Watch the webinar here.
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, several presentations from experts and limited time for Q&A is typically offered.
This year, CUPA experimented with the “flipped classroom” format, meaning that registrants were expected to watch, at their convenience, a pre-recorded presentation about expanded access. Then, on Wednesday, May 21st, from noon-1pm Eastern time, CUPA hosted a forum in which attendees asked their questions about expanded access to CUPA’s experts. Attendees were encouraged to submit questions ahead of time; however, they were also be able to submit questions during the one-hour forum.
This webinar 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 webinar features 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.