| March 26, 2010, edition
#23 |
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Dear ecopa messenger subscriber,
The new ecopa Board has met on February 10, 2010 in Brussels, the minutes are available on request from the Secretary General, Stijn Budts.
In regard to the START-UP project, the organizers of the various workshops are meeting on Friday March 26, 2010 to finalize the report, issue recommendations from the discussions
and come up with a road map for the EU Commission for future follow up.
Watch for the next ecopa messenger in June, and please direct future news updates and contributions to Troy Seidle at tseidle@hsi.org.
Bernward
Garthoff
P.S.: Any proposal or recommendation regarding style, content or distribution of the newsletter is highly welcome and appreciated.
If you know other people or institutions interested, have them visit our website and subscribe
to this newsletter. |
I.1.1. Recent News on
REACH and GHS
First REACH list of dangerous chemicals agreed:
EU Member States approve world-wide rules for labelling of chemicals
The European Commission welcomed the agreement by the EU Member States to align EU legislation on classification, labelling and packaging of substances and mixtures to the United
Nations Globally Harmonised System (GHS). This new system is supposed to ensure that the same hazards will be described and labelled in the same way all around the world. By using internationally
agreed classification criteria and labelling elements, it is expected to facilitate trade and to contribute towards global efforts to protect humans and the environment from hazardous effects of
chemicals. The new regulation will complement the REACH regulation on the registration, evaluation, authorisation and restriction of chemicals. The European Parliament already the 3rd of September
this year approved the GHS regulation. The next step will be its publication in the Official Journal of the EC.
The regulation will require companies to classify, label and package appropriately their hazardous chemicals before placing them on the market. It aims to protect workers, consumers
and the environment by means of labelling which reflects possible hazardous effects of the chemical, while also taking over from REACH notification of classifications to the European Chemicals Agency
(ECHA) in Helsinki.
The regulation will after a transitional period replace the current rules on classification, labelling and packaging of substances (Directive 67/548/EEC) and mixtures (Directive
1999/45/EC). After entry into force, the deadline for substance classification according to the new rules will be 1 December 2010 and for mixtures 1 June 2015.
More information about the new rules can be found under:
Whether the highly acclaimed expectations are
later met by reality, has to be seen. |
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ECHA (European Chemical
Agency) |
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European Chemicals Agency is operational
European Chemicals Agency (ECHA) runs the REACH-IT portal.
More information here: http://echa.europa.eu/doc/press/
Access to REACH-IT portal: http://echa.europa.eu/reachit_en.asp
ECHA held its first stakeholder’s day on October 10, 2008. The outcome is published here:
General information and more events by ECHA, related to REACH, see the website:
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I.1.2. European Partnership on Alternative
Approaches to Animal Testing (EPAA)
For outcome of the recent Mirror Group meetings and the last workshops, see the EPAA-website:
EPAA-newsletter of December 2009 is published and can be read here:
NEWS:
A flash report on the Workshop on Dissemination, which took place on November 5, can now be read on the following link:
EPAA-events are listed under: http://www.epaa.eu.com |
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I.1.3. IMI is launched
The Innovative Medicines Initiative (IMI) has been launched on April 30, 2008. This is an initiative launched by both the European Commission and the EFPIA, the
European Federation of Pharmaceutical Industry Associations. The goal of this initiative is to give an impulse to biopharmaceutical innovation in Europe. Universities, hospitals and public institutions
can get financing for a research project.
IMI organises annual calls to be participated by academia and small companies. The subjects are determined by the EFPIA in cooperation with the European Commission.
The first calls are out by now.
Innovative Medicines Initiative (IMI): the Commission and the pharmaceutical industry have launched the second call for research proposal towards more efficient
drug development methods, on November 27, 2009.
The application deadline for the new Call for proposals was February 8, 2010 and the results will be announced in Summer 2010.
More information can be found here:
See the website of IMI here and check the upcoming
events:
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I.2.1. Nanotech
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.
US Environmental Protection Agency (EPA) and its Science Policy Council has also installed a
Framework for Application of the Toxicity Equivalence Methodology for Polychlorinated Dioxins, Furans, and Biphenyls in Ecological Risk Assessment
Organized in accordance with EPA’s
Guidelines for Ecological Risk Assessment, this framework is intended to assist EPA scientists in using the toxicity equivalence methodology in ecological risk assessments that involve
dioxins and dioxin-like chemicals, as well as to inform EPA decision makers, other agencies, and the public about this methodology.
More information see here:
I.2.2. Review of Directive 86/609
The new version is out since November 5th, 2008, and being discussed in the member states and its administrative representative groups. Article 44-46 in chapter IV, address
alternatives specifically. See more under III.2.13.
Progress can be followed under:
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II.1. EU 6th Framework
Programme Projects / ecopa Working Groups |
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II.1.1.1. Recent News on FP6 and FP7 projects
NEWS:
Next Board Meetings will be determined following the ecopa Annual Meeting and the hand over Meeting of December 2009.
Representatives of ecopa in EU projects 6th Framework Programme:
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SSA project ForInViTox (Forum for
researchers and regulators to meet manufacturers of toxicology test methods) - ecopa is represented by Dr. Odile De Silva. |
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BioSim – Flavia
Zucco represents ecopa in this EU Project. |
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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. |
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ACute Tox – Peter Maier is
the representative in the Advisory Board. |
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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. |
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PREDICTOMICS – Bernward Garthoff
was the representative in the Advisory Board, the project has been finalized. |
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Liintop – Horst Spielmann is
the representative in the Advisory Board. |
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ReProTect – Karin Gabrielson,
Vera Rogiers and Bernward Garthoff (Chair) were representatives on the Supervising Board, and ecopa was seconding in the dissemination of results. The project has ended with December
2009. |
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START-UP – START-UP is
the ecopa-follow-up-project for CONAM and will end in the first quarter of 2010. |
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ESNATS - ecopa is lead part of the
dissemination workpackage. |
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ecopa – latest ecopa-Board
Meeting took place on February 10, 2010 in Brussels. |
The European Commission has published a booklet on all European FP7-projects concerned with alternative testing, it was also distributed by ecopa. You can download it from this
link:
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
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The 16th Congress on Alternatives
to Animal Testing – Linz 2010 is being prepared, it will take place on September 3-5, 2010 in Linz, Austria. |
II.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
II.1.1.2.5. Dutch Platform
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In the spring of 2009 the call
for the ZonMw 'Alternatives for Animal Use' research programme was opened. The call was specifically open to projects in the phase of (pre)validation and implementation. In December 2009 nine
high quality research projects were rewarded. In total, approximately 2,2 million euro was granted. The topics of the rewarded projects are:
- 'Development of tolerogenic vaccines in animal-free models'
- 'Implementation of (Q)SAR and physiologically-based kinetic (PBK) modeling techniques into a (Q)SAR-PBK approach for predicting dose-response relationships for
rat and human and deriving safe exposure limits in risk assessment practice'.
-'In vitro genotoxicity test using metabolic competent 3D human bronchial epithelial model as alternative to in vivo genotoxicity studies with inhalation exposure'
- 'Pre-validation of a two-tiered approach to determine the skin sensitizing capacity and potency of chemicals'
- 'Validation and implementation of rapid and cost-effective human in vitro screening assays to predict genotoxicity and carcinogenicity of chemicals and pharmaceuticals'
- Toxicogenomics of precision-cut liver slices for prediction of human liver toxicity, a prevalidation study' -' A human model for bone metastasis'
- 'Implementing and (pre) validation of combined existing in vitro assays for the hazard identification of chemicals following oral exposure'
- 'Interlaboratory study for replacement of the lethal challenge procedure by serology in lot release potency testing of whole cell pertussis vaccines'
To ensure further developments in the field of risk assessment we can now also welcome the Innovationprogramme ASAT "Assuring Safety without Animal Testing" within ZonMw. The ASAT program
was initiated by the Dutch government to develop a new risk assessment method without animal use. In 2010 one of the initiatives will be to improve communication and cooperation between regulators/regulatory
bodies and scientists.
Furthermore, in the beginning of this year the analyses of trends in society and science concerning animal experimentation were completed and presented to the ministry
of Health, Welfare and Sports (VWS). ZonMw together with the Netherlands Knowledge Centre for Alternatives to animal use (NKCA) was commissioned to perform a programming study resulting in a
Dutch (research) agenda on 3R activities. The report is expected to be finished this summer and will be presented to the ministry VWS. The ministry will send the reports on trends and the 3R
agenda to the Dutch government. |
II.1.1.2.6. Finnish Platform
» Fincopa
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Chair: Adjunct Prof. Tuula Heinonen, Ph.D.
(director of FICAM, the Finnish Centre for Alternative Methods, http://www.ficam.fi) tuula.heinonen@uta.fi
Secretary General: Dr Eila Kaliste, Ph.D. (presenting officer, Regional State Administrative Agency for Southern Finland), eila.kaliste@avi.fi
In 2009 Fincopa took part in the organizations of the scientific programme of the START-UP Refinement Workshop organized by IPAM (in cowork with Fincopa and Polcopa)
February 26-27, Rome.
In connection of the 30-year Anniversary Symposium of the Finnish Society of Toxicology, FST (May 26-27.Tampere) Fincopa contributed to the organization of the session “Intelligent testing
strategy”.
In 2010 Fincopa continues the cowork with the FST by organizing a half-day session in the joint symposium of FST and Fincopa, April 26-27, Helsinki. The main topic
of the symposium is REACH and the testing requirements under it. Fincopa will have its Annual Meeting on April 27 at the end of the scientific symposium.
Activities in the EU 6th Framework programme:
- ReProTect project: Prof Kirsi Vähäkangas, partner
- ACuteTox project: Prof. Hanna Tähti, Advisory Board Member |
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Fincopa'‘s website:
http://www.uta.fi/jarjestot/fincopa/ |
II.1.1.2.7. French Platform
» Plateforme Nationale pour le développement des Méthodes alternatives à l’experimentation animale
II.1.1.2.8. German Platform
» Stiftung
set
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Stiftung set organized, together
with the Hungarian platform hucopa, the Workshop on Replacement on October 2-3, 2009. This Workshop was part of the FP7 EU-project START-UP.
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II.1.1.2.9. Hungarian Platform
» Hucopa
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In 2009, hucopa was mainly engaged
in organizing the 3rd START-UP Workshop, a workshop on Replacement held in Budapest, at Ferihegy Airport on 2-3 October 2009. hucopa organized the workshop in cooperation with the German Platform,
the Foundation for the Promotion of Alternate and Complementary Methods to Reduce Animal Testing (SET). Following the START-UP workshop, as a joint event, a local conference of the Hungarian
platform was held on the 3R topicalities in Hungary.
Furthermore, the beagle and laboratory rodent adoption/retirement project of hucopa remained to be successful. Future plans of hucopa for the next years:
To draw public into the 3R sphere and to distribute information about animal welfare efforts in research, hucopa plans to organize a conference for the public on
3Rs. Furthermore, we will continue the successful adoption/retirement project of lab animals. On the side of education (and future veterinarians) the Department of Physiology and Biochemistry,
Faculty of Veterinary Sciences (Budapest) aims to introduce a new elective course on 3Rs and alternatives to animal testing for veterinary students in Hungarian and in English. In addition, the
Department plans to improve their recently renewed, 3R-conscious Physiology lab course and aims at enriching their tools with Team-based Learning and Distance Learning, in cooperation with the
Purdue University (IN, USA).
More emphasis will be put on the expansion of hucopa and on building new public and professional relations. As an organic part of it, hucopa intends to search for
new funds. Last but not least, hucopa plans to improve the webpage and to develop its English version.
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II.1.1.2.10. Italian Platform
» IPAM
- Italian Platform on Alternative Methods
II.1.1.2.11. Irish Platform
II.1.1.2.12. Norwegian Platform
» Norecopa
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Norecopa started 2010 by launching
a totally redesigned website (www.norecopa.no),
making it easier to find 3Rs resources. Although much of the site is in Norwegian, it includes English-language sections with, among other things, an A-Z of guidelines that are of use when planning
experiments that may involve animals, plus all the presentations delivered at its consensus meetings on fish and wildlife research.
Norecopa has started to plan its next international consensus meeting. This time the subject will be: Harmonisation of the Care and Use of Agricultural Animals in
Research”. The provisional dates for the meeting are 10th-12th May 2011 at Oslo airport, Gardermoen. Please contact Norecopa (post@norecopa.no)
if you would like to suggest topics for this meeting. More information will be posted later on Norecopa’s website.
Norecopa is following up its last consensus meeting (on the care and use of fish in research) by creating a number of working groups, to tackle the specific issues
raised at the meeting. These include challenges of vaccine development and testing, the production of an English-language compendium in lab animal science for fish researchers, and working groups
that will produce guidelines for categories of severity and identification methods.
An English translation is now available of the main points in a report commissioned by Norecopa and financed by the Norwegian Research Council, which looked at the
research needs within welfare of fish used in research. This English summary can be accessed here:
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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
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REMA celebrated its 10th anniversary on
December 1, 2009 in Madrid. A presentation of Bernward Garthoff on behalf of ecopa was disseminated. |
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REMA board had a meeting in February 25th
at the Instituto Nacional de Sanidad Ambiental (Instituto de Salud Carlos III) in Madrid. The Spanish platform is preparing a round table in the IUTOX Congress (http://www.iutox2010.org/) to
be celebrated in Barcelona July 19-23, 2010. The title will be “Role of in vitro and in silico alternative methods and global impact for regulatory processes”. The applicability
of alternative methods in regulatory processes will be discussed. IUTOX will be an adequate forum for this topic because global approaches are requiring harmonised validation and acceptability.
Participants representing industry and some institutions promoting alternatives have been invited. ECOPA will be represented by Adela López de Cerain. Next board meeting has been planed
for June 21 in Barcelona under the sponsor of Laboratorios Ferrer. |
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The REMA activities can be found
at (Spanish version):
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II.1.1.2.15. Swedish Platform
» Swecopa
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Swecopa held its AGM on March 31, 2009.
Karin Gabrielson Morton was re-elected to chair Swecopa. Other board members are Dr Cecilia Clemedson (Swedish Fund for Research without Animal Experiments), Professor Roland Grafström
(Karolinska Institute), Dr Krister Martin (AstraZeneca), Rebecca Ceder (Karolinska Institute) and Helena Elofsson (Board of Agriculture). |
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News from Swecopa is published
on the website www.swecopa.se under “News”.
A newsletter in Swedish is also available at http://www.swecopa.se/swe_sid5_aktuellt.html
E-mail at info@swecopa.se if
you want to receive the newsletter. |
II.1.1.2.16. Swiss Platform
» 3R
Research Foundation Switzerland
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:
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are to be found on the forum of the ecopa website, see the comment under II.1. |
II.1.2. ReProTect
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
As part of the project, a review “of the Implementation of the Embryonic Stem Cell Test (EST)” has been published in ATLA, see publication section. The final Annual General Meeting was
held near Ispra, Italy on December 7, 2009.
At the end of the year 2009, this project has ended.
A brochure on the activities within ReProTect is available:
Publishable executive summary 2008
A publishable executive summary for the year 2008 can be downloaded from the website:
You find an informative flyer below, as well as the brochure presenting the first results.
ecopa is involved in the Board and the results dissemination. |
II.1.3. ACuteTox
II.1.3.1. Recent News
A list of all publications produced by the Consortium is available on the web site as well as the project structure and a profound overview. Link below.
The latest newsletter as of February 2008 can be read here:
E-learning program for in vitro methods
The scientific coordinator of the FP6 project ACuteTox, Expertrådet, is producing an e-learning program for the testing strategy and the methods that will be the result of the project. To
get a good implementation and a wide use of the in vitro methods it is important to make it convenient for the industry to use them. One way is to produce interactive manuals that make it
possible to attain reproducible results with high and equal quality in all laboratories.
Expertrådet has developed a pedagogic model for an interactive manual within the ACuteTox project. The SOP text is supplemented with short video sequences, photos and drawings that clarifies
critical phases of the test methods. Each test will be presented in three different levels: 1) an introduction level where the tests are presented briefly to demonstrate the opportunities of the
test; 2) a second level with the SOPs of the tests and with video sequences or pictures that demonstrate how to carry through the tests; 3) in the third level the scientific documentation and background
of the tests could be find. The second level is the main part of the e-learning program that will consist of the interactive manual.
This model could also be useful for the other FP6 projects within the in vitro area and it would certainly be convenient for the endusers if the e-learning programs from the different projects
looked similar and had the same pedagogic model. Expertrådet is willing to assist other in vitro projects to produce similar e-learning programs.
Contact for more information: http://www.expertradet.se, http://www.acutetox.org
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II.1.4. Sens-it-iv
Sens-it-iv is an integrated EU-funded research project (LSHB-CT-2005-018681)involving 28 partners, drawn from across Europe, of which 9 represent industry, 15 groups represent universities or
research institutes, while 4 groups represent organizations. They are joined together by the common goal of developing alternative strategies to animal testing for the assessment of skin and/or
respiratory sensitizing potential of chemicals. This includes the development of predictive in vitro methods.
ecopa is part of work package 9 and is responsible for “Technology transfer and Dissemination”. Technology transfer and dissemination of project results, including knowledge,
will be a key activity throughout the term of the Sens-it-iv project.
II.1.4.1. Recent News
ecopa has taken over the responsibility "spreading the news/results" of this EU project, and released a brochure covering the activities on behalf of Sens-it-iv, and supported the
website creation. The folder and poster can be downloaded on the website www.sens-it-iv.eu, section press material. Technology transfer and dissemination of project results, including knowledge,
will be a key activity throughout the term of the Sens-it-iv project.
The first Sens-it-iv Newsletter appeared on December 14, 2006 and by now the 37th edition is available via the website or the link below. The newsletter is coordinated by the
WP9 leader.
The Sens-it-iv Newsletter Nr. 37 is out:
Newsletter-subscription possibility on the website.
The General Assembly will be held from April 26-28, 2010 in Berlin, Germany.
A Summer school has been held from June 29th till July 2nd, 2009 with the title: practical and theoretical course on Sens-it-iv in vitro methods at the University of Applied
Sciences HU, Utrecht, The Netherlands. The course was about theoretical and practical laboratory aspects of sensitization, pathology, cell culture models, data handling and experimental design.
A next Summer School will be organised in 2011. More information will be disseminated via the newsletters and the website.
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II.1.5. BioSim
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.1.5.1. Recent News
The BioSim project is now ended. The final 5th BioSim Conference was held in Christiansborg, Copenhagen, from August 25 to 29, 2009, hosted by the Danish Parliament, and attended
by about 160 participants.
The meeting, this time, covered other aspects than the scientific ones, which have been, however, the most relevant and interesting.
Presentations have been given by institutional and political representatives on the relevance of this project for the Danish institutions, in terms of international prestige,
scientific and educational impact. From the University side, the relevance of interaction between natural and technical sciences has been stressed, as well as that between academia and industries.
The challenge that universities are now facing is to prepare students for jobs which do not yet exists: thus there is a special need of economical but also cultural investment. A session has been
devoted to “Biosimulation vis-a-vis the ethical and social issues of global drug development”. Some lectures from Novo Nordisk A/S researchers and administrators on industrial research
and social responsibility were given.
Moreover, the relevance gained by the Corporate Social Responsibility (CSR), which implies a change in the attitudes of the Companies in relation to ethical “hot” issue, has been illustrated
by an EU Commission representative. The EU-perspective is whereby companies may integrate societal and environmental concerns in their business operations and in their interactions with the stakeholder
on voluntary basis. CSR, indeed, can be a tool that not only opens the dialogue among companies and the public at large, but also may have a positive feedback on the economy of the enterprise.
The main scientific session was dealing with “Biosimulation and model-based treatment of patients” and “Application of biosimulation in drug development”. The final sessions
were devoted to the use of biosimulation in the health sciences and to the most recent results of the BioSim project. The issue of why, where, and when the modelling should be applied has been widely
debated: still more rational approaches are needed, together with semantic clarification concerning f.i. the very concept of “system”. Moreover, it should not be forgotten that modelling
may start from data and not from a hypothesis and, thus, data source, mining etc., is of extreme importance. The Virtual Human and Personalised Medicine have been recurrent topics, which may look,
at glance, still very far away technological goals, but scientific approaches such as biosimulation of complex system, makes them thinkable, and even feasible, in a not too far future.
It goes without saying that much appreciation has been expressed for the outstanding scientific guidance of Erik Mosekilde, which, from now on, will act as counsellor of any
future plan, and for Anne Marie Clemensen, who made such a wide network to work easily and friendly, coping at the same time with the expected time schedule and administrative issues.
The principal Scientific Officer of the BioSim, presenting the next calls in the area of predictive medicine, provided ideas and information about future possibilities for this
network, or at least part of it, to continue its successful journey... and we are sure that this would be the case. |
II.1.6. Liintop
II.1.6.1. Recent News
Structure of the project, information
on partner and new on events can be taken from the website:
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II.1.7. carcinoGENOMICS
carcinoGENOMICS is an Integrated FP6 Project financially supported by the European Commission (LSHB-CT-2006-037712).19 groups are present of which 6 represent industry, 11 represent universities
or research institutes, while 2 groups represent organizations.
II.1.7.1. Recent News
The last carcinoGENOMICS Board Meeting was held
in Basel, Switzerland on February 11-12, 2010.
A workshop in regard to capacity building will be held on May 27-28, 2010 in the Crown Plaza Hotel in Brussels, in conjunction with the next Board Meeting.
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II. 2. EU 7th Framework
Programme Projects, Initiatives and Technology Platforms |
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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.
The twelfth SusChem newsletter is now online:
SusChem is organising a ‘hybrid materials workshop’ on March 3-4, 2010 in Luxembourg.
II.2.2. Regulations of the 7th Framework Programme
Update 7th EU RTD- Framework Programme
Though intended as part of the EU-competitive efforts in Research and Development, the EU still is behind its own targets laid down in the Lisbon Strategy. According to the
EU statistics officer, the 27 EU states invested in 2006 as much (or little) as in the year before, i.e. 210 billion EURO equivalent to 1.84% of its economical output. Lisbon asks for 3% in 2010.
Guidance on FP7 implementation
A number of guidance documents and preparatory work are carried out by the European Commission in view to install the basis of the FP7 implementation. The following documents
are available for consultation on http://cordis.europa.eu/fp7/find-doc_en.html where
they can also be downloaded:
• a standard Model Grant Agreement,
• a draft Guide for Beneficiaries,
• a draft Guide to Financial Issues,
• a draft Guide to IPR and
• a draft Checklist for the Consortium Agreement.
ecopa is interested to participate with partners in some of the calls dealing with alternative methods and being announced in the future, esp. within the HEALTH resp. the ENVIRONMENT sectors
of the 7th FRP. |
II.2.3. START-UP
ecopa submitted a proposal for a Support Action in the HEALTH-2007-1.3-2 call: Bottlenecks in reduction, refinement and replacement of animal testing in pharmaceutical discovery and development.
The proposal is called “Scientific and technological issues in 3Rs alternatives research in the process of drug development and Union politics” with the acronym: START-UP.
Several NCPs are collaborating in this project. The project was approved “Grant Agreement” No. 201187 and signed on March, 12, 2008. Project no. LSHB 201187.
II.2.3.1. The Abstract of the proposal
The START-UP project is concerned with the identification and proposals to abolish bottlenecks in the 3Rs approach in pharmaceutical discovery and development. The goal of the project is
the organisation of 3 Workshops in order to determine a) the state of the art of each of the 3Rs in the EU, b) to assess European strength and gaps in 3Rs and c) the identification of rate
limiting steps on the political, scientific, technological level. As a result, a Consensus Paper containing the concepts and suggestions for a Roadmap for future research will be produced.
Stakeholders (among them European Pharmaceutical Industries (EPI)) have identified bottlenecks in drug development and in the integration of in vitro methods Early identification of wrong
candidates for further development and avoiding efforts for under-performing candidates, are essential for the competitiveness of European Industry. Identification of bottlenecks in the implementation
of reduction, refinement and replacement of animal experimentation in drug R&D, should assist in identifying the best in vitro and in vivo systems, and to speed up the drug development
process. Existing hurdles in the scientific, technological, political and environmental level (including regulatory), play a substantial role and are rate-limiting in developing new drugs, including
biological entities (almost 50% of the currently developed products).
ecopa (the quadripartite umbrella NGO for alternatives) structures with its VUB partner this support action around 3 major workshops which was preceded by 3 Expert Meetings redefining and
prioritising current bottlenecks in 3Rs methodology; with EPI, drug discovery and development. Each phase has its own specific needs, and analysing the present limitations and gaps needs to be addressed,
e.g., many cell systems do not yet have the required stability for genomics, proteomics or metabonomics analysis; many current in vitro cell systems lack crucial bioactivation capability.
Consequently, the status of satisfactory “predictive” pharmacology and toxicology in vitro has not yet been reached.
In terms of politics and ethical concerns, considerable differences in regard to the use and development of transgenic animals, human tissues and stem cells create an atmosphere
of insecurity for an effective academia and industry cooperation.
The final goal of this action is a Consensus Document that analyses present status.
Details of the project were presented by the Chair of ecopa on the occasion of the 11th Linz Alternative Congress, September 28-30, 2007.
NEWS:
The first major workshop of the START-UP project, on Refinement, was held in Rome, Italy, at the L’Istituto Superiore di Sanità (ISS) on February 26-27, 2009. The second workshop,
on Reduction, has been held on July 3-4, 2009, in Innsbruck, Austria. The third workshop, on Replacement, was held on October 2-3, in Budapest, Hungary.
At the moment, reports are being prepared for editing the final report to be supplied to the European Commission, by the end of February, 2010. |
II.2.4. 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, developed the logo, and is leading the respective workpackage.
NEWS:
The upcoming esnats General Meeting is scheduled for April 26-28, 2010 in Ispra/Italy.
Esnats-website: http://www.esnats.eu |
III.1. Events
III.1.1. ecopa events
III.1.1.1. 10th Annual ecopa Workshop
The future ecopa Annual Meetings will be:
11th: end of November 2010
III.1.1.2. ecopa Board meeting
The next ecopa Board meetings:
- The exact date still has to be set. |
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eSI - ecopa Science
Initiative |
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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 reports, presentations, and the final programs of all the events up to now, are listed on
the ecopa website in the archive section. |
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III.1.2. other
events
III.1.2.1. Literacy courses in molecular biology/biotechnology
Designed for people in companies or organizations that are faced with biological information but have no formal training: attorneys, business people, chemists, computer scientists,
engineers, healthcare professionals, investors, journalists, politicians, regulatory affairs specialists...
Next sessions in 2010:
January 28-29 , Rolle (Lausanne-Geneva) Red Biotechnology (medicine and pharma); February 11-12, Bern Red Biotechnology (medicine and pharma); February 18-19, Uetliberg (Zurich)
General Biotechnology (red + white + green); April 8-9, Uetliberg (Zurich) Red Biotechnology (medicine and pharma)
For more information:
» http://www.loroch.ch/molbio/course_announcement.htm
III.1.2.2. i-SUP2010: Innovation for Sustainable Production 2010
April 18-21, 2010 in Bruges, Belgium
I-SUP2010 will focus on the intertwining of all those disciplines involved in sustainable development taking into account societal, technological and scientific issues in a
broad and integrated range of domains. I-SUP2010 invites you to discuss with all stakeholders involved in this process by combining six international congresses at the same time and the same location,
each aimed at a specific target audience of industry leaders, universities, research institutes and decision makers covering such fields as: Sustainable production, Sustainable chemistry, Sustainable
energy, Materials for sustainable Production, Carbon Capture and Storage (CCS) and In vitro methods replacing animal testing (CARDAM).
For more information:
» http://www.i-sup2010.org
III.1.2.3. Cell-Based Assays: Improved platforms and techniques for drug discovery, development and toxicity testing
April 20-22 2010 at BSG House, London , UK
For more information:
» http://www.bioportfolio.com/cgi-bin/acatalog/Cell-Based-Assays.html
III.1.2.4. IVTIP Spring Meeting 2010 Integrated In Vitro Testing Strategies
May 18, 2010 at Hotel Ramada Encore, CH-1227 Carouge-Geneva, Switzerland
Inspired by the latest US Environmental Protection Agency (EPA) strategic plan for evaluating the toxicity of chemicals ‘Toxicity Testing in the 21st Century: A vision and a strategy’,
IVTIP organized a meeting (November 26th 2009, Edegem, Belgium) to discuss among scientists, key opinion leaders, developers and users of 3Rs-related tests and strategies how this vision could be
transformed into a visionary reality.
One of the emerging concepts focused on integrating a defined number of tests modeling in vivo-relevant and well-characterized toxicity pathways representing mechanistic endpoints.
Realizing that integrated in vitro testing strategies (ITS) currently are used in several sectors for early decision-making during product discovery and development, IVTIP have organized a meeting
with the theme: Integrated In Vitro Testing Strategies - Implementation Challenges.
For more information:
» http://www.ivtip.org/
III.1.2.5. Drug Safety Conference
May 25-27, 2010 in Washington DC, USA
The objective of this new conference is to bring together the three corners of the safety triangle: Industry, Academia and Regulators. With the emergence of biologics and biologicals,
and the application of new approaches and techniques for drug discovery, the need for clarity, transparency and accountability has grown. It is the expense of time, resources and effort that require
attrition – not drug discovery. Therefore it is essential that the three corners of the ‘safety triangle’ can see one another, recognise one another’s position, communicate
and interact. The purpose of this meeting therefore is to highlight the gaps between industry, academia and regulators and identify ways of bridging them. To do so, participants are encouraged to
consider ways of overcoming the three main obstacles to progress: the restrictions of economics, the clarity of regulatory guidance and the limits of scientific knowledge.
For more information:
» http://mail.elsevier-alerts.com/go.asp?/bECO001/m9AOD51F/uJXFV51F/x9HGV51F
III.1.2.6. Practical Methods for In Vitro Toxicology Workshop 2010
June 15-17, 2010 in Gaithersburg, Maryland, USA
The practical methods course combines both lecture and laboratory activities to provide a comprehensive introduction to in vitro toxicology.
For more information:
» http://events.constantcontact.com/register/event?oeidk=a07e2odovlhc093dc92
III.1.2.7. Skin in Vitro 2010
June 8-9, 2010 in Frankfurt Am Main, Germany
Human reconstructed skin models have become increasingly important during the last few years in different fields.
Reconstructed epidermis models already fully replace animal testing for skin corrosivity and skin irritation testing. They are used for substance testing in the regulatory context
of the cosmetics directive and under the REACH legislation. More complex skin models are established research tools for the cosmetics and pharmaceutical industry as well as for academia. Especially
in this area, the diversity of skin models and applications is rapidly growing.
The scope of this symposium is to discuss in depth the progress in use of skin models in research, efficacy and toxicity testing.
For more information:
» http://www.skininvitro2010.org
III.1.2.8. Submission of abstracts for ESTIV 2010 | EUSAAT 2010 | Linz 2010 is now open
September 2-4, 2010 in Linz, Austria
Abstracts can now be submitted for the forthcoming congress ESTIV 2010 / EUSAAT 2010 / Linz 2010. The deadline for the submission of lectures is April 30, 2010, deadline for
the submission of posters is May 28, 2010.
For more information:
» http://www.eusaat.org/index.php/2010/submissionofabstracts |
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III.2.
Awards and Publications
III.2.1. Booklet on Alternative Testing Strategies
The European Commission has published a booklet on all European FP7-projects concerned with alternative testing.
You can download it from this link:
» http://cordis.europa.eu/documents/documentlibrary/106691831EN6.pdf
III.2.2. The revision of the EU Directive on the protection of animals used for scientific purposes
This has been published by the Authority of the House of Lords. This report is a reaction from the UK National Parliament to the Commission’s proposal (COM(2008)543) for the revision of Directive
86/609/EEC on the protection of animals used for experimental and other scientific purposes.
You can download it from this link:
» http://www.publications.parliament.uk/pa/ld200809/ldselect/ldeucom/164/164i.pdf
III.2.3. Hugo van Poelgeest award for Alternatives
Call in regard to this four-year award of 10.000 Euro for June 2010.
For more information:
» http://www.uu.nl/NL/faculteiten/diergeneeskunde/Actueel/
nieuwsfaculteit/Pages/HugoPoelgeestprijs.aspx
III.2.4. NC3Rs Newsletter Issue 25 released
For more information:
» http://www.nc3rs.org.uk/
III.2.5. European Medicines Agency publishes draft paper for the strategic development until to 2015
The European Medicines Agency has published a draft paper setting out its vision for the strategic development of the Agency for the five years to 2015. Building on the progress
of its previous five-year strategy, the Road Map to 2015 charts the way forward for the Agency amid rapid developments in medical science and pharmaceutical research, as well as the continuing evolution
of the European and international regulatory environments. With this strategy paper to guide it, the Agency will seek to consolidate its achievements to date and further strengthen its role as a
guardian of human and animal health in the European Union.
The document is available on the following webpage:
» http://www.ema.europa.eu/pdfs/general/direct/directory/29989509en.pdf
III.2.6. EFSA published an opinion on the replacement, reduction and refinement of animal testing
Existing approaches incorporating replacement, reduction and refinement of animal testing: applicability in food and feed risk assessment.
The founding Regulation of EFSA requires the Authority to contribute to a high level of protection of human life and health, and in this respect to take account of animal health
and welfare. EFSA is committed to a proactive animal welfare approach, based on sound scientific principles and the need to ensure that adequate data are available for a reliable risk assessment.
In this context, EFSA and its Scientific Committee recognise the importance to stimulate the use of food and feed assessment approaches that would not only minimise the number of experimental animals
and any suffering, but also work towards their replacement.
For the full text:
» http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902559349.htm
III.2.7. ESTIV Newsletter Issue 27 released
For more information:
» http://www.estiv.org/
III.2.8. Science Room eBulletin November 2009
For more information:
» http://www.scienceroom.org/
III.2.9. Stem cells online journal
For more information:
» http://www.stemcellsportal.com
III.2.10. A Review of the Implementation of the Embryonic Stem Cell Test (EST)
The report and recommendations of the ECVAM/ReProTect Workshop organized in May 2008 in Frankfurt/Germany were published recently in ATLA 37, 313–328, 2009.
Board Members of ecopa were contributing in the organisation and critical discussions, as well as the final publication. |
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III.3. Calls and Vacancies
III.3.1. Call for research proposals – NC3Rs
Using the 3Rs as a framework for improving models of health research is a priority for the NC3Rs. Asthma has been chosen as the first priority area. NC3Rs is working with Asthma
UK in seeking high quality applications to develop new experimental models of asthma with improved scientific and clinical relevance and reduced reliance on the use of animals and/or improved animal
welfare.
The deadline for submitting an application is April 14, 2010.
For more information:
http://www.nc3rs.org.uk/asthmaaward
III.3.2. ECVAM is renewing its Scientific Advisory Structure: Two Open Calls for Scientists
The European Centre for the Validation of Alternative Methods (ECVAM) is currently renewing its Scientific Advisory Structure.
Two Open Calls: ESAC and EEP
In the context of this renewal (more details below), ECVAM is publishing Two Open Calls for the Expression of Interest addressed to experts in life and environmental sciences,
medicine, chemistry, toxicology, test method and test strategy validation, risk assessment and scientists knowledgeable in other areas such as statistics, biometry, epidemiology, modelling approaches.
• The first call is dedicated to the new ECVAM Scientific Advisory Committee (ESAC). The 19 ESAC members, preferably senior scientists with a generalist profile, will be in charge of
advising ECVAM on all scientific aspects of its work and in particular with regard to the scientific validity of methods which replace, reduce or refine animal experiments. Deadline for submitting
an expression of interest in the ESAC was September 30, 2009. In the mean time members were identified and informed.
• The second call concerns the formation of an ECVAM Expert Pool (EEP), supporting ECVAM's mission through direct expert advice to ECVAM and ESAC, e.g. through their participation in ESAC
Working Groups, task forces or workshops. Preference will be given to experts with profound specialist knowledge in one or few areas. The call will be published mid September. No deadline is
foreseen at present.
All relevant information including the application procedure can be found on:
http://ecvam.jrc.ec.europa.eu/index.htm
III.3.3. Unilever-Hamner Postdoctoral Fellowship
Deadline: March 31, 2010.
The Hamner Institutes for Health Sciences in Research Triangle Park, North Carolina is seeking a postdoctoral fellow in its Program in Chemical Safety Sciences to study DNA
damage response pathways. Under supervisions by both experimental and computational biologists, the successful candidate will use integrated systems biology approach to develop in vitro assays and
in silico models for toxicity pathway perturbation by genotoxic agents. Applicants should have a Ph.D. or equivalent in biology, toxicology, or related discipline, supplemented with evidence of
mathematical, programming, and modeling skills, or a Ph.D. in chemical/biomedical engineering, mathematics, or physics with sufficient training in molecular and cell biology. Excellent communication
skills and the ability to work both independently and as part of a team will be essential.
For more information:
http://www.thehamner.org/careers/current-openings/index.html
III.3.4. Unilever-Hamner Assistant Investigator for in vitro Genotoxicity Research
Deadline: March 31, 2010.
The Hamner Institutes for Health Sciences is seeking an enthusiastic and innovative individual to lead a research effort to examine dose-dependencies of DNA-damage stress response
pathway function with different classes of compounds. The research will be closely aligned with new testing and risk assessment initiatives proposed in the 2007 NRC report, Toxicity Testing in the
21st Century: A Vision and A Strategy. Tools involved in the research include genomics, high content assay (HCA), and computational systems modeling. Ph.D., Sc.D., DVM and/or MD plus 2-3 years of
postdoctoral training and at least 5-7 years of research experience is required. Previous experience with DNA-damage/repair pathways, mutational analysis, and/or dose response modeling is preferred.
For more information:
http://www.thehamner.org/careers/current-openings/index.html |
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III.4 VARIA
III.4.1. Euro MP calls for action to find & fund alternatives to animal testing
Local Labour Euro MP, Arlene McCarthy is calling for European action to find more alternatives to experiments on animals. Animal Welfare Campaigner Arlene said: “But increased funding, better
coordination and acceleration of administrative procedures could help even more, and I want the Commission to look at ways we can go further, faster.” Arlene has added her name to a Written
Declaration in the European Parliament. This calls for increased funding for the replacement of research using animals, and asks the European Commission to look into various options for increasing
the funds available for this work. Arlene added “One option to fund this would be the introduction of a “research levy” of 1% of the selling price of products that contain ingredients
tested on animals. This would mean that a product normally costing £5.00 would be just 5p more. “I’m aware that, at present, many researchers argue that some animal experiments
are necessary to ensure the safety of products; that there just aren’t sufficient alternatives available. We have to address this point.” “We’ve taken important steps in
Europe towards limiting tests on animals. The European Commission provides funding and services to promote the development and validation of alternatives to animal methods, not least through ECVAM
(the European Centre for the Validation of Alternative Methods).”
For more information:
» http://www.arlenemccarthy.labour.co.uk
III.4.2. CAAT 3Rs Centers website
Across the globe, organizations are working to reduce, refine, and replace animal experiments. You can search for these organization by the map, by name, keywords, or by associated
tags. This database is provided and maintained by The Johns Hopkins University Center for Alternatives to Animal Testing (CAAT).
For more information:
» http://caat.jhsph.edu/international_alternatives/
III.4.3. Nanotech safety bill introduced to US Senate
Nanotechnology safety legislation designed to address potential health and safety risks posed by the technology has been introduced to the US Senate.
For more information:
» http://www.in-pharmatechnologist.com/Industry-Drivers/
Nanotech-safety-bill-introduced-to-US-Senate
III.4.4. First university in the Ural region signs formal agreement on stopping animal experiments
On February 4, 2010 a formal agreement between Perm State Pharmaceutical Academy and the International Network for Humane Education (InterNICHE) was signed. Perm State Pharmaceutical
Academy now becomes the tenth Russian higher education institution to sign a contract with InterNICHE concerning the introduction of alternatives to animal labs. According to the contract terms,
InterNICHE grants the academy computer programs for use in the classroom as an alternative to dissection and animal experimentation, while the Academy guarantees to stop all animal labs for students
and commits to alternatives.
For more information:
» http://www.vita.org.ru
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