Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products

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TitleCommittee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products
Date15/11/2016 - 16/11/2016
LocationEuropean Medicines Agency, London, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Programme of the Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products (English only) 2016-08-16 2016-11-15
Presentation - Introduction and regulatory update (Paula Salmikangas) (English only) 2016-12-02  
Presentation - EU Support to ATMP developers (Patrick Celis) (English only) 2016-12-02  
Presentation - Chimeric antigen receptor (CAR)-T cells (David Lebwohl) (English only) 2016-12-02  
Presentation - Clinical development and innovation in engineered T cell therapies (Bruce Levine) (English only) 2016-12-02  
Presentation - NK Cells (Evren Alici) (English only) 2016-12-02  
Presentation - Engineered CAR-T therapies (Julianne Smith) (English only) 2016-12-02  
Presentation - CARs and TRUCKs: how engineered T cells become living factories(Hinrich Abken) (English only) 2016-12-02  
Presentation - ACTR (Antibody Coupled T-cell Receptor): A universal approach to T-cell therapy (Michael Vasconcelles) (English only) 2016-12-02  
Presentation - Manufacturing challenges - now and how will we ensure patient access to these medicines (Bo Kara) (English only) 2016-12-02  
Presentation - Quality development considerations - Regulatory perspective (Christiane Niederlaender) (English only) 2016-12-02  
Presentation - Biomarkers of response/safety for anti-CD19 CAR T cell therapy(Margo Roberts) (English only) 2016-12-02  
Presentation - Preclinical safety testing of enhanced-affinity TCRs for adoptive T-cell therapy (Andrew Gerry) (English only) 2016-12-02  
Presentation - Beyond HER2 CAR T-cells: consider how far you have fallen… (Nabil Ahmed) (English only) 2016-12-02  
Presentation - Assessment challenges in the non-clinical development of CAR and TCR modified effector cells (Björn Carlsson) (English only) 2016-12-02  
Presentation - Clinical and regulatory challenges in the development of CAR-modified and TCR-modified T-cells in the EU (Martina Schüßler-Lenz) (English only) 2016-12-02  
Presentation - Experience from scientific advices for CARs/TCRs (Olli Tenhunen) (English only) 2016-12-02  
Presentation - FDA pilot project to develop a clinical database to examine safety in trials using CAR T-cells (Maura O’Leary) (English only) 2016-12-02  
Presentation - Challenges related to the translation of TCRs to the clinic – the view of an academic developer(Gerald Willimsky) (English only) 2016-12-02  
Presentation - Taking CARs/TCRs from first-in-man trials to marketing authorisation – the view from a pharmaceutical developer (Stanley Frankel) (English only) 2016-12-02  

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  • Registered participants will receive a confirmation of participation no later than 4 weeks before the workshop.