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Session 5b: Case Studies on Challenges for Gene Editing Technology
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
Genome edited products have recently entered the clinical development phase. These products face very specific CMC challenges due to the technology employed, e.g. off-target editing, translocation. 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 genome edited product specific CMC challenges during product development
- Determine approaches to address the challenges to ensure regulatory compliance
- Form strategies supporting development programs using genome editing technology
Speaker(s)
Speaker
Kristy Wood, PhD
Intellia Therapeutics, United States
Vice President Nucleic Acid Therapeutics Development & Manufacturing
Speaker
Paul Kopesky, PhD
Beam Therapeutics, United States
Senior Director, Process Development
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