NIST and FDA are actively collaborating on projects that address regulatory and measurement challenges for cell therapies and regenerative medicine products. These collaborations leverage NIST expertise in measurement sciences to address specific analytical challenges as well as FDA regulatory science, research and review expertise in these advanced application areas to ensure that the science and standards developed address significant regulatory challenges that recur across the field. Building on the success of the previous NIST-FDA Cell Counting Workshop, NIST and FDA plan to host a Workshop to examine measurement challenges associated with flow cytometry.
Flow cytometry is a powerful tool for cell characterization and function analysis. Despite wide use of flow cytometry, the challenges associated with robust cellular measurands, the lack of adequate biological and non-biological reference materials, and the complexity of the instrumentation have resulted in few standards to address measurement assurance. This workshop will identify application challenges in clinical and cell manufacturing settings, and potential solutions for overcoming gaps in obtaining sufficient measurement assurance for flow cytometry. The expected outcome of the workshop is a Whitepaper to be published in a peer reviewed journal as well as input into standards and best practices for quantitative, comparable flow cytometry.
8:30-9:00 am Registration
9:00-9:15 am Welcome (S. Lin-Gibson, NIST) View Presentation
9:15-9:30 am Introduction/Workshop Goals (S. Bauer, FDA) View Presentation
9:30-9:45 am Introduction to Measurement Assurance Concepts (J. Elliott,
NIST) View Presentation
Topic 1: Standardization Strategies in Flow Cytometry (30 min talk/10 min Q&A)
9:45-10:25 am Presentation by Heba Degheidy (FDA) View Presentation
10:25-10:40 am Coffee break
Topic 2: Reference Materials (biological and non-biological) for Flow Cytometry (30 min talks/10 min Q&A)
10:40-11:20 am Presentation by Lili Wang (NIST) View Presentation
11:20-Noon Pre-meeting Survey Guided Discussion on Gaps, Needs, etc.
in Flow Cytometry with Subject Matter Experts (SME) View Presentation
12-1:00 pm Lunch
Topic 3: Best Practices to Get to High Confidence Data and Case Studies (30 min talks/10 min Q&A)
1:00-1:40 pm Presentation by Julie Bick, FlowMetric Diagnostics (CRO) View Presentation
1:40-2:20 pm Presentation by MaryAlice Stetler-Stevenson, NCI (Fed) View Presentation
2:20-3:00 pm Presentation by Virginia Litwin, Caprion (CRO) View Presentation
3:00-4:30 pm Discussion with SMEs on Best Practices, Other Strategies, View Presentation
Challenges, Quantitation, Gating, New Methods and Moving
4:30-5:00 pm Workshop Summary View Presentation
5:30 pm Meeting Adjourned