Latest & next steps:

• The ERC governing body has already been established and it has held its first meetings in order for the ERC to be operational right from the start of the FP7.
• A detailed Commission proposal on the EIT is expected in June 2006. The EIT's first 'knowledge communities' are expected to be in place by 2009-2010.

Source: EurActiv News, April 26, 2006

....and other EU news

Commission consults on securing sufficient organ supply

Annually, 40,000 patients in Europe are on a waiting list to receive a new organ. Currently, few exchanges of organs occur between EU-25. The main European organ exchange organisations (EOEOs) recommend development of systems for offering excess organs and the exchange of patients between countries, which raise questions such as the reimbursement of costs, common transplant list admission criteria and prevention of registration on multiple transplant lists.

An EU directive on setting quality and safety standards for human tissues and cells was adopted in 2004 and for blood and blood products in 2002.

Further reading:

• Commission press release: Organ Donation: Commission launches public consultation (27 June 2006) [FR] [DE]
• Eurotransplant International Foundation: European Organ Exchange Organisations: summary report on individual activities & joint initiatives

Source: www.euractiiv.com

New initiative launched for SMEs: JEREMIE

The European Commission, the European Investment Bank and the European Investment Fund have launched a new initiative called: "Joint European Resources for Micro to Medium Enterprises Initiative" (JEREMIE) that will contribute to growth and employment in line with the renewed Lisbon agenda.

JEREMIE is meant to help Small and Medium Enterprises (SMEs) access financing in the framework of the European Regions. This initiative will allow some of the Member States and Regions' structural funds to be transformed into special financial products to contribute to SMEs' needs as long as they fulfil certain requirements.

The initiative is expected to begin its operational phase in January 2007, with multiple objectives, including: improving business' conditions (including their funding and development), managing the scarce public resources granted under the EU programmes, coordinating and increasing efficiency of the management of public resources.

Source: IPR HelpDesk June 8, 2006

Scientists think communication is bad for their careers

A study entitled the Factors affecting science communication concludes that, in British universities, a 'research driven' culture, the pressure to publish research, to attract funding to their departments and build career on 'hard research' are key barriers to scientists communicating their work with the public. Lack of time, due to the need to spend more of it on research was cited as an important reason for not getting engaged with science communication activities.

The survey reveals that the scientists even highlight public engagement work, such as debates, dialogues, exhibitions and media appearances, as being bad for their careers. According to the report, "some said that it was seen as being done by those who were 'not good enough' for an academic career, that it was 'light' or 'fluffy' and risked reinforcing negative stereotypes for women involved in these activities".

In recent years the Commission has intensified its efforts to communicate EU funded research activities to the general public. Thus it aims to enhance the communication between scientists and citizens in general, as citizens need to be informed about the rapid advances in science and the scientists need to understand the social context in which they operate.

Promoting a positive image of R&D in general, and attracting more young people into scientific careers in Europe, is also relevant to the Lisbon agenda, which states R&D as the key to innovation and competitiveness.

Further reading:

• The Royal Society, Research Councils UK and the Wellcome Trust: Factors Affecting Science Communication (29 June 2006)
• The Royal Society press release: Research pressure in universities is barrier to scientists communicating work to public (29 June 2006)

Source: EurActiv News, July 5, 2006

EU innovation really trailing US?

It is commonly held that the EUs efforts and attitudes towards innovation are trailing far behind the US. However, closer examination reveals that this may be a major over-generalisation. Innovation performance in some EU member states far outstrips that in most US states. Equally, sectors show wide variation. An Innovation Trend Chart policy workshop held in November 2005 looked in detail at EU-US comparisons, aiming to characterize the innovation gap more precisely and define what each can learn from the other. Below follow weak and strong points.

The US:

• has no national innovation policy, but a National Innovation Act was introduced in the US Senate in December 2005. There are only modest national support programmes for SMEs, but some states have focused strategies (i.e. Michigan focuses on biotechnology and California on stem cell research);
• applied R&D spending has gone down from 0.27% of GDP in the mid 1980s to 0.15% now. This is also true for basic research (apart from health)
• the US has a 20-30 years head start with forming new companies, which have provided most of the economic growth.
• There are good university-industry links, but there is concern about declining numbers of science and technology graduates and of foreign students.
• In the US, there are just a few advanced 'hot spots', but most states are neither innovative nor showing strong growth;

The EU:

• Some EU sectors are innovating in a much more sustained way than in the US (notably automobile, space and aircraft technologies). Some EU states lagging behind are improving in absolute terms;
• The target to invest 3% of GDP on R&D by 2010 only makes sense for a limited number of regions.
• The EU has a Strategic Priorities for Research and Innovation since 1995 and is regularly revising it;
• Many EU universities are still hampered by intellectual property issues. Overall, the EU is weaker on exploitation.
• Leading EU innovator countries are Germany, Switzerland, Sweden and Finland. Their US counterparts are Washington, Idaho, California, New Mexico, Illinois, Michigan, Massachusets, Connecticut, New York and Delaware.
• EU members states with an average performance include Ireland, Iceland, the UK, France, Belgium, the Netherlands, Italy and Austria.

For more information, see www.ppionline.org and www.technopolis-group.com

Source: European Innovation, March 2006, pp 24-25

Eurobarometer: EU citizens gaining trust in biotech, except GM food

Eurobarometer surveys on biotechnology and life sciences are being conducted every three years. In comparison to earlier surveys, the Eurobarometer 2005 survey shows that EU citizens are, in general, more optimistic about technology. However, whereas "there is widespread support for medical (red) and industrial (white) biotechnologies" there is "general opposition to agricultural (green) biotechnologies in all but a few countries," concludes the report. Europeans see genetically modified (GM) food as "not being useful, as morally unacceptable and as a risk for society".

The survey shows large support for the development of nanotechnology, pharmacogenetics and gene therapy, which most Europeans consider as "useful to society and morally acceptable". The claim that European public opinion is a constraint to technological innovation and contributes to the technological gap between the United States and Europe, is therefore, according to the report, invalid.

Comparing public opinions on both sides of the Atlantic, the report says there is a striking difference between the American and European public opinions on GM food and nanotechnologies. Europeans fiercely oppose GM food and largely support advances in nanotechnology, whereas in the US the opposite holds true.

Further reading:

• Eurobarometer: Europeans and Biotechnology in 2005: Patterns and Trends (May 2006)

Source: EurActiv News, June 21, 2006

More on REACH

US companies fear 'black list' effect of REACH

A proposal to keep a register of chemicals selected for priority health and safety checks under REACH will create a "black list effect" that US companies fear will be used by green NGOs to force substances out of the market even before they are evaluated.

The REACH proposal defines some chemical as being "of very high concern" to human health and the environment, requesting that they be evaluated as a top priority by the future European chemicals agency in Helsinki. Substances "of very high concern" are defined as those blamed for causing cancer, genetic mutations or reproductive problems and which tend to build up in the human body and the environment [carcinogenic, mutagenic and reproductive toxic (CMR); persistent, bioaccumulative and toxic (PBT); and very persistent and very bioaccumulative (vPvB)].

However, the European chemicals agency will still be able to authorise these substances in cases where their replacement proves too difficult, too costly or when there are no alternatives. In their first reading on REACH last year, the EU Council of Ministers agreed that the agency would be able to allow the temporary use of these chemicals only under three circumstances:

• their risks for human health or the environment are "adequately controlled"
• the social and economic benefits of the substance outweigh those risks; or
• analysis has shown "suitable alternative substances do not exist"

In a position paper dated 10 April 2006, the American Chamber of Commerce to the EU (AmCham EU) says it is "strongly opposed" to the elaboration and publication of a so-called "candidate list" of substances of very high concern to be assessed in priority under REACH.

AmCham EU argues the mere publication of the list "will have a de facto black list effect" that is likely to cause massive business disruptions even before the agency assesses whether they can be authorised despite their high toxicity.

It says publication will make it very difficult in practice for companies making consumer products (eg, toys, food packaging and cosmetics but also others such as cars and computers) to justify the presence of 'substances of very high concern' in their products.

It expects that manufacturers will require suppliers to provide them only with raw materials that do not appear on the list, forcing them to transform complex supply chain arrangements and causing "major business disruptions and unnecessary barriers to trade".

But what AmCham EU fears the most is that the list "will be used by green NGOs and their Governmental supporters to force companies not to use these substances". Such an outcome would constitute an unnecessary obstacle to trade, opening the prospect of a WTO dispute in accordance with article 2.2 on technical barriers to trade (TBT), says AmCham EU.

On the NGO side of the fence, chemical safety campaigner Justin Wilkes at WWF's EU office prefers to turn the argument the other way round. He says making the list public would actually allow manufacturers to be informed early on about substances likely to be banned in the future, giving them more time to adapt to a changing business environment. "It is beyond doubt that there will be a list," Wilkes says. But he admits that the issue of determining whether it should be made public under REACH is still open to consideration in second reading. In any case, he warns, if the candidate list is not made freely available, the WWF and Greenpeace will publicise their own.

Latest & next steps:

• October 2006: Expected vote in Parliament Environment Committee (second reading)
• 24 October 2006: Expected vote in Parliament Plenary (second reading)
• End 2006: Expected second reading in Council and possible final approval of REACH

Source: EurActiv News April 28, 2006

Animal use

Public Consultation on revision Animal Research Directive

The European Commission has recently started the public consultation on their proposals to revise Directive 86/609, which regulates animal experimentation within the EU. The Commission has adopted a careful approach with the consultation, by offering two quite different versions: one for the public and the other for experts in "animal welfare, animal testing, animal science, natural sciences (especially biology, medicine, pharmacology and toxicology), legal and economic affairs related to these areas."

Although the expert consultation form is lengthy (it contains length explanations about the proposals), it is only necessary to comment on those parts which are of concern. The closing date for submission is August 18. Submissions can only be made through the web.

http://ec.europa.eu/environment/chemicals/lab_animals/ia_info_en.htm#5

The public consultation is fairly short and concentrates on opinions about the appropriate levels of protection for laboratory animals, the acceptability of various purposes for using animals, which species should be used, transparency and alternative methods.

The results of the consultation will be made public, but the expert version of the consultation allows users to withhold their name and institution from being made public.

Source: EBRA Bulletin, June 2006

Primate research to be curtailed

Only second generation (ie F2) captive-bred primates could be used in the future for research, although there might be a phase-in period for this change.

The 2002 figures show that 9,267 non-human primates were used in scientific procedures in the EU. Of these, 1095 were new-world primates, the vast majority of which would have been marmosets, which are routinely bred in long-term colonies and this would be at least second generation captive bred. The remaining 8075 are old world primates, nearly all of which would be macaques. The vast majority of these are imported into the EU.

The main macaque breeders are in Mauritius, Philippines. China and Israel.

The vast majority of macaques are used in the EU for the development and testing of pharmaceuticals and vaccines, although a significant minority is used in academic research in the neurosciences. Since there is little prospect of a supply of F2 animals becoming available, this proposal would cause all pharmaceutical and vaccine industry primate work and much academic primate neuroscience research to be moved out of the EU.

Source: EBRA Bulletin, June 2006

Animal right extremists target GSK investors

Animal rights activists have continued their campaign of intimidation after it was revealed that GlaxoSmithkline (GSK) shareholders were sent letters demanding they sell any shares held within the company. The act was carried out as part of an increasingly violent campaign against the Huntingdon Life Sciences laboratory in Cambridgeshire, which GSK are known to have close links with. According to details published in the Guardian newspaper, an anonymous animal rights group claimed to be writing to all 170,000 small investors warning them to sell up. However, it is unclear how many did receive a letter. The letter stated that animal rights activists would "hold Huntingdon Life Sciences accountable for its acts of animal cruelty" and warned that every shareholder would receive the letter in the next two weeks."

GSK issued a statement and advice instructing shareholders on action to be taken should they receive one of these letters. The statement also reassured shareholders that the police had been informed and an investigation had been started.

Source: www.DrugResearcher.com, May 9, 2006

Public petition to support animal research

A pioneering website has been set up that enables members of the UK public to express their support for medical research that uses animals as subjects. The move is in response to recent news reports that have portrayed animal research as an unnecessary process, which has been carried despite mass protests from the general public.

The website aims to gather the details of those that log on forming a petition that effectively gives a voice to the "silent majority" who accept the need for animal studies. The petition, which has been set up by The Coalition for Medical Progress (CMP), includes pharmaceutical companies and those involved in academic research. In signing the petition, the visitor agrees to three statements that embody why animal research experimentation is important and necessary.

The statements read: "Medical research is essential for developing safe and effective medical and veterinary treatments, requiring some studies using animals. Where there is no alternative available, medical research using animals should continue in the UK. People involved in medical research using animals have a right to work and live without fear of intimidation or attack."

The People's Petition is available at:

http://www.thepeoplespetition.org.uk/

Source: www.DrugResearcher.com, April 20, 2006

Nano News

Sugar and olive oil for drug delivery nanomaterials

US scientists have discovered that sugar and olive oil do not just belong in the kitchen - but could potentially be used to develop naturally-derived nanomaterials for drug delivery systems and biological scaffolds.

Fundamental research from the US (Rensselaer Polytechnic Institute in New York ) suggests that an enzyme could convert sugars in the presence of olive oil to form organic gels called 'nano organogels'. These organic gel nanomaterials could be used to encapsulate pharmaceutical products to create new drug delivery systems, as well as being used to build 3D biocompatible scaffolds for tissue engineering and designing membranes. The science behind the gels entailed using the enzyme lipase B from Candida antarctica (CALB) to form esters of trehalose, a sugar found naturally in mushrooms, honey, lobster and shrimp. The trehalose diesters then self-assemble into 3-D fibres measuring between 10 and 50 nanometers in diameter. As the fibres entangle, a large amount of solvent gets packed together, trapping some 10,000 molecules. Disintegration of the gels could occur, said the researchers, by re-exposure to lipase, an enzyme that is naturally present in the human intestine. This research opens up the possibility that active pharmaceutical ingredients (APIs) could be encompassed in the trehalose nano-gels, with release dependent on re-exposure to the enzyme.

In addition to olive oil, researchers also successfully tested the trehalose esters in six other organic solvents, including acetonitrile, acetone, isopropanol, and ethyl acetate. The scientists found that longer ester-chain trehalose derivatives could form gels in olive oil with relatively low minimum gelation concentrations. The researchers did try other sugars, including sucrose, maltose and lactose, but gels were only formed in the presence of trehalose. The findings are currently available online in advance of print publication July 17 by the journal Angewandte Chemie.

Source; In-pharmatechnologist.com, July 17, 2006

Magnetic nanoparticles show promise in targeted drug delivery

Researchers have developed a new nanocarrier system for the delivery of drugs. The nanocarrier system contains iron and so can be directed by a magnetic field to specific areas of the body, a technology which could prove invaluable in the treatment of diseases such as cancer.

For their drug delivery vehicle, researchers used polymer micelles, which are nanosized, water-dispersible clusters of polymeric molecules, and so are excellent nanocarriers for (photodynamic therapy (PDT) drugs, which are mostly water-insoluble. Along with the photodynamic drug, they encapsulated inside the nanocarriers iron oxide nanoparticles, which allowed them to respond to externally applied magnetic fields. Not only does the new system allow the guided and precise delivery of drugs to chosen areas of the body, a tumour for example, avoiding serious side effects, but it also enhances the cellular uptake of the PDT drugs it transfers. Although PDT is one of the most promising treatments for cancer as well as cardiovascular, dermatological and ophthalmic diseases, it has numerous side effects, including the patient's strong sensitivity to light for four to six weeks after treatment.

In the experiments, nanocarriers were shown to be efficiently taken up in vitro by cultured tumour cells in the area exposed to the magnetic field, as demonstrated by confocal microscopy. Once the magnetic field was applied, the concentration of drug inside the tumor cells in the target area increased. While the team demonstrated their method with PDT drugs, the technique would also be useful in delivering gene therapy, chemotherapy or practically any kind of pharmaceutical treatment into cells.

Preliminary studies in live animals have indicated that an applied magnetic field can effect a localized accumulation in the tumor site and the team is beginning in vivo studies on the new drug delivery method.

Source: www.DrugResearcher.com, June 27, 2006

Use of silver nanoparticles expanding for antimicrobial applications

Silver nanoparticles are emerging as one of the fastest growing product categories in the Nanotechnology industry, according to Bourne Research (http://www.bourneresearch.com). The market research firm reports that the ability to produce particles of silver at the nanoscale is allowing companies to leverage its known antimicrobial properties in ways never before imagined as an effective means of infection control.

Bourne Research reports that the medical sector was one of the first on board where end-uses have already migrated from burn dressings to surgical instruments and hand sanitizers. In addition, a recent study by a leading supplier of textiles to hospitals showed a dramatic reduction of infectious microbes in curtains embedded with silver nanoparticles. Sportswear manufacturers are also embracing its use to prevent odor in clothing. In the home, consumers can already find washing machines, refrigerators, HVAC filters, brooms and even food containers that employ silver nanoparticles to kill bacteria and limit mold growth -- and this is just the beginning.

Source:
Genetic Engineering News, April 18, 2006
www.genengnews.com/news/bnitem.aspx?name=556549

Scientists To Tackle Illness With 'silver Bullet', Medical News Today, 31 March 2006, http://www.medicalnewstoday.com/medicalnews.php?newsid=40586#

Microchips wired with proteins

The University of Arizona is combining biology and electronics to develop a new type of mirochip. This microchip will have wiring consisting of microtubuli, hollow protein filaments that a play a role to unravel chromosomes during mitosis.

The hollow protein filaments are coated on the inside with a very thin layer of copper, allowing electrical conductivity, while the outside layer acts as an insulator. Research focuses on genetic modification of the microtubule to investigate their adhesion to metal surfaces.

So far, the scientists can already synthesize the microtubules and grow them in every possible length on every possible surface. The protein filaments measure approx 25 nanometer across and may reach a total length of 100 nanometer.

Apart from their use in microchip technology, the filaments may also be used in drug discovery and testing. Synthetic microtubule are an effective platform to test drugs that are able to destroy microotubuli in tumour cells.

Source:
UA pursues revolutionary approach, The Arizona Republic, May 3, 2006, www.azcentral.com/arizonarepublic/business/articles/0427biz-innovator0427.html

Research News

Nematodes useful to screen drug compounds

Researchers from the UK and The Netherlands genetically modified nematode worms (C.elegans) to have human receptors in their nerves, which they use to detect and avoid harmful chemicals in their environment. The research carried out involved breeding the worms to include somatostatin receptors. These receptors are normally activated by the somatostatin hormone that plays a key role in neural signalling. Worms were also introduced with chemokine receptor 5, which responds to a molecule called chemokine that plays an important role in the immune system.

Experiments with these modified worms involved placing somatostatin or chemokine in the pathway of the modified worms, which they moved away from when confronted. In his paper, published in the journal Biomedcentral Biology, John McCafferty, principal investigator at the Sanger Institute, said: "To survive, the worms have to taste and smell the environment around them, and they will automatically swim towards food and away from harmful chemicals. We basically hijacked that system to make them respond to human signalling molecules, and effectively they are tasting the human signalling molecules and swimming away from them."

The use of a worm represents a screening method at its most basic and provides a viable alternative to the robotics and high-speed computer technology involved in drug compound screening. Additionally, it eliminates the need for a highly specialised and expensive tissue culture lab to run an efficient screening operation.

Source: www.DrugResearcher.com, July 21, 2006

NIH project to map human cancer genome

The National Institute of Health (NIH, USA) has the ambitious plan to identify the range of genetic mutations causing all types of human cancer: the Cancer Genome Atlas (TCGA) project. The project will last nine and will cost 1.35 $ billion and will be a joint initiative of the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI). TCGA will begin as a 3 year, 100 m$ pilot. During this pilot, the genomes of five cancer types will be studied. During the full scale project, approximately 50 cancer types will be studied.

For more information, see http://cancergenome.nih.gov

Collaboration to develop human-on-a-chip technology

Schering, acting through its Schering Plough Research Institute (SPRI), signed a contract with Hurel to join the joint scientific collaboration of pharmaceutical firms organized by Hurel.

Under the agreement, SPRI will provide both scientific guidance as well as funding as Hurel continues its one-year R&D program aimed at validating and developing its microfluidic, human-on-a-chip cell-based assay platform technology. In July 2005, the company had already signed a similar collaborative agreement with Johnson & Johnson Pharmaceutical Research & Development, L.L.C., ("J&JPRD"), making J&JPRD the first pharmaceutical company to enter the Joint Scientific Collaboration ("JSC").

At present there are no rapid preclinical tools to mimic the in vivo interplay of enzymes and transporters. What is needed is a simple flow-through assembly that must be amenable to incorporating hepatocytes and enterocytes, and should be high-throughput. Such a novel tool would provide great insights into the ADME of new molecular entities, expose the reasons for the discordance often found between the ADME characteristics of drug molecules across animal species versus humans, and thereby materially reduce the need to rely on animal studies of the metabolism of drugs intended for humans."

Source: Genetic Engineering News, July 25, 2006

About HµREL:

HµREL Corporation is a development-stage enterprise based in Beverly Hills, California. HµREL is presently inaugurating a Joint Scientific Collaboration ("JSC"), through which a group of global pharmaceutical and consumer products firms will collectively provide scientific guidance and funding as HµREL carries out a one-year research and development program aimed at fully validating its technology and readying its first products for general, commercial release. HµREL projects its JSC laboratory activities to commence in the third quarter of 2005.

HµREL's first product&emdash;a microfluidic circuit that models real-time protein binding, metabolism, and extraction in the liver&emdash;will comprise the world's first comprehensive, in vitro test of first-pass liver bioavailability in humans or other species. Other HµREL applications slated for early development include devices customized for studying various multi-organ toxicities (e.g., liver/lung or liver/cardiac), as well as for studying the integrated mechanisms of absorption and bioavailability of orally administered compounds.

For more information, see www.hurelcorp.com

Key to growing new human stem cells found

Scientists at Duke University Medical Center have demonstrated they can grow human stem cells in the laboratory by blocking an enzyme that naturally triggers stem cells to mature and differentiate into specialized cells. In their study, published on line and in the upcoming August 1, 2006, issue of the PNAS, the investigators discovered that an enzyme, aldehyde dehydrogenase (ALDH), stimulates hematopoietic stem cells to differentiate into blood or immune cells. They inhibited this enzyme in stem cell cultures and successfully increased the number of stem cells by 3.4 fold. Moreover, they demonstrated the new stem cells were capable of fully rebuilding the blood-forming and immune systems of immune-deficient mice. Unraveling the pathways that regulate self-renewal or differentiation in human stem cells can facilitate the ability to expand the growth of human stem cells for therapeutic uses."

Source: Genetic Engineering News July 27, 2006

Business News

Delta acquired by NovoZymes

UK company Delta was acquired by Novozymes, effective 6th July, and has changed its name to Novozymes Delta Ltd. NovoZymes Delta has as lead product Recombumin®, the world's first and only animal-free, commercially available recombinant human albumin. It is also well known for its yeast expression systems for safe and cost-effective recombinant protein production, as well as for its antibody fragment and albumin fusion technologies.

Source: http://www.deltabiotechnology.com/downloads/NovozymesDelta070706_2.pdf

New software for rapid in-silico drug screening by Tripos

Company Tripos has introduced its answer to rapid in-silico drug screening with its virtual screening software that uses a fully automatic flexible molecular docking algorithm to offer speed, accuracy and usability advantages over current methods.

The software aims to provide a solution to the problem of screening large compound libraries, which remains an expensive and time-consuming task. Computational high-throughput screening can enrich the fraction of suitable compounds in a screening collection, thereby reducing the cost of biological testing in lead discovery.

Two aspects determine the quality of a docking method: docking accuracy and screening enrichment. Docking accuracy measures the likelihood that a method will correctly identify and recognise the true binding mode of a ligand bound to a target protein. Screening enrichment measures the relative improvement in the identification of true binding ligands using a docking method versus random screening. Surflex-Dock addresses the protein ligand docking problem, demonstrating a novel approach that is faster, more accurate, and is five to ten-fold more specific than competing methods in detecting true binding ligands from non-binding ligands in computational screening applications. The docking search engine makes use of a patented technology.

Source: www.DrugResearcher.com, July 5, 2006

Human tissue worth more than diamonds

Using human instead of animal tissue in earlier stages of new drug testing will help to more accurately predict the safety of new treatments, especially liver toxicity - one of the most common reasons for a drug not being approved. This will help identify toxicity problems with new drugs before they are tested on humans, and thus reduce the number of new drug failures and speed up drug development. The Critical Path (C-Path) Institute, set up by the University of Arizona, and the US Food and Drug Administration (FDA) to investigate ways of improving drug development, believes that a ten per cent increase in the speed of drug development can save $100m for every new drug.

However, traditionally it has been hard for drug firms to get hold of human tissue due to ethical issues and the challenges of patient and family consent. As a result, human tissue is said to be worth more than diamonds, being valued at $500/gram. Furthermore, research with human tissue has often been problematic due to inconsistent standardization and quality control of the samples being sourced by researchers.

UK's Pharmagene merged with US company Asterand in January 2006 to form a human tissue supply and research services company with an extended tissue supply network of over 70 sites in the US and Europe as well as a biorepository over 300,000 samples, making it the largest contract research organisation (CRO) of its kind in the world. The company offers supply services involving the processing and banking of tissue as well as research services and data generation.

Currently, the firm is working with 18 of the top 20 pharma companies.

Source: www.DrugResearcher.com, July 6, 2006

Neuropharma presents new mechanism of action for Altzheimer's drug

Neuropharma has developed a new treatment for Alzheimer's Disease, based on a novel mechanism of action that targets a little-known enzyme that contributes to the proliferation of the neurodegenerative disease.

NeuroPharma's lead compound, NP-12, has a new mechanism of action that may slow the neurodegenerative process by inhibiting the GSK-3 enzyme involved in the excessive phosphorilation of the tau protein and in the deposit of neurofibrillary tangles, one of the neurodegenerative lesions associated with neuronal death and correlated with the dementia severity.

"Proof of efficacy in several animal models and the toxicological and safety regulatory studies have shown that NP-12 could be a promising treatment for Alzheimer's disease with an innovative therapeutic approach," said Ana Martínez, R&D Director of Neuropharma.

Speaking at the 10th International Conference on Alzheimer's Disease (ICAD) taking place in Madrid from 15th to 20th July, NeuroPharma revealed that it had designed the Phase I clinical development (safety assessment and dose escalation) to establish the safety of the compound in humans and define the optimal dose for the Phase II and III trials.

"To date, NP-12 has been administered to more than 30 subjects. We have not observed any relevant adverse event," said Teodoro del Ser, medical director of the Company.

Source: www.DrugResearcher.com, July 17, 2006

NorayBio links with BioDynamics on Noraymet ADME software

NorayBio has licensed its biopharmaceutical platform Noraymet ADME (biopharmaceutical software for the prediction of human pharmacokinetics of new compounds derived from in vitro ADME data) to the English CRO BioDynamics. The companies will collaborate to further develop the software to refine human pharmacokinetic modelling. In addition to BioDynamics, NorayBio has licensed Noraymet ADME to the Spanish pharmaceutical company Faes Farma and the Finish CRO Novamass.

Julio Font (Managing Director, NorayBio): BioDynamics decision to act as a strategic partner on the enhancement of Noraymet ADME and to act as a reference customer is an important validation of the work we have undertaken in producing Noraymet ADME.
Stephen Lewinton (Managing Director, BioDynamics): I see this as an exciting opportunity for BioDynamics to enhance its discovery support services by facilitating cost effective prediction of human pharmacokinetics. Poor ADMET properties remain a key cause of compound failure in clinical development and we see a significant opportunity to refine predictions by linking in vitro and in vivo data. I was particularly impressed by the robust scientific data that has been used to develop this software and the attention that has been given to making it user friendly.

NorayBio is a bioinformatics company that designs, develops and implements software for bioscience, with great expertise in the development of software for biopharmaceutical research, mainly for ADMET, metabolism and pharmacokinetics studies. BioDynamics provides a wide range of metabolism, radiosynthesis and bioanalytical services to support both drug discovery and development. BioDynamics discovery services incorporate a wide range of in vitro and in vivo ADMET assay

Source: NorayBio Press Release, August 3, 2006.

More information: efernandez@noraybio.com

Practical help for innovators

SME managers can now use a new tool to support innovation activities: the InnoSupport guide. With the tool they can learn, in a quick and practical way, about a wide range of innovation tools. It provides SMEs with ideas and lets them quickly choose the tools which could be useful, such as black box method, system and process analysis, SWOT analysis, brainstorming, knowledge management strategies, benchmarking and much more. There is also information on related policies, intellectual property management, the financing and marketing of innovation and links to innovation networks.

The tool is (freely) available at: www.innosupport.net

It is available as a searchable web-based tool and as a (hefty!) pdf-file. For more information, please contact the coordinator, Gerd Zimmer, at zimmer@pro-kompetenz.de

Stem cell use set to rise despite objections

Stem cell-based research is poised to enter the next stage as a positive shift in government attitude together with encouraging public and private funding across several major healthcare markets is expected to promote this research like never before.

According to Frost and Sullivan's report: "Current Clinical Applications and Trials of Stem Cell-Based Therapies," increased R&D funding from governments and venture capital firms has only arisen after they have recognized the immense potential of stem cell applications in medical treatments.

One place that has made significant headway is the Asian continent, particularly South Korea. Despite last year's scandal, in which a South Korean cloning pioneer admitted fabricating results in key stem cell research, there is no doubt that the country has reached a stage in research that is envied throughout the world. The report warned of over-hyping this new technology, as the significant process gained cannot not hide the fact that stem cell-based therapies still remain in the pre-clinical stage.

Pharmaceutical and biotech companies are in limbo at the moment, unsure as to the potential of such a revolution in treatment. One company which has taken the plunge is US-based biotechnology company Advanced Cell Technologies (ACT). Its research is based on using human embryonic cells (hES). The company recently announced the derivation of hES cells without exposure to feeder layer or serum environment, representing a vital step towards commercially viable embryonic stem cell derived transplant therapy. Likewise, Geron Biomed is also using hES cells in its therapeutic research programs, focusing on spinal cord injury, heart disease, diabetes, osteoarthritis and osteoporosis. It is currently working on animal models in these areas to demonstrate proof of concept before looking towards clinical studies.

For pharmaceutical companies, stem cells contribute to drug discovery through their application in finding novel drug targets and through the development of new technology platforms. Therefore, pharmaceutical companies will increasingly explore the different methods in which stem cells can be used in the drug discovery phase to accelerate the discovery of novel drug molecules. A preclinical trial conducted by Cytori Therapeutics has yielded results that support therapeutic opportunities for adult stem and regenerative cells derived from fat tissue in the treatment of cardiac injury following heart attack.

The report; "Current Clinical Applications and Trials of Stem Cell-Based Therapies" (B706-52) is available now from Frost and Sullivan's website.

Source: www.DrugResearcher.com, April 24, 2006

News from ECVAM

ECVAM Workshop Report on Repeated dose toxicity in vitro available online

The new ECVAM Workshop Report no. 56 with the title "The Assessment of Repeated Dose Toxicity In Vitro: A Proposed Approach." is now available.

The Workshop Report can be downloaded from the ECVAM Website. Please select inside "Publications" the section Workshop Reports.

Source: ECVAM News, July 2007

New Ecvam Workshop Report on Marine Biotoxin Testing

The new ECVAM Workshop Report no. 55 with the title "Three Rs Approaches in Marine Biotoxin Testing" is now available.

The Workshop Report can be downloaded from the ECVAM Website. Please select inside "Publications" the section Workshop Reports.

Call for Expression of Interest (CEI) to participate in ECVAM Projects

In the future, most of the projects funded by ECVAM will be assigned based on a restricted call for offer sent to competent organisations / institutes or companies, which have been included on a list of potential contracters. This list is being set up by the EC-JRC Institute for Health and Consumer Protection, that launched a call for expression of interest (CEI) to all institutions active in the field of animal testing.

Those organisations, institutes or companies wishing to be included on the list of service providers are invited to submit an application in accordance with the rules set out in the official notice published in the Supplement to the Official Journal of the European Union on 8th of March 2006 for the purposes specified.

Access to the official notice:

• Document no: 2006/S 46-047741 available from the Tenders Electronic Daily Homepage (useful search terms are "ecvam" or "ispra")
• See also on the ECVAM Webpage in the section News, Events and Meetings

Deadlines and validity of the list resulting from the call for expression of interest:

The list of potential service providers will remain valid for 3 years from the date of dispatch of this notice (24.02.2006). Interested parties may submit an application at any time during the period of validity of the list, with the exception of the last 3 months.

Contact for applications: silvia.bottini@cec.eu.int , Fax: +39-0332-789434

Please consult first the original document of the official notice.

News from ICCVAM

Validation status 3T3 NRU basal cytotoxicity methods

A peer review panel was convened by NICEATM / ICCVAM on May 23, 2006, to evaluate the validation status of the in vitro 3T3 and normal human keratinocyte (NHK) neutral red uptake (NRU) basal cytotoxicity test methods. On August 3 SACATM will discuss the conclusions of this meeting, which are found in the _Peer Review Panel Report: The Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing._ This report and other background / meeting information are available through links on the ICCVAM home page http://iccvam.niehs.nih.gov

On the web

Innovative Medicines Initiative

Information on IMI, the Innovative Medicines Initiative, can be found on: http://ec.europa.eu/research/fp6/index_en.cfm?p=1_innomed and http://cordis.europa.eu/lifescihealth/innovativemedicines.htm

EPAA

Information on EPAA, the European Partnership on Alternative Approaches to Animal Testing, now has its own website:
http://ec.europa.eu/enterprise/epaa/index_en.htm.

Animal Welfare and Alternatives Awards for 2006

Procter & Gamble have announced the Animal Welfare and Alternatives Awards for 2006. Closing dates for application is August 11.

Info can be found on:
http://www.pg.com/science/animal_alt.jhtml
or
http://www.pg.com/science/awa_awards_intro.jhtml

Forward Focus Newsletter on Alternatives and Welfare (#3)

The latest edition of the Forward Focus Newsletter is now available on the P&G website. It details innovations in alternatives and animal welfare from P&G. A copy may be downloaded at;
http://www.pg.com/science/PG_Q1_06.pdf

AGENDA

Mammalian cell culture
14-16 August, 2006, Boston, USA

Information: www.healthtech.com/2006/cst/index.asp

24th Scandinavian Society for Cell Toxicology (SSCT) workshop
September 7-9, 2006, Grinda, Stockholm

First International Conference on Environmental Toxicology
11 - 13 September, 2006, Mykonos, Greece

Information: http://www.wessex.ac.uk/conferences/2006/toxic06/

The 3Rs: recent developments
14-15 September 2006, York, UK

www.thebts.org

EUROTOX 2006/6 CTDC Congress
20-24 September, 2006, Cavtat/Dubrovnik, Croatia

Information: www.eurotox2006-6ctdc.org

European Biomarkers Summit
September 26-27, 2006, Prague, Czech Republic

Information: www.biomarkerssummit.com

From Human Genetics to prediction of risks and responses
to drugs and to the Environment
September 28-October 2, 2006 Thira (Santorin)

http://biol.prospective-conf.u-nancy.fr/

INVITOX2006: 14th International Workshop on In Vitro Toxicology
2-5 October, 2006, Ostend, Belgium

Information: http://www.invitox2006.org

15th International Congress of the European Ass. of Tissue Banks
4-7 October, 2006, Varna, Bulgaria

Information: http://bgatb.net/eatb_15th_congress.htm

5th Annual Meeting European Tissue Engineering Society
8-11 October, 2006, Rotterdam, The Netherlands

Information: http://www.etes2006.org/

CASCADE course in Philosophy of Risk in Practical Risk Assessment
October 9-13, 2006, Stockholm, Sweden

Information: www.cascadenet.org

Proteomics: opportunities for diagnostics, pharmaceuticals and
the Clinical Laboratory
October 13-14, 2006, Baltimore USA

Information: www.aacc.org/meetings/proteomics

Drug metabolism
October 2006

Information: www.pharmaxl.net/home.html

4th International Symposium The Science & Technology of Skin Engineering
October 15-17, 2006, Shanghai, China

Information: www.mci-group.com

IVTIP plenary meeting
October 26-27, 2006, Hamburg, Germany

Information: ivtip@planet.nl

International Congress of Nanotechnology
October 30-Nov 2, San Francisco USA

Information: www.nanotechcongress.com

CAAT 25th anniversary symposium
2nd November, 2006, Baltimore, USA

Information: CAAT Newsletter

American College of Toxicology 27th Annual Meeting
5-8 November 2006, Palm Springs, Colorado USA

www.actox.org

Invitrotrain 4th practical course on alternative methods
in Reproductive Toxicology
Dec 7-8, 2006, Berlin, Germany

Information: http://userpage.fu-berlin.de/~invitrot/

ICT XI International Congress of Toxicology
15-19 July 2007, Montreal, Canada

Information: http://www.ict2007.org

6th World Congress on Alternatives & Animals in the Life Sciences
21-25 August 2007, Tokyo, Japan

Information: www.knt.co.jp/2007/wc6