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

• Date:
  Tuesday, 15 November - Wednesday, 16 November 2016 , All day
• 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

Draft Reference Number: EMA/481413/2016

Presentation - Introduction and regulatory update (Paula Salmikangas)

Presentation - EU Support to ATMP developers (Patrick Celis)

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

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

Presentation - NK Cells (Evren Alici)

Presentation - Engineered CAR-T therapies (Julianne Smith)

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

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

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

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

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

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

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

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

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

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

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

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

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

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