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Tuesday, June 29 • 4:00pm - 5:00pm
#255 SL: Treating Covid-19 Patients with Unproven Interventions Outside Trials: EUAs, Expanded Access, Right to Try, and Off-Label Use

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-586-L04-P; CME 1.00; IACET 1.00; RN 1.00

Three routes to access unproven treatments outside of clinical trials will be presented, using Covid-19 as a case study. Presenters will address legal/regulatory, ethical, and pragmatic issues concerning patient care and medical research.

Learning Objectives

Discuss three routes - EUA, non-trial preapproval access (Expanded Access and Right to Try), and off-label use of an approved product – by which patients may receive unproven treatments outside of clinical trials; Describe the trade-offs inherent in providing access to unproven treatments in the context of Covid-19.

Chair

Alison Bateman-House, PhD, MA, MPH

Speaker

Panelist
Holly Fernandez Lynch, JD, MA

Panelist
Christopher Robertson, JD, PhD, LLM

Panelist
Paul Aliu, PharmD, MBA, RPh, PMP


Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, Dept of Population Health, NYU Grossman School of Medicine, United States
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Grossman School of Medicine and a Professor of Practice in Law at University of Arizona James E. Rogers College of Law. She is co-chair of the Working Group on Compassionate Use... Read More →
HF

Holly Fernandez Lynch

John Russell Dickson, MD Presidential Asst Prof, Medical Ethics & Health Policy, University of Pennsylvania, United States
A lawyer and bioethicist by training, Professor Fernandez Lynch’s scholarly work focuses on the ethics and regulation of research with human subjects and related issues, including IRB oversight, access to investigational medicines, and FDA policy.
CR

Christopher Robertson

N.Neal Pike Scholar and Professor of Law, Boston University, United States
Professor Robertson is an expert in health law, institutional design, and decision making. His wide-ranging work includes torts, bioethics, professional responsibility, conflicts of interests, criminal justice, evidence, the First Amendment, racial disparities, and corruption.
avatar for Paul Aliu

Paul Aliu

Head Global Governance Office, Chief Medical Office, Novartis Pharma AG, Switzerland
Paul is the Head of Global Governance in the cross-divisional Chief Medical Office at Novartis, with responsibility for the oversight, standards, training and systems for compassionate use/expanded access, grants and post-registration medical programs (e.g. Investigator initiated... Read More →

Tuesday June 29, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Forum |   09: Regulatory, Forum |   05: Patient Engagement, Forum