Resources
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Management of Manufacturing Changes and
Comparability of Cellular and Gene Therapy
Products
Speaker Presentation Salz Tal US FDA 2020
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A Risk-Based Approach to the Implementation of a Control Strategy for Advanced Therapy Medicinal Products
Speaker Presentation Pillsbury Darius ValSource 2020
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Challenges with Cell Based Medicines in the EU
Speaker Presentation Menezes Ferreira Margarida 2020
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CMC Challenges During Accelerated Development of Human Cell & Gene Therapy Products - A CBER Perspective
Speaker Presentation Kwilas Anna US FDA 2020
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Usage of an mRNA Platform Technology for “Light Speed” Development of a Vaccine Against SARS-CoV-2
Speaker Presentation Kuhn Andreas Biontech 2020
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INO-4800: One SARS-CoV-2 Vaccine, One Decade of Innovation
Speaker Presentation Juba Rob Inovio 2020
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CMC Considerations for Accelerated Development of ATMP
Speaker Presentation Hoefnagel Marcel Medicines Evaluation Board 2020
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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