CBI’s Expanded Access Programs 2019 focuses on the design, development and practical implementation of Early Access Programs.
The summit convenes top industry stakeholders and regulators to examine current approaches for providing investigational, pre-launch or end-of lifecycle drugs to patients for treatment purposes. A multi-stakeholder faculty addresses key issues affecting EAPs and reviews the potential impact of the evolving legislative landscape.
Key Topics to Be Addressed:
- Implement practical guidelines for responding to inquiries around Right to Try;
- Assess whether there is an opportunity to seek reimbursement through traditional payer channels;
- Navigate the development process of sibling Early Access Programs;
- Bring the patient voice into the development of Early Access Programs (EAPs);
- Learn how global organizations are handling new legislation on patient privacy;
- Explore how crowd funding bridges Right to Try, stem cell and new frontiers; and
- Discuss post-clinical trial access when a program does not meet endpoints.