The Expanded Access Summit®, our flagship event, is the world’s largest annual conference on pre-market access to medicines. The Summit focuses on feasibility for all stakeholders and the integration of well-designed access programs in the modern clinical development process.

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

Our flagship event, the Expanded Access Summit® was launched in 2017 to provide a best-practices forum for thought leaders in industry, healthcare, and public policy. The Summit has become the world’s largest and most influential annual conference on pre-market access to medicines. The third annual Expanded Access Summit was held Jan. 27-29, 2020 at the National Press Club, Washington DC and featured Anthony Fauci, MD (NIAID), Janet Woodcock, MD (FDA), Chris Austin MD (NCATS), Michael Kurilla MD, PhD (NCATS), Peter Hutt (Author, Food and Drug Case Law), Robert Walker (BARDA) and 30 other high level officials and experts.

For years, conferences in this topic struggled to advance the field.  Instead of addressing the fundamental barriers, many focused on ways for life science companies and health systems to say “No” to stakeholders seeking treatment access. They perpetuated unfounded perceptions of EAPs impeding clinical research, and they failed to examine the true feasibility factors of successful access programs. That’s why we created the Expanded Access Summit. It’s why we invited the highest level of leadership from industry, clinical care, patient advocacy, and government.  The goal is to continually establish new best practices, dispel prevailing myths, and to break through the most stubborn barriers to innovation.

The Expanded Access Summit is constructive and thorough.

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

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