5
Panel
Sessions
3
Test-Case
Deep Dives
20+
Leading
Speakers
Session Recordings
Opening Session | RWE Perspectives: Diversity in Data, Devices and Patient Populations
Speakers
- Sandra Siami, MPH, Senior Vice President, National Evaluation System for health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium (MDIC) [Moderator]
- Felipe Aguel, Ph.D., Deputy Office Director, Office of Clinical Evidence and Analysis (OCEA), Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA)
- Elisabeth M. Oehrlein, Ph.D., MS, Assistant Vice President, Research & Programs, National Health Council
- Vasum Peiris, M.D., MPH, FAAP, FACC, FASE, Chief Medical Officer for Pediatrics and Special Populations, CDRH, FDA
- Mohamed Salama, M.D., Professor of Pathology, Mayo Clinic; Chief Medical Officer, Mayo Clinic Laboratories
Test-Case Session | Pediatric Clinical and Health Services Outcomes Following Tympanostomy Tube Insertion
Speakers
- Keondae Ervin, MS, Senior Project Manager, NESTcc, MDIC (Moderator)
- Keith Jansen, President and CEO, AventaMed
- Christopher Forrest, M.D., Ph.D., Director of PEDSnet and Professor of Pediatrics, Children’s Hospital of Philadelphia
- Eric Mann, M.D., Chief Medical Officer, Office of Health Technology 1 (OHT1)/Office of Product Evaluation and Quality (OPEQ)/CDRH, FDA
Test-Case Session | Estimating and Validating Diagnostic Cancer Biomarker IVD Test Panel Characteristics and Clinical Utility for Indeterminate Pulmonary Nodule Risk Stratification in Patients with Lung Cancer
Speakers
- Pablo Salcedo, M.D., Research Scientist, NESTcc, MDIC (Moderator)
- Stephen Deppen, Ph.D., MA, MS, Assistant Professor of Thoracic Surgery and Epidemiology, Vanderbilt University Medical Center
- Soma Ghosh, Ph.D., Chief, Molecular Pathology & Cytology Branch in Division of Molecular Genetics & Pathology, OHT7/OPEQ/CDRH, FDA
Test-Case Session | Use of Real-World Evidence to Characterize Patients with Uncontrolled Hypertension
Speakers
- Keondae Ervin, MS, Senior Project Manager, NESTcc, MDIC (Moderator)
- Eric Barrette, Ph.D., MA, Senior Director, Global Health Economics and Outcomes Research, Medtronic
- Yuan Lu, ScD, Assistant Professor, Yale School of Medicine
- Meir Shinnar, M.D., Ph.D., Medical Officer, Circulatory Support Devices, OHT2/OPEQ/CDRH, FDA
- Naomi Aronson, Ph.D., Executive Director, Clinical Evaluation, Innovation, and Policy, Blue Cross Blue Shield Association
Closing Session | Digital Devices: Ecosystem Innovation and the Impact of RWE
Speakers
- Sandra Siami, MPH, Senior Vice President, NESTcc, MDIC (Moderator)
- David Feygin, Ph.D., MBA, Chief Digital Health Officer & VP IT Digital Health & Data Solutions, Boston Scientific
- Frederic S. Resnic, M.D., MSc, Chairman, Division of Cardiovascular Medicine, Lahey Hospital & Medical Center; Professor, Tufts University School of Medicine
- David Rhew, M.D., Global Chief Medical Officer and Vice President of Healthcare, Microsoft
- Anindita (Annie) Saha, Assistant Director, Digital Health Center of Excellence, CDRH, FDA
*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.
