Simulations Plus and the University of Bath Awarded New FDA Grant

Project will focus on the development of a modeling & simulation framework to support an assessment of bioequivalence for locally-acting drugs in the gastrointestinal tract

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that, through a joint proposal with the University of Bath’s Department of Life Sciences, it has been awarded a new funded grant from the U.S. Food and Drug Administration (FDA) to advance state-of-the-art, physiologically-based biopharmaceutics (PBBM)/pharmacokinetics (PBPK) modeling approaches that can inform regulatory decisions on innovator and generic products for locally-acting drugs in the gastrointestinal (GI) tract.

For this award, Dr. Nikoletta Fotaki, Professor in Pharmaceutics, her collaborators (Dr. Bernardo Castro Dominguez, Assistant Professor, Department of Chemical Engineering) and her lab at the University of Bath will generate in vitro data from different systems for selected commercial formulations, including conditions simulating healthy, ulcerative colitis (UC), and Crohn’s disease (CD) GI environments, to assess drug release and characterize the critical quality attributes (CQAs) of the marketed products to generate and evaluate formulation variants. The scientific team at Simulations Plus will apply these data sets, along with additional pathophysiology information for UC and CD populations, to enhance and validate the Advanced Compartmental Absorption and Transit (ACAT™) model within the GastroPlus® platform and determine the impact of changes to CQAs and physiological variables on local and systemic exposure in patient groups. The resulting outcome will provide the foundation of a viable alternative to in vivo studies for the establishment of bioequivalence (BE) for locally-acting GI products.

Dr. Haiying Zhou, Sr. Director, Simulation Technologies at Simulations Plus and co-Principal Investigator for this project, said: “The story of GastroPlus started in 1998, and for nearly twenty-five years it has been, time and time again, independently verified as the preeminent software for predicting oral drug absorption for pharmaceuticals and chemicals alike. This new collaboration with Dr. Fotaki, her team, and the FDA will look to build upon our foundation to improve the accuracy of drug concentrations predicted locally within gut tissue and outline novel strategies for applying in vitro systems and in silico models to lower regulatory burden and minimize the need for animal and human studies as new formulation approaches are evaluated for addressing GI diseases.”

FDA scientific and program staff will actively collaborate with the University of Bath and Simulations Plus. Dr. Zhou, with assistance from Dr. Maxime Le Merdy, Dr. Daniela Silva, Dr. Noam Morningstar-Kywi, and Dr. Viera Lukacova, will coordinate modeling and simulation activities of the contract.

“Thanks to this FDA-funded partnership with Simulations Plus, the future is coming much quicker than we predicted, and this project will be a great way for both industry and academia to make that leap from research into real life applications, with potential benefits of tangible patient outcomes,” said Dr. Fotaki. “Our goal is to allow realization of new models that will bridge the gap between in vitro and in vivo data, and the final framework and best practices developed under this contract will be meaningful for both the FDA as well as the end users in the companies that develop therapies for this disease space.”

“There are few, if any, organizations that have six funded partnerships with the leading global health authority entering 2023 like Simulations Plus,” added Dr. Le Merdy, Associate Director, Research and Collaborations. “This award achieves a significant objective for us, as we will now be partnering with the FDA to provide validated, innovative solutions for all major dosing routes around the body. By working to ensure that all future improvements are accessible to industry, nonprofit and academic researchers alike, our advancements in modeling and simulation science will benefit both those within the research community as well as patients everywhere.”

Funding for this collaboration is made possible by the Food and Drug Administration through grant award 1U01FD007660-01. 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 organization imply endorsement by the United States Government.

About the Fotaki Laboratory in the Department of Life Sciences at the University of Bath

The principal achievements in Dr. Fotaki’s laboratory are in translational biopharmaceutics, with expertise and research being focused on PBPK modeling and PBBM, development of in vitro and in silico tools for predicting absorption and in vivo drug/formulation performance in normal and special populations (i.e., pediatrics, disease states), dissolution methods, formulation development, in vitro-in vivo correlations and biowaivers. Dr. Fotaki has published 87 peer-reviewed articles in highly respected journals in the pharmaceutics field as well as one book and 10 book chapters.

About Simulations Plus

Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.

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