Ethan Chen is being honored in Category 4: Using Innovative Technologies to Deliver Simple, Seamless, and Secure Services for modernizing the FDA’s data and AI infrastructure to accelerate and improve regulatory review. As Director of the Division of Data Management Services and Solutions in the FDA’s Office of Digital Transformation, Ethan is consolidating fragmented legacy systems into secure, unified platforms that give reviewers faster access to the information they need to evaluate drug submissions.

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In 2025, Ethan delivered the enterprise data platform supporting Elsa, FDA’s secure AI assistant, which retrieves and summarizes scientific and regulatory information across multiple systems. He also developed analytics tools that automate repetitive searches and document assembly and created a unified platform connecting safety data, sponsor submissions, and decades of previous FDA reviews. A secure FISMA High AI environment allows reviewers to use advanced large language models while keeping sensitive regulatory information within FDA-controlled systems.

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These innovations are dramatically reducing the time employees spend locating and analyzing information. Tasks that previously took hours—or, in some cases, several days—can now be completed in minutes, allowing reviewers to focus more attention on scientific analysis and decision-making. Consolidating legacy programs also generated $14 million in savings in FY2024 and another $8 million in early FY2025. By combining secure AI with unified, accessible data, Ethan is building a more efficient regulatory review environment with the potential to help safe and effective medicines reach the public faster.