July 22-23, 2015 | Bethesda, MD
New draft legislation and widespread advocacy efforts aim to improve patients’ access to experimental unapproved medicines. CBI’s Expanded Access Programs is the industry’s leading event dedicated to the nuances and complexities of designing and implementing early access programs.
Expanded Access Programs focuses on U.S and global considerations for a variety of access management programs, including, but not limited to: Expanded Access Programs, Early Access Programs, Compassionate Use Programs, Named Patient Programs and Managed Access Programs.
The FDA and a broad array of key stakeholders are coming together for an in-depth and meaningful discussion on Expanded Access Programs where the implications, prevailing policies and current industry approaches are discussed in detail. Don’t miss the opportunity to join your peers and share best practices around providing investigational, pre-launch or end-of-lifecycle drugs to patients for treatment purposes.
Richard Klein, Patient Liaison Program Director, Office of Health and Constituent Affairs, FDA
Trailblazing Industry Thought Leaders and Pioneeering Patient Advocacy Perspectives Include:
Abigail Alliance, Alcon, Ax-S Pharma, ALS Emergency Treatment Fund, Biotechnology Industry Organization, Bristol-Myers Squibb, CurePSP, Eli Lilly and Company, Janssen R&D, Max Cure Foundation, Inc., Millennium, The Takeda Oncology Company, former NORD, Novartis Oncology, Pfizer Inc,, Sage Therapeutics, The Leukemia & Lymphoma Society, and more!
Advanced Discussions on Key Issues and the Path Forward for Early Access and Compassionate Use:
- Deep-dive into the Andrea Sloan CURE Act and “Right to Try” Laws
- Assess the new FDA guidance and early access form
- Explore new models for simplified and accelerated access to investigational medicine
- Enhance global protocol development and analyze country-specific regulations
- Benefit from physician collaboration models for advancing access to lifesaving therapies
- Navigate the pricing, payment and reimbursement policy for EAPs
- Discuss strategies for ethical, compliant and successful managed access programs
- Implement innovative outreach and educational efforts to align stakeholders
- Leverage social media for advocacy, access and awareness
- Optimize strategies for forecasting and establishing supply
Visit www.cbinet.com/expandedaccess for more information. Drug Channels subscribers will save $400 off the standard registration rate when they use discount code HKM882*
*Cannot be combined with other offers or used towards a current registration. Cannot be combined with special category rates. Other restrictions may apply.
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