Enhance Clinical Trial Design with Organoid-based Biomarker Research

Patient-derived organoids (PDOs) offer more reliable models of human disease, improving the translatability of preclinical findings and the likelihood of clinical trial success. Their ability to mimic patient-specific biology and support a wide range of experimental readouts enables researchers to capture rich multi-dimensional datasets for biomarker identification. However, to fully harness PDO data for clinical insights, researchers need a robust solution to centralize, process, integrate and analyze this complex data landscape – alongside clinical and pre-clinical data - while ensuring governance and regulatory compliance. Genedata Profiler meets this need with a purpose-built solution that empowers organoid-based biomarker research and thus enhances clinical trial design.

It enables researchers to generate clinically relevant hypotheses, such as identifying which patients are most likely to respond to treatment, using a structured, multi-step approach involving:

• Capturing PDO data from multiple molecular readouts
• Centralizing this data in a single point of access
• Processing and quality control of omics data
• Integrating omics and efficacy data
• Identifying biomarker candidates (e.g., differentially expressed genes) - and building predictive models (ML component)

These hypotheses can then be tested using public data sources or data from trials to evaluate the predictive power and relevance of identified biomarkers using Genedata Profiler interactive dashboards.

Boost Confidence in Biomarkers with PDO Models and a Comprehensive Data Platform

Genedata Profiler streamlines the process of PDO-based biomarker discovery by providing an end-to-end solution that:

• Centralizes multimodal data collected from diverse experimental approaches and data sources
• Structures and organizes data for improved findability.
• Transforms raw inputs into clean, interoperable, analysis-ready datasets while ensuring complete data lineage and auditability.
• Equips researchers with advanced visualization and analytics tools incorporating AI and ML-based methods to derive insights.

With consolidated multi-source data and analytic capabilities in a single GxP-ready environment, researchers can generate consistent, reliable scientific results and build predictive models ready for clinical validation. By combining the physiological relevance and reproducibility of organoid models with the analytical power of Genedata Profiler, scientists can boost confidence in their biomarker relevance and accelerate the translation of their discoveries into clinical practice, ultimately improving clinical trial success and patient outcomes.

An interactive data visualization approach available out-of-the-box for exploration and hypothesis validation using public data sources. Here the Kaplan Meyer plot shows the survival probability for two groups of patients.

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