ISCT North America Regional Meeting Preview: What to Expect from the Laboratory Practice Committee Concurrent and Roundtable Sessions

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Ashley Krull, Ph.D.
Associate Director, Cell Therapy Manufacturing and Engineering
James Cancer Hospital Cellular Therapy Laboratory
Assistant Professor, Hematology
The Ohio State University
Columbus, Ohio, United States

The ISCT Laboratory Practices Committee (LPC) has a strong lineup of sessions organized for the ISCT North America Regional Meeting in Houston, Texas. The LPC championed the inclusion of seven sessions in the meeting agenda. The sessions will kick off at 8 AM on Friday September 8^th and run through Saturday September 9^th at 5:30 PM. The LPC members purposefully chose topics that have universal appeal and applicability but that are often not discussed in as great of detail as members desire. The LPC hopes that attendees can take advantage of the discussions and come away with actionable insights that will advance work at their home institutions.

The individual sessions and learning objectives and outlined below in order of occurrence. The sessions are also designated as a roundtable (RT) or concurrent session (CCS).

Friday, September 8th
8:00 – 9:00	RT	It’s All About People – How to Build and Foster Thriving CGT Teams Description: Discuss pathways to attract, train and retain qualified staff, including regulatory requirements in different regions, and both formal and the in-house training programs that meet regulatory requirements. Learning Objectives: To discuss innovative pathways to attract, train and retain qualified staff: formal training programs; in-house training programs; professional societies training programs/resources. Presenters: Moderator: Elena Maryamchik Lauren McVoy Jelena Holovati Ashley Krull Maggie DiGuardo
9:15 – 10:15	CCS	Events in the CTL – The Quadruple C – Cryopreservation, Citations, Contamination, and CAPA Description: Discuss things that can go wrong in the laboratory; for example, deviations/non-conformances/disasters and quality systems processes in action (e.g., CAPA) Learning Objectives: Appreciate the application of identify-fix-learn-improve nonconformance management through real life laboratory examples in some key areas of GMP manufacturing: 1) Audit citations; 2) Contamination events; 3) Cryopreservation deviations or alternatively. After this presentation participants should be able to: 1. Understand unexpected issues that may take place while performing cryopreservation. 2. Discuss scenarios in which microbial contamination of cellular therapy products occur and how to address them. 3. Describe the most frequently encountered FACT citations during cellular processing facility inspections. Presenters: Moderator: Yossi Schwartz Cheryl Cox Jelena Holovati Yossi Schwartz
13:45 – 14:45	CCS	Current vs Future: A Sustainable Business Model for Collection Facilities Description: Description of current model of collection facilities, challenges with existing model, innovative solutions to overcome these challenges and tying these solutions to business sustainability. Learning objectives: After this presentation participants should be able to: 1. Understand the current model of collection facilities. 2. Discuss the challenges with the existing model. 3. Describe possible solutions to overcome these challenges: - Creative scheduling - Contract collection agencies/facilities Presenters: Moderator: Yossi Schwartz Yara Park Lee Buckler Hope Guidry-Groves
16:45 – 17:45	CCS	Game-Changers for Optimizing the Operations at Cell Therapy Processing Facilities Learning Objectives: 1. Prevailing model of cell therapy processing facilities 2. Challenges with the existing model 3. Possible solutions to overcome these challenges: - Creative scheduling - Specialization - Personnel Presenters: Moderator: Elena Maryamchik Yongping Wang Emily Hopewell Bonus brief session (COI, labeling): Karen Moniz, ICCBBA
Saturday September 9^th
8:00 – 9:00	CCS	Release Assay Validation 101 Description: Discuss best practices for validating qPCR and flow cytometry assays, particularly for novel CAR T cell products or other in-house developed products. Learning Objectives: 1. Describe regulations/best practices around GMP release assay validation; 2. Discuss the design of a standard flow cytometry assay validation; 3. Present the elements included in a standard PCR-based assay validation. Presenters: Moderator: Ashley Krull Scott Jones Brigitte Senechal Melba Page
11:00 – 12:00	CCS	ABCs of POC Manufacturing of IEC Description: Simplified presentations on key elements involved in point of care manufacturing of immune effector cell products. Learning objectives: 1. Provide examples of successful POC manufacturing of IEC 2. Describe challenges in establishing POC manufacturing of IEC 3. Relate strategies to overcome challenges in establishing POC manufacturing of IEC Presenters: Moderator: Olive Sturtevant Sarah Nikiforow Don Siegel Timothy Wiltshire
16:30 – 17:30	RT	The Ever-Evolving Stem Cell Processing Lab – How Should It Look in 2024 Description: Many stem cell processing labs have evolved from performing routine procedures (RBC depletion, cryopreservation, etc.) to perform more complex procedures like CD34 selection and TCR ab/CD19 depletion. And now many even handle cryo/shipment/receipt and storage of licensed products and late-phase products. This session will discuss what these new responsibilities are and how they are handled. Learning Objectives: 1. Describe what new roles and responsibilities processing labs have evolved to oversee 2. Discuss what changes had to be made to accommodate these changes Presenters: Moderator: Yossi Schwartz Kathryn Bushnell Wes McKinney Julie Annis