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Virtual

Nov 08, 2021 10:00 AM - Nov 10, 2021 3:45 PM

Advanced Therapies: Innovations in CMC Conference

Solutions for CMC challenges in the development and commercialization of cell therapy, gene therapy, and gene editing products.

Session 5b: Case Studies on Challenges for Gene Editing Technology

Session Chair(s)

Eliana  Clark, PhD

Eliana Clark, PhD

Senior Vice President Technical Operations and Quality

Intellia Therapeutics, Inc., United States

Kirsten  Messmer, PhD, RAC

Kirsten Messmer, PhD, RAC

Senior Research Analyst

POLITICO's AgencyIQ, 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)

Kristy  Wood, PhD

Speaker

Kristy Wood, PhD

Intellia Therapeutics, United States

Vice President Nucleic Acid Therapeutics Development & Manufacturing

Paul  Kopesky, PhD

Speaker

Paul Kopesky, PhD

Beam Therapeutics, United States

Senior Director, Process Development

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