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Day 3 - Flow Cytometry Standards Consortium Public Workshop

Friday, November 3, 2023 – 8:30 am to 5:00 pm ET



Time Topics

8:30 – 9:00 am

Welcome, Opening Remarks, & Overview of Current NIST Advanced Therapy Program
Sheng Lin-Gibson, Biosystems & Biomaterials Division (NIST)

9:00 – 10:20 am

NIST Flow Cytometry Standards Consortium

  • Consortium overview  Lili Wang (NIST)
  • WG1: Instrument Standardization  Paul DeRose (NIST)
  • WG2: Assay Standardization  Lili Wang (NIST)
  • WG3: Data Standards  John Elliott (NIST)
  • Planned WG4: Gene Delivery – Ed Kwee, Jamie Almeida (NIST)

Session Moderator: Paul DeRose 

10:20 – 10:35 am


10:35 – 11:35 am

Updates on documentary standards on flow cytometry for cell and gene therapy products

  • UK perspective on flow cytometry standards – Sandrine Vessillier (NIBSC/MHRA, UK)
  • Using Documentary Standards to Bridge Gaps – Virginia Litwin (CLSI/ISAC)
  • Cytometry standards ecosystem is crucial for reusing data in the ImmPort repository – Dawei Lin (NIAID/NIH)

Session Moderator: John Elliott 

11:35 am – 12 pm       Panel Discussion Synergy on best practices and standards

12:00 – 1:00 pm

Lunch Break

1:00 – 1:25 pm

FDA’s perspectives on standardization of flow cytometry measurements for cell and gene therapies
Heba Degheidy (FDA)

1:25 – 2:40 pm

Needs, gaps, and opportunities for the use of flow cytometry for cell and gene therapies

  • The many facets of flow cytometry for CAR T cell therapy development Xiuyan Wang (MSKCC)
  • An academic lab perspective on next-generation CART19 products’ characterization when working with cryopreserved patient cells – Patrizia Porazzi (UPenn)
  • Clinical applications of flow cytometry in CAR-T therapy – The unmet needs and future opportunities – Hao-Wei Wang (NCI/NIH)
  •  Bioanalytical Challenges with Development of Cell Therapies – Mahwish Natalia (Taketa)

Session Moderator: Ed Kwee 

2:40 – 3:10 pm

Moderated panel discussion on future actions/activities addressing unmet needs and challenges
Session Moderators: All ‘Needs’ and ‘Documentary Standards’ section speakers  Heba Degheidy, and Lili Wang

3:10 – 3:25 pm


3:25 – 4:40 pm

Advanced Technology/Capability Showcase 

  • FLEXible solution for EV analysis – Matthew Goff (Beckman Coulter)
  • Introduction to ThinkCyte VisionSort and Ghost Cytometry – Paul Fallon (ThinkCyte)
  • Gold-standard sample preparation of the past, present and future - the promise of automation Namyong Kim (Curiox)
  • Serial cytometry: Estimating per-particle uncertainties and improving instrument performance through repeated measurements – Greg Cooksey (PML/NIST)
  • Single cell barcoding method reduces spillover spread via multi-pass (TM) flow cytometry Marissa Fahlberg (LASE Innovation)
  • MHC MACSimer technology to advance TCR-T cell therapy analytics – Laura Mara Muller (Miltenyi)
  • Vesicle flow cytometry (vFC) measurement of individual EVs, viruses, and VLPs – John Nolan (Cellarcus)
  • Cell mimic innovations as a bridge in assay development in advanced therapies – Anh-Tuan Nguyen (Slingshot)
  • Using modern Machine Learning and large curated databases for standardization of cytometry data and analysis Karsten Miermans ( GmbH)

Session Moderators: Jamie Almeida & Jerilyn Izac 

4:40 pm Workshop Summary, future consortium activities & impact, next steps, and closing remarks - Ed Kwee, Lili Wang

5:00 pm


Created September 6, 2023, Updated November 3, 2023