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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!
Take advantage of our negotiated room rate of $269/night for a King room.
Online reservations are now open.
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!
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.
Great speakers / topics and overall very well done.