The European Association for Predictive, Preventive and Personalised Medicine (EPMA) considers acute problems in medical sciences as well as the quality and management of medical services challenging health care systems in Europe and worldwide. This actuality has motivated the representatives of EPMA to comment on the efforts in promoting an integrative approach based on multidisciplinary expertise to advance health care-related research and management. The current paper provides a global overview of the problems related to medical services: pandemic scenario in the progression of common non-communicable diseases, delayed interventional approaches of reactive medicine, poor economy of health care systems, lack of specialised educational programmes, problematic ethical aspects of several treatments as well as inadequate communication among professional groups and policymakers. In the form of individual paragraphs, the article presents a consolidated position of PPPM professionals towards the new European programme ‘Horizon 2020’ providing the long-lasting instruments for scientific and technological progress in medical services and health care-related programmes. In the author's opinion, Horizon 2020 provides unlimited room for research and implementation in Predictive, Preventive and Personalised Medicine. However, the overall success of the programme strongly depends on the effective communication and consolidation of professionals relevant for PPPM as well as the communication quality with policymakers. Smart political decision is the prerequisite of the effective PPPM implementation in the health care sector. This position is focused on the patients' needs, innovative medical sciences, optimal health and disease management, expert recommendations for the relevant medical fields and optimal solutions which have a potential to advance health care services if the long-term strategies were to be effectively implemented as proposed here. For many acute and chronic disorders, the current health care outcomes are considered as being inadequate: global figures cry for preventive measures and personalised treatments. In fact, severe chronic pathologies such as cardiovascular disorders, diabetes and cancer are treated after onset of the disease, frequently at near-end stages. Pessimistic prognosis considers pandemic scenario for type 2 diabetes mellitus, neurodegenerative disorders and some types of cancer over the next 10–20 years followed by the economic disaster of health care systems in a global scale.Advanced health care promotes the paradigm change from delayed interventional to predictive medicine tailored to the person, from reactive to preventive medicine and from disease to wellness. The innovative Predictive, Preventive and Personalised Medicine (PPPM) is emerging as the focal point of efforts in health care aimed at curbing the prevalence of both communicable and non-communicable diseases such as diabetes, cardiovascular diseases, chronic respiratory diseases, cancer and dental pathologies. The cost-effective management of diseases and the critical role of PPPM in modernisation of health care have been acknowledged as priorities by global and regional organisations and health-related institutions such as the Organisation of United Nations, the European Union and the National Institutes of Health.http://www.epmanet.eu/) promotes the integrative concept of PPPM among health care stakeholders, governmental institutions, educators, funding bodies, patient organisations and in the public domain.PPPM is the new integrative concept in health care sector that enables to predict individual predisposition before onset of the disease, to provide targeted preventive measures and create personalised treatment algorithms tailored to the person. The expected outcomes are conducive to more effective population screening, prevention early in childhood, identification of persons at risk, stratification of patients for the optimal therapy planning, prediction and reduction of adverse drug-drug or drug-disease interactions relying on emerging technologies, such as pharmacogenetics, pathology-specific molecular patters, subcellular imaging, disease modelling and individual patient profiles. Integrative approach by PPPM is considered as the medicine of the future. Being at the forefront of the global efforts, the European Association for Predictive, Preventive and Personalised Medicine groups and patient cohorts. Considering this long-term mission, a particular role is dedicated to the multidisciplinary and trans-domain education in PPPM requiring innovative design of specialised didactic materials. In this context, an integration of a spectrum of professional groups into the overall concept of PPPM is a particular advantage of the EPMA/Springer book series The additional bibliographic details of the series are the following:Series Editor: Olga GolubnitschajaReleased volumes:–Healthcare Overview: New Perspectives (Ed: V. Costigliola) ISBN 978-94-007-4602-2–New Strategies to Advance Pre/Diabetes Care: Integrative Approach by PPPM (Ed: M. Mozaffari) ISBN 978-94-007-5970-1–Neurodegenerative Diseases: Integrative PPPM Approach as the Medicine of the Future (Ed: S. Mandel) ISBN 978-94-007-5865-0–Drug Delivery Systems: Advanced Technologies Potentially Applicable in Personalised Treatments (Ed: J. Coelho) ISBN 978-94-007-6009-7Volumes releasing in 2014–2015:–Rare Diseases: Integrative PPPM Approach as the Medicine of the Future (Ed: M. Özgüç)–Individualised Medicine: Ethical, economical and historical perspectives ;–Preventive and Predictive Genetics: Towards Personalised Medicine –Circulating nucleic acids in early diagnosis, prognosis and treatment monitoring: an introduction (Ed: P. Gahan).The juristic protocol has been signed—the Association is born now. Its objectives are to create and promote the concepts and practical realisation of Predictive, Preventive and Personalised Medicine.The founder members of the Directorate are shown in Figure Predictive Diagnostics and Personalized Treatment: Dream or Reality, edited by O. Golubnitschaja published in 2009  have been published by the specialised issue of In the year 2010, the European Commission has organised a series of preparatory workshops in order to create Horizon 2020 Figure . SeveralThe finalising conference in the preparation of Horizon 2020 by the EU Commission took place in Brussels on May 12–13, 2011 —see Figure Horizon 2020 is the financial instrument implementing the Innovation Union Europe 2020 , a flagsHorizon 2020 follows achievements in the previous programme, 7th Framework Programme for Research and Technological Development (2007 to 2013). Horizon 2020 differs in the structure from FP7, by coupling research and innovation, aiming to achieve this with its emphasis on excellent science, industrial leadership and tackling societal challenges , Competitiveness and Innovation Framework Programme (CIP), and the European Institute of Innovation and Technology (EIT).Horizon 2020 brings several novelties. Amongst them are the following:•Simplification through a simpler programme architecture (structure)•Simplified access for all companies, universities, institutes in all EU countries and beyond•Single set of rules with a simplified reimbursement procedure.•Single point of access for participants.Horizon 2020 is open to everyone, with a simple structure that reduces red tape and time so participants can focus on what is really important. This approach makes sure new projects get off the ground quickly and achieve results faster.The EU Framework Programme for Research and Innovation will be complemented by further measures to complete and further develop the European Research Area. These measures will aim at breaking down barriers to create a genuine single market for knowledge, research and innovation .Horizon 2020 will focus resources on three distinct, yet mutually reinforcing, priorities, where there is clear Union added value. These priorities correspond to those of Europe 2020 and the Innovation Union   European Research Council.•Support the most talented and creative individuals and their teams to carry out frontier research of the highest quality by building on the success of the Future and Emerging Technologies (FET).•Fund collaborative research to open up new and promising fields of research and innovation through support for Marie Skłodowska-Curie actions ('Marie Curie actions').•Provide researchers with excellent training and career development opportunities through the research infrastructures (including eInfrastructures) accessible to all researchers in Europe and beyond.•Ensure that Europe has world-class Industrial Leadership – This will aim at making Europe a more attractive location to invest in research and innovation (including eco-innovation), by promoting activities where businesses set the agenda. It will provide major investment in key industrial technologies, maximise the growth potential of European companies by providing them with adequate levels of finance and help innovative small and medium enterprises (SMEs) to grow into world-leading companies. This will(2)  leadership in enabling and industrial technologies, with dedicated support for informatics and communicating technologies (ICT), na2chnologies, advanced materials, biotechnology, advanced manufacturing and processing, and space, while also providing support for cross-cutting actions to capture the accumulated benefits from combining several Key Enabling Technologies.•Build access to risk finance.•Facilitate innovation in SMEs.•Provide Union wide support for Societal Challenges – This reflects the policy priorities of the Europe 2020 strategy and addresses major concerns shared by citizens in Europe and elsewhere. A challenge-based approach will bring together resources and knowledge across different fields, technologies and disciplines, including social sciences and the humanities. This will cover activities from research to market with a new focus on innovation-related activities, such as piloting, demonstration, test beds, and support for public procurement and market uptake. It will include establishing links with the activities of the European Innovation Partnerships. Funding will be focussed on the following challenges:(3) •Health, demographic change and well-being.•Food security, sustainable agriculture, marine and maritime research and the bioeconomy.•Secure, clean and efficient energy.•Smart, green and integrated transport.•Climate action, resource efficiency and raw materials.•Inclusive, innovative and secure societies.The EIT will play an important role by combining excellent research, education and innovation, thus integrating the knowledge triangle. The EIT will do so primarily through the Knowledge and Innovation Communities (KICs). In addition, it will ensure that experiences are shared beyond the KICs through targeted dissemination and knowledge-sharing measures.The Joint Research Centre's activities will be an integral part of Horizon 2020, providing robust, evidence-based support to Union policies. This will be driven by customer needs complemented by forward-looking activities.Horizon 2020 will be a 7-year programme and there may be significant shifts in the broader economic and policy context as the programme progresses. Ensuring Horizon 2020's continued relevance will therefore also require to adjust priorities and resources, as and when necessary. As such, flexibility clauses have been included in the proposal in this respect.The implementation of Horizon 2020 will also take a strategic approach to programming of research and innovation, using joint actions and modes of governance aligning closely with policy development yet cutting across the boundaries of traditional sectoral policies. This will be based on sound evidence, analysis and foresight, with progress measured against a robust set of indicators.As regards the funding of research activities involving human embryonic stem cells, the Horizon 2020 legislative package is fully in line with the approach supported by the European Parliament and the Council upon their adoption of the FP7 legislation, as set out in the Commission's statement of 2006 (OJ L412 of 30 December 2006).International cooperation with the third countries is necessary to address effectively many specific objectives defined in Horizon 2020. This is the case in particular for all the societal challenges addressed by Horizon 2020, which need to be tackled at the global level. International cooperation is also essential for frontier and basic research in order to capture the benefits from emerging science and technology opportunities. Promoting the international mobility of researchers and innovation staff is crucial for enhancing this global cooperation. Activities at the international level are equally important to enhance the competitiveness of European industry by promoting the take-up and trade of novel technologies, for instance through the development of worldwide standards and guidelines and by promoting the acceptance and deployment of European solutions outside Europe.The aim of international cooperation in Horizon 2020 will be to strengthen the Union's excellence and attractiveness in research, to tackle global challenges jointly and to support the Union's external policies. The focus of international cooperation in Horizon 2020 will be on cooperation with three major country groupings:(1)  Industrialised and emerging economies.(2)  Enlargement and neighbourhood countries.(3)  Enlargement of developing countries.Where appropriate, Horizon 2020 will promote cooperation at the regional or multilateral level. International cooperation in research and innovation is a key aspect of the Union's global commitments and has an important role to play in the Union's partnership with developing countries, which are often disproportionately affected by global challenges. This cooperation will promote inclusive growth and progressing towards the achievement of the Millennium Development Goals and other goals agreed in the framework of international sustainable development.Horizon 2020 will continue with the principle of general openness, while encouraging reciprocal access to third country programmes. In addition, a range of targeted actions will be implemented taking a strategic approach to international cooperation on the basis of common interest and mutual benefit and promoting coordination and synergies with Member State activities. Dedicated support measures to assist the strategic approach and the process of priority setting are included in the ‘Inclusive, innovative and secure societies' challenge.•COM/2011/0808 Horizon 2020—The Framework Programme for Research and Innovation—Communication from the Commission.•COM/2011/0809 Proposal for a Regulation of the European Parliament and Council establishing Horizon 2020—the Framework Programme for Research and Innovation (2014–2020).•COM/2011/0810 Proposal for a Regulation of the European Parliament and Council laying down the rules for the participation and dissemination in Horizon 2020.•COM/2011/0811 Proposal for a Council Decision establishing the Specific Programme implementing Horizon 2020.•COM/2011/0812 Proposal for a Council Regulation on the research and training programme of the European Atomic Energy Community (2014–2018) complementing Horizon 2020.•COM/2011/0817 Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 294/2008 establishing the European Institute of Innovation and Technology (EIT).•COM/2011/0822 Proposal for a Decision of the European Parliament and of the Council on the Strategic Innovation Agenda of the European Institute of Innovation and Technology (EIT): the contribution of the EIT to a more innovative Europe.‘…to improve the lifelong health and well-being of all.’Health, demographic change and well-being is the first and financially significantly supported societal challenge , cancer, diabetes, neurological and mental health disorders, overweight and obesity and various functional limitations are major health and societal problems for the future. In Europe, CVD annually accounts for more than 2 million deaths and costs the economy more than EUR 192 billion while cancer accounts for a quarter of all deaths and is the number one cause of death in people aged 45–64. Over 27 million people in the EU suffer from diabetes and the total cost of brain disorders  has been estimated at EUR 800 billion.•The research and development of new drugs and vaccines are becoming more expensive and less effective.•Health and illnesses cannot be solved at national levels separately; the coordinated European approach will enhance to eliminate fragmentation and duplicity in research, will contribute to addressing these challenges and deliver better health and well-being for all European citizens.•The innovative approach depends on excellence in research to improve our fundamental understanding of health, disease, disability, development and ageing (including of life expectancy), and on the seamless and widespread translation of the resulting and existing knowledge into innovative and effective products, strategies, interventions and services.•As a new progressive feature is the implementation of ICT techniques, technologies and tools. These include the development of long-term cohorts and the conduct of clinical trials, the clinical use of ‘omics’ or the development of ICT and their applications in health care practice, notably eHealth and mHealth.•Big data means that biomedical research and health care bring every minute new information, data/data sets about an individual, cohort, population. Big data is difficult to collect, store, save, share and work with.•The requirements of specific populations are also best addressed in an integrated manner, in the development of stratified and/or personalised medicine, in the treatment of rare diseases, and in providing assisted and independent living solutions.•Coordinated European effort will contribute to the ongoing development of the European Research Area (ERA). It will interface with activities developed in the context of the Health for Growth Programme and the European Innovation Partnership on Active and Health Ageing.Health care is changing•From illness to health.•From treatment to prevention and early diagnostics.•From approach one-fits-all to personalised medicine.Effective health promotion prevents disease, improves well-being and is cost effective. Health promotion and disease prevention depend on an understanding of the determinants of health, on effective preventive tools, such as vaccines, on effective health and disease surveillance and preparedness, and on effective screening programmes.An increasing disease and disability especially in an ageing population places further demands on health and care sectors. If effective health and care is to be maintained for all ages, efforts are required to improve decision-making in prevention and treatment provision, to identify and support the dissemination of best practice in the health and care sectors and to support integrated care and the wide uptake of technological, organisational and social innovations empowering, in particular, older persons as well as disabled persons to remain active and independent. Doing so will contribute to increasing and lengthening the duration of their physical, social and mental well-being.As a consequence of the accumulating clinical data and knowledge about the epidemiology and pathological mechanisms of the most frequent causes of morbidity and mortality, we are currently reconsidering our view of the origins and progression of cardiovascular, oncologic and neurodegenerative diseases. The majority of these pathologies are of chronic nature: they progress from precursor lesions over one or even several decades of life; therefore, it is often too late for effective therapeutic intervention. An excellent example is the pandemic of type 2 diabetes mellitus witnessed in the European Union. In most industrialised countries and countries with large populations, the permanently growing cohort of diabetics creates a serious health care problem and a dramatic health economic burden. The estimate for diabetes prevalence in the years 2025–2030 is half a billion patients worldwide  require a systematic approach, with the best coordinated involvement of collaborative, multidisciplinary inter/national teams of clinicians, scientists and health care professionals across the spectrum of the medical field. The A number of molecular mechanisms have received considerable attention in contributing to the understanding of the pathogenesis underlying DM and its attendant complications  is the most frequent birth complication with the prevalence between 1 and 100 cases per 1,000 live births in diverse populations worldwide  asphyxia, a postnatal manifestation of hypoxic-ischaemic encephalopathy (HIE) is frequently observed being associated with either mild or severe organ damage in asphyxiated newborns, both leading to the development of chronic pathologies. The severe insults often cause neurodegenerative diseases, mental retardation and epilepsies manifested later in life. The mild insults lead to so-called ‘minimal brain-damage disorders’ such as attention deficits and hyperactivity, but can also be associated with the development of schizophrenia, lifelong functional psychotic syndromes and damage and pathologies of other life-important organs . In some particular cases, it is difficult to discriminate between mild and severe asphyxia: advanced methodology to improve diagnosis of birth asphyxia and prediction of individual short- and long-term outcomes obligatorily needs to be developed. The complete overview to the central biological processes affected by perinatal asphyxia is schematically presented in Figure Paradigm change from delayed reactive medicine to predictive diagnostics followed by targeted prevention before manifestation of pathology presents innovative concept for advanced health care. Pre-selection of healthy but pathology-predisposed individuals represents the primary task in the overall action. One of the best examples might be given on the cohort of healthy vasospastic individuals who, however, represent a group of risk strongly predisposed to several pathologies due to vascular dysregulation with concomitantly shifted gene expression and other syndrome-specific alterations at molecular and subcellular levels as it is demonstrated in Figure Over 300 million diabetics frequently affected by poly-neuropathy as secondary complication, 18 million patients with Alzheimer's disease , neurodegenerative eye diseases with leading causes of blindness—diabetic retinopathy and estimated 70 million glaucoma patients worldwide, millions of patients with Parkinson's disease, multiple sclerosis, epilepsy, cerebral palsy and dementia in the elderly—these are all the patient cohorts with severe neurological disorders, who demonstrate dramatically decreased life quality. Progressive neurodegeneration is the common feature of multifactorial physical and cognitive disability. Permanently increasing numbers of those patients as well as dramatic disease-related economical burden indicate that current education, research and health care in this field are far from optimal and should be corrected. Since neurodegeneration is a chronic process, which begins long before the onset of clinically diagnosed symptoms, currently there is an evident lack of targeted prevention in any age-category inchoate with early childhood, over adolescence until late adulthood .This depends much on diagnostic, preventive and treatment approaches which health care will preferably adopt in the near future. Without innovation in health care, neurodegenerative disorders can reach more than 30% of global disease burden until 2020. In contrast, effective utilisation of advanced early/predictive diagnostics, preventive and personalised medical approaches could enable a significant portion of population to reach the 100-year age limit remaining vibrant in excellent physical and mental health as actively contributing members of society. Specialised calls of Horizon 2020 aim at solving the accumulated problems and promote active and healthy ageing, early risk detection, mental well-being within ageing populations, application of ICT technologies for independent living with cognitive impairments as well as robotics services within assisted living environments.Through the support of the Alexander von Humboldt Foundation in the years 2012–2013, EPMA has performed a specialised project focused on the collaboration among PPPM-related professional groups and policymakers. This project was aimed at identifying problems and deficits in health care of common and pandemic chronic diseases such as type 2 diabetes mellitus. Interviews performed with experts from all countries of the European Union, Israel, Russia and Turkey resulted in the conclusion that one of the common deficits is a missing communication and collaboration between individual professional groups on one side and health care professionals and decision-makers on the other side. Moreover, there are difficulties in accessing national regulatory bodies to enhance the message of patient-focused health care. This evidence demonstrates that decisions in the health care sector are generally made without consideration of accumulated professional knowledge. This may explain the lack of sufficient efficacy currently observed in health care systems.In contrast, if well established, the collaboration with governmental bodies may lead to the reconsideration of current national and European guidelines for health care-relevant research activities and medical services both advanced by PPPM. There are following emerging issues to be within the instruments and programmes of Horizon 2020:•Promoting research fields focused on the patient needs•Mandating a paradigm shift from reactive to predictive and preventive medicine.•Creating specialised state budgets to target preventive measures against pandemic incidence of non-communicable chronic diseases.•Forcing an effective implementation of innovative predictive diagnostics.•Advancing bioinformatics to meet biomedical and clinical needs.•Facilitating digital representation of health data to improve professional communication and optimise diagnostic and treatment approaches.•Introducing optimal medical records.•Standardising predictive technologies for human safety testing.•Creating new educational programmes for professionals to implement integrative medical services in predictive, preventive and personalised medicine.•Creating educational measures to increase the understanding of innovative diagnostic technologies and targeted preventive measures in the general population.•Creating new economic models to motivate health responsibility.As health care is subject to national subsidiarity, there are substantial variations in the level of provision in different countries. However, corresponding standards might be introduced at the European level to promote inter-European mobility and to avoid economic discrepancies and conflict of interest .in silico medicine for improving disease management and prediction; treating disease; transferring knowledge to clinical practice and scalable innovation actions; better use of health data; active ageing, independent and assisted living; individual empowerment for self-management of health; promotion of integrated care; improving scientific tools and methods to support policy making and regulatory needs; optimising the efficiency and effectiveness of health care systems and reducing inequalities by evidence-based decision-making and dissemination of best practice; and innovative technologies and approaches. Work programme for 2014 and 2015 [The most important features of SC1 especially for the two open calls 2014, 2015 are the following: improving health promotion and disease prevention; understanding disease and improving diagnosis; developing effective screening programmes and improving the assessment of disease susceptibility; improving surveillance and preparedness; developing better preventive vaccines; using and 2015  .PHC 8–2014: Vaccine development for poverty-related and neglected infectious diseases: tuberculosis.PHC 9–2015: Vaccine development for poverty-related and neglected infectious diseases: HIV/AIDS.3. Improving diagnosis.in vitro devices, assays and platforms.PHC 10–2014: Development of new diagnostic tools and technologies: in vivo medical imaging technologies.PHC 11–2015: Development of new diagnostic tools and technologies: PHC 12–2014/2015: Clinical research for the validation of biomarkers and/or diagnostic medical devices.4. Innovative treatments and technologies.PHC 13–2014: New therapies for chronic non-communicable diseases.PHC 14–2015: New therapies for rare diseases.PHC 15–2014/2015: Clinical research on regenerative medicine.PHC 16–2015: Tools and technologies for advanced therapies.PHC 17–2014: Comparing the effectiveness of existing health care interventions in the elderly.PHC 18–2015: Establishing effectiveness of health care interventions in the paediatric population.5. Advancing active and healthy ageing.PHC 19–2014: Advancing active and healthy ageing with ICT: service robotics within assisted living environments.PHC 20–2014: Advancing active and healthy ageing with ICT: ICT solutions for independent living with cognitive impairment.PHC 21–2015: Advancing active and healthy ageing with ICT: early risk detection and intervention.6. Integrated, sustainable, citizen-centred care.PHC 23–2014: Developing and comparing new models for safe and efficient, prevention oriented health and care systems:PHC 24–2015: Piloting personalised medicine in health and care systems.PHC 25–2015: Advanced ICT systems and services for Integrated Care.PHC 26–2014: Self-management of health and disease: citizen engagement and mHealth.PHC 27–2015: Self-management of health and disease and patient empowerment supported by ICT.PHC 28–2015: Self-management of health and disease and decision support systems based on predictive computer modelling used by the patient him or herself.PHC 29–2015: Public procurement of innovative eHealth services.7. Improving health information, data exploitation and providing an evidence base for health policies and regulation.PHC 30–2015: Digital representation of health data to improve disease diagnosis and treatment.PHC 31–2014: Foresight for health policy development and regulation.PHC 32–2014: Advancing bioinformatics to meet biomedical and clinical needs.PHC 33–2015: New approaches to improve predictive human safety testing.PHC 34–2014: eHealth interoperability.Coordination activities summarised in Tables HCO 1–2014: Support for the European Innovation Partnership on Active and Healthy Ageing.HCO 2–2014: Joint Programming: Coordination Action for the Joint Programming Initiative (JPI) ‘More Years, Better Lives—the Challenges and Opportunities of Demographic Change’.HCO 3–2015: Support for the European Reference Networks: efficient network modelling and validation.HCO 4–2014: Support for international infectious disease preparedness research.HCO 5–2014: Global Alliance for Chronic Diseases: prevention and treatment of type 2 diabetes.HCO 6–2015: Global Alliance for Chronic Diseases: 2015 priority.HCO 7–2014: ERA-NET: Establishing synergies between the Joint Programming on Neurodegenerative Diseases Research and Horizon 2020.HCO 8–2014: ERA-NET: Aligning national/regional translational cancer research programmes and activities.HCO 9–2014: ERA-NET: Systems medicine to address clinical needs.HCO 10–2014: ERA NET: Rare disease research implementing IRDiRC objectives.HCO 11–2015: ERA-NET: Collaboration and alignment of national programmes and activities in the area of brain-related diseases and disorders of the nervous system.HCO 12–2015: ERA-NET: Antimicrobial resistance.HCO 13–2015: ERA-NET: Cardiovascular disease.HCO 14–2014: Bridging the divide in European health research and innovation.HCO 15–2014: Mobilisation and mutual learning action plan.HCO 16–2014: National Contact Points.Other actions are also available:HOA 1–2014/2015: Subscription fee: Human Frontier Science Programme Organisation.HOA 2–2014/2015: Tenders for programme evaluation, studies and impact assessment and for conferences, events and outreach activities.HOA 3–2014/2015: Presidency events—eHealth.HOA 4–2014/15: Independent experts assisting in proposal evaluations and project reviews.HOA 5–2014: Grant to the Global Alliance for Chronic Diseases.HOA 6–2014: Stem cell research outreach.HOA 7–2015: eHealth Sectoral Inducement Prize.HOA 8–2015: Inducement prize.For getting all relevant information about the upcoming call in Horizon 2020 SC1, every participant has to register at PARTICIPANT PORTAL  then in For many acute and chronic disorders, the current health care outcomes are considered as being inadequate ,20. CurrThe following actualities motivate the introduction of predictive and prognostic approaches into daily medical services:–Reactive disease care.–Delayed intervention.–Untargeted medication.–Overdosed and poisoned patients.–Low effectiveness of treatments.Current deficits in medical services such as missing toxicological examination of the prescribed medication and ethically problematic delayed reactive and inadequate treatments require new strategies for a targeted prevention of diseases and negative side effects of treatments . Clinicain vitro diagnostic providers. The globalisation of markets and laboratory-related business requires the comparability, or the unification, of laboratory test values. The mobility of both patients and health care professionals as well as the increasing global data flow require such comparability [Accuracy, sensitivity and specificity of predictive and prognostic tests are the premise of advanced health care. There is the evident necessity to enable globally comparable investigative, diagnostic and prognostic strategies to be reliably implemented. This requires regulatory oversight and meaningful engagement with rability . Hence, In order to create a robust investigative platform, the utilisation of appropriate predictive and prognostic approaches should be mandated, which means an extensive collaboration between relevant professional organisations on one side and policymakers on the other side resulting in a well-organised promotion and widespread application of the predictive medical care in health care systems.in vitro diagnostics and accurate evaluation of pathology-relevant and potential risk factors. For laboratory diagnostics, it is highly recommended to perform analysis at complementary levels and consider stage-specific molecular patterns, such as DNA polymorphisms, transcriptional regulation, shifted protein expression patterns, post-translational modification, stage-specific subcellular imaging and altered activity of enzymatic complexes.Optimal clinical decisions result from a multidisciplinary approach performed by specialists with complementary analytical expertise. Therefore, the overall task is formulated as the integrative medical approach of the multimodal diagnostics, application of health- versus disease-specific biomarker patterns, creation of individual patient profiles and widespread medical records which altogether allow for treatments tailored to the person . MultimoShifting the role of laboratory medicine from the ‘passive performing’ to the ‘active advising’ is the consequent paradigm change in health care resulting from the above-listed necessities and expected innovations. This reconsideration of the laboratory-clinician interface might significantly advance the quality of current medical services, although the implementation of this approach across countries should be adapted to local conditions. Well-known motivating actualities for the reconsideration are, for example, so-called within-individual variations as well as grey-zone results, when individual laboratory parameters range between ‘healthy’ and ‘unhealthy’ zones and any interpretation is problematic for clinicians. Therefore, recommendations by the laboratory tests/interpretations to assist clinical practice are essential ,26. ThisCurrent trends in Europe demonstrate dramatic demographic shifts in favour of elderly subpopulations. With type 2 diabetes mellitus, pandemic and its severe secondary complication such as stroke, 50% of people after 85 years of age are affected by Alzheimer's disease , neurodegenerative eye diseases which are the leading causes of blindness, diabetic retinopathy and estimated 70 million glaucoma patients worldwide, and there are millions with Parkinson's disease, multiple sclerosis, epilepsy and dementia in the elderly . OptimisThe evident pandemic of common chronic diseases, the consequences of a reactive approach and hence poor economy of disease care as well as dramatic social and ethical problems that result from delayed medical services necessitate experts to reconsider the current paradigm of reactive disease care in favour of health care. This means that there is a mandated progressive implementation of a new philosophy of the well-being concept tailored to the person  as a spectrum of personalised measures for professional care that promotes the mental and physical health of an individual . Consequin vitro diagnostic testing is hampered by a lack of funding for studies aiming at the effective validation of the clinical utility of novel biomarkers. Consequently, a deep analysis of how to shorten the time span between a discovery of new molecular targets, creation of valid health- versus disease-specific biomarker patterns and their effective utilisation in daily practice is the strategic point of highest priority [Current calculations demonstrate a long-term trend of the dramatic crisis in the creation of clinically useful molecular entities . Further, an innovation in priority . Up to tpriority . The pro–Emerging technologies in population screening .–Set-up of pathology-specific biomarker patterns instead of ineffective single molecules.–Non- or minimally invasive diagnostic tools .–Effective promotion of validation studies.–Transparent schemes for functional contacts between researchers who discovered new targets and implementing industrial partners.–Dramatic improvements in national and international patenting systems.An effective implementation of the above-listed measures may favour more flexible small- and middle-sized industrial companies in the competitive process of PPPM-related innovation.in vitro diagnostics, development of biomarker patterns and novel drug targets. However, currently, biobanking is facing major viability challenges. As for individual types of biological material , national laws vary for local instructions and legal approaches and how samples may be collected, stored, retrieved and tested. In plenty of cases, this may be quite restrictive and incompatible with rules that are legal for other countries. The analytical quality of collections is frequently compromised as the storage condition for the samples is changing. Donation of samples to a biobank not only requires anonymity but also strict control over record linkage and access. Sample collections with a permission of specialised ethical commission should be hosted by viable academic units and health facilities with a proven record of research and should not be exploited for commercial gain but for the common good. Disease-focused collections require acquired samples to be retrospectively valid for a development of novel biomarkers. Such biomarkers need to have a demonstrated clinical utility prior to their introduction in medical services. For a disease-specific biobanking, the disease needs to have been well characterised for each patient, with immaculate record-keeping, to enable to draw conclusions on the new markers. These critical problems may be optimally solved by relevant professional groups with complementary expertise such as the European Federation of Clinical Chemistry and Laboratory Medicine, EPMA and ESBB followed by adequate decisions of policymakers resulting in the creation of a robust juristic platform. An international biobanking, if designed as being reliable for advanced health care services, needs an adequate juristic platform that considers the following interests of all parties involved in the research, business and health care, namely: (1) donors of biological materials, (2) clinicians providing patient records, (3) laboratory units collecting the samples, (4) storage units, (5) research analysing the collections and creating new diagnostic and drug targets, (6) patenting institutions, (7) health care industry, (8) patient cohorts, (9) groups at risk, (10) general population and (11) educators.Well-organised biopreservation and biobanking is expected to create a robust platform for the optimal set-up of health- and disease-specific biomarker patterns and drug targets. Therefore, ethically correct and technologically excellent biopreservation and biobanking are central activities in the field of PPPM. As it has been formulated in the EPMA White Paper in 2012 , a list How can integrative analytical data in the above-delineated context and for the listed purposes be treated? A creation of innovative medical records is considered as a priority for scientific, coordinated and implementation-oriented programmes of multidisciplinary character. Further, creation of innovative medical records might be a strong driver for standardising communications in the broader health-related scientific community and health care industry ,20,32. HThe mission of integrative bioinformatics is to provide technological tools enabling collaboration across medical fields, scientific disciplines and geographical barriers in order to fulfil the following tasks:–Gathering of complex data received from emerging technologies, such as medical imaging, pharmacogenetics, clinical omics, pathology-specific molecular patters, disease modelling and individual patient profiles.–Undertaking both retrospective and prospective analyses of biodata, information and knowledge related to the (epi-) genome and its links to disease for translational medicine.–Providing help with information and knowledge to advance health-related sciences and to make health care services more reliable.–Analysing complex technological inputs for making optimal clinical decisions.–Learning from what has happened at the individual, process and health system levels to promote the integrative approach by predictive, preventive and personalised medicine (PPPM).–Creating patient records and securing safety treatment of patient databases.–Promoting standardisation in health care.–Presenting integrated data innovatively to enhance comprehension.From what was mentioned previously, it is getting clear that the innovative technologies of multidisciplinary analysis summarised by comprehensive patient records provide the complete information about individual health- and pathology-specific profiles as well as about potential disease predispositions of the individual. Therefore, the concomitant professional activities should be dedicated to the ethical issues, namely–Secure the rights of the patient.–Secure the strict control over but also the rights of the specialised PPPM centres.–Clearly define the authorisation to access individual records in the database.–Clearly define the authorisation to interpret individual data.–Secure and guarantee the access to the database for authorised professionals only.–Regularly analyse potential long-term consequences of the recorded data: health benefits for patients versus potential danger of data misuse and wrong interpretation.–If necessary, revise the juristic platform to satisfy the needs of patients properly.A high quality of ethical standards is the prerequisite for the successful implementation of PPPM in health care systems ,33.‘Nothing about me without me’ is an excellent slogan of the Society of Participatory Medicine  which ceTaking into account the challenges of current health care systems and paradigm shift from reactive to predictive medicine, a new professional environment should be created to promote research in innovative bio/medical fields and implementation of PPPM in health care. For that, a new professional set-up is needed. However, for their daily communication, different professional groups currently utilise different professional ‘languages’, as a consequence of the ‘classical’ domain-relevant education less understandable for others. This frequently leads to misunderstandings when a great innovation proposed by one professional group is underestimated  by the others, resulting in delays in the implementation across diverse areas in predictive, preventive and personalised medicine. Breaking such communication barriers is a great challenge which can be solved only by international and multidisciplinary networking providing the necessary environment for a creation of multifaceted didactic materials, new programmes specialised in multidisciplinary education and, finally, a new culture of communication of PPPM stakeholders. Herewith, the authors present a consolidated position to the point made as follows: the innovative PPPM-related multidisciplinary educational programmes for professionals should be prioritised in the New European Framework Programme Horizon 2020 as well as by other global and topic-relevant national programmes .The EPMA Journal focusing on multidisciplinary research in traditional and innovative medical fields. In particular, since 2010 the journal regularly updates both needs and achievements in the field of PPPM applied to common and rare diseases [In order to promote a new culture of communication of stakeholders in PPPM, worldwide pioneer initiatives have been developed by diseases . The fol–Health care overview in European countries and worldwide.–New guidelines in health care.–PPPM applied to chronic non-communicable diseases .–PPPM in rare diseases.–PPPM in dentistry.–Predictive medicine in groups at risk.–Reproductive medicine.–PPPM in pregnancy, neonatology and paediatrics.–Body culture, individualised exercise training.–Nutritional aspects in PPPM.–Healthy ageing.–Evidence-based traditional and alternative medicine.–Integrative bioinformatics, patient records and disease modelling.–Treatments tailored to the person.–Innovative drug delivery systems and new therapies.–Validation of biomarkers.–Standardisation of innovative biomedical approaches.–Economic, ethical, legal, social and other relevant aspects of PPPM.–Collaboration strategies of professional groups with complementary expertise.—see Figure EPMA has released the package of recommendations for their consideration by research units, educators, health care industry, policymakers, and funding bodies to cover current knowledge deficits in the field and to introduce integrative approaches for advanced diagnostics, targeted prevention, treatments tailored to the person and cost-effective health care. This fundamental document has been published as the EPMA White paperCurrently, any multidisciplinary meeting and collaboration of professional groups related to health care usually are results of an enthusiastic initiative of single groups who realise that a multidisciplinary consolidation is the only way on how to advance actual knowledge and services.Consolidation of professional groups involved in PPPM-related research and health care services is a multifunctional task which should be performed at several levels of activities:–Mandated optimal set-up of multidisciplinary stakeholders in diagnostics and in the prevention and treatment of individual pathologies.–Regular meetings of stakeholders with multidisciplinary expertise motivated and regulated by health care-related national and international programmes.–Multidisciplinary education as an obligation for related professional groups.–Creation of optimal economic conditions motivating a multidisciplinary expertise to be applied in health care sciences and services.Implementation of the innovative PPPM concepts in health care is a 3-dimensional challenge necessitating1. International coordination, networking and dissemination as a global approach for combating major pathologies and improving economy of health care.2. Coordination, networking and dissemination for more effective treatment of collateral pathologies (e.g. frequent cardiovascular complications occur in patients with a history of diabetes).3. Coordination, networking and dissemination among stakeholders .Within the ‘trans-domain’ action, for structuring the work and transparency of the action, individual professional domains may be grouped into two categories of primary expertise : (A) ‘General ’ and (B) ‘Technological tools’.A. General domains represent following professional groups and activities: Development of PPPM concepts in health care, Integrative Bioinformatics, Translational Medicine, Traditional, Complementary and Alternative Medicine, TCAM, Health care economy, Medical Ethics, Evidence-based assessment of health, Food, Well-being, Professional integration in personalised medicine, Integrative Education in PPPM, Promotion of young professionals, Creation of innovative PPPM-relevant programmes for research and implementation, Dissemination.B. Technological tools are specialised professional activities in Laboratory Medicine, Medical Imaging, Predictive Diagnostics, Biopreservation and Biobanking, Disease Modelling, and Patient Profiling, Targeted Prevention, Gender Medicine, Clustering of Specialised Centres, Validation and Standardisation, Patenting and Industrial Products, Evaluation of Clinical Application.A synthesis of professional domains is highly recommended as the trans-domain action to address current deficits in PPPM-relevant professional knowledge and health care. For that, well-designed coordinating measures, data dissemination and networking among bio/medical scientists, research centres, health care providers, industrial partners, educators, patient organisations, policymakers, regulatory, funding and publishing bodies, and the public domain are essential to be performed according to the general scheme shown in Figure The coordination in ‘Integrative Education in PPPM’ should foresee following measures:•A deep analysis of current barriers and actions needed to implement multidisciplinary programmes in PPPM, taking into account the existence of specific directives for medical education and the short list of recognised medical specialties.•A consequent creation of the PPPM-specific ‘Communication Units’ to analyse the deficits in multidisciplinary communication and to coordinate the measures aimed at addressing these deficits, both in the short-term (bridging the acute interdisciplinary communication) and in the long-term  ones.•Recruiting PPPM multidisciplinary taxonomy for educational purposes.•Elaboration of the didactic approach and recommendations for preparing a series of ‘White papers’ and ‘Position papers’ dedicated to the innovative concepts of PPPM and input to standardisation bodies, policymakers, regulators and users.•Establishing innovative initiatives in the education of professionals to identify main concepts and competence frameworks bridging separate fields of science/disciplines to achieve breakthroughs that require an interdisciplinary approach.•Describing technological scenarios for learning that might be useful to build spaces where knowledge can be constructed collaboratively.•Based on the experience from the performance of the above measures, a creation of new well-designed university curricula on PPPM.This is a strategic issue for policymakers after detailed consultations with the relevant health care professionals. In order to effectively promote advanced medical services, much more harmonisation among stakeholders is needed across the Europe. The process of harmonisation requires clear focuses and should result in reasonable standards introduced for comparable/analogous functional elements and systems. All of the existing systems should be carefully analysed at the European level before corresponding standards may be elaborated and introduced in daily medical practice.The European standards recommended by experts, in particular, for analytical systems are as follows :•Consistent standards of laboratory  practice.•Conformance with all relevant international standard systems.•Equivalent units of measurement.•Traceability of the measures.•Equal quality of measurements.•Equal reference systems.•Equal evaluation systems.The European standards recommended for the European electronic patient record are as follows:–Mandated multidisciplinary examination approach.–Unified communication protocols for data exchange between different information systems in health care.–Consolidated algorithms.–Standardised and complex interpretation of analytical results.It is obvious that these listed measures are tasks superior to the national level. This may be effectively achieved, if corresponding European resources will be adequately mobilised, including consolidated professional efforts and dedicated budgets.The new European programme Horizon 2020 is certainly not a hype but a hope for the optimistic scenarios in health care research and implementation, which Predictive, Preventive and Personalised Medicine creates a robust platform for. Horizon 2020 places to the disposal of professionals the long-lasting instruments for scientific and technological progress in medical services and health care-related programmes. However, the overall success of the programme strongly depends on the effective communication and consolidation of all the stakeholders relevant for PPPM research and implementation as well as the communication quality between health care providers and policymakers followed by the most optimal political decision in favour of an active PPPM realisation in health care sector.Since 2008, EPMA considers acute problems in medical sciences as well as the quality and management of medical services challenging health care systems in Europe and worldwide. The Association is focused on the creation of the long-term strategies and professional consolidation to promote PPPM-related innovation in research and health care. Using a well-consolidated expertise, EPMA has contributed with the evidence-based scientific PPPM protocols to the contents of Horizon 2020—the facts that EPMA members are much proud about. Consequently, a series of the PPPM-relevant projects of the EPMA experts and our partners in Europe and worldwide are currently under consideration, preparation and submission procedure that follows already the very first calls released by the EU Commission within the Horizon 2020 for the years 2014–2015. The projects are focused on the patients' needs, innovative medical sciences, optimal health and disease management, coordinating and networking measures, expert recommendations for the relevant medical fields and optimal solutions which have a potential to advance health care services if the long-term strategies were to be effectively implemented as elaborated and published in the scientific works and fundamental documents of the EPMA consortia.Also in the future, EPMA will consequently follow the fundamental principles of the Association such as the full transparency of the global strategies, permanent information stream towards the stakeholders and best possible consolidation of the professionals in PPPM. Over the entire lifetime of the Horizon 2020, EPMA will permanently update the world with the regularly published position paper which will inform about the PPPM-relevant projects submitted and evaluated to the individual topics/call and the European programme as a whole.The authors declare that they have no competing interests.OG, JK and VC have drafted the manuscript and circulated it with the members of the Association in order to finalise the EPMA position. All authors read and approved the final manuscript.The article is published on behalf of the European Association for Predictive, Preventive and Personalised Medicine and expresses the consolidated position of the EPMA members and representatives.


Current plans for control of pandemic influenza vary, and many do not include nonpharmaceutical interventions. This review assesses differences and similarities of the states in planning for pandemic influenza. We reviewed the recently posted plans of 49 states for vaccination, early epidemic surveillance and detection, and intraepidemic plans for containment of pandemic influenza. All states generally follow vaccination priorities set by the Advisory Committee on Immunization Practices. They all also depend on National Sentinel Physician Surveillance and other passive surveillance systems to alert them to incipient epidemic influenza, but these systems may not detect local epidemics until they are well established. Because of a lack of epidemiologic data, few states explicitly discuss implementing nonpharmaceutical community interventions: voluntary self-isolation (17 states [35%]), school or other institutional closing (18 [37%]), institutional or household quarantine (15 [31%]), or contact vaccination or chemoprophylaxis (12 [25%]). This review indicates the need for central planning for pandemic influenza and for epidemiologic studies regarding containment strategies in the community. Much recent attention, public, governmental, and academic, has been focused on the possibility of an influenza pandemic, possibly arising from a mutated or genetically reassorted strain of the currently circulating avian influenza virus (H5N1). In the United States, state and local health departments are primarily responsible for detecting an outbreak and implementing the public health response. Accordingly, individual states and the US Department of Health and Human Services (HHS) have each recently released pandemic influenza plans and guidelines. These plans are now available . BecauseForty-nine states have Internet websites that include statewide pandemic influenza procedures and plans or, in a few instances, have simply addressed broad questions about state-based responses to pandemic influenza . Often tAlmost all of the states' plans address a wide range of issues regarding command and control, surveillance, vaccination, antiviral drugs, communication, and emergency management and containment measures. The purpose of this review was to focus on community public health strategies, especially vaccination, surveillance and detection, and containment, which the various states develop as they refine their plans.In general, all 49 states with posted plans are in accordance with one another on vaccination priority strategies . Many stNonetheless, general agreement exists, explicit or implicit, to provide vaccination during a pandemic that is prioritized by those most likely to acquire, become ill, or die from pandemic influenza . GeneralThe first 3 of the these groups were variously prioritized by the states as high-priority vaccine recipients, but all states consider these 3 groups as the highest priority. A few states, such as Maine, have estimated that 15%–20% of their populations would be in such high-priority groups to be vaccinated.,Of the 49 states that have posted their plans, all rely on the National Sentinel Physician Surveillance (NSPS), the nationwide 122 Cities Mortality Reporting System of pneumonia- and influenza-related deaths ,.Although many states describe plans for enhanced surveillance during pandemic influenza, relatively few (12 [25%]) currently have or envision real-time syndromic surveillance of influenzalike illness (ILI) in persons seeking care at clinics or hospital emergency departments to detect the onset of pandemic influenza .  To ourEight states (16%), including California , New York and Hawaii, are developing ways of screening incoming international travelers. However, current plans for other international entry points, such as Seattle, Portland, Chicago, and Atlanta, do not indicate any similar (foreign) international traveler quarantine and testing activities.The various state plans are markedly heterogeneous in their personal contact-avoidance measures and prophylaxis . Most stSeventeen (35%) states explicitly plan or are considering recommending (voluntary) personal social isolation on the community level, such as staying at home or keeping children at home if they feel sick. Eighteen (37%) other states cite federal or state regulations that indicate that health authorities may close schools, businesses, and other institutions during a severe outbreak, although they are not required to resort to such closures. However, 15 (31%) other states also indicate legal ability to quarantine persons, households, or institutions. Given the high cost and limited supply of neuraminidase inhibitor antiviral drugs and an uncertain supply and effectiveness of future vaccines, only 12 (25%) states plan or consider using either chemoprophylaxis (such as oseltamivir) or vaccination of household and other close nonhospital contacts in their plans to retard epidemic influenza.The control of future pandemic or interpandemic influenza will necessarily rely on each individual state's plan to vaccinate persons and detect and contain this disease. Still, the current national (HHS) pandemic influenza plan presents only a categorization and listing of steps, rather than explicit direction for the states. This lack of central coordination can result in a patchwork of plans that will not adequately detect and control this or other respiratory disease pandemics.,Given the lack of clear guidance, coupled with the fact that no one knows when an influenza pandemic may strike, what its characteristics will be, and the effectiveness and quantity of strain-specific vaccine, the evolving state plans are nonetheless in agreement in adhering generally to ACIP and HHS guidelines for prioritizing vaccination  to review pandemic preparedness issues.Why are there these state plans so disparate? We believe some of the problem results from weak central  direction, as has been a criticism of national bioterrorism preparedness , and get,However, we also believe that answers are lacking to several key epidemiologic questions necessary for rational planning. What is the typical intrahousehold or institutional attack rate, and would vaccination or chemoprophylaxis of contacts retard or stem outbreaks? How well do masks work for pandemic influenza in the community, and when and for how long should they be used? Does closing a school or other institution actually reduce community-level illness and death? Does earlier detection of influenza in a community lead to behavior changes that could stem an outbreak? We know of no studies designed to address these and several other issues; e.g., the Models of Infectious Disease Agents Study (MIDAS) (Thus, we believe that a revision of the national pandemic influenza plan, which despite unavoidable gaps in our knowledge, relies on professional and public health opinion to provide more uniform, specific, and practical influenza protection, avoidance and containment practices for pandemic and interpandemic influenza in the community would be helpful. We also believe it would be prudent to begin studies and, in the interim, create expert panels to determine if masks, school closings, social isolation, and several other nonpharmaceutical strategies would be useful in reducing the illness and death caused by pandemic influenza and its spread in the community.


Genomic Observatories Network (GOs Network) for which this document will serve as its Founding Charter. We define a Genomic Observatory as an ecosystem and/or site subject to long-term scientific research, including (but not limited to) the sustained study of genomic biodiversity from single-celled microbes to multicellular organisms.The co-authors of this paper hereby state their intention to work together to launch the An international group of 64 scientists first published the call for a global network of Genomic Observatories in January 2012. The vision for such a network was expanded in a subsequent paper and developed over a series of meetings in Bremen (Germany), Shenzhen (China), Moorea (French Polynesia), Oxford (UK), Pacific Grove , Washington , and London (UK). While this community-building process continues, here we express our mutual intent to establish the GOs Network formally, and to describe our shared vision for its future. The views expressed here are ours alone as individual scientists, and do not necessarily represent those of the institutions with which we are affiliated. Achieving these challenges, however, requires a greatly improved understanding of human interactions with the natural environment. Towards that end, the GOs Network aims to observe DNA sequences -- the biocode -- across the principal levels of biological organization  up to the planetary genome [Key outcomes of 21Some of the terms we use here require definition  to be recognized as a Genomic Observatory, one or more institutions  should express, and preferably have demonstrated, their long-term commitment to the scientific study of that system’s genomic biodiversity. One important feature of this definition is that it allows the establishment of new genomic observatories, while recognizing the value of those that have existing time-series data already.Most importantly, we define a ‘Genomic Observatory’ as an ecosystem, and/or a site within an ecosystem, that is the subject of long-term scientific research, including (but not limited to) the sustained study of genomic biodiversity. An The mission of the GOs Network is to work towards Biocoding the Earth; integrating DNA data into Earth observing systems and eventually building a global Genomic Observatory within the Global Earth Observation System of Systems (GEOSS) .The vision of the GOs Network is to:• Advance the science of biodiversity genomics through a global network of premier research organizations generating well-contextualized genomic biodiversity observations compliant with global data standards.• Coordinate a set of long-term DNA-centric research programs (actions) at local, regional, and global scales that help develop and implement common standards and best practices for quantifying genomic biodiversity and mapping biotic interactions over time.• Partner with natural history museums, repositories, and bio-banks,  ) to pres• Work with the broader scientific community to develop predictive models of biodiversity, ecosystem services and evolutionary potential  - especi• Provide training, technical assistance, resources, and best practice guides as a learning platform for individuals and organizations wishing to carry out genomic observations at genomic observatories and beyond.The GOs Network is a collaboration of the Genomic Standards Consortium (GSC) and the Group on Earth Observations (GEO) through its Biodiversity Observation Network (GEO BON) . The GSCWorking under GEO reflects our mission of integrating genomic data into GEOSS, while working under GSC ensures that these data are fit for that purpose. Initially, a GOs Network Board, including representatives of key stakeholders, will administer the GOs Network and set its strategic objectives (this charter). One of the first tasks of the Board is to define criteria for membership of the GOs Network and to put in place a governance mechanism and operating procedures. All co-authors of this article are considered “founding individual members” of the GOs Network.Genomic Biodiversity Working Group (GBWG) - a collaboration of the GSC and the Biodiversity Information Standards organization (TDWG.org); and (5) contributing to GEO and GEOSS, particularly through the cross-cutting Working Group 1 (Genetics) of GEO BON.The GOs Network will focus on coordinating activities, such as (1) Organizing an annual meeting (GOs Network Conference) involving all network members and other interested parties worldwide; (2) Co-organizing regional and thematic meetings (GOs Network Workshops) in collaboration with partner organizations; (3) Maintaining a online registry of Genomic Observatories; (4) Participating in standards development efforts, for example, through the Ocean Sampling Day (OSD) [The GOs Network will support actions aiming to build a coordinated and well-contextualized set of genomic biodiversity observations and archived vouchers . In particular, the GOs Network aims to provide a roadmap for ecosystem-based Genomic Biodiversity Assessment Reports as one of its contributions to GEO BON. These reports might start with a simple checklist of species, building up to a DNA barcode library and eventually to metagenomic inventories. The former will contribute towards the International Barcode of Life (IBOL) initiative and work towards the latter is already underway through the GOs Network’s first action, ay (OSD) , an initay (OSD) , particuhttp://biocodecommons.org/). Eventually, the Biocode Commons might aim to provide a one-stop shop for genomic biodiversity data and scientific workflows from genomic observatories. We believe that wherever feasible these data should be fully compliant with global data standards, machine-readable, and (while respecting legitimate concerns for privacy and for the protection of endangered species) accessible without restriction to the scientific community [The GOs Network intends to adopt the Biocode Commons as its informatics stack - a primary forum for sharing tools that support genomic observations from collection through analysis and publication, bringing together developers, scientists and standards  Network brings together premier research sites to develop ‘systems-based’ approaches that integrate genomics into ecological, evolutionary, and socio-environmental studies. This paper outlines the network’s mission and seeks broad community participation in this collaborative effort.GEO: Group on Earth Observations; GEO BON: Group on Earth Observation Biodiversity Observation Network; GEOSS: Global Earth Observation System of Systems; GGI: Global Genome Initiative; GGBN: Global Genome Biodiversity Network; GSC: Genomic Standards Consortium; IBOL: International Barcode of Life; OSD: Ocean Sampling Day.The authors declare that they have no competing interests.ND and DF drafted the original text with detailed input from GOs Steering Committee members  and broad consultation with all the co-authors. All authors read and approved the final manuscript.


Diagnostic tools appropriate for undertaking interventions to control helminth infections are key to their success. Many diagnostic tests for helminth infection have unsatisfactory performance characteristics and are not well suited for use in the parasite control programmes that are being increasingly implemented. Although the application of modern laboratory research techniques to improve diagnostics for helminth infection has resulted in some technical advances, uptake has not been uniform. Frequently, pilot or proof of concept studies of promising diagnostic technologies have not been followed by much needed product development, and in many settings diagnosis continues to rely on insensitive and unsatisfactory parasitological or serodiagnostic techniques. In contrast, PCR-based xenomonitoring of arthropod vectors, and use of parasite recombinant proteins as reagents for serodiagnostic tests, have resulted in critical advances in the control of specific helminth parasites. The Disease Reference Group on Helminths Infections (DRG4), established in 2009 by the Special Programme for Research and Training in Tropical Diseases (TDR) was given the mandate to review helminthiases research and identify research priorities and gaps. In this review, the diagnostic technologies relevant to control of helminth infections, either available or in development, are reviewed. Critical gaps are identified and opportunities to improve needed technologies are discussed. The technical limitations of currently available diagnostic methods for helminth infections impose significant constraints on current initiatives to control these infections, as discussed in other reviews of this collection For each of these activities, the technical requirements for diagnostic tests differ and pose different technical challenges. Furthermore, for each helminth species, the biology of the parasite , and of the parasite–host system  impose different constraints on diagnostic capacity. In addition, intensity of infection is a critical determinant of transmission dynamics, morbidity, and disease burden. Thus, the need to assess infection burden is critical to understanding density-dependent regulatory mechanisms of parasite transmission and morbidity. Yet, with few exceptions, this critical parameter is difficult to quantify accurately with current diagnostic tools.Not only are techniques for the diagnosis of individual infections important, but also techniques for assessment in communities and larger regions are necessary. In this respect, a major obstacle to the implementation of cost-effective control is the lack of accurate descriptions of the geographical distribution of infection. The effectiveness of large-scale integrated programmes for the control of neglected tropical diseases (NTDs) in general, and helminth diseases in particular, depends on appreciation of the geographical overlap between the different NTDs. However, in spite of being co-endemic in most countries, different NTDs can exhibit limited geographical overlap at sub-national scales, necessitating a more geographically targeted approach for their control. Therefore, techniques appropriate for the diagnosis and surveillance of helminth infections are essential for solving many of the control challenges described in other articles of this collection Ascaris); 2) serological assays, where parasite-specific antibodies are detected in serum samples; 3) antigen detection tests, where a parasite biomarker is detected; 4) molecular diagnosis, where parasite nucleic acid is detected; and 5) other specific tools for parasite detection in arthropod vectors or snail (or other) intermediate hosts.The range of diagnostic tools that are available at present can be classified into: 1) parasitological tests, where the parasite (or more frequently parasite transmission stages), sampled from appropriate tissues or body fluids, is directly visualised using a microscope  established in 2009 by the Special Programme for Research and Training in Tropical Diseases (TDR), available diagnostic tests for the six helminth human infections, within the remit of the DRG4, are considered in the context of the specific technical requirements of diagnostic tests needed for control of these parasites, and critical gaps in diagnostic technology are identified. The technical issues related to the performance of tests using parasitological, serological, antigen detection, molecular detection, and other specific tools for diagnosis in vectors and intermediate hosts are detailed in the following supplementary files: APOC, African Programme for Onchocerciasis ControlCAA, circulating anodic antigenCCA, circulating cathodic antigenCFA, circulating filarial antigenCHD, cystic hydatid diseaseDDIA, dipstick dye immunoassayDEC, diethylcarbamazineDFID, Department for International Development, United KingdomDRG4, Disease Reference Group in Helminth InfectionsFDA, Food and Drug Administration, United StatesFECRT, faecal egg count reduction testFIND, Foundation for Innovative New DiagnosticsGIS, geographical information systemICT, immunochromatographic testITS, internal transcribed spacerLAMP, loop-mediated isothermal amplificationLF, lymphatic filariasisLIPS, luciferase immunoprecipitation systemMDA, mass drug administrationMDG, Millenium Development GoalMDSS, Medical Device Safety Service, European UnionM&E, monitoring and evaluationmf, microfilariaeNCC, neurocysticercosisNTD, neglected tropical diseasePCR, polymerase chain reactionPDIP, Product Development and Implementation PartnershipPOC, point-of-careRAPLOA, rapid assessment procedure of loiasisR&D, research and developmentREA, rapid epidemiological assessmentREMO, rapid epidemiological mapping of onchocerciasisSAE, severe adverse eventSEA, soluble egg antigenSTH, soil-transmitted helminthiasisTB, tuberculosisTDR, Special Programme for Research and Training in Tropical DiseasesWHO, World Health OrganizationScalable cost-effective tests for individual diagnosis. Ideally these should be suitable for point-of-care (POC) use, or in environments where technical resources are limitedTests suitable for large-scale surveys, for example for epidemiological surveillanceTests capable of quantifying infection intensity (worm burden) reliably, a diagnostic parameter that is critical when dealing with helminth infectionsTests enabling quantification of suboptimal responses to control interventions including prompt detection of drug resistanceHigh specificity and sensitivity as infection prevalence and intensity decrease throughout intervention, enabling to assess programme end pointsAscaris lumbricoides, hookworm , and Trichuris trichiura  are focused on morbidity control through community-based deworming programmes, particularly among school-age children by annual or twice annual distribution of a single dose of a broad spectrum benzimidazole anthelmintic, either albendazole or mebendazole Current control programmes for the intestinal nematodes or soil-transmitted helminthiases (STHs), namely, those caused by Improve and validate tools for quantifying intensity of infection (worm burden), including both biomarkers (coproantigen) and molecular methods (PCR-based)Refine/develop methods to assess response to treatment for monitoring of drug efficacyRefine methods for more accurate quantification of egg countsDevelop and validate methods for quantifying parasite genetic diversity and population structureDevise diagnostic tools  to assist elimination. Most available diagnostic methods are too insensitive for M&E and surveillance once infection prevalence falls to very low levelsO. volvulus, L. loa, and B. malayi infection that can be used in combination with current tools to assess active infectionDevelop circulating antigen tests for detection of Identify and validate informative molecular markers for detection of heritable changes in drug efficacy, and develop cost-effective tools to detect such changesDevelop and validate methods for quantifying parasite genetic diversity and population structureRefine antigen tests and optimise algorithms for their combination with existing diagnostic assays including parasitological, immunological, and ultrasound toolsDevelop assays for assessment of worm burden in areas of varying endemicityIdentify and standardise markers and assays for resistance to praziquantel for monitoring of drug efficacyImprove and standardise protocols for monitoring of infection in humans and snails by molecular methodsDevelop and validate methods for quantifying parasite genetic diversity and population structureDevelop rapid, sensitive, and specific point-of-care (POC) tests for canine echinococcosisDevelop rapid, sensitive, and specific POC tests for human taeniasisTaenia solium infections in pigsDevelop sensitive and specific tests for detection of viable Devise quantitative tests to determine intensity of infectionDevelop species-specific monoclonal antibodies suitable for use in specific coproantigen detection testsValidate effective and inexpensive molecular methods for differentiation of fluke species with similar egg morphologyFor the STHs, intensity of infection is a major determinant of morbidity, infection dynamics, and response to therapy, as well as a crucial variable for epidemiological modelling Schistosoma mansoni eggs in human faecal samples, is the most widely used method, and has undergone a number of validation studies Of the quantitative methods described for egg counting, the Kato-Katz method A. lumbricoides and hookworm infection Although quantitative measurement of infection intensity by egg counting before and after treatment is the best available method for assessment of anthelmintic efficacy, this approach suffers from a number of significant drawbacks. For example, the relationship between worm burden and egg output is not linearly proportional, with density-dependent fecundity resulting in the potential underestimation of adult worm burden, for example in The weaknesses in study design and consequent uncertainties in measures of STH anthelmintic drug efficacy have been reviewed T. trichiura and A. lumbricoides, it has not been possible to develop such phenotypic tests due to the lack of egg hatch in the external environment, and an inability to readily assess parasite viability ex vivo.Pilot phenotypic tests of anthelmintic response have been developed for hookworms, taking advantage of the characteristic of hookworm eggs, whereby eggs passed in the faecal stream mature into infective larvae over a number of days A. lumbricoidesT. trichiuraSome work has been conducted to develop molecular methods to genotype intestinal nematode parasites for genetic markers of anthelmintic resistance http://www.thiswormyworld.org/ website. Although mathematical models of transmission  on a global basis have highlighted specific deficiencies in the diagnostics for the filariases, particularly in elimination settings. Some relate to the problem of surveillance when infection prevalence falls to low levels. In such settings, most available methods are too insensitive, even if active case detection were logistically feasible. Other specific issues include prediction of the risk of severe adverse events (SAEs) when individuals with high grade microfilaraemia with Infection intensity may refer to adult worm burden or microfilarial load. The relationship between microfilarial load, as assessed by quantification of blood microfilaraemia in LF and loaisis, or of microfilaridermia by skin snip in onchocerciasis, and the total adult parasite burden is at best semi-quantitative. In addition to limitations imposed by sampling methodology and measurement error, microfilarial load is significantly affected by immune-mediated parasite clearance mechanisms, and processes regulating the fecundity of adult worms. Assessment of adult worm burden in onchocerciasis by nodule palpation suffers from both sensitivity and specificity problems in addition to complications brought about by the aggregation of adult worms in nodules. Nodule prevalence in a sample of adult hosts has been used to estimate a measure of community infection for onchocerciasis, by relating nodule to microfilarial prevalence. While palpation of onchocercal nodules is the major tool for determination of infection prevalence and rapid epidemiological mapping of onchocerciasis (REMO) in areas of the African Programme for Onchocerciasis Control (APOC), where it is used for identification of communities at risk Circulating filarial antigen (CFA) in bancroftian filariasis is a product of adult worms, with the majority being produced by adult female worms. As it is very difficult to enumerate adult worm numbers in humans, the relationship between CFA level and parasite burden is difficult to establish, but has been achieved in relevant animal models Wolbachia endobacteria Aside from assessment of changes in microfilarial counts following treatment, diagnostics for establishing cure of filariasis are generally lacking, and as discussed in Wolbachia therapy) In LF, the detection of the “filarial dance sign” in worm nests by ultrasound has been advocated to determine adult worm viability after macrofilaricidal chemotherapy  in areas co-endemic for onchocerciasis. The first approach was based on using elevation and remote sensing images to define high-risk areas based on geographic factors such as vegetation cover and forest boundaries that defined the limits of breeding of the Chrysops vector Loa loa (RAPLOA) uses a standardised questionnaire to enquire for history of eye worm or Calabar swelling alone or in conjunction with confirmation of presence of L. loa microfilaraemia in a survey sample For bancroftian filariasis, CFA assays, in the form of immunochromatographic card tests (ICTs), have been successfully incorporated into programmes to map the distribution of bancroftian filariasis S. japonicum), increasing attention to the animal reservoirs will be required. A detailed discussion of the strengths and weaknesses of diagnostic tests appropriate for diagnosis of schistosomiasis is available in To date, most schistosomiasis control programmes have aimed at morbidity reduction rather than elimination of infection Although estimation of the intensity of schistosomiasis infection is an essential requirement for the implementation of control programmes, M&E, for assessment of efficacy of anti-bilharzial drugs, and as the most important determinant of morbidity, available diagnostics are suboptimal for this purpose.Schistosoma infection Quantitative egg counting following urine filtration or Kato-Katz smear are the standard techniques for estimation of intensity of S. mansoni in Egypt A number of reports from endemic areas have suggested that resistance or tolerance to praziquantel might exist in S. mansoniAs schistosomiasis is characterised by focal distribution and large-scale patterns of transmission that are influenced by climatic and environmental conditions, the integrated use of geographical information systems (GIS), remote sensing, and geostatistics has provided new insights into its ecology and epidemiology at a variety of spatial scales The key interventions for control of cystic hydatid disease (CHD) are continuous mass chemotherapy with praziquantel administered to dogs along with changes to husbandry so that raw offal is not fed to dogs. The development of an efficacious sheep vaccine (EG95) Echinococcus worms in dogs can be undertaken by egg counting and by worm counting after arecoline purge. As even a few lightly infected dogs can sustain infection transmission, due to the high biotic potential of cestodes, the intensity of infection is a parameter of less importance in echinococcosis.Quantification of the burden of As described above, the main control tool is mass chemotherapy of dogs; thus, surveillance for treatment efficacy in individual dogs, reinfection rates, or emerging resistance are not priority parameters for surveillance. Instead the number and coverage of dog treatments is the most important variable in control programmes.E. granulosus have been comprehensively studied by Gemmell and co-workers The transmission dynamics of Taenia solium is in a much earlier stage. Pilot intervention studies have been undertaken since 1989 using mass chemotherapy of the human population with praziquantel Control of taeniasis/cysticercosis due to In both porcine and human cysticercosis, most infected individuals carry a few parasites, and indeed most (>90%) human tapeworm carriers harbour a single tapeworm, with infections with more than two tapeworms being extremely rare, and therefore unlikely to have implications for transmission control. On the other hand, a high number of brain cysts in a human NCC patient is usually associated with that person carrying a tapeworm, and heavy infections in pigs mark the proximity of a human tapeworm carrier. However, identification of heavily infected humans or pigs requires brain imaging in humans or necropsy of pigs; thus, their use in control is very limited. Tongue-positive pigs may serve as a proxy for heavy cysticercosis infections. Whether transmission of taeniasis in endemic populations is mostly driven by the majority of pigs infected with few cysts (and thus difficult to detect), or by the few pigs with many cysts  is an unknown but important question Intestinal tapeworm infections are usually cured with a single dose of niclosamide. The only way to confirm cure is to identify tapeworm scoleces and proglottids following combined niclosamide and purgative therapy T. solium eggs is the placement of “sentinel” pigs from non-endemic areas in an area under surveillance and their monitoring by periodic serology Since no established control programmes have reached the surveillance stage, no standard methods exist. Surveillance of cysticercosis in pigs has been proposed as a practical, inexpensive, and sensitive method for indirectly assessing human risk, and for monitoring the effectiveness of community-based control programmes Human taeniasis usually has very low prevalence and human cysticercosis may present years after infection, so neither of these represent an appropriate target for active surveillance. Screening of household contacts of cases may be a useful mean of identification and treatment of tapeworm carriers Clonorchis sinensis, Opisthorchis viverrini, Op. felineus, Paragonimus spp., and other related fluke species, including misdiagnosis of infecting species, underestimation of prevalence, and inaccurate estimates of infection intensity, has been recently reviewed The inadequate state of diagnostic tests for zoonotic trematodes, and particularly Op. viverrini, worms were found in up to 20% individuals with a negative faecal egg examination As for intestinal nematodes, faecal egg counts do not correlate particularly well with the actual worm burden As outlined in this manuscript and accompanying supplemental files, there is a significant literature on prototype diagnostic tests for helminth infections. Once prototype diagnostic devices for helminth infections reach an acceptable level of technical performance, their further development beyond proof of concept requires that a range of significant challenges be overcome. As is the case in the more prominent diseases such as AIDS, tuberculosis (TB), and malaria, the development of critically needed diagnostic tests has assumed lower research priority compared to other areas such as vaccine and drug development. The lack of funding dedicated to development of diagnostics for helminth infections remains a significant impediment, as discussed in Boatin et al. The likely limited interest in commercialisation, a consequence of the limited financial return, is a major impediment to the development of diagnostic tests. This is due to a range of factors including: a) the low priority for making a specific diagnosis of most of these conditions in endemic settings; b) the low royalty for licensing (<5% in most settings) http://www.mdss.com/IVDD/ivddtoc.htm), and represents a further deterrent. While gaining formal regulatory approval may not be essential for the deployment of a new diagnostic test for helminth infections or other NTDs, such approval carries significant advantages. A minimum requirement for purchase is evidence of good manufacturing practices, as documented by either compliance with ISO 13485:2003 or 21 CFR 820 from the FDA. Once such compliance has been demonstrated, it is likely to be easier to gain financial support from donors and funders for purchase of a diagnostic test for use in public health control programmes.Further, the significant investment is required for diagnostic tests to gain regulatory approval from the US Food and Drug Administration (FDA) Despite these challenges, examples exist of diagnostic devices or platforms relevant to helminth infections and others NTDs that have successfully reached market. These include circulating antigen tests for filariasis Examination of the landscape of diagnostic tests and their pathway to deployment therefore indicates that the standard commercial pathway is not well suited to meeting the needs for diagnostics to aid in the control of helminth parasites. Indeed, in a recent review of the global investment for NTDs http://www.finddiagnostics.org), an organisation that focuses on a small number of diseases including TB, sleeping sickness, and malaria. It is supported by the World Health Organization, the Bill & Melinda Gates Foundation, the European Commission, the Government of The Netherlands, UNITAID, DFID, and others.A novel approach to bridging the gap between demonstrating a technically satisfactory diagnostic assay, and bringing the product in question to the market entails the formation of organisations specifically tasked with this mission. The foremost example of such a Product Development and Implementation Partnership (PDIP) is the Foundation for Innovative New Diagnostics Click here for additional data file.Text S2Diagnostics for Filariases.(DOCX)Click here for additional data file.Text S3Diagnostics for Schistosomiasis.(DOCX)Click here for additional data file.Text S4Diagnostics for Cystic Hydatid Disease.(DOCX)Click here for additional data file.Text S5Diagnostics for Taeniasis Cysticercosis.(DOCX)Click here for additional data file.Text S6Diagnostics for Food-Borne Trematodiases.(DOCX)Click here for additional data file.