CUPA Expanded Access 1O1 Webinar Registration

Every spring, CUPA hosts a free webinar covering the basics of the expanded access (aka "compassionate use") pathway of access to investigational medical products in the US. Intended for those new to expanded access, we typically offer several presentations from experts and limited time for Q&A.

This year CUPA is experimenting with the "flipped classroom" format, meaning that registants will be expected to watch, at their convenience, a pre-recorded presentation about expanded access. Then, on Wednesday, May 21st, from noon-1pm Eastern time, CUPA will host a forum in which attendees may ask their questions about expanded access to CUPA's experts. Attendees are encouraged to submit questions ahead of time; however, they will also be able to submit questions during the 1-hour forum.

This event is intended for: patients and patient advocates; clinicians and affiliated healthcare workers; those involved in medical product development (industry, research, regulatory, etc.); and any others who wish to better understand how patients in the US may access investigational medical products outside of clinical trials.

This event will feature the following expanded access experts:

Jinsy A. Andrews, MD, MSc is an associate professor of neurology in Columbia University’s Division of Neuromuscular Medicine and the director of neuromuscular clinical trials in the Department of Neurology

Claudia Hirawat is the owner and executive chair of VOZ Advisors, & until 2015, she was president of PTC Therapeutics, Inc.

Richard Klein, the director of Expanded Access Programs and Policy for the GE2P2 Global Foundation, worked at the FDA for more than 40 years before leaving the agency in 2017.

Mary Elizabeth Williams is a doctoral candidate of medical humanities, journalist, author, and one of the first people in the world in a groundbreaking immunotherapy clinical trial, an experience which she chronicled in her Alvarez Award-winning science memoir, A Series of Catastrophes & Miracles.

Lindsay McNair, MD, MPH, MS is Principal Consultant at Equipoise Consulting, LLC. From 2013 to 2023, Dr. McNair was the Chief Medical Officer for the WIRB-Copernicus Group.

Name*

First NameLast Name

Email*

example@example.com

I most closely identify as (pick one)*

Patient or caregiver to a patientPatient advocate (not primarily patient or caregiver)Involved in medical product development (industry) 4Involved in medical product development (academic)Involved in medical product development (government, philanthropy, or other)ClinicianNon-clinical healthcare workerOther

On a scale where 1 means none and 5 means expert, what would you rate your knowledge of expanded access in the US prior to participating in this flipped classroom webinar?*

1 is None, 5 is Expert

How did you learn about this event?*

If you heard about the event from another organization, what organization?

I understand that the webinar will be recorded and may be posted on CUPA's YouTube channel.*

I understand and agree

Working Group on Compassionate Use & Preapproval Access (CUPA) Free Spring Webinar

"The Basics of Expanded Access in the US"

Wednesday, May 21st