Tuesday, June 20 • 4:00pm - 5:15pm
#276: Defining the Science of Patient Input to Enhance Drug Development and Approval: Tools

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-526-L04-P; CME 1.25; IACET 1.25; RN 1.25

Presenters will discuss how patient input and real world evidence can be used to meet the "adequate and well-controlled studies" standard. The panel will discuss the meaning of the science of patient input, and provide examples of successfully using patient input (e.g., in making trial endpoint decisions; weighing benefit/risk; modifying study protocols based on patient input, etc.) within the regulatory context to enhance drug development and approval by incorporating the patient voice. Gaps and challenges with suggested solutions will be discussed, and differences among US and non-US regulatory agencies may be considered.

Learning Objectives

Define the science of patient input; Describe the challenges and solutions to successfully incorporating the patient voice into drug development.


Roslyn F Schneider


Evolving Methods of Including Patients' Input in Drug Development
Roslyn F Schneider

Incorporating Patient Preferences in Drug Development and Approval
Kevin Marsh, PhD, MSc

Incorporating the Patient Perspective into a Target Product Profile for Intercepting Alzheimer’s Disease
Bennett Levitan, MD, PhD

avatar for Roslyn Schneider

Roslyn Schneider

Global Patient Affairs Lead, Pfizer Inc
Roz leads Global Patient Affairs at Pfizer, a hub of patient centricity, driving integration of patient experiences and perspectives across the company and the product lifecycle. She held roles in Medical Affairs, Medical Strategy and Medicine Development for twelve years at Pfizer... Read More →

avatar for Bennett Levitan

Bennett Levitan

Senior Director, Benefit-Risk Assessment, Global R&D Epidemiology, Janssen Research & Development, LLC
Bennett Levitan, MD-PhD is Senior Director, Dept of Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk assessment to Janssen and has led numerous teams in preparation of benefit-risk assessments. He co-led development of the PhRMA BRAT Framework... Read More →
avatar for Kevin Marsh

Kevin Marsh

Executive Director, Evidera
Kevin Marsh is Executive Director of Outcomes Research for Evidera. His research interests include using MCDA and quantitative preference data to inform health decisions, including pipeline optimisation, authorisation, reimbursement, and prescription decisions. He actively contributes... Read More →

Tuesday June 20, 2017 4:00pm - 5:15pm
S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616