SYMPOSIUM: TRANSLATING PATIENT PREFERENCE RESEARCH INTO REGULATORY PRACTICE

Monday, October 19, 2015: 12:00 PM - 1:00 PM
Grand Ballroom B (Hyatt Regency St. Louis at the Arch)

A variety of scientific methods are now commonly used to quantify patient preferences. During 2015, there have been several initiatives designed to incorporate patient-preference information in policy-relevant decisions – especially regulatory benefit-risk analysis. The Medical Device Innovation Consortium (MDIC), a public-private partnership that engaged industry, government, and patient stakeholders, developed both a framework for identifying when and how patient preferences could be incorporated in regulatory submissions for medical devices and a catalog of methods that would be suitable for quantitatively assessing preferences. The FDA’s Center for Devices and Radiological Health (CRDH) has further facilitated the translation of patient preference research into practice through the release of draft guidance detailing how patient preference information can be used in regulatory submission, review and labeling of medical devices. Furthermore, CRDH completed a case study on weight-loss device preferences and demonstrated how this information can be utilized to inform regulatory decision-making. Finally, Parent-Project Muscular Dystrophy (PPMD) demonstrated that patient organizations can play a leading role in conducting patient-preference study that can be informative to regulatory decisions. This session will highlight how patient preference information can be translated in to practice within the context of regulatory benefit-risk analysis and in promoting patient-focused drug/device development.

Moderator:

John F.P. Bridges, PhD
Johns Hopkins Bloomberg School of Public Health
Associate Professor
Health Policy and Management

John F P Bridges is a SMDM member and advocate for the study of patient preferences. In addition to academic contributions advancing and applying stated-preference methods, John has increasingly worked with diverse groups to ensure that the views of patients and caregivers are incorporated into decision making. He is also the founding editor of The Patient - Patient-centered Outcomes Research.

Presenters:

Anindita Saha, BS
Food and Drug Administration, Center for Devices and Radiological Health
Director, External Expertise and Partnerships

Anindita (Annie) Saha is an expert in the field of patient and stakeholder engagement and Director of External Expertise and Partnerships in the FDAs Center for Devices and Radiological Health (CDRH). She is leading force with in CRDHs Patient Preference Initiative and member of the steering committee MDIC Patient-centered Benefit Risk Project.

A. Brett Hauber, PhD
RTI Health Solutions
Senior Economist, Vice President of Health Preference Assessment, RTI Health Solutions
Health Preference Assessment

A. Brett Hauber is a SMDM member and an expert in preference research. Brett has devoted his career to incorporating patient preferences into treatment, policy, and regulatory decisions. He works both with pharmaceutical sponsors and regulatory agencies to include quantitative data about patient, caregiver, and provider preferences in key healthcare decisions. Brett was an advisor to the MDIC Patient-centered Benefit Risk Project and the lead on the MDIC catalogue of patient preferences methods.

Telba Irony, PhD
Food and Drug Administration, Center for Devices and Radiological Health
Chief, Biostatistics, Office of Device Evaluation

Telba Irony is an expert in Bayesian statistics and has been a leading proponent for the measurement of patient-preference in the context of regulatory science. Telba has been leading the Decision Analysis initiative at CDRH, which involves benefit-risk assessments, patient preference surveys, and decision tools for CDRHs Innovation Pathway. She is on the board of the Medical Device Innovation Consortium (MDIC) and in the steering committee of the Patient-Centered Benefit-Risk working group.

Holly Peay, PhD
RTI International
Research Scientist, Division of Education and Workforce Development: Early Education, Disability and Health Group
Education and Outreach

Holly Peay is an expert in community-engaged approaches to exploring needs, preferences, and decision-making. Current a research scientist at RTI International, Holly was previously active at Parent Project Muscular Dystrophy (PPMD), co-leading the DuchenneConnect Patient-Powered Research Network through PCORnet and PPMD research on patient-centered regulatory benefit-risk. She was also a member of the steering committee that drafted FDA guidance of Duchenne muscular dystrophy.