The next plenary meeting of IVTIP will be held on:
The meeting will be hosted by company Neuropharma, Spain.
Central themes will be 'REACH implementation, sensor technologies and applied genomics/proteomics'.
Endless wrangling over the consequences of REACH on Europe's chemicals industry led the Commission to agree, on an exceptional basis, on two additional impact assessment studies:
A high-level stakeholders' group made up of representatives of the three European institutions, NGOs and industry was appointed to oversee both studies. The Commission departments for environment and enterprise policy signed a memorandum of understanding with European business organization UNICE and the European Chemicals Industry Council (CEFIC) to agree on the terms.
Both sides agreed that the KPMG study would aim to analyze the potential effects of REACH along the whole chemicals supply value-chain, from producers to downstream industry users such as the car industry. Four industrial sectors were selected: automotive, electronics, packaging and inorganics (metals). In July 2004, the two NGOs in the high-level group - WWF and the European Environmental Bureau (EEB) - rejected the methodology adopted for the KPMG study, saying it was biased and used exaggerated cost scenarios.
The REACH impact study carried out by KPMG for the European chemical industry (CEFIC) and business association UNICE was made public on 27 April 2005.
In the final report, KPMG insists that the study is not intended to provide a general macro-economic impact assessment resulting in loss of GDP or employment. It underlines the study only provides business case studies based on interviews.
Key findings of the report:
Commenting on the meeting of the high-level group, Enterprise commissioners Verheugen and Environment Commissioner Dimas explained in unison that there had been a very constructive debate in the group. They also highlighted that the KPMG study did not add much to the debate as it confirmed most of the conclusions of the extended impact assessment undertaken by the Commission itself. Mr. Verheugen stated that there was "light at the end of the tunnel" for this debate. However, he also explicitly said that "REACH will not ruin the European chemicals industry" and that the "financial" battle (the debate about the costs) is over.
At a press conference, business federations UNICE and CEFIC stressed that the study was not "intended to quantify direct or indirect costs from a macro-economic perspective". It had to examine the "mechanisms of business decisions… throughout the value chain"; Klaus Mittelbach of the German BDI commented that on the issue of costs, the findings of the new report are "comparable" to the Arthur D. Little impact assessment carried out for industry in 2003;
The business representatives said that they accepted all the conclusions of the KPMG study and underlined the following issues:
The industry suggests several improvements with, as the most important one, a pre-registration phase with prioritisation of the most dangerous substances.
Although still criticizing the "biased methodology" of the KPMG study, green NGOs EEB and WWF concluded that the report contradicts the worst case scenarios of the industry and is in line with the Commission's own impact assessment. Furthermore, the NGOs:
Source: Euractiv News, May 2, 2005
Brands took centre stage at a "substitute with style" catwalk organised by Greenpeace on 26 April. The aim was to persuade Brussels decision-makers that multinational corporations can opt for substitutes of hazardous chemicals without compromising their balance sheet and raise their image at the same time.
Under the spotlight, flashes and TV cameras, models showcased "toxic-free" products from brands including Hennes & Moritz, Marks & Spencer (clothing), Ecover (detergents), Ikea (furniture), Lavera (cosmetics), Sony (consumer electronics), Reebok (shoes) and Sony-Ericsson (mobile phones).
"The consumer brands in our catwalk are the most responsive to public concern about health and the environment, and they clearly demonstrate that substitution is possible and already happening," said Nadia Haiama-Neurohr from Greenpeace's European Unit.
Source: Euractiv News May 2, 2005
Position of the Royal Society of Chemistry: Is the right solution within REACH? (by Dr. David Giachardi, Chief Executive of the Royal Society of Chemistry). Article is available on the secure part of the IVTIP website
REACH in industrial platforms &endash; the role of microbiologists. Article By Dr. Joan-Albert Vericat, chairman of IVTIP (Perspectives in International Microbiology (2005) 8:59-62 (www.microbios.org)
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.
FP7 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).
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:
| Information society | 11.2 billion euros |
|---|---|
| Health | 7.35 billion euros |
| Transport (including Aeronautics) | 5.25 billion euros |
| Nanosciences, nanotechnologies, materials and new production technologies | 4.27 billion euros |
| Security and space | 3.5 billion euros |
| Energy | 2.59 billion euros |
| Environment (including climate change) | 2.24 billion euros |
| Food, agriculture and biotechnology | 2.17 billion euros |
| Socio-economic sciences and the humanities | 0.7 billion euros |
| Total | 39.267 |
This proposal will now be sent to European Parliament and Council for adoption (co-decision procedure).
See also:
The Seventh Framework Programme: Cooperation, Ideas, People and Capacities
Source: CORDIS News, Friday 22 April 2005
The following definitive versions of FP7 documents are now available on EUR-Lex:
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
A 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
The 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
Underfunding 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
In 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:
The survey confirms a remarkable finding from the February 2005 Eurobarometer on the Lisbon agenda: 63% of Europeans think that protecting the environment should take priority over economic competitiveness (against 24% who disagree).
Source: Euractiv News, May 2, 2005
The 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
New 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. Around _7 million 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
The 4th and final call for proposals in FP6, with a deadline of November 2005, will again address the issue of 'Development of new in vitro tests to replace animal experimentation'. Priority will be given to the development of alternatives that will reach the level of maturity for formal validation according to international standards for subsequent regulatory acceptance. There is a particular reference to testing intended for the REACH scheme: "the challenge is therefore to develop robust and effective in vitro methods that will withstand the requirements of international validation".
Topics:
Predictive in vitro testing
strategies for human exposure to chemicals;
Workshop on business opportunities for in vitro pharmaceutical
toxicology
Researchers and regulators meet manufacturers of toxicology test
methods;
STREP for SMEs: Development of new in vitro tests to replace
animal experimentation (linked to REACH).
Pharmacogenomic and toxicogenomic studies often require analysis of gene expression changes in tissues that were not frozen immediately, such as tissue from human cadavers or deceased animals that are not immediately ready for testing and have been stored. The problem in these cases is the inherent instability of RNA, which can mean that the amount measured is not a true representation. To overcome this problem, US company Genpathway has developed a system (TranscriptionPath) that does not measure RNA itself, but rather the transcription complexes formed as RNA is synthesised by RNA polymerases from the DNA template.
At the at 2005 Society of Toxicology Annual Meeting, held in New Orleans on 6-10 March, Genpathway presented data from analyses of post-mortem tissues that had been stored under suboptimal conditions for up to 24 hours. In the studies, mice were initially dosed with compounds known to induce liver toxicity for varying amounts of time. Their livers were assayed by TranscriptionPath and also for RNA levels using reverse-transcriptase PCR, a standard technique for RNA profiling. The company's researchers found that in animals stored for three hours at room temperature plus 21 hours in the fridge &endash; not uncommon in drug testing labs - levels of transcription were similar to those from animals that were tested immediately. In contrast, RNA levels from the stored animal tissues were very low due to degradation. In addition, they found that even in animals stored and processed under optimal conditions, TranscriptionPath detected gene expression changes with greater accuracy compared with measurement of RNA levels.
Source: www.in-pharmatechnologist.com, March 18, 2005
ECVAM would like to draw attention that there are two Marie Curie Fellowship work opportunities in the project area "Pathogenesis of Pulmonary disease" at the J.R.C. Ispra in ECVAM: one for an early stage researcher (3 years), and one for an Experience Researcher (2.5 years). To apply, send a CV and a letter of intent explaining motivations and interest in the position. Please contact Maria Prieto (maria.prieto-pilar@jrc.it ) for more information.
Full descriptions also available from the "Work Opportunities "area of the ECVAM website under "About ECVAM ".
ECVAM would like to inform you of the launch of the website of IHCP (J.R.C. Instititute for Health and Consumer Protectionof which ECVAM is a Unit) which can be accessed through the following link: IHCP website
On the website you will find job opportunities, subscribe to a mailing list, and the main news and events of the Institute;
The Institute for Health and Consumer Protection (IHCP) has published in the Supplement to the Official Journal of the European Union a prior information notice about planned projects of its Units (which include ECVAM) to be carried out this year. Reference document nr.: 2005/S 65-062174 . Please note that the document can be found on the EU Publications Office website (EU Publication Office); just choose your language and use search terms such as Ispra, ECVAM or the document number given above.
ECVAM wishes to inform you that the Workshop Report 51 " Dendritic Cells as a Tool for the predictive Identification of Skin Sensitisation Hazard" (Casati et al. (2005). ATLA 33, 47-62) is now online and can be downloaded directly from the ECVAM website
The EDQM with the support of the EVCAM recently organised a symposium in Geneva on the 3Alternative to whole cell pertussis vaccine potency assay. The aim of the meeting was to determine whether a replacement test to the current assay could be evaluated within the Biological Standardisation Programme. For more information on the meeting, the press release, programme and for copies of the slides presented, please visit the EDQM website:
http://www.pheur.org/site/page_dynamique.php3?lien=M&lien_page=27&id=2
Source: EDQM news, April 4, 2005
Now available: the Expert Panel Report on the Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants. The Report can be accessed on line at
http://iccvam.niehs.nih.gov/methods/ocudocs/EPreport/ocureport.htm.
A copy of the FR notice can be found at:
http://iccvam.niehs.nih.gov/docs/FR/7013513.pdf in PDF or
http://iccvam.niehs.nih.gov/docs/FR/7013513.htm in HTML.
The Nuffield Council on Bioethics is publishing a Report, The ethics of research involving animals, which seeks to clarify the debate on research involving animals and aims to help people think through the ethical issues that are raised. The Report also makes practical recommendations for future policy and practice, relating, among other things, to the use of GM animals, ways of improving the quality of debate, the implementation of the Three Rs (Refinement, Reduction and Replacement), and responsibilities of researchers, reviewers and funding bodies. The launch of the Report on May 25 in Central London will provide an opportunity to discuss its principal conclusions and recommendations with members of the Working Party.
This meeting is open to everyone. Admission is free but places must be reserved in advance. If you would like to attend and for more information please send your title, name, affiliation and email address to:
E-mail: bioethics@nuffieldfoundation.org
Tel: +44 (0)20 7681 9619
Fax: +44 (0)20 7637 1712
The digital version of the
NCA Newsletter 18 (March, 2005) is now available on
http://www.nca-nl.org/English/Newsletters/newsletters.html
The NCA Newsletter contains interesting articles on:
Toxicogenomics and Predictive Toxicology: Market and Business Outlook is a new CHAAdvances Report that addresses the significant need and potential for predictive toxicology in drug development.
To view a table of contents for this report, please visit
http://www.advancesreports.com/all_reports/2004_43_predictive_toxicology/overview.html
Information: http://www.nsti.org/StemCellStrategies
Information: ivtip@planet.nl
Information: www.colipa.com
More information: EDQM, http://www.pheur.org
Information: www.aapspharmaceutica.com/nationalbiotech
Information: Conference Ref: A6-4305
http://www.management-forum.co.uk/Filestore/Brochures/6-4305%20LW.pdf
Information: https://commerce22.datapipe.com/chidb/2005/byg/reg.asp
Information: https://commerce22.datapipe.com/chidb/2005/byg/reg.asp
Information: http://www.iqpc-pharma.com/GB-2453/S.
Information: www.efb.org
Information: www.ctw-congress.de/act2005
More information: http://www.management-forum.co.uk/Filestore/Brochures/5-6005,A9-61,11-60%20LW.pdf
Information: www.genomicsmomentum2005.org/
Information: www.kbfi.ee/toila2005.
Information: http://nanotechcongress.com