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Opportunities and Challenges of Collecting Data in a Pre-Approval Access Setting: A Multi-Stakeholder Perspective
Session Chair(s)
Beverly L Harrison
Head, Patient Support, Janssen Pharmaceutical Companies of Johnson & Johnson, United States
This session reviews the benefits and risks of collecting real world data through single-patient requests (SPRs)/expanded access programs (EAPs) in a pre-approval access (PAA) setting and discusses what may confer the highest value to an organization from a multi-stakeholder perspective.
Learning Objective : Recognize relevance and value for an organization of collecting real world data: Discuss the value of real world data from a pre-approval access (PAA) setting as it relates to regulatory and access strategies; Describe benefits and risks of collecting real world data in an single-patient requests (SPR)/named-patient program (NPP) and its potential implications on regulatory and access strategies.
Speaker(s)
Sasha Richardson, MBA, MSc
Managing Director, EY, United States
Pre-Approval Access and Real World Evidence Landscape Set-up
Arnaud Foucher, MBA, MS
EMEA Medical Program Director, Medical Affairs, Europe, Middle-East and Africa, Janssen, France
Panelist
Alison Bateman-House, PhD, MA, MPH
Assistant Professor, Division of Medical Ethics, Dept of Population Health, NYU Grossman School of Medicine, United States
Panelist
Michael Fine, MD
Medical Director, Health Net, United States
Panelist
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