Simulations Plus, Inc. (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, announced the extension of two separate research collaborations with the U.S. Food and Drug Administration (FDA) and the National Institute of Environmental Health Sciences (NIEHS). The extended projects support ongoing federal research efforts focused on the development of new approach methodologies (NAMs) and advancing computational approaches for food and chemical safety assessments.
Recent guidance from the FDA and other regulatory agencies encourages the use of non-animal based research, including in silico , mechanistic, and data-driven methods intended to support food and chemical safety evaluations. The extended collaborations align with these broader federal initiatives by supporting research into the application, evaluation, and refinement of computational toxicity models.
“We appreciate the opportunity to continue our collaborations with the FDA and NIEHS,” said Viera Lukacova, Chief Scientific Officer of Simulations Plus. “The research being conducted through these projects addresses important challenges, and we are pleased to contribute our scientific engines in support of federal research efforts. We look forward to continued collaboration to advance the scientific foundation for food and chemical safety assessment through AI-enabled and in silico approaches.”
FDA Research Collaboration
The extended agreement with the FDA’s Human Foods Program allows scientists to continue research involving computational models to support chemical safety assessments for food-related substances.
Following the completion of earlier project objectives, the FDA elected to extend the collaboration with Simulations Plus to further expand and refine AI-based safety models for use in regulatory research. New federal funding dedicated to food and chemical safety modernization will provide this collaboration with expanded access to curated toxicological datasets for further training, validation, and benchmarking of Simulations Plus’ AI/ML models.
NIEHS Research Collaboration
The extended collaboration with NIEHS focuses on computational approaches relevant to environmental and exposure-related chemical safety research. This work addresses a broad range of chemicals and exposure scenarios, consistent with NIEHS’s mission to support research on environmental influences on human health.
NIEHS’ collaboration with Simulations Plus is part of a national effort to modernize chemical safety assessment through AI-powered new approach methodologies and will continue the application of the company’s software engines to help with the design, validation, and benchmarking of new experimental systems under evaluation.
Advancing NAM Research
The extensions reflect continued federal interest in evaluating computational and AI-based approaches, areas in which Simulations Plus has longstanding technical expertise.
“For 30 years, our company has helped lay the scientific foundation for what is now known as model-informed drug development,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “Our experts helped standardize methods that are now widely accepted by industry and regulators alike, and we are proud to continue pioneering the science and technology that support better-informed decisions across pharmaceutical development, food safety research and chemical risk assessment.”
