Expanded Access 2.0

January 22-23, 2019

National Press Club – Washington D.C.

Co-Produced By

Check out our speakers:

The Second Annual National Forum on Pre-Approval Access

Integrating treatment-use trials into the clinical development of new therapeutics for serious diseases

  • Inclusivity in Clinical Drug Development
    2017 FDARA (PDUFA VI) calls for better patient representation in the clinical development process through a combination research trials and expanded access trials.   Join the discussion on optimizing these two channels for engaging more patients.
  • An Emerging Marketplace for Early Access?
    Who pays for exploratory treatment options?  There is demand, a capability to supply, and regulatory systems that accommodate informed choice.   Are we prepared for a marketplace for research-stage medicines?
  • Get Past the Politics
    The Summit is for unbiased, intellectual discussion on how early access works and how it can be put to better use.  Our all-star panelists will cut through the recent noise that has obscured the core issues of feasibility, ethics, and value.
  • The Real Opportunity for Real World Data
    Expanded Access may be the largest source of consented patient outcomes information, from which to inform further research studies, strengthen regulatory claims, and improve provider care decisions.  Learn the history and latest approaches.
  • Collaborative Access Networks
    Can we make Expanded Access more feasible for research centers and clinics?  See the latest innovative partnerships among doctors, health systems, pharmaceutical companies, and granting organizations.
  • Precision Medicine and Clinical Discovery
    Discoveries gained from Expanded Access programs have given insight to who benefits from a new medicine and who does not.  Join the discussion about new paradigms for discovery and adaptive clinical research.

The apex topics, the strongest speaker faculty, back for Round 2.  Join us for this landmark event!

Featured Speakers

Conference Location

National Press Club

The Expanded Access Summit will be held at the National Press Club Main Ballroom in the historic National Press Building.

Conference attendees can secure a special rate at the JW Marriott, which is located next to the National Press Building.

Take advantage of our negotiated room rate of $269/night for a King room.
Online reservations are now open.

You can book online using this link.

If you prefer to book over the phone, please call (800) 393-2503

Highlights from the
2017 Expanded Access Summit

Join Attendees from world-class
companies and organizations

2017 companies included Pfizer, Takeda, Janssen, Bayer, Eli Lilly, Biogen, Alnylam, Vertex, Bluebird, Amicus, Ultragenyx, AmpliPhi, Wave Life Sciences, Neuralstem, Incyte, Asuragen, Astellas, Tesaro, Ovid, Spectrum, ALS Association, Parent Project Muscular Dystrophy, Kids V Cancer, BIO, FDA, NIH, Patient Advocate Foundation, the FNIH Biomakers Consortium, and more.

What People Say about the Summit

The Expanded Access Summit provided a platform where attendees could not only get up to speed on changes regarding Expanded Access but could also have an open dialogue. And the food was superb!

Jennifer Cahill
North Highland

The Expanded Access Summit provided attendees a front row seat for a lively exchange of opinions by distinguished KOLs addressing the ethical and logistical challenges in providing marginalized patients with earlier access to experimental therapies.

Maria Hardin
Patient Assistance Fund Consultant

Great speakers / topics and overall very well done.

Nancy Beck
Avalere Health


We look forward to seeing you in WASHINGTON!

Register now to ensure best price admission and hotel room availability.