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Monday, June 24 • 3:30pm - 4:30pm
#158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-568-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the evolution of patient-focused outcome assessment and how current FDA efforts and resources support measuring what matters most to patients in medical product development. Join the Study Endpoints Community for a follow up Round Table discussion on Tuesday, June 25, 9:30-10:30AM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Describe FDA's activities to promote patient voice in outcome measurement; Describe FDA resources to support the science of patient input in medical product development.


Elektra Johanna Papadopoulos, MD, MPH


Update from CDRH
Michelle Tarver, MD, PhD

Telba Irony, PhD

Industry Perspective
Robyn T. Carson, MPH

Patient Perspective
Bray Patrick-Lake, MS


Elektra Papadopoulos

Associate Director for the Clinical Outcome Assessment Staff, OND, CDER, FDA
Dr. Papadopoulos serves as the Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The staff provides consultation to CDER’s Review Divisions as well as other FDA Centers on clinical outcome... Read More →
avatar for Michelle Tarver

Michelle Tarver

Director of Patient Science and Engagement, PSE, CDRH, FDA
The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Her program interacts with digital health... Read More →
avatar for Robyn Carson

Robyn Carson

Head, Patient-Centered Outcomes Research, Global Evidence and Value Development, Allergan
Robyn T. Carson has worked in the pharmaceutical industry for 12 years and leads the Patient-Centered Outcomes Research (PCOR) function at Allergan. In this role, Robyn is responsible for the development of innovative strategies to evaluate meaningful outcomes to patients and consumers... Read More →
avatar for Telba Irony

Telba Irony

Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA
Telba is Deputy Director of the Office of Biostatistics and Epidemiology at CBER. She joined FDA to implement the use of Bayesian statistics for the regulation of medical devices and led the Decision Analysis initiative including Bayesian statistics, benefit-risk determinations, and... Read More →
avatar for Bray Patrick-Lake

Bray Patrick-Lake

Director of Stakeholder Engagement, Duke Clinical Research Institute
Bray Patrick-Lake supports efforts to actively engage patients, health advocacy organizations, and other stakeholders in Duke Clinical Research Institute’s local and national research programs. She has led extensive efforts through the CTTI to incorporate patient voice into clinical... Read More →

Monday June 24, 2019 3:30pm - 4:30pm PDT
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum |   05: Patient Engagement, Forum