Simulations Plus Supports New FDA Roadmap for Reducing Animal Testing in Preclinical Safety Studies

Modeling and simulation will be a key component for shift to non-animal methodologies

Introducing NAMVantage(TM), a flagship package offering PBPK and QSP professional services and regulatory strategy combined with built-in coaching and training

Simulations Plus, Inc. (NASDAQ:SLP) ("Simulations Plus"), a leading provider of cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced its support of the U.S. Food and Drug Administration's (FDA) recently announced roadmap for reducing animal testing through the use of new approach methodologies (NAMs). Simulations Plus has long provided the industry-leading software and consulting service expertise to successfully implement the FDA roadmap.

"We are excited to see that the FDA is elevating its continued commitment to reduce animal testing through innovative science, as outlined in the new Roadmap to Reducing Animal Testing in Preclinical Safety Studies," said Shawn O'Connor, Chief Executive Officer of Simulations Plus. "The science has evolved—today, modeling and simulation can offer human-relevant insights that not only complement but in many cases can begin to replace traditional animal studies. This allows our clients to get new treatments to patients faster and improve lives around the world. At Simulations Plus, we've supported this vision for nearly 30 years, and we're proud that our software and services are helping to make it a reality. Having collaborated with the FDA on more than 15 projects over the past decade, we understand the agency's focus on integrating new methodologies like computational modeling that will help reduce and eventually eliminate animal testing. This roadmap is an important step toward a future where safer, faster, and more sustainable drug development is possible, and we look forward to continuing our close collaboration with the FDA and industry to support this important transformation."

Over the past four decades, modeling and simulation for drug development has gained traction within the pharmaceutical industry and achieved broad acceptance by global regulators. Approaches such as population pharmacokinetics (popPK), exposure-response analysis, and physiologically based pharmacokinetic (PBPK) modeling are now widely used to support regulatory submissions and interactions. The new FDA roadmap outlines a path to incorporate methodologies such as organ-on-a-chip, advanced in vitro assays, and computational modeling in preclinical safety studies, with an initial focus on monoclonal antibody (mAb) testing.

Simulations Plus software platforms are utilized by mAb-focused researchers for key decision-making, including:

• GastroPlus accelerates the assessment of dosing and delivery strategies needed to achieve desired clinical endpoints, enabling researchers to reduce—and in some cases, eliminate—animal testing during non-clinical development.
• MonolixSuite™, a fast, easy-to-use, and powerful suite of applications for pharmacometrics analysis, modeling, and simulation employs algorithms ideally suited to leverage model-based translation from sparse pre-clinical data to support prediction of human outcomes as well as to simulate efficient study designs in silico to further optimize development programs and enhance a compound's benefit-risk profile.

In addition, Simulations Plus' software and consulting services are regularly relied upon by researchers to predict efficacy and safety of compounds and prioritize top drug candidates for further development—contributing to a reduction in animal testing and more focused clinical trials. Some of these other Simulations Plus platforms include:

• ADMET Predictor®, the flagship machine learning (ML) platform for ADMET modeling, with extended capabilities for data analysis, metabolism prediction, and AI-driven drug design.
• DILIsym®, the leading quantitative systems toxicology (QST) platform for predicting and explaining drug-induced liver injury (DILI).
• OBESITYsym™, the only quantitative systems pharmacology (QSP) platform for predicting drug efficacy for weight loss and nausea side effects. 

Pharmaceutical companies also leverage the expertise of Simulations Plus consultants during development in the areas of PBPK, quantitative systems pharmacology/toxicology (QSP/QST), clinical pharmacology and pharmacometrics. Simulations Plus' PBPK services team delivers high-value scientific expertise to help clients replace or reduce animal testing by developing and validating predictive PBPK models that integrate standard in vitro and in silico data to simulate human and animal pharmacometrics. GastroPlus currently includes eight animal species and human models, including non-human primates, minipigs and dogs. By tailoring these models to specific program needs—including interspecies extrapolation, first-in-human dose selection, and safety margin assessments—the team supports regulatory submissions that align with NAMs, helping clients accelerate development timelines while promoting ethical research practices.

"We applaud the FDA's forward-thinking approach to advancing non-animal methodologies, particularly for monoclonal antibody development," said John DiBella, President of PBPK Solutions of Simulations Plus. "At Simulations Plus, we've been pioneering the integration of artificial intelligence and machine learning (AI/ML) with mechanistic modeling for years—delivering predictive, human-relevant insights and toxicology forecasting for our clients. Our software has already been at the center of dozens of peer-reviewed publications validating our approach in the mAb research space. We are dedicated to advancing the industry through innovative, proven tools that accelerate this crucial regulatory evolution."

"Quantitative systems toxicology (QST) modeling will be essential in reducing reliance on animal testing by predicting toxicologic risk for patients as well as providing mechanistic insights into drug safety that are grounded in human biochemistry and physiology," said Steven Chang, President of QSP Solutions of Simulations Plus. "Our safety-focused modeling approaches have long been used to inform regulatory as well as pharma company decision-making to identify safe and effective dosing paradigms. Our QST model, BIOLOGXsym, is well-positioned to bridge the need for reduced animal testing by incorporating ‘liver-on-a-chip' data as inputs to help drug developers assess and improve liver safety in large molecules, including mAbs. We're proud to offer some of the most trusted and widely used toxicology modeling software platforms in the industry, empowering our partners to confidently align with the FDA's vision for the future."

Many organizations will need more than new modeling tools and in vitro systems. To follow the FDA roadmap, companies not currently incorporating NAMs into their development processes and timelines may also require consulting services, regulatory guidance and training on new tools.

"The FDA's roadmap sends a clear signal that the future of preclinical safety assessment lies in innovative, non-animal methodologies—and modeling and simulation will be central to that shift," said Sandra Suarez-Sharp, President of the Regulatory Strategies Center of Excellence of Simulations Plus. "Software and models are already available to support several modeling activities, but where many biopharmas may encounter challenges is in developing regulatory strategies that effectively incorporate the key points outlined in the FDA's roadmap. At Simulations Plus, we are positioned to help companies interpret and apply emerging expectations, offering expert guidance to integrate modeling and simulation and risk assessment into regulatory strategies with confidence and credibility."

Simulations Plus is pleased to introduce NAMVantage^™, its flagship package offering PBPK and QSP software, professional services and regulatory strategy combined with built-in coaching and training. This comprehensive solution offers clients full support for the FDA's NAM roadmap. In addition, companies seeking immediate training for their scientists will find quick access through the Learning Services program, which offers workshops and on-demand courses, and the popular MIDD+ events that offer free in-person training. For more in-depth training on actual projects, the Consult +Coach program allows researchers to learn alongside expert modelers during a consulting study.

To learn more about modeling and simulation software, regulatory support, or training opportunities, visit www.simulations-plus.com.

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, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, 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.

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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," "will", "can", "believe", "expect," "anticipate" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) 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. Forward looking statements contained in this press release include, but are not limited to, statements about expectations for the second half of 2025 and anticipated projections for fiscal year 2025. Factors that could cause or contribute to such differences include, but are not limited to: our ability to integrate our ALI and MC business units, our ability to meet our stated guidance, 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, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual and current reports and filed with the U.S. Securities and Exchange Commission.

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