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NIST Organizers: Lili Wang, John Elliott, Sheng Lin-Gibson
FDA Organizers: Steven Bauer, Heba Degheidy, Judy Arcidiacono
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.
Agenda
8:30-9:00 am Registration
9:00-9:15 am Welcome (S. Lin-Gibson, NIST) Presentation (Download Slides)
9:15-9:30 am Introduction/Workshop Goals (S. Bauer, FDA) Presentation (Download Slides)
9:30-9:45 am Introduction to Measurement Assurance Concepts (J. Elliott, NIST)
Presentation (Download Slides)
Topic 1: Standardization Strategies in Flow Cytometry (30 min talk/10 min Q&A)
9:45-10:25 am Presentation by Heba Degheidy (FDA) Presentation (Download Slides)
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) Presentation (Download Slides)
11:20-Noon Pre-meeting Survey Guided Discussion on Gaps, Needs, etc. in Flow Cytometry with
Subject Matter Experts (SME) Presentation (Download Slides)
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)
Presentation (Download Slides)
1:40-2:20 pm Presentation by MaryAlice Stetler-Stevenson, NCI (Fed)
Presentation (Download Slides)
2:20-3:00 pm Presentation by Virginia Litwin, Caprion (CRO) Presentation (Download Slides)
3:00-4:30 pm Discussion with SMEs on Best Practices, Other Strategies, Challenges, Quantitation,
Gating, New Methods and Moving Forward Presentation (Download Slides)
4:30-5:00 pm Workshop Summary Presentation (Download Slides)
5:30 pm Meeting Adjourned
Hilton, 620 Perry Parkway, Gaithersburg, Maryland 20877
Phone: 301-591-9598
Deadline is October 10th to reserve your room.
Booking has closed.
If you are not registered, you will not be allowed on site. Registered attendees will receive security and campus instructions prior to the workshop.
NON U.S. CITIZENS PLEASE NOTE: All foreign national visitors who do not have permanent resident status and who wish to register for the above meeting must supply additional information. Failure to provide this information prior to arrival will result, at a minimum, in significant delays (up to 24 hours) in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12. When registration is open, the required NIST-1260 form will be available as well.
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