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Session 5c: Case Studies on Challenges for Cell-based Therapeutics
Session Chair(s)
Eliana Clark, PhD
Senior Vice President Technical Operations and Quality
Intellia Therapeutics, Inc., United States
Kirsten Messmer, PhD, RAC
Owner
KM Intel LLC, United States
Cell-based products use ‘living’ cells which creates additional challenges. These products face very specific CMC challenges due technology employed and need for maintaining cell product viability. This session will discuss case studies for 2-3 different gene edited products.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand cell-based product specific CMC challenges during product development
- Determine approaches to address the challenges to ensure regulatory compliance
- Form strategies supporting development programs using cell-based therapies
Speaker(s)
Speaker
Sunitha Lakshminarayanan, MBA, MS
Bristol Myers Squibb, United States
Head and Executive Director of Cell Therapy Process Engineering
Speaker
Richard Anderson, PhD, MSc
Fate Therapeutics, Inc., United States
Senior Director
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