Here - Stiftung Forschung 3R

approval by ECVAM, the European Center
for Validation of Alternative Methods.
Experimental Design
The project that originally was submitted
to the European Commission (EC) was
budgeted for € 18.7 million. The request
by the EC to reduce this budget to €14.7
million forced the Consortium to chose
between ‘developing novel tests but using
existing markers’ and ‘subjecting existing
tests to extensive -omics analysis’.
Considering the ultimate deliverables of
the project, the Sens-it-iv choice was to
select the second possibility (-omics) for
the sake of mechanistic understanding
(Figure 1).
During the course of the project, emerging
knowledge was invested in an effort to
acquire access to the novel tests that were
cut out of the budget. This was made
possible by the Consortium Agreement
making Sens-it-iv an intellectual property
rights (IPR)-free project as far as test
development is concerned.
This investment was supported by
partners from industry and academia,
and resulted in additional national and
international funding allowing the original
objectives related to the development of
novel tests to be pursued as well (€ 18.7
million). It has to be stressed that the
novel tests coming into the project this
way are not the property of Sens-it-iv and
therefore do not fall under the Consortium
Agreement vis-à-vis IPR. The owners of the
tests made the tests available for further
development and refinement (WP8), and
marker identification (WP2). Examples
of such novel tests include the dendritic
cell (DC) migration test, the alveolarendothelial
lung model and the bronchial
lung model.
An additional budget (€500,000) was
assigned by the Dutch funding agency
ZonMW to run a pre-validation study on
a selected test approach and to transfer
lung EC-based tests to the Cultex system
(allowing for aerosol/gas exposure of
cell cultures). These activities will extend
beyond the Sens-it-iv project (31 March
2012).
Project Structure
In order to make it possible to manage
such a large and complex project properly,
the Sens-it-iv project was split in 3
modules, each with a specific duration and
each grouping specific research activities
covered by dedicated work packages
(WPs).
As compared to the original structure,
three important changes were suggested
and accepted by the General Assembly in
October 2007 and 2008 (Figure 2).
Training for Pre-Validation (Months 24-38)
This training was introduced in order to
familiarise the partners with the procedures
of pre-validation before tests were selected
for evaluation and refinement (Technology
Module). Three very simple dendritic cell
(DC)-based assays that were selected.
The result of this bridging activity was
an understanding for the requirements
PROGRESS REPORTS FROM EU-FUNDED PROJECTS
Progress Report 2011 & AXLR8-2 Workshop Report
159