Gold-Star Donor Selection Focus Day

Thursday May 12, 2022 | 8.30-4.30pm EST

8:30 am Registration & Coffee Networking

9:00 am Chair’s Opening Remarks

9:10 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

Exploring Donor Selection in Different Cell Types

10:00 am Creating the Ultimate Donor Pool for Tissue Regeneration, Longevity and Scalability

Synopsis

  • 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

11:30 am Innate vs acquired Properties: How Donor Selection and Manufacturing Processes Interact to Determine MSC Potency

  • James Ankrum Associate Professor, Biomedical Engineering, University of Iowa

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

12:00 pm Roundtable Session: What Makes a Donor Cell Fit for Use?

  • James Ankrum Associate Professor, Biomedical Engineering, University of Iowa

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?

12:30 pm Lunch Refreshment Break & Networking

1:30 pm 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

2:00 pm Reviewing the Evolution of Donor Selection and Transplant Platforms to Streamline Allogeneic Therapy Development

  • Mahasweta Gooptu Attending Physician & Assistant Professor of Medicine, Harvard Medical School

Synopsis

  • Addressing HLA assessment in allogeneic cell-based therapies: how important is it?
  • Understanding donor characteristics and their impact on the final therapy can ultimately improve clinical outcomes
  • Translating learnings from allogeneic stem cell transplantation to NK cell adoptive therapies

Integration of Datasets to Optimize Donor Selection for Allogeneic Therapies

2:30 pm Integrated Multiomic Profiling of Donor Cells to Develop Next-Generation Off-the-Shelf Products

  • Rong Fan Professor, Biomedical Engineering, Yale University

Synopsis

  • 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

3:00 pm Afternoon Refreshment Break & Networking

Regulatory Considerations for Donor-Derived Products

3:30 pm Mining Potential Hurdles in the Regulatory Path of Allogeneic Cell Therapy

  • Manal Morsy SVP, Head of Global Regulatory Affairs, Athersys

Synopsis

  • Outlining the different regulatory expectations and donor selection criteria across the US, EU and Japan
  • Exploring the power of transparent communications to overcome potential regulatory stumbling blocks
  • Addressing regulatory pathways to facilitate efficient and expedient product development

4:00 pm Exploring Regulatory Considerations for Gene Edited and Non-Gene Edited Donor-Derived Material

  • Amy McCord Director, Global Regulatory Affairs, CMC Cell Therapy, Takeda

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

4:30 pm Closing Remarks & Close of Focus Day