Speakers: Scott Swain, PhD, MPH

Scott Swain, PhD, MPH

Director of Regulatory Science and Real-world Evidence
Cardinal Health


Scott Swain, PhD, MPH is Director of Regulatory Science and Real-world Evidence at Cardinal Health Insights & Engagement, where his responsibilities include developing strategies to incorporate alternative study designs, such as real-world evidence (RWE), to increase efficiency of clients’ medical product development from early clinical phases through regulatory submission and post-marketing. Previously, as Lead Epidemiologist in the FDA/CDER Division of Epidemiology, Dr. Swain led the epidemiology team overseeing RWE safety and efficacy issues for oncology, hematology, and medical imaging products. He has over a decade of experience with epidemiological study design, protocol and statistical analysis plan development, and conducting research using large, multi-level electronic healthcare datasets, and has published dozens of abstracts and presentations for scientific conferences and manuscripts in peer-reviewed journals. Dr. Swain earned a PhD in Epidemiology and a Certificate in Pharmacoepidemiology from Johns Hopkins University, and a Master of Public Health in Epidemiology at George Washington University.

The Strategic Role of Real-World Data in Medicine

Abstract: Real-world data (RWD) stands at the forefront of contemporary drug development, offering valuable insights across the medical product lifecycle. This presentation will explore the multifaceted role of RWD, examining its application from initial development through post-market analyses. Highlighting concrete examples, we will cover definitions, use cases, strengths, limitations, and the impact of RWD on reducing the time and cost of drug development while improving patient outcomes.