Simulations Plus Partners with Large Pharmaceutical Company to Develop the Virtual Bioequivalence Trial Simulator™ Module

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Funded collaborative research effort strengthens the population simulation functionality in GastroPlus®

LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it has entered into a new funded collaboration with a large pharmaceutical company to develop the Virtual Bioequivalence (BE) Trial Simulator™ in GastroPlus®.

“We are beyond pleased to announce this collaboration, which will enhance the GastroPlus physiologically based biopharmaceutics (PBBM) / physiologically based pharmacokinetic (PBPK) platform to evaluate population and formulation variability on the BE of different products,” said Viera Lukacova, director of Simulation Sciences for Simulations Plus. “Working closely with our partner’s team of biopharmaceutics scientists, we intend to improve virtual BE trial simulation methodologies and efficiently address regulatory concerns as model results are reviewed.”

John DiBella, Lancaster division president for Simulations Plus, added: “We recently presented at the workshop co-hosted by the U.S. FDA and University of Maryland CERSI on the application of translational modeling strategies to support drug product development. It was evident that the use of PBBM / PBPK technology will significantly impact development and simplify regulatory decisions in a variety of ways. Our collaborator has engaged with global health authorities on numerous projects, and they identified a critical need to automate simulation activities and streamline the process of submitting data packages for regulatory purposes within a supported, validated platform. Similar to other collaborations which funded development of new functionality, Simulations Plus maintains the right to license this module to all clients, and we aim to have the first commercial version available in 2020. We welcome this interaction and invite future collaborations to drive advances to modeling and simulation sciences.”

About Simulations Plus, Inc. Simulations Plus, Inc., is a premier developer of drug discovery/development software and a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions and quantitative systems pharmacology models for drug-induced liver injury, drug-induced kidney injury, and nonalcoholic fatty liver disease. Our software is used to conduct drug research by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading provider for physiologically based pharmacokinetic modeling and simulation. Visit us online www.simulations-plus.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

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Simulations Plus Investor Relations Ms. Renee Bouche 661-723-7723 renee@simulations-plus.com Hayden IR Mr. Cameron Donahue 651-653-1854 cameron@haydenir.com

Source: Simulations Plus, Inc.

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