Expanded Access 3.0

The third annual

Expanded Access Summit

The global forum on pre-market access to medicines

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

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

Register now

The
Science

The
Regulation

The Most Relevant Innovations

The Best Paths Forward

Bringing together world leaders in integrating treatment-use trials into the clinical development of new therapeutics for serious diseases.

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!

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?

Are we prepared for a marketplace for research-stage medicines? Who pays for exploratory treatment options? There is demand, a capability to supply, and regulatory systems that accommodate informed choice.

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.

View the agenda

A Few of Our Featured Speakers

Janet Woodcock, MD

Director, Center for Drug Evaluation and Research, FDA

Chris Austin, MD

Director, National Center for Advancing Translational Sciences, NIH

Frank Young, MD, PhD

Executive Vice President Clinical & Reg Affairs, TissueTech Inc.; Former FDA Commissioner, 1984-1989

Marjorie Speers, PhD

Executive Director, Clinical Research Pathways

Michael Kurilla, MD, PhD

Director of the Division of Clinical Innovation, NCATS-NIH

Marc Boutin, JD

Chief Executive Officer, National Health Council

Suanna Bruinooge, MPH

Director of Research Strategy, CENTRA, American Society of Clinical Oncology (ASCO)

View all 30+ Speakers

WHAT PEOPLE SAY ABOUT THE SUMMIT

“I can honestly say it was the best meeting/conference I have ever attended – bar none. Excellent speakers, great discussion, fantastic venue, flawless execution.”

Stuart Bell, PhD
Inceptua Ltd

WHAT PEOPLE SAY ABOUT THE SUMMIT

“Academic medical centers should make time to attend!”

Patricia Mendoza, RN
Houston Methodist Research Institute

WHAT PEOPLE SAY ABOUT THE SUMMIT

“The Expanded Access Summit stands out by focusing on the search for solutions. The discussion brings together the right players – patient advocates, regulators, drug developers — to not only describe barriers to expanded access but also to brainstorm and share strategies for overcoming them. It was a call to action in a high-energy, friendly, focused atmosphere.”

Elena Gerasimov, MP, MPH
Director of Programs, Kids v Cancer

WHAT PEOPLE SAY ABOUT THE SUMMIT

“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

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

Conference Location

The National Press Club

The 2020 Expanded Access Summit will take place in the Ballroom of the National Press Club, a historic venue at the heart of Washington D.C.

Register Now

JW MARIOTT

OFFICIAL CONFERENCE HOTEL

Located just around the corner from our conference venue at the National Press Club, the JW Mariott is within easy walking distance of the White House, the National Mall, Ford’s Theatre and the Smithsonian Museums.

Book Your Stay

Book Online

Registered conference attendees can secure a special rate at the JW Mariott using this link.

Book by Phone

If you prefer to book by phone, please call 1-(562)-513-2218

National Press Club

14th Street Northwest, Washington, DC, USA

JW Mariott

1331 Pennsylvania Avenue Northwest, Washington, DC, USA

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.

Past Attendees by Organization Type