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ACTIP
Bulletin 46 |
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Next meeting ACTIP:The next plenary meeting of ACTIP will be held in Edinburgh, December 7-8, 2006 Information on the programme has been sent separately to ACTIP member companies.
In this issue: European competitiveness Stem cell news R&D spending
News from the Commission
European competitivenessEU's 'Nordic three' beat US in competitiveness challengeThe World Economic Forum (WEF) releases its Global Competitiveness Report annually, which provides an overview of the key factors for driving productivity and competitiveness and ranks the 125 countries covered according to their performance in these areas. Contrary to last year's report, which showed that the EU's largest member states had been losing their competitive edge, the 2006-2007 edition, released on 26 September 2006, sees some of Europe's 'big guns' making sharp progress and the 'Nordic three' knocking the US out of the top five. The EU now counts six member states (the Nordic three, UK, Netherlands and Germany) in the top ten and, although most have not made any significant upwards moves in the rankings, the economies most often described as Europe's main rivals in its race for competitiveness have not fared too well either. The US has tumbled down the league, dropping from first to sixth place, overtaken by three EU member states, in a sign that the EU is making progress towards the Lisbon goal of becoming "the most competitive and dynamic knowledge-based economy in the world" by 2010. Although Germany and the United Kingdom continue to rank in the top ten, the UK is still lagging on innovation, whereas Germany's cumbersome labour regulations are holding the business community back. France has fallen from 12th to 18th position, due to the lack of efficiency and flexibility of its labour market and its badly targeted public expenditure. Italy has continued its downward slide to 42nd place in this year's report. Having run budget deficits without interruption for the past 20 years, public debt levels are among the highest in the world. The study points to "deep-seated institutional problems" which have led to bad government spending, over-regulation and poor quality public services. As in previous years, Poland and Greece remain the worst performers in the EU &endash; similar to the results of the World Bank study on "Doing Business in 2007", which showed the two countries to be among the worst places to do business in the world. Other new member states, however, including Estonia (25), the Czech Republic (29) and Slovenia (33), have performed quite well. And, among the candidate countries, Turkey and Croatia both seem to have benefited from the "EU bonus", moving up impressively in the rankings by 12 places each, to positions 59 and 51 respectively.
Further reading:
Source: EurActiv News, September 27, 2006
Large increase in private-sector R&D investmentThe EU 2006 Industrial R&D Investment Scoreboard indicates that between July 2005 and August 2006, private-sector investment increased by an average 5.3%. This represents a major change from the stagnation of the year before and the 2% decrease registered in 2004. The EU Industrial R&D Investment Scoreboard is published annually by the Commission and provides information on the top 1,000 EU companies and top 1,000 non-EU companies which invest the most in research and development. The EU aims, as part of the Lisbon objectives, to invest 3% of GDP in research by 2010. Two thirds of the 3% should come from the private sector. Five of the EU's top R&D investors are German (DaimlerChrysler leading, Siemens the second), two are based in the UK, one in Finland, Sweden and France. Among the top 10 EU companies stand three car industry companies, three pharmaceuticals and two telecommunications-equipment giants. By comparison, four of the top six world R&D investors are car manufacturers. Further reading: DG Research and Joint Research Centre: The 2005 EU Survey on R&D Investment Business Trends in 10 sectors (23 August 2006) Source: EurActiv News, October 6, 2006
Policy issuesEU funding of stem cell research to trigger 'brain gain'?The EU's science and research ministers reached a political agreement on FP7 on 24 July 2006, paving the way for continued EU funding of embryonic stem cell research on a case-by-case practice. On 19 July US president Bush vetoed the use of federal funding for stem cell research. Some think that the EU's positive attitude towards this type of research could increase brain drain of scientists with an interest in stem cell research from the United States. However, the ban of federal funding in the US does not make embryonic stem cell research illegal in the US and individual States, such as California, have their own stem cell funding initiatives, and private companies are free to carry out their own research. Source: EurActiv News, July 26, 2006
FP7 issuesProposal for EU Medicines Research AcademyThe Innovative Medicines Initiative (IMI), a pan-European public and private sector collaboration between various health stakeholders, has published a new version of its Strategic Research Agenda (SRA). The agenda recommends establishments of a European Medicines Research Academy to fill in the gaps the IMI has identified within medicines development education and training. The IMI, launched in 2004, aims to support faster discovery and development of more effective innovative medicines with fewer side-effects. Its new SRA identifies predicting safety (early safety evaluation), predicting efficacy (better understanding of clinical basis of diseases), bridging gaps in knowledge management (lack of data pooling and processing infrastructure) and bridging gaps in education and training as the main bottlenecks in the current biomedical R&D process. In addition to the establishment of the European Medicines Research Academy, the SRA recommends the creation of a European Centre of Drug Safety Research and regional centres of excellence and of a Knowledge Management Platform to develop effective data integration and analysis tools. Implementation of the Strategic Research Agenda would require 460 million euros per year from 2007 to 2014. The Innovative Medicines Initiative will be proposed for Joint Technology Initiative (JTI) status in the FP7, subject to approval by member states.
Source: EurActiv News, September 19, 2006
ERC Scientific Council launchedThe European Research Council (ERC) will be set up under FP7. A first call for proposals will be launched in late 2006 or early 2007. The ERC will be the first pan-European funding agency for frontier research offering individual talented researchers the support and visibility required to strengthen Europe's scientific creativity and performance. It will be an autonomous organization under the scientific governance of an independent Scientific Council. The Scientific Council consists of 22 eminent researchers (only five of them women) drawn from across Europe. The founding members of this Council were nominated by the European Commission following an independent identification process involving Europe's research community. The Scientific Council is chaired by prof Fotis Kafatos (London); vice-chairs are held by Dr. Daniel Esteve (France) and Prof Helga Nowotny (Vienna). The Scientific Council has decided to set up two funding streams: the ERC starting grant will provide support to the independent careers of excellent researchers at the stage of establishing their first research team; and the ERC advanced Grant, which will provide broader support for excellent and innovative frontier research projects by individual teams led by investigators at all career stages. Further information can be found on: http://erc.europa.eu
Scientists slam European Institute of TechnologyScientists say creation of a European Institute of Technology (EIT) is not the answer to the lack of innovation in Europe. A politically motivated idea, starting from a wrong premise and with a vague and then unrealistic financial underpinning, will not help Europe forward," comments Euroscience on the Commission plan for a European Institute of Technology (EIT). The pan-European association of individuals interested in constructing scientific Europe 'from the bottom-up', states, in its opinion on 31 July 2006, that Europe's two major problems are lack of innovation and the current, uniform, university system. Establishment of a new institution will resolve none of them. Euroscience questions, in particular, the efficiency of "widely dispersed virtual knowledge communities governed at a distance by a board of governors" to develop strategic technologies and innovations. Instead, the association urges reform of European universities, which are "wrestling with large student numbers, antiquated facilities, dispersed research capabilities and tight government control". According to Euroscience, European universities seriously lack differentiation. Therefore, the association fully supports the establishment of the European Research Council (ERC), a European structure to support basic research, set to be operational in early 2007. "Europe clearly needs continental mechanisms to fund frontier research," states the opinion. European-wide competition on research funding will enhance diversity among universities as, in order to excel, the universities need to specialise in a few research fields. "This is the right way forward as Europe needs centres of excellence," said Peter Tindemans from Euroscience. Other groups representing academics hold similar views, including representatives of the European universities, the European University Association (EUA), the League of European Research Universities (Leru) and the Coimbra Group universities: they all doubt the relevance of an EIT. Further reading:
Source: EurActiv News, September 11, 2006
…. but research advisors now support EITAfter initially considering Commission plans for a European Institute of Technology (EIT) too ambitious, the executive's adviser group on research policy now supports it. Following the Commission's renewed communication on the European Institute of Technology (EIT) in June 2006, the European research advisory board (EURAB) has drafted a second opinion, this time positive, on the issue. EURAB's first opinion on the Commission proposal for EIT was critical, as the idea was considered "top-down" and fears were expressed that it would take part of the money earmarked for the European Research Council (ERC), intended to fund basic research. The second opinion stated that the advisory group's contentment with the renewed proposal and notes the evolution since the first discussions for an EIT in February 2005. EURAB has particularly welcomed the proposed "light" administrative structure comprising an autonomous governing board with limited membership, now proposed by the Commission, but insists that this Board must have at least a 50% share of industry representatives. The advisors stress that, "to succeed, the EIT will need to have the involvement of and full support from the business community from the outset" and that the independent nature of the governing board has to be clearly established and protected. The Commission's formal proposal on the EIT, including budget, is expected to be published by the end of 2006. Further reading:
Source: EurActiv News, September 11, 2006
….while businesses asks: 'Why should we invest in EIT?'The Commission adopted its official proposal for the European Institute of Technology (EIT) on 18 October 2006. The final proposal does not differ greatly from the two previous Commission communications on the issue except that the Knowledge Communities are now described as Knowledge and Innovation Communities and that this document, finally, spells out the budget foreseen for the institute. Some 2.4 billion euro is foreseen to be spent between 2008 and 2013. The Commission proposes 310 million euro to be allocated directly from the EU budget, mainly for the initial start-up phase. The rest, 2.1 billion euro , is expected to come from the private sector. The institute will also be eligible to apply for money from EU aid funds - the Knowledge and Innovation Communities can, for example, apply for project funding under FP7. Education Commissioner Jan Figel said that an "EIT foundation" could be established to gather the necessary funds. The European Chambers of Commerce immediately reacted to the proposal, asking for clarification. "Where will the money come from?" asks the association, which represents more than 18 million enterprises in Europe. In particular, it wants to know how the Commission intends to attract private investors. Next steps: Parliament and Council could adopt the proposal before the end of 2007 or early 2008. EIT's governing board could be appointed in 2008. EIT could be operational in 2009. Source: EurActiv News, October 18, 2006
EU research facilities to pool international talentThe European Strategy Forum on Research Infrastructures (ESFRI) has published its first road map for new European research infrastructures. After two years of negotiations and consultation with high-level European and international experts and representatives from member states' ministries of research, 35 large-scale infrastructure projects, which a sufficient number of member states are ready to support, have been identified. Projects for infrastructures range from a research icebreaker vessel for marine research to next-generation radio telescope or European social survey monitoring long-term changes in social values throughout Europe. Seven key research areas covered are: environmental sciences; energy; materials sciences; astrophysics, astronomy, particle and nuclear physics; biomedical and life sciences; social sciences and the humanities; computation and data treatment. Some 14 billion euro are needed to make all 35 projects to come true. So far, the EU has, through the FP6, funded only existing research infrastructures. The upcoming FP7 will finance both existing and new ones with 1.7 billion euro from 2007-2013. The success of the 35 projects thus depends on member states willingness to support them. Calls for European research infrastructures, under FP7, will be launched in 2007 and 2010. All these projects will be pan-European, which means that every scientist has open access to these infrastructures. The only influence of a member state paying or not paying for the project is then on governance, the way the project is managed and the long-term vision for the next 20-30 years.
Source: EurACTIV news, October 19, 2006
Other EU NewsEurobarometer: 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. Further reading:
Source: EurActiv News, June 21, 2006
Research News
Stem cell newsKey to Growing new human stem cells foundScientists 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. The discovery may enable scientists to rapidly grow stem cells and transplant them into patients with blood disorders, immune defects, and select genetic diseases, said the researchers. 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. Source: Genetic Engineering News July 27, 2006
Creating human embryonic stem cells without destroying embryosUS biotech company, Advanced Cell Technology, announced that its scientists have found a ground-breaking technique for growing human stem cells from an early human embryo without destroying it. The new technique, consisting of removing one of the eight cells of a three-day-old embryo instead of destroying a five-day-old embryo with about 150 cells, has however been criticized due to lack of medical evidence as to whether a fetus missing one cell will develop into a normal child. In addition, the new method would mean that parents would have to give their ethical consent for the donation of one cell. Further reading:
Source: EurActiv News, August 24, 2006
Preclinical research with human embryonic stem cells in ScotlandGeron and the University of Edinburgh are collaborating to conduct preclinical safety and efficacy studies with three cell types derived from human embryonic stem cells (hESC). The cell types are hepatocytes for the treatment of liver failure and osteoblasts and chondrocytes for the treatment of musculoskeletal disorders, including osteoarthritis, bone fractures and osteoporosis, said Geron officials. The studies, based at the University's Centre for Regenerative Medicine, will be under the direction of John Iredale, Phil Newsome, Brendon Noble, and Hamish Simpson. Source: Genetic Engineering News on-line, August 8, 2006
Singapore firm develops clinically compliant human embryonic stem cellsES Cell International (ESI) produced four new clinically compliant human embryonic stem (hESC) lines. Another four are expected to be banked soon. ESI also intends to distribute research-grade versions of the stem cells to academic researchers worldwide through the A*STAR Singapore Stem Cell Consortium (SSCC). The SSCC Stem Cell Bank will be responsible for growing the cells under non-cGMP conditions for distribution to academic researchers. This development will facilitate lab research while allowing users the option of securing the clinically compliant versions of exactly the same cell lines they were using in their research. Source: Genetic Engineering News, August 1, 2006
Therapeutic approachesBacteria make anti-cancer drugsScientists are looking into the possibility of using bacteria to make a new library of anti-cancer compounds that are usually too difficult to create synthetically. The discovery could provide the basis for developing useful new anti-cancer drugs. The researchers from the University of Warwick have been focusing on the bacterium Streptomyces coelicolor, which can naturally produce red-coloured alkaloids called prodiginines. A synthetic prodiginine analogue called GX15-070 is currently in phase 1 and 2 cancer treatment trials. This group of antibiotics has stimulated much recent interest as they can be used to target and kill cancer cells. However, analogues of other prodiginines, such as streptorubin B, could be even more powerful anti cancer tools, but they cannot currently be easily synthetically produced on a lab bench. By manipulating the enzyme content of the bacteria, the researchers involved aim to produce a range of different compounds based closely on the form of streptorubin B normally formed by the bacteria. Some of these analogues of streptorubin B could provide the basis for developing useful new anti cancer drugs. Streptomyces coelicolor can claim the title of medicine's favourite as the bacterium, and its family members, provides most of the world's antibiotics. Streptomyces, which is found in almost all soils, is a harmless relative of the bacteria that cause tuberculosis, leprosy and diphtheria. It is also a very productive natural factory. Streptomyces is used to make over half of the naturally derived antibiotics in current use and produces many other pharmaceuticals, such as anti-cancer agents and immuno-suppressants a total of over 6,000 different chemical products. Source: www.DrugResearcher.com, November 1, 2006
Drug delivery: how ultrasound slips drugs into cellsUsing several types of microscopy, researchers from the Georgia Institute of Technology showed that ultrasound waves punched holes in (cancer) cells' membranes. The pressure of the ultrasound creates tiny bubbles; when the bubbles burst, a wave of fluid movement opens up a small breach. The damage is temporary: researchers found that within minutes, the cells could manufacture and dispatch tiny spheres of membrane material that would patch the holes. The ultrasound technique could become a way to target delivery of gene therapy or chemotherapy to specific tissues, or to transport large--molecule drugs that can't otherwise pass through cell membranes. Ultrasound wands could be pressed against the skin, with their energy focused on specific internal tissues. Safety studies are likely to take several years, but if all goes well, this could become an approved procedure in five to ten years. Source: TechnologyReview.com, November 14, 2006
Enzyme breaks down Alzheimer's plaque componentCurrent drugs to treat Alzheimer's disease, donepezil, rivastigmine and galantamine, are of some value in certain people with early stages of the disease. Patients only continue this treatment if the person improves or at least does not become worse, and people must be reviewed every six months. Medical researchers are currently investigating other medical treatments, including anti-oxidants, brain stem cell therapy and a vaccination to stop the build up of plaques in the brain (a hallmark of Alzheimer's disease). In yet another approach, researchers at Washington University School of Medicine in St. Louis showed that an enzyme, matrix metalloproteinase 9 (MMP-9), degrades abnormally aggregated proteins known as amyloid fibrils, a main ingredient of brain plaques. In the brain, support cells known as astrocytes make MMP-9. MMP-9 has already been linked to cancer metastases, vascular disease, arthritis and arthritis and establishing a direct Alzheimer's link is encouraging as previously identified enzymes only degrade a smaller, nonaggregated component of Alzheimer's plaques. Source: www.DrugResearcher.com, October 27, 2006
Malaria, tuberculosis, AIDSSimple eye test can diagnose severe malariaDiagnosing cerebral malaria &emdash; a severe complication of malaria in which the Plasmodium falciparum parasite infects capillaries that flow through the tissues of the brain &emdash; can be difficult, as patients can be unconscious and have a number of other illnesses. Now researchers have found that certain changes on the retina are unique to severe forms of malaria: white opaque patches and whitened blood vessels, bleeding of the retina and swelling of the optic nerve. This will enable doctors to determine whether a child is suffering from cerebral malaria or some other, unrelated illness, and prescribe immediate treatment accordingly. The diagnosis only requires an instrument called an ophthalmoscope, which is commonly used in Africa for studying eye disease. Diagnosis requires special training in eye examination, but is relatively straightforward and cost effective, which is essential in resource-poor settings such as Africa. A multi-centre evaluation of the findings will be undertaken by researchers in Gabon, the Gambia, Ghana and Kenya. Reference: American Journal of Tropical Medicine and Hygiene, November 6, 2006 Related articles: Folic acid for pregnancy affects malaria treatment 'Safe alternative' treatment for malaria in pregnancy Researchers stop side effects of disused malaria drug Malaria in pregnancy 'more complex than thought' Hybrid molecule could treat drug resistant malaria Source: www.SciDev.net, November 8, 2006
Scientists discover how body recognises TBScientists have discovered how the body's immune system detects the tuberculosis bacterium, a finding that could aid the development of novel vaccines and drugs to artificially trigger an immune response (Science 314, 5798 (2006) pp. 454 &endash; 458). The bacterium Mycobacterium tuberculosis infects one-third of the world's population and is responsible for two million deaths each year. Paul Lehner of the UK-based Cambridge Institute for Medical Research and colleagues identified a receptor on the host cells known as CCR5 that triggers the immune cells' response to tuberculosis (TB). The team demonstrated that without this receptor, Mycobacterium tuberculosis was able to thrive inside host cells, as the immune cells did not receive the signal from CCR5 to attack them. These results describe a novel mechanism whereby Mycobacterium tuberculosis communicates with the human immune system: an important and novel link between the immune system and the pattern-recognition based mechanisms that respond to infections. Further reading: New test diagnoses TB in half the time Faster, better TB test could be only a few years away 'Virtually untreatable' TB hits South Africa Human TB gene identified Funding boost for research into TB and malaria drugs Single genetic change 'can multiply TB risk by seven' Source: www.SciDev.net, October 23, 2006
WHO calls for cheaper tuberculosis tests for developing worldThe UN health agency called for industry investment in better tuberculosis (TB) testing methods in a recent report, stressing the impressive market available for these diagnostic tests in developing countries. According to the report, the global market for TB diagnostics is US$1 billion each year &emdash; more than twice what is spent globally on drugs used to treat the disease. The lack of knowledge in industry about the global market for TB diagnostics is one of the reasons behind the limited funding for exploring new tests. Many of the deaths caused by TB in the developing world are due to wrong or late diagnosis. The most widely used method is where some sputum from a patient's lung is examined under a microscope to look for the bacteria that cause TB. Yet this test has only 40-60 per cent accuracy under field conditions, falling to 20 per cent when patients are also infected with HIV. The technology needed to create more accurate and cheaper tests already exists, however, and new tests could easily be developed with funding, says the report. Above all, there is a great need for tests that can detect latent TB and identify people at high risk of developing the active disease, which kills some 1.7 million people every year. Today's newest and most sophisticated techniques for TB detection require sophisticated laboratory equipment that is too costly for poor countries. Source: www.SciDev.Net, October 27, 2006
WHO needs to do more to combat XDR-TB, claims reportAccording to the international medical humanitarian organisation Médecins Sans Frontières (MSF), the World Health Organisation (WHO) has failed to address the emergence of extensively drug-resistant (XDR) tuberculosis. The problem is HIV infection dramatically increases the risk of developing active tuberculosis and is driving the TB epidemic in Africa. HIV renders tuberculosis more difficult to diagnose (due to higher incidence of sputum negative disease), and treat (due to interactions and side-effects). The increasing spread of multidrug-resistant TB (MDR-TB) and the unruly nature of persistent infections pose additional challenges to treatment with currently available anti-TB drugs. The situation is exacerbated by the increasing emergence of extensively drug-resistant (XDR) TB. Resistance to at least two main first-line drugs and additionally to three or more of the six classes of second-line drugs makes this form of TB virtually untreatable with available drugs. These observations are fully outlined in a report, produced by MSF, whose analysis warns a greater investment is clearly required to make TB history, something they think the WHO are not doing. The report said the WHO would need to get newer drugs to patients as soon as possible by working with regulatory agencies and pharmaceutical companies to ensure fast-track clinical development and availability of new drugs for "compassionate use." In addition, the organization will also need to push to accelerate the development of more easy-to-use tests. This will require WHO to take a lead and not simply delegate responsibility to product development partnerships, the report added. The MSF's report can be viewed here. Source: www.DrugResearcher.com, November 1, 2006
TB strain identified as 'virtually untreatable'The World Health Organisation (WHO) has revealed details of a 'super strain' of tuberculosis, which is not only resistant to first choice treatment drugs, but also to three or more of the six classes of second-line drugs. The news is a worrying development as the emergence of strains that are resistant to the multitude of drugs has gained significant momentum. TB presently causes about 1.7m deaths a year worldwide. The WHO also recognised the threat of TB amongst people living with HIV/AIDS. Treating the two diseases at the same time is difficult because of negative interactions between some ARVs used to treat HIV/AIDS and TB drugs. Resistance to anti-TB drugs in populations is a phenomenon that occurs primarily due to poorly managed TB care. Problems include incorrect drug prescribing practices by providers, poor quality drugs or erratic supply of drugs, and also patient non-adherence. Globally, the WHO estimates there are about 425,000 cases of Multidrug Resistant (MDR)-TB a year, mostly occurring in the former Soviet Union, China and India. Drug resistance data available from Africa has indicated that while population prevalence of drug resistant TB appears to be low compared to Eastern Europe and Asia, drug resistance in the region is on the rise. The WHO stated that given the underlying HIV epidemic, drug-resistant TB could have a severe impact on mortality in Africa and requires urgent preventative action. Source: www, DrugResearcher.com, September 11, 2006
Discovery could halt antibiotic resistant spreadResearchers think that they have developed an effective tactic, which aims to stop the spread of bacterial infections that have become resistant to antibiotic treatment paving the way for future therapies. The strategy does not involve killing the bacteria directly, but utilising a group of compounds that can block the chemical signals that the bacteria use to communicate in an effort to stop their spread. These compounds, small organic molecules that are called 'conversation stoppers,' could help deliver a powerful dose to knock out deadly infections when combined with the killing power of antibiotics. In addition, these 'conversation stoppers' do not target bacterial growth, so the potential for the development of bacterial resistance is minimised. The ability to interfere with bacterial virulence by intercepting bacterial communication networks represents a new therapeutic approach and is clinically timely. Recently it has been found that the use of 'microwave-assisted chemistry,' a novel laboratory technique for heating chemical reactions using microwaves, can dramatically accelerate the synthesis of AHL analogs that can either block or stimulate bacterial communication. So far, the researchers have identified at least two compounds that show particular promise at blocking biofilm formation in Pseudomonas aeruginosa, a bacterium that is a common cause of death in people with cystic fibrosis, AIDS and severe burns. The research was described recently at the 232nd national meeting of the American Chemical Society. Source; www.DrugResearcher.com, September 13, 2006
AIDS on rise in EuropeAccording to the latest statistics on reported HIV infections in EU countries, there has been nearly a doubling of the cases between 1998 and 2005. Estonia reports more than twice as many cases as the other member states and the number of new infections in Portugal is also above the EU average. The most common method of transmission is heterosexual intercourse and 50% of the latest cases affect people aged 15-25. A recent Eurobarometer on AIDS prevention shows that young people are less and less aware of this major public health threat that particularly affects developing countries' economies. A recent workshop organised by the European Centre for Disease Prevention and Control (ECDC) estimated that one third of Europeans infected are unaware that they are HIV positive. A new Commission campaign AIDS-remember me?, launched on 15 November 2006, urges young people "to remember that HIV/AIDS is still with us". Young Europeans are invited to watch an online video show featuring a series of HIV/AIDS campaign ads from across Europe and vote for their favourite. People aged 15-25 are also invited to participate into a competition and propose a scenario for a video clip promoting prevention of infection by the HIV virus. A conference on HIV prevention will take place during the German EU Presidency on 12-13 March 2007. Further reading:
Source: EurActiv News, November 16, 2006
Genomics, proteomicsBreast and colon cancers genetically mappedScientists from the Johns Hopkins Kimmel Cancer Center have produced a genetic map that shows nearly 200 mutated genes, most previously unknown, help tumors emerge, grow and spread. The researchers discovered that mutated genes in breast and colon cancers were almost completely distinct, suggesting different pathways for the development of each of these cancer types. Each individual tumor appeared to have a different genetic blueprint, which could explain why cancers can behave very differently from person to person. It also gives rise to the concept of personalized treatments to treat this variation in the disease. Personalized medicine or pharmacogenomic analysis can identify disease susceptibility genes representing potential new drug targets. This may well lead to novel approaches in drug discovery, an individualized application of drug therapy, and new insights into disease prevention. Source: www.DrugResearcher.com, October 31, 2006
Nano newsSpeed-reading the GenomeLast week, the National Human Genome Research Institute in Bethesda, MD, announced more than $12 million in grants for researchers who are developing technologies to slash the costs of mapping a mammalian genome from around $10 million to $1,000. Some scientists believe that new twists on a decade-old idea, called nanopore sequencing, could speed up the sequencing process and provide a more complete map of the genome. In nanopore sequencing, strands of DNA move through a small hole in a (silicon semiconductor) membrane with sensors that read off the base pairs of genetic code one by one. The hole, or nanopore, is about the size of a DNA molecule, or 1 to 2 nanometers in diameter, and the membrane separates positively and negatively charged solutions. Another approach to nanopore sequencing involves designing a DNA sequencer based on a modified fluorescence microscope and arrays of many nanopores. First, the DNA is incubated with four different fluorescent labels. The labels make the strand too big to go through the hole, so they have to pop off for the strand to advance. As the DNA moves through the nanopore base by base, the microscope will detect the labels as they pop off. Source: www.TechnologyReview.com, October 11, 2006
Nano probe gains new insights into cell activityUS researchers have created a nanoscale probe that can capture the topography of biological objects in their normal environment, which paves the way for the discovery of new biomarkers leading to better drug design on the cellular level. The researchers have created the Scanning Mass Spectrometry (SMS) probe, which works by pulling biomolecules (proteins, metabolites, peptides) precisely at a specific point on the cell/tissue surface, ionise these biomolecules and then producing "dry" ions suitable for analysis and then transport those ions to the mass spectrometer for identification. The SMS probe can be integrated with the Atomic Force Microscope (AFM) or other scanning probes, and can not only image biochemical activity but also monitor the changes in the cell/tissue topology during the imaging. The probe potentially allows simultaneous detection of complex mechano-bio-electro-chemical events underlying cell communication. Source: www.DrugResearcher.com, July 28, 2006
Business News
R&D spendingBig pharma splash out on R&DNew data gathered by the Financial Times Research Centre shows that on average, the top 30 pharma firms spent almost 17 per cent of sales on research last year, not so surprising considering that bringing a new drug to market can now cost anything between $900m (¤715m) and $1.2b. As expected, the big spender is Pfizer, with over 14 per cent of its £27bn sales invested in R&D in 2005, followed by GlaxoSmithKline with over £3bn spent on research during the same year, and French giant Sanofi-Aventis with £2.7bn. Meanwhile, it seems that Big Pharma is changing its approach on how to spend it. The report suggests that relying on in-house research and development only has become increasingly complex in terms of budget and resources and it is now almost unviable for companies to have control over all the aspects of drug development. As a result, companies are staying away from big mergers with other giant companies and are instead buying smaller biotech companies, entering joint ventures or in-licensing drugs, according to the report. "Shifting away from over-reliance on in-house R&D makes sense, but brings new risks too," the report said. This is due to the failure of the majority of biotech start-ups and to the fact that academic researchers now try to commercialise their work at a much earlier stage. According to the report, this leads to companies rushing to buy overpriced acquisitions of academic ventures with no real product in sight. The report also shows that the biggest players are not necessarily the most profitable. The most profitable companies last year were either young biotech firms with successful drugs or reputable pharma companies with off shored operations taking advantage of the lower costs and high-skill base of developing countries. The world's biggest players in the pharmaceutical industry is Pfizer with a market capitalisation of over $100bn. GlaxoSmithKline is just behind with a stock-market value of $85bn. Roche Holding comes third with a stock market value of almost $84bn. Novartis, Sanofi-Aventis and AstraZeneca come in next with $79bn, $63bn and $ 52bn respectively. Source: www.DrugResearcher.com, October 24, 2006
Market research dominates early-phase spendingPharmaceutical companies are spending big on market research during the early stages of drug discovery. Regardless of whether they are promoting a future blockbuster drug or a small, niche brand, all drug companies tend to spend heavily on market research in early drug development up until Phase II, according to a recent study published by pharmaceutical business intelligence firm Cutting Edge Information. Between pre-clinical and phase II, niche brand teams allocated 53 per cent of their total commercialization budget to market research, while mid level brands spent 42 per cent and blockbusters only spent 38.5 per cent. This is because in the early stages of a drug's development, it is difficult to assess whether the majority of marketing resources should be allocated until a drug's benefits become clearer and a clinical profile is established. Therefore, a brand team relies heavily on market research during the early stages to identify unmet treatment needs and outline the drug's competitive environment in order to spot potential problem areas that could affect commercial development in the years ahead. This allows any potential challenges to be tackled by the drug company as early as possible and also allows them to guide the R&D process more effectively towards desired clinical endpoints. Source: www.drugresearcher.com, August 18, 2006
FacilitiesMerck plans new biopharmaceutical production facility in Darmstadt, GermanyMerck KGaA is planning a biopharmaceutical production plant at its headquarters in Darmstadt. The plant will cost approximately Euro190 million and close to 200 new positions will be created. This is the second largest investment made by the company in its 338-year history. Initially, the new plant will produce the monoclonal antibody drug Erbitux for the treatment of colorectal and head and neck cancer. Merck acquired the rights to develop and market Erbitux outside the U.S. and Canada from Imclone. According to the company, Merck first launched Erbitux in 2003 and now markets it in 52 countries. Merck says the oncology drug is its top-selling product. Source: Genetic Engineering News, September 6, 2006
AstraZeneca opens first clinical pharmacology unit (CPU) in the U.S.AstraZeneca opened its first U.S.-based clinical pharmacology unit (CPU) at the University of Pennsylvania. The company considers this opening a significant investment in research capabilities in the Delaware Valley. The CPU will have electrocardiology (ECG) collection systems, telemetry systems, and electronic data-capture systems. These technologies will provide critical information, such as toxicity and the relationship between drug dose and its actions. AstraZeneca has five CPUs and one ECG center across Sweden, the U.K., and, now, the U.S. The new facility will add significantly to its global capability to conduct important safety and tolerability studies that support development of new medicines for patients. Source: Genetic Engineering News, September 27, 2006
VaccinesPfizer breaks into the DNA-based vaccine marketPfizer acquired PowderMed, a privately held U.K. company specializing in DNA-based vaccines with a pipeline of influenza and viral diseases. This acquisition is a strategic opportunity to enter the vaccine market. Pfizer believes that PowderMed's DNA-based platform could circumvent the challenges of egg- and cell-based vaccine technology. While the research is at an early stage, DNA-based vaccines may be the next major innovation against the threat of influenza and other chronic viral diseases. PowderMed's technology may lead to new vaccines that are easier to use and store than current vaccines and may have the advantage of being more quickly adaptable to changing strains of influenza." PowderMed's vaccine development program is centered on its Particle Mediated Epidermal Delivery (PMED) technology, a needle-free delivery system that delivers DNA-coated microscopic gold particles into the skin using pressurized helium gas, triggering an immune response. PMED vaccines have been shown to evoke antibody- and cell-mediated immune responses, which could lead to improved efficacy compared to traditional vaccines, according to Pfizer. PowderMed's most advanced candidate is entering Phase II trials for seasonal flu. The company's pipeline also includes vaccines in Phase I development for herpes simplex virus and chronic hepatitis B and a preclinical study on genital warts. This transaction is expected to close in the fourth quarter of 2006. Source: Genetic Engineering News, October 10, 2006
First avian flu vaccines get EU-wide authorizationRecently, the Commission has decided to give an EU-wide authorisation for two veterinary vaccines, adopted by the European Medicines Agency's (EMEA) in July 2006. The authorisation is being granted "under exceptional circumstances". The EMEA's veterinary committee adopted its first positive opinions on the two vaccines by concluding that "the benefits from immediate authorisation in preparation for the upcoming high risk period [autumn migration] outweigh the potential risks". The vaccines can be used for chickens and Pekin ducks. They reduce the symptoms of avian flu and the transmission of the virus by the infected birds. There are currently no outbreaks of avian flu in domestic or wild birds in the EU. Source: EurActiv News, September 12, 2006
Sanofi breaks ground in cell culture-based vaccine productionWith the first clinical trial of its cell culture-based seasonal influenza vaccine commencing in the US, Sanofi Pasteur has demonstrated the production scale potential of a cell line in a successful bioreactor run of 20,000L, using the Per.C6 cell line licensed from Crucell. The scale up and the clinical trial conducted are part of a contract awarded by the US Department of Health and Human Services (HHS) to accelerate the development of a new cell culture-based influenza vaccine. Besides eliminating the need for chicken eggs, the cell culture process has the potential to reduce from four weeks to two or three weeks the start-up time for manufacturing once the virus strain has been identified, resulting in a more predictable manufacturing process. Apart from influenza, Crucell's PER.C6 technology is being used in programmes for the development of vaccines against Ebola, malaria and West Nile disease. Source: www.DrugResearcher.com, September 28, 2006
Sanofi Pasteur throws $30m into Canadian vaccine plantFrench vaccine giant Sanofi Pasteur has announced a $30m (23.5m euro) capital expansion project at its Connaught Campus in Toronto, significantly increasing manufacturing capacity for its popular acellular pertussis and polio vaccines. With this expansion the company is seeking to secure supply in Canada and around the world for its Pentacel and Quadracel vaccine combinations, now licensed in 52 countries in Europe, Asia and the Americas. Pentacel, a combination vaccine which protects children against five diseases - tetanus, diphtheria, polio, whooping cough and haemophilus influenzae type b - is the leading children's vaccine in Canada for these five major diseases, used in infants of 2,4,6 and 18 months, while the Quadracel combination is used in children at 4 to 6 years. Details of the expansion were not provided but it is understood that over 1,100 employees research, develop, manufacture and market vaccines to Canada and the world from the company's north Toronto site. Source: www.DrugRresearcher.com, September 21, 2006
EU firms win US vaccine contractsThe US has just allocated more than 1 billion US$ to the development of new anti-influenza vaccines. Including against bird flu. Three European laboratories have received the lion's share of the funding: Solvay in Belgium (US$ 298.58 million), GlaxoSmithKline UK (US$274.75 million) and Novartis Switzerland (US$220.51 milllion). All these firms are now working on cell culture. Source: RTD Info, August 2006
AcquisitionsUetikon acquires 80% in ArchportCU Chemie Uetikon, a fine chemicals company and part of the Swiss based CPH Chemie and Papier Holdings AG, has acquired an 80% shareholding in the bioprocessing services company Archport Ltd. This acquisition will broaden the company's technology base enabling it to become a complete systems partner of the global pharmaceutical sector. Archport Ltd was established in 1998 at Dublin City University to provide contract production and development services to the biopharmaceutical industry. The company's range of services include GMP-compliant animal cell culture and downstream processing activities for development or manufacture of active pharmaceutical ingredients (APIs). CU Chemie Uetikon GmbH based in Lahr, Germany, provides production partnership for the pharmaceutical industry. Source: Eunan McGlinchy, Archport Ltd Merck acquires Serono for 10.4bn eurosGerman drug manufacturer Merck has acquired the Swiss biotech company Serono in a deal worth SFr16.6bn (10.4bn euros) that has taken the industry by surprise and could signal the start of considerable consolidation for big pharma. The Merck-Serono deal follows agreements struck with giants such as Pfizer and GlaxoSmithKline as smaller companies combine resources and knowledge in a bid to maintain competitive. Analysts have also expressed surprise at the timing of the deal, having come so soon off the back of a failed attempt to purchase German-based firm Schering. This latest deal appears to have been worth the wait and effort as the purchase makes Merck the seventh largest drug group in Europe. Serono will become Europe's largest biotechnology company with pro forma 2005 sales of 7.7bn euros, including 3.6bn euros in bio-pharmaceutical sales Source: www.DrugResearcher.com
Lonza to acquire Cambrex' Bio Businesses for $460MLonza will buy Cambrex' Bioproducts and Biopharma segments for $460 million in cash, according to a definitive stock purchase agreement between the two companies. Lonza says that this marks the company's largest acquisition. Subject to stockholder approval and customary regulatory approvals, Cambrex expects to close the transaction between January and February, 2007. Cambrex has three business segments: Bioproducts, Biopharma, and Human Health. The Bioproducts business manufactures and markets research, therapeutic, and analytical testing products, based on cell biology and used in drug discovery and biotherapeutic manufacturing. The Biopharma business offers process-development services and contract manufacturing under cGMP conditions for therapeutic proteins, vaccines, and other biologic drugs. Source: Genetic Engineering News, October 24, 2006
Drug discovery and developmentAM-Pharma receives patent for antimicrobial peptideAM Pharma has been awarded a US and EU patent for its antimicrobial peptide to be used in the development of a novel class of drugs with high efficacy against a broad spectrum of bacterial, fungal and viral infections. The antimicrobial peptide, Lactoferrin (LF) is a metal binding glycoprotein found in milk, tears, saliva, bronchial, intestinal, and other secretions. Lactoferrin also plays an important role in numerous inflammatory and immune response functions. This protein displays antimicrobial properties against Gram-positive and Gram-negative bacteria by limiting the availability of environmental iron. However, since iron-saturated hLF is also able to kill certain bacteria, mechanisms other than iron-depletion apparently are involved in the antibacterial activity of lactoferrin. AM-Pharma's research has resulted in a first lead, hLF1-11, which consists of the first eleven amino acids of lactoferrin. Its mechanism of action is predominantly through the intermediacy of cells and/or components of the host as opposed to a direct interaction with the pathogen. This would explain the extremely low dosages required in vivo and the in vivo efficacy against a broad range of different microbes such as bacteria, fungi, and possibly viruses. Recent results from Phase I clinical trials in humans showed that hLF1-11 was safe and induced no signs of toxicity, immune responses or other adverse events that could be attributed to the peptide. Based on these findings hLF1-11 is currently evaluated in a Phase II trial as an effective and safe antibacterial and antifungal substance for the prevention of severe fungal and bacterial infections, especially in patient undergoing bone marrow stem cell transplantations. Source: www.DrugResearcher.com, Aug 17, 2006
New biochip could accelerate drug developmentResearchers at Purdue University have been working on a device that measures the concentration of ions as they enter and exit cells. The technology measures electrical activities of cells and can obtain 60 times more data in one reading than is possible with current technology. The current technology for analyzing cells' electrical activity, called "patch clamping," uses a tiny electrical probe viewed under a microscope. The technique requires a lot of know-how and hand-eye coordination. The hope is this biochip could accelerate drug development targeting ion channels, i.e. for muscle and nerve disorders like epilepsy. The biochip records ion concentrations in up to 16 living cells temporarily sealed within fluid-filled pores in the microchip. With four electrodes per cell, the chip delivers 64 simultaneous, continuous sources of data. This data allows for a more detailed understanding of cellular activity compared to current technology, which measures only one point outside one cell and cannot record simultaneously. The chip also directly records ion concentrations without harming the cells, whereas present methods cannot directly detect specific ions, and cells being studied typically are destroyed in the process. Source: www. DrugResearcher.com, October 24, 2006
Novel search engine speeds up drug researchScientists have come up with an innovative tool that may accelerate the drug development process. The tool consists of a search engine that is connected to a giant database. The intention is the two elements work in tandem to connect human diseases with potential drugs to treat them, as well as predict how new drugs work in human cells. The tool, known as Connectivity Map allows researchers to screen compounds against genome wide disease signatures, rather than a pre-selected set of target genes. This research effort aims to generate a detailed map that links gene patterns associated with disease to corresponding patterns produced by drug candidates and a variety of genetic manipulations. The Connectivity Map is the work of The Broad Institute, a research collaboration involving faculty, professional staff and students from throughout the Massachusetts Institute of Technology (MIT) and Harvard academic and medical communities and is governed jointly by the two universities. The Connectivity Map is the subject of three new research papers that are published in the journals Science and Cancer Cell. Source: www.DrugResearcher.com, October 2, 2006
Protein Structure Initiative (PSI) provides materials repositoryThe |