FDA and Triangle CERSI offer free workshop on rare diseases
The Triangle Center of Excellence in Regulatory Science & Innovation (Triangle CERSI) invites you to join FDA, researchers, clinicians, and innovators for a free, one-day virtual workshop open to the public focused on emerging scientific and regulatory pathways for advancing surrogate endpoints in rare disease drug development.
This workshop is being convened in support of the Rare Disease Endpoint Advancement (RDEA) Pilot Program, established under the FDA User Fee Reauthorization Act of 2022 and the Food and Drug Omnibus Reform Act of 2022. The RDEA program is intended to support the development of efficacy endpoints for rare disease treatments by fostering dialogue among FDA, researchers, clinicians, industry, patient communities, and other stakeholders.
Date & Time
Monday, May 18
9:00 AM - 4:30 PM EDT
Location: Zoom
Topics to be covered:
- Mechanistic and Translational Evidence Considerations for Supporting a Novel Surrogate Endpoint Biomarker (FDA Presentation)
- Pathways for Engagement with FDA related to Biomarker Science (FDA Presentation)
- Cases Studies of RLSEs in rare disease drug development (FDA Presentation)
- Leveraging Disease Models from New Approach Methodologies and Biochemical Signatures as Endpoints (Invited Panelists)
- Use of Digital Health Technologies as Biomarkers (Invited Panelists)
- Real-World Whole-Person Data Management (Invited Panelists)
Triangle CERSI is partnering with the UNC School of Medicine to offer ACCME-based continuing medical education credit.
register