Building Predictive Biomarker & Endpoint Strategies to Prove Antifibrotic Activity Earlier in Clinical Development
2:01 pm - Tuesday 1st December 2026
As antifibrotic developers aim to intervene earlier in disease, traditional endpoints such
as FVC, eGFR, biopsy, and long-term clinical outcomes may be too slow, invasive, or
insensitive to demonstrate early therapeutic benefit. This workshop will explore how
biomarker, imaging, and endpoint strategies can be integrated to detect antifibrotic
efficacy sooner, enrich the right patients, and build confidence in early proof of disease
modification.
Discussion Topics Include:
- Integrating multi-omic approaches combining proteomics, spatial transcriptomics, and single-cell sequencing to capture the complexity of fibrotic disease progression, improving trial success rates and accelerating paths to approval
- Defining what earlier proof of antifibrotic efficacy should look like across lung, kidney, liver, gut, and skin fibrosis, and where traditional endpoints such as FVC, eGFR, biopsy, and long-term outcomes fall short
- Evaluating how circulating biomarkers, imaging, digital pathology, collagen turnover markers, and molecular signatures can be integrated to detect treatment response earlier
- Utilizing non-invasive biomarker strategies including blood-based assays and advanced imaging to enable frequent longitudinal monitoring, improving patient recruitment and retention while detecting drug activity with greater sensitivity
- Navigating regulatory hurdles in endpoint acceptance
