Resources
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Comparability Strategies for Autologous Genetically Modified Hematopoietic Stem Cells (GM-HSC)
Speaker Presentation Havert Michael Bluebird Bio 2020
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Alternative Monitoring Approaches for New Aseptic Fill Technologies for Individualized Therapies: Closed Gloveless Filling Isolators.
Speaker Presentation Glunz Alexander Genentech 2020
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Re-thinking Comparability Assessments for
Individualized Therapeutics
Speaker Presentation Francissen Kathy Genentech 2020
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Manufacturing Logistical and Capacity Considerations For Cell and Gene Therapy Products
Speaker Presentation Finn Thomas US FDA 2020
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Introduction to SARS-CoV-2 and COVID-19
Speaker Presentation Dormitzer Philip Pfizer 2020
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Relative Infectivity as a Reliable Alternative to the TCID50 Assay
Speaker Presentation Cheung Win Den REGENXBIO 2020
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FDA’s Approach to the Development of Cell and Gene Therapy Products
Speaker Presentation Witten Celia US FDA 2019
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Regulatory Considerations for
Analytical Development of Gene
Therapy Products
Speaker Presentation Whatley Angela US FDA 2019
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Integrated Design of Facilities and Operations for Autologous Cell Therapies
Speaker Presentation Vernon Aaron Autolus Therapeutics 2019
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Regulatory Update for Cell and Gene Therapies -Health Canada - 1
Speaker Presentation Storbeck Christopher Health Canada 2019
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Design Considerations for ATMP Premises From the EU Point of View
Speaker Presentation Rietveld Annie Rietveld Biofarmaconsultancy 2019
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Facilitating Expedited Development of
Advanced Therapy Products
Speaker Presentation Oh Steven US FDA 2019
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Regulation of ATMPs in the UK – ‘With or Without EU’
Speaker Presentation Niederlaender Christiane MHRA 2019
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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