Gold-Star Donor Selection Focus Day
Thursday May 12, 2022 | 8.30-4.30pm EST
North Shore Ballroom B
8:30 am Registration & Coffee Networking
8:50 am Chair’s Opening Remarks
9:00 am Panel Discussion: Donor Selection for Best-in-Class Allogeneic Cell Therapy
Synopsis
- Highlighting phenotypic considerations for donor-derived allogeneic cells
- Considering the manufacturing logistics of donor screening, and working with blood banks and centers to establish donor banks
- Commenting on the ethical considerations of profiting from a donor-derived product
9:45 am Achieve Manufacturing Consistency by Starting with Consistent PBMC Raw Materials
Synopsis
- Start with the end in mind
- Variables that effect apheresis procedures
- Straying from the pack
Exploring Donor Selection in Different Cell Types
10:00 am Creating the Ultimate Donor Pool for Tissue Regeneration, Longevity and Scalability
Synopsis
*Virtual presentation
- Exploring demographics: to what extent do sex, age and health status play a role in potency?
- Creating the ultimate donor pool to drive the scalability of your product
- Outlining the optimal MSC donor pool for therapeutics tissue regeneration
10:30 am Morning Refreshment Break & Networking
11:15 am Donor Selection Considerations for Generating iPSC Starting Material for an Allogeneic Stem Cell Derived T-cell Product
Synopsis
- Using healthy donor blood to create clinical grade iPSC lines
- Selecting iPSC lines for product development
11:30 am Innate vs acquired Properties: How Donor Selection and Manufacturing Processes Interact to Determine MSC Potency
Synopsis
- MSCs from different tissues sources vary widely in properties
- MSCs from the same tissue but different donors vary widely in potency
- Manufacturing processes can be used to enhance innate donor characteristics
11:45 am Scalability Considerations When Using Cord Blood as an Allogeneic Starting Material
Synopsis
- Attributes of cord blood units across the domestic inventory
- Advantages in using an off the shelf starting material
- Learnings from having the most diverse adult donor registry and visibility to the cord blood unit registry
12:15 pm Lunch Refreshment Break & Networking
1:15 pm Innate vs acquired Properties: How Donor Selection and Manufacturing Processes Interact to Determine MSC Potency
Synopsis
- MSCs from different tissues sources vary widely in properties
- MSCs from the same tissue but different donors vary widely in potency
- Manufacturing processes can be used to enhance innate donor characteristics
1:45 pm Roundtable Session: What Makes a Donor Cell Fit for Use?
Synopsis
- What criteria should be used to evaluate donors?
- What potency assays should be used to evaluate lots of cell product?
- What safety criteria should be considered when selecting donors?
2:30 pm Afternoon Refreshment Break & Networking
Integration of Datasets to Optimize Donor Selection for Allogeneic Therapies
3:00 pm Integrated Multiomic Profiling of Donor Cells to Develop Next-Generation Off-the-Shelf Products
Synopsis
*Virtual presentation
- Exploring integrated multiomic profiling and unbiased canonical pathway analyses
- Reviewing results that unveil heterogeneities in the transcriptional, phenotypic, functional and metabolic profiles of donor CAR T cells
- Providing a mechanistic basis for ameliorating clinical outcomes and developing next-generation allogeneic therapies
Regulatory Considerations for Donor-Derived Products
3:30 pm Exploring Regulatory Considerations for Gene Edited and Non-Gene Edited Donor-Derived Material
Synopsis
- Variability in key regulations for donor selection/testing for global products
- Considerations for donor selection during development
- Regulatory challenges for allogeneic donor-derived products illustrated through case studies