The next plenary meeting of IVTIP will be held on:
November 11-12, Cambridge, UK
The meeting will be hosted by Huntingdon Life Sciences.
There is still a strong likelihood that the meeting will be preceded by an ESTIV / ECOPA / IVTIP meeting on alternatives for REACH, so please reserve the date of November 10 as well.
With great pleasure we can announce that IVTIP member SkinEthic Laboratories is preparing an Initial Public Offering at the Bourse in Paris. An introductory meeting will be held on June 28 in Paris. We wish Bart de Wever and his colleague a lot of success with the IPO and congratulate them with this milestone.
Trade organisations systematically inflate cost estimates to fight the proposed overhaul of the EU's chemical policy (REACH), says 'Cry Wolf', a study by the Chemical Secretariat and sponsored by WWF. In each of the five case studies presented in the report, final results have fallen far short of the catastrophic outcomes predicted by industry, the charity says. "It is time to remind politicians that industry has a long track record of crying wolf over environmental law,"said Tony Long, Director of WWF European Policy Office. He appeals to politicians and especially MEPs not to fall for industry offensives and its battle cry of 'competitiveness' in the current debate on REACH.
However, not all industry organisations criticise REACH. A report by Nordic consumers, environmental and business organisations points to the great leap forward on innovation that REACH offers to industry.
Asked for comment on the WWF report, the European chemical industry association, CEFIC, pointed to the sheer diversity of studies published on REACH to this day. All point to very different results according to the organisations from which they originate. An expert at CEFIC told us the study most commonly used by the chemicals industry was the one carried out by independent consultants MERCER for the French Union des Industries Chimiques (UIC). None have so far originated from CEFIC, he said, so they cannot fully endorse it.
A definitive impact assessment of REACH is to be launched this year after UNICE, CEFIC and the Commission reached an agreement two weeks ago. The study will associate diverse stakeholders, including NGOs, and is expected to come up with undisputed estimates in terms of costs and benefits. The report could be out as early as autumn 2004.
Official documents:
Commission/DG Enterprise: "Assessment of the Business Impact of the new regulations in the Chemicals Sector"
Source: Euractiv News, April 29, 2004
A group of leading scientists and doctors, including Luc Montagnier, Hubert Reeves, and Nobel Prize winners Jean Dausset and FranÁois Jacob, have warned about chemical pollution being "the main cause of current human scourges such as cancers, infertility and congenital diseasesî.
At a Paris conference hosted by the UN on 7 May, they pointed to "rising incidence of cancers, particularly non-smoking cancers, among the populations of highly industrialised nations"since 1950. "Industrial chemicals has been incriminated as a major cause of increasing cancer rates and other chronic diseases,"they pointed out, adding that "in Europe, 15 per cent of couples are now infertile"partly because of chemical pollution. Moreover, they added, child cancers are also on the rise (+0.8 per cent per year in Europe).
The group launched the 'Paris Appeal ', which calls upon all decision-makers to take measures. These include "banning all products that are certainly or likely to be carcinogenic, mutagenic or reprotoxic (CMRs) for human beings"and "applying the precautionary principle to all chemicalsî.
In this respect, the group referred to the EU's REACH initiative as "unprecedented, and overdue legislative proposals for the regulation of industrial chemicals"that "should be strengthened, rather than weakened following strong opposition by EU and US chemical industriesî.
Source: Euractiv, May 7, 2004-06-24
Document: Association pour la Recherche Thérapeutique Anti-Canc´reuse (ARTAC): The Paris Appeal
Source: Euractiv News, May 13, 2004
Since its presentation by the Commission in October 2003, the REACH proposal has started a difficult institutional decision-making process. The Commission had originally hoped to get its controversial proposals through first reading in Parliament before the end of its five-year term, but this failed because of internal wrangling between the EP's environment and industry committees over who should be the lead committee.
In the meantime, intensive lobbying from the chemicals industry had transformed the REACH draft legislation into the litmus test for the Lisbon Agenda (the EU's ambition to become by 2010 "the most competitive knowledge economy in the worldî). The letter written by Blair, Schrˆder and Chirac to President Prodi in September 2003 testified to the political leaders' concerns that the Commission's proposals might endanger the industrial competitiveness of the European chemicals industry.
In March, the Commission decided to undertake a further impact assessment to clarify the impact of REACH. It set up an Impact Assessment Working Group, representing various stakeholders (industry and NGOs) to study the effect of the REACH proposals on the business supply chain (with special attention on SMEs), on innovation, and on the new Member States. The final report of this Assessment Working Group is expected at the end of the year.
Outstanding issues:
Next Steps:
The Environment Ministers will have a debate on REACH in their next Council on 28 June.
Source: Euractiv News , May 21, 2004
In the month of May, the UK Government today announced that it is establishing a national centre for research into the 3Rs and animal welfare. The centre, which will be known as the National Centre for the Replacement, Refinement and Reduction of Animals in Research, will report to the Office of Science and Technology. Funding for the 3Rs will double from
£330,000 to £660,000 this financial year, with further increases expected thereafter.
The Government believes that current developments in science are providing significantly more opportunities to do work on the 3Rs - replacement of animal use, refinement of the procedures involved to minimize suffering and reduction of the number of animals used. The increased funding will ensure that we can take advantage of these opportunities.
The new National Centre for the Replacement, Refinement and Reduction of Animals in Research will:
* develop a UK strategy for the implementation of the 3Rs;
* fund high quality research that advances the 3Rs;
* provide advice on the 3Rs and animal welfare to the scientific community;
and
* work with regulators on the acceptance of alternative methods for regulatory toxicology.
The Centre for Best Practice for Animals in Research (CBPAR) established by the Medical Research Council will form the core of the new centre. The new centre's announcement implements the recommendation of a House of Lords Select Committee investigation into animals in scientific procedures, that a Centre for the 3Rs should be established.
Sources: The House of Lords report: http://www.publications.parliament.uk/pa/ld/ldanimal.htm
The report of the Inter-Departmental
Group on the 3Rs is at:
http://www.homeoffice.gov.uk/docs2/interdept3rs.html
Ther European College of Laboratory Animal Medicine and the European Society of Laboratory Animal Veterinarians have launched a new foundation (non profit organization and charity) for refinement. The foundation aims to support studies on the discovery, validation and implementaton of refinements in care and use of animals in research and testing. During 2004 and 2005 it intends to offer a number of grants of 20,000 euro each. The foundation has received significant donations from Pfizer, CharlesRiver, GSK and Aventis. More info at: www.eclameslavfoundation.org
Source: EBRA Bulletin spring 2004
With new EU regulations coming into force on both the testing of chemicals and cosmetics, the demand for alternatives to animal experiments has escalated. The European Commission is committed to a reduction in animal testing, as evidenced by its investment in this area. But still more could be done, say both EU Research Commissioner Philippe Busquin and a number of scientists.
In light of the two new regulations affecting animal testing - one of which will require additional tests on chemicals, the other of which requires cosmetics manufacturers to reduce and eventually stop testing ingredients on animals - a briefing was held in Brussels on 23 June. Present were the EU Research Commissioner, scientists and Prince Laurent of Belgium, who is President of an animal welfare foundation.
"The process of making available alternatives has reached a new dimension," said Thomas Hartung from the European Centre for the Validation of Alternative Methods (ECVAM), which is part of the Commission's Joint Research Centre (JRC). "It is my view that the time for this idea has come, and the Commission is supporting it on a new scale," he added.
These comments can be verified with hard facts in terms of EU spending. The Commission has already awarded 20 million euro to research in this area under the Sixth Framework Programme (FP6) in response to proposals received following the first call alone. More projects are expected to receive funding following the closure of the second call, which is now open.
ECVAM has also seen an increase in its budget - from 25 million euro under FP5, to 35 million euro under FP6. The centre is, however, struggling to keep up with demand. In the 11 years since ECVAM was founded, 16 methods have been validated, and two more are currently undergoing peer review, which Dr Hartung sees as a huge success. But, he added, 'At the moment we have more methods that we could validate than we are able to. For the first time in history we have become the bottleneck.'
All speakers agreed that the next step must be to speed up the validation process. This normally takes around three years, although the new pyrogen test took seven years to validate in all OECD (Organisation for Economic Cooperation and Development) countries.
The validation process should be accelerated "for the security of consumers first of all, then for the wellbeing of animals and the protection of the environment, but also in order to ensure the future of research and to maintain the leadership position that the European Union occupies in this area," said Mr Busquin.
Several scientists made the point that alternative testing methods not only avert animal suffering, but are cheaper and more efficient. "In-vitro tests have all the potential to be robotised. This could never happen with animal testing," said Dr Hartung.
What more can the EU do to encourage the development, validation and employment of alternative testing methods? Joan-Albert Vericat, director of preclinical development at NeuroPharma in Spain, and a member of the 'In-vitro testing industrial platform', believes that technology transfer is letting down European efforts to accelerate the introduction of alternative testing methods. Mr Vericat suggested that the 'problem regarding technology transfer' means that the results of EU projects are not getting the attention they warrant.
Mr Vericat also called for a wide scale evaluation of EU funded projects, and the targeted dissemination of these evaluation results to small and medium sized enterprises (SMEs).
Referring indirectly to the current EU moratorium on funding embryonic stem cell research at EU level, Mr Busquin also claimed that research using embryonic stem cells would accelerate the development of alternative methods: 'Researchers financed by the European Union are resorting to molecular and cellular biology, and to increasingly effective biotechnology methods, which give, for example, the means to carry out a scientific evaluation of toxicity [...]. The use of human cell cultures, including embryonic stem cells, contributes significantly to advances in alternative methods.'
Concluding the event, Prince Laurent appealed to those present to 'spread the word' about alternative testing methods so as to put regulators hand-in-hand with those developing these new tests.
Source: CORDIS News, June 24, 2004
' EU Research Commissioner Philippe Busquin expressed his frustration at the lack of EU funding available for research projects on 26 April, and hinted that a way may be found to support projects which do not make it onto the Framework Programme shortlist in the future.
The Sixth Framework Programme (FP6) has been very successful, said Mr Busquin. Perhaps too successful, as the success rate does not reflect the many excellent project proposals that the Commission has received.
'Sometimes I feel like giving up because we have not been able to fund so many excellent projects,' said the Commissioner. 'I think in FP7 we must put our thinking caps on and work out how to fund other projects, even if 100 per cent funding is not a possibility,' he added.
The Commissioner is, however, hoping that funding will not be so restricted under FP7. The Commission's financial perspectives for 2007 to 2013 propose that the percentage of the EU's budget channelled into research increased from seven per cent to 16 per cent.
Source: Cordis RTD News, April 29, 2004
Research Commissioner Philippe Busquin has criticized the current focus of the EU budget on agriculture at the expense of what he considers to be more important policy areas. "If EU Member States are serious about making Europe the most competitive economy by 2010, they have to readjust their budgetary priorities. Not agriculture but research, innovation and education are needed to achieve the Lisbon goal,"Busquin said at a Commission conference on 'Communicating European Research', held in Brussels on 11-12 April 2004.
Busquin therefore called on governments to put their money where their mouth is and to increase R&D spending to three per cent of GDP. "European research needs a qualitative and quantitative boost, as it generates more than half the economic growth. Studies show that reaching the three per cent target would trigger a period of growth and create more than ten million jobs between 2010 and 2030."
The commissioner also reiterated his intention to double the Commission's research budget, mainly for the next Research Framework Programme (FP7), due to start in 2006. However, he stated that not only a financial boost was needed, but that the investment had to go to the right structure and priority areas that were correctly evaluated and organised.
Source: Euractiv News, May 13, 2004
The 4th call for proposals for the FP6 priority area Life Sciences, genomics and biotechnology for health has been published on June 15. The closing date will be November 16, 2004, and the reference in the Official Journal is OJ C128 of 15.06.2004. The available budget amounts to 540 million¨. One of the topics mentioned is area1.2.3 - Development of new in vitro tests to replace animal experimentation.
The call and text of the Work Programme,
as well as supportingg documentation, are available at:
http://fp6.cordis.lu/lifescihealth/call_details.cfm?CALL_ID=148#
This area will focus on the development of alternatives that will replace the need for animal experiments, reduce the number of animals required, or reduce significantly experimental animal suffering, according to the definition of "The Three Rs"of Russell and Burch (The Principles of Humane Experimental Technique, (1959) London, Methuen).
The topics considered will have to contribute directly to the aims of Directive 86/609/EEC regarding the protection of animals used for experimental and other scientific purposes, and to be in line with the protocol annexed to the Treaty of Amsterdam on the welfare requirements regarding the formulation and implementation of Community policies including research. Priority will be given to the development of those alternative methods that will reach the level of maturity for formal validation according to international standards for subsequent international regulatory acceptance and finally for world-wide application in industry, regulatory establishments and elsewhere.
In vitro methods will play a major role under the new chemicals system of the Community on the registration, evaluation and authorisation of chemicals. In vitro methods should accelerate testing and render it more efficient. The challenge is therefore to develop robust and effective in vitro methods that will withstand the requirements of international validation.
Specific suggestions for projects are given below.
LSH-2004-1.2.3-1: Cell systems as a means to enhance toxicity testing - INTEGRATED PROJECT. Cell-based model systems will be developed for testing the toxicity of biologicals, pharmaceuticals, chemical compounds, directly related to human health. Research is expected to make use of the opportunities offered by functional genomics and cell biology to deliver faster tools with proven potential for multiple applications in relevant industrial sectors and to make a substantial contribution to the "Three Rs"(replacement, reduction and refinement of animal experiments, cfr. introduction). The involvement of SMEs is expected in all aspects of the research programme. The development stages could include the use of array technology, organotypic models derived from cultured human cells, the demonstration and validation ones will make use of the already existing (toxicological) data, thus avoiding unnecessary experiments.
LSH-2004-1.2.3-2: Optimization and pre-validation of in-vitro models for the study of drug absorption, modification and detoxification in the liver and in the intestinal epithelium (especially orientated towards involvement of SMEs) &endash; STREP. Research in this STREP will contribute to the various phases of a fully integrated drug development programme. In vitro screening techniques represent a significant market opportunity, and growth is predicted in this market segment. Studying the absorption by the intestine, the distribution to the organism, and the metabolism by the liver will provide supportive information to augment the interpretation of toxicology findings, reinforcing drug efficacy.
LSH-2004-1.2.3-3: Socio-economic impact on the "Three Rs" of the portfolio of the 5 research contracts in the "Cell Factory"5th Framework Programme, area 3.1.4 &endash; SSA. Further information on the projects concerned can be found on CORDIS (http://www.cordis.lu/life/src/projects.htm)
LSH-2004-1.2.3-4: Workshop: how to integrate and make optimal use of animal data, non-animal data and predictions from computer-based modelling in assessing the risk of chemical compounds. &endash; SSA.
LSH-2004-1.2.3-5: Mini-pigs as models for toxicity testing of new drugs and chemicals: impact assessment &endash; SSA.
Directive 2004/23/EC on 'setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells' was published on March 31, 2004. This directive, however, falls short of addressing issues concerning the marketing of human tissue engineered products.
The new legislation on human tissue engineered products (TEPs) will need to take into consideration a number of issues.
The proposal is expected to come out in mid-2004.
Source: Euractive, 30/04/2004
The US may be losing its longstanding scientific and technological hegemony as the rest of the world is catching up in the pursuit of excellence, warns the US National Science Foundation in its 'Science and Engineering Indicators 2004'. In particular, the report points to a decline in foreign researchers immigrating to the US, a decrease in the share of patents granted to US scientists and in the number of US articles in key science journals.
The US research base has been highly reliant on the influx of foreign researchers, but as other regions, such as the EU and Asia, are wizening up to the dangers of 'brain drain' and its impact on innovation and growth, increased efforts are being undertaken to retain talent. "For many years we have benefited from minimal competition in the global science and engineering labor market,"said Warren M. Washington, chairman of the panel, the US National Science Board. "But attractive and competitive alternatives are now expanding around the world."Moreover, restrictive immigration policies since September 11 have resulted in a massive drop in visa applications by students and scientists.
Although the overall number of patents is rising in the US, only 52 per cent of them are now issued to US scientists. The EU's share of foreign-owned US patents has now reached 35 per cent and the share of Asian economies rose steeply from less than 2 to 12 per cent since 1990. A similar development can be noticed in the area of science and technology output, which is measured by the number of publications in leading science journals. Traditionally the strongest publisher of articles, the US output has dramatically declined compared to the EU and Asia, and it now only represents 29 per cent of total publications.
R&D funding is still going strong in the US thanks to growing private investment. Federal R&D funding is, however, increasingly focusing on security and defense spending, thereby neglecting other research areas. The American Association for the Advancement of Science (AAAS) has pointed out that the budgets of 21 out of 24 government agencies funding research are likely to be cut in 2005.
Source: Euractiv, 05/05/2004 12:30
Time-saving overview: Investment in Research
Press Articles: Der Spiegel , New York Times
Until now, DNA chips have had to be designed for use in a particular environmental system of interest (i.e., yeast or human cells). Recently, Roth et al. have developed an oligonucleotide microarray platform that allows the analysis of any biological system without the restriction of probes specific to an organism. The authors have used a clever combination of DNA processing enzymes and a microarray containing all possible hexamer combinations of the four DNA nucleotides.
Source: Nature Biotechnology, vol 22, April 2004, pp 418-426
Quake and colleagues have designed microfluidic chips that integrate several steps in nucleic acid analysis, from the metering of cells and reagents to cell lysis and nucleic acid recovery. After the nucleic acid is captures in the chip, it is amplified by PCR in a conventional format and run out on gels. The chips show high sensitivity: 2-10 cells are sufficient to detect an mRNA of moderate abundance. The authors also demonstrated parallel analysis of multiple (three) bacterial samples.
Source: Nature Biotechnology, vol 22, April 2004, pp 435
In the states of New Jersey and at Harvard University, new centers for stem cell research will soon be opened. To circumvent president's Bush's embryonic stem cell policy, both New Jersey and California have legalized their ES cell research. In California, a coalition of scientists and patient advocacy groups are trying to collect enough signatures to get a 3 billion $ stem cell funding bond on the November 2004 ballot.
Source: Nature Biotechnology, vol 22, April 2004, pp 371
The regional government of Andalusia in Spain licensed ES cell lines from the UK Stem Cell Bank and is planning to licence more ES cell lines from the Karolinska Institute. The cell lines will be held at the newly created ES cell bank in Granada and made available to scientists in three laboratories in Granada and Malaga. However, the Spanish government called on the Spanish Constitutional Court to rule whether Anadalusia has the legal authority to fund research projects using ES cells. A national law amended in 2003 prohibits this. The verdict is expected in June.
Source: Nature Biotechnology, vol 22, April 2004, pp 373
Devising a 3D scaffold that can attract stem cells and direct their differentiation is an important goal in tissue engineering. An important step forward has been made by Stupp et al, who describe a self-assembling nanofiber network that direct neural progenitor cells (NPCs) to form neurites (in neurospheres) in vitro. Compared with other scaffolds, these nanofibers form neurites that are larger and have larger processes. The authors also injected the used peptide amphiphile solution into tissue and showed that the nanofibers form in vivo as well.
Source: Science 303, 1352-1355, 2004-05-11
Neural progenitor cells, which can differentiate only to specific neural cell types, such as motorneurons or dopaminerg neurons, have a very limited in vitro lifespan, limiting their potential usefulness. However, recently Goldman et al have produced immortalized neural progenitor cells by overexpression of the gene for human telomerase reverse transcriptase in cells isolated from human foetal spinal cord. Neuronal function in vitro was seen by electrophysiological measurements of calcium and sodium fluxes. When these cells were cultures for over two years or engrafted in the injured spinal cord of adult rats for six months, no signs of tumour formation were found.
Source: Nature Biotechnology vol 22 no 3 March 2004, pp 297-305
One of the major goals of proteomics is to determine all the possible interactions among proteins within a proteome (giving and 'interactome'). The interactome involves pull-down experiments in which one protein at the time acts as bait. Recently, Lappe & Holm propose an alternative 'pay as you go' strategy designed to optimize the number of baits analyzed, based on the principle that in protein interaction networks the nodes with the most interactions provide the highest amount of information. The approach translates in substantial cost and time savings.
Source: Nature Biotechnology, vol 22, January 2004, pp 98-103
It is widely accepted that cloned animal run the risk of a shorter lifespan compared to normally bred animals. This has formerly been attributed to premature ageing or senescence and to accumulation of abnormalities in gene expression in their tissues. Recently, however, it has been argued by Fulka et al. that these problems arise because the process of nuclear transfer used to create cloned animals skips one of the two essential, independent steps involved in the reprogramming of cell nuclei. It is thought that the first reprogramming event results in the initial de-differentiation of the transferred nucleus, making it competent to direct the development of the embryo. The second reprogramming event has at least three roles: 1) to erase epigenetic errors; 2) to erase and re-establish genomic imprinting, and 3) to adjust definitively telomere length. This involves reprogramming of imprinted and non-imprinted genes. The authors presume that cloned animals die earlier because they accumulate abnormalities in expression of different genes.
Source: Nature Biotechnology, vol 22, Jan 2004, pp 25
Giot et al recently reported the largest protein interaction map to date and the first genome wide study for a multicellular organism: the protein interaction map of the fly, Drosophila melanogaster. Building the interaction map required a tour de force of PCR to amplify all 14,000 predicted melanogaster open reading frames. The fly network has generated many novel hypotheses for biologists working on individual proteins, pathways or processes. The interactome is also important since 44% of all fly genes have homologs in the human genome.
Source: Science 302, 2003, pp 1727-1736
The 3R Research Foundation Switzerland published its 26th 3R-Info-Bulletin of May 2004. This issue is devoted to the generation and use of a mouse Kuppfer cell line by Dr. Regine Landmann of the University Hospital Basel. This is the first report of the successful generation of a stable, clonal Kuppfer cell line representing a subpopulation within the Kuppfer cells of rodent livers. The clone allows molecular studies of the anti-infective and immune functions of Kuppfer cells. The applications for the use of Kuppfer cell line in disease models are multiple:
(1) in sepsis and alcoholic hepatitis, signalling in Kuppfer cells after stimulation with bacteria or bacterial products can be analyzed; (2) in liver regeneration: identifying factors that modulate gene and protein expression in Kuppfer cells and in studying interactions with other liver or blood cells in co-cultures; (3) in liver transplantation: study of the in vitro consequences of antigen presentation.
Source: 3R Info Bulletin no 26, May 2004;
regine.landmann@unibas.ch
Company Intervet has created a new Award, theÝ"Intervet Dieter Lutticken Awardî, to reduce the number of animals used in testing for development and production of animal veterinary medicines.
The new Award shall encourage scientist or life science research institutions to work in research areas that serve the 3R's concept, i.e. Reducing, Refining or Replacing the use of animals in testing for development and production of veterinary medicines.
The award, worth 20,000 euro, will be given annually to scientists or institutions that have delivered excellent contributions to the 3R's concept for the development and production of veterinary medicinal products, documented by a publication in the last two years.
This years's deadline: September 30, 2004. The award will be first granted in 2005.
For more information contact:
sabine.schueller@intervet.com
In January, the US FDA implemented regulations to promote safety for companies that handle reproductive tissue and human cellular products, including stem cells derived from various blood sources such as umbilical cord blood. Now, all tissue banks will have to register with the agency and list each of their cell or tissue products. The decision is welcomed because cell and tissue products are becoming more common sources of therapeutics.
Source: Nature Biotechnology vol 22, nr 3, p 262
In its April issue, Nature published an editorial containing a warning for over eagerness regarding setting up clinical trials with stem cells. In particular there are problems with respecvt to reproducibility. The editorial argues that many animal experiments are still needed before it is medically ans ethically justified to initiate clinical trials with humans.
These comments accompany two reports included in Nature of April 8. The reports describe the outcome of experiments aimed at consolidating earlier results. Proof for correctness was not found. Combined with experiences from other experiments, this should lead to a pause in the initiation of human clinical trials. However, there is tremndous pressure from very ill patients, and pressure from industrial and investment companies which want to see a return on their investment. Since it concerns the use of own tissues and cells, there are few regulatory hurdles to take, despite unknown risks regarding complications. The editorial board of Nature therefore argues that more experimental evidence should be presented before permission is to be granted for a clinical trial.
Source: No consensus on stem cells, Nature 428, 587 (08 April 2004); doi:10.1038/428587a
http://www.nature.com/cgi-taf/DynaPage.taf?file=/nature/journal/v428/n6983/full/428587a_fs.html
ScanBalt BioRegion, based in Copenhagen, is a network of networks encompassing regional biotech clusters across Scandinavia, Northern Germany and the Baltic states. ScanBalt is attempting to develop a coordinated approach to the creation and management of intellectual property arising from life sciences. Collectively, the ScanBalt region has a population of 85 million people, 63 universities and 870 biotechnology related companies. One action is the establishment in the Baltic region of a not for profit IP Knowledge Centre, with the aim to put in place the kind of infrastructure that would allow investors and companies to more easily conduct due diligence.
Source: Nature Bio-entrepreneur web portal,
http://www.nature.com/bioent,
Jan 15, 2004
On 20th April, the European Coalition to End Animal Experiments (ECEAE) staged a demonstration on the Cefic premises. They were protesting about the use of "cruel"and "scientifically outdated"animal tests by chemical companies in the context of World Lab Animal Week.
CEFIC communicators emphasized that the chemical industry shares public concern about animal testing and strongly supports efforts to develop alternatives. The meeting was calm and non-hostile, with the participants agreeing to meet again to discuss the issue in greater depth.
Cefic encourages the development of scientifically valid, predictive and rational alternatives that reduce, refine and replace the need for animals in chemicals testing. Through its LRI research programme, Cefic is currently supporting research in animal-free assessment methodology (e.g. (Q)SAR***). Its members are actively engaged in developing alternative methods of testing.
ECEAE recently sent a letter to CEOs of major chemical companies enquiring about their company's policy or attitude towards animal testing in the context of REACH. They consider animal experiments cruel and unreliable, and want to see them replaced by humane non-animal tests.
Earlier this month, politicians and scientists in the UK were angered when the Government told Parliament REACH would involve animal testing of chemicals that had been in general use for decades. Many consider such testing unnecessary.
Source: CEFIC News, issue 22, May 2004
One year ago Nature Biotechnology launched
the world's first internet portal providing freely accessible,
regularly updated practical advice and information on starting
up a biotechnology venture. Please consult:
www.nature.com/bioent/
Systems biology is still attracting attention. Accordingly, there are many course and training programmes in systems biology on offer. Here we list the ones available in Europe:
Flanders and Ghent University, Belgium:
http://www.psb.ugent.be
Max Planck Institute of Molecular Genetics,
Berlin, Germany:
http://lectures.molgen.mpg.de
Max Planck Institute of Dynamics of
Complex Systems, Magdeburg, Germany:
www.mpi-magdeburg.mpg.de
University of Rostock, Germany, Systems
Biology and Bioinformatics:
www.sbi.uni-rostock.de
University of Stuttgart, Systems Biology
Group, Germany:
www.sysbio.de
German Systems Biology Research program:
www.systembiologie.de
Manchester Interdisciplinary Biocenter:
www.mib.umist.ac.uk
University of Texas program in System
Biology etc:
www.utsouthwestern.edu/utsw/home/education/integrativebiology
Now available on-line is the completely updated version of the website on Endocrine Disrupters, by the Dept. of Food Safety and Veterinary Public Health of the Istituto Superiore di Sanit¦. The website includes a full English version.
News from ECVAMAÝcopy of the last issue of the ECVAM Newsletter ofÝMarch 2004 can be downloaded from the ECVAMÝwebsite.
ECVAM is setting up a new activity on electronic learning (e-learning) within its information services. The scope is to provide multimedia learning tools on selected alternative methods which will be made available via the ECVAM website and/or on CD-ROM.
The duties of the person taking care about this task will include, among others, the identification, collection and preparation of the content material (concertation) in close cooperation with the IT company. It will involve regular contacts with the respective scientists and eventually the organisation of workshops on the matter.
Application: Potential candidates will be selected at the end of May/beginning of June from the Commission's ELSA database (External onLine Submission Application) in which the registered people indicate their profile and expertise by selecting the appropriate keywords.
ELSA Internet address: http://ecvam.jrc.it/mailbot/Redirect.cfm?MessageID=215&ListID=53&Link=elsa.cordis.lu/
Deadline: The first call for applications ends July 15, 2004.
In May the OECD announced that it had endorsed four ECVAM-validated toxicity test methods that avoid the use of animals. The tests are expected to reduce the number of animals used in toxicity testing by 6%in Europe and further afield. The alternatives have been included in international guidelines and cover tests for human skin corrosion and phototoxicity and dermal absorption of chemicals
ECVAM wish to inform that the Institute for Health and Consumer Protection (IHCP) has published in the Supplement to the Official Journal of the European Union the prior information notice about planned projects of its Units (which include ECVAM) to be carried out during this year and, therefore, open call for tenders can be expected.
More information:
a. Reference document nrs.: 2004/S 67-056645 (supplies - IHCP units), 2004/S 67-056646Ý (services - IHCP units), 2004/S 70-058876 (services)
b. OJ Supplement ns: 67 and 70
c. Internet address:
http://ecvam.jrc.it/mailbot/Redirect.cfm?MessageID=210&ListID=53&Link=ted.publications.eu.int/static/home/en/homepage.ini?SID=&time=Fri%20Apr%2023%2010%3A14%3A30%20UTC+0200%202004
Help: put the respective OJ Supplement number in the search field on the top and use "ECVAM"or "Ispra"as the keywords in the full text search option.
The US-NICEATM in collaboration with the US-ICCVAM, is seeking nominations of scientific experts to evaluate the validation status of in vitro test methods for determining the potential ocular irritancy of chemicals and other substances.
More information at :
ICCVAM/NICEATM website: http://ecvam.jrc.it/mailbot/Redirect.cfm?MessageID=212&ListID=53&Link=iccvam.niehs.nih.gov/methods/eyeirrit.htm
US Federal Notice: http://ecvam.jrc.it/mailbot/Redirect.cfm?MessageID=212&ListID=53&Link=iccvam.niehs.nih.gov/docs/FR/6921565.pdf
The availability of the document "Recommended Performance Standards for In Vitro Test Methods for Skin Corrosion" [NIH Publication No. 04-4510] was announced in the Federal Register on Friday, May 28, 2004.Ý A copy of the FR notice can be found at: http://iccvam.niehs.nih.gov/docs/FR/6930693.pdf in PDF or http://iccvam.niehs.nih.gov/docs/FR/6930693.htm in HTML. This notice can also be accessed from the ICCVAM home page at http://iccvam.niehs.nih.gov through the links in the "Announcements"box.
The publication can be found on the ICCVAM web site at the following URLs:
http://iccvam.niehs.nih.gov/methods/ps/ps044510.pdf (complete 5.6 MB PDF file) or in sections at http://iccvam.niehs.nih.gov/methods/ps/ps044510.htm.
For more information on dermal corrosion and irritancy, please visit the
dermal corrosivity page at http://iccvam.niehs.nih.gov/methods/epiderm.htm.
The minutes of the 4th ECOPA Workshop, held in October 2003, are available on the ecopa website at: www.ecopa.tsx.org
We received the following list with the titles of 11 new publications on the use of SkinEthic human tissue models from Bart de Wever at SkinEthic Laboratories:
Validation of the human epidermis model SkinEthic for skin corrosion testing according to the new OECD test guideline 431. M. Liebsch, H. Kandarova, H. Spielmann, R. Guest, A. Whittingham, N. Warren, M. Remmele & B. De Wever. Presented at the Society of Toxicology, Baltimore, USA. March 2004.
The importance of Multiple Endpoint Analysis (MEA) using reconstructed human tissue models for irritation and compatibility testing. B. De Wever, M. Cappadoro, M. Rosdy. Presented at the Society of Toxicology, Baltimore, USA. March 2004.
The use of a human reconstituted epidermal model for the occupational hazard assessment of pharmaceutical process materials. C. Seaman, B. De Wever, M. Cappadoro, A. Whittingham, R. Guest & C. Prusiewicz. Presented at the Society of Toxicology, Baltimore, USA. March 2004.
The use of a human reconstituted corneal epithelial model for the occupational hazard assessment of pharmaceutical process materials. C. Seaman, B. De Wever, M. Cappadoro, A. Whittingham, R. Guest & C. Prusiewicz. Presented at the Society of Toxicology, Baltimore, USA. March 2004.
Multi-center prevalidation using an in vitro reconstituted human corneal epithelial model to assess the eye irritation potential of chemicals. B. De Wever, M. Cappadoro, F. Straube, N. Alépee, F. Van Goethem, P. VanParys & E. Adriaens. Presented at the Society of Toxicology, Baltimore, USA. March 2004.
The expression and activation of Protease-Activated Receptor-2 correlate with skin color. L. Babiar-Magee, N. Chen, M. Seiberg and C.B. Lin. Pigmented Cell Research, 17, 3, 207-316, 2004.
In vitro skin irritation: facts & future: state of the art review of mechanisms and models. T. Wells, D.A. Basketter, K.R. Schrˆder, Toxicology In Vitro 18, 231-243, 2004.
An optimized in vitro approach to assess skin irritation and phototoxicity of topical vehicles. B. De Wever, M. Rosdy and A.M. Goldberg. In Dermatotoxicology 6th Edition, Chapter 43, p 849-869, Ed. Taylor and Francis, 2004.
Expression analysis of Candida albicans lipase gene family during experimental infections and in patient samples. F. Stehr, A. Felk, M. Kretschmar, B. Mahnss, K. Neuber, B. Hube and W. Schafer, FEMS Yeast Research, 4, 4-5, 401-408, 2004.
Reduced expression of the hyphal-independent Candida Albicans proteinase genes SAP1 and SAP3 in the efg1 mutant is associated with attenuated virulence during infection of oral epithelium. HC Korting, B. Hube, S. Oberbauer, E. Januschke, G. Hamm, A. Albrecht, C. Borelli and M. Schaller. J. of Medical Microbiology, 52, 623-632, 2003.
Assessment of the skin photoprotective capacities of an organo-mineral broad-spectrum sunblock on two ex vivo skin models. C. Gelis, S. Girard, A. Mavon, M.Delverdier, N. Paillous, P. Vicendo. Photodermatol. Photoimmunol. Photomed. 19, 242-253, 2003.
Upon request, I can send you an electronic version (pfd) of each of them.
Source: Bart de Wever, SkinEthic Laboratories, June 2, 2004
Information: colipa@colipa.be
Organization: blhata@uta.fi
or www.uta.fi/fst
Information: http://www.mbio.au.dk/~clark/workshop/homepage.htm
Information: www.esof2004.org
Information: www.genomicsmomentum2004.org/
Information: www.estiv.org\\invitox.html
Information: www.healthtech.com/2004/prc/index.asp
Information: Bart De Wever, Business Development Director, SkinEthic
Laboratories
Phone: +33.493.97.77.27; Fax: +33.493.97.77.28;
E-mail: bdewever@skinethic.com
website: www.skinethic.com/
Information: www.zet.or.at/kongress/Linz2004
Information: aparsons@healthtech.com
Information: Mary Ann Brown, Senior Conference Director, Cambridge
Healthtech Institute
Fax: 617-630-1325 • E-mail: mabrown@healthtech.com