes well, they’ll be a bigger part of the movement away from animal testing – and the ethical problems and inaccuracies that come with it – and help bring beneficial drugs to market much faster in the process.

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