VeriSIM Life’s Alignment with Recent FDA Draft Guidelines

The increasing relevance of artificial intelligence (AI) and machine learning (ML) in healthcare and medical technology makes it no surprise that the FDA has recently released new documents addressing their usage. As AI and ML continue to revolutionize drug development, regulatory bodies must ensure these technologies are safe, effective, and ethically deployed. The rapid evolution of AI-driven tools demands updated guidelines that address transparency, data integrity, and bias mitigation while fostering innovation. 

The FDA released such a document in November titled “M15 General Principles for Model-Informed Drug Development.” This document emphasizes the strategic use of computational modeling and simulation methods to integrate nonclinical and clinical data, thereby enhancing decision-making in drug development. In January 2025, the FDA released a second document sharing many of the same ideas, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.”  

VeriSIM Life's BIOiSIM platform is highly aligned with the core principles of both documents, as it leverages advanced artificial intelligence (AI) and machine learning (ML) approach to simulate complex pharmacokinetics and pharmacodynamics models. This approach ensures robust predictions of drug behavior in diverse patient populations, aligning directly with the guideline's emphasis on physiologically based pharmacokinetics (PBPK) and quantitative systems pharmacology.

BIOiSIM's ability to integrate preclinical and clinical datasets facilitates a data-driven approach to decision-making, mirroring the MIDD framework's call for transparency and multidisciplinary collaboration in evidence generation. By providing a dynamic and iterative platform for model validation, applicability assessment, and regulatory alignment, BIOiSIM addresses key elements such as Model Influence, Risk, and Impact, as outlined in the guidelines. The platform’s focus on early planning and regulatory engagement also ensures that its outputs meet the FDA's standards for evidence submission, reducing the risk of model-associated errors in decision-making.

For client projects, VeriSIM Life employs MIDD principles to address specific "Questions of Interest," such as optimizing dose selection or predicting clinical outcomes in challenging populations like pediatric or rare disease patients. For each client, BIOiSIM’s models are tailored to the "Context of Use," with explicit definitions of their role, scope, and alignment to regulatory decision-making. For instance, the platform supports early regulatory engagement by providing data-backed justifications for proposed modeling approaches, including detailed Model Analysis Plans (MAPs) that outline the technical criteria and assumptions underpinning simulations. Those MAPs serve as the foundation for alignment with regulatory authorities and ensure the models are "fit-for-purpose," as emphasized in the FDA’s framework.

Internally, VeriSIM Life utilizes BIOiSIM to drive innovation in drug development by advancing predictive toxicology, optimizing preclinical and clinical study designs, and simulating patient stratification strategies. Key MIDD elements, such as model verification, validation, and risk assessment, are embedded into every stage of model development. For example, sensitivity analyses and scenario simulations are used to assess model robustness and reduce the model risk, ensuring confidence in predictions even when working with limited or incomplete datasets. By documenting outcomes through Model Analysis Reports (MARs) and integrating them into collaborative workflows, VeriSIM Life ensures transparency, reproducibility, and regulatory readiness.

Furthermore, VeriSIM Life's commitment to comprehensive documentation, ranging from MAPs to MARs, is aligned with the FDA’s recommendations for detailed reporting and submission practices. The platform's ability to handle simulation methods, sensitivity analyses, and scenario planning ensures compliance with the technical criteria for model evaluation. By fostering early regulatory alignment and adhering to these robust practices, VeriSIM Life's technology exemplifies the FDA's vision for MIDD as a tool for accelerating drug development while ensuring patient safety and efficacy.

Through this rigorous implementation of MIDD principles, VeriSIM Life’s BIOiSIM platform not only enhances decision-making for clients but also accelerates internal drug discovery initiatives, aligning with the FDA’s vision of efficient, data-driven, and patient-centric drug development.

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