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May 2008 |
Next meeting ACTIP:
The next plenary meeting of ACTIP will be held in Brussels/Chateau de Limelette 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:
News from the Commission
Nano news
Monoclonal antibody news
Stem cell news
Research News
Business News
People
Agenda
€2 billion for EU pharma innovation
Announced in the EU's Seventh Framework Programme for Research (FP7), Joint Technology Initiatives (JTIs ) are meant to establish long-term, public-private partnerships on specific research areas, combining private-sector investment with national and European public funding. The novelty of JTIs is that the research topics are defined by industry.
One of the six areas in which JTIs could be established is innovative medicines. The aim of the Innovative Medicines Initiative (IMI), a public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), is not to produce new drugs, but to conduct research into tools to develop new drugs, overcome bottlenecks in the development of innovative medicines and boost investment in European biopharmaceutical R&D.
Apart from the costs associated with drug development, IMI is all the more important as Europe was once known as the 'world's pharmacy'". Until 1998, seven out of ten new medicines originated from Europe, whereas today the number is only three out of ten.
A first call for proposals for research projects in the areas of brain disorders, metabolic and inflammatory diseases was launched on 30 April 2008. Projects should involve a variety of stakeholders such as academia, research centres, SMEs, patient groups, public authorities and competitors in the research-based pharmaceutical industry. Some €123 million will be granted to the most promising research projects in these areas later this year. In the future, IMI calls will also cover cancer and infectious diseases.
IMI, will fund research into these five fields of diseases with some €2 billion over the next five years. The aim is to address current long delays or bottlenecks in the pharmaceutical R&D process.
The identified bottlenecks for which better tools are required to speed up the discovery and development of new drugs are:
• Safety evaluation: speeding up identification of new products with the best benefit-risk ratios and a greater likelihood of success;
• Prediction of efficacy: the development of biomarkers that can be used as tools to understand the biology of a disease and the effects of a new pharmaceutical compound;
• Knowledge management: supporting safety and efficacy of projects as well as information sharing, modelling and simulation tasks, and;
• Gaps in education and training: supporting the medicine development process.
The initiative also foresees the establishment by 2013 of a European Medicines Research Academy (EMRA), "a pan-European platform for educating and training current and future professionals involved in biomedical R&D, including regulatory officers".
Source: Euractiv News, May 5, 2008
EU technology institute to start operations by 2010
After the Parliament's Industry Committee, in late February 2008, approved the Council's common position on the European Institute of Innovation and Technology (EIT) , the regulation was finally adopted in the House by second reading on 11 March. The institute is expected to start work towards its establishment this summer. But even after this final approval, opinions diverge on the necessity of the institute, which was originally designed as the European rival to the US Massachusetts Institute of Technology (MIT). Nevertheless, concrete research, education and innovation actions are expected to start by 2010.
Once the EIT is established, the first Knowledge and Innovation Communities (KICs ) on climate change, renewable energy and next-generation information and communication technologies (ICTs) are expected to be established within eighteen months. If operations begin in summer 2008, the first KICs could see the light of day by 2010.
Contrary to the MIT, the European institute will not resemble a university in a specific geographic location, but will instead be a virtual network of universities, companies and other stakeholders expected to form the KICs. Each KIC must have at least three partner organisations, based in two or more member states. At least one of these partners must be a university and at least one a private company.
Source: EurActiv News, March 12, 2008
EU leaders to address research spending shortfalls
Despite multiple EU initiatives aimed at increasing investment in research in R&D to 3% of GDP by 2010 - a target agreed upon by EU leaders in order to meet the bloc's Lisbon growth and jobs goals - Eurostat figures show that the objective remains far out of reach.
Sweden (3.82%) and Finland (3.45%) remain the biggest spenders in terms of percentage of GDP, followed by Germany (2.51%), Austria (2.45%) and Denmark (2.43%). However, if measured by volume, Germany, France and the UK continue to spend the most - €58, €38 and €32 respectively. Together, they are responsible for around 60% of total R&D expenditure, which amounted to €210 billion in the EU 27 in 2006. The lowest R&D intensities were registered in Cyprus (0.42%), Romania (0.46%) and Bulgaria (0.48%).
The new statistics also rank countries according to the proportion of scientists and engineers in their population. Here, the EU-27 average was 4.8% in 2006. The highest shares of scientists and engineers were found in Belgium (7.9%), Ireland (6.8%) and the Nordic countries (6.7-6.0%) and the lowest in Portugal (2.7%), Bulgaria, Austria and Slovakia (all 3.0%).
Increasing the number of scientists throughout the bloc will be a key EU consideration, as is the objective to enhance the mobility and career prospects of researchers by building a European Research Area (ERA). The aspiration is to remove all obstacles to the cross-border mobility of knowledge in the EU and allow for free movement of knowledge, defined as a "fifth freedom". It would, for example, include initiatives to remove barriers to researchers wishing to work in another member state.
More: Commission press release: EU27 R&D spending stable at 1.84% of GDP in 2006 (10 March 2008)
Source: EurActiv News, March 11, 2008
EU R&D policy 'overambitious'
As long as there is no integrated market for innovation in the EU and until academic research receives better funding, the EU is doomed to miss its ambitious targets on R&D, argues Brussels-based think tank Bruegel.
In a policy brief published on 26 February 2008, Bruno van Pottelsberghe, a senior fellow at Bruegel, argues that common European R&D targets "make little economic sense in an EU where industrial specialisation differs substantially across countries". Van Pottelsberghe argues that setting a business-funded R&D target at the country level is "either wishful thinking or an implicit industrial policy".
He explains that it makes no sense to compare countries like Luxembourg, which specialises in finance, and Finland, which specialises in ICT, because the innovative efforts that are required to introduce new financial products are not included in R&D statistics. On the contrary, Finland's specialisation in an industry which is highly R&D intensive would, in fact, lead one to expect even higher R&D intensity than is currently the case.
"Similarly, a country specialised in tourism, fashion, services or food would logically have lower R&D intensity than a country specialised in the pharmaceuticals, engineering or biotech industries," writes Pottelsberghe.
According to him, only Sweden and the United States outperform other countries, such as Finland and Japan, in R&D intensity once industrial specialisation is taken into account. "Something other than technological specialisation thus seems to drive R&D intensity" in these countries, writes Pottelsberghe.
The reasons for the Swedish and US performance, put forward in the Bruegel policy brief are two-fold. First, the larger the market for products and services, the bigger the expected return on investment and the more the business will invest in R&D. "The US benefits from a huge homogeneous market with one main language and regulation," writes Pottelsberghe, adding that a patent granted by the European Patent Office costs about 11 times more than its US equivalent.
Market size cannot, however, be the explanation for the Swedish performance, which is rather the result of very high spending on academic research - the highest, as a percentage of GDP, among all OECD countries. Strong emphasis on academic research is also a stimulus for business R&D as universities generate new ideas, which are then transferred to the private sector, writes Pottelsberghe. Furthermore, academic research attracts more business funding and "promotes the setting up of scientific clusters".
To read Bruegel's full policy brief 'Europe's R&D: missing the wrong targets?', click here.
Source: EurActiv News, February 28, 2008
Member states outline research and innovation priorities
EU ministers for internal market, industry and research met on 25 February 2008 to agree on key competitiveness and innovation issues they would like to see addressed by the EU in 2008. In particular, the ministers are calling on member states and the Commission to increase their efforts by investing more in higher-quality knowledge and innovation and to unlock EU business potential by ensuring the smooth functioning of the internal market.
In addition, the ministers ask the Commission and member states to develop initiatives for "joint programming of research in areas where this approach is appropriate," leading to the launch of more strategic and better-structured joint programmes and common calls for projects as of 2010. The Commission is expected to present a communication on joint research programming in 2008.
The Council is also recommending better promotion of the different instruments of the current EU research framework programme (FP7), such as the European Research Council (ERC), which awards grants for independent researchers to conduct basis research, and the new €2 billion instrument to fund 'riskier' research in Europe, the Risk-Sharing Finance Facility (see EurActiv 05/06/07).
The document on key issues also defines the "free flow of knowledge" as the "fifth freedom" by removing, for example, barriers to researchers wishing to work in another member state.
The member states are asked to continue implementing their higher education reforms and modernising universities in view of enabling them to "develop their full potential" as partners of the private sector in creating and using knowledge and innovation.
Source: EurActiv News, February 26, 2008
EU pushes for better knowledge transfer
A Commission Communication (April 2007) on improving knowledge transfer between research institutions and industry across Europe urges for better exploitation of research results to generate more innovation and increase EU industires competitiveness. Voluntary guidelines for universities and other research institutions are annexed to the Communication.
As a follow-up to this Communication, the Commission adopted, on 10 April 2008, a specific, non-binding Recommendation aimed at helping member states to adapt their national policies on the management of intellectual property (IP) and knowledge transfer (KT) activities.
The aim of the recommendation is to improve KT in particular at trans-national level, as several individual initiatives taken at national level lack coherence and hamper transnational knowledge transfer and wider exploitation of research results.
In order to turn research into competitiveness and welfare, research results need to be translated into socio-economic benefits, useful products, new jobs and companies. There are a number of knowledge transfer mechanisms which enable to do so, but these are underused in Europe. Examples are R&D collaboration with industry, licensing from universities to industry and the creation of spin-off companies. In all these activities, the management of intellectual property is very central and should be managed on a proper and professional way."
A "Code of Practice" annexed to the Recommendation gives universities and public research organisations "operational principles which they should rely on when developing or reviewing institutional policies".
The EU executive hopes that the code will be used as reference by European universitites and PROs to define internal IP and KT policies and guide them in collaborative and contractual research within Europe and with third countries.
Source: EurActiv Newsletter, April 11, 2008
Positive discrimination needed for female scientists
The European Parliament's Committee on Women's Rights and Gender Equality adopted a report on 14 April on the role of women in science. It draws attention to the current under-representation of female scientists, which it says is a waste of the potential of female science graduates.
Promoting women in science is not just about a feminist quest for equality but fundamentally about European growth, innovation and competitiveness in the future.
However, things "don't seem to be changing naturally" and thus measures should be taken at European and national level in order to bring an end to prevailing stereoptypes preventing women from succeeding in scientific careers.
First, the education system should do more to encourage young girls to opt for scientific careers than is currently the case. In addition, special funding should be allocated to female scientists to enable them to pursue their careers. The use of role models and improved mentoring schemes may also attract more young women to study science.
The report also recommends implementing gender mainstreaming in the EU and national programmes. Further, the report argues that Europe should not shy away from positive discrimination. It should not be an end in itself, but it is necessary to take measures that counteract the current systems and traditions, because these obviously in some way 'positively discriminate' men.
Source: EurActiv News, April 16, 2008
Ageing EU science workforce risk to innovation
Ageing populations in the science and technology professions are putting the EU's innovation potential at risk, according to its statistics agency Eurostat, which published new figures on March 18.
The situation is in analogy to Japan, where the rapid ageing of Japanese society has increased the proportion of middle-aged and senior citizens in scientific professions. As the trend of lower birth rates coupled with populations is set to continue, the Japanese expect that the number of researchers and engineers will decrease rapidly. To remedy the situation, the country's industry, academia and research institutions recommend special treatment for older researchers so that they can continue their work and show their creativity.
As for the EU, the percentage of scientists and technologists aged 45-64 fluctuated between 30% and 50% in 2006. Bulgaria, Finland, Germany and Sweden had the highest proportion of senior scientists and technologists in the EU 27 at around 46%. Meanwhile, Spain and Ireland had the lowest proportion (30%) as well as a relatively high number of young ones in the 25-34 age group. The statistics also conclude that senior employed scientists and technologists aged 45-64 were less mobile than younger ones.
In terms of human resources, it is estimated that in the EU an extra half a million researchers (or 1.2 million research-based staff) are needed to meet the Lisbon goals of innovation and competitiveness.
Source: EurActiv News, March 25, 2008
Tuberculosis on the rise in Central and Eastern Europe
EU data and a World Health Organisation (WHO) report have highlighted the need for improved health systems to deal with a rise in drug-resistant tuberculosis in Eastern Europe and former Soviet states.
The report reveals a slowdown in progress on TB control throughout the world. In particular, the disease is being diagnosed more slowly than before. The report also reveals that multidrug-resistant tuberculosis (MDR-TB) has reached the highest levels ever recorded, which could further slow progress in controlling the disease. MDR-TB has risen sharply within Europe over the last decade and many countries are struggling to manage this increase. Eastern European countries are particularly affected, with 12 of the 14 most affected areas in that region alone.
Cases of drug-resistant tuberculosis are particularly prevalent in the former Soviet republics, where health systems are frequently too under-staffed and under-funded to deal with the disease adequately. Specialised agencies dealing with tuberculosis often do not contact general health services, allowing TB cases to slip through the net.
Additionally, cases have arisen in the socially disadvantaged sections of Western European societies, where migrant workers and asylum seekers are often not covered by healthcare.
The European Centre for Disease Prevention and Control (ECDC) recently published an action plan to fight TB in the EU . The plan's four key areas for action are: ensuring prompt and quality TB care for all, strengthening health systems, development and assessment of new tools and building partnerships and international collaboration.
Source: EurActiv News, March 26, 2008
Nanotech faces moral opposition in the US
Europe's favourable public opinion on nanotechnology could help the EU to take the lead in this promising research field as recent survey results suggest that a majority of Americans, based on religious beliefs, find it morally unacceptable. The study carried out by the University of Wisconsin, Madison Survey Center revealed that only 29.5% of Americans find nanotech morally acceptable, whereas significantly higher percentages were observed in Europe. Some 54% of respondents in the UK, 63% in Germany and 72% in France had no moral objection to nanotech.
The reason behind this difference in attitude is religion: those with strong religious convictions view researchers as "playing God" when they create new materials or means to "enhance human qualities" through nanotechnology, biotechnology or stem cell research. However, ignorance has nothing to do with people's moral doubts on nanotechnology as the survey showed that respondents are well-informed about nanotech and its potential benefits.
Source: EurActiv News, February 20, 2008
EU leading in nanotech safety research
A new US study shows EU member states invest nearly twice as much as the United States in research addressing the potential environment, health or safety hazards of nanotechnologies.
While the positive potential of nanotech is acknowledged, good understanding its risk potential is necessary, states the US Project on Emerging Nanotechnolgies (PEN) in a risk research inventory update published on 19 April 2008.
The report argues that "comparatively little US government money has been spent on ensuring that scientists know how to control or prevent possible nanotechnology environmental, health, and occupational and general safety (EHS) risks". Just $13 million (€8.16 million) of the total $1.4 billion (€0.878 million) allocated to the US National Nanotechnology Initiative (NNI ) in 2006 was spent on highly relevant nanotech risk research - despite government claims that it had spent triple that ($37.7 million).
The project argues that at the same time, European countries together invested some $24 million in this type of research. According to the European Commission's implementation report on the EU nanosciences and nanotechnologies action plan 2005-2009, some €28 million of Community funds have been dedicated to projects specifically focused on risk research since 1998. Safety research is said to "significantly increase" in the bloc's Seventh Framework Programme for R&D (2007-2014).
Source: EurActiv News, April 22, 2008
On the rise: nanoemulsion vaccines
Credit: Michigan Nanotechnology Institute
Specialized nanoemulsions--made up of tiny soybean oil droplets suspended in water, studded with bits of pathogenic organisms, and swabbed into the nose--may be the vaccines of the future. Nanoemulsion vaccines, which have previously proved effective against influenza and anthrax, have now been shown to generate immunity to smallpox and HIV in mice.
The technology derives from the cosmetic industry, where nanoemulsions were developed to allow skin creams to easily penetrate through pores and down hair shafts. It is this property that makes the vaccines so successful.
Each miniscule oil droplet--just 200 nanometers in diameter--bears at its surface either all or part of the pathogen targeted by the vaccine. When the nanoemulsion enters the nose, the droplets burrow down into the mucosal tissue and are taken up by immune cells called dendritic cells. Once introduced to their target in this way, the dendritic cells go about mounting an immune response.
Because the nanoemulsion delivers the pathogen directly to dendritic cells, immune-stimulating adjuvants are unnecessary. Because these vaccines are administered through the nose, they produce immunity not just in the bloodstream but also in the mucosal tissues of the nose, mouth, lungs, and urogenital tract.
Regarding HIV in particular, recent studies have shown that shortly after infection, the virus replicates extensively in the genital mucosa. A strong mucosal immune response against the virus would prevent such replication, slowing or stopping the virus before it could reach the bloodstream.
Besides its promise as an HIV vaccine, the new technology also has the potential to radically change the face of smallpox vaccination by obviating the need to use a live virus. The nanoemulsion--which, thanks to the destructive surface tension of its oil droplets, is an effective antimicrobial solution--actually kills the vaccinia virus. But because it shuttles the dead virus directly to dendritic cells, the establishment of cellular immunity is not compromised.
These new smallpox and HIV studies further expand the repertoire of diseases amenable to nanoemulsion vaccines, although no such vaccines have yet been used on humans. Nanoemulsions are uniquely suited to the demands of vaccination in developing countries because the constituent proteins are stabilized, require no needles or costly inhalers, and can survive high temperatures.
Source: MIT Technology Review.com, March 4, 2008
Sigma-Aldrich and MorphoSys ally to provide research antibodies
Sigma-Aldrich and MorphoSys are collaborating to provide research antibodies for specific targets based on MorphoSys' platform through Sigma-Aldrich's distribution capabilities.
MorphoSys' AbD Serotec unit will develop and qualify unique antibodies from the HuCAL GOLD library against targets that Sigma-Aldrich will identify and supply. Sigma-Aldrich will offer these recombinant antibodies for research applications through its online sales platforms Antibody Explorer™ and Your Favorite Gene Search™.
HuCAL GOLD is a phage-display library developed for the in vitro generation of specific and fully human antibodies. The diversity of the library guarantees fast and successful generation of high-quality antibodies to targets that have previously been difficult to probe with standard antibody-generation technologies, according to MorphoSys.
Source: GEN News highlights, February 27, 2008
Approval for Chugal's mab to treat rheumatoid arthritis
On May 9, Roche announced that results from the LITHE study show that Actemra (tocilizumab) can significantly inhibit structural damage to joints in patients with rheumatoid arthritis (RA), a critical measure of effectiveness of an RA treatment. Actemra also improved the patients' physical function after one year of therapy, leading to a better quality of life. The LITHE study is the fifth global phase III trial on Actemra to successfully meet its primary endpoints in patients with moderate to severe RA.
Actemra is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.
Earlier, on April 15, Roche announced that their alliance partner company Chugai has received approval in Japan for the use of Actemra, in patients suffering from rheumatoid arthritis (RA).
Japan is the first market worldwide to get access to Actemra for the treatment of RA. Actemra is awaiting approval in the United States and Europe.
Source: Roche Group Media Relations, Press Release, April 15
Herceptin approved in Japan for early treatment of HER2-positive breast cancer
Roche announced that Chugai Pharmaceutical Co. Ltd received approval from the Japanese Health Authority for use of Herceptin in early treatment for women with HER2-positive breast cancer. The approval was based on the impressive HERA (HERceptin Adjuvant) study results demonstrating that Herceptin significantly reduced the risk of death and recurrence by more than one third (34% and 36% respectively), in women with HER2-positive early-stage breast cancer when given following surgery and standard chemotherapy. HER2-positive breast cancer affects approximately 20% to 30% (2) of women with breast cancer.
Prior to Herceptin, these patients had a particularly poor outlook because of the aggressive nature of their HER2-positive cancer.
Evidence that Herceptin benefits patients with HER2-positive breast cancer across all stages of the disease continues to mount, with more than 450,000 patients worldwide treated and a huge clinical study programme ongoing that includes women with early breast cancer, women with advanced (metastatic) breast cancer and women who need further treatment when their disease comes back.
Herceptin (trastuzumab) is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche.
Source: Roche Group Media Relartions Press release, February 26, 2008
Plucking cells out of the bloodstream
Bioengineers at the University of Rochester have developed an implantable device that captures very pure samples of stem cells circulating in the blood. The device, a length of plastic tubing coated with proteins, could lead to better bone-marrow transplants and stem-cell therapies, and it also shows promise as a way to capture and reprogram cancer cells roaming the bloodstream. The company CellTraffix is commercializing the technology.
The new device mimics a small blood vessel: it's a plastic tube a few hundred micrometers in diameter that's coated with proteins called selectins. Selectins cause [some] cells to stick and slow down. Different types of selectins associate with different kinds of cells, including platelets, bone-marrow-derived stem cells, and immune cells such as white cells.
In an upcoming publication in the British Journal of Hematology, it will be reported that selectin-coated microtubes implanted in rats can capture very pure samples of active stem cells from circulating blood.
CellTraffix CEO Tom Fitzgerald says that the company's first product, a kit that will enable researchers to capture large numbers of stem and cancer cells in the lab, will likely reach the market early next year. The company hopes to begin clinical testing of the anticancer coatings by early 2010.
Source: MITTechnologyReview.com, February 13, 2008
Mini Stem-Cell Labs
Credit: Science Magazine
Scientists at Northwestern University have engineered a "miniature laboratory" in the form of a tiny, gel-like sac, in which they successfully grew stem cells, delivering proteins and nutrients to the cells through the sac's membrane. Researchers say that the sac may act as a delivery system for stem cells and other drugs, shielding them until they reach their target.
Researchers developed the sac from a combination of two molecules: a peptide amphophile (PA), a synthetic molecule that was developed seven years ago, and hyaluronic acid (HA), a molecule found in joints and cartilage. The team first poured the PA solution in a large vial, then added the HA solution. Almost instantly, the two liquids began to solidify at the point of contact. The lighter PA molecules surrounded the HA molecules, sealing them in to create a single pouch, or sac. Interestingly, the sac continued to grow even after its formation, expanding and creating a thicker membrane the longer it remained in solution. Researchers stopped its growth by simply removing the sac from the vial with a pair of tweezers. The scientists can tailor the sac's size and thickness by simply leaving it in solution for various lengths of time.
In a second round of experiments, the team combined stem cells with the HA solution, then poured the mixture into a vial with PA molecules. This time, the PA molecules encapsulated both the HA molecules and the stem cells. Researchers added specific proteins to the solution and found that they penetrated the sac's membrane despite its thickness. These proteins stimulated stem cells to differentiate into cartilage, effectively creating a miniature stem-cell laboratory inside the sac.
Such sacs may provide safe, enclosed environments in which to grow stem cells before transplanting them into the body. As a delivery vehicle, the sacs can be grown small enough to travel through the bloodstream, or robust enough to be sutured onto a target tissue or organ.
In the next year, the team plans to grow other cells within these sacs and study the growth of tumors, for example, in reaction to specific drugs or molecules. You can also have colonies of different cells in different sacs together--a raspberry of sacs--and you can expose them to multiple signals. This might be valuable in cell biology, studying signals between cells in a three-dimensional environment. Also advantageous is the ability to potentially organize cells into unique structure, which offers the potential to develop specialized tissue structures.
Source: MIT Technology Review, April 2, 2008
EU Life Competence Database
The Life Competence database is an online network and knowledge sharing contact system filled with EU research projects in healthcare biotechnology that have been funded by the EU Commission under FP6. It enables companies, universities, NGOs to find out what research is going on in their area and who are the partners, people and organisations (companies and universities) working in this field. It also enables companies and academia to keep track of the EU projects their organization is involved in or on what their competitors are doing!
The development cost of this project has been funded by the EU Commission for the last two years. Along with partners AVEDAS and the KAROLINSKA INSTITUTE, EuropaBio is looking to continue the project and make it self financing through sponsorships. The database is on http://europabio.euproject.eu/. Interested companies should contact EuropaBio's Secretary-General, Johan Vanhemelrijck, j.vanhemelrijck@europabio.org.
Source: Personal communication EuropaBio
EU funded projects poverty-related diseases
A catalogue can be downloaded (more than 300 pages!!) containing summaries and participants of all FP6 funded projects on poverty-related diseases HIV/AIDS, malaria and tuberculosis.
http://ec.europa.eu/research/health/poverty-diseases/doc/catalogue-3rdcall_en.pdf
Anti-HIV gel fails to prevent infection
Trials of a vaginal gel in South Africa have failed to prove conclusively that it prevents HIV transmission from men to women. The microbicide, Carraguard, underwent phase III clinical trials in 6000 women between 2004-2007. But on February 14 it was published that although safe, the microbicide had been found not effective.
Most women enrolled on the Carraguard trial reported only using the gel before sex some of the time, which could have affected the results, say the researchers. Govender said researchers were now analysing social aspects of the Carraguard data.
Nevertheless, Carraguard will continue to be used in further trials. The Population Council will commence phase I safety trials of a new microbicide, PC-815 - which comprises Carraguard and an antiretroviral drug called MIV-150 - this year.
Carraguard contains carrageenan, a chemical derived from seaweed that is effective against HIV in the laboratory. The addition of an antiretroviral drug to the microbicide should also prevent the HIV from multiplying.
Source: SciDev.Net, February 26, 2008
Avastin now approved for three cancers
Roche announced that Genentech has received U.S. Food and Drug Administration (FDA) accelerated approval for Avastin (bevacizumab), in combination with paclitaxel chemotherapy, for the first-line treatment of patients with locally recurrent or metastatic breast cancer. The approval is based on a phase III study (E2100) which showed that for patients with metastatic breast cancer the addition of Avastin to paclitaxel compared to paclitaxel alone doubled the chance of being alive without the disease advancing ("progression-free survival"). In Europe Avastin received full approval for the treatment of metastatic breast cancer in March 2007.
Avastin is the first anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival benefit for colorectal, lung, breast and, renal cell cancer patients.
Source: Roche press release, February 23, 2008
Merck warned by FDA over vaccine plant failings
The US Food and Drug Administration (FDA) has sent Merck & Co a warning letter saying it has failed to correct a number of manufacturing deficiencies at its main vaccine manufacturing plant in West Point, Pennsylvania. The agency highlighted several areas in which the plant deviated from good manufacturing practices (GMP). For example, Merck is accused of not investigating why some batches of product were outside of specifications, as well as "failure to maintain production and process control," according to the FDA.
Merck issued a recall for two vaccine products made at the plant - the childhood combination vaccines PedvaxHIB and Comvax - at the end of last year after some lots were found to have contamination problems. It also recently had three lots of its MMR II (measles, mumps and rubella) vaccines suspended by Health Canada after serious allergic reactions were seen among some recipients.
Other products made at the West Point facility include Merck's much-touted new cervical cancer vaccine Gardasil, as well as established products such as Vaqta for hepatitis A and Recombivax HB for hepatitis B. However, the FDA said it did not expect supplies of these products to be interrupted as a result of the warning letter.
News of the manufacturing problems come at a time when Merck is seeing remarkable growth in its vaccines business and has positioned the division as a key growth driver in the coming years. First quarter vaccine sales rose 9 per cent to just under $1bn, with Gardasil accounting for $390m of that total.
Source: In-Pharmatechnologists News, May 5, 2008
Sweden recalls Sanofi's enoxaparin after OSCS contamination
Swedish authorities have recalled Sanofi Aventis' low molecular weight injectable blood thinner Lovenox (enoxaparin), known locally as Klexane, after four batches of the blockbuster drug were found to contain oversulfated chondroitin sulphate (OSCS). OSCS has been previously identified as a contaminant in batches of Baxter's unfractioned heparin product that has been linked to around 81 deaths in the US.
So far, however, no adverse reactions had been observed in Sweden and the recall is a precautionary measure. Sanofi found the contaminated batches using the nuclear magnetic resonance based testing procedure that it instituted on 1 April this year. The contamination had not been identified in either of the two competitor low molecular weight products sold in the country, Fragmin (dalterapin sodium), sold by Pfizer, or Leo Pharma's Innohep (tinzaparin sodium), or indeed in the fractionated heparin that is also marketed by the latter firm.
Meanwhile, US investigations into the OSCS found in Baxter's products are ongoing. It appears that the contamination appears to be a result of a deliberate and widespread switching of raw materials in China.
Source: www.In-pharmatechnologist.com, April 30, 2008
Pfizer to build 190m Irish biologics plant
Pfizer's plans for a new €190m manufacturing plant in Shanbally, Ireland suggest that the firm is intent on fulfilling its pledge to become a "top five biologics producer in the next eight years."
The facility will produce small quantities of candidate drugs for clinical trials, creating around 100 jobs when it becomes operational at the end of 2009. More specifically, it will manufacture and purify a variety of mammalian cell derived proteins at pilot scale on behalf of PGR&D [Pfizer Global Research and Development].
The investment is in marked contrast with Pfizer's ongoing programme of cost cutting and restructuring which, as recently as last month, saw chief financial officer Frank D'Amelio announce plans to reduce its number of production facilities to 44 by the end of 2009.
Additionally, the plant is a further indication that Pfizer is looking to biologics to bolster its portfolio ahead of the impending loss of patent protection for some of its highest earning products. In recent years, the firm has developed its biotechnology arm with the acquisition of a number of specialists, including ConvX and PowderMed, in 2006 and 2007.
Source: www.In-pharmatechnologist.com, May 7, 2008
New continuous reactor offers advantages
UK-based AM Technology has developed the Coflore Agitated Cell Reactor (ACR) which it claims offers significant advantages over traditional continuous stirred tank reactors. The ACR is a multistage continuous stirred tank reactor (CSTR) the size of a kitchen microwave for reactions taking between 10 seconds and over 100 hours.
AM Technology founder Robert Ashe said the intention when developing ACR was to create a reactor which competed "with oscillating flow reactors (OFR) and traditional multi-vessel CSTR but was much simpler and cost less than its competitors."
The ACR uses a series of ten reaction cells linked by channels cut into a metal block instead of multiple reaction tanks. One side of the metal block is a cooling plate to facilitate heat transfer. The reactive mixture flows through channels to the cells sequentially. Within each cell is a free moving agitator element; the agitators sequentially decrease in size. This insures a uniform level of reaction in each cell.
When draining the mixture the cell block oscillates, so that the product that entered the reactor first, leaves it first. This is performed without the need for flush fluid and ensures that almost 100 per cent of the product is recovered, an important consideration when dealing with valuable material.
Source: In-pharmatechnologists News, May 5, 2008
BioInvent's development pipeline
In March, company BioInvent reached an agreement with Bayer HealthCare for research and development of new antibody-based drugs. Under this agreement up to 14 projects could be developed.
BioInvent is currently running three projects in the development phase.
(1) Thrombosis (TB-402), a human antibody binding to Factor VIII. Extensive testing in several animal models has shown that TB-402 strongly reduces the risk of thrombosis without increasing the risk of bleeding. The project is carried out within the alliance with ThromboGenics NV.
Results of the completed Phase l trial show that TB-402 is both safe and well-tolerated. No serious adverse events related to TB-402 were reported. Preparatory work for the Phase II trial is underway.
(2) Atherosclerosis (BI-204).The product candidate BI-204 targets oxidized forms of the LDL cholesterol (oxLDL). BI-204 has in preclinical studies reduced inflammatory processes and reduced plaque formation significantly. BI-204 is developed in collaboration with Genentech, Inc.
In January 2008 BioInvent and its partner Genentech initiated a Phase I study in Denmark.
(3) Cancer (TB-403). The product candidate TB-403, aimed at the PlGF growth factor, has in preclinical studies demonstrated good specificity for the target protein PlGF and inhibition of PlGF-associated angiogenesis and tumour growth in animal models. The project is being developed within the framework of the alliance with ThromboGenics NV.
In preclinical development is:
(4) Cancer (BI-505)
The drug candidate BI-505 is a human antibody that targets the adhesion protein ICAM-1 (also called CD54). In tumour cells the expression of ICAM-1 is elevated and it is therefore a candidate for being a suitable target protein for a therapeutic antibody. In addition to inducing apoptosis the antibody also provides important immuno-effector functions that help to kill tumour cells. BI-505 has in different animal models proved to be very effective at killing tumours and more effective than existing drugs.
BI-505 is in the preclinical development phase, the stage preceding clinical trials. The company is currently scaling up production processes in order to be able to produce material for planned preclinical and clinical studies.
Source: Press Release BioInvent, April 10, 2008. More at www.bioinvent.com
Roche strengthens R&D pipeline with P13-K pathway research
Roche announced that it will acquire Piramed Limited, a privately-owned UK company focusing on therapeutics targeting PI3-kinase (PI3-K). The PI3-K pathway is known to play an important role in disease progression and in resistance to chemotherapeutics in cancer cells. Pre-clinical studies have demonstrated the activity of PI3-K inhibitors in a broad range of tumours such as breast and lung cancer, as well as their potential importance in treating inflammatory diseases such as rheumatoid arthritis.
Through this acquisition, Roche's R&D pipeline is strengthened by Piramed's two major research programmes targeting PI3-K-alpha in oncology and PI3K-delta in inflammatory disease. The PI3-K-alpha programme has a compound in phase I of clinical development and is currently being developed in collaboration with Genentech, in whom Roche has a majority ownership interest. The previously unpartnered PI3-K-delta programme, while at a pre-clinical stage, will be integrated into the Roche Group's inflammatory R&D portfolio.
Source: Roche Group Media Relations, Press Release. April 15, 2008
New Secretary General EuropaBio
Following the retirement of Dr. Johan Vanhemelrijck on July 1st 2008, Willy De Greef (53) will become the new Secretary General of EuropaBio.
Willy De Greef is a plant biologist with extensive experience in tropical crop breeding (through research management positions in the Democratic Republic of Congo, Malawi and Cameroon) and in technology transfer related to agricultural biotechnology. He has been head of regulatory affairs for two biotechnology leaders, Plant Genetic Systems in the 1980s, and Syngenta Seeds from the late 1990s until 2003. He has been involved in the policy and public debate around agricultural biotechnology (OECD, UNIDO, Biodiversity Convention, Cartagena Biosafety Protocol) and in the development of the regulatory framework since 1986. He has contributed to the development of rational regulatory frameworks for biotechnology for developing countries and in capacity building for biotechnology researchers in the developing world in biosafety assessment and regulatory compliance. Recently he has been head of regulatory affairs and new projects for D1 Oils Plant Science, a biofuel company.
Source: EuropaBio Press Release, April 15 2008
BioForum VII - Biotechnology and Biobusiness Trade Fair
15-16 May 2008 , Lodz, Poland
Information: 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
EuropaBio's 1st European Forum for Industrial Biotechnology 2008
September 15-17, Brussels, Belgium
Information: www.efib2008.com
European Bioperspectives
Oct 7-9, Hanover, Germany
nformation: www.bioperspectives.org
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
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