|
|
February 2008 |
Next meeting ACTIP:
The next plenary meeting of ACTIP will be held in Brussels on
May 22-23, 2008
and is hosted by GSKBio. The meeting will focus on novel approaches in vaccine development, speedy regulatory procedures and research in animal cell technology.
In this issue:
Bioprocessing and production facilities
Antibody News
Business News
Vaccine News
Research News
News from the Commission
Agenda
Bioprocessing and production facilities
Ditch batch: continuous with micro-reactors is the future
At the end of January’s Informex show in New Orleans, experts at a packed out session discussed the potential of up-and-coming continuous processing technologies and posed the question: is batch processing yesterday's technology?
Trevor Laird, founder and CEO of Scientific Update, commented that a key factor deterring industries from adopting continuous processes is the flexibility that batch processing offers. As part of the session on continuous processing and its potential in pharmaceutical/chemical manufacturing, Laird suggested that processing equipment such as microreactors could present an effective solution.
Eliminating the problem of costly, dedicated plants required by traditional continuous processing, small continuous microreactors retain the flexibility of batch manufacturing whilst bringing a host of added bonuses such as better selectivity a high temperatures, high throughput, and are suitable for fast reactions and reactions with unstable intermediates.
Laird also highlighted that the often-problematic task of scale-up could be less of a challenge using microreactor technology:
Several companies have already taken the initiative and started on the continuous processing path. Lonza, particularly, has thrown its weight behind the technology, working directly with microreactor manufacturers to develop flexible systems that can be used on the multi-kilo and ton scale, and successfully scaling up some of the resultant processes. Organon and AstraZeneca are already beginning to use microreactors for some processes, and with the recent $65m hook-up between Novartis and MIT to 'revolutionise' pharmaceutical production with continuous manufacturing, the sector looks ripe for growth over the coming years.
French/Swiss firm AETDEV has also developed reactor technology in this area, with DSM and UK firm Phoenix Chemicals also achieving the yield and efficiency improvements that continuous processing technologies can bring.
Source: In-pharmaTechnologist.com, January 31, 2008
Singapore's biomedical manufacturing down a third in December
In Singapore, biomedical manufacturing output in December 2007 contracted by 34 per cent compared with December 2006.
For the whole of 2007, manufacturing output from Singapore's biomedical cluster dipped by 0.6 per cent against the previous year, with API production falling by 2.5 per cent but medical technology rallying with an increase of 15.4 per cent
Pharmaceutical production has been an important component in the diversification of Singapore's manufacturing output, accounting for an estimated 10% of the island's non-oil exports. Favourable business conditions have drawn a number of big hitters to Singapore, such as GlaxoSmithKline, Lonza, Merck & Co, Novartis, Pfizer, Sanofi-Aventis and Schering-Plough.
Novartis gave Singapore a crowning vote of confidence last October when it announced plans for a $700m (€476.7m) biotechnology facility, to be built alongside the company's new solid-dose manufacturing plant on the island. The project, which is expected to be completed by 2012, represents Singapore's largest ever vertically integrated investment and the most Novartis has ever splashed out on a single manufacturing facility.
Source: In-PharmaTechnologist.com, January 28, 2008
Roche expands capacity for biopharmaceuticals
Roche has announced major investments at three of its European sites, continuing its drive to strengthen its position in the biopharmaceutical market.
The Swiss pharma has earmarked CHF430m ($391.6m) to expand capacity at three sites in Germany and Switzerland. Around CHF280m is going towards beefing up biotech R&D activities at the firm's site in Penzberg, Germany, focusing on the development and production of biopharmaceuticals for oncology indications.
A further CHF150m will be invested in the sites at Mannheim, Germany, and Kaiseraugst, Switzerland, to expand capacity for syringe filling activities for drugs such as anaemia treatment Mircera (methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon alfa-2a) for hep C, and rheumatoid arthritis treatment Actemra (tocilizumab).
According to Franz Humer, Roche CEO, the move safeguards and expands production of the company's products in light of the heavy demand for the firm's biopharmaceuticals.
Currently half of Roche Group's top 10 pharmaceuticals are products of biotech research, accounting for around 45 per cent of the pharma division's total sales. Measured by sales and manufacturing capacity for biopharmaceuticals, the Roche Group claims it is the leading biotech firm worldwide.
In addition to Basel and Penzburg, the company has biopharmaceutical manufacturing facilities in South San Francisco (US, Genentech), Vacaville (US, Genentech), Oceanside (US, Genentech), Utsunomiya (Japan, Chugai) and Ukima (Japan, Chugai).
Source: In-pharmaTechnologisyt.com, January 21, 2008
CMC buys Lilly/ICOS facility
Denmark-based CMC Biopharmaceuticals has snapped up Eli Lilly's recently acquired biologics facility for an undisclosed amount.
The Bothell facility, Washington State, US, originally belonged to ICOS, but in January this year, drug giant Eli Lilly purchased ICOS Corporation for $2.3bn. Now CMC has taken on the biologics development and manufacturing operations, named CMC ICOS Biologics, in a move which sees the company's operations expand in the US. The company already has a biotech presence in Washington state in Seattle.
In a statement, CMC said it was planning "significant investment" in the facility with the aim to enable production of late stage clinical trial and commercial biopharmaceuticals.
The operation would continue to develop and manufacture therapeutic proteins for early clinical trials and would retain the existing 127 employees working at the biologics facility.
Source: www.DrugResearcher.com, December 4, 2007
Antibody News
BioInvent and ThromboGenics start clinical trials of TB-403 for the treatment of cancer
BioInvent International AB (Nordic Exchange: BINV) and co-development partner ThromboGenics NV have received approval from the regulatory authorities in Denmark to initiate a Phase I clinical trial of the novel anti-cancer agent TB-403. TB-403 is a monoclonal antibody that targets the angiogenic factor PlGF (placental growth factor). TB-403 has demonstrated strong inhibition of PlGF-associated angiogenesis and tumour growth in animal models, without affecting healthy tissues. This product candidate is being developed within the framework of the alliance between ThromboGenics and BioInvent.
The first Phase I clinical study will be performed in Denmark, with the first subject expected to be recruited in the study soon. The trial is a double-blind and within-group randomised trial testing single-doses of TB-403 or placebo at three escalating levels in 16 healthy male subjects. The objective is to monitor tolerability and safety after three single escalating intravenous doses. Furthermore, pharmacokinetics will be determined with the objective to create the basis for a safe and efficient introduction of the compound in the subsequent repeat-dose trial.
The repeat-dose trial is expected to start during the third quarter 2008. The trial will be a study of tolerability, pharmacokinetics and pharmacodynamics in patients with advanced cancer.
For more reading: Anti-PlGF Inhibits Growth of VEGF(R)-Inhibitor-Resistant Tumors Without Affecting Healthy Vessels, Carmeliet, Fischer, et al, Cell 131, 463–475, November 2, 2007.
Source: BioInvent Press Release, January 18, 2008
For more information please contact Dr. Cristina Glad at BioInvent
cristina.glad@bioinvent.com
Crucell, Sanofi mix it up with rabies cocktail deal
Crucell last week announced that it has entered into an agreement with vaccine specialist Sanofi Pasteur for its next generation rabies antibody cocktail.
Crucell has been working on the antibody cocktail for several years, having used its MAbstract drug target discovery technology to come up with the combination of two human anti-rabies antibodies.
While there is no treatment for rabies once symptoms have appeared, lethal rabies can be prevented by post-exposure prophylaxis via the combined administration of a rabies vaccine and rabies immune globulin (RIG). Neither vaccine nor RIG is effective if administered alone. RIG, however, is in short supply (particularly in Asian countries where rabies is a common threat), and carries certain safety concerns as it originates from human or equine blood.
Crucell has tackled this need by developing a combination antibody product that can be produced using its popular PER.C6 technology. Data from the company's First-in-Man Phase I study presented in October, showed that the antibody cocktail was well tolerated, with results comparable to current immunoglobulin products.
The company has forecast peak sales of the antibody cocktail to exceed $300m, and claims the product has the potential to replace the traditional serum-based products that are the mainstay of current rabies treatment.
Source: In-pharmaTechnologist.com, Janaury 7, 2008
Astellas snaps up cancer antibody specialists Agensys
Japanese drugmaker Astellas has agreed to acquire US biotech firm Agensys as part of its plan to ramp up antibody research, especially in the field of cancer.
Using data from IMS Health, Astellas has predicted that sales of cancer drugs will double between 2005 and 2015 to over €21bn and believes the majority of this growth will be down to antibodies and molecular targeted drugs. The two sectors are predicted to account for over €6bn of that growth (Y420bn (€2.6bn) and Y129bn to Y913bn and Y615bn for antibodies and targeted therapies respectively).
A bonus in the deal is that because Agensys already had one antibody in the clinic, the firm also has a GMP manufacturing facility, which can produce enough drug to complete Phase I and early Phase II clinical trials. The facility includes cell culture and purification instruments.
Agensys' most advanced drug candidate is AGS-PSCA, which is a fully human monoclonal antibody that targets Prostate Stem Cell Antigen (PSCA), which is found on tumour cells from the majority of patients with all stages of prostate, pancreatic and bladder cancers. The company also has two more antibodies in Phase 0 and eight in preclinical testing.
Earlier, as part of the strategy to up their antibody work, Astellas has already bought a non-exclusive license to Regeneron's VelocImmune technology and bought access to a phage display library from MorphoSys.
Source: www.DrugResearcher.com, November 27, 2007
Sanofi-Aventis and Regeneron to collaborate on human therapeutic antibodies
Sanofi-Aventis and Regeneron Pharmaceuticals have entered into a collaboration agreement to discover, develop and commercialise fully-human therapeutic antibodies using Regeneron's VelociSuite of technologies.
The first therapeutic antibody to enter clinical development under the collaboration is an antibody to the Interleukin-6 receptor (IL-6R) which has started clinical trials in rheumatoid arthritis.
Source: www.In-Pharmatechnologist.com, Nov 30, 2007
BioWa and Lonza agreement for potent antibodies
BioWa and Lonza are joining forces to develop a new technology platform to produce more potent antibodies with enhanced cell-killing powers. The agreement will see the combination of BioWa's Potelligent technology with Lonza's GS (glutamine synthetase) Gene Expression System and CHOK1SV cell line. The aim is to produce a high-yield mammalian expression system which will produce more potent antibodies with an enhanced antibody-dependent cellular cytotoxicity (ADCC).
Under the terms of the agreement, the companies intend to make the new Potelligent CHOK1SV cell line available for licensing and it will be offered as part of Lonza's development services in combination with Lonza's GS Gene Expression System.
Potelligent technology involves the reduction of the amount of fucose in the carbohydrate structure of an antibody using a proprietary fucosyltransferase-knockout CHO cell line as a production cell.
Potelligent antibodies are designed to increase the ADCC activity of an antibody - where an antibody first binds to an antigen on tumour cells and then to Fc receptors on monocytes, macrophages, and natural killer cells, for example. These cells then engulf the tumour cell and destroy it. The activity makes the antibody more potent.
Genentech, Biogen Idec, Medarex, MedImmune and Takeda are all licensed to use the Potelligent technology.
GS is the enzyme responsible for the biosynthesis of glutamine from glutamate and ammonium in an enzymatic reaction that provides the only pathway for glutamine formation in a mammalian cell. Thus, in the absence of glutamine in the growth medium, the GS enzyme is essential for the survival of the mammalian cells in culture.
Some mammalian cell lines, such as mouse myeloma lines, do not express sufficient GS to survive without added glutamine, so with these cell lines a transfected GS gene can function as a selectable marker by permitting growth in a glutamine-free medium.
Other cell lines however, such as Chinese Hamster Ovary (CHO) cell lines, do contain sufficient active GS to survive without exogenous glutamine and in these cases the specific GS inhibitor, methionine sulphoximine (MSX), can be used to inhibit endogenous GS activity such that only transfectants with additional GS activity can survive.
Using this method, cell lines have been created that are capable of producing 5.5g/L of recombinant antibody with specific production rates of typically 20 to 50pg/cell/day.
Source: www.DrugResearcher.com , December 12, 2007
GSK allies with OncoMed to beat cancer stem cells
GlaxoSmithKline (GSK) and OncoMed are teaming up to develop novel antibody therapies that target the cancer stem cells believed to play a key role in forming cancers. The deal includes OncoMed's lead antibody drug candidate, OMP-21M18 which is expected to enter clinical trials in 2008, subject to a successful investigational new drug (IND) application.
The agreement will see OncoMed using its in vivo xenograft cancer stem cell models to identify monoclonal antibodies that act against a specific and undisclosed cancer stem cell pathway. The most promising of these, including OMP-21M18 will be developed to the clinical proof-of-concept stage across a range of indications when GSK will then have an exclusive option to license the antibodies and take over responsibility for their clinical and commercial development.
OncoMed's xenograft cell models are more representative of human tumours than the cell line approach typically used in cancer research, with therapeutics that are active against primary human tumour xenografts being more likely to be effective against tumours in the clinic. The xenograft models have enabled OncoMed to assess the importance of specific target proteins implicated with human cancers and biological pathways that regulate stem cell biology.
Source: www.DrugResearcher.com, December 11, 2007
MorphoSys and Novartis forge strategic alliance
to establish innovative therapeutic antibody pipeline
MorphoSys AG announced the formation of one of the most comprehensive strategic alliances with Novartis in the discovery and development of biopharmaceuticals. The deal is aimed at establishing a pipeline of innovative drugs, and combines MorphoSys’s and Novartis’s research and development capabilities. Novartis becomes MorphoSys’s preferred collaborator for HuCAL-based drug discovery, allowing MorphoSys to progress to the next stage of its corporate development, which involves a greater focus on drug discovery and development within the Novartis alliance, and proprietary drug development, thereby substantially reducing MorphoSys’s reliance on new or extended fee-for-service discovery deals. The expanded alliance also includes rights to codetail co-developed products in specific territories through creation of MorphoSys’s own sales force. In addition to programs pursued jointly, Novartis has accelerated its plan to internalize MorphoSys’s leading human antibody technology, HuCAL, at its research sites under the option agreed in the original contract. The structure and the financial terms of the collaboration further create a solid financial footing allowing MorphoSys to accelerate and broaden its proprietary drug development efforts and participate in development activities with Novartis.
The collaboration has a term of 10 years. Novartis has the option to prolong the collaboration for a further two years or to conclude the alliance after 7 years in
certain limited circumstances.
Source: MorphoSys Press release, December 2, 2007
Lonza introduces new Human Natural Killer Cells
Lonza has announced the availability of Poietics® Human Natural Killer (NK) Cells, new cryopreserved, ready to use primary cells for immunology research in areas such as, Immune cell activation/regulation, cancer, autoimmune disease/HIV, viral infection/vaccine development, immunotherapy and transplantation/graft vs host disease.
The immunotherapy market is valued at over $12 billion and is expected to double in the next 5 years. Several new technologies focused in this cancer immunotherapy are still at early preclinical research stages. As a result, there is a growing need for NK cells from various donors for this research. Other market opportunities include autoimmune disease research, such as multiple sclerosis and related chronic inflammation which study how natural killer cells act as a first line of defense against these infections and provide protection.
Source: Lonza Press Release, January 10, 2008
Malaria vaccine enters second stageA malaria vaccine has performed well in a small clinical trial of adults in Mali, leading to testing being expanded to children. Sixty Malian volunteers between the ages of 18 and 55 from Bandiagara — a rural town in northeast Mali where malaria is common — were injected with either a full or half dose of the malaria vaccine or a control rabies vaccine, to distinguish between natural, background immunity and that which is induced by the vaccine.
The participants were injected three times over three months, beginning at the end of the malaria transmission season. At the end of the following malaria season, participants receiving the vaccine had up to six times the amount of antibodies to Plasmodium falciparum — the malaria parasite — as they has at the beginning of the study.
The vaccine, 'FMP2.1/AS02A', is based on a protein of P. falciparum and two immuno-stimulants, including a compound from the soap bark tree, long used in traditional medicines in Latin America.
Researchers are now conducting phase I and II clinical trials in the same region, this time among 400 children aged between one and six in the Dogon country outside Bandiagara.
Link to full paper in PLoS ONE
Reference: PLoS ONE 3, e1465. doi:10.1371/journal.pone.0001465 (2008)
Related SciDev.Net articles:
Antimalaria vaccine candidate rolls towards success
Malaria vaccines: research problems and priorities
Source: SciDev.net, January 31, 2008
Invitrogen acquires liver test experts CellzDirect
Invitrogen will pay $57m (€38.3m) for CellzDirect, currently based in North Carolina. The acquired firm specialises in hepatocyte-based cell products and related services to predict a compounds effects on metabolism in the liver.
Invitrogen already offers a number of complete cell systems, including primary cells, media, matrices and growth factors and the addition of CellzDirect's products will complement them.
According to the firm's head of Cell Systems, Nicolas Barthelemy, Invitrogen were particularly impressed by the way CellzDirect communicated constantly with scientific leaders, the medical community and regulators to drive forward their research.
Source: In-pharmaTechnologist.com, January 15, 2008
Curiox' mini-bioassay tech to aid cheaper drug development
Curiox Biosystems has developed a miniaturisation platform that enables cheaper and more efficient bioassays to be conducted, potentially slashing the costs of life science and drug discovery research.
The company developed the DropArray, a miniaturisation platform that can reduce the amount of material and reagent required to conduct a cell-based assay by a factor of a 1000 and reduce the reaction time by a factor of ten. It achieves this by integrating unique surface chemistries with a microfluidics system that enables test volumes to be reduced from 50-100µl down to 100nl.
The reduction in sample volumes provides advantages for protein-based assays such as ELISA (enzyme-linked immunosorbent assay) enabling tests to be run on small samples of human (or animal) serum.
Source: www.DrugResearcher.com, December 17, 2007
Acute toxicity test useless, scrap regulatory requirement
Thousands of rodents lives will be saved each year if a specific animal test is being scrapped following a review by 18 pharmaceutical companies.
The firms, a list of which reads like a who's who of pharma, got together with the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (UK NC3Rs) to examine a particular toxicity test and found it was redundant. The process was supported by the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Already the companies involved have cut the number of animals used in acute toxicity tests by 70 per cent and the NC3R will be hoping more firms follow suit. However, toxicity tests utilise 500,000 rats and mice every year and cutting this test will only reduce that number by 15,000.
The single dose acute toxicity test is normally used to identify the minimum lethal dose of a medicine. However, following four years of data collection, the working group decided that the information obtained from the test had little or no value in assessing the risk to humans.
It was crucial that a number of pharma firms signed up to the review process as, for it to be worthwhile, data on as many different drugs as possible needed to be shared. In the end, preclinical and clinical data from 74 compounds was put under the spotlight.
The reviewers asked themselves if there was a better way to conduct this type of test. Writing in the latest edition of the Regulatory Toxicology and Pharmacology journal, they concluded that toxicity information "can be obtained from other studies, which are performed at more relevant doses for humans and are already an integral part of drug development."
The next step is to change the regulations that require this test to be carried out and discussions with regulatory bodies have already begun.
The paper is entitled 'A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development' and includes authors from AstraZeneca, Roche, Eli Lilly, Johnson & Johnson (J&J), Pfizer, Novartis, Sanofi-Aventis, GlaxoSmithKline (GSK), Bayer Schering Pharma, Boehringer Ingelheim, Servier, Charles River Laboratories, Covance Laboratories, Nycomed, Aptuit, MDS Pharma Services and Huntingdon Life Sciences.
Source: In-pharmaTechnologist.com, January 10, 2008
Biochips help reduce the need for animal testing
US researchers have developed a new biochip technology that could dramatically reduce the need for animal testing during drug development safety studies.
The new biochip technology, developed by a team of researchers at Rensselaer Polytechnic Institute, the University of California at Berkeley, and Solidus Bioscience, is called the DataChip and comprises over 1000 three dimensional tissue cultures that mimic how cells would be arranged in the body to provide researchers with a fast screening system capable of predicting the potential toxicity of a drug candidate to various organs. Earlier, they developed the MetaChip which mimics the metabolic reactions of the human liver where seemingly benign chemicals can become highly toxic.
By varying the ratios of enzymes on the MetaChip, scientists could develop personalised chips that predict a patient's response to a particular compound.
Source: www.DrugResearcher.com, December 20, 2007
Meeting the 3Rs (reduction, replacement and refinement in animal testing) in PBK modeling
ECVAM (the European Centre for the Validation of Alternative Methods (ECVAM) has communicated that the new ECVAM Workshop Report no. 63 with the title "Physiologically-based Kinetik Modelling (PBK Modelling): Meeting the 3Rs Agenda" is now available.
The Workshop Report can be downloaded from from the ECVAM Website by selecting the "Publications" section and then "Workshop Reports".
Source: ECVAM news flash, December 21, 2007
New drug target leaves lung cancer cells alone, lonely and dying Scientists have recently discovered that by cutting off a key gene, lung cancer tumour cells are left 'homeless' and they can't survive on their own.
•
Prof. Fu and his collaborator, Dr Fadlo Khuri, deputy director of clinical and translational research at Emory Winship Cancer Institute, chose to focus on the gene 14-3-3zeta because it is activated in many lung tumours. In addition, recent research elsewhere shows that lung cancer patients are less likely to survive if the gene is on overdrive in their tumours.There are seven 14-3-3 genes, each designated with a Greek letter. Their protein products act as adaptors that can clamp onto other proteins, depending on whether the target protein has been phosphorylated or not. One of the pathways 14-3-3 helps control is epidermal growth factor receptor (EGFR) signalling, which drives the growth of lung cancer.
The scientists used RNA interference (RNAi) to selectively silence the 14-3-3zeta gene. They found that when 14-3-3zeta is turned off, lung cancer cells become less able to form new tumour colonies in a laboratory test. In particular, the tumour cells once again become vulnerable to anoikis (Greek for homelessness), a form of cell death that occurs when cells that are accustomed to growing in layers find themselves alone.
Further experiments also showed that 14-3-3zeta regulates the Bcl2 protein family, which is a popular target for cancer drug developers thanks to its role in cell death. If 14-3-3zeta is absent, it upsets the balance within the Bcl2 family.
The finding has implications beyond lung cancer, in that 14-3-3zeta is also activated in other forms of cancer such as breast and oral, he notes.
Source: www.DrugResearcher.com; January 2, 2008
Invitrogen 'clicks' with Harvard for assay tech
Invitrogen has exclusively licensed 'click chemistry' technology from Harvard University that greatly simplifies the fluorescent-labelling of biomolecules for use in proliferation assays.
This advancement allows researchers to examine cell proliferation in parallel with other biomarkers thus enhancing the power of this fundamental method for assessing cell health, determining genotoxicity and evaluating anti-cancer drugs.
Source: www.DrugResearcher.com, December 12, 2007
EU R&D project agencies launched
Two new agencies were established on 14 December 2007 to manage research projects funded by the EU. One is dedicated to the management of the basic research projects funded by the European Research Council (ERC) and the other, the Research Executive Agency, to managing the process of receiving proposals and organising their evaluation for the whole FP7 programme.
According to the Commission, in 2007 alone, the number of proposals to be evaluated reached 27,000 and required the hosting of 8,000 experts.
According to the Commission, "these agencies are just one strand of wide-ranging actions within FP7 to improve the efficiency of research management [...] Other examples include: reducing the reporting requirements on project participants; creating the Risk-Sharing Finance Facility so that FP7 money is used to leverage considerable additional financial resources for research; a unique registration facility for project applicants and a more streamlined computer system."
-
Commission press release: Two new executive agencies bolster European research (14 December 2007) [FR] [DE]
-
Official Journal of the European Communities Council Regulation laying down the statute for executive agencies to be entrusted with certain tasks in the management of Community programmes (19 December 2002) [FR] [DE]
Source: EurActiv News, December 18, 2007
EU ethics group advises against cloning animals for food
In a recent opinion, the European Group on Ethics for science and new technologies did not find any argument to justify the production of food from clones and their offspring. Instead, it recommends promoting public debates on the impact of cloning farm animals on agriculture, the environment and society at large.
In March 2007, the Commission asked the EU's Food Safety Authority (EFSA) for a scientific opinion on the implications of animal cloning on food safety, animal welfare and the environment. In parallel, the EU executive also asked the European Group on Ethics for science and new technologies (EGE) to give an opinion on the ethics of cloning. Cloning is not a commercial practice in Europe and products from clones are not known to have entered the European food chain as yet. However, according to the Commission, products from clones are "on the verge of widespread commercial use" and are "expected to spread within the global food chain before 2010".
The EFSA's draft opinion on the safety of cloning, published on 11 January 2008, states that "it is very unlikely that any difference exists in terms of food safety between food products from clones and their progeny compared with conventionally-bred animals."
The US FDA's Final Risk Assessment, published on 15 January 2008, concluded that "meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals," but did not reach, due to insufficient information, any conclusion on the safety of food from clones of other animal species, such as sheep.
On January 16, however, the EGE issued an opinion in which it said that "does not see convincing arguments to justify the production of food from clones and their offspring".As reason it states that "considering the current level of suffering and health problems of surrogate dams and animal clones, the EGE has doubts as to whether cloning animals for food supply is ethically justified. Whether this applies also to progeny is open to further scientific research."
In addition, the EGE recommends conducting further studies and analyses on the long-term animal welfare and health implications for clones and their offspring as well as taking proper measures to preserve the genetic heritage of species of farm animal and address intellectual property and product labelling issues. Furthermore, it recommends promoting public debates "on the impact of farm animal cloning on agriculture and the environment, on the societal impact of increasing meat consumption and rearing bovines, as well as the fair distribution of food resources".
Source: EurActiv News, January 18, 2008
EIT agreed but funding still to be found
The EU-27 ministers in charge of competitiveness reached, on 23 November 2007, a political agreement on a compromise text put forward by the Portuguese Presidency on the Commission's proposal for a regulation establishing the European Institute of Innovation and Technology (EIT).
Several countries have already expressed their desire to host the institute and in the Council discussions, on 23 November, some member states pressed for the EIT's governing board to be established "as soon as possible". "Poland will do its outmost to contribute to the financing of EIT," said the Polish Minister, arguing for the EIT governing board to be set up in Poland.
While the content of the regulation is now known and agreed upon, the precise funding of the institute remains somewhat unclear. The sources of the Community contribution to the EIT will be subject to a separate agreement "which is to be found at a later stage".
The Council has agreed to allocate some €308.7 million of Community money to the EIT's initial phase, 2008-2013, but no money is foreseen for that purpose in the EU's long-term budget. Part of the amount could be assigned to the EIT from the 2008 budget.
Source: EurActiv News, November 23, 2007
Majority of Europeans 'interested' in science
An EU surveyon European citizens' interest in scientific research and their views on how science is represented in the media was published on 3 December 2007 at the first European Forum on Science Journalism.
The survey reveals that a majority (57%) of Europeans are interested in scientific research. The highest interest was recorded in the Nordic and the Benelux countries as well as France. The average interest in the 12 new central and eastern European member states was only 38%, compared to 62% in the EU 15.
The survey also reveals a difference in the subjects of interest, with the newer member states more focused on information technology and space and the EU 15 reporting higher levels of interest in medicine, the environment and energy.
A majority of Europeans consider the scientific information they get from the media to be reliable (65%), objective (63%) and useful (60%). However, half of the repondents (49%) found that the issues are difficult to understand and not entertaining (51%). Furthermore, most of the respondents said they would prefer scientists (52%) to present scientific information rather than journalists (14%), and that they would prefer regular short news reports rather than longer in-depth pieces.
Along with the Eurobarometer survey, two studies assessing the attitudes of European scientists and media representatives on the practices, challenges and opportunities they encounter in their daily work were published, as well as an EU guide to training in science journalism.
Source: EurActiv News, December 5, 2007
Communication dimension' needed for European research
The Commission wants to strengthen the culture of science communication in Europe in order to avoid misperceptions that could lead to public opposition to scientific advances and thus lost innovation opportunities.
In the framework of the creation of the European Research Area (ERA), the Commission aims to promote effective public communication of scientific research activities and results. The EU executive thinks that "the media can play a crucial role as an interface in the science domain, helping to increase public support and understanding regarding the need to create a knowledge-based society".
Furthermore, science communication "could contribute to encouraging investments in research and justifying public funding" as well as attracting more European young people to careers in science to contribute to the EU's future competitiveness.
A report on research and societal engagement by the Commission's own research advisory board (EURAB), published in June 2007, stated that researchers should remain aware of "how the actions of the past have generated negative public perceptions of research today (regarding issues arising from nuclear energy, GMOs and pesticides) and that better dialogue with the public either directly or via the societal actors could have prevented much of the friction and lost potential innovative developments in these research fields."
Source: EurActiv News, December 6, 2007
Interview: 'We need a revolution in science culture
Scientists cannot continue living in their own world and need to formulate new research questions together with citizens to tackle global challenges, argues researcher Marie-Claude Roland.
Researchers live in a system that has so far been completely autonomous and cut out of society. When you read Merton's Sociology of Research (1976), it is a system which is autonomous, self-regulated and with no contact with society. This is why so many researchers have problems in talking about the impact of their research," said Marie-Claude Roland, a researcher specialising in science communication and helping scientists improve their communication skills, in an interview with EurActiv.com.
She argued that "researchers are in a situation of non-communication" as they understand publishing as a mere validation process of their research [publishing results in a scientific paper]. "I try to tell researchers that it is not worth publishing if they don't have anything to say. The problem is that when the papers are published there's no message in them, you just need to look at the titles of papers to see that," she added.
"One of the weaknesses of research projects funded by the European Commission, for example, is the section entitled 'impact of your research'. Researchers are not really aware of the impact of their research. They are just trying to use society as an alibi to get some funding for their work," continued Roland.
She also said that new technologies have made research very technical and that even young researchers are very method and technique-orientated. Researchers often work with keywords and do not consider the wider relevance of their research subject or spend enough time formulating questions or reformulating problems, she added.
However, "research cannot be separate from society anymore," said Roland, urging researchers to work with citizens to understand their concerns and involve them in the core process of formulating new problems and questions.
"This is what the changing paradigm in communicating science is about. It is a cultural revolution where end-users and other stakeholders need to be involved in the process. Research and science culture can no longer exist outside mainstream culture and society. The threats to the planet and human life are now much too big. We need a revolution in science culture," said Roland.
Asked why we need to communicate science, she said that science is communication and unless it is communicated, science does not exist.
Source: EurActiv News, December 10, 2007
State-funded research gets Commission green light
The Commission adopted, on 14 December 2007, a new strategy on investing public money in high-risk technological research.
The aim of the Communication on Pre-commercial procurement: Driving innovation to ensure sustainable high quality public services in Europe is to give the green light to procurers of innovative new products and services that address the needs of tomorrow. It thus identifies some flexibility for the member states in this area.
The member states have been waiting for this green light for legal reasons - to be sure that if they start doing more of this type of research procurement, the Commission will not attack them for violation of EU state aid rules.
The new strategy is also a pre-condition for the Commission's lead markets initiative, and is expected to help reduce the research investment gap with the United States, as the European public sector has enormous purchasing power of €1,700 billion but currently only 0.15% (less than €3 billion) is used for procuring the research and development of new products and services.
-
Commission Communication: Pre-commercial procurement: Driving innovation to ensure sustainable high quality public services in Europe
(14 December 2007) [FR]
[DE]
[Commission staff working document - Accompanying document]
Source: EurActiv News, December 19, 2007
RESCUE (Research Experience of Stem Cells in EUropean Society
Feb 8-10, 2008 - Basel, Switzerland
www.rescuesociety.org
International Workshop Molecular Modeling and Simulation in Applied Material Science
March 10 -11, 2008, DECHEMA-Haus, Frankfurt am Main/Germany
Information: www.dechema.de/International_Events-lang-en.html
5th International Meeting Bioprocess Technology-The Netherlands link
Development and Production of Antibodies, Vaccines, and Gene Vectors
April 7-9, 2008, Amsterdam, The Netherlands
Information: www.wilbio.com
BioVision Alexandria2008
12-16 April 2008 Alexandria, Egypt
For more information: www.bibalex.org/biovisionalexandria/
4th annual Bioprocess International European Conference & Exhibition
21-24 April 2008, Vienna, Austria
Information: www.bpi-eu.com
1st European Conference on Process Analytics and Control Technology EuroPact2008
April 22-25, 2008 Frankfurt am Main, Germany
Information: http://eventsdechema.de
BioForum VII – Biotechnology and Biobusiness Trade Fair
15-16 May 2008 , Lodz, Poland
Information: http://www.bioforum.pl/www/
Biopharmaceuticals: why use yeasts?
22-23 May 2008, Zurich, Switzerland
Information: www.biotech2008.ch/about_/scope/
ACTIP meeting
May 22-23, 2008, Brussels, Belgium
More information: ACTIP Secretariat
7th European Symposium on Biochemical Engineering Science ESBES-7
Faro/Portugal Sep 07, 2008 - Sep 10, 2008
Information: www.esbes2008.org
Cell Culture scale-up and purification of biological products
September 8-10, 2008, Philadelphia, PA
Information: www.wilbio.com
IBS2008 - The 13th International Biotechnology Symposium and Exhibition
October12-17, 2008 - Dalian, China
www.ibs2008.org
The 16th Annual Congress of the ESGT
Nov 13-16, 2008 – Brugge, Belgium
Information: www.esgt.org
ACHEMA 2009
11 - 15 May 2009, Frankfurt am Main, Germany
29th International Exhibition-Congress on Chemical Engineering,
Environmental Protection and Biotechnology
Information: www.dechema.de/International_Events-lang-en.html
Home | Objectives | Organization | Members | News and Info. | Publications | Products | Interesting Links | Library | Secure
© ACTIP 2008