Cell Therapy Focus Day
Tuesday 28th March 2023

10:30 am Chairperson’s Opening Remarks

10:45 am Discussing the Challenges Faced in Analysing & Characterizing Cell Therapy Products

  • Mia Wang Senior Director & Team Leader - Chemistry, Manufacturing & Controls Cell Therapy, Sana Biotechnology

Synopsis

  • Outlining the unique challenges in cell therapy product characterization that need to be overcome
  • Reviewing the current methods and tools utilized by cell therapy manufacturers for characterization studies
  • Discovering future trends currently emerging in the cell therapy world

11:15 am Panel Discussion: Reviewing the Design of Potency Assays for Cell Therapy Comparability Exercises

  • Julia Sable Director - Chemistry, Manufacturing, Controls & Project Management, Tmunity Therapeutics Inc.

Synopsis

• Highlighting the focus of cell therapy potency assays on signalling, cell killing and target markers • Illuminating crossovers with gene therapy potency assays • Rethinking potency assays for gene therapy based on the approaches taken in cell therapy

12:00 pm Lunch

1:00 pm Panel Discussion: Elucidating the Lessons Learned in Cell Therapy Assay Development for Applications in Gene Therapy

Synopsis

• Highlighting the similar challenges between assay development for cell and gene therapy comparability

• Discussing how these challenges were overcome in the cell therapy world

• Debating potential applications of these solutions to gene therapy comparability

1:45 pm The Impacts of Process Improvements on Cell Therapy Development & CQAs

Synopsis

• Outlining the selection of in vitro assays commonly used for cell therapy comparability

• Discussing opportunities for developing a more robust selection of assays for gene therapy based on those applied in cell therapy

• Debating applications of different assays and how to identify the most appropriate tests for your assessments

2:30 pm Panel: Untangling FDA Requirements for CQAs in IND Applications for Cell Therapy Products

Synopsis

• Describing expectations from the FDA on how to maintain CQAs after a method or product change in development of cell therapies

• Avoiding common shortcomings with comparability assessments when presented to FDA regulators

• Applying advice to future development and comparability strategies

3:15 pm End of Cell Therapy Focus Stream Pre-Conference Day