VeriSIM Life Formalizes Research Collaboration with FDA/NCTR, Advancing the Next Generation of Mechanistic AI for Drug Development

Material Transfer Agreement establishes a formal framework for collaboration, reinforcing BIOiSIM's role as a scientifically defensible, mechanistically grounded AI platform designed for the rigor of translational drug development.

SAN FRANCISCO--(BUSINESS WIRE)--Drug development remains one of the most resource-intensive and failure-prone endeavors in modern science. Despite significant advances in artificial intelligence and computational chemistry, the fundamental translational gap between preclinical models and human clinical outcomes persists, contributing to late-stage failure rates that cost the industry hundreds of billions of dollars annually.

VeriSIM Life was founded to solve that problem. The company's core platform, BIOiSIM, is a hybrid mechanistic-AI system that integrates mechanistic quantitative models and machine learning into a unified translational framework spanning drug discovery, preclinical development, clinical optimization, and regulatory submission support.

VeriSIM Life has entered into a Material Transfer Agreement (MTA) with the FDA's National Center for Toxicological Research (FDA/NCTR), establishing a framework for ongoing scientific collaboration. The collaboration builds on prior peer reviewed work, including a 2025 co-authored publication demonstrating BIOiSIM's ability to predict drug induced liver injury. This agreement builds on VeriSIM’s ongoing scientific engagement with FDA/NCTR researchers and reinforces the rigor, transparency, and translational relevance of BIOiSIM’s mechanistically grounded AI system.

BIOiSIM supports pharmaceutical and biotechnology companies across therapeutic areas with mechanistically grounded AI that generates transparent, scientifically defensible evidence for research, development, and regulatory decision making.

The collaboration strengthens VeriSIM's position at the forefront of mechanistically grounded AI, advancing computational approaches that improve human relevance, support regulatory science, and accelerate better drug development decisions.

"BIOiSIM was built on the belief that AI should do more than generate predictions. It should explain the biology behind them and provide evidence scientists can trust. Our collaboration with FDA/NCTR advances that vision by strengthening the scientific foundation for more predictive, transparent, and human relevant drug development."

Jo Varshney, DVM/PhD, Founder & CEO, VeriSIM Life

About VeriSIM Life

VeriSIM Life is redefining drug development with mechanistically grounded AI. Its BIOiSIM platform enables pharmaceutical and biotechnology companies to make earlier, more confident decisions by generating transparent, biologically grounded evidence across discovery and development. VeriSIM's technology is helping reduce the cost, time, and risk of bringing new medicines to patients. The company is headquartered in San Francisco, California.