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The Challenges, Solutions and Right To Try Surrounding Expanded Access
Session Chair(s)
David Vulcano, MBA, RAC
Honorary President (SCRS); VP, Clinical Research Compliance and Integrity (HCA
HCA Healthcare | Society Clinical Research Sites, United States
Many states are enacting "Right to Try" legislation as an effort to provide access to investigational therapies to those in their state with terminal illnesses and seemingly nowhere else to turn. These efforts present logistical and ethical dilemnas. This forum will try and explain the ethical dilemnas surrounding Expanded Access and what industry needs to know when requesting expanded access from the FDA.
Learning Objective : Identify the ethical dilemmas surrounding expanded access; Describe what they need to know when requesting Expanded Access from the FDA; Compare and contrast varying state legislative efforts in the right to try movement.
Speaker(s)
The Challenge of “Compassionate Use”
Alison Bateman-House, PhD, MA, MPH
NYU Grossman School of Medicine, United States
Assistant Professor, Division of Medical Ethics, Dept of Population Health
What You Need To Know When Requesting Expanded Access
Richard Klein
GE2P2 Global Foundation, United States
Director, Expanded Access Programs & Policy, Former FDA, Patient Liaison
Comparison of States "Right to Try" Legislation
David Vulcano, MBA, RAC
HCA Healthcare | Society Clinical Research Sites, United States
Honorary President (SCRS); VP, Clinical Research Compliance and Integrity (HCA