ecopa - european consensus-platform for alternatives
December 24, 2007, edition #14-2007
Dear ecopa messenger subscriber,

The end of the year 2007 saw a series of substantial meetings on alternatives: the epaa Annual Meeting, addressing “Regulatory Acceptance”, and our own ecopa Annual Meeting, where the workshop presented a check on what has been achieved in alternative test methods, funding of these, Europe-wide, and what can, resp. cannot be expected.

Website 8th Annual ecopa Workshop - Presentations
Website 8th Annual ecopa Workshop - Photographs

A further highlight was the welcoming of two new member platforms, i.e. the Plateforme Nationale of France, and Norecopa from Norway. ecopa covers now 13 countries on the European continent (see minutes).

The theme of the Annual meeting “Potential improvement in the development of alternative methods: Needs in risk assessment of new technologies and their products vs use of alternatives” provided also the groundwork for the new ecopa EU 7th FP-project START-UP (support-action). This project “Scientific and Technological issues in the 3Rs Alternatives Research in The process of drug development and Union Politics” was a major topic that fits into that overall subject, and which ecopa is following with its member NCPs.

The minutes of the Annual Meeting can be found in the next news letter edition.

During the Annual Meeting there was also the election of the Board of ecopa for the years to come.

The Executive Board and most of the NCP-delegates as well as 3R-experts were re-elected: Flavia Zucco left the Board (thanks a lot for her valuable service in the past years), and a new Italian 3R-expert has been elected: Isabella de Angelis. Congratulations!

Please also note that the next eSi (ecopa Science Initiative) – Workshop in Alicante/Spain initially scheduled for end of September 2008 has been moved to October 16-19 or 2-5, 2008, due to conflicting dates.

With the best wishes for a Merry Christmas and a Healthy, Prosperous and Challenging Year 2008!


Bernward Garthoff
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 (bgarthoff@t-online.de). If you know other people or institutions interested, have them visit our website and subscribe to this newsletter.
ecopa Issue # 14 (December 2007) top
I. ecopa:
I.1 General News
    1.1 News on REACH
    1.2 EU Partnership (EPAA)
I.2 Other News (Miscellaneous)
    2.1 Nanotech
    2.2 Review of Directive 86/609

II. EU 6th and 7th Framework Programme Projects / ecopa Working Groups / Platforms:
II.1 EU 6th and 7th Framework Programme Projects / ecopa Working Groups
    1.1 CONAM / Platforms
    1.2 ReProTect
    1.3 PREDICTOMICS
    1.4 ACute Tox
    1.5 Sens-it-iv
    1.6 BioSim
    1.7 Liintop
    1.8 carcinoGENOMICS
II.2 EU 7th Framework Programme Projects, Initiatives and Technology Platforms
    2.1 SusChem
    2.2 Preparation 7th Framework Programme Projects
    2.3 Regulations of the 7th Framework Programme
    2.4 START-UP
    2.5 ESNATS

III. Miscellaneous:
III.1 Events
    1.1 ecopa events
    1.2 Other events
III.2 Awards, Publications, Newsletters
III.3 Calls and Vacancies
III.4 Varia
ecopa I.1. General News top
I.1.1. Recent News on REACH

Most of the facts and the implementation aspects of REACH are found in the 60-page-report "Impact of REACH", first edition of a new series of ecopa-publications (electronic version). A print-version is available on request. Copies on CD also available, contact the ecopa secretariate.
Adobe Reader PDF Impact of REACH (804 kb)

In the meantime, the new executive director of EChA has been selected, and is taking office. His name is Geert Dancet, and he has been, already temporarily, in charge. He has been with the ranks of the EU Commission (see CV) before, and was involved in some of the preparatory work for REACH and the set-up of EChA in Helsinki.

Meanwhile, the race is on to compare the regulatory systems for chemicals: the US Government Accountability Office (a Congress institution) assessed in their August-report the “Chemical Regulation: Comparison of US and Recently Enacted European Union Approaches to Protect against the Risks of Toxic Chemicals”, concluding that a system modeled after REACH could amend some of the perceived deficiencies in TSCA (the US Toxic Substances Control Act, enacted 1976, with the authorized agency EPA).

The table below gives an overview on REACH information requirements and timetable reg. chemicals regulation: (Source/acc. to ICIS, Nov. 4, 2007)

Volume (tons/year) 1-10 10-100 100-1000 >1000
Preregistrationss 12-18 months after entry into force (June-Nov. 2008)
Information required Identity of manufacturer
Contact person
Substance identifier
Tonnage band
Registration
Information Annex VII VIII IX X
Chemical Safety Report No Yes Yes Yes
Time after entry into force 2018 2018 2013 End 2010
Registration 3,5 years (= End 2010)
EPAA www.epaa.eu.com top
I.1.2. European Partnership on Alternative Approaches to Animal Testing (EPAA)

The EU Commission under lead of Commissioners Verheugen and Potocnik, had initiated a partnership program with the industry and industry associations resp. individual companies. A first kick off meeting was held on November 7, 2005 – a follow-up on this approach "Europe goes alternative" will be held each year.

This year’s conference focused on regulatory acceptance:
Workshop on "Regulatory acceptance of 3 Rs methods and strategies" held November 5, 2007, in Brussels, Belgium, European Commission/DG Enterprise and Industry.

Further information on the website:
Website http://ec.europa.eu/enterprise/epaa/conf.htm

Progress report 2007 published:
Website http://www.indepaa.org/EPAA/Pages/download?docid=4987

The EPAA has agreed for 21 activities to be carried out over the next 5 years. Current co-chairs are: Mme Lalis, Mr Charles Laroche (DG ENT, Unilever).
As co-chair representing industry in the EPAA, the ecopa-Board-member and treasurer Dr. Bernward Garthoff, DMV, was elected in September. Serving in his function during 2008 together with Dir. Georgette Lalis of DG ENT, representing the Commission in the partnership, the important phase of the REACH-implementation will be addressed.

A mirror group of stakeholders including animal welfare bodies and patient groups will again have the chance to give input into a future Mirror Group Meeting end of January, most likely January 30, 2008. ecopa is represented here by three of its members.

Website http://ec.europa.eu/enterprise/epaa/uc.htm

For the 4th EPAA-newsletter, see the website:
Website http://ec.europa.eu/enterprise/epaa/news.htm
ecopa I.2. Other News top
I.2.1. Nanotech

Besides of the discussions on the ecopa Annual Workshop 2005 on new technologies, several partners have worked and discussed on nanotechnology, e.g. at the last eSI-workshop.

The US Environmental Protection Agency (EPA) and its Science Policy Council has issued a nanotechnology white paper. The paper is aimed at providing information on the science issues and needs associated with nanotechnology, and to communicate them to stakeholders and the public.

The European Scientific Committee on Consumer Products (SCCP) has just finished a position paper reg. an opinion on the safety of nanoparticles used in cosmetics. It will appear on the SCCP website, beginning of January 2008.

Website http://www.epa.gov/osa/nanotech.htm


I.2.2. Review of Directive 86/609

On June 25, 2007, Green MEP Satu Hassi tabled an oral question for the Commission on the review of the Directive 86/609 on animal testing, asking about the timeline for the publication of the proposal and reasons for the delay:
Committee on Environment, Public Health and Food Safety oral question from Satu Hassi (Verts/ALE, FI) to the Commission:
Adobe Reader PDF http://www.europarl.europa.eu/meetdocs/2004_2009/documents/cm/672/672183/672183en.pdf
ecopa II.1. EU 6th Framework Programme Projects / ecopa Working Groups top
II.1.1.1. Recent News on FP6 and FP7 projects

The recent ecopa-Board meeting was held on September 27, 2007 in Linz, Austria, before the 14th Congress on Alternatives to Animal Testing. Next Board meeting will be held in spring: March 4, 2008, venue to be determined.

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.
A 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.
PREDICTOMICS – Bernward Garthoff is the representative in the Advisory Board.
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.
CONAM – The last CONAM and Board review meeting was held on March 6, 2007 in Paris. The CONAM-project has, thus, successfully been finalized by submitting the final report.
ecopa–The Board of ecopa was re-elected with the following changes: Flavia Zucco left the Board (thanks a lot for her valuable service in the past years), and a new Italian 3R-expert has been elected: Isabella de Angelis.

Actual composition of ecopa-Board
Executive Board Persons involved Function
Daily follow-up, elected by General Assembly Vera Rogiers (B, Ac) Chairperson
José Castell (E, Ac) Vice-Chairperson
Bernward Garthoff (D, I) Treasurer
Board
Elected NCP members by General Assembly Peter Maier (CH, AnW/I)
Roman Kolar(D, AnW)
Walter Pfaller (A, Ac)
Jan van der Valk (NL, Ac)
3R-experts
Elected by General Assembly Odile de Silva(F, I)
Horst Spielmann (D, G)
Isabella De Angelis (I, Ac)
Ac: Academic; I: Industry; AnW: Animal Welfare; G: Governmental.


II.1.1.2. Platforms

II.1.1.2.1. Austrian Platform
» z e t – Austrian Centre for Alternative and Complementary Methods to Animal Testing

The Linz-congress has taken place on September 28-30, 2007, the “14th Congress on Alternatives to Animal Testing & 11th Annual Meeting of MEGAT - Middle European Society for Alternatives to Animal Testing”, Linz, Austria.


II.1.1.2.2. Belgian Platform
» Foundation Prince Laurent


II.1.1.2.3. Czech Platform
» CZECOPA


II.1.1.2.4. Danish Platform
» DACOPA

DACOPA has decided to postpone the Opening Symposium initially scheduled for November 9, 2007. The new date will be sometime during 2008; exact date has not yet been decided upon.


II.1.1.2.5. Dutch Platform
» NCA - The Netherlands Centre Alternatives to Animal User


II.1.1.2.6. Finnish Platform
» Fincopa

A short report of the meeting of Fincopa board (Helsinki, August 17, 2007.

The meeting was the first meeting of the board elected in the business meeting in May 2007. Professor Hanna Tähti stepped down as chairman (2003-2007) of Fincopa, and is now followed by Dr Eila Kaliste.

The new board is:
Dr. Eila Kaliste (President), Dr. Paula Vesa (Secretary), Dr. Marianna Norring (Treasurer), Prof. Kirsi Vähäkangas (Vice- President), Dr. Christina Björklund, Dr. Helinä Ylisirniö, Prof. Hanna Tähti (Past President) and Dr. Kimmo Louekari. The members represent the four parties as follows: research (2), administration (2), animal protection (2) and industry (2). In addition there are nominated vice members for each board member. The complete list can be found at the web page of Fincopa:
Website http://www.uta.fi/jarjestot/fincopa/index-suomi.htm
The coming activities of Fincopa were discussed. Fincopa will organize in connection of the annual meeting on Spring 2008 a seminar. In this seminar, state of the development of alternative methods will be presented. The follow-up of the alternatives applied in REACH will be another important topic.
The board discussed the strategy and coordination of the cowork in the development of alternative methods in Finland. The process should follow the proposals presented in the Memorandum of the working group of the Ministry of Agriculture and Forestry, published in 2006. One of the proposals was that “ A national Centre for Alternative Methods should be founded to promote, organizes and coordinate research, communication and education on alternative methods”.
The contacts with Estonian colleagues and the possibility to organize the Finnish–Estonian coowork in ecopa were discussed.
Prof. Kirsi Vähäkangas was elected to represent Fincopa at the ecopa meeting November 24/25, 2007.
Five new members were elected.
The last board meeting took place on December 04, 2007.

Adobe PDF PDF: Fincopa Activity Report 2006 (21 kb)


II.1.1.2.7. Latest news on the creation of the French platform

The set up of the French platform has been finalized. The official inauguration meeting of the "Plateforme Nationale pour le développement des Méthodes alternatives à l’experimentation animale” took place on November 16, 2007, Paris, France. Isabelle Fabre presented the French platform at the annual ecopa meeting on November 24/25, 2007.

It has been presented that the French platform is constituted of a Steering Committee and 2 Technical Scientific Committee (TSC), one dedicated to health products, secretariate associated with Afssaps, the other one dedicated to chemicals, secretariate associated with Ineris.

In the framework of the TSC for chemicals, Ineris is setting up a big project involving up to 125 french researchers; the project named ANTIOPES, the title being "Integrated Analysis of predictive toxicity for environmental health". This project includes alternative methods to animal testing as recommended by REACH.

Ineris plans to organize a meeting to present this project on February 8, 2008 in Paris, France.

Ineris is going to invite personalities from national and international organisms involved in the environmental field and in alternative to animal testing.

Horst Spielmann and Vera Rogiers have been invited to represent ecopa in that project initiated by Ineris.
Présentations GIS
Adobe Reader PDF PDF: GIS Introduction (32 kb)
Adobe Reader PDF PDF: Le médicament Stratégie 3R (1.1 MB)
Adobe Reader PDF PDF: Grandes orientations possibles des activités du GIS sur les substances chimiques (724 kb)
Adobe Reader PDF PDF: Grandes orientations (748 kb)
Adobe Reader PDF PDF: La plate-forme nationale Méthodes alternatives (684 kb)
Adobe Reader PDF PDF: Methodes alternatives(884 kb)
Adobe Reader PDF PDF: Groupement d'Intérêt Scientifique (1 MB)
Adobe Reader PDF PDF: Que fait-on en France pour le développement des « méthodes alternatives »? (664 kb)


II.1.1.2.8. German Platform
» Stiftung set

The Annual Report for 2006 has been approved by the council on June 28, 2007 and is to be found on the website.
Website http://www.tierversuche-ersatz.de/
Adobe Reader PDF PDF: set Activity Report (76 kb)


II.1.1.2.9. Hungarian Platform

The new executive Board has been elected:
It consists of Lajos Balogh, chair, Eva Hercsuth, heading the Animal welfare platform, Prof Tibor Bartha, heading the Academy, Laszlo Pallos, Authority Zsuzsa Somfai, Industry.


II.1.1.2.10. Italian Platform
» IPAM - Italian Platform on Alternative Methods

Adobe Reader PDF PDF: IPAM annual report 2006 (5 kb)


II.1.1.2.11. Irish Platform


II.1.1.2.12. Norwegian Platform
» Norwegian School of Veterinary Science

With the assistance of the Norwegian Ministries , a permanent, ecopa-style, National Consensus Platform in Norway was established. The official opening ceremony took place on October 10, 2007, in Oslo/Norway, at the Norwegian School of Veterinary Science. Our treasurer Bernward Garthoff was present and introduced the work and support of ecopa.

Adobe Reader PDF PDF: Presentation by Dr. Bernward Garthoff (1,8 MB)

 
Website http://oslovet.veths.no/fag.aspx?fag=56

Adobe Reader PDF PDF: Presentation Norecopa at the recent ecopa Annual meeting (204 kb)


II.1.1.2.13. Polish Platform
» polcopa


II.1.1.2.14. Spanish Platform
» REMA – Red Española para el Desarrollo de Métodos Alternativos a la Experimentación Animal

The REMA activities can be found can at (Spanish version):
Website http://www.remanet.net/actividades/


II.1.1.2.15. Swedish Platform
» Stiftelsen Forskning utan djurförsök

Karin Gabrielson had been replaced by Cecilia Clemedson due to her maternity leave, who was the official contact for Swecopa until recently. Karin Gabrielson Morton is back as the chair person and contact of Swecopa as of August. Staffan Jakobsson, deputy chair of Swecopa, passed away after having been severely ill for a very short time only. Our sincere condolences.
Government support for 3Rs research
The Swedish Animal Welfare Agency was closed down in July of 2007. The National Board of Agriculture has taken over the responsibility for all tasks regarding laboratory animals and research into 3R's alternatives, from the Animal Welfare Agency. A total of 9,9 million SEK has been allocated to 3R's reseach in 2007, to be compared to 18,6 millions in 2006. The funding for 2008 has not yet been decided, but it is likely to be less than in 2007.

Also, it is still not known if there will be future funding for Patric Amcoff's position at the OECD.
References/links to the Swecopa website should be changed to:
Website http://www.swecopa.se


II.1.1.2.16. Swiss Platform
» 3R Research Foundation Switzerland

Update on Activities:

Latest bulletin of May 2007 to be found here:
Website http://www.forschung3r.ch/en/publications/bu35.html

Meeting to mark the 20th anniversary of the 3R Research Foundation and the 20th anniversary of the Swiss Laboratory Animal Science Association (May 2007).

This meeting was held on September 3-4, 2007 at the Zurich-Irchel University in Zurich. On both days more than 400 persons attended the conference, The focus on day 1 was on „Humane Endpoints“. 39 speakers from Germany, Netherlands and Switzerland presented their results and shared their experience with the audience in two parallel sessions and 4 workshops.
On day two, the focus was on the 3Rs in all his facets (see program). More than 260 persons attended the 3R sessions. 14 invited speakers showed how the 3Rs improve animal welfare, experimental design and results (see photos). The summaries of the papers given have been collated in a 70 page brochure.

Adobe Reader PDF PDF: 3R-Brochure (1,8 MB)

Website http://www.forschung3r.ch/en/news/index.html

On March 26, 2007 the Administrative Board approved the Annual Report for 2006. Direct link:
Website http://www.forschung3r.ch/en/information/jb06.html


II.1.1.2.17. UK Platform
» The Boyd Group, founding member of ecopa, decided to withdraw from the ecopa-umbrella-activity, effective November 2007.

Further information and reports are available at the Group's web-site:
» http://www.boyd-group.demon.co.uk


Interested to form a new national platform in your country?
Please contact us (» contact section).

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 Workshop:
Adobe Reader PDF PDF: A guided tour to become full members/associate members in ecopa (200 kb)
All the abstracts of the following projects are to be found on the forum of the ecopa website, see the comment under II.1.
ReProTect www.reprotect.eu top
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 partners.

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

The last Supervising Board Meeting was held on June 28/29, 2007 in Madrid, Spain

The Annual Research Area meeting and the Meeting of the Executive Committee was held in Ispra, Italy November 26/27, 2007. A brochure on the ongoing activities is available.
Adobe Reader PDF PDF: ReProTect Brochure

Adobe Reader PDF PDF: Executive Summary (224 kb)

Also, please find a respective flyer below, and the brochure with first results.
Adobe Reader PDF PDF: ReProTect Flyer (320 kb)

ecopa is involved in the Board and the results dissemination.
Predictomics www.predictomics.com top
The ecopa-induced 6th Framework Programme project Predictomics (STREP) started in 2003, with a total of 14 partners .The overall funding is 2.3 mio EUR. The contract with the EU was signed on September 1, 2004; the administration throughout the project is done by REMA. The project will end on December 31, 2007.


II.1.3.1. Recent News

Find the non-confidential information on the First Annual Report of the PREDICTOMICS project here:
Adobe Reader PDF PDF: Publishable Executive Summary

The consortium has launched a new website with several improvements to facilitate the dissemination of the research done. In the public accessible part, clear and easy to understand information is provided to a general reader, as well links to contact the individual groups through the webmaster.

The 6th meeting took place on December 10-11, 2007 in Valencia/Spain.

Websites: www.predictomics.com or www.predictomics.org

Adobe PDF PDF: PREDICTOMICS - Specific Target Research Project (268 kb)
Adobe PDF PDF: PREDICTOMICS - Short-term in-vitro assays for long term toxicity (392 kb)
ACute Tox  www.acutetox.org top
II.1.4.1. Recent News

Adobe Reader PDF PDF: ACuteTox Summary Report (80 kb)
Adobe Reader PDF PDF: ACuteTox - Optimisation and pre-validation of an in vitro test strategy (44 kb)
Adobe Reader PDF PDF: ACuteTox - Integrated Project (324 kb)
Adobe Reader PDF PDF: ACuteTox - Integrated Project (136 kb)

The first ACute Tox newsletter appeared in December 2006 with amongst others a summary of the project results accomplished during the first project year. The last ACuteTox newsletter appeared in July 2007 and the next newsletter will be available and distributed by next month.

The main results achieved in 2006 are summarized in a press release which you can download from the website
Adobe Reader PDF http://www.acutetox.org/docs/Press_release_ACuteTox_Augt_07_english.pdf

A mid-term report on the project has been submitted by end of September 2007.
Adobe Reader PDF PDF: ACuteTox Mid-term report (92 kb)

You can subscribe to it by sending an email to ACuteTox@expertradet.se and in the mean while, it can be consulted on the website:
Website http://www.acutetox.org
Sens-it-iv www.sens-it-iv.eu top
Sens-it-iv is an Integrated Project financially supported by a grant from the European Commission (LSHB-CT-2005-018681).28 groups overall, of which 9 represent industry. 15 groups represent universities or research institutes, while 4 groups represent organizations.


II.1.5.1. 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.

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. ecopa released a brochure covering the activities on behalf of Sens-it-iv, and supported the website creation

The twelfth newsletter will appear mid December. Subscription possibility on the website.

The General Assembly Sens-it-iv and Meeting of Sens-it-iv Management Team, Steering Committee took place on October 22-26, 2007 in Ispra, Italy.
Adobe PDF PDF: Sens-it-iv - First publishable summary (114 kb)
Adobe PDF PDF: Sens-it-iv - Publishable executive summary - 2nd year (80 kb)
BioSim http://www.biosim-network.net top
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 Programme.

II.1.6.1. Recent News

The third scientific conference for the BioSim Network took take place in Potsdam, Germany, from October 10-13, 2007.

The BioSim network of excellence, now in the third year of activity, has accomplished already many tasks. The first and most important one is that very coherent sub-networks assembled around specific topics. This is the case of diabetes, cancer and circadian rhythms, hypertension and cardiovascular diseases.

In those areas, mathematical simulation has been proven to be possible from gene expression to whole-body metabolism, covering, in between, also cell signalling, metabolic regulation and intracellular fluxes of molecules. The pathway of collaboration is still scattered, but the trials performed are very promising and, for some of them, is already possible to forecast clinical outcomes. The area of mental disorders and neuronal system is still in search of optimal interfaces among different possible collaborators, being competences still a bit far from each other: therapeutic effects of desynchronizing brain simulation goes together with models for sleep-wake cycles or energy metabolism related to inclusion formation in neuronal disease. However a fruitful dialogue is started and integrated possible tasks are explored.

Some application has been shown concerning computer simulation in the design of clinical trials and in predicting human metabolic clearance, by incorporating population variability. More in general the aspect of the contribution of modelling and biosimulation to health care has been discussed and a relevant approach has been presented, consisting in the Innovative Medicine Initiative (IMI) which will be eventually approved by the end of the year (www.imi-europe.org). It is a joint initiative between the EU Commission and EFPIA, to launch a research project aimed at improving the drug efficacy and minimising the counter effects. An increased collaboration among industries and academia is at the basis of this effort.

Being biosimulation in the phase of blooming, the methodological aspects are of great interest: challenges of modelling cell synchronisation, the role of noise in cellular processes or mapping the sensitivity of regulatory networks are met with success, with the aim of applying them to other organisms or pathway in the search perhaps (again!) of the universal fundamental formula!

For more information the home page of the project is the following:
Website http://www.biosim-network.net
ecopa Liintop top
II.1.7.1. Recent News

ecopa - Representative in Liintop is Horst Spielmann.
Adobe Reader PDF PDF: Liintop Summary (22 kb)

The Kick-off meeting of Liintop was organized on January 12-13, 2007 in Rome, Italy. The agenda of the last Management Team Meeting, held June 18, 2007 in Manchester, UK, can be found on the website.

The next meeting of all Working groups will take place in Rennes on 24-25 Jan 2008.

Microsoft Word http://www.liintop.cnr.it/img3/MTMeetingSchedule.doc
CarcinoGENOMICS CarcinoGENOMICS top
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.1.8.1. Recent News

The Kick-off meeting of CarcinoGENOMICS took place November 5-7, 2006 in Maastricht, the Netherlands.
Adobe PDF PDF: CarcinoGENOMICS Press Release (24 kb)

The 1st Consortium & General Assembly Meeting was held on Nov. 6-8, 2007 in Valencia/Spain. A questionnaire of the WP 11 (the workpackage directed by ecopa) regulatory group is available on the carcinoGENOMICS website: www.carcinogenomics.eu for consultation and input. It was also distributed at the last EPAA-meeting which was covering regulatory aspects (Nov. 5, 2007/Brussels/Belgium).

Website http://www.carcinogenomics.eu/index.php?id=110
ecopa II. 2. EU 7th Framework Programme Projects, Initiatives and Technology Platforms top
The EU-Parliament decided on the initiatives of industry and science enforcing European competitivity by Dec. 11. For the so-called “4 Flagship”-programs, a total of 2.67 billion € will be expensed, Under these, the allocation of funds for Innovative Medicine (1.0 bn), and Nanotechnology (0.45 bn) are prominent!
SusChem SusChem top
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.
Website http://www.suschem.org/

The 5th Stakeholder Meeting took place on March 8, 2007 at the Concert Noble in Brussels.

Presentations available on suschem website
Website http://www.suschem.org/content.php?pageId=3428

The next event listed on the SusChem calendar is the 6th Stakeholder and brokerage event on January 29-30, 2008 - in Berlin, Germany. On the second day panel-led discussions on major issues of sustainable chemistry cover the nanosciences and the climate change. Both panels will involve representatives from industry, academia and the NGO community.
The afternoon is devoted to a workshop , which will explain how to prepare a good proposal foir collaborative research in FP 7.


II.2.2. Preparation 7th Framework Programme Projects

The objective of a workshop "EU funded research on alternatives to animal experimentation: stocktaking from FP6 and views for the future" that took place on June 13-14, 2006 was to identify gaps in research in the area of development of alternatives to animal testing, to explore ways to close this gap, and to identify opportunities for strategic research activities to be formulated and implemented under FP7.

Additional info on this workshop with the official report and the new topics that were discussed for future projects can be found here:
Adobe PDF PDF: Group A Report (Contribution of QSAR/QSPR to alternatives) (960 kb)
Adobe PDF PDF: Group B Report (Nanotechnology and alternatives) (36 kb)
Adobe PDF PDF: Group C Report (Alternatives and Drug Discovery / Development) (88 kb)

Given ecopa’s follow up-project START-UP (see topic II.2.4) the Group C report will be a basics for discussion.


II.2.3. Regulations of the 7th Framework Programme
Update 7th EU RTD- Framework Programme

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.
START-UP START-UP top
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, if approved accordingly and negotiated with the Commission.

II.2.4. 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 will be 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.
Adobe PDF PDF: Presentation by Prof. Vera Rogiers (1,2 MB)


II.2.5. ESNATS

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.
ecopa Miscellaneous top
III.1.1. ecopa events

III.1.1.1. 9th Annual ecopa Workshop

The next, 9th Annual ecopa Workshopwill take place on November 29-30, 2008 in Brussels .

The future ecopa Annual Meetings will be:
10th: November 28-29, 2009
11th: end of November 2010


III.1.1.2. ecopa Board meeting

Adobe Reader PDF PDF: Minutes of the ecopa Board Meeting: September 27, 2007, Linz, Austria (32 kb)

The next ecopa Board meetings:
March 4, 2008
September 23, 2008
March 3, 2009
September 16, 2009


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.

The next workshop is to take place in October  2008 in Pueblo Acantilado; Alicante, Spain; either October 16-19 or October 2-5 ,2008 will be the date. It will focus on "Scientific and technological progress in 3 Rs alternatives in the pharmaceutical and cosmetic area: current and in future”.
III.1.2. other events

III.1.2.1. The 6th SusChem Stakeholder Meeting and 2nd Brokerage Event
to be held on  29 and 30 January 2008 at the Hotel Concorde in Berlin.

For more information:
» http://www.suschem.org


III.1.2.2. EUROTOX 2008
to be held in Rhodes, Greece from October 5–8, 2008. The theme of the Congress is "FROM TOXINS TO OMICS : HEALTH, SAFETY AND WELL-BEING''. Its scientific programme comprises symposia and workshops accordingly whereas distinguished and renowned speakers will address the participants, presenting the current and latest scientific innovations, discoveries and practices on important subjects in the multidisciplinary field of Toxicology.

For more information visit:
» http://www.eurotox2008.org/


III.1.2.3. Recombinant Antibodies Annual Conference 2008
New approaches and opportunities for faster antibody developmen
t

to be held in London on the 23rd – 25th January 2008.

For more information:
» http://biotechnology-europe.com/events/


III.1.2.4. International Congress on In Vitro Toxicology, ESTIV2008
to be held at Djurönäset in Stockholm 25–28 Sept, 2008.

For more information:
» http://www.estiv2008.org
III.2. Awards and Publications

III.2.1. Announcement of the Doerenkamp-Zbinden-Prize 2008

The Doerenkamp-Zbinden Foundation for Animal-Free Research will again award a prize for outstanding achievements in scientific animal protection in 2008. Suggestions for the prize may be made by members of the Foundation Board or the Scientific Advisory Committee of the Doerenkamp-Zbinden Foundation as well as by recognized institutions of science and animal protection (e.g. universities, scientific societies, private research institutions, interregional animal protection organisations). Direct applications for the prize are not possible. Suggestions may be made by December 15, 2007.

If no convincing suggestions for a laureate are made to the Foundation Board, the prize will not be awarded in 2008. According to the deed of the foundation scientific methods which can replace or reduce animal experiments that cause pain and suffering, especially to non-human primates, dogs, rabbits and cats as well as pigs, horses and ruminants are worth funding. Work in basic research will be considered preferentially according to the new deed of the foundation.

The prize is endowed with 25 000 CHF and can be shared.
For more info see website:
» http://www.doerenkamp.ch/en/default.html?id=64


III.2.2. Dieter Luetticken Award

Announcement of the Intervet’s award 2008

Intervet offers the Dieter Lütticken award to promote scientists or life science research institutions working in research areas that serve the 3R-concept i.e. reducing, refining or replacing the use of animals in testing for development and production of veterinary medicines. The total funding for the award is 20,000 Euro.

Intervet actively screens at country level for suitable applications. However, Intervet welcomes submissions for the Dieter Lütticken Award from all scientists and life-science research institutions, excluding commercial organizations.


III.2.3. EPAA Newsletter, October 2007

The 4th edition of the EPAA-newsletter ia available now.
» http://ec.europa.eu/enterprise/epaa/news.htm


III.2.4. New ECVAM Workshop Reports no's 60 and 63 - now available online

ECVAM wishes to inform, that the new ECVAM Workshop Reports no. 60 "Chemical Respiratory Allergy: Opportunities for Hazard Identification and Characterisation" and no. 63 "Physiologically-based Kinetik Modelling (PBK Modelling): Meeting the 3Rs Agenda" are now online.

The Workshop Report can be downloaded from the ECVAM Website. Please select inside the section "Publications / Workshop Reports.


III.2.5. Biographics Laboratory 3R-newsletter (fall 2007)

The VirtualToxLab has been launched on the internet. It claims to estimate the toxic potential of drugs and environmental chemicals towards a total of currently nine receptor models completely in silico.
http://www.biograf.ch/downloads/newsletter.pdf


III.2.6. DG SANCO Newsletter

The second issue of the newsletter of DG SANCO concerning the activities of the Commission Scientific Committees SCHER (Scientific Committee on Health and Environmental Risks), SCCP (Scientific Committee on Consumer Products) and SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) has been published. This Newsletter is also available on DG SANCO website.
» SANCO-c7-newsletter@ec.europa.eu


III.2.7. SCAW's 2007 Rowsell Award and New Publication

SCAW (Scientists Center For Animal Welfare)announces the recipients of the annual Harry C. Rowsell Award:
Steven P. Pakes, DVM, PhD, the Award will be presented at SCAW’s 2007 Winter conference in San Antonio.


III.2.8. EU animal statistics

The 5th report on the statistics and number of animals used in research is published by the EU Commission.
» http://ec.europa.eu/environment/chemicals/lab_animals/pdf/staff_work_doc_sec1455.pdf


III.2.9. 26. Tierschutzforschungspreis / 26th Research Award for Animal Welfare

of the German Ministery for Agriculture associated with € 15,000 was given to Dr. Ellen Fritsche, The University of Duesseldorf, Germany and Dr. Christoph Giese, ProBioGen, Berlin, Germany on December 11, 2007.


III.2.10. Research Expenditure for 3R Alternatives: A Review of National Public Funding Programmes in European Countries

ecopa, in cooperation with P+G and Eurogroup for Animals has finalized a survey of funding Alternatives; as presented at the ecopa Annual, and here is the report. Cumulative data on Germany and EU FP 5,6,7 funding was given in Garthoff’s presentation.


III.2.11. Swiss Laboratory Animal Science Association announces newsletter
III.3. Calls

III.3.1. The call for experts for the seventh framework programme has been launched

The personal data collected in the context of the present call will be processed in accordance with the Regulation (EC) n° 45/2001 of the European Parliament and of the Council of December 18, 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies on the free movement of such data.
» https://cordis.europa.eu/emmfp7/index.cfm?fuseaction=wel.welcome


III.3.2. The ECLAM ESLAV Foundation is now accepting applications for funding in 2008-2009

It is a charitable organisation that funds studies for the discovery, validation and implementation of refinement of the care and use of animals in research.
In particular the Foundation funds small studies, up to 20000 euros in the following areas:

- Refinement in experimental techniques, anaesthesia and analgesia to reduce pain and distress
- Objective measures of animal welfare.
- Studies to ensure scientific basis for housing and husbandry standards
- Validation of environmental enrichment to improve behavioural well being

Funding applications for 2007-2008 are now closed. Until 2008-2009 applications are open (early 2008) for information only an application form, including guidelines for applicants and information how to submit an application, can be downloaded here: 2007-2008 form.

The Foundation's website can be found at:
» http://www.eclameslavfoundation.org
with a grant application form at:
» http://www.eclameslavfoundation.org/applications.htm
A leaflet describing the Foundation is available at:
» http://www.eclameslavfoundation.org/promotion/2007Flyer.pdf
III.4 VARIA

III.4.1 Public Consultation on the Green Paper 'European Research Area: New Perspectives'

The European Commission invites citizens and stakeholders to participate in the debate on the European Research Area (ERA), in particular by putting forward their views in this public consultation. The consultation is based on the questions raised in the Green Paper 'The European Research Area: New Perspectives'.
The results of the debate will be used by the Commission to prepare initiatives that will be proposed in 2008.
More detailed information can be found on:
» http://ec.europa.eu/research/era/consultation-era_en.html

For more information and to participate in the consultation please visit the consultation web site.
» http://ec.europa.eu/yourvoice/ipm/forms/dispatch?form=ERAGreenPaper


III.4.2. The NC3Rs - Information Portal - Species selection

The British NC3Rs has an extensive Information Portal where to find a wide range of references and links for guidance on implementing the 3Rs.
A new section on species selection has recently been added. Where animal use is necessary in research or testing, the choice of species (and breed/strain) should always be carefully considered and justified. This page sets out some of the factors to consider, particularly in relation to the 3Rs.


III.4.3. Training Course on metabolism:

ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development, January 22nd and 23rd 2008, Brussels, Belgium.

For more information:
» http://www.mondialresearchgroup.com


III.4.4. An Innovative Website on Non-Animal Methods of Toxicity Testing

AltTox.org offers three ways to help accelerate progress on in vitro and in silico approaches to toxicity testing.

For more information:
» http://www.alttox.org/



III.4.5. Open Call for Traineeship at ECVAM

The Institute for Health and Consumer Protection (IHCP) has launched an open call for traineeship as part of a scientific trainees programme within the framework of the traineeship scheme of the Joint Research Centre (JRC). ECVAM as part of the IHCP offers one of the positions, with a duration of 12 months, to work on alternative methods to animal testing in the field of topical toxicity for individuals who have just finished their University, Master's degree or PhD.

More information: General conditions (IHCP website), specific information on the ECVAM traineeship: Project n° 023/TR/IHCP/ECVAM/2007.

First cut-off: 18 January 2008.

Contact for applications: Elena Moneta, Tel.: +39 0332 786204, e-mail: jrc-pns-recruitment-ihcp@ec.europa.eu.

For more information:
» http://ecvam.jrc.ec.europa.eu/index.htm