Home | Objectives |  Organization | Members | News and Info. | Publications | Products | Interesting Links | Library | Secure ACTIP Bulletin 40 December 2004 Next ACTIP meeting   The next ACTIP meeting will be held in Antwerp, Belgium   On December 9-10, 2004   The two central themes of the meeting will be 'High production strategies' and 'Tissue engineering'. By now, you should all have received details of the meeting. If not, please contact the ACTIP Secretariat.   In this issue:   WHO report highlights priority medicine needs News from the Commission Research News Business news On the web Agenda   WHO report highlights priority medicine needs   The World Health Organisation (WHO) has released a report, entitled "Priority Medicines for Europe and the World", which highlights urgent needs for pharmaceutical innovation from a public health perspective. In the category of 'future health threats', the report points out that antibacterial resistance is a major problem in Europe.The WHO recommends a combination of better surveillance, prevention, research and development as well as international co-operation to address this threat. The report also recommends policy action to prevent the devastation of an influenza pandemic and the development of effective pharmacological tools to help people give up smoking. The research highlights an additional 14 priority conditions where pharmaceutical gaps exist. The authors recommend that pharmaceutical innovationÝbe encouraged by a shorter medicine development process and a reviewedÝreimbursement procedureÝin view of the EU's single market and the G-10 recommendations. The text argues that pharmaceutical innovation should be underpinned by a more attractive basic research environment. The report highlights the special needs of three population groups (elderly, women and children) which should be addressed when it comes to medicine development. The changing composition of elderly people's bodies and their liver metabolisms means dosages need to be adapted while the shortage ofÝclinical trials in women and children requires attention. The authors of the report point to the EU's responsibilities towards the developing world. "Europe can and should play a global leadership role in public health," states the text. WHO: Priority Medicines for Europe and the World Project "A Public Health Approach to Innovation" WHO press release: Landmark report could influence the future of medicines in Europe and the world European Federation of Pharmaceutical Industries and Associations (EFPIA): Position Paper - Barriers to Innovation in the Development of New Medicines in Europe and Possible Solutions to Address these Barriers (November 2004) Source: Euractiv, Friday 19 November 2004   News from the Commission   European Research Council urgently needed, say 52 scientific organisations A letter calling for urgent action on the European Research Council, a pan-European funding organization for basic research at European level, was published in the August edition of Science Magazine. The appeal is drafted by the Initiative for Science in Europe (ISE) and co-signed by many of the leading European scientific organizations. The ISE writes in its press release that "a mass petition of this kind on science policy is almost unheard of in Europe and indicates the importance these organizations attach to the ERC debate". The letter says that an ERC is needed to ensure that Europe funds the best research and to combat the fragmentation of research efforts at European level. It is also needed to urgently regain the ground lost vis-à-vis the United States in attracting foreign scientists and in simply just retaining Europe's own brains. According to the letter, Europe's performance in scientific publishing and Nobel prizes has deteriorated as well. The appeal welcomes the preparatory work done so far by the Commission on basic research and on setting up an ERC . However, the letter warns that if special attention is not given to the ERC, the project may be shelved in favor of other more short-term issues. The focus of the ERC is on the long-term benefits of basic research for a knowledge-based society. The Member States are very positive about the idea and the Research Commissioner Philippe Busquin hopes that a decision on the European Research Council for basic research would be agreed during the Dutch Presidency before end of December 2004. Source: CORDIS News, August 28, 2004   No more comparisons with the US," EU policy-makers agree At a conference held on 15 October 2004, over sixty senior representatives from EU institutions, industry and NGOs discussed potential ways forward for the struggling Lisbon agenda . The aim was to make recommendations to the Barroso Commission of how to embrace its responsibility to help get EU competitiveness back on track. Several main messages evolved from the discussion. In particular, participants agreed that the constant comparison between the US and the EU economies was not very useful. "Being competitive does not necessarily mean being the same," one MEP pointed out. "Europe is different from the US and Japan," a Commission official added. "Let's build on those things that are strongly European. Perceived constraints such as environmental and social standards can be turned into opportunities." Instead, there was a strong agreement that better benchmarking was neededÝ within Europe. In this respect, the environmental and social pillars of the Lisbon process must not be neglected. "The old-fashioned debate in which competitiveness is seen as a prerequisite for sustainable development is wrong," one senior officialÝemphasized. "Europe must seize its opportunities in the areas that it can lead on, such as resource efficiency." Source: EurActiv News, October 19, 2004     The future of science and technology in Europe On 16 June 2004, the European Commission presented its suggestions as regards the future EU research policy in a communication entitled "Science and technology, the key to Europe's future - Guidelines for future European Union policy to support research". In this interesting document, the Commission proposes, among other measures, to double the annual budget allocated to European research for the duration of the next Framework Programme (FP7), to organize the EU action around 6 major objectives (such as the creation of European centers of excellence and the development of research infrastructures) in order to increase its impact, and to improve the functioning of the future Framework Programme through its revision and simplification in the light of the experience acquired under the precedent Framework Programmes. Please note that an open consultation will shortly be launched by the Commission in order to give all interested parties the possibility to express their opinion as regards these propositions. Communication from the European Commission "Science and technology, the key to Europe's future - Guidelines for future European Union policy to support research" COM(2004) 353 Related press release of the European Commission Source: IPR Helpdesk News June 18 2004   Marimon report: EU research instruments unclear in their goals The long awaited Marimon report on the mid-term evaluation of the new instruments of the EU's Sixth Framework Programme (FP6) was presented to the informal Competitiveness Council on 3 July 2004. The report contains 12 recommendations on ways to make the Integrated Projects (IPs) and Networks of Excellence (NoEs) more effective. The report addresses the following main issues: Costs and administrative hurdles involved in submitting a proposal: the panel found that the costs and risks of participation in FP6 were "unreasonably high". Size of projects and 'critical mass': Many participants have overestimated the required size of a consortium, submitting proposals with far too many project partners. Clarification of the instruments' goals: Evaluation procedure: The group proposes the implementation of a two-step evaluation procedure, whereby applicants first submit a short proposal, which would be evaluated according to a few specific criteria such as adequacy and excellence. If participants receive positive feedback, a more detailed proposal would be prepared. This procedure would help to reduce the costs and risk of participation. SME participation: Although FP6 stipulates a 15 per cent target for SME participation, the achieved level has been disappointingly low. Increased flexibility for participants: The panel has raised its concern about the limitation of certain calls to certain instruments, Dr Marimon suggested that researchers select the most appropriate instrument to meet their research objectives. Source: CORDIS News, July 7, 2004   ....and the Commission's 'corrective measures' to improve the FP6 instruments The Commission published its response to the Marimon report on 27 August. It points out that many of the expert panel's recommendations actually match the Commission's own findings and that it has already taken 'corrective measures' on some points. It also states that the period reviewed by the panel is only to a limited extent representative of the full term of the FP6, since the evaluation was carried out during the year in which most of the projects using the new instruments had just been launched. The Communication outlines an analysis on, and an answer to each of the 12 recommendations. The Commission's reactions to the main recommendations made by the expert panel can be summarised as follows: Clarification of the instruments' goals: The Commission recognises that the goals of the new instruments have not been stated clearly enough. It will disseminate a 'summary table' restating each instrument's specific objective, expected scope, Community-financed activities and the Community financing mechanism before October 2004. 'Size' of projects and 'critical mass': The Commission has already taken 'corrective measures' on clarification of these two terms. A 'read this first' notice has been drafted and included in the guide for proposers.'Good examples' of networks of excellence and integrated projects have been provided. Small and Medium-sized Enterprise (SME) and industry participation: The Commission admits that the networks of excellence are not really orientated for SMEs or industry. It mentions, however, a possibility of associating SME and industry to this instrument through their presence in steering committees, which provide advice on the conduct of networks. The Commission is also convinced that now that the 'size'-issue of the projects has been clarified, the integrated projects will attract more smaller actors. Increased flexibility for participants: The Commission rejects recommendations which would allow researchers to define their own specific research objectives and to make their own choice of instrument. This would diminish the value of EU support to research, says the Commission. Evaluation procedure: The Commission is reluctant to adopt the proposed two-step evaluation procedure. According to its experience, this method has led to longer delays in processing the proposals and increased the workload. Costs for participants and administrative hurdles: The Commission says that difficulties associated with implementing the new instruments should diminish as users familiarise themselves with these instruments. Some 'corrective measures' for simplifying the submission of a proposal have already been taken. The 'corrective measures' that can already be introduced in the FP6 will be taken before December 2004, most of them before October. The remaining measures will be included in the proposal for FP7, which is scheduled for early 2005. Source: CORDIS News, September 16, 2004   Research News   Human genome ever smaller Following the Humane Genome Project, first counts indicated that the human genome might contain 100,000 genes. This number was later reduced to approx 30,000. However, the most recent map of the human genome project suggests that men might have as few as 20,000-25,000 genes. This again demonstrates that humans are not unique because of their number of genes, but because of the way these genes co-operate and influence each other. It is also thought that one gene can be used in different ways, triggered by an as yet unknown mechanism. Some speculate that such a mechanism might be hidden in junk-DNA, which accounts for 90% of all DNA. Repeting DNA sequences are very well preserved among different species, suggesting that they are of great importance, even when they are not coding for proteins. Source: Nature, October 21, 2004   .... and junk-DNA is expressed after all....... Researchers from the US Columbia University, Yale University and Dutch Amterdam Medical Centre have made a gene expression map of Drosophila. Apart from the coding regions, they have also studied systematically non-coding regions by making microarrays with probes for every 1,000 genomic base pairs. For the non-coding regions 90,000 probes were made; 40% of these probes were expressed (and thus encoding). The expressed products were most likely small pieces of RNA, microRNA or miRNA ñ that is, RNA which is not coding for a protein but might influence expression of other genes. Source: BioNieuws, October 29, 2004   UN petitioned to ban human cloning At the end of August, 67 National Academies of Science petitioned the United Nations (UN) for a total ban on reproductive cloning of human beings. Several UN member countries find a ban on human cloning unacceptable, since it will block further research into therapeutic cloning. The petition is mainly intended against experiments as carried out by Panos Zavos of the Centre for Reproductive Medicine in Kentucky. Recently Zavos announced experiments in which denucleated bovine egg cells received human DNA of respectively an 18 month old baby, an 11 year old girl and a 33 year old man. In all three cases the family had approached Zavos for a cloning procedure. Pending a worldwide ban, there are numerous initiatives in several countries Reproductive cloning is now illegal in Singapore, as it is in nearly 30 countries. Sources: UN urged to Outlaw cloning of babies, Telegraph, 30 August 2004 Fury at cloning scientist's use of DNA from the dead, The Scotsman, 1 September 2004, http://news.scotsman.com/scitech.cfm?id=1024712004 Singapore bans human cloning, stem cell research OK, Reuters, 2 September 2004   Controversial stem cell research at Harvard A group of researchers of the Harvard Stem Cell Institute has approached the ethical Committee of Harvard University for permission to clone embryos in order to harvest stem cells. Should the Ethical Committee approve this request, Harvard would be the first university where this type of research will be carried out. Source: Harvard scientists ask to clone human embryo; Washington Post, October 14, 2004,http://www.washingtonpost.com/wp-dyn/articles/A29937-2004Oct13.html   Prion research network launched The Commission has launched a European research network for prion diseases. With 52 laboratories in 20 countries, this Network of Excellence brings together Europe's top experts for prevention, control, treatment and risk analysis of prion diseases. A major focus of the research will be on the questions of how prion modifications occur, how they develop in animals, how they are transferred to humans and how they affect human health. The EU will provide the project with 14.4 million euro of funding. "The European Commission has made a sustained effort to tackle the BSE crisis on several fronts," said Research Commissioner Philippe Busquin. "This has included a special action plan for research, launched in 1996, which rapidly mobilised 50 million euros worth of research involving more than 120 laboratories throughout Europe. As part of the European Research Area, the NeuroPrion Network of Excellence is the logical next step." Since BSE was first identified in 1996, outbreaks have been reported in all but four EU Member States, with 180,000 diagnosed cases in the UK alone. The cost of BSE to the 15 Member States has been estimated at over 90 billion euro. Moreover, the BSE crisis has heavily impacted on public trust in governments' scientific judgement. 146 cases of the human form, vCJD, have been reported so far. Source: CORDIS News, June 3, 2004   EU gives 12m euros for development plant vaccines I n July, the EC announced the start of the European pharma Planta Consortium. This consortium, made up by various research institutes and companies from 11EU member states and South Africa will focus on the development of vaccines made in plants against such diseases as HIV/AIDS, tuberculosis and rabies, with an emphasis on diseases prevalent in developing countries. Preference will be given to the production of immunotherapeutic biomolecules in seeds, since seeds can be made in large quantities and are easy to harvest. Candidate crops include tobacco, maize, potato and tomato. In the next 5 years, the consortium plans to move fr o m experimental approaches up to clinical trials. EU funding will be 12 m euros for the first 5 years . Sources: EU 'pharming' solutions to major diseases, European Commission, 30 September 2004 http://europa.eu.int/comm/research/headlines/news/article_04_09_30_en.html Plant-made Pharmaceuticals: Progress and Protests, ISB News Report, October 2004, http://www.isb.vt.edu/news/2004/news04.oct.html#oct0406   Prodigene to market plant-based pharmaceutical ingredients Earlier this year, ProdiGene Inc. announced the imminent market release of TrypZean"!, t he first phamaceutical product produced in a genetically modified crop. It is a protease produced by the pancreas and is used in the production of human and vetrinary vaccines, in cell cultures and for wound treatment. Prodigene claims to offer with this ingredient a safe alternative to veterinary derived proteases. In addition, ProdiGene produces AproliZean", a genetically modified cattle-aprotinin. Aprotinin inhibits the formation of trypsin, plasmin and other serin-proteases. It is used to stem bleedings during surgery and for wound treatment. This summer ProdiGene has applied for approval to start a large-scale production of genetically modified maize with trypsin and aprotinin components. This application has led to protest from the US Grocery Manufacturers of America. Finally, ProdiGene has announced it will start research into a veterinary vaccine against gastroenteritisvirus in pigs. The antigens for this vaccine will also be produced in genetically modified maize. In feed experiments with pigs, increased immunity was observed. On the same topic: Dow AgroSciences has started construction work on a production facility for veterinary vaccines on the basis of transgenic plants. The first product, a chicken vaccine, is expected to be produced in 2006. Sources: Prodigene brings Plant-Produced Recombinant Trypsin to Market, ProdiGene News, April 27, 2004, http://www.prodigene.com/0501.htm Prodigene shows Lactogenic Immunity with an Oral Swine Vaccine, ProdiGene News, June 23, 2004, http://www.prodigene.com/0501.htm Plant-made Pharmaceuticals: Progress and Protests, ISB News Report, October 2004, http://www.isb.vt.edu/news/2004/news04.oct.html#oct0406 SemBioSys Genetics Inc. Signs Feasibility Agreement With Dow Agrosciences, Biospace, 11 May, 2004, http://www.biospace.com/news_story.cfm?StoryID=16111620&full=1   Fish as cheap bioreactor for protein drugs The New Scientist recently reported on a genetically modified Tilapia fish which is modified to produce to coagulation protein factor VII . This product is developed by the US firm AquaGene in Florida and the University of Southampton in the UK. So far, Factor VII is produced from human blood (with limited availability and efficiency) and from genetically modified CHO cells. Both methods make Factor VII a rare and costly medicine. The researchers expect that Tilapia-produced Factor VII will be much cheaper because Tilapia breeding is rapid and easy. It is expected that Tilapia might be able to produce another 20 therapeutic medicines as well. Source: Can fish factories make cheap drugs?Ý New Scientist, September 11, 2004, http://www.newscientist.com/news/news.jsp?id=ns99996367   In vitro human blood-brain-barrier model A French group (Pierre Olivier and co-workers) have very recently produced and characterized an immortalized human brain endothelial cell line hCMEC/D3 that stably retains morphological characteristics of primary brain endothelial cells and expresses specific brain endothelial markers and cell surface adhesion molecules. Moreover, hCMEC/D3 cells display highly restricted paracellular permeability to hydrophilic molecules and permeability to several standard compounds that can be correlated to their in vivo brain perfusion capacity. The authors believe that this cell line can constitute a very promising in vitro model of human BBB. A patent application (through INSERM) and a manuscript will be submitted within a couple of weeks. The authors are looking for an industrial partnership on this topics. They would be very happy to enter scientific discussions, under a confidentiality agreement. If you are interested, please contact: Dr. Pierre-Olivier COURAUD Directeur de Recherche; Directeur du Département de Biologie cellulaire Institut COCHIN; INSERM U567 - CNRS UMR8104; 2 rue Méchain 75014 PARIS - France; Tel: (33)1 40 51 64 01; Fax: (33)1 40 51 64 30 e-mail: couraud@cochin.inserm.fr   Mapping DNA of 15 mouse strains The National Institute of Environmental Health Sciences will invest $13 million to map the DNA of 15 mouse strains important to laboratory research on human health. This initiative, called the "Resequencing Project" will launch the Institute's Center for Roden Genetics." More info: see http://www.niehs.nih.gov/oc/news/micedna.htm   Business news   Whooping cough epidemic in the Netherlands The Netherlands State Institute for Vaccines (RIVM) is reporting an epidemic of whooping cough. Until October 2004, already 7,000 cases have been reported for the year 2004. The number of whooping cough patients has been increasing steadily since 1996 and has never been as high as this year, despite the fact that nearly all children are being vaccinated. Also other European countries are reporting an increase in the incidence of whooping cough. As for the cause: some researchers believe in the 'decreasing immunity' theory, based on decreasing circulation of the bacterium among the population (regular exposure to the bacterium is needed for sustained immunity levels). However, increasing evidence is suggesting that the bacterium is mutating under pressure of the extensive vaccination campaigns. If correct, this would imply that a complete new approach to vaccination is needed, since all current vaccines against whooping cough are based on bacterial strains dating to the 1950s. Source: BioNieuws 17, October 2004   California votes yes on stem cell initiative The Gates Foundation is supporting the California Stem Cell Initiative, along with many other high profile groups and individuals. This importantÝinitiative, voted on in November, would raise $3 billion -- $300 million per year for 10 years -- for stem cell research ONLY in California. This level of funding has the potential to rapidly accelerate the application of these powerful stem cell technologies towards developing novel drugs and therapeutic approaches for treating devastating diseases. Source: http://www.curesforcalifornia.com   Research agreement GenOway and Pfizer GenOway has entered into a research agreement with Pfizer to provide Pfizer researchers in the USA with a genetically modified rat model based on GenOway's nuclear transfer technology. GenOway is the European leader in transgenesis and   On the web   Information on European research Europa.eu.int/comm./research/infocentre/index_en.cfm Industrial research: Europa.eu.int/comm./research/industrial_technologies/index_en.html   Marie Curie actions: Europa.eu.int/comm./research/fp6/mariecurie-actions/indexhtm_en.html Europa.eu.int/comm./research/infocentre/index_en.cfm   Agenda PepTalk 2005 January 10-13, 2005, San Diego, Cal USA Information: nicolel@healthtech.com Phacilitate Cell & Gene Therapy Forum 2005 January 24-26 January, Washington DC, USA Information: http://www.phacilitate.co.uk/pages/cgtherapy2005/ Process Validation for Biological Production Conference 14-15 February 2005, Basel, Switzerland Information:http://www.ef-international.co.uk World Life Sciences Forum, BioVision April 11-15, 2005, Lyon, France Information: http://www.biovision.org/ Molecular Medicine Tri-Conference April 19-22, San Francisco, USA Information: http://www.chi-MolecularMed.com Pathway Analysis for target and compound evaluation April 20-22, 2005, San Francisco, USA Information: http://www.chiMolecularMed.com ESACT 2005 5 - 8 June 2005 - Harrogate, North Yorkshire, UK Information: http://www.esact2005.org 7th Conference Protein Expression in Animal Cell September 18 - 22, 2005, Crete, Greece Information: http://WWW.PEACE-CONFERENCE.ORG     ACTIP bulletin no. 40, December 2004     Back To Top.   Home | Objectives |  Organization | Members | News and Info. | Publications | Products | Interesting Links | Library | Secure © ACTIP 2004