Pragmatic Approach, South Carolina
Smith F. Heavner, PhD, RN, FCCM, is an evaluation scientist who shapes public health systems by translating between clinicians, regulators, and data systems to build decision-grade evidence pipelines. Dr. Heavner designs rigorous, fit-for-purpose real-world evidence (RWE) strategies that connect clinical care, patient perspectives, data science, and regulatory decision-making. His work focuses on electronic health records, natural history studies, and external controls in rare diseases, with emphasis on methodological clarity, cohort definition, endpoint alignment, and bias mitigation to ensure evidence is actionable for high-stakes decisions.
Dr. Heavner is Senior Scientific Director at the Critical Path Institute’s (C-Path) Data Collaboration Center, where he leads real-world evidence and evaluation initiatives. His work includes oversight of large-scale EHR-based registries, data governance frameworks, and mixed-methods evaluation programs designed to support the use of real-world data in regulatory submissions. Across these efforts, he focuses on cohort definition, endpoint alignment, data quality, and bias mitigation to ensure regulatory ready evidence generation.
Dr. Heavner holds national leadership roles within the Society of Critical Care Medicine (SCCM) and the American Evaluation Association, contributing to major initiatives in data harmonization, registry development, and learning health system infrastructure. In recognition of his contributions, he is a Fellow of the American College of Critical Care Medicine and a recipient of the Clemson University Centennial Alumni Award.
He holds faculty appointments spanning public health, medicine, and law, reflecting a commitment to training translational scientists capable of working across clinical, regulatory, and methodological boundaries. His background in nursing continues to inform his emphasis on pragmatic, ethically grounded approaches to evidence generation that remain closely aligned with patient experience and real-world care delivery.
SCCM Discovery Critical Care Innovation Incubator
Saturday, March 21, 2026
7:00 AM - 7:00 PM Central Time
Disclosure(s): No relevant financial relationship(s) to disclose.
Table 12: ICU Centers of Excellence
Monday, March 23, 2026
2:30 PM - 3:30 PM Central Time
Disclosure information not submitted.