Passage of 21st Century Cures and increased FDA patient engagement have resulted in growing collaboration between manufacturers and patient organizations in research and development while insurance trends have mandated increased patient burdens. These trends are particularly important in orphan disease. NIH/NCATS research agreements, participation in clinical trial design and FDA advisory board meetings, and access initiatives are ways that biotechnology companies and patient organizations share common goals, but barriers such as a lack of understanding on drug development, some government guidelines, and patient and HCP mistrust threatens to derail progress. A lack of educational materials for both patients and physicians complicates all relationships. To be truly “patient centric,” companies and advocacy organizations need to do the hard work to build partnerships from the ground up. This session will explore best practices and trends that will inform the future.

Ability Level: All

Session ID: 21088