Simulations Plus Receives New Grant Award From the FDA

Improvements to the GastroPlus^® platform will increase its impact in driving research and regulatory decisions on dermatological products

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that it has been awarded a new funded cooperative agreement, for $250,000 per year for up to two years, to further enhance the predictive power of the mechanistic Transdermal Compartmental Absorption and Transit (TCAT™) model in GastroPlus^® in support of regulatory interactions.

Dr. Viera Lukacova, Chief Scientist at Simulations Plus, said: “We have been engaged with various groups at the FDA since 2014 on numerous funded research programs focused on physiologically based pharmacokinetic (PBPK) modeling of complex generics and non-oral administration routes. We are delighted to have earned the FDA’s confidence to broaden our relationship with another project through a competitive bidding process. This grant award has several major aims, including the expansion of dermal formulations which can be mechanistically simulated via the TCAT model within GastroPlus, implementation of new virtual population groups, and extension of bioequivalence calculations to account for local skin concentrations. These advancements will enable researchers and regulatory scientists to more quickly, and easily, simulate countless scenarios with improved accuracy, leading to updated scientific and regulatory standards for supporting innovative development and bioequivalence assessments for dermatological products.”

Under the cooperative agreement, FDA and Simulations Plus scientific and program staff will actively assist and participate in project activities in a partnership role with several leading pharmaceutical, generic, consumer goods, and contract research organizations. Drs. Jessica Spires and Manas Shah, Senior Scientists II at Simulations Plus, will serve as principal investigators and have primary responsibility for the scientific, technical, and programmatic aspects of the award and day-to-day management of the project.

“The TCAT model in GastroPlus is being utilized today by an ever-growing number of companies and academic centers worldwide to support product development and risk assessment activities,” added John DiBella, Simulations Plus Division President. “This new award, and the access to novel data which comes with it, will allow us to develop and validate innovative in vitro-in vivo strategies and further cement GastroPlus as the preeminent dermal absorption/PBPK modeling platform. Simulations Plus will own all intellectual property developed within the GastroPlus program, and updates will be integrated into future versions of the optional dermal module. As always, we continue to invite future collaborations to drive advances to modeling and simulation science which benefit our entire user community and, most importantly, the patients that we serve.”

Funding for this collaboration is made possible by the Food and Drug Administration through grant 1U01FD007320-01. 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 25 years, Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries Cognigen, DILIsym Services, and Lixoft, 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, chemical, consumer goods companies, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on Twitter | Read our Environmental, Social, and Governance (ESG) Report.

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