Risk Management
Drug development is long, resource-intensive, and uncertain, and Sanofi needed a better way to assess safety, efficacy, and competitive differentiation of drug candidates before advancing them into later clinical phases.
Reported impact
Sanofi says virtual patients enable faster first assessments of safety and efficacy, better accuracy, potential reductions in the number of trial patients needed, evidence generation for hard-to-recruit subtypes, and research cycles that can shrink from weeks to hours.
Sanofi describes an in-house AI-based digital twinning approach for early drug development using virtual patient populations. The implementation starts by ingesting available clinical trial data from live patients together with disease biology, pathophysiology, and known pharmacology data. These inputs are combined in a single computational framework built with quantitative systems pharmacology (QSP) modeling and AI models. Within that framework, Sanofi generates digital twins of human patients, simulates an investigational compound's mechanism of action on disease pathways, and measures predicted effects on clinical endpoints such as cytokines, lung function, and exacerbations. The virtual patient computer platform is then used to run blind predictions against Phase 1b trial results, compare candidate performance with existing therapies, and support R&D teams in deciding whether to move compounds into the next clinical phase.
Sanofi combines clinical trial data from live patients with disease biology, pathophysiology, and known pharmacology in a single QSP-based computational framework. That framework generates virtual patients, simulates a compound's mechanism of action on disease pathways, and produces predicted clinical effects that R&D teams compare with observed Phase 1b results and other therapies before advancing development.
"Drug development is long, resource-intensive and marked by uncertainty at every turn."
"In this 'blind' model prediction, the model's results were a good match to the data observed in the Phase 1b study."
"Once this framework is in place, we can simulate an investigational compound's mechanism of action (MOA) in digital patients to understand how that compound might work on known disease pathways or drivers."
"Our teams can scale and accelerate research processes from a matter of weeks to just hours"
"Through digital trials, we can conduct faster first assessments of the safety and efficacy of drug candidates with better accuracy, and potentially even reduce the number of patients needed in clinical trials."
"Using what is called quantitative systems pharmacology (QSP) modeling of a disease and available clinical trial data from live patients, we can create digital twins of the human patients seen in the clinic."
"When generating the virtual patients, we take all of the available data on disease biology, pathophysiology, and known pharmacology, and integrate it into a single computational framework."
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Scoring methodology
Customer Reference Value measures usefulness as a customer reference. Evidence Confidence measures the quality and traceability of available evidence, not independent verification.
Traceability
Field coverage shows which facts each source supports. Dates are shown only when documented by the source.
Sanofi has moved into its new global headquarters in the 17th arrondissement of Paris, at 46-48 Avenue de la Grande Armée.
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