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DIA 2021 Global Annual Meeting

Navigating Non-Trial Preapproval Access as a Patient

Session Chair(s)

Alison Bateman-House, PhD, MA, MPH

Alison Bateman-House, PhD, MA, MPH

  • Assistant Professor, Division of Medical Ethics, Dept of Population Health
  • NYU Grossman School of Medicine, United States
In this interactive live session, we will cover the patient experience in recieving non-trial preapproval access. This panel discussion features experts in industry, FDA policy, ethicists, and patient advocacy.
Learning Objective : Identify the overlapping roles of industry and government with regard to non-trial preapproval access to investigational medical products; Describe and apply the process through which patients go to receive non-trial preapproval access; Recognize policies on Expanded Access and Right to Try from the perspective of patients/patient advocates.

Speaker(s)

Richard Klein

Facilitator

Richard Klein

  • Director, Expanded Access Programs & Policy, Former FDA, Patient Liaison
  • GE2P2 Global Foundation, United States
Mariah Sage Gustafson, MA

Facilitator

Mariah Sage Gustafson, MA

  • Researcher, Grossman School of Medicine
  • NYU Langone, United States
Anne Donguy

Facilitator

Anne Donguy

  • Patient Advocate, Sweden