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CMC Strategy Forum North America July 2024 Scientific Program
Scientific Program: CMC Strategy Forum North America July 2024
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Comparability for Cell and Gene Therapy Products
Summary Paper: CGTP Summit 2023
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Plenary Session 4 - Potency Assays for Gene Edited Products Summary
Speaker Presentation Pannullo Nicole Plenary Session 4 Summary 2024 -
Plenary Session 4 – Potency Assays for Gene Edited Products Summary
Speaker Presentation Cannon Alkeiver Plenary Session 4 Summary 2024
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Gene Therapy Product Analytics: Potency Method Validation and Optimization
Speaker Presentation Zhang Wandong, BioMarin Pharmaceutical Inc., 2024
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PMDA’s Vision in New (Fifth) Mid-term Targets-International Vision
Speaker Presentation Maruyama Yoshiaki, PMDA, 2024
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Approaches to Potency Assays for CRISPR Genome Editing Therapeutics
Speaker Presentation Wood Kristy, Intellia Therapeutics, Inc., 2024
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Overview of Current Genomic Analytical Tools to Enable Advancement of Investigational in vivo Genome Editing Products into Clinical Studies
Speaker Presentation Seitzer Jessica, Intellia Therapeutics, Inc., 2024
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Balancing Flexibility and Standardization of AAV Manufacturing Processes
Speaker Presentation Segura Gally Mercedes, ElevateBio, 2024
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EU Regulatory Update
Speaker Presentation Reischl Ilona, AGES BASG, 2024
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Cellular Engineering to Address Manufacturing and Regulatory Concerns
Speaker Presentation McDevitt Todd, Genentech, a Member of the Roche Group, 2024
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Shoring up Your Platform: Applying Knowledge Management and Regulatory Considerations to Gene Therapy Development
Speaker Presentation Holmes Shannon, Ultragenyx Pharmaceutical Inc., 2024
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Utilizing HiBiT TCK Bioassays To Validate Cell Therapy & mAb-Mediated Immunotherapy Potency
Speaker Presentation Hess Nicholas, Promega Corporation, 2024
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ICH CGT DG: Progress Toward Delivering a Strategic Roadmap for ATMPs
Speaker Presentation Francissen Kathleen, Genentech, a Member of the Roche Group, 2024
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LYFGENIA's Journey: Lessons Learned in the Development of LVV-based Cell & Gene Therapy Products
Speaker Presentation d'Anjou Marc, bluebird bio, Inc., 2024
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Off-Target Analysis of Genome Editing Products
Speaker Presentation Choi Yongwook, CBER, FDA, 2024
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Potency Method Development, Bridging and Control Strategies for AAV Gene Therapy
Speaker Presentation Carlson Ping, Passage Bio, Inc. 2024
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Potency Assurance for Cellular and Gene Therapy Products
Speaker Presentation Byrnes Andrew, CBER, FDA, 2024
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Leveraging an Established NGS Assay to Sequence Single-Guide RNAs (sgRNA)
Speaker Presentation Bova Rebecca, MilliporeSigma, 2024
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Potency Development for an in Vivo AAV Gene Editing Therapy
Speaker Presentation Bhattacharya Debaditya, ElevateBio, 2024