2021 Virtual Annual Public Forum Agenda

MDIC’s 2021 Annual Public Forum will include live sessions on June 1-2 from 1-5 pm ET each day, plus on-demand sessions available throughout June and July.

June 1, 2021

TimeTopicSpeakers
1:00 – 1:04 pmWelcome RemarksPamela Goldberg, MBA | MDIC President and CEO
1:04 – 1:36 pmFireside Chat with Acting FDA CommissionerActing FDA Commissioner Dr. Janet Woodcock

Pamela Goldberg, MBA | MDIC President and CEO

1:36 – 2:20 pmClinical Diagnostics Fingerstick BlueprintCarolyn Hiller, MBA | Program Director, Clinical Diagnostics, MDIC

Shridhara Alva, PhD | Senior Director, Clinical Affairs, Abbott
Diabetes Care (moderator)

Timothy Stenzel, MD, PhD | Director of
Office of In Vitro Diagnostics and Radiological Health, OHT7, FDA CDRH

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
for Disease Control and Prevention

Daralyn W. Hassan, MS, MT(ASCP) | Clinical
Laboratory Scientist, Division of Clinical Laboratory Improvement and Quality, Centers for Medicare & Medicaid Services

2:20 – 3:08 pmNESTcc 2021: Evolving the Future and Setting the Standards for Real-World EvidenceSandra 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 pmPatient Perspectives: COVID-19, Access to Data and Care, and Engaging Patients through Digital HealthJijo 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 pmCDRH Town HallNadim 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
Program Director for Cybersecurity, Digital Health Center of Excellence (DHCoE),
FDA CDRH

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 pmClosing Remarks

June 2, 2021

TimeTopicSpeakers
1:00 – 1:02 pmWelcome RemarksPamela Goldberg, MBA | MDIC President and CEO
1:02 – 2:00 pmMedical Device CybersecurityJithesh 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 pmCase for Quality Collaborative CommunityJoseph 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 pmCollaborative Communities: Putting the Community in the Driver’s Seat to Navigate Healthcare ChallengesJeff 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 pmCMS Town HallJo 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 pmClosing RemarksPamela 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
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