The next plenary meeting of IVTIP will be held on:
May 11-13, 2005, Madrid, Spain
The meeting will be hosted by company Neuropharma, Spain.
Central themes will be 'REACH implementation, sensor technologies and applied genomics/proteomics.
IVTIP members and special invited guest/observer companies will soon receive the full details of the meeting. Please contact the IVTIP secretariat for the agenda and practical details of the meeting should you not have received any information by Mid March.
Lobbying efforts by green activists and industry representatives are being shifted towards MEPs as the EU's chemicals bill enters its parliamentary phase. Diverging business voices are making themselves heard.
On January 19, 2005, a key all-day hearing on the EU's proposed regulation on the registration, evaluation and authorisation of chemical products (REACH) was held in Parliament as the bill enters its legislative phase.
On 17 January, the European employers association UNICE unveiled fresh recommendations on how to improve the bill "to make it manageable for producers and users of chemicals" alike. These include the so-called downstream industries (metal industry and non-ferrous metals) which have so far been campaigning separately.
UNICE's new approach shifts the priority for testing and registration from an emphasis on the quantities of chemicals to be registered alone to the health and environmental risks of chemicals along the whole supply chain.
"Volume alone is not a sufficient criterion to determine the amount of data that are needed to assess the potential impacts of a chemical for human health or the environment," UNICE said in a statement.
It also wishes to limit the scope of REACH to "genuine chemicals by excluding raw materials and waste" in the way the extracting industries have asked. Concerning compulsory data-sharing, as proposed by Britain and Hungary, UNICE demands that it be based "on voluntary consortia and in line with competition and compliance rules".
But this new, less uncompromising stance is being challenged by companies such as H&M, Electrolux, Boots and Marks & Spencer, who are calling for stronger chemical legislation.
"We believe that REACH is a great opportunity to re-build confidence in chemicals, those who make them and those who use them," says Stephen Johnson, Sustainable Development Manager at Boots.
Others such as Electrolux see REACH as "an important tool in accomplishing our objectives regarding safe products, safe production and environmental protection".
This view is supported by MEP Lena Ek, the shadow rapporteur for the Parliament's Industry Committee. NGOs WWF, Greenpeace, Friends of the Earth Europe, European Public Health Alliance Environment Network and EEB have been busy promoting this view.
Source: EurActiv News, January 19, 2005
The timetable for the adoption of the report on REACH, in the Enviornment Committee in the European Parliament, has been set as follows:
* Rapporteur (Sacconi) to send draft report to translation: 15 February 2005
* Discussion of draft report: 14 March 2005
* Deadline for amendments: 28 April 2005
* Vote in Committee: September 2005
* First reading vote in plenary: 24-27 October 2005
Pharmacogenomics will alter the balance of power in the way drugs are developed, tested, marketed and prescribed during the next decade, and the blockbuster business model of big pharmaceutical companies will eventually give way to a more targeted approach. The report, is entitled Personalised Medicine: The Emerging Pharmacogenomics Revolution and has been released by PricewaterhouseCoopers.
The pharmaceutical sector has seen many setbacks within the last 12 months concerning many of its bestselling drugs. This has not only raised questions about patient safety but also issues concerning clinical practice and the interpretation of trial data.
Blockbuster drugs, those with peak annual global sales of $1 billion and prescribed for general population use, can cost upwards of $800 million to develop, according to some industry experts, and take between 8 and 12 years to advance from the lab to the pharmacy. Yet these drugs are typically effective in only 40 to 60 per cent of the patient population.
According to PriceWaterhouseCoopers: Pharmacogenomics would enable drug marketers and physicians to target therapies to smaller patients populations, those for whom they know the drug would actually work. Targeted therapies are set to increase as pharmacogenomics could expand markets and revenues. This can be achieved by defining new uses for existing drugs, "rescuing" drugs in development, managing product life cycles, and dominating niche markets. Better- targeted drugs also could reduce the massive marketing costs vital to blockbuster drugs.
The authors of the report were keen to stress that pharmacogenomics, for all its promise, is not an immediate substitute for the existing blockbuster model. Not all therapy areas are well suited to pharmacogenomics products, and products that are safe and inexpensive will continue to perform well.
Pharmacogenomics will require fundamental changes in the regulatory, clinical and reimbursement landscape. The current regulatory and reimbursement frameworks in the US are built around the blockbuster approach, yet new structures are being explored.
The FDA has approved a handful of existing pharmacogenomic products and is preparing guidelines for future products. Large third-party payers also are staying abreast of pharmacogenomic developments and are drafting policies to guide reimbursement structures.
Source: InPharma-technologist.com, February 28, 2005
Many businesses have difficulty understanding the potential of nanotechnology and some are sceptical about its long-term potential.
The term nanotechnology is a catch-all for any technology operating at 100 nanometres or less (a nanometre is 1 billionth of a meter). Although it is fairly advanced at the laboratory stage, it has proved more difficult to replicate on a commercial scale. Most of the current applications of materials nanotechnology are nano-particle based, and include sunscreens, cosmetics and thin film coatings for various objects. The use of nanotechnology is already delivering advanced products that could not be achieved using conventional technologies, however future applications of nanotechnology promise much more, with the potential for new and revolutionary applications across all sectors of business and industry. Here are some examples.
Japanese company GSI Creos has unveiled the first prototype of a new cell culture reactor that uses nanotechnology to support the growth of more cells than conventional reactors. The bioreactor could potentially boost the yield of biological drugs made in cells.
GSI Creos exhibited its prototype at the Nano Tech 2005 exhibition, which opened at the Tokyo Big Sight exhibition on February 23.
The system makes use of GSI Creos' proprietary Carbere carbon nanotube technology, used to form nanoscale cups that can be added to a bioreactor as a powder. Carbere has a unique herringbone structure of stacked bottomless cups, making them particularly suited for use as an additive with good dispersion properties.
The result is a dramatic increase in the surface area for cell suspension. Initial experiments suggest that cells grow 30 per cent faster and lived 30 per cent longer than those grown in conventional reactors.
The company is gearing up to provide Carbere prototype samples to laboratories in the pharmaceutical, medical and food sectors, so that specific applications of the technology can be explored.
Source: In-Pharmatechnology.com News, February 24, 2005
The emergence of nanotechnology is likely to have a significant impact on drug delivery sector, affecting just about every route of administration from oral to injectable, according to specialist market research firm NanoMarkets. NanoMarkets believes that not only will the nano-enabled drug delivery market be one of the first true nanomedicine markets to evolve, but as it does so, the revenues from nanoenabled drug delivery systems will be quite large. Below we give a state of the art overview.
For injectable drugs, nanotechnology is already generating new dosage forms that are easier to administer, more pleasant for the patient to receive and confer a competitive advantage in the marketplace. For example, at the start of this year Johnson & Johnson revealed that Elan's NanoCrystal technology would be used in a Phase III clinical trial for an injectable formulation of paliperidone palmitate, a drug for schizophrenia. This is a new 'nano formulation' of an older drug which overcomes the original's insolubility, by reducing the particle size to under 200 nm.
Nanotechnology is also opening up new opportunities in implantable delivery systems, which are often preferable to the use of injectable drugs, because the latter frequently display first-order kinetics (the blood concentration goes up rapidly, but drops exponentially over time). In contrast, implantable time release systems may help minimize peak plasma levels and reduce the risk of adverse reactions, allow for more predictable and extended duration of action, reduce the frequency of re-dosing and improve patient acceptance and compliance. Already a nanostructured material exists that effectively stores an active compound in nanosised pockets that release minute amounts of drug as the silicon dissolves.
Nano-implants will also be used in the not-too-distant future for treating cancer. Among the first nanoscale devices to show promise in anti-cancer therapeutics and drug delivery are structures called nanoshells, which typically have a silicon core that is sealed in an outer metallic core. By manipulating the ratio of wall to core, the shells can be precisely tuned to scatter or absorb very specific wavelengths of light. For example, gold encased nanoshells have been used to convert light into heat, enabling the destruction of tumours by selective binding to malignant cells. A physician can use infrared rays to pass harmlessly through soft tissue, while initiating a lethal application of heat when the nanoshells are excited.
Some researchers are also experimenting with temperature-sensitive drug delivery control methods, using nanoshells that release their payload only when illuminated with the proper infrared wavelength.
Despite these advances, the vast majority of consumers prefer an oral drug delivery system to implantables or injectables. With this in mind, various development groups are working to enhance traditional oral delivery systems with nanoengineered improvements. The basic idea is that by increasing bioavailability, nanoparticles can increase the yield in drug development and may help treat previously untreatable conditions.
Because of the blood brain barrier (BBB) many new chemical entities aimed at treating brain disorders have proved not to be clinically useful. Nanoparticles have been demonstrated to cross the BBB with little difficulty and companies such as Germany's NanoPharm have developed systems capable of reaching the brain for anaesthesia (Dalargin; an analgesic), cancer drugs, and various other therapeutics.
Meanwhile, researchers at the University of Texas at Austin have described a means of using nanospheres for oral drug delivery. These nanosphere carriers are derived from hydrogels, which are highly stable organic compounds that swell when their environment becomes more acidic. They have been successfully formulated into controlled-release tablets and capsules, which release active compounds when the hydrogel body swells.
NanoMarkets also suggests that nanomaterials provide a unique opportunity for rapid topical delivery of active compounds. Given their very small size, nanoparticles are able to enter human tissues and cells quickly, and companies such as Novavax have already developed regulated topical systems that take advantage of the unique properties of micellar nanoparticles. Novavax is developing two hormone replacement therapies, called Estrasorb (which received FDA approval in October 2003) and Androsorb which successfully completed Phase I human trials in 2003.
Finally, nanotechnology is finding new applications in the area of toxin removal. Colloidal dispersions have been demonstrated to remove potentially lethal compounds from the bloodstream, including high concentrations of lipophilic therapeutics, illegal drugs, and chemical and biological agents. A team of scientists at the University of Florida and Clarkson University in Potsdam, New York, has demonstrated favourable results to this end, using biocompatible microemulsions. These oil-in-water systems have a rapid and efficient absorption capacity for many target molecules that are frequently overdosed, whether this be intentional or accidental. The microemulsions use a polymeric surfactant, in combination with an ionic co-surfactant.
Source: InPharma-technologist.com, March 6, 2005
Researchers in the US (MIT and Lankenau) have shown that nanoparticles can be used to deliver genetic material into cells safely and effectively, potentially overcoming the primary obstacle to the development of gene therapy: the use of viral vector delivery systems (see the US death following gene therapy using an adenoviral vector and the French finding of a high number of leukemia cases following retroviral gene therapy in children with X-SCID).
The nanotechnology-based approach used by the researchers has minimal toxic side effects to normal cells. The MIT group identified a polymer termed C32 capable of delivering genes to cancer cells more efficiently and with less toxicity than other polymers that have been tested in the field to date. C32 works by condensing the DNA in a gene and allowing the resulting nanoparticles that are formed to enter cells through a process called endocytosis. Therapeutic genes delivered to cells in this manner are able to drive cellular production of a gene-encoded protein through normal processes.
The researchers used the polymer to deliver a genetically modified diphtheria toxin gene that would be produced only in prostate cells. When this was injected into the prostate tumours in animals, tumour growth was suppressed or reversed (in 40 per cent of cases), relative to untreated tumors.
The results of the study were reported as a cover article in a recent issue of the Proceedings of the National Academy of Sciences.
Source: In-pharmatechnologist.com News, January 25, 2005
The German government is the latest in Europe to start a programme to support companies and academics working in the emerging field of 'bionanotechnology'.
Similar efforts to boost research in nanotechnology have already been unveiled in the UK and France.
The Federal Ministry for Education and Research (BMBF) funded programme is aimed at supporting industry-led consortia that are working in the areas of pharmaceutics and medical technology. Key topics of interest include drug transport, nanoscale drug delivery systems, implantation and regenerative medicine, and in vivo diagnostic/molecular imaging.
The Nanotechnology for Health and Society (NanoforLife) project is part of a wider set of government funding that has provided a fund of _50 million for bionanotechnology efforts between 2000 and 2006. The funding covers preclinical and Phase I clinical trials, and covers up to 50 per cent of costs for a company and up to 100 per cent of additional costs for research facilities. The submission deadline for NanoForLife is 15 April, 2005.
Source: In-Pharmatechnologist.com News, February 14, 2005
On April 25-26, a conference will take place in Brussels devoted to issues for business in nanotechnology. This conference is applicable to all sectors of industry and all sizes of organization that have any involvement in manufacturing or producing goods. It is a critical event for those who want to understand the concepts behind nanotechnology, invest in the technology or incorporate it into their business strategy. The event will also be extremely useful for those currently involved in nanotechnology projects, especially those businesses needing to learn more about commercialisation and investing in the industry.
Nanotechnology: Issues for Business
April 25-26, Brussels, Hotel President WTC
Email: wtc.info@presidenthotels.be
Website: http://www.presidenthotels.be/wtc/en/welcome.htm
The European Commission has invested in a FP6 Network of Excellence called Blue Bio-net aimed at exploiting the sea for drug development. The project aims to network together researchers and companies. Institutes and companies interested in the effort are encouraged to contact the coordinator.
For more information: schimmel@bis-bremerhaven.de
Another recently started project funded with 10 million Euros is also a Network of Excellence: Marine Genomics, aiming to integrate approaches throughout Europe. One example will be the development of high-throughput gene sequencing techniques for the study of marine biology. Another aspect is offering partners access to technology platforms, for example experimental equipment and databases that integrate the produced data. The network brings together 44 institutes from 16 EU countries.
Further on marine biotechnology: Spanish PharmaMar started in 2004 a Multicenter phase II trial of Aplidin, a novel marine anti-tumor agent derived from the marine tunicate Aplidium albicans, in small cell lung carcinoma.
Source: EuroBiotechNews no 6, vol 3, 2004
A 10 million euro grant from the EU will allow researchers throughout Europe to advance their research in the field of 'biological crystallography,' which aims to create precise, 3-D "architectural" models of biological molecules.
The EU project BIOXHIT ((Biocrystallography on a Highly Integrated Technology Platform) plans to integrate and develop technologies at European centres for research in structural biology.
One immediate effect of BIOXHIT will be a reduction in the time involved in obtaining each structure. The project specifically calls for improvements in the process by which samples are handled, the equipment needed to detect X-ray patterns, and the computers and software needed to model structures.
One result of this might be to attract more researchers to work on protein structures.
Source: CORDIS News, February 11, 2005
The project started in 2003 with 14 partners. The overall funding is scheduled to be 2.3 mio _. Contract with the EU was signed on September 1, 2004; the administration is done by REMA. The kick-off meeting was held in Valencia on September 24-25 near Valencia, Spain.
The Predictomics project addresses the urgent need to develop in vitro based systems which are capable of predicting long term toxicity in humans.
The major objectives of this project are:
ReproTect was started in 2003 with 21 partners. The overall funding is scheduled to be 9.1 mio _, resp. 13.5 mio _. Contract with the EU was signed on July 1, 2004; the administration is performed by Prof. Michael Schwarz, University of Tübingen. The kick off meeting and the Supervisory Board-meeting took place in Ispra/Italy at the ECVAM-Location on July 18-21, 2004. (Links not open to the public yet!)
ReProTect intends to explore reproductive toxicity. The project will drive R&D toward alternatives to animal tests according to the needs identified, with the main intention to pre-validate and validate the most promising ones. The project will develop a novel approach in hazard and risk assessment of reproductive toxicity, by a combination and application of in vitro, tissue and sensor technologies.
Analysis of the stakeholder consultation held last year June on Internet shows that Commission's plans for future science and research policy are on the right track. The consultation gathered reactions from over 1700 organisations and individuals. One third of the responses was received from individuals and one fourth from academic world.
The objective of 'Making Europe more attractive to the best researchers' clearly ranks as the highest with nearly 100 per cent of stakeholders considering this priority very important.
Each of the five other priorities set out in the June Communication received an equally strong, broad support. However, space and security related research, the two additional, specific priorities identified in the Commission's communication, received substantially lower support from the stakeholders, who stressed that such research "must strike the right balance with fundamental liberties, human rights and social values".
Source: EurActiv News, December 22, 2004
On January 25, a first meeting took place of the Identification Committee convened by the European Commissioner for Science and Research, Janez Potoènik, to recommend the composition of the governing body of a future European Research Council. The Commissioner is keen to ensure that the European Research Council will remain scientifically independent, which is why he has asked Lord Patten to chair a group of experienced and respected scientists to identify possible members of the governing body. The members of the Identification Committee are:
The establishment of the European Research Council will be included in the proposal for a Seventh Framework Programme for Research and Development that the Commission will present in April 2005. A European Research Council will focus on basic investigator-driven research, in recognition of its importance for future innovation and economic growth. The Commission's intention with the creation of such a mechanism is to focus on scientific excellence, identified by fellow scientists, rather than the Commission.
Source: Press Release European Commission, January 25, 2005
The EU's goal under the Lisbon Agenda is to increase research and development (R&D) investment to at least 3 percent by 2010, with at least two thirds of the total expenditure coming from the private sector. The EU falls far short of reaching this objective.
A Eurostat report on R&D expenditure in the EU, published on 24 February 2005, covers the developments in the EU-25 from 1998 to 2002/2003.
R&D expenditure: The EU-25's R&D expenditure saw a total annual increase of 4 percent between 1999 and 2002 (only 2.7 per cent in the US, and 2.2 per cent in Japan). The fastest annual growth rates, more than 11 per cent, were registered by Estonia, Cyprus and Hungary.
R&D intensity: EU R&D expenditure as a percentage of the GDP grew from 1.82 per cent in 1998 to 1.93 per cent in 2002. R&D expenditure in the US increased to 2.76 percent in 2003 and to 3.12 per cent in Japan in 2002. At this rate, the Barcelona objective of spending 3 per cent of the GDP on R&D will be achieved at 2045.
Public and private sector funding: European business financed 55 per cent of the total R&D spending in the EU, whereas the shares of the private sector in the US and Japan were significantly higher - 67 percent and 74 percent respectively. However, in Sweden, Finland and Ireland more than two thirds of the expenditure was financed by the business sector.
Source: CORDIS News, January 11, 2005
The first European industrial R&D investment scoreboard reveals that investment in R&D by the top 500 European companies between 2002 and 2003 fell by 2%, whereas for the non-EU 500 companies it grew by 3.9%. The scoreboard, which was produced as part of the European research investment action plan, makes it possible to compare research investment among EU companies and sectors, and with US and Japanese companies.
Europe is seriously lagging behind in its objective of increasing investment in research to three per cent of GDP by the year 2010. The first industrial R&D investment scoreboard providing a full picture of the competitive situation of EU firms in the global R&D environment shows that European R&D investment is declining and highly concentrated along three dimensions:
To raise the number of European "industrial R&D champions we need to create an environment that supports such investment", said Janez Potoènik, the commissioner for science and research. However, "the commitment of the companies themselves is crucial".
Source: EurActiv News, January 14, 2005
ince 1999, the number of applications for approvals on new drugs has fallen from 27 to 17, says a recent report commissioned by the European Commission. The report indicates that the decrease in innovation is due mainly to three type of factors: the increase in costs of developing new and innovative drugs, the expected low return from innovation and industry restructuring (mergers and acquisitions).
To encourage innovation in the sector, the report recommends that the Commission, member states and industry co-operate closely on a number of issues. These include improving communication between regulatory authorities and industry during the key phases of product development, co-ordination of tax incentives for research and development and improving public-private co-operation in research.
The upcoming Luxembourg and United Kingdom presidencies of the European Union have signaled in their common draft programme that "improving the state of the competitiveness of the pharmaceutical industry" is one of the priorities of the innovation and enterprise policy area.
Source: EurActiv News, December 15, 2004
The pharmaceutical and biotechnology industries in the 'new' EU countries are rapidly expanding, presenting considerable potential, although parallel imports remain a challenge.
That is the verdict of a report from Frost & Sullivan, which has shown that while the old EU has been increasing at eight per cent annually, the new EU has grown at a rate of 16.5 per cent over the past five years.
Globally, the EU healthcare industry is the second largest after North America. Estimated at nearly $7.0 billion (_5.3 billion), the pharmaceutical market in the 'new' EU countries', Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia, represents about eight per cent of the EU 15 market.
Both Poland and Hungary, which contribute 45 per cent and 23 per cent of the accession countries' total pharmaceutical market value respectively, have been growing by almost 20 per cent since 1998.
Propelled by the advantages of low costs and easy patient recruitment, the 'new' EU offers tremendous scope for conducting clinical trials. Already, large multi-national pharmaceutical and biotechnology companies from Western Europe and from the United States are carrying out clinical trials on rare diseases and diseases relevant to large worldwide markets.
With big pharma not dominating the 'new' EU market as it does the EU15 and the United States, the top position in four 'new' EU countries is still occupied by a local participant, acquiring a local company offers a means to gaining a foothold.
Source: In-pharmatechnologist.com News, February 21, 2005
The Animal Health and Welfare Panel of the European Food Safety Authority has set up a working party to look at a number of issues that could be addressed in the revision of Directive 86/609 on "the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes". The working party will be chaired by Professor David Morton of Birmingham University in the United Kingdom.
Dr Beatrice Lucaroni of the Directorate-General for Research, Technology and Development told a recent meeting organised by EFPIA, the European pharmaceutical industry association, that the working party had been asked to look at whether the use of invertebrates in research and testing should be covered by the new Directive, to what extent fetal and embryonic forms of animals should be included, the most appropriate methods of euthanasia and which experimental animals should be purpose-bred. It is understood that working party members would like to comment on other areas as well.
The working party is not expected to report before June 2005, following which it could take several months for a draft of the new Directive to be prepared. After further internal consultations on the draft, the Commission would publish it for a stakeholder consultation. Observers believe that there is little political impetus to speed up the process either inside the Commission or the European Parliament.
Source: EBRA (European Biomedical Research Association) Bulletin, December 2004
The Long-range Research Initiative (LRI) is globally co-ordinated by the International
Council of Chemical Associations (ICCA) to provide science-based information to
protect health and the environment. Three regional bodies (Europe, Japan, USA) run co-ordinated research strategies and research projects in key areas. For Europe info is available through CEFIC (www.cefic.org)
In Europe the LRI programme now encompasses over 50 projects and studies involving more than 150 scientists from 90 research institutes in 15 European countries. The results of LRI research are publicly available and are frequently published in peer reviewed journals. There are four main areas represented in the current LRI research portfolio. These are:
- The environmental fate and effects of chemicals
- Environmental and human exposure assessment
- Risk assessment methodologies
- Endocrine disruption
A new integrated website is available listing all LRI results:
www.icca-chem.org/sectionO2c.html
Entering a topic and/or chemical of interest will result in a list of links to all available
relevant LRI research information.
The Netherlands has set up a programme to boost its biotechnology sector by helping small and medium-sized biopharma firms to develop and manufacture products. The scheme &endash; called BioConnection &endash; is a collaboration between the Dutch government, Akzo Nobel and the wider business industry, and is claimed to be the first 'one-stop-shop' in Europe to offer start-up biopharmaceutical companies the use of dedicated, centralised production facilities, as well as other activities such as formulation development.
The aim is to provide a boost for the Dutch biotechnology sector, which ranks eighth in Europe with 138 companies at the end of 2003, employing 2,100 people and with an overall turnover of _170 million, out of a total European biotech sector turnover of _11.1bn in the same year.
Akzo Nobel's healthcare business Organon is at the heart of the project, and will house the BioConnection biotechnology centre at its Oss site in the Netherlands The Dutch government and Organon are putting _15m into the project, with the bulk of this money going towards the establishment of a lyophilisation (freeze-drying) unit at Oss. This is being built as part of Organon's previously disclosed plan to construct a new parenteral medicines production plant, due to come on-line in 2008.
Similar schemes aimed at improving the access of small biotech players to development and production facilities have been set up in the UK and France, with the UK project leading the field at present with a dedicated facility &endash; the National Biomanufacturing Centre &endash; due to start operating in early 2006.
Source: In-Pharmatechnologist.com, March 2, 2005
Recently-formed cell culture specialist Celliance has introduced a new supplement (Hybri-CYTE) designed to boost the growth of cells used in research and bioprocessing, that does not contain fetal bovine serum.
Hybri-CYTE &endash; the first of what will be a completely new range of serum free supplements - is designed for use in hybridoma cell culture and has been shown to work with mouse, rat and rabbit derived cell lines.
It incorporates a number of Celliance's proprietary cell culture products, such as Celliance's flagship EX-CYTE growth enhancing media supplement, Probumin BSA and Incelligent Animal Free insulin. Celliance was formed last Autumn by Serologicals Corp of the US with the express aim of boosting the firm's presence in the serum-free supplement market.
Source: In-pharmatechnologist.com News, February 16, 2005
Serologicals has continued its acquisitive streak, buying the cell culture business Specialty Media from Sentigen Holding Corp. Specialty Media develops and supplies a variety of specialty stem cell culture media formulations and supplements, cells and research reagent tools to the life sciences industry.
While in a fairly embryonic stage at present, the market for stem cell-based therapies and tissue engineering is tipped to grow to around $10bn in 2013, according to a recently published report from Visiongain.
The cell culture market &endash; including media, sera and reagents used in R&D and production - is growing fast on the back of a rising focus on biological drug development by the drug industry. For example, the US market was valued at just over $900m in 2003, but looks set to swell to $1.7bn by 2008, according to data from BCC.
Source: In-pharmatechnologist.com News, February 23, 2005
According to a recent report (Business Communications Company (BCC), projected sales for the worldwide DNA sequencing and proteomics markets are expected to rise at an average annual growth rate of 17.6 per cent from $7.8 billion (_5.9 billion) in 2004 to $17.5 billion in 2009. Beyond 2009, growth is expected to continue as new applications are developed and global market penetration continues.
Proteomics is a field that is younger than DNA sequencing and although applications are more limited, the impact of the technology could prove to be enormous. The industry is growing more by a diffusion process as the technology gradually replaces older laboratory methods.
However, there are still problems to growth simply because the use of the technology changes so many existing processes that extensive retooling may be required, and researchers are cautious about quickly embracing such change. For example, the use of the latest DNA sequencing technologies may not be compatible with existing equipment and hence researchers may be reluctant to invest in new and complex diagnostic tools.
Source:. www.bccresearch.com, February 23, 2005
This month, the German Research Council (DFG) has awarded a new prize to scientists whose work has improved the protection of animals used in research.
The inaugural awards went to Klaus Otto, 51, professor of experimental surgery and anaesthesiology at the central animal laboratory of the University of Hanover's Medical School, and Lisa Wiesmueller, 43, head of gynaecological oncology at the University of Ulm. The Ursula M. Hondel Animal Protection Prize, which carries a cash award of 12,500 (US $16,200), was created with a cash donation from Mrs. Hondel, a long-time supporter of animal protection issues.
Otto was recognized for his work to find more accurate means of measuring the effectiveness of general anesthesia on animals used in research. Instead of traditional measuring methods such as heart rate, blood pressure, and pupil dilation, Otto uses electroencephalograms to measure brain activity. Wiesmueller was honoured for developing a test using human cell culture to detect potential carcinogenic effects or genetic damage from medicines and food additives. Such testing currently requires the use of animals.
Source: EBRA (European Biomedical Research Association) Bulletin, December 2004
As of November 15, 2004, research institutions in Singapore are required to follow new guidelines on the use and care of research animals. The guidelines are meant to improve and standardize the treatment of research animals within Singapore, where previously, research institutions followed their own standards for the use of research animals. The new guidelines
were developed by the Agri-Food and Veterinary Authority (AVA) in conjunction with many groups, including research and educational institutes and animal protection organizations. They were modeled after regulations existing in the United States, Australia, and Canada.
Source: Channel News Asia, October 29, 2004 (http://www.channelnewsasia.com/stories/singaporelocalnews/view/114310/1/.html)
The U.S. Department of Agriculture has issued a formal complaint against the University of California, San Francisco (UCSF) for scores of alleged Animal Welfare Act (AWA) violations that occurred between 2001 and 2003. Some of the alleged violations specified in the complaint include inadequate veterinary care and unsanitary conditions, avoidable pain and
distress following surgery, water deprivation of monkeys to the extent of causing weight loss, and excessive breeding of marmosets. Other complaints address failure to get approval for various protocols and protocol
changes. Earlier, UCSF had been sent a Letter of Warning by USDA in 1999 for AWA violations and was fined $2000 for violations that occurred in2000.
Sources: San Francisco Chronicle, September 15, 2004
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/09/15/MNG088P5B61
USDA's formal "complaint" against UCSF
(see http://www.idausa.org/news/currentnews/usda/ucsfcharges.pdf)
Figures released by the Association of the British Pharmaceutical Industry (ABPI) has revealed that the level of intimidation posed by animal extremists reaches as far as the suppliers who do business with companies involved with animal research.
The statistics show that major increases in the number of abusive or threatening phone calls made to companies engaging in animal research accompanied a continuing jump in recorded damage to company, personal and public property. The last quarter of 2004 showed a total of 42 such "incidences" - 37 per cent of the year's total. It compares with 22, 23 and 26 per cent respectively in the previous three quarters of the year. Comparable figures for 2003 are not available.
Additional figures showed the total number of threatening and abusive phone calls and other communications amounted to 108 during 2004, compared with 38 in 2003 and 23 the previous year. There were 177 instances of damage to company, personal and private property during the year, compared with 146 the previous year and 60 the year before.
The fact that more and more suppliers are being forced to drop their business with companies involved in animal research is worrying. If this trend continues, pharmaceutical companies will seriously consider whether it is still appropriate to carry out this essential research work in the UK.
In January 2004, Cambridge University abandoned plans to build a £32 million (_46 million) neurology centre, in part by protests, some of them violent and plans for a Cambridge primate laboratory had to be scrapped. A planned research laboratory at Oxford University was also halted because of the costs of protecting against attacks.
Source: InPharma-technologist.com, January 24, 2005
Animal rights activists campaigning against a UK laboratory animal breeder have dug up a grave and removed the remains of an elderly woman. An animal rights group called Save the Newchurch Guinea Pigs has been campaigning against David Hall, a company based near Burton-on-Trent (UK) that breeds specific pathogen free guinea pigs, although they have denied any involvement in this incident. One night in October, the grave of Mrs Gladys Hammond at St Peters Church in nearby Yoxhall was desecrated and her remains removed. Mrs Hammond, who died in 1997, was the mother-in-law of one of the Hall brothers who run the guinea pig breeding business.
Source: EBRA (European Biomedical Research Association) Bulletin, December 2004
A new primate breeding facility, called Noveprim, was recently built near the town of Camarles in northern Spain by the Centre de Recherches Primatologiques (CRP), the long-established Mauritius breeder. Protests against the centre began as soon as the plans were announced and have been growing since then.
The first batch of 300 macaques was brought into the Noveprim facility a few months ago. The Altarriba Foundation, based in Barcelona, is urging people to write to Pasqual Maragall, president of the autonomous Catalonian government, asking him to prevent the animals from being sold for research.
Source: EBRA (European Biomedical Research Association) Bulletin, December 2004
The ECVAM Workshop Report 50 " Strategies to Replace In Vivo Acute Systemic Toxicity Testing " Gribaldo et al. (2004). ATLA 32, 437-459 is now available on the ECVAM website, in the section Publications.
A Summary of the Workshop on the Validation Principles for Toxicogenomics-Based test Systems, co-organized by ECVAM, ICCVAM, is available on the ECVAM website, under the section: Publications, ECVAM Task Areas, Task Areas Publications 2004 - 2005. This document can also be downloaded directly from the ECVAM Homepage.
The ECOPA Forum Section is now available via the ecopa page or the direct link
(http://ecopa.vub.ac.be/forum/).
To access the general discussion section, users need to be registered to post messages in this section, but they can read all posts in here.
The BRDs, as well as any additional analyses, on the four test methods, can be viewed at http://iccvam.niehs.nih.gov/methods/ocudocs/ocu_brd.htm. As a reminder, NICEATM invites written comments on each of the BRDs.
To view a table of contents for this report, please visit http://www.chadvisors.com/services/Microarrays2004/toc.cfm.
To view a table of contents for this report, please visit http://www.chadvisors.com/services/PredTox/toc.cfm.
For information about Microarrays: Technologies, Applications, Markets, please visit http://www.chadvisors.com/services/Microarrays2004/toc.cfm
For information on lobbying, please visit: www.lobbyism.info
The website contains a database with lobbyists and lobbying organisations, reports and articles.
Patent information is available at: http://www.freepatentsonline.com
This web site has free PDF downloading (instead of having to page through TIFFs like at the US Patent Office), and is faster than the US Patent Office's site.
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