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NIST-FDA Flow Cytometry Workshop: Building Measurement Assurance in Flow Cytometry

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)   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
                                             Forward 

4:30-5:00 pm                        Workshop Summary  View Presentation

5:30 pm                                Meeting Adjourned

Hilton, 620 Perry Parkway, Gaithersburg, Maryland 20877
Phone: 301-591-9598

Deadline is October 10th to reserve your room.
Click here to book your room now >>>> for $109/night
Group Name: NIST/FDA Workshop Group Code: ONF

 

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.

*New Visitor Access Requirement: Effective July 21, 2014, Under the REAL ID Act of 2005, agencies, including NIST, can only accept a state-issued driver's license or identification card for access to federal facilities if issued by states that are REAL ID compliant or have an extension. Driver's licenses from nine states and territories are not compliant and will not be accepted as identification.Click here for a list of alternative identification and further details>>

Created May 24, 2017, Updated November 22, 2017