The next plenary meeting of IVTIP will be held on:
May 8-9, 2006, Bilbao, Spain
The meeting will be hosted by IVTIP member companies Gaiker and Progenika.
Central themes will be announced later, but the meeting will include a review of the EU project 'ToxDrops' and presentations on 'non-testing alternatives'.
Commission Vice President Gunter Verheugen, who is also Commissioner for enterprise and industry, takes a particular interest in alternatives to animal testing and, together with Research Commissioner Janez Potocnik, is holding a 'Europe goes Alternative' conference at the European Parliament in Brussels on 7 November.
According to the Commission, the objectives of the conference are to demonstrate that the European Union keeps animal welfare high on the political agenda and remains in the lead for animal protection; to demonstrate industry's approach to actively research alternative methods; to demonstrate progress made in the area of alternative methods to animal tests at EU and international level; and to identify further possibilities to improve development and validation of alternative methods.
The conference is aimed at the all three R's rather than just replacement alternatives. One important aspect of the event will be the launch of a Declaration on the Three R's with backing from the Commission and the pharmaceutical, chemical and cosmetic industries.
The draft programme and on-line registration can be found at
http://europa.eu.int/comm/enterprise/events/animal_tests/index_en.htm
On 5 July 2005, the European Commission published an open call for tender to carry out a preliminary impact assessment of the revision of Directive 86/609. The closing date for tenders was 14 September 2005.
According to the Commission, the objective of the impact assessment is: "To provide targeted support to the revision of the Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes by analysing, critically reviewing and assessing policy options, their impacts, testing the conclusions and providing justifiable and quantitative (where possible) indications of the related benefits and costs.
The impact assessment must be completed in nine months, and, according to the Commission, this means that legislation is likely to be drafted by the end of 2006.
The Animal Health and Welfare Committee of the European Food Safety Authority (EFSA) will soon produce their report on a number of issues raised in the preparations for drafting the revision of Directive 86/609 on the protection of laboratory animals. In particular it covers
The report will be published on the EFSA website in November.
Source: EBRA Bulletin, October 2005
The Council has adopted a 'researcher's package' to attract foreign researchers to the EU. It consists of a directive, which sets out a specific procedure for admitting non-EU nationals for the purposes of scientific research and a recommendation, which facilitates the admission of non-EU nationals to carry out scientific research in the EU. A recommendation to make it easier to issue uniform short-stay visas for researchers was adopted in September 2005.
The aim of these measures is to foster the admission and mobility of non-EU researchers in Europe and to enhance Europe's attractiveness for researchers from around the world.
Source; Eur-activ News, October 14
Recently, the Commission issued an update of the integrated research and innovation action plan, which calls for a major upgrade of the conditions for research and innovation in Europe. The plan is particularly focused on improving the conditions for private sector investment in R&D and innovation.
It tables 19 already existing and new initiatives and clearly indicates what is expected from the Commission and what is expected from the member states to make these initiatives a reality. The new actions of the plan include:
"The 'update upgrade' plan shows the actions to be taken in R&D in order to contribute to the Commission's Growth and Jobs Initiative and the aim of these measures is to assure the functioning of the research internal market," said the Commissioner Potoãnik.
The proposed measures are cross-sectoral and provide the same regulatory and political framework conditions for all stakeholders - independent of sector or size of the player. Different stakeholders will then tailor these instruments according to their specific needs.
Related steps of the Commission include:
Source: Euractiv News, October 12, 2005
Following a future study on the consequences, opportunities and challenges of modern biotechnology for Europe, the Commission is set to update the EU's biotech strategy before 2007 and tune it to the Lisbon Agenda.
In January 2002, the Commission adopted a Communication entitled 'Life Sciences and Biotechnology: A Strategy for Europe'. The strategy consists of specific policy orientations and a 30-point action plan to turn the policy into action. Since the adoption of the European biotechnology strategy, the Commission issues yearly reports on its implementation - the first progress report was published in March 2003, the second in April 2004.
The Commission's 3rd progress report on the European strategy for life sciences and biotechnology states that 2004 seems to have been a year of consolidation rather than growth for European biotechnology. The report highlights some progress since the last report but states that the situation regarding European biotechnology and its competitiveness still needs to be improved, mainly because of:
In the report, the Commission announced that a reflection on the role of life science and biotechnology in the Lisbon Agenda was necessary. Accordingly, the Commission's Joint Research Centre (JRC) launched, on 21 October 2005, a study on the social, economic and environmental consequences and challenges of modern biotechnology. The Council and all stakeholders are invited to participate in this reflection process.
The study aims also to increase public awareness and understanding of life sciences and biotechnology.
Source: EurActive News, October 27
A public consultation on whether and how to create a European Institute of Technology (EIT) has been opened by the European Commission today. It will gather the views of stakeholders on how an 'EIT' could strengthen research, education and market innovation in Europe. The public consultation will run until mid-November, and will feed into a wider analysis by the European Commission services.
The idea of establishing a European Institute of Technology (EIT) was mentioned in the Commission's mid-term review of the Lisbon Process in February 2005 and the European Council took note of the Commission's intention in March.
Ján Figel', European Commissioner in charge of Education, Training, Culture & Multilingualism said that "a European Institute of Technology could play an innovative role in supporting knowledge transfer, attracting the best researchers and companies from around the world to work in partnership". Such an EIT should draw on the considerable strengths of existing European institutions.
Once the public consultation is concluded, the Commission will consider whether it wishes to take the matter further, and may then prepare a paper for the Spring European Council in March 2006. If the idea of the establishment of an EIT were to be approved by the European Council, the Commission would make a formal legislative proposal to the Council and the European Parliament.
More information & online consultation available at :
http://europa.eu.int/yourvoice/ipm/forms/dispatch?form=EIT
http://europa.eu.int/comm/education/eit/index_en.html.
Source: Euractiv News September 20, 2005
Europeans want ethics to play an essential role in scientific research and demand harmony between the methods and goals of scientific research and moral and ethical principles, show two recent Eurobarometer surveys: 'Europeans, science and technology' and 'Values, science and technology' , both published in June 2005.
The main objective of the 'Europeans, science and technology' poll was to gather Europeans' general attitudes towards science and technology. The underlying objective of the 'Values, science and technology' poll was to gather Europeans' views on social values and ethics as well as citizens' perceptions of actors involved in science and technology as well as the decision-making procedure. The final objective was to assess the perceived influence of ethics on science and technology in the future.
The studies cover the populations of the EU member states, of the candidate countries (Bulgaria, Romania Croatia and Turkey) and the three EFTA countries (Iceland, Norway and Switzerland) - a total of 570 million people.
The results also show that there is a "latent" interest among Europeans for science and technology and implicit demand for more information. The positive role scientists play in society is widely recognised but the way scientists handle information towards the public is criticised.
In addition, the two surveys point out that:
Source: Euractiv News, June 17, 2005
Commission Vice-President Günter Verheugen has announced a new strategy for the pharmaceutical industry aimed at closing the gap with the US on innovation and research and development. In a speech to the European Federation of Pharmaceutical Industry and Association (EFPIA), on 1 June 2005, Verheugen regretted that in recent years Europe had fallen behind the US in the production of new medicines. His new strategy, he said, was aimed at ensuring that Europe once more becomes "the natural home for pharmaceutical innovation".
The Commission's strategy focuses on three areas:
More readiing:
Source: Euractiv News, June 3, 2005
A new website to facilitate the work of the Pan European Business Co-operation Schemes (PES) has been launched under the auspices of the European Commission and with the participation of the Euro Info Centre Network (EIC) and the European Association of Regional Development Agencies (EURADA). The site is intended to promote business opportunities and relations among around 4,000 SMEs from over twenty economic sectors in EU member States, candidate and neighboring countries, at 32 international trade fair matchmaking events, workshops and coaching activities over the next two years. The Commission has allocated 6 million Euros to the project.
SMEs represent much of Europe's economy and are considered vital in building bridges across Europe and beyond. The PES schemes are aimed at unlocking the potential of SMEs to drive jobs and growth.
Useful websites:
Source: IPR Helpdesk, 16 May 2005
There is a general lack of understanding of how advances in science and technology affect our lives. Against this background, controversial or sensational reporting on food safety, GMOs, bird flu, global warming or, for example, stem cell research can leave citizens confused and frightened and science misunderstood. This is why scientists are increasingly asked to communicate their work to a wider audience and science communicators and the media to act as the responsible bridge between the scientists and society. Some steps taken so far include:
Source: Euractiv News, November 3, 2005
On 23 August, 2005, the family at the heart of one of the longest-running campaigns of intimidation by animal rights activists announced that they were to stop breeding guinea pigs for medical research. Christopher and John Hall said that they had had enough and would discontinue the breeding the animals at Darley Oaks Farm, Staffordshire in the North of England. A prolonged campaign of hate mail, hoaxes, and harassment culminated in the theft of the body of Gladys Hammond, mother-in-law of Christopher Hall from a graveyard in October 2004. To date the body has not been recovered.
Some tactics used by protestors had been peaceful. But others included hate mail, malicious phone calls, fireworks, a paedophile smear campaign, paint stripper on cars and arson attacks. The family had to give up going to their local pub after threats to staff working there. Since January 2003, Staffordshire police have received reports of more than 460 incidents at the farm or related targets. The farm's owners, workers, and any business in the area which has had contact with them have all come under attack from animal rights activists. In addition to the local pub, the fuel supplier and even the farm's domestic cleaner have been targeted by violent extremists.
Commenting on the closure, the UK BioIndustry Association said: "The BIA applauds the Hall family's resilience in the face of a violent campaign of intimidation by animal extremists. The widespread public revulsion at the campaign, which has included the theft of a family member's remains, demonstrates that these deplorable tactics go far beyond the boundaries of legitimate protest. Commitment from the government on tackling animal extremism, together with new legislation, is a move in the right direction. It seems likely that protestors will now use the same tactics at other animal breeding establishments. "
Source: EBRA Bulletin, October 2005
Animal activists' latest target in its campaign of terrorism has centred on a chain of children's nurseries that has links with the chemicals testing company, Huntingdon Life Sciences (HLS).
Day Nurseries, which offered childcare vouchers to HLS employees, is to sever all associations with the company after the directors of the nursery received letters that threatened its staff with physical force.
Leapfrog, which runs 102 nurseries and has become the biggest provider of childcare in the UK, has been the latest in a string of targets that have ties to HLS, which has been the subject of sustained protests over its use of animals, particularly in experiments in drug research.
The activists made their intentions clear on the website Bite Back, which stated that they had sent "warning letters" to firms supplying HLS, giving them seven days to end their relationship or "suffer the consequences."
A spokesman for the nursery firm said: "Directors of Leapfrog Nurseries have received threats from animal liberation activists as a direct consequence of childcare vouchers being supplied to employees at HLS ..." "Our business is childcare and we have to take every precaution when it comes to the security and safety of those children and our employees. Therefore the company has taken the decision to withdraw the scheme with immediate effect at HLS."
Source: Euractiv News, September 29, 2005
Animal rights activists, who engage in acts of violence, could be prosecuted under new anti-terror legislation proposals outlined by the Government that aim to crack down on recent attacks on British Universities with animal research interests.
The Terrorism Bill, outlined by Home Secretary Charles Clarke, will make glorifying or indirectly encouraging terrorism an offence, punishable by up to seven years' imprisonment.
Clarke told the Joint Committee on Human Rights: "It's not targeted specifically at that sort of terrorism but I certainly think that animal rights terrorism is something that has to be attacked."
In July of this year, Oxford University was targeted in an arson campaign, which resulted in an estimated £500,000 (¤719 000) worth of damage to boats and property. The attack was specifically intended to halt construction of a primate research centre.
In addition, June of this year saw a broker to the drug company Phytopharm quit after a bomb exploded beneath the car of one of the firm's executives. A group linked to the Animal Liberation Front claimed responsibility for the attack saying it had placed the device under the car of the company's finance director Michael Kendall last month.
"Those who argue that committing terrorist acts to promote the cause of 'animal rights' and to justify it by reference to a phrase such as 'violence begets violence' is illegitimate and would be covered by this legislation, as I understand it," Clarke commented.
These latest measures serve to reassure the pharmaceutical companies, who have expressed reservations that the violence on the mainland has caused them to seriously consider whether it is still appropriate to carry out this essential research work in the UK.
Source: EBRA Bulletin October 2005
For a full update on REACH, including the votes in the Eeuropean Parliament, look at the secure part of IVTIP's website under 'presentations of the IVTIP meeting in Rotterdam'. For IVTIP members only.
The debate on the REACH proposal has gained momentum with important EP Committees voting on hundreds of amendments.
The EU environment ministers, which met on October 17, debated key issues related to the REACH proposal. Debated was the issue on how to treat chemicals when they are incorporated into products such as plastic bottles (so-called 'substances in articles'). Questions there have been raised when considering chemicals in products imported from outside the EU, which do not need to go through the REACH registration and evaluation system. A distinction here is made between:
One proposal is to narrow the scope of REACH to tackle only those substances that are intended to be released when they are of very high concern to health or the environment. At the same time, it was proposed to broaden the scope of REACH by requiring companies to notify the agency when one of their products contains at least 0.1% of a substance of very high concern, whether or not it is intended to be released.
Earlier in October, the Competitiveness Council met and outlined the elements of a possible compromise on the registration aspects of REACH. There was broad support for requiring less safety data for chemicals produced or imported between one and 10 tonnes a year. The measure is aimed to cater for the concerns of small businesses that fear they could be driven out of business because of the high administrative costs that REACH is expected to entail.
Source: Euractiv News, October 13, 2005
Cefic, the European Chemical Industry Council welcomes the outcome of the votes, on Tuesday, in the Industry Committee (ITRE) and the Internal Market and Consumer Protection Committee (IMCO) of the European Parliament on the Commission(tm)s proposal on REACH A broad majority made up by the three largest groups in the Parliament (EPP, PES, ALDE) gave its support for the compromise packages. Cefic appreciates the efforts of the major political groups to find a way forward in a constructive manner, and considers that these efforts to seek compromises are giving encouraging signals.
The chemical industry acknowledges that the main elements of the compromise packages are going to the right direction. Namely, the risk-based approach is taken into account better than in the Commission(tm)s proposal, and the role of the Central Agency has been strengthened. The outcome also improves the possibilities for SMEs to fulfil the requirements of REACH; this reflects the results of the multi-stakeholder project called SPORT (Strategic Partnership on REACH Testing), which revealed that the REACH process, as proposed by the Commission, is too bureaucratic and burdensome - especially for the SMEs.
The compromises achieved in the two Committees could pave the way for a more workable REACH. However, Cefic believes that the REACH proposal needs to be further improved and refined; most importantly, being the application of a risk-based approach throughout the process, notably in the authorisation and restriction of chemicals.
Source: CEFIC press release September 18, see also www.cefic.org.
The WWF on 6 October released the results of a new survey revealing traces of 73 man-made hazardous chemicals in the blood of grandmothers, mothers and children in 13 European families.
Called 'GenerationsX', this survey is the last in a series aimed at stirring the EU debate on chemicals. It comes as the EU Parliament and Council of Ministers prepare to issue their verdict on REACH in November.
Toxicologists are currently at odds over how to interpret the data collected by these so-called biomonitoring studies. They admit they lack the scientific knowledge to determine the potential health risks posed by trace amounts of chemicals found in people's blood.
The WWF says newer chemicals were found in highest quantity among the younger generation. These include brominated flame retardants, perfluorinated chemicals and artificial musks contained in daily consumer items such as computers, textiles, cosmetics or electrical appliances. In contrast, it says, the grandmothers' generation is the most contaminated with older, banned chemicals, such as DDTs and PCBs.
CEFIC's response: the WWF does not mention that "the traces of chemicals were usually found in extremely low concentrations that do not necessarily constitute a health risk". The study should thus "not be a cause for alarm", CEFIC says, adding that "many toxicologists confirm that the public is unfairly pressured by this incomplete information".
BSEF, the international organisation of the bromine industry producing fire safety chemicals, has condemned the WWF study for its "alarmist rhetoric" which it said is "at odds with the scientific data". "Even the maximum levels detected are extremely low (in parts per billion) and […] below any level of concern as established by EU risk assessments. By way of example, a part per billion is roughly equivalent to one second per 32 years," the BSEF said in a statement.
Source: Euractive News Oct 7, 2005
Analysis of blood taken from 42 mothers and the umbilical cord of 27 newborn babies has revealed the presence of man-made hazardous chemicals in every sample. The umbilical cords and blood were tested for eight chemicals, including musks used in perfumes, brominated anti-flammable agents used in textiles, a pesticide which has already been banned worldwide, and phtalates used to soften plastic objects such as toys. The samples were also tested for perfluorinated compounds which are used to make non-stick frying pans and water-repelling coatings.
The results were published on 8 September by Greenpeace and the WWF as part of a campaign to strengthen the REACH proposal to regulate chemicals in the EU.
The European chemical industry council (CEFIC) says it is aware of the societal concerns caused by chemicals and "takes its responsibility to address it seriously".
Still, it guards against all undue alarm. "The presence of trace amounts of a chemical substance does not necessarily constitute a health risk and should not cause alarm," wrote CEFIC at the conclusion of a conference on environment and health in December last year.
CEFIC points out to independent experts and paediatricians who agree that "whilst trace amounts of chemicals can be detected in the blood, there is no evidence of harm at these levels". According to CEFIC, biomonitoring provides "a one-off measurement of the trace levels typically found, but does not provide any information of whether the levels vary over time or what was the source of exposure".
Dr Gavin ten Tusscher, a paediatrician quoted in the WWF/Greenpeace study and a member of an advisory group on biomonitoring to the European Commission agrees that there should be no immediate cause for alarm. "I would not advise people to worry, but I would recommend that they put pressure on policymakers to change legislation".
Source: Euractiv News, 19 September 2005
On October 4, many of the amendments to REACH (the Registration, Evaluation, and Authorisation of Chemicals) were accepted at the European Parliament Environment Committee vote. Should all of the accepted amendments be accepted in the final legislation, the lives of many millions of animals will be saved, plus human health and the environment protected.
It is good news that measures to ensure mandatory data sharing were supported, and are to be considered a condition for registration. This is particularly important as a large number of the substances to be tested under REACH are manufactured or imported by several companies, and in different tonnages, creating an enormous potential for duplicate animal testing.
And it is good news that the Chemicals Agency, ECVAM, and other stakeholders might be able to evaluate proposals for tests being put forward. This could ensure that modern scientific tests, rather than animals are employed.
It was also accepted that substances produced in amounts of 1 - 10 tons and 10 - 100 tons should not incur animal testing. This could mean that over 20,000 of the approximately 30,000 chemicals will not be tested through animal means.
Source: British Union for the Abolition of Vivisection, October 4
Neither environmental NGOs nor industry lobbyists will ultimately win the battle over REACH as the chemical legislation makes its way through Parliament, predicts Lena Ek MEP in an interview with EurActiv.
Lena Ek MEP (ALDE, Sweden) is the rapporteur on REACH (for opinion only) for the Industry, Research and Energy Committee (ITRE) in the European Parliament. Her report was voted on by her Committee on 13 September. Lena Ek did not expect any major overhaul of the proposal in the final stages of negotiations.
Volume versus risked based approach: Asked if there was a chance that the original Commission approach based on the volumes of chemicals produced or imported could fundamentally be overturned, she said "it seems unlikely". "You can see that in the Council, for a number of months there has been no discussion at all concerning the risk-based approach. No member state put forward this position," said Ek.
The European Chemical Industry Council (CEFIC) has been pushing for chemicals' evaluation and registration starting with those which are of highest concern to health or the environment as "a prerequisite" for an effective REACH that delivers its objectives. "Instead, the discussion has focused on the Commission proposal and the Slovene-Maltese proposal in the Council. The Slovene-Maltese proposal currently discussed in the Council would allow different rules to apply for chemicals produced or imported in small volumes (between 1 and 10 tonnes per year).A risk-based approach would be applied for these small volumes only.
According to Ek, the risk-based approach advocated by some industry lobbies has fundamental flaws: "The risk-based approach had the underlying effect of transferring the burden of proof from the industry to the agency. That is my main criticism […]. I feel that industries should take more responsibility and are capable of doing so".
SMEs: "When you look at the various proposals that have been submitted as amendments, you have to be very careful, as the interests of big industry do not always coincide with the interests of the small industries, SME's or downstream users," she adds.
One substance one registration (OSOR): On the 'One Substance One Registration' (OSOR) proposal to allow consortia to be formed for registration as a way of reducing costs for SMEs, she is positive: "OSOR is good, but you also need to have an opt-out. You can take most of OSOR but not the whole proposal…"
Source: Euractiv News, September 15, 2005
SkinEthic and EDI GmbH have announced a major innovation for testing anti-inflammatory / anti-allergic skin products or active compounds in vitro.
The new high-end test model combines the well-established SkinEthic 3D epidermis ( RHE ) with the innovative immuno-pharmacological whole-blood models of EDI GmbH. These are linked together in a "communicating test unit" which allows a completely novel approach to testing activities of dermatological preparations on the human immune system under in-vivo-like conditions. This new co-culture model enables for the first time the testing of even final formulations (e.g. creams or ointments) together with human immune cells, which is usually impossible for several reasons. Moreover, absorption and anti-inflammatory activities can be investigated simultaneously in the very same culture. More information at:
www.edigmbh.de/edi_english/pdfs/edi-co2_skin.pdf
Source: SkinEthic Newsletter, October 25, 2005
According to a recent study, in the US 20% of the human genes have been patented, in particular by universities and companies. This is made possible by the US patent law which allows intellectual property protection on human genes.
The patents on human genes are held by 1.156 different patent holders, 63% of these companies. Witth 2,000 patents, Incyte Genomics (California) is the largest patent holder. Most patents cover one gene, but there are also patents which cover more, sometimes as many as 10 genes.
Sources:
One-Fifth of Human Genes Have Been Patented, Study Reveals, National Geographic News, October 13, 2005, http://news.nationalgeographic.com/news/2005/10/1013_051013_gene_patent.html
Intellectual property landscape of the human genome, Kyle Jensen and Fiona Murray, Science Policy Forum, VOL 310, 239-240, 14 October 2005, http://www.sciencemag.org/cgi/reprint/310/5746/239.pdf
According to a new report, the biopharmaceutical market is predicted to increase from $1.4 billion (¤1.14 billion) in 2003 to $2.6 billion in 2006. The market was dwarfed by the pharmaceutical industry 20 years ago but continues to outgrow its rival increasing its market share each year.
In 2000-2003, regulators in North America and Europe approved a total of 64 biopharmaceuticals for human use.
The approved drugs included hormones, blood factors, thrombolytics, vaccines, interferons, monoclonal antibodies (MAb), and therapeutic enzymes.
All of the 64 new biopharmaceuticals approved were protein-based drugs and an increasing number have undergone some form of engineering. The primary method of producing these biopharmaceuticals is mammalian cell culture.
The report: "Mammalian Cell Culture: Production Technologies and Market Overview," is available to buy from Research and Markets.
Source: www.drugresearcher.com, September 22, 2005
Researchers have claimed that a new microchip (the microfluidic system) could cut animal testing in the pharmaceutical industry as well as speed up drug development. By increasing the efficiency of preclinical testing of new drugs the new chip is also set to save on costs. The microfluidic system will provide data on how the body handles a drug for example, how it is eliminated and how it is metabolised. It is hoped the chip will speed up a process that currently makes for laborious and tedious work.
The 22mm microfluidic circuit, developed initially by researchers at Cornell University, contains an arrangement of interconnected "organ" or "tissue" compartments, which will assess the effects of a potential new drug, compound in animals, or humans, in a high throughput manner. In addition, the system is also an in vivo surrogate. Each compartment contains a culture of living cells from animals or humans to mimic the function of particular organs and tissues, such as liver, heart, lung or fat cells. The compartments are connected by microchannels through which a blood substitute (culture medium) circulates. The test drug is added to this culture medium and circulates round the device. Its effects on the cells within each compartment can then be measured.
Source: www.DrugResearcher.com, September 26, 2005
A novel chip-based in vitro testing methodology has been developed by the Technical University of Munich (Heinz Nixdorf Lehrstuhl fuer Medizinische Elektronik). The advantages of this technique are measurements of cell metabolism and morphology in real time, without fluorescent markers.Measurements are made using low-cost multiparameter (impedance, pH, O2,temp, also MEA) disposable planar semiconductor chips in multiwell plates.
Plates with 24 cells exist, and can be scaled to 96 for high throughput parallel testing. Technical University Munich has used the approach for chemosensitivity studies for individualized therapy, for example (see
http://www.lme.ei.tum.de/englisch/research).
Cell cultures (or other cells, neurons, etc) are applied directly to the chips contained in well plates to perform toxicity tests. The tests are not endpoint tests and can continuously monitor the effects of different substance doses, for example, over long periods to examine both acute and chromic affects that may emerge even in low doses over a period up to several weeks.
The group is looking for additional partners on this project, particularly a cosmetics or pharmaceutical company interested to assist with validation of the in-vitro data with in-vivo data (potentially also to eventually commercialize if appropriate), and / or an independent testing lab/facility examining in vitro approches.
For more information, please contact richard.dixon@wtc-consult.de and consult http://www.wtc-consult.de
The New Zealand company Living Cell Technologies (LCT) is investigating the possibility to treat the effects of Huntington's Disease by transplanting pig brain cells. Following successful experiments with monkeys, permission has been asked from the US FDA to conduct the first experioments in humans. The pig cells are so-called maintenance cells: they clean up toxins and produce a number of hormones and neurotropins, proteins essential for the functioning and protection of brain cells.
Source: Pig cell implants in Huntington's trial, NewScientist.com, 11 August 2005, http://www.newscientist.com/article.ns?id=mg18725124.400
Researchers from the Kingston University in Surrey (UK) have identified cord blood stem cells which have comparable characteristics to embryonic stem cells. These so-called Cord-Blood-derived Embryonic-like stem cells' (CBE's) are pluripotent as embryonic stem cells and more versatile than adult stem cells found in i.e. bone marrow. .
Cord blood is already used as an alternative to bone marrow transplants. Annually, thousand of parents of newborn babies already have their children's cord blood stored for future eventualities.
Source: Cord blood yields 'ethical' embryonic stem cells, New Scientist.com, 18 August 2005, http://www.newscientist.com/article.ns?id=dn7864&print=true
Stem cells have the potential to become an effective diagnostic tool singling out those susceptible of atherosclerosis, say researchers. These cells could also help to predict regeneration of heart cells following a heart attack.
This application adds to the growing interest in stem cells, where their ability to differentiate into other cell types raises the prospect they could be used to treat diseases, for example by creating new insulin-producing tissue for diabetes.
Diagnostic perspectives based on the analysis of the biochemical characteristics of these "uncommitted" cells were presented at the Second Annual European Vascular Genomics Network (EVGN &endash; www.evgn.org) Meeting which was held in Hamburg in parallel to the 3rd European Meeting on Vascular Biology and Medicine (www.emvbm.org).
While in a fairly embryonic stage at present, the market for stem cell-based therapies and tissue engineering is tipped to grow to around $10bn in 2013, according to a recently published report from Visiongain.
Source: www.DrugResearcher.com, October 3, 2005
Stem cells cultured in the laboratory show a disconcerting number of mutations after a while. Many of these mutations are cancer related. This is the result of a comparative study with 9 stem cell lines, in which DNA characteristics of the original and daughter cell lines were compared. This suggest that work with stem cells preferably is based on fresh stem cells.
This finding follows earlier reports that most embryonic stem cell lines are contaminated with the animal cells used as feeder cells.
Source: Gene defects plague stem-cell lines, Nature, 5 September 2005.
According to new study, the virus that causes AIDS is becoming more sensitive to drug treatments, contradicting a wealth of research that demonstrates the emergence of drug resistant viral strains.
The news contrasts the widely-held belief that HIV would increase in virulence as it passed through more and more human hosts. Confirmation of this discovery could shape the direction and approach of current HIV drug research.
Scientists from the Institute of Tropical Medicine, in Antwerp, compared HIV-1 samples from 1986-89 and 2002-03. They found that the 2002-03 samples did not replicate as efficiently. This would imply that over a number of generations, HIV could become less harmful to its human hosts. However, they were only able to compare 12 samples from each time period, and they were unable fully to tease out any effect that drug therapy may have had on the virus.
Some strains of HIV have become naturally resistant to the presence of drugs such as antiretroviral therapy. It has been estimated that up to 20 per cent of new infections now involve the transmission of resistant virus, meaning new classes of HIV drugs (especially against novel targets) will provide the only hope of treatment for an increasing number of patients.
The researchers, writing in the journal Aids, stressed the discovery did not mean efforts to prevent the spread of HIV should be scaled down.
Exactly why the virus seems to be weakening over time is unclear although theories have been out forward.
"These findings suggest that HIV-1 replicative fitness may have decreased in the human population since the start of the pandemic," the study said. "This 'attenuation' could be the consequence of serial bottlenecks during transmission and result in adaptation of HIV-1 to the human host." If this were to be true, HIV could become less harmful to its human hosts.
According to the World Health Organisation, other diseases - such as smallpox, TB and syphilis - have shown similar behaviour, weakening over time.
Scientists have pointed to the phenomenon that demonstrates a natural trend to reach an equilibrium between the agent and the host interests, in order to guarantee concomitant survival for a longer time.
Source: www.drugresearcher.com, September 30, 2005
ECVAM has launched an Open Call for Tender on the subject "Evaluation of the performance of five selected in vitro blood-brain barrier models for predicting absorption/uptake into the brain". Document number and source: 2005/S 193-189737 (Supplement to the Official Journal of the European Union)
Contact Address: silvia.bottini@cec.eu.int , Fax: +39-0332-789434
The ECVAM Scientific Advisory Committee (ESAC) has endorsed a Strategy on Fish testing on 27/09/2005 .
Reference article : "A strategy to reduce the use of fish in acute ecotoxicity testing of new chemical substances notified in the European Union" Jeram et al , Regulatory Toxicology and Pharmacology 42 (2005) 218-224.
For more information follow the link
The Good Cell Culture Practise (GCCP) Task Force Report 2 ( Coecke et al, 2005) is now online and can be accessed from the ECVAM Homepage rolling banner or from the section "Publications" - "Task Force Reports"- section "Good Cell Culture Practice".
The report "Validation of Toxicogenomics-Based Test Systems: ECVAM-ICCVAM/NICEATM Considerations for Regulatory Use ".August 2005 , Corvi et al . is now online on the Environmental Health Perspectives Website. This report can be accessed directly using the DOI number 10.1289/ehp.8247. (just click on the DOI link and copy and paste the number. )
This information is also available from the ECVAM Website in the section "Publications" ,"ECVAM Task Areas" ,"Toxicogenomics"
Workshop Report 52 " Current Status of methods for defining the Applicability Domain of (Quantitative) Structure-Activity Relationships " Netzeva et al. (2005). ATLA 33, 155-173 is now online and can be downloaded directly from the ECVAM homepage, ECVAM website, and also in the section Publications, Workshop Reports.
July 26, 2005: ICCVAM hosts the revised analyses for four in vitro test methods for detecting ocular corrosives and severe irritants. This addendum, which includes a revised list of proposed reference substances, is applicable to each of the four draft Background Review Documents (BRDs) released to the public on November 3, 2004. The four test methods are the Bovine Corneal Opacity and Permeability (BCOP) assay, the Hen's Egg Test-Chorionallantoic Membrane (HET-CAM), the Isolated Rabbit Eye (IRE) assay, and the Isolated Chicken Eye (ICE) assay.
The Addendum can be accessed on line at http://iccvam.niehs.nih.gov/methods/ocudocs/reanalysis.htm. A copy of the FR notice can be found at: http://iccvam.niehs.nih.gov/docs/FR/7043149.pdf in PDF or http://iccvam.niehs.nih.gov/docs/FR/7043149.htm in HTML.
November 3: The availability of an Addendum to the March 2005 Expert Panel Report on the Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants was announced in the Federal Register (Vol. 70, No. 211, pg. 66451) this morning. The Addendum is available at http://iccvam.niehs.nih.gov/methods/ocudocs/EPreport/EPrptAddend.htm. The March 2005 Expert Panel report can be accessed on line at http://iccvam.niehs.nih.gov/methods/ocudocs/EPreport/ocureport.htm. A copy of the FR notice can be found at: http://iccvam.niehs.nih.gov/docs/FR/7066451.pdf in PDF or http://iccvam.niehs.nih.gov/docs/FR/7066451.htm in HTML.
The NICEATM invites public comment on the expert panel report and addendum. Written comments should be received on Friday, December 2, 2005. Please send comments by: email to niceatm@niehs.nih.gov,
After a lengthy preparation, the Dutch Foundation for Information about Animal Research launched its website on May 15. Recent surveys by the Foundation for Animal Protection showed that a small majority of the Dutch does not support animal research and a large majority does not support animal research for any purpose if the laboratory animals suffer great discomfort.
Organisations supporting the new Foundation include the VSOP, the Dutch Genetic Alliance. This is an umbrella organization of about sixty national, disease-linked, parent and patient organizations, most of them concerned with genetic and/or congenital disorders; the FMWV. The Federation of Medical Scientific Organisations, representing about 50 scientific organizations varying from hematology to tissue engineering and molecular biology; the NVP: the Dutch Association for Laboratory Animal Science.
The priorities for the Dutch Foundation now are consolidating the financial situation for at least three years, preparation of educational material and the formation of a speakers pool. Their website can be found at: http://www.informatiedierproeven.nl
Source: EBRA Bulletin May 2005
If you work with animals, or benefit from experiments using animals in your research, a recently issued briefing paper may well be of interest to you, because it gives concise background on the impending revision of the EC Directive on research animal welfare - full title: Directive 89/609/EEC on the protection of Animals used for Experimental and other Scientific purposes. Most importantly for researchers using animals, it describes some possible revisions, and their consequences for research, and serves as a starting point for getting involved in the political process surrounding the directive amendment process.
The document was produced by the EMBO Science & Society Programme, and can be downloaded as a pdf file from the following page: http://www.embo.org/scisoc/animal_research.html .
Following the voluntary retirement of the only Austrian colony of laboratory chimpanzees in 2004, the government is now suggesting that their national legislation should be amended to formally ban the use of great apes.
Education, Science and Culture Minister Elisabeth Gehrer commented, "Great apes are the animals most closely related to humans. It is of particular concern for me that there is this explicit prohibition. This will ensure that no such animal experiments are carried out in the future either."
Meanwhile, four leading scientific organisations in the United Kingdom have announced that they will be conducting a major review of the use of primates in research. The Academy of Medical Sciences, the Royal Society, the Medical Research Council and the Wellcome Trust are setting up a working group to examine the recent, current and future scientific basis for biological and medical research involving non-human primates.
Source: EBRA Bulletin May 2005
At the end of May, the European Court of Human Justice rejected the French appeal against the EU legislation banning the testing of cosmetics on animals. The French government launched their appeal in 2003 on the grounds that the ban was incompatible with World Trade Organisation rules and that it would damage European business interests.
The 2003 Directive bans the marketing of cosmetics that have been tested on animals &endash; even those imported for outside the EU - from March 2009, although an exception is made for three specified types of animal testing, for which the ban would not come into effect until 2013.
Source: EBRA Bulletin May 2005
Three awards in the area of animal alternatives are offered by the the Proctor and Gamble company. These are grouped in three categories : Alternatives, Welfare and Local Community Initiatives.
Each award has a value of 25,000 euro .
Source: P&F Focus nr 2. More information : Proctor and Gamble Alternative Awards
Forward Focus is a quarterly newsletter that is distributed via email and posted online at http://www.pg.com/science/animal_alt.jhtml.
InterNICHE, supported by Proefdiervrij, announces the 2005 Humane Education Award for replacement of harmful animal use in higher education. 20,000 Euro (US$ 25,000) is available to be split between successful proposals.
Proposals are invited from all countries for initiatives to replace harmful animal use in biological science, medical and veterinary medical education. Applicants may be teachers, students, campaigners or any other individuals committed to enhancing the efficacy and ethics of life science education.
The deadline for applications is 25th November 2005.Applications must be submitted through the on-line form at
www.interniche.org/award/2005award.htm
In March this year, the 'Science in Society Forum' took place. The session entitled "Civil Society and science: A new role for NGOs?" took place on 9 March at the Forum. The very interesting report of this session is available online at: http://europa.eu.int/comm/research/conferences/2005/forum2005/docs/library_report_ong_en.pdf.
More Information: E.C. DG ENTR Unit F3 Cosmetics
Info: BioConferences International
Email: jyurewicz@healthtech.com
Information: http://ecopa.vub.ac.be/index.php?request=/content/news/reach_ws_05_programme.php
Information: http://ecopa.vub.ac.be
Information: http://www.aavmc.org/meetings_events/2006EducationalSymposium.htm
information: http://caat.jhsph.edu/dnt/
Information: info@iantra.it
Information: http://www.regonline.co.uk/eventinfo.asp?EventId=18578%20
Information: http://www.zet.or.at/kongress/Linz2006/
Information: http://www.invitox2006.org/
Information: http://www.knt.co.jp/ec/2007/wc6/