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Expanded Access Summit 3.0

January 27, 2020 - January 29, 2020

FDA Commissioner Scott Gottlieb released new comments this week on the Agency’s commitment to improving Expanded Access in the U.S. Add that to his recent memo recognizing the extraordinary potential of real-world evidence generated from pre-market clinical programs. Are you ready to use Expanded Access to engage more patients in your drug development plan?

Our all-star speaker faculty now includes Dr. Michael Kurilla, Director of the Division of Clinical Innovation at the NIH National Center for Advancing Translational Sciences (NCATS). With keynote speeches from Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, and Dr. Kate Goodrich, Director of the Center for Clinical Standards and Quality at CMS, this Health & Human Services trifecta will lead the largest public event ever to focus on pre-approval drug access. Be part of it, as we set the path for integrating modern, data-generating Expanded Access programs (EAPs) in the clinical development of new medicines worldwide.


The National Press Club
529 14th Street NW, 13th Floor
Washington, DC 21740 United States


Center for Leading Innovation & Collaboration
View Organizer Website