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Next meeting ACTIP:The next plenary meeting of ACTIP will be held in Berlin, Germany on May 15-16, 2006. The programme focuses on 'contribution of animal cell culture to speed to market' and stem cell contributions. Please contact the Secretariat if you have not received the information for the meeting.
In this issue:
News from the CommissionNew director DG ResearchSince January 1, 2006, the EC's Research DG has been headed by Jose Manuel Silva Rodrigues. His predecessor, Achilleas Mitsos, remains in DG Research in the important post of adviser hors classe.
Get going on R&D spending, experts tell EUEU business is spending only 44% for Research and Development (R&D) of what Japanese companies are spending, according to new figures by Eurostat. The EU is still the second most important investor into R&D worldwide, but more efforts are needed to drive innovation and create US-style centres of excellence, policy makers, senior researchers and business leaders agreed at the European research and innovation day organised by Microsoft on 6 November 2005 in Brussels. MEP Jorgos Chatzimakakis (ALDE, Germany) said Europe's problem was not that there is not enough innovation, but rather the relatively weak link between business and research: "What is needed is transforming patents into products." "The US has most of the world's top universities, and spending per student is two to three times higher than in the EU", said Carl Bildt, the former prime minister of Sweden, who has become a special envoy for the UN. We have a better level of basic education here, but by losing out to the US in higher education it means that they can attract all the best talent, and it's mainly down to money."
Source: Euractiv News, January 3, 2006
Expert group calls for public procurement to boost innovationA recent expert report argues that public sector demand for new products and services can boost innovation and increase investment in and take-up of related R&D. The report of the expert group for 'pre-commercial procurement of innovation' suggests that national administrations should come together to share the risks and the benefits of pursuing novel services and products with the providers themselves. A European dimension on pre-commercial procurement would build critical mass on the demand side, stimulate competition and exploit economies of scale and scope, and stimulate the uptake of European research. Finally, co-operation on European level would reduce the risks for the individual procurers of purchasing yet-to-be proven technologies." Along the same lines the Aho-report Creating an innovative Europe (January 2006) highlighted the need to develop a European level strategy on the matter. The Aho-report considers e-health, pharmaceuticals, energy, environment, transport and logistics, security and digital content as the top large-scale sectors in which market creation is urgently needed.
Source: EurActiv News, March 31, 2006
New services to help SMEsUnder the EC's Innovation programme, an accompanying measure has piloted four services to help start-up companies. The initiative is called SUN&SUP (Start-up networks and start-up providers). The four services are: (1) Invest Academy to help entrepreneurs to understand finance issues and prepare credible business plans; (2) NXD Network, to recruit experienced entrepreneurs to become non-excutive directors, helping start-ups as they develop; (3) Fame, a service enabling start-up to find an appropriate mentor from the pool of experienced entrepreneurs in the area; (4) Fuzzy Set, a novel risk evaluation and decision-making tool for entrepreneurs, in particular for high-tech companies. For more information: www.sunsup.org
Few EU companies in high R&D intensive sectorsThe 2005 industrial R&D investment scoreboard provides a full picture of the competitive situation of the top 700 EU and 700 non-EU firms in the global R&D environment. Compared to the 2004 scoreboard (see EurActiv 13 December 2004), the new report shows a slight increase (0.7%) of R&D investment by EU companies. However, non-EU companies continue to invest more and faster (6.9%), contributing to the increasing R&D gap. The 2005 scoreboard also shows that EU companies are less present in highly R&D intensive sectors such as biotechnology, health and information technology and invest more in medium R&D intensive sectors such as automobiles. The report states that the EU is weak in enabling SMEs to grow into large R&D investors, particularly in emerging R&D intensive sectors. Individually, EU companies such as Daimler-Chrysler or Nokia performed as well as non-EU companies such as Microsoft and Toyota. Source: Euractiv News, Dec 9, 2005-12-12
Results from the 2005 biotechnology reportResults from the third report on the 2002 Community Strategy for Europe on Life Sciences and Biotechnology. The report is the third of its kind laying out what needs to be done by the Commission, other European institutions as well as public and private stakeholders to deliver on the aims set out in the Commission's biotechnology strategy of 2002. The Commission has responded in its report by priorities for future action. Below is the list of current concerns and needs (in red), followed by the intended action at Commission or Member State (MS) level: (1) Assessment and cost-benefit analysis of biotechnology and genetic engineering: Action: Commission: To carry out an independent study on social, economic and environmental consequences, opportunities and challenges of modern biotechnologyTo update the Community Strategy on Life Sciences and Biotechnology well before the European Spring Council 2007 (2) Intellectual Property (IP) Protection: A simplified, workable and affordable European patenting system is needed. Enforce implementation of IP Directive Action: Member States: to fully and swiftly transpose and implement Directive 98/44/EC Commission, Member States, interested parties:to continue exploring whether further harmonisation would be desirable on the issue of scope of patents of gene sequences (3) Networking Europe's biotechnology: Draw on the results of the successful work of informal network with Member States officials on competitiveness issues. Action Commission and Member States: to continue co-operation and exchange of information through the existing Biotechnology network with Member States. Member States: to repeat, in 2006, the benchmarking programme to provide a basis for an exchange of best practices and fine-tuning of policies. To report on progress in implementation of biotech strategy (4) Funding Research in Europe The 7th Framework Programme should be designed with a streamlined administration system to encourage greater participation, and radically increase the number of participating SMEs. Action Commission: to simplify procedures and instruments in FP7 to make participation easier; to bring together relevant technologies and sectors to develop a European Knowledge-Based Bio-Economy (5) Improving the regulatory framework Review of the pharmaceutical legislation Registration and licensing procedures of medicines derived from biotechnology are still too complex and too expensive. Legislation on Genetically Modified Organisms (GMOs) Action Member States: MS should remain responsible for the correct implementation of EU legislation on GMOs that they have adopted; to play their role in the implementation of the new regulatory framework on GMOs Action Commission: to complete labelling thresholds for the adventitious or technically unavoidable presence of authorised GM seeds in seeds of both conventional and organic varieties; to increase cooperation and consensus among decision-makers through a coordination network (6) Tissue Engineering. A clear regulation for human tissue engineered products, harmonisation of national existing regulations and increased promotion in Member States is needed. Action Commission: to finalise legislation aimed at harmonising authorisation procedures for marketing products/processes from human tissue engineering, which guarantee a high level of protection for patients, before end 2005 (7) Genetic Testing. Lack of an adequate quality assurance system for genetic testing. Action Commission and Member States: to enhance the EU-wide exchange of information on best practice and collaboration regarding the development and use of genetic testing through the open method of coordination. Commission: to submit a proposal for a directive on the protection of workers' personal data in 2005; to analyse the possibility of setting standards on genetic testing (8) Pharmacogenetics. Uncertainty regarding the potential impact of pharmacogenetics on health care and its ethical, legal and socio-economic implications Action Commission: To launch initiatives on the potential benefits, risks and possible new policy issues, including a prospective study (9) Bio-Banks. Ethical concerns regarding the collection and storage of human biological material Simultaneous need to optimise the use of bio-banks through collaboration in order to ensure progress European biomedical science Action Commission and Member States: Recommendations for general principles governing bio-banks (data and sample sharing for research purpose)
France to build a European Institute of Technology in ParisThe idea of a European Institute of Technology (EIT) was originally proposed by Commission President Barroso as part of the revised Lisbon agenda and the ambitious growth and jobs strategy for the EU to attract the best brains and investors to Europe. The EIT is inspired by and has as its current model the American Massachusetts Institute of Technology (MIT). While a European stakeholder consultation on the EIT is currently underway, countries are already competing to host the institute. After France successfully negotiated the creation of the international experimental fusion reactor (ITER) in Cadarache - it has now announced its advanced plans for the creation of a European Institute of Technology (EIT) in Paris. The aim is to stop the 'brain drain' of the best scientists and to turn the French capital into a 'European technology research hub'. The institute, expected to be operational in five to seven years would house around 300 scientists, half of which Europeans, half from all around the world. France seems to have decided to bring its plan forward irrespective of any EU decision (current EU-consultation on EIT) on the subject. The European research advisory board (EURAB) has warned the Commission against the European Massachusetts Institute of Technology-like ambitions, saying that such a "world-class research institute cannot be created top down" and can only grow over time out of existing research communities and with close relations with the most advanced industries. Science and Research Commissioner Janez Potoãnik supports the idea of building a network of existing universities rather than creating a new institution. Source: EurActiv News, October 12, 2005
Buzek backs more R&D on allergic diseases in FP7The Parliament rapporteur on the EUs 7th framework research programme, FP7, Jerzy Buzek, backs the inclusion of allergic diseases under the general health thematic research in the future FP7. He is supported by health NGOs representing both doctors in allergology and patients suffering from asthma and allergies. In the current Commission proposal for FP7, allergies figure only under the food thematic research. Allergies result from complex interactions between genes and environment. Allergic diseases have dramatically increased since 50 years due to a number of different factors: increased exposure to allergens, pollutants, dietary changes, the way food is processed, housing architecture and water supply. Currently, nearly 1 in 3 children are allergic and 30-50% of them develop asthma. Allergies have a huge negative impact on health, quality of life, education and career achievement an thus present a major health economic burden for the EU. Prevention, not only treatment, of allergic disease is very important in terms of research for patients. There are big difference in prevalence of allergies in Europe, the northern countries being 'the most allergic'. The further south the country lies, the less people have allergies, which get even more rare towards the east. "However, allergy prevalence has started to increase in the east as well, propably due to lifestyle changes. Curiously, the United Kingdom stands out for having, by far, the most allergies in Europe. Currently, GA_LEN, Global Allergy and Asthma European Network, an EU network of excellence under FP6, brings together European research excellence to develop new ways of preventing and managing allergies and asthma.
Source: EurActiv News, April 4
Regulatory News
Orphan drugs rarely approvedA report recently published in the British Journal of Clinical Pharmacology assessed the methodological quality of OMP (orphan medical products) dossiers and discussed possible reasons for the small number of products licensed in Europe. According to the report, 255 possible drugs for rare diseases were reviewed by the EMEA's (European Medicines Agency) committee for orphan medical products between August 2000 and December 2004. Only 18 products (7.1%) were approved, of which 10 under exceptional circumstances requiring additional studies to maintain market authorisation. During the same period, 79% of other drug applications submitted to EMEA were approved. The study states that the OMP dossiers were often poor in methodology, such as inappropriate clinical design, and suggests that the poor documentation supporting the applications may have limited the number of new orphan medicinal products. It also concludes with a suggestion that manufacturers need more EU incentives to develop OMP. British Journal of Clinical Pharmacology: Abstract of the report "Orphan drug development is progressing too slowly" by Roberta Joppi, Vittorio Bertele, Silvio Garattini Source: EurActiv News, March 7, 2006
No approval for first transgenic animal-produced productFourteen years after GTC Biotherapeutics saw the birth of its first transgenic goat, the first application submitted by any company to any US or European regulatory authority for the approval of a recombinant therapeutic protein produced transgenically has not had a happy ending, subject to appeal at least. European regulators decided late February not to allow GTC to market ATryn, an anti-clotting agent produced in transgenic goats, in the EU, on the basis that not enough surgical cases were brought before them &endash; they got five out of the twelve requested - and the fact that results from patients treated in a compassionate use programme and at childbirth could not be accepted. The news caused jitters among biotech firms who have invested hundreds of millions in transgenic drugs and so the EMEA quickly went out of its way to stress that "the grounds for refusal have nothing to do with the use of a transgenic animal." With this rejection, the bar has been set very high for the regulatory approval of transgenically produced pharmaceuticals. The full realisation of transgenically produced pharmaceuticals depends on the convergence of continued successful and innovative research and development activities, on a favourable regulatory climate and on public acceptance. ATryn may have been a specialised drug for a rare hereditary disease but it is a stepping stone, getting that first drug manufactured by an animal or a plant approved. Source: Europe Rejects Genetically Engineered Drug, New York Times, 24 February, 2006, http://www.nytimes.com/2006/02/24/business/worldbusiness/24drug.html
Positive advice EMEA on OmnitropeEMEA has issued a positive advice on Omnitrope, the recombinant growth hormone produced by Sandoz. According to EMEA, Omnitrope is identical to Genotropin of manufacturer Pfizer, and therefore can be seen as safe and effective. Omnitrope is the first biosimilar drug to be approved in Europe. Industry sees this positive advice as an important step forwards in receiving marketing approval for biotech edicines. Amgen, the world's largest biotech foirm, soon expects to receive a positive advice from EMEA for marketing approval of biosimilar EPO. Source: Genotropin, http://www.genotropin.com/
US approves new veterinary plant vaccineDowAgroSciences is the first company to receive marketing approval for a veterinary vaccine made in plants. It concerns a chicken vaccine made in transgenic tobacco plants. The transgenic tobacco is not grown in the field, but cultured as cells in a bioreactor. The cells produce a sub-unit vaccine against Newcastle Disease, a viral infection which can occur in all avians. The plant cells grow on a medium containing water, salt and sugars. Without disclosing a reason, Dow will not market the new vaccine. One probability is that already several vaccines against Newcastle Disease exist. However, Dow views the approval as an important step in the development of plant vaccines. The company is developing several plant veterinary vaccines, of which market introduction is expected in 1009 and 2010. Source: Dow AgroSciences Achieves World's First Registration for Plant-Made Vaccines. Dow AgroSciences, January 31, 2006, www.dowagro.com/newsroom/corporatenews/2006/20060131b.htm
Nanomedicine needs regulatory guidelinesThe European Science Foundation (ESF) has conducted a two-year foresight study on nanomedicine, the medical application of nanotechnology. The study is first of its kind in Europe and states that the old continent is at "the leading edge of this new wave of technology". Thanks to the tiny size of nanoparticles, nanomedicine tools can manipulate biological systems of human body at a molecular level and may well revolutionise medical care and research. According to Professor Ruth Duncan from the University of Cardiff, "Europe is at the forefront of R&D in several areas of nanomedicine, including the development of nano-scale pharmaceuticals and drug delivery systems". However, the study states that there is an urgent need to improve communication, interdisciplinary collaboration and nanomedical education. A regulatory process specific to nanomedical agents must also be created to help translate laboratory findings into clinical applications and marketable products. Otherwise Europe risks losing the medical and economic benefits from the advances of nanomedicine. More reading: European Science Foundation (ESF): ESF Forward Look on Nanomedicine 2005 (15 December 2005) Source: EurActiv.com, January 17, 2005
WTO gives third world generic drug boostAfter a two-year tug-of-war, the World Trade Organization (WTO) has solidified a landmark agreement to allow poor nations to import generic versions of patented drugs to treat serious diseases or epidemics. The ruling finally makes permanent a temporary waiver introduced in 2003 to the Agreement on Trade-related Intellectual Property Rights (TRIPS), allowing developing countries with no manufacturing capacity to import generic drugs from foreign countries under a compulsory-license system. Prior to the amendment, the first made to WTO rules since its introduction 10 years ago, countries could only break patents for drugs produced by domestic manufacturers to serve the home market. The current waiver remains until the new ruling becomes permanent on 1 December 2007, by which date all 148 WTO members should have ratified the amendment in accordance with their national laws. Under the agreed system, developing countries will notify the WTO of the medicines they need, and generic manufacturers will be able to apply to meet the demand. This would involve contacting their national authorities for a 'compulsory license' from the holder of the drug's patent. Source: www.DrugResearcher.com, December 7, 2005
Research News
Finally, function for prionsBone marrow stem cells need the prion protein PrP to continue cell division and survival in the long term. This is a finding of American biologists on the basis of research in mice. This is the first time that convincing evidence has been presented for the famed protein.The PrP-protein comes to expression on the surface of stem cells which develop into lymphocytes and red blood cells. Source: PNASonline, January 30, 2006
3D structure of HIV viruses unraveledAn English/German team of researchers has elucidated the 3D structure of the HIV virus. Because of the variability of the virus, the researchers investigated similiarities between the structures of seventy individual viruses. In addition, various photos were made of the 70 viruses. The photos show that HIV-viruses have a cone-shaped nucleus spanning the width of the viral membrane. The HIV viruses contain a cone-shaped nucleus, spanning the width of the viral membrane. The outer surface contains spikes binding to human immune cells and allowing the virus entry into the cell. With most viruses, the internal structure determines the size; with HIV viruses, the outer membrane determines the size. This limits the various ways in which the virsus can assemble. Source: Structure, reported in Life Sciences, March 1, 2006
Ceragenix' drug compound found to kill HIV strainsThe Ceragenin (CSA) family are synthetically produced small molecule chemical compounds comprised of a sterol backbone with amino acids and other chemical groups attached to them. These compounds have a net positive charge that is electrostatically attracted to the negatively charged cell membranes of certain viruses, fungi and bacteria. CSAs have a high binding affinity for such membranes (including Lipid A) and are able to rapidly disrupt the target membranes leading to rapid cell death. While CSAs have a mechanism of action that is also seen in antimicrobial peptides, which form part of the body's innate immune system, they avoid many of the difficulties associated with their use as medicines. Scientists from the Vanderbilt and Brigham Young Universities as well as Ceragenix Pharmaceuticals, demonstrated broad spectrum antibacterial activity with the CSAs with one candidate, CSA-54, potently inhibiting HIV infection of primary human CD4+ T cells, the virus's in vivo targets. Additionally, the compound was found not to be toxic to epithelial cells at concentrations significantly higher than those required to kill the virus. CSA-54 killed a wide range of HIV isolates, and completely blocked genetically engineered HIV that enters the cells independent of the cell surface receptor the virus normally uses. This finding indicates that CSA-54 most likely attacks the viral membrane and disrupts the virus from interacting with its target cells, similar to some of the known microbicidal peptides. This is important, as a compound that targets the viral membrane is likely to be effective against all strains of the virus, regardless of mutations, as the viral membrane remains unchanged. Late last year, the company Ceragenix demonstrated the antibacterial properties of CSA-13 against vancomycin resistant staph aureus ("VRSA"), vancomycin intermediate resistant staph aureus strains ("VISA"), vancomycin resistant erterococci ("VRE"), community associated methicillin-resistant staph aureus ("CA-MRSA") and hospital acquired MRSA, as well as key gram negative pathogens such as pseudomonas aueroginosa and E. Coli, and bioterrorism surrogate strains for anthrax, listeria and plague. Source: www.DrugResearcher.com, February 21, 2006
Anti-HIV enzyme from sunflowersResearchers at the University of Bonn have discoverd that sunflowers infected with a yeast will produce an antiviral enzyme effective against HIV infection (dicaffeoyl quinic acid (DCQA). Normally, the enzyme is extracted from artichoke or wild chicory, but because of the low content (1,000 dollar/mg), this enzyme is too expensive for medical treatment. With the German discovery, the application of a new group of anti-AIDS medicines comes within reach. Researchers hope to cultivate sunflowers or cells of other plants in a mix of nutrients and the yeast, resulting in the production of DCQA. It is also being studied which genes are being activated in the sunflower to produce DCQA. Should it be one gene, than genetically modified bacteria might cheaply produce DCQA. Source: AIDS-Medikament aus Sonnenblumen, Universität Bonn, Januar 2006, http://www.uni-bonn.de/Aktuelles/Presseinformationen/2006/005.html
Transcription explains difference between man and apeThe most importance difference between man and chimpanzee is not in the genes but in the gene regulation. This is the result of a comparative genetic study showing that in particular the expression level of transcription factors has been changed under evolutionary pressure. In addition, genetic sequences of transcription factors are prone to evolutionary press. Researchers from the University of Chicago draw these conclusions following microarray comparisons of the genomes of four primates: man, chimpanzee, urangutan and rhesus monkeys. Source: Nature, March 9, 2006
Pigs with healthy fatty acidsAmerican scientists have developed transgenic pigs producing omega-3 fatty acids. These fatty acids are known for their health effects in humans. The scientists want to use these pigs in studies on the effects of increased blood levels of omega-3 fatty acids on the heart. The scientists used a 'humanised' gene from Caenorhabditis elegans, a worm whose genome was mapped in 1998. This fat-1 gene encodes for the enzyme n-3 fatty acid synthase. The construct also contained a promotor gene from chicken and a marker gene for neomycin resistance. This construct was transplanted Source: Researchers Create Pigs that Produce Heart-Healthy Omega-3 Fatty Acids, Eurekalert, 26 March 2006, http://www.eurekalert.org/pub_releases/2006-03/uopm-rcp032106.php Generation of cloned transgenic pigs rich in omega-3 fatty acids, Liangxue Lai et.al., Nature Biotechnology, Advance Online Publication, 26 March 2006, http://www.nature.com/nbt/journal/vaop/ncurrent/pdf/nbt1198.pdf
Progress in xenotransplantationResearchers at the University of Minnesota succeeded in curing monkeys with diabetes type 1. They achieved this feat by implanting insulin producing cells from pigs into the monkeys. Following the implant, the monkeys lived for 6 months without insulin injections and with normal blood sugar levels. The donor cells reside in the liver and are not rejected by using a novel system which does not activate the monkey's immune system. The researchers are serious regarding clinical research in humans: they are already building special pig keeping facilities. Source:
U pig cell research offers hope for diabetes cure;
By Jeremy Olson, Pioneer Press Feb. 19, 2006
Transgenic mice to produce EPO in milkAt present, human EPO (erythropoietin) is made in genetically modified bacteria. Ti be effective, it has to be injected. A group of researchers at the University of Gyeongsang (South Korea) recently announced the creation of nine genetically modified mice which produce EPO in their milk. In addition, they have made genetically modified pigs which produce EPO in their milk as well. The ultimate goal is to produce EPO cheaper than with the current methods. Source: Mice Created to Produce Key Human Blood Protein; Transgenic Research. Korean Times; 22-02-2006. http://times.hankooki.com/lpage/200602/kt2006022217324353460.htm
Grapefruit flavonoid may repair DNA, protect against cancerGrapefruit and oranges contain flavonoids, which have received much attention because of their ability to scavenge free radicals. American and Chinese researchers have now reported that one specific flavonoid, naringenin, has anti-cancer effects beyond that of an antioxidant. The study, published in the February issue of the Journal of Nutritional Biochemistry (vol. 17, pp. 89-95) looked at the effect of naringenin on DNA repair in human prostate cancer cell cultures (cell line LNCaP). Induction of DNA repair by naringenin may contribute to the cancer-preventive effects associated with an increased dietary intake of fruits containing flavonoids. The naringenin is proposed to function by stimulating the so-called Base Excision Repair (BER) cellular mechanism that repairs DNA during the replication stage. This was supported by measurable and significant increases in two of the main enzymes in the BER pathway, DNA poly-beta and hOGG1. This study comes hot on the heels of other research reporting the benefits of grapefruit. Israeli scientists showed that eating a red grapefruit daily could lower blood cholesterol by 15 per cent (Journal of Agricultural and Food Chemistry published on-line, doi:10.1021/jf058171g). Source: www.DrugResearcher.com, February 17, 2006
Wine compound extract used as anti-aging drug?Researchers from Lay Line Genomics, a company focused on neurodegenerative and ageing related diseases, used a short-lived fish as an animal model to test the effects of resveratrol on aging-related physiological decay. Resveratrol is an organic compound naturally present in grapes and and particularly enriched in red wine. Resveratrol was added to fish food and fed to the experimental fish. They found that this treatment increased longevity and also retarded the onset of aging-related decays in memory and muscular performance. Resveratrol appears to be the first molecule to consistently cause life extension across very different animal groups such as worms, insects, and fish, and it could become the starting molecule for the design of drugs for the prevention of human aging-related diseases. The compound was previously shown to prolong lifespan in non-vertebrate model organisms such as yeast, the worm C. elegans, and the fruit fly Drosophila. However, until now, life-long pharmacological trials were performed in the worm or fly model organisms because of their very small size, very short natural lifespan, and affordable cultivation costs. Laboratory mice, on the other hand, live more than two years and are relatively expensive to maintain, making large-scale, life-long pharmacological trials in mice unaffordable. The fish model seems to be an affordable alternative. Source: www.DrugResearcher.com, February 21, 2006
DNA-wrapped nanotubes as biosensorsResearchers at the University of Illinois have wrapped single-walled carbon nanotubes with double stranded DNA in a way reminiscent of wrapping a pencil with electricity wire. This novel bionanostructure allows the intracellular detection of contaminants. The system is based on the characteristics of the secundary structure of DNA, of which exist both a natural, right-turning B-form and an alternative, left-turning Z-form, and natural fluorescence of carbon nanotubes in the near-infrared spectrum. The thermodynamics as a result of polymorphistic alternations between the B- and the Z-form influence the electronic structure and optical emission in the near-infrared. Thge system could be shown to work in practice. Low concentrations mercury could be detected in blood and in living mammalian cells and tissues. Sources:
DNA wrapped Carbon Nanotubes Serve as Sensor in
Living Cells, Medical News Today, 27 January 2007,
www.medicalnewstoday.com/medicalnews.php?newsid=36674
Researchers prove custom-designed enzymes are possibleBengt Mannervik and his research team at Uppsala University, in collaboration with Hak-Sun Kim's research team in Korea, have converted an enzyme in human cells that participates in normal metabolism into an enzyme that degrades cefotaxime, an antibiotic similar to penicillin. The human enzyme was complemented with parts from the bacterial enzyme beta-lactamase, which bacteria use to break down antibiotics of the penicillin type. The scientists then managed to isolate bacteria with the new enzyme and to show that they enhanced their capacity to survive by degrading cefotaxime. The study shows that it is possible to drastically alter the properties of a natural protein and that an enzyme's functions can be custom-designed for new uses. Source: www.DrugResearcher.com, January 31, 2006
Dog genome unraveledAmerican, British and French researchers have completed the mapping of the dog genome using the genome of Tasha, a boxer. The dog genome is the latest in a growing list of species of which the genome has been mapped. Comnparison of the different genomes of different species yields interesting functional information. Studying the dog genome may also give more knowledge about human diseases. Dogs know approximately 5000 diseases which show strong comparisons with human diseases. Sources:
Marc Van Montagu elected new president of the European Federation of BiotechnologyProfessor Marc Van Montagu, who has received numerous awards for his pioneering scientific work, has been elected new president of the European Federation of Biotechnology (EFB). He officially took office at the last Executive Board meeting of the Federation in Barcelona on January 14. According to Prof. Van Montagu, one of his immediate goals for the EFB will be to "help stimulate capacity building in Europe to diminish the political attitude against transgenic plants, and therefore sometimes against biotechnology and science in general". It is necessary that scientists "communicate with society to clarify how important transgenic plants and biotechnology in general are for Europe", said Montagu. Source: EFB, Anna Alsina, Communications Coordinator, European Federation of Biotechnology. E-mail: anna@efb-central.org
Business News
Xceleron leads EU microdose programmeAs proof of microdosing's potential in drug development, bioanalytical CRO, Xceleron, is to lead the European Union Microdose AMS Partnership Programme (EUMAPP) having additionally been awarded ¤2.1 million to further develop this technology. The 30-month EUMAPP project gathers together 10 organisations from 5 different countries (United Kingdom, Sweden, Netherlands, France and Poland) that aim to promote this technology as a viable experimental technique. The programme aims to additionally certify high and low voltage AMS technologies as the most accurate in measuring microdosing values. This programme follows on from the successful CREAM trial and will add 7 more drugs to the growing portfolio of compounds tested by Xceleron, said Professor Colin Garner, Xceleron's CEO. The microdosing approach conducted with Accelerator Mass Spectrometry (AMS) offers new ways of developing drugs by bridging the gap between the laboratory and the clinic. Working on the principle that 'the best model for man is man', the human microdosing concept, enabled by the ultra-sensitive analytical technology of Accelerator Mass Spectrometry (AMS), enables the safe introduction of sub-pharmacological doses of new drugs into man much earlier than ever before possible. In this way, ADME/PK data in the target species (man) is gathered rather than relying on animal models that may well not prove to be of any use. Source: www.DrugResearcher.com, January 31, 2006
Crucell and DSM expand agreementCrucell and DSM have announced the expansion of its original agreement, building on existing work achieved in the PER.C6 Protein and Monoclonal Antibody Licensing Business. Plans to expand on the original deal are based on the successful outcome between the two companies and the hope is any product born out of this agreement will make a significant impact in the burgeoning protein market. Under the terms of the new agreement, which was signed in 2002 and has been amended, the two companies will produce recombinant proteins and monoclonal antibodies on PER.C6 to increase licensing and royalty income. The partnership's Research and Development to create this new platform will be based around a new joint R&D centre, located in the Netherlands and the US East Coast. Crucell and DSM's package will include optimised clone generation technology, tailored media, batch, fed-batch and perfusion fermentation processes, fermentation equipment design, scale-up and scale-down solutions and regulatory support. Based on the progress made and milestones achieved with PER.C6 and an extensive evaluation of the market, DSM has selected the PER.C6 protein and monoclonal antibody licensing business with Crucell as one of its focal points for intensified innovation in its new strategy, Vision 2010. In line with this strategy re-orientation DSM Biologics will concentrate its contract manufacturing activities in Groningen in the Netherlands, and will focus on supporting licensees of the PER.C6 technology. To date, Crucell and DSM have signed 20 PER.C6 licenses for production of various proteins, including licenses to companies with marketed proteins such as Merck, Roche, Ely Lilly/AME and J&J/Centocor. Crucell's PER.C6 expression platform has been a real asset to the company, and has been licensed to numerous companies to produce vaccines and protein therapeutics. Source: www.drugresearcher.com, January 3, 2006
Boehringer and Evotec extend drug discovery collaborationBoehringer Ingelheim has extended its joint drug discovery collaboration with Evotec initiated in September 2004, which targeted therapeutics acting on G-Protein Coupled Receptors (GPCRs). The extension will include targets from different target classes, including ion channels and enzymes. Evotec,, drug discovery and development service providers, and Boehringer aim to jointly identify and develop pre-clinical development candidates suitable for future selection as drug candidates for clinical testing. Their areas of focus, GPCRs, are involved in a wide variety of body processes from vision to sexual development as well as many endocrinological and autoimmune disorders. To underlie their importance, amongst the 100 top-selling drugs, 15 are ion-channel modulators that represent a total market value well in excess of $15 billion (12.6 billion euro) The extension, which effectively doubles the already sizeable programme, has now been extended to the end of 2008, having originally been projected to end in August 2007. Financial terms of the deal were not disclosed. Source: www.DrugResearcher.com, January 17, 2006
Wyeth opens Dublin drug discovery research facilityWyeth are to establish a Bio-therapeutic Drug Discovery Research Facility in Dublin. The facility adds to a burgeoning platform of companies. Located at the Conway Institute in University College Dublin the facility will comprise 12 research scientists, and will be located within the Discovery Unit, which is directed toward new chemical and biological entities. The Development Unit's activities will concentrate on three distinct product families &endash; antibodies, fusion proteins and native biologics. Wyeth said the results of Wyeth Research Ireland's work would feed into the Wyeth Grange Castle Campus fully integrating the unit from discovery through development to full-scale manufacture. Ireland has become a favorite of the pharmaceutical company with the formation of a four-year research project with Dublin University aimed at improved the efficiency of biologics production, earlier this year. Added to the investment of nearly $2 billion in the Grange Castle facility, where site development work began in October 2002, the firm has invested heavily in the last few years to become one of the largest global biotech companies with the aim of combining a biotech culture with the resources and global reach of a large pharmaceutical company. Source: www.DrugResearcher.com, December 22, 2006
Manufacturing contract for world-first cancer vaccineAnticipating a US Food and Drug Administration (FDA) approval this year, Dendreon has awarded Diosynth Biotechnology with a long-term contract to supply its novel vaccine for prostate cancer &endash; the third most common cancer in the world. If approved, Dendreon's Provenge (sipuleucel-T) will be the first cancer vaccine ever to reach the market. The product is currently in late-stage clinical development and is also now undergoing a biologics license application (BLA) with the FDA. Once approved, Diosynth will manufacture Provenge for market launch and commercial sale in its facility in North Carolina, US, where the company currently produces the product on a small scale to supply clinical trials. Once demand for Provenge increases, Diosynth plans to upscale manufacturing and will shift production to its large-scale cell culture facility in the Netherlands. Provenge may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. It is delivered via Dendreon's proprietary antigen delivery cassette technology, which uses a recombinant form of an antigen found in approximately 95 per cent of prostate cancers, prostatic acid phosphatase (PAP), to stimulate the patient's immune system to attack the cancer cells. Although both Phase III clinical trials of Provenge have so far missed their primary endpoint of slowing tumor progression, after following patients for a longer period of time, Provenge did appear to extend survival and a third trial is now underway. The commercial launch of the drug will therefore depend largely on whether any established survival benefit is significant enough for the FDA to accept the data and give the green light for production. Source: www.DrugResearcher.com, March 13, 2006
Pharming into anti-agingThrough its recent acquisition of Dutch company DNage, Pharming has expanded its activities into the field of aging. DNage is studying aging at molecular level and aims to develop drugs against aging diseases. One of the first targets is the Cockayne syndrome, characterized by a defect gene that normally repairs damaged DNA. Because of the defect, DNA damage accumulates rapidly and patients show aging symptoms as early as 10 years old. Pharming expects that DNage acquisition will lead to additional business development opportunities. Source:
Pharming press release March 26, 2004
Researchers give 'one-off vaccines' a shotA consortium of British private companies and a university facility has been awarded $2.6m (¤2.13m) by the UK's Department of Trade and Industry (DTI) to produce a slow release vaccine which will eliminate the need for booster doses, improving compliance and slashing the cost of vaccination. According to the World Health Organisation (WHO), around 200m of booster doses are needed each year, for diseases such as tetanus, pertussis and polio, and since the average cost per dose, including transport cold chain and staffing, is $5, the potential for annual saving worldwide reaches $1bn. It all depends on whether researchers can make a vaccine whose dose is released gradually, stimulating the body's immune system over a longer time and allowing full protection to be achieved with a single injection. Medical technology firm Cambridge Biostability, which leads the project, believes it knows how to achieve this using nanotechnology and is confident it can have such a vaccine in the market in just five years. They stabilize the vaccine by embedding it in tiny microspheres, made of calcium phosphate glass, which dissolve in the body fluids. Proprietary nanoparticles within the microsphere ensure the vaccine release will be slower and the vaccine continues to be released into the body over a longer time period. What is more, these stable liquid vaccines can be stored safely without the need for a cold chain and do not require reconstitution or bactericides, which are major causes of vaccine safety and wastage problems. Source: www.DrugResearcher.com, March 20, 2006
Publications:
European Technology Platforms Leaflet, 6 pp, publications 2006/11 Rtd-technology-platforms@cec.eu.int
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silico applications in drug
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