Smith Smitty Heavner

Background

About Smith Smitty Heavner

I am a scientific executive with national leadership in real-world evidence generation, data harmonization, and regulatory science. My clinical foundation as a critical care nurse shapes my approach to research and evaluation, ensuring that data systems, analytical methods, and evidence frameworks remain grounded in patient realities and frontline clinical decision-making. I design and lead large-scale data ecosystems, evaluate programs, and build infrastructures that support real-world data as a regulatory-grade asset. Across roles at the Critical Path Institute (C-Path), I partner closely with the U.S. Food and Drug Administration (FDA) to advance drug repurposing, clinical trial innovation, and standards for high-quality evidence generation. My portfolio includes more than $16 million in research funding and multi-institutional programs that align federal agencies, academic centers, industry collaborators, and clinical networks.I am recognized for shaping scientific frameworks, advancing national data efforts, and mentoring cross-disciplinary scientific teams. My work reflects a commitment to translating clinical insight and data science into actionable regulatory and organizational strategy.Honors include election as a Fellow of the American College of Critical Care Medicine (FCCM), the Clemson University Centennial Alumni Award, and multiple Presidential Citations from the Society of Critical Care Medicine.Scientific domains:Real-world evidence | Data harmonization | Clinical and biomedical informatics | Evaluation science | Drug repurposing | Evidence generation strategy | Implementation science | Critical care