Resources
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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
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Advancing Manufacturing for Advanced Therapies
Speaker Presentation Marks Peter FDA 2018
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mRNA as a Platform Technology Ideally Suited for Individualized Therapeutics
Speaker Presentation Kuhn Andreas RNA Pharmaceuticals 2018
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FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing
Speaker Presentation Koo Lily FDA 2018
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From Academia to Industry: Lessons Learned in the Development of CAR-T Therapies
Speaker Presentation Kassim Sadik Mustang Bio 2018
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Regulatory Perspective on Potency Assays for Cell-Based Products
Speaker Presentation Hoefnagel Marcel Medicines Evaluation Board 2018
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Early Stage Manufacturing
Considerations for Cell Therapy
Products
Speaker Presentation Finn Thomas CBER FDA 2018
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Comparability Considerations in the Development of Gene Therapy Products
Speaker Presentation Baffi Robert BioMarin Pharmaceutical 2018