Vincent Ko
Seminars
Tuesday 16th March 2027
Workshop C | Building the Next Generation of CKD Endpoints to Shorten Development, Expand Beyond Proteinuria & Create Regulatory-Ready Evidence
2:30 pm
Proteinuria, UACR and eGFR have transformed kidney drug development, but they do not adequately serve every disease, mechanism or patient population. This collaborative workshop will examine GFR slope, novel tubular and molecular biomarkers, hierarchical composite endpoints, natural history datasets, real-world evidence and disease-specific surrogate strategies. Participants will explore what is needed to move promising biomarkers from biological association to accepted development tools and ultimately regulatory endpoints.
What attendees will gain: Greater clarity on selecting and validating endpoints capable of making CKD trials faster, smaller and more disease appropriate.
Key questions:
- What should replace or complement proteinuria in nonproteinuric CKD?
- When can GFR slope support shorter and smaller registrational programs?
- Which emerging biomarkers are sufficiently mature to influence Phase I/II decisions today?
- How should developers demonstrate that a biomarker meaningfully predicts long-term clinical benefit?
- Where can FDA and EMA expectations be aligned to avoid duplicative development?
