InSilicoTrials Joins ARPA-H CIRCLE Team to Build a Regulatory-Ready Platform for Critical Illness Digital Twins
As a subawardee to Sage BioNetworks, InSilicoTrials will provide the platform for testing, validating and running in
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InSilicoTrials, a cloud-based platform for AI and computational modeling and simulation in healthcare, today announced that it is a subawardee on a team led by Sage BioNetworks, which has received an award from the Advanced Research Projects Agency for Health (ARPA-H) under the Critical Illness Immunological Reprogramming and Control Point Learning Engine (CIRCLE) program.
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InSilicoTrials Joins ARPA-H CIRCLE Team
Critical illness, including severe infections, traumatic injuries and complications of chronic disease, often turns deadly when the body’s immune and inflammatory response spirals out of control and leads to organ failure. ARPA-H’s CIRCLE program aims to develop AI-driven, patient-specific digital twins that let clinicians track and modulate that response in real time, so they can intervene with greater precision and speed.
Within the TWIN-DECC project, InSilicoTrials will extend its existing in silico trials platform into a secure, regulatory-ready environment where digital twin models developed across the CIRCLE program can be tested, evaluated and combined. InSilicoTrials work will focus on automated credibility assessment of digital twin models (verification, validation and uncertainty quantification), co-simulation of mechanistic, AI and hybrid models, and in silico trials on validated digital cohorts, together with the FDA-ready documentation needed to move these tools toward clinical use.
We team with Sage BioNetworks to bring together expertise in AI and model evaluation, critical care, immunology and regulatory science.
“Years ago, when we set out to build technology capable of making computational models credible enough for real patients, this is exactly the kind of recognition we were working toward,” said Luca Emili, Executive Chairman of InSilicoTrials. “Being selected to bring that platform into ARPA-H’s CIRCLE program, alongside Sage Bionetworks and this outstanding team, tells us that verification and validation of digital twins is no longer just an ambition — it is now part of one of the most advanced R&D efforts in the field. I could not be prouder of what our team, together with Sage Bionetworks, has achieved to earn this opportunity.”
“Critical care is where the promise of digital twins meets its toughest test: decisions are made in hours, and every patient responds differently,” said Mario Torchia, CEO of InSilicoTrials. “We’re proud to contribute our platform to Sage BioNetworks’ team and to the CIRCLE program. Our goal is to help make sure these models are credible, rigorously validated and ready for the bedside.”
“A digital twin is only useful in the ICU if clinicians and regulators can trust it,” said Dr. Vincenzo Carbone, Head of Research & Innovation at InSilicoTrials. “By automating verification, validation and uncertainty quantification, and letting teams run in silico clinical trials on validated digital cohorts, we can speed up how quickly promising models are refined and assessed for real patients.”
This project is funded, in whole or in part, by the Advanced Research Projects Agency for Health (ARPA-H) under the CIRCLE initiative. The views and conclusions contained herein are those of the authors and should not be interpreted as representing the official policies of ARPA-H or the U.S. Government.
About InSilicoTrials
InSilicoTrials is the simulation company founded by experts in life sciences, cybersecurity and digital innovation. Its platform uses AI and simulation to predict drug and medical device safety and efficacy, speed up R&D, and streamline clinical trials for pharmaceutical, biotech, medical device and research organizations. With a global network of more than 70 scientific partners and hundreds of integrated models, InSilicoTrials helps organizations modernize drug and device development.
Learn more at www.insilicotrials.com.
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