June 1, 2021
| Time | Topic | Speakers |
|---|---|---|
| 1:00 – 1:04 pm | Welcome Remarks | Pamela Goldberg, MBA | MDIC President and CEO |
| 1:04 – 1:36 pm | Fireside Chat with Acting FDA Commissioner | Acting FDA Commissioner Dr. Janet Woodcock
Pamela Goldberg, MBA | MDIC President and CEO |
| 1:36 – 2:20 pm | Clinical Diagnostics Fingerstick Blueprint | Carolyn Hiller, MBA | Program Director, Clinical Diagnostics, MDIC
Shridhara Alva, PhD | Senior Director, Clinical Affairs, Abbott Timothy Stenzel, MD, PhD | Director of Corinne Fantz, PhD | Chief Medical Partner for Core Lab and Point of Care, Roche Diagnostics Rex Astles, PhD | Lead, Data Science Team, Division of Laboratory Systems, Center Daralyn W. Hassan, MS, MT(ASCP) | Clinical |
| 2:20 – 3:08 pm | NESTcc 2021: Evolving the Future and Setting the Standards for Real-World Evidence | Sandra Siami, MPH | Senior Vice President, NESTcc
Adrian Hernandez, MD, MHS | Professor of Medicine at Duke School of Medicine, Vice Dean and Executive Director of the Duke Clinical Research Institute (DCRI) Felipe Aguel, PhD | Deputy Office Director, OCEA, FDA CDRH David Maggs, MD | Vice President, Medical Affairs, BD |
| 3:08 – 3:52 pm | Patient Perspectives: COVID-19, Access to Data and Care, and Engaging Patients through Digital Health | Jijo James, MD | Chief Medical Officer, Johnson & Johnson Medical Devices Companies (moderator)
Heidi Dohse | Patient Advocate Brian Walsh | Patient Advocate Stephen Mikita | Patient Advocate Cherise Shockley | Patient Advocate |
| 3:52 – 4:58 pm | CDRH Town Hall | Nadim Yared | President and CEO, CVRx | MDIC Board Chair (moderator)
Jeff Shuren, MD, JD | Director, FDA CDRH Maureen Dreher, PhD | Assistant Director, Division of Clinical Science & Quality/OC, FDA CDRH Andrew Farb, MD | Chief Medical Officer, Division for Cardiovascular Devices, FDA CDRH Michelle Tarver, MD, PhD | Deputy Director, Office of Strategic Partnerships & Technology Innovation, FDA CDRH Kevin Fu, PhD | Acting Director, Medical Device Cybersecurity Francisco “Cisco” Vicenty | Program Manager, Case for Quality, FDA CDRH Timothy Stenzel, MD, PhD | Director, Office of In Vitro Diagnostics and Radiological Health (OIR), FDA CDRH Sean Tunis, MD MSc | Senior Advisor, Office of the Commissioner, FDA Daniel Caños, PhD, MPH | Director, OCEA, FDA CDRH |
| 4:58 – 5:00 pm | Closing Remarks |
June 2, 2021
| Time | Topic | Speakers |
|---|---|---|
| 1:00 – 1:02 pm | Welcome Remarks | Pamela Goldberg, MBA | MDIC President and CEO |
| 1:02 – 2:00 pm | Medical Device Cybersecurity | Jithesh Veetil, PhD | Program Director, Data Science & Technology, MDIC
Suzanne Schwartz, MD, MBA | Director of the Office of Strategic Partnerships & Technology Innovation, FDA CDRH Greg Garcia | Executive Director, Cyber Security Health Sector Coordinating Council Rob Suarez | VP, Chief Information Security Officer, BD Chris Tyberg | Division Vice President, Product Security, Abbott Ken Hoyme, MS | Senior Fellow, Product Security, Boston Scientific |
| 2:00 – 2:50 pm | Case for Quality Collaborative Community | Joseph Sapiente | AVP, Case for Quality, MDIC (moderator)
Francisco “Cisco” Vicenty | Program Manager, Case for Quality, FDA CDRH Robert Becker | Head of Plant Quality, Edwards Lifesciences Ravi Nabar | Head of Global QMS and Compliance, Illumina Kathryn Merrill | Quality and Regulatory Program Director, Medtronic Alan Baumel | Program Director, Advanced Manufacturing, MDIC |
| 2:50 – 3:55 pm | Collaborative Communities: Putting the Community in the Driver’s Seat to Navigate Healthcare Challenges | Jeff Shuren, MD, JD | Director, FDA CDRH (moderator)
Michelle Tarver, MD, PhD | Deputy Director, Office of Strategic Partnerships & Technology Innovation, FDA CDRH Joseph Sapiente | AVP, Case for Quality, MDIC Jithesh Veetil, PhD | Program Director, Data Science & Technology, MDIC Robert Giffin, PhD | Director of Research, NESTcc |
| 3:55 – 4:51 pm | CMS Town Hall | Jo Carol Hiatt, MD, MBA | Vice President, Health Economics and Patient Value, MDIC (moderator)
Tamara Syrek Jensen, JD | Director, Coverage and Analysis Group (CAG), Centers for Medicare & Medicaid Services (CMS) Steven Farmer, MD, PhD | Chief Strategy Officer, CAG, CMS Jason Bennett | Acting Director, Technology Coding and Pricing Group, Center for Medicare, CMS |
| 4:51 – 4:55 pm | Closing Remarks | Pamela Goldberg, MBA | MDIC President and CEO |
On- Demand Session Topics
- Building the Foundation for Active Surveillance
- Science of Patient Input: Patient Involvement in Clinical Trials
- MDIC External Evidence Methods (EEM) Framework for leveraging external data in regulatory decision-making
- Artificial Intelligence powered cancer diagnostics: How regulatory science can re-shape digital diagnostics
- Medical Extended Reality (MXR): Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine
- COVID Diagnostics Heroes Panel
