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Tuesday, June 28 • 2:00pm - 3:15pm
#236: Expanded Access: Ethical, Regulatory, and Policy Challenges and Considerations

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-522-L04-P; CME 1.25; IACET 1.25; RN 1.25

The legislative and regulatory landscapes for expanded access to investigational therapies are evolving due in part to public attention. This session will examine strategies proposed by stakeholders to address ethical, regulatory, and policy considerations.

Learning Objectives

Recognize FDA requirements for expanded access and the current regulatory, political, and social environment; Identify challenges faced by stakeholders from ethical, regulatory, and policy perspectives; Describe industry best practices for managing expanded access programs.


Kim M. Quaintance-Lunn


Is There a Better Way? An Industry Perspective
Sandra A. Morris, PhD, PMP

The Ethics of Compassionate Use
Alison Bateman-House

avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Head, US Regulatory Policy, Bayer
Kim Quaintance-Lunn serves as the Head, US Regulatory Policy at Bayer. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the development of regulatory strategies. Kim previously served as Senior Director, Global Regulatory Policy and Intelligence, Eisai Inc, and Associate Director for Regulatory Affairs, Office of New... Read More →

avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, New York University Langone Medical Center
Alison Bateman-House holds PhD and Masters of Public Health degrees from Columbia University and a Masters of Bioethics from the University of Virginia. She has advanced training in both social science and bioethics, and she has worked in the fields of bioethics and public health ethics at several universities, including the New York University Langone Medical Center. At NYU, she part of the Division of Medical Ethics, and she is Deputy... Read More →
avatar for Sandra Morris

Sandra Morris

Vice President, Strategy Realization, Johnson & Johnson
Dr. Morris is currently VP, Strategy Realization for the J&J CMO. Prior to joining J&J, Dr. Morris spent 18 years at Merck where she was VP, Global Project Management. Dr. Morris received her PhD in Organic Chemistry and completed postdoctoral research in biochemistry.

Tuesday June 28, 2016 2:00pm - 3:15pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA