Results

Periodic Report Summary - T-REC (Building research capacity of blood transfusion services in Africa)

Wed, 17 Apr 2013 00:00:01 GMT

LIVERPOOL SCHOOL OF TROPICAL MEDICINE
Project context and objectives: This project aims to build sustainable capacity for health research in Africa by coordinating and supporting training and networks for blood transfusion research. The project addresses a specific need identified by the blood transfusion services in sub-Saharan Africa (SSA) to increase their own capacity to do research which meets local health priorities. The project coordinates links between transfusion services and academic institutions in SSA and Europe to teach research skills to transfusion service professionals and to promote transfusion research as an exciting topic with high public health impact. We engage key stakeholders (transfusion service directors and staff, biomedical and social scientists and clinicians and researchers) in all aspects of the programme to ensure that we generate evidence that is useful and addresses priority knowledge gaps. The project objectives are to: 1. coordinate programmes to train African transfusion service professionals to do research which meets the needs of the service and the local population; 2. coordinate research opportunities within Africa's transfusion services for external undergraduate, Master and PhD students; 3. support transfusion policy makers, service managers and researchers to work together to identify research needs, develop research strategies and use research to inform policy and practice; 4. strengthen the research systems, infrastructure and networks within and between transfusion services and academic institutions in Africa, the European Union (EU) and beyond. Project results: 1. Management and coordination The Consortium was established initially with membership from the following organisations: - Liverpool School of Tropical Medicine (LSTM). - Ministry of Health, Ghana Blood Transfusion Service (GBTS). National Blood Service Zimbabwe Association (NBSZ). Rijksuniversiteit Groningen (RUG). Københavns Universitet (UCPH). The consortium was expanded on the 1st January 2012 to include the Africa Society of Blood Transfusion (AfSBT). This Institution was unable to join at the start of the project because documentation regarding the legal status of AfSBT was insufficient. At the end of 2011, this was corrected and AfSBT joined the T-REC consortium following acceptance of a contract amendment. The management office at LSTM has been established and a website to publicise the T-REC initiative (www.t-rec.eu) has been set-up and updated on a regular basis. The Consortium has met face-to-face on two occasions; in July 2011 at the launch meeting in Ghana and in June 2012 at the AfSBT biennial congress. In addition a launch meeting in Zimbabwe was held in October 2011, which many consortium members attended. Other consortium meetings have been held remotely, including the initial start-up meeting in April 2011 and a mid-year review in January 2012. Sustained interaction by E-mail and Skype has allowed the consortium to discuss progress and issues on an ongoing basis and ensure that project progress is in line with the deliverables and milestones. 2. PhD Incentives A total of four PhD students (two from Ghana and two from Zimbabwe) were selected through a competitive process and have started their PhDs in collaboration with local and European Universities. Their research focuses on priority areas for SSA such as blood donor motivation, blood safety and transfusion economics. 3. In-service research skills The DPDM course has been rolled out from Kumasi in Ghana to Accra and also to Harare in Zimbabwe and local tutors have been trained to manage the course. The first batch of six students have graduated in Ghana and nine Zimbabwe students will graduate early in 2013. 4. Research bursaries Meetings have been held with local academic institutions for scientists, nurses and media students to disseminate information about the student research bursaries. Six students have enrolled onto the programme in Ghana and places have been advertised in Zimbabwe for 2012 / 13 students. 5. Research use, dissemination and sustainability This activity will be focused in the latter part of the project, but some dissemination activities and presentation of research work has already taken place (summarised on our website). An open session dedicated to T-REC was held at the African Society for Blood Transfusion meeting in Mauritius in July 2012 and articles about T-REC have been published in Africa Health, Transfusion Today and the Bulletin of the Royal College of Pathologists. Plans for a transfusion network in SSA have been developed and research activities in transfusion in SSA are being entered into a database. Potential impact: The expected results are twofold. Firstly research generated through the T-REC programme by the PhD, diploma and bursary students will provide evidence to stakeholders that can be used to modify current policy related to blood transfusion in SSA. Secondly the project will increase the number of individuals researching transfusion topics in SSA and enhance the ability of transfusion services and policy makers to support and utilise locally generated research. Ultimately this enhanced research capacity will contribute to more effective and safer supply of blood for patients with severe anaemia, particularly women and children, in SSA. List of websites: www.t-rec.eu

Periodic Report Summary - ENNSATOX (Engineered nanoparticle impact on aquatic environments: structure, activity and toxicology)

Wed, 17 Apr 2013 00:00:01 GMT

UNIVERSITY OF LEEDS
Project context and objectives: The main aims and objectives of the ENNSATOX project are to: 1. Source and comprehensively characterise a representative group of nanoparticles: ZnO, SiO2 and TiO2 and other metal oxides of varying morphology and dimension. 2. Characterise the interaction of nanoparticles with biological models, such as supported phospholipid membranes of increasing complexity, in vitro models of cell and tissue culture, in vivo models of several different species of key indicator organisms. A feature of this objective will be a direct comparison of the effects in the different groups which will lead to the configuration of generalisations of nanoparticle biological activity. 3. Formulate direct and predictive structure-activity relationships between nanoparticle form and nanoparticle biological activity. Success in this objective will be achieved following results from objectives 1 and 2 and is a central feature of ENNSATOX. 4. Analyse the behaviour and fate of nanoparticles and their impact on models of biota in environmental aquatic systems. This advances on the initial structural-activity relationships by testing their application in the environmental aquatic situation. 5. Configure a mathematical model for the behaviour of nanoparticles in aquatic environments taking account of their interactions with biota of increasing complexity. This objective will quantify the interactions and will serve as a means of verifying and measuring previous objectives 1-4. 6. Draw up standard procedures for the exploitation and dissemination of the results for statutory planning and accredited use. Project results: Characterisation protocols for nanoparticles (diagrams of techniques). A considerable amount of activity has gone into the updating of methods for characterising NPs. Indeed whole protocols have been continually developed for measuring: NP particle size, state of aggregation, stability over time. The result of this is that a comprehensive characterisation procedure has been developed for each group of sourced and / or synthesised NPs. ENNSATOX now has a full systematic set of characterisation protocols for NPs. Since commercially sourced ZnO nanoparticles were not of acceptable quality for investigating fundamental mechanisms of toxicity, a number of ZnO nanoparticle samples of different size and shape were synthesised in house. Handling protocols for nanoparticles. In carrying out toxicological testing of NPs, characterisation is only the first step. The subsequent protocol is the handling of the NPs prior to and during the testing. This is extremely important to ensure complete stability of the NPs and to make certain that the assay procedure and result is related to properties of the NPs previously characterised and not to other characteristics of the NP dispersion. A particular problem in any toxicological assay is that the assay procedure is responding to some impurity in the sample. This particular error, i.e. contamination must not be allowed to enter into the ENNSATOX programme and good housekeeping and handling of NPs guarantees the maintenance of high standards in this respect. The handling of NPs in the programme has been developed as a systematic and disciplined protocol. The procedures involved include purification followed by dilution and dispersion. The handling procedures were developed in period 2 individually and appropriately for two groups of NPs: ZnO and TiO2 respectively. A constant monitoring of the state of the NPs during handling was carried out to check the NP dispersion's stability. Supported model membrane tests: Both ZnO and TiO2 nanoparticles have been comprehensively tested for biomembrane activity on a series of membrane models of increasing complexity. Experiments on the biomembrane activity of ZnO show that its activity is complicated by its tendency to aggregate and dissolve in aqueous solution. Extensive testing with the previously developed nanosensor showed that both ZnO and TiO2 nanoparticle biomembrane activity was inversely related to their particle size. The nanosensor flow system has been modified to accommodate nanoparticle dispersions which have a tendency to aggregate and in the case of ZnO to dissolve. The results of the high throughput algal tests have been directly compared with those from the ENNSATOX nanosensor to understand the role of the biomembrane in the toxicity of NP to algae. ZnO and TiO2 activity towards cell cultures, fresh water and marine algae, crustaceans and zebra fish has been investigated. Particular attention has been paid to chronic toxicity to these organisms and bioavailability. During period, five different samples of in-house synthesised ZnO and five different samples of commercially sourced TiO2 samples were sent out to the consortium members. Results from all the tests using the same well-characterised standard nanoparticles have been compared and related to the results of the model biomembrane: NP interactions. Investigations of the aqueous chemistry of both ZnO and TiO2 particles have been carried out in addition to studies on their uptake by and permeation in biogels. Theoretical simulations have also been very successful and the simulation results compare very well with experimental results. The following mechanisms have been simulated: ZnO nanoparticle solubility, nanoparticle sedimentation and nanoparticle uptake by single cells. Quality assurance (QA) has been maintained throughout. In all toxicity testing QA is absolutely of prime importance to ensure the continual credibility of the testing procedures. QA has been rigorously maintained using the following procedures: (a) Partner laboratory and office visits by coordinator and project manager. To-date, all partners have been visited and their facilities scrutinised. (b) Reporting results on standard characterised NP dispersions distributed by the Leeds team. (c) Consortium meetings are a very effective way of maintaining high standards in the project. Each Work package (WP) leader reports on work done and plans for the next six months. The talks are open to questioning and scrutiny by the remaining consortium members. A kick-off meeting and a total of five consortium meetings have been held. Already widespread dissemination conferences, papers, articles: SETAC has ensured that ENNSATOX has a wide international profile and presented a poster at its annual conference in Seville. The coordinator and project manager have attended all NanoSafety cluster meetings during period 2. In each meeting a poster and formal talk about ENNSATOX was presented. All other partners have attended conferences and meetings and presented results and findings from ENNSATOX. Potential impact: Main results achieved in the project: Protocols for the characterisation of nanoparticle dispersions have been developed and are being continually updated, ZnO nanoparticles have been synthesised in-house and together with TiO2 particles have been characterised, a high-throughput membrane based chip sensor has been developed for nanotoxicity assay and modified for the assay of soluble and aggregating nanoparticles, a series of toxicological tests on ZnO and TiO2 particle dispersions have been carried out by all partners and compared, the charge and surface activity of TiO2 in dispersion has been characterised and the solubility of commercial ZnO dispersions has been comprehensively defined. The final results delivered from ENNSATOX are: 1. full characterisation of commercial and in-house synthesised SiO2, ZnO and TiO2 dispersions prior to, during and following their employment in toxicology testing; 2. intercalibration of toxicology results from effects of SiO2, ZnO and TiO2 on successively more complex levels of biological organisation from in vitro models of cell membrane and cell cultures to multicellular organisms of crustaceans and fish. This will lead to a full understanding of the toxicity mechanisms involved at the molecular level; 3. full understanding of the behaviour of dispersions of SiO2, ZnO and TiO2 with respect to charge and surface chemical characteristics in model environmental aquatic systems; and 4. a comprehensive predictive mathematical model which describes the behaviour of SiO2, ZnO and TiO2 following discharge into the aqueous environment and their subsequent impact on model organisms in the environment including their uptake by these organisms. The impact and use (including the socio-economic impact and the wider societal implications of the project so far) are listed in the following: (i) Better in vitro or in vivo methodologies for the regulatory demands for the safety assessment of nanotechnology products. Already an intercalibrated high-throughput on-line membrane-based sensor has been developed and is being used as a central facility for the EU NanoSafety cluster. (ii) Better understanding of the impact of the nanoparticles on health, safety and the environment. Results have defined the biomembrane activity of commercial SiO2, ZnO and TiO2 particle dispersions in relation to their size and shape. A comprehensive understanding of the physical mechanisms of SiO2, ZnO and TiO2 biomembrane activity has now been developed. (iii) Safe and cost-effective minimisation of the exposure of workers and consumers. Toxicity results on commercial nanoparticle dispersions provide a very relevant platform for the evaluation of Health and Safety protocols to be used by workers and consumers. Much of this information has been disseminated not only through presentations and publications but also through the EU NanoSafety cluster and NANOIMPACTNET meetings and workshops. (iv) Sustainable and responsible development. Three aspects of sustainable and responsible development have been addressed by ENNSATOX. These are: (a) living within environmental limits, (b) using sound science responsibly and (c) achieving a sustainable economy. (v) Support to research and regulation. The findings of the toxicity and biological activity of SiO2, ZnO and TiO2 can be used to formulate statutory controls, risk assessments and regulation on the use of nanoparticle materials. These discussions are being carried out through the EU NanoSafety cluster workshops. To summarise - the major socio-economic impact of the findings has been in: 1. the development of a high-throughput membrane-based sensor for screening nanotoxicity available to all members of the EU NanoSafety cluster; 2. the development of a physical understanding of the biomembrane activity of SiO2, ZnO and TiO2 which is fundamental to the development of risk assessments; 3. an understanding of the toxicity of SiO2, ZnO and TiO2 dispersions which provides a background to developing statutory controls on the use of these materials; and 4. the development and verification of mathematical models simulating the solubility of ZnO nanoparticles, the sedimentation of nanoparticles and the uptake of nanoparticles by unicellular organisms. List of websites: www.ennsatox.eu

Final Report Summary - SOM (Support and opposition to migration - A cross national comparison of the politicisation of migration)

Wed, 17 Apr 2013 00:00:01 GMT

UNIVERSITE DE NEUCHATEL
Executive summary: Since the 1960s, substantial numbers of immigrants migrated to Western Europe. At least from the mid-Nineties onwards, the presence and integration of immigrants became a contested issue in most receiving countries. Indeed, the reaction to immigrants has not been the same in all countries: There are substantial differences in the timing and extent of the politicisation of the issue of immigration. Even where we observe similar migration patterns, policy responses and societal tensions associated with migrant groups seem to differ noticeably. The SOM project seeks explanations to the cross-country differences in the politicisation of immigration and the integration of immigrants. It compares seven Western European countries that differ institutionally, as well as in the number and nature of immigrants they received. The process of politicisation is described in terms of salience of the issues of immigration and integration, as well as in terms of polarisation of opinions around those issues. High salience implies that immigration is talked about, whereas polarisation refers to differences in opinions. Immigration is considered politicised when high levels of salience and polarisation are observed at the same time. The aims of the project include: 1. increasing knowledge about conflicts over the social and political participation of immigrants in Western Europe; 2. determining why and when potential conflicts become politicised examining both anti-immigration and anti-racist movements; and 3. increasing knowledge of how institutional conditions constrain processes of politicisation. The output of the project includes a large longitudinal cross-country dataset of political claims. Newspaper articles from 1995 to 2009 were chosen to observe political claims claims-making. A political claim describes any public political activity such as a press statement, a protest or a policy initiative by which political actors call for change in policy. This dataset allows exploring how and when immigration and integration become politicised. In addition the SOM project gathered data as explanatory factors: extensive demographic data, information on the legal situation and immigration policies, as well as institutional factors related to the electoral and party systems of the countries. In comparative analyses the project found that across all seven countries, the salience of immigration was relatively low in 1995. It increased in the early 2000s to decrease again somewhat in the late 2000s. Within this pattern, there are large variations from year to year, but these increases and decreases in salience differ from country to country. Immigration and integration appears least salient in Ireland and Wallonia, and most in the Netherlands and Austria. At the same time, immigration is a more contested issue in certain countries than others. The United Kingdom (UK) displays the highest level of polarisation over time, the German speaking part of Switzerland the lowest. It appears that in countries where party politics are dominated by two large parties (UK and Spain), the issue of immigration is most polarised. Neither the salience nor the polarisation of the issue are directly related to the influx of immigrants, the share of foreign born residents, the policy responses, or the state of the economy. Indeed, country specific factors affect polarisation and salience of immigration. In all countries politicisation is a mixture of political leadership or initiative, and circumstances that provide opportunities to influence politics. In most countries politicisation is driven by political parties. This is less pronounced in Ireland, the UK, and Switzerland, where the process of politicisation often is initiated by civil society actors and journalists. Systemic features of these countries may explain these differences. Project context and objectives: The aim of the comparative project SOM is to determine why and when potential conflicts over migration become politicised. The guiding research question is: 'What causes large cross-national differences in the ways the presence of immigrants and their full political and social participation becomes contested and politicised'? The project pursued four avenues in order to address the research question. First, the project partners seek to contribute to the contemporary literature on political debates and policies about migration and integration. In particular they project increases knowledge about the conflicts over the social and political participation of immigrants in Western Europe. Second, despite the fact that conflicts are at the heart of political sciences, little is known about?issue formation. 'Why and when do potential conflicts become politicised, and when and why do they not become politicised'? By addressing these questions, the project is relevant to a much broader group of researchers than those interested in immigration and interaction policies. Third, the project increases knowledge of the way political processes are constrained by institutional conditions. By including a temporal dimension in the research design, the project makes strides toward better understanding the involved dynamics. Fourth, the project provides policy-relevant information by assessing which actions of state intuitions have been more or less successful in managing conflict on immigration and integration. From the point of view of policy-making, the fact that immigration becomes a contested issue is not necessarily a ?political? or ?social? problem, but may be just part of ordinary policy processes in which opposite views emerge around how to manage society. However, when contestation transforms into conflict, and especially violent conflict, social cohesion might be at risk. It is therefore, in our opinion, relevant for policy-makers to learn which institutions might promote heightened conflict and which might reduce it to reasonable contestation. To better understand the dynamics of politicisation, the project covers countries with different political reactions to immigration. It includes two countries where immigration started relatively late (Spain and Ireland), three countries where new or established parties successfully mobilised support on the anti-immigration issue (Switzerland, Belgium notably in Flanders, and Austria), one country with many immigrants, yet without giving rise to successful anti-immigration parties (UK), and one country where such parties have been around for a long time, but only very recently with some electoral success (the Netherlands). The inter-country variation allows to explain overarching trends and to identify which systemic elements contribute to determining politicisation. The SOM project adopted a variety of methodological approaches mixing quantitative and qualitative techniques. A quantitative content analysis of newspapers over a period of 15 years (1995-2009) plays a central role in the project. Specifically, political claims? made in the media were sampled, coded and measured over time and across countries. To identify politicisation, the study made use of a random sample of newspapers, consisting of 700 days per country across two different newspapers (one tabloid and one broadsheet). In Belgium and Switzerland we accounted for the presence of linguistic regions by including two newspapers of the major language regions respectively. The project recognises two aspects of politicisation, namely salience and polarisation. Salience was measured in terms of number of claims on the issue per sampled day. This provides an average number of claims that is expressed here in yearly terms, by employing of moving averages. Moving averages are particularly suitable to describe long term trends. Polarisation is measured, employing a 5-point scale, on whether the relevant political claim is displaying a position favourable or hostile towards migrants. Project results: The SOM project seeks to explain cross-country differences in the politicisation of the migration issue. It compares seven Western European countries that differ institutionally, as well as in the number of immigrants they received. The process of politicisation is described in terms of salience of the issues of immigration and integration, as well as in terms of polarisation of opinions around those issues. Immigration is considered properly politicised when high levels of salience and polarisation are observed at the same time: many claims are made about immigration and integration, and political actors take different views on the issue. Substantial numbers of immigrants arrived in Western Europe since the 1960s. At least from the mid-Nineties onwards, the presence and integration of immigrants has become a contested issue in all but a few receiving countries. However, there are substantial differences between countries in the timing and extent of the politicisation of the issue of immigration, despite similar migration patterns, policy responses and possible societal tensions associated with migrant groups. The output of the project includes a large longitudinal (1995-2009) cross-country dataset of political claims. Political claims are public political activities such as press statements, protests or policy initiatives by various political actors, and are observed via newspapers. This dataset allows exploring how and when immigration and integration become politicised. In addition, the SOM-project gathered demographic and legal data on immigration and civic integration to be used as explanatory factors. Furthermore, information on the political system such as their electoral and party systems of the countries under study is integrated in the analysis. The key findings of the project are as follows: First, across all seven countries, the salience of immigration and integration was relatively low in 1995. It increased in the early 2000s and in most countries decreased somewhat in the late 2000s. An exception Is Austria, where the salience of immigration and integration increased toward the end of the period covered. The salience of immigration and integration is expressed as the relative number of political claims found on a fixed number of newspaper editions around randomly sampled days. Second, there are country-specific trends. Across countries, the issue is least salient in Ireland and Wallonia, and most in the Netherlands, Austria and Spain. All countries experience peaks of politicisation at different points of time. In the Netherlands peaks follow traumatic events as the murders of Pim Fortuyn and Theo van Gogh, but after the shocks, the saliency of the issue returns rapidly to much lower levels. The peaks in Spain are not related to such events; while Austria is the only country where there has been a clear upward trend in salience throughout the period covered. Third, the debate has shifted from questions of immigration to questions of integration. Within the overall theme of the project, we distinguished between claims made pertaining to migration and claims pertaining to civic integration. The proportion of claims about migration decreased relative to the proportion of claims about migrant integration. This trend is fairly uniform across countries. Ireland and Austria stand out as countries where asylum seekers are more politicised than in the other countries under study. Fourth, immigration is a more contested issue in certain countries than others. The United Kingdom displays the highest level of polarisation over time, the German speaking part of Switzerland the lowest. There are substantial fluctuations over time, but countries where party politics is dominated by two large parties (UK and Spain) tend to be the most polarised. The German speaking part of Switzerland, which displays an over-time increase in terms of salience, surprisingly presents low polarisation scores. As such, we hardly find a simultaneous presence of high salience and high polarisation, which constitutes the basis for politicisation. Similarly, the two Belgian regions show very similar degrees of polarisation. Combining salience and polarisation, Flanders displays higher degrees of politicisation of immigration than Wallonia. In the Netherlands, by contrast, the issue of immigration appears to have been latently salient but not strongly polarised over time. The peaks in salience in 2001 / 2002 and 2004 are not reflected in high polarisation. In Ireland, immigration displays the lowest degree of saliency, and it appears to have been an issue on which no strongly polarised positions were voiced. In the United Kingdom, a high level of polarisation is registered, in fact the highest in the group of countries under study here. Polarisation is relatively stable in the late 1999s and early 2000, and it then fluctuates quite a bit. However, values remain on the high side of the spectrum, showing that political actors tend to voice quite opposed positions on the issue of immigration. In Austria, polarisation does not fluctuate very much. Peaks are present in 1996 and in 2004, but the overall tendency seems to be characterised by little polarisation. Spain, despite the lack of anti-immigrant parties at the national level, does show some degrees of polarisation, with the second highest average of the countries studied in the project. All values fluctuate very little over time. Surprisingly, the radical right parties are not the main claimant at the level of parties. This finding is particularly strong in Austria, and with reference to the Freedom Party (FPÖ). It is the mainstream parties that most frequently appear as claimants on the immigration issue. This difference does not change during the FPÖ?s participation in federal government (2000-2005), or for the Swiss People's Party (SVP) which is part of government. At the other end of the spectrum, immigrant actors and organisations play virtually no role as claimants in the politicisation of immigration. Claims-making on immigration in Austria is first and foremost a discussion about and of immigrants, not by immigrants themselves. Fifth, salience and polarisation of immigration and integration are not clearly related to the influx of immigrants, to the share of foreign-born residents, the policy responses, or the state of the economy. There is no systematic relationship between the number of immigrants in a country or the number of immigrants entering a country and the extent to which the issue is politicised. This remains true when we distinguish between different kinds of immigrants coming from different parts of the world. Moreover, there is also no direct relationship between our indicators of politicisation and measures of the state of the economy, such as growth in Gross domestic product (GDP). The issue of immigration does not ?automatically? become politicised once there are a large number of immigrants. Sixth, country-specific factors affect polarisation and salience of immigration. In all countries, politicisation is a mixture of political leadership or initiative, and circumstances that provide opportunities to influence politics. There are, however, large differences between the countries in the extent to which ministers and parliamentarians dominate the debate on immigration and civic integration. In most countries politicisation is driven by political parties (top-down), but in Ireland, the UK and to a lesser extent Switzerland, there is more room for civil society actors and journalists (bottom-up). In Ireland and the UK, parties are much less prominent in the debate than in the other countries. Systemic features of these countries may explain these differences. Preliminary analysis shows that in all countries the mainstream parties, who in the past or currently hold government responsibility, have an incentive not to politicise the issue. Yet, they were largely unsuccessful in doing so. In countries with multiparty systems (Belgium, Austria, Switzerland and the Netherlands), it was relatively easy for radical right parties to form and to challenge the mainstream parties on this sensitive issue. Such politicisation often took place in these countries, referendums were often the catalysing events. In Belgium party actors were slightly less dominant in the debate than in the other multi-party systems. A tentative explanation is that the cordon sanitaire against the anti-immigration parties Vlaams Belang and Front National enabled the mainstream parties to avoid the debate on immigration related issues. In the UK, where party politics is dominated by two large parties, politicisation on the issue did not take place in the party arena as much as in the other countries. Due to the electoral system, the mainstream party has more opportunities to keep the issue off the party agenda. Spain is also mostly dominated by two parties. Here, however, governments could not keep the issue off the agenda, when large numbers of boat people from Western Africa arrived on the Canary Islands. Yet, perhaps interestingly, the parties de-politicised the issue around the Madrid bombing in 2004. In Ireland the issue was hardly politicised throughout the period. This had partially to do with the specific structure of the Irish party system, where the government party took the most right-wing positions on immigration of all parties, thus leaving no room for the opposition or for an anti-immigration party to form. In addition to knowledge, the project produced large datasets. These data are freely available from the project dataverse: http://dvn.iq.harvard.edu/dvn/dv/som. This Harvard-backed data repository is widely recognised in academic circles, and allows convenient data sharing in multiple file formats. Basic descriptive analyses can be carried out online. The dataset from the media analysis will be added to the Dataverse within a year of the project end. All documentation, including the codebook and reliability analyses, has already been made available to other researchers by publishing them as SOM working papers. All SOM Working Papers are distributed through the Social Science Research Network (http://ssrn.com) to reach a wider audience. In addition to the working papers, the project partners were actively engaged on several conferences. The first journal articles are under review and around eight are near completion. A book is in preparation. Potential impact: The rise of anti-immigrant movements and politicisation of immigration mean that the research produced by the project is topical. A state-of-the-art website was set up at the beginning of the project and regularly kept updated. Full description of project goals, structure, events, and consortium participants are listed. All working papers, policy briefs, and published data are available from the website. Users can subscribe to the project newsletter. The website will be maintained beyond the formal end of the project to inform about publications and other relevant activities. The project partners have made available all deliverables that are of general or specialist interest as working papers. To reach a wider audience, the working papers were disseminated using the Social Science Research Network (http://ssrn.com). Some of the working papers were in the top-10 of relevant categories, indicating interest among academics. Academic research beyond these deliverables was undertaken, and several publications are close to submission to top journals. Most of these papers are jointly authored, many of which by researchers who did not know each other before the beginning of the project. An edited book on the countries in the study is in preparation. Three policy briefs were written to present the empirical findings of the project and reflect on the policy implications. These are available on the project website, and were distributed to interested individuals through the SOM newsletter and personal networks. Members of the advisory board work in policy-related areas and were keen to disseminate the findings of the project. At the final conference in Brussels and at national dissemination events the project partners took care to disseminate research findings beyond the academic setting to policymakers, practitioners, and interested stakeholders. The research was internally reviewed at SOM workshops, but also externally at academic conferences. This happened both within the IMISCOE network as well as in international conferences. Future collaboration in the framework of Horizon 2020 is strongly considered, and the project partners have already developed joint proposals on related issues. A privately funded project at the Université libre de Bruxelles is under way to study and analyse the recent shift towards more restrictive integration policies. The idea is to reproduce the analytical design of SOM, based mostly upon an in-depth analysis of claims in the media, in order to see whether we can trace back what are the sources of the recent shift observed in several EU countries towards more restrictive integration policies. A joint project by the Universities of Neuchâtel and Vienna was submitted to SNSF and FSW to study the politicisation of and mobilisation against asylum seekers. The partners in Brussels and Dublin collaborate on a joint research project on the personal vote in PR list systems. They are collaborating on the use of the mock-ballot technique for the elections studies conducted in Belgium in 2012 and 2014. The project is financed by the FNRS and the Belgian Science Foundation (BelSpo). Without SOM, these collaborations would certainly not have existed. List of websites: www.som-project.eu

Periodic Report Summary - ANTIGONE (Anticipating the global onset of novel epidemics)

Wed, 17 Apr 2013 00:00:01 GMT

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Project context and objectives: In recent years, an increased number of zoonotic viruses and bacteria have crossed the species barrier to humans and caused or threatened to cause human pandemics with high morbidity and mortality. Examples in recent years are the influenza A / H1N1 pandemic and the outbreak of enterohaemorrhagic Escherichia coli (EHEC) O104:H4. Because of our inability to predict the emergence of these pathogens, it is difficult to take preventive measures. For any zoonotic virus or bacterium to emerge from its original animal reservoir(s) and develop into a pathogen with human pandemic potential, it must successfully cross various consecutive and interdependent barriers. These barriers may be divided into three categories: 1. the interspecies barriers, which encompass those that determine the level and nature of exposure to pathogens; 2. the intrahuman barriers, which determine the ability of a zoonotic pathogen to gain access to the appropriate tissue, replicate in the appropriate cell type, deal appropriately with the host immune response, and be excreted from the infected human host; and 3. the interhuman barriers, which a zoonotic pathogen must overcome in order to acquire the ability and opportunity to transmit efficiently among humans and cause human epidemics or pandemics. We term this interlinked sequence of events from animal reservoir to human pandemic the chain of emergence. It is poorly understood which pathogen, host, vector, and environmental factors allow zoonotic pathogens to successfully cross these barriers. A better understanding of these factors will not be realised if addressed from the narrow perspective of a specific category of pathogens, a single discipline (e.g., virology or bacteriology), or a specific reservoir host (e.g. bats), which will inevitably omit a substantial part of the factors contributing to emergence of viruses and bacteria with human pandemic potential. For this reason, ANTIGONE will address this topic from the perspective the chain of emergence. In this way, focus is achieved on the determining factors and justice is done to the variety of zoonotic viruses and bacteria, reservoir host species, and routes of transmission involved over all stages in the chain of emergence. In order to identify the key factors that render zoonotic pathogens prone to cross the species barrier and gain efficient transmissibility among humans, we have the following main objectives: - to identify and understand the key factors that render zoonotic viruses and bacteria with human pandemic potential prone to cross the species barriers, adapt to the human host and further to gain human-to-human transmissibility; - to translate our increased understanding of key factors in the chain of emergence to risk assessment, and options for prevention and intervention of human pandemics emerging from zoonotic pathogens; - to develop and implement a One Health training programme, combining human and veterinary medical expertise with those from other relevant disciplines, in order to equip the future generation of scientists with the necessary knowledge to deal with emerging zoonotic infectious diseases. In order to reach these objectives, we have a two-pronged approach. First, we perform primary research studies to fill important gaps in our understanding of how zoonotic pathogens can gain pandemic potential. These studies focus on selected viruses and bacteria, including SARS coronavirus, Nipah virus, Ebola virus, E. coli, M. bovis, and S. suis. Integral to these activities is a cross-disciplinary training programme for young scientists (Young ANTIGONE) and the development of risk assessment models. Second, we organise expert workshops where experts from the human and veterinary fields, from within and outside ANTIGONE, discuss key issues in infectivity, pathogenicity, and transmissibility of zoonotic pathogens and determine general criteria to assess the risk of these pathogens to gain human pandemic potential. Project results: Primary research was performed at levels of interspecies, intrahuman, and interhuman barriers. Samples were collected from host (animal) reservoirs for the selected model pathogens, and from their vectors in case of vector-borne pathogens, as well as from humans which were potentially exposed to these reservoir species and pathogens. Appropriate isolates and strains of model pathogens have been selected and genome sequences have been generated for some of those model pathogens and were characterised by different techniques. Laboratory assays have been developed, and in vitro and in vivo experimental systems were established. For E. coli, samples were collected from putative environmental and animal reservoirs of diarrhoeagenic and O104:H4 serotype E. coli, as well as from healthy and ill patients and analysed. In vitro and in vivo systems were developed to be able to compare host response in reservoir hosts and humans for EHEC and related E. coli strains. Furthermore, the susceptibility of the O104:H4 outbreak strain to a panel of antibiotics was determined. To assess the risk of introduction of zoonotic pathogens into human populations, mathematical models are being developed. At this stage of the project, work has concentrated on collecting relevant data for parameterising these models. The first of five annual one health courses was successfully organised and the first of five Expert workshops, concentrating on analysis of interspecies barriers, is in preparation. Four panels (wildlife, livestock, human, and environment) were assigned, and the forty experts were invited. Research published in Journal of Virology on hepatitis E virus (HEV), an important cause of liver disease in humans, showed the presence of HEVs in African, central American, and European bats. Results suggest that hepeviruses invaded mammalian hosts non-recently and underwent speciation according to their host restrictions. Human HEV-related viruses in farmed and peridomestic animals might represent secondary acquisitions of human viruses, rather than animal precursors causally involved in the evolution of human HEV. Research on HPAIV H5N1, a virus that has infected over 1 000 people since 1997 with a case fatality rate of about 60 %, published in Science, showed that several recently circulating isolates of HPAIV H5N1 are only a few mutations away from becoming efficiently transmissible among mammals, and highlighted critical areas of research to mitigate this risk. Research published in mBio on the newly emerged human coronavirus EMC, which was diagnosed as a cause of severe respiratory disease in several people this year, some of whom died, showed that this coronavirus uses a receptor that is conserved between bats, pigs, and humans, suggesting that there is a low barrier against host switching. Research published in the Journal of Proteomics and Bioinformatics on tuberculosis, brucellosis, and anaplasmosis showed that all three pathogens use the Jak-STAT pathway to control infection in their natural reservoir hosts, which helps to understand the pathogenicity of these bacteria in humans. Research on the relationship between climate change and emergence of tick-borne diseases indicated that the combination of climate, host abundance and social factors may explain the upsurge of epidemics transmitted by ticks to humans. Research on EHEC O104:H4 indicated that, based on in vitro studies to evaluate antibiotics, ciprofloxacin should not be used in patients infected with EHEC O104:H4, and, in general, in patients with diarrhea, if an EHEC etiology cannot be excluded. In contrast, meropenem, azithromycin, rifaximin might represent therapeutic options in patients with EHEC O104:H4 infection if antibiotic treatment is necessary. The first of five 'One Health' courses, a key part of the Young ANTIGONE cross-disciplinary training programme for young scientists, was successfully held in Rotterdam in autumn 2012, and proved to be successful in providing integration between human and veterinary medicine and other relevant disciplines. Potential impact: ANTIGONE will contribute to a better understanding of the emergence and transmission of pathogens with pandemic potential by a combination of expert workshops and primary research studies. In the expert workshops, we will identify the key factors that render zoonotic pathogens prone to cross the species barrier by making a concerted and intensive effort to synthesise the expertise of ANTIGONE with existing available knowledge on the emergence of infectious diseases of zoonotic origin. In the primary research studies, we will fill in critical gaps in our knowledge of the process of pathogen emergence. This combination of studies provides the necessary breadth (expert workshops) and depth (primary research study) for an optimal improvement of our understanding of zoonotic pathogen emergence. This will help to predict the zoonotic and pandemic potential of zoonotic pathogens, and improve our abilities of early detection and effective response against outbreaks of emerging zoonotic pathogens. In addition, ANTIGONE will provide a relevant combination of training in human medicine, veterinary medicine, and other critical disciplines 'One Health' to prepare a new generation of scientists to deal with tomorrow's global health problems. ANTIGONE will reduce the separation between human and veterinary medicine in the surveillance, research, prevention and mitigation of emerging infectious diseases by training a new generation of scientists in the concept of 'One Health'. ANTIGONE will contribute to improved preparedness planning, in particular modelling and prediction, but also development of appropriate intervention measures by filling in critical gaps in our knowledge of zoonotic pathogen emergence, by identifying the key factors allowing zoonotic pathogens to cross the species barrier at each of three levels (interspecies, intrahuman, interhuman), by performing primary research studies on risk assessment and modelling of emerging zoonotic diseases, by bringing together scientists from ANTIGONE and from the rest of the world together with policy makers together to integrate, synthesise, and translate the state-of-the art, and by equipping a new generation of scientists with the knowledge to deal with these diseases. The primary research studies indicated above will provide new data on critical gaps in our knowledge of the emergence of significant zoonotic pathogens, including Nipah virus, Crimean Congo Haemorrhagic Fever virus, SARS-coronavirus, Influenzavirus, Ebola virus, hanta virus, Escherichia coli, Mycobacterium bovis, Coxiella burnetii, Borrelia burgdorferi, Anaplasma phagocytophilum, Yersinia pestis and Streptococcus suis. This new knowledge in itself will contribute to the expected impact by generating new opportunities for prevention and control of emerging zoonotic pathogens. A core component of this project is to synthesise the expertise of ANTIGONE with existing available knowledge across the spectrum of emerging infectious diseases, in order to identify the key factors that render zoonotic pathogens prone to cross the species barrier for each of the three categories: interspecies, intrahuman, and interhuman. This synthesis will form an important contribution to the expected impact of ANTIGONE by showing the way to target and improve efforts in preparedness planning, prevention, and intervention of emerging zoonotic pathogens. We thus expect ANTIGONE to not only create a step-change in scientific basis for, but critically also in the implementation of, broadly effective preparedness plans, prevention strategies, and intervention strategies. List of websites: www.antigone-fp7.eu

Periodic Report Summary - PROMETHEUS (Process contaminants: mitigation and elimination techniques for high-quality food and their evaluation using sensors and simulation)

Wed, 17 Apr 2013 00:00:01 GMT

ASSOCIATION DE COORDINATION TECHNIQUE POUR L'INDUSTRIE AGROALIMENTAIRE
Project context and objectives: Since the discovery of trace amounts of acrylamide in a wide range of food products in 2002, great attention and concern has been raised on the possible safety problems associated with substances formed during heat processing of foods. Built on the previous European Union (EU) projects HEATOX and ICARE, PROMETHEUS has the objective to help the European food industry to reduce consumer exposure to undesirable compounds formed during food processing without affecting food quality or reducing microbiological safety. The project investigates: - four mitigation strategies: vacuum baking, high hydrostatic pressure treatment, ohmic heating and microencapsulation of heat-labile ingredients; - three innovative monitoring strategies to simultaneously measure the relevant contaminants, their precursors and some quality indicators: front face fluorescence analysis to monitor food process contaminants, ambient mass spectrometry and computer vision based on image analysis. Nutritional and sensorial indicators will also be measured for each food products. The data obtained will allow modelling of the reactions that form contaminants and affect food quality. The studies are lead on food models (infant formulas, biscuits, canned baby foods, and canned fish and vegetables) that have been selected for their nutritional relevance to the consumers, especially infants and children. Processing contaminants (acrylamide, 3-monochloropropanediol esters, glycidol esters, furan, hydroxymethylfurfural and carboxymethyllysine) have been chosen for their toxicology and relevance to the food product and process. The expected project outcomes will help the food industry to better control the safety and overall quality parameters of their products by implementing the most promising innovative technologies. Project results: During the first year and a half, the main activities implemented in PROMETHEUS concerned: WP1 - Innovative analytical techniques: - The colour vision camera has been adapted in the baking oven to measure on line biscuit surface heterogeneity and global browning process in relation to the time-temperature. Satisfactory regression models over acrylamide and HMF have been obtained when a given recipe is considered. The great advantage of the technique is to provide real time assessment of the biscuit colour which is an important sensorial parameter. In contrast the possibility to predict neoformed contaminant in biscuit is limited by the influence of recipe changes that would oblige to construct new models any times ingredients or formulation are changed. - The front face fluorescence technology by contrast allows extracting multivariate information within the fluorescence fingerprint of the biscuit, baby puree, infant formulas and fish, that can be further used in multilinear regression over neoformed contaminants, even if the recipe is variable. A sensor integrating the optical, electronic and computer devices was developed equipped with a heat and pressure resistant probe related to the illuminating sources (LEDs) and to the spectrometer (recovered emitted light from the sample) using optical fibres. It enables, after implementation of calibration models, monitoring neoformed contaminants online or spore decontamination at line in food products. Developments have been focused on implementation in oven for baking biscuits and in ohmic heating systems for sterilising baby food, carrot purees and infant formulas. The sensor can also be used as Research and development (R&D) analysor for rapid at line analyses. - Direct ambient real-time (DART) analyses have been applied to each food matrix to identify neoformed molecular masses appearing in positive and negative ion detection modes when heat?treating the product. Some signal identification is running, regarding on the one hand recipe ingredients degrading upon processing, and on the other hand, aromatic compounds, or intermediary compounds of heat-driven reactions forming during the process. - The construction of a database for each food matrix is in progress. The data base will include process parameters, recipe description, results of conventional and alternative analytical techniques to characterise the sample regarding neoformed contaminants and nutritional composition. WP2 - Alternative processing technologies: - Baking biscuits under vacuum with similar final water content considerably decreased the concentration of HMF and acrylamide to trace levels. However the absence of browning at the surface obliges to combine the alternative baking technology to either infrared browning at the end or with conventional baking to obtain sensorial acceptable biscuits. - High pressure demonstrated the huge gain in time for fish and carrot puree decontamination compared to retorting. Study on the impact on neoformed contaminants is in progress. - Similarly ohmic heating sterilisation showed to allow both gain in treatment time and improvement in neoformed contamination, by decreasing up to 3-4 times the level of furan in vegetable and vegetable + meat baby food. - Finally, encapsulation of reactive ingredients in biscuits and infant formulas revealed to be efficient when vitamin C in IF or NaCl in biscuit are concerned with significant impact on carboxymethyllysine in IF and HMF and 3MCPD in biscuits. WP3 - Modelling of reactions leading to NFC: Simple theoretical scheme of reactions leading to most representative neoformed contaminants in each food model has been designed. Based on analytical results obtained in WP2 experiments and inserted in the database (WP1), first attempts of reaction modelling are being developed. A first model for acrylamide formation in biscuits seems satisfactory. In case of unsatisfactory prediction, empirical models will be designed. From these models, optimisation of process parameters to mitigate NFC will be achieved and studied in WP4. The concrete results achieved after one year and a half include: - a prototype of an online fluorescence sensor; - a prototype for monitoring bacterial spore germination at line; - a camera prototype to monitor browning in biscuits online; - a list of compounds degrading and forming during heat process of food products; - a website dedicated to PROMETHEUS project. Potential Impact: The project outcomes will help to protect the consumers by providing them with high quality ready-to-eat food products thanks to validation of alternative technologies for milder food processing while maintaining the sensorial and nutritional quality of the product. It will improve the competitiveness of the food industry by anticipating future regulations on neoformed contaminants, and help it to innovate by implementing new technologies in order to better control the safety and overall quality of their products. List of websites: http://processing-contaminants-prometheus.com/

Periodic Report Summary - SPA (Support to precursor SSA services)

Wed, 17 Apr 2013 00:00:01 GMT

EUROPEAN UNION SATELLITE CENTRE
Project context and objectives: The Support to Precursor SSA Services - SPA project is a Seventh Framework Programme (FP7) support action (grant agreement No. 262930, theme SPA.2010.2.3-2: Security of space assets from on-orbit collisions) managed by the European Union Satellite Centre (EUSC), under the full control of Member States. SPA started on the 1st of march 2011 with duration of eighteen months. the spa project aims to contribute to the technical definition of the governance and data policy for a european space Situational Awareness (SSA) capability by testing possible models in the EUSC?s operational and secure premises (located at the Torrejón Air Base in Spain near Madrid). Three preliminary services of relevance for civilian security and the Common Foreign and Security Policy (CFSP) and have been defined for assessment: - satellite conjunction warning (i.e. protecting operational satellites from collisions); - satellite Over-flight (i.e. the knowledge of satellites position with time); - space Debris Re-entry Prediction (i.e. warning of space objects re-entry to Earth's surface). The SPA project is structured into seven WPswith associated tasks and clearly identified milestones. Each Work package (WP) is led by an expert in the respective knowledge field and assisted by other EUSC staff. The seven SPA WPs are: - WP1 'Project management' ensures that the project is given a management level suitable to European Commission REA standards. - WP2 'SSA precursor service definition', characterises three SSA preliminary services related to the protection of space infrastructure having relevance to civilian security as well as the CSDP. - WP3 'Adaptation, integration and testing', provides a suitable secure environment to host a preliminary SSA system. WP4 - 'SSA prototype hosting', integrate an SSA prototype system based on European Space Agency (ESA) development an COTS suitable to be developed by ESA in order to implement preliminary SSA services. - WP5 'Precursor services testing', validates the requirements for preliminary services determined in WP2, being the core element of the SPA project. WP6 - 'Dissemination', conveys the experiences obtained during the development of the SPA project. WP7 - 'Support', provides technical coordination and support for the proper management of the SPA project. During its first nine months, SPA has achieved the following: In WP2-SSA 'Precursor service definition', three SSA preliminary services have been characterised. Those services are related to the protection of space infrastructure with special relevance to civilian security as well as the CSDP. Additionally, requirements for governance and data policy have been identified and outlined. Those services and requirements are the basis for the rest of the project and their outputs have been consequently used by WPs 3-6. The focus of WP3 lies on the provision of a secure environment to host a preliminary SSA system. In particular, the adaption of SPA's dedicated areas within the EUSC secure premises has been described, as well as a traceability matrix concerning the requirements set on WP2. In that sense, adaptation consists of the conditioning of a protected SPA office space which provides a routine working environment for the project and a dedicated server rack on the EUSC server room to hold all the additional equipment that will support the demonstrators. In parallel, the WP4-SSA has been focused on the definition, installation and validation of different software products for the SPA demonstrator platform. As a first achievement, access to ESA?s CRASS software at EUSC has been completed. Additionally, other COTS software, such as AGI STK, have been already identified, installed and used for the implementation of preliminary services, such as the overflight. Besides, coordination activities with ESA have started in order to install the software to be developed as part of the ESA SSA Preparatory programme (ESA SSA PP), mainly related to the CO-VIII (Core) and DC-II (Data Centre) activities. In WP5-Precursor Services Testing, the establishment of a preliminary SSA service workflow has been the major task. The workflow has been based on the output of WP2, the findings on requirements to CSDP and those on governance and data policy, and technical requirements. All the results obtained from WP2, WP3, WP4 and WP5 during the development of the first nine months of the project have been disseminated in WP6-Dissemination, and in particular through the first SPA Technical Workshop, the SPA Technical Forum, the SPA promotional video, different presentations and conferences. The next phase of SPA support action will be focused on the assessment of test cases suitable to provide technical inputs for the definition of models of governance and data policy for SSA and the validation of the identified SSA requirements for the described SSA-SST services using the software hosted at the EUSC. The final output of the SPA project will be a report summarising knowledge gained, lessons learned and recommendations for further development of SSA in Europe, particularly on the technical aspects of its Governance and data policy. Regarding the impact and benefits of the SPA project and considering in particular the communication from the European Commission towards a space strategy for the European Union that benefits its citizens? [RD-6], space is important for European economies and societies. Several European policies and resolutions, such as the European Space Policy (RD7), the fifth and seventh Space Council Resolutions (RD-8)(RD-9) and the draft code of conduct for outer Space activities [RD-10], have recognised the importance of an SSA capability in Europe, highlighting the significant consequences on security, safety and economic activities in case on any disruption in the availability and functioning of space-based systems. SSA capabilities support the protection of European space infrastructure and guarantee safe operations by providing alerts of potential hazards in a sufficient time to allow preventive actions to be taken. This way SSA is supporting all the benefits derived from space as well as underpinning direct benefits to society, economy and security. The EUSC, contributing through the SPA project to the current SSA activities in Europe, is supporting the socio-economic benefits attached to Space, also contributing to the protection of space assets which in turn will provide services needed to ensure the safety and the well-being of EU citizens. The SPA Web Page has been added to the EUSC Web Page (to maximise the number of possible contacts) and contains a presentation of the project activities and some other information for general public and interested users. Moreover people can contact the SPA Team using a dedicated email address to request more information about the SPA activities. The SPA email address is: spa@eusc.europa.eu The SPA Web Page is reachable at the following address: http://www.satcen.europa.eu/index.php?option=com_content&task=view&id=60&Itemid=84 Project results: Additionally, a transversal collaboration activity across WPs is done between the SPA project and ESA SSA PP team, including coordination meetings, involvement in external requirements reviews and key ESA SSA PP programme activities. WP2 - SSA preliminary services definition During the first half phase of the project, three preliminary indicative services have been identified and confirmed as relevant by consultation with key European SSA stakeholders. These services are satellite over-flight, satellite conjunction warning and Space re-entry prediction. The suitability, relevance and outline of these services have been discussed face to face during the 1st technical workshop. In that sense, background information from key European SSA entities, US, EU, ESA and national level has been studied and evaluated. Regarding the task 2.1) SSA services definition to support civilian crisis management and CSDP, the three services (Satellite Over-flight and satellite conjunction warning) have been defined, illustrated and outlined. The associated deliverable D2.1 findings on SSA requirements to support civilian security and CSDP, has been written and submitted on time on the 31 August 2011. Concerning the task 2.2) Governance data policy requirements, after the study and investigation of related documentation and resources, a number of possible architecture models which comply with the key requirements and needs of a future SSA-SST capability in Europe have been identified. Similarly, related to the data policy, key requirement sets and sources have been identified, analysed and documented. Main important issues and bases of the data policy have been outlined in D2.2 findings on SSA Precursor service requirements for governance and data policy. Regarding the task 2.3 technical requirements, technical needs for the SPA prototype and the required setup have been detailed. As a main requirement, SPA prototype must be flexible in terms of usage of different software packages (ESA and external). Additionally, the completion of this task has facilitated the advance of the setup of the identified technical infrastructure that will support the work of the coming WPs. The deliverable associated to this task, D2.3 'Technical requirements for prototype hosting', has been submitted on time on the 31 August 2011. WP3 - Adaptation, integration, validation and testing During the mid-term period of the project, a suitable secure environment to host a preliminary SSA system has been studied. In particular, the deliverable D3.1 'Acceptance of a SSA hosting area' describes the adaption of SPA dedicated areas within the EUSC secure premises, as well as a traceability matrix concerning the requirements set on D2.3 'Technical requirements for prototype hosting'. The adaptation is the conditioning of a protected SPA office space which provides a routine working environment for the project and a dedicated server rack on the EUSC server room to hold all the additional equipment that will support the demonstrators. WP4 -? Prototype hosting During the reporting period and based on the installed infrastructure result from WP3 activities, it has been started the activities of definition, installation and validation of different software products for the SPA demonstrator platform. As a first achievement, access to ESA's CRASS software at EUSC has been completed. Additionally, other COTS software, such as AGI STK, have been already identified, installed and used for the implementation of preliminary services, such as the overflight. Besides, coordination activities with ESA have been started in order to organise and have installed the software to be developed as part of the ESA SSA PP, mainly related to the CO-VIII and DC-II activities. The complete definition of the rest of COTS and ESA software to be used in the demonstrators is currently on-going. WP5 - Preliminary services testing During the first nine months of the project, the activities of WP5 have been started covering technical inputs for the definition of a governance and data policy for SSA through the implementation and evaluation of initial precursor SST services using the prototype system defined in WP3 and WP4. In particular, the task 5.1) definition of preliminary services work flow, that establishes a preliminary SSA service workflow based on previous work and the outputs of WP2. As a result of this task, the deliverable D5.1 Precursor service workflow has been written and submitted on 30 November 2011. To date the EUSC and the SPA project has data available from the Spanish Royal Navy Observatory ROA, (Real Instituto y Observatorio de la Armada), the Mallorca Observatory OAM (Observatorio Astronómico de Mallorca), Spain, Rutherford Appleton laboratory, RAL Chilbolton Radar site (UK) and the GRAVES (Grand Réseau Adapté à la Veille Spatiale) instrument, France. Particularly, the SPA team has been involved in the formal ESA SSA PP external System Requirements Review (SRR) process that took place from September to November 2011. The EUSC has been one of the main participants providing inputs, improvements and recommendations to the existing system requirements. From the total of 197 Review item discrepancies (RIDs), 119 (60.5 %) have been provided by the EUSC, being almost all of them commented and agreed during the review. WP6 - Dissemination During the first nine months of the SPA´s project, valuable dissemination activities have been done. The SPA project has been presented to 33 events with different audiences (general public, EUSC?s visitors and key stakeholders) and 5 abstracts / articles have been accepted in international conferences and workshops. Additionally, two promotional videos have been realised to disseminate EUSC activities related with the SPA project. Moreover: - The SPA webpage, describing the SPA project, has been added to the existing EUSC website to reach the largest possible audience. The current version of the webpage is online at the following address: http://www.satcen.europa.eu/index.php?option=com_content&task=view&id=60&Itemid=84; - The SPA technical forum has been realised and is now open to selected contributors from EU MS, EC, EEAS, ESA and EDA. - The 1st SPA technical workshop has been held the 28th of June 2011 with ten participants from EUSC and ten external participants from MS, EC, EEAS, EDA and ESA. - The dissemination plan (IR6.0), the Summary Workshop Report (D6.1), the Promotional Video (D6.2), the Summary of communication actions (D6.5) have been realised and submitted to REA. During the reporting period, progress reports about the status of the SPA project in M3 (D7.1 Periodic Report 1) and M6 (D7.2 Periodic Report 2) have been submitted to the REA. Additionally, the Mid-Term Report and the Gender Issues Intermediate Report have been also written and submitted in M9. SPA Project management during the period The SPA project is on schedule (no deviations from the Work Plan) and within budget (330 889.05). The original SPA scope is fully valid. Initially identified risks have not been materialised (without any additional risks). During the reporting period (from 1 March 2011 to 30 November 2011), 12 (twelve) deliverables have been produced and submitted to the REA in accordance with the SPA Work Plan. Potential impact: Space assets are essential for the activities of modern societies. Communications, navigation, positioning and timing, meteorological and scientific services, geospatial information, understanding of Earth environment, civilian and Common Foreign and Security Policy (CFSP) operations, to name just a few services, rely on space assets. Any disturbance of these activities could damage or completely disrupt services needed to ensure the safety and the well-being of European Union (EU) citizens. In September 2008, the 5th Space Council underlined the need for Europe to develop a capability for SSA, drawing on existing capabilities and infrastructures both at national and European level. SSA refers to the knowledge of location and function of space objects and the space environment, including operational satellites, space debris, near Earth objects and space weather. The 7th Space Council invited the European Commission and the EU Council, in close cooperation with ESA and Member States, to propose a Governance scheme and a Data Policy for a future European SSA capability. The development of a European SSA capability will underpin the exploitation of European space assets contributing to access (and utilisation) of space for Europe (as requested by the European Space Policy). This way the EU and its Member States will be able to better use space, strengthening their security and economy in accordance with the Europe 2020 Strategy. The SPA supporting action main objective is to perform a study summarising the gained knowledge, including lessons learned, on SSA during the execution of the SPA project, as well as recommendations in view of further developments of SSA in Europe, particularly on the technical aspects of its Governance and data policy. SPA is supporting SSA activities in Europe and consequently Space through: - the identification and characterisation of indicative services, such as the satellite conjunction alert, satellite over-flight and space re-entry prediction; - the contribution from a technical side to the definition of a European SSA governance and data policy; - the evaluation of SSA-SST use case scenarios in order to outline SSA-SST data policy and Governance technical inputs; - the identification of best practices and standards in security and data handling. The main benefits of SPA project for the EU, EU Member States, EU citizens and other SSA stakeholders are: EU and its MS - to support EU MS national security and sovereignty; - to support the secure and traceable information exchanges among all SSA elements; - to support SSA activities adding value in data policy issues; - to exploit the expertise of the EUSC in handling, analysing and disseminating data of both civilian; - and military origin with multiple levels of confidentiality in a secure environment; - to simulate indicative SSA scenarios using a demonstration platform and promote innovation through the definition of SSA services and products; - to facilitate the dialogue among key SSA stakeholders through the establishment of a technical forum and workshops. ESA - to bridge the gap with policy makers and technical developers; - to provide advice in handling, analysing and disseminating sensitive data and derived products within the highest security standards. EU citizens - to protect and add value to services needed for the well-being and safety of EU citizens; - to support the identification of new services needed for the well-being of EU citizens. Other SSA stakeholders - to support SSA activities, adding value in data policy issues from a technical point of view; - to guarantee interoperable information exchanges among all the SSA elements. Third parties - to communicate in order to reach a common understanding of space capabilities. Use and dissemination of foreground Results generated by FP7 projects are required to be disseminated and promoted as swiftly and effectively as possible to benefit the whole interested community. At the same time a dialogue with Institutions and SSA key stakeholders is needed to contribute effectively (with a pragmatic and focused approach) to the technical definition of European SSA Governance and data policy. To reach these objectives, selected key audiences have been reached with focused messages, validated by the different SSA actors. Different communication strategies have been implemented, based on appropriate tools and activities such as, a webpage (added to the EUSC website and containing a presentation of the project activities), an internal workspace (a secure site allowing the SPA team to exchange useful information internally at EUSC), a technical forum (a collaboration tool used to allow institutions and key stakeholders to cooperate actively to the SPA project and containing all the SPA deliverables submitted to EC / REA). SPA has been presented by the EUSC mainly to Institutions and key stakeholders (such as the ambassadors of EU MS in Spain, the EDA SSA PT, the EEAS, the ESA SSA PP Team, the EUSC board, and the EUSC expert users). Also interested parties and general public have been informed (mainly through the participation to some international conferences or workshops and the production of articles). The key messages disseminated by SPA (with the agreement of participants to the second stakeholders advisory board meetings) have been: - security IN space is critical to have security FROM space; - the development of a European SSA capability. - Will protect space assets and satellite-based services which in turn are protecting EU citizens and operations/missions and consequently will improve the sustainability of space. - Will be a key tool to achieve CFSP results supporting national security and sovereignty; The main challenge on Data Policy is to facilitate the optimisation of SSA resources usage including the contribution of EU MS capabilities and protecting EU, EU MS and allies interests through security requirements and regulations. - contributing to SSA activities, the EUSC (a CFSP agency linking space and security) is: - exploiting its expertise in secure data handling (highlighting security aspects); - contributing to the protection of space assets needed to perform its mission; - enhancing its know-how by studying SSA-SST services relevant to civilian security and CFSP; - increasing SSA awareness in EU (also spreading gained knowledge). The SPA FP7 support action is: - under the full control of EU MS benefiting from their support; - developed in the EUSC secure environment; - complementing current SSA activities in Europe from a technical side. All EU Member States have been invited to cooperate on the implementation of the SPA Study and the interested parties have been invited to participate to the SPA technical workshops; moreover representatives from EC, EDA, EEAS and ESA have been invited. More details on the dissemination activities of the SPA project are treated in the SPA deliverable D6.6 - Summary communications actions with SSA key stakeholders 2. Societal Implications According with the EC reporting guidelines, this section describes the societal implications of the SPA project filling out a questionnaire addressed in annex 1. Moreover, specific information about SPA project societal implications has been already addressed in the following deliverables: D7.6 - Gender issues intermediate report This deliverable reports on gender aspects within the SPA project. D6.5 -?Summary communications actions with ssa key stakeholders 1 and D6.6?-Summary communications actions with SSA key stakeholders 2. These deliverables describe the dissemination activities of the SPA project and they also address media and communication issues. List of websites: http://www.satcen.europa.eu/index.php?option=com_content&task=view&id=60&Itemid=84

Periodic Report Summary - EUROBIOFORUM II (International forum for European life sciences funders and performers)

Wed, 17 Apr 2013 00:00:01 GMT

PUBLI MARKET B.V.
Project context and objectives: EUROBIOFORUM is a four-year project which aimed to create a platform for public funders and performers in the area of personalised medicine. The EUROBIOFORUM partners are Publimarket BV (NL), the Helmholtz Association (DE) and the French National Research Agency ANR. To meet the challenges of personalised medicine, it is important that both research performers and funders join forces and set objectives for the near future. EUROBIOFORUM aims to create a mechanism to foster dialogue, cooperation and coordination between research funders and performers. The main ambition of EUROBIOFORUM is to provide insight into the current initiatives and key players in personalised medicine in Europe. From this starting point, strategic alliances and partnerships will be facilitated to empower the field, warrant scientific, economic and societal success and capitalise on European added value. EUROBIOFORUM aims to function as an incubator to stimulate and facilitate alliances to converge their thoughts and ideas into concrete practical actions. Project results: This section describes the results and outcomes during the reporting period, as well as the activities which have led to these achievements. Many activities have resulted in methodologies and tools that can be used for the full duration of the project. 1. A stakeholder's network and database -Identification of most important organisations and contacts through intensive desk research. - approaching relevant stakeholders by phone and email; - visiting stakeholders to discuss participation in EUROBIOFORUM and specifically in the EBF conference 2012; - maintaining personal and electronic contact with stakeholders. 2. A multidisciplinary strategic advisory board - identifying potential board members and approaching them; - establishing the board and maintain personal contact; - organising brainstorms and discussions, together with EBFs partners to discuss topics and agenda for the 2012 conference. 3. Communication strategy - developing a communication strategy for EBF, development of a targeted overall communication structure and planning, and a specific online strategy to facilitate stakeholders; - developed tools: a communicative and informative website, social media accounts, digital templates for invitation e-mailing, folders, factsheets, and PPPs to facilitate meetings with stakeholders, partners and board members. 4. Personalised medicine observatory (part 1) - developed by means of desk research and interviews by telephone; - building the observatory online as part of the EBF website; - developing a future strategy for the observatory in order to proceed with part 2 (expanding content and visualisation); - the online database is publicly available at www.eurobioforum.eu. 5. EUROBIOFORUM Community (part 1) - creating the Community and attracting members; - the EBF website functions as an online platform in which policy makers, funders and scientists involved in PMed can share their thoughts and ideas; - developing a strategy to start online discussions and polls for the EBF Community (part 2). 6. Stakeholders meeting of May 2011 - communication activities to interest stakeholders for EBF; - inviting a selection of stakeholders for participation in the meeting; - actually hosting 20 participants from 11 European organisations to exchange ideas and viewpoints on PMed in Europe; - identification of important topics for the next EBF project years. 7. EUROBIOFORUM 2012 conference in April - communication activities to attract stakeholders to the conference: personalised e-mailings, web- and social media campaigns and phone calls; - preparatory activities with speakers; - organising the logistics of the conference; actually hosting 60 participants from 14 countries; - sharing thoughts on how to start removing the complex barriers to implement PMed; - identification of themes: how to get research results into the clinic, how to educate physicians and the general public, how to cope with the large amounts of data, and how to prepare stakeholders for radical change; - decision making about the set-up of small pilot projects to evaluate the effectiveness of PMed and raise awareness amongst stakeholders. 8. Special interest groups - establishment of a special interest group to discuss the feasibility of an ERA-NET on PMed; - organising a satellite meeting in April 2012; - the initiative will be continued and has been taken over by BMBF as an early spin-off of EBFs activities; - a CSA proposal has been submitted for the last Seventh Framework Programme (FP7) 'Health' call. Secondly, establishment of a special interest group to discuss cross-border cooperation between bioregions and bioclusters. 9. Overall conclusion after 18 months - through continuous personal contact by means of phone, email and visits, through the EBF 2012 conference, through dedicated meetings, workshops and extensive web- and social media campaigns, EUROBIOFORUM so far has contributed to the creation of a European network enabling to deliver the promises of personalised medicine in a more coordinated way. Potential impact: EUROBIOFORUM expects at the end of the project to have made a solid contribution to the following results in the field of personalised medicine: - the foundation of an active and informing network to track, trace and monitor developments; - improved coordination between research, policymakers and funders; - synergy between stakeholder, the only way to meet the upcoming challenges; - enhanced interaction and network building to drive success within personalised medicine; - broadened insight for every stakeholder of what is happening in the field; - improved position of Europe as the research and implementation capital of personalised medicine. List of websites: www.eurobioforum.eu

Periodic Report Summary - INDIGO (Innovative training and decision support for emergency operations)

Wed, 17 Apr 2013 00:00:01 GMT

DIGINEXT SARL
Project context and objectives: Modern societies have experienced a spate of catastrophic events in recent years. Terrorist attacks (London, Madrid), factory explosions (Toulouse), floods and storms (Louisiana) these are but a few examples of crises and disasters that threaten the security, prosperity and well-being of citizens. Urbanised areas are especially vulnerable to the onset of crises and disasters. The combination of dense population concentrations (35 million in Tokyo, 10 million in Paris) and complex architectural environments makes it very hard to anticipate, prepare for and manage the impact of natural, industrial or man-made incidents. The recent crises have demonstrated the inherent difficulties that urban safety and crisis managers face when a large-scale disaster threatens an urban environment. In this ever-changing environment, it is hard to design proper emergency plans, to train security organisations and effectively handle crisis management procedures. Therefore, it is essential for public authorities to better plan and train organisations and crisis managers and to provide relevant systems for complex crisis management across organisational and geographic boundaries. This is no easy task, as research has shown. New approaches and technologies should therefore be researched and developed to serve these critical needs. Based on both the experience and results of the CRIMSON project, funded by the European Commission (EC) in the frame of the preparatory action for security research, and drawing on the consortium's extensive expertise in crisis management, the INDIGO consortium has identified a strong need for an innovative and unified approach extending and broadening the advances of CRIMSON to the entire security field in order to enhance planning, training and crisis management operations. Indeed, CRIMSON produced a critical breakthrough by enabling the simulation of urban crises for the purpose of enhancing operational preparedness. However, this system is limited to the training of crisis managers, in outdoor environments, without connection to physical simulation or the possibility to involve field staff forces. INDIGO aims to provide a revolutionary solution that will enable inter-organisational preparation and response to transboundary crises and disasters, in any environment. INDIGO will allow for inter-organisational exercising, information sharing and analysis mining both horizontal and vertical relations. With regard to the latter, the relation between central command centres and field units is traditionally underdeveloped, both before and during crises. First responders are insufficiently involved in large-scale strategic exercises because these are very complex and expensive to organise and manage. The proposed system will prove an essential and integrated tool for training personnel, planning operations, and facilitating crisis management and cooperation across organisations and nations. It will enable users to: - display and manipulate an operational representation of the situation that is as complete and as easy to understand as possible, for indoor and outdoor situations; - simulate different evolving scenarios for planning, training, and anticipating future states and impending developments during operations, and analyse events after the crisis; - involve first responders and emergency field units in simulated exercises; - enhance the work across organisational boundaries and decision levels. Since the project began, the consortium has met end users to determine the requirements of the system. Based on those requirements and the vision of the partners, specifications were designed and development on the system has begun. The first milestone at M19, the 'Beta validation', has been successfully passed. End users have enjoyed this training session based on a tailored scenario, called the Géométhane scenario. Thanks to this fruitful experience which showed the work and integration achieved, commercial discussions are already in progress. Project results: The first work achieved is the study of the state of the art in the various fields that INDIGO is based on, such as massive geographic dataset modelling, new devices and interfaces for map manipulation, the history and the results of symbology but also crisis management tools. The second work achieved was definition of end requirements and specifications for the system. A questionnaire on the needs for crisis management training tools was distributed to end users and analysed which formed the basis of the user requirements document and the technical specifications. Early non-working mock-ups of the desktop tool and mobile tool at the end-user workshop in November 2010 were shown and received mostly positive feedback. For the March 2011 meeting in Géométhane, a limited but working prototype of the desktop and mobile tools but also a demo of tactile map manipulation were shown. At this point, the consortium gave much more pointed feedback, stressing the importance of filtering function for example. CNR and CRS4 decided to focus on the possibilities of online reconstruction of 3D scenes based on photographs. In March, CNR showed the result of a quick reconstruction of the Géométhane site. The first major milestone, the 'Beta release and validation', required an advanced integration of the tools at the middle term of the project. Beta preparation has led to a scenario involving an external end user, an industrial gas storage site, as well as fire-fighters and police officers. This scenario had to respect their constraints, as well as to anticipate future needs. Four internal meetings were required to ensure an appropriate Beta Validation. End users did welcome the carrousel form were they could overview each individual INDIGO tools, but also the full scale exercise were they could appreciate the technology proposed within a real training session. All validation procedures passed successfully and fruitful users' feedback consolidated end user requirements. These gatherings were used to complete the final user requirements and the INDIGO technical roadmap was consolidated. A taxonomy covering symbols from 17 organisations across 12 countries was assembled, over 30 responses of end users needs regarding symbology were collected thanks to an online questionnaire. The developed Beta emergency symbol set has been released to other EU projects, such as E-SPONDER, ESS and BESST. Feedbacks have been gathered to consolidate the final emergency symbol set. In addition, the set and its source are available freely on the project website. The next major milestone is the final release to be stressed during the final validation and the second full scale exercise. For the second full scale exercise, CRISM has successfully enrolled major Swedish civil security actors into an INDIGO training session. A crucial component is the completeness of the scenario and its acceptance with respect of their constraints. Many meetings were required between CRISM and their end users to agree on the content. Technical achievements of the in-progress scenario were shown to Swedish and consortium end users during a workshop help in April. Positive feedbacks illustrate that the project is on the right track. Two exercise tests are planned before the exercise to be held in October. Besides the project website (http://indigo-project.eu) which is updated regularly, the INDIGO project has been presented at 5 international showcases, as well as 7 international conferences, including the international symposium and crisis management and the ISCRAM conference, where a collaborative paper of the consortium was accepted. The consortium has met 10 times but also met directly with end-users at several points. 19 deliverables were sent to the EC, with limited delay. Potential impact: The combination of intuitive crisis scenario building tools, simulation and communication capacity, visualisation tools, and the simultaneous support of decision makers and field units will help to bridge cultural and institutional differences that so often impede effective collaboration in the face of crisis. Effective crisis management works in the phase leading up to disasters: by enhancing general awareness and facilitating communication in the network, crisis managers can improve their joint capacity to ?read? early warning signals (which will help minimise or possibly even prevent the evolving disaster). INDIGO will improve the capacity of crisis actors to communicate better and build scenarios based on early warning signals. This will allow crisis managers to bring their administrative potential to bear on the earliest phases of the evolving crisis, which should translate directly into a higher quality of life, health and safety of citizens. INDIGO will clearly and rather radically improve the quality of training exercises, especially by addressing common pathologies in command and control, coordination, information processing and sharing, creating a shared picture of the situation, and enabling more flexible, credible and stimulating large-scale exercises that would be impossible to satisfactorily run with current means. In large scale exercises, operators have to train using paper indications or calling the training centre to get information about their supposed situation or the measurements they are supposed to get. During actual crisis, they work with very little information and very close to the crisis arena. This puts them either not in the correct conditions during exercises or in direct danger during crisis, which is exacerbated by incomplete or wrong information, faltering command-and-control systems, and uncoordinated actions of multiple organisations. INDIGO directly and markedly addresses these conventional shortcomings. INDIGO will significantly enhance critical decision support, and, as a result, command and control during crises and disasters by enabling the easy understanding of the common operational picture, the rapid creation and adaptation of what-if scenarios and the visualisation of their impact on the situation. Decision makers will have access to near-complete, easy to understand, three-dimensional (3D) representations of evolving situations and will have means to anticipate the consequences of actions and decisions. INDIGO will save money as trainers will be enabled to design their own scenarios, include many participants, and run scenarios again in slightly different forms to enhance learning all this without having to involve expensive consultants. The direct off-spin is that all network participants will become familiarised with INDIGO, which will enhance its effectiveness during a crisis. The proposed Emergency 2D / 3D symbology reference can become a standard in the field and will strongly enhance the understanding of the situation across organisational boundaries and the effectiveness of their collaborations. The consortium expects the INDIGO project to stimulate the indirect creation of new forms of activities. It is indeed envisaged to see, in the near future, the emergence of spin-offs from the consortium or independent Small and medium-sized enterprises (SMEs) selling specific INDIGO services, dedicated plug-ins or content for the INDIGO system, which will be open to third-party developers thanks to both its software developer's kit and the compliance to international standards. Consortium end users are anticipating a new business opportunity in the development of additional knowledge for the INDIGO assistants. If successful, we foresee that the INDIGO related activities could develop like those related to the Geographic information systems (GIS) or the Computer aided design (CAD) systems. Numerous SMEs were born around the world to provide services and plug-ins for these systems. List of websites: http://indigo-project.eu

Periodic Report Summary - GENIS LAB (The gender in science and technology lab)

Wed, 17 Apr 2013 00:00:01 GMT

FONDAZIONE GIACOMO BRODOLINI
Project context and objectives: The GENIS LAB project aims at implementing structural changes in a group of selected scientific organisations in order to overcome the factors that limit the participation of women in research, despite their excellent departure conditions in terms of talents and competences. GENIS LAB concept moves from the acknowledgement that a decade of gender in science activities promoted by the European Commission (EC) has sorted evident changes in the gender dimension of science. Through the 'Science in society' work programme, EC has financed several projects aimed at raising awareness on the gender inequalities in research organisations and universities. However, there still are several factors which limit or impede the change towards an effective equality between men and women in science. These factors appear to be linked to organisational systems and to the relation between individuals and the organisations. Thus, a complex intervention focusing on organisational dynamics, as the one proposed by GENIS LAB, is aimed to have an effective impact on the conditions of women and men in research organisations. In this perspective, project objectives are to: - improve women researchers' working conditions; - improve women researchers' career opportunities in research organisations; - improve organisational climate in the workplace, acting on organisational culture; - fight against negative stereotypes, within research organisation but also in a wider context; - contribute to the creation of positive stereotypes. GENIS-LAB is represented by a consortium involving a group of scientific research bodies aiming at improving the gender dimension of research: - Spanish Superior Council for Scientific Research / Institute for Polymer Science and Technology (CSIC / ICTP ) (Spain). - Leibniz-Institut für Polymerforschung (IPF) Dresden e.V. (Germany). - National Institute for Nuclear Physics (INFN) (Italy). - Blekinge Institute of Technology (BTH) (Sweden). - Faculty of Technology and Metallurgy, University of Belgrade (FTM UB) (Serbia). - National Institute of Chemistry (NIC) (Slovenia). Scientific organisations are supported by a group of technical partners organisations that provide and share innovative methodologies for gender mainstreaming in science: Fondazione Giacomo Brodolini (project coordinator - Italy), International Training Centre of the ILO - Gender Unit (Italy), Associazione Donne e Scienza (Italy). Being aware of the complexity of the purpose, GENIS LAB consortium proposes an integrated and systemic approach, focusing on three levels: - the organisational level: identification of specific management tools and definition of self-tailored action plans (TAPs) for scientific organisations, aimed to promote internal structural changes; - the social / environmental level: training and support actions for HR managers aimed at fighting against stereotypes (de-constructing the stereotyped relation between women and science). Actions will support cultural changes within the organisation through the re-definition of excellence evaluation criteria; - the transnational / European level: promotion of networking and mutual learning actions among involved scientific organisations and, more generally, the European science community, to support the exchange of experiences, practices, efficient management tools. The driving idea is to promote and support structural changes, on the basis of self-TAPs, agreed and endorsed by the top management of each scientific institutions, in order to obtain a more equalitarian approach towards (women) talents, based on the recognition of skills and competencies and suitable to overcome gender discriminations. At the organisational level, the GENIS LAB approach focuses on three axes, identified as macro-areas that define gender discrimination in research organisations: - human resources management and gender; - organisational culture and stereotypes; - financial dimension and gender budgeting. In order to promote and sustain organisational change in the framework of each scientific organisation, GENIS LAB proposes to: - perform a gender-oriented organisational analysis, using participatory gender audit methodology, designed by ITC / ILO, integrated with FGB gender budgeting approach; - define a self-TAPs to be implemented in each organisation; - implement two-year action plans in each scientific organisation, supported by technical experts. Project results: During the first 18 months, GENIS LAB partners have been involved in implementing a set of activities generally meant to create the conditions for the promotion of organisational change within each scientific organisation, through the definition and implementation of TAPs. In particular, the first 9 months of the project have been devoted to a gender-targeted and comparative organisational analysis (WP2) in each of the six scientific partners' organisations. The methodology adopted for the analysis was based on an adaptation of the Participatory Gender Audit process, defined by ITC/ILO, to the specific context and purpose of the GENIS-LAB project. The PGA includes an analysis of the specific factors that create obstacles to women's participation in scientific research decision-making, and the development of additional tools to assess gender equality issues within organisations (e.g. re-definition of criteria for organisational assessment related to human resource and gender; gender stereotypes; gender-responsive budgeting). After defining and sharing the methodology with all partners, scientific institutions were individually involved in a participatory organisational self-assessment analysis, aimed, among others to draw a ?gender profile? of their institution in quantitative and qualitative terms and to identify possible obstacles to gender equality and entry points for future actions. ITC / ILO and FGB staff visited the organisations in order to be able to capture contextual and cultural differences and get opinions from all different staff within the organisations. Visits included confidential individual interviews with representative samples of staff, group discussions with the GENIS-LAB team of the institution, information and feedback sessions with the institutions?management, participatory workshops or focus groups. Results of PGAs within each scientific organisations are included in reports, which also include recommendations. The finalisation of the reports has involved the top managers of the institutions, who have approved them and shared with the staff. The six reports are available on-line in the intranet part of the dedicated website www.genislab-fp7.eu. Next step in the GENIS LAB project was the cooperative pooling of gender management tools (WP3). More specifically, the consortium activated virtual gender laboratories on organisational dimensions considered by consortium partners as most relevant in determining gender inequalities in research organisations and universities: human resources management and gender, organisational culture and stereotypes, financial dimension and gender budgeting. The main aim of the laboratories is to identify effective gender management tools focusing on these three organisational dimensions. To stimulate a more active debate in the Labs as a follow up of the activities implemented in WP2, the steering committee defined a strategy focusing on a blended approach (online and offline activity): online meeting with the experts (via Skype) have been added to Labs activity; focuses on Labs activity have been introduced in steering committee periodic meetings. The main issues emerged from the discussion in the Labs have been shared among all partners in the first thematic workshop, held in Belgrade in February 2012. Furthermore, FGB has organised additional site visits to scientific partners as a way to discuss gender budgeting issues with scientific organisations, given the high level of innovation represented by the application of gender budgeting in scientific organisations. As a result, partners started to be more active on the Labs and to activate peer to peer exchanges. At the end of the first period of activity of the virtual labs, each technical partner has collected the contributions from the virtual labs and has integrated them with theoretical and practical background in order to produce the 3 thematic reports. The reports reflect the complexity of the organisational dimensions, providing introduction to the dimension, practical tools, suggestions for the implementation in scientific organisations. The reports are conceived as thesauruses supporting the definition and implementation of the self-TAPs for structural change in scientific organisation. Dissemination activities have also been carried out. Several dissemination tools have been designed, in order to raise awareness on relevant stakeholders, even though the project is still at month 18, and the main outputs will be issued in the following months. In particular, a dedicated website is online since the very first months of the project (http://www.genislab-fp7.eu/), presenting the project aims, partners, activities and tools, and including a restricted blog area where partners can interact (the labs), and a library session, where participants and interested people can find documents, articles and information on gender in science, and been updated on project activities. Furthermore, a project brochure and a poster have been created, and disseminated in project and external events linked to women and science, e.g. European gender summit, EPWS meetings, GENDERA conference, in order to reach the highest possible coverage of stakeholders. A periodic newsletter has also been issued every six months, aimed to inform stakeholders and partner institutions on project activities and on how and what Europe is actually carrying out the promotion of gender equality in science. Newsletters are available at: http://www.genislab-fp7.eu/index.php/newsletter. All GENIS LAB scientific partners have organised a launching conference between March and April 2011, involving their top management and internal staff, in order to present GENIS LAB objectives and expected results, and commit the entire organisation to the project activities. The launching conferences were beneficial to create a cooperative and collaborative environment within the scientific organisations staff, which helped the smooth implementation of the participative gender audits and the rest of project activities. Also the transnational conference in Madrid (September 2011) and the first thematic workshop in Belgrade (July 2012) were useful to increase the commitment of partners. Potential impact: Main results of these first 18 months are the following: - common gender based organisational assessment tool (D.2.1); - six gender-based organisational assessment reports approved by institutions (D2.2); - summary of all findings, challenges, good practices and recommendations shared with and discussed among all institutions (basis for WP3 and WP4); - start up and functioning of three virtual labs: Human Resources management and gender, organisational culture and stereotypes, financial dimension and gender budgeting; - thematic reports containing effective gender management tools on human; - resources management and gender, organisational culture and stereotypes, financial dimension and gender budgeting (D3.1). More generally, such results were beneficial to raise awareness within scientific institutions on the existence of a gender problem which negatively affect the well-being and the efficiency of their organisations. Project staff members were collaborative along the PGAs and lab? activities, and also supportive to involve top managers in all phases guaranteeing the commitment of each institution to the project objectives and activities. The activities carried out so far have set the ground for the definition, and then, the implementation of the TAPs, depicting strengths and weaknesses for each organisation in all dimensions analysed by the project, namely human resource management and gender, organisational culture and stereotypes, gender budgeting. Next steps will involve a more detailed definition of actions to be included in the TAPs, which will be achieved through individual meetings with partners, transnational conference in Turin to be held in September, and feedback from the scientific committee of the project. TAPs will be implemented starting from January 2012. List of websites: http://www.genislab-fp7.eu

Periodic Report Summary - CANCERALIA (Development of novel diagnostic and therapeutic approaches to improve patient outcome in lung and pancreatic tumours)

Wed, 17 Apr 2013 00:00:01 GMT

FUNDACION CENTRO NACIONAL DE INVESTIGACIONES ONCOLOGICAS CARLOS III
Project context and objectives: Lung and pancreatic cancer represent major public health challenges in Europe and the western world. Tumours arising in the lung, mainly related to tobacco smoking, constitute a major cause of cancer death as a result of their late presentation and the lack of curative therapies in advanced tumours. Pancreatic tumours, namely Pancreatic ductal adenocarcinoma (PDAC) are the fourth cause of cancer death because incidence is essentially identical to mortality, also as a result of late presentation and lack of active therapeutic agents. Importantly, in the last few years targeted therapy is beginning to offer some new opportunities for improved patient management. Signalling cascades involved in cell proliferation and protein synthesis have been extensively investigated in cancer models. However, the regulation of lipid biosynthesis - a process required for cell proliferation - has been analysed to a lesser extent. There is increasing evidence that the products of genes involved in lipid metabolism such as Fatty Acid Synthase (FAS) and Acyl-coA carboxylase (ACA) are overexpressed in cancer cells and play crucial roles in tumour growth. Choline kinase alpha is one of the major enzymes involved in the synthesis of phosphatidyl choline, the major membrane lipid, regulated by Rho family of GTPases. Therefore, this enzyme and the whole membrane lipid metabolism pathway constitute important novel targets for diagnosis and therapy in cancer. Several groups have provided strong evidence that choline kinase alpha expression has potential as a novel marker in Non-small cell lung cancer (NSCLC) and in bladder cancer. The study of the whole lipid synthesis pathway may provide specific signatures that are more predictive than the analysis of single genes on their own. Because membrane lipid biosynthesis is essential in general for cell growth it is also possible that molecular analysis of this pathway may also predict response to other therapies, including the standard chemotherapies used in lung and pancreatic cancer. Further to transcriptome signatures and protein expression, analysis of the lipid product profile of tumours and comparison with corresponding normal tissue also provides opportunities for biological knowledge and marker development. In addition, the uptake of choline as a marker of choline kinase activity and of the metabolic status of cells / tissues constitutes a potential approach for early diagnosis and therapeutic monitoring of tumours using non-invasive technologies, such as Positron emission tomography (PET). Small molecule inhibitors of choline kinase alpha have already been developed and have reached early clinical trials, thus providing strong support to the notion that this enzyme and the whole pathway need to be thoroughly explored in order to identify novel therapeutic targets and to anticipate the mechanisms of drug resistance once activity is demonstrated in the clinical setting. To fulfil the needs of personalised medicine, it is also essential to identify genetic or tumour markers that may predict response to therapy. This should also accelerate drug development in patients. The general objective of the project is to develop improved strategies for the assessment of risk, diagnosis, and therapy of these two tumours, focusing on targets related to the biochemical pathways involved in lipid metabolism and small G proteins. The specific objectives of the project are to: 1. develop new tools to assess risk and for improved and early diagnosis; 2. identify novel germline and tumor markers for early diagnosis and establishment of prognosis; 3. identify molecular markers predictive of response to conventional therapy; 4. identify mechanisms involved in the generation of resistance to drugs targeting the lipid metabolism pathway; 5. design novel therapeutic strategies based on the knowledge generated in (4) using combinatorial treatments. Project results: To perform high quality translational research it is first essential to establish standardised operating procedures so that the results obtained in different laboratories are comparable. We have compared methods for Ribonucleic acid (RNA) extraction and transcript analysis used in the consortium laboratories, focusing on genes of interest, and have established their general validity. We have also developed common and standardised tools for collection of clinical data, collection and processing of clinical samples and laboratory information. We have collected close to 200 NSCLC frozen samples with clinical and pathological annotation and have extracted RNA to assess the expression of a panel of genes (CANCERALIA genes) and compare levels in tumour vs. normal, in different histological subtypes of NSCLC, and for lipidomics. The comparison of gene expression and lipidomic profiles has already been completed for 10 cases showing promising interesting results that will need to be confirmed in the larger series. Such studies have not been performed in the past in any large series of tumours. As of PDAC, the difficulties in tissue collection are well known: not only due to the low number of patients who get operated but also because of the difficulties in obtaining high-quality RNA. Based on pilot studies, we have chosen to use fine needle aspiration specimens for rea-time quantitative polymerase chain reaction (RT-qPCR) transcript profiling. Lipidomics assays will not be possible in these samples but we will use other models (see below) to compare gene expression and lipid profiles. These samples are currently being analysed. To relate expression profiles from formalin-fixed paraggin-embedded tissues to clinical and pathological characteristics and to patient response to conventional therapy we have searched extensively for samples but recent changes in patient management, mainly in patients with NSCLC, render these studies difficult because of their need for patient molecular stratification. We have devised strategies to overcome these limitations. To assess the role of germline variants in CANCERALIA genes in risk and prognosis, we have selected genes and tag Single nucleotide polymorphisms (SNPs) for genotyping. The selected SNPs have not shown association with risk but the findings are promising regarding prognosis and response to therapy. The efforts to recruit cases and controls for the risk studies have included retrospective series (mainly for NSCLC) and also prospective series (PDAC). Standard questionnaires, data collection forms, and databases have been created and implemented across the consortium groups. We have opted to concentrate first on the PDAC study while the lung cancer series are established. As of PDAC, close to 1600 cases have been recruited in a European-based study and for most of them germline Deoxyribonucleic acid (DNA) (blood or saliva) is available. Control recruitment is somewhat behind but is progressing steadily. This series will allow establishing training and validation sets. In addition, we have established collaborations with other Consortia for validation. Based on the results of PDAC the final strategy for NSCLC will be chosen. To develop models predictive of response to choline kinase alpha inhibitors we have generated primary cultures of NSCLC and have classified the tumours as resistant or sensitive and have performed gene expression analysis of both tumour types. Resistant tumours are characterised by expressing high levels of ASAH1, thus constituting a possible marker predictive of lack of response and a new possible therapeutic target. In PDAC we have concentrated on analysis of sensitivity of cell lines while short-term primary cultures are established. We have identified that there is a modest correlation between choline kinase alpha levels and sensitivity to inhibitors. Furthermore, gene / protein expression, response to inhibitor, and changes in lipidomics patterns have been analysed. In response to choline kinase inhibitor, selective modulation of lipid elongation and saturation has been identified. Methods for genetic inhibition of choline kinase have been established and are being used to assess how they affect sensitivity to inhibitors. Cell lines resistant to choline kinase inhibitors have been generated and RNA-Seq has been done (analysis ongoing) to assess gene expression profiles. Studies in NSCLC (with platinum) and PDAC (with gemcitabine) have shown in vitro potential for combination therapies. To develop choline-based non-invasive imaging strategies we have improved methods to synthesise and label precursor molecules with methods that are simpler to use in the clinical setting. NSCLC lines have been used to compare choline kinase expression, sensitivity to inhibitor (also in combination with cisplatin) and radioactive choline uptake in vitro and in vivo. These experiments are the basis for the design of a clinical trial to assess precursor uptake by PET in patients with NSCLC and the proposal is currently under evaluation by the regulatory authorities. Potential impact: Metabolism is emerging as a fundamental area for therapeutic development in oncology Our focus on the metabolism of membrane lipids is thus timely in this context. The consortium's main assets are its multidisciplinary component and its focus on experimental analyses leading to clinical translation. The Standard operating procedures (SOP) that we have developed in several Work packages (WPs) have potential for across-laboratory implementation. The questionnaires generated for recruitment and interview of NSCLC and PDAC patients, the SOPs for biological sample collection, and the databases established are also potentially useful to other groups and consortia. We have identified hurdles that will need to be overcome in order to develop gene profiles and drugs in patients with these two tumour types, both retrospectively and collectively. Through WP4 we will determine how genetic variation in the membrane lipid metabolism pathway contributes to cancer risk in these two tumours. The SNP signature should lead to re-sequencing studies of regions of interest using second-third generation sequencing that will identify the causal variants involved in risk whose functional role could be assessed in vitro. This is an essentially unexplored area where the project will provide strong background information. Through WP7 we are developing novel, close to the clinic, tools that allow to evaluate the activity of choline kinase in vivo through non-invasive PET technology. The development of novel precursors and novel labelling methods will improve on the clinical applicability. These tools should impact both on early diagnosis and in monitoring response to therapy (possibly both to choline kinase inhibitors and to other drugs, given the general role of membrane lipid synthesis in tumour proliferation). In addition, WP7 together with WP6 will provide important information on combinational therapies. Through WP2 we expect to establish a solid background of the relationship between gene expression signatures and lipidomics profiles and their association with histological subtypes, prognosis and response to therapy. We will identify a genetic expression signature to be validated in additional settings. The genes selected in the signature will constitute relevant target for antibody development in order to develop a diagnostic/prognostic kit that may be applicable to diagnostic samples (formalin-fixed) in the clinical setting. The correlation of mRNA, protein, and lipid patterns provides an integrated appraisal of lipid metabolism in tumor cells that can be compared to normal tissues and may herald clinical application. It will also point to additional therapeutic targets since our CANCERALIA list is heavily enriched in enzymes that are druggable. These studies will be complemented by results from WP3 that will provide information on the association between these genes and their products with prognosis and with response to conventional therapies. The work in WP5 and WP7 will be fundamental to identify markers predictive of response to choline kinase alpha inhibitors that could be applied in the clinical setting in combination with the signatures described above. In addition, the transcriptomic differences between sensitive and paired-resistant lines will allow to foresee which molecular mechanisms can be anticipated as relevant for acquired resistance to therapy (i.e. ASAH1), Importantly, such mechanisms may also be relevant for intrinsic resistance. In our preliminary experiments we have also identified novel enzymes that could cooperate with choline kinase alpha as targets for novel therapies. In addition to these scientific expected results, the work will lead to patents (one application already filed during the first half of the project) for diagnostic, prognostic, and therapeutic applications. We expect that the IP derived from the project will be substantially expanded during the second half of the project. Finally, we have established a comprehensive, dynamic, multidisciplinary team that has the potential for stable collaboration in this research area that is under-represented at the present time in Europe. The joint epidemiologic, clinical, molecular (genetic and biochemical), and imaging approaches involved in the project offer unprecedented opportunities in the field. List of websites: http://www.canceralia.eu/

Periodic Report Summary - IMPACTT (Immunoglobulin IgY pseudomonas - a clinical trial for cystic fibrosis treatment)

Wed, 17 Apr 2013 00:00:01 GMT

UPPSALA UNIVERSITET
Project context and objectives: The objective of the IMPACTT project is to provide an oral immunotherapy based intervention therapy for prophylaxis and treatment of P. aeruginosa infections in patients with Cystic fibrosis (CF) and to make this treatment available to clinicians for the treatment of CF-patients worldwide. CF is a severe inherited disease with premature death characterised by progressive obstructive pulmonary disease. CF is the most frequent life threatening genetic disease in Europe, with around 40 000 patients. In some countries the median age of death of people with CF is more than 35 years while in others, the majority die during childhood. 80 % of all CF patients are infected with the gram-negative bacterium Pseudomonas aeruginosa (PA) and by the age of 18 a majority of the CF patient population is infected with PA. Although early PA infections are possible to eradicate with heavy doses of antibiotics repeated PA infections will occur, leading inevitably to a chronic state. When the infection becomes chronic, PA is practically impossible to eradicate by antibiotics. Chronic pulmonary infection with PA leads to a more progressive decline in pulmonary function, which is the leading cause of morbidity and mortality in CF patients. It also leads to a heavy use of antibiotics to treat exacerbations of PA infections. PA cultures from CF patients are more resistant to antibiotics than cultures isolated from other patient groups. It is thus especially important to the CF community to find effective alternatives to the current antibiotics. Researchers at immunsystem AB (partner 2) have developed avian antibodies against pseudomonas (anti-Pseudomonas IgY), which has received orphan drug designation by the EMA (ref. no. EU 13 / 08 / 56). The active ingredient in anti-pseudomonas IgY is a water soluble extract from the egg yolk of hens that have been vaccinated with PA. The egg yolk (containing the IgY) from these hens is diluted in water, after which the IgY fraction is collected and 70 cc of the solution is bottled in 100cc bottles. No other ingredients are added. The patient gargles with the solution every night. IgY activity against PA is present in saliva and oro-pharynx overnight and prevents PA from entering the lungs. A previous phase I clinical studies have shown that anti-pseudomonas IgY, prevents recurrent and chronic infections with PA in CF patients with total absence of adverse events. A single daily gargle with a solution of anti-pseudomonas IgY can postpone infections and keep the patient in good health. Furthermore, these patients require fewer courses of antibiotics). Although the active substance does not have market authorisation in the European community, Swedish CF- patients have been granted license for prophylactic treatment with the drug on a named-patient basis by the Swedish MPA. The IMPACTT project explores the state-of-the-art of yolk immunotherapy; and moves beyond basic research on oral immunotherapy with yolk antibodies into a pharmaceutical treatment that will benefit the CF community within the European Union (EU) and worldwide. To do this, we conduct a prospective randomised, placebo-controlled, double blind, multi-centre study (phase III). We are also evaluating clinical efficacy and safety of avian polyclonal anti-pseudomonas IgY in prevention and treatment of recurrence of PA infections in CF patients in order to get the drug registered. The number of patients needed (180) included in the trial is calculated from our earlier results in the initial open controlled study. Parallel to this, further in vitro studies will be performed to demonstrate mode of action and animal studies to provide data on safety and toxicity of the product. Project results: The official start date of IMPACTT was 1 January 2011. The clinical trial is the main part of the IMPACTT project but it also has preclinical studies, and information/webpage and management tasks, which are of importance for the success of the project. During the project's start-up phase UnitechPharma, Matfors, Sweden, was subcontracted to the Swedish partner 2, immunsystem AB, for the production of active and placebo formulations for the clinical study. All steps of the production were initiated, inspected and approved; and received the Swedish MPA approval. The first produced batches from the subcontractor were bottled in May 2011, and were used for validation of the production. Additional forced stability testing and real time stability testing of the produced batches, to verify the shelf life of the produced formulation, was performed. Finally, the ethical permits, documentation, quality control testing and contracts needed for the production of the formulation place were successfully completed. A verified operational production of formulation from the egg to the patient is in place. To do this, the production and shipment of doses required a detailed logistics management. This management is coordinated by partners 1 and 2, in close collaboration of partners 3 and 7. Pharmacy Mainz, a subcontract to partner 1, performs the randomisation and individual patient labelling of the doses. These partner's management-level collaborative work also handle the shipments to the sites which is performed approximately twice during a three month period. Each patient receives formula for three months per shipment at their visits to the CF centres. Setting up a multicentre clinical study is very complex. The study protocol was prepared in collaboration with the CF patient organisations and the European CF clinical trial network. For regulatory and ethical approvals, in this multinational clinical study, a two-step procedure was chosen. In a first step approval was sought in Germany. Thereafter approval was aimed at in the other participating countries (Italy, Belgium, Sweden, France). A sequential instead of the VHP-procedure (voluntary harmonisation approach) approach was taken to try to eliminate protocol variations between countries. Germany, with an excellent organisation of the CF network and a good existing clinical trial infrastructure, achieved the regulatory / ethics approval in the anticipated project timeframe. The application in Germany was submitted late summer 2011. After some discussion with the German MPA and amendments, the study protocol and ethical application were approved in Germany, and the recruitment in a substantial number of sites started early. Due to the complexity of the approval procedure and the trial set up, input from the German experience could be used to optimise the procedures in the other countries. The results of the German approval process were fed into preparation work of the other countries and experiences with the complex logistics of the clinical trial (e.g. handling of medicinal product) transferred to the other countries. The first patient was included in Germany in November 2011. At 18 months we are recruiting patients in Germany, Belgium, Sweden and Italy. The MPA and ethical approvals are only the first steps in a clinical trial. Each centre has to be trained, inspected and approved for the specific clinical trial before it can enrol patients. Preclinical studies indicate bacterial opsonising properties of IgY and subsequent improved bacterial phagocytosis. IgY also increases the percentage of bacterial killing. For internal and external communication we have developed a Web site with open and internal pages. Besides overall project management, the project has a management structure that mainly focuses on the daily coordination activities of the clinical study. Regular meetings are held to ensure that everything is developing according to plan. The central project management is led by partner 1. Potential impact: Much of modern medicine is based on our ability to treat infections. Antimicrobial resistance is thus a major public health threat to the society. In 2009, ECDC and EMA estimated that each year 25 000 Europeans die as a direct consequence of a multidrug-resistant infection. Not only does antimicrobial resistance have a significant human impact, but it also has large economic consequences. It is critical that we quickly find alternative to the traditional antibiotics that do not lead to further antibiotics resistance. Antibodies have been effective against bacteria for millions of years without the development of resistance. The high specificity of the antibodies may thus be used to treat infectious diseases without creating resistance. 80 % of all CF patients are infected with the gram-negative bacterium PA. When the infection becomes chronic, PA is practically impossible to eradicate by antibiotics. Chronic pulmonary infection with PA leads to a more progressive decline in pulmonary function, which is the leading cause of morbidity and mortality in CF patients. It also leads to a heavy use of antibiotics to treat exacerbations of PA infections. The uses of antibiotics have resulted in an increase in antibiotics resistant PA infections in the CF population rendering the treatment to be less effective. PA cultures from CF patients are more resistant to antibiotics than cultures isolated from other patient groups. It is thus especially important to the CF community to find effective alternatives to the current antibiotics. The objective of the IMPACTT project is to provide an oral immunotherapy based intervention therapy for prophylaxis and treatment of P. aeruginosa infections in patients with CF and to make this treatment available to clinicians for the treatment of CF-patients worldwide. The core of the IMPACTT project is the clinical study. The IMPACTT project explores the state-of-the-art of yolk immunotherapy; and moves beyond basic research on oral immunotherapy with yolk antibodies into a pharmaceutical treatment that will benefit the CF community within the EU and worldwide. To do this, we conduct a prospective randomised, placebo-controlled, double blind, multi-centre study (phase III). We are also evaluating clinical efficacy and safety of avian polyclonal anti-pseudomonas IgY in prevention and treatment of recurrence of PA infections in CF patients in order to get the drug registered. The IgY formulation is prepared from eggs from laying hens vaccinated against P. aeruginosa. The antibodies are purified from the egg yolk by water extraction. The formulation thus only contains egg proteins and water. When administered orally, the risk of serious adverse events should not be larger than the risk associated with eating eggs. The treatment should thus be safe. An effective prophylactic treatment with IgY should reduce the number of PA infections. This would reduce the need for antibiotics and thus also reduce the antibiotics resistance. This would allow the continuous effective use of antibiotics to treat PA infections in CF patients also in the future. An EMA approved IgY based drug would also promote the development of other IgY based treatments e.g. against other multidrug-resistant bacteria. Thus, the project could eventually lead to the development of a whole range of new IgY based oral immunotherapies that would help in the fight against antibiotics resistance. IgY treatment is not only limited to humans, but can also be used for the prevention of infections in animals e.g. weaning diarrhoea in piglets. List of websites: www.impactt.eu

Periodic Report Summary - SACCESS (Supporting the EU access to South Africa's research and innovation programmes)

Wed, 17 Apr 2013 00:00:01 GMT

FOUNDATION FOR RESEARCH AND TECHNOLOGY HELLAS
Project context and objectives: The ACCESS4EU project was aimed at enhancing the access opportunities, and hence the participation, of EU member states and associate countries, private and public research units in the national research and innovation programmes facilitated by South Africa. The project focused on the substantial collection of information regarding national research and innovation capacities and programmes within South Africa with the objective to disseminate that information to the widest possible number of researchers and other stakeholders, aiming at the creation of effective collaborations between the European Union (EU) and the South Africa Research and development (R&D) communities. In addition the project contributed to the work programme of the Joint science and technology cooperation committee (JSTCC). The articulation of information with other ACCESS4EU was targeted with the aim of achieving greater dissemination of the knowledge on the existent participation opportunities at research and innovation programmes managed by South Africa, as well as to magnify the context and effect of the disseminated information. Project results: Following the first successful 18 months of its duration, SACCESS not only has managed to maintain its robust performance, but has accelerated even further to secure high impact results. The second half of the project was concerned with the dissemination of the research and innovation opportunities for cooperation through South African funded programmes to EU research community. The work undertaken is based entirely on the project's previous activities of identifying those research and innovation opportunities for cooperation. The dissemination activities were thoroughly planned from the very beginning of the project, and the partners had adequate experience and networks to satisfy the challenging role. Moreover, it should be noted that the partners of SACCESS went the extra mile by performing activities not necessarily agreed initially, but activities with increased importance that offered further visibility about the project and its objectives but most importantly offered enhanced awareness raising for research and innovation cooperation between EU and South African researchers. Potential impact: Before SACCESS little had been done to enforce the participation of European researchers to programmes managed by South Africa. The concept, and subsequently the structure of the SACCESS project, was based upon this identified need. Through SACCESS much has been achieved. This is a shared South African and European view as SACCESS managed to: - map the research and innovation capacity in South Africa; - map the available collaboration opportunities through South Africa's programmes; - create mechanisms to disseminate information on collaboration opportunities through South Africa's programmes; - identify problems related to European researchers participation, with the aim to plan initiatives to increase success rates. SACCESS focused on enhancing research collaboration by encouraging the participation of European researchers to South Africa's programmes, with the aim to identify Science and technology (S&T) activities of mutual interest. The main objective was thus, to provide a comprehensive mapping of the research and innovation capacity (identifying main organisations and their particular interests and activities), the existent collaboration opportunities and the barriers to access. Furthermore, to disseminate information to the relevant stakeholders within Europe and to act as a focal point of communication and promotion with regards to participation in South Africa's programmes. Lastly, to generate and provide feedback which will contribute to improved policy making in the field of enhancing Europe - South Africa cooperation. In conclusion, SACCESS managed to: - increase the participation of European stakeholders to South Africa's research and innovation programmes; - improve the prospects of research activities which are of international dimension and of mutual interest to Europe and South Africa. It is the project partners of SACCESS that need to be acknowledged for managing to pull together the necessary resources to achieve a remarkable performance throughout the project. In addition, it is the project partners that created an identity for the project itself, by developing a number of tools (The website of SACCESS can be found at http://www.SACCESS-project.eu The DVD of SACCESS can be found at http://www.SACCESS-project.eu/dvd) which were thoroughly used, as well as a comprehensive dissemination strategy which outlines the guidelines according to which information was successfully disseminated to European researchers. The composition of the project partners of SACCESS guaranteed quality both in terms of a sound South African representation with knowledge of the programme owners in South Africa, as well as a European representation with long experience in project management as well as a strong background of information dissemination within Europe. List of websites: www.SACCESS-project.eu

Final Report Summary - SACCESS (Supporting the EU access to South Africa's research and innovation programmes)

Wed, 17 Apr 2013 00:00:01 GMT

FOUNDATION FOR RESEARCH AND TECHNOLOGY HELLAS
Executive summary: This ACCESS4EU project was aimed at enhancing the access opportunities, and hence the participation, of European Union (EU) Member Atates and associate countries, private and public research units in the national research and innovation programmes facilitated by South Africa. The project focused on the substantial collection of information regarding national research and innovation capacities and programmes within South Africa with the objective to disseminate that information to the widest possible number of researchers and other stakeholders, aiming at the creation of effective collaborations between the EU and the South Africa Research and development (R&D) communities. In addition the project contributed to the work programme of the Joint science and technology cooperation committee (JSTCC). The articulation of information with other ACCESS4EU was targeted with the aim of achieving greater dissemination of the knowledge on the existent participation opportunities at research and innovation programmes managed by South Africa, as well as to magnify the context and effect of the disseminated information. In conclusion, SACCESS managed to: - increase the participation of European stakeholders to South Africa's research and innovation programmes; - improve the prospects of research activities which are of international dimension and of mutual interest to Europe and South Africa. Project context and objectives: SACCESS (www.saccess-project.eu) is aimed at enhancing scientific cooperation between SA and the EU by identifying and promoting to EU researcher's research collaboration opportunities through South Africa's research and innovation programmes. From its conception and design, the work is split into three pillars. - The first pillar is concerned with the mapping of the existing opportunities for EU researchers which involves close cooperation with South Africa's programme owners. - The second pillar is concerned with the wide dissemination of such access opportunities to EU researchers. Effectively reaching out to EU researchers and informing them about the research and innovation collaboration opportunities that exist within programmes managed by South Africa. A series of tools for this purpose need to be in place especially with regards to the pan-European approach the project will follow to reach out to as many researchers as possible. - The third pillar is concerned with the collection of valuable information to contribute and further boost policy dialogue, and to add to the works of the African EU JSTCC with regards to facilitating reciprocity between Europe and South Africa. Project results: Since the beginning of the project a significant amount of the projects activities has been achieved. The first 18 months of the project were related mostly to the two first pillars. As such the efforts of the partners have been focused in identifying the programme owners on South Africa as well as trying to set up the tools which will assist with information dissemination within Europe with the aim of stimulating the interest of European researchers to take advantage of the existing South African research and innovation opportunities. More specifically, with regards to identifying the South African opportunities for research and innovation cooperation, an awareness raising session was delivered to the European project partners with the view of informing them about the innovation system, the structure of the research function, the administration of research grants, the latest funding innovation and research programmes, and the basics of the framework for SA-EU research collaboration. DST, along with IRD, have generated two reports which include very detailed information about the innovation landscape in South Africa, but most importantly about South African research and innovation opportunities. Such information did not exist in previous documents and a series of interviews needed to take place following the identification of suitable programme owners. The interviews carried out revealed quite some opportunities, especially in the form of fellowships, and gave a clear idea to all partners of the extent to which South African are open to European participation. Finally, templates were also devised, to allow for appropriate presentation of the data collected. Following the first successful 18 months of its duration, SACCESS not only has managed to maintain its robust performance, but has accelerated even further to secure high impact results. The second half of the project, which is chiefly the matter this report focuses on, was concerned with the dissemination of the research and innovation opportunities for cooperation through South African funded programmes to the European Union research community. The work undertaken is based entirely on the project's previous activities of identifying those research and innovation opportunities for cooperation. The dissemination activities were thoroughly planned from the very beginning of the project, and the partners had adequate experience and networks to satisfy the challenging role. Moreover, it should be noted that the partners of SACCESS went the extra mile by performing activities not necessarily agreed initially, but activities with increased importance that offered further visibility about the project and its objectives but most importantly offered enhanced awareness raising for research and innovation cooperation between EU and South African researchers. Potential impact: Before SACCESS little had been done to enforce the participation of European researchers to programmes managed by South Africa. The concept, and subsequently the structure of the SACCESS project, was based upon this identified need. Through SACCESS much has been achieved. This is a shared South African and European view as SACCESS managed to: - map the research and innovation capacity in South Africa; - map the available collaboration opportunities through South Africa's programmes; - create mechanisms to disseminate information on collaboration opportunities through South Africa's programmes; - identify problems related to European researchers participation, with the aim to plan initiatives to increase success rates. SACCESS focused on enhancing research collaboration by encouraging the participation of European researchers to South Africa's programmes, with the aim to identify Science and technology (S&T) activities of mutual interest. The main objective was thus, to provide a comprehensive mapping of the research and innovation capacity (identifying main organisations and their particular interests and activities), the existent collaboration opportunities and the barriers to access. Furthermore, to disseminate information to the relevant stakeholders within Europe and to act as a focal point of communication and promotion with regards to participation in South Africa's programmes. Lastly, to generate and provide feedback which will contribute to improved policy making in the field of enhancing Europe - South Africa cooperation. List of websites: www.saccess-project.eu

Periodic Report Summary - FEMHEALTH (Assessing the impact of fee exemption on maternal health in west Africa and Morocco: new tools, new knowledge)

Wed, 17 Apr 2013 00:00:01 GMT

University of Aberdeen
Project context and objectives: Background to the project User fee exemption for normal deliveries, caesarean sections and other obstetric complications has been introduced by many governments, especially in West Africa, in recent years. However, the current evidence base regarding the impact of this policy is not well developed, in part because of evaluation designs that are not able to capture all the necessary information for policy-makers to make informed decisions. FEMHEALTH goal and objectives This programme aims to reduce this gap by developing research methodologies and tools that will lead to enhanced research on policy implementation, stronger evidence and improved dissemination. The objectives of the project are to: 1. develop new methodological approaches for the evaluation of complex interventions in low-income countries; 2. improve the health of mothers and their newborns by performing comprehensive evaluations of the impact, cost and effectiveness of the removal of user fees for obstetric care on maternal and neonatal health outcomes and service quality; and 3. facilitate a broad exchange of evidence between policy-makers, researchers and other stakeholders. Research methods FEMHEALTH takes a multidisciplinary and innovative approach to complex evaluations. The team includes people with backgrounds in health economics, health financing, epidemiology, public health, sociology, anthropology, statistics, obstetrics and midwifery, as well as communication and management. Structure of programme FEMHEALTH is funded under the European Commission (EC)'s Seventh Framework Programme (FP7). It runs from January 2011 to December 2013. The research consortium consists of eight partners operating across six countries. The focal countries for the evaluations of national policy are: Benin, Mali Burkina Faso and Morocco. These countries were selected on the basis of having recently introduced national fee exemption policies for obstetric care and of having expressed an interest, at policy-making levels, in the research goals. Most face serious challenges in improving maternal health indicators. In addition, there is evidence that francophone countries as a group receive less financial and technical support from the international community. The focus of this research is therefore on francophone West Africa and the Maghreb. Participant organisations comprise: University of Aberdeen, United Kingdom responsible for coordination of programme (WP1), 'Health policy and finance' (WP2) and 'Dissemination of results' (WP5), Institute of Tropic Medicine, Antwerp responsible for 'Local health systems' (WP3) and 'Community of practice' (WP5), London School of Hygiene and Tropical Medicine carrying out 'Quality of care and health outcomes' (WP4) and health policy, Agence de Formation, de Recherche et d?Expertise en Santé pour l?Afrique (AFRICSanté) leading Burkina Faso programme (WP6) Centre de Recherche en Reproduction Humaine et en Démographie (CERRHUD) leading Benin programme (WP7) Centre d'Appui à la Recherche et à la Formation (CAREF) leading Mali programme (WP8); Institut National d?Administration Sanitaire (INAS) leading Morocco programme (WP9) and Institut de Recherche en Sciences de la Santé (IRSS), Burkina Faso leading community of practice component (WP5). Project results: Work to date FEMHEALTH has completed the preparatory phase and is now engaged in field work. In the first six months of the project, a meeting was held to harmonise plans across the work packages and countries and to ensure that all participants had a good grasp of the overall project, and their role and relationships within it. Each team also contributed to the communication planning and the development of the websites (one for the overall project, and one for the nascent community of practice). Within the thematic work packages, literature reviews were undertaken, and work was started on the research tools. An overall causal framework for the research was developed to link together the different sets of activities and hypotheses. In the study countries, situation analysis documents were drawn up to identify the background and state of knowledge on the national policies. Links were also developed with local policy-makers. Information was gathered to enable a systematic process of selecting the research sites in each of the four study countries. On a more regional basis, the community of practice activities got underway, including establishing a site, recruiting members and a facilitation team, and issuing newsletters. During the second six months, tools were finalised, translated (where necessary) and tested in each country context. A meeting was held in month 11, to harmonise across countries and work packages and to plan the fieldwork phase. This was combined with a community of practice-sponsored meeting on exemption policies for maternal health in the Africa Region, which was attended by representatives of 11 countries in Bamako in November 2011. Protocols for the FEMHEALTH research in each country were developed and presented for ethical approval. During the third six months, after ethical approval in relevant study countries and northern research partner institutions, fieldwork began in three countries and is ongoing, alongside secondary data analysis. Meetings and training events have been held within all work packages to plan for the analysis phase, which begins now. Communications activities are ongoing, including: regular communication with decision-makers in study countries; regular communication between community of practice members on issues relating to financial access to health care; published articles, which are starting to appear (one has been published and two are submitted on the community of practice); and abstracts accepted for symposia (FEMHEALTH has two panels accepted for the Beijing Health Systems Research conference in October 2012). A framework for monitoring and evaluating the community of practice has also been developed, and is now being implemented. Potential impact: Programme outputs We expect to generate the following outputs: 1. a comprehensive multi-disciplinary understanding of the positive or negative impact of the policies on health outcomes for mothers and babies, quality of care, and access to emergency care in each of the countries; 2. cross-country learning and recommendations generated on how to improve policies to remove user fees; 3. methodological advancements in relation to health policy and financing tools, tools for mapping the effects of policies on the local health system, and the use of realist case studies and near miss events; 4. a vibrant regional community of practice is in place and growing, involving major stakeholders. Innovation will relate to the following areas: - developing a policy implementation measurement tool that describes interventions in terms of their adherence to original objectives, their eventual scope and penetration; - developing innovative methodologies for health policy analysis, focusing on what drives policy change and how policy is transferred, both from international to national level (and back), but also regionally; - developing a comparative case study design, based on realist evaluation that focuses on adequacy and plausibility of effect of intervention rather than on probability and provides policy relevant information; - testing the use of critical events (maternal, neonatal and health care near miss) as an entry point for the evaluation of changes to quality of care and health outcomes; - piloting a new way of synthesising and disseminating results to policy-makers using a network beyond the four countries - a community of practice which encourages cross-learning between policy-makers, international organisations and researchers and between countries in the region. The project will impact on several main actors: - women and their families in Africa and other resource-poor settings; - national stakeholders at policy and health service levels ; - the global health and safe motherhood community; - the scientific community working on complex health care evaluations. Dissemination will be carried out through well-maintained relationships and networks at local, national, regional and international levels. For further information, see www.abdn.ac.uk/femhealth List of websites: http://www.abdn.ac.uk/femhealth/

Periodic Report Summary - OBELIX (Obesogenic Endocrine disrupting chemicals: linking prenatal exposure to the development of obesity later in life)

Wed, 17 Apr 2013 00:00:01 GMT

STICHTING VU-VUMC
Project context and objectives: The incidence of childhood obesity has reached epidemic proportions globally. Despite advancements in knowledge on the endocrine and neuronal regulation of energy balance, there is still much uncertainty related to the etiology and underlying physiological mechanisms of obesity. There is accumulating evidence that factors that influence long-term risk of obesity and related disorders begin very early in life. Early life exposure to environmental contaminants has been implicated in altering developmental programming. The OBELIX project examines the hypothesis that prenatal exposure to Endocrine disrupting compounds (EDCs) in food plays a role in the development of obesity later in life. This project focuses on six major classes of EDCs found in food including dioxins and dioxin-like Polychlorinated biphenyls (PCBs), non-dioxin-like PCBs, brominated flame retardants, organochlorine pesticides, phthalates and perfluorinated compounds. OBELIX proposes a multidisciplinary approach that combines epidemiology, neonatology, endocrinology, toxicology, analytical chemistry and risk assessment to address the objectives of the project: 1. to assess prenatal exposure in humans to major classes of EDCs using mother-child cohorts from four European countries (Belgium, the Netherlands, Norway and Slovakia) with different food contaminant exposure patterns; 2. to relate early life exposure to EDCs with clinical markers, novel biomarkers and health effect data related to obesity; 3. to perform hazard characterisation of early life exposure to EDCs for the development of obesity later in life, using a mouse model; 4. to determine mechanisms of action of obesogenic EDCs with epigenetic analysis in in vivo and in vitro models; and 5. to perform risk assessment of early life exposure to obesogenic EDCs. Project results: OBELIX started in May 2009 and has now reached the end of the second 18 month reporting period (April 2012). Progress has been made in all Work packages (WPs). In WP1 ('Human exposure and heath assessment'), perinatal exposure data of five of the six main classes of chemicals has become available from the Belgian, Norwegian and Slovakian cohorts. This includes non-dioxin like PCBs (PCB153); organochlorine pesticides (DDE and HCB), brominated flame retardants (BDE47, BDE99 and HBCD), dioxins (PCDD / Fs and dioxin-like activity measured with CALUX) and perfluorinated compounds (PFOS and PFOA). A novel method has been developed for the analysis of the sixth class of chemical, the hydroxylated metabolites of the phthalate DEHP, in human milk. In the fourth cohort, the Zwolle cohort, established within OBELIX, a total of 136 participants have been recruited. For statistical analysis of associations between exposure and health outcomes, a database has been constructed in which the data of the OBELIX cohorts have been uploaded after the necessary data transfer agreements have been signed by each partner. Research hypotheses have been formulated and a statistical analysis plan has been developed and agreed upon, and analysis is underway. A total of 7 publications have been produced already in this WP, demonstrating both single cohort and combined analysis, and introducing new models of postnatal exposure assessment. WP2 ('Hazard characterisation') aims to assess the developmental origin of obesity, and underlying mechanisms, induced by EDCs using perinatal exposure studies with mice. An exposure model is applied with C57BL6 dams crossed with FVB fathers and oral exposure of dams during a wide developmental window, i.e. from 2 weeks prior to mating until weaning of the progeny. A total of five animal studies were either finalised or are ongoing in period 2. The selected test EDCs are bisphenol A (BPA), Perfluorooctane sulfonate (PFOS), Tetrachlorodibenzodioxin (TCDD), bis(2-ethylhexyl) phthalate (DEHP) and PCB 153. Analysis of results from the BPA further supported the observed body weight changes in full consistency with the sex differences, i.e. decreased physical activity in males only, increases and decreases in serum lipids, fat pad weights and adipocyte sizes in males and females, respectively, and concordant changes in the endocrine profile. The study with PFOA showed decreased body weight in females only, again supported by decreases in fat pad weight, adipocyte size, and serum lipids. The high fat diet supplied during the last weeks of the study did not affect the phenotype in either sex. Studies with TCDD and DEHP were initiated, and because no body weight effects were observed in the first weeks, the studies were extend to a final duration of one year. Both studies are ongoing, as well as the PCB 153 study. The extension of the three animal studies necessitated the cancellation of the final sixth animal study. Epigenetic analysis was initiated in liver Deoxyribonucleic acid (DNA) of the BPA study (males only), suggesting decreased global DNA methylation, and methylation changes in specific loci, which are presently being verified through dedicated PCR. In vitro mechanistic studies have revealed that some OBELIX chemicals, such as BPA and BDE 47, can induce adipocyte differentiation in the murine 3T3-L1 preadipocyte cell line, which is associated with a decrease in global DNA methylation (Bastos Sales et al, submitted for publication). In addition, preliminary experiments with umbilical cord mesenchymal stem cells indicate that BPA and DEHP induce adipogenesis. WP3 ('Risk assessment') has the goal to analyse the risk of EDC exposure for the development of obesity and related disorders later in life, taking in account human exposure levels and contaminant intake through food. In this second period, food questionnaire data has been compiled from four OBELIX cohorts (FLEHSI, HUMIS, Michalovce and Zwolle) including translation, harmonisation and the development of a common database. Two approaches have been developed to assess the dietary exposure to EDCs in the cohorts. Comparisons between EDC body burden and estimated cumulated dietary intakes are ongoing. Preliminary risk assessment has been carried out using results of the BPA animal studies augmented with literature, and indicate that effects of BPA on body weight and related metabolic parameters may be found at levels lower than those used to establish the current tolerable daily intake level. Potential Impact: The expected outcome of OBELIX is the generation of new knowledge about prenatal exposure to major classes of EDCs and their potential to form a risk factor for obesity later in life. Such knowledge is needed to underpin appropriate regulation of EDCs. The urgent need for studying the impact of food contaminants on obesity development is based on two observations: (i) prevalence of overweight and obesity among children has increased in most developed societies, particular over the last 20 years, and (ii) the current obesity epidemic cannot be fully explained by genetic factors or by changes in physical, socio-cultural, economic and political factors. The insights gained in OBELIX may have important socio-economic implications, as strategies aiming at prevention of weight gain and obesity are likely to be more cost effective and to have a greater impact on long-term control of body weight than treating obesity once it has developed. List of websites: www.theobelixproject.org