Resources
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Managing Accelerated Development Industry Experience
Speaker Presentation Momonoi Yoko Celgene 2019
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Comparability Approach for an Individualized Product
Speaker Presentation Kuhn Andreas Genentech 2019
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FDA Perspective on Commercial Facility
Design for Cell and Gene Therapy Products
Speaker Presentation Koo Lily US FDA 2019
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FDA’s Regulatory Perspective on Individualized Neoantigen‐specific Cancer Vaccines
Speaker Presentation Husain Syed US FDA 2019
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Regulation of Regenerative Medicine in Taiwan
Speaker Presentation Hung Wen Yi Taiwan FDA 2019
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Recent Developments in ATMP Regulation in Europe
Speaker Presentation Hoefnagel Marcel Medicines Evaluation Board 2019
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Regulatory Updates for Human Cell
Therapy Products:
An FDA Perspective
Speaker Presentation Eacho Melanie US FDA 2019
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Breaking the Traditional CMC Development Pathway
Speaker Presentation Beumer Sassi Alex Voisin Consulting 2019
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Address the Need of Standards Development in the CGT Space:
SCB & Standards Initiatives
Speaker Presentation Zhang Jiwen Tmunity Therapeutics 2018
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Process Considerations for Cryogenic Shipping
Speaker Presentation Vermeyen Craig Kite Pharma 2018
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Genetically Modified Cells: Regulatory Expectations for Marketing Authorization in Europe
Speaker Presentation Timon Marcos AEMPS 2018
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Lifecycle Management: Challenges and Lessons Learned from Kymriah™ (CD19 CAR T)
Speaker Presentation Thatcher Anthony Novartis 2018
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Comparability Studies - Unique Challenges and Key Considerations for Cell and Gene Therapy Products (CGTPs)
Speaker Presentation Taraporewala Zenobi CBER FDA 2018
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Regulatory Update for Cell and Gene Therapies -Health Canada
Speaker Presentation Storbeck Christophe Health Canada 2018
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Manufacturing of Gene Therapy Products: Advances in Process Development and Scale-Up Methods to Meet Future Demand
Speaker Presentation Simpson Curran REGENXBIO 2018
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Clinical Trials with ATMPs in Europe Getting Started
Speaker Presentation Reischl Ilona BASG/AGES 2018
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Standards for Cell Therapy, Case Study: CD34+ Cell Enumeration Standards
Speaker Presentation Potts Rebecca USP 2018
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Lentiviral Vectors – Considerations for Their Use in Gene-Modified Cell Therapy Production
Speaker Presentation Miskin James Oxford BioMedica 2018
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Comparability Is Not a Nightmare, Just Think Ahead
Speaker Presentation Menezes Ferreira Margarida Infarmed 2018
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Considerations in Validating Car T Cell Therapy Manufacturing Processes
Speaker Presentation Mccue Justin Juno 2018