Objective to define best practices for the use of novel PBK modeling strategies to support animal-free safety assessment of new chemicals

Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced a newly funded research project with the International Collaboration on Cosmetics Safety (ICCS) to evaluate the use of physiologically-based kinetic (PBK) modeling approaches to advance animal-free science for cosmetics and other non-pharmaceutical ingredients.

In a competitive bidding process, Simulations Plus was selected for its proposal to establish workflows for probabilistic PBK modeling of new chemicals based on pharmacokinetic (PK) analogs. Simulations Plus will review ICCS-provided data, select target-source pairs based on similarity criteria, build PBK models for source chemicals, and apply these in virtual populations to predict exposure for target chemicals. The results and best practices will be published.

“We are excited to partner with ICCS and its membership, which includes major cosmetics and consumer product companies, ingredient suppliers, trade and research organizations, and animal welfare NGOs. Our mutual goal is to expand the use of PBK models for the safety assessment of new chemicals developed in an animal-free paradigm,” said Dr. Priyata Kalra, Senior Scientist at Simulations Plus and principal investigator for this collaboration. “Using data from ICCS, we will collaboratively develop a PBK-based read-across concept for various chemicals and exposure routes (intravenous, oral, dermal) across virtual populations of different species (humans and rodents). This partnership is expected to result in general workflows and guidance for implementing this approach in animal-free safety assessments.”

“We have pioneered the integration of machine learning with PBK models, coupled with limited in vitro data, to accurately predict safety exposure levels in animals and humans,” added Dr. Maxime Le Merdy, Director of PBPK Research & Collaborations at Simulations Plus. “We believe our expertise in this space, combined with ICCS’s commitment to advancing animal-free research and development, will help drive innovation in the non-pharmaceutical markets we serve. As a recognized global leader in modeling and simulation, we look forward to collaborating on this important research project that will help establish best practices and a comprehensive framework as valuable guidance tools for companies and regulatory agencies.”

About Simulations Plus, Inc.

With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics (PBPK), quantitative systems pharmacology/toxicology (QSP/QST), and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | YouTube.

About the International Collaboration on Cosmetics Safety

The International Collaboration on Cosmetics Safety (ICCS) is a global initiative, headquartered in New York, focused on advancing the adoption of animal-free assessments of cosmetics, and their ingredients, for human health and environmental safety. ICCS brings together scientists and experts from cosmetics manufacturers and suppliers, industry and research associations, and animal protection organizations to drive greater global awareness and confidence in animal-free science through research, education, and regulatory engagement. Building on nearly four decades of progress in the development, evaluation, and use of animal-free approaches, we aim to accelerate the transition to animal-free safety science through widespread adoption and use. For more information, visit our website at www.iccs-cosmetics.org/.

Environmental, Social, and Governance (ESG)

We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our 2023 ESG update.

Forward-Looking Statements

Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “expect,” and “anticipate” mean that these are our best estimates as of this writing, but 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: changes to our relationship with ICCS, the parameters and process used to develop the PBK models in collaboration with ICCS, market and regulatory acceptance of such models, the accuracy of predictions developed using such models, our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software, the general economics of the pharmaceutical industry, market conditions, macroeconomic factors, 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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