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Erudio Bio submitted comments to the FDA's Request for Information on the Expedited Investigational New Drug Pilot Program, outlining a strategy to modernize the pre–first-in-human stage of drug development. The proposal calls for higher-fidelity, higher-throughput biophysical measurements integrated with AI and physics-based simulations anchored to experimental data, enabling developers to identify promising candidates earlier, eliminate likely failures before substantial resources are committed, and improve the quality and safety of IND submissions. Erudio Bio emphasized that adopting these advanced tools could accelerate clinical development, reduce costs and failure rates, and strengthen U.S. leadership in next-generation medicine.
https://www.regulations.gov/comment/FDA-2026-N-4699-0011Erudio Bio today announced a grant from the Gates Foundation to support bioTCAD™, an AI platform that pairs advanced modeling with Erudio’s multiplex force-spectroscopy binding measurements. The project aims to make preclinical drug design more reliable and faster—ultimately lowering the cost of developing medicines for diseases that disproportionately affect people in low- and middle-income countries. “AI needs trustworthy experimental labels to predict what actually works,” said Kee-Hyun Paik, PhD, Erudio’s co-founder and CEO. “With the foundation’s funding support, we’ll scale bioTCAD to generate high-quality binding data and put it to work on high-burden diseases.”
Gates Foundation Erudio Bio Grant