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ACTIP Bulletin 51

November 2007

 

Next meeting ACTIP:

The next plenary meeting of ACTIP will be held in

Ivrea, Italy, November 29-30, 2007

and is hosted by RBM-MerckSerono.

Central themes will be PAT implementation and removing bottlenecks in downstream processing.
The meeting is only accessible to ACTIP members and invited observers.

In this issue:

Bioprocessing and production facilities

Antibody News

Research News

Business News

Biomarker market predicted to explode

News from the Commission

Agenda

 

Bioprocessing and production

DSM takes on purification tech

Netherlands-based DSM has invested an undisclosed sum in Danish purification technology company Upfront Chromatography to boost its protein separation business.

Rhobust focuses on two main application areas - the recovery and purification of monoclonal antibodies, therapeutic proteins and other biomolecules from blood plasma or bioreactors, and the isolation of functional proteins and other biomolecules for use as food ingredients, industrial enzymes, nutraceuticals and healthcare products.

The recent success of DSM in biopharmaceutical production has led to what the company called a "significant urgency" to develop more efficient purification methods for monoclonal antibodies and other biopharmaceutical proteins.

"Upfront is at the forefront of technological breakthroughs in downstream processing. Through our investment we want to support further developments in the company which will benefit both DSM and Upfront," DSM pharmaceutical products chief executive Leendert Staal said in a statement.

The Rhobust technology relies on the Expanded Bed Adsorption Principle which allows the chromatography beads to fluidise in the feed stream which is pumped at low pressure.
The expanded bed allows impurities to pass through the system freely and eliminates pre-filtration steps of packed-bed implementations. The beads used in the Rhobust technology are made from agarose polymers.

Source: www.DrugResearcher.com,
September 24, 2007

 

ProMetic purification tech gets selected

ProMetic's purification technology has been implemented in a large-scale biomanufacturing process with an undisclosed client for a product that will be used in clinical trials.

The collaboration between ProMetic Life Sciences' UK subsidiary, ProMetic BioSciences Ltd (PBL), and a biomanufacturing client has seen the successful implementation of a ProMetic Mimetic Ligand affinity adsorbent used for separating biological materials.

Approximately 800 litres of a commercial Mimetic Ligand product was packed into and operated in a 1.8 meter diameter process chromatography column, the company said in a statement. The purified undisclosed biological product would be used in the next phase of clinical studies.

The Mimetic Ligand technology is highly specific for the targeted protein and can be purified in fewer steps than conventional methods and can be more cost effective compared to biological ligands, the company claims.
The company has synthetically 'mimicked' and enhanced the natural molecular affinity of binding ligands to produce molecules that are highly specific and selective in binding proteins. The synthetic molecules can therefore be used to purify a target protein by binding it out of a mixture, or using the same process to target and remove a contaminant.

Common purification targets using the technology include albumin, proteases, kinases, cytokines and antibodies, and the firm's client list includes GlaxoSmithKline, Novo Nordisk and the Menarini Group among others.

Source: www.DrugResearcher.com,
September 19, 2007

 

UK-based GE Healthcare introduces nine new product lines

GE Healthcare recently introduced the 'ReadyToProcess' portfolio, which is a range of products designed to meet the biopharmaceutical industry's needs for increased speed, simplicity and safety for all areas of bioprocessing.

The portfolio covers bio fermentation, mixing, connectivity, chromatography, filtration, buffer preparation, sensing and storage solutions, with further phased launches scheduled up till 2009. All allow customers to develop lean processes in biomanufacturing. They deliver flexibility and lower customers' financial risk and are fully mobile, quick-to-deploy complete solutions for biomanufacturing.
Features currently include disposable Wave technologies, newly-developed filtration technologies are also available with chromatography tools coming soon.
ReadyToProcess is planned to be the most complete portfolio of ready-to-use and disposable biopharmaceutical productionsolutions.

Source: www.DrugResearcher.com,
October 10, 2007

 

BioProcessors unveils new cell culture services

US drug discovery firm BioProcessors has unveiled a new range of cell culture services to assist in biopharmaceutical process development. The company said it can now offer customers "a hosted cell culture development project", which can range from a simple screening experiment to more comprehensive production clone selection, clone stability, media optimization, or process development experiments.

As part of the service offering, BioProcessors will use its SimCell technology, which it says enables the performance of high throughput cell culture experiments for the development and optimisation of biopharma manufacturing processes, allowing full and fractional factorial statistical experiments to be undertaken "at a fraction of the time and cost associated with conventional scaledown technologies".

The company's new services offering has been facilitated through the recent expansion of its existing facility in Woburn, Massachusetts, where a second SimCell system was added.

Source: www.DrugResearcher.com,
October 9, 2007

 

Amgen indefinitely postpones Irish plant

Amgen has announced the 'indefinite postponement' on plans for its $ 1bn (¤ 0.71bn) manufacturing facility in Cork, Ireland. The move comes after the announcement back in April that the US biotech company would delay construction of the Irish plant, which was to become its new major manufacturing facility, following a "global assessment" of the company's manufacturing needs.

According to the company, the latest announcement follows "an updated review of its business plans, concurrent with an evolving business environment".

While Amgen "expects" to maintain ownership of the site, the company announced it would cease current activity in Cork and throughout 2008.
The company has struggled of late. In August, Amgen announced it would slash 12 to 14 per cent of its workforce - up to 2,600 jobs - in an attempt to offset the difficulties the company had been facing

with the sales of its anaemia blockbusters and save the company more than $ 1bn over the next year. The Irish plant was originally due to be operational in 2009, but the delay, announced in April, pushed that behind schedule with the company expecting the plant to be up and running in late 2012 with licensing for the formulation, filing and finishing facilities expected in late 2014.
Amgen gave no estimate of when the company hoped the Irish plant could make a come back and be operational by.

Source: www.DrugResearcher.com,
October 5, 2007

 

Indian firm takes over German biologics plant

An Indian firm has taken over the contract biologics manufacturing business of German corporation Siegfried. The deal is a further sign of the ambition of Indian firms to break into the burgeoning biopharmaceuticals market.
India's
Avesta Biotherapeutics and Research is now the new owner of Berlinbased Siegfried Biologics and its 50 employees, gaining a capability in developing biologics, from cell line generation, upstream process development, through to manufacturing.

Avesta plans to use the facility to make an entry into the world of making good manufacturing practice (GMP)-compliant biopharmaceuticals for the regulated US and European markets. Iinitially the firm will concentrate on manufacturing biologics for the semi-regulated markets of Brazil, Russia, India and China, where small molecule drugs prevail in the market.

Source: http://www.DrugResearcher.com,
October 15, 2007

 

Antibody News

Polyclonal antibodies developed in transgenic chickens

The era of human polyclonal antibodies has dawned as efforts get underway to produce the next generation therapeutics in transgenic chickens.

Origen Therapeutics has been awarded a $ 2m (¤ 1.4m) three-year grant from the National Institute of Standards and Technology (NIST) to develop human polyclonal antibodies by creating genetically modified chickens. The chickens will deposit large amounts of the antibodies into their eggs.

Monoclonal antibodies (MAbs) are the current therapeutic antibody of choice and command a market of $ 20bn (¤ 14.1bn) annually. Produced in a single type of immune cell, MAbs attack a single antigen type on the surface of a pathogen.

Polyclonal antibodies (PAbs) on the other hand, are produced from different B cells (immune cells) but all attack the same pathogen. Each antibody binds to a different surface antigens on the pathogen increasing the efficiency of the immune response.

Up till now, the polyclonal antibody market has been stifled due to technology.
Currently the only PAbs are in the form of gamma globulin purified from donated blood of human volunteers. However, the human donor approach has its limitations.

Origen believed that human polyclonal antibodies "will be an important class of products in the near future" as they have the ability to target multiple disease indications including infections, cancer and autoimmune diseases while also having the means to provide pre-treatment in the form of passive immunity.

"In transgenic chickens, we will introduce human versions of these antibody genes . . . When the transgenic chicken is immunised with an antigen such as Staphylococcus aureus, it's B cells will be activated and will produce human antibodies that bind specifically to the Staph bacteria. These antibodies will then form the basis for the polyclonal antibody therapeutic," Fitzpatrick said.

The California-based company has so far developed the technology for inserting genetic modifications into the chicken genome. The next step will be to apply the technology to insert human antibody sequences into the chicken and then to test and verify that the human sequence antibodies are produced as expected.

Found in the egg yolk, the antibodies would be extracted by separating the yolk from the egg white - using conventional methods commonly found in the food industry - then mixing the yolk with water and chilling the mixture. The yolk materials and antibodies separate with the yolk materials sinking and the antibodies staying suspended in the solution. A variety of fractionation and purification steps is then required to collect the pure antibody.

The PAbs can be collected at levels of about 200mg per egg. Origen estimates that if 100mg is collected per egg, a flock of 3,500 hens will produce approximately 75kg of antibody per year. As yet, the company has no manufacturing site for the PAbs.

The company is aiming to target Staphylococcus aureus once the platform technology is completed. According to Origen, the use of transgenic chickens is a practical choice for the production of PAbs because chickens are known to have a robust immune response to human antigens, the antibodies are easily collected from the eggs and the system is easily scalable.

Source: www.DrugResearcher.com,
October 4, 2007

 

Antibody alternatives continue topull in the cash

Ablynx, one of the two main players in the miniature antibody sector, has signed 'by far' the biggest deal in its history, to help Boehringer Ingelheim develop up to ten so called 'Nanobodies'.
The molecules are touted as a superior alternative to conventional monoclonal antibodies (mAbs) as they are cheaper and easier to manufacture, while retaining their selectivity and efficacy.

Due to their reduced size, the antibody rivals can be administered in a variety of ways: injected, orally, in sprays or creams, as opposed to full size antibodies, which can only be delivered by injection.

Currently, this sector of biologic therapies is dominated by Ablynx and GlaxoSmithKline (GSK), the latter through their £ 230m (¤ 340m) acquisition of Domantis earlier this year.

Ablynx, developed its alternative miniantibodies following the discovery that camels and llamas (camelidae) possess fully functional antibodies that lack light chains. These heavy-chain antibodies contain a single variable domain (VHH) and two constant domains (CH2 and CH3).

Importantly, the cloned and isolated VHH domain is a perfectly stable polypeptide harbouring the full antigen-binding capacity of the original heavy-chain antibody. These heavy chain VHH domains form the basis of Ablynx's Nanobodies and the molecules are slightly ahead of GSK's in terms ofdevelopment: the final Phase I results of ALX-0081 are expected this month.

The collaboration between Ablynx and Boehringer Ingelheim will focus on multiple diseases, including immunology, oncology and respiratory, with both parties able to propose possible targets.

Source: www.DrugResearcher.com,
September 10, 2007

 

Research News

Dutch Cabinet awards NGI ¤ 271 million

The Dutch government will continue its investment in genomics by contributing ¤ 271 million in the coming years to the Netherlands Genomics Initiative (NGI). With this decision, the Dutch cabinet recognises the excellent results of the NGI Genomics Centres during their first term, both scientifically and in terms of valorisation.
The continuity that this decision provides for the most successful NGI Genomics Centres will ensure continued excellence in their performance, with an increased focus on valorisation.
In its second term, NGI aims to maximize the economic and societal value of its excellent scientific research.

Source: NGI Newsflash, September 18, 2007

 

EU to fund stem cell assay development collaboration

Stem Cell Sciences (SCS) has received a ¤ 2.4m boost from the European Union (EU) for its new drug screening development programme using neutral stem cells. The NEUROscreen project, funded under FP6, will focus on developing new assays using SCS' technology to grow neural cells that can be used to discover new candidate medicines for the treatment of cancer, Alzheimer's disease stroke and epilepsy.
The company will receive ¤ 0.42m of the total ¤2.4m that is earmarked for the three year project with the remainder going to its collaborators.

According to the UK-based company, its Neural Stem (NS) cell line is the first tissuespecific cell line that can grow stably in the laboratory as a pure population of stem cells without ongoing differentiation that can be grown as a monolayer in serum-free culture media. The use of the company's animal-free cell culture media means that batch-to-batch variability is minimised, ensuring reproducible cell viability. The cells can also be differentiated into both neurons and glia for use either as investigational cell therapies or in discovery assays.

Source: www.DrugResearcher.com,
September 27, 2007

 

Stem cell breakthrough avoids embryo controversy

US researchers have developed a way of creating primate embryonic stem cells that avoids the need to use fertilised embryos, potentially leading to more ethical ways of curing degenerative diseases.

The new technique uses a modification of the somatic cell nuclear transfer ' (SCNT) technique to combine the genetic material from a masque monkey's skin cell with an egg to create stem cells that had identical nuclear DNA to the donor cell.

The new research has been published as an advanced online publication in the journal Nature by scientists from the Oregan Health & Science University (OHSU), US.

The procedure used in this study is similar to that proposed by Dr Stephen Minger of Imperial College London,UK, to create 'hybrid embryos' where the egg would come from a different species than the nuclear DNA.

However, even though the group developed two stem cell lines using the technique, their development used over 300 monkey eggs - a success rate of only 0.7 per cent.

Source: www.DrugResearcher.com,
Nov 15, 2007

 

No embryo required: human stem cells from the skin

Two sets of scientists have independently created human stem cells from just reprogrammed skin cells, with no embryo and thus, perhaps no ethical dilemma. One group in the US and another in Japan used a retrovirus to carry four genes to the fibroblast cells, converting them to pluripotent cells "that exhibit the essential characteristics of embryonic stem cells," according to James Thomson and his colleagues at University of Wisconsin-Madison - one of the teams to crack the problem.
"It's going to completely change the field," said Thomson. His group, including lead researcher Junying Yu have published their results in the online edition of the journal
Science.

The Japanese group who have succeeded in doing just this is headed by Shinya Yamanaka at Kyoto University. In June 2005, they accomplished it in mice and since then have been toiling to repeat their success using human cells. The results of their success have been published in the journal Cell.

Although the techniques pioneered by Thomson and Yamanaka are essentially the same, there are some crucial differences. Both teams used the OCT3/4 and SOX2 genes but whereas Yamanaka then added KLF4 and c-MYC to the mix, Thomson used NANOG and LIN28.

This confers one definite advantage to Thomson's technique because the rival method involves the oncogene c-MYC. However, Yamanaka used adult human cells, whereas Thomson's group created the stem cells from foetal fibroblasts, or postnatal foreskin fibroblasts.
The two methods also differ in terms of efficiency: Yamanaka's technique reprogrammed one in 5,000 cells; Thomson's was better for foetal cells - one in around 4,500 - but less successful for postnatal cells where the efficiency was about one in 10,000.

Source: www.Drusearcher.com,
November 21, 2007

 

Business News

Sanofi pushes on with cell culture flu shot

Sanofi Pasteur has kicked off Phase II trials of its cell culture-based seasonal flu vaccine in the US, part of a five year project with the US Department of Health and Human Services (HHS).

The vaccine is based on Crucell's popular PER.C6 cell line, which has proved promising in terms of developing an effective cell based vaccine that can be manufactured on a commercial scale.

Crucell's PER.C6 cell line has shown its potential for commercial scale manufacturing of the flu shot, demonstrated in a successful bioreactor run of 20,000 litres. Sanofi used the services of the biologics arm of Swiss firm Lonza to achieve the scale-up process for the vaccine. The US-based facility for which Sanofi will present a feasibility study will be designed to supply 300 million doses of monovalent flu vaccine annually.

Sanofi will not be first to the market with a flu vaccine making use of cell culture based techniques. Back in June 2007, for example, Swiss firm Novartis was granted EU approval of its cell-based seasonal flu jab, Optaflu. The vaccine should be available in Germany and Austria for this year's flu season, and remaining EU countries in time for next year. US submission is anticipated during 2008.

Both Novartis and Sanofi Pasteur are also in the process of developing cell-based vaccines against various strains of avian flu.

Source: www.DrugResearcher.com,
November 7, 2007

 

BioReliance launches new genotoxicity test service

Bioreliance has signed a deal with Gentronix to provide the UK firm's novel DNA damage testing tool as a service for biopharma companies for the first time. The company will offer Gentronix's GreenScreen HC in vitro assay as part of its portfolio of genotoxicity screening services.

Gentronix launched GreenScreen HC in February and claims its assay gives correct negative results for non-carcinogens, including many which give misleading positive results in other in vitro tests. In addition, GreenScreen only needs a few milligrams of test compound as opposed to the gram quantities required by current regulatory tests.

The core technology underlying the GreenScreen product range is a yeast strain that has been genetically modified to produce a Green Fluorescent Protein (GFP) when its DNA damage repair systems are activated. As the damage occurs the cells become increasingly fluorescent, hence acting as indicators for the presence of genotoxic agents.

GreenScreen is available commercially to drug companies but the new deal with BioReliance makes Gentronix' assay the first to be available as a service.

Source: www.DrugReseacher.com,
September 17, 2007

 

Merck, Crucell strengthen vaccine partnership

Dutch firm Crucell has strengthened its relationship with Merck & Co, granting the pharma heavyweight exclusive use of its popular PER.C6 technology in two disease areas.

The agreement also gives Merck the option for access to Crucell's AdVac adenovirusbased vector technology. Under the terms of the agreement, Crucell also gains rights to certain cell-line technologies developed by Merck for the production of recombinant proteins.

Although the two companies are refusing to disclose which infectious diseases the deal covers, Crucell representatives seemed pleased that the deal further broadens the number of disease areas covered by the popular PERC6 technology.

Source: www.DrugResearcher.com,
September 10, 2007

 

Crucell up on MedImmune deal

Company MedImmune will be collaborating with Crucell to develop new antibodies for hospital acquired infections. The collaboration is an exclusive licensing and research deal to further develop and commercialise one of Crucell's panels of bacterial antibodies, primarily to treat and prevent hospital acquired bacterial infections.

MedImmune has been granted an exclusive license to work on the antibodies within one of Crucell's MAbstract technology programmes, as well as having access to the Dutch firm's antibody capabilities for further R&D.

The proprietary MAbstract antibody technology can be used for fast selection of monoclonal specificities and to identify unique targets on proteins, viruses, bacteria and live cells or tissues. It can also be used to identify the binding regions of antibodies on antigens, to help with development of vaccines or small molecule inhibitors.

Although results from the collaboration are unlikely to emerge for several years, the deal is seen as an "important validation" of Crucell's technology, and a positive extension of its business.

Source: www.DrugResearcher.com,
October 15, 2007

 

Merck failure not our fault, says Crucell

Crucell''s shares have taken a hit when the news that Phase I and II trials of Merck's investigational HIV vaccine (produced using Crucell's technology) were being discontinued after the treatment failed to prevent HIV infection in trial subjects.

Crucell issued a statement yesterday saying that, disappointing as the news regarding Merck's investigational vaccine was, it does not appear to have had anything to do with the efficacy or safety of the PERC6 technology.

The potential HIV jab was a trivalent vaccine that used an adenovirus vector to transport three synthetically produced HIV genes into patients' cells. The delivery of these genes was hoped to stimulate a potent cellular immune response to HIV, resulting in an army of destructive T cells that would rid the body of HIV-infected cells.

Merck abandoned the vaccine trials after a review by the Data Safety and Monitoring Board (DSMB) highlighted that the jab failed to meet its endpoint, with results showing very little difference in the incidence of HIV infection between subjects given placebo and those injected with the real vaccine.

Merck and Crucell have a long-standing relationship, one that was expanded only two weeks ago as Crucell granted the firm access to the PER.C6 technology for use in two additional disease areas.

According to a Crucell spokesperson, the relationship between the two companies remains strong, and Merck is continuing other projects making use of the PER.C6 technology for other development projects.

Source; www.DrugResearcher.com,
September 26, 2007

 

Biomarker market predicted to 'explode'

Analysts from BCC Research predict in a new report 'Biomarkers: The Expanding Global Market', that the global market for biomarkers will grow from a predicted value of $ 5.6bn in 2007 to $12.8bn by 2012 at a compound average growth rate (CAGR) of 18 per cent.

BCC research segmented the biomarker market into three main sections: biomarker discovery, molecular diagnostics and clinical trials.

Of these, the biomarker discovery for applications in drug discovery, preclinical studies of drug development and diagnostics research applications was the largest and accounted for nearly 48 per cent of the total market in 2007.

This market is expected to grow to at a CAGR of 16.9 per cent to reach nearly $ 6bn by 2012.

The second biggest segment was found to be the use of biomarkers on molecular diagnostics applications which was estimated to be worth $2.3bn in 2007. The report predicts this market will grow at a CAGR of 17.5 per cent to be worth $ 5.2bn by 2012.

The clinical trials market has been predicted to see the largest growth rate with a CAGR of 23.5 per cent, to reach $1.8bn by 2012 (up from 612 m$ now), and has already been spotted by many CROs (contract research organisations), with Covance having launched a 'biomarker expert team' earlier this year.

Advances in technology that enable faster metabolomic, proteomic and genomic data acquisition as well as its integration with clinical trial data using bioinformatics software will all be major driving forces behind the growth of the biomarker area.

Source: www.DrugResearcher.com,
November 7, 2007

 

News from the Commission

EU overtakes US in productivity growth

For the first time since 2001, the EU has outstripped the US in productivity growth, according to a recent competitiveness report from the European Commission that sees Europe 'on a growth path'.

The EU hailed its best economic performance since 2000 with growth rates at 3% and worker productivity growing strongly at 1.5% in 2006, according to the Commission's annual competitiveness report, published on 5 November.
Productivity grew stronger in the EU than in the US (1.4%) in what the Commission hopes is a "long-term trend".

However, in real terms, the EU is still lagging behind the US, where productivity per person employed is about 39% higher.
Thus the EU is only just starting to narrow its productivity gap with the United States.

Overall, the European industries (services and manufacturing) retain their positions on the global market better than their US or Japanese counterparts, according to the report. At the same time, internal performance has been less positive, with rather low growth in value-added, labour and total factor productivity since 1995.

Further reading EU official documents:

• Commission: Raising productivity growth: key messages from the European Competitiveness Report 2007 (31 October 2007)

Source: EurActiv News, November 6, 2007

 

EU drug regulations not good enough

The European Medicines Agency (EMEA) is prejudiced in favour of big pharma and EU drug regulations need an overhaul, a new report says.

Published in the October 20 issue of the BMJ, the report, How can we regulate medicines better?, attacks the EMEA and suggests drug approval is flippant.

"Too many drugs are approved on the basis of surrogate end points that are not valid predictors of therapeutic end points," report authors Silvio Garattini and Vittorio Bertele said.

"New drugs have only to show they are of good quality, effective, and safe, independently of any reference or comparison to drugs already on the market . . . It is easier to get to the market by proving a new product is similar to standard available treatments than by failing to show it is superior."

Currently, the EMEA gives opinions on the quality, safety and efficacy of new drugs seeking approval. This opinion is used by the European Commission to decide whether to grant a license.

The two authors, from the Mario Negri Institute for Pharmacological Research in Italy, suggested new drugs should be required to have added value to already available treatments such as greater efficacy or less toxicity, or be cheaper.

The report also attacked the EMEA for its lack of transparency - "there is no reason to hide data on toxicology and clinical evaluation" which is "essential to understand why a new drug has been approved or a new indication granted".

Other information the report suggested should be made transparent included the size of the majority that approved a given drug, the reasons of the minority for opposing approval, conflicts of interest, and post-marketing commitments and their fulfilment.

The European drug system's weakness in pharmocovigilance was also highlighted.

"It relies on national activities, which in several cases are limited to spontaneous reports from patients and doctors. Clearly, collection of data about drug toxicity could be strengthened by establishing a net work covering all 25 European countries, coordinated by the EMEA," the report said.

The report finally claimed the regulatory system was "subject to bias and suspicion", particularly as the EMEA is part of the EU general directorate of enterprise and industry rather than the general directorate of health and consumers.

The EMEA declined to comment and the European Commission was unavailable for comment at time of publishing.

Source: www.DrugResearcher.com,
October 22, 2007

 

Commission eyes role as 'EU research ministry'

"The Commission is currently a funding institution for research and innovation projects. We want to change this so that we can concentrate more on policies and become like an EU research ministry, a true policymaker for the European Research Area (ERA)," said Research Commissioner Janez Potocnik, speaking at a European Policy Centre (EPC) policy dialogue on 11 October 2007.

"We want to create a specific agency next to the European Research Council (ERC ) to outsource management of research projects so that, in-house, we can be more efficient on policies. We will slowly phase out by 2013 [end of the current framework programme FP7]" added Potocnik. The Commission then hopes to have the time and resources, during FP8, "to get closer to researchers and the market".

Source: EurActiv News, October 15, 2007

 

ERA: Commission 'should facilitate, not regulate'

Preliminary results of a broad consultation on the future of the European Research Area (ERA) show that scientists prefer voluntary cooperation, networking and exchange of best practice to binding legislative action at European level.

Despite some progress made since 2000 in building a European Research Area (ERA), "progress is far too slow and too timid," said Research Commissioner Janez Potocnik, presenting the preliminary results of a public consultation on the issue, speaking at a conference on the Future of Science and Technology in Europe on 8 October 2007.

The consultation results show that nobody wants top-down coordination, but rather people support defining and implementing "modalities that stimulate and reward bottom-up initiatives for more competition and more cooperation."

"Stakeholders advocate that the Commission facilitate rather than regulate (e.g. via the open method of coordination, issuing principles to be shared and guidelines)," states the summary report on the results of the consultation.

An in-depth analysis of the results of the consultation is underway and the Commission will propose new initiatives for ERA in 2008.

Source: EurActiv News, October 9, 2007

 

Parliament backs European Institute of Technology

The European Parliament endorsed, on 26 September 2007, the Commission's proposal for establishing a European Institute of Technology. Green MEPs, however, despite supporting the original idea, voted against the proposal, saying that it lacked a realistic budget and was poorly defined.

In its first-reading report, the plenary backed its Industry and Research Committee's plea to rename the EIT the European Institute of Innovation and Technology, so as better to reflect its primary focus. The MEPs also voted for the institute to be established, as initially proposed by the German Presidency, only after a pilot phase in which two or three Knowledge and Innovation Communities (KICs) had run projects to test the feasibility of such an institute.

The MEPs also recommended that every KIC should consist of at least three partner organisations, located in at least two different participating states and including at least one higher-education institution and one private company.

Regarding the budget issue, the MEPs agreed with the Commission that ¤ 308.7 million of the expected total funding of some ¤ 2.4 billion between 2008-2013 should come from the Community budget.

The Commission proposed last week to revise the EU's long-term budget for 2007-2013 in order to ensure the funding for EIT and Galileo, another ailing EU project. The amount dedicated to the EIT would increase from ¤3 million in 2008 to ¤ 30 million in 2010 and ¤ 127 million in 2013.

The Commission expects that the remaining ¤ 2.1bn will be generated from the partners involved in the KICs, in part through EU's Framework Research Programme (FP7), regional funds, memberstate funding and partners' own money.

The Council will now examine the proposal and formulate, a common position, which could then be voted on in an early second reading in the Parliament. First call for proposal for KICs could be launched in Summer 2008, at the earliest.

Source: Euractiv News, September 26, 2007

 

Commission's view on European research too narrow'

The Commission's Green Paper on new perspectives for the European Research Area (ERA), adopted in Apri 2007, launched a public debate on how to overcome persistent barriers to building a true ERA allowing free movement of researchers, technology and knowledge between the EU-27 and putting an end to the fragmentation and duplication of research (see EurActiv 05/04/2007).

The document raises a number of questions on how to deepen and widen the ERA so that it fully contributes to the renewed Lisbon Strategy aiming for more growth and jobs.

The Green Paper was accompanied by a background document providing a detailed assessment of the progress made on the ERA since 2000, as well as an analysis of the current situation and challenges.

"Some progress has been made since the concept was endorsed at the Lisbon European Council in 2000. However, there is still much further to go to build ERA," the document stated.

The consultation on the Commission's Green Paper on ERA closed on 31 August 2007.

The first responses welcome the Commission's initiative to review the ERA, but argue that it fails to address the right issue, lacks ambition and focuses too much on the Commission's own role in the European research system.

According to stakeholders, too much emphasis is being placed on the role of governments and intergovernmental structures at the expense of other stakeholders, such as the national and European research organisations, those involved in funding research and the private sector.

"More than 90% of public R&D funding still occurs at national level," reiterate the heads of European Research Councils (EUROHORCs) and the European Science Foundation (ESF).

Source: EurActiv News, September 11, 2007

 

Agenda

ACTIP meeting: focus on PAT implementation and downstream processing
November 29-30, 2007, Ivrea, Italy
Information: ACTIP Secretariat


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