WILMINGTON, DE — InSilicoTrials has joined a federally funded effort to develop patient-specific digital twins for critical care, taking responsibility for technology designed to test whether the computational models are sufficiently validated and documented for potential clinical and regulatory use.
The Wilmington company is a subawardee to Sage BioNetworks on a team receiving funding from the Advanced Research Projects Agency for Health, or ARPA-H, through its Critical Illness Immunological Reprogramming and Control Point Learning Engine program, known as CIRCLE.
CIRCLE is developing artificial intelligence-driven digital twins intended to model individual patients’ immune and inflammatory responses during critical illness. The goal is to give clinicians tools for tracking those responses and potentially adjusting treatment before uncontrolled inflammation contributes to organ failure.
Under the team’s TWIN-TECC project, InSilicoTrials will adapt its existing computational clinical-trial platform into a secure environment for evaluating and combining digital twin models developed through CIRCLE.
Its work will include automated verification, validation and uncertainty quantification, along with co-simulation of mechanistic, AI and hybrid models. The platform will also support in silico clinical trials using validated digital cohorts.
A central part of the assignment is producing documentation intended to meet Food and Drug Administration requirements as researchers seek to move the models toward clinical use.
“A digital twin is only useful in the ICU if clinicians and regulators can trust it,” Vincenzo Carbone, InSilicoTrials’ head of research and innovation, said. He said automating model verification and validation could accelerate the assessment and refinement of potential clinical tools.
Critical illness presents a particularly demanding test for digital-twin technology because treatment decisions can be time-sensitive and patients can respond differently to severe infections, traumatic injuries and complications of chronic disease.
“Critical care is where the promise of digital twins meets its toughest test: decisions are made in hours, and every patient responds differently,” InSilicoTrials Chief Executive Officer Mario Torchia said.
The project brings together Sage BioNetworks, InSilicoTrials and other participants with expertise spanning artificial intelligence, model evaluation, critical care, immunology and regulatory science.
The work is funded in whole or in part by ARPA-H under the CIRCLE initiative.
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