IVTIP Bulletin 21
June 2003

In this issue

IVTIP website

The IVTIP website remains very successful. Here are some statistics: in April 2003, the homepage received 9,207 hits, with 4,418 specific requests for pages. The most popular pages were the newsletter, the protocols page and the research pages, but in fact all pages and files receive between 50-100 visits per month. Of the visitors, 27% have an industry address. More than 4,500 visitors directly link onto the homepage, while only a minority arrives there through a search machine such as google or yahoo. In preceding months similar patterns were seen.


Commission consultation on REACH

On May 7, revised plans for REACH were put forward by Environment Commisisoner Margot Wallstrom and enterprise counterpart Erkki Liikanen. Liikanen said the Commission now estimates REACH will cost around 4 billion to implement until 2020. A new Chemicals Agency, initially to be based in Ispra, would provide 'guidelines' for the testing of release of toxic chemicals from endproducts, such as computers or television sets.

The Commissioners also presented a joint 'orientation' paper and announced that a final online consultation period over the proposed new chemicals regulation has been extended from 5 to 8 weeks. The consultation was started on May 14. This means that the draft regulation, promised to be put forward by July 2003 at the latest, will be stalled considerably. It means that the Members of Parliament will not discuss the plans until the autumn, and the June 2004 EP elections could further delay the process.

Source: European Voice, May 8-14, 2003


Calls for more control on Endocrine Disruptors

Exposure to chemicals is leading to an increase in testicular cancer and lower sperm counts among men across Europe, according to the environmental campaign group World Wide Fund for Nature (i.e. in Denmark 40% of young men have subnormal sperm counts; Scottish men born in the 1970s are producing around 20% less sperm than their fathers; in England and Wales there has been a 50% increase in breast cancer and a doubling of prostate and testicular cancer between 1971-1997). The WWF claims it is not uncommon to find traces of 300 chemicals in the human body (although it admits that the increasing incidence of cancer and infertility problems may in part be due to better diagnoses and people living longer). It has launched a declaration signed by 68 European top scientists which calls for tougher measures to reduce the level of dangerous chemicals in the atmosphere. In particular they are targeting very persistent chemicals and endocrine disruptors. The WWF circulated the findings to coincide with the final online consultation on the ECs REACH proposal.

Source: European Voice May 22-28, 2003


Call for international treaty on scientific exchange

A prominent US law professor from Stanford University has called for an international treaty on sharing scientific and technological information, to be based on the arrangements already agreed for free trade under the World Trade Organisation (WTO) system.

John Barton, who is also chair of the international commission on intellectual property, claimed in a recent presentation to the United Nations conference on trade and development that scientific progress requires the sharing of information, and that this collaboration is being hindered.

'Science and technology require a commons of data, ideas and insight. Everyone benefits from the openness of that commons. A scientist or engineer is more effective if he or she has access to the work of predecessors [...]. Exchange of data and scientific communication across border is not only part of the mythology of science; it also contributes to the rate of progress of science and technology,' said Professor Barton.

Professor Barton believes that the exchange of information is being restricted by three things: national protectionism, the expansion of intellectual property protection and the lack of contact between scientists from developing countries and the rest of the world. 'The world as a whole loses,' he said.

The solution, according to Professor Barton, is an international treaty, under which countries would make their subsidies and data available in return for the same gesture by other countries. This is also the philosophy behind the WTO agreement.

'As with free trade, the net benefits are positive, for a more inclusive and open global scientific/technological commons will be more dynamic. To do this requires a treaty that defines rules freeing scientific/technological exchange and establishes procedures for negotiating regular improvements and expansions of those rules,' explained Professor Barton.

The whole world would benefit from such cooperation, said the professor, quoting EU Research Commissioner Philippe Busquin, who has argued that the European Research Area 'must be opened up to the rest of the world. This openness should enable EU countries to benefit from international cooperation in science and technology, paving the way for closer political and economic relations with third countries.'

In addition to provisions securing equal access to scientific and technological support and capability, such a treaty could also ensure that the benefits of publicly funded research are available to all, and not only those in whose country the research was conducted, Professor Barton elaborated. He also suggested that the agreement could override restrictions preventing students from studying in other countries and researchers from gain experience abroad. He also proposed balanced safeguard provisions in such a treaty in order to ensure that intellectual property rights are managed in a fair way and to protect national security.

'For a treaty with a global scientific focus, there are two reasonable negotiating fora. One is UNESCO, the United Nations Educational, Scientific and Cultural Organisation. This might be a good place to begin, but is certainly more scientific than technological. The better forum for the more technological issues, and possible for all issues, is the WTO,' argued Professor Barton.

Source: CORDIS RTD News, April 24, 2003


On the web

New Biosociety web page

The Research DG of the European Commission has implemented the new Biosociety web site: http://europa.eu.int/comm/research/biosociety/index_en.htm

This website aims primarily at stimulating interactions between biotech researchers and social scientists, economists and ethical experts active in the field of life sciences. It also informs and opens a dialogue with interested citizens on relevant European policies and research activities.


International Federation of Animal Health

The International Federation of Animal health has a new website: http://www.ifahsec.org


Clinical research with human in vitro models

There is a great and increasing need for human tissue for research as the result of continuously expanding possibilities of biotechnological science. It has been forecast that the greatest development and economic potential in the coming years will be achieved by the use and breeding of human cells (i.e. for human genomics, tissue regeneration, therapeutic cloning and for clinical research).

Human liver cells are of major importance in clinical research, and the test models developed can help to replace animal experiments. It was shown that such cells obtained from human tissue outside of the body come very close to the natural or pathological function. The Center for Liver Cell Research at the University Hospital of Regensburg has been very successful in isolating, preserving and cultivating primary human liver cells from discarded human tissue under standardized conditions.

As the use of human material in research is increasingly expanding in the field of biotechnology and of industrial research, it is essential to guarantee a controllable and therefore transparent obtainment procedure in addition to consent by the local ethic commissions. Against this background the charitable state-controlled 'Human Tissue and Cell Research (HTCR) was founded in 2000 in Regensburg, Germany. It takes over the following tasks in a European system of human tissue banks (European Network for Research Tissue Banks ENRTB):

The main objective of the foundation is to take care of the ethic and legal preconditions for the use of human material. Also the transfer and use of human tissue is controlled by the Foundation: for this purpose the foundation has an ethics council and a scientific council which examines the research activities with the human tissue and give their approval on written enquiry.

For contacts: Human Tissue and Cell Research Foundation (HTCR), University Hospital Regensburg, Franz-Josef-Strauss Allee 11, 93053 Regensburg, Germany

plaen@biocam.de


News from ICCVAM

Oral Toxicity

Update Oral Toxicity Workshop

Dr. Elizabeth Julien, Senior Scientist, ILSI

Risk Science Institute, Washington DC, informed ICCVAM of a recent upgrade to information from the Acute Oral Toxicity Test Guidelines Workshop that was convened last year (Feb 19-21, 2002). The upgrade includes the speaker biographies, presentations, case studies, and a page with links to additional documents and resources, among other items.

To view the update, please click on the attached link http://rsi.ilsi.org/activities/actslist.cfm?pubentityid=13&pubactivityid=317, "Putting Acute Oral Toxicity Test Guidelines into Practice".


ICCVAM Acute Oral Toxicity documents

ICCVAM Up-and-Down Procedure Report (NIH Pub. No. 02-4501 - Nov. 2001)

Vol. 1 at http://iccvam.niehs.nih.gov/methods/udpdocs/udpfin/vol_1.pdf

Vol. 2 at http://iccvam.niehs.nih.gov/methods/udpdocs/udpfin/vol_2.pdf

For more information on the UDP, please visit

http://iccvam.niehs.nih.gov/methods/udp.htm

ICCVAM Report of the International Workshop on In Vitro Methods for

Assessing Acute Systemic Toxicity (NIH Pub. No. 01-4499 - Aug 2001) at

http://iccvam.niehs.nih.gov/methods/invidocs/finalall.pdf

ICCVAM Guidance Document on Using In Vitro Data to Estimate In Vivo Starting

Doses for Acute Toxicity (NIH Pub. No. 01-4500 - Aug. 2001) at

http://iccvam.niehs.nih.gov/methods/invidocs/guidance/iv_guide.pdf


LLNA preferred for skin sensitization testing

 On March 26, 2003, the availability of the revised final U.S. EPA OPPTS 870.2600 Test Guideline - Skin Sensitization, incorporating the Local Lymph Node Assay (LLNA) as the preferred method for sensitization testing, was announced in the Federal Register. The FR notice can be viewed at http://iccvam.niehs.nih.gov/docs/EPA/6814635.pdf in PDF or

http://iccvam.niehs.nih.gov/docs/EPA/6814635.htm in HTML format.

The guideline is available in PDF at the following link: www.epa.gov/opptsfrs/OPPTS_Harmonized/870_Health_Effects_Test_Guidelines/Revised/870r-2600.pdf.

The LLNA reduces the number of animals needed for testing and provides for improved animal welfare compared to other dermal sensitization test methods.

The LLNA test guideline is fully harmonized internationally as OECD Test Guideline 429, adopted 24 April 2002.

This document can be purchased from the OECD. Please visit their "Section 4: Health Effects" page:
www.oecd.org/oecd/pages/home/displaygeneral/0,3380,EN-document-524-14

-no-no-6775-0,00.html.


News from the Commission

SME's a MUST in most EU FP6 projects

On December 19, the Commission (Research DG Genomics & Health programme staff) organised a meeting with representatives from industry platforms, EuropaBio SME project, Innovation Relay Centres, National Focal Points, etc. They were looking for help in order to reach one of the targets set to FP6: obtain a 15% participation (in financial terms) of SME's throughout the programme.

The message was clearly delivered: proper participation of SME will be an important selection criteria. Such involvement should not be superficial: the concerned enterprises should play an active and essential role in the implementation of the projects and in most cases (for Integrated Projects or Networks of Excellence) one SME might even not be enough.

Having set this objective, and decided to apply this as a strict selection criteria, Commission officials are left with the need for ideas on how to achieve this ambitious target without jeopardizing the whole programme and its overall effectiveness.

Participants in the meeting suggested possible leads for making the programmes more ìattractiveî to SME's - or tools available for identifying possible candidates. The task is now with representatives from National Focal Points and Innovation Relay Centres, mostly, or industrial associations, to figure out which company should be suitable candidates in the various projects under preparation.

One recommended source of information would be the 'Partners for Life': this is a EU funded project and they claim to be in contact with over 40.000 SME's.

The 15% SME target is also intended to apply to clinical trials and the question was raised about the professionalism of newcomer SME's in this area, knowing that the number of patients available is the ìlimiting factorî and that there are ethical rules.

One clear message to the Commission is that payments should be made more regularly in the case of SME's. Normal practice at EU level indeed requires that SME's deliver formal evidence that they are ìfinancially healthyî before signing the contracts but the start up's should not be put at risk because of financial uncertainties created by the Commission.

Should you think about any other possible suggestion for the Commission please write to torbjoern.ingemansson@cec.eu.int


Russians in FP6, and their networks as an example?

It has been predicted that participation in the Sixth Framework Programme (FP6) will be much easier for Russian entities than in previous framework programmes. In an interview Vladimir Belokurov, Vice-Rector of Lomonosov Moscow State University, outlined how Russia had been able to participate in former framework programmes, but its researchers had not known how they should go about doing so. He added that they had also been disadvantaged by a lack of contact with EU researchers.

"In FP6, things may be easier as there is a reversed process: European scientists know the Russian experts ...they are inviting them to participate in projects in Germany, France and elsewhere."

Professor Belokurov described Russian experience of EU research programmes as positive, citing ideas, calculations and methodology as the main areas where his compatriots have played a significant role. He also emphasized that basic science is still seen as important in Russia: "Fundamental sciences are needed in every sector. It wouldn't be wise to concentrate only on industry driven initiatives."

It has been suggested that the EU could learn from Russia's internal networks, known as 'scientific schools'. These networks build strong relations between distinguished scientists from different universities and their pupils. '[They] share the same language, they collaborate on research and they transfer their knowledge to the younger generations. This powerful system has been preserved for years, despite the various socio-economic changes,' explained Professor Belokurov.

For a full version of the interview with Professor Belokurov, visit www.cordis.lu/greece/press24.htm .


Council on competitiveness

On May 13, The EU Council met to discuss competitiveness in the European Union. While commenting on the Commission document 'Strengthening European Innovation Policy', it was stressed that:


Action plan for 3% target

At the same meeting, Commissioner Busquin presented the April 30 communication 'Investing in research: an action plan for Europe (ì3% targetî). The Council held a preliminary exchange of views. Discussion centred mainly on issues such as:

The Action Plan put forward by the Commission suggests some 50 new actions in research and innovation policies as well as in other policy areas. Many of the actions are geared to making Europe more attractive for private investment in R&D. The main challenge of the Barcelona objective on RTD is the raising of business contribution to the Gross Expenditure for R&D from 56% in 1999 to 67% in 2010, while total GERD/GDP will increase from 1.9 to 3% in 2010.

Furthermore, the Council discussed the progress report on the 'Life Sciences and Biotechnology a strategy for Europe, presented by Commissioners Liikanen and Busquin. In the communication, the Commission sets out the progress made and anticipates emerging issues with regard to its strategy. The member states took the opportunity to discuss the priority actions taken by them, as the strategy is put into place.


Directive on cells and tissues available

Also available on the secure part of the IVTIP website is a pdf-copy of the proposal for a directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells. (2002/0128(COD). The cells covered are used for application to the human body, and the directive is meant to ensure a high level of protection of human health. The directive does not apply to tissues and cells used as an autologous graft within the same surgical procedure.


Candidate countries pro animal experiments

The first major European Commission survey of attitudes to science in the candidate countries was published in early April 2003, and showed interesting differences in attitudes to animal experimentation between the candidate countries and existing member states. In November 2002 sample questions were fielded to a total of 12,247 nationals in the 13 candidate countries.

While people in the member states are completely divided over the issue of experiments on animals like dogs and monkeys (45% agree, 41% disapprove), the overwhelming majority of the candidate region supports such experiments (63% pro, 22% against) if they targeted human health problems. The proportion of opponents to animal experimentation was lowest in Bulgaria (only 8% disapprove). The proportion of opponents to animal experiments was comparable to the EU average only in Malta and Slovenia.

Source: EBRA bulletin, Spring 2003


Public opinion on biotechnology

Eurobarometer 2002

In 1991, 1996 and 1999 the European Commission sampled the opinion of EU citizens on biotechnology. The most recent one, covering 2002, gives the result of an inquiry among 16,500 Europeans in every EU member state. A detailed summary of the results is available on:
http://europa.eu.int/comm/public_opinion/archives/eb/ebs_177_en.pdf .


The following picture emerges:

Europeans are not technophobic and trust that new technologies will contribute to quality of life improvements;

Europeans support medical applications of biotechnology. A majority is averse to genetically modified foods;

Support for genetically modified crops is more or less stable, but there are important differences between the various countries;

Consumer and environmental organizations and medical staff are seen as trustworthy sources of information on biotechnology; the verdict on trustworthiness of industry and politicians is still very low (5-3%).


Public....... more confidence with more transgenic words?

Generally, we all know what is meant with a transgenic or genetically modified organism: the organism into which hereditary (genetic) material from another organism has been introduced. These, however, are process-based terms, and they have resulted in very little appreciation for the sources, extent and novelty of genetic modifications made in GMOs. Not surprisingly, indiscriminate scientific, public and regulatory scrutiny based on misleading conceptual assumptions have developed into negative perceptions of GMOs, particularly among EU citizens.

Kaare Nielsen of the University of Tromso in Norway hypothesizes that this failure to establish, from the onset, explicit terminology to categorize the various applications of gene technology in breeding have contributed to this skepticism and to rejection of the technology by many consumers. His main criticism is on the current process-based categorization of GMOs. He therefore proposes the adoption of alternative categories that would shift focus to a product-based perception of gene technology. Accordingly, he arrives at five categories of GMOs as defined by their biological relevance which also address ethical, religious and public concerns. The proposed terms permit a more precise communication of the sources of genetic variability used in gene technology based upon breeding. When reading the article, I had this 'of course' experience (or Aha-erlebnis), and personally (HH) I would be pleased if we could see some of these terms in communications about GMOs. So here are the terms and the five categories, each followed by the source of genetic modification, the genetic variability via conventional breeding and the genetic distance:

Source: Nature Biotechnology, March 2003, vol 21, pp 227-228


UK public more favorable to animal experiments

UK polling specialists MORI sampled the view of UK citizens on the use of animals in medical research. The results showed that the British public opinion appears to be swinging in favor of the use of animals in medical research.

On conditional acceptance of animal experiments (provided that certain conditions are met), 90% approved (versus 84% in 1999), but with changes regarding the species: 80% finds the use of human volunteers acceptable; the use of rats, mice and bacteria(!) is acceptable to 63-66%; rabbits are acceptable to 49% of the people, and monkeys to 39%. On the regulatory system, 50% said they had a lack of trust (versus 64% in 1999). 89% of respondents said they found physical violence against people involved in animal experimentation to be unacceptable, and 83% disapproved of destruction or damage to property.

These results were presented at the launch of CMP, the Coalition for Medical Progress, a new alliance set to explain the case for medical progress and the benefits brought about by animal research. Founding members include academic funding agencies, companies involved in medical research, trade unions, medical research charities and trade associations. The British government supports the aims of CMP and is closely working with it.

Source: EBRA Bulletin Spring 2003


Research news

Discovery gene of lethal form of skin cancer

The incidence of the most aggressive form of skin cancer, melanoma, has doubled over the last 20 years in the U.S.

Because malignant melanoma is generally unresponsive to chemotherapy, scientists are particularly interested in figuring out how it progresses and developing new means of treatment. Researchers have now identified a gene that causes melanoma in mice. In humans, the same gene is involved in a third of melanoma cases.

http://sciam.rsc03.net/servlet/cc?lJpDWXXElJpPkpJhFmLkkHDLlE0EVX


Review: proteomic analysis

A useful review titled 'Proteomic analysis of post-translational modifications' appeared recently in Nature Biotechnology (Matthias Mann and Ole Jensen). Classic techniques and mass spectrometry are used widely in the analysis of individual, purified proteins, but to characterize any single protein in complete detail is still a substantial research project, which by proteomic standards requires large amounts of protein and a combination of different techniques. The article reviews four different experimental approaches how to assess systematically the post-translational modifications of large numbers of proteins:

The authors end with the hope that once PTM analysis can routinely be done at the proteomic level, the involvement of PTM in disease can be studied much more systematically than has thus far been possible, and greater understanding of disease etiology will ultimately deliver many new targets for research against diseases.

Source: Nature Biotechnology, March 2003, vol 21, pp 255-261).


Metabolic pathway engineering: new trick for yeast

In a recent article it was described by Szczebara et al. how a yeast strain was equipped with an altered sterol pathway that can use a simple carbon source to synthesize hydrocortisone, an anti-inflammatory steroid hormone commonly used for the treatment of ailments such as arthritis, skin disorders and adrenal insufficiency. The altered pathway consists of 9 new genes and 4 gene deletions. Baker's yeast normally lacks the enzymatic machinery for synthesizing complex steroids. The authors managed the feat by combining heterologous gene expression of a single plant enzyme and eight mammalian proteins to mimic adrenal biosynthesis of hydrocortisone. Furthermore, four targeted gene deletions removed unwanted endogenous metabolic activity, while the yeast endogenous NADPH cytochrome P450 reductase was used to supply electrons to the mammalian CYPs. This work demonstrates the feasibility of transferring a complex biosynthetic pathway from higher eukaryotes into micro-organisms.

Source: Nature Biotechnology February 2003, vol 21, pp 143-147


....and yeast also for antibody display

Therapeutic and proteomics applications require the high throughput isolation of human antibodies. Recently, it was described how a large non-immune library of human single chain variable fragments of antibodies have been displayed on the surface of yeast. The authors used flow-cytometric and magnetic-bead screening methods to isolate the antibody fragments with nanomolar antigen-binding affinity. Key attributes of the yeast antibody library include the ability to amplify the library without measurable loss of clonal diversity and the capability to carry out simultaneous multiplex screens with at least a dozen different protein, peptide and hapten antigens.

Source: Nature Biotechnology February 2003, vol 21, pp 163-166


The advent of meptides

A number of seemingly unrelated neurodegenerative diseases, including Alzheimer's, Parkinson's and Huntington's diseases, CJD and ALS have all recently been linked to a common pathogenic process called amyloidosis. In each case a specific peptide or protein clumps together in a specific part of the brain to form toxic soluble oligomers and/or insoluble fibres, which are widely believed to cause the progressive degenerations of neurons associated with these diseases. These oligomers and fibres are comprised of beta-sheets which form by association of peptides as extended beta-strands.

Several academic groups and (at least) one biotech company are now working on a novel class of synthetic peptide derivatives (meptides) which can inhibit and reverse this process of protein/peptide aggregation in vitro. Meptides are virtually identical to natural peptides, except that they have methyl groups attached to the backbone nitrogen atoms of alternate amino acid residues. The methyl groups force the meptide molecule into the active beta-strand confirmation of a forming oligomer, but occupy only one edge of the beta-strand. The methyl groups block this edge of the molecule from associating with another beta-strand, while the other edge remains free. Consequently, the meptides are able to bind specifically to the peripheral strands of a growing beta-sheet and prevent its extension.

These meptides have the potential to yield effective treatments or perhaps even outright cures for many of the neurodegenerative diseases mentioned earlier. They could make promising drug candidates because they are very small (MW approx 600 Da) and probably very non-immunogenic, are soluble and resistant to degradation.

Source: Kelvin Stott and Andrew Doig, European Biopharmaceutical Review, Spring 2003. Contact: Kelvin_stott@senexis.com and Andrew.doig@umist.ac.uk


Stem cell news

DG Research report on human embryonic stem cells research

Commission Services (contact: Dr. Line Matthiessen) have released a report on the scientific, ethical, legal and socio-economic issues related to human embryonic stem cell research. The question on how to decide on EU funding for projects involving research with human embryonic stem cells was left open in decision-making process on the EU's FP6. The report reviews the potential benefits of human stem cell research and the pros and cons of using stem cells from different sources. It also reviews the current state of legislation in various EU member states and the governance of human stem cell research under FP6.

The report provided the basis for an open and informed debate which took place on April 24. That debate will contribute to defining guidelines for EU-funded stem cell research.

The report 'Commission staff working paper report on human embryonic stem cell research' (SEC(2003)441) is available on the secure part of the IVTIP website or may be downloaded from the EU's europa site: http://europa.eu.int/comm/research/conferences/2003/bioethics/index_en.html


Potent stem cells in baby teeth

Your seven-year-old's baby tooth may be worth a lot more than the quarter the tooth fairy left under the pillow. Scientists have discovered that the pulp inside deciduous teeth is a treasure trove of fast-growing stem cells. Naturally-shed choppers could thus provide an easily accessible new source of these sought-after cells for clinical studies of stem-cell transplantation and tissue engineering.

http://sciam.rsc03.net/servlet/cc?lJpDWXXElJpPkpJhFmLkkHDLlE0EVT


International stem cell project

Discussions have begun on the possible creation of an international stem cell research consortium that aims to coordinate existing resources, such as human stem cell lines, in order to avoid duplication of research. Another aim is collaboration and assessment of each country's strengths. The initiative is promoted by the UK Medical Research Council. Countries possibly participating are the ones already funding such research: US, Canada, Australia, Finland, Sweden, Singapore and Israel. At present, the UK has the most favorable stem cell legislation, while US researchers have the most expertise in how stem cells specialize. Two expert working groups have been formed, one that will focus on the quality requirements to carry out stem cell research and the second to outline ethical rules in each country.

Source: Nature Biotechnology, March 2003, vol 21, pp 220.


Neural commitment after ES monoculture

Mouse embryonic stem cells are competent for production of all fetal and adult cell types, but their utility as a developmental model or as a source of defined cell populations for pharmaceutical screening or transplantation is limited because of poor control of differentiation in vitro. In a recent article, Ying and colleagues reported that neither multicellular aggregation nor coculture is necessary for mouse embryonic stem cells to commit efficiently to a neural fate. Using adherent monoculture, they eliminate inductive signals for alternative fates and thereby induced cells to develop into neural precursors. This process required autocrine fibroblast growth factor.

Source: Nature Biotechnology, February 2003, vol 21, pp 183-186


Cryopreservation stem cells

Company CryoCell Europe started two years ago with the cryopreservation of stem cells from cord blood for autologous use. In the US, the activity, which started there eight years ago, is a great success, with 25,000 of the annual 50,000 samples banked in the USA handled by CryoCell. In Europe, so far there have been 6,000 samples stored. However, CryoCell Europe has a wider scope than its American counterpart: it recently acquired German company MainGen in Frankfurt, which has a lot of know-how in the area of stem cell technology. CryoCell Europe is also involved in a large Multicenter (33) clinical trial whereby stem cells from bone marrow are injected into patients with an acute myocardial infarct. So far, the results are promising, with the heart's condition improving to the pre-infarct level.

Source: Management Info 2003


New stem cell biology partnership

On April 8, US company VistagenTherapeutics announced the signing of a strategic research partnership with Sanwa Kagaku Kenkyusho Co. Ltd., (ìSKKî), an established international pharmaceutical company headquartered in Nagoya, Japan. Under the new agreement, both companies will utilize VistaGen's portfolio of stem cell technologies to develop innovative stem cell based discovery tools for internal research programs and commercialization with third parties. Terms of the agreement provide VistaGen with upfront technology license fees, an equity investment, and several years of funded research. Vistagen's stem cell technology platform is used for drug discovery, proteomics and in vitro toxicology.


Business News

Medicon Valley comes out top

A new study from the Boston Consulting Group places the Denmark-Sweden 'Medicon Valley' among the best of Europe's Biotech Clusters. There are four major pharmaceutical corporations (Novo Nordisk, AstraZeneca, LEO Pharma and H. Lundbeck), and 115 life science companies of the latter, 55 have emerged since 1998. They have been nourished by the regions 12 universities (including the ones from Lund and Copenhagen), highly qualified pool of employees, and from clinical testing resources that are among the best in Europe. In total, 41,000 of the three million people living in the Medicon Valley region are employed in the life science industry. The Consultant's report found Medicon valley to be the world's best in terms of research for diabetes and highly attractive in three other commercially vibrant areas: immunology/inflammation, neuroscience and cancer. Furthermore, Medicon Valley has a higher number of partnerships and a greater incidence of partnerships per company than any other place in the world.

The region is very active in pulling resources together. Here are some of the most prominent projects:

Copenhagen BioCenter: a new research facility. Will be a strong cross-disciplinary environment. To be completed 2004;

Biotech Research & Innovation Center (BRIC), Copenhagen: to be located within the BioCenter in 2005. Objective is to be a front-line, inter-disciplinary biotechnological research unit with focus on bioinformatics, gene expression, transgenic technology and functional analysis;

Center for Stem Cell Biology and Cell Therapy, Lund: a multidisciplinary center for stem cell biology and cell therapy to be located at the BioMedical Center. Also new areas such as embryonic stem cells, functional stem cell genomics and non-mammalian stem cell biology.

Center for diabetes and stem cell research, Lund: a multidisciplinary centre for diabetes research and stem cell research initiated by the Lund and Malmo University Hospitals. Focus on genetics, cell biology and pathophysiology of islets of Langerhans

Swe-Gene-Proteomics Center, Lund: SweGene is a consortium within the field of functional genomics established by several Universities in Gotheborg and Lund. Purpose is to create common technology platforms and research centers in southwestern Sweden. Has a prominent proteomics centre in Lund.

Source:European Biopharmaceutical Review, Spring 2003. The report 'Commercial Attractiveness of Biomedical R&D in Medicon Valley' by The Boston Consulting group can be downloaded at www.mediconvalley.com


Publications

Summary of REACH

Jan van der Valk of NCA sent us the following message:

Karin Gabrielson of the Swedish Fund for Research without Animal Experiments has summarized the EU draft new Chemicals Legislation, REACH (Registration, Evaluation and Authorisation of Chemicals). She has made these document available through the NCA website: http://www.nca-nl.org

Follow the link on the home page under "latest news" items.


AGENDA

Biologic 2003
June 4-6, 2003, Geneva, Switzerland

Information: www.pharma-rd.net

ICCVAM Workshop 2003
Practical Methods in In Vitro Toxicology,
June 10 - 12, 2003

Information: http://iccvam.niehs.nih.gov/meetings/iivs03wkshp/iivs03flyer.pdf .

COLIPA General Assembly
June 25-28, Luxembourg

Information: COLIPA. Ms Brigitte Frere, email: bfrere@colipa.be

9th Meeting of the International Neurotoxicology Association
(INA-9) 22
June 27, 2003 Dresden, Germany

Info: http://www.ina-9.org/

Genetics. Genomes, the linkage to life
July 6-12, 2003, Melbourne Australia

Organization: www.geneticscongress2003.com

9th European Association for Veterinary Pharmacology and Toxicology Congress
July 13-18, 2003, Lisboa, Portugal

Information: http://www.fmv.utl.pt/eavpt2003/congress.htm

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

Organisation: ECB11, Tel + 41 61 686 28 28; fax: +41 61 686 21 85;
email: info@ecb11.ch;
web:www.ecb11.ch

6th Conference on Protein Expression in Animal Cells
September 7-11, 2003, Montreal, Canada

Information: Amine Kamen, Biotechnology Research Institute,
tel + 514 496 0915, fax + 514 496 6785
Email: 6thPEACe@nrc.ca;
www.bri.nrc.ca/6thPEACe

Environmental Health Risk 2003
17-19 September 2003 Catania, Italy

Information: www.wessex.ac.uk/conferences/2003/healthrisk03/index.html

Strategic Resource management
September 18-19, 2003 Philadelphia, PA, USA

Information: www.PharmaSeries.com

17th forum for Applied Biotechnology
18-19 Sept, 2003, Gent, Belgium

Organization: fab2003@biomath.rug.ac.be

41st Congress of the European Societies of Toxicology
"Eurotox 2003"
September 28 - 1 October 2003 Florence, Italy

www.eurotox2003.org/

BioValley Life Sciences Week
October 13-17, 2003, Basel, Switzerland

Information: info@biovalleybasel.com

Epidos Annual Conference Patinnova '03
November 10-12, 2003, Luxembourg

Information: www.patinnova.org
Or www.european-patent-office.org/epidos/conf/eac2003/

CORDIA-EuropaBio Convention 2003
Dec 2-4, 2003, Vienna, Austria

Information: clare.king@reedexpo.co.uk
www.cordiaconvention.com

BioSquare 2004
March 10-12, 2004, Basel, Switzerland

Information: info@biovalleybasel.com

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

Organization: blhata@uta.fi
or www.uta.fi/fst

EuroScience Open Forum 2004(ESOF2004
August 25 28 August 2004, Stockholm

Information: www.esof2004.org