Division of Medical Ethics Working Group on Compassionate Use & Preapproval Access | NYU Langone Health

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Division of Medical Ethics Research Division of Medical Ethics Working Group on Compassionate Use & Preapproval Access

Division of Medical Ethics Working Group on Compassionate Use & Preapproval Access

The Working Group on Compassionate Use and Preapproval Access (CUPA), part of NYU Langone’s Division of Medical Ethics, was founded in 2014 to explore ethical issues surrounding access to investigational medical products before they receive regulatory approval. Such issues include the fairness and transparency of access decisions, the role of social media in influencing these decisions, and legislative efforts concerning preapproval access, both through clinical trials and non-trial mechanisms, such as expanded access and right to try.

CUPA continues to advance knowledge about preapproval access, identify best practices, make policy recommendations, and bring to the forefront ethical concerns that need further attention.

Who We Are

CUPA is co-chaired by Arthur L. Caplan, PhD, founding director of the Division of Medical Ethics, and Alison Bateman-House, PhD, MPH, assistant professor in the division. By design, CUPA has representation from all stakeholder communities that are involved in preapproval access. Our members represent a wide variety of fields, including bioethics, clinical trial design, government, industry, law, medicine, and patient advocacy.

What We Do

The following are CUPA’s main responsibilities, activities, and accomplishments:

  • We issue policy factsheets and recommendations on issues related to preapproval access.
  • We work with patient groups and medical providers to demystify preapproval access and to create community-specific resources.
  • We educate members of the pharmaceutical and biotechnology industries about preapproval access, best practices, and what ethical concerns need to be addressed.
  • Publishing in peer-reviewed journals and mainstream publications, CUPA members have received extensive coverage in major media outlets including The New York Times, the Los Angeles Times, CBS, STAT, Harper’s Magazine, Forbes, and NPR, among others.
  • Serving as the independent go-to resource for issues related to preapproval access, both in the United States and internationally, CUPA members have provided congressional testimony and speak frequently at conferences and seminars around the world.

Learn more about seeking preapproval access to an investigational medical product from our resources.

Our Members

Our members, who come from within NYU Langone and from outside entities, represent a wide variety of fields, including medicine, law, industry, and patient advocacy. This enables us to draw on the perspectives of all stakeholders involved in this preapproval access.

Alison Bateman-House, PhD, MPH
Co-Chair, Working Group on Compassionate Use and Preapproval Access
Assistant Professor, Department of Population Health

Arthur L. Caplan, PhD
Co-Chair, Working Group on Compassionate Use and Preapproval Access
Director, Division of Medical Ethics
The Drs. William F. and Virginia Connolly Mitty Professor of Bioethics, Department of Population Health

Jinsy A. Andrews, MD, MSc
Assistant Professor of Neurology, Columbia University Irving Medical Center

Nancy Beck, PhD
Healthcare Consultant

Hayley M. Belli, PhD, MS
Postdoctoral Fellow, Department of Population Health

Carolyn Riley Chapman, PhD, MS
Postdoctoral Fellow, Department of Population Health

David R. Curry, MS
Executive Director, Center for Vaccine Ethics and Policy

Nancy N. Dubler, LLB
Adjunct Professor, Department of Population Health

Kelly McBride Folkers, MA
Research Associate, Department of Population Health

Pat Furlong, MS, RN
Founding President and CEO, Parent Project Muscular Dystrophy

Kay Holcombe, MS
Senior Adviser, Milken Institute

Lisa Kearns, MS, MA
Senior Research Associate, Department of Population Health

Laura Kimberly, MSW, MBE
Assistant Research Scientist, Hansjörg Wyss Department of Plastic Surgery and Department of Population Health

Richard Klein
Former Director, Patient Liaison Program, FDA Office of Health and Constituent Affairs

Andrew McFadyen
Executive Director, The Isaac Foundation

Jennifer Miller, PhD
Founder, Bioethics International
Assistant Professor, Yale University School of Medicine

Kenneth I. Moch, MBA
President and CEO, Cognition Therapeutics, Inc.

Robert Nelson, MD, PhD, MDiv
Senior Director of Pediatric Drug Development, Johnson & Johnson

Barbara Redman, PhD, MBE
Associate, Department of Population Health

Christopher T. Robertson, JD, PhD
Professor of Law and Associate Dean for Research and Innovation, University of Arizona James E. Rogers College of Law

David I. Scheer, MS
President, Scheer & Company, Inc.

Lesha D. Shah, MD
Clinical Assistant Professor, Department of Child and Adolescent Psychiatry

J. Russell Teagarden, DMH, MA
Fellow, GE2P2 Global: Governance, Ethics, Evidence, Policy, Practice

David Wallach, MPH, CPH
Director, Research Regulatory Services, NYU Langone

Tom Watson
Executive Vice President of Early Access Programs, Bionical

Disclosure

The Working Group on Compassionate Use and Preapproval Access is an independent, separate entity from the Division of Medical Ethics Compassionate Use Advisory Committees, though the idea for the committees came from discussions among our members. The Division of Medical Ethics pays overhead costs and other expenses for the Working Group. We receive income from a variety of sources, including private gifts and contracted projects. Individual members are not compensated. We do not represent an official view of NYU Langone Health or any employer or other institutional affiliation of any working group member.

The Working Group advises state and federal legislators and FDA leadership on policy, but we do not advocate for particular legislation or promote an agenda. Our members have testified about patient access to investigational drugs before the Subcommittee on Health of the U.S. House of Representatives’ Energy and Commerce Committee.

Contact Us

For general inquiries, please contact Lisa Kearns, MS, MA, senior research associate, at lisa.kearns@nyulangone.org. For media inquiries or to sign up to receive occasional emails about compassionate use and preapproval access, please contact Beba Blagojevic, project coordinator, at bratislava.blagojevic@nyulangone.org or 646-501-2832.