Lunch & Learn | Unlocking the Potential of Clinical Pharmacology Studies: Gaining Deeper Insights with PBMC and Flow Cytometry Technologies brought to you by Celerion

Learning Labs have limited capacity and rooms will fill up quickly! Arrive early to ensure you can secure your spot.

Lunch will be served.

Biomarkers are integral to clinical pharmacology studies, enabling confirmation of proof-of-mechanism, assessment of target engagement, detection of early efficacy signals, and informing dose selection. The potential of cellular biomarkers to provide more mechanistic and cell-specific data has increasingly gained interest in the past decade.

Peripheral blood mononuclear cells (PBMCs), in combination with flow cytometry and other analytical platforms, offer a powerful tool for investigating drug activity at the cellular level. This presentation will illustrate how PBMC-based endpoints have enhanced decision-making in absolute bioavailability, organ impairment studies, and biosimilar development programs.

Since PBMC sample stability is a critical factor, isolation should begin within 24-48h for optimal data quality. Other aspects affecting PBMC integrity include shipment delays and prolonged storage that can compromise cell viability and assay performance, and common cryopreservation agents like DMSO may adversely affect downstream applications, including cytokine analysis and stimulation assays.

We will explore sample processing considerations and integration of PBMC endpoints in clinical studies using a range of platforms, thus demonstrating how cellular biomarkers can expand the interpretability of clinical pharmacology trials, supporting both small molecule and biologic drug development.

Key Takeaways:
• PBMC analysis may yield a wealth of pharmacodynamic data, including cell-specific target engagement, drug activity assessment, and immune cell
profiling to maximize data from clinical pharmacology studies.
• In addition to flow cytometry, PBMCs are compatible with diverse bioanalytical platforms, such as LC-MS/MS, ligand binding assays and cytokine
release assays.
• Optimal and instant processing of PBMCs samples is critical for downstream assay performance.

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This event is sponsored by an ASCPT Partner organization. The content of the session is provided for informational purposes only and does not constitute or imply ASCPT's endorsement, recommendation, or approval of a specific institution, service, employer, or content.