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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 -
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
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QbD Tools for MAbs Don't Quite Work for CGT Products
Roundtable Session 2 - Table 8 Notes: CGTP 2024
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Process Validation Approaches for Complex Modalities
Roundtable Session 1 - Table 8 Notes: CGTP 2024
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Non-Viral Delivery Options for Cell-based Gene Therapy Products
Roundtable Session 1 - Table 7 Notes: CGTP 2024
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Material Classification for Genome Editing Components
Roundtable Session 1 - Table 5 Notes: CGTP 2024
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ICH M4Q CTD Structure - Considerations for ATMPs - Industry Experience and Challenges
Roundtable Session 2 - Table 4 Notes: CGTP 2024