Expanded Access 3.0

January 27-29, 2020
National Press Club
Washington, D.C.

Get on the alert list for the “Industry Best Practices” publication and for Expanded Access 3.0 program updates!

Check out our speakers:

The Third 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 3.  Join us for this landmark event!

Featured Speakers

What People Say about the Summit

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.

You can book online using this link.

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

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.


We look forward to seeing you in WASHINGTON!

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