Course Agenda
Day 1  (8:30AM-4:00PM)

  • Lecture 1: Introduction into regenerative medicine and cell therapies
  • Lecture 2: FDA guidance on Biologics: overview
  • Lecture 3: Cell Sourcing and donor eligibility: Current regulations
  • Lecture 4: Differences between minimally manipulated and manipulated cell therapies
  • Lecture 5: Regulatory requirements for comparability of cell banks and lines 
  • Lecture 6: Choice of animal model, bio distribution and defining clinical dose
  • Lecture 7: Testing of clinical target material versus analogous animal cells
  • Q&A or other topics
Day 2  (8:30AM-4:00PM)
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  • Lecture 8: Differences between cell therapy and traditional clinical trials, considerations for the Design of Clinical Trial of cell therapy products 
  • Lecture 9: Importance of refinement and validation of surgical techniques
  • Lecture 10: Regulatory challenges for the manufacture and scale-out of autologous cell therapies
    • Refinement and validation of manufacture
    • Establishing release criteria
    • Potency assay
    • Control of materials, including obtaining source material, tracking and cross contamination
  • Lecture 11: Requirements for CMC
  • Lecture 12: Reducing the risk in cell therapy manufacture
  • Lecture 13: BLA process
  • Lecture 14: FDA vs EMA regulatory environment
  • Q&A or other topics