• Collaboration with regulatory, industry, and academic partners will support and accelerate the development and validation of workflows to conduct virtual bioequivalence studies

LANCASTER, Calif. / Sep 21, 2023 / Business Wire / Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced it has been awarded a new funded grant from the U.S. Food and Drug Administration (FDA). The grant will be used to validate and define best practices for physiologically based biopharmaceutics/pharmacokinetics (PBBM/PBPK) modeling workflows to simulate virtual bioequivalence (VBE) studies in support of regulatory biowaivers.

The scientific team at Simulations Plus, with partners from the FDA, industry, and academia, will apply public and proprietary datasets to validate the ability of GastroPlus® and other software to predict inter- and intra-subject variability when performing virtual population simulations. Enhancements to the existing VBE simulation engine within GastroPlus will be implemented, and best practices will be defined for VBE evaluation using mechanistic PBBM/PBPK approaches. The goal of this work is to inform regulatory decisions and guide innovator and generic drug developers in the design of VBE studies for distinct types of drug products.

Dr. Frederico Martins, Principal Scientist and LATAM Scientific Lead, PBPK Solutions, and Principal Investigator for this grant, said: “At the recent PBBM/PBPK workshop sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA, it became clear that regulatory agencies worldwide are actively promoting the increased adoption of VBE approaches in numerous ways. The many case studies presented at the workshop, nearly all of which utilized GastroPlus simulations, firmly reinforced GastroPlus as the leading software platform for drug product development. With this new award, we are poised to shape industry best practices and define innovative workflows for leveraging in vitro systems and in silico models to further reduce regulatory burden and minimize the need for human studies.”

FDA scientific and program staff will actively collaborate with Simulations Plus and others from industry and academia. Dr. Martins, with assistance from Simulations Plus colleagues Dr. Maxime Le Merdy, Dr. Géraldine Cellière, and Mr. James Mullin, will coordinate all activities of the award.

“With a rich and enduring history of fruitful partnerships with the FDA, we have consistently demonstrated our commitment to collaboration and excellence in research and regulatory affairs,” added Dr. Le Merdy, Associate Director, Research & Collaborations of PBPK Solutions. “Our mission with this award is clear: to set the industry standard and provide invaluable guidance for all companies navigating the regulatory assessment of new and generic formulations. By diligently striving to make all forthcoming enhancements accessible to industry, nonprofit organizations, and academic researchers, we will enable the advancement of modeling and simulation applications. This commitment ensures that the benefits extend not only to those within the scientific community but also reach patients worldwide.”

Funding for this collaboration is made possible by the Food and Drug Administration through grant award 1U01FD007906-01. 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 Simulations Plus, Inc.

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 artificial intelligence (AI)/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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