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

EventHumanAdvanced therapiesInnovation

Date: Tuesday, 15 November 2016 - Wednesday, 16 November 2016
Location: European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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

DraftReference Number: EMA/481413/2016

English (EN) (87.38 KB - PDF)

First published: 16/08/2016Last updated: 15/11/2016

Presentation - Introduction and regulatory update (Paula Salmikangas)

English (EN) (1.56 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - EU Support to ATMP developers (Patrick Celis)

English (EN) (833.29 KB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Chimeric antigen receptor (CAR)-T cells (David Lebwohl)

English (EN) (1.11 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Clinical development and innovation in engineered T cell therapies (Bruce Levine)

English (EN) (2.19 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - NK Cells (Evren Alici)

English (EN) (6.05 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Engineered CAR-T therapies (Julianne Smith)

English (EN) (1.34 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - CARs and TRUCKs: how engineered T cells become living factories(Hinrich Abken)

English (EN) (3.53 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - ACTR (Antibody Coupled T-cell Receptor): A universal approach to T-cell therapy (Michael Vasconcelles)

English (EN) (3.34 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Manufacturing challenges - now and how will we ensure patient access to these medicines (Bo Kara)

English (EN) (1.2 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Quality development considerations - Regulatory perspective (Christiane Niederlaender)

English (EN) (374.32 KB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Biomarkers of response/safety for anti-CD19 CAR T cell therapy(Margo Roberts)

English (EN) (1.71 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Preclinical safety testing of enhanced-affinity TCRs for adoptive T-cell therapy (Andrew Gerry)

English (EN) (4.65 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Beyond HER2 CAR T-cells: consider how far you have fallen… (Nabil Ahmed)

English (EN) (4.7 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Assessment challenges in the non-clinical development of CAR and TCR modified effector cells (Bjà¶rn Carlsson)

English (EN) (1.4 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Clinical and regulatory challenges in the development of CAR-modified and TCR-modified T-cells in the EU (Martina Schà¼àŸler-Lenz)

English (EN) (1.27 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Experience from scientific advices for CARs/TCRs (Olli Tenhunen)

English (EN) (859.31 KB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - FDA pilot project to develop a clinical database to examine safety in trials using CAR T-cells (Maura O’Leary)

English (EN) (672.26 KB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Challenges related to the translation of TCRs to the clinic – the view of an academic developer(Gerald Willimsky)

English (EN) (6.39 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

Presentation - Taking CARs/TCRs from first-in-man trials to marketing authorisation – the view from a pharmaceutical developer (Stanley Frankel)

English (EN) (2 MB - PDF)

First published: 02/12/2016Last updated: 02/12/2016

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