IVTIP Bulletin 18
September 2002


Next IVTIP meeting:
October 24-25, 2002
Hosted by TNO Nutrition & Food Research

And to celebrate the 10th anniversary of IVTIP member company SkinEthic Laboratories:

SkinEthic Laboratories Workshop
Reconstituted Human Epidermis and Corneal Epithelium as Alternative Methods to Animal Testing
October 25, 2002, Nice, France
Organization: SkinEthic Laboratories: http://www.skinethic.com

In this issue


3R Conference

On July 9-10 last, DG Research and ECVAM jointly organized a conference to assess the latest scientific advances, the 3Rs in practice and the 3Rs in the current European and international regulatory context. Participants were 70 invited stakeholders of research, industry, patients groups, animal rights groups, media, policy makers and regulators. In his presentation, Dr. Bruno Hansen of DG Research specifically mentioned IVTIP as a valuable and respected forum of European industry with respect to contacts with the Commission, EU researchers and the transfer of know how and technology.

Commissioner Philippe Busquin called for a EU-wide action: "the Commission is committed to fostering the 3Rs, including through its own research funding, but we can only get good results if there is a joint effort between scientists, national administrations, industry, NGOs and European policy makers". The R&D push is heavily related to the new EU system for registration, evaluation, authorization and restriction of chemical substances, which foresees risk assessment for 30,000 chemical substances by 2012 at a cost of 2,1 billion EURO. The R&D push could be even more critical if the European Parliament succeeds in forcing through its stance against cosmetics tested on animals.

With regard to policy, it was stressed that the majority of animal testing takes place in fundamental biological research, applied medical and dental research, applied research in veterinary medicine and in breeding programmes. However, despite this, Mrs Roth Behrendt of the European Parliament stated that "the EP wished to tackle animal testing with regard to chemicals and cosmetics, but would not question its use as regards pharmaceuticals". A missed opportunity, since the IVTIP meetings show that novel approaches in the drug discovery process in the pharmaceutical industry are resulting in fewer animal testing and greater efficiency.
Another remarkable quote of the day came from Prof Michael Balls, who observed that "the use of transgenic animals has increased tremendously and is way over the top. In the UK, 1 out of 5 animals used is a genetically modified animal." One way out of this dilemma is the use of cell culture models, as was demonstrated by a presentation of Dr. Buerstedde on the BT40 cell line. However, the issue is not only one of progress in research on alternatives but also of increasing awareness about alternative approaches among researchers. Clearly, a lot of mentality changes are still needed.

In the regulatory arena, it was remarked that there is support for an audit of current animal testing in Europe before the development of more legislation. Also, there is a call to speed up the process of regulatory acceptance. Overall, it was observed that there is a lack of candidate tests being developed. But these are needed more than ever, with a great pressure to develop testing relating to endocrine disruptors.

Alternative tests are now available for skin corrosion, phototoxicity, genotoxicity, acute oral toxicity (in vivo), skin sensitization (in vivo) and developmental toxicity. On the short term alternatives are expected for acute oral toxicity in vitro, skin irritation in silico and skin sensitization in silico. On the medium term (2006) alternatives are expected for eye irritation, skin irritation (in vitro and in silico), skin sensitization (in vitro), acute oral toxicity (in silico) and genotoxicity (in silico). On the long to very long term (2010 and later) alternatives are pursued for respiratory sensitization, biokinetics, target organ/system toxicity, chronic toxicity, non-genotoxic carcinogenicity and reproductive toxicity.

With respect to research, opportunities are offered by the 'omics' and new developments in biotechnology. But equally necessary is training of researchers and scientists in using alternatives. Funding opportunities are available in FP6 within the larger projects, but the participants to the congress would have preferred an earmarked budget.

For the programme and copies of the speeches, please visit:
http://europa.eu.int/comm/research/info/conferences/rrr/rrr_en.html
Paper handouts and copies of the list of participants are available upon request from the IVTIP Secretariat.


Chemicals: voluntary initiatives and assessments

A central feature in the EU Chemicals Policy Review is the so-called REACH (Registration, Evaluation and Authorization of chemicals) approach, which proposes a mechanism for authorizing and controlling the use of chemicals that give rise to particular concern.
The European Chemical Industry (CEFIC) supports the aims of the chemicals policy review, but maintains that future legislation should embody a number of general principles. These include the concept of risk assessment whereby the safety of any given chemical is judged on how and where it is used and not just on its intrinsic properties. Furthermore, REACH should not duplicate work already done. For example, substances controlled by existing legislation should not need to be re-prohibited and existing data gathering initiatives should be taken into account. Of particular interest in this respect are two voluntary programmes and the obligatory work under the EU Existing Substances Regulation, which are reviewed here.

ICCA HPV initiative

Launched by the International Council of Chemical Associations (ICCA), the High Production Volume (HPV) chemicals initiative is a voluntary programme under which the chemical industry undertakes to provide harmonized, internationally agreed data on the properties of about 1,000 common chemicals. These chemicals represent in excess of 90% of the world's chemical production. It will also provide initial assessments of their intrinsic hazard. The work is being carried out in collaboration with the OECD under the refocused OECD HPV Chemicals programme. Under the pilot phase, successfully completed at the end of 2001, the OECD assessed 42 reports covering 46 chemicals.

HERA initiative

The Human and Environment Risk Assessment (HERA) initiative was launched in 1999 and is jointly run by CEFIC and AISE (the International Association for Soaps, Detergents and Maintenance Products). The companies affiliated produce the chemical ingredients on the one side, and formulate the finished products on the other.
This voluntary chemical management programme provides a common framework for assessing the risks of household cleaning products and demonstrates that this process can produce relevant, properly evaluated safety information. HERA supports the risk-based approach which looks at a product's intrinsic hazards in the context of its use and exposure. Phase 1 of HERA addresses 14 substances/families representing, in volume terms, more than 70% of the chemicals used in household detergent formulations. For more information, see http://www.heraproject.com

Risks assessments for existing substances

The debate over the EU White Paper sometimes obscures the fact that existing legislation on chemicals management requires a great deal of input from the industry, in particular for substances already identified as needing attention. In 2001, work began on the 31 chemicals on the 4th Priority List published by the EU Commission in October 2000. The European Chemicals Bureau provides more information on:
http://ecb.jrc.it/existing-chemicals/ (click on Newsletters)

Source: CEFIC Annual Review 2001
See also: www.CEFIC.org


News from the Commission

FP6 project modalities

In the soon to start FP6, the EC has looked for modalities to integrate European research and technological activities in a sustainable way. Consortia/project partners will receive more autonomy in the content and execution of the project. This will be done by means of four new project modalities:

Next to the new large project modalities there will be other instruments for implementing FP6 priority themes, called the 'stairway of excellence:


SMEs in FP6

In FP6, there will be a large commitment to SMEs. For example, 15% of the budget for the 7 thematic priorities is earmarked for SMEs. The European Commission has expressed its concern to have the highest participation of SMEs. It is clearly stated that whatever the size of the projects, special requirements for the participation of SMEs will be enforced so as to make sure the largest number of them will be able to participate. Special attention is also being given by the Commission to the administrative burden at submission and evaluation of projects. The Commission has committed to streamlining the process.

More than ever, partnership will be a prime tool to maximize collaboration with Europe. The Belgian BioIndustry Association is contributing to the search for partners with a powerful pan-European project database and expressions of interests that they have received from SMEs, universities, industries and other organizations located in the different member states. Access to the database is through:
http://www.bba-bio.be/smes/

Source: BBA newsletter


MEPs want 2-step procedure

The European Parliament's research committee is asking for a two-stage proposal procedure for Framework Programme 6: applicants should only be asked to submit a full research proposal if a summary proposal is successfully reviewed. Many potential applicants are deterred by the low success rate and the disproportionate cost-benefit ratio. Particularly with complex proposals, it would be better to spend money elaborating them later.
Source: Research Europe, June 6 2002


Advisory Board calls for evaluation reforms

The EU Research Advisory Board recently issued its first formal advice to the Commission. The board was set up a year ago to give high level advice on research. Here a short list of some of the recommendations:
high risk proposals with the potential for high returns should be encouraged in FP6;
abolish the current practice of project proposers and evaluators;
decentralize the present evaluation system (evaluators working from home and by email);
for new instruments, selected projects should be continuously monitored by a small group including one of the people who evaluated the project.

See the full report at:
http://europa.eu.int/comm/research/eurab/index_en.html


New in FP6

The Commission intends to simplify the procedures of proposal making. In short:

The application:
the application presents an outline of the work plan;
the detailed implementation plan refers to the first 18 months only;
the core consortium needs to be identified in advance, not all other partners;
besides a written presentation a hearing to elucidate the application may be organized.

Evaluation of the application will be based upon a peer review in stages, with as selection criteria:
common values as scientific excellence, relevance, added value etc (see also FP5);
scale of ambition;
critical mass to match the scale of ambition;
quality of knowledge and exploitation management plan (exploitation plan refers to Integrated Projects);
quality of project management.

Evaluation and negotiation
External experts will be involved in the evaluation and negotiation process, which aims to determine and finalize the objectives; conclude the financial plan; set the financial ceiling; agree principles for changing the implementation plan, governance and consortium and detail the first 18 months implementation and budget. The elaboration is open to change.
The Commission aims to conclude a contract with the co-ordinator only. Subsequently, the co-ordinator has to associate with the members of the core consortium. The consortium agreement will become even more important.
At the end of each 12 month period an update of the work plan and the budget is requested. Changes in the consortium and the work plan must involve an open and competitive call procedure, to be managed by the consortium but involving independent experts. Commission project officers and external experts will review the project annually. The midterm review will include a go-no go decision. The end of term review will focus on the management of knowledge.


Draft FP6 contracts published

The Commission has posted draft versions of model contracts for FP6 on its website: an outline contract, core contract and general conditions applicable to all funding instruments. Also a checklist for consortium agreements. The drafts can be found at:
http://europa.eu.int/comm/research/fp6/working-groups/model-contract/index_en.html


Human resource and mobility in FP6

The human resource and mobility component in FP6 will be characterized by significant more money, more different actions, extension of the duration of many grants and extension of the scheme outside of the borders of the EU and associated countries.

A provisional overview is given here (no official document yet, so there might be some changes in a later stage):

Fellowship category:
Marie Curie individual Intra-European Fellowships (new: no age limit). 1-2 years;
New: Marie Curie Individual Outgoing International Fellowships (to work in established 3rd country research centers);
New: Marie Curie Incoming International Fellowships (to attract top class researchers from 3rd countries);

Excellence promotion and recognition:
New: Marie Curie Excellence Grants (4 years, for creating excellent research teams);
Marie Curie Excellence Awards (scientific prizes);
Marie Curie Chairs (to attract world-class researchers);

Return and re-integration mechanisms:
New: Marie Curie Re-integration Grants (reintegration fellowship researcher);
New: Marie Curie Reintegration Grants (professional return to Europe, 2 years);
New: co-operation with and within national and regional programmes (proximity support for researchers, in particular for networking);

Host-driven actions:
Marie Curie Research Training (3 years training to young researchers);
New: Marie Curie Host Fellowships for Early Stage Research Training;
New: Marie Curie Host Fellowships for the Transfer of Knowledge (aimed at less-favored regions and associated countries);
Marie Curie Conferences and Training Courses (for junior researchers).

A strategy is needed to make full advantage of all opportunities.

A full overview is available upon request from the IVTIP Secretariat: mailto:IVTIP@IVTIP.org


Five options for FP6 infrastructure

DG Research is proposing five schemes for the support of research infrastructures in FP6. The plans have a budget of around 450 million EUROs.
transnational access to infrastructures (100% costs involved, incl. travel and subsistence);
integrated infrastructure initiatives, to develop complimentary capabilities and synergies;
Support for high speed computer networks;
Feasibility and design studies for new infrastructures or underpinning technologies;
Construction of new infrastructure;
Support measures for workshops, database and foresight studies.
Source: http://europa.eu.int/comm/research/nfp/infrastructures.html


Monitoring experts

If you are not participating in an EU project, you can propose to become an independent expert monitoring the EU RTD programmes. This is assessing the progress of implementation and whether objectives, priorities and financial resources are still appropriate. Deadline for the 2003 monitoring exercise (in a panel) is September 15, 2002.
See:
http://www.cordis.lu/expert-monitoring/home.html


Business News

Agreement on principles and criteria for assessment of chemicals

Experts from OECD countries, including government, academia, industry and animal welfare representatives, have agreed on fundamental scientific principles and practical criteria for the regulatory acceptance of test methods used for safety assessment of chemical substances and products. This occurred at a conference held from 6-8 March 2002 in Stockholm.
The agreement reached in Stockholm includes detailed guidance on the description of a new benchmark for the quality of testing methods (Test Description Prediction). The Conference further agreed on the need form and the details of an independent review process to confirm the quality of each validation study. The results of the conference for the basis for a new OECD Guidance Document. Once formally adopted by OECDs member countries, it will be used as the international consensus document for the validation and regulatory acceptance of new methods in hazard assessment.

Source: NCA News nr 12, March 2002
See also:
http://www.oecd.org/ehs/test
or contact:
mailto:herman.koeter@oecd.org


EBRA back in business

After a couple of years of inactivity, the European Biomedical Research Association (EBRA) has been relaunched with a base in Brussels.
EBRA likes to be fully representative of academia, patients and the pharmaceutical industry with an interest in making sure that properly controlled animal research continues. The relaunch came in preparation of the proposed revision of Directive 86/609/EEC, which governs the "approximation of laws, regulations and administrative provisions of Member States regarding the protection of animals used for experimental and other scientific purposes". The first text for such a revision is expected by the end of 2003, following the work of a still to be set up Working Group composed of representatives from industry, NGOs and member states.

Source: EBRA Bulletin May 2002


UK not committed to animal experiment alternatives

A Committee of the UK House of Lords has concluded in a July report that the development of alternatives to animal research in the UK is being impeded by inertia in the UK scientific community and across government.. The Committee also concluded that 'it would appear that alternative methods could be of scientific benefit, therefore there is a need to shift this quite substantially up the agenda on all fronts. But the Committee has been unimpressed with the attitude of the Department of Health and the UK Home Office. For example, the Department of Health does not have a specific budget for alternatives. One proposal which the Committee has expressed support for is the establishment of research centers focusing on the issue of alternatives. The Medical Research Council has taken the lead on this, but progress has been slow. The Center is to be launched this autumn and its aim is to set best standard guidelines for the MRC, looking at issues such as the use of transgenic animals and the statistical design of experiments. The new best practice center will not itself work on developing alternatives.
The Committee is also considering whether the government should promote in vitro research using human tissue.

Source: Research Europe, May 9, 2002


Advisors say Europe needs primate centers

The Commission's Scientific Steering Committee, a senior scientific advisory body, has stated that Europe must maintain facilities for research on non-human primates. The Committee says that the use of non-human primates in research must be decided on a case-by-case basis, taking into account the possible existence of alternatives, ethical considerations and the implications of not carrying out the research. However, it thinks that for certain experiments there are no alternatives to the use of non-human primates. In making its recommendation, the committee stresses that unnecessary, duplicated or redundant research using non-human primates should be avoided at 'all costs'.

There are two other advisory committees addressing this issue: the European Group on Ethics of Sciences and New Technologies, and the Scientific Committee on Animal health and Animal Welfare. Both are preparing statements on related issues.

Source: Research Europe, April 25, 2002


Comparing skin models

At the Free University of Berlin, a study was carried out comparing advantages and disadvantages of reconstructed epidermis, monolayer cultures of keratinocytes and fibroblasts and excised skin versus animal models and human volunteers.

Skin from human volunteers is eminently suitable at low cost, needing informed consent from the volunteers. However, not all compounds can be tested, in particular not the severe ones.
Excised human skin can be used to test all compounds, is available at low cost, gives good information and only requires information to the donor. However, the skin has a limited survival period, with the barrier function only available for a limited period. Additional disadvantages are the absence of information about the skin, pretreatments or the donor's health.
Skin from animals can be used to test all compounds, but in general the barrier function is less than in humans and the comparability to humans is bad, with generally more hair follicles, less barrier function and a different enzyme scheme.
Monolayer cultures of keratinocytes and fibroblasts can only be used to test water-soluble compounds. The comparability to humans is limited since only one cell type is present, and the barrier function is absent. However, they are very sensitive to measurement of irritation experiments and for the investigation of molecular mechanisms.
Reconstructed epidermis can be used to test all compounds and is readily available, but the barrier function is impaired, resulting in increased permeation rates, transdermal water loss and enhanced irritation levels. It remains a challenge to further develop reconstructed skin models with a higher barrier function.

Source: Kleuser et al, NewDrugs pp40: Human keratinocytes and human skin models for drug testing. A copy of the article is available from the IVTIP Secretariat.


E&Y 2002: Beyond Borders

At the BIO Conference in June 2002, Ernst & Young's Global Health Sciences Group launched the latest of their well-respected regional biotechnology industry reports.
The theme of the book is very much the inescapable reality of looking 'beyond borders' and understanding the impact of this in virtually every activity in which the biotechnology industry engages. For example, an international perspective is required not only in biomedical research but also in technology innovation and commercialisation, intellectual property filing and enforcement, product development and regulatory approval, public policy, pricing and reimbursement, and the ethical debate. But also in seeking capital and investors.
The authors identify the following critical characteristics in the development of a thriving biotechnology industry:
risk taking culture that encourages entrepreneurial behaviour;
competitive, free market economy;
intellectual property protection;
academic support for technology transfer;
government support for funding basic research, but also tax incentives
public regulatory system that fosters confidence in the safety and efficacy of new products.

For more information, see:
http://www.ey.com/beyondborders


334 Biotech-pharma mergers in 2001

The global value of pharmaceutical mergers and acquisitions in 2001 almost doubled to USD 61 billion from USD 34 billion in 2000. A total of 334 deals were reported, with 97 in Western Europe, 19 in Eastern Europe, 125 in North America, 84 in Asia/Pacific (most in India, which is anticipating the signing of GATT), and 10 in the rest of the world.

The following key trends were apparent in 2001:
consolidation of biotech-biotech deals;
a shift in favour of product-based businesses (away from focus on technology platforms)
acquisition by biotech companies of commercial infrastructure from pharma companies.

The global top 10 deals in 2001 were:
Immunex/Amgen (16,900 million USD)
Alza/Johnson & Johnson (11,070 million USD)
DuPont Pharmaceuticals/Bristol-Meyers Squibb (7,800 million USD)
Roche (20%)/Novartis (2,788 million USD)
COR Therapeutics/Millennium Pharmaceuticals (2,417 million USD)
ImClone Systems (19.9%)/Bristol-Meyers Squibb (2,007 million USD)
Aviron/MedImmune (1,665 million USD)
Chugai Pharmaceutical/Roche (1,240 million USD)
FH Faulding/Mayne Nickless (1,218 million USD)
Mayne Nickless-Faulding Oral Pharma/Alpharma (660 million USD).

Source: EBR spring 2002, Neal Ransom, PriceWaterhouseCoopers HYPERLINK mailto:neal.j.ransome@uk.pwcglobal.com neal.j.ransome@uk.pwcglobal.com


Top 10 biotech and pharma companies

In June, Genetic Engineering news published a list of the annual top 50 Biotech Companies and the annual Top 10 Pharmaceutical companies for the year 2001. Here we will give the first 10 on both lists, with their market capitalisation in billions of USD:

Top 10 Biotech companies:
Amgen: 52,28 billion USD
Genetech 18,53 billion USD
Serono 17,97 billion USD
Immunex Corp 14,26 billion USD
Genzyme Corp 8,44 billion USD
Idec Pharmaceut. Corp 8,03 billion USD
MedImmune 7,89 billion USD
Chiron Corp 7,39 billion USD
Gilead Sciences 6,38 billion USD
Biogen 6,17 billion USD

Top 10 pharmaceutical companies:
Pfizer 234,1 billion USD
Johnson & Johnson 195,6 billion USD
GlaxoSmithKline 148,6 billion USD
Merck & Co 126,2 billion USD
Novartis AG 106,5 billion USD
Abbot Labs 84,1 billion USD
AstraZeneca 81,5 billion USD
Wyeth 78,6 billion USD
Eli Lilly & Co 76,4 billion USD
Bristol-Meyers Squibb Co 56,9 billion USD
Source; Genetic Engineering News June 2002


Spain opens genomics/proteomics centre

On April 24, the Spanish government has officially opened its Foundation for the Development of Proteomics and Genomics Research. Its main objective will be to promote genomics and proteomics research. But the initiative is also intended to channel the efforts of Spain's biotechnology companies, and to encourage spin-offs and stimulate venture capital. Companies collaborating with the foundation in developing research projects will be able to take advantage of intellectual property resulting from those projects.
Source: Research Europe, May 9, 2002


-.and go-ahead in Grenoble

Plans to build a new structural genomics outstation in Grenoble are to go ahead without the financial backing of industry. The project, a joint venture between the European Synchrotron Radiation Facility, the Institute Laue-Langevin and the European Molecular Biology Laboratory was to be financed in large part by an industrial consortium. However, members of the consortium are said to have dwindled and its future is uncertain. However, new support for the project has come from the Institute for Structural Biology. The new initiative is called the Partnership for Structural Biology. It is intended that the partnership will provide Europe with a platform where it can compete with the United States and Japan in terms of high throughput macro-molecular crystallography.
Source: Research Europe, April 25, 2002


No stem cell patents

Unmodified human stem cells should not be patentable, according to the European Group on Ethics in Science and New Technologies. Such isolated cells are so close to the human body, to the foetus or to the embryo, they have to be considered as a form of commercialisation of the human body, says their opinion published on May 7. Likewise, patents on unmodified stem cell lines would be too broad, resulting in 'adverse effects on the aim to support further innovation to the benefit of health care'.
However, the group is not against patenting all stem cells or stem cell lines. Stem cells which have been modified by in vitro treatments or genetically modified so that they have acquired characteristics for specific industrial application should be patentable. In all cases, applicants for patents involving human stem cells should declare where the cells came from. Donors should be informed of the possibility of patenting and they are entitled to refuse such use.
A cautious approach is called for regarding cloning techniques for obtaining human embryonic stem cells for therapeutic purposes.
The opinion can be found on:
http://europa.eu.int/comm/european_group_ethics


Research news

Grant for stem cells as in vitro screening assays

VistaGen Therapeutics, Inc. of the USA is one of the global leaders in the in vitro applications of stem cell technologies for drug discovery and development. VistaGen's portfolio of proprietary stem cell technologies and information products are beginning to be used in the pharmaceutical industry to accelerate drug development across several therapeutic.
On July 9, 2002, it was announced that the U.S. National Institutes of Health (NIH) has awarded the company a $199,566 Phase 1 Small Business Innovation Research (SBIR) grant to develop biomathematical systems to analyse data in VistaGenís in vitro screening assays.
In the study covered by this new grant, VistaGen scientists will evaluate genomic and proteomic data generated from ongoing stem-cell based evaluation of known anti-cancer drugs. Mathematical and statistical analysis systems will be developed to test existence and reproducibility of patterns related to toxicology of both FDA approved compounds and new drug candidates. The informatics study will be performed in collaboration with Tripos' ( http://www.tripos.com), a leading provider of discovery chemistry, integrated discovery software products, software consulting services, and discovery research services.


Animal-free screening of biological materials

The 3R Research Foundation of Switzerland has recently (May 2002, info bulletin 20) presented the results of two successful projects concerned with the replacement of the Mouse Antibody Production (MAP) tests. This MAP test is traditionally used to screen biological material prior to their use in vivo on contamination by rodent viruses. Biological materials are serum, transplantable tumours, cell cultures and hybridoma lines. The MAP test has several disadvantages, such as the use of animals, cost and slowness (5-6 weeks). Previous attempts to replace the MAP test with an in vitro assay using virus isolation in cell culture were unsatisfactory with respect to virus detection. However, the newly developed Infectious Microbe PCR Amplification Test (IMPAT) was able to identify viral DNA directly in vitro. In comparative studies between the MAP and IMPAT tests, the new test was found to be more specific and sensitive in most cases than the MAP test. Other advantages are:
no animals required (replacement);
test-time reduced to 1-2 days;
smaller variability
no risk to animal facility or investigators.

While the MAP test only detects the immune response, the IMPAT detects the presence of nucleic acids from infectious but also from non-infectious, inactivated virus.

Source: 3R Research Foundation, Info Bulletin 20, May 2002. See also www.forschung3r.ch
A copy of the Bulletin may be requested from the IVTIP Secretariat.


Gender discrimination real

Statistical work by the Helsinki Group on Women in Science has offered proof that gender discrimination in science is real and widespread. According to a report published in June, women now constitute the majority of undergraduate students. Although they remain a minority in some science subjects and in engineering, they are in the majority in medical and biological sciences. However, women are a tiny minority of people in top scientific jobs. See:
http://www.cordis.lu/improving/women/helsinki.htm
Lab-on-a-Chip: micro-electronics for biochemical analysis

In addition to microarrays, work is in progress to realise fully automated laboratories on a chip (lab-on-chip). A lab-on-chip will be capable of analysis or synthesis of biochemicals on a chip, normally performed in a fully equipped laboratory. Like microarrays, they exist as plates of glass, resins or silicium, but filled with tiny channels in which reactions and analyses can take place. The lab-on-chip may also contain electrodes, micropumps, valves, biosensors or photodiodes.
Source: Technieuws 40, nr. 3-4, 39-48,
http://www.technieuws.org/cgi-twa/twa.pl/Tokyo/235.html


News from ICCVAM

Evaluation 3 corrosivity tests

The report, ICCVAM Evaluation of EPISKIN, EpiDerm (EPI-200), and the Rat Skin Transcutaneous Electrical Resistance (TER) Assay - In Vitro Test Methods for Assessing the Dermal Corrosivity
Potential of Chemicals (NIH Publication 02-4502, June 2002), has been announced in the Federal Register and can be viewed online at:
http://iccvam.niehs.nih.gov/methods/epiddocs/cwgfinal/cwgfinal.pdf
or as separate sections in pdf format at:
http://iccvam.niehs.nih.gov/methods/epiddocs/cwgfinal/cwgfinal.htm
You can also access these documents from the ICCVAM home page at
http://iccvam.niehs.nih.gov by visiting the links in the announcements box. For more information, please visit the Dermal Corrosivity page at
http://iccvam.niehs.nih.gov/methods/epiderm.htm .

The report contains test method summary reports, protocols,

and the ICCVAM's final recommendations on the three methods.

Report endocrine disruptors

The following report is available: "Global Assessment of the State-of-the-Science of Endocrine Disruptors (WHO/PCS/EDC/02.2). The global comprehensive review can be viewed on the "New @ IPAC" page at
http://www.who.int/pcs/pcs_new.html , or as individual chapters linked from the Table of Contents at:
http://www.who.int/pcs/emerg_site/edc/global_edc_TOC.htm .
The report is also available at the ICCVAM website http://iccvam.niehs.nih.gov/methods/endocrine.htm under "Other Related Pages and Sites."

Printed copies of the report can be obtained by contacting: Ms. Kathy Prout at the World Health Organization
prout@niehs.nih.gov


Publications

Supplement 4.3 of the European Pharmacopoeia

With the release of supplement 4.3, the 4th Edition of the European Pharmacopoeia has added 36 new monographs and chapters on a wide range of subjects, including human and veterinary vaccines. The 4th edition has been in force since January 1, 2002 and now contains 1638 specific monographs, including 103 on vaccines, 28 monographs on the most commonly used dosage forms, and more than 200 general methods. The 4th edition is updated 3 times a year.
Source: EDQM news, June 14, 2002


On the web

Resource Centre

The European Resource Center for Alternatives to animal use in higher education (EURCA) actively promotes the use of animal free models in education through outreach activities and through the following website:

http://www.eurca.org

The EURCA database, available on its website, holds reviews for:
Blood physiology
Frog heart
Langendorff heart
Muscle physiology
Experiments in human Neuromuscular physiology
Simulation of pharmacological experiments on rabbit jejunum and on the guinea pig ileum
Sniffy - a virtual rat
Vertebrate dissection guide
Nerve Physiology
Soon reviews will be available for:
SimHeart
Cellular respiration
SimMuscle
Anesthesia of Rats
Vertebrate dissection guide - the rat
The rat, a practical dissection guide

Source: NCA News, March 2002
Or contact: Jasmijn de Boo, EURCA, NCA, Yalelaan 17, Utrecht, The Netherlands. Email: j.deboo@vet.uu.nl


AGENDA

A number of interesting conferences and workshops is coming up. Of all the events mentioned here, the detailed programmes and registration/application forms are available from the IVTIP Secretariat.

4th SME Days
September 25-27, 2002, Leeds, UK

Organisation: http://www.betatechnology.co.uk
Tel: + 44 1302 322 633

Eurotox 2002, the 40th Congress of the European Societies
of Toxicology
September 15-18, 2002, Budapest, Hungary

Organisation: Ms Alicia Druga, tel + 36 1 169 14 25;
fax: + 361 169 3229

BioArrays in Europe
September 30-October 2, 2002, Cambridge UK

Organisation: http://www.BioArraysEurope.com

European Society of Gene Therapy
10th Annual Meeting
October 13-16, 2002, Antibes, France

Organisation: Congrex Sweden, Tel: + 46 84 59 6600;
fax: + 46 86 61 9125;
email: esgt@congrex.se

Genomex
October 14-16, 2002, London, UK

Organisation: www.pharma-rd.net

INVITOX 2002
16-19 October 2002, Formia, Italy

Organization: ESTIV, email: floestiv@tiscalinet.it
or invitox@iss.it

IVTIP Plenary meeting
October 24-25, Zeist, The Netherlands

Organization: IVTIP Secretariat: IVTIP@IVTIP.org

SkinEthic Laboratories Workshop
Reconstituted Human Epidermis and Corneal Epithelium
as Alternative
Methods to Animal Testing
October 25, Nice, France

Organization: SkinEthic Laboratories: http://www.skinethic.com

Launch EUs 6th Framework Programme
November 11-13, 2002, Brussels

Organization: DG Research, tel + 32 295 99 71; fax: + 32 2 29582 20;
email: rtd-conference2002@cec.eu.int;
web: http://europa.eu.int/comm/research/conferences/2002

JAACT 2002
November 11-15, Fuchu City, Japan

Organisation: JAACT. Web: http://www.tuat.jp/~jaact02/

BioTech Helsinki 03
March 24-26, 2003, Helsinki, Finland

Organization: Finish Bioindustries/Sitra/Tekes. Tel: + 358 91728 43 14.
Web: http://www.biotechhelsinki.com

BioVision 2003
April 8-11, 2003, Lyon France

Organisation: www.biovision.org

2003 Congress on in vitro biology
May 31-June 5, 2003, Portland OR, USA

Organization: www.sivb.org

18th ESACT meeting
Animal Cell Technology meets Genomics
May 11-15, 2003, Granada, Spain

Organization: ESACT, www.esact.org or
+ 34 932 388 777

11th European Congress on Biotechnology, 25th anniversary of EFB:
Building bridges between biosciences and Bioengineering
24-29 August, 2003, Basel, Switzerland

Organization: ECB11, Tel + 41 61 686 28 28; fax: + 41 61 686 2185;
email: info@ecb11.ch;
web:http://www.ecb11.ch

10th International Congress of Toxicology
July 11-16, 2004, Tampere, Finland

Organisation: University of Tampere, Ms Hanna Tahti, tel + 3583215 6672;
fax: + 358 3215 6170;
email: :blha-ta@uta.fi;
web: www.uta.fi/fst