Here - Stiftung Forschung 3R

WP1 with input from other partners and
the project advisors finalised the chemical
list to be used in Phase II for the further
development and improvement of the
prediction models. This list of chemicals
and the list of chemicals for the interlaboratory
reproducibility were shared
with the University of Maastricht who
will be responsible for their coding and
distribution.
Challenges & Solutions
Given the fact that the carcinoGENOMICS
project has entered its last year, the main
challenge is to finalise it in due time. This
in particular refers to:
• Finalising interlaboratory
comparisons of selected cellular
models and predictive toxicogenomics
• Finalising testing an additional 15
model compounds per selected
cellular model
• Finalising in-depth data analysis
through advanced bioinformatics/
biostatistics, including crossplatform,
cross-study meta-analyses
• Preparing a final report covering all
endpoints at the transcriptomic and
cytomic level that allow discrimination
between genotoxic and non-genotoxic
carcinogens in the selected liver-,
kidney- and lung-based in vitro models;
• Based on the ultimate outcome of the
work, to define conclusions that can
be shared with external stakeholders
at the last capacity-building workshop.
The solution is that should set backs occur,
the Co-ordinator will request an extension
of the project’s deadline by 6 months.
Next Steps
For Phase II, e.g., the fifth and last year
of the carcinoGENOMICS project, selected
human cellular models will be challenged
with a second series of test selected
carcinogens and non-carcinogens, thus
providing more information on the
accuracy of generated gene signatures for
predicting genotoxicity and carcinogencity
in vivo. In parallel, first steps of the formal
pre-validation process will be completed,
in particular focussing on the evaluation of
inter-laboratory variability of these assays
by using a limited set of compounds.
These will be the first toxicogenomics
assays in vitro to be subjected to prevalidation
under the guidance of
ECVAM. Unfortunately, given time and
resources available, this pre-validation
work needs to be of modest proportions,
implying that for further validating and
establishing these promising models,
follow-up work will be still required after
the carcinoGENOMICS project will have
ended. This also related to informing
important stakeholders such as regulatory
authorities in the domain of chemical
safety. Follow-up work is also related to
informing important stakeholders such
as regulatory authorities in the domain of
chemical safety.
60 PROGRESS REPORTS FROM EU-FUNDED PROJECTS
Progress Report 2011 & AXLR8-2 Workshop Report