Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products
Date:
15/11/2016 to 16/11/2016
Location:
European Medicines Agency, London, UK
The CAT is organising a two day workshop to discuss the scientific developments and regulatory requirements for products manufacture and testing, non-clinical studies and clinical development of genetically modified cell-based cancer immunotherapy products. These novel cancer immunotherapy treatments based on genetically modified T-cells are being developed and tested in clinical trials in a variety of cancers, but there are still scientific and regulatory challenges to overcome to bring these innovative products to the market. The workshop is available for participants from regulatory authorities, academia, hospitals, industry, journalists and interested members of the public.
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Programme of the Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products (PDF/87.38 KB)
Draft
First published: 16/08/2016
Last updated: 15/11/2016
EMA/481413/2016 -
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Presentation - Introduction and regulatory update (Paula Salmikangas) (PDF/1.56 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - EU Support to ATMP developers (Patrick Celis) (PDF/833.29 KB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Chimeric antigen receptor (CAR)-T cells (David Lebwohl) (PDF/1.11 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Clinical development and innovation in engineered T cell therapies (Bruce Levine) (PDF/2.19 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - NK Cells (Evren Alici) (PDF/6.05 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Engineered CAR-T therapies (Julianne Smith) (PDF/1.34 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - CARs and TRUCKs: how engineered T cells become living factories(Hinrich Abken) (PDF/3.53 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - ACTR (Antibody Coupled T-cell Receptor): A universal approach to T-cell therapy (Michael Vasconcelles) (PDF/3.34 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Manufacturing challenges - now and how will we ensure patient access to these medicines (Bo Kara) (PDF/1.2 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Quality development considerations - Regulatory perspective (Christiane Niederlaender) (PDF/374.32 KB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Biomarkers of response/safety for anti-CD19 CAR T cell therapy(Margo Roberts) (PDF/1.71 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Preclinical safety testing of enhanced-affinity TCRs for adoptive T-cell therapy (Andrew Gerry) (PDF/4.65 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Beyond HER2 CAR T-cells: consider how far you have fallen… (Nabil Ahmed) (PDF/4.7 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Assessment challenges in the non-clinical development of CAR and TCR modified effector cells (Bjà¶rn Carlsson) (PDF/1.4 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Clinical and regulatory challenges in the development of CAR-modified and TCR-modified T-cells in the EU (Martina Schà¼àŸler-Lenz) (PDF/1.27 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Experience from scientific advices for CARs/TCRs (Olli Tenhunen) (PDF/859.31 KB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - FDA pilot project to develop a clinical database to examine safety in trials using CAR T-cells (Maura O’Leary) (PDF/672.26 KB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Challenges related to the translation of TCRs to the clinic – the view of an academic developer(Gerald Willimsky) (PDF/6.39 MB)
First published: 02/12/2016
Last updated: 02/12/2016 -
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Presentation - Taking CARs/TCRs from first-in-man trials to marketing authorisation – the view from a pharmaceutical developer (Stanley Frankel) (PDF/2 MB)
First published: 02/12/2016
Last updated: 02/12/2016