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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!
What People Say about the 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.