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Next meeting ACTIP:
Please take note: the next ACTIP meeting will be held
In Lund, Sweden on June 16-17, 2005
And will be hosted by ACTIP member company BioInvent International. The programme will focus on technology aspects of animal cell cuiltures (batch versus continuous processing, and the importance of medium optimization), and on stem cells for research and therapy.
The meeting is only open for ACTIP members and invited observers. Please contact the ACTIP Secretariat. for more information.
In this issue:
The EUs new Research Framework Programme 2007-2013 (FP7) Review of nanotechnology in pharma Short News various organizations
The EU's new Research Framework Programme 2007-2013
On 6 April 2005, the Commission adopted its proposal for EU's 7th Framework Programme, which will follow the current 6th FP (2002-2006) and will cover a 7-year period (2007-2013). The proposal takes account of the views expressed by the other EU institutions, the member states and by various stakeholders including the scientific community and industry. The proposal also takes account of the criticism expressed by the Marimon report and the 5-year-assessment of the EU research. Main idea: "The 7th Framework Programme will not be 'just another Framework Programme', according to Science and Research Commissioner Potoènik. Indeed, in its content, organisation, implementation modes and management tools, the FP7 is designed as a key contribution to the relaunched Lisbon strategy. FP7 is centered on innovation and knowledge for growth and it will continue the drive towards the European research area (ERA. StructureFP7 will be organised into four specific programmes, corresponding to four major objectives of European research policy: 1. Co-operation: refers to gaining leadership in key scientific and technology areas by supporting co-operation between universities, industry, research centres and public authorities across the EU and with the rest of the world. Trans-national cooperation will remain the main instrument for carrying out research activities. This programme will be organised into 9 sub-programmes (see table 1. below) covering the nine different thematic research areas receiving Community support (the so called thematic priority areas). All FP6 thematic priorities will continue to be supported in the FP7. Only one new priority, 'Space and security', has been added to the previous set of themes. Even though the programme will be organised into operationally autonomous sub-programmes, joint, cross-thematic approaches to research subjects of common interest are allowed. 2. Ideas: refers to the establishment of an autonomous European research council (ERC), which will support and stimulate the creativity and excellence of European research through the funding of ground-breaking research carried out by individual teams competing at European level. 3. People: refers to the so called 'Marie Curie' actions, which strengthen training, the career prospects and mobility of European researchers. Better focus will be given on key aspects of skills and career development, increasing mobility between university and industry, and strengthening links with national systems. 4. Capacities: refers to developing and fully exploiting the EU's research capacities through large-scale research infrastructure, regional cooperation and innovating SMEs. In addition to the four specific programmes, the FP7 includes a specific programme for the non-nuclear activities of the Joint Research Centre (JRC).
BudgetThe proposed total budget for FP7 (64.282 billion) and the Euratom Treaty research activities (2.800 billion) is 67.082 billion euros. Cooperation and Ideas will receive around 70 per cent of the funds, People and Capacities around 20 per cent and the remaining ten per cent will go to the JRC and the Euratom programme activities. The budget has a yearly average of around 10 billion euros, but the Commission proposal envisages starting in 2007 with around six billion euros and increasing the yearly expenditure gradually to reach 15 billion euros budget in 2013. Table 1. The nine thematic research areas and budget breakdown of the Cooperation-programme:
Next steps: This proposal will now be sent to European Parliament and Council for adoption (co-decision procedure).
See also: Source: CORDIS News, Friday 22 April 2005
Documents on FP7The following definitive versions of FP7 documents are now available on EUR-Lex:
News from the Commission
Experts support the creation of a European Research Council
An expert panel installed by the European Commission to assess the impact of a European Research Council has found that a pan-European mechanism funding frontier research would have a major effect on the level of excellence of research in Europe. In their view, a European Research Council would be arguably the single most important means to remedy Europe's current weakness in high-quality research and in new, fast-developing research areas. This report comes only a short time after the European Commission's proposal for such a mechanism as part of its proposals for the 2007-2013 Framework Programme for Research and Development, and supports the approach to this new body taken by the Commission. The report "Frontier Research: The European Challenge" is the result of the work of a high-level group set up by the Commission, chaired by William C. Harris of the Science Foundation Ireland, and composed of eminent scientists, research managers and economists from Europe and the United States. The group was asked to examine the effects and benefits of creating a new European funding mechanism to support the very best research carried out at the frontiers of knowledge. The report identifies a series of key challenges facing European research that a European Research Council (ERC) could help address. These include:
The High Level Group of experts also identified a number of important impacts and benefits above and beyond what can be achieved by national funding mechanisms:
The group also concluded that the potential benefits of the ERC could not be realized by other means. Unless Europe makes a commitment to frontier research, it risks becoming a continent of imitators rather than innovators. The Commission has proposed the establishment of an ERC within its proposal for FP7. To read the full report: http://europa.eu.int/comm/research/future/pdf/hleg_fullreport_frontier_research_april2005.pdf The executive summary of the report can be found on: http://europa.eu.int/comm/research/future/pdf/hleg_exec-sum_frontier_research_april2005.pdf
Source: EU Press Report, April 21, 2005
Science and Technology, Europe's futureA general consultation for views on the Commission proposal "Science and Technology, the key to Europe's future- Guidelines for future European Union policy to support research", was launched in July 2004 and closed on 15 October 2004. Over 1700 organisations and individuals from across the European Union and beyond expressed their views. 97% of respondents were positive about a stronger support to research at European level. Over 80% thought that the 6 objectives proposed by the Commission in the June 16 Communication are important or very important. The European Commission proposes a significant expansion of the European Community research budget for the period 2007-2013 (see article on FP7) and has identified six major objectives:
In its plans, the Commission proposes using the most efficient means of implementation, including management through partnership with the Member States and research actors, and "externalised" management. Read the Commission Communication on the future EU research policy: Science and Technology, the key to Europe's future - guidelines for future European Union policy to support research (also in: ; more information and other languages are available via Prelex) Source: CORDIS News, April 5, 2005
EU needs more new researchersThe number of European researchers may have risen slightly from 5.4 per 1000 of the workforce in 1999 to 5.7 in 2001. But it still remains significantly lower than the level in the USA (8.1) and Japan (9.1). In a bid to change this situation the Commission wants to make a career in science more attractive through a European Charter for Researchers and a Code of Conduct, adopted on 11 March 2005. The aim is to give individual researchers the same rights and obligations wherever they may work throughout the EU. Key objectives are to provide researchers with long term career prospects by improving their employment and working conditions, to create more favourable conditions for mobility within a given research career path and to introduce different means of judging scientific merit. Source: EurActiv News, March 14, 2005
Tax incentives for closer university-industry linksUnderfunding and inflexible systems are so acute in some countries that they impede the reform process at universities, says the Commission in a communication on how to make European universities contribute fully to the Lisbon strategy. Encouraging closer links between universities and industry, the Commission proposes tax incentives (initially at least) as a way to promote these partnerships. The Commission laments the fact that EU countries spend on average just 1.1% of GDP on higher education, on a par with Japan but much less than Canada (2.5%) and the US (2.7%). It estimates that an investment of 2% of GDP is the minimum needed for knowledge-intensive economies. Education and Culture Commissioner Ján Figel is arguing for in-depth revision of curricula to ensure the highest level of academic content but also to respond to the changing needs of labour markets. In the communication, the Commission calls on the Council to adopt a resolution for a new type of partnership between the state and universities and for sufficient investment to make it possible to modernise the higher education system. More reading at:
Source: Euractiv News, April 21, 2005
Eurobarometer: citizens want strong environment policyIn the second half of 2004, interviews were conducted with nearly 10,000 Eurocitizens to construct a new Eurobarometer. Nine out of ten Europeans say that decision-makers should pay as much attention to environmental considerations as to economic and social factors when taking decisions. Other findings of this survey:
Source: Euractiv News, May 2, 2005
Review of nanotechnology in pharma
Nanotechnology to revolutionise drug deliveryThe emergence of nanotechnology is likely to have a significant impact on drug delivery sector, affecting just about every route of administration from oral to injectable, according to specialist market research firm NanoMarkets. NanoMarkets believes that not only will the nano-enabled drug delivery market be one of the first true nanomedicine markets to evolve, but as it does so, the revenues from nanoenabled drug delivery systems will be quite large. Below we give a state of the art overview. New dosage forms for injectable drugs. Nanotechnology is already generating new dosage forms that are easier to administer, more pleasant for the patient to receive and confer a competitive advantage in the marketplace. For example, at the start of this year Johnson & Johnson revealed that Elan's NanoCrystal technology would be used in a Phase III clinical trial for an injectable formulation of paliperidone palmitate, a drug for schizophrenia. This is a new 'nano formulation' of an older drug which overcomes the original's insolubility, by reducing the particle size to under 200 nm. Implantable delivery systems. Implantable time release systems may help minimize peak plasma levels and reduce the risk of adverse reactions, allow for more predictable and extended duration of action, reduce the frequency of re-dosing and improve patient acceptance and compliance. Already a nanostructured material exists that effectively stores an active compound in nanosised pockets that release minute amounts of drug as the silicon dissolves. Anti-cancer therapeutics. Among the first nanoscale devices to show promise in anti-cancer therapeutics and drug delivery are structures called nanoshells, which typically have a silicon core that is sealed in an outer metallic core. By manipulating the ratio of wall to core, the shells can be precisely tuned to scatter or absorb very specific wavelengths of light. For example, gold encased nanoshells have been used to convert light into heat, enabling the destruction of tumours by selective binding to malignant cells. A physician can use infrared rays to pass harmlessly through soft tissue, while initiating a lethal application of heat when the nanoshells are excited. Some researchers are also experimenting with temperature-sensitive drug delivery control methods, using nanoshells that release their payload only when illuminated with the proper infrared wavelength. Oral delivery systems. Various development groups are working to enhance traditional oral delivery systems with nanoengineered improvements. The basic idea is that by increasing bioavailability, nanoparticles can increase the yield in drug development and may help treat previously untreatable conditions. For example, researchers at the University of Texas at Austin have described a means of using nanospheres for oral drug delivery. These nanosphere carriers are derived from hydrogels, which are highly stable organic compounds that swell when their environment becomes more acidic. They have been successfully formulated into controlled-release tablets and capsules, which release active compounds when the hydrogel body swells. Crossing the blood brain barrier. Nanoparticles have been demonstrated to cross the BBB with little difficulty and companies such as Germany's NanoPharm have developed systems capable of reaching the brain for anaesthesia (Dalargin; an analgesic), cancer drugs, and various other therapeutics. Topical delivery. Given their very small size, nanoparticles are able to enter human tissues and cells quickly, and companies such as Novavax have already developed regulated topical systems that take advantage of the unique properties of micellar nanoparticles. Novavax is developing two hormone replacement therapies, called Estrasorb (which received FDA approval in October 2003) and Androsorb which successfully completed Phase I human trials in 2003. Toxin removal. Colloidal dispersions have been demonstrated to remove potentially lethal compounds from the bloodstream, including high concentrations of lipophilic therapeutics, illegal drugs, and chemical and biological agents. A team of scientists at the University of Florida and Clarkson University in Potsdam, New York, has demonstrated favourable results to this end, using biocompatible microemulsions. These oil-in-water systems have a rapid and efficient absorption capacity for many target molecules that are frequently overdosed, whether this be intentional or accidental. The microemulsions use a polymeric surfactant, in combination with an ionic co-surfactant. Source: InPharma-technologist.com, March 6, 2005
EU project aims to make nanotechnology safeNew drug delivery systems based on nanoparticles are said to be on the cusp of delivering significant improvements in drug therapy, reducing the amount of active drug that needs to be delivered to the patient, targeting the medicine more effectively to the site in the body it is needed, and reducing side effects, as well as potentially reducing the cost of therapy. But despite the promise, there are real concerns that exposing patients to nanoparticles might unleash unexpected toxicities, a fear backed up to some extent by the recent discovery that nanoparticles exposure in animals can lead to neurological damage. To explore this risk further, the European Commission has set up a research project with partners across industry (including BASF) and academia aimed at developing methods for the safe use of nanoparticles. As of April 2005, 23 partners from seven EU countries started work on Nanosafe2, a project with a budget of approximately 12.4 million euros. Around 7 million euros is being provided by the EU's research funding programme and the remainder by the companies involved. The key goal of the Nanosafe2 research programme is to establish processes to detect, track and characterise nanoparticles. Such methods are a prerequisite for determining any possible risks to man or the environment, and for further optimising the safety of production processes and plants. Nanosafe2 will look at the entire lifecycle of nanoparticles, from their production and storage through to transport and use in a finished product. The results of the research will subsequently be made available worldwide in the form of databases, official procedures and workshops. Source: www.In-pharmatechnologist.com, April 26, 2005
Business News
Crucell to make Ebola vaccine for NIH unitDutch biotechnology company Crucell has won a _21.4 million contract to produce a vaccine against Ebola for the US government's Vaccine Research Centre. The contract will see Crucell using its human cell line PER.C6 to produce up to 10 batches of vaccine against Ebola, one of the most virulent diseases known that causes death in 50 to 90 per cent of clinically ill cases. The vaccine batches will be used for Phase I and II clinical trials. The latest agreement extends an existing arrangement with the US National Institutes of Health in the area of Ebola. Last month, Crucell licensed rights to NIH patents covering Ebola vaccine components, such as the antigens and vectors. In addition, the license covers 'one-shot' emergency vaccination strategies that have been shown to be effective in animal models. Crucell's PER.C6 expression platform has by now been licensed to numerous companies to produce vaccines and protein therapeutics. Compared to the most commonly-used cell lines, such as Chinese hamster ovary (CHO) cells, PER.C6 does not require amplification of inserted genes to deliver stable clones. Source: www.in-pharmatechnologist.com, April 14, 2005
Lonza aims to get bigger in peptidesLonza is planning a major exansion of its peptides manufacturing capacities at Visp, Switzerland. The investment totals about CHF 24 million (_20m) and is focused on several areas of Lonza's peptides and oligonucleotides (tides) large-scale current Good Manufacturing Practice (cGMP) manufacturing activities. By expanding its manufacturing activities Lonza is responding to the increasing number of new entities entering clinical phase trials. The demand for clinical trial material (CTM) will be met by the construction of a new mid-scale tides plan, as well as additional high performance liquid chromatography (HPLC) purification and new freeze-drying equipment. Source: www.In-Pharmatechnologist.com, May 2, 2005
Overcapacity in biopharmaA second market research report has found evidence that production capacity in the market for contract manufacturing of biopharmaceuticals is now in excess, in contrast to the hitherto prevailing wisdom that the sector has been suffering from undercapacity. The report, just published by HighTech Business Decisions, suggests that in 2004 and 2005, the industry has a slight excess of capacity as new capacity continues to come on-line in and process improvements are being made. This ties in with recently-published research from Frost & Sullivan which predicted that biomanufacturing will be in overcapacity through to 2011. In addition to new expression technologies, cell line development, and biomanufacturing platforms offered for mammalian cell culture and microbial fermentation, some contractors are gearing up to produce novel product types that require specific biomanufacturing expertise such as antibody fragments, fusion proteins, antibody drug conjugates, gene therapy, and novel proteins. The market for biopharmaceutical contract manufacturing reached $1.7bn in 2004, with healthy growth forecast for 2006. Based on revenues, the top biopharmaceutical CMOs include Avecia Biotechnology, Boehringer Ingelheim, Cambrex Biopharmaceutical Services, Diosynth Biotechnology, DSM Biologics, Lonza Custom Manufacturing and Sandoz, according to HighTech. Source: In-pharmatechnologist.com, March 9, 2005
Research News
Foot and mouth peptide improves antibody productionScientists at US biotechnology firm Cell Genesys have developed a gene expression technology that could improve the commercial production of monoclonal antibodies and other complex therapeutic proteins. The system enables the production of full-length monoclonal antibodies at commercially relevant levels from a single production cell line, and cuts the time required to develop cell lines that can be used for commercial production can be significantly shortened from months to weeks. The discovery relies on the use of a peptide called 2A, derived from the virus that causes foot and mouth disease, alongside viral vectors used to deliver genetic material into cells. To overcome usual problems of stable expression, the Cell Genesys researchers' transfect the sequences coding for the light and heavy chains of the antibody alongside a sequence that codes for the 2A peptide. The latter acts as a bridging sequence, allowing both the heavy and light chains to be read form a single frame. The production levels achieved with the technology may be more than double those achieved with conventional technologies. Importantly, this gene expression technology can potentially provide the same advantages to the production of therapeutic protein products, including those comprised of multiple subunits or polypeptide chains. Source: on-line issue Nature Biotechnology, April 17, 2005
Short news various organizations
New building for the EDQMThe ceremony to lay the first stone of the new EDQM building took place in Strasbourg on 28 April 2005. The new building, specially designed to function as a European centre for pharmaceutical excellence, will be completed by the end of 2006. Source: Cordis News, May 2, 2005
News from EFBThe European Federation of Biotechnology has opened a new, permanent EFB European Central Office in Barcelona on 1st March. The contact details are as follows: European Federation of Biotechnology; Pg. Lluis Companys 23; 08010, Barcelona Spain Tel: +34.93.268.7700
Also, a new General Secretary, has been appointed: Christian Suojanen, General Secretary European Federation of Biotechnology Pg. Lluis Companys 23; 08010, Barcelona; Spain Tel: +34.93.268.7700 Email: generalsecretary@mail-central.com
Agenda
Stem cell strategies May 12-13, Anaheim, California USA Information: www.nsti.org/StemCellStrategies
EU
chemistry and pharmacy regulatory procedures and
requirements 12&13 May Cork 26&27 September Budapest 17&18 November Barcelona More information: www.management-forum.co.uk/Filestore/Brochures/5-6005,A9-61,11-60%20LW.pdf
Quality
control of medicinal products: place and role of
the European OMCL
Network May 27, 2005, University La Sapienza, Roma, Italy More information: EDQM, http://www.pheur.org
ESACT 2005 5 - 8 June 2005 - Harrogate, North Yorkshire, UK Information: www.esact2005.org
Novel target class: microRNA in Human Disease and Development June 12, 2005, San Francisco, Ca USA Information: https://commerce22.datapipe.com/chidb/2005/byg/reg.asp
2005 AAPS National Biotechnology Conference June 5-8, 2005, San Francisco, Ca, USA Information: www.aapspharmaceutica.com/nationalbiotech
EAPB Membership meeting June 13, Nice, France Information: www.efb.org
cGMP training for Biotechnology and Pharmaceutical Industries in Europe June 13-14, London, UK For more information: www.usaspi.com
ACTIP meeting June 16-17, 2005, Lund, Sweden Information: ACTIP Secretariat
Improving Solubility & Permeability in Drug Candidates June 23-24, London UK Information: www.iqpc-pharma.com/GB-2453/S.
ECB12 August 21-24, 2005, Copenhagen, Denmark Information: www.efb.org
International Congress of Nanotechnology 2005 October 31 to November 4, 2005, San Francisco, USA Information: http://nanotechcongress.com
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