The FDA Maps Out the Future of Animal-Free Drug Development - and Quris’ Bio-AI is Ahead of the Curve. “Companies that submit strong safety data from non-animal tests may receive streamlined review” - FDA The agency just released a roadmap to a future where preclinical drug safety relies on computational and human-relevant models - organs-on-chips, AI, and advanced in vitro systems. This is a major milestone that directly supports Quris-AI’s mission to build a predictive platform capable of fully replacing animal studies in drug toxicity assessment. Small Molecule DILI Prediction - Proven and Validated Using our hybrid Bio-AI approach, our platform has already become the most accurate in predicting drug-induced liver injury (DILI), validated by multiple pharmaceutical partners and benchmarked against industry standards. Expanding to Large Molecules and DDI Monoclonal antibodies are a central focus of the FDA’s roadmap, and we’re already on it. We’ve partnered with top-tier biotech to adapt our Bio-AI platform to large molecule safety and drug–drug interaction predictions. By integrating immune components into human-derived organ models, and tuning our models with the additional immune-related data, our AI captures systemic immune responses, detects toxicity signals, and identifies structural risks from antibody sequences - even with limited real-world data. Toward a Multi-Organ Predictive Platform We are advancing our Bio-AI approach toward systemic toxicity prediction by expanding the platform with additional organ models and training the AI to generalize across organ types and biomarkers with minimal additional data - driving scalability and reducing the data burden. This progress is highlighted in our recently published proof-of-concept multi-model study on liver-dependent neurotoxicity. https://lnkd.in/dPDVmud8 The future of preclinical testing is happening now at Quris AI. We’re actively exploring new collaborations to accelerate this transformation together. Let’s talk.
Today, the FDA is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs, and ultimately, drug prices. https://lnkd.in/ehX6dX94