Workshop on site and histology - Independent indications in oncology

  • Email
  • Help

Details

TitleWorkshop on site and histology - Independent indications in oncology
Date14/12/2017 - 15/12/2017
LocationEuropean Medicines Agency, London, UK
SummaryBiological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. This workshop aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment.

All documents

Name Language First published Last updated
Agenda - Workshop on site and histology - Independent indications in oncology (English only) 2017-11-30 2017-12-14
Registration form - Workshop on site and histology - Independent indications in oncology (English only) 2017-11-20  
Presentation - Session 1: Definition of a driver. Cellular/tissular mechanisms supporting that a driver becomes a target multiple drivers, mechanisms of resistance (Christian Rolfo) (English only) 2018-02-07  
Presentation - Session 1: Non-clinical models: tumour models - proof of concept (Edward Rosfjord) (English only) 2018-02-07  
Presentation - Session 1: Nonclinical Models: proof of concept (Jan Willem van der Laan) (English only) 2018-02-07  
Presentation - Session 2: Parameters guiding a site/histology - independent drug development (Jan Schellens) (English only) 2018-02-07  
Presentation - Session 2: The BRAF story (Yibing Yan) (English only) 2018-02-07 2018-02-14
Presentation - Session 3: How could molecular profiling impact histology independent labels in the future? (Marlene Thomas) (English only) 2018-02-07  
Presentation - Session 3: Designs for basket clinical trials and the exploratory/confirmatory paradigm (Richard Simon) (English only) 2018-02-07 2018-02-20
Presentation - Session 4: What defines the disease and populations? How to deal with large subgroups within an indication? Heterogeneity, lack of historical real-life data, rarest subtype (Jan Bogaerts) (English only) 2018-02-07  
Presentation - Session 4: Statistical considerations for the development of diagnostic tests (Olivier Collignon) (English only) 2018-02-07  
Presentation - Session 4: Accuracy of diagnostic methods and impact on clinical management : the lymphopath network experience (Philippe Gaulard) (English only) 2018-02-07  
Presentation - Session 4: What have we learnt from the anti PD1- PDL1 story? (Jorge Camarero ) (English only) 2018-02-07  
Presentation - Session 5: Design concept for a confirmatory basket trial (Robert Beckman) (English only) 2018-02-07  
Presentation - Session 5: Post-approval confirmatory/supplementary data: registries and observational trials (Vincent Ho) (English only) 2018-02-07  
Presentation - Session 5: Approval of pembrolizumab (MSI-H/dMMR) and considerations for site-agnostic development of drugs in oncology (Steven Lemery) (English only) 2018-02-07  
Presentation - Session 5: Considerations in development of pembrolizumab in msi-h cancers (Christine Gause) (English only) 2018-02-07  
Presentation - Session 5: Histology independent indications - the HTA view (Anja Schiel) (English only) 2018-02-07  

Media Videos

To view the broadcast, please ensure that Adobe Flash Player is installed.

Note that you should see the live broadcast or the message ‘We are currently not broadcasting’ below, on this page.  If the area below is black or in case of difficulties viewing the broadcast, please try connecting directly to our Ustream channel: European Medicines Agency or try viewing from an unrestricted connection, for example over wifi or 3G. For technical information about the required network security settings, please see this Ustream help page.

We recommend to press the ‘HD’ symbol on the player and select the option '720' to obtain the best quality of the video. For further assistance, please consult the Ustream Help Center



Registration

  • Registration open until 01/12/2017
  • Places limited

Live broadcast

  • 14/12/2017
    14:00 - 19:30 UK time
  • 15/12/2017
    08:30 - 14:00 UK time

small format video Icon To watch the broadcast click on 'Multimedia' tab.

Video recording

A video recording will be made available after the event. 

To view use the ‘Multimedia’ tab.

Contact point:

oncwp@ema.europa.eu