Reykjavik - Decode Genetics, a pioneering Icelandic biotechnology company, has filed for bankruptcy. The firm has been experiencing serious financial trouble since autumn last year when it informed investors of insufficient funds...
Reykjavik - Decode Genetics, a pioneering Icelandic biotechnology company, has filed for bankruptcy. The firm has been experiencing serious financial trouble since autumn last year when it informed investors of insufficient funds to carry on trading without selling off various business arms. The firm was one of the first in the world to market disease risk DNA tests directly to the public, and had invested heavily in basic research to uncover the genetic origins of conditions such as breast and prostate cancer, heart disease, and diabetes. This produced a string of publications in renowned scientific publications, but never generated a profit. The company began work in 1996 with the central idea that, because of the populations's relatively undisturbed immigration history over the past 100 years, the Icelandic population is a resource for high quality genetic data. To date, Decode Genetics has collected the genetic information of 140,000 Icelanders. Thousands of others have committed their genetic profile to Decode Genetics for testing. Now Saga Investments, a venture capital group has agreed to buy Decode's core science operations.the Iceland-based subsidiary Islensk Erfdagreining, and its drug discovery and development programs. This agreement is subject to a number of contingencies, including a competitive bidding procedure and court approval in accordance with bankruptcy law. Islensk Erfdagreining conducts deCODE’s human genetics research, manages its population genetics resources and provides its personal genome scans, DNA-based risk assessment tests, and genomics services for contract customers. deCode made clear that neither data nor samples can ever be sold, besause they are not owned by the firm but by the individuals who gave their informed consent for defined reseach purposes.
Europe’s ambitious pilot biobanking project, the BBMRI (Biobanking and Biomolecular Resources Research Infrastructure) has attracted massive investment from national biobanking initiatives. The project is to link up to 300...
“We are also in close talks with Luxembourg,” Zatloukal told EuroBiotechNews. This summer the small country began hiring staff for the establishment of the Integrated Biobank of Luxembourg (IBBL), which is part of a EUR140m biomedical research initiative designed to push Luxembourg into the upper echelon of biomarker discovery centres in the world. Both the Dutch investment and the talks with the IBBL in November have led to rumours about who will lead the BBMRI in the future. “It is true that one centre must lead the BBMRI after the preparatory phase, due to the establishment of the so-called ERIC status. Both the Netherlands and Austria have applied, “ said Zatloukal. “But there isn’t any competition, and it looks like Austria will take on this role.” For implementation of ERIC (European Research Infrastructure Consortium) status, the BBMRI must be anchored within a single member state. With the new scheme, Europe is seeking to outweigh a major disadvantage European researchers have compared to their US counterparts. “We have more samples and data relating to samples than anywhere else in the world,” according to BBMRI managing director Professor Eero Vuorio. But differing regulations among EU member states make it difficult to pool resources, which is an important prerequisite to attracting cooperation with the pharmaceutical industry. The ERIC scheme offers several advantages that should help to overcome the typical fragmentation of EU research. The BBMRI could hire staff in several member states under a common contract, for example, which would allow greater researcher mobility while retaining health and social security benefits. The ERIC scheme also offers VAT-free status to the BBMRI. The respective ministers of the partners that are supporting the the project financially are expected to decide which country will host the BBMRI by next year. Soon after, says Zatloukal, the European Commission will decide on ERIC status.
IBBL could eventually support
While more investment in the BBMRI is expected to come from additional national biobanking programmes, a cooperation with the IBBL might also offer an opportunity for US researchers to access Europe’s biobanking resources and research market via the Luxembourg Programme in Personalized Medicine, which includes three major projects: – Creation of the IBBL in partnership with the Arizona-based Translational Genomics Research Institute(TGen). – The Arizona-based Partnership for Personalized Medicine, which will work on IBBL-based lung cancer projects. – The Center for Systems Biology Luxembourg (CSBL), which is intended to track the genetic basis of disease and develop protein-based tests, will cooperate with Amgen founder Leroy Hood.B
The biopharmaceutical industry has seen plenty of change over the past 20 years, with the yield of recombinant proteins increasing from tens of milligrams to more than 10 grams per liter for some monoclonal antibodies in early...
The biopharmaceutical industry has seen plenty of change over the past 20 years, with the yield of recombinant proteins increasing from tens of milligrams to more than 10 grams per liter for some monoclonal antibodies in early development . As batch volumes increase in parallel, we face the real likelihood of 50- to 100-kg batches of protein in the not so distant future . The majority of industry professionals now agree there are at least minor limitations in downstream processing, and in some cases major bottlenecks, with cost and capacity issues being most important . Downstream processing is driven by mass rather than volume, and it is apparent that technological advances in downstream processing have failed to keep up with productivity increases upstream. This is because the rational approach, continuous upscaling, is no longer sufficient due to costs, technical limitations and the difficulties encountered in retrofitting existing facilities. Therefore the debate has turned to alternative solutions: streamlining operations, introducing novel high-technology solutions and revisiting older technologies to reduce the costs of large-scale processes.
Most companies are actively streamlining their purification strategies to guarantee best practice under the restrictions we now see in the industry while reducing product cost as far as possible. Antibodies are at the forefront of this development, since they represent more than 50% of all biopharmaceuticals in the pipeline, yet have enough conserved properties to allow meaningful cross-platform comparisons. Significant benefits can be obtained by using generic platform processes that are adjusted rapidly to match the requirements of new products.
Streamlining operations –
The vast majority of companies employ a three-column platform comprising Protein A affinity chromatography for product capture, followed by a combination of cation exchange (CEX), anion exchange (AEX) and/or hydrophobic interaction chromatography (HIC) for polishing and virus removal. As cell culture titers increase and purification trains are challenged with larger amounts of antibody per fermentation cycle, costs increase in proportion to production scale – so there is no economy of scale effect. Rather than upscaling, companies are therefore fine-tuning their processes, as exemplified by Pfizer’s platform for antibody production, where depth filtration at the 500-litre scale was augmented with continuous flow centrifugation at the 1200-litre scale, the order of polishing steps was changed and the AEX column was replaced with a membrane adsorber, reducing the overall process time by almost 50%.
Revisiting old technologies –
the Ghost of Christmas Past
The implementation of inexpensive solutions that have been used successfully in industries with lower manufacturing costs (e.g. the food and chemical industries) is one low-technology approach that can be used in the manufacture of biopharmaceuticals. Harvesting, which tends to involve complex filtration and/or centrifugation trains to remove small (sub-micrometer) particles, can be simplified by the use of flocculants to create larger particles that are easier to separate from the cell culture fluid. Flocculation has been used mainly for the removal of whole cells from fermentation broth, and more recently for the removal of cell debris and proteins. Precipitation is among the simplest and least expensive fractionation methods, since it can be achieved by simple changes in solution conditions, e.g. the addition or removal of salt (salting out), metal ions, organic solvents, polymers/polyelectrolytes, or even by changes in temperature and pH. Precipitation can be used not only to remove impurities but also to isolate a target antibody, which in the latter case also reduces the processing volume. Several groups have developed methods to precipitate antibodies in large-scale processes, and this could replace Protein A chromatography in the long term. For the final purification steps, another traditional technology that is being considered for use in biopharmaceutical manufacturing is crystallisation, which involves the formation of a regularly-structured solid phase that impedes the incorporation of contaminants or solvent molecules, and therefore yields products of exceptional purity. Protein crystallisation has been incorporated into several current manufacturing processes, including those for recombinant insulin, aprotinin and Apo2L.
New technologies – the Ghost of Christmas Yet to Come
The development of new, high-tech solutions can also help to reduce the cost of downstream processing, and disposable membrane adsorbers are at the forefront of this field. Disposable modules are already integral to many processes, particularly for filtration and media/buffer storage, but interest in membrane chromatography is growing because of the many advantages of membrane adsorbers over equivalent resin-packed columns, including the elimination of cleaning and validation costs and the much smaller footprint of membrane adsorbers. A range of different membranes is available with functional groups equivalent to the corresponding resins, e.g. membranes containing quaternary ammonium groups for anion exchange, polyallylic ligands for the removal of contaminants under high salt conditions (Salt Tolerant Interaction Chromatography, STIC), or phenyl groups for hydrophobic interaction chromatography. Another significant functional advantage of membranes over resins is that the transport of solutes to their binding sites occurs mainly by convection, while pore diffusion is minimal. Because of these hydrodynamic benefits, membrane adsorbers can operate at much greater flow rates than columns, considerably reducing buffer consumption and shortening the overall process time up to 100-fold. The use of membrane adsorbers can be viewed as the equivalent of shortening traditional columns to near zero length, allowing large scale processes to run with only a small pressure drop at very high flow rates . Even so, they continue to provide adequate binding capacity for large biomolecules such as
viruses and DNA, so they can play an important role in the overall viral clearance strategy for antibody purification . For example, the process capacity of multi-layer Q membranes is much higher than equivalent volumes of resin with no loss of performance in contaminant and virus removal . For smaller molecules, resins offer a higher capacity, but membrane absorbers offer speedier processing. The availability of STIC closes another gap in antibody purification as it enables the direct processing of CEX-eluates (cation exchange) without dilution.
Conclusions – A Tale of
The perceived bottleneck in downstream processing can be addressed by streamlining today’s production processes, and to achieve this there are two technological approaches which can be used alone or in combination. The first is to replace the most expensive and time-consuming unit operations with new, high-tech solutions that offer more capacity, more efficiency and a smaller footprint, both in terms of the equipment itself and the room required for buffer preparation and storage. Disposable membrane adsorbers provide a key example of this approach. The second approach is to revisit older and more established technologies that are already widely used in the food and chemical industries. More and more processes are now benefiting from low-cost, low-technology solutions such as precipitation and crystallization in place of expensive chromatography trains. The combination of these two approaches on a case-by-case basis should allow downstream processing to cope with the increasing titers we can now see on the horizon. D
References  Gottschalk, U. New and unknown challenges facing biomanufacturing. BioPharm International 2005 March, 24-28.  Kelley, B. Designing a 10 ton antibody process: Is conventional chromatography limiting? 232nd American Chemical Society National Meeting, Sept 10-14, 2006, SanFrancisco, CA, BIOT division, paper 133.  6th Annual Survey of Biopharmaceutical Manufacturing. Eric S. Langer, BioPlan Associates Inc. 2009  Glynn J et al. (2009) The development and application of a monoclonal antibody purification platform. Biopharm Intl Supplement Oct. 2009 (15-19)  Thömmes J, Gottschalk U (2009) Alternatives to packed-bed chromatography for antibody extraction and purification. In: Gottschalk U (ed) Process-scale Purification of Antibodies. Wiley, NY.  Wang M., Diehl T., Aguiar D., Dai X.-P., Arunakumari, A., (2009). Precipitation of Process-derived Impurities in non-Protein A Purification Schemes for Antibodies. Biopharm Intl Supplement Oct. 2009 (4-10)  Przybycien, T., Narahari, S., Steele, L. (2004). Alternative bioseparation operations: life beyond packed-bed chromatography. Current Opinion in Biotechnology 15, 469–478.  Klyushnichenko, V. (2003). Protein crystallization: from HTS to kilogram-scale. Current Opinion in Drug Discovery and Development 6, 848-854.  Peters, J., Minuth, T., Schröder, W. (2005). Implementation of a crystallization step into the purification process of a recombinant protein. Protein Expression and Purification 39, 43-53.  Gottschalk U (2009) Bioseparation in antibody manufacturing: the good, the bad and the ugly. Biotechnol Prog. 24:496-503  Zhou, J.; Tressel, T. Basic concepts in Q membrane chromatography for large-scale antibody production. Biotechnol. Prog. 2006, 22, 341-349.  Zhou, J. Orthogonal Virus Clearance Applications in Monoclonal Antibody. In: Process Scale Purification of Antibodies. Gottschalk U, ed. John Wiley & Sons  Faber, R., Yang, Y., Gottschalk, U., Development of Salt Tolerant Interaction Chromatography (STIC) for Large Scale Polishing with convective Media. BioPharm Intl. Oct. 2009 (11-14)
Contact Dr Uwe Gottschalk Vice President Purification Technologies Sartorius Stedim Biotech GmbH August-Spindler-Str. 11 37079 Göttingen email@example.com www. sartorius-stedim.com
Only a year after bioprocessing world market leader Millipore Corp. entered into a partnership with Dutch stainless steel bioreactor specialist Applikon Biotechnology BV, the companies have rolled out a major project – the...
Dr. Andrew Bulpin is Vice President Upstream Processing at Millipore Corp., Billerica (US). After completing undergraduate studies, he undertook his PhD in Chemistry from the University of Caen (France). Bulpin then moved to the Australian National University at Canberra to pursue research on stereoselective synthesis. Later achieving his MBA from the University of Strathclyde (Glasgow, UK), he began his business career at a blood transfusion diagnostics company (Institut Jacques Boy, Reims, France) before joining Serologicals (Livingston, UK). Bulpin ultimately moved into a marketing position at the company’s US headquarters at Atlanta before Serologicals was acquired by Millipore in July of 2006. He then moved into his current business unit and position.
Euro|BioTech|News Dr Bulpin, last year Millipore entered into a development and commercial alliance with Applikon Biotechnology B.V., a specialist for stainless steel bioreactors. Could you please describe the plan behind this partnership, and outline the market forces that drive it?
Bulpin: Millipore has long been engaged in single-use disposable manufacturing products. One of the product ranges obviously missing was bioreactors in the upstream area. It was a strategic gap, and we were looking to close it. Millipore has expertise in plastics engineering, we were therefore looking for a partner company for bioreactors that could deal with the controllers and the software – and that was Applikon. The alliance was split into two halves. First off, it was a co-development arrangement; the second portion was a commercial arrangement. With the co-development, we worked together to develop a bioreactor aimed specifically at process development. The arrangement is limited to bioreactors scaled from 500 millilitres to 40 litres. We have effectively reached the end of that co-development arrangement now with the launch of the Mobius® CellReady 3L bioreactor. The commercial agreement is very straightforward. Both parties can sell complete systems – by that I mean the controller, sensors, software, and the disposable bioreactor as a start-up kit. The kit will include six of the disposable bioreactors. Thereafter, all repeat orders for the consumables will go exclusively to Millipore.
Euro|BioTech|News The current product is a 3-litre bioreactor. When will Millipore expand the scale?
Bulpin: We expect to launch two different sizes as part of a scaleable range in 2010. Furthermore, we have certainly been looking at a programme for developing a scalable bioreactor for use in pilot plants and small production scales.
Euro|BioTech|News What are the differences in Millipore’s strategy and product development compared to its competitors’ portfolios?
Bulpin: You have to look at the product we have brought to launch; the Mobius CellReady 3L bioreactor is a very simple form for a plastic single-use version of the glass and stainless steel bioreactor in use today in process development labs. Format, use and application are all very familiar. When you compare it with the competition, I think people are very familiar with the single-use bioreactor in the pillow-shaped format. While functional, the major challenge to this design is that the working volume for the system is only 50 percent of the total bag size, limiting its scalability. Alternative, scalable products are not currently available for process-development applications.
Euro|BioTech|News Could you please outline the fields of application for the Mobius CellReady, and explain what distinguishes it from first-generation disposable reactors?
Bulpin: This bioreactor is designed for the process development laboratory. It’s a bench-scale bioreactor, and as such it is the first-in-class. When you look at the other players out there who are developing single-use bioreactors, significant focus has been at pilot or at production scale. The Mobius CellReady bioreactor has a classical shape; it’s a rigid injection mould, and the material is a polycarbonate that is compatible with cell-culture processes. It is designed to perform exactly like the Applikon 3-litre glass fermenter with stirred-tank design. We designed it to fit to any controller out on the market. Basically, all you need is an adaptor for the motor. The Mobius CellReady comes pre-assembled and gamma-irradiated. In other words, you take it straight out the box, put it on the bench and inoculate it.
Euro|BioTech|News Does it also feature disposable sensors?
Bulpin: No. The current version does not have disposable sensing. We are relying on people to use their existing electrochemical sensors, which means that they have to be inserted under laminar flow. We talked to our customers about this extensively, and the indication we got back was that people prefer the reliability of the electrochemical sensors, and they didn’t see this as a major challenge.
Euro|BioTech|News What are the specific advantages of a disposable system over stainless steel reactors for process development?
Bulpin: The major advantage is that it is ready to use. When you look at how most process development labs run today, after having finished a cell-culture run, you have to autoclave the used bioreactor with the content to inactivate anything inside, then wash it, clean it, and reassemble it. Then you have to autoclave it again before you can inoculate. Depending on the way the laboratory is structured, this can take from one to four days. Once a run is finished with a disposable reactor, you can take the next one off the shelf and inoculate. That is much more efficient when you’re looking at operation and turnaround time in a laboratory. Often, the highly trained PhD scientists are the ones doing the cleaning of the bioreactors, because they want to make sure that if there’s a failure, it’s not due to dirty equipment. It’s very expensive, however, to have PhD bottlewashers. If you look at the savings you can make concerning turnaround time – we’re talking about 1-3 days with an average cell-culture run time of 12 days – you can save up to 25% of your time for extra science.
Euro|BioTech|News Is there anything like this system under development at your competitors‘?
Bulpin: I’m sure that people will copy the system. Euro|BioTech|News What are your market expectations for the new system?
Bulpin: We’ve had very positive feedback from alpha and extensive beta testing. So we are very optimistic that the system, which is now out on the market, will do very well commercially. When we initially framed our marketing plans, we expected the uptake to be moderately slow, because we expected the Mobius CellReady to be introduced either with the purchases of completely new systems and/or to replace glass and stainless steel as some of the older glass bioreactors broke. But if what we have found through our own internal use at Millipore gives us an indication of what’s going to happen out on the market, we underestimated. We discovered that people would much rather take a Mobius CellReady straight out of the box and use it rather than be forced to do their own washing-up. Although we have a lot of glass and stainless steel bioreactors in our own laboratories, they aren’t being used. There’s already 100% use of the Mobius CellReady bioreactor.
Euro|BioTech|News What can you say about the overall cost when you compare reuseable and single-use systems?
Bulpin: You have to consider different factors when carrying out such a comparison. One is the total cost of acquisition. Another is turnaround time, which affects the amount of time available for extra research and so on. We do have a costing-model. The value proposition for a single-use bioreactor is very compelling.
Euro|BioTech|News Into what fields of disposable technology is Millipore planning to expand in the future?
Bulpin: We would expect to be a player in virtually all the fields for which we have individual devices. When you look more generally at the reduction in capital investments coupled with increased manufacturing flexibility, disposable technologies make huge sense. While the first biopharmaceutical processes yielded 0.5-1.0g product per litre, we are now in the 5g range. This ten-fold increase in yield means that what you historically needed a 15,000-litre bioreactor to produce, you can today produce in 1500 litres. This means that disposable bioreactors are a viable option right up to production scale. Moreover, if you consider the advances being made in molecular biology – breaking larger historical patient populations into smaller subpatient populations based on phenotype – then the absolute kilogramme requirement for any given antibody will progressively get smaller. The ultimate endstate of this scenario is personalised medicine, which translates into more and more drug diversity and a need for greater flexibility around manufacturing. We are going to produce multiple drugs in a single-production facility, which is ideally suited for flexible single-use production.
Euro|BioTech|News In which areas does Millipore feel comfortable, and in which fields do you think you need to grow?
Bulpin: We feel comfortable in all the areas we are active in today, both upstream and downstream. And we will continue to expand our capabilities while innovating to compress the production template.
Shipments of soybeans from the US are unlikely to return to normal anytime soon, even though in November the European Commission expanded the range of transgenic species that may enter the bloc. “It‘s highly unlikely that imports...
The industry’s claims are supported by EU Agriculture Commissioner Mariann Fischer Boel, who called on member states in October to approve the GM maize crops. “The last thing EU farmers need now is an increase in feed prices,” she said, adding that EU countries should listen to scientific evidence rather than emotional appeals when deciding on new biotech products. The coalition agreement for the newly-elected German government also supports dropping the zero-tolerance EU rule. While the EU has approved a string of GMOs, it does not currently permit the import of others – even in minute amounts – until EU approval for the product is given. New EU approval for GMO imports has been slowed to a standstill by public concerns about safety.
New study war heating up
A new industry-sponsored information campaign aimed at promoting science-based policy has now come into play. “Science Matters”, which was launched by international PR giant Grayling in September, has received EUR100,000 in support from several chemical companies, according to EU observer. The information campaign will not focus solely on GMOs, but will also touch on other fields that are of concern to the wider public such as nanotechnology or risk assessment of chemicals. According to the campaign’s supporters, environmental risk assessment has become politicised in the EU. Critics say they are concerned that “Science Matters” will be just another PR campaign serving the interests of its supporters. According to sources from the European Greens, previous campaigns run by Graylings are full of misinformation. A month after “Science Matters” was launched, GMO opponents under former anti-GMO Greenpeace activist Christoph Then threw open a competing information portal called “Testbiotech”. It focuses exclusively on GMO risk assessment, and criticises the European Food watchdog EFSA for only relying on data delivered by the companies seeking GMO market approval. Testbiotech has just released a report attacking the current approach to GMO crop safety assessment. Instead of focussing on specific genetic events, its authors ask readers to take into acount that genetic engineering could have an impact on genetic regulation networks. They called for the establishment of a crash-test for GMOs that provides information on how they react to stress. Called “Risk reloaded”, the study has been distributed to members of the European Parliament.
Brussels – European Commission President Jose Manuel Barroso is planning to appoint a chief scientific adviser to combine the process of political decision-making with scientific advice in fields like GMOs, synthetic biology, and...
Brussels – European Commission President Jose Manuel Barroso is planning to appoint a chief scientific adviser to combine the process of political decision-making with scientific advice in fields like GMOs, synthetic biology, and climate change. The new post comes during a period when the Commission evaluates its institutions and the panels that have provided focused scientific advice in specific fields of expertise. Details of the job are expected to be discussed by spring of 2010.
Brussels/New York – China’s annual research output exploded in the past decade, soaring from 20,000 publications in 1998 to 112,000 a decade later. It has now outpaced the EU and Japan, and is set to overtake the US within the...
Brussels/New York – China’s annual research output exploded in the past decade, soaring from 20,000 publications in 1998 to 112,000 a decade later. It has now outpaced the EU and Japan, and is set to overtake the US within the next ten years if the trend continues (http://researchanalytics.thomsonreuters.com/grr/). The number of Chinese research papers is currently increasing at an annual rate four times faster than in the US. According to the analysis based on Thomson Reuters’ ISI Web of Science, China quadrupled output of published agribiotech papers from 2004-2008 compared to the preceding four years. In the same period, it showed a similar increase in research papers in immunology, microbiology, and genetics.
Brussels/Strasbourg – The pharmaceutical industry has agreed to accept a review of direct-to-consumer information on prescription medicines prior to its publication on the Internet or in newspapers. According to Euractiv, EFPIA...
Brussels/Strasbourg – The pharmaceutical industry has agreed to accept a review of direct-to-consumer information on prescription medicines prior to its publication on the Internet or in newspapers. According to Euractiv, EFPIA chief Arthur Higgins confirmed in November that a majority of the members in the EU pharma association have agreed to the establishment of an independent authority with the power to decide whether data on how the drug works, its interactions and side-effects are purely factual. Experts say this should help pacify critics of the EU’s pharmaceutical package, which is to allow the industry to communicate directly to consumers. Critics have argued that allowing companies to provide information on their own products would open the door to direct advertising for prescription medicines. At a meeting with EU parliamentarians organised by conservative French MEP Françoise Grossetête, Higgins criticised EU health ministers for having apparently shelved a plan to provide high-quality information on diseases and treatments to consumers. “Patients need to be equipped to make informed choices,” he said, and has lobbied MEPs and patient organisations to prevent the proposal from being diluted or dropped. Direct-to-consumer advertising (DTCA) is currently only permitted in the US and New Zealand. Pharma companies are primarily interested in so-called product claim advertisements, which link the brand names of certain pharmaceuticals with claims about indications and efficacy. Most industry analysts agree that the intent behind investing in such advertisements is unquestionably to generate a financial return. According to IMS Management Consulting, which analysed sales increases in 49 advertised US brands, the return on investment “is nearly unprecedented in terms of the positive sales response generated.” Having proven an effective means of marketing that complements campaigns targeting health professionals, annual investments in DTCA in the US climbed from US$35m in 1996 to US$4.25bn in 2005. According to estimates, DTCA in the US already makes up around 15% of total expenditures on pharma promotions.
Brussels – In the run-up to the presentation of the European Commission’s new European Innovation Act next spring, the SME interest group at Business-Europe has begun lobbying for lower taxes, financial aid and a set of common IP...
Brussels – In the run-up to the presentation of the European Commission’s new European Innovation Act next spring, the SME interest group at Business-Europe has begun lobbying for lower taxes, financial aid and a set of common IP rules. In its position paper “Innovation: Building a Sucessful Future for Europe”, the lobby group has called on the Commission to follow the example of France, which offers tax exemptions to all SMEs that channel more than 15% of their total expenditure into R&D, and exempts “YIC companies” from all corporate and capital gains tax for up to 8 years after their foundation. BusinessEurope has also called for the creation of an integrated venture capital market, and wants to expand the volume of risk-sharing products offered by the European Investment Bank to circumvent the current financing bottleneck for high-tech SMEs. The paper also criticised the EU‘s efforts to create a European Research Area, and proposed establishing more flexible financing and staffing rules within European R&D programmes like the FP7 and Joint Technology Initiative. BusinessEurope President Jürgen R. Thumann said the first Barroso Commission recognised the need for a broad-based innovation strategy, and added that “the forthcoming European Innovation Plan should be a decisive milestone in this process.”
Brussels – The Innovative Medicines Initiative (IMI) has published its second call for funding. “By accelerating and optimising R&D processes, we are trying to remove bottlenecks in the drug development process,” explained Arthur...
Brussels – The Innovative Medicines Initiative (IMI) has published its second call for funding. “By accelerating and optimising R&D processes, we are trying to remove bottlenecks in the drug development process,” explained Arthur Higgins, president of the European Federation of Pharmaceutical Industries and Associations (EFPIA). The umbrella organisation’s member companies are participating in the research initiative together with the European Commission, which will support applicants with EUR76.8m of funding in this round. EFPIA’s Public Private Partnership with the Commission is aimed at speeding up the discovery and development of new medicines in the field of cancer, inflammatory and infectious disease. Detailed descriptions of the topics to be funded are available at http://imi.europa.eu/calls-02_en.html.
7th Berlin Conference on IP in Life Sciences: Big Data, Big Drugs
The health care industry faces significant transformation, driven by a boom in knowledge within biomedical sciences and breakthrough technologies such as gene sequencing. The management of "big data“ will change the understanding of diseases, development of drugs and treatment of patients. more