Day 3 - Flow Cytometry Standards Consortium Public Workshop

8:30 – 9:00 am

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

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

Break

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 

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

Break

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 (Hema.to GmbH)

Session Moderators: Jamie Almeida & Jerilyn Izac 

5:00 pm

Adjourn