Simulations Plus and the University of Connecticut Receive New FDA Grant to Expand Mechanistic Modeling Approaches for Long-Acting Injectables

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Funded collaboration will leverage current FDA partnership to include additional LAI technologies

LANCASTER, Calif., November 13, 2024--(BUSINESS WIRE)--Simulations Plus, Inc. (Nasdaq: SLP) ("Simulations Plus"), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced that it has been awarded a newly funded grant from the U.S. Food and Drug Administration (FDA) to use physiologically based pharmacokinetic (PBPK) approaches in GastroPlus® to build and validate mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectable (LAI) technologies through a joint proposal with the University of Connecticut’s School of Pharmacy, Department of Pharmaceutical Sciences.

This project aims to use the GastroPlus PBPK platform to investigate the intricate relationship between LAI formulation critical quality attributes (CQAs) and physiological factors at the injection site to accurately predict in vivo drug release and absorption. Dr. Diane Burgess, Board of Trustees Distinguished Professor of Pharmaceutics and Pfizer Distinguished Endowed Chair of Pharmaceutical Technology at the University of Connecticut and her lab will generate in vitro and in vivo data for marketed LAI suspension products using novel discriminatory systems. The scientific team at Simulations Plus will use this data, along with additional inputs from research collaborators, to develop PBPK models and apply them to validate mechanistic IVIVCs. This effort is expected to lay the groundwork for a practical alternative to in vivo studies in establishing bioequivalence (BE) for additional LAI product technologies.

"LAI formulations are becoming increasingly important in pharmaceutical pipelines and product portfolios due to their ability to improve patient compliance and deliver extended drug release," said Dr. Daniela Silva Ryan, Scientist II at Simulations Plus and principal investigator for this grant. "Preclinical and clinical studies to evaluate new formulation designs are lengthy and expensive. With this new grant, we expect our work within GastroPlus to demonstrate how PBPK modeling can reduce development time and costs, while streamlining regulatory processes for both innovator and generic formulations."

FDA scientific and program staff will actively collaborate with the University of Connecticut, Simulations Plus, and select industry partners. Dr. Silva Ryan, with assistance from scientists at Simulations Plus, will coordinate the contract’s modeling and simulation activities.

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