Materials
Session I: Introductions & Project Overview
Welcome & Introductions
Veronica Miller, Forum
José-Alain Sahel, UPMC*
Jim Wang, Regeneron
Governance & Forum Process
Sehyr Khan, Forum
Alessi Ayvaz, Forum
Objectives for Ocular Diseases Forum 2 (ODF2)
Claire M. Gelfman, Forum
Jim Wang, Regeneron
Regulatory Perspective: Call for Collaboration
Heidi Becker & Lola Fashoyin-Aje, Center for Biologics Evaluation and Research, FDA
Session II: Endpoints for IRDs: Building Consensus
Landscape for IRD Drug Development: Potential Endpoints in Clinical Trials
Tomas Aleman, Scheie Eye Institute, University of Pennsylvania
Regulatory Endpoints and Trial Design for IRDs [REDI] Working Group – RUSH2A Key Findings
Jacque Duncan, UCSF Department of Ophthalmology*
FFB Clinical Consortium FST Data Review
David Birch, Retina Foundation of the Southwest
FST in Clinical Trials: Phase I/II Data
Laura Pardon, Atsena Therapeutics
Session II: Endpoints for IRDs: Building Consensus (Continued)
Questionably/Definitely/Decreased AutoFluorescence (QDAF, DDAF, DAF) on Short Wavelength-AutoFluorescence: Current Understanding and Rationale
Bart Leroy, Ghent University
Session III: Patient Perspectives in IRDs and AMD: Call for Clinical Trials and a Path Forward
Living with Retinal Disease: A Patient (Parent) Perspective
Marylee Dilling, Blue Cone Monochromacy Families Foundation
Patient Engagement Strategies in Clinical Trials
Julia Carpenter-Conlin, Alkeus
Session IV: PROs and PROMs
Current Landscape for AMD Drug Development
Cheryl Rowe-Rendleman, Omar Consultants*
Case Study: GA Clinical Trials
Peter Kaiser, Cole Eye Institute*
Session V: Wrap Up & Next Steps
Summary & Next Steps
Veronica Miller, Forum
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