Prioritisation, promotion and implementation of future research based on the application of the 3Rs
In the field of research, EPAA is exploring opportunities to prioritise, promote and implement future research in the field of the 3Rs. That means:
- Identification of priorities for future 3R-oriented research, which is seen as a core activity of the partnership.
- Identification of gaps and opportunities to improve animal welfare through reduction, refinement and replacement.
- Collation and exchange of knowledge from different industry sectors, Commission, regulatory bodies and academia.
- Interaction with other working groups in order to accelerate development, validation and acceptance of alternative methods.
perspectives on safety
Under this action a workshop on "New Perspectives on Safety"
was held on 28-29 April 2008 in Brussels, bringing together
eminent scientists from different disciplines under the moderation
of the Editor-in-Chief of Nature. The main objective was to
advise on the research needed to enable future hazard identification
(i.e. potential of exogenous chemicals or proteins to elicit
adverse effects) with regard to chronic repeat dose systemic
toxicity without the use of animal testing. This represents
one of the most challenging questions in safety testing, and
specifically for alternative approaches to animals. The proceedings
of the workshop are available
Based on the recommendations of the 2008 workshop, the EPAA
decided to examine in more detail how recent scientific and
technological developments in :
a) STEM CELLS RESEARCH and
b) in COMPUTATIONAL CHEMISTRY combined with SYSTEMS BIOLOGY
could be exploited to develop novel approaches for assessing
repeat dose systemic toxicity without animal testing.
Two Task-Forces (or project teams) have been set within the
Platform on Science to coordinate activities to this respect.
Stem cells task force
As a first follow-up to the 2008 workshop, an expert meeting
with members from industry and academia took place Ispra, Italy
in October 2009 to discuss future directions of stem cell research
for safety testing. A report of this meeting is available
In October 2011, a new meeting with experts from industry,
ECVAM and academics involved in stem cells research projects
was held in Ispra, Italy. The flash report of this meeting is
Computational chemistry & systems biology Task
A follow-up workshop on computational chemistry and systems
biology took place on 5-7 July 2010 where invited experts discussed
strategies to exploit recent advances in computational chemistry
to define truly novel approaches to toxicity testing. The flash
report of this meeting is available
In 2011, the Computational chemistry Task Force proposed to
organize a new meeting with experts early in 2012 to design
research packages that would be needed for developing an integrated
model of (mitochondrial) liver toxicity.
Special attention will be paid to Ensure complementarity with
other ongoing initiatives, e.g. SEURAT-1, DILI (IMI), Tox21,
virtual liver projects at EPA and in Germany.
Workshop "New Perspectives on Safety"
28-29 April 2008, Brussels
Workshop "Harnessing the Chemistry of Life: Revolutionising
5-7 July 2010, Brussels
In vitro metabolism
One of the major drawbacks of most in vitro methods
compared to intact organisms is at present their inability or
low competence to metabolize xenobiotics. The EPAA organised
a workshop on 24-25 November 2008, in Düsseldorf, to discuss
the current knowledge in this field of science, and evaluate,
together with regulators, what information concerning metabolism
is needed to permit safety assessment of substances. In addition,
the need and the possibilities to integrate metabolic competence
into in vitro test systems were examined in order to
make them more predictive for toxicity assessment. More detailed
information can be found here.
In 2011, an EPAA Task Force (ADME TF), under the leadership
of ECVAM, organized a workshop on 13-14 October in Ispra, Italy.
The potential for further integration of PBTK modelling into
the prediction of in vivo dose-response curves without animal
experiments was examined.
Progress report on in vitro metabolism
Workshop "In vitro ADME in Safety
Testing", Düsseldorf, 24-25 November 2008
Report of the workshop "Potential for further integration
of toxicokinetic modeling into the prediction of in vivo dose-response
curves without animal experiments" - Ispra, 13-14