The 2021 Expanded Access Summit ® is on hold and will not be held on its originally scheduled dates (Sept 27-30).
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The Expanded Access Summit® is the world’s largest annual conference on pre-market access to medicines. The Summit focuses on the core feasibility factors and the innovations that enable greater use of Expanded Access and other "treatment-use" trials. Join us at EA4-Virtual as we again set new best practices for integrating research into modern healthcare for everyone.

Janet Woodcock, MD; FDA
Expanded Access 3.0, January 28, 2020

Hilary Marston, MD, MPH; NIAID, NIH
Expanded Access 3.0, January 28, 2020

Michael Kurilla, MD, PhD; NCATS, NIH
Expanded Access 3.0, January 28, 2020

The Expanded Access Summit® was launched in 2017 to provide a best-practices forum for thought leaders from the highest level of leadership in industry, clinical care, patient advocacy, and government. It has since become the world’s largest and most influential annual conference on pre-market access to medicines. 

Each year the Summit examines the four major feasibility factors of pre-market access:

Operational efficiency

Learning outcomes and research value

Financial collaboration, cost recovery, and reimbursement from payers

Alignment with healthcare delivery organizations

Expanded Access 4.0 Program

Join us each day for professionally mastered livestreams of panelists, slides, and Q&A sessions.

CE / CME accreditation is available.

Day 1

Theme: “Hardcore History”, An Innovators Toolkit for EA

Sept 27, 11:00am – 3:00pm EST

Theme: “Hardcore History”, An Innovators Toolkit for EA

Session 1
“The Truth Behind the Headlines”: Expanded Access over 30 years
Networking Intermission
Session 2
Global regulatory landscapes, expectations, and business doctrine

Day 2

Theme: The Research Value of Modern Early-Access Programs

Sept 28, 11:00am – 3:00pm EST

Theme: The Research Value of Modern Early-Access Programs

Session 1
New tech for including more patients in clinical development
Networking Intermission
Session 2
Learning more and (more-efficiently) from treatment programs

Day 3

Theme: The Healthcare Value of Modern Early-Access Programs

Sept 29, 11:00am – 3:00pm EST

Theme: The Healthcare Value of Modern Early-Access Programs

Session 1
The value prospect for HCPs, hospitals, and health systems
Networking Intermission
Session 2
The value prospect for government and private health plans

Day 4

Theme: X-Factors of Radical Change in Healthcare Product Access

Sept 30, 11:00am – 3:00pm EST

Theme: X-Factors of Radical Change in Healthcare Product Access

Session 1
Speed round and interactive challenge
Special program with audience participation / breakout & report
Session 2
Partnering event, wrap-up, and prizes

Previous Speakers Include:

Janet WoodCock, MD
Acting Commissioner, FDA
Toni Fauci, MD
Director, National Institute of Allergy and Infectious Diseases (NIAID), NIH
Chris Austin, MD
Former Director, National Center for Advancing Translational Sciences, NIH
Robert Walker, MD
Director, Division of Clinical Development, Biomedical Advanced Research and Development Authority (BARDA), HHS
Marjorie Speers, PhD
Executive Director, Clinical Research Pathways
MICHAEL KURILLA, MD, PHD
Director of the Division of Clinical Innovation, NCATS-NIH
MARC BOUTIN, JD
Former Chief Executive Officer, National Health Council
SUANNA BRUINOOGE, MPH
Director of Research Strategy, CENTRA, American Society of Clinical Oncology (ASCO)
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Expanded Access 4.0 (virtual conference)

2021

The 4th Annual Expanded Access Summit®
The Leading Global Forum on Pre-Market Access to Medicines

Type Early-Bird Pricing
Through July 15, 2021
Standard Pricing
Corporate $750 $1100
Health System / Government / Non-Profit $200 $250
Member of the Public / Guest Pass
(No partnering meetings, no affiliation displayed)
$50 $60
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