Workshop B: Bridging the Phase II Endpoint Gap in Rare Kidney Disease Trials by Validating Surrogate Biomarkers Across Diseases & Data Platforms to Enable Earlier Proof-of-Concept & Accelerate Drug Development

Identifying reliable Phase II endpoints remains one of the biggest barriers to accelerating drug development in rare kidney diseases. While hard outcomes such as dialysis or kidney failure are well established for late-stage trials, earlier signals of efficacy are often unclear or inconsistent across diseases. This interactive workshop will bring together industry and clinical experts to discuss how surrogate biomarkers can be validated and implemented to enable earlier proof-of-concept studies. Attendees involved in clinical development, translational research, and biomarker discovery will benefit from practical insights into how endpoints are being evaluated.

Join this interactive workshop to:

  • Understand the Phase II endpoint gap and why traditional renal outcomes are difficult to apply in early-stage trials
  • Interrogate mechanistic biomarkers in cohort studies to identify potential responder patient populations and aid in Phase II trial design
  • Explore how consortia such as PARASOL are validating endpoints through collaborative datasets, translational studies, and longitudinal cohorts
  • Identify strategies to integrate biomarkers into trial design to generate earlier efficacy signals and support regulatory acceptance