FDA enlists virtual patients for in silico trials

Computational modeling is an exciting area of biomedical research that uses computers to simulate biological systems, referred to as “in silico” research.

In July French company, Dassault Systèmes, a pioneer in 3D design software and creator of the Living Heart Project, announced that its collaboration with the U.S. Food and Drug Administration (FDA) will be extended for another 5 years.  This partnership, begun in 2014, focuses on in silico testing for potential therapeutic devices to treat heart disease.

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The Living Heart Project  is a scientifically validated, fully authentic, three-dimensional model of the human heart and cardiovascular system for use by medical professionals.

The simulated heart allows clinicians, researchers and device manufacturers to explore the heart and its response to treatments, including testing treatments such as pacemaker leads, cardiac valves and stents, all without using animals.

Approximately 51% of animal studies are done to test for medical products or devices translating into about a million animals yearly. In silico trials have the power to spare animals – typically dogs, pigs, sheep, rats and mice – from the extreme pain of experiments that induce cardiac disease, damage the heart and implant devices.

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FDA and Dassault are conducting in silico clinical trials to transform how new devices can be tested without injuring animals, as well as to enhance the safety of clinical trials for humans. Their successes in the past 5 years include simulating blood flow in a beating heart and determining whether a drug will cause arrhythmia, the number one reason drugs fail in clinical trials. 

Computational modeling can also advance personalized medicine. A patient’s own CT or MRI scan can be input to predict their unique biological response to treatment.

The Living Heart Project also includes The Virtual Operating Room, where clinicians can carry out simulated surgical procedures in real time.  Wearing specialized eyeglasses, scientists can explore deep inside the simulated heart using holographic 3D technology and visualize the minute intricacies of the human heart and surrounding vessels.

Tina Morrison, Ph.D, Deputy Director in the Division of Applied Mechanics at the FDA emphasizes “In some cases, in silico clinical trials have already been shown to produce similar results as human clinical trials.”

Dassault’s Living Heart Project has exciting implications for replacing animals in heart device testing while finding much needed treatments for heart disease, the leading cause of death in humans.

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