RESEARCH TRIANGLE PARK, N.C.– Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of biosimulation and AI-powered modeling tools, has voiced strong support for the U.S. Food and Drug Administration’s (FDA) recently unveiled roadmap aimed at reducing animal testing in preclinical safety studies. The company announced the launch of NAMVantage™, a new service package that integrates PBPK and QSP modeling, regulatory strategy, and built-in training to help biopharma organizations transition to non-animal testing methods, in line with FDA goals.
Shawn O’Connor, CEO of Simulations Plus, welcomed the FDA’s initiative, stating that modeling and simulation technologies have reached a point where they can begin to replace traditional animal studies in many cases. He noted that the company has supported the FDA’s vision for nearly three decades and has collaborated on over 15 FDA projects in the past ten years. According to O’Connor, the FDA’s roadmap reflects a significant step toward a more ethical, efficient, and human-relevant approach to drug development.
The roadmap outlines a regulatory path for incorporating new approach methodologies (NAMs), including organ-on-a-chip systems, advanced in vitro assays, and computational models. An initial focus will be placed on monoclonal antibody (mAb) therapies. These tools are intended to improve the accuracy and speed of drug development while reducing the ethical and logistical burdens associated with animal testing.
Simulations Plus has long offered software and consulting services that align with this shift. Its GastroPlus platform helps researchers model drug absorption and delivery to reduce or avoid animal testing. MonolixSuite supports pharmacometrics analysis and in silico trial design. ADMET Predictor, powered by machine learning, allows for predictive toxicology and drug design. DILIsym and OBESITYsym offer mechanistic modeling for assessing liver toxicity and metabolic outcomes, respectively.
Company leadership emphasized that software alone is not enough for many drug developers unfamiliar with NAMs. John DiBella, President of PBPK Solutions at Simulations Plus, said the company has been at the forefront of integrating AI and machine learning with mechanistic modeling, producing human-relevant predictions and supporting peer-reviewed research in mAb development. Steven Chang, President of QSP Solutions, highlighted the importance of quantitative systems toxicology in assessing drug safety without the need for animal models. He added that the BIOLOGXsym platform can incorporate data from emerging tools like liver-on-a-chip systems to improve safety predictions in biologics.
Sandra Suarez-Sharp, President of the company’s Regulatory Strategies Center of Excellence, said that as the FDA roadmap becomes a guiding document for the industry, biopharma firms will need support interpreting and applying the agency’s expectations. She noted that Simulations Plus is uniquely equipped to help companies integrate NAMs into development plans and regulatory strategies with confidence.
The company sees this regulatory evolution as a turning point for the industry and believes that modeling and simulation will be central to a future where safer, faster, and more sustainable drug development can thrive.
