Real-World Evidence to Assess Medical Devices: Advances through the National Evaluation System for health Technology (NEST)
Date/Time: July 9, 2020 | 9:00 a.m. – 10:30 a.m.
Background: The Food and Drug Administration funded the Medical Device Innovation Consortium to create the National Evaluation System for health Technology (NEST). The mission of the NEST Coordinating Center (NESTcc) is to accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE) and innovative research. NEST has created a Data Network with over 13 Data Partners.
Objectives: To provide an overview of the NEST initiative, the NESTcc’s role in facilitating the timely, reliable and cost-effective development of high-quality RWE, the NESTcc test cases and demonstration projects, and their values from the perspectives of regulators, health systems, and industry. Anyone who is interested in learning the latest regulatory initiative in RWE innovation would benefit by attending.
Description: This 90-minute symposium will bring together leaders representing key stakeholders across the medical device ecosystem involved in NESTcc programs.
Shumin Zhang, MD, ScD
Director Regulatory RWE & Epidemiology, Johnson & Johnson
Daniel Caños, PhD
Acting Director, Office of Clinical Evidence and Analysis, U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH)
Robbert Zusterzeel, MD, PhD, MPH
Research Network Director, National Evaluation System for health Technology Coordinating Center (NESTcc)
Joseph Drozda, MD
Director of Outcomes Research, Mercy Health
Danica Marinac-Dabic, MD, PhD, FISPE
Associate Director of the Office of Clinical Evidence and Analysis (OCEA), U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH)