A tentative schedule of events for Medical Devices - Patient Engagement in Real World Evidence (RWE): Lessons Learned and Best Practices is provided below for the convenience of conference attendees.

This one-day workshop will be held on Wednesday, Sept. 12, 2018, at the University of Maryland School of Pharmacy, located at 20 N. Pine Street in Baltimore, Md.

TimeActivity
7:30-8:30 a.m. Registration, Coffee, and Light Breakfast
8:30 a.m. - 12:30 p.m. Morning Sessions
8:30-9:40 a.m. Session 1: Framing the Challenge
Pharmacy Hall, Room N103

Welcoming Remarks
Natalie D. Eddington, PhD, FCP, FAAPS
Dean and Professor
University of Maryland School of Pharmacy

Opening Remarks
Jeffrey E. Shuren, MD, JD
Director
Center for Devices and Radiological Health
Food and Drug Administration

Patients and Patient Groups Perspective
Terrie Cowley
President and Co-Founder
The TMJ Association, Ltd.
9:40-10:15 a.m. Session 2: Keynote
Pharmacy Hall, Room N103

Key Opportunities and Introduction of Keynote Speaker
Fadia T. Shaya, PhD, MPH
Professor, Department of Pharmaceutical Health Services Research
Associate Director, Center on Drugs and Public Policy
University of Maryland School of Pharmacy

Keynote Presentation
Anne C. Beal, MD, MPH
Associate Director, Center on Drugs and Public Policy
Global Head of Patient Solutions
Sanofi
10:15-10:30 a.m. Coffee Break
Pharmacy Hall, Balch Gallery
10:30-11:30 a.m. Session 3: Building the Infrastructure
Pharmacy Hall, Room N103

Clinical and Translational Research Infrastructure, ICTR at UMB
Stephen N. Davis, MBBS, FRCP, FACE, MACP
Dr. Theodore E. Woodward Chair in Medicine
Director, General Clinical Research Center
Director, Clinical and Translational Sciences Institute
University of Maryland School of Medicine

Transparency in the Infrastructure
Francis B. Palumbo, PhD, JD
Professor, Department of Pharmaceutical Health Services Research
Executive Director, Center on Drugs and Public Policy
University of Maryland School of Pharmacy

Clinical and Translational Research for Medical Devices: Bioinformatics in the Context of ICTR and Patient Engagement
Fadia T. Shaya, PhD, MPH
Professor and Vice Chair, Department of Pharmaceutical Health Services Research
Associate Director, Center on Drugs and Public Policy
Institute for Clinical and Translational Research Bioinformatics
University of Maryland School of Pharmacy

Overview of NEST
Rachel R. Rath, MPH
Deputy Director, NEST Coordinating Center
Medical Device Innovation Consortium
11:30 a.m. – 12:30 p.m. Session 4: Case Studies
Pharmacy Hall, Room N103

Case Study #1: Women's Health Technologies Coordinated Network (CRN) and Beyond -- Engaging and Empowering our Patient Partners
Courtney E. Baird, MS
Research Data Analyst
Division of Comparative Effectiveness and Outcomes Research
MDEpiNet, Weill Cornell Medicine

Case Study #2: The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) -- What Do We See Next?
Philip Goodney, MD, MS
Surgeon and Health Services Research
Center for the Evaluation of Surgical Care, Dartmouth

Case Study #3: The RADCOMP Consortium Experience: Patient Engagement in a Large Pragmatic Randomized Clinical Trial
Joey Mattingly, PharmD, MBA
Assistant Professor, Department of Pharmacy Practice and Science
Director of Operations, PATIENTS Program
University of Maryland School of Pharmacy

C. Daniel Mullins, PhD
Professor and Chair, Department of Pharmaceutical Health Services Research
Director, PATIENTS Program
University of Maryland School of Pharmacy
12:30-1:30 p.m. Lunch
Pharmacy Hall, Balch Gallery
1:30-2:45 p.m. Small Group Concurrent Breakout Sessions
Small groups will work in parallel to bring together best practices and lessons learned for patient engagement to develop and use real-world evidence.
  • Breakout Session 1
    Pharmacy Hall, Room N306
    Moderator: Kathleen Hewitt, DNP, RN, CPHQ, Associate Vice President, National Cardiovascular Data Registry
  • Breakout Session 2
    Pharmacy Hall, Room N310
    Moderator: Kathryn (Katie) M. O'Callaghan, Assistant Director for Strategic Programs, Center for Devices and Radiological Health, FDA
  • Breakout Session 3
    Pharmacy Hall, Room N314
    Moderator: Danica Marinac-Dabic, MD, PhD, FISPE, MMSc, Director, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA
2:45-3:15 p.m. Afternoon Refreshments and Snack Break
Pharmacy Hall, Balch Gallery
3:15-4:15 p.m. Closing Session
Pharmacy Hall, Room N103

Panel Discussion
Moderators from breakout sessions will note overlapping points and engage in a panel discussion.

Fadia T. Shaya, PhD, MPH
Professor and Vice Chair, Department of Pharmaceutical Health Services Research
Associate Director, Center on Drugs and Public Policy
Institute for Clinical and Translational Research Bioinformatics
University of Maryland School of Pharmacy

Danica Marinac-Dabic, MD, PhD, FISPE, MMSc
Director, Division of Epidemiology, Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration

Closing Remarks
Lisa Miller Noel, PhD
Senior Fellow, Office of Center Director
Center for Devices and Radiological Health
Food and Drug Administration