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Next meeting ACTIP:
The next plenary meeting of ACTIP will be held in Gottingen, Germany on December 8-9, 2005
The programme focuses on high expression systems, novel approaches in downstream processing and biogenerics. Please contact the Secretariat if you have not received the information for the meeting.
In this issue:
Briefing paper: consequences for research on animals
Briefing paper: consequences for research on animals
If you work with animals, or benefit from experiments using animals in your research, a recently issued briefing paper may well be of interest to you, because it gives concise background on the impending revision of the EC Directive on research animal welfare - full title: Directive 89/609/EEC on the protection of Animals used for Experimental and other Scientific purposes. Most importantly for researchers using animals, it describes some possible revisions, and their consequences for research, and serves as a starting point for getting involved in the political process surrounding the directive amendment process. The document was produced by the EMBO Science & Society Programme, and can be downloaded as a pdf file from the following page: http://www.embo.org/scisoc/animal_research.html .
News from the CommissionCouncil adopts measures to attract foreign researchers to EUThe Council has adopted a 'researcher's package' to attract foreign researchers to the EU. It consists of a directive, which sets out a specific procedure for admitting non-EU nationals for the purposes of scientific research and a recommendation, which facilitates the admission of non-EU nationals to carry out scientific research in the EU. A recommendation to make it easier to issue uniform short-stay visas for researchers was adopted in September 2005. The aim of these measures is to foster the admission and mobility of non-EU researchers in Europe and to enhance Europe's attractiveness for researchers from around the world. • Commission press release: Researcher's package adopted (12 October 2005) • PreLex: Commission communciation on the presentation of a proposal for a directive and two proposals for recommendations on the admission of third-country nationals to carry out scientific research in the European Community [FR] [DE] Source; Eur-activ News, October 14
'New' EU action plan to boost R&D and innovationRecently, the Commission issued an update of the integrated research and innovation action plan, which calls for a major upgrade of the conditions for research and innovation in Europe. The plan is particularly focused on improving the conditions for private sector investment in R&D and innovation. It tables 19 already existing and new initiatives and clearly indicates what is expected from the Commission and what is expected from the member states to make these initiatives a reality. The new actions of the plan include:
"The 'update upgrade' plan shows the actions to be taken in R&D in order to contribute to the Commission's Growth and Jobs Initiative and the aim of these measures is to assure the functioning of the research internal market," said the Commissioner Potoãnik. The proposed measures are cross-sectoral and provide the same regulatory and political framework conditions for all stakeholders - independent of sector or size of the player. Different stakeholders will then tailor these instruments according to their specific needs. Related steps of the Commission include:
Further reading:
Source: Euractiv News, October 12, 2005
Commission to update EU's biotech strategyFollowing a future study on the consequences, opportunities and challenges of modern biotechnology for Europe, the Commission is set to update the EU's biotech strategy before 2007 and tune it to the Lisbon Agenda. In January 2002, the Commission adopted a Communication entitled 'Life Sciences and Biotechnology: A Strategy for Europe'. The strategy consists of specific policy orientations and a 30-point action plan to turn the policy into action. Since the adoption of the European biotechnology strategy, the Commission issues yearly reports on its implementation - the first progress report was published in March 2003, the second in April 2004. The Commission's 3rd progress report on the European strategy for life sciences and biotechnology states that 2004 seems to have been a year of consolidation rather than growth for European biotechnology. The report highlights some progress since the last report but states that the situation regarding European biotechnology and its competitiveness still needs to be improved, mainly because of:
In the report, the Commission announced that a reflection on the role of life science and biotechnology in the Lisbon Agenda was necessary. Accordingly, the Commission's Joint Research Centre (JRC) launched, on 21 October 2005, a study on the social, economic and environmental consequences and challenges of modern biotechnology. The Council and all stakeholders are invited to participate in this reflection process. The study aims also to increase public awareness and understanding of life sciences and biotechnology.
Source: EurActive News, October 27
A European Institute of Technology?A public consultation on whether and how to create a European Institute of Technology (EIT) has been opened by the European Commission today. It will gather the views of stakeholders on how an 'EIT' could strengthen research, education and market innovation in Europe. The public consultation will run until mid-November, and will feed into a wider analysis by the European Commission services. The idea of establishing a European Institute of Technology (EIT) was mentioned in the Commission's mid-term review of the Lisbon Process in February 2005 and the European Council took note of the Commission's intention in March. Ján Figel', European Commissioner in charge of Education, Training, Culture & Multilingualism said that "a European Institute of Technology could play an innovative role in supporting knowledge transfer, attracting the best researchers and companies from around the world to work in partnership". Such an EIT should draw on the considerable strengths of existing European institutions. Once the public consultation is concluded, the Commission will consider whether it wishes to take the matter further, and may then prepare a paper for the Spring European Council in March 2006. If the idea of the establishment of an EIT were to be approved by the European Council, the Commission would make a formal legislative proposal to the Council and the European Parliament. More information & online consultation available at : http://europa.eu.int/yourvoice/ipm/forms/dispatch?form=EIT http://europa.eu.int/comm/education/eit/index_en.html. Source: Euractiv News September 20, 2005
Eurobarometer: Europeans want a balance between ethics and scientific progressEuropeans want ethics to play an essential role in scientific research and demand harmony between the methods and goals of scientific research and moral and ethical principles, show two recent Eurobarometer surveys: 'Europeans, science and technology' and 'Values, science and technology' , both published in June 2005. The main objective of the 'Europeans, science and technology' poll was to gather Europeans' general attitudes towards science and technology. The underlying objective of the 'Values, science and technology' poll was to gather Europeans' views on social values and ethics as well as citizens' perceptions of actors involved in science and technology as well as the decision-making procedure. The final objective was to assess the perceived influence of ethics on science and technology in the future. The studies cover the populations of the EU member states, of the candidate countries (Bulgaria, Romania Croatia and Turkey) and the three EFTA countries (Iceland, Norway and Switzerland) - a total of 570 million people. The results also show that there is a "latent" interest among Europeans for science and technology and implicit demand for more information. The positive role scientists play in society is widely recognised but the way scientists handle information towards the public is criticised. In addition, the two surveys point out that:
Source: Euractiv News, June 17, 2005
Commission push on pharma innovationCommission Vice-President Günter Verheugen has announced a new strategy for the pharmaceutical industry aimed at closing the gap with the US on innovation and research and development. In a speech to the European Federation of Pharmaceutical Industry and Association (EFPIA), on 1 June 2005, Verheugen regretted that in recent years Europe had fallen behind the US in the production of new medicines. His new strategy, he said, was aimed at ensuring that Europe once more becomes "the natural home for pharmaceutical innovation". The Commission's strategy focuses on three areas:
More readiing:
Source: Euractiv News, June 3, 2005
Commission launches website promoting SME relations across EuropeA new website to facilitate the work of the Pan European Business Co-operation Schemes (PES) has been launched under the auspices of the European Commission and with the participation of the Euro Info Centre Network (EIC) and the European Association of Regional Development Agencies (EURADA). The site is intended to promote business opportunities and relations among around 4,000 SMEs from over twenty economic sectors in EU member States, candidate and neighboring countries, at 32 international trade fair matchmaking events, workshops and coaching activities over the next two years. The Commission has allocated 6 million Euros to the project. SMEs represent much of Europe's economy and are considered vital in building bridges across Europe and beyond. The PES schemes are aimed at unlocking the potential of SMEs to drive jobs and growth. Useful websites: Pan-European Business Co-operation Schemes: http://eic.cec.eu.int/PES/Pes.html Euro Info Centre Network (EIC): http://eic.cec.eu.int/ European Association of Regional Development Agencies (EURADA): http://eic.cec.eu.int/ Source: IPR Helpdesk, 16 May 2005
Business news
FDA drops plans for follow-on biologics policyFDA does not plan to release any documents concerning follow-on biologics regulation in the near future, Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb said Oct. 3. "I am not sure that we are going to have much more to say on [follow-on biologics] in the near future in terms of actual paper or policies that we announce," Gottlieb said during a Food & Drug Law Institute teleconference. Gottlieb said a number of questions - scientific, legal and regulatory - need to be addressed before the agency will be prepared to issue further guidance on follow-on biologics. The agency has been working on documents concerning generic biologics for years; FDA has previously described a series of planned public documents on the topic. As recently as August, FDA announced intentions to release a historical "white paper" on follow-on biologics regulation by "late summer to fall". Section 505(b)(2) of the Food, Drug & Cosmetic Act has been identified as one possible pathway for bringing follow-on biologics to market. However, Gottlieb emphasized that a number of legal and regulatory hurdles remain before 505(b)(2) can become a viable pathway. Source: The Pink Sheet Daily: October 3, 2005
Crawford resigns as FDA CommissionerThe US Food and Drug Administration (FDA) has found itself once again without a permanent Commissioner after the current incumbent - Lester Crawford - resigned after 18 months in the post. Crawford was appointed acting FDA Commissioner March 2004, after having stepped into the job on an interim basis on two prior occasions. After a long, contentious and drawn-out appraisal process he was finally granted the permanent position in July. However, his application for the permanent post and subsequent tenure has been dogged by persistent criticism on issues such as the FDA's recent record on monitoring drug safety, the politically-sensitive issue of expanding access to emergency contraception and his opposition to the re-importation of prescription drugs. The FDA's postponement last month of a decision on whether Barr Laboratories' emergency contraceptive Plan B should be made available over-the-counter - which prompted 13 US Senators to seek a non-partisan probe into the agency's actions and the resignation of assistant FDA Commissioner for Women's Health Susan Wood &endash; has been a key source of criticism for the Commissioner. Source: www.DrugResearcher.com, September 29, 2005
Lonza wins biopharma contract from UCBLonza has won a major new contract for its biopharmaceutical manufacturing facility in Visp, Switzerland, making bulk actives for Belgian company UCB. This is a boost for Lonza, which has been hit by product cancellations in its biologics production business, just as it has been investing in the commercial scale biopharmaceutical manufacturing facility at Visp. The new facility, due to start operating in the second half of 2006, will contain two production trains with a fermentation capacity of 15,000 litres each. Under the terms of the long-term supply agreement with UCB, Lonza will manufacture PEGylated antibody fragments at Visp. UCB has reserved a fixed annual manufacturing capacity for recombinant microbial products, covering the period 2006 &endash; 2012 with an extension option. Source: www.In-pharmatechnologist.com, May 13, 2005
US report: 20% human genes patentedAccording to a recent study, in the US 20% of the human genes have been patented, in particular by universities and companies. This is made possible by the US patent law which allows intellectual property protection on human genes. The patents on human genes are held by 1.156 different patent holders, 63% of these companies. Witth 2,000 patents, Incyte Genomics (California) is the largest patent holder. Most patents cover one gene, but there are also patents which cover more, sometimes as many as 10 genes.
Sources: One-Fifth of Human Genes Have Been Patented, Study Reveals, National Geographic News, October 13, 2005, http://news.nationalgeographic.com/news/2005/10/1013_051013_gene_patent.html Intellectual property landscape of the human genome, Kyle Jensen and Fiona Murray, Science Policy Forum, VOL 310, 239-240, 14 October 2005, http://www.sciencemag.org/cgi/reprint/310/5746/239.pdf
Cell culture sector boosts biopharm fortunesAccording to a new report, the biopharmaceutical market is predicted to increase from $1.4 billion (1.14 billion euro) in 2003 to $2.6 billion in 2006. The market was dwarfed by the pharmaceutical industry 20 years ago but continues to outgrow its rival increasing its market share each year. In 2000-2003, regulators in North America and Europe approved a total of 64 biopharmaceuticals for human use. The approved drugs included hormones, blood factors, thrombolytics, vaccines, interferons, monoclonal antibodies (MAb), and therapeutic enzymes. All of the 64 new biopharmaceuticals approved were protein-based drugs and an increasing number have undergone some form of engineering. The primary method of producing these biopharmaceuticals is mammalian cell culture. The report: "Mammalian Cell Culture: Production Technologies and Market Overview," is available to buy from Research and Markets. Source: www.drugresearcher.com, September 22, 2005
New Pfizer plant in SwedenCompany Pfizer is to build a major new pharmaceutical production plant for production of the company's growth hormone, Genotropin. The production of other drugs would be moved to the new plant in the long term. The new plant will be built near Pfizer's existing site in Strangas near Stockholm. Source: EuroBiotechNews 6-7, vol 4, 2005, pp 17
Healthy growth therapeutic mab'sMoonoclonal antibody therapies have overcome their early hurdles and are now a booming business area, according to a new report from company Datamonitor. In 2004, global mab sales rose by 48% and passed the 10 billion $ mark. In the early days, mouse-derived mabs caused serious side-effects, but now, safer and more effective humanized and fully human antibodies are pouring onto the market. Datamonitor forecasts that the mabs market will treble in size by 2010. Source: New Drugs, June 2005
Cipla to sell generic version of TamifluIndia's second largest biogeneric company, Cipla, announced plans that will see it become the first company to sell a generic version of the anti-influenza drug Tamiflu. The company claimed it was already making generic Tamiflu (oseltamivir phosphate) and should have its first batch of 1,300 treatments on the market in early 2006. Tamiflu, which reduces the severity and spread of traditional flu, is already in short supply throughout the world, as countries gather stockpiles of the drug amid fears of a possible avian flu epidemic. Demand for Tamiflu in the US alone has jumped sevenfold in the past eight weeks from this time last year. Generic manufacturers cannot yet legally sell the patented drug Tamiflu in the West and parts of Asia, including India, which recently tightened its patent laws. But the laws in many of these countries allow governments to invalidate patents during emergencies, such as a pandemic. Brokers in London estimate the total market for bird flu-related medicines could top £3 bn (¤4.4 bn). Source: www.DrugResearcher.com, October 17, 2005
Research NewsXenotransplants with pig brain cellsThe New Zealand company Living Cell Technologies (LCT) is investigating the possibility to treat the effects of Huntington's Disease by transplanting pig brain cells. Following successful experiments with monkeys, permission has been asked from the US FDA to conduct the first experioments in humans. The pig cells are so-called maintenance cells: they clean up toxins and produce a number of hormones and neurotropins, proteins essential for the functioning and protection of brain cells. Source: Pig cell implants in Huntington's trial, NewScientist.com, 11 August 2005, http://www.newscientist.com/article.ns?id=mg18725124.400
Embryonic stem cells in cord bloodResearchers from the Kingston University in Surrey (UK) have identified cord blood stem cells which have comparable characteristics to embryonic stem cells. These so-called Cord-Blood-derived Embryonic-like stem cells' (CBE's) are pluripotent as embryonic stem cells and more versatile than adult stem cells found in i.e. bone marrow. . Cord blood is already used as an alternative to bone marrow transplants. Annually, thousand of parents of newborn babies already have their children's cord blood stored for future eventualities. Source: Cord blood yields 'ethical' embryonic stem cells, New Scientist.com, 18 August 2005, http://www.newscientist.com/article.ns?id=dn7864&print=true
Stem cells to have diagnostic tool applicationStem cells have the potential to become an effective diagnostic tool singling out those susceptible of atherosclerosis, say researchers. These cells could also help to predict regeneration of heart cells following a heart attack. This application adds to the growing interest in stem cells, where their ability to differentiate into other cell types raises the prospect they could be used to treat diseases, for example by creating new insulin-producing tissue for diabetes. Diagnostic perspectives based on the analysis of the biochemical characteristics of these "uncommitted" cells were presented at the Second Annual European Vascular Genomics Network (EVGN &endash; www.evgn.org) Meeting which was held in Hamburg in parallel to the 3rd European Meeting on Vascular Biology and Medicine (www.emvbm.org). While in a fairly embryonic stage at present, the market for stem cell-based therapies and tissue engineering is tipped to grow to around $10bn in 2013, according to a recently published report from Visiongain. Source: www.DrugResearcher.com, October 3, 2005
Gene defects when culturing stem cellsStem cells cultured in the laboratory show a disconcerting number of mutations after a while. Many of these mutations are cancer related. This is the result of a comparative study with 9 stem cell lines, in which DNA characteristics of the original and daughter cell lines were compared. This suggest that work with stem cells preferably is based on fresh stem cells. This finding follows earlier reports that most embryonic stem cell lines are contaminated with the animal cells used as feeder cells. Source: Gene defects plague stem-cell lines, Nature, 5 September 2005.
HIV virus attenuatingAccording to new study, the virus that causes AIDS is becoming more sensitive to drug treatments, contradicting a wealth of research that demonstrates the emergence of drug resistant viral strains. The news contrasts the widely-held belief that HIV would increase in virulence as it passed through more and more human hosts. Confirmation of this discovery could shape the direction and approach of current HIV drug research. Scientists from the Institute of Tropical Medicine, in Antwerp, compared HIV-1 samples from 1986-89 and 2002-03. They found that the 2002-03 samples did not replicate as efficiently. This would imply that over a number of generations, HIV could become less harmful to its human hosts. However, they were only able to compare 12 samples from each time period, and they were unable fully to tease out any effect that drug therapy may have had on the virus. Some strains of HIV have become naturally resistant to the presence of drugs such as antiretroviral therapy. It has been estimated that up to 20 per cent of new infections now involve the transmission of resistant virus, meaning new classes of HIV drugs (especially against novel targets) will provide the only hope of treatment for an increasing number of patients. The researchers, writing in the journal Aids, stressed the discovery did not mean efforts to prevent the spread of HIV should be scaled down. Exactly why the virus seems to be weakening over time is unclear although theories have been out forward. "These findings suggest that HIV-1 replicative fitness may have decreased in the human population since the start of the pandemic," the study said. "This 'attenuation' could be the consequence of serial bottlenecks during transmission and result in adaptation of HIV-1 to the human host." If this were to be true, HIV could become less harmful to its human hosts. According to the World Health Organisation, other diseases - such as smallpox, TB and syphilis - have shown similar behaviour, weakening over time. Scientists have pointed to the phenomenon that demonstrates a natural trend to reach an equilibrium between the agent and the host interests, in order to guarantee concomitant survival for a longer time. Source: www.drugresearcher.com, September 30, 2005
Plant vaccinesThe last few years, much research is conducted to produce directly edible plants which produce a vaccine. One condition is that such a medicinal plant cannot be allowed to enter the regular food-feed chain. Critics claim that it will be impossible to prevent such a mixture, and that it is therefore better to stop these developments now. A second point of criticism is efficiency, since it has been found to be extremely difficult to cultivate plants with a constant vaccine yield. Another difficulty is effectivity, since the oral route is not an easy one for immunity. Because of these disadvantages, scientists are working to produce vaccines in non-edible plants, such as tobacco. The active vaccine could then be recovered and given as an injectable. Source: Genetically engineered alfalfa and lettuce provide healthy pigs, July 29, 2005,
Foot-and mouth disease vaccine from transgenic plantsArgentinian researchers have developed a genetically modified alfalfa which produces a vaccine against foot- and-mouthh disease. The researchers claim that production in plants is cheaper than other methods and results in a vaccine that has a more stable shelf life. The modification consists of expression of genes coding for the foot and mouth disease virus VP1 polyprotein and 3C protease. are genes coding for the The product has been tested in mice, where it resulted in a successful immune reaction and protection against the virus. Sources: Banning the Foot and Mouth Disease Virus soon with a promising vaccine, Checkbiotech, 28 September 2005, http://www.checkbiotech.org/root/index.cfm?fuseaction=newsletter&topic_id=1&subtopic_id=2&doc_id=11314 Development of transgenic alfalfa plants containing the foot and mouth disease virus structural polyprotein gene P1 and its utilization as an experimental immunogen, Vaccine Vol 23, Issue 15, 7 March 2005
Industrial protein manufacture in plantsResearchers from the German biotech company Icon Genetics have come up with a new method to produce therapeutic proteins in plant leaves. After they transferred an optimized vector based on TMV into tobacco leaves they yielded up to 4 grams protein per kilo biomass leaves. Protein production in plants allows for posttranslational modification. The modification consists of a new protocol to transfer the vector into tobacco leaves. Source: EuroBiotechNews 6-7, vol 4, 2005, pp 41
Eggs instead of bioreactorsThe business of producing biopharmaceuticals started in the 1950s using eggs for the production of attenuated viruses. Now, Now, the Roslinn Institute and companies Oxford BioMedica and Viragen have reported the cost-effective production of therapeutic antibodies in eggs laid by a transgenic hen. They reported successful expression and recovery of high yields of a humanized therapeutic antibody. However, no yields were given. Source: EuroBiotechNews 6-7, vol 4, 2005, pp 43
Agenda
International Congress of Nanotechnology 2005 October 31 to November 4, 2005, San Francisco, USA Information: http://nanotechcongress.com
The 6th European Biotechnology Symposium November 13-15, 2005, Copenhagen Info: BioConferences International
12th Annual Viral Vector & Vaccines Conference Nov 14-16, 2005, Austin Texas USA
3rd Annual Strategic Resource Management The Key to Increasing R&D Productivity December 1-2, 2005 - Philadelphia, Pennsylvania Email: jyurewicz@healthtech.com
Plenary ACTIP meeting December 8-9, 2005 Gottingen, Sartorius Information: actip@planet.nl
Stem cells & regenerative medicine Jan 23-25, 2006, San Francisco, USA Recombinant DNA technology for the 21st century Nov 21-22, 2005, AstraZeneca, Loughborough, UK
Biofine 2006 May 4-5, 2006, Barcelona, Spain
Biofine USA 2006 September 7-8, 2006, San Diego, California
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