|October 30, 2009, edition
|Dear ecopa messenger subscriber,
In Budapest/Hungary, the EU 7th Framework Programme research project START-UP, directed by ecopa, had its major workshop in this year on October 2-3, 2009. By this last workshop, the ‘active’ part
of the START UP-project has come to an end. The topic was “Bottlenecks in the pharmaceutical industry”, with regard to possibilities to further pursue replacement and identify actions
for a roadmap. Yet another format by which regulators and industry scientists presented and discussed in sequence.
This START-UP-workshop on Replacement was organized by the Hungarian and the German platform organizations, hucopa and set.
ecopa has had its 2008-Annual Meeting addressing deadlines in the EU last November:
This year’s Annual meeting is going to take place on November 28-29, 2009 at the Brussels Sheraton Airport Hotel, as usual, addressing the 10-years’ anniversary of ecopa. The
draft program is to be found here:
In Budapest, at the last ecopa Board Meeting held on October 1, 2009, the preparations for the elections were taken up. Progress will be informed upon.
Please register as soon as possible, because there will be more people interested than usually: registration form see here:
This year, beside of the scientific workshop on Saturday, there will be a preceding meeting of the National Consensus Platforms on Friday afternoon, also preparing the elections
for the new ecopa Board to be performed then subsequently on Sunday morning.
Treasurer ecopa on behalf of the ecopa Management Board
P.S.: Any proposal or recommendation regarding style, content or distribution of the newsletter is highly welcome and appreciated (firstname.lastname@example.org).
If you know other people or institutions interested, have them visit our website and subscribe
to this newsletter.
||Issue # 21 (October 2009)
|I.1.1. Recent News on
REACH and GHS
First REACH list of dangerous chemicals agreed:
EU Member States approve world-wide rules for labelling of chemicals
The European Commission welcomed the agreement by the EU Member States to align EU legislation on classification, labelling and packaging of substances and mixtures to the United
Nations Globally Harmonised System (GHS). This new system is supposed to ensure that the same hazards will be described and labelled in the same way all around the world. By using internationally
agreed classification criteria and labelling elements, it is expected to facilitate trade and to contribute towards global efforts to protect humans and the environment from hazardous effects of
chemicals. The new regulation will complement the REACH regulation on the registration, evaluation, authorisation and restriction of chemicals. The European Parliament already the 3rd of September
this year approved the GHS regulation. The next step will be its publication in the Official Journal of the EC.
The regulation will require companies to classify, label and package appropriately their hazardous chemicals before placing them on the market. It aims to protect workers, consumers
and the environment by means of labelling which reflects possible hazardous effects of the chemical, while also taking over from REACH notification of classifications to the European Chemicals Agency
(ECHA) in Helsinki.
The regulation will after a transitional period replace the current rules on classification, labelling and packaging of substances (Directive 67/548/EEC) and mixtures (Directive
1999/45/EC). After entry into force, the deadline for substance classification according to the new rules will be 1 December 2010 and for mixtures 1 June 2015.
More information about the new rules can be found under:
Whether the highly acclaimed expectations are
later met by reality, has to be seen.
||ECHA (European Chemical
|European Chemicals Agency (ECHA) runs the
More information here: http://echa.europa.eu/doc/press/
Access to REACH-IT portal: http://echa.europa.eu/reachit_en.asp
ECHA held its first stakeholder’s day on October 10, 2008. The outcome is published here:
General information and more events by ECHA, related to REACH, see the website:
|I.1.2. European Partnership on Alternative
Approaches to Animal Testing (EPAA)
For outcome of the recent Mirror Group meetings and the last workshops, see the EPAA-website:
EPAA-newsletter of September 2009 is published and can be read here:
EPAA Annual Meeting 2009 will take place on Nov. 6, 2009 in Brussels in the premises of the European Commission (Charlemagne Building) Deadline for online registration is October
30, 2009. The conference theme is “dissemniation of 3R-aspects”.
EPAA-events are listed under: http://www.epaa.eu.com
|I.1.3. IMI is launched
The Innovative Medicines Initiative (IMI) has been launched on April 30, 2008. This is an initiative launched by both the European Commission and the EFPIA, the
European Federation of Pharmaceutical Industry Associations. The goal of this initiative is to give an impulse to biopharmaceutical innovation in Europe. Universities, hospitals and public institutions
can get financing for a research project.
IMI organises annual calls to be participated by academia and small companies. The subjects are determined by the EFPIA in cooperation with the European Commission.
The first calls are out by now.
Executive Director appointed
At its meeting of June 10, 2009 the Innovative Medicines Initiative Joint Undertaking's Governing Board took the decision to appoint Professor Michel Goldman as Executive Director of the
IMI JU. Professor Goldman was chosen out of a shortlist of candidates following the selection and appointment procedures. He will take his position once the employment contract with the IMI JU
has been finalized and signed.
Michel Goldman is Professor of immunology at the Faculty of Medicine of the Université Libre de Bruxelles (ULB) in Belgium.
Outcome of First Call published. More see here:
A working group with IP experts and representatives of the IMI Founding members and of the Member States has been set up at the request of the IMI JU Governing Board.
The aim is to exchange views on the IMI IP policy and coordinate a targeted dialogue between interested parties. Clarification note - IMI IP policy available. More info see here:
More information can be found here:
See the website of IMI here and check the upcoming
Ecological Risk Asessment Symposium
The US Environmental Protection Agency (EPA) and its Science Policy Council had issued a nanotechnology white paper. The paper was aimed at providing information on the science
issues and needs associated with nanotechnology, and to communicate them to stakeholders and the public.
US Environmental Protection Agency (EPA) and its Science Policy Council has also installed a
Framework for Application of the Toxicity Equivalence Methodology for Polychlorinated Dioxins, Furans, and Biphenyls in Ecological Risk Assessment
Organized in accordance with EPA’s
Guidelines for Ecological Risk Assessment, this framework is intended to assist EPA scientists in using the toxicity equivalence methodology in ecological risk assessments that involve
dioxins and dioxin-like chemicals, as well as to inform EPA decision makers, other agencies, and the public about this methodology.
More information see here:
I.2.2. Review of Directive 86/609
The new version is out since November 5th, 2008, and being discussed in the member states and its administrative representative groups. Article 44-46 in chapter IV, address
Progress can be followed under:
Update on Dir 86/609 Follow up Legislation: With
the first reading on May 5 of this year, in the European Parliament, the legislative process has been further initiated. Under Czech Presidency, and since midst of the year,
Swedish Presidency, the process has been pursued by the Member States Working Groups for the Council in several meetings; the last months even bi-weekly. The next level for
the Council side, to start by beginning of November, is the consultation series of the attachees of the permanent representations of the Member States. It is expected that the
consultation process should still be finalized by the end of the year, when EC, Council and Parliament will have to finalize their consultations; a first informal meeting between
these parties - called trilog - has taken place on October 14, 2009.
||II.1. EU 6th Framework
Programme Projects / ecopa Working Groups
|II.1.1.1. Recent News on FP6 and FP7 projects
Next Board Meetings will be determined following the ecopa Annual Meeting end of November 2009.
Representatives of ecopa in EU projects 6th Framework Programme:
||SSA project ForInViTox (Forum for
researchers and regulators to meet manufacturers of toxicology test methods) - ecopa is represented by Dr. Odile De Silva.
||BioSim – Flavia
Zucco represents ecopa in this EU Project.
||CarcinoGENOMICS – Bernward
Garthoff is the ecopa representative in this IP FP6 project. ecopa has taken over the Work Package of dissemination of results of the consortium.
questionnaire of the WP 11 regulatory group can be found on the carcinoGENOMICS website for consultation and input.
Input is requested and welcome from
representatives of regulators, authorities, agencies and especially from toxicologists in industry and academia.
||ACute Tox – Peter Maier is
the representative in the Advisory Board.
||Sens-it-iv – Vera Rogiers (represented
by the ecopa secretariate) is the representative in the Advisory Board, and ecopa is seconding in the dissemination of results.
||Liintop – Horst Spielmann is
the representative in the Advisory Board.
||ReProTect – Karin Gabrielson,
Vera Rogiers and Bernward Garthoff (Chair) are representatives on the Supervising Board, and ecopa is seconding in the dissemination of results.
||START-UP – START-UP is
the ecopa-follow-up-project for CONAM.
||ESNATS - ecopa is lead part of the
||ecopa – latest ecopa-Board
meeting took place on October 1, 2009 in Budapest/Hungary. The minutes of the ecopa-Board Meeting can be obtained here:
The European Commission has published a booklet on all European FP6-projects concerned with alternative testing. You can download it from this link:
II.22.214.171.124. Austrian Platform
e t – Austrian Centre for Alternative and Complementary Methods to Animal Testing
|| The 16th Congress on Alternatives
to Animal Testing – Linz 2010 is being prepared, it will take place on September 3-5, 2010 in Linz, Austria.
II.126.96.36.199. Belgian Platform
II.188.8.131.52. Czech Platform
II.184.108.40.206. Danish Platform
II.220.127.116.11. Dutch Platform
» Currently not active
II.18.104.22.168. Finnish Platform
II.22.214.171.124. French Platform
» Plateforme Nationale pour le développement des Méthodes alternatives à l’experimentation animale
II.126.96.36.199. German Platform
||Stiftung set organized, together
with the Hungarian platform hucopa, the Workshop on Replacement on October 2-3, 2009. This Workshop was part of the FP7 EU-project START-UP.
II.188.8.131.52. Hungarian Platform
||In context with the START-UP
Workshop on Replacement in Budapest on October 2–3, 2009, jointly organized by the Hungarian and the German Platform. hucopa organized an additional Workshop in Hungarian language, the
according press release as well in local language.
Pictures of the event can be found here:
II.184.108.40.206. Italian Platform
- Italian Platform on Alternative Methods
II.220.127.116.11. Irish Platform
II.18.104.22.168. Norwegian Platform
||Two centres for the 3Rs in Norway:
The Norwegian Reference Centre for Laboratory Animal Science and Alternatives (http://oslovet.veths.no)
is based at the Laboratory Animal Unit at the Norwegian School of Veterinary Science. Karina Smith at the Centre maintains the NORINA database of audiovisual alternatives
and the TextBase database of literature within laboratory animal science (http://oslovet.veths.no/textbase). The
Laboratory Animal Unit is accredited by AAALAC International. The Centre maintains a large website with information on the 3Rs.
In October 2007, the organisation Norecopa was launched. Norecopa is Norway’s Consensus Platform for Replacement, Reduction and Refinement of Animal Experiments (http://www.norecopa.no).
Norecopa is a member organisation with a board of representing the 4 stakeholders interested in animal research (regulators, academia, industry and animal welfare organisations). Norecopa is
recognised by ecopa (http://www.ecopa.eu)
as Norway’s national platform for the 3Rs. Norecopa’s annual budget is at present sufficient to finance the secretary in a part-time position (50%), pay for the administrative work
and some scientific activity. Norecopa is working to increase funding, and not least, to establish a research and development fund for work within the 3Rs.
Norecopa and the Reference Centre cooperate closely with the Norwegian Research Council and the Norwegian Animal Research Authority (the regulatory body). The NRC
has funded a report on research needs related to the welfare of fish in research. Norecopa has also started to produce position statements, so far on toeclipping and fasting of rodents. Both
websites hold extensive information on existing guidelines for the use of animals in research.
The Reference Centre and Norecopa have together arranged two international consensus meetings on harmonisation of the care and use of animals in research: one on
fish and one on wildlife research. The third such meeting (on fish) was held in September 2009. All the presentations and conclusions from these meetings are available from the Norecopa website:
||Latest newsletter of norecopa can be obtained
II.22.214.171.124. Polish Platform
II.126.96.36.199. Spanish Platform
» REMA – Red
Española para el Desarrollo de Métodos Alternativos a la Experimentación Animal
||The REMA activities can be found
at (Spanish version):
II.188.8.131.52. Swedish Platform
||Swecopa held it’s AGM on March 31.
Karin Gabrielson Morton was re-elected to chair Swecopa. Other board members are Dr Cecilia Clemedson (Swedish Fund for Research without Animal Experiments), Professor Roland Grafström
(Karolinska Institute), Dr Krister Martin (AstraZeneca), Rebecca Ceder (Karolinska Institute) and Helena Elofsson (Board of Agriculture).
|| News from Swecopa is published
on the website www.swecopa.se under “News”.
A newsletter in Swedish is also available at http://www.swecopa.se/swe_sid5_aktuellt.html
E-mail us at email@example.com if
you want to receive the newsletter.
II.184.108.40.206. Swiss Platform
Research Foundation Switzerland
|| On May 28, 2009, the Administrative
Board approved the Annual Report on the Foundation’s activities during 2008 as well as the financial statements for the year. A total of CHF 553,360.00 was allotted to research projects,
while 6 new projects were approved for funding and two final reports were submitted.
Further details on the website:
Five new projects initiated in 2009 by the 3R Research Foundation Switzerland
Engineering of a human brain tumor model to replace animal experimentation Dr. Olivier Preynat, Department of Pathology and Immunology, Faculty of Medicine, University
of Geneva, Switzerland
Reducing the number of fish and their suffering during acute toxicity testing of potential environmental pollutants (OECD Guideline no. 203). Dr. Hans Rufli, ecotoxsolutions,
Generic in vitro evaluation assay for immunological correlates of protection, to replace animal challenge infection Dr. Kenneth McCullough and Dr. A. Summerfield, Institute of Virology
and Immunoprophylaxis (IVI), Mittelhäusern, Switzerland
A novel in vitro model for holistic assessment and optimisation of engineered tissue for functional cartilage repair Dr. Zhijie Luo and Prof. Jennifer Kirkham, Leeds Dental Institute,
University of Leeds (UK)
Establishment of an organ ex-vivo tissue slice model for cardiovascular research in particular for therapeutic atherosclerosis targeting Prof. Patrick Hunziker and
Dr. K. Bänziger, University Hospital, Basle, Switzerland
Latest bulletin of June 2009 “Refined ex-vivo rodent heart model reduces in vivo experimentation” to be found here:
Interested to form a new national platform in your country?
Please contact us (» contact
For an upfront info how to create a platform in your country, and which criteria to apply? See also the presentation of Jose Castell at the Stakeholder Workshop in Prague ECVAM/ecopa Stakeholder
|All the abstracts of the following projects
are to be found on the forum of the ecopa website, see the comment under II.1.
This 6th FP-project, that ecopa had co-initiated and in which ecopa is represented with 3 members in the Supervising Board including the Chairperson, was started in 2003 with 21
The overall funding is scheduled to be 9.1 mio EUR, resp. 13.5 mio EUR. Contract with the EU was signed on July 1, 2004; the administration is performed by Prof. Michael Schwarz,
University of Tübingen.
II.1.2.1. Recent News
As part of the project, a review “of the Implementation of the Embryonic Stem Cell Test (EST)” has been published in ATLA, see publication section.
The next Supervising Board Meeting will be held on December7-8, 2009 in Ispra, Italy at ECVAM.
A brochure on the ongoing activities within ReProTect is available.
Go to the website here:
Publishable executive summary 2008
A publishable executive summary for the year 2008 can be downloaded from the website:
You find an informative flyer below, as well as the brochure presenting the first results.
ecopa is involved in the Board and the results dissemination.
II.1.3.1. Recent News
A list of all publications produced by the Consortium is available on the web site as well as the project structure and a profound overview. Link below.
The latest newsletter as of February 2008 can be read here:
E-learning program for in vitro methods
The scientific coordinator of the FP6 project ACuteTox, Expertrådet, is producing an e-learning program for the testing strategy and the methods that will be the result of the project. To
get a good implementation and a wide use of the in vitro methods it is important to make it convenient for the industry to use them. One way is to produce interactive manuals that make it
possible to attain reproducible results with high and equal quality in all laboratories.
xpertrådet has developed a pedagogic model for an interactive manual within the ACuteTox project. The SOP text is supplemented with short video sequences, photos and drawings that clarifies
critical phases of the test methods. Each test will be presented in three different levels: 1) an introduction level where the tests are presented briefly to demonstrate the opportunities of the
test; 2) a second level with the SOPs of the tests and with video sequences or pictures that demonstrate how to carry through the tests; 3) in the third level the scientific documentation and background
of the tests could be find. The second level is the main part of the e-learning program that will consist of the interactive manual.
This model could also be useful for the other FP6 projects within the in vitro area and it would certainly be convenient for the endusers if the e-learning programs from the different projects
looked similar and had the same pedagogic model. Expertrådet is willing to assist other in vitro projects to produce similar e-learning programs.
Contact for more information: http://www.expertradet.se, http://www.acutetox.org
ACuteTox goes into a new phase
The testing within the ACuteTox project has been finalised and data has been quality checked. The data is now being analysed with partial least squares regression (PLS) analyses
in order to find the combination of assays giving the best prediction. However, so far different combinations of basal cytotoxicity tests and specific tests only marginally improve the prediction
compared to using basal cytotoxicity tests alone. By taking kinetic factors into account, the prediction could be approved further. The following four kinetic factors seem to be important: oral
absorption, clearance, lipophilicity and protein binding. It has been concluded that further data analysis and data mining is needed before the construction of the testing strategy can be initiated.
This data analysis and data mining will be carried out by an independent expert that has not been involved in the assay development and testing. These analyses have started in November 08.
Sens-it-iv is an integrated EU-funded research project (LSHB-CT-2005-018681)involving 28 partners, drawn from across Europe, of which 9 represent industry, 15 groups represent universities or
research institutes, while 4 groups represent organizations. They are joined together by the common goal of developing alternative strategies to animal testing for the assessment of skin and/or
respiratory sensitizing potential of chemicals. This includes the development of predictive in vitro methods.
ecopa is part of work package 9 and is responsible for “Technology transfer and Dissemination”. Technology transfer and dissemination of project results, including knowledge,
will be a key activity throughout the term of the Sens-it-iv project.
II.1.4.1. Recent News
ecopa has taken over the responsibility "spreading the news/results" of this EU project, and released a brochure covering the activities on behalf of Sens-it-iv, and supported the
website creation. The folder and poster can be downloaded on the website www.sens-it-iv.eu, section press material. Technology transfer and dissemination of project results, including knowledge,
will be a key activity throughout the term of the Sens-it-iv project.
The first Sens-it-iv Newsletter appeared on December 14, 2006 and now the 32nd edition is available via the website or the link below. The newsletter is coordinated by the WP9
The Sens-it-iv Newsletter Nr. 32 is out:
Newsletter-subscription possibility on the website.
The General Assembly has been held on October 5, 6 and 7, 2009, at Hotel Pueblo Acantilado, in El Campello near Alicante, Spain. A Summer school has been held from June 29th
till July 2nd, 2009 with the title: practical and theoretical course on Sens-it-iv in vitro methods at the University of Applied Sciences HU, Utrecht, The Netherlands. The course was about
theoretical and practical laboratory aspects of sensitization, pathology, cell culture models, data handling and experimental design.
A next Summer School will be organised in 2011. More information will be disseminated via the newsletters and the website.
BioSim, or "Biosimulation A New Tool in Drug Development" started December 1, 2004. BioSim is a Network of Excellence supported by the European Commission as part of its 6th Framework
II.1.5.1. Recent News
The BioSim project is now ended. The final 5th BioSim Conference was held in Christiansborg, Copenhagen, from August 25 to 29, 2009, hosted by the Danish Parliament, and attended
by about 160 participants.
The meeting, this time, covered other aspects than the scientific ones, which have been, however, the most relevant and interesting.
Presentations have been given by institutional and political representatives on the relevance of this project for the Danish institutions, in terms of international prestige,
scientific and educational impact. From the University side, the relevance of interaction between natural and technical sciences has been stressed, as well as that between academia and industries.
The challenge that universities are now facing is to prepare students for jobs which do not yet exists: thus there is a special need of economical but also cultural investment. A session has been
devoted to “Biosimulation vis-a-vis the ethical and social issues of global drug development”. Some lectures from Novo Nordisk A/S researchers and administrators on industrial research
and social responsibility were given.
Moreover, the relevance gained by the Corporate Social Responsibility (CSR), which implies a change in the attitudes of the Companies in relation to ethical “hot” issue, has been illustrated
by an EU Commission representative. The EU-perspective is whereby companies may integrate societal and environmental concerns in their business operations and in their interactions with the stakeholder
on voluntary basis. CSR, indeed, can be a tool that not only opens the dialogue among companies and the public at large, but also may have a positive feedback on the economy of the enterprise.
The main scientific session was dealing with “Biosimulation and model-based treatment of patients” and “Application of biosimulation in drug development”. The final sessions
were devoted to the use of biosimulation in the health sciences and to the most recent results of the BioSim project. The issue of why, where, and when the modelling should be applied has been widely
debated: still more rational approaches are needed, together with semantic clarification concerning f.i. the very concept of “system”. Moreover, it should not be forgotten that modelling
may start from data and not from a hypothesis and, thus, data source, mining etc., is of extreme importance. The Virtual Human and Personalised Medicine have been recurrent topics, which may look,
at glance, still very far away technological goals, but scientific approaches such as biosimulation of complex system, makes them thinkable, and even feasible, in a not too far future.
It goes without saying that much appreciation has been expressed for the outstanding scientific guidance of Erik Mosekilde, which, from now on, will act as counsellor of any
future plan, and for Anne Marie Clemensen, who made such a wide network to work easily and friendly, coping at the same time with the expected time schedule and administrative issues.
The principal Scientific Officer of the BioSim, presenting the next calls in the area of predictive medicine, provided ideas and information about future possibilities for this
network, or at least part of it, to continue its successful journey…and we are sure that this would be the case.
| II.1.6. Liintop
II.1.6.1. Recent News
Structure of the project, information
on partner and new on events can be taken from the website:
carcinoGENOMICS is an Integrated FP6 Project financially supported by the European Commission (LSHB-CT-2006-037712).19 groups are present of which 6 represent industry, 11 represent universities
or research institutes, while 2 groups represent organizations.
II.1.7.1. Recent News
A workshop was organized by the carcinoGENOMICS
project, the subject is ‘Genomics in Cancer Risk Assessment’. It took place on August 27 - 28, 2009 on San Servolo Island, Venice, Italy. This was a parallel Satellite Workshop to the
10th International Conference on Environmental Mutagens (ICEM), on Augustus 20 - 25, 2009 in Firenze and the VIIth World Congress on Alternatives & Animal Use in the Life Sciences, on August
30 – September 3, 2009 in Rome, Italy.
At this workshop on Genomics in Cancer Risk Assessment the state-of-affairs in chemical cancer risk assessment was explored and the possible contribution of genomics and systems
toxicology with respect to tackling the current flaws and uncertainties were discussed. Most importantly, the organizers were successful in bringing together leading experts from academia, industry
and regulatory authorities for this. They were also able to identify the road lying ahead: by taking the systems toxicology approach, generating mechanistic information on toxic responses from bioassays
consisting of human cells, and linking this with growing insights in molecular processes underlying human pathophysiologies.
For more information:
The next carcinoGENOMICS Board Meeting and Annual Meeting will be held in Barcelona/Spain on November 11-13, 2009. ecopa took over the dissemination, ecopa-members presenting.
MPIMG publishes a book on systems biology methods
In this book that was partly funded within carcinoGENOMICS, basic tools and methodologies for analysing biological networks are described. The intended readership of the book
are students and lecturers but also advanced researchers.
Klipp E, Liebermeister W, Wierling C, Kowald A, Lehrach H, Herwig R (2009) Systems biology - a textbook. Wiley-VCH Weinheim. In press.
Publisher's website advertisement:
|| II. 2. EU 7th Framework
Programme Projects, Initiatives and Technology Platforms
|II.2.1. Sustainable Chemistry (SusChem)
The Technology Platform SusChem has been formed and finalized its Implementation Action Plan. The action plan can be downloaded from the SusChem website.
SusChem newsletter #12 is now online:
A detailed review of the SusChem platform activities can be found in a supplement of the September 22 issue (2008) of the ICIS Chemical Business.
II.2.2. Regulations of the 7th Framework Programme
Update 7th EU RTD- Framework Programme
Though intended as part of the EU-competitive efforts in Research and Development, the EU still is behind its own targets laid down in the Lisbon Strategy. According to the
EU statistics officer, the 27 EU states invested in 2006 as much (or little) as in the year before, i.e. 210 billion EURO equivalent to 1.84% of its economical output. Lisbon asks for 3% in 2010.
Guidance on FP7 implementation
A number of guidance documents and preparatory work are carried out by the European Commission in view to install the basis of the FP7 implementation. The following documents
are available for consultation on http://cordis.europa.eu/fp7/find-doc_en.html where
they can also be downloaded:
• a standard Model Grant Agreement,
• a draft Guide for Beneficiaries,
• a draft Guide to Financial Issues,
• a draft Guide to IPR and
• a draft Checklist for the Consortium Agreement.
ecopa is interested to participate with partners in some of the calls dealing with alternative methods and being announced in the future, esp within the HEALTH resp. the ENVIRONMENT sectors
of the 7th FRP.
ecopa submitted a proposal for a Support Action in the HEALTH-2007-1.3-2 call: Bottlenecks in reduction, refinement and replacement of animal testing in pharmaceutical discovery and development.
The proposal is called “Scientific and technological issues in 3Rs alternatives research in the process of drug development and Union politics” with the acronym: START-UP.
Several NCPs are collaborating in this project. The project was approved “Grant Agreement” No. 201187 and signed on March, 12, 2008. Project no. LSHB 201187.
II.2.3.1. The Abstract of the proposal
The START-UP project is concerned with the identification and proposals to abolish bottlenecks in the 3Rs approach in pharmaceutical discovery and development. The goal of the project is
the organisation of 3 Workshops in order to determine a) the state of the art of each of the 3Rs in the EU, b) to assess European strength and gaps in 3Rs and c) the identification of rate
limiting steps on the political, scientific, technological level. As a result, a Consensus Paper containing the concepts and suggestions for a Roadmap for future research will be produced.
Stakeholders (among them European Pharmaceutical Industries (EPI)) have identified bottlenecks in drug development and in the integration of in vitro methods Early identification of wrong
candidates for further development and avoiding efforts for under-performing candidates, are essential for the competitiveness of European Industry. Identification of bottlenecks in the implementation
of reduction, refinement and replacement of animal experimentation in drug R&D, should assist in identifying the best in vitro and in vivo systems, and to speed up the drug development
process. Existing hurdles in the scientific, technological, political and environmental level (including regulatory), play a substantial role and are rate-limiting in developing new drugs, including
biological entities (almost 50% of the currently developed products).
ecopa (the quadripartite umbrella NGO for alternatives) structures with its VUB partner this support action around 3 major workshops which was preceded by 3 Expert Meetings redefining and
prioritising current bottlenecks in 3Rs methodology; with EPI, drug discovery and development. Each phase has its own specific needs, and analysing the present limitations and gaps needs to be addressed,
e.g., many cell systems do not yet have the required stability for genomics, proteomics or metabonomics analysis; many current in vitro cell systems lack crucial bioactivation capability.
Consequently, the status of satisfactory “predictive” pharmacology and toxicology in vitro has not yet been reached.
In terms of politics and ethical concerns, considerable differences in regard to the use and development of transgenic animals, human tissues and stem cells create an atmosphere
of insecurity for an effective academia and industry cooperation.
The final goal of this action is a Consensus Document that analyses present status.
Details of the project were presented by the Chair of ecopa on the occasion of the 11th Linz Alternative Congress, September 28-30, 2007.
The first major workshop of the START-UP project, on Refinement, was held in Rome, Italy, at the L’Istituto Superiore di Sanità (ISS) on February 26-27, 2009. The second workshop,
on Reduction, has been held on July 3-4, 2009, in Innsbruck, Austria. The third workshop, on Replacement, was held on October 2-3, in Budapest, Hungary.
At the moment, reports are being prepared for editing the final report to be supplied to the European Commission, by the end of February, 2010.
Project acronym: ESNATS
Project full title: Embryonic Stem cell-based Novel Alternative Testing Strategies
Grant agreement no.: FP7 - 201619.
The aim of the ESNATS project is to develop a novel “all-in-one” toxicity test platform based on embryonic stem cells (ESCs), in particular human ESCs, to accelerate drug development,
reduce R&D costs and propose a powerful alternative to animal tests in the spirit of the “Three R principle”. ESNATS objectives will be achieved in a 5 year multi-disciplinary collaboration
of leading European researchers in alternative testing, toxicology, ESC research, genomics, modelling, and automation. The consortium will also include representatives from regulatory bodies, the
pharmaceutical industry and ethical advisors to provide guidance to ensure rapid applicability of the developed test systems.
ecopa has taken over some tasks in disseminating results of this project, developed the logo, and is leading the respective workpackage.
Last esnats-Board Meeting and Summer School took place on Sept. 23-24, 2009 in Zermatt/CH.
The upcoming esnats General Meeting is scheduled for April 26-28, 2010 in Ispra/Italy.
III.1.1. ecopa events
III.1.1.1. 10th Annual ecopa Workshop
The future ecopa Annual Meetings will be:
10th: November 28-29, 2009
11th: end of November 2010
III.1.1.2. ecopa Board meeting
The next ecopa Board meetings:
- Dates will be set after the 10th Annual ecopa Workshop
||eSI - ecopa Science
|III.1.1.3. eSI: ecopa Science initiative
The eSI-Conference under the general heading: "Reaching the young scientist" is an initiative organised by ecopa aimed at bringing together senior as well as young researchers to
discuss about the new technologies and their applicability in ‘in vitro’ research as well as to improve creativity and innovation in the search for alternative methods. ecopa had
performed a detailed literature analysis of the last 5 years of research in alternative methods and had concluded that this area of applied research is drying out.
The full report, presentations, and the final program are listed on
the ecopa website in the archive section.
NEWS: The latest workshop has taken place in Pueblo Acantilado; Alicante, Spain on October 16-19, 2008, with the attendance of senior scientists and young researchers of 14 countries. It
focussed on "Recent developments and potentially novel approaches of science to alternative testing of cosmetics and pharmaceuticals”. It was held together with the European Partnership
for Alternative Approaches to Animal Testing, EPAA.
New aspects of pharmaceutical and cosmetic research are covered also in regard to the START-UP project. Sponsoring was provided by Badecos/Rogiers, Bayer, set and EPAA.
Presentations and photographs:
III.1.2.1. 18th International Congress of the European Association on Tissue Banks
November 4-6, 2009 in Cracow, Poland
The 18th Annual Congress of the European Association of Tissue Banks, is being held in Cracow, Poland from the 4th – 6th November 2009. The meeting will comprise plenary sessions with renowned
experts on: European regulation and its implementation, Vigilance & Surveillance, Irradiation, TSE’s including vCJD and Skin grafts. There will also be free paper presentations -awards
for best poster, best presentation and also the Professor Anna Dziedzic-Goclawska Award for Novice Investigators.
For more information:
III.1.2.2. EPAA 2009 Annual Conference
November 6, 2009 at the Charlemagne Building, Brussels, Belgium
The EPAA is a partnership between the European Commission and industry from seven sectors, all committed to joining forces for the promotion of the 3Rs in regulatory testing.
This year, in particular dissemination of 3Rs will be addressed, including issues such as: The role that dissemination plays or should play in advancing research into 3Rs, sharing good practice,
enhancing (international) regulatory acceptance and improving uptake of 3Rs techniques, Information needs and information gaps and the most efficient dissemination mechanisms.
For more information:
III.1.2.3. IVTIP 21C Autumn Meeting - Toxicology in the 21st century - working our way towards a visionary reality
November 26, 2009 at the Hotel Ter Elst, Edegem, Belgium
With this meeting IVTIP wants to actively contribute to driving this vision towards a practical tool that is broadly applicable for toxicity testing. This objective will be
pursued by addressing the following issues:
- The concerns, needs and expectations living within various industries and regulatory authorities with respect to this visionary strategy;
- The technological reality and its capability (or lack thereof) to support this vision.
For more information:
III.1.2.4. 2nd Annual: Immunogenicity 2009:Assessing the Risk and Clinical Relevance of Immunogenicity in Biotherapeutics Development
January 14–15, 2010 in Barcelona, Spain
This marcus evans conference offers the environment for benchmarking and networking with thought-leading researchers in immunogenicity. Scientists from pharmaceutical and biotech
companies present industry case studies and new academic findings, while representatives of regulatory agencies give updates and answer questions from the audience.
For more information:
III.1.2.5. 2nd International Conference on Drug Discovery and Therapy
February 1–4, 2010 in Dubai, UAE
The 2nd ICDDT 2010 will highlight cutting-edge advances in all major disciplines of Drug Discovery and Drug Therapy. This four-day event will feature recent findings from leading
industrial, clinical and academic experts in the field, in the form of lectures and posters. The 2nd ICDDT 2010 will promote the translational nature of modern biomedical research, with an equal
number of speakers/participants those who are basic scientists in drug discovery and those who are medical doctors associated with direct patient care and research.
For more information:
III.1.2.6. i-SUP2010: Innovation for Sustainable Production 2010
April 18-21, 2010 in Bruges, Belgium
I-SUP2010 will focus on the intertwining of all those disciplines involved in sustainable development taking into account societal, technological and scientific issues in a
broad and integrated range of domains. I-SUP2010 invites you to discuss with all stakeholders involved in this process by combining six international congresses at the same time and the same location,
each aimed at a specific target audience of industry leaders, universities, research institutes and decision makers covering such fields as:
for sustainable Production, Carbon
Capture and Storage (CCS) and In
vitro methods replacing animal testing (CARDAM).
For more information:
Awards and Publications
III.2.1. Booklet on Alternative Testing Strategies
The European Commission has published a booklet on all European FP6-projects concerned with alternative testing.
You can download it from this link:
III.2.2. Catalogue on: Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment
In recent years, completion of the sequencing of the human genome as well as the genomes of dozens of other organisms and subsequent development of tools for comprehensive analysis
of other cellular constituents have revolutionized biology. These new technologies, referred to broadly as “genomics,” have integrated biologic sciences with information sciences and
engineering. The application of these new technologies to toxicology has opened a new era in which genetic variation and expression signatures might be used to screen compounds for hazard identification,
to assess cellular responses to different doses, to classify toxicants on the basis of mechanisms of action, to monitor exposure of individuals to toxicants, and to predict individual variability
in sensitivity to toxicants. In pharmacology, these technologies have been used both to detect desired cellular responses to drugs and to monitor potential toxicity.
You can download the catalogue from this link:
III.2.3. Dieter Lütticken Award 2009
Candidates should give full contact details, co-operation partners, an executive summary of the studies and an argumentation why they should be taken into consideration, a publications
list related to the studies and a selection of copies of those publications which give a good overview of the work.
For application forms please contact:
Intervet Global Communications Animal Health, Boxmeer, The Netherlands
This year’s deadline is November 15, 2009
The document is available here:
III.2.4. EPAA Newsletter September 2009
The EPAA Newsletter of September 2009 is available now. You can read it here:
III.2.5. NC3Rs Newsletter 23 (September 2009)
The 23rd edition of the NC3Rs-newsletter (September 2009) is available now. You can subscribe for this here:
III.2.6. EFSA published an opinion on the replacement, reduction and refinement of animal testing
Existing approaches incorporating replacement, reduction and refinement of animal testing: applicability in food and feed risk assessment.
The founding Regulation of EFSA requires the Authority to contribute to a high level of protection of human life and health, and in this respect to take account of animal health
and welfare. EFSA is committed to a proactive animal welfare approach, based on sound scientific principles and the need to ensure that adequate data are available for a reliable risk assessment.
In this context, EFSA and its Scientific Committee recognise the importance to stimulate the use of food and feed assessment approaches that would not only minimise the number of experimental animals
and any suffering, but also work towards their replacement.
For the full text:
III.2.7. Toxicity testing gets a makeover
The European Commission has revealed details of a major new research programme to develop a modern, high-throughput approach to repeat-dose toxicity testing.
For the full text:
III.2.8. Article in Altex: Research Expenditure for 3R Alternatives
Title: A Review of National Public Funding Programmes in European Countries Authors: Tonia Devolder, Kirsty Reid, Vera Rogiers, Simon Webb and David Wilkins Summary: A survey
of publicly funded research specifically targeting alternatives to animal testing was conducted over 2006/2007. Responses were received from 16 European countries (Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Slovakia, Spain, Sweden, Switzerland and the United Kingdom). The responses were compiled by national agencies or national
consensus platforms. The current annual total across the 16 countries was estimated as € 17 million. The largest contribution came from Germany with € 4.6 million (27% of the total). Also
collated was information on the existence of a national strategy on alternatives research, the focus of any such strategies, the research priority setting process, stakeholder consultation in that
process, project funding preferences or limits, coordination mechanisms and the separation of responsibilities of competent authorities (i.e. for research support, laboratory animal welfare and
chemicals management). Countries with national strategies (France, Germany, the Netherlands, Sweden, Switzerland and the UK) are skewed towards the higher end of the spending distribution. These
6 countries account for over € 12 million, i.e. >70% of the overall total of national spending identified. Most countries have national consensus platforms. These should help to both stimulate
stakeholder consultation and further national spending on alternatives research. The situation regarding the separation of responsibilities of competent authorities (i.e. for research support, laboratory
animal welfare and chemicals management) is mixed. A degree of overlap exists in many cases. A research strategy that is receptive to and reflects regulatory developments – such as REACh with
its marked resultant increase in animal use – is an obvious need that is as yet unmet in many of the countries surveyed. The need for a mechanism to collate details of active research projects
within Europe as a whole was also identified.
For more information:
III.2.9. Stem cells online journal
For more information:
III.2.10. A Review of the Implementation of the Embryonic Stem Cell Test (EST)
The report and recommendations of the ECVAM/ReProTect Workshop organized in May 2008 in Frankfurt/Germany were published recently in ATLA 37, 313–328, 2009.
|III.3. Calls and Vacancies
III.3.1. Open Call for the Expression of Interest in membership in ECVAM's Scientific Advisory Committe (ESAC)
The European Centre for the Validation of Alternative Methods (ECVAM), hosted by the Institute for Health and Consumer Protection (IHCP) of the European Commission's Joint Research Centre (JRC),
has launched an Open call for the renewal of its Scientific Advisory Structure. The "Open Call for the Expression of Interest" is directed to generalist scientific experts
from the area of life and environmental sciences, medicine, chemistry, or toxicology. The Committee shall cover a wide range of experience, including testing, validation of test methods, risk assessment/risk
management of chemical substances.
The 19 ESAC members will be in charge of advising ECVAM on all scientific aspects of its work and in particular with regard to the scientific validity of methods that would
replace, reduce or refine animal experiments. Experts should come from industry, regulatory agencies and administrations, academia, or other interested social groups, i.e. all relevant stakeholder
communities, but will be appointed to ESAC ad personam and must act independently when serving in ESAC. Up to 4 ESAC members might come from non-EU countries.
All relevant information including the application procedure can be found on
Deadline for application was September 30, 2009.
III.3.2. 4th call of the EC Seventh RTD Framework Programme
This call will address the replacement of animal tests in repeated dose systemic toxicity testing, through the topic HEALTH.2010.4.2-9 "Towards the replacement of repeated dose systemic toxicity
testing in human safety assessment", of the Health Programme. The topic might be of interest to you and your project partners. It is strongly supported by industry and in particular by The
European Cosmetics Association (COLIPA). More information about additional funding possibilities may be obtained from the COLIPA's website (www.colipa.eu)
and in the enclosed COLIPA's leaflet. It is important to note that the funding modalities differ from the standard FP7 funding schemes.
This information is also available here:
III.3.3. ERC-starting grants call open for GRANTS PhD-holders (2 to 10 years PhD-holder)
NEW CALL + NEW ELIGIBILITY CRITERIA
The ERC- European Research Council has launched its 3rd call for ERC Starting Grants (ERC 2010-StG).
- Physical Sciences & Engineering Domain (Panels PE1 - PE10) Deadline: October 28, 2009
- Life Sciences Domain (Panels LS1 - LS9) Deadline: November 18, 2009, 17.00 (Brussels local time)
- Social Sciences & Humanities Domain (Panels SH1 - SH6) Deadline: December 9, 2009, 17.00 (Brussels local time)
Budget: EUR 528 237 600 (indicative)
More info + Details:
2010 ERC Work Programme (.pdf) (updated version dated 29/07/09, published on 04/08/09 (the only page that has changed since the first version published on 30/07/09 is the cover
ERC-2010-StG (.pdf) (30/07/09)
Guide for Applicants:
Guide for Applicants (.pdf) (dated July 2009, published 04/08/09)
Who can apply ?
Eligible Researcher (“Principal Investigator”)
§ The ERC actions are open to researchers of any nationality who would like to establish their research activity in any Member State as well as any Associated Country.
§ The Principal Investigator can be of any age and nationality and he/she can reside in any country in the world at the time of the application.
§ The objective of the ERC-STG is to provide critical and adequate support to the independent careers of excellent researchers.
§ The ERC Starting Grant Principal Investigator must have been awarded his/her first PhD (or equivalent doctoral degree) at least 2 and up to 10 years prior to the publication date of the call
for proposals of the ERC Starting Grant = 30/07/2009).
§ Principal Investigators are sub-divided during evaluation in two main streams, with applicants being awarded their PhD at least 2 and no more than 6 years (broadly described as "starters")
or over 6 but no more than 10 years (broadly described as "consolidators") prior to the call publication.
§ Extensions of this period may be allowed only in case of eligible career breaks which must be properly documented: maternity (18 months per child born before or after the PhD award) & paternity
leave (accumulation of actual time off for children born before or after the PhD award) and leave taken for long-term illness, national service. Leave taken for unavoidable statutory reasons (e.g.
clinical qualifications) may also count as an extension. The cumulative eligibility period should not in any case surpass 14.5 years following the award of the first PhD. No allowance will be made
for part-time working (2 years of half-time working count as 2 full-time years).
Eligible Scientific Fields
§ Applications may be made in any field of research:
§ Funding of human embryonic stem cell research will be possible within the ethical framework defined in the EC 7th Framework Programme7 as well as the Ideas Specific Programme.
Electronic and single submission of full proposal
The evaluation will take place in 2 steps following the single submission of a full proposal.
Step 1: Following the submission of the proposal, Section 1 of the proposal will be assessed and marked
Step 2 : The complete version of the retained proposals will be assessed and ranked by the panels during of the evaluation.
III.3.4. ECVAM is renewing its Scientific Advisory Structure: Two Open Calls for Scientists
The European Centre for the Validation of Alternative Methods (ECVAM) is currently renewing its Scientific Advisory Structure.
In the context of this renewal (more details below), ECVAM is publishing Two Open Calls for the Expression of Interest addressed to experts in life and environmental sciences,
medicine, chemistry, toxicology, test method and test strategy validation, risk assessment and scientists knowledgeable in other areas such as statistics, biometry, epidemiology, modelling approaches.
The first call is dedicated to the new ECVAM Scientific Advisory Committee (ESAC). The 19 ESAC members, preferably senior scientists with a generalist profile, will be in charge of advising
ECVAM on all scientific aspects of its work and in particular with regard to the scientific validity of methods which replace, reduce or refine animal experiments. Deadline for submitting an
expression of interest in the ESAC was September 30, 2009.
The second call concerns the formation of an ECVAM Expert Pool (EEP), supporting ECVAM's mission through direct expert advice to ECVAM and ESAC, e.g. through their participation in ESAC Working
Groups, task forces or workshops. Preference will be given to experts with profound specialist knowledge in one or few areas. The call will be published mid September. No deadline is foreseen
All relevant information including the application procedure can be found on:
III.3.5. ECVAM launches an open call for tender
Phase III — Prevalidation of the 3 methods subdivided into 3 lots: lot 1 - Direct Peptide Reactivity Assay (DPRA); lot 2 - Myeloid U937 Skin Sensitisation Test (MUSST); lot 3 - human Cell
Line Activation Test (hCLAT).
The Institute for Health and Consumer Protection (IHCP) has launched an open call for tender, for ECVAM of the In Vitro Methods Unit. The aim of the call is to invite laboratories to participate
in the initial phase (phase III prevalidation) of the evaluation of three test methods designed for the assessment of the skin sensitisation potential of substances. The three methods are: 1) the
Direct Peptide Reactivity Assay, 2) the Myeloid U937 Skin Sensitisation Test (MUSST) and 3) the human Cell Line Activation Test (h-CLAT). Within this project the selected laboratories will work
in close contact with multinational companies as well as the European Commission's Joint Research Centre.
Access to the official notice available from the Tenders
Electronic Daily Homepage:
Deadline for submitting offers: October 13, 2009
Further information including the relevant tender documents can be obtained from
+39-0332-789197; Fax: +39-0332-789434
III.3.6. New Grant Applications invited now by Dr. Hadwen Trust
The Dr Hadwen Trust is currently inviting new grant applications for research proposals to develop, validate or implement non-animal methods which contribute to the replacement
of animal experiments in medical research. There is a total budget of £400,000 on offer for proposals directed at replacing the use of living animals in current procedures. For fuller details
III.3.7. Tierschutzforschungspreis – Ausschreibung BMELV / Call by the German Ministry for Food, Agriculture and Consumerhealth: 29th Award of Animal Health Research
Deadline: March 31, 2010
Details (in German only) here:
III.4.1. Countries Unite to Reduce Animal Use in Product Toxicity Testing Worldwide
U.S., Canada, Japan and European Union Sign International Agreement
Representatives from four international agencies, including the director of the U.S. National Toxicology Program (NTP), today signed a memorandum of cooperation that could reduce
the number of animals required for consumer product safety testing worldwide. The agreement between the United States, Canada, Japan and the European Union will yield globally coordinated scientific
recommendations on alternative toxicity testing methods that should speed their adoption in each of these countries, thus reducing the number of animals needed for product safety testing.
The memorandum is available at:
The press release can be found here:
III.4.2. CAAT 3Rs Centers website
Across the globe, organizations are working to reduce, refine, and replace animal experiments. You can search for these organization by the map, by name, keywords, or by associated
tags. This database is provided and maintained by The Johns Hopkins University Center for Alternatives to Animal Testing (CAAT).
For more information:
III.4.3. ALARMTOX - Aquatic biotoxin detection methods
The mouse bioassay (MBA), developed by Yasumoto et al. (1978), is one of the currently used analytical methods for lipophilic toxin detection in shellfish. Despite being a useful
surveillance tool for consumer protection, the method presents obvious ethical problems. Moreover, sensitivity is sometimes insufficient to detect toxin levels at the EU regulatory limit values
and the whole process requires long analysis times; false negative and false positive results have also been reported.
ALARMTOX project has been started. The main objective is to develop assays and biosensors for the detection of aquatic biotoxins (marine and continental waters).
For more information: