5
Virtual
Sessions
3
Test-Case
Presentations
20
Panel
Speakers
Session Recordings
Industry Insights: What’s Next for Real-World Evidence?
Speakers
- Sandra Siami, MPH, Senior Vice President, Medical Device Innovation Consortium (MDIC) (Moderator)
- Jennifer Kerr, MS, CCRA, RAC, President, Cook Research Incorporated; NESTcc Governing Committee Member, Medical Device Manufacturers Association (MDMA) nominee
- Danelle Miller, BS, MA, J.D., Vice President of Global Regulatory Policy and Intelligence, Roche Diagnostics; NESTcc Governing Committee Member, AdvaMed nominee
- Diane Wurzburger, J.D., Regulatory Affairs Executive, GE Healthcare; NESTcc Governing Committee Vice Chair, Medical Imaging & Technology Alliance (MITA) nominee
Real-World Clinical Outcomes in Patients with Mechanical Heart Valve Replacement and Anticoagulation Variability
Speakers
- Pablo Salcedo, M.D., NESTcc Project Manager, MDIC (Moderator)
- Julie Prillinger, Ph.D., Senior Principal Scientist, Global Data Science & Analytics, Abbott
- Pingsheng Wu, Ph.D., Research Associate Professor, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center
- Rebecca Ward, MPH, Epidemiologist, Heart Valve Devices Team (HVDT), Office of Cardiovascular Devices, Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)
RWE Analysis for Pre-Market and Post-Approval Studies of an Annular Closure Device
Speakers
- Dure Kim, PharmD, NESTcc Research Scientist, MDIC (Moderator)
- Jacob Einhorn, MS, Chief Technology Officer and Co-Founder, Intrinsic Therapeutics
- Kevin Haynes, PharmD, MSCE, Principal Scientist, HealthCore
- David Hwang, Ph.D., Biomedical Engineer, Division of Spinal Devices, OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, CDRH, FDA
Feasibility of Using Real-World Data to Evaluate Thermal Ablation of Liver Tumors
Speakers
- Keondae Ervin, MS, NESTcc Project Manager, MDIC (Moderator)
- Shumin Zhang, M.D., ScD, Director of Regulatory RWE & Epidemiology, Medical Devices, Johnson & Johnson
- Sreekanth Vemulapalli, M.D., Assistant Professor of Medicine, Core Faculty Member, Duke-Margolis Center for Health Policy
- Anjana Jain, Ph.D., Team Lead, Non-Light Based Energy Devices Team, Office of Surgical and Infection Control Devices, CDRH, FDA
Ecosystem Perspectives: Driving RWE Innovation Forward
Speakers
- Robert Giffin, Ph.D., NESTcc Director of Research, MDIC (Moderator)
- Felipe Aguel, Ph.D., Deputy Office Director, Office of Clinical Evidence and Analysis, CDRH, FDA
- Jennifer Luray, MPA, Vice President of Strategy and Communications, Research!America; NESTcc Governing Committee Member
- Tamara Syrek Jensen, J.D., Director, Coverage and Analysis Group, Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services; NESTcc Governing Committee Member
*Funding for this forum was made possible, in part, by the Food and Drug Administration through grant (1 U01 FD 006292-01). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
