Workshop Agenda

Understanding Patients' Preferences: Stimulating Medical Device Development in Kidney Disease

August 12-13, 2015
Hilton Baltimore BWI Airport
Baltimore, MD

Wednesday, August 12

Welcome Remarks
Frank Hurst, MD, FASN
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Patients and Their Government: Shared Expectations and Responsibilities Determine High Impact Engagement (Slides)
Paul T. Conway
Kidney Transplant Recipient, President of the American Association of Kidney Patients

Opening Remarks
Robert Califf, MD
Deputy Commissioner of Medical Products and Tobacco, FDA

Panel Discussion
Panelists: Paul T. Conway and Robert Califf, MD

FDA's Patient Preference Initiative for Medical Device Development(Slides)
Kathryn M. O'Callaghan
Center for Devices and Radiological Health, FDA

The Science of Measuring Patient Preferences (Slides)
John F. Bridges, PhD
John Hopkins Bloomberg School of Public Health

Patients' Preferences in Dialysis: What Do We Know?
Francesca Tentori, MD
Arbor Research Collaborative For Health

Panel Discussion
Panelists: Kathryn M. O'Callaghan, John F. Bridges, PhD, and Francesca Tentori, MD

Thursday, August 13

Session 1: How can patients and care partners assist in developing new medical devices?

Engaging Patients in the Development of Medical Devices
Linda C. Upchurch, MBA, MHA
NxStage Medical, Inc.

Determining Acceptable Benefits and Risks of Emerging Therapy: A Patient Community's Approach (Slides)
Holly L. Peay, PhD, CGC
RTI International and Duchenne Connect Network, a program of Parent Project Muscular Dystrophy

First Things First! Prioritizing Patient Preferences (Slides)
F.P. Wieringa, PhD
Delegated by the Dutch Kidney Foundation and Dutch Kidney Patient Association

Panel Discussion
Panelists: Linda Upchurch, MBA, MHA, Holly Peay, PhD, CGC, and F.P. Wieringa, PhD

Breakout Discussions: Summary of the Breakout Discussions

Session 2: How can patients and care partners help ensure the success of future clinical trials?

Clinical Trials in Kidney Disease: Where are all the Patients? (Slides)
Jennifer Flythe, MD, MPH, FASN

Patient Informed Clinical Trials
Sally Okun, RN, MMHS
PatientsLikeMe, Inc.

Patient-reported Outcomes Instruments in Dialysis: Are We Measuring the Right Outcomes? (Slides)
Jennifer Flythe, MD, MPH, FASN
University of North Carolina, Chapel Hill

Patient and Care Partner Engagement in Clinical Research (Slides)
Celeste Castillo Lee
Patient Advocate for the Vasculitis Foundation
KHI Board of Directors Member and Chair of the KHI Patient and Family Partnership Council

Panelist Discussion
Panelists: Jennifer Flythe, MD, MPH, FASN, Sally Okun, RN, MMHS, and Celeste Castillo Lee

Breakout Discussions: Summary of Breakout Discussions

Session 3: How can patients and care partners help with the decision to make a new device available as well as improve a device once it is on the market?

The Patient Voice and the FDA
Steve L. Morin, RN, BSN
Office of Health and Constituent Affairs, FDA

FDA Regulatory Decision Making: Obesity Study as a Potential Tool (Slides)
Anindita Saha, BSE
Center for Devices and Radiological Health, FDA

Patient Impact on Benefit-Risk
Dalia Jacob, MD Baxter Healthcare, Inc.

Panel Discussion
Panelists: Steve L. Morin, RN, BSN, Anindita Saha, BSE and Dalia Jacob, MD

Breakout Discussions: Summary of Breakout Discussions

Wrap-Up / Closing