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X-WR-CALDESC:Events for Rare Disease Network at UNC
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DTSTART;TZID=America/New_York:20260518T090000
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SUMMARY:Advancing Novel Surrogate Endpoints For Rare Disease Drug Development Workshop
DESCRIPTION:Advancing treatments for rare diseases requires innovative ways to measure success. \nJoin 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. \nThis 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. \nTopics to be Covered\n\nMechanistic and Translational Evidence Considerations for Supporting a Novel Surrogate Endpoint Biomarker (FDA Presentation)\nPathways for Engagement with FDA related to Biomarker Science (FDA Presentation)\nCases Studies of RLSEs in rare disease drug development (FDA Presentation)\nLeveraging Disease Models from New Approach Methodologies and Biochemical Signatures as Endpoints (Invited Panelists)\nUse of Digital Health Technologies as Biomarkers (Invited Panelists)\nReal-World Whole-Person Data Management (Invited Panelists)\n\nPlease register for this event via the event website.
URL:https://www.med.unc.edu/raredisease/event/advancing-novel-surrogate-endpoints-for-rare-disease-drug-development-workshop/
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