Name
Considerations in Rare Disease Clinical Trials
Date & Time
Monday, May 22, 2023, 2:00 PM - 3:30 PM
Location Name
Commonwealth A (2nd Fl)
Description
There are unique considerations for the design and conduct of clinical trials for rare diseases.
Rare diseases can have genotypic and phenotypic heterogeneity and there may be a lack of clinically meaningful endpoints and biomarkers.
Come hear experts provide the principal investigator, patient advocacy, and regulatory perspectives for how these considerations can be addressed within the context of therapy development for small populations with high unmet needs.
Speakers
Cynthia Rothblum-Oviatt - Science Policy Analyst - FDA
Mike Hu - Cofounder - Project GUARDIAN
David Weinstein - Founder - Weinstein Rare Disease and Clinical Developmental Consulting
Mike Hu - Cofounder - Project GUARDIAN
David Weinstein - Founder - Weinstein Rare Disease and Clinical Developmental Consulting
CIP CEU Credits
1.15