Reserve the date!!
The next plenary meeting of IVTIP will be held on:
April 19-20, 2007, Leipzig, Germany
Reserve dates April 26-27 April, 2007
To be hosted by Dr. Andreas Emmendoerffer, Euroderm.
In due course, IVTIP members will receive details about the location/accommodation and the agenda.
The World Economic Forum (WEF) releases its Global Competitiveness Report annually, which provides an overview of the key factors for driving productivity and competitiveness and ranks the 125 countries covered according to their performance in these areas.
Contrary to last year's report, which showed that the EU's largest member states had been losing their competitive edge, the 2006-2007 edition, released on 26 September 2006, sees some of Europe's 'big guns' making sharp progress and the 'Nordic three' knocking the US out of the top five.
The EU now counts six member states (the Nordic three, UK, Netherlands and Germany) in the top ten and, although most have not made any significant upwards moves in the rankings, the economies most often described as Europe's main rivals in its race for competitiveness have not fared too well either.
The US has tumbled down the league, dropping from first to sixth place, overtaken by three EU member states, in a sign that the EU is making progress towards the Lisbon goal of becoming "the most competitive and dynamic knowledge-based economy in the world" by 2010.
Although Germany and the United Kingdom continue to rank in the top ten, the UK is still lagging on innovation, whereas Germany's cumbersome labour regulations are holding the business community back. France has fallen from 12th to 18th position, due to the lack of efficiency and flexibility of its labour market and its badly targeted public expenditure.
Italy has continued its downward slide to 42nd place in this year's report. Having run budget deficits without interruption for the past 20 years, public debt levels are among the highest in the world. The study points to "deep-seated institutional problems" which have led to bad government spending, over-regulation and poor quality public services.
As in previous years, Poland and Greece remain the worst performers in the EU &endash; similar to the results of the World Bank study on "Doing Business in 2007", which showed the two countries to be among the worst places to do business in the world. Other new member states, however, including Estonia (25), the Czech Republic (29) and Slovenia (33), have performed quite well. And, among the candidate countries, Turkey and Croatia both seem to have benefited from the "EU bonus", moving up impressively in the rankings by 12 places each, to positions 59 and 51 respectively.
Further reading:
Source: EurActiv News, September 27, 2006
The EU 2006 Industrial R&D Investment Scoreboard indicates that between July 2005 and August 2006, private-sector investment increased by an average 5.3%. This represents a major change from the stagnation of the year before and the 2% decrease registered in 2004.
The EU Industrial R&D Investment Scoreboard is published annually by the Commission and provides information on the top 1,000 EU companies and top 1,000 non-EU companies which invest the most in research and development. The EU aims, as part of the Lisbon objectives, to invest 3% of GDP in research by 2010. Two thirds of the 3% should come from the private sector.
Five of the EU's top R&D investors are German (DaimlerChrysler leading, Siemens the second), two are based in the UK, one in Finland, Sweden and France. Among the top 10 EU companies stand three car industry companies, three pharmaceuticals and two telecommunications-equipment giants. By comparison, four of the top six world R&D investors are car manufacturers.
Further reading: DG Research and Joint Research Centre: The 2005 EU Survey on R&D Investment Business Trends in 10 sectors (23 August 2006)
Source: EurActiv News, October 6, 2006
The EU's science and research ministers reached a political agreement on FP7 on 24 July 2006, paving the way for continued EU funding of embryonic stem cell research on a case-by-case practice. On 19 July US president Bush vetoed the use of federal funding for stem cell research.
Some think that the EU's positive attitude towards this type of research could increase brain drain of scientists with an interest in stem cell research from the United States. However, the ban of federal funding in the US does not make embryonic stem cell research illegal in the US and individual States, such as California, have their own stem cell funding initiatives, and private companies are free to carry out their own research.
Source: EurActiv News, July 26, 2006
While most of the attention in Brussels is focused on the REACH proposal, industry is moving on with a multi-million innovation plan aimed at taking it closer to environmental sustainability.
Industry participants at the European Technology Platform for Sustainable Chemistry (SusChem) have adopted a draft action plan to focus European R&D spending on the most promising areas with respect to future sustainability and profits.
The draft maps out a programme of medium and long-term activity that will be constantly reviewed. Priorities focus around eight themes: bio-based economy; energy; health care; information and communication technologies; nanotechnology; sustainable quality of life; sustainable product and process design; and transport.
Funding estimations are "in the order of 1.4 billion euro annually in the coming years" around half of which is expected to come from public sources whether at European or national level.
SusChem was launched jointly in 2004 by the European Chemical Industry Council (CEFIC) and biotech industry group EuropaBio to focus European research in chemistry. It adopted a Strategic Research Agenda (SRA) in November 2005.
Further reading:
Source: EurActiv News, August 29, 2006
The Innovative Medicines Initiative (IMI), a pan-European public and private sector collaboration between various health stakeholders, has published a new version of its Strategic Research Agenda (SRA). The agenda recommends establishments of a European Medicines Research Academy to fill in the gaps the IMI has identified within medicines development education and training.
The IMI, launched in 2004, aims to support faster discovery and development of more effective innovative medicines with fewer side-effects. Its new SRA identifies predicting safety (early safety evaluation), predicting efficacy (better understanding of clinical basis of diseases), bridging gaps in knowledge management (lack of data pooling and processing infrastructure) and bridging gaps in education and training as the main bottlenecks in the current biomedical R&D process.
In addition to the establishment of the European Medicines Research Academy, the SRA recommends the creation of a European Centre of Drug Safety Research and regional centres of excellence and of a Knowledge Management Platform to develop effective data integration and analysis tools.
Implementation of the Strategic Research Agenda would require 460 million euros per year from 2007 to 2014. The Innovative Medicines Initiative will be proposed for Joint Technology Initiative (JTI) status in the FP7, subject to approval by member states.
Source: EurActiv News, September 19, 2006
The European Research Council (ERC) will be set up under FP7. A first call for proposals will be launched in late 2006 or early 2007. The ERC will be the first pan-European funding agency for frontier research offering individual talented researchers the support and visibility required to strengthen Europe's scientific creativity and performance. It will be an autonomous organization under the scientific governance of an independent Scientific Council. The Scientific Council consists of 22 eminent researchers (only five of them women) drawn from across Europe. The founding members of this Council were nominated by the European Commission following an independent identification process involving Europe's research community.
The Scientific Council is chaired by prof Fotis Kafatos (London); vice-chairs are held by Dr. Daniel Esteve (France) and Prof Helga Nowotny (Vienna).
The Scientific Council has decided to set up two funding streams: the ERC starting grant will provide support to the independent careers of excellent researchers at the stage of establishing their first research team; and the ERC advanced Grant, which will provide broader support for excellent and innovative frontier research projects by individual teams led by investigators at all career stages.
Further information can be found on: http://erc.europa.eu
Scientists say creation of a European Institute of Technology (EIT) is not the answer to the lack of innovation in Europe. A politically motivated idea, starting from a wrong premise and with a vague and then unrealistic financial underpinning, will not help Europe forward," comments Euroscience on the Commission plan for a European Institute of Technology (EIT).
The pan-European association of individuals interested in constructing scientific Europe 'from the bottom-up', states, in its opinion on 31 July 2006, that Europe's two major problems are lack of innovation and the current, uniform, university system. Establishment of a new institution will resolve none of them. Euroscience questions, in particular, the efficiency of "widely dispersed virtual knowledge communities governed at a distance by a board of governors" to develop strategic technologies and innovations.
Instead, the association urges reform of European universities, which are "wrestling with large student numbers, antiquated facilities, dispersed research capabilities and tight government control". According to Euroscience, European universities seriously lack differentiation. Therefore, the association fully supports the establishment of the European Research Council (ERC), a European structure to support basic research, set to be operational in early 2007. "Europe clearly needs continental mechanisms to fund frontier research," states the opinion. European-wide competition on research funding will enhance diversity among universities as, in order to excel, the universities need to specialise in a few research fields. "This is the right way forward as Europe needs centres of excellence," said Peter Tindemans from Euroscience.
Other groups representing academics hold similar views, including representatives of the European universities, the European University Association (EUA), the League of European Research Universities (Leru) and the Coimbra Group universities: they all doubt the relevance of an EIT.
Further reading:
Source: EurActiv News, September 11, 2006
After initially considering Commission plans for a European Institute of Technology (EIT) too ambitious, the executive's adviser group on research policy now supports it.
Following the Commission's renewed communication on the European Institute of Technology (EIT) in June 2006, the European research advisory board (EURAB) has drafted a second opinion, this time positive, on the issue. EURAB's first opinion on the Commission proposal for EIT was critical, as the idea was considered "top-down" and fears were expressed that it would take part of the money earmarked for the European Research Council (ERC), intended to fund basic research. The second opinion stated that the advisory group's contentment with the renewed proposal and notes the evolution since the first discussions for an EIT in February 2005.
EURAB has particularly welcomed the proposed "light" administrative structure comprising an autonomous governing board with limited membership, now proposed by the Commission, but insists that this Board must have at least a 50% share of industry representatives. The advisors stress that, "to succeed, the EIT will need to have the involvement of and full support from the business community from the outset" and that the independent nature of the governing board has to be clearly established and protected.
The Commission's formal proposal on the EIT, including budget, is expected to be published by the end of 2006.
Further reading:
Source: EurActiv News, September 11, 2006
The Commission adopted its official proposal for the European Institute of Technology (EIT) on 18 October 2006. The final proposal does not differ greatly from the two previous Commission communications on the issue except that the Knowledge Communities are now described as Knowledge and Innovation Communities and that this document, finally, spells out the budget foreseen for the institute.
Some 2.4 billion euros is foreseen to be spent between 2008 and 2013. The Commission proposes 310 million euros to be allocated directly from the EU budget, mainly for the initial start-up phase. The rest, 2.1 billion euros, is expected to come from the private sector. The institute will also be eligible to apply for money from EU aid funds - the Knowledge and Innovation Communities can, for example, apply for project funding under FP7. Education Commissioner Jan Figel said that an "EIT foundation" could be established to gather the necessary funds.
The European Chambers of Commerce immediately reacted to the proposal, asking for clarification. "Where will the money come from?" asks the association, which represents more than 18 million enterprises in Europe. In particular, it wants to know how the Commission intends to attract private investors.
Next steps:
Parliament and Council could adopt the proposal before the end of 2007 or early 2008.
EIT's governing board could be appointed in 2008.
EIT could be operational in 2009.
Source: EurActiv News, October 18, 2006
The European Strategy Forum on Research Infrastructures (ESFRI) has published its first road map for new European research infrastructures. After two years of negotiations and consultation with high-level European and international experts and representatives from member states' ministries of research, 35 large-scale infrastructure projects, which a sufficient number of member states are ready to support, have been identified.
Projects for infrastructures range from a research icebreaker vessel for marine research to next-generation radio telescope or European social survey monitoring long-term changes in social values throughout Europe. Seven key research areas covered are: environmental sciences; energy; materials sciences; astrophysics, astronomy, particle and nuclear physics; biomedical and life sciences; social sciences and the humanities; computation and data treatment.
Some 14 billion eurosare needed to make all 35 projects to come true. So far, the EU has, through the FP6, funded only existing research infrastructures. The upcoming FP7 will finance both existing and new ones with 1.7 billion euros from 2007-2013. The success of the 35 projects thus depends on member states willingness to support them. Calls for European research infrastructures, under FP7, will be launched in 2007 and 2010.
All these projects will be pan-European, which means that every scientist has open access to these infrastructures. The only influence of a member state paying or not paying for the project is then on governance, the way the project is managed and the long-term vision for the next 20-30 years.
Source: EurACTIV news, October 19, 2006
Eurobarometer surveys on biotechnology and life sciences are being conducted every three years. In comparison to earlier surveys, the Eurobarometer 2005 survey shows that EU citizens are, in general, more optimistic about technology. However, whereas "there is widespread support for medical (red) and industrial (white) biotechnologies" there is "general opposition to agricultural (green) biotechnologies in all but a few countries," concludes the report. Europeans see genetically modified (GM) food as "not being useful, as morally unacceptable and as a risk for society".
The survey shows large support for the development of nanotechnology, pharmacogenetics and gene therapy, which most Europeans consider as "useful to society and morally acceptable". The claim that European public opinion is a constraint to technological innovation and contributes to the technological gap between the United States and Europe, is therefore, according to the report, invalid.
Further reading:
Source: EurActiv News, June 21, 2006
With time running out for agreement on Reach, the European Union's regulatory regime for chemicals, year-long discussions between the European parliament and EU states broke down on 20 November.
However, the suspension of the talks is likely to be short-lived; the parliament's negotiating position is becoming precarious.
Outstanding issues centre on whether industry should discontinue production and use of dangerous substances as safer substitutes are identified, and parliamentary demands that authorisations for the most toxic substances should be limited to five years.
If MEPs fail to complete second reading soon, the European Commission could in theory deem the Reach regulation to have been adopted by default.
However, with ministers' indulgence, MEPs have scheduled a vote for 12 December - almost a fortnight after the deadline laid down in procedural rules.
The Commission proposes that behind-the-scenes talks should resume on 27 November. Any agreement must be initialled by 7 December - the deadline for tabling amendments for the 12 December vote.
Parliamentary rapporteur, Italian Socialist MEP Guido Sacconi is reportedly ready to drop Strasbourg's demands for time-limited authorisations, as long as toxin risks are 'adequately controlled' - a proviso which MEPs have hitherto rejected as unenforceable.
In return, Sacconi wants the 'substitution principle' to be reinforced.
Lack of time is not the only problem facing MEPs: at second reading, amendments must be backed by a 'super-majority' of at least half of the Parliament's 732 serving members, otherwise ministers' preferred version of Reach will prevail.
If a late breakthrough allows MEPs simply to rubber-stamp an agreement with ministers, Reach will enter into force around April, 2007, with a Helsinki-based European Chemicals Agency becoming fully operational a year later.
Otherwise, ministers and MEPs may have to settle their differences through formal 'conciliation' procedures which could take six months to complete. Reach would then not enter in force until late 2007.
Source: Chemistry News, November 24, 2006
The European parliament has secured backing for a long-awaited regulatory regime for Europe's chemicals industry: registration, evaluation and authorisation of chemicals (Reach). Reach was approved in Strasbourg after a marathon vote on 1038 amendments. It was first published by the European Commission in 2003, following five years of preliminary discussions.
One key issue yet to be resolved is whether authorisations for marketing and use of substances potentially harmful to health or the environment should be time-limited, making them subject to review by the Helsinki-based European Chemicals Agency which will be established under Reach. Governments must now determine their own common position, although political group leaders &endash; and EU Environment Commissioner Stavros Dimas &endash; predict that emerging consensus between MEPs and ministers will lead to an outline political agreement in December.
A second reading of the proposal is due in 2006, and Reach is likely to enter into force late 2006/early 2007, launching a phased, 11-year programme of mandatory registration of around 30 000 substances.
It was predicted that EU ministers would clear the proposal in November, but Germany's new Chancellor Angela Merkel asked UK premier Tony Blair to postpone the vote to allow time for her incoming coalition government to scan the revised draft. Berlin's role in the Reach debate has been crucial: there are powerful German chemical interests at play, and Germany has the largest national delegation in the European Parliament. German MEPs dominate the industry-friendly centre-right European People's Party (EPP), the largest political group in Strasbourg.
After the vote, Dutch MEP Ria Oomen-Ruijten, the EPP spokesperson on Reach, complained that Socialist-backed amendments had introduced an 'overly complex system of authorisation renewal, at five-year intervals, which means that chemical products must undergo the procedure again.' She told Chemistry World: 'We in the EPP wanted a system based on a scientific risk approach, with no time limit if the risk of the chemical is adequately monitored.' Oomen-Ruijten suggested that ministers have already made up their minds to support Reach, and would overturn the parliament's amendments on time-limited authorisations. She claimed that the UK government had shown her a draft of the forthcoming December agreement, which indicates that ministers prefer a risk-based approach.
The UK is hoping to record at least one major success before the end of 2005: a go-ahead for Reach would overcome criticism faced over an apparent lack of progress during the country's six-month presidency of the EU. Reach developments are being closely monitored by the US. Guido Sacconi, the Italian MEP who steered the legislation through its parliamentary stages reported, 'The US administration is not happy about Reach and actively lobbied against it. Washington fears demands from environmental and public health activists for the creation of a similar regime'. Arthur Rogers
Source: Chemistry News, November 18, 2006
The European Commission continues to be accused by European industry of pushing 'green policies' that are stifling progress and global competitiveness - the controversial REACH chemicals legislation remains a sore point.
These concerns were most recently raised at a workshop in Brussels this month, attended by politicians and manufacturers from a wide range of industries in Europe, run by the Alliance for a Competitive European Industry (Alliance). At the workshop, a number of delegates spoke up against the European Commission's perceived lean towards green and how this is damaging industry.
"Currently environmental groups are the ones steering European legislation," said Hungarian MEP Edit Herczog.
"The industry needs to take action and do more to influence politicians, while at the same time improve its public image, because currently for a politician, being industry-friendly is a suicide route."
"While this situation continues, it is spelling out economic suicide for the European economy," added Ivan Hodac, secretary general of the European Automobile Manufacturers Association (ACEA).
When challenged on how to overcome these problems, Heinz Zourek, the European Commission's Enterprise and Industry director-general said that the industry could do more by improving the way they communicate and providing more reliable and transparent information, pointing to the example of the controversial REACH chemicals legislation.
"The industry's view on the REACH regulation was represented only by the chemical industry, which has a bad reputation, and was considered to be overly aggressive and one-sided in their interests," said Zourek. "Downstream users spoke out far too late, which is why the industry failed to influence MEPs."
Indeed, it appears the industry has learnt a costly lesson. The approval of the REACH legislation remains a major sticking point throughout many European industry sectors, particularly the chemicals industry, who fiercly criticise the European Commission of pandering to environmental group minorities at the expense of innovation, competitiveness and viability throughout European businesses.
Last month, the Chemical Business Association (CBA), formerly known as the British Chemical Distributors and Traders Association (BCDTA), announced that it believes the industry's worst fears about the financial burden that REACH will impose on smaller and medium-sized firms (SMEs) appear to be justified. The claim followed the European Commission's release of the draft budget for the European Chemicals Agency (ECA), which will have the task of managing the technical, scientific and administrative aspects of REACH. The CBA said its analysis of fees payable by the industry to the ECA under the REACH legislation reveals some major increases. Furthermore, the CBA pointed out that the estimated cost for establishing the ECA in Helsinki &endash; one of the most expensive cities in the world - has more than doubled from euros 359m to euros 1,189m.
"The Commission maintains that many of the additional costs have resulted from the extra responsibilities imposed on the Agency by political decisions. This may well be, but the fact of life remains that the chemical industry is being asked to pick up the tab for these decisions &endash; which will only serve to erode the competitiveness of the sector and damage SMEs," said Whyte.
"In addition, the Commission also admits that Helsinki represents the equivalent of a 'green field' site and that 'no synergies are possible with existing institutions'. On balance, the decision to base the ECA in Helsinki appears to be a masterful piece of strategic planning."
Source: www.DrugResearcher.com, October 4, 2006
While EU lawmakers prepare for a decisive round of negotiations on REACH, work on the implementation of the new chemicals legislation is already well under way.
Efforts at helping businesses comply with REACH are stepping up with a final decision on the EU chemical regime expected before year-end.
An interim strategy was put in place by the Commission as early as 2004 to ensure smooth implementation of the legislation once it is adopted. So-called REACH implementation projects (RIPs) will be running until the agency becomes fully operational in 2008. Work focuses on five key areas:
The Commission held a workshop on 25 September to provide guidance to producers and downstream-users of chemicals under REACH. The programme included an overview of timelines and obligations to establish the safe use of a chemical.
Meanwhile, a series of trial runs with business stakeholders took place last year to simulate how REACH would actually work in practice.
Despite the efforts made, not everybody seems satisfied with the Commission's moves to facilitate REACH implementation.
On 13 September, the United States Council for International Business - a trade body whose membership includes some 300 leading US companies with combined annual revenues in excess of $3 trillion - hit out at the Commission's guidelines for REACH implementation.
The final guidelines, known as RIP 3.8, relate to substances that are contained in finished products, or 'substances in articles' in REACH jargon. But with the number of chemicals in finished products, such as computers, sometimes amounting to 100 or more, registration can become somewhat complicated.
"We are concerned that these guidelines are neither workable nor proportionate," said Andrea Fava, USCIB's manager of environmental affairs. USCIB recommended the revision of the proposed guidelines, saying that its members are "concerned about the workability of the draft from both the compliance and enforcement perspectives". USCIB has also expressed concern that the guidelines go beyond the scope of the draft chemicals legislation.
"We urge that further input be considered and that the guidance for articles be revised," said the USCIB statement.
In June this year, the European Chemicals Industry Council (CEFIC) launched ReachCentrum, a help desk to support companies along the value chain to fulfil the requirements of REACH. CEFIC said the Brussels-based ReachCentrum will draw from experience gained with European Commission projects that is says have given CEFIC "unique expertise on REACH". "CEFIC is now turning this expertise into practical help to companies." Services provided will include consortia management, "including Chinese walls facility to preserve confidentiality" and a registration service to handle submissions of dossiers to the future chemicals agency.
Source: EurActiv News, September 29, 2006
'How will consumers be informed about chemicals?' remains an issue for the second reading of REACH. Industry wants to limit categorisation to proven risks, while NGOs are pushing for guidelines based on the precautionary principle, including hazard labelling.
The aim of REACH is to improve the protection of human health and environment through better and earlier identification of the properties of chemical substances. Once in place, it will require industries to provide safety information on the different chemical substances used in their everyday consumer products such as toys, textiles, cosmetics, food or detergents.
In view of the second reading of REACH, two recent stakeholder meetings brought stakeholders together to discuss REACH from the consumers' point of view. Friends of Europe organised a lunch debate on 13 September to know How Safe is REACH making Europe's consumers? and the Commission organised a seminar to debate the Assessment of Consumer Exposure to Chemicals in Consumer Products on 29 September.
Experts estimate that chemicals in all types of consumer products are the main source of 'total human exposure to chemicals'. One of the major issues under discussion on risk assessment is the difficulty to define the 'total exposure' to these hazardous 'coctails of chemicals' in the long run, rather than exposure to one single chemical in a very defined, traceable context.
"We can never have an idea of the total exposure. It is relatively easy to establish health effects of short-term, direct, clear exposure, but long-term effects of unsystemic exposure are far more complicated," said Lea Hansen from the Danish Ministry of Environment in the Commission exposure assessment seminar.
The Commission's approach to risk assessment is science-based and therefore requires lots of data. Currently, the Commission lacks proper chemical-exposure assessment data and tools to assess the potential health risks.
In 2003, the EU launched a project called EIS-ChemRisks to provide tools and reference data for harmonised exposure-assessment procedure for consumer products and articles. It also aims to generate and validate scenarios of exposure assessment.
Accurate information for consumers is judged to be of utmost importance to foster and maintain consumer confidence in the chemical industry and its products. However, the industry and NGOs remain divided over what should be communicated to consumers. Industry wants to communicate the established facts on the risks of some chemicals, whereas NGOs fear this would lead to simple risk communication and want more consumer access to information on hazards and the potential long-term health effects of total exposure to 'cocktails of chemicals'.
"Consumers desperately lack awareness on REACH. Nobody knows the initiative," said Laura Degallaix, environment, safety and health officer at BEUC after the Friends of Europe lunch debate. Several participants also underlined that "a standard consumer is a confident one and trusts that the products put on sale are safe".
According to Bo Oscar Jansson, Professor at Stockholm University, the major sources of exposure to the chemicals are a) production process; b) industrial use; c) consumer use, and; d) waste. He argues that "production and industrial use together form the major risks, but consumer use and waste have more risks. Especially, exposure over time is far bigger from consumer use and waste than production and industrial use."
However, Matti Jantunen, Research professor at the Finnish National Public Health Institute, argues that of all environmental exposure-related risk-factors, industry chemicals form the smallest group. "Even if REACH would eliminate all potential health risks from the chemicals assessed, it would have no real effect on the state of public health and death statistics, as the total risks from chemicals come from elsewhere. The main sources of exposure to harmful, for example, carcinogenic substances, are particles released during all kinds of burning, such as forestfires, grilling of food or industrial and domestic waste burn, as well as smoking, even passive, and various emissions from transport," Jantunen told EurActiv.
"We have solid evidence that the majority of the chemicals surrounding us are not natural but are released," as a result of industrial processes and via use of consumer products, argued DG Health and Consumer Protection Director Agne Pantelouri in the Commission seminar on consumer exposure. She added that "all the sources of regular exposure, food and non-food, need to be assessed, because making a distinction between the sources is useless. If we have no data on exposure, we can not talk about risk management."
"The question is, how do we combine the need for more efficient drugs, cosmetics and cleaning products with safety? In other words, how do we combine innovation and safety?" said Paula Pinho, a member of Commissioner Kyprianou's cabinet.
Source: EurActiv News, September 29, 2006
One of the most influential medical journals, The Lancet, has weighed into the European REACH chemicals debate, which is at near boiling point as the draft legislation approaches its final approval date in December.
In the November 8 online version of the Journal appeared a peer-reviewed article showing that as many as one in six children could be developing neurodevelopmental disorders from exposure to industrial chemicals. Neurodevelopmental disorders such as autism, attention deficit disorder, mental retardation, and cerebral palsy are becoming increasingly common, although at present their causes are mostly unknown. However, authors of the report pinpointed 202 industrial chemicals, including metals and inorganic compounds, organic solvents and pesticides, that are known to potentially harm the human brain and identified over 1,000 other chemicals that are also likely to be neurotoxic in humans due to their known harmfulness in animals.
"The combined evidence suggests that neurodevelopmental disorders caused by industrial chemicals has created a silent pandemic," said the report.
The authors view the problem as "the tip of a very large iceberg" and criticise the proposed REACH (Registration, Evaluation and Authorisation of Chemicals) agreement as being inadequate for not taking neurodevelopmental disorders into account.
Source: www.DrugResearcher.com, November 9, 2006
Doctors and cancer researchers have renewed calls for REACH to phase out toxic chemicals believed to cause illness. But arguments persist that the effects of tiny levels of exposure are still largely unknown.
Pr. Dominique Belpomme, chairman of the French cancer research organisation ARTAC was in Parliament with other scientists and MEPs on 18 October, 2006 to warn about "the serious dangers" that chemical pollution represents to humans.
In the past 20 years, the cancer rate among newborn babies has risen by a steady 1% every year, Belpomme pointed out, saying fetuses are exposed to "hundreds of chemicals" in the womb.
"It is obvious [that the rise in cancers] is due to chemical pollution", Belpomme said. He singled out formaldehyde, a chemical used in plywood and carpets, and brominated flame retardants used in consumer electronics as two main culprits.
"Today …children are no longer the only ones at risk: the whole human race itself is in danger," said Belpomme, the leading scientist behind the Paris Appeal, a petition which calls for the phase out of toxic chemicals.
Since it was launched in 2004, the petition has claimed backing from numerous international scientists, Nobel Prize winners, 1,000 NGOs and 250,000 individual citizens.
They are calling on EU lawmakers to support REACH, the draft EU law that seeks to screen around 30,000 existing chemical substances for health and environmental safety.
"Doctors and scientists … firmly reiterate the necessity to reinforce REACH and regret that the Council decisions were made without consulting doctors and scientific experts," the signatories write.
"They urge the Parliament members to decide beyond traditional political splits, as the sanitary situation has become extremely serious in terms of cancer and reprotoxicity."
Dr Andreas Kortenkamp, head of the centre of toxicology at the School of Pharmacy, London University said: "This is the first evidence that chemicals in our environment, with oestrogenic properties that are 'accidental', and not just natural hormones or pharmaceutical oestrogens may contribute to the development of breast cancer."
Others are more careful: Dr Andrew Smith, told the BBC: "Any toxicologist will tell you that dose - the amount - is the important thing. I would rather we didn't find these chemicals present, but trying to ascribe toxicity to them is a different matter."
Belpomme agrees that scientific uncertainties remain about the effects of low-level chemical contamination. "We don't know," he admitted. "But the principle of precaution should prevail in such cases and the toxic substances phased out wherever possible," he added.
Source: EurActiv News, November 13, 2006
A new ethics report has raised concerns about using animal-human embryonic hybrids in drug testing in which the creation of these chimeras are creating exciting avenues of research as well as controversy.
The formation of these hybrids is a relatively recent phenomenon with some scientists say the more humanlike the animal, the better research model for testing drugs or possibly growing "spare parts," such as livers, to transplant into humans.
Watching how human cells mature and interact in a living creature may also lead to the discoveries of new medical treatments.
However, the moral implications about the creation of animal-human mixtures, especially at the embryonic and foetal level are deep as the creation of animals with certain kinds of human characteristics or with human brain and reproductive cells, would be offensive and unnatural.
The report, published by the Scottish Council on Human Bioethics (SCHB) was written in the light of new draft legislation on human embryology being prepared by the UK Department of Health (which is to be published during the course of summer 2006).
The report lists a series of 15 recommendations designed to allay concerns to whether or not chimeras would be used for procedures that are problematic or risky.
The recommendations state that:
- The creation of an embryo containing cells made up of both human and animal chromosomes should be prohibited.
- The insertion of a human cell nucleus or chromosomes into a non-human egg stripped of its chromosomes enabling an embryo to exist should be prohibited.
- The mixing of animal and human gametes should be prohibited.
"The fertilisation of animal eggs with human sperm should not continue to be legal in the UK for research purposes," said Calum MacKellar, director of research of the SCHB.
"Most people are not aware that these kinds of experiments have been taking place in the UK and find it deeply offensive; parliament should follow France and Germany and prohibit the creation of animal-human hybrid embryos."
The SCHB is also calling on government not to use animal eggs to create cloned animal-human embryos in order to address the serious shortage of human eggs that are available. This procedure is currently unregulated by legislation in the UK.
The potential power of embryonic and foetal inter-species mixtures became clear about a decade ago in a series of dramatic experiments on chickens and quails. The resulting offered astonishing proof that complex behaviours could be transferred across species.
Source: www.DrugResearcher.com, August 11, 2006
Covance, the world's largest provider of drug-development services, is bracing itself for the onslaught of protests by animal rights activists who are demonstrating against the building of a $100m (¤78.6) laboratory in the US.
The use of live animals in laboratories for the testing of drugs has become normal practice for outsourcing firms that are involved in managing clinical trials. However, Covance's stance on their use has attracted condemnation from animal rights organisations concerned with how the animals are treated.
Covance's purchase of a 38-acre site in Chandler, Arizona, is with the specific intention of building a 600,000-square-foot medical research and animal-testing campus that will employ up to 1,200 people.
Since those plans were made public last year, Covance has had to deal with a storm of protest from organisations such as the Physicians Committee for Responsible Medicine and Citizens Against Covance based in Chandler.
On July 14 of this year, Covance filed a rezoning request with Chandler, a move that will start a lengthy public process that has pushed the firm into the media spotlight and fan the flames of a very emotive issue.
Just last week, Covance received official backing from the Chandler Chamber of Commerce.
This was less than a week after a city planner requested more information about the companies planned "pathological waste thermal destruction unit:" an incinerator that could be used for animal carcasses.
Protestors, which also include the People for the Ethical Treatment of Animals (PETA), an international animal rights group, have vehemently objected to these incinerator plans.
They have objected to the potential for these animals to carry diseases and to the possibility that Covance would build an incinerator to dispose of animal carcasses.
Covance has hit back, saying that animal testing is part of developing drugs to cure diseases and that the company treats animals humanely.
They deny that there would be health risks posed by laboratory animals.
This has not been the first time the parties have crossed paths. In October 2005 Covance settled a lawsuit against PETA, in which PETA agreed to a ban on conducting any infiltration of Covance for five years.
In addition, PETA operative, Lisa Leitten, accepted a three-year ban on infiltrating any commercial animal research facility worldwide. PETA and Leitten also agreed to provide all video footage and written notes taken from Covance.
According to the US Department of Agriculture, the total number of animals used in that country in 2002 was 1,137,718, not counting birds, mice, and rats, which make up around 85 per cent of research animals. Other sources estimate the percentage of all lab animals that are rats, mice, or birds at 85-90 per cent, or 95 per cent. The Laboratory Primate Advocacy Group has used these figures to estimate that 23-25m animals are used in research each year in America.
Source: www.DrugResearcher.com Aug 17, 2006
Pharmaceutical company Eli Lilly, has been asked by animal welfare group People for the Ethical Treatment of Animals (PETA) to justify its decision to outsource its animal testing to countries with no or poor animal welfare standards, which go against Lilly's commitment to reducing, refining, and replacing its use of animals. PETA is concerned that Lilly may be trying to avoid US animal welfare laws by selecting countries with less stringent rules as well as a more relaxed attitude to animal testing.
A recent article in Forbes magazine discussed Lilly's outsourcing to China, where, "scientists are cheap, lab animals plentiful, and pesky protesters held at bay." The article also cited a pharmaceutical industry executive who "admits that Chinese testing companies lack quality control and high standards on treatment." Relocating research to a region with non-existent or weak animal welfare standards is in direct conflict with Lilly's stated commitment to reducing, refining, and replacing its use of animals.
Eli Lilly has recently announced plans to set up research units in China as it looks towards taking a slice of the booming outsourcing industry in the East. Currently, the global market for animal testing, which was worth $3bn last year, could double by 2008.
Source: www.DrugResearcher.com, November 17, 2006
UK government legislation designed to curb animal extremism appears to be working as statistics published this week records a reduction in the number of incidents provoked by animal rights extremists during the first half of this year.
The introduction of measures in the UK within the last two years to combat the threat from animal rights extremists include the creation of a specialist police team and new powers to protect scientists. The laws were put in place as the UK's biotech sector has grown to become the largest in Europe and second globally only to the US. Britain has around 455 dedicated biotech businesses.
Published by the Association of the British Pharmaceutical Industry (ABPI) the report found that incidents of attacks on people's private homes, usually in the middle of the night, causing damage and leaving threatening messages &endash; 'home visits' - declined to just 15. This figure represented fewer than half the number in the same period last year and 14 per cent of the total for the first six months of 2004.
"These figures mark a sea change in the level of attacks and harassment in the UK and substantive progress towards Government objectives," said Philip Wright, Director of Science and Technology at the ABPI. "While the number of 'home visits' is at an all-time low, the new figures also show a drop in virtually every area of illegal activity by extremists. The pharmaceutical industry will be very much encouraged by these figures, which show that good progress has been made by the Government in combating animal rights extremism."
The ABPI attributes the reduction to a three-pronged strategy of new legislation; enhanced policing with co-ordinated enquiries; and working with stakeholders to combat attacks.
Source: www.DrugResearcher.com, August 2, 2006
Legislation gives additional legal protection to scientists and companies that provide services and support for animal research
Recently, the US House of Representatives has passed the Animal Enterprise Terrorism Act (S 3880), a bill that expands protection for scientists by outlawing economic damage against "animal enterprises," including organizations involved in academic and commercial research and testing. President Bush is expected to sign the bill soon. The Senate already passed this [iece of legislation by unanimous consent in September 2006.
The measure provides a graduated scale of prison time and fines for people found guilty of harassing, intimidating, trespassing against or vandalizing the property of anyone associated with animal research. The bill also affords protection to so-called "tertiary" targets: third-parties such as customers, bankers, accountants, insurance providers, and other service providers, who have been targeted by militant animal rights activists in the US and UK.
Between January 1990 and June 2004 SHAC, the Animal Liberation Front, and other extremists committed more than 1,100 acts of terrorism, causing more than $120 million in damage, said Rep. John Sensenbrenner (R-Wis.) during debate on the House floor. The new bill makes it a crime to trespass, harass, vandalize, or otherwise threaten anyone associated with an animal enterprise, including scientists and their families. Similar legislation was enacted in England last year. To address First Amendment concerns, the new bill specifically permits peaceful picketing, demonstrations, and "lawful boycotts" against animal enterprises. "This bill does not satisfy everyone, but it does represent a reasonable compromise," said Rep. Robert Scott (D-Va).
Links within this article:
"Animal Enterprise Terrorism Act" (S 3880)
http://thomas.loc.gov/cgi-bin/query/z?c109:S.3880
National Association for Biomedical Research
Animal Enterprise Protection Act of 1992
http://www.nal.usda.gov/awic/legislat/pl102346.htm
Source: The Scientists, November 16, 2006
A group of researchers have come together to form a coalition, which aims to campaign for the revision directives on the protection of animals used for scientific research.
The group, known as the European Coalition for Biomedical Research (ECBR), brings together 34 societies and associations representing approximately 37,000 academics. They aim to draw attention to the host of Community legislation that covers the protection and welfare of animals.
In particular the coalition is to focus on Directive 86/609/EEC, adopted in 1986, which covers the protection of animals used for experimental and other scientific purposes.
Animal experimentation, be it for the development of new chemicals or medicines, for physiological studies, for studying environmental effects or for testing new food additives, has to be carried out in compliance with Directive 86/609.
The Directive was designed to improve controls on the use of laboratory animals, set minimum standards for housing and care, as well as the training of personnel involved with laboratory animals.
The Directive also aimed to reduce the number of animals used for experiments, and was the basis for the establishment of the European Centre for the Validation of Alternative Methods (ECVAM).
The European Commission told Cordis News: "In recent years, it has become increasingly apparent that the Directive needs to be revised in order to promote improvements in the welfare of laboratory animals and to further foster the development of alternative methods."
The Commission thought that a number of the Directive's provisions were open to interpretation, and that the style of some provisions was more political than regulatory in nature.
In addition, new techniques such as the use of transgenic animals and cloning have been developed since the Directive was implemented.
There was also no mention of ethical review processes, compulsory authorisation of experiments or the 3Rs - Reduction, Refinement and Replacement. Over the past 40 years the Three Rs have become widely accepted ethical principles to be embedded in the conduct of animal based science.
The newly formed ECBR believes that some of the revisions will hinder scientific research. "Whilst there is much that is sensible, there are also some rather dangerous suggestions," said Mark Matfield, Director of the European Biomedical Research Association and Secretary General of the ECBR. Dr Matfield gives the example of a proposal to limit the use of non-human primates in research to those that have been bred for two or more generations in captivity. "There aren't enough of these two-generation captive bred laboratory primates, and it would take years for sufficient numbers to become available," he added.
A 2005 statistical report by the European Commission reported that 10.7m animals were used in 2002 in experiments (figures from France referred to 2001). Of these, 0.1 per cent were primates, making the number around 10,700.
Source: www.DrugResearcher.com, November 13, 2006
A recent report by the Royal Society and the Royal Academy of Engineering accuses the UK government of slow progress in conducting research on the health and environmental impacts of free nanoparticles. The Nanonscience and Nanotechnologies: opportunities and uncertainties report urges the government to control the commercial development of nanotechnologies until appropriate reseach has been conducted.
Various sectors such as food, chemicals, electronics, cosmetics and medicine already use or are currently developing nano-applications. However, the behaviour of nanoparticles inside the body (inhaled, swallowed, absorbed through skin or injected) is not yet known. The effects of free nanoparticles on the air or water are also unknown.
In June 2005, the Commission adopted an action plan for 2005-2009 defining actions for the "immediate implementation of a safe, integrated and responsible strategy for Nanosciences and Nanotechnologies (N&N)". The Commission highlights the need to respect ethical principles and to integrate societal (health, environmental and regulatory) considerations linked to nanotechnologies into the R&D process at an early stage and to encourage dialogue with citizens.
Further reading:
The Royal Society and the Royal Academy of Engineering: Nanoscience and nanotechnologies: opportunities and uncertainties - Two-yearoreview of progresson Government actions: Joint academies' response to the Council for Science and Technology's call for evidence (October 2006)
Source: EurActiv News, November 6, 2006
A Finnish Presidency conference on nanotechnologies gathered representatives from public administrations, industries, the research community and consumers' and environmental organisations on 14-15 September 2006 to discuss safety as a prerequisite for the development of a competitive and innovative European nanotechnology sector.
The Nanotechnologies: Safety for Success conference touched upon various sectors currently developing nano-applications, such as food, chemicals, electronics, cosmetics and medicine. However, no matter what the sector, "the development of high technology, such as nanoscience and technology, requires public engagement and trust", summarised the Finnish Minister for Health and Social Affairs, Liisa Hyssälä.
The potential risks of nanotechnology include the risk to health and environment of nanoparticles and materials. The nanoparticles can be inhaled, swallowed, absorbed through skin or injected, but the behaviour of nanoparticles inside the body is not as yet known. As to environmental risks, the effects of free nanoparticles on the air or water are also unknown.
In June 2005, the Commission adopted an action plan for 2005-2009 defining actions for the "immediate implementation of a safe, integrated and responsible strategy for Nanosciences and Nanotechnologies (N&N)". A recent Eurobarometer shows large public support for their development.
Source: EurActiv News, September 15, 2006
Last week, the National Human Genome Research Institute in Bethesda, MD, announced more than $12 million in grants for researchers who are developing technologies to slash the costs of mapping a mammalian genome from around $10 million to $1,000. Some scientists believe that new twists on a decade-old idea, called nanopore sequencing, could speed up the sequencing process and provide a more complete map of the genome.
In nanopore sequencing, strands of DNA move through a small hole in a (silicon semiconductor) membrane with sensors that read off the base pairs of genetic code one by one. The hole, or nanopore, is about the size of a DNA molecule, or 1 to 2 nanometers in diameter, and the membrane separates positively and negatively charged solutions.
Another approach to nanopore sequencing involves designing a DNA sequencer based on a modified fluorescence microscope and arrays of many nanopores. First, the DNA is incubated with four different fluorescent labels. The labels make the strand too big to go through the hole, so they have to pop off for the strand to advance. As the DNA moves through the nanopore base by base, the microscope will detect the labels as they pop off.
Source: www.TechnologyReview.com, October 11, 2006
US researchers have created a nanoscale probe that can capture the topography of biological objects in their normal environment, which paves the way for the discovery of new biomarkers leading to better drug design on the cellular level. The researchers have created the Scanning Mass Spectrometry (SMS) probe, which works by pulling biomolecules (proteins, metabolites, peptides) precisely at a specific point on the cell/tissue surface, ionise these biomolecules and then producing "dry" ions suitable for analysis and then transport those ions to the mass spectrometer for identification.
The SMS probe can be integrated with the Atomic Force Microscope (AFM) or other scanning probes, and can not only image biochemical activity but also monitor the changes in the cell/tissue topology during the imaging.
The probe potentially allows simultaneous detection of complex mechano-bio-electro-chemical events underlying cell communication.
Source: www.DrugResearcher.com, July 28, 2006
Company ProImmune has introduced a tool for evaluating and characterising CD4+ single antigen-specific T cells, enabling evaluation of the T cell immune response in a range of disease areas including, autoimmune disease, cancer and infectious diseases.
The biotechnology company have made this instrument available to those involved in drug discovery and research, responding to an often-quoted problem regarding current methods in exploring CD4+ single antigen-specific T cells.
Traditional functional assays, such as proliferation or cytokine secretion, for studying antigen-specific CD4+ T cells are not truly antigen-specific.
The MHC tetramer, a more recently available tool, has been difficult to reproduce with a high level of consistency, which has meant that these reagents have not been widely accessible.
ProImmune's Class II Ultimers, claim to be the next-generation of MHC Class II multimers, with a superior peptide-linked planar design to improve the interaction between the MHC-peptide complexes and the T cell receptors, for detection of CD4+ single antigen-specific T cells.
The detection of CD4+ T cells using MHC tetramers has also been difficult due to the low frequency of these T cells (down to 1 in 100,000 white blood cells) and the low avidity of binding between the MHC-peptide binding complex and the T cell receptor. The peptide-linked planar design of Class II Ultimers addresses these issues by improving reproducibility and sensitivity of CD4+ T cell detection.
In addition, the Class II Ultimer fluorescent detection label has been optimised to maximise the signal to noise ratio of this assay.
Source: www.DrugResearcher.com, November 6, 2006
The FDA has completed Phase I of the Micro Array Quality Control (MAQC) Project and has published a report with the conclusion that different micro array platforms generated similar gene-expression patterns. The results of the study were also published in a series of papers in Nature Biotechnology last week. The MAQC project was initiated by the FDA's National Center for Toxicological Research (NCTR) in February 2005 to address reliability, performance, quality, and data-analysis issues. The first phase of the MAQC project involved 137 scientists from 51 organizations, including government agencies, manufacturers of micro array platforms and RNA samples, micro array service providers, and academic labs, according to Leming Shi, Ph.D., NCTR, coordinator of the MAQC project.
The second phase of MAQC project will focus on predictive signatures and biomarker development.
Source: Genetic Engineering News online, September 13, 2006
Scientists have developed a new computerised system for controlling cognitive science experiments through automating animal behaviour analysis, allowing efficient drug screening and potentially shortening development time for new drugs. The computer-controlled system is set to offer a new methodology for rapid and efficient drug screening which could solve the need to employ a highly specialised and expensive screening lab to run a high throughput drug screening operation.
A number of academic and commercial pharmaceutical projects have generated large genetic, proteomic, or small-molecule (drug) libraries that must be screened to identify compounds of interest to both biomedicine and basic biology. Currently, many pharmaceutical companies are screening 100,000&endash;300,000 or more compounds per screen to produce approximately 100&endash;300 hits. On average, one or two of these become lead compound series. Larger screens of up to 1,000,000 compounds in several months may be required to generate something closer to five leads.
Typically, current screening is conducted on single cells in culture, or in organisms such as yeast. However, these strategies are insufficient for studying the effect of compounds on complex multicellular systems or nervous system function. If scientists want to find a drug that improves memory or works as a sedative, single-cell models are not informative. Screens on multicellular models, such as zebrafish, have been successful but the current necessity for manual analysis has made it impractical for high-throughput neurological screens.
Scientists from the Forsyth Center for Regenerative and Developmental Biology developed a computer-controlled system to overcome a number of problems that exist in current attempts to understand how the brain and nervous system give rise to memory, behaviour, and cognition by studying animal model systems. The system consists of a set of small chambers monitored by digital cameras with chamber containing a set of light, vibration, and other devices.
The computer constantly monitors the animal's position and orientation within each dish and provides rewards or noxious stimuli in accordance to the pre-established 'learning' program. For example, a worm may be rewarded with the turning off of a bright light whenever it stays in a small area at the centre of the dish, thus training it to remain in a particular location. Or a tadpole may be trained to move for 5 seconds whenever a bright light is applied making it easy to designate some chambers as controls (where a random or opposite relationship between stimulus and response is given).
The system can automatically produce movies of each animal's chamber and a data file from which one can easily compute time spent in each area of the dish, average movement. By running a given protocol in this device, a researcher can gather data for many days without any involvement on their part, thus freeing up valuable time and removing sources of bias. Other labs are then able to analyse the data remotely and mine it to requirements.
Source: www.DrugResearcher.com, August 23, 2006
Gentronix has been granted a research award, which is to fund a potentially viable alternative to animal testing, reducing the need for their use during drug development. The research award of £133,024 (196,714 euros ) has been granted to Gentronix by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs).
The test specifically focuses on the development of a novel genotoxicity assay in a human liver cell line, designed to reduce the use of live animals in drug development. As well as providing a valuable new tool to confirm positive data from existing tests, the new human cell-based genotoxicity test aims to reduce the number of compounds going on to animal testing. The use of this new test will not only reduce the number of animals used in genotoxicity testing but also reduce the considerable costs of conducting animal tests.
The existing mammalian cell in vitro tests are highly sensitive so most carcinogens are identified, but many safe compounds are also falsely identified as potential carcinogens. Because this can lead to needless loss of useful new drugs, live animal tests are still conducted when there is only one in vitro positive result. By using a new high specificity human cell-based genotoxicity test, the aim will be to reduce the number of compounds tested on animals.
Preliminary validation studies with a new human cell genotoxicity test have demonstrated an ability to detect all direct acting mechanistic classes of genotoxic chemicals, as well as aneugens and compounds disrupting DNA replication and repair. Results recently reported by Gentronix and GSK in Mutation Research show the new assay to have sensitivity comparable to that of existing mammalian in vitro genotoxic assays, but uniquely combined with very high levels of specificity. However, some compounds (promutagens) are only carcinogenic after passing through the liver, and regulations require a separate test to be performed using liver tissue extracts.
Source: www.DrugResearcher.com, August 11, 2006
Scientists at Duke University Medical Center have demonstrated they can grow human stem cells in the laboratory by blocking an enzyme that naturally triggers stem cells to mature and differentiate into specialized cells. The discovery may enable scientists to rapidly grow stem cells and transplant them into patients with blood disorders, immune defects, and select genetic diseases, said the researchers.
In their study, published on line and in the upcoming August 1, 2006, issue of the PNAS, the investigators discovered that an enzyme, aldehyde dehydrogenase (ALDH), stimulates hematopoietic stem cells to differentiate into blood or immune cells. They inhibited this enzyme in stem cell cultures and successfully increased the number of stem cells by 3.4 fold. Moreover, they demonstrated the new stem cells were capable of fully rebuilding the blood-forming and immune systems of immune-deficient mice.
Source: Genetic Engineering News July 27, 2006
US biotech company, Advanced Cell Technology, announced that its scientists have found a ground-breaking technique for growing human stem cells from an early human embryo without destroying it.
The new technique, consisting of removing one of the eight cells of a three-day-old embryo instead of destroying a five-day-old embryo with about 150 cells, has however been criticized due to lack of medical evidence as to whether a fetus missing one cell will develop into a normal child. In addition, the new method would mean that parents would have to give their ethical consent for the donation of one cell.
Further reading:
Source: EurActiv News, August 24, 2006
Geron and the University of Edinburgh are collaborating to conduct preclinical safety and efficacy studies with three cell types derived from human embryonic stem cells (hESC). The cell types are hepatocytes for the treatment of liver failure and osteoblasts and chondrocytes for the treatment of musculoskeletal disorders, including osteoarthritis, bone fractures and osteoporosis, said Geron officials. The studies, based at the University's Centre for Regenerative Medicine, will be under the direction of John Iredale, Phil Newsome, Brendon Noble, and Hamish Simpson.
Source: Genetic Engineering News on-line, August 8, 2006
ES Cell International (ESI) produced four new clinically compliant human embryonic stem (hESC) lines. Another four are expected to be banked soon. ESI also intends to distribute research-grade versions of the stem cells to academic researchers worldwide through the A*STAR Singapore Stem Cell Consortium (SSCC). The SSCC Stem Cell Bank will be responsible for growing the cells under non-cGMP conditions for distribution to academic researchers. This development will facilitate lab research while allowing users the option of securing the clinically compliant versions of exactly the same cell lines they were using in their research.
Source: Genetic Engineering News, August 1, 2006
Using several types of microscopy, researchers from the Georgia Institute of Technology showed that ultrasound waves punched holes in (cancer) cells' membranes. The pressure of the ultrasound creates tiny bubbles; when the bubbles burst, a wave of fluid movement opens up a small breach. The damage is temporary: researchers found that within minutes, the cells could manufacture and dispatch tiny spheres of membrane material that would patch the holes. The ultrasound technique could become a way to target delivery of gene therapy or chemotherapy to specific tissues, or to transport large--molecule drugs that can't otherwise pass through cell membranes. Ultrasound wands could be pressed against the skin, with their energy focused on specific internal tissues. Safety studies are likely to take several years, but if all goes well, this could become an approved procedure in five to ten years.
Source: TechnologyReview.com, November 14, 2006
Covance has announced it has licensed the use of a technique that is the only known in-vitro method to predict in-vivo liver disposition allowing users to identify and select better drug candidates.
The technique, B-CLEAR, has already demonstrated distinct characteristics in current proprietary absorption, distribution, metabolism, excretion and toxicology (ADMET) technologies. It gives scientists the ability to generate physiologically relevant data and enable decision making in pivotal areas related to hepatic transport and adverse drug interactions.
Current drug R&D methods rely heavily on ADMET &endash; a technique that incorporates a variety of methods such as animal models to predict the efficacy of a potential drug.
In-silico modelling for ADMET is also becoming a popular method used for predictive toxicology. Normally, the use of in-silico modelling will be used in conjunction with other methods to determine compound characteristics.
Covance intend to use B-CLEAR as an early discovery screen for promotion of compounds, a source of lead optimization guidance, and a tool to address development-stage drug transport questions, enabling better prediction of bioavailability, pharmacokinetics, species-specific drug dosing and candidate selection. The B-CLEAR product line characterises compounds' hepatobiliary disposition (hepatic uptake, excretion and biliary clearance). Human (B-CLEAR-HU), monkey (B-CLEAR-MK), dog (B-CLEAR-DG), rat (B-CLEAR-RT), and mouse (B-CLEAR-MO) hepatocytes are available on the B-CLEAR system.
Between forty and sixty per cent of lead compounds fail ADMET (absorption, distribution, metabolism, excretion and toxicology) testing, and only ten per cent of drugs that start clinical trials ever get approved. Overall, this means that seventy two per cent of drug development costs are wasted on failures. This has created a general theme in drug discovery to get much more information about drug compounds earlier in the process, to cut attrition rates by making compounds 'fail faster.' This involves much more use of computer modelling, high content screening and miniaturised assays.
Source: www.DrugResearcher.com, October 20, 2006
New data gathered by the Financial Times Research Centre shows that on average, the top 30 pharma firms spent almost 17 per cent of sales on research last year, not so surprising considering that bringing a new drug to market can now cost anything between $900m (euro 715m) and $1.2b.
As expected, the big spender is Pfizer, with over 14 per cent of its £27bn sales invested in R&D in 2005, followed by GlaxoSmithKline with over £3bn spent on research during the same year, and French giant Sanofi-Aventis with £2.7bn.
Meanwhile, it seems that Big Pharma is changing its approach on how to spend it. The report suggests that relying on in-house research and development only has become increasingly complex in terms of budget and resources and it is now almost unviable for companies to have control over all the aspects of drug development.
As a result, companies are staying away from big mergers with other giant companies and are instead buying smaller biotech companies, entering joint ventures or in-licensing drugs, according to the report. "Shifting away from over-reliance on in-house R&D makes sense, but brings new risks too," the report said. This is due to the failure of the majority of biotech start-ups and to the fact that academic researchers now try to commercialise their work at a much earlier stage. According to the report, this leads to companies rushing to buy overpriced acquisitions of academic ventures with no real product in sight.
The report also shows that the biggest players are not necessarily the most profitable. The most profitable companies last year were either young biotech firms with successful drugs or reputable pharma companies with off shored operations taking advantage of the lower costs and high-skill base of developing countries.
The world's biggest players in the pharmaceutical industry is Pfizer with a market capitalisation of over $100bn. GlaxoSmithKline is just behind with a stock-market value of $85bn. Roche Holding comes third with a stock market value of almost $84bn. Novartis, Sanofi-Aventis and AstraZeneca come in next with $79bn, $63bn and $52bn respectively.
Source: www.DrugResearcher.com, October 24, 2006
Pharmaceutical companies are spending big on market research during the early stages of drug discovery. Regardless of whether they are promoting a future blockbuster drug or a small, niche brand, all drug companies tend to spend heavily on market research in early drug development up until Phase II, according to a recent study published by pharmaceutical business intelligence firm Cutting Edge Information. Between pre-clinical and phase II, niche brand teams allocated 53 per cent of their total commercialization budget to market research, while mid level brands spent 42 per cent and blockbusters only spent 38.5 per cent.
This is because in the early stages of a drug's development, it is difficult to assess whether the majority of marketing resources should be allocated until a drug's benefits become clearer and a clinical profile is established.
Therefore, a brand team relies heavily on market research during the early stages to identify unmet treatment needs and outline the drug's competitive environment in order to spot potential problem areas that could affect commercial development in the years ahead. This allows any potential challenges to be tackled by the drug company as early as possible and also allows them to guide the R&D process more effectively towards desired clinical endpoints.
Source: www.drugresearcher.com, August 18, 2006
Researchers at Purdue University have been working on a device that measures the concentration of ions as they enter and exit cells. The technology measures electrical activities of cells and can obtain 60 times more data in one reading than is possible with current technology. The current technology for analyzing cells' electrical activity, called "patch clamping," uses a tiny electrical probe viewed under a microscope. The technique requires a lot of know-how and hand-eye coordination. The hope is this biochip could accelerate drug development targeting ion channels, i.e. for muscle and nerve disorders like epilepsy.
The biochip records ion concentrations in up to 16 living cells temporarily sealed within fluid-filled pores in the microchip. With four electrodes per cell, the chip delivers 64 simultaneous, continuous sources of data. This data allows for a more detailed understanding of cellular activity compared to current technology, which measures only one point outside one cell and cannot record simultaneously. The chip also directly records ion concentrations without harming the cells, whereas present methods cannot directly detect specific ions, and cells being studied typically are destroyed in the process.
Source: www.DrugResearcher.com, October 24, 2006
Scientists have come up with an innovative tool that may accelerate the drug development process. The tool consists of a search engine that is connected to a giant database. The intention is the two elements work in tandem to connect human diseases with potential drugs to treat them, as well as predict how new drugs work in human cells. The tool, known as Connectivity Map allows researchers to screen compounds against genome wide disease signatures, rather than a pre-selected set of target genes.
This research effort aims to generate a detailed map that links gene patterns associated with disease to corresponding patterns produced by drug candidates and a variety of genetic manipulations.
The Connectivity Map is the work of The Broad Institute, a research collaboration involving faculty, professional staff and students from throughout the Massachusetts Institute of Technology (MIT) and Harvard academic and medical communities and is governed jointly by the two universities.
The Connectivity Map is the subject of three new research papers that are published in the journals Science and Cancer Cell.
Source: www.DrugResearcher.com, October 2, 2006
The Protein Structure Initiative (PSI) has established efficient pipelines for determining the 3-D shapes of proteins and is now creating new mechanisms for sharing the resources it has developed with the scientific community. The 10-year PSI effort, which started in 2000 and is sponsored by the National Institute of General Medical Sciences (NIGMS), funded a materials repository in September. In fall 2007, PSI will create an information hub (a Knowledge Base) where researchers can search for and submit structural information.
The Harvard Institute of Proteomics will operate the PSI-Materials Repository (PSI-MR). With $5.4 million in funding over five years, the new PSI-MR will store and ship PSI-generated clones, which can be used to make specific proteins for studies on their structure and function. Researchers will be able to order clones.
To date, the PSI research centers have produced more than 100,000 clones. The current centers are expected to produce a total of 20,000 clones annually. By centralizing the availability of these materials, valuable resources are put at researchers' fingertips.
Source: Genetic Engineering News, November 6, 2006
Several drug development companies are implementing leaner business models, outsourcing nearly all stages of the drug development process in response to escalating development costs in a move that is proving increasingly popular within the industry.
This so-called virtual model refers to the business practice of outsourcing all stages of drug product life-cycle avoiding huge fixed costs and protecting against booms and busts caused by erratic pipelines. The primary advantage of the virtual drug development model is time savings as the result of the flexibility by outsourcing companies to adapt to rapidly changing priorities.
With the virtual model bottle-necks are being worked through, clearing the backlog and further streamlining the overall drug discovery process. Internally, the model can focus on core competencies whilst maximising use of existing resources. There is no need to prioritise projects based on limited specialised resources. Externally, there is scope to expand the skill base and resources. Other advantages include gaining the advice of independent experts and therefore gaining access to innovative ideas and exploiting emerging opportunities. Finally, a pro is the ability to provide a smoother transition in response to the EU Clinical Trials directive by integrating advisors and experts with the necessary insight to navigate the new regulations.
However, the virtual model is not without its disadvantages. Some activities are being difficult to out-source and there are the inevitable quality/audit/regulatory compliance issues. There is also the initial time consuming problem of identifying suitable partnerships and to develop constructive relationships.
Source: www.DrugResearcher.com, September 29, 2006
ECVAM's new database service will (finally) go online on the 29 October. The new address (http://ecvam-dbalm.jrc.cec.eu.int) is already visible on the ECVAM homepage. The date has been chosen in occasion of the 15th anniversary of ECVAM
Now available is the "ICCVAM Biennial Progress Report - December 2005". This report provides a description of the activities carried out during the past two years by ICCVAM and NICEATM. A PDF version of this report is located at URL:
http://iccvam.niehs.nih.gov/about/annrpt/bienrpt044509.pdf.
Please visit the Biennial
Report Page
(http://iccvam.niehs.nih.gov/about/annrpt/annrpt.htm)
for previous progress reports, relevant FR notices and press releases.
You can also access this
report from the ICCVAM home page at
http://iccvam.niehs.nih.gov
through the links in the "Announcements" box.
Source: ICCVAM mailing list, November 17, 2006
The final Background Review Documents (BRDs) on the _Current Status of In Vitro Test Methods for Detecting Ocular Corrosives and Severe Irritants_ for the Bovine Corneal Opacity and Permeability, the Isolated Chicken Eye, the Isolated Rabbit Eye, and the Hen_s Egg Test-Chorioallantoic Membrane test methods are now available on-line at http://iccvam.niehs.nih.gov/methods/ocudocs/ocu_brd.htm.
The European Commission has just launched the Health-EU portal. It is a quality website offering information under such headings as My Health, My Environment, My lifestyle etc. It is not only of interest to the general public but also a valuable tool for scientists, health professionals and politicians interested in progress in research. The site offers reliable links to specialist sites.
Information: http://userpage.fu-berlin.de/~invitrot/
Information: www.informa-ls.com/immuno/2
Information: www.selectbiosciences.com
Information: for members only
Information: www.Bio2007.org
Information: http://www.ict2007.org
Information: http://www.knt.co.jp/2007/wc6