Simulations Plus Announces Extensions of U.S. FDA and NIEHS Research Collaborations
MWN-AI** Summary
Simulations Plus, Inc. (Nasdaq: SLP), a leader in AI-accelerated drug development, has announced the extension of significant research collaborations with the U.S. Food and Drug Administration (FDA) and the National Institute of Environmental Health Sciences (NIEHS). These collaborations aim to advance the development of New Approach Methodologies (NAMs) and computational approaches for assessing food and chemical safety.
As regulatory agencies increasingly advocate for non-animal testing methods, including in silico and mechanistic models, Simulations Plus's extended partnerships align with this paradigm shift. The new agreements allow for the continuation of research that focuses on refining and expanding computational toxicity models, crucial for evaluating food safety.
Viera Lukacova, Chief Scientific Officer of Simulations Plus, noted the importance of these collaborations, emphasizing their role in tackling critical challenges in food safety through innovative, AI-enabled methodologies. The collaboration with the FDA's Human Foods Program specifically involves enhancing AI-based safety models following successful prior project objectives, supported by new federal funding aimed at modernizing food and chemical safety assessments.
Similarly, the NIEHS collaboration focuses on leveraging computational methods to study a broad spectrum of chemicals and exposure scenarios, in line with NIEHS’s goal of examining environmental impacts on human health. The use of Simulations Plus's software is integral to designing and validating experimental systems for chemical safety research as part of a national modernization effort.
CEO Shawn O’Connor highlighted Simulations Plus’s track record of over 30 years in model-informed drug development, positioning the company as a pioneer in the integration of advanced technologies into regulatory science. This step reinforces Simulations Plus’s commitment to contributing to safer food and chemical practices through scientific innovation.
MWN-AI** Analysis
Simulations Plus, Inc. (Nasdaq: SLP) has made a significant move in the biopharma sector by extending its research collaborations with the U.S. FDA and NIEHS. This initiative aligns with growing federal interest in non-animal testing methodologies, particularly leveraging AI to enhance food and chemical safety assessments. As the company continues to reinforce its position as a pioneer in computational toxicity models, investors should consider several key implications.
Firstly, the extensions signify a valuable endorsement of Simulations Plus' expertise in model-informed systemic approaches, which are increasingly critical as regulatory frameworks evolve. A sustained partnership with entities like the FDA indicates strong confidence in their technological prowess and enhances the company's credibility in the market. This trust could facilitate future opportunities and contracts, thereby creating paths for revenue growth.
Moreover, the increasing focus on AI-enabled and in silico methodologies provides Simulations Plus a competitive edge. With the FDA's new funding initiatives supporting modernization in safety assessments, there will be enhanced access to essential toxicological data. Investors should monitor how effectively the company can utilize this data to further refine its AI models, particularly as demand for efficient, ethical testing alternatives rises.
However, potential investors must remain cognizant of inherent risks. As indicated in the company’s forward-looking statements, market dynamics, regulatory acceptance, and technological evolution present uncertainties that could influence financial outcomes. Keeping a close eye on the success of these collaborations and their impact on financial metrics is crucial.
In conclusion, Simulations Plus stands at a pivotal juncture with these collaborations. For investors, the company presents an intriguing opportunity, contingent upon its ability to navigate regulatory landscapes and capitalize on advancing methodologies in safety assessments. Thus, maintaining a balanced view of potential benefits and risks is advisable.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Extended projects support ongoing research into computational approaches and new approach methodologies for food and chemical safety assessment
Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced the extension of two separate research collaborations with the U.S. Food and Drug Administration (FDA) and the National Institute of Environmental Health Sciences (NIEHS). The extended projects support ongoing federal research efforts focused on the development of new approach methodologies (NAMs) and advancing computational approaches for food and chemical safety assessments.
Recent guidance from the FDA and other regulatory agencies encourages the use of non-animal based research, including in silico , mechanistic, and data-driven methods intended to support food and chemical safety evaluations. The extended collaborations align with these broader federal initiatives by supporting research into the application, evaluation, and refinement of computational toxicity models.
“We appreciate the opportunity to continue our collaborations with the FDA and NIEHS,” said Viera Lukacova, Chief Scientific Officer of Simulations Plus. “The research being conducted through these projects addresses important challenges, and we are pleased to contribute our scientific engines in support of federal research efforts. We look forward to continued collaboration to advance the scientific foundation for food and chemical safety assessment through AI-enabled and in silico approaches.”
FDA Research Collaboration
The extended agreement with the FDA’s Human Foods Program allows scientists to continue research involving computational models to support chemical safety assessments for food-related substances.
Following the completion of earlier project objectives, the FDA elected to extend the collaboration with Simulations Plus to further expand and refine AI-based safety models for use in regulatory research. New federal funding dedicated to food and chemical safety modernization will provide this collaboration with expanded access to curated toxicological datasets for further training, validation, and benchmarking of Simulations Plus’ AI/ML models.
NIEHS Research Collaboration
The extended collaboration with NIEHS focuses on computational approaches relevant to environmental and exposure-related chemical safety research. This work addresses a broad range of chemicals and exposure scenarios, consistent with NIEHS’s mission to support research on environmental influences on human health.
NIEHS’ collaboration with Simulations Plus is part of a national effort to modernize chemical safety assessment through AI-powered new approach methodologies and will continue the application of the company’s software engines to help with the design, validation, and benchmarking of new experimental systems under evaluation.
Advancing NAM Research
The extensions reflect continued federal interest in evaluating computational and AI-based approaches, areas in which Simulations Plus has longstanding technical expertise.
“For 30 years, our company has helped lay the scientific foundation for what is now known as model-informed drug development,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “Our experts helped standardize methods that are now widely accepted by industry and regulators alike, and we are proud to continue pioneering the science and technology that support better-informed decisions across pharmaceutical development, food safety research and chemical risk assessment.”
About Simulations Plus, Inc.
Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com .
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”, “expect,” “anticipate,” and similar expressions (or the negative of such terms, 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 include but are not limited to statements regarding our fiscal year 2026 guidance, revenue growth, anticipated margins and profitability, demand to software and services, the impact of pricing actions, client spending levels, market conditions, the development, capabilities, regulatory acceptance, regulatory compliance and commercialization of AI-enabled and could-based solutions, the timing and content of product initiatives discussed at Investor Day, and our ability to execute our long-term strategic vision. These forward-looking statements are based on current assumptions and expectations that involve risks and uncertainties that could cause the actual results to differ materially from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our internal operational structure, our ability to maintain our competitive advantages and commercialize AI and cloud-enabled solutions, evolving regulatory and data privacy standards governing AI technologies, 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. No regulatory authority has endorsed, approved, or validated the Company’s products, platforms, or AI-related approaches.
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Investor Relations Contact :
Lisa Fortuna
Financial Profiles
310-622-8251
slp@finprofiles.com
FAQ**
How do the extended collaborations with the FDA and NIEHS impact Simulations Plus Inc. SLP's position in the field of food and chemical safety assessment?
What specific advancements in AI-based safety models are anticipated as a result of the collaboration between Simulations Plus Inc. SLP and the FDA's Human Foods Program?
Can you provide details on how the expanded access to curated toxicological datasets will enhance the capabilities of Simulations Plus Inc. SLP's AI/ML models?
In what ways will the results of the ongoing research collaborations influence regulatory practices for food safety connected to Simulations Plus Inc. SLP's methodologies?
**MWN-AI FAQ is based on asking OpenAI questions about Simulations Plus Inc. (NASDAQ: SLP).
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