| 2006-03-15, edition #07-2006 |
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Dear ecopa-messenger subscribers,
This is the first "ecopa messenger" edition in 2006, and it gives updates on our 6th Annual ecopa Meeting of December 2005, topic: "Nanotech, Biotech and other technologies: safety testing and research requirements". For those interested in new technologies such as biotech and nanotech, in the regulatory
and alternative method testing in these areas this will certainly be a major infobox
» Presentations
of the ecopa Annual Workshop
» Photos of the ecopa Annual Workshop
The forthcoming CONAM/ecopa -Board Meeting on March 15/16, 2006 in Basle/CH will address the CONAM/ecopa-Status and planning for the events of 2006 and beyond - see the timeline below as proposed at the last Board Meeting December 16, 2005.
In addition, this ecopa messenger summarizes the results of the REACH impact workshop of Feb.1, 2006 as well. All presentations can be found under the link below, and will form the basis for the consensus report on the potential "impact of REACH" to be finalized by the CONAM Chemical Policy Working Group.
» Presentations of the REACH Workshop
» Photos of the REACH Workshop
After the outcome of the REACH discussions in the Committees, European Parliament and Council at the end of last year, this EU Chemical Policy Workshop on REACH detailed the impact of the REACH proposals on animal testing of chemicals under "REAlity CHeck: Proposals, Amendments and Conclusions - from the alternative point of
view".
As a special, participants received a free copy of the "animal test calculator" prepared by our Chemical Policies Working Group (THANKS to Simon Webb and Karsten Mueller!).
And as usual, there are updates in this newsletter on the 6th EU Framework Programme projects that ecopa is participating in, such as ReProTect, PREDICTOMICS and Sens-it-iv, Lintop, Carcinogenomics and Bio-Sim, as well.
Any proposal or recommendation regarding style, content or distribution of the newsletter is highly welcome and appreciated (bgarthoff@t-online.de).
Bernward Garthoff
Treasurer ecopa
on behalf of the ecopa Management Board
P.S.: If you know other people or institutions interested, have them visit our website and subscribe to this newsletter. |
Recent News on REACH
After the discussions of the European Parliament (November 17, 2005) and of the EU Council for Competition (December 13, 2005) the first reading was accomplished. The procedure proceeds with the 2nd reading (scheduled for May) to reach a common joint draft of these institutions by autumn to the end of 2006, so that REACH can become effective by beginning of 2007.
Actually, preparing for implementation is ongoing. As Mark Blainey, also speaker of the Commission DG ENV at the ecopa REACH impact-workshop, put it recently at a London CIA conference: "REACH will arrive quicker than you
think. Now is the time to start to prepare". Geert Dancet (EU Comm. Director General DG ENT ) indicated that it is to be expected that the formal adoption of a common position would be even arrived at May 2006, and the 2nd reading in the EP might even follow within 3 months, to achieve councils decision thereafter (source: ICIS Chemical Business, Feb. 6-12, 2006, p. 35, p.25).
Until now, discussions on and implementations of alternative methods usage within the REACH legislation have been minimal - besides of the EU-Commission/Industry Partnership program initiated by Nov. 7, 2005. ecopa (by virtue of its Chemical Policy Working Group) has certainly drawn more attention to the impact of REACH on potential testing in animals, by its workshop on Feb. 1 and especially by the development of the Animal Calculator Tool.
ecopa has developed this impact software for free. The software will allow anybody to calculate the impact REACH will have on chemical testing requirements and on resulting animal numbers. All scenarios current and existing in future, can be modeled with it - it is also downloadable from our website - it gives you the final "TOTAL" based on your individual input or REACH input.
Toxicological comments on the REACH legislation are given in Arch. Toxicol. 2006, Jan 13.
Also, there was a study commissioned by the EU Environment Commission which concluded that the environmental and health benefit of REACH might outstrip the economic cost of implementing it. The report: "The Impact of REACH on the Environment and Human Health" was compiled by consultancy DHi. The authors, however, stress that its results a based on a "very weak data set".
More EU REACH information / Partnership on REACH alternatives
The EU Commission under lead of Commissioners Verheugen and Potocnik, has initiated a partnership program with the industry and industry associations resp. individual companies. A first kick off meeting was held on November 7th, 2005 – a follow up on this approach "Europe goes alternative" will be held each year; this will be done in kind of a workshop, assumed to happen in November each year.
» http://europa.eu.int/comm/enterprise/events/animal_tests/conference/formreg.htm
The partnership between the Commission (Entreprise and Research in the lead, but also SanCo and Environment involved) and Industry is working on several levels currently:
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development of an action programme due for end of March |
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defining a structure for the partnership in future |
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defining the support and communication activities of the Partnership |
EU-Community Action Plan
Also, the EU Commission has released a Working Document and a Communication to the Parliament and Council as the basis of a "Community Action Plan on the Protection and Welfare of Animals, 2006-2010".
GHS
The EU is not only in the process of developing and putting in place the new chemicals policy REACH, but it is planning to implement the globally harmonized system (GHS) for the classification and labeling of chemicals at the same time. The best current estimate is that REACH will come into force early in 2007. Clearly, the GHS is behind REACH in the regulatory process though the first version is around since 2003, after 10 years of preparation. The Commission has drafted much of the
proposal to implement GHS and will meet key stakeholders in 2006 for an abbreviated public consultation. |
In memoriam
It is with the deepest sorrow that we have to inform that Prof.Dr. Peter Rudas, Professor at the Szent Istvan University, Budapest, and co-founder of HUCOPA was severely injured in a car accident and died on Feb. 13, 2006 at the age of 55.
European Presidency
European Presidency is changing every 6 months. Next after the Austrian Presidency ending in June 2006, will be Finland for the second half of 2006. Starting 2007, the Presidency in the Council will be done by a group of 3 member states.
First half of 2007 Germany
Second half of 2007 Portugal
First half of 2008 Slovenia
Second half of 2008 France
First half of 2009 Czech Republic
Second half of 2009 Sweden
First half of 2010 Spain
Second half of 2010 Belgium
First half of 2011 Hungary
Second half of 2011 Poland
First half of 2012 Denmark
Second half of 2012 Cyprus |
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Statement regarding SCALE |
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During the ecopa Annual Workshop 2004, the proposal of a new ecopa Statement regarding SCALE was agreed to. In the mean time, a lot of European citizens have signed our statement, but as this EU-programme is further to evolve, we ask you urgently to keep on undersigning. These will be used to document the will of European
citizens to Commission and Parliament.
Please find the full text below and sign-in on our website:
» ecopa statement in regard to SCALE (with sign-in). |
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Technical Info to use the Forum of ecopa |
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The Forum Section is now available via the ecopa page or the direct link:
» http://ecopa.vub.ac.be/forum/
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In regard to EU Project/ecopa Working Groups:
to read and post messages in the Forum-section of the ecopa website, the users need to register themselves. After registration (and authorization by Board and Webmaster), each user-address has to be activated for this section. |
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In regard to the General Discussion Section:
the users need to be registered to post messages in this section, but they can read all posts in here. |
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The Forum itself is quite self-explanatory, here is just a short introduction and in addition you will find a detailed Q+A Section there as well: (» forum
FAQ) |
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When you have registered, click on a section to view or post a message. |
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To post a message, click in a section on "new topic". When there already is a message in a section, you can click on "new reply" to directly reply to that message. You can click the button "pm" under a message, to write a private message to the author. |
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Start learning by doing, for any other questions or problems you can have a look at the forum-FAQ Section (» forum
FAQ) or send a mail to the Webmaster. |
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Second update on the 7th Framework Programme |
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Status: Beginning of 2006
On September 21 2005, the EU Commission proposed the draft for the specific programmes within the framework of the 7th FP. The European Parliament started its debate on the 7th FP by January 30, 2006. It is the goal to reach agreement by October 2006 to start the Programme on time by 2007.
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Health (7.35 bn EUR): focus on "translational research", i. e. turning basic research into clinical applications respectively development and validation of new therapies |
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Food, Agriculture and Biotechnology (2.17 bn EUR): focus on healthier and qualitatively better food, sustainable production and usage of renewable bio-resources |
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Information and Communication Technologies |
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Nanosciences, Nanotechnologies, Materials and new product technologies |
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Energy |
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Environment |
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Transport (Aeronautics) |
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Socio-Economic Sciences and the Humanities |
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Security and Space |
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EU 6th Framework Programme Projects / ecopa Working Groups |
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Details, Minutes, Contract numbers and alike will be dispatched on the FORUM pages in future, once activated by the individual teams.
NOTICE:
To avoid misunderstandings and because of inquiries at the ecopa Annual Meeting December 2005 - please, be informed and take note that the following abstracts of the EU 6th FP Projects are original abstracts of the project proposals submitted to the EU Commission in most cases, and are not supposed to be adapted after the final contract agreements. Therefore, they will remain and read in their initial form. |
Abstract of the project
The CONAM project is proposed by ecopa. This is the only quadripartite not-for-profit organisation that promotes a consensus strategy for 3R-alternative methods in the EU. Innovative is that the 4 parties having a major interest, animal welfare, industry, government and academia, are equally represented and reach consensus. Actually, national consensus platforms of 10 Member States, 2 Associate States and 2 Associate Candidate Countries are involved.
The objective of CONAM is to build a solid network on 3R-alternatives, ideally including all European countries and with the aim to deliver critical consensus expert opinions on 3R-issues, to draw attention on new alternatives and technologies, to disseminate this information and to initiate collaboration.
Identified priorities are:
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Consensus networking on 3R-alternatives with focus on website expansion, to support existing and new national consensus platforms, to stimulate collaboration and linking in particular with non-EU candidate countries. |
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Ethics with emphasis on harmonisation and consensus by analysing and proclaiming shared ethical, legal and societal values, to continue dialogue where others failed and to develop consensus documents with focus on "omics" technology, access to human data and samples. |
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Education activities to support (inter)national training and education of 3R-methods with focus on non-EU candidate countries. |
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Legislative issues with emphasis on the EU Chemicals Policy: to harvest relevant information on the translation of the EU White Paper into legislation, to disseminate and discuss among the 4 parties, to come with a consensus paper to advice the EU decision making process. ecopas networking offers equilibrated, scientifically-sound
and technically-relevant expertise and experience. The opportunities of emerging "omics" technologies should be fully explored, including ethical, educational and socio-political impact. |
Recent News
Representatives of ecopa in EU projects 6th Framework Programme:
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BioSim – Flavia Zucco accepted the invitation to represent in the just started EU Project |
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Carcinogenomics – A further person will be named the ecopa representative in this upcoming IP FP6 project |
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ACute Tox – Peter Maier is the representative in the Advisory Board. |
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Sens-it-iv – Vera Rogiers is the representative in the Advisory Board |
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PREDICTOMICS – Bernward Garthoff is the representative in the Advisory Board |
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Lintop – Horst Spielmann will be the representative in the Advisory Board |
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ReProTect – Karin Gabrielson, Vera Rogiers and Bernward Garthoff (Chair) are representatives on the Supervising Board |
Next CONAM Review Board Meeting will take place on March 16th, 2006 in Basle.
Platforms
Austrian Platform
» z e t – Austrian Centre for Alternative and Complementary Methods to Animal Testing
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The Austrian Platform is currently preparing the program for its next alternatives meeting in Linz/Austria. It will be held from June 2 to 4, 2006. There is a session planned for 3 R-success stories, to be attended by participants of the new member states and the EU Commission. |
Spanish Platform
» REMA – Red Española de Métodos Alternativos
Dutch Platform
» NCA - The Netherlands Centre Alternatives to Animal User
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A report entitled "Regulatory Animal Testing" by Schiffelers et al. Utrecht University, has recently appeared. The study describes the factors and actors that influence the use of animal testing to comply with regulatory requirements. The study was conducted in the framework of the ZonMw "Limits to Animal
Testing" programme. (available as a PDF doc at www.bio.uu.nl under "publications") |
Danish Platform
» DACOPA
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Most likely, the Danish Platform will be officially established within the next days. The name of the new association will be DACOPA - the Danish Ministery of Justice to be implementing it. CONGRATULATIONS! |
Swiss Platform
» 3R Research Foundation Switzerland
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Update on Activities and the Annual Report:
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Finnish Platform
» Fincopa
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Fincopa, the Finnish national platform of ecopa was officially established in Tampere 21.09.2003, during the Scandinavian Workshop on In Vitro Toxicology, in a meeting of 10 Finnish participants representing academia, industry, animal welfare and government. In the meeting the goals of this Finnish national platform were
defined and a draft of the rules of Fincopa was presented. Fincopa was registered as an official society in the Register of Foundations by the National Board of Patents and Registration of Finland 09.11.2004. |
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The number of members in November 2005: 31
The members of board in 2005 (with personal deputy members):
Hanna Tähti (Sakari Alaranta), president
Eila Kaliste, secretary (Maria Anderson)
Marianna Norring (Riitta Salmi), treasurer
Risto Rydman (Paula Hirsjärvi)
Timo Ylikomi (Seppo Peuranen), deputy president
Christina Björklund (Juha Korpinen)
Hannele Huuskonen (Pia Korjus)
Kimmo Louekari (Outi Vainio) |
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Meetings:
1. Board meetings (22.03.2005, Helsinki and 03.11.2005, Helsinki)
2. Annual meeting (20.05.2005, Turku) |
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Participations in scientific and other meetings/activities:
Eila Kaliste and Marianna Norring:
ecopa/CONAM Consensus Meeting 2005, June 9-12, Hotel Mons, Ljubljana, Slovenia |
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Hanna Tähti, Eila Kaliste, Marianna Norring, and several others:
5th World Congress on Alternatives & Animal Use in the Life Sciences, Berlin August 21-25 2005 |
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Organisation of REACH seminar in Helsinki: 3.11.2005 together Finnish Laboratory Animal Science Association and Finnish Society of Toxicology: 63 participants Presentations: Hanna Tähti: In vitro -testien kehitystilanne vaihtoehtona toksikologiselle testaukselle (Situation of in vitro testing as an alternative to toxicologic
testing); Kimmo Louekari: Pohjoismainen yhteistyö ja REACH (Nordic cooperation and REACH) Several members gave their opinions in their own organisations about the new national law for laboratory animal activities in year 2004. In 2005, the members were also consulted in the committees of Parliament during the reading of this law. Members participated in the preparation of the working group report 'Coordination of alternative methods for animal experiments in Finland', Ministry
of Agriculture and Forestry. |
UK Platfrom
» The Boyd Group
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The Boyd Group was founded in 1992 as a forum for dialogue on contentious issues related to the use of animals in science. Its aims are to encourage productive debate about animal experimentation and alternatives, in order to clarify key issues of concern, work towards consensus where possible, make practical recommendations towards
achieving common goals, and inform a wider public. The Group currently has more than 40 participants, representing a wide range of stakeholders, including veterinarians, scientists using animals (from industry and academia), members of animal welfare organisations, anti-vivisectionists, members of government and charitable bodies funding or directly engaged in research, philosophers and others. Further information and reports are available at the Group's web-site:
» http://www.boyd-group.demon.co.uk |
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Activities since the last ecopa workshop |
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1. Project and report on classifying the severity of animal procedures |
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Working in association with the RSPCA, the Boyd Group completed a project to examine current practice in the assessment of laboratory animal suffering and, in particular, the role and value of schemes for classifying the severity of animal procedures. Three focus groups were organised to explore these areas, involving:
– laboratory animal veterinary surgeons and animal care and welfare officers;
– representatives of animal welfare and anti-vivisection organisations; and
– researchers from a range of different establishments (all holders of project and/or personal licences under the UK Animals (Scientific Procedures) Act 1986). |
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The resulting report Boyd Group/RSPCA (2004). Categorising the severity of scientific procedures on animals: summary and reports from three round-table discussions. RSPCA Research Animals Department. http://www.boyd-group.demon.co.uk was widely disseminated late in 2004. It illustrates a remarkable convergence of opinion on the
key issues and possible ways forward. The results have informed the discussions of a Working Group on Suffering and Severity, set up in 2005 by the UK government's statutory advisory committee on the use of animals in scientific procedures, the Animal Procedures Committee (APC). |
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Further, as a result of involvement in the focus group discussions, the UK Laboratory Animal Science Association (LASA), in association with the APC and the Boyd Group, has recently completed a pilot study of the feasibility of retrospectively reporting and publishing data on the severity of suffering actually experienced by animals
in scientific procedures, for public information. The report of this study will be published soon, via the APC's web-site:
» http://www.apc.gov.uk |
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2. Project concerning the education of new biomedical researchers |
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The Boyd Group is now pursuing a project aimed at enhancing new biomedical researchers' understanding and acceptance of the key principles outlined in the Boyd Group/RSPCA report, by:
a) reviewing current UK provision of training and other support for the development of new biomedical researchers - understanding of laboratory animal welfare science and ethics, and their influences on scientific results;
b) considering and recommending practical steps to help fill gaps and meet researchers' needs;
c) collating and, if necessary, preparing resources to guide and support biomedical researchers' personal development, training and engagement in this area. |
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3. Targets |
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In the last two months, dialogue has been initiated within the Boyd Group regarding the possibility of setting national 'targets' for the elimination or reduction of certain current uses of laboratory animals (and better application of the Three Rs). This will involve participants from 'all four parties' (including both anti-vivisectionists
and researchers who use animals). |
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Boyd Group/RSPCA (2004). Categorising the severity of scientific procedures on animals: summary and reports from three round-table discussions. RSPCA Research Animals Department.
» http://www.boyd-group.demon.co.uk. |
Polish Platform
» polcopa
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The Polcopa Founding Committee was finally established. The members who agreed to contribute the development of the platform are: |
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ACADEMIA:
Prof. B. Pastuszewska (Kielanowski Institute of Physiology and Animal Nutrition, Polish Academy of Sciences); Dr. M. Stepnik; The National Centre for Alternative Methods in Toxicity Assessment (NCAM) |
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INDUSTRY:
Dr. R. Debowska (Dr Irena Eris Cosmetic Laboratories); Dr. M. Jozefowicz (Procter & Gamble) |
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ANIMAL WELFARE:
W. Muza (Polish Society for Protection of Animals); P. Grzybowski (GAJA Association for Animal Protection) |
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Draft of the Polcopa Statute was prepared by NCAM and sent out to the Founding Committee members for consultation. The Statute was prepared according to the Polish Act on Associations (1989) and assumes Polcopa to be a non-profit organization. After reaching a consensus the Statute will be submitted to the National Court Register. |
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The main aims of the Association are the following:
Organizing and supporting any activities aiming at development and promotion of scientific research in the field of alternative methods in toxicity testing on animals; gathering people working in this field; dissemination of the scientific achievements to different target groups; Representing the Polish Association on national and international level. The Association will realize its aims through: Organizing scientific meetings, seminars, training courses, conferences, public
lectures etc. Cooperation with National and Local Ethics Committees on Animal Experimentation, the Ministry of Health, the Ministry of Education and Science, as well as other departments, universities, institutions in Poland and outside, Cooperation with related associations in Poland and outside, Publishing activity, giving an opinion on current status and needs in the field of alternatives in Poland, Scientific advising and consultations concerning animal experimentation. |
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NCAM prepared a draft of Polcopa questionnaire on alternative methods available in Poland and sent it out to the Founding Committee members for consultation. After reaching a consensus the questionnaire will be sent out to identified target institutions. |
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NCAM created a draft Polcopa web site (» www.imp.lodz.pl/polcopa) in polish version. This site will be continuously
updated as well as transformed into English version. |
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Dissemination activity of Polcopa members included the following presentations/lectures and posters: |
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1. "Cosmeticus - meeting for cosmetic industry and scientists", 14.07.2005, Krakow, Poland.
Presentation: "In vitro and in vivo tests in polish cosmetic industry" by Bazela K.
Organized by The Centre of Innovation, Technology, Transfer and University Development, Jagiellonian University. |
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2. "Concepts of Animal Welfare" 15.X.2005, Bydgoszcz, Poland.
Presentation: "In vitro tests in cosmetology - alternative for animal research" by Bazela K. and Solyga A. |
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3. "Synergistic effect of three active cosmetic ingredients on human skin cell cultures" by Debowska R., Bazela K., Rogiewicz K., Eris I.
European Academy of Dermatology and Venerology, October, London, 2005. |
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4. Course on "New legal realities in the field of cosmetics", 26-28.01.2005, Warsaw.
Lecture: "Toxicity Assessment using Alternative Methods" by Stepnik M.
Organized by International Research Institute, Warsaw. |
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5. Course for physicians specializing in occupational medicine, 26.09.2005, Lodz, Poland.
Lecture: "Alternative Methods in Toxicology" by Stepnik M. Organized by Nofer Institute of Occupational Medicine, Lodz, Poland. |
Norwegian Platform
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The developing Norwegian Platform has performed a study on National Consensus Platforms in general.
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Hungarian Platform
Obituary: Prof. Peter Rudas (Chair of the Hungarian National Consensus Platform)
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We announce with deep regret that professor Peter Rudas (1951), head of the Department of Physiology and Biochemistry, at the Faculty of Veterinary Science since 1990, Szent István University in Budapest, died in a traffic accident on 13 February, 2006.
Professor Rudas, Chair of the Hungarian National Consensus Platform, initiated interactive computer and media training for veterinary students in Hungary. His research interest was concerned with thyroid physiology, endocrinology and molecular biology. Professor Rudas was the President of the International Society for Farm Animal Endocrinology and the Hungarian deputy of the European Resource Centre for Alternatives in Higher Education. He was also the Director of the PhD
School for Veterinary Sciences at the Veterinary Faculty of the Szent István University, Budapest, and a key organiser of the Summer School for Young Endocrinologists (organized for international PhD students). His achievements have been acknowledged by several highly recognised awards.
We offer our condolences to his family and all his collaborators on the sudden loss of Professor Peter Rudas.
For expression of sympathy please contact via e-mail: szajbertne.nagy.krisztina@aotk.szie.hu. |
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In future, the FORUM page for CONAM will also be activated, see above for technical details.
Also, the FORUM will contain the more general information available on the CONAM project, which will not necessarily be referred to by this newsletter so, check it out (» ecopa forum).
As part of the CONAM project and in response to the request of the E U, we will give any news, minutes of project (as far as they are non-confidential and non-proprietary) or post relevant info in the respective Forum Section. We will refer to it by use of the Newsletter. Also, as part of ecopa extended mission, we will refer to up coming events such as local workshop, conferences, meetings of the NCPs or ecopa working group etc. on our Website (» events
section), and if appropriate, in this newsletter.
Please supply us with the relevant info whenever deemed useful in your own interest.
Interested to form a new national platform in your country, if not existing?
Please contact us (» contact section).
For an upfront info how to create a platform in your country, and which criteria apply to be official recognized by ecopa , refer to the presentation of Jose Castell at the Stakeholder Workshop in Prague
» ECVAM/ecopa Stakeholder Workshop |
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.
Abstract of the Project
ReProTect is an Integrated Project of the EU (IP) funded within the 6th Framework Programme. This Integrated Project, putting together 35 different European partners from Academia, SMEs, Governmental Institutes and others intends to explore the most complicate and delicate field of toxicology, the reproductive toxicity. The investigation in this field currently requires substantial number of animals and the main objective of this IP is to reduce this number. The project will drive the
R&D toward alternatives to animal tests according to the needs identified, with the main intention to pre-validate and validate the most promising ones. This represents the ambition of developing a novel approach in hazard and risk assessment of reproductive toxicity, by a combination and application of in vitro, tissue and sensor technologies. The project will run over 5 years.
Recent News
Call for new partners in the ReProTect project, please see under Calls.
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PDF: Minutes of the 4th ReProTect Supervising Board Meeting, Dec. 15 2005 (82 kb)
At present not available for the public! |
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PDF: Minutes of the Teleconference of the ReProTect Supervisory Board Members, Jan 23 2006 (67 kb)
At present not available for the public! |
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PDF: Position Paper "ReProTect" (103 kb)
At present not available for the public! |
Next Supervising Board Meeting is scheduled for July 5, 2006 in Uppsala, Sweden.
For contact: reprotect@jrc.it |
The ecopa-induced 6th Framework Programme project has been started in 2003, with 14 partners, all in all. The overall funding is scheduled to be 2.3 mio EUR. Contract with the EU was signed on September 1, 2004; the administration is done by REMA.
Abstract of the Project
The development of new pharmaceutical compounds will be more efficient if human relevant toxicology information early in the selection process is available. While acute toxicity can be reasonably detected during the early preclinical stages of drug development, long-term toxicity is more difficult to predict, relying almost exclusively on animal experiments. Animal experimentation of this kind is expensive and time consuming, raises ethical issues and does not necessarily represent
best toxicological relevance to man. This project addresses the urgent need to develop in vitro based systems which are capable of predicting long term toxicity in humans.
The major objectives of this project are:
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To develop advanced cell culture systems which as best possible represent the human liver and kidney in vivo. This will be achieved using combined strategies namely: co-cultures of resident cell types, targeted cell transformation, stem cell technology and new developments in organotypic cell culture (i.e. perfusion
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To identify specific early mechanistic markers of toxin induced cell alterations by using integrated genomic, proteomic and cytomic analysis. |
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To establish and prevalidate a screening platform (cell systems together with analysis tools) which is unambiguously predictive of toxin induced chronic renal and hepatic disease. |
This proposal is unique in its mechanistic integration of the three levels of cellular dynamics (genome, proteome and cytome) together with advanced cell culture technology to detect early events of cellular injury. Only with such an integrated approach will in vitro techniques ever be applicable to predicting chronic toxicity in man.
This project, if successful will (1) contribute to the replacement of animal testing in drug development, (2) increase the speed and decrease the cost of bringing new pharmaceutical compounds to the patient and (3) increase our understanding of toxin induced chronic disease development.
Recent News
The kick-off meeting was held on September 24 and 25, 2004 close to Valencia.
» Minutes of the Predictomics Kick-Off meeting
The 2nd meeting was held near Innsbruck, Austria. This 1st Interim Meeting of the project PREDICTOMICS took place at the "Tiroler Bildungsinstitut” in Vill, near Innsbruck, during April 12-15, 2005, organised by Prof. Walter Pfaller and Dr. Paul Jennings, of the Innsbruck Medical University, Department of Physiology and Medical Physics.
After an initial reviewing of the milestones scheduled for the first six months of the Project done by the coordinator at the get-together meeting, the two subgroups “liver” and “kidney” met separately to analyse their respective work progress. Both groups examined in detail the strategies being employed to preserve the differentiated phenotype of cells in culture, and the developments in the “omics” technologies that will be applied to examine the
effects elicited by chronic toxins. Attention was also devoted to discuss about the suitability of the model substances selected in this study, which comprise few representative chronic toxicants.
The metabolic competence of kidney cells was an important issue raised during the common discussions that followed the two sub-groups meetings. A collaboration between the liver and kidney groups was planned to characterise the kidney cells used in this project (RNA, protein and activity measurements), and to compare with human kidney extracts and/or freshly isolated kidney cells.
The follow-up meeting discussing the 1st Annual Report took place in the Netherlands in September 2005, and the planning for 2006 was done in Brussels beginning of 2006.
Next Project Meeting for the 2nd Annual Report is scheduled for Sept. 20/21, 2006 in Montpellier, France.
Find the non-confidential information on the First Annual Report of the PREDICTOMICS project here:
» Publishable Executive Summary
Websites: www.predictomics.com or www.predictomics.org |
Abstract of the project
Allergies to sensitising agents are steadily increasing. Risk assessment for potential skin- or lungsensitisers, completely depends on animal testing. The overall objective of Sens-it-iv is to produce in vitro alternatives for these assays, and develop them up to the level of pre-validation. Besides reducing animal experimentation, an increase the accuracy of predicting sensitising potencies is expected.
In vitro mechanisms, relevant for in vivo sensitisation, will be identified at the level of human lung or skin epithelial cells (EC), dendritic cells (DC) and T-cells. These efforts imply specific scientific (S) and technologic (T) objectives:
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Existing data on sensitising, irritating and toxic compounds are collected (S). |
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In vivo changes induced by selected compounds in the specified cell types are described using functional genomics (S). |
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Similarly, the impact of compounds on individual cells, and the interaction between these cells is assessed in vitro (S). |
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The physico-chemical properties of chemicals responsible for metabolic activation and haptenformation are determined (S). |
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The data are collected in an Inductive Database allowing queries for data patterns and predictive models (T). |
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Mechanisms specifically involved in skin and respiratory sensitisation are identified using bio-informatics (S). |
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The information is used to adapt/improve existing techniques, and to develop organotypic models derived from human cells assays (T). |
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A proof of principle is established on a set of selected skin and respiratory sensitisers, irritants and toxic compounds (T). |
Recent News
CONAM / ecopa has taken over the responsibility "spreading the news/results" of this EU project, and just released a brochure covering the activities on behalf of Sens-it-iv, and supported the website creation.
Website: www.sens-it-iv.com |
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.
BioSim aims at contributing to the fulfillment and to the establishment of the 3R- Declaration. The purpose of the Network is to illustrate how the use of professional, physiologically based simulation models can help the pharmaceutical industry develop safe and effective drugs at significantly lower costs and with fewer animal and human trials. The idea is that computer simulation should go hand in hand with the trials throughout the whole development process. This represents a more
rational approach than a purely empirical test procedure.
Recent News
Biosimulation - a New Tool in Drug Development. (BioSim) is a Network of Excellence financed by the European Commission under the VIFP.
It involves 26 academic research groups, 9 small and medium sized enterprises, Novo Nordisk, and the regulatory authorities in Sweden, Spain, Netherlands and Denmark.
The purpose of the NOE is to develop mathematical models that can contribute to a better understanding of human physiological and pathological processes and gradually provide the basis for a more rational drug development process.
Application of computer simulation in the drug development process can reduce the use of laboratory animal significantly through a more rational exploitation of the information acquired in each test and through a better planning of the experiments.
Flavia Zucco has been invited, as member of the ecopa board, to be a member of the Scientific Advisory Board (SAB) of this project.
At this conference, among others, have been presented models of glucose-insulin control system, of cardiac arrhythmia, of biochemical reactions, of drug administration and circadian cycle, of hypertension and nephron interaction.
Objectives:
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Establish how biosimulation can contribute to the implementation of the 3Rs in animal and human research |
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Establish if and how the 3Rs principle in animal research can be expanded to experiments on humans |
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Increase the awareness among European research groups involved in biosimulation of the principle of the 3Rs in animal research |
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Increase the awareness among European research groups involved in alternative methods research of the potentialities of biosimulation |
For more information the home page of the project is the following:
» www.biosim-network.net |
| ecopa - Representative in Lintop is Horst Spielmann.
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Abstract of the project
The eSI Conference under the heading: "Reaching the young scientist" was 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.
ecopa had invited some renowned European scientists, i.e. "doyens" in their field of research such as proteomics, genomics, pharmaco- and toxicogenomics, but also of other areas that might have relevance to the development of alternative methods. It was not asked for immediate proposals for alternatives application from these key note speakers in their state of the art-presentation, but this had to be back in their mind, of course. In addition, ecopa has asked experts
of technology applications to give their input as well. Also, ecopa invited some young research scientists and postdocs who might have some application for their current reseach projects.
The Workshop took place with 52 participants representing 14 European countries, 6 companies, thereof 1 SME.
Recent News
The next eSI Workshop will be held September 29 - 30 2006 at Pueblo Acantilado near Alicante, Spain |
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InterNICHE book on-line
Free download of InterNICHE book "From Guinea Pig to Computer Mouse: Alternative Methods for a Humane Education" (2nd ed.).
The publication "From Guinea Pig to Computer Mouse" (2nd ed.) is now available for free download as a pdf document. First published in 2003, with minor updates made in February 2006, the 520-page book provides full details of over 500 alternatives, including description, specification and source. It also offers background information on the diversity of alternative tools and approaches, a review of published studies that assess alternatives through learning performance, and
an exploration of curricular design. The book provides links to over 600 further resources.
See News at the InterNICHE website for links to the download page:
» http://www.interniche.org |
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EU, 6th Framework Programme Call
Please, find below the information for new call for in vitro area under FP6 Priority 'Policy oriented research' Scientific support to policies - SSP.
FP6-2005-SSP-5-A: Call for proposal
Activity(s) called: Policy-orientated research
Publication date: 22 December 2005
Closing date(s): 22 March 2006at 17.00 (Brussels local time)
Task 5: To enhance the development and validation of alternative in vitro tests for chemical substances: To organise an international workshop with leading experts on QSARs (Quantitative Structure Activity Relationship) for genotoxicity and carcinogenicity.
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ECVAM, Call for Expression of Interest
The EC-JRC Institute for Health and Consumer Protection, Ispra, Italy has launched a call for expression of interest (CEI) concerning the validation of alternative test methods. All institutions active in the field of animal alternatives testing are called to indicate their interest to collaborate with ECVAM.
All organisations, institutes or companies wishing to be included on the list of service providers are invited to submit an application in accordance with the rules set out in the official notice published in the Supplement to the Official Journal of the European Union on 8th of March 2006 for the purposes specified.
Access to the official notice:
Deadlines and validity of the list resulting from the call for expression of interest:
The list of potential service providers will remain valid for 3 years from the date of dispatch of this notice (24.02.2006). Interested parties may submit an application at any time during the period of validity of the list, with the exception of the last 3 months.
Contact for applications:
silvia.bottini@cec.eu.int, Fax: +39-0332-789434
Please consult first the original document of the official notice. |
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ESF/European Science Foundation, New and Expected Calls 2006
1. General Info:
The ESF-European Science Foundation is the European association of 78 national research organisations in 30 countries. ESF promotes high quality science at a European level. It acts as a catalyst for the development of science by bringing together leading scientists and funding agencies to debate, plan and implement pan-European initiatives.
ESF covers all scientific domains:
– Life, Earth and Environmental Sciences
– Physical and Engineering Sciences
– Social Sciences
– Humanities
– Medical Sciences
I. ESF Exploratory Workshops
– for workshops to be held between 01 January and 31 December 2007
– across all scientific domains
– awards up to 15.000€
– each year, ESF supports approximately 50 Exploratory Workshops across all scientific domains
– deadline: 02 May 2006 (midnight CET)
– http://www.esf.org/esf_genericpage.php?language=0§ion=2&domain=0&genericpage=2493
Details:
The focus of the scheme is on projects aiming to open up new directions in research or to explore emerging research fields with potential impact on new developments in science. Proposals should demonstrate the potential for initiating follow-up research activities and/or developing future collaborative actions. Interdisciplinary topics are encouraged.
II. EUROCORES (European Science Foundation Collaborative Research)
The scheme provides a framework to bring together national research funding organisations to support European research.
II.1. EUROCORES THEME CALL:
The EUROCORES Theme Call is an important step to identify new areas for European collaborative research across all scientific fields. This creates future funding opportunities by developing the themes for new EUROCORES programmes.
Submission open from: March 2006 (expected)
Deadline for submitting proposals: 1st June 2006
http://www.esf.org/esf_activity_home.php?language=0&domain=0&activity=7
II.2. EUROCORES PROJECT CALL:
Each year a call for Collaborative Research Projects (CRPs) is announced, based on EUROCORES themes selected the previous year. Out of the 52 EUROCORES-Themes submitted on 15 June 2005, 5 THEMES were selected by the EUROCORES Committee to turn these five proposals into potential new EUROCORES Programmes. If sufficient level of interest and commitment by funding agencies are generated, calls will be launched for these CRPs:
RNA Quality: Quality Control of Gene Expression – RNA surveillance
EuroQUAM: Cold Quantum Matter
Inventing Europe: Inventing Europe. Technology and the Making of Europe, 1850 to the Present
CORISK: Coping with Risk: Vulnerability, Risk Perception, Risk Assessment and Decision Making under Uncertainty in Europe
TECT: The evolution of cooperation and trading: from microbes to man
More information: www.esf.org/eurocores
III. ESF Research Networking Programmes
Long term networking activities bringing together nationally funded research groups, to address a major scientific orresearch infrastructure issue. Proposals must show the potential to be carried out at the European level.
– Award will be to a max. value of up to €120 000 annually, normally 4-5 years
– Submission open from: 1st July 2006
– Deadline for submitting proposals: 30th October 2006
– New Programmes should be launched from 1st January 2008
– More information: www.esf.org/programmes
IV. Applications for EURYI Awards
These awards enable outstanding young scientists in any area of scientific research, from any country in the world, to create their own research teams at European universities and other research institutions. EURYI is a joint initiative of Eurohorcs and ESF. The 4th EURYI Call is expected to open later this year.
– Award will be to a max. value of up to €1 250 000 over a five-year period
– Submission open from: 1st September 2006 (expected)
– Deadline for submitting proposals: 30th November 2006
– More information: www.esf.org/euryi
V. ESF Research Conferences will be announcing a separate call in the spring.
More information: www.esf.org/conferences
VI. ESF-European Science Foundation
Standing Committee for the Social Sciences: Call for proposals for European Collaborative Research Projects (ECRP) - ECRP 2006 competition
Submission open
Deadline for Proposals: 28 April 2006; Decisions will be announced in February 2007
More info: http://www.esf.org/
2.Specific Dates in summary
I. ESF Exploratory Workshops:
Submission open
Deadline: 02 May 2006
II. EUROCORES (European Science Foundation Collaborative Research)
– THEMES:
Submission open in March
Deadline: 01 June 2006
– PROJECTS: expected
Submission not open yet
III. ESF Research Networking Programmes:
Submission open from: 1st July 2006
Deadline for submitting proposals: 30th October 2006
IV. EURYI Awards
Submission open from: 1st September 2006 (expected)
Deadline for submitting proposals: 30th November 2006
V. ESF Research Conferences: to be announced in a separate call in the spring.
VI. ESF-European Science Foundation
Submission open
Deadline for Proposals: 28 April 2006
Decisions will be announced in February 2007 |
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