Workshop on the challenges for the approval of anti-cancer immunotherapeutic drugs

• Date:
  Thursday, 4 February 2016, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Programme - Challenges for the approval of anti-cancer immunotherapeutic drugs

Presentation - The immunotherapy of cancer: past, present and the next frontier (Ira Mellman) - S1.1

Presentation - The challenges of the different stakeholders: an academic perspective (Heinz Zwierzina) - S1.2

Presentation - Challenges of anti-cancer immunotherapy development- industry perspective (Eric Rubin) - S1.3

Presentation - Challenges for the different stakeholders: regulatory perspective (Francesco Pignatti) - S1.4

Presentation - Lessons learnt - Melanoma: academic perspective (Paolo Ascierto) - S2.1

Presentation - KEYTRUDA® (pembrolizumab): melanoma lessons learnt (Roger Dansey) - S2.2

Presentation - Immunotherapies in melanoma: regulatory perspective (Jorge Camarero) - S2.3

Presentation - Non-small cell lung cancer (NSCLC), academic perspective: lessons learnt (Enriqueta Felip) - S2.4

Presentation - Non-small cell lung cancer (NSCLC) regulatory – industry perspective (Catherine Weil) - S2.5

Presentation - Immunotherapies in lung cancer: regulatory perspective (Jorge Camarero) - S2.6

Presentation - Safety – immune related adverse events (irAE) focus on non-small cell lung cancer (NSCLC) (Aaron Hansen) - S2.7

Presentation - Biomarkers for PD-1/L1 inhibitors: regulatory considerations (Marc Theoret) - S3.1

Presentation - Blueprint project: PD-L1 IUO assay characterization (Rasika Kalamegham) - S3.2

Presentation - Novel biomarkers: pitfalls, limitations, emerging options (Bernard Fox) - S3.3

Presentation - mRNA- and peptide-based anticancer immunotherapies (Michael Platten) - S4.1

Presentation - Chimeric antigen receptor T cells charting the course from clinical trials to commercialization (Stanley Frankel) - S4.2

Presentation - Peptides, cell therapy (Thomas Hinz) - S4.3

Presentation - Differences between the use of immunotherapy in the adjuvant as opposed to advanced setting (Jessica Menis) - S5.1

Presentation - Study design and analysis in late-stage cancer immunotherapy trials (Tai-Tsang Chen) - S5.2

Presentation - CT design - combinations (Samir Khleif) - S5.3

Presentation - How do we sequence or combine immunotherapies with targeted therapies: European perspective (Paolo Ascierto) - S5.4

Presentation - Characterizing the contribution of monotherapy components (Ramy Ibrahim) - S5.5

Presentation - Challenges in evaluating relative effectiveness (Mira Pavlovic) - S6.1

Presentation - Capturing added value in immuno-oncology: balancing rapid access and new metrics for valuation (Patrick Hopkinson) - S6.2

Presentation - Time for the European reference relative efficacy assessment (Francesco De Lorenzo) - S6.3

Presentation - Patient reported outcomes in an era of immunotherapy drug development (David Cella) - S6.4

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