Optimize U.S. and Global Models to Ensure Access to Investigational and Unapproved Drugs
- Alexandria, VA
21st Century Cures: Industry Alert The process for patients to gain access to experimental medicines is about to profoundly change, becoming more prescribed, formalized and transparent. With the passage of the 21st Century Cures in the Senate, stakeholders are set to convene at the annual Expanded Access Programs conference in Alexandria, VA to navigate the plethora of changes.
Current legislation is quickly paving the path for easier patient access to experimental unapproved drugs. CBI’s Expanded Access Programs is the industry’s leading event dedicated to the nuances and complexities of designing and implementing early access programs. Focused 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.
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.
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