Core Insights - Simulations Plus, Inc. has announced the extension of two research collaborations with the FDA and NIEHS, focusing on new approach methodologies (NAMs) and computational approaches for food and chemical safety assessments [1][2][4] FDA Research Collaboration - The collaboration with the FDA's Human Foods Program will continue to utilize computational models for chemical safety assessments related to food substances [4] - The FDA has chosen to extend this collaboration to enhance AI-based safety models, supported by new federal funding aimed at modernizing food and chemical safety [5] NIEHS Research Collaboration - The partnership with NIEHS will concentrate on computational methods relevant to environmental and exposure-related chemical safety research, aligning with NIEHS's mission to investigate environmental impacts on human health [6][7] - This collaboration is part of a national initiative to modernize chemical safety assessments using AI-driven methodologies [7] Advancing NAM Research - The extensions of these collaborations indicate a sustained federal interest in computational and AI-based approaches, areas where Simulations Plus has established technical expertise over the years [8] - The company has been instrumental in developing model-informed drug development practices for 30 years, contributing to standardized methods accepted by both industry and regulators [9]

Company Overview - Simulations Plus, Inc. is a global leader in model-informed and AI-accelerated drug development, focusing on enhancing biopharma innovation through advanced software and consulting solutions [4]. Event Announcement - The company will host a virtual Investor Day on January 21, 2026, providing an in-depth look at its long-term strategy, product roadmap, and financial outlook, along with a Q&A session with the executive leadership team [2][7]. Industry Context - Biopharma companies are increasingly prioritizing predictability, transparency, and scientific rigor in drug development, and Simulations Plus aims to support these needs through its unified strategy [3]. Strategic Vision - The event will showcase Simulations Plus' vision for an integrated, AI-enabled modeling ecosystem that spans discovery, development, clinical operations, and commercialization [3]. Agenda Highlights - The agenda will include updates on the industry environment, the company's unified product and technology strategy, advances in scientific services supporting client workflows, and financial priorities and outlook [7].