Amelia Spinrad
RA Gilead Sciences
Amelia Spinrad is an Associate Director of Regulatory Affairs at Gilead Sciences, where she serves as the regulatory representative on the Managed Access Program Oversight Committee (MAPOC). Her work focuses on U.S. regulatory strategy for expanded and managed access programs in rare diseases, spanning support for single patient INDs as well as Expanded Access Program protocols. She manages programs that balance urgent patient need with the collection of data that may be informative for regulatory purposes.
Seminars
Thursday 16th July 2026
Regulatory Considerations in Leveraging Data in Rare Disease Development
8:30 am
- Providing expanded and managed access pathways that balance patient access with the collection of data that may be informative for U.S. regulatory purposes
- Designing to leverage data to help address development gaps in rare diseases, such as underrepresented geographies (e.g., U.S. patients)
- Streamlining managed access processes to ensure programs are feasible and accessible for regulators and treating physicians, while maintaining strategic alignment across internal company stakeholders
