Workshop on the challenges for the approval of anti-cancer immunotherapeutic drugs
Immunotherapy is becoming a fast growing area of new medicinal products in oncology. These new agents have brought important advances in patient care and have considerably changed the landscape of treatment options in melanoma and lung cancer patients. However, there are still many challenges on how to bring these agents through regulatory approval and into clinical practice. Appropriate patient population selection, new clinical trials designs, rational for the mechanism of action in different tumour types, innovative immunological-based products used in combination and assessing relative efficacy of these novel immunomodulating therapies are some of the key issues that we propose to address in a workshop organised with the Cancer Drug Development Forum (CDDF). The aim is to address these highly relevant issues and their impact on the regulatory environment.
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Programme - Challenges for the approval of anti-cancer immunotherapeutic drugs (PDF/1.52 MB)
First published: 02/02/2016
Last updated: 03/02/2016 -
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Presentation - The immunotherapy of cancer: past, present and the next frontier (Ira Mellman) - S1.1 (PDF/5.62 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - The challenges of the different stakeholders: an academic perspective (Heinz Zwierzina) - S1.2 (PDF/1.85 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Challenges of anti-cancer immunotherapy development- industry perspective (Eric Rubin) - S1.3 (PDF/725.52 KB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Challenges for the different stakeholders: regulatory perspective (Francesco Pignatti) - S1.4 (PDF/873.51 KB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Lessons learnt - Melanoma: academic perspective (Paolo Ascierto) - S2.1 (PDF/5.05 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - KEYTRUDA® (pembrolizumab): melanoma lessons learnt (Roger Dansey) - S2.2 (PDF/1.12 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Immunotherapies in melanoma: regulatory perspective (Jorge Camarero) - S2.3 (PDF/1.3 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Non-small cell lung cancer (NSCLC), academic perspective: lessons learnt (Enriqueta Felip) - S2.4 (PDF/1.61 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Non-small cell lung cancer (NSCLC) regulatory – industry perspective (Catherine Weil) - S2.5 (PDF/260.49 KB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Immunotherapies in lung cancer: regulatory perspective (Jorge Camarero) - S2.6 (PDF/1.66 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Safety – immune related adverse events (irAE) focus on non-small cell lung cancer (NSCLC) (Aaron Hansen) - S2.7 (PDF/954.45 KB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Biomarkers for PD-1/L1 inhibitors: regulatory considerations (Marc Theoret) - S3.1 (PDF/533.22 KB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Blueprint project: PD-L1 IUO assay characterization (Rasika Kalamegham) - S3.2 (PDF/342.82 KB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Novel biomarkers: pitfalls, limitations, emerging options (Bernard Fox) - S3.3 (PDF/2.37 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - mRNA- and peptide-based anticancer immunotherapies (Michael Platten) - S4.1 (PDF/3.55 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Chimeric antigen receptor T cells charting the course from clinical trials to commercialization (Stanley Frankel) - S4.2 (PDF/1.38 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Peptides, cell therapy (Thomas Hinz) - S4.3 (PDF/805.71 KB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Differences between the use of immunotherapy in the adjuvant as opposed to advanced setting (Jessica Menis) - S5.1 (PDF/1.15 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Study design and analysis in late-stage cancer immunotherapy trials (Tai-Tsang Chen) - S5.2 (PDF/940.97 KB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - CT design - combinations (Samir Khleif) - S5.3 (PDF/1.09 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - How do we sequence or combine immunotherapies with targeted therapies: European perspective (Paolo Ascierto) - S5.4 (PDF/3.47 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Characterizing the contribution of monotherapy components (Ramy Ibrahim) - S5.5 (PDF/928.49 KB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Challenges in evaluating relative effectiveness (Mira Pavlovic) - S6.1 (PDF/1.36 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Capturing added value in immuno-oncology: balancing rapid access and new metrics for valuation (Patrick Hopkinson) - S6.2 (PDF/832.85 KB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Time for the European reference relative efficacy assessment (Francesco De Lorenzo) - S6.3 (PDF/1.82 MB)
First published: 08/04/2016
Last updated: 08/04/2016 -
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Presentation - Patient reported outcomes in an era of immunotherapy drug development (David Cella) - S6.4 (PDF/963.43 KB)
First published: 08/04/2016
Last updated: 08/04/2016