Simulations Plus, Inc. (“Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, 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.
“It is a privilege to continue combining our expertise with Simulations Plus and the FDA to advance the research on LAI formulation performance even further,” added Dr. Burgess. “The agency’s trust and confidence in this partnership underscores the leadership role both organizations have in our respective spaces. Together, we aim to develop models that bridge the gap between animal and human data and reveal the intricate relationships between formulation properties and injection site physiology, providing insight into virtual BE approaches for this growing drug delivery technology.”
Funding for this collaboration is made possible by the FDA through grant award 1U01FD008304-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organizations imply endorsement by the United States Government.
