When it comes to novel drug discovery and development, flow cytometry is known for being both a powerful and versatile technology. It can deliver valuable information to advance early biomarker development, tolerability, clinical studies and even companion diagnostics. But leveraging flow cytometry technologies to answer analytical questions and empower decision making from the research lab to the clinic requires a deep knowledge of cutting-edge approaches.
Virginia Litwin, PhD, principal scientist, hematology/flow cytometry at Covance and her team are examining current trends in rare event analyses assays to ensure that performance is well characterized and fit-for-purpose – particularly in regulated environments. They are also addressing the various hurdles associated with analyzing cellular biomarkers for immunotherapy and adoptive cell therapy.
The team will share insights on these topics, alongside other industry experts at the 32rd Congress of the International Society for Advance of Cytometry (CYTO 2017) in Boston.
- Finding the Needle in the Haystack: Rare Event Detection and Validation of the Lower Limit of Quantification, June 11, 3:30 p.m. – 5:00 p.m.
While both AAPS and ICCS have published white papers on the analytical validation of flow cytometric methods, there is still work to be done regarding best practices for the validation of rare events and establishing a lower limit of quantification (LLOQ). A panel of industry experts will explore how the concepts of LLOQ, limit of blank (LOB) and limit of detection (LOD) apply to flow cytometry, what defines a “blank” sample, experimental design for LLOQ validation and creation of validation samples, and more.
- Optimizing Biomarkers for Immunotherapy and Adoptive Cell Therapy, June 13, 5:00 p.m. to 6:30 p.m. While the role of flow cytometry in translational science has increased dramatically, challenges remain. This workshop will focus on standardizing assays and instruments between laboratories, with a focus on establishing standards that will facilitate successful assay and data exchange; a discussion of the use and usefulness of various beads, assay controls and quality controls to ensure robust data sets from multicenter, longitudinal studies; and, how to tackle the challenges associated with successfully measuring biomarkers for adoptive cellular therapies and rare event detection.
Learn more about the latest advances and industry-leading research being conducted by the Covance flow cytometry team at CYTO 2017, and learn more by visiting Covance.com.