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  5. POSTPONED: Public Workshop - Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond - 03/31/2020 - 03/31/2020
  1. Workshops & Conferences (Medical Devices)

Workshop

Event Title
POSTPONED: Public Workshop - Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond
March 31, 2020

Postponed

Date:
March 31, 2020
Time:
8:30 AM - 4:30 PM ET

The FDA, like other government agencies, is taking the necessary steps to ensure the agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, we are cancelling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Where possible the agency will leverage technology to host meetings allowing for remote participation.

The March 31, 2020 public workshop on "Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond" is postponed to a later date. Please follow the FDA’s website for updates.

Please contact CDRH-PPI@fda.hhs.gov with questions.

The Food and Drug Administration (FDA), along with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), is announcing the following public workshop entitled “Using Patient Preference Information in Medical Device Regulatory Decisions:  Benefit-Risk and Beyond”. The purpose of the public workshop is to discuss and explore potential applications, challenges, and opportunities of using Patient Preference Information.

INTRODUCTION
Patient Preference Information (PPI) is increasingly being used in regulatory decision making for medical devices. This workshop will provide a forum to engage key stakeholders, including patients, researchers, regulators, payers, and the life sciences industry, to discuss and explore potential applications, challenges, and opportunities of using PPI across the healthcare ecosystem. Topics that will be discussed include the value of including PPI in different settings, case studies highlighting the use of PPI, and methodologies for collecting PPI. Additional topics are outlined in the Agenda below. A pre-event webinar “Patient Preference Information – What It Is and What It Is Not.” is open to all on March 4, 2020 at 12:00 p.m. ET.

DATE AND TIME
This workshop will be held on March 31, 2020, from 8:30 a.m. to 4:30 p.m. (ET).

AGENDA
The following Agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

7:30AM – 8:30AM Summit Registration
8:30AM – 8:45AM Welcome – Nancy S. Berg, CEO/Executive Director, ISPOR, Lawrenceville, NJ, US and Suzanne Schrandt, Founder, CEO, & Chief Patient Advocate, ExPPect, LLC and Society to Improve Diagnosis in Medicine, Arlington, VA, US
8:45AM – 10:00AM       Session 1: Introduction to and Background of Patient-Preference Information (PPI)
This session will provide an overview of PPI and the various terms referenced in this field. This will include a discussion on the fundamentals of how PPI differs from other types of patient-provided information and the different types of regulatory decisions that can be informed by PPI. A review of current regulatory documents that involve PPI, as well as an explanation of the quality measures considered by CDRH will be presented.
Brett Hauber, PhD, Senior Economist & Vice President, Health Preference Assessment, Health Preference Assessment, RTI Health Solutions, Research Triangle Park, NC, US
Anindita Saha, BSE, Director of External Expertise and Partnerships (EEP), U.S. Food and Drug Administration, Silver Spring, MD, US
10:00AM – 10:15AM Break
10:15AM – 12:15PM   Session 2: Case Studies for Use of PPI in Medical Device Decision-Making Processes
This session will be comprised of 4 separate case study presentations involving PPI.  The cases will offer insights into the reason or indication for the PPI study, problems/challenges that were successfully addressed or unsuccessfully resolved, and a summary of the overall outcomes and lessons learned.  Time for audience Q/A will follow at the end of the session.
Barry R. Liden, Vice President Patient Engagement, Edwards Lifesciences, Washington, DC, US
Dan Harfe, VP Regulatory/Quality/Strategy, Smith+Nephew, Menlo Park, CA, US
Christine Poulos, PhD, Senior Research Economist, RTI Health Solutions, Research Triangle Park, NC, US
Todd Snell, MBA, Senior Vice President of Quality Assurance, Regulatory and Clinical Affairs, NxStage Medical of Fresenius Medical Care North America, Waltham, MA, US
Kimberly Brown-Smith, MD, PhD, Clinical Team Leader, Office of Compliance, Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST), Division of All Hazards Response, Science and Strategic Partnerships (DARSS), U.S. Food and Drug Administration (FDA), Silver Spring, MD, US
Michelle Tarver, MD, PhD, Director, Patient Science & Engagement Program, Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST), Division of All Hazards Response, Science and Strategic Partnerships (DARSS), U.S. Food and Drug Administration (FDA), Silver Spring, MD, US (moderator)
12:15PM – 1:15PM Lunch
1:15PM – 2:45PM   Session 3: Methodologic Issues for PPI Studies
This session will involve 4 distinct presentations on methodologic considerations associated with regulatory decisions in PPI studies, including strategies that have and have not been successful, inclusion of heterogeneity of preferences in studies and regulatory submissions, and overall summaries of what’s worked and what hasn’t worked methodologically. Time for audience Q/A will follow at the end of the session.
Bennett Levitan, MD, PhD, Senior Director, Benefit-Risk Assessment, Epidemiology, Janssen Research & Development, Titusville, NJ, US
Juan Marcos Gonzalez, PhD, Assistant Professor, Duke Clinical Research Institute, Duke University, Duke Clinical Research Institute, Durham, NC, US
Ryan Fischer, Senior Vice President, Community Engagement, Parent Project Muscular Dystrophy, Hackensack, NJ, US
David Gebben, PhD, Staff Fellow, Patient Science & Engagement Program, Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST), Division of All Hazards Response, Science and Strategic Partnerships (DARSS), U.S. Food and Drug Administration (FDA), Silver Spring, MD, US
Shelby Reed, RPh, PhD, Professor, Duke Clinical Research Institute, Durham, NC, US (moderator)
2:45PM – 3:00PM             Break
3:00PM – 4:15PM  Session 4: Implementation / Process of Obtaining and Using PPI – the ‘Beyond’
This session will focus on the implementation of PPI studies and the process of obtaining and using PPI through discussion amongst a multi-stakeholder panel. Topics for discussion include identification of challenges or barriers present in the process, where PPI has been or could be collected along the product lifecycle, how and where information from PPI studies has been used outside of regulatory decision-making processes.  Time for audience Q/A will follow at the end of the session.
Dean Bruhn-Ding, President Regulatory Affairs & Quality Assurance, CVRx, Inc, Minneapolis, MN, US
Ravi Jayadevappa, PhD, Research Associate Professor, Geriatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, US
Louis Jacques, MD, Chief Clinical Officer, ADVI, Washington, DC, US
Melissa West, Acting Vice President, Research, Discovery and Innovation, Kidney Health Initiative, Washington, DC, US
Lucinda Orsini, DPM, MPH, Associate Chief Science Officer, ISPOR, Lawrenceville, NJ, US (moderator)
4:15PM – 4:30PM       Closing Remarks
This session will reflect on the day’s discussion and suggest next steps to continue to advance the utilization of PPI in medical devices.
Michelle Tarver, MD, PhD, Director, Patient Science & Engagement Program, Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST), Division of All Hazards Response, Science and Strategic Partnerships (DARSS), U.S. Food and Drug Administration (FDA), Silver Spring, MD, US
4:30PM Summit Adjourned

 

CONTACT
For questions regarding workshop content please contact:

Michelle Tarver, MD, PhD
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
301-796-6884
Email: CDRH-PPI@fda.hhs.gov  

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