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Balancing Flexibility and Standardization of AAV Manufacturing Processes
Speaker Presentation Segura Gally Mercedes, ElevateBio, 2024 -
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
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Approaches for Establishing Comparability for Cell Therapy Products
Speaker Presentation Agarwal Nitin, Kite, a Gilead Company, 2024 -
Analytical and Multi-Level Comparability for Genome Editing Components for Allogeneic CAR T Cell Therapy
Speaker Presentation Camperi Julien, Genentech, a Member of the Roche Group, 2024
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Case Study in Comparability for an iPSC-Derived, Genome-Edited Cell Therapy Product
Speaker Presentation Dashnau Jennifer, Century Therapeutics, 2024
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Analytical Comparability for Autologous CAR-T Products
Speaker Presentation Yue Hai, Bristol-Myers Squibb Company, 2024
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Comparability Study Considerations in the Development and Approval of AMTAGVI (lifileucel)
Speaker Presentation Natarajan Arvind, Iovance Biotherapeutics, 2024
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Comparability Considerations when In-Licensing an Early-Stage Academic Program
Speaker Presentation Chiu Annie, CARGO Therapeutics, 2024
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Advancing Stem Cell Therapy Development - Overcoming Challenges and Expanding Horizons
Roundtable Session 2 – Table 7 Notes: CGTP 2024
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Platform Applications Outside of AAV Gene Therapy Field
Roundtable Session 1 – Table 9 Notes: CGTP 2024