Plenary
Description
Room: Hall A (Level 100)
FIRST PLENARY SESSION: INFLECTION POINT FOR REAL-WORLD EVIDENCE? THE TRANSFORMATIONAL ROLE OF DIGITAL HEALTH
In the last 10 years, we have witnessed an exponential increase in the generation of digital health data from electronic health records (EHRs), claims, billing and patient- and device-generated data. At the same time, it’s being increasingly recognized that traditional clinical trials are expensive, lengthy, and do not adequately study the patient’s specific characteristics (e.g. age, gender, ethnicity, co-morbidities) treatment preferences. The promises of real-world evidence – lower cost; higher quality (including retaining randomization); near real time; regulatory, coverage, and clinical support; and patient decision making – are being addressed on many fronts in a number of transformational and innovative programs. Experience and resources developed on the technical, governance, and policy fronts are supporting accelerated learning. Are we finally at the inflection point to deliver on the promises of real-world evidence and digital health?  The panel is composed of a number of leaders who have been working in this area on cutting-edge initiatives and will be interviewed on what they have learned to date, current barriers to the use of real-world evidence, and what the future holds both within and outside of the United States.

Moderator: Rachael L. Fleurence, PhD
Executive Director, National Evaluation System for Health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium (MDIC), Arlington, VA, USA

Speaker: Adrian F. Hernandez, MD, MHS
Vice Dean, Clinical Research, Duke University School of Medicine, Durham, NC, USA

Speaker: Michelle McMurry-Heath, MD, PhD
Worldwide Vice President and Global Head, Regulatory Affairs, Johnson & Johnson Medical Device Companies, Washington, DC, USA

Speaker: Danica Marinac-Dabic, MD, PhD, MMSc, FISPE
Director, Division of Epidemiology, Center for Devices and Radiological/OSB, U.S. Food & Drug Administration, Silver Spring, MD, USA

Speaker: Sally Okun, RN, MMHS
Vice President, Policy & Ethics, PatientsLikeMe, Cambridge, MA, USA

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