Leveraging Real-World Evidence for Predictive Biomarker Discovery and CDx Development

Music City Center 

Companion diagnostics (CDx) are essential in precision oncology, guiding targeted therapies based on biomarker status. During biomarker discovery stage, research-use-only assay and early-phase clinical trial data are often used to identify a potential predictive biomarker. However, the non-fully validated assay and single-arm design of Phase I trials with limited sample size in multiple indications pose significant challenges.

Real-world evidence (RWE) can help address these challenges by providing insights into biomarker expression within target populations, evaluating patient demographics and treatment patterns, and estimating biomarker prevalence. Additionally, RWE facilitates the construction of synthetic control arms, enhancing the robustness of predictive biomarker assessments and supporting CDx assay development.

This presentation will showcase current applications of RWE in biomarker discovery and CDx development. Furthermore, we will discuss the potential applications for developing AI-based approach to predictive biomarker value using real-world available genomic data.

Real-World Evidence

Biomarker Discovery

Companion Diagnostics (CDx)

Oncology 

Biopharmaceutical Section