Simulations Plus, Inc., a leading provider of cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, has officially extended its support of the U.S. Food and Drug Administration’s new roadmap for reducing animal testing through the use of new approach methodologies (NAMs).
According to certain reports, assuming the stated roadmap ends up reaching fruition, it will build upon pharmaceutical industry’s four decades-long transition towards modeling and simulation for drug development, while simultaneously leveraging regulatory agencies’ growing acceptance of the same.
You see, approaches like population pharmacokinetics (popPK), exposure-response analysis, and physiologically based pharmacokinetic (PBPK) modeling are now highly prevalent in the context of supporting regulatory submissions and interactions. Keeping that into consideration, FDA’s new roadmap outlines a path to incorporate methodologies, such as organ-on-a-chip, advanced in vitro assays, and computational modeling in preclinical safety studies. This it also does with an initial focus on monoclonal antibody (mAb) testing.
“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.”
In the similar regard, Simulations Plus software platforms are also being utilized by mAb-focused researchers for key decision-making.
For instance, the company’s GastroPlus is specifically designed to accelerate the assessment of dosing and delivery strategies that are needed for achieving desired clinical endpoints. By doing so, the technology makes it possible for researchers to reduce, and in some cases, even eliminate, animal testing during non-clinical development.
Joining that would be MonolixSuite™, which packs together a fast, easy-to-use, and powerful suite of applications for pharmacometrics analysis, modeling, and simulation. The solution also employs algorithms ideally suited to leverage model-based translation from sparse pre-clinical data for supporting prediction of human outcomes, as well as simulating efficient study designs in silico.
“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, Regulatory Strategies Center of Excellence, 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. 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.”
Apart from that, we must also mention how Simulations Plus’ software and consulting services are regularly relied upon by researchers to predict efficacy and safety of compounds before prioritizing top drug candidates for further development.
These services include ADMET Predictor®, the company’s flagship machine learning (ML) platform for ADMET modeling, with extended capabilities for data analysis, metabolism prediction, and AI-driven drug design. Alongside that, we have DILIsym®, which would be a leading quantitative systems toxicology (QST) platform for predicting and explaining drug-induced liver injury (DILI).
Rounding up highlights would be a OBESITYsym™, the only quantitative systems pharmacology (QSP) platform to predict drug efficacy for weight loss and nausea side effects.
“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,” said Steven Chang, President of QSP Solutions, Simulations Plus
