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August 2006 |
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Next meeting ACTIP:The next plenary meeting of ACTIP will be held in Edinburgh, December 7-8, 2006Information on the programme will be sent separately to ACTIP member companies.
In this issue:
News from the Commission &endash; FP7 issues
First reading in EP: FP7 adoption moves forwardThe Parliament has, in its first reading on FP7 on 15 June 2006, overwhelmingly backed the Commission views on the future of European research. It followed the line of its Industry committee and agreed that embryonic stem cell research may continue to be financed under the current case-by-case approach used in FP6. MEPs want to split one of the nine thematic research areas proposed by the Commission, security and space, into two separate headings. FP7's Co-operation programme would thus consist of 10 themes. MEPs highlight health and energy as their major priorities among the thematic research areas. MEPs wish to earmark at least 15% of the Co-operation programme to SMEs, this quota is currently effective in FP6, but was not proposed by the Commission for FP7. In addition, instead of one evaluation of FP7 in 2010, two interim assessment, in 2009 and in 2011, are needed. The Parliament also passed an amendment to bring the budget of FP7 in line with the Financial Perspective agreement: 50.521 billion euro for 2007-2013. As to the European Research Council (ERC), the Parliament backs its establishment as an executive agency, which, after a transition period, should become an independent structure. The Parliament is set to hold its second reading on FP7 right after the summer holidays, in autumn 2006. In the meanwhile, the issue will be at the Council's table. First calls for proposals for FP7 projects could be published earliest in December 2006, for submission in March 2007, and, after an evaluation period, the first FP7 project could be kicked off at the end of 2007 or early 2008. Further reading: • Committee on Industry, Research and Energy: Report on the proposal for a decision of the European Parliament and of the Council concerning the seventh framework programme of the European Community for research, technological development and demonstration activities (2007 to 2013) (1 June 2006) [FR] [DE] • Parliament press: MEPs back euro 50bn programme for research and development (15 June 2006) [FR] [DE] Source: EurActiv News, June 15, 2006
Commission's revised FP7 proposal: better framework conditions for researchFollowing Parliament's amendments and Council's views on the initial proposal, the Commission has tabled a revised proposal for the EU's future research 2007-2013 (FP7). The revamped proposal is said to "take up in spirit and content, if not necessarily always with the exact wording, to a large proportion the position taken by the other institutions". The unofficial version of the document shows no major content-related changes, but a number of clarifications and additions in many parts, especially in the different individual research themes. Along with supporting SMEs, regions, research infrastructures and linkages between science and society, the revised proposal now has a new chapter, Support to the coherent development of research policies. It states as its objectives "enhancing the effectiveness and coherence of national and Community research policies and their articulation with other policies, improving the impact of public research and its links with industry, and strengthening public support and its leverage effect on investment by private actors". Other modifications and clarifications touch upon, for example, the criteria used to identify potential Joint Technology Initiatives, the European Research Council's staffing arrangements and role of its scientific council. Furthermore, the much debated ethical principles, including funding for embryonic stem cell research, are now explained in far greater detail (Article 6) than in the initial proposal. Concerning the Parliament's amendment to separate the Space & Security into two individual themes, the Commission's preliminary version on the revised FP7 still keeps them together in one theme. The budget remains that of the revised package for EU programmes in 2007-2013 adopted on 24 May 2006 - 54.58 billion euro. Latest & next steps: • The official revised FP7 proposal should be published soon. • The Council will now discuss the revised proposal. Council aims to reach a political agreement on 25 September 2006. • The Parliament is set to hold its second reading on FP7 in autumn 2006. Source: EurActiv News, June 29, 2006
Council agrees: EU funding for stem cell research continuesThe EU research ministers, gathering in an extraordinary meeting on 24 July 2006, reached a political agreement on FP7. The agreement was reached by a small majority, as the Austrian, Lithuanian, Maltese, Polish and Slovakian delegations voted against. The council debate focused on funding research activities involving human embryonic stem cells, which a German-lead coalition tried to exclude from the agreement. After assurances that no funding will be granted to research activities which destroy human embryos or are aimed at procurement of stem cells, Germany and some others changed their position, making an agreement possible. The funding for embryonic stem cell research, therefore, continues under the current case-by-case practice, forbidding research into human cloning and research that would result in hereditable changes. No activity will be funded that is forbidden in all member states and research projects will only be considered for funding from member states where the research is legal. Further reading: • Council press release: Provisional conclusions of the Competitiveness Council (24 July 2006) • Guardian Unlimited: US faces science brain drain after Europe backs stem cell funding Source: EurActiv News, July 24, 2006
The European Parliament adopts the Competitiveness and Innovation Framework ProgrammeThe European Parliament recently adopted the Commission's proposal for the EU's Competitiveness and Innovation Framework Programme (CIP), the first of its kind, which will cover the period from 2007 to 2013. The CIP was designed to group all Community actions meant to support innovation and competitiveness, and is considered one of the main tools for the achievement of the Lisbon objectives. It contains three basic programmes, mainly the Entrepreneurship and Innovation Programme, focused on Small and Medium Enterprises; the ICT Policy Support Programme, meant to enhance the use of information and communication technologies; and the Intelligent Energy - Europe Programme to support sustainable development. This is the first time in the EU's history that the Parliament has adopted a framework programme after the first reading. Source: IPR HelpDesk June 6, 2006
News from the Commission &endash; policy issuesIndustry, commission and member states take stock of biotech progressIn view of the EU's life sciences and biotech strategy mid-term policy review, the industry, EU institutions, and member states came together around a biotech policy round table on June 20, 2006 to discuss the progress made, the changes needed and new policies required to guide Europe towards bio-economy. Bio-based economy stands for a vision of a society, which is not dependent on fossil fuels for energy and industrial raw materials, but uses bio-fuels made directly from plant/crop-based renewable sources. In the event, the Commission presented the preliminary results of a study, currently being drafted by the Joint Research Centre (JRC), on the consequences, opportunities and challenges of modern biotechnology for Europe. The joint industry, Austrian and Finnish Presidencies' press release on the event states that the implementation of the EU life sciences and biotechnology strategy, adopted in 2002, is advancing, but that EU biotech companies still have difficulties in raising risk capital to finance R&D, the development of the regulatory system varies across the member states and communicating biotech issues to citizens has proven difficult. Further reading: • Joint Research Centre: The Biotechnology for Europe Study - Consequences, opportunities and challenges of modern biotechnology for Europe [Background] • The European bio-based economy website (a joint industry and science initiative) Source: EurActiv News, June 20, 2006
Technology Platforms need to remain open and transparentThe Austrian EU Presidency organised a major conference on European Technology Platforms (ETPs) in Vienna on 4-5 May 2006. The event brought together, for the first time, the stakeholders of all different 29 platforms, aiming to promote cross-platform exchanges of experience and networking in complementary research and technology areas. "Over the last three years, ETPs have become a powerful and rallying force for reaching Europe's goal of becoming a dynamic knowledge-based economy. They are now recognised at the highest political level as a key component of the renewed Lisbon strategy for transforming knowledge into growth," said Science and Research Commissioner Janez Potoãnik. This recognition is due, according to Potoãnik, to the fact that the ETPs really unite all relevant stakeholders around common objectives, they are industry-lead ensuring focus on potential future markets and they help overcome fragmentation of European research efforts. For the continued success of ETPs, Commissioner Potoãnik highlighted the need for the platforms to remain open to all stakeholders and transparent in their activities. These factors being even more crucial now that the Strategic Research Agendas begin to be implemented. "Closed shops of narrow groupings must be avoided at all cost," said Potoãnik. Secondly, the Commissioner underlined the importance of avoiding undue proliferation of ETPs. "Platforms are intended to focus on key areas for European competitiveness. This means that there should not be an infinite number," he explained. Most of the current 29 platforms have, by now, defined their objectives and drafted a Strategic Research Agenda. They are thus moving into the implementation, operational phase and setting up research and development activities, mobilising funds and exploring the potential for a Joint Technology Initiative. European Technology Platforms can, indeed, evolve into a Joint Technology Initiative (JTI), which is a long-term public-private partnership at European level, provided for in the Article 171 of the Treaty. The Commission's official proposal for FP7 identifies the first set of JTIs in the areas of innovative medicines, nanoelectronics, embedded computing systems, hydrogen and fuel cells, aeronautics and air traffic management and global monitoring for environment and security. Further JTIs may be identified during the implementation of FP7. Further reading: • CORDIS News: Potocnik outlines key role for technology platforms under FP7 (4 May 2006) Source: EurActiv News May 5, 2006
Technology platforms to identify lead market opportunitiesThe Commission and member states agree that the creation of innovation-friendly lead markets is one of the main conditions for an innovative Europe and increased competitiveness. "Technology platforms could help create dynamic market conditions whereby more demanding and novelty-seeking customers and potential higher returns on investment would act as a strong pull on private research and innovation," predicts the EU Science and Research Commissioner Janez Potoãnik. He sees these stakeholder platforms as detectors of potential market opportunities and barriers to be addressed by co-ordinated public action. Creation of Europe-wide lead markets requires also early prospective development of standards by stakeholders, anticipative product market regulation, improved intellectual property rights regime and public procurement as the driver for the demand for innovative goods and services, listed Potoãnik. The Technology Platforms bringing together all stakeholders would be an ideal tool for discussions on these issues. Further reading: • Commission press release: Commissioner Janez Potoãnik's speech: European Technology Platforms: Developing Lead Markets (5 July 2006) • Commission: 2006 &endash; Aho Group Report "Creating an Innovative Europe" • CORDIS: European Technology Platforms (ETPs) Source: Euractiv News, July 6 2006
European Research Council reveals its launch strategyThe Scientific Council of the European Research Council (ERC) has published, on 28 April 2006, its outline strategy for the launch of the ERC and explained how it will support young researchers at its start-up phase. The ERC is expected to be operation right from the start of the FP7, January 2007. Two funding streams, operating on a 'bottom up' basis across all research fields will be the core of the ERC's operations for the period of FP7, 2007-2013: • ERC Starting Independent Research Grant Scheme: in the start up phase of the ERC, priority will be given to independent researchers who are at the stage of establishing their first research team or doing their own independent research. A detailed note on this grant has been published. This grant will represent around a third of the ERC's annual budget (300-350 million euro a year). Around 200 grants are expected to be made annually, each for up to 5 years. • Advanced Investigator research Grant Scheme will be established later on for projects lead by researchers at all career stages. A detailed note on this grant scheme will be published as soon as its parameters have been developed. "We are releasing these strategy notes today to give a clear indication of our thinking at an early stage, enabling the research community better to prepare for the launch of the ERC," said the Chairman of the Scientific Council Professor Fotis Kafatos. Further reading: • The Scientific Council of the European Research Council (ERC): Strategy Note - The ERC Launch Strategy" note (28 April 2006) Source: EurActiv News, May 3 2006
Commission paper on European Institute of TechnologyIn a recent communication to the Council, the European Commission outlined its plans for the creation of a European Institute of Technology (EIT). The proposal for the creation of an EIT was first made during the mid-term review of the Lisbon strategy and the Commission has already received extensive feedback from stakeholders and Member States through a consultation process. The EIT is one of the EU actions meant to strengthen innovation in Europe. It is conceived as an autonomous organisation, directed by a Governing Board, which will identify key interdisciplinary areas and appoint and support Knowledge Communities around Europe in order to carry out research, education and innovation in these areas. Knowledge Communities will integrate members from universities, research centres and industry, in order to promote the link between research, education and innovation. These three elements compose what is known as the "knowledge triangle". The Commission communication will add to the debate regarding the EIT, and a formal proposal for the EIT's creation is expected by the end of the year. Source: IPR HelpDesk June 15, 2006
ERC and EIT to be complementaryThe European Research Council (ERC) and the European Institute of Technology (EIT) are meant to be complementary. The first will be supporting frontier research and new ground-breaking discoveries, the second applied research and transfer of knowledge to innovative market applications. In separate events, two Commissioners emphasised, on 25 April 2006, the need for the scientific freedom of these bodies. Speaking at the London School of Economics, the Commissioner for Science and Research, Janez Potoãnik, addressed the importance of the future European Research Council (ERC), giving his full support for its scientific freedom. "At the heart of the ERC concept is the recognition that practicing researchers are best placed to identify those exciting new opportunities and directions at the forefront of knowledge that will lead into the industries, markets, and broader social innovations of the future," said Potoãnik. The Commissioner sees that the EU as a whole has problems in supporting new, emerging research fields, such as biotechnology or nanosciences, in managing their growth and assuring high research quality. "These problems suggest a mismatch between the institutional set-up for research in most European countries and the requirements of new leading sciences. Existing research funding mechanisms tend to support more established disciplines where the division between basic and applied research is more pronounced," he continued. Addressing the European Parliament's Culture and Education Committee, the Commissioner for Education, Culture and Languages, Jan Figel expressed his views on the future European Institute of Technology (EIT). "The EIT governing board will consist of independent experts free from member states and the Commission," he assured. The MEPs members of the Culture Committee voiced concerns about the intellectual fragmentation the EIT might bring among the European universities. They also questioned the funding of the future institution, fearing that the EIT would be built with FP7 money, at the expense of the European Research Council. Acknowledging that an EIT is a good idea, some MEPs however thought that it would be better to support existing institutions of excellence. The European universities have expressed their reluctance to the establishment of an EIT (see EurActiv 5 April 2006). The results of the stakeholder consultation on EIT were published in March 2006. 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
News from the Commission: regulatory issues
EU gives boost to orphan drugs developmentMore than 450 applications for orphan drug designation have been submitted between April 2000 and April 2005 and, of those, more than 260 have been designated and 22 have gone on to receive a marketing authorisation," concludes a Commission report on the impact of the first five years of the EU's orphan medicine regulation. According to the Commission, the response to the orphan legislation, which provides for the pharma companies a 10-year market exclusivity for the orphan medicinal products, reduction of EMEA fees and support for R&D, has "far exceeded initial expectations". Biotech industry has welcomed the report acknowledging the progress made, but states that "timely and equitable access for patients to the approved medicines remains an issue". It also claims that "additional economic incentives in most member states are still needed as some member states are delaying reimbursement of orphan drugs, thus limiting patient access to these drugs". Further reading: • Commission press release: Fighting rare diseases: 22 new orphan drugs in five years (26 June 2006) [FR] [DE] • CORDIS News: Orphan medicine legislation spurs on research, innovation and growth, claims report (27 June 2006) • European Organisation for Rare Diseases (Eurodis): Improving patient access to orphan drugs in Europe (April 2006) Source: www.euractiv.com ,June 27, 2006
Commission consults on securing sufficient organ supplyAnnually, 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
Quick authorisation for emergency medicines approvedThe Commission has adopted a new regulation for early market authorization of certain medicinal products. The authorization concerns new drugs aimed for patients suffering from rare and life threatening diseases for which no treatment exists. This procedure, adopted on 6 April 2006, concerns also 'emergency medicines', which aim to respond to dangers such as bio terrorist attacks or influenza pandemic. Medicines will be approved under new conditional marketing authorization rules, which oblige drug companies to complete medicines' safety and effectiveness studies. A one-year market authorization will be granted if the Commission's expert advisory committee on medicines rules that "the benefits of the medicine outweigh its risks" and that "the benefits to public health of the immediate availability of the medicine outweigh the risk inherent in the fact that additional data are still required". Currently, it takes 10 years from the discovery of a medicine to its market introduction. The Commission hopes that shortening this long regulatory process (safety and effectiveness assessments, clinical trials) for emergency medicines will save lives and reduce suffering. The new rules are also expected to boost innovation in pharmaceuticals as the new regulation will allow for quicker returns on investment in product development. Further reading: • Commission press release: Commission allows early authorisation for emergency medicines (6 April 2006) [FR] [DE] Source: EurActiv News, April 7, 2006 ....and other EU news
New initiative launched for SMEs: JEREMIEThe 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 careersA 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
Research news
Sugar and olive oil for drug delivery nanomaterialsUS 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 deliveryResearchers 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 applicationsSilver 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
Microchips wired with proteinsThe 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
Modified yeast could produce key malaria drugGenetically modified baker's yeast could help overcome a global shortage of the most effective malaria drug, according to research published in Nature of 13 April. The World Health Organization recommends using artemisinin-based drugs to treat malaria, but with 300-500 million people being infected each year, suppliers are unable to meet the demand. The drug's main component artemisinin is found in the sweet wormwood plant, Artemisia annua, but extracting it is costly and time consuming. Now researchers of the University of California at Berkeley USA have created yeast factories that can make the chemical precursor of artemisinin nearly 100 times as fast as it can be extracted from plants. The yeast was genetically modified by addition of two genes from sweet wormwood to its DNA. A "simple and inexpensive purification process" is all that is needed to extract artemisinin from the modified yeast, say the researchers. They say their method is more reliable than plant-based methods because it is not subject to factors that such as the weather. It is also cheaper and produces a purer form of artemisinin than can be extracted from sweet wormwood. They add, however, that more work is needed to optimise the amount of artemisinin produced. Source: SciDev.Net , April 12, 2006 Link to full paper in Nature Reference: Nature 440, 940 (2006)
Nematodes useful to screen drug compoundsResearchers 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 genomeThe 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 Business News
Practical help for innovatorsSME 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
Invitrogen's Scottish investment good for regionInvitrogen has announced the opening of a new research facility to be located in Scotland. To be located in Inchinnan, Scotland, it will become the company's expanded European headquarters. Invitrogen, keen to make more of an impact in Europe with its technologies for disease research, drug discovery and commercial bio-production, aims to create six new global corporate research centres. Invitrogen's new £17m (euro24m) investment closely follows a hive of Scottish activity that has seen Aptuit raise £20m for a research centre in West Lothian; the £165m flotation of Optos in Fife, and Cyclacel raising £25m from a rights issue. Invitrogen's investment has been supported by £4.3m from the Scottish Executive. Source: DrugResearcher.com, June 12, 2006
Garden of Eden begins biomanufacturing bloomMomentum is growing at the UK's new National Biomanufacturing Centre (NBC) as its operator Eden Biodesign inked a second contract at the centre, which was set up to establish England's Northwest as one of the top biomanufacturing hubs in Europe. Under the new contract, Eden will develop and manufacture monoclonal antibodies against a novel cancer antigen, to be used in investigational cancer-killing drugs being developed by the University of Liverpool. The UK is now second only to the US in terms of its biopharmaceuticals development pipeline, however, the country's industry still lags a long way behind the US and the UK government has been making a concerted effort to close this gap. The NBC, which officially opens later this year in Speake, is a £34.3m (¤49.8m) government-funded initiative led by the Northwest Regional Development Agency (NRDA) to assist UK academia in developing and commercialising their biopharma discoveries. Biopharma development and manufacturing services firm, Eden Biodesign won the contract to operate the centre on behalf of the NRDA. The NBC provides the expertise and facilities to support new and existing biotech companies, offering product development services designed to fill in the skill and resource gaps. It also provides training in biomanufacturing and analytical sciences, delivering the skilled workforce required to expand the UK biopharmaceutical sector. There is also an Access Fund of nearly £3m to small to medium companies and academic groups biotech firms who need assistance in purchasing development and clinical manufacturing services from the NBC. Source: In-PharmaTechnologist.com, July 20, 2006
Biovitrum creates largest CRO in the Nordic regionBiopharma company, Biovitrum has purchased iNovacia in a deal that makes iNovacia the Nordic region's largest contract-research organization (CRO) in early drug discovery. For Biovitrum, the formation and spin-off of existing company, iNovacia offers an opportunity to secure regional access to key technical expertise for early drug discovery projects. The market for contract research in the pharmaceutical industry is undergoing strong growth internationally and opinion is divided on which country will represent the next big market in outsourcing. As well as the Nordic countries, the Netherlands, with its huge pension fund industry, is frequently mentioned, and is even a topic of conversation in ultra-conservative and protective Switzerland. Source: www.DrugResearcher.com, June 7, 2006
New manufacturing process can double HIV vaccine productionThe Immune Response Corporation (IRC) collaborated with US biotech firm Irvine Scientific to develop a serum-free cell culture medium for the HIV vaccine production process that eliminates all animal-derived components and thus the risk of prion and microbe contamination, improves viral yield, and provides consistently high cell growth through to full-scale production. Through a process of screening and optimisation, the two firms have demonstrated that the human T-cell lymphoma cell line HUT-78 (chronically infected with HIV-1) can be grown and reliably passaged in a chemically-defined cell culture medium, with cell densities exceeding two million cells/ml and a two-fold improvement in initial HIV-1 viral antigen yields over traditional serum-supplemented medium. The IRC said it now plans to use this technology towards the development of a preventive HIV vaccine and is also currently evaluating this approach for a therapeutic vaccine in clinical trials of its second-generation HIV immunotherapy IR103, based on the company's patented, whole-inactivated virus technology. Source: www.DrugResearcher.com, July 7, 2006
Reversal of transgenic goat decision opens the door for 'pharming' in EuropeThe world's first drug made from a genetically engineered goat (ATryn made by GTC Biotherapeutics) has been given the thumbs up in Europe after being initially rejected in February. The decision has reopened the door for marketing approval of other drugs made by transgenic animals or plants. The potential of transgenic animals and plants for the cheap and efficient production of biopharmaceuticals is huge and could reap sales of more than $12bn (euro 10bn) by 2012 according to market research firm Kalorama. The European Medicines Agency's (EMEA's) review process was the first regulatory examination of a transgenically produced therapeutic protein anywhere in the world, representing the first real sign that the many transgenic drugs in the biopharma pipeline can gain acceptance from regulators. ATryn, the new drug that has just been given the nod, is an anti-clotting agent and has been cleared for use in surgery in people with a rare congenital disease, antithrombin deficiency. Only one person in every 3,000 to 5,000 people suffer from the condition, making clinical studies hard to conduct and as a result, European regulators initially rejected the drug on the grounds that not enough surgical cases were brought before them &endash; they got five out of the twelve requested &endash; and the fact that results from patients treated in a compassionate use programme and at childbirth could not be accepted. However, on appeal, a reconsideration of the evidence to include the nine cases of women given ATryn in childbirth led to an EMEA backflip. Upon approval, ATryn will be the only available antithrombin product that is not derived from the human blood supply and will also be the first antithrombin product approved for use in all 25 countries of the EU. In addition to the ATryn program, GTC has in development a recombinant human alpha-1 antitrypsin, a recombinant human albumin, a CD137 antibody to stimulate the immune system as a potential treatment for solid tumors, and a malaria vaccine. Other firms active in the transgenic arena include Pharming, Hematech/Kirin Brewery and Avigenics. Dutch company Pharming is developing a drug for hereditary angioedema that is expressed in the milk of rabbits; US firm Hematech, owned by Japan's Kirin Brewery is focusing on human antibody-producing cows that will be used for the development of large quantities of polyclonal antibodies, which could form the basis of drugs for viral or bacterial infections and autoimmune disorders; while US-based Avigenics is pursuing avian transgenesis for treatments in oncology, infectious disease and autoimmune disease. Source: In-Pharmatechnologist.com, June 22, 2006
Iomai registers needle-free vaccination patentVaccine developer Iomai has received a new US patent which outlines methods for inducing an immune response to Iomai's novel skin-patch-based vaccines (transcutaneous immunization technology or ITC). TCI technology uses a patch placed on the surface of the skin to deliver vaccines and adjuvants to a group of antigen-presenting cells called Langerhans, located on the skin's outermost layer, which in turn deliver the vaccines and adjuvants to the nearby lymph nodes to produce a sustained immune response. The needle-free technology can be applied to a wide range of vaccines, so Iomai has submitted to the US Department of Health and Human Services (DHHS) a proposal to receive government funding for further development of its adjuvant skin patch for pandemic influenza. Iomai will develop a plan to produce 150m doses of its patch in a six-month period if awarded the contract. Iomai's immunostimulant patch can be used with any avian flu vaccine to boost supplies by up to 100-fold, allowing much smaller doses of vaccine to be administered - a 'dose-sparing' approach to vaccination. Travelers' diarrhea also has no approved vaccine at present, so Iomai's patch-based vaccine delivery promises convenience while avoiding systemic exposure to antigens or adjuvant. Source: www.In-pharmaTechnology.com, June 22, 2006
Cuba's tobacco finds use in vaccine purificationThe first ever monoclonal antibody obtained starting from transgenic plants with the purpose of purifying a human vaccine has been registered with Cuban authorities, meaning cigars may not be the only application the country's tobacco is used for in the future. Cuba's official news agency reported the antibody is used in the process of purifying the active pharmaceutical ingredient (API) of the Hepatitis B vaccine produced in Cuba by Havana's Genetic Engineering and Biotechnology Center (CIGB), sold under the trademark of Heberbiovac-HB. CIGB scientists say obtaining the antibody from genetically modified tobacco plants, has advantages over the traditional process of starting from the ascitic liquid of the mouse, due to higher levels of safety and production. They also stress that tobacco plantations that are genetically modified have nothing to do with the commercial strains of that plant and that the CIGB has taken appropriate actions to avoid possible risks to the environment when cultivating engineered strains. This production process is confined to special controlled growing areas where the technology specifically created with that purpose is in use, according to the good agricultural production practices demanded in the obtaining of vegetable biomass for pharmaceutical applications, the CIGB said. The monoclonal antibody obtained from transgenic plants obtained the license from the National Center of Biological Safety that is part of the Cuban Ministry of Science, Technology and the Environment. Source: www.DrugResearcher.com, June 15, 2006
Stem cell use set to rise despite objectionsStem 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
New source of Tamiflu ingredient could boost productionAmerican chemists have found that seeds of the sweetgum fruit contain significant amounts of shikimic acid, the main starting material for Tamiflu, in a discovery that could prove vital, as demand for the drug skyrockets amidst bird flu fears. Roche is battling to meet demand for Tamiflu by increasing its external contractors and finding new methods to produce shikimic acid, as sales this year for the drug are expected to reach 1.1bn to 1.2bn Swiss francs (¤7bn-¤7.5bn). But the shikimic acid used in the manufacturing of Tamiflu is obtained almost exclusively from the pods of the star anise, a fruit that is found mainly in China and whose availability has dwindled due to high demand for the flu drug. Researchers however have discovered that shikimic acid can also be extracted from the seeds of the sweetgum fruit, which is abundant in North America, in yields of around 1.5 per cent, so just 4Kg of sweetgum seeds are enough for 14 packages of Tamiflu. Shikimic acid is also found in the leaves and bark of the sweetgum tree, but it is most abundant in the fruit. The fruit emerges as a green seedpod that later dries into a brown, spiny husk, which releases an abundance of tiny, grain-like seeds. The extraction of shikimic acid from the seeds is achieved using methanol as a solvent, thus obtaining other cellular material from the seeds as well, including DNA. To date Roche has accepted pandemic orders for Tamiflu from more than 65 countries worldwide, with several nations ordering enough of the drug to cover 20 percent to 40 per cent of their populations. Source: www.DrugResearcher.com, April 12, 2006
Celera makes good on human genome projectIn 2001, Celera Genomics (Rockville, MD) published its findings of the human genome sequence. It appears Celera is seeing the fruits of its labor with the discovery of genetic markers that could be developed into clinical IVDs. Recently Celera announced the presentation of data supporting a constellation of seven SNPs that predicts the risk of cirrhosis in patients with chronic hepatitis C (CHC). It is believed that these SNPs offer a better predictor than present clinical risk factors for the disease. Using a combination of SNPs as a prognostic tool suggests that the information will be applicable to a larger fraction of individuals infected with the hepatitis C virus (HCV), will likely prove more robust across risk groups tested, and have more compelling use for patient management than current methodologies. The seven SNPs were identified and validated through multiple research studies that were conducted during a three-year period. The studies involved approximately 1500 individuals infected with CHC, whose samples were tested for the presence of approximately 25,000 SNPs as part of a Celera functional genome scan. Celera also announced the publication of findings describing two novel genetic markers associated with an increased risk for myocardial infarction (MI). Neither of the two gene variants has previously been associated with MI. The retrospective research study evaluated DNA samples from more than 2000 individuals to compare patterns of genetic variation in people with a history of early-onset MI with those with no history of MI. The study identified genetic markers in two genes that are associated with increased risk for early-onset heart attack: VAMP8, which is involved in platelet aggregation, and HNRPUL1, which encodes a ribonuclear protein. Source: IVD Technology, July 2006
Agenda
Global mRNA
and Protein Expression Analysis European
Biomarkers Summit From Human
Genetics to prediction of risks and responses to drugs and to
the Environment Proteomics:
opportunities for diagnostics, pharmaceuticals and the Clinical
Laboratory Drug metabolism International
Congress of Nanotechnology Plenary meeting
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