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Next meeting ACTIP:
The next plenary meeting of ACTIP will be held in Cambridge, UK on
November 17-18, 2008
and is hosted by MedImmune. The meeting will focus on novel approaches in antibody discovery and technology, as well as antibody production.
In this issue:
Top 8 pharma industry issues
News from the Commission
Business news
Manufacturing and facilities
Drug discovery and development
Monoclonal antibody news
Stem cell news
Research News
Useful websites
Agenda
Borgas sets out top 8 pharma industry issues
The pharmaceutical industry must adapt its processes and strategies to cope with a new tougher operating environment, according to Stefan Borgas, CEO of Lonza, in a recent speech delivered to the European Fine Chemicals Group.
- Science, not marketing. Industry should continue to veer away from being marketing-led, which was instituted in the 1990s. More science-based operations will also better use university innovations, now a fairly untapped source.
- More careful regulators. Public anger at side effects and litigation have contributed to a tougher regulatory environment. Advice: do not fight it, but invest in new quality systems and traceability processes.
- More patients. More patients as a result of opening markets lead to more drugs sold but also lower prices. Capacities must grow, with greater integration of production, formulation, sales and distribution;
- Intellectual property. Pressure to make cheap drugs available in less developed countries should lead to collaboration with global agencies to clarify and standardise the rules for generics;
- Pricing pressures: only 10% of a drug’s price is in the molecule. Cut costs back through innovation and make those efforts transparent.
- End of blockbuster model: targeted drugs, delivered to smaller patient groups, means more flexibility and scalability in manufacturing;
- Production overcapacity: overcapacity for the manufacture of chemical ingredients is 60%. Biologics capacity looks to follow the same path. Continue to close plants and build newer ones with greater efficiency.
- Substance quality. The outsourcing model as a whole should be questioned, with recent scandals and substandard antibodies.
Source: www.In-pharmatechnologist.com, October 23, 2008
News from the Commission
Single access point to research careers in Europe launched
Language and cultural barriers as well as fragmented information on available career opportunities are currently hindering researchers' mobility in Europe, said Science and Research Commissioner Janez Poto?nik at the launch of 'EurAxess' on 24 June.
EurAxess
a pan-European initiative by 35 European countries, is a new web portal which aims to facilitate researchers' access to information on their mobility options and help them pursue a career in Europe. It provides a single access point for job offers, assistance for professional stays in a foreign country, information on the rights and duties of researchers and their employers as well as access to a network of European researchers working outside Europe.
It thus regroups four existing EU initiatives to promote researchers' mobility and career development: the European Researchers' Mobility Portal, the ERA-MORE Network, the European Charter & Code for researchers and their recruitment and the ERA-Link.
As part of the relaunched European Research Initiative the Commission last month adopted a Communication on creating better careers and more mobility for researchers. Among the EU executive's proposals was the creation of pan-EU pension schemes targeted at researchers.
Source: EurActiv News, June 26, 2008
Technology platforms failing on R&D commercialisation
More regulatory and standardisation efforts are needed to help translate research results into new products and services, concludes an independent evaluation of the European technology platforms (ETPs).
It is clear that the 30-odd ETPs launched by the EU since 2003 have contributed to more R&D investment and helped to overcome EU research fragmentation, said Research Commissioner Janez Poto?nik at a meeting of the platforms' industrial leaders on 30 September. However, he noted that a recent evaluation of the platform had "identified some areas where we might consider changing the way in which ETPs work".
The evaluation shows that industry has not made as much progress as expected. In particular, the practical results are still very low-level and disappointing. In addition, the ETPs fail to make research results more easily translatable into new products and services. To remedy the situation, the evaluation recommends that ETPs "move beyond scientific and technological challenges" and instead start focusing on the application of research results. Those platforms which are more advanced and have already developed their SRAs should focus on "the regulations and standards that affect the commercialisation of research".
In addition, the evaluation concludes that the platforms have "underachieved" regarding the identification of future education and training needs and recommends the introduction of more initiatives in this field in the near future.
Source: EurActiv News, October 3, 2008
EU innovation institute to be open to world
Universities, researchers and businesses from outside Europe "are not out of the game," said Bálint Magyar, a former minister of education and current member of the Hungarian Parliament, as he revealed operational details of the EIT, the EU's pet project for boosting research and innovation in its 27 member states, in the interview. But the main focus of the future Knowledge and Innovation Communities (KICs) would be in Europe and their actors would "have to be European".
Climate change, renewable energy and the next generation of information and communication technologies (ICT) have featured among the planned focus areas for KICs.
As for the structure of the new EU institute, Magyar revealed that it will employ 60 people, the number considered "optimal" by the Commission. No fixed physical location had yet been designated for the institute in its host city, Budapest. A decision on where this "3,000 m2" building will be located would be taken later, he said, adding that it needed to stay somewhere else "for a transitional period".
The governing board was currently determining the criteria for the first tenders, to be published and evaluated in 2009. The winners of these EIT tenders will start implementing their projects in 2010, providing the institute's first tangible results.
Source: EurActiv News, September 22, 2008-09-29
Commission seeks end to EU-27 'research labyrinth'
The EU executive is calling on member states to take seriously its recent call for joint priority-setting and joint action on science and research policy and implement a coherent EU framework for scientific cooperation with non-EU countries if it is to remain a leading actor, particularly in the field of information and communication technologies (ICT).
"Our international partners are attracted by Europe as a model of regional integration, but they are faced with a multitude of governmental actors and research priorities when they want to engage in concrete cooperation," said Science and Research Commissioner Janez Poto?nik, presenting a Commission proposal  for an EU framework for international scientific cooperation on 24 September.
According to Poto?nik, the EU 27 need to get their act together and "transform Europe's research labyrinth into a European Research Area [ERA] open to the world, attracting the best brains and contributing to address global challenges".
The overall aim of the proposal is to encourage EU countries to work together with the Commission to identify and agree on joint scientific cooperation activities with partners in important third countries. Brussels stressed key partners would be those with whom cooperation brings "clear added value for Europe in addressing key global challenges" and promoting both EU policy goals and global sustainable development.
Source: EurActiv News September 25, 2008
Parliament demands ban on animal cloning for food
On September 3, the European Parliament called on the Commission to submit proposals prohibiting the use of cloned animals in food products following the publication of a highly cautious report by the EU's food safety authority on the issue. The parliamentary resolution was adopted by 622 MEPs in favour with just 32 against amid 25 abstentions.
It calls for an EU-wide ban on food from cloning animals; on farming cloned animals or their offspring for food supply purposes; on placing meat or dairy products derived from cloned animals or their offspring on the market, and; on importing cloned animals, their offspring, semen or embryos as well as meat or dairy products derived from cloned animals or their offspring.
The move follows the publication of a highly cautious scientific opinion by the European Food Safety Authority (EFSA) on the implications of animal cloning on food safety, animal health and the environment (EurActiv 25/07/08).
While EFSA had found that "food safety concerns are considered unlikely," it warned that the lack of available data on the subject meant the risk assessment was plagued by uncertainty and should be reconsidered at a later date. The EFSA report had also highlighted the "significant animal health and welfare issues" faced by cloned animals compared to conventionally bread ones.
Source: EurActiv News, September 4, 2008-09-10
Business News
GE unveils new AxiChrom columns
GE Healthcare’s range of AxiChrom columns will simplify manufacturing operations, improve reproducibility and allow for faster change over.
The columns, which will initially be available across the 50 to 1,000mm diameter range, feature GE’s new Intelligent Packing system, which provides an automated preparation method that ensures optimal and reproducible compression. The technology can significantly reduce the level of operator expertise required. Studies indicate that packing conducted using the system has a 95 per cent success rate, which is much higher than for alternate approaches. Another feature of the AxiChrom range is their reduced maintenance time, since they can be serviced in a little over an hour, rather than the full day required by older chromatography apparatus.
Although the line offers a wide range of column diameters, providing reproducible chromatography options for drugmakers scaling up production, GE has plans to develop a 4,000mm version for very large manufacturing runs.
Source: www.In-pharmatechnologist.com, October 9, 2008
Solvay triumphs in acquisition Innogenetics with $316M offer
The bidding battle between Solvay Pharmaceuticals and Gen-Probe over Innogenetics has come to an end, with Solvay the winner. Solvay’s latest offer values molecular diagnostic firm Innogenetics at €200.7 million, or $316.04 million. The $6.50 per share represents a 74% premium to Innogenetics closing price on April 24, the day before Solvays made the initial offer. Solvay expects to close the transaction in the second half of this year.
Source: Gen News Highlights July 9, 2008
Invitrogen willing to pay $6.7B for Applied Biosystems
Invitrogen reports that it is willing to pay $6.7 billion for Applera’s Applied Biosystems through a cash and stock transaction. This combination will create a formidable supplier of reagents and systems, expected to generate approximately $3.5 billion in combined sales.
Invitrogen expects that the merger should generate a run rate of approximately $125 million in cost savings by the third year. An important area that will help the combined company save money will be in the purchasing of raw materials as well as equipment and services to run the firm. Also, they will get rid off redundant resources including staff, especially in the sales and support department, since the two companies have similar products and thus similarly focused sales teams. Consolidation of manufacturing facilities are seen as another way the entity will look to shave costs.
The new entity will be called Applied Biosystems and will be headquartered in Carlsbad, CA, USA. This transaction combines the industry’s premier consumables provider with the industry’s premier systems provider to create a worldclass biotechnology tools company.
Source: GEN News highlights, June 12, 2008
Manufacturing and facilities
DSM and Crucell announce record achievement in PER.C6® Technology
DSM Biologics and Crucell N.V. announced another breakthrough in the production of IgG antibodies using PER.C6® technology. By employing the PER.C6® human cell line and proprietary XD(TM) technology, a record yield of over 27 grams per liter has been achieved. In March 2008 a yield of 15 grams per liter was reported.
This milestone is the new manufacturing paradigm for mammalian cell culture to produce protein products effectively, where the industry has struggled to date with low yields and unstable platforms. This record surpasses all other production systems including those previously set by PER.C6® technology itself.
Scientists at PERCIVIA PER.C6® Development Center, a joint venture between DSM and Crucell, have shown that they can reproducibly manufacture a record amount of product with over 95% viability and unchanged product quality. This accomplishment was achieved using standard bioreactor equipment and readily available cell culture medium. The result of this effort provides the entire biotechnology industry with a reliable production platform to economically manufacture large amounts of therapeutic proteins with ease.
Source: DSM and Crucell Press Releases, June 16, 2008
Rentschler and Boehringer Ingelheim offer combined production services
Rentschler Biotechnologie and Boehringer Ingelheim inked a preferred partnership agreement that allows their respective clients to use the other’s facilities. Rentschler’s clients will have access to Boehringer Ingelheim’s large-scale mammalian biopharmaceutical production plants in Biberach, Germany. Also, Boehringer Ingelheim’s clients will be able to use Rentschler’s facilities for process development and intermediate-scale clinical supply production.
The firms believe that companies will benefit from the combined development and manufacturing know-how and facilities, leading to increased flexibility and ultimately more customized services.
Rentschler Biotechnologie is a CMO focused on process development and small-to-medium scale production of mammalian cell-derived biopharmaceuticals. The company currently operates eight independent GMP lines with fermentor volumes of up to 500 L. A 2,500 L fermentor was recently qualified as well, according to the firm. Boehringer Ingelheim offers similar services with technologies optimized for large-scale industrial production. The company runs one of the largest biotech facilities with fermenter volumes of up to 15,000 L.
Source: GEN News highlights, May 21, 2008
AmVac and Bayer to develop plant-based production process for flu vaccine
AmVac is commencing a research program with Bayer Innovation on a novel production approach for an influenza vaccine. Antigens will be produced, reportedly for the first time, in tobacco plants, which along with AmVac AG's adjuvant MALP-2 are to be developed into a new generation of flu vaccines.
The research unit for the preclinical work has been opened on June 12 at the Parco Scientifico e Tecnologico in Catania, Sicily. Joint R&D work will begin with Bayer’s subsidiary Icon Genetics.
By switching the production base to plants, the Icon Genetics’ magICON technology enables shorter expression times compared with current methods, according to the firms. Also, using tobacco plants means that there will be no contamination by animal proteins such as egg protein. It also has the potential to reduce production costs, the collaborators report.
The ultimate goal is to achieve preclinical results locally as soon as possible and to prepare effectively for any clinical trials.
Source: GEN News highlights, June 12, 2008
Merck opens dedicated technology training centre in Taiwan
Merck KGaA opened the Asian Technology Training Centre in Xihzi City, Taipei County, Taiwan. The Centre will help local customers that use Merck’s chromatography products for the production of biologic drugs and is a reflection of Taiwan’s bioprocessing infrastructure. By now, Taiwan boasts three science bases: Hsinchu; the Central Taiwan Science Park and the Southern Taiwan Science Park. The three science park’s alone already generated more rtan USD 60.8 bn last year.
This infrastructure has proved very attractive to industry players like Applied Biosystems, Invitrogen, Dionex and Novartis, which, in addition to Merck, have all established a presence in the country. Since 2007 Taiwan has launched further measures to encourage both national and international and local biotechnology companies. These measures include a 35% tax break on R&D spending and the insistence that all mabnufacturers comply with EU inspection rules.
Source: www.In-pharmatechnologist.com, October 28, 2008
Spain’s first therapeutic protein plant due in 2009
Spanish biotech company 3P Biopharmaceuticals is on course to complete its therapeutic protein manufacturing plant in Noain, Spain at the start of 2009.
The plant will be the first in Spain to produce therapeutic proteins for laboratories and pharmaceutical companies. An investment of €15m has been made to construct the plant.
Source: www.In-Pharmatechnologist.com, August 11, 2008
Lonza opens Guangzhou engineering services unit
Lonza hopes that the new business it has set up in China will help cement its position as a leading provider of services to the country’s pharmaceutical manufacturing sector.
The unit, which is based in China’s Guangzhou Nansha economic development zone, became operational on August 1 and the main business focus will be to manage projects and to perform maintenance services for industrial clients. The business scope also includes the design and fabrication of complex modular production systems.
At present, Lonza has several production, R&D and sales operations in China. The company is a major producer of niacinamide (vitamin B3) for drug and nutraceutical manufacturers in the region.
Lonza’s existing set up In Guangzhou also produces active pharmaceutical ingredients (API), chemical intermediates and other products for the pharmaceutical sector.
The firm established a small scale plant in late 2007 and plans to begin large scale operations at the facility in the fourth quarter this year. In addition, In Liyang, Lonza operates a plant producing pyromellitic acid and pyromellitic dianhydride, while in Nanjing it is constucting a microbial control plant.
Source: www.In-Pharmatechnologist.com, August 6, 2008
Rentschler sells drug division and invests in biotech production facility
Contract development and manufacturing specialist Rentschler has set its sights firmly on the biotechnology market with the announcement of a €14m ($22m) investment in its production facility in the southern German city of Laupheim.
The move, which comes only months after the completion of €50m worth of development work at the site, coincides with the sale of Rentschler's pharmaceutical division to fellow German company Riemser Arzneimittel.
The divestiture coupled with the increased biotechnology investment is clearly an indication of Rentschler's belief in Europe's developing biotechnology contract research and manufacturing services (CRAMS) sector.
At present, the firm has nine stand-alone GMP suites with volumes of 30, 250, 500 and 2,500 litres, allowing the production of material for clinical trials and for market supply. The range of services also comprises the sterile filling of pre-filled syringes and injection vials.
Source: www.In-Pharmatechnologist.com, July 15, 2008
Roche invests in diagnostics facility at Penzberg
Roche is investing 215 million Swiss francs (136 million euros) in research, development and production at its site in Penzberg, near Munich. The money will be used to construct a multi-purpose building for Roche Diagnostics. The new building will house laboratories and production facilities for the Roche Applied Science and Roche Professional Diagnostics business areas. The building will be used by both the Development and Production departments. From about the middle of 2010, the complex will be manufacturing products ranging from biotech constituents for immunodiagnostics and the life-science market through to complete immunodiagnostic test kits. These test kits are used worldwide in diagnostic systems such as COBAS and Elecsys.
Source: Roche Group Media Relations Press Release, October 1, 2008
Sanofi invests in Chinese clinical R&D capacity
Sanofi-Aventis intends to expand its clinical research unit in Shanghai, China, and intends to develop it into its Asian R&D hub. The facility, established in 2005, has already been involved in several global registration studies. The new Centre will support global Phase I-IV studies, and will also ramp up local registration work and broaden the scope of clinical operations in China.
Drug discovery is another important aspect, as witnessed by its new deal with the Shanghai Institutes for Biological Sciences (SIBS), which represents 8 of the country’s top scientific institutes.
Source: www.In-pharmatechnologist.com, October 23, 2008
GSK to shut Crawley plant
GlaxoSmithKline (GSK) plans to close its plant in Crawley, UK by the end of 2011. At present, the facility manufactures both the Parkinson's disease drug Requip (ropinirole HCl) and the beta blocker Coreg CR (carvedilol phosphate), as well as various treatments for HIV/AIDS, skin infection, depression and hypertension.
The closure is part of the GSK restructuring plan, announced last October. Regrettably these have resulted in the proposed closure of the manufacturing site based in Crawley with inevitable job loses.
Source: www.In-Pharmatechnologist.com, July 15, 2008
Drug discovery and development
AmVac and Bayer to develop plant-based production process for flu vaccine
AmVac is commencing a research program with Bayer Innovation on a novel production approach for an influenza vaccine. Antigens will be produced, reportedly for the first time, in tobacco plants, which along with AmVac AG's adjuvant MALP-2 are to be developed into a new generation of flu vaccines.
The research unit for the preclinical work has been opened on June 12 at the Parco Scientifico e Tecnologico in Catania, Sicily. Joint R&D work will begin with Bayer’s subsidiary Icon Genetics.
By switching the production base to plants, the Icon Genetics’ magICON technology enables shorter expression times compared with current methods, according to the firms. Also, using tobacco plants means that there will be no contamination by animal proteins such as egg protein. It also has the potential to reduce production costs, the collaborators report.
The ultimate goal is to achieve preclinical results locally as soon as possible and to prepare effectively for any clinical trials.
Source: GEN News highlights, June 12, 2008
Lonza to co-develop Novartis biologics
Lonza is to co-develop and manufacture Novartis' biological pipeline as part of a long term strategic partnership that has been struck between the companies.
The deal gives Novartis access to the most advanced technology and processes available to develop new biological medicines faster for the benefit of patients. At the same time, it allows Novartis to delay investments into manufacturing.
Upon successful development of a product Novartis can choose to shift production in-house or continue to use Lonza's facilities.
Financial details of the deal have not been disclosed but it represents a significant coup for Lonza, which through the agreement is branching out beyond its typical contract manufacturing work to a joint development project.
Biologics now make up around 25 per cent of the drug candidates in Novartis' pipeline, with the company putting a strategic focus on their development.
Source: www.In-Pharmatechnologist.com, July 15, 2005
Enlight Biosciences seeded with $39M to challenge high attrition rates in R&D
Pfizer, Eli Lilly, Merck & Co. are investing $39 million to form a company to address the issue of high attrition rates in drug development. The new entity, Enlight Biosciences, has been cofounded by PureTech Ventures and academic researchers. Enlight will develop technologies in a precompetitive model according to what its founding members require. All three firms will have access to any technology or tests developed.
Enlight Biosciences has reportedly already begun studies in molecular imaging, biologics, and drug delivery. The company will work on technologies that: increase the likelihood of success for drugs that pass early development milestones, help with early prediction of human response, provide accurate readouts of animal and human response to intervention, such as molecular imaging and biomarkers, and make promising chemical and biological compounds better suited to human treatment in terms of formulation and drug delivery.
Source: Gen News highlights July 10, 2008
Monoclonal antibody news
CytoDyn starts candidate HIV MAb production
New Mexico-headquartered drugmaker CytoDyn has begun the good manufacturing practice (GMP) standard production of the developmental candidate anti-HIV monoclonal antibody Cytolin (lymphocyte function-associated antigen-1).
While the agent has yet to be fully humanized, animal studies and anecdotal data from its off-label use in volunteers with advanced disease indicate that it can help maintain the functioning of the immune system in infected individuals.
Cytolin belongs to a new class of biologics that prevent the destruction of the immune system during human infection. While other non human primates can catch both HIV and analogous agents such as simian immunodeficiency virus (SIV), the viruses only cause disease in humans due to a characteristic flaw in the human immune response that causes the proliferation of CD8 T lymphocytes.
While Cytolin does not stop this proliferation, it is designed to interact with the LFA-1 protein on the surface of killer CD8 lymphocytes, preventing the molecule from directing the destruction of CD4 helper cells. As a result, CD4 cell levels are maintained at a sufficient threshold to control HIV infection for an extended period, potentially arresting the transition from long-term infection to AIDS.
CytoDyn will use the murine version of Cytolin, for which there is already a considerable amount of human experience, to conduct a randomized trial to supplement data from an earlier Phase Ib/IIa study. The firm aims to complete the trial before the end of the year.
Source: www.In-Pharmatechnologist.com, July 7, 2008
Daiichi Sankyo gets access to Seattle Genetics’ Antibody-Drug Conjugate Platform
Daiichi Sankyo obtained a license to Seattle Genetics’ antibody-drug conjugate (ADC) platform for use in solid tumors for $4 million upfront. Under the exclusive, worldwide agreement, Seattle Genetics will also receive progress-dependent milestone payments and mid-single digit royalties on worldwide net sales of resulting ADC products.
Daiichi Sankyo will leverage the technology to target a single antigen found on multiple types of solid tumors. ADCs utilize the targeting ability of mAbs to deliver potent, cell-killing payloads to specific cells, according to Seattle Genetics. To date, the firm has generated more than $65 million through ADC technology license agreements with numerous companies including Genentech, Bayer, CuraGen, Progenics, and AstraZeneca.
Source: Gen News Highlights July 8, 2008
Actemra shows superiority over current standard of care in rheumatoid arthritis
The novel rheumatoid arthritis drug Actemra (tocilizumab) has shown superiority over the current standard of care, methotrexate (MTX), by achieving a greater reduction of signs and symptoms (e.g. swollen and tender joints) at 6 months in patients suffering from rheumatoid arthritis (1). This positive outcome makes Actemra the first and only biologic therapy to have achieved superiority over MTX.
Furthermore, nearly three times as many patients treated with Actemra achieved disease remission (as defined by the globally recognised measure DAS28 <2.6) (2), the ultimate goal of treatment in this currently incurable condition. The outcome is significant as RA is a debilitating long-term disease and current medicines give little hope of remission or cure – as such new treatment options are urgently needed.
Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development program of five Phase III trials was designed to evaluate clinical findings of Actemra. The five studies have reported meeting their primary endpoints. Actemra is awaiting approval in the United States and Europe. In Japan, Actemra was launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan.
Source: Roche Media Communication, June 12, 2008
MabThera delays disease progression Leukaemia
Roche announced that a Phase III study investigating MabThera (rituximab) in combination with chemotherapy has shown a significant improvement in progression free survival in patients with relapsed or refractory Chronic Lymphocytic Leukaemia (CLL), the most common form of adult leukaemia.
The pivotal REACH trial successfully met its primary endpoint by showing that patients treated with MabThera in combination with the current standard chemotherapy were able to significantly extend the amount of time they lived without their disease progressing, compared to patients treated with chemotherapy alone. Preliminary analysis of the safety data is in line with previous trials.
Source: Roche Corporate Communications, October 8, 2008
Roche gains access to new screening platform for antibody therapeutics
Roche and ARIUS Research Inc. have announced that the two companies have signed a definitive agreement for Roche to acquire ARIUS in an all-cash transaction at a price of approximately C$191 million. ARIUS is the developer of a proprietary antibody platform called FunctionFIRST, which rapidly identifies and selects antibodies based on their functional ability to affect disease before progressing into clinical development. The FunctionFIRST platform will allow Roche to further strengthen its developmental portfolio, initially within the areas of oncology and inflammatory diseases where this new technique offers potentially broad therapeutic applications.
The FunctionFIRST approach provides Roche with a large library of antibodies from which they can identify the best new drug candidates for the development of clinically differentiated medicines."Roche's capabilities in biopharmaceutical research, development, manufacturing and commercialisation offers ARIES the ideal opportunity to realise the full potential of their approach and pipeline of candidate drugs."
Source: Roche Group Media Relations Press Release, July 23, 2008
Continuing Herceptin treatment prevents disease progression in women with aggressive metastatic breast cancer
New data presented at the American Society for Clinical Oncology Annual Meeting (ASCO) demonstrate that Herceptin helps women with advanced (metastatic) HER2-positive breast cancer live longer without their cancer progressing. The final analysis of the randomized phase III GBG-26 study showed that Herceptin continued to work in women who needed additional treatment after their cancer progressed during previous Herceptin treatment.
GBG26 is the first randomized phase III study conducted in women with HER2-positive breast cancer that require additional treatment for their advanced disease and have received Herceptin as part of their initial therapy. The study reinforces that Herceptin works across all stages of the disease and confirms its position as the foundation of care for HER2-positive breast cancer.
Source: Roche Media Relations, May 30, 2008
BioInvent and ThromboGenics report positive Phase I results for anti-PlGF cancer therapeutic TB-403
BioInvent International AB and co-development partner ThromboGenics NV reported that the results from the first Phase l study of novel anti-cancer agent TB-403 showed that it is safe and well tolerated, with pharmacokinetic properties enabling it to be developed for the treatment of cancer. The companies also announced that they have received approval from the regulatory authorities in Denmark to initiate a second repeat-dose Phase I clinical trial of TB-403 in patients with advanced solid tumours.
TB-403 is a monoclonal antibody that targets the angiogenic factor PlGF (placental growth factor). The product has demonstrated inhibition of PlGF-associated angiogenesis and tumour growth in animal models, without affecting healthy tissues. The completed Phase I study was a double-blind, randomised trial testing a single-dose of TB-403 at three escalating levels or placebo in 16 healthy male subjects. The results of the trial have shown that TB-403 met both primary endpoints regarding safety and tolerability, and secondary endpoints examining pharmacokinetics. These results have provided the basis for a safe and efficient introduction of the compound into a subsequent repeat-dose trial in patients for which BioInvent and ThromboGenics have now received approval.
The second Phase I trial will be a study of tolerability, pharmacokinetics and pharmacodynamics in patients with advanced cancer. Up to 30 patients with metastatic or unresectable solid tumours will be enrolled in this open, dose escalation multi-dose study. The study will take place in Denmark and patient recruitment is due to begin shortly.
Source: BioInvent Press Release, June 3, 2008
Genentech, Glycart and Roche collaborate for potential cancer therapy
Genentech, Inc., GlycArt, a company wholly-owned by Roche, and Roche have entered into a collaboration agreement, including a licence from GlycArt to Genentech, for the joint development and commercialization of GlycArt’s GA101 molecule. The companies will be developing GA101, a humanized anti-CD20 monoclonal antibody engineered to increase both direct- and immune-mediated target cell death, for the potential treatment of hematological malignancies and other oncology-related B-cell disorders such as non-Hodgkin’s lymphoma.
This collaboration with GlycArt and Roche for the GA101 molecule complements our existing research program and our focus on innovative compounds, “said Hal Barron, M.D., Genentech Senior Vice President, development and chief medical officer. “We are pleased that through this program we may have the potential to offer a new option to treat patients with hematological malignancies.” more
Source: Roche Group Media Relations Press Release, October 3, 2008
Stem cell news
Deal for development of insulin-producing cells
Novo Nordisk are teaming up with Cellartis AB and Lund University Stem Cell Center to develop a cell therapy for treating insulin-dependent diabetes, with the long-term goal being the creation of a cure.
The deal grants Novo exclusive rights to develop and commercialize any products the collaboration creates which could be used in the treatment of diabetes. Cellartis will acquire the exclusive rights to certain other products developed during the research.
The new team will be investigating how to programme stem cells to create insulin-producing beta cells for the treatment of diabetes.
Source: www.In-pharmatechnologist.com, October 29, 2008
Researchers derive hESCs from four-cell embryo
A Belgian scientist reported that he was able to develop human embryonic stem cells (hESCs) from a blastomere of a four-cell stage embryo at the “European Society of Human Reproduction and Embryology” meeting. The results from the reported study, done by Hilde Van de Velde of the Vrije Universiteit Brussel, confirm his group’s previous report that at the four-cell stage the cells are equal and totipotent.
“Previously, scientists have been able to derive hESC lines at the eight-cell stage,” notes Dr. Van de Velde. “But success rates were variable, and it was necessary to culture them by mixing with established hESC lines. We have been able to derive hESCs at an earlier stage of embryonic development and without the need for co-culture with established hESC lines.”
Dr. Van de Velde used mature eggs donated by couples being treated at the University's IVF center. Embryos were obtained after intracytoplasmic sperm injection using sperm from a consenting donor. Then, three good quality four-cell stage embryos were split into 12 single blastomeres and allowed to grow in vitro to produce 12 morulas; the morula stage occurs 96 hours after fertilization when the egg divides four to five times.
The morulas were cultured in the conventional way for hESC derivation. Dr. Van de Velde reports that one morula resulted in a stable hESC line. His team thus concluded that at least one cell was pluripotent.
Source: Gen News Highlights July 10, 2008
Stem cells without side effects
Last year, researchers announced one of the most promising methods yet for creating ethically neutral stem cells: reprogramming adult human cells to act like embryonic stem cells. This involved using four transcription factor proteins to turn specific genes on and off, resulting in cells called induced pluripotent stem (iPS) cells. The first generation of iPS cells was created using a retrovirus to insert the four transcription factors into skin cells. Because a retrovirus, by definition, inserts itself permanently into its host's DNA, this ensured that the transcription factors were transferred, but it also led to the propagation of the virus itself. Furthermore, since the virus confers self-renewal capabilities to its new host cell, many believed that the retrovirus might be required for iPS cells to reproduce.
New research by Konrad Hochedlinger and his colleagues at Harvard University, the Harvard Stem Cell Institute, and the MGH Center for Regenerative Medicine shows that a different type of virus--an adenovirus--can make the transfer in mouse fetal liver cells without permanently integrating itself. The resulting iPS cells can divide indefinitely but show no trace of the virus--just a temporary infection that disappears within a short time. "That means that the four transcription factors themselves are sufficient to induce pluripotency in adult cells," Hochedlinger says.
While retroviral techniques allow scientists to turn about one in every 1,000 skin cells into an iPS cell, the adenovirus is far less efficient: only one in every 10,000 to 100,000 fetal liver cells can be converted.
Hochedlinger and his colleagues are now working to increase the efficiency of their adenovirus technique and to repeat their methods to create human iPS cells.
Source: www.TechnologyReview.com, September 25, 2008
UK MPs vote for human-animal hybrid embryos
Scientists will be allowed to create hybrid human-animal embryos after UK MPs overwhelmingly voted in favour of radical stem cell research.
During passionate exchanges in the House of Commons, critics of the controversial embryo research proposals warned that Britain was "crossing a Rubicon" and risked becoming a "rogue state". But they were heavily outnumbered by those who argued forcefully in favour of the potential for stem cell research using hybrids which scientists believe may transform the lives of millions and eventually stamp out some diseases altogether.
Under the new laws, British scientists will get the right to conduct the most far reaching research into hybrid embryos in the world. As a result of the measures to be introduced in the Human Fertilisation and Embryology Bill, they will be able to boost stocks by creating embryos using animal matter, mainly from cows and rabbits.
MPs also voted against an amendment to ban the creation of saviour siblings by a majority of 179. 163 voted for the ban, and 342 voted against.
Source: www.Telegraph.co.uk, May 20, 2008
Research News
EU cash for plant cell biosynthesis
The production of pharmaceutical products in plant cells has been given a boost, after the European Union ploughed $8.8m into a research programme. Funding was awarded to the SmartCell project, which aims to manipulate plant cells to produce commercially viable yields of pharmacologically active secondary metabolites.
VTT Technical Research Centre is coordinating the project, which is a collaboration between 14 leading European research institutes and five enterprises of varying sizes.
Plants produce a wide range of secondary metabolites, some of which have been found to be pharmacologically active. However, these compounds are generally produced in very small amounts over a long period of time, making commercially viable extraction difficult. The research aims to manipulate a plant cell’s secondary metabolite synthesis pathway to produce sufficient yield of a pharmacologically active compound. Initial research will focus on the synthesis of terpenes, which are produced by a wide variety of plants.
Terpenes were selected as their production showed promise in preliminary tests and because paclitaxel, a member of the same chemical family, is partially produced from plant cell cultures. Derivatives of terpenes include steroids, menthol, camphor and cannabinoids.
Work on the project is due to commence in January 2009 and run for four years, with a total budget of $12.5m.
Source: www.In-pharmaTechnologist.com, September 24, 2008
Counting cells in seconds
In this image taken with the cell counter, yeast cells are circled in blue, red blood cells are circled in red, and beads are circled in green.
Credit: Aydogan Ozcan
A simple, lensless imaging system being developed by researchers at the University of California, Los Angeles, uses a chip like the one found in a digital camera to count and distinguish different types of cells in blood and drinking water, and simple algorithms to identify and count the cells. The imager could be carried in a device the size of a cell phone and used to monitor water quality and to provide cheap diagnostics in rural and underdeveloped areas.
The imager can find small numbers of cells in a large, unprocessed sample. A water or blood sample is loaded onto a glass slide above a light-sensing chip identical to those used in consumer digital cameras; then it's illuminated from above. What we record is not an image but a diffraction signature, says Aydogan Ozcan, an assistant professor of electrical engineering at UCLA who's developing the cell counter. Unlike conventional microscopes, which take detailed pictures of very small samples, Ozcan's diffraction technique is rapid and inexpensive. The blurred, pixellated images created by his cell counter are of such low quality that Ozcan doesn't call the system a microscope. But these images contain just enough information to identify and count cells, which is all that's needed for many clinical diagnostic applications.
The counter has high throughput--while it's capable of detecting small numbers of cells, it can image as many as 100,000 cells in a 20-centimeter-squared field of view in one second.
So far, Ozcan's group has developed protype cell counters on the lab benchtop. Next, he says, he'll convert a cell phone into a mobile diagnostic lab by taking out the camera lens and putting in the imaging chip and a mechanical system to load microscope slides.
Source: www.TechnologyReview.com, September 27, 2008
Researchers' 'Facebook' launched
ResearchGATE is an online social network for scientists provided by the German company ResearchGATE GmbH. It was founded and developed by a group of natural and computer scientists as well as economists from Hannover and Harvard Medical Schools and the University of Leeds.
Launched on 23 May 2008, it gives registered users a free-of-charge platform where they "can present their research work in a personal profile, exchange messages and build individual groups for peer-to-peer discussions". The online service is equipped with search engines that allow access to specific topics and conversations and identification of "researchers from around the world with similar interests".
This international networking technology will allow cross-sectoral linking of researchers and scientists, helping, for example, a biologist to find a statistician for high-class data analysis, as well as "instant peer reviewing" of the research process, according to ResearchGATE.
The social network service for researchers will be presented at the EuroScience Open Forum (ESOF 2008 ), where it hopes to gain further visibility. Eventually, the organisers hope to discuss the prospect of Community funding for the network with the European Commission.
The European Science Foundation (ESF) is already committed to spreading the idea of the 'Facebook' among its scientists and programmes and is set to post job advertisements for researchers on it.
Source: EurActiv News, June 5, 2008
Useful websites
For more information, please see:
EU Research: http://europa.eu.int/comm/research
Seventh Framework Programme: http://europa.eu.int/comm/research/future/index_en.cfm
Research Programmes and Projects:http://www.cordis.lu
Additional Information for SMEs:
http://cordis.europa.eu/fp7/cooperation/health-additional_en.html
EMEA SME Office:
http://www.emea.eu.int/SME/SMEoverview.htm
ERC:
http://ec.europa.eu/erc/index_en.cfm
RTD Info Magazine:
http://europa.eu.int/comm/research/rtdinfo/
Information:
research@ec.europa.eu
Agenda
The 16th Annual Congress of the ESGT
Nov 13-16, 2008 – Brugge, Belgium
Information: www.esgt.org
ACTIP meeting
November 17-18, 2008, Cambridge UK
Information: ACTIP Secretariat
Speed and Safety in Drug Discovery
Discussion meeting
November 26, 2008, London, UK
More information: http://www.drugtestingconference.com/
Advanced Therapy Medicinal Product Development and Regenerative Medicine
November 25-26, Langen, Germany
Information: www.pei.de/atmp2008
Biotechnology Business Exchange (BBE2008)
December 8 2008, London UK
Information: Click here for the website
BioNanoMed 2009
January 26-27, 2009, Krems, Austria
Information: http://www.bionanomed.at/
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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