Medizin / Medicine

Nach Datum der Veröffentlichung sortiert/ Sorted by date of publication

Bundesförderungen / Federal Funding

BMBF: Förderung von Forschungsprojekten zu ethischen, rechtlichen und sozialen Aspekten der Neurowissenschaften

Die neurowissenschaftliche Forschung liefert kontinuierlich Fortschritte in Bezug auf unser grundlegendes Verständnis zur Struktur und Funktion des menschlichen Gehirns unter gesunden und pathologischen Bedingungen. Dieses Wissen ist von grundlegender Bedeutung für die Entwicklung neuer Diagnosen und Behandlungen für Patienten mit Erkrankungen. Das Förderziel dieser Maßnahme ist es, die ethischen, rechtlichen und gesellschaftlichen Implikationen von Entwicklungen in den Neurowissenschaften zu identifizieren, wissenschaftliche Grundlagen für einen informierten gesellschaftlichen und wissenschaftlichen Diskurs zu legen, Chancen und Risiken, die sich aus dem technischen und methodischen Fortschritt ergeben, zu bewerten sowie den allgemeinen Wissensstand zu erweitern. 

Das Förderangebot beinhaltet zwei eigenständige Module. Interessierte können Anträge zu beiden Modulen stellen. Diese müssen getrennt gestellt werden.

Modul A: Forschungsprojekte 

Gefördert werden innovative, interdisziplinäre Forschungsprojekte, die in der Regel in Verbünden bearbeitet werden sollen. Die Projekte müssen ethische, rechtliche, gesellschaftliche, normative, kulturelle, ökonomische und/oder soziale Implikationen und Fragestellungen adressieren, die sich aus den Fortschritten in den Neurowissenschaften oder Anwendungen neurowissenschaftlicher Technologien ergeben.

Modul B: Wissenschaftliche Querschnittsmaßnahme (Research Hub)

Gefördert wird ein Querschnittsprojekt als Einzelprojekt oder Verbundvorhaben.

Antragsberechtigt sind staatliche und staatlich anerkannte Hochschulen, außeruniversitäre Forschungseinrichtungen und Wissenschaftseinrichtungen sowie Unternehmen der gewerblichen Wirtschaft. Die Zuwendungen werden im Wege der Projektförderung als nicht rückzahlbarer Zuschuss gewährt.

Das Antragsverfahren ist zweistufig angelegt.

Frist: Anträge sind bis spätestens 14. Dezember 2021, 14.00 Uhr vorzulegen

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BMBF: Bilaterale Zusammenarbeit in Computational Neuroscience: Deutschland – USA

Das Verständnis komplexer neurobiologischer Systeme, von genetischen Faktoren über zelluläre Prozesse bis zum komplexen Zusammenwirken von Neuronen, neuronalen Schaltkreisen und Systemen zur Steuerung von Verhalten und Wahrnehmung, ist eine der spannendsten und schwierigsten Aufgaben heutiger Forschung und Technik. Erkrankungen des Nervensystems sind auch mit komplexen neurobiologischen Vorgängen verbunden, die zu tiefgreifenden Veränderungen auf allen Ebenen der Organisation führen können. Ziel dieser Maßnahme ist es, durch Vernetzung der im Bereich Computational Neuroscience tätigen Wissenschaftlerinnen und Wissenschaftler, durch wissenschaftlichen transnationalen Austausch und interdisziplinäre Zusammenarbeit der relevanten Fachdisziplinen einen gemeinsamen kooperativen Fortschritt bei der methodischen Unter­suchung und dem Verständnis komplexer neurowissenschaftlicher Fragestellungen zu erreichen.

Der Schwerpunkt dieser Initiative liegt auf innovativen Forschungsarbeiten und Ressourcen und soll dazu beitragen, dass Expertinnen und Experten aus den Bereichen Theorie, Computational Science, Technik, Mathematik und Statistik moderne rechnergestützte Methoden zur Bearbeitung dynamischer und komplexer neurowissenschaftlicher Probleme einsetzen und entwickeln. 

Antragsberechtigt sind staatliche und staatlich anerkannte Hochschulen und außeruniversitäre Forschungseinrich­tungen sowie Unternehmen der gewerblichen Wirtschaft.  Die Zuwendungen werden im Wege der Projektförderung als nicht rückzahlbarer Zuschuss gewährt.

Das Antragsverfahren ist zweistufig angelegt.

Frist: Bis zum 23. November 2021 sind Projektskizzen einzureichen

Zur Ausschreibung

Horizon Europe

Setting up a European Electronic Health Record Exchange Format (EEHRxF) Ecosystem

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

  • Individuals, researchers, health services and the workforce across borders in the EU Digital Single Market use significantly improved and interoperable cross-border digital health solutions thanks to sophisticated ICT toolbox, representative use case applications, a Pan-European ecosystem of early adopters, and a framework for sustainability and exploitation. These will also contribute to the European Health Data Space.
  • Individuals have an improved level of accessibility, control and portability of health data, including donation for research across Europe and jurisdictions.
  • Policy makers and members of the eHealth Network are better informed and advised regarding potential evolutions of the EEHRxF and its extension to other uses cases.
  • Different target populations such as designers, developers, health care professionals, and individuals have access to exploitation and capacity building support, such as training material, dedicated tools, guidelines, mentorship and collaboration programs.

Scope:

Interoperability of Electronic Health Record is key for the exchange and the portability of health data in view of better health outcomes and treatments. The EU has supported projects to ensure cross-border sharing of health data and, in 2019, adopted a Recommendation on EEHRxF. There is a need to continue supporting the uptake of new use cases (i.e. laboratory results, medical imaging and reports, and hospital discharge reports) and take on board possible new requirements, and ultimately to bring together policy actors and stakeholders.

Applicants should propose activities in all of the following areas:

  • Building on the outcomes of activities and projects related to the EEHRxF Recommendation, establishing and sustaining a scalable public infrastructure for digital health innovation based on the EEHRxF principles and the functional and technical specifications of its information domains (i.e. medical imaging, discharge letters, laboratory results, etc.). This infrastructure must provide a REST AP] to third-party developers, which should comprise a coherent set of functionality that significantly improve the development and deployment of interoperable cross-border digital health solutions. It should specifically allow individuals accessing and providing their own (electronic) health records across national borders. The infrastructure must ensure compliance with the General Data Protection Regulation, the Network and Information Systems Directive and the operation in a European Digital Single Market.
  • Demonstrating feasibility of real-life interoperable digital solutions for use by individuals, researchers, health services and the workforce across borders in the EU Digital Single Market by leveraging the above EEHRxF-based infrastructure. Emphasis should be given to specific fields of high societal relevance and high prevalence. Omics type of information associated to the use and exchange of health datasets and artificial intelligence should be strongly considered with special regard to analysis and corresponding further health-related data. Integration with population-based patient registries such as cardiovascular disease, congenital anomalies, diabetes, rare diseases, and cancer are highly recommended. Relevant activities of the eHealth Network should be taken into account. For all relevant data (e.g. from hospitals, doctors or user-generated) ethics and legal issues should be considered appropriately. Local, regional, national and cross-border aspects (to cover e.g. differences in languages and terminologies) should be given adequate consideration.
  • Establishing and sustaining a Pan-European ecosystem of digital health stakeholders by promoting and ensuring adoption of the EEHRxF-based infrastructure, involving both supply and demand sides, reinforcing collaboration and networking between the different actors working on digital health innovation across Europe around that infrastructure, and more particularly ensuring strong involvement and coordination at the governance level with the national authorities and Ministries represented in the eHealth Network and the eHealth agencies underneath it. The latter should include innovation initiatives related to a coherent selection of the following: clinical research, clinical trial integration, outcomes-based research, monitoring or decision aids for individuals, and business analytics, as well as application designers and developers, SMEs, innovation hubs, professionals networks e.g. rare disease network, health professionals and patient associations, and standardisation bodies.
  • Creating and validating a framework for enabling further exploitation of the public infrastructure for digital health innovation, including its terms of reference, governance and operations rules and procedures, as well as support for capacity building such as training material, guidelines, mentorship and collaboration/twinning programs for designers, developers, health care professionals, policymakers, SMEs, etc.

In this topic the integration of the gender dimension (sex and gender analysis) in research and innovation content is not a mandatory requirement.

Deadline: 21 April 2022, 17:00:00 Brussels time

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Optimising effectiveness in patients of existing prescription drugs for major diseases (except cancer) with the use of biomarkers

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored and contributing to all of the following expected outcomes:

  • Diagnostics industries move towards market approval for companion diagnostics.
  • Regulatory authorities approve companion diagnostics and make recommendations for the prescription of existing drugs.
  • Health care providers use biomarkers with existing pharmaceuticals to treat more efficiently and cost-effectively patients, with less adverse effects.

Scope:

The applicants should perform the clinical validation of qualified biomarkers (not limited to molecular biomarkers) that will enable the identification of appropriate patients to ensure an effective and efficient use of existing pharmaceuticals in the treatment of major diseases and conditions. The relevant biomarkers should allow providing the right medicinal product, at the right dose and the right time, according to the concept of personalised medicine, taking into account, among others, differences of sex, age, ethnicity and gender identity. This topic refers to medicines that are already on the market and not to the validation of biomarkers for the development of new medicinal products. It addresses broadly prescribed medicines for major diseases and conditions, including but not limited to cardiovascular diseases. A condition is that preliminary studies or publications have demonstrated that the pharmaceuticals considered are efficient in less than 50% of the population treated. This topic excludes cancer and rare disease treatments. The applicants should consider existing guidelines, standards and regulations, as appropriate. Synergies with relevant European Research Infrastructures are encouraged.

Cross-cutting Priorities: Socio-economic science and humanities

 

21 April 2022 17:00:00 Brussels time

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Vaccines 2.0 - developing the next generation of vaccines

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

  • The scientific and clinical communities use the increased knowledge on pathogens and better understanding of the immune system’s role in infectious diseases to develop vaccines with improved efficacy.
  • Vaccine manufacturers use more innovative and sustainable manufacturing technologies and improved GMP manufacturing know-how for producing the next generation of vaccines.
  • A diversified portfolio of vaccine candidates ready for testing in clinical trials help policy makers and funders to make informed decisions about support to vaccine development.
  • New innovative and improved design of preclinical/clinical studies that match the features of the next generation of vaccines is available for clinical community and regulators, and will shorten vaccine development time.

Scope:

Infectious diseases, including antimicrobial resistant (AMR) infections, remain a major threat to health and health security in the EU and globally. The availability of more effective, accessible and affordable vaccines would provide the most cost-effective preventive measure against the health threat of epidemics and AMR pathogens. Vaccines against diseases, such as AIDS, tuberculosis (TB), malaria, neglected tropical diseases, hepatitis C and water-borne diseases are essential to achieve the WHO targets to control the spread of infectious diseases. The first generation of vaccines against some of the pathogens have proven to be suboptimal and not effective enough to protect the population. Many viruses of pandemic potential are variable in their surface antigen composition, and novel technologies are required to develop efficient vaccines against each new variant efficiently and in a short timeframe. To ensure that more effective, accessible and affordable vaccines against all major infectious diseases become a reality, it is essential to sustain a diverse and modernised vaccine development pipeline.

Proposals should aim to diversify and accelerate the global vaccine research and development pipeline, and to strengthen the current leading role of the EU in vaccine research and development. Proposals should cover those pathogens, which still lack vaccines of sufficient efficacy, but where earlier efforts have already produced promising vaccine candidates.

The proposals should address several of the following areas:

  • Innovation and integration of expertise and capabilities, including alignment of preclinical and clinical models, biomarker studies and new vaccine approaches from discovery to late stage development, from bench-based research to clinical development of promising preventive candidates.
  • Application of iterative processes (including cross-learning, back-translation steps, integrative analysis of data) to allow exploitation and integration of novel findings between clinical, preclinical and discovery research and development.
  • Deciphering mechanisms of protection of candidates, new approaches to antigen discovery and immunogen engineering, reverse vaccinology, evaluation of vaccines in novel platforms and technologies, novel adjuvants, innovative vaccine manufacturing approaches, relevant animal models, evaluation of alternative vaccine delivery routes.
  • Effective, evidence-based decision-making for progression of vaccine candidates in the pipeline based on transparent and objective portfolio management. Regulatory requirements be considered. Sex, gender, age and socio-economic factors should be taken into account.

Cross-cutting Priorities: International Cooperation; Socio-economic science and humanities

Deadline: 01 February 2022 17:00:00 Brussels time

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Scaling up multi-party computation, data anonymisation techniques, and synthetic data generation

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

  • The EU contributes strongly to global standards for health data through enhancement of common European standards for health data (including medical imaging data) by researchers and innovators. Researchers and innovators contribute to GDPR compliant guidelines and rules for data anonymisation.
  • Innovators have access to advanced secure data processing tools to test and develop robust data-driven digital solutions and services in response to the needs of researchers, clinicians and health systems at large.
  • Cross-border health data hubs further facilitate the innovation process by providing secure, trustable testing environments for innovators.
  • Clinicians, patients and individuals use a larger variety of high quality data tools and services for wellbeing, prevention, diagnosis, treatment and follow-up of care.
  • Researchers and innovators have more opportunities for testing and developing GDPR compliant data driven solutions based on actual needs of the health care environments.

Scope:

It is essential to speed up and facilitate innovations in the field of data-driven tools and services for wellbeing, prevention, diagnosis, treatment and follow-up of care, among others. However, limited access by developers to health data and secure testing environments hinder the development of innovative data-driven digital health products and services.

Therefore, the proposals are expected to scale up multi-party computation, data anonymisation techniques and synthetic data generation. To ensure privacy, the data analytics should be conducted in a distributed way among processors that grant third parties access to analysis outcomes but not to the underlying data. The developers should have access to distributed testing data sources and cloud and computing resources at large scale, with a view to improving the speed and robustness of multi-party computation solutions for innovators. The aim is to allow secure GDPR-compliant data processing for research, and clinical purposes.

The proposals should consider the use of synthetic, i.e. artificially generated, data as they allow researchers and developers to test, verify and fine-tune algorithms in large-scale data experimentations without re-identifiable personal data.

In addition, the proposed anonymisation techniques will have to be sophisticated and robust enough to tackle the challenge of anonymised data sets that still make it possible to trace back to individuals.

The proposals are expected to foster the development of secure, interoperable, transparent - and therefore trustable - cross-border health data hubs that can facilitate the provision of the required testing environments for innovators. This will support the uptake of new data tools, technologies and digital solutions for health care.

To this end, integration of national/regional health data hubs/repositories/research infrastructures is appropriate to achieve the scope of the topic. The proposals are expected to address all of the following areas:

  • Consolidate and scale up multi-party computation and data anonymisation techniques and synthetic data generation to support health technology providers, in particular SMEs.
  • Support the development of innovative unbiased AI based and distributed tools, technologies and digital solutions for the benefit of researchers, patients and providers of health services, while maintaining a high level of data privacy.
  • Advance the state-of-the-art of de-identification techniques, to tackle the challenge of anonymised datasets that can be traced back to individuals.
  • Develop innovative anonymisation techniques demonstrating that effective data quality and usefulness can be preserved without compromising privacy.
  • Explore and develop further the techniques of creating synthetic data, also dynamically on demand for specific use cases.
  • Widen the basis for GDPR-compliant research and innovation on health data.
  • Ensure wide uptake and scalability of the methodologies and tools developed, promote high standards of transparency and openness, going well beyond documentation and extending to aspects such as assumptions, architecture, code and any underlying data.

Deadline: 21 April 2022 17:00:00 Brussels time

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Pandemic preparedness

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • The scientific community has better understanding of the biology of the pathogens (virus, bacteria etc.), its transmission, its interaction with humans, animals and plants, in particular in view of emerging threats to human health, such as infectious diseases and anti-microbial resistance.
  • Health care providers and practitioners have access to and use appropriate medical countermeasures, e.g. vaccines, diagnostics, therapeutics and digital solutions.
  • Health authorities have the evidence-base and tools for better public health measures.

Scope:

The COVID-19 pandemic has revealed weaknesses in the ability of the Union and its Member States to respond quickly and effectively to such an unprecedented health emergency. Therefore, the Commission is stepping up its efforts in supporting the Union’s ability to respond to serious cross-border threats.

Member States agreed to step up their coordination in the area of pandemic preparedness research and aim to establish a European partnership on pandemic preparedness. A dedicated coordination support actionwill help develop a common long-term Strategic Research and Innovation Agenda for such a partnership.

A key component for the European Health Union will be the establishment of the Health Emergency Preparedness and Response Authority (HERA) for which the Commission will put forward a legislative proposal by the end of 2021. It should build on experiences dealing with COVID-19, SARS and influenza, and consider emerging biological threats to human health, e.g. in the context of climate change, deforestation and biodiversity loss.

This topic aims to contribute and complement both of these initiatives, notably by addressing priority research and innovation gaps also identified by Member States and that would contribute and support the establishment and work of a potential future Health Emergency Preparedness and Response Authority (HERA).

Research focussing on ‘pathogen X’ from threat assessment, horizon scanning for the identification of potential medical countermeasures and innovative technologies, including the development of standardised research protocols would be in the scope of this topic.

Cross-cutting Priorities: International Cooperation

Deadline: 21 April 2022 17:00:00 Brussels time

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Boosting mental health in Europe in times of change

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several impacts of destination 1 “Staying healthy in a rapidly changing society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

  • Health care professionals, national/regional public authorities and other relevant actors in key settings (e.g. schools, workplaces, etc.):
    • Have access to and apply evidence-based, innovative, cost-effective/cost-neutral, large-scale, comprehensive strategies and interventions for the promotion of mental health and the prevention of mental ill health, targeting the most vulnerable populations;
    • Adopt clinical guidelines, best practices, implementation strategies and policy recommendations (as applicable to them) to mitigate the mental health burden and help cope with the (combined) effects of a transforming Europe (e.g. the socio-economic consequences of the COVID-19 pandemic, climate change, environmental degradation, energy transition, demographic and migration factors, digitalisation, and exponential technological advancements);
  • The scientific community together with the public authorities anticipate new and emerging risks to mental health associated with a transforming Europe, contributing to better and inclusive public mental health preparedness.
  • Citizens have access to and make use of new tools and services to take informed decisions about their wellbeing and mental health care needs (including for self-management and self-care).
  • Citizens feel less stigmatised and marginalised due to their mental ill health.

Scope:

Against the backdrop of a transforming Europe and in the midst of a global pandemic, the EU is committed to lead the transition to a healthier planet and a new digital world. The health and wellbeing of its citizens is a prerequisite to achieve this aspiration.

On the one hand, extreme weather and environmental disasters have risen dramatically over the last decade. Links between these events and serious mental health problems, including anxiety, depression, post-traumatic disorder and suicide, have been reported. Moreover, several new words such as “eco-anxiety”, “ecoparalysis” and “ecological grief” have been coined to express the acute and/or chronic effects on mental health caused by climate and environmental changes.

On the other hand, digital technologies and the achievement of the Digital Single Market – one of the EU’s key priorities – are transforming our economy, our industries as well as our culture and lifestyle. Digitalisation, including digitally-enabled technologies such as robotics and artificial intelligence, are penetrating much faster into societies than in the past and affect us all. Accordingly, the “Fourth Industrial Revolution”’ is changing the way we work (e.g. workplaces, working practices and patterns, the workforce and its skills, and how we perceive work) as well as the way we live. The exponential incorporation of digital technologies in our daily lives has already caused profound changes in the way we communicate and is likely to have significant impact (both positive and negative) on mental health and intellectual/cognitive ability, in particular of the youth. Digital platforms can provide mental health support as well as increase social inclusiveness. However, digital technologies also introduce new risks, such as continuous connectivity, cyberbullying and exposure to inappropriate or fake content.

Accordingly, the proposed research should aim to deliver in all three dimensions listed below, focusing on one or several of the (combined) effects of a transforming Europe highlighted in the “Expected Outcomes”[1].

  1. Provide a comprehensive knowledge base of how a transforming Europe can influence mental health in a fast-evolving society, especially in the most vulnerable populations, by consolidating data from relevant sources and/or acquiring new data, and by reviewing existing methodologies.
  2. Develop and implement (pilot and/or scale-up) interventions, which promote wellbeing and prevent mental illness to help cope with and mitigate the stress of a changing society, including digitalisation, climate change and/or other factors highlighted in the “Expected Outcomes”.8 The interventions should target relevant settings (e.g. workplaces, schools) and the most vulnerable populations (e.g. children and adolescents, the elderly, people with pre-existing health conditions and co-morbidities and other high-risk groups such as socio-economic disadvantaged groups, migrants, etc.). Integration of care and coordination among different settings from communities to health care is desirable. The effectiveness of the interventions should be evaluated, inter alia, in terms of health outcomes, (comparative) cost-effectiveness, implementation facilitators and barriers. Depending on the aspects covered by the proposed research, desired outputs may include, but are not limited to:
    • Evidence-based guidelines for health care professionals on the promotion of mental wellbeing and prevention of mental illness related to ICT and climate and environment change (including screening methods).
    • Evidenced-based pedagogical practices for education professionals to foster mental health promotion in schools (including higher education) and/or via eLearning.
    • Consultation during school time to educate students (e.g. on coping with change) and to detect early students at risk.
    • Educational material and campaigns targeting the most vulnerable groups, (e.g. children and the elderly), disseminated via the most appropriate and effective media and communication channels, to improve health literacy, skills, attitudes and self-awareness leading to a better (self-)management of wellbeing and/or mental ill health.
    • Studies on occupational mental health in the workplace, in particular in small and medium-sized enterprises, e.g.: i) understanding the impact of a 24-hour digital economy on workers’ well-being, also in terms of managerial control mechanisms, work-life balance and privacy and developing/piloting new methods to protect and support workers’ well-being in this respect; ii) designing information and training campaigns for workers to integrate the already visible impacts of digitalisation-induced changes into the professional risk assessment processes; iii) developing return-to-work programmes, also exploring innovative collaboration between mental health services, (life-long) education, and employment sectors. This will ensure appropriate support to better integrate individuals affected by mental ill health in the workforce and the society.
  3. Inform policy-makers and regulators on: i) the prevalence and burden of mental ill health related to a transforming European society (e.g. digital technologies, climate change, etc); and/or ii) the effects of a transforming European society (e.g. digitalisation, climate change and transition to “green jobs”) on occupational mental health; and/or iii) the (comparative) cost-effectiveness of public mental health interventions/policy choices.

Research should be multidisciplinary, including medical sciences, social sciences, the humanities, and the arts, if relevant. It is important to consider aspects such as (associated) behavioural patterns, stigma and novel social dynamics as well as different socioeconomic, cultural and geographical contexts. In all instances, sex and gender-related issues must be taken into account. All data should be disaggregated by sex, age and other relevant variables, such as by measures of socioeconomic status (i.e. take into account the socioeconomic gradient in mental health). International collaboration is encouraged.

Proposals should involve end-users (including civil society organisations) and/or strategic partners in the design and during the course of the project. Possible end-users and strategic partners could include local or regional authorities, community services, employers, schools/universities, cultural institutions, insurance companies, civil society organisations, communities, among others. Proposals should adopt a patient-centred approach that empowers patients, promotes a culture of dialogue and openness between health professionals, patients and their families, and unleashes the potential of social innovation.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

Cross-cutting Priorities: International Cooperation; Social Innovation; Socio-economic science and humanities; EOSC and FAIR data

[1]For instance, the socio-economic consequences of the COVID-19 pandemic, climate change, environmental degradation, energy transition, demographic and migration factors, digitalisation, and exponential technological advancements.

Deadline: 01 February 2022 17:00:00 Brussels time

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Better financing models for health systems

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 4 “Ensuring access to innovative, sustainable and high-quality health care”. More specifically, this topic aims at supporting activities that are contributing to some of the following expected impacts:

  • Health and social care services and systems have improved governance mechanisms and are more effective, efficient, accessible, resilient, trusted and sustainable, both fiscally and environmentally. Health promotion and disease prevention will be at their heart, by shifting from hospital-centred to community-based, people-centred and integrated health care structures and successfully embedding technological innovations that meet public health needs, while patient safety and quality of services is increased.
  • Health policy and systems adopt a holistic approach (individuals, communities, organisations, society) for the evaluation of health outcomes and value of public health interventions, the organisation of health care, and decision-making.

To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • Decision and policymakers in the field of health care avail of new approaches to financial planning and financing mechanisms that provide flexibility to stretched health budgets, including alternative procurement and contractual methods;
  • Decision and policymakers in the field of health care apply cost-effective spending strategies based on the optimisation of the use of resources, while maintaining or improving health outcomes in an equitable way;
  • Decision and policymakers in the field of health care access tools that enable them to better remunerate, contract and incentivise health care professionals and providers;
  • Decision and policymakers in the field of health care take evidence-based and socially equitable health care financial decisions.

Scope:

In 2017, spending on health care in the EU stood at 9.6% of gross domestic product, ranging from over 11% in France and Germany to less than 6% in Romania. In most countries, in-patient care services made up the bulk of health spending, while spending on pharmaceuticals also accounted for a large share of health expenditure in some countries.[1]

Due to demographic changes in the EU with a population projected to continue ageing and higher expectations regarding provision of health care services, public health threats with relevant repercussions for society and the introduction of innovative and digital solutions to improve health care systems’ functioning, the demand for health care services as well as the budgetary pressures on health care systems are and will keep increasing.

Future models of care delivery will have to take into account both the systemic and multi-dimensional performance perspective and to look at relevant outcome and quality indicators, structure of care delivery, and knowledge base regarding optimal care delivery systems,

Therefore, research and innovation should tackle the challenges of financing health care services in the EU by addressing one or more of the following:

  • Financing of health care – development of new cost-effective models for financing and reimbursement, including incentive mechanisms and outcome-based financing in order to promote good performance of the health care systems.
  • Financing of preventive health care – novel models and appropriate structure of financial incentives for effective health promotion and disease prevention, financial incentives for stronger co-operation between primary care and public health services, long-term sustainable financing mechanism for local- and municipality-run promotion programmes and the assessment of personal health risk behaviour and its potential impact on health costs.
  • Innovative purchasing and contract methods – new strategies for contracting provision of health care services (public sector hired services) as well as solutions to better assess provision capacity and quality, to assess markets, and cost-effectiveness as well as equal access of contracting-out services. This can help align the incentives of providers with those of patients and the public good.
  • New and improved tools for better design of incentives for health care professionals – incentives that minimise differentiation between services and “cream-skimming” by patients, fostering better health care planning, optimized use of health care services and avoidance of resources’ overconsumption and -waste.

Value-based pricing- and payment models for health technologies are not in the scope of this topic; such models are covered by topic “New pricing and payment models for cost-effective and affordable health innovation” (HORIZON-HLTH-2022-IND-13-03) under destination 6.

Research and innovation in these areas should take into account the potential impact of public health emergencies and threats on the sustainability, financing, as well as the effective and efficient functioning of EU health care systems.

To ensure wide uptake by user communities and scalability of the models and methods across health systems, actions should promote the highest standards of transparency and openness, going well beyond documentation and extending to aspects such as assumptions, architecture, code and any underlying data.

Applicants are highly encouraged to actively involve public authorities (i.e. ministries of finances and health, procurement agencies/procurers and agencies responsible for the management of health services contracts, public health and health-policy institutes, health administrations, among other) in the proposals.

Projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate, and in particular they are expected to liaise with successful applicants under topic “New pricing and payment models for cost-effective and affordable health innovation” (HORIZON-HLTH-2022-IND-13-03) and the consortium to be created under the planned “European Partnership on Transforming Health and Care Systems” (HORIZON-HLTH-CARE-2022-IND-10-01). These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activity without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

Cross-cutting Priorities: Foresight; Socio-economic science and humanities; Innovation Procurement

[1]Health at a Glance: Europe 2018.

Deadline: 21 April 2022 17:00:00 Brussels time

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Enhancing cybersecurity of connected medical devices

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • Stakeholders (e.g. manufacturers, suppliers, health care providers, integrators, operators) apply measures to identify and address cybersecurity risks and gaps in connected medical devices.
  • Stakeholders adopt and use newly developed risk benefit analysis schemes and capabilities for cybersecurity of connected medical devices.
  • Stakeholders adopt and use newly developed methodologies and toolboxes for ensuring cybersecurity of connected medical devices by design.
  • Stakeholders adopt and use fit for purpose guidance covering challenges posed by connected medical devices, including software.

Scope:

The proposals are expected to help strengthening cybersecurity maintaining the performance of medical devices while preserving or enhancing safety, security and data confidentiality, integrity and availability. The applicants should tackle the cybersecurity issue of connected medical devices and in vitro diagnostic medical devices, in particular those that are connected to the internet, allow remote access to data and exchange private or proprietary data. They should also consider the implications of Regulation (EU) 2017/745[1] on medical devices and Regulation (EU) 2017/746[2] on in vitro diagnostic medical devices regarding qualification and classification of software. In their proposals, applicants should consider to maximise synergies with relevant initiatives, activities and programmes.

Proposals are expected to address some or all of the following:

  • Systematic review of current standards/guidelines/best practices applied to cybersecurity of connected medical devices, with the final objective to identify and specify gaps and requirements based on evidence.
  • Propose risk benefit analysis schemes for cybersecurity of connected medical devices, taking into account several novel technological developments (e.g. 5G networks, big data, artificial intelligence, cloud computing, augmented reality, blockchain) and interconnection architectures.
  • Explore, develop and validate novel methodologies and toolboxes for ensuring cybersecurity of connected medical devices by design.
  • Identify representative case studies, evaluate the applicability of existing guidance MDCG 2019-16 (guidance on cybersecurity for medical devices[3]) and make recommendations to (better) address specificities of the connected medical device, including software, of different risk classes.
  • Assessment of the applicability (and revision) of current guidance, the MDCG 2019-16 (guidance on cybersecurity for medical devices), to connected medical device, including software.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

In this topic the integration of the gender dimension (sex and gender analysis) in research and innovation content is not a mandatory requirement.

[1]OJ L 117, 5.5.2017, p. 1

[2]OJ L 117, 5.5.2017, p. 176

[3]ec.europa.eu/docsroom/documents/41863

 

Deadline: 21 April 2022 17:00:00 Brussels time

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Computational models for new patient stratification strategies

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored and contributing to some of the following expected outcomes:

  • Clinical researchers use effective health data integration solutions for the classification of the clinical phenotypes.
  • Researchers and/or health care professionals use robust and validated data-driven computational tools to successfully stratify patients.
  • Regulatory bodies approve computer-aided patient stratification strategies to enable personalised diagnosis and/or personalised therapy strategies.
  • Health care professionals adopt evidence-based guidelines for stratification-based patient management superior to the standard-of-care.

Scope:

In the era of big and complex data, the challenge remains to make sense of the huge amount of health care research data. Computational approaches hold great potential to enable superior patient stratification strategies to the established clinical practice, which in turn are a prerequisite for the development of effective personalised medicine approaches.

The proposals may include a broad range of solutions, such as computational disease models, computational systems medicine approaches, machine-learning algorithms, Virtual Physiological Human, digital twin technologies and/or their combinations, as relevant. The topic covers different stages in the continuum of the innovation path (i.e. translational, pre-clinical, clinical research, validation in the clinical and real-world setting, etc.), as relevant to the objectives of the proposals.

The topic will support the development of the computational models driven by the end users' needs.

Proposals should address several of the following areas:

  • Establish interdisciplinary research by bridging disciplines and technologies (disease biology, clinical research, data science, -omics tools, computational and mathematical modelling of diseases, advanced statistical and/or AI/machine learning methods, Virtual Physiological Human and/or digital twin technologies).
  • Develop new computational models for the integration of complex health data from multiples sources, including structured and unstructured data.
  • Develop and optimise robust, transparent and accurate computational models to guide patient stratification strategies for improving clinical outcomes.
  • Demonstrate, test and clinically validate such models with respect to their utility to realistically stratify patients with the aim of improving the standard-of-care.
  • The development of new patient stratification strategies guided by computational models and the validation of the new concepts of stratification in pre-clinical and/or clinical studies.

The proposals should adhere to the FAIR data[1] principles, adopt data quality standards, data integration operating procedures and GDPR-compliant data sharing/access good practices developed by the European research infrastructures, wherever relevant. In addition, proposals are encouraged to adopt good practices of international standards used in the development of computational models, and make available the tools and solutions developed early. Proposals aiming to develop computational models of high technology readiness level are encouraged to deliver a plan for the regulatory acceptability of their technologies. Early interaction with the relevant regulatory bodies is recommended (i.e. the EMA qualification advice for new technologies, etc.) for the proposals contributing to the development of new medicinal products, improvement of the effectiveness of marketed products and the development of medical devices. The proposals aiming to validate their models as high-risk medical devices in the relevant clinical environment are encouraged to deliver a certification implementation plan.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate. In addition, the proposals will be encouraged to exchange with other successful proposals developing AI algorithms and in silico models under other relevant topics.

Cross-cutting Priorities: EOSC and FAIR data

[1]FAIR data are data, which meet principles of findability, accessibility, interoperability, and reusability.

Deadline: 01 February 2022 17:00:00 Brussels time

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Personalised blueprint of chronic inflammation in health-to-disease transition

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 1 “Staying healthy in a rapidly changing society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to several of the following expected outcomes:

  • Researchers and medical professionals understand the chronic inflammation factors triggering the health-to-disease transition and subsequently provide optimal counselling to citizens for improving their health.
  • Health care professionals have access to and employ objective health indicators of chronic inflammation for monitoring the health status, establishing personalised prevention measures and improving the health outcomes for citizens.
  • Health care professionals have the scientific evidence and understanding of health-to-disease transition to develop and use improved guidelines for personalised prevention strategies to tackle chronic diseases.
  • Citizens are better informed to actively manage their own health, have the tools to maintain their healthy status, improve their health and reduce their risk for developing chronic diseases.

Scope:

Personalised approaches for disease prevention seek to determine the predisposition to disease and deliver timely and targeted prevention measures. Understanding the risk factors that trigger the health-to-disease transition is essential for delivering personalized prevention measures or reducing the burden of chronic diseases.

A large body of clinical evidence has accumulated over the past decade demonstrating that chronic inflammation is a process implicated in chronic diseases/disorders. Inflammatory response is a physiological process helping the body to heal against harmful entities, but when dysregulated it could lead to unresolved chronic local or systemic inflammation. The later in combination with the person’s genotype, phenotype, medical history, nutritional and well-being status, life-style and/or occupational/environmental/life stressors is likely to be involved in driving the health-to-disease transition, leading to the onset of chronic diseases.

Proposals should be of multidisciplinary nature involving all relevant stakeholders and may cover several different stages in the continuum of the innovation path (from translational research to validation of the findings in human studies etc.), as relevant.

Proposals are expected to develop and implement data-driven, personalised approaches to identify the drivers of chronic inflammation that may determine the transition from health to pre-symptomatic and early stages of chronic diseases/disorders. The topic does not exclude any diseases/disorders. The human studies and human data utilised/generated should be compatible to an age range as representative as possible to the pre-disease phase and onset of the disease to be studied, in order to boost the fast translation of the research results into proof-of-concept studies.

Proposals should develop personalised diagnosis and/or prevention strategies linked to chronic systemic/local inflammation and assess the effects of different types of interventions and/or their combinations i.e. pharmacological, non-pharmacological, nutritional supplements, diet and life-style modifications, as relevant. Sex and gender differences should be investigated, wherever relevant.

The proposals should address several of the following areas:

  • Integrate state-of-the-art knowledge and data from suitable human studies (i.e. medical/clinical, well-being, life-style etc.) to identify actionable factors linking chronic systemic and/or local inflammation to the health-to-disease transition. Take stock of omics (i.e. genomics, metabolomics, nutrigenomics, microbiomics etc.), of dynamic measurements of the health and well-being status, and of data-driven analytical tools in order to identify biomarkers and other health indicators linked to the health-to-disease transition.
  • Understand at the systems-level the human biology and physiology underlying chronic inflammation in connection to the tissues/organ dysregulation, organ cross-talk and homeostasis breakdown triggering the health-to-disease transition, taking into account the person’s genotype, phenotype, medical history, nutritional and well-being status, life-style and/or occupational/environmental/life stressors.
  • Develop and deploy robust sensors, devices and/or mobile apps and other innovative technologies to monitor dynamically the individual’s health status and to identify objective indicators of chronic inflammation correlative to the health-to-disease transition.
  • Implement proof-of-concept human studies to assess the beneficial effect of diverse prevention and/or interventions strategies with the aim to demonstrate improved health outcomes.
  • Test suitable interventions with the aim to demonstrate the reduction and/or reversion of the pre-disease state linked to chronic systemic and/or local inflammation.

Proposals should adopt a patient-centred approach to inform and empower patients, promote a culture of dialogue and openness between health professionals, patients and their families, and unleash the potential for social innovation.

The proposals should adhere to the FAIR[1] data principles and adopt wherever relevant, data standards and data sharing/access good practices developed by existing European health research infrastructures.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

Cross-cutting Priorities: Social Innovation, Socio-economic science and humanities; EOSC and FAIR data

[1]FAIR data are data, which meet principles of findability, accessibility, interoperability, and reusability.

 

Deadline: 21 April 2022 17:00:00 Brussels time

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Prevention of obesity throughout the life course

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several impacts of destination 1 “Staying healthy in a rapidly changing society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • Researchers, developers of medical interventions, and health care professionals have a much better understanding of basic biological pathways (genetic and epigenetic blueprints) conferring susceptibility to and protecting against overweight/obesity, i.e. how genetic, epigenetic, environmental, socio-economic and lifestyle factors interact to drive or prevent the transition from normal weight to overweight/obesity throughout the life course.
  • Health care professionals, national/regional/local public authorities and other relevant actors (e.g. schools, canteens, hospitals, work places, shopping malls, sport centres):
    • Have access to, adopt and implement evidence-based clinical guidelines, best practices, coordinated, pan-European, multidisciplinary preventive strategies, policy recommendations and/or new policies to fight overweight/obesity and their co-morbidities throughout the life course.
    • Have access to and make use of a robust outcomes framework and tool-kit for standardised collection of economic and cost data related to the prevention and treatment of overweight/obesity and its co-morbidities at population level across European regions and countries.
    • Adopt and implement tailor-made prevention campaigns to tackle overweight/obesity, including campaigns for improving integration of health education into academic learning and raising awareness of health care providers and citizens.
  • Citizens have access to and make use of new tools and services to make informed decisions about lifestyle choices that will prevent them from becoming overweight/obese.

Scope:

Obesity is one of the most serious public health challenges of the 21st century. Although health has improved in the EU over the last decades, the prevalence of obesity has tripled in many countries of the EU. It is known that once individuals become overweight or obese, they are at risk of developing related diseases (diabetes, cardiovascular diseases, cancer). Overweight and obesity are largely preventable. In the current pandemic, the issue of overweight/obesity has become even more prominent, highlighting the need for prevention of overweight/obesity.

Increased efforts in research and innovation are critical for developing and testing the impact of tools, initiatives, interventions, strategies, programmes, policies and their implementation to prevent overweight/obesity. The use of best practices, harmonisation guidelines and/or standard operating procedures, developed at various levels (from local to national) in the EU and beyond, will be the foundation for new research.

Cultural diversity, urban/rural dichotomy, socio-economic status, age groups, sex and gender differences should be investigated, where relevant. Strong collaborations across sectors and with other European projects dealing with issues such as agriculture, aquaculture, food, environment, etc. are welcome. Proposals should engage citizens, civil society organisations (e.g. employers/employee organisations, charities), authorities (e.g. municipalities and health authorities) and institutions (schools, canteens, hospitals, work places, shopping malls, sport centres), local producers, etc. in the development of their actions to ensure acceptability and deployment. Proposals should aim to develop scientifically robust and transparent methodologies, building on achievements from previous research activities.

Proposals should address several of the following research bottlenecks:

  • A comprehensive understanding of biological pathways (genetic, epigenetic, molecular, microbiome, and/or neuroimmune) conferring susceptibility to and protecting against uncontrolled “weight gain".
  • Identification of socio-economic and lifestyle factors influencing consumer behaviour and their association to overweight/obesity prevention.
  • Identification of pre-obesity biomarkers (genetic, laboratory, imaging, etc.) and their association to lifestyle and environmental interventions aiming at obesity prevention and tailored to specific target populations.
  • Mapping existing implementation research activities to prevent overweight/obesity, outcome analyses and identification of best practices.
  • Conducting a thorough meta-review of information from available scientific literature and identification of the relationship between the risk for overweight/obesity and the biology of obesity, lifestyle habits, exposures, susceptibility to co-morbidities and/or all of their combinations.
  • Developing recommendations and guidelines for what constitutes an appropriate healthy diet for different age and health groups.
  • Understanding the causal links between overweight/obesity and sedentary behaviour, quality and quantity and types of food/drinks, physical activity, and personality traits.
  • Designing a creative and engaging programme to reach the optimal balance between diets and physical activity for the prevention of overweight/obesity.
  • Analysing obesity stigma, stress and work-life balance, circadian rhythm disruption, mental health (including psychological problems), screen-time dependency, drugs and side effect of drugs, for the prevention of overweight/obesity.
  • Addressing inequality aspects of overweight/obesity at multiple levels, taking into account vulnerable groups, gender and socio-economic factors.
  • Setting up pilots to assess the effectiveness of obesity management strategies, including cost-effectiveness, and analyse the impact of inactions, taking into account co-morbidities and value-based care system.
  • Developing a system for monitoring population indicators relevant to overweight/obesity by extending European Core Health Indicators.

Proposals should adopt a patient-centred approach that empowers patients, promotes a culture of dialogue and openness between health professionals, patients and their families, and unleashes the potential of social innovation.

Proposals could consider the involvement of the European Commission's Joint Research Centre (JRC) whose contribution could consists of providing added-value regarding aspects of healthier school environments, effectiveness of policies influencing food preferences as well as improving the food offer and food environment.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

Cross-cutting Priorities: Social Innovation; Societal Engagement; Socio-economic science and humanities

 

Deadline: 01 February 2022 17:00:00 Brussels time

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New methods for the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

  • Health regulatory bodies and/or Health Technology Assessment (HTA) bodies adopt optimised data-driven methodologies for the effective use of real-world data (including omics data)[1], and/or synthetic data derived from digital twins and advanced computational methods (such as modelling and simulation or approaches based on machine learning/AI), for the assessment of medicinal products and/or digital health innovations.
  • Health regulatory authorities and bodies (e.g. medicines agencies, HTA bodies, notified bodies for medical devices) use optimised guidelines for the development and assessment of medicinal products and/or medical devices including digital health innovations.
  • Health regulatory authorities and bodies across Europe are trained in data-driven decision making using emerging data types.

Scope:

With the emerging use of real-world data (RWD) and synthetic data by the pharmaceutical industry and medical devices industry, regulators and HTA bodies need to perform targeted validation of claims through independent analysis. The principal aim of this topic is to address the data needs of health regulatory bodies and HTA bodies across the EU, as outlined in the recently published “HMA-EMA Joint Big Data Taskforce Phase II report: ‘Evolving Data-Driven Regulation’”[2] and its associated DARWIN (Data Analysis and Real World Interrogation Network) project[3].

To harness the potential of RWD and synthetic data from digital twins and advanced analytical models, and make them actionable for health regulatory decision-making and for health technology assessment, targeted research is needed on the evidentiary value of these data for a number of relevant use cases. In addition, methods need to be developed to increase the usability of such data by different stakeholder groups. Doing so will contribute to the European Health Data Space and maximise the positive impact of DARWIN in driving up the quality of evidence and decisions on the development and use of medicines and digital health innovations.

Access to and analysis of RWD and synthetic data can inform regulatory decision-making throughout the product lifecycle, namely: 1) support product development (e.g. scientific advice, PRIME[4]),); 2) support authorisation of new medicines and digital health innovations; and 3) monitor the performance of medicines and digital health innovations on the market (effectiveness and safety). Eventually, this will put in place methods and processes that will enable continuous learning from pre-authorisation procedures and authorisation applications on the use of RWD and/or synthetic data.

Proposals should address all of the following areas:

  • Develop a set of evidentiary standards to be pre-specified and used in the analysis of real-word evidence and/or synthetic data applied to different types of regulatory advice and/or health technology assessment and decisions on the safety and efficacy/effectiveness of medicines and digital health innovations (e.g. in complement to clinical trial data in an authorisation application, or for extension of indications, post marketing surveillance, amendment of product information or regulatory actions on the marketing authorisation due to safety concerns). This includes validating the use of advanced analytical methods for regulatory decision-making and/or health technology assessment.
  • Address aspects that would enable moving towards a standard data quality framework reproducible across different types of RWD and/or synthetic data sources for regulatory decision-making and/or health technology assessment, with a characterisation of the data collection, management and reporting and an empirical data quality validation. In this regard, it will be important that successful proposals liaise with and closely monitor the work carried out in the context of the European Health Data Space.
  • Enhance the performance and efficiency of large randomised clinical trials and new models of clinical trials by developing standardised processes and methods to access RWD and/or synthetic data (e.g., facilitating the detection of various types of health outcomes during the treatment period of a double-blinded trial by linkage to appropriate electronic health care record databases, etc.), for regulatory decision-making and/or health technology assessment.
  • Define methodological standards for the regulatory acceptability of RWD, and/or synthetic data in the context of clinical trials augmented with RWD, and/or synthetic data, for regulatory decision making and/or health technology assessment.
  • Test the ability of machine learning methods to help identify relevant RWD, and/or synthetic data to match with and to interpret clinical trials, for regulatory decision‑making and/or health technology assessment.
  • Assess and validate how machine learning methods can be systematically harnessed to screen a large amount of data, including unstructured data, in many electronic databases to identify factors affecting efficacy and safety of treatments and/or digital health innovations, for regulatory decision-making and/or health technology assessment. The cross-border interoperability dimension should be taken into account.

Proposals should involve researchers who are specialised in the use of real-world data and/or synthetic data to evaluate medicinal products and/or health care digital innovation products and services. Proposals should involve national competent authorities (national health care product regulatory bodies and/or medical device notified bodies) and could involve citizens and patients’ representatives where relevant. Proposals should include capacity-building efforts to address inequalities of health regulatory processes across Europe. This should comprise education and training activities and sharing of best practices.

In addition to national competent authorities, proposals could consider the involvement of the European Medicines Agency (EMA) for an added value in order to provide an effective interface between the research activities and regulatory aspects and/or to translate the research results into validated test methods and strategies that would be fit for regulatory purpose.

Proposals could also consider the involvement of the European Commission's Joint Research Centre (JRC) to provide added-value regarding health registry data, interoperability, harmonisation and quality and linking with other data.

Cross-cutting Priorities: Socio-economic science and humanities; EOSC and FAIR data

[1]Real world data is an umbrella term for data regarding the effects of health interventions that are not collected in the context of highly-controlled RCTs. Instead, RWD can either be primary research data collected in a manner which reflects how interventions would be used in routine clinical practice or secondary research data derived from routinely collected data (https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-use-real-world-data-pre-authorisation-what-can-it-answer-peter-mol_en.pdf)

[2]https://www.ema.europa.eu/en/documents/other/hma-ema-joint-big-data-taskforce-phase-ii-report-evolving-data-driven-regulation_en.pdf

[3]https://www.ema.europa.eu/en/documents/presentation/presentation-proposal-darwin-eu-data-analytics-real-world-interrogation-network-parlett-ema_en.pdf

[4]https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines

 

Deadline: 21 April 2022 17:00:00 Brussels time

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Trustworthy artificial intelligence (AI) tools to predict the risk of chronic non-communicable diseases and/or their progression

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 1 “Staying healthy in a rapidly changing society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes.

  • Clinicians, medical professionals and citizens have access to and use validated AI tools for disease risk assessment. Hence, citizens are better informed for managing their own health.
  • Health care professionals utilise robust, trustworthy and privacy-preserving AI tools that help them to assess and predict the risk for and/or progression of chronic non-communicable diseases. Hence, citizens benefit from improved health outcomes.
  • Health care professionals develop evidence-based recommendations and guidelines for the implementation of AI-based personalised prevention strategies. Hence, citizens benefit from optimized health care measures superior to the standard-of-care.
  • Health care professionals employ quantitative indicators in order to identify and follow-up on individuals with high risk for the development and/or risk for the progression of chronic non-communicable diseases.

Scope:

It is widely recognised that health systems must put more emphasis on prevention and adopt a person-centred approach. Artificial intelligence (AI) along with the increased availability of health data hold great potential to pave the way for personalised prevention and enable progress towards risk prediction and early detection of chronic non-communicable diseases.

This topic will support multidisciplinary research, build on broad stakeholder engagement and support proposals developing novel robust and trustworthy[1] AI tools to enable timely personalised prevention approaches for chronic non-communicable diseases/disorders. The topic does not exclude any diseases/disorders.

Proposals are expected to develop and test AI tools for assessing and predicting the risk of developing a disease and/or the risk of disease progression once it is diagnosed, taking into account the individuals’ (or groups) genotypes, phenotypes, life-style, occupational/environmental stressors and/or socio-economic and behavioural characteristics, as necessary. Sex and gender aspects should be considered, wherever relevant.

The AI tools may include a broad range of technological solutions on their own and/or in combination with other relevant state-of-the-art technologies (i.e. AI algorithms, mobile apps and sensors, robotics, e-health tools, telemedicine etc.)

Proposals should implement proof-of-concept studies to test and validate the performance of their AI tools in the real-world setting and compare their performance to the established practice.

The applicants should ensure that the AI tools developed are driven by relevant end-users/citizens/health care professionals needs. Therefore, the proposals are expected to introduce concrete measures for the involvement of the end-users throughout the AI development process and not only in the last phases of development. SME(s) participation is encouraged with the aim to strengthen the scientific and technological basis of SME(s) and valorise their innovations for the people’s benefit.

Proposals should address all of the following:

  • Leverage existing high-quality health-relevant data from multiple sources (i.e. cohorts, electronic health records and registries, taking into account the individual’s genotypic/phenotypic, medical, life-style, socio-economic, behavioural data etc.) and/or generation of new high-quality health data necessary for the rigorous development of the AI disease-risk tools.
  • Develop the adequate performance metrics to assess the technical robustness of the developed AI tools for risk assessment of disease and/or disease progression and in particular their accuracy, reliability, reproducibility and generalisability. Proposals should assess the possible inherent bias introduced to the AI tools originating from the data quality used for their development.
  • Develop the criteria to assess the effectiveness of the AI tools for disease risk assessment in terms of improving health outcomes and enabling personalised prevention strategies.
  • Implement proof of concept and/or feasibility studies to validate the AI tools for risk assessment of disease and/or disease progression in a relevant end-users environment and/or real-world setting and assess their performance in comparison to the standard-of-care.

Proposals should adhere to the FAIR[2] data principles and apply good practices for GDPR-compliant personal data protection. Proposals are encouraged to implement international standards and best practices used in the development of AI solutions.

Integration of ethics and health humanities perspectives to ensure an ethical approach to the development of AI solutions. In relation to the use and interpretation of data, special attention should be paid to systematically assess for gender and ethnic bias and/or discrimination when developing and using data-driven AI tools.

To ensure citizens’ trust, wide uptake by user communities and scalability of the solutions across clinical contexts, actions should promote the highest standards of transparency and openness of the AI tool, going well beyond documentation and extending to aspects such as assumptions, architecture, code and underlying data.

Applicants are highly encouraged to deliver a plan for the regulatory acceptability of their technologies and to interact at an early stage with the regulatory bodies, whenever relevant.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

Cross-cutting Priorities: Socio-economic science and humanities; EOSC and FAIR data

 

[1]Ethics Guidelines for Trustworthy AI, published by the European Commission’s High Level Expert Group on Artificial Intelligence, ec.europa.eu/futurium/en/ai-alliance-consultation/guidelines.

[2]FAIR data are data, which meet principles of findability, accessibility, interoperability, and reusability.

 

Deadline: 01 February 2022 17:00:00 Brussels time

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Methods for assessing health-related costs of environmental stressors

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 2 ‘Living and working in a health-promoting environment’. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

  • EU and national public authorities regularly use economic and health modelling in policy impact assessments and policy evaluation, and promote the use of these to other stakeholders;
  • Stakeholders agree on the most relevant population health and quality of life metrics, including DALYs (Disability Adjusted Life Years) or QALYs (Quality Adjusted Life Years)[1], and economic metrics;
  • The stakeholder community follows common guidelines and methodologies for integrative socio-economic assessments and cost-benefit analysis of environmental pollution in Europe.

Scope:

Policy-makers face challenges when devising pollution mitigation measures and having to assess the health costs emerging from life-long exposures to environmental stressors or the benefits from clean environments. Deaths and disabilities resulting from pollution carry a quantifiable economic cost to society, but there are significant uncertainties in the cost estimates methodologies. There is also paucity of data to evaluate the economic benefits of clean environments.

Impact Pathway Analysis[2] and Health Impact Assessment (HIA)[3] are methodologies, which can be useful in linking scientific knowledge with environmental economics for informing policy action in diverse sectors such as transport, energy, chemicals, occupational health etc.

Proposed research activities should mainly aim to improve the calculation of the socio-economic costs (and/or benefits) of health impacts during the life-course associated to environmental stressors, or combinations of these, advance methodological approaches and foster their acceptance as common good practice.

Proposals should consider all of the following activities:

  • Systematic review and exploitation of latest evidence of exposure-response functions and causation resulting from published medical and scientific research accumulated data from the past 10-20 years, including results published based on EU-funded research projects;
  • Identification of data gaps as regards environment and health risk factors and health-related tangible and intangible costs and recommendations on priorities for new data collections;
  • Advancement of methodological rigor and consistency in accounting for morbidity and mortality, disabilities, linking valuation of statistical life and/or life-years with quality adjustments within a unified framework, based on the most recent data available and adapted to the needs and circumstances in Europe;
  • Application of experimental approaches addressing the potential link of quality of life and the burden of disease indicators with more integrative impact indicators (e.g. reflecting subjective well-being, health, work-life balance, education, housing, etc.) and identification of how national contexts can impact on health-related costs of the same environmental and occupational exposure;
  • Enhancement of the understanding of the role of discounting and other methods for weighing present and future costs and benefits;
  • Development of innovative tools, methods and models, and associated guidelines for health impact assessments and related cost-benefit analysis;
  • Consultation of experts and stakeholders on tools, models, methods and assessments developed towards a shared agreement of these;
  • Development of case studies involving public authorities comparing the costs of action and non-action in at least three EU or associated countries;
  • Delivery of FAIR[4] data and a user-friendly access to an open knowledge base including results, methodologies and data appropriate for use in public policies and budget allocations.

Projects could consider the involvement of the European Commission’s Joint Research Centre (JRC) in the field of health impacts of environmental stressors.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

Whenever appropriate, the use of environmental data and products coming from the Copernicus[5] programme, specifically the Copernicus Atmosphere Monitoring Service (CAMS) and the Copernicus Climate Change Service (C3S), is encouraged.

Cross-cutting Priorities: EOSC and FAIR data; Socio-economic science and humanities

[1]While introducing relevant changes, it should be ensured that metrics respect the UN Convention on the Rights of Persons with Disabilities.

[2]http://arirabl.org/untitled/

[3]Health Impact Assessment (HIA) has been defined by WHO European Centre for Health Policy as a combination of procedures or methods by which a policy, programme or project may be judged as to the effects it may have on the health of a population.

[4] FAIR data are data, which meet principles of findability, accessibility, interoperability, and reusability.

[5]https://www.copernicus.eu/en

 

Deadline: 21 April 2022 17:00:00 Brussels time

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Non-communicable diseases risk reduction in adolescence and youth (Global Alliance for Chronic Diseases - GACD)

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • Health care practitioners and providers in low- and middle-income countries (LMICs) and those in high-income countries (HICs) serving vulnerable populations have access to and use specific guidelines to implement prevention interventions able to support adolescents and young people to decrease future risks of developing NCDs.
  • Public health managers and authorities have access to improved insights and evidences on the NCDs related to behaviours and conditions in youth and adolescence. They establish improved health policies to diminish these risks, including to facilitate the deployment of effective public health interventions.
  • Researchers, clinicians and authorities have an improved understanding of the factors that influence the implementation of preventive actions that address risk behaviours in youth and adolescence.
  • Communities and local stakeholders and authorities are fully engaged in implementing and taking up health interventions and thus contribute to deliver better health.

Scope:

The European Commission is a member of the Global Alliance for Chronic Diseases (GACD), an alliance of international funding agencies representing over 80% of the world’s public health research funding and the first collaboration of its kind to specifically address non-communicable diseases (NCDs). The GACD supports implementation science to improve health outcomes. This topic is launched in concertation with the other GACD members funding agencies and aligned with the GACD call 2021.

The topic is focused on implementation research about common risk prevention interventions targeting adolescents and youth to reduce the impact of non-communicable diseases (NCDs) in low- and middle-income countries (LMICs) and vulnerable populations in high-income countries (HICs). Proposals should focus on implementation science around evidence-based interventions that promote healthy behaviours, and that have the potential to profoundly reduce the risk of chronic diseases and multimorbidity.

The GACD Alliance is particularly interested in funding projects that focus on interventions that reduce health risk and/or enhance a healthy lifestyle in young people, which the WHO defines as the period from ages 10-24 and includes adolescence (ages 10-19) and youth (15-24). Adolescence and youth mark a period of emerging independence and an important time for laying the foundations of good health. Adolescence and youth is a period in life where patterns of behaviour are established around diet, physical activity, substance use and sexual activity, which can affect their health in the present; in their future adult lives; and even in the next generation. In the transition from childhood to adulthood, young people become increasingly exposed to harmful products such as tobacco, alcohol and drugs, and can experience devastating mental health issues such as depression, anxiety, self-harm, substance abuse and addictions, as well as eating disorders and suicide. Over 150 million young people smoke; 81% adolescents do not meet physical activity guidelines; 11.7% of adolescents partake in heavy episodic drinking; and suicide has emerged as a leading cause of death in young people globally.

All proposals must make the case for why their selected life stage is a critical period for the reduction of NCD risk in the communities where the research will be undertaken. There are a range of evidence-based interventions, including the WHO Best Buys, which aim to reduce the health risks associated with common NCD risk factors. Implementation research is necessary to understand the uptake, accessibility, acceptability, adaption, sustainability and costs of known interventions for use in young adults and adolescents. Applicants are invited to consider interventions at the individual, family, community (e.g., work or school) or population level. Multi-sectoral approaches and a combination of different types of interventions, including biomedical, digital (such as artificial intelligence and big data), socio-behavioural, and/or structural[1] are encouraged. Projects will be expected to build on evidence-based interventions that focus on prevention interventions and strategies that reduce common risk factors for chronic non-communicable diseases, or that promote healthy behaviours. Such interventions/strategies might include, but are not limited to, those in the following three areas: nutrition, physical activity, and/or sleep; tobacco, substance abuse and/or alcohol use; social wellbeing and loneliness . Proposals should be gender-responsive and consider socioeconomic, racial or other factors that relate to equitable impacts of the intervention or barriers to equitable implementation.

Proposals should include implementation research outcomes (e.g. feasibility, fidelity and/or adaptation, spread and/or penetration, acceptability, sustainability, uptake, and cost effectiveness) and where relevant, include service outcomes (e.g. efficiency, safety, effectiveness, patient-centeredness, timeliness). The aim is to harmonise the research common goals and the outcomes assessment of GACD-funded projects in order to maximise the potential for learning across the network and the impact of the initiative as a whole. To this end, all funded teams are expected to use explicit indicators and measures of project context, reach, outcomes evaluation and scale-up potential in their plans and protocols. In this topic, the use of the following measures is encouraged: evidence of uptake of promoted healthy behaviours; evidence of reduction in harmful behaviours; and proxy mental and/or physical health outcomes, if appropriate (pre- and post- intervention PHQ-9 scores, blood pressure, HbA1C, etc.).

Proposals should include a strategy to include policy makers and local authorities, as well as other relevant stakeholders such as community groups. Such engagement should inform the conception and development of the project and should continue throughout the duration of project and afterwards during the knowledge translation phase. Participants that are local stakeholders can be powerful assets to the projects indeed. Their contributions should be nurtured through meaningful engagement throughout all phases of the project, not only as participants in the research undertaken.

Cross-cutting Priorities: International Cooperation; Socio-economic science and humanities; Societal Engagement

[1]Structural interventions are defined as interventions that attempt to change the social, physical, economic, or political environments in order to improve health behaviours and outcomes, altering the larger social context by which health disparities emerge and persist. They can include policy-driven fiscal or legislative changes focused on social and/or commercial determinants of health.

 

Deadline: 21 April 2022 17:00:00 Brussels time

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New pricing and payment models for cost-effective and affordable health innovations

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

  • Health authorities and insurers adopt new payment models for health technologies, including pharmaceuticals.
  • Health industries anticipate better the marketing conditions for innovative health technologies. Patients and health care providers have faster access to innovative health technologies.
  • Health authorities, insurers and health care providers have affordable innovative health technologies both on short and longer terms.

Scope:

Applicants are requested to propose new value-based pricing and reimbursement models that can help ensure equitable access to effective, efficient, affordable, and sustainable health technologies, including medicines, while supporting innovation and industrial competitiveness. The research should tackle the issue globally and be based on a multidisciplinary approach combining economic science, political science and sociology. The proposals should not be limited to the study of cost-effectiveness analyses and thresholds in decision-making. They should also address long term intended and unintended consequences of pricing and reimbursement decisions. Moreover, they should consider the potential limitation of no-coverage decision for products with high budgetary impact. Applicant consortia should include regulators and public entities that are in charge of attributing value tags to health technologies, negotiating with health technology manufacturers and/or reimbursing medical costs. Differences between public and private sectors could be considered, as appropriate. Proposals should also consider citizens engagement and dialogue, for seeking wider input and support, and could encourage other social innovation approaches.

Applicants should propose activities in all of the following areas:

  • Affordability of health innovations.
  • Variety of pricing/payment schemes in the EU.
  • Cost-effectiveness and budget impact (including life-time indirect medical costs).
  • Impact of payment schemes (e.g. pay-for-performance/multi-annual instalments) on long-term competition in health technology markets, in particular the pharmaceutical market.
  • Potential influence of post-launch evidence-generation plans agreed with regulators and downstream decision makers (HTAs, payers) on the payment models.
  • Transparent and comprehensive assessment of technology and medicine development costs, taking into account public investments and incremental character of some innovations (e.g. new indications).
  • Development, integration and harmonisation of tools that allow for validation and revision of clinical evidence and cost-effectiveness, and long-term financial planning for effective and transparent decision-making.
  • New methods for definition of cost-effectiveness thresholds, integration of greener production and environmental impact, rational applications in real world contexts, comparative analysis of influence in decision-making and influence in the formulation of prices of technologies.
  • Potential equity issues derived by payment models and the measures for their mitigation.

Cross-cutting Priorities: Socio-economic science and humanities; Social Innovation

 

Deadline: 21 April 2022 17:00:00 Brussels time

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Pre-clinical development of the next generation of immunotherapies for diseases or disorders with unmet medical needs

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • The scientific and clinical communities make effective use of the pre-clinical validation of new immunotherapies for high burden diseases or disorders with unmet medical needs.
  • The scientific and clinical communities have access to new knowledge allowing for a better understanding of the mode of action of the next generation of immunotherapies and/or combinatorial treatments, which enables further development and optimisation of treatments.
  • The scientific and clinical communities have access to and use new personalized models (in vitro and in vivo) for high burden diseases or disorders as well as protocols for the next generation of immunotherapies.
  • Health care professionals have access to and use new evidence-based safety and efficacy guidelines for immunotherapies. Proof-of-clinical concept, when applicable, as single or combinatorial treatment, should be compared to existing approaches.

Scope:

Immunotherapy is defined as a treatment able to stimulate or restore the ability of the immune (defence) system to fight infection, disease or disorder. It has proved to be a valuable medical treatment notably when preventive interventions are not available. Passive and active immunotherapies (such as antibody-based, RNA-based and cell-based therapies, respectively) are covered by this topic, which is aiming at the pre-clinical to first-in human development of next generation immunotherapies for unmet needs.

Proposals should build on existing knowledge in the field, when available, in order to save time and to avoid spilling resources, and could build on the knowledge of the interaction between the immune system (innate and adaptive arms) and the microbiota, or take advantage of key enabling technologies such as biotechnology and nanotechnology, advanced manufacturing, imaging, 5G, internet of things, artificial intelligence and existing databases.

The next generation of immunotherapies are needed in order to improve and diversify the capabilities of health care for several communicable and non-communicable diseases[1] that cannot be effectively tackled with the currently available treatments.

Proposals are expected to address some of the following research gaps for the development of the next generation of effective and safe immunotherapies:

  • Preclinical development and study of new immunotherapeutic agents in vitro and in relevant animal model(s) of the disease(s). This includes understanding of the therapy’s agent(s) mode of action, its toxicity, the development of related potency assay(s), and its/their validation in vitro and in vivo. A robust regulatory and Health Technology Assessment (HTA) strategy should be in place at the start of the proposal.
  • Off-the-shelf therapies, including the cell-based therapies, will be considered as assets during the evaluation.
  • Proposals could include proof-of-concept (PoC)/first-in-human studies for testing the new therapies, with a clear regulatory and clinical pathway [2] and should address as appropriate the therapy-related potential for adverse side effects. PoC and clinical studies in humans should take sex, gender, age and socio-economic factors into account, where relevant. Phase II studies or later phase trials will not be supported.
  • Development of a standardised framework for assays and data usage to enable a robust assessment of the safety and efficacy.
  • In case treatments are already available for the proposed targeted disease(s), a justification of the need for development of a new immunotherapy treatment is requested.
  • The proposed action should include a pathway of the necessary steps to ensure sustainable therapeutic agent production (considering intellectual property management if relevant) and uptake by health systems and rapid access to patients.

Projects may consider the use of the nanobiotechnology infrastructure platform of the European Commission’s Joint Research Centre, in particular for the accurate physicochemical characterization of therapeutic proteins and antibodies.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

Projects could consider the use of the Nanobiotechnology infrastructure platform of the European Commission’s Joint Research Centre, in particular for the accurate physicochemical characterization of therapeutic proteins and antibodies.

Cross-cutting Priorities: Socio-economic science and humanities

[1]Excluded from the scope are the preventive vaccines, the immunotherapies for rare diseases and the repurposing of drugs as they are covered by other topics in the HE research programme 2021-2022. Research on cancer immunotherapies is excluded as it will be covered by the Mission on Cancer.

[2]In case proposals are involving clinical studies, please use the document on essential information for clinical studies provided on the portal.

 

Deadline: 01 February 2022 17:00:00 Brussels time

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Development of new effective therapies for rare diseases

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • Researchers and developers make the best use of the state-of-the-art knowledge and resources for a fast and effective development of new therapies for rare diseases.
  • Researchers and developers increase the development success rate of therapies for rare diseases by employing robust preclinical models, methods, technologies, validated biomarkers, reliable patient reported outcomes and/or innovative clinical trials designs.
  • Developers and regulators move faster towards market approval of new therapies for rare diseases (with currently no approved treatment option) due to an increased number of interventions successfully tested in late stages of clinical development.
  • Healthcare professionals and people living with a rare disease get access to new therapeutic interventions and/or orphan medicinal products.

Scope:

Despite the considerable amount of knowledge that has been accumulated and the new orphan medicines developed in recent years, the number of available therapies for rare diseases remains low, as fewer than 6% of rare diseases have an approved treatment option.

The joint evaluation[1]of the regulations on orphan medicinal products and paediatric medicines concluded that those regulations have boosted the development for new therapies for rare diseases but have not yet adequately managed to direct research and innovation in areas of greatest unmet medical need. Actually, there is an urgent unmet medical need for the development of therapies for rare diseases, where there is still no approved therapeutic option available.

Therefore, proposals should aim to develop therapies for rare diseases with no approved therapeutic option. Proposals should focus on group(s) of rare diseases with commonalities, such as shared biological features, possibly within the same and/or across different medical areas within the rare diseases landscape[2]. Thus, proposals should not address a single disease only (for example with an Orphacode representing a single disease).

The therapies to be developed may include a broad family of therapeutic interventions such as small molecule(s), advanced therapy medicinal products, repurposing of existing medicinal products, including non-pharmacological interventions and/or their combinations, as relevant. Sex and gender aspects should be considered, where relevant. To ensure that the needs of people living with a rare disease are adequately addressed, the involvement of patient representatives in all phases of the research and development process is strongly encouraged. Rare infectious diseases and rare cancers are excluded from this topic and will not be considered.

The topic will support proposals covering several different stages in the continuum of the innovation pathway (i.e. translational, preclinical, clinical research, validation in the clinical and/or real-world setting etc.), as relevant. SME(s) participation is encouraged with the aim to strengthen the scientific and technological basis of SME(s) and valorise their innovations for the benefit of people living with a rare disease.

The proposals should address most of the following research activities:

  • Establish multidisciplinary collaborations between all relevant stakeholders by integrating disciplines, technological developments and existing knowledge. Integrate harmonised data from multiple sources (i.e. natural history studies/clinical trials, multi-omics, medical imaging, registries etc.) by utilising data analytics and/or other suitable methods, with the aim to understand the pathophysiology/heterogeneity of the rare diseases concerned and to identify therapeutically actionable mechanisms.
  • Develop and utilise relevant preclinical models and/or innovative tools/technologies to: verify molecular/cellular pathways/genes that can be therapeutically targeted, increase the confidence in the targets selection and/or perform toxicity studies. When using disease models the applicants should describe how well the model replicates the pathology or the human condition.
  • Develop and/or execute innovative clinical trials designs for small populations and novel approaches to assess and monitor the safety and efficacy of the proposed interventions. Such approaches may include but are not limited to: biomarkers defining robust surrogate and clinical endpoints; artificial intelligence tools/medical devices/biosensors/ companion/ complementary diagnostics for defining reliable patient reported outcomes; modelling and simulation and in-silico trials methodologies.
  • Carry out preclinical proof-of-concept (PoC) studies and/or multinational interventional clinical studies[3] to demonstrate the safety and efficacy of the therapeutic interventions under study. Preclinical PoC studies should include late-stage preclinical studies (i.e. toxicological properties, adverse effects etc.). Clinical studies may cover all necessary development stages. Applicants should propose a clear exploitation pathway through the different necessary steps (research, manufacturing, regulatory approvals and licensing, IP management etc.) in order to accelerate marketing authorisation and uptake by the health systems.

Proposals should involve group(s) of rare diseases (i.e. a rare disease being individually defined in the European Union as affecting not more than five in 10.000 persons). Proposals that plan to run clinical trials should demonstrate that they have already taken into account scientific advice[4] or protocol assistance from EMA. In particular, proposals planning the clinical development of orphan medicinal products should demonstrate that they have been granted approval for an orphan designation at the latest on the date of the call deadline.

Proposals should adhere to the FAIR[5] data principles and take stock, wherever relevant, of data standards, harmonisation guidelines and good practices for data sharing/access developed by existing European health research infrastructures (i.e. ESFRI infrastructures[6]). Proposals should take stock, where relevant, of the FAIR guidance, of good practices for analytical methods and preclinical models and of good exploitation strategies for the translation of research results into high impact interventions, developed by the European Joint Programme on Rare Diseases[7] (EJP RD) and other relevant EU-funded projects. Whenever the proposed data sources or fields of application include genomics, the proposals should take into account, where relevant, the data standards, and legal, ethical and technical interoperability requirements and guidelines agreed within the 1+ Million Genomes initiative[8]. Data-intensive proposals, particularly those using data from patient registries, could consider the involvement of the European Commission's Joint Research Centre (JRC) and take stock of the tools and services provided by the European Platform on Rare Disease Registration (EU RD Platform), including the adoption, where relevant, of the European standards such as the "set of common data elements”[9]. In addition, synergies should be sought with the European Reference Networks[10], where relevant.

Projects funded under this topic will contribute towards the goals of the International Rare Diseases Research Consortium (IRDiRC) that supports the development of 1000 new therapies for rare diseases by 2027 and may take stock of the IRDiRC Orphan Drug Development Guidebook[11], where relevant.

Cross-cutting Priorities: Socio-economic science and humanities; International Cooperation; EOSC and FAIR data

[1]https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/orphan-regulation_eval_swd_2020-163_part-3.pdf

[2]Medical areas such as: neurology, immunology, dermatology, endocrinology-metabolism etc. - see EMA therapeutic areas: www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines

[3]Template for providing essential information in proposals involving clinical studies ec.europa.eu/research/participants/data/ref/h2020/other/legal/templ/h2020_tmpl-clinical-studies_2018-2020_en.pdf

[4]https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance

[5]FAIR data are data, which meet principles of findability, accessibility, interoperability, and reusability.

[6]2018 Roadmap of the European Strategy Forum on Research Infrastructures (ESFRI) with list of ESFRI research infrastructures (pp 15-17), ec.europa.eu/info/sites/info/files/research_and_innovation/esfri-roadmap-2018.pdf.

[7]https://www.ejprarediseases.org/

[8]https://digital-strategy.ec.europa.eu/en/policies/1-million-genomes

[9]https://eu-rd-platform.jrc.ec.europa.eu/set-of-common-data-elements_en

[10]https://ec.europa.eu/health/ern_en

[11]https://irdirc.org/orphan-drug-development-guidebook-materials/

 

Deadline: 01 February 2022 17:00:00 Brussels time

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Integrated surveillance system to prevent and reduce diet-related non communicable diseases (NCDs)

Expected Outcome:

In line with the European Green Deal priorities and the farm to fork strategy for a fair, healthy and environmentally friendly food system, as well as with the EU’s climate ambition for 2030 and 2050, the successful proposal will support R&I aiming to reduce diet-related non-communicable diseases (NCDs). It will contribute to the transformation of food systems to deliver co-benefits for climate (mitigation and adaptation), environmental sustainability and circularity, dietary shifts, sustainable healthy nutrition and safe food, food poverty reduction and empowerment of communities, and thriving businesses.

Project results are expected to contribute to all of the following outcomes:

  • Improving public health by introducing improved NCDs biomarkers.
  • Better understanding of human (male and female) physiology, metabolic regulation and the links between all aspects of nutrition and health, microbiome and disease development.
  • Robust and reliable knowledge base on variations in human health in response to nutrition and other relevant factors. Translation of this knowledge into innovative and effective food and nutrition solutions to improve people’s health and wellbeing in ways that are adapted to women and to men, while simultaneously taking into account other dimensions of sustainability such as climate and the environment.
  • Comprehensive evidence base on links between nutrition/health and disease by conducting hypothesis-driven studies and adopting more integrated research approaches.
  • Improved public awareness and a healthier diet which will reduce NCDs in particular in vulnerable population groups across Europe, addressing health inequalities.

Scope:

Unsustainable and unhealthy diets, with an increased demand for livestock products and calorie-dense and nutrient-poor foods that are often highly processed (high in calories, sugars, sodium/salt, saturated fat and alcohol, and low in wholegrains, fruits and vegetables, legumes, nuts and seeds), are the leading NCD risk factor and a driver of high obesity rates. In Europe, at present, more than half of the adult population is overweight or obese, and children and population groups of lower socio-economic status are the most severely affected. NCDs such as cardiovascular diseases, cancers, chronic respiratory diseases and diabetes are responsible for the deaths of 41 million people each year, equivalent to 71% of all deaths globally[1]. NCDs have a negative impact on both lives and health budgets but are largely preventable through effective interventions that tackle shared risk factors (such as unhealthy diets, physical inactivity, tobacco use and alcohol abuse).

The complexity of the interactions between diet and human health requires multi-level engagement and inter- and transdisciplinary approaches to improve public health and reduce Europe’s major health and economic burden. The development of new societally acceptable approaches/strategies/tools for healthy and sustainable diets that reduce diet-related NCDs requires a systemic approach involving a wide diversity of actors and sectors at different levels (from local to international). These include policy makers and public authorities, health care providers, schools and higher education establishments, food producers and processors, retailers, hospitality and food services (e.g. restaurants, canteens), researchers, non-governmental consumer and patient organisations, science brokers and private individuals.

Proposals should consider a range of diet-related NCDs, geographic, socio-economic, behavioural and cultural factors. The gender dimension of the research is particularly important for this topic. Data collected and integrated by the private and public sectors should be broken down by gender and by socio-economic groups.

Where relevant, activities should build and expand on the results of past and ongoing research projects. Selected projects under this topic (and under the HORIZON-HLTH-2022-STAYHLTH-01-05-two-stage topic: Prevention of obesity throughout the life course) are strongly encouraged to participate in joint activities as appropriate, possibly in the form of project clustering, workshops, etc. Proposals are expected to show support for common coordination and dissemination activities. Applicants should plan the necessary budget to cover such activities.

Proposals are expected to address the following:

  • Mapping and monitoring of the diet-related NCD situation (e.g. cardiovascular and heart diseases, obesity, diabetes, cancer and allergies) at the EU level, based on a literature review to better understand the relationship between lifestyle (including diet, nutrition and alcohol, physical activity), physiological and genetic parameters including the human microbiome, gender and sex, geographical placement (national/regional/neighbourhood and rural/urban zone), socio-economic, cultural and environmental (with particular reference to the human exposome) factors, biological parameters (including genomics and microbiomes), and the risk of NCDs.
  • Development of standardised methods for collecting (missing) data, using existing data/studies/cohorts and increasing the use of big data and artificial intelligence to elucidate the complex interactions between diet and human health.
  • Development of advanced and easy-to-use biomarkers of risk/response for NCDs, including non-invasive and microbiome-based ones.
  • Assessment and monitoring of the impact of existing measures/interventions/policies in the EU on reducing NCDs.
  • Investigating and generating a strong evidence base for the key physiological processes involved in the development of NCDs and how they may be affected by nutrition (from specific nutrient, dietary components to foods and dietary patterns) and other factors (e.g. geographical, biological, socio-economic, cultural, environmental, educational), taking into account individual genotype-phenotype status.
  • Development of a strong evidence base on the risks of unhealthy diet and unhealthy food (high in calories, sugars, sodium/salt, saturated fat and alcohol, low in wholegrains, fruits and vegetables, legumes, nuts and seeds, and often highly processed) within the development of NCDs versus healthy food/products.
  • Identifying high risk/vulnerable populations across Europe, better understanding their predisposition to diet-related diseases, and designing specific hypothesis-driven research and well-controlled intervention studies with very strict conditions to reduce dietary and health inequalities in different countries, regions, rural and urban areas.
  • Developing more targeted recommendations for effective and cost-efficient integrated policies (such as social, fiscal, regulatory, marketing) in the short-, medium- and long term. These are to support Member States and associated countries and policy makers in designing effective and cost-efficient policies that focus on prevention and promote healthy diets to reduce diet-related NCDs, taking into account environmental, gender, social and economic sustainability aspects.
  • Undertaking risk/benefit cost analyses for the different options proposed to better predict and understand effective and long-term impacts and facilitate informed policy decisions and societal debate.

The required multi-actor approach (see the eligibility conditions) must be implemented by involving a wide diversity of food system actors and conducting inter- and trans-disciplinary research.

This topic should involve the effective contribution of SSH disciplines.

Cross-cutting Priorities: Social Innovation; Socio-economic science and humanities

[1]IPES FOOD 2019. Towards a Common Food Policy for the European Union: The policy reform and realignment that is required to build sustainable food systems in Europe. International Panel of Experts on Sustainable Food systems; ECIPE.Europe’s Obesity Challenge.2016

 

Deadline: 15 February 2022 17:00:00 Brussels time

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Weitere Förderungen / Other funding bodies

DFG: Novel Production Processes through Cross-Scale Analysis, Modeling and Design of Cell-Cell and Cell-Bioreactor Interactions

The German Research Foundation has approved the extension of the Priority Programme “Novel Production Processes through Cross-Scale Analysis, Modeling and Design of Cell-Cell and Cell-Bioreactor Interactions”. This call invites project proposals for the second three-year funding period.

The Priority Programme sets a defined research objective on cell-cell and cell-bioreactor interactions in biotechnological production processes for the production of raw materials, fine chemicals, aroma substances, technical or therapeutic proteins as well as pharmaceutically active components such as antibiotics or precursors of drug synthesis.

The research should focus on at least one of the following questions:

  • quantitative characterisation and use of synthetic mixed cultures for production processes
  • process engineering and metabolic engineering strategies and their use for the construction of synthetic mixed cultures
  • strain construction for mixed cultures and their use in reaction-engineered defined bioprocesses
  • development and application of processes and apparatuses for fermentation technology for mixed cultures
  • development and application of modeling and regulation concepts for mixed cultures
  • development and application of quantitative methods and models for the identification of possible performance losses during scale-up
  • development and application of scale-up strategies to avoid performance losses at production scale
  • development and use of particularly robust host systems for scale-up

Deadline: Applications must be submitted to the DFG by 1 Februrar 2022

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DFG: Deutsch-afrikanische Kooperationsprojekte in der Infektiologie/ German-African Cooperation Projects in Infectiology

Die Deutsche Forschungsgemeinschaft fordert zur Einreichung von Antragsskizzen für gemeinsame Forschungsvorhaben mit Wissenschaftlerinnen und Wissenschaftlern in Afrika auf. 

Gegenstand der Ausschreibung ist:

  • Erforschung von tropischen Infektionskrankheiten bei Mensch und Tier
  • Etablierung oder Vertiefung gleichgewichtiger Partnerschaften zu gegenseitigem Nutzen, um afrikanischen Wissenschaftlerinnen und Wissenschaftlern Forschung in den vor Ort wichtigen Themen zu ermöglichen und langfristig der deutschen Wissenschaft in Afrika Forschungsmöglichkeiten zu erschließen
  • Nachhaltige Förderung und Unterstützung akademischer und beruflicher Karrieren von jungen afrikanischen Wissenschaftlerinnen und Wissenschaftlern
  • Stärkung der innerafrikanischen wissenschaftlichen Vernetzung

Anträge müssen grundsätzlich von in das deutsche Wissenschaftssystem integrierten Forscherinnen und Forschern gestellt werden, denen auch die Projektverantwortung zukommt. 

Frist: Projektskizzen sind bis zum 27. Oktober 2021 einzureichen

Zur Ausschreibung

The Deutsche Forschungsgemeinschaft calls for draft proposals of joint research projects between scientists in Germany and Africa.

The scope of the call includes:

  • Investigation of neglected tropical infectious diseases in humans and animals
  • The establishment or consolidation of mutually beneficial equal partnerships that allow African researchers to investigate topics of local significance and that open up research opportunities in Africa for German scientists in the long term
  • Support and funding for the academic and professional careers of young African researchers 
  • To strengthen research networks within Africa

The principal investigator submitting the proposal must be integrated into the German research system and is in charge of the project. 

Deadline: Proposals must be submitted by 27 October 2021

More Information

Dauerhaft laufende Ausschreibungen / Ongoing calls

DIVI: Forschungsförderung im Bereich der intensiv- und notfallmedizinischen Gesundheitsfachberufe

Die DIVI Stiftung vergibt eine Forschungsförderung in Höhe von 5.000 Euro im Bereich der Gesundheitsfachberufe. Darunter fallen insbesondere Berufe im Gesundheitswesen, der Gesundheitsförderung, der medizinischen Therapie und Diagnostik sowie der Rehabilitation. Der Preis wird in Form einer einmaligen finanziellen Zuwendung zur Unterstützung von klinischen und wissenschaftlichen Projekten in der Intensivmedizin und Notfallmedizin vergeben.

Die finanzielle Zuwendung des Stipendiums dient als Beitrag für Sachmittel und/oder Aufwendungen zur Implementierung und Realisation von wissenschaftlichen Aktivitäten in den Gesundheitsfachberufen.

Der/die Bewerber/-in sollte Mitglied der DIVI oder einer medizinisch-wissenschaftlichen Gesellschaft sein, die Intensivmedizin und/oder Notfallmedizin als einen der fachlichen Schwerpunkte ausweist bzw. Mitglied der DIVI ist.

Frist: Bewerbungen sind bis zum 31. Juli 2021 einzusenden

Zur Ausschreibung

Wilhelm Sander-Stiftung: Krebsforschung

Seit ihrer Gründung vor über 40 Jahren hat die Wilhelm Sander-Stiftung über 2.200 Forschungsprojekte gefördert und ein Fördervolumen von über 236 Mio. ausgeschüttet (Stand 31.12.2018). Unterstützt werden von der Wilhelm Sander-Stiftung hauptsächlich Forschungsprojekte mit dem Schwerpunkt Krebsforschung (klinisch und klinisch-experimentell). Die Förderung ist beschränkt auf Deutschland und die Schweiz.

Bitte reichen Sie vor der ausführlichen Antragstellung eine kurze Voranfrage bei der Wilhelm Sander-Stiftung ein, um sicher zu stellen, dass das geplante Forschungsprojekt für das aktuelle Förderspektrum der Stiftung geeignet ist.

Frist: Jederzeit

Zur Ausschreibung

BMBF: Alternativmethoden zum Tierversuch

Das Bundesministerium für Bildung und Forschung (BMBF) beabsichtigt, die im internationalen Vergleich führende Position Deutschlands im Bereich der Alternativmethoden zum Tierversuch zu sichern und weiter zu stärken. Unter Alternativmethoden zum Tierversuch gemäß dem 3R-Konzept nach Russel und Burch (1959) sind Testverfahren zu verstehen, die entweder Tierversuche vollständig ersetzen (Replacement) oder – falls dieses nicht möglich ist – zumindest eine Reduzierung der Anzahl der verwendeten Tiere (Reduction) bzw. eine Minderung des Belastungsgrades der Tiere (Refinement) erlauben. In Modul I werden FuE-Vorhaben sowie Vorhaben zur Validierung von Methoden gefördert, die im regulatorischen Bereich, in der anwendungsorientierten sowie in der Grundlagenforschung wesentliche Beiträge im Sinne des 3R-Konzeptes leisten können. Förderwürdig sind Vorhaben, die den Ersatz von Tierversuchen, eine Reduktion von Versuchstierzahlen oder eine Minderung des Belastungsgrades bezüglich Schmerzen, Leiden oder Schäden bei Versuchstieren erwarten lassen. Dies gilt auch für den Bereich der Aus-, Fort- oder Weiterbildung sowie für die Herstellung, Gewinnung, Aufbewahrung oder Vermehrung von Stoffen, Produkten oder Organismen, wenn dabei Tierversuche zur Anwendung kommen. In Modul II werden Vorhaben gefördert, die der Verbreitung von Alternativmethoden dienen. Hierzu zählen insbesondere Schulungen, Trainings- und Fortbildungskurse sowie Strategien zur Implementierung entwickelter Methoden. Darüber hinaus sind ergänzende Begleitstudien, Workshops und gegebenenfalls andere Maßnahmen im Sinne des 3R-Konzepts grundsätzlich förderfähig, sofern sie einen Beitrag zur Verbreitung von Alternativmethoden leisten können, der Bewertung bestehender 3R-Potenziale oder der Ausarbeitung von Handlungsempfehlungen für eine Weiterentwicklung des Förderschwerpunktes dienen. In beiden Modulen ist eine Begleitung des Vorhabens durch erfahrene Mentoren förderfähig.
Die Zuwendungen können im Wege der Projektförderung als nicht rückzahlbare Zuschüsse gewährt werden. Das Förderverfahren ist zweistufig angelegt.

Frist: 15. März eines jeden Jahres

Zur Ausschreibung

Änderung der Richtlinie zur Förderung von „Alternativmethoden zum Tierversuch“ vom 02.03.2021

BMBF: KMU-innovativ: Mensch-Technik-Interaktion

Mit dieser Fördermaßnahme verfolgt das Bundesministerium für Bildung und Forschung das Ziel, das Innovationspotenzial kleiner und mittlerer Unternehmen (KMU) im Bereich Spitzenforschung zu stärken. Gegenstand der Förderung sind risikoreiche industrielle Forschungs- und vorwettbewerbliche Entwicklungsvorhaben, die technologieübergreifend und anwendungsbezogen sind. Diese FuE-Vorhaben müssen dem Bereich Mensch-Technik-Interaktion zuzuordnen sein. Wesentliches Ziel der BMBF-Förderung ist die Stärkung der Marktposition der beteiligten KMU. Gefördert werden Forschungs- und Entwicklungsvorhaben aus einem breiten Themenspektrum, die ihren Schwerpunkt an den drei Themenfeldern im MTI-Forschungsprogramm orientieren:

  • Intelligente Mobilität (Fahrerassistenzsysteme, Intentions­erkennung und Nutzererleben)
  • Digitale Gesellschaft (Robotik, Wohnen/Wohnumfeld, vernetzte Gegenstände)
  • Gesundes Leben (körpernahe Medizintechnik, Implantate, Prothesen/Orthesen und Pflegetechnologien)

Einzel- oder Verbundvorhaben ohne Beteiligung von KMU sind von der Förderung ausgeschlossen. Das Förderverfahren ist zweistufig angelegt.

Frist: 15. Oktober und 15. April eines jeden Jahres

Zur Ausschreibung

BMBF: KMU-innovativ: Medizintechnik

Das BMBF will mit dem Fachprogramm Medizintechnik die medizintechnische Forschung und Entwicklung stärken und zugleich die Leistungsfähigkeit des Gesundheitssystems sowie die internationale Wettbewerbsfähigkeit der Branche am Standort Deutschland ausbauen. Das Fachprogramm Medizintechnik zielt darauf ab, innovative Ansätze aus der Forschung schneller in die Anwendung zu überführen und setzt im Kern auf eine versorgungs- und zugleich industrieorientierte Innovationsförderung der Medizintechnik-Branche.  Antragsberechtigt sind KMU, im Rahmen von Verbundprojekten sind auch Hochschulen, außeruniversitäre Forschungseinrichtungen und mittelständische Unternehmen, die einschließlich verbundener oder Partnerunternehmen nicht mehr als 500 Beschäftigte haben, im Folgenden größere Mittelständler genannt, antragsberechtigt.
Die Förderdauer beträgt bis zu drei Jahren. Das Förderverfahren ist zweistufig angelegt.

Frist: 15. Oktober und 15. April eines jeden Jahres

Zur Ausschreibung

BMBF: Stärkung des Transfererfolgs in den Lebenswissenschaften „GO-Bio initial“

GO-Bio initial ist ein Baustein zur Umsetzung der Hightech-Strategie 2025 der Bundesregierung, die eine deutliche Stärkung des Ideen-, Wissens- und Technologietransfers vorsieht. Ziel von GO-Bio initial ist die Identifizierung und Entwicklung lebenswissenschaftlicher Forschungsansätze mit erkennbarem Innovationspotenzial. Dazu sollen die Arbeiten, die in der sehr frühen Phase des Innovationsgeschehens – dem sogenannten „Fuzzy Front End of Innovation“ (FFE) – stattfinden, mit einer Förderung unterstützt werden. Das FFE umfasst die Ideen- und Findungsphase, die mit der initialen Problemdefinition und der Entscheidung, ein Innovationsvorhaben anzustoßen, endet. Im Ergebnis der geförderten Projekte soll der weitere Verwertungsweg für eine gegebene Idee klar vorgezeichnet sein. Über den Abschluss der Ideen- und Findungsphase hinaus soll ein Reifegrad der Forschungsresultate erzielt werden, der eine Weiterführung der Projekte in anderen etablierten Förderprogrammen der Validierungs-, Gründungs- und Firmenkooperationsförderung, wie z. B. VIP+, EXIST-Forschungstransfer, KMU-innovativ oder GO-Bio, ermöglicht. Als übergeordnetes Ziel wird somit der lückenlose Transfer vielversprechender früher Ideen in die Anwendung verfolgt.

Gegenstand der Förderung ist die Identifizierung und Weiterentwicklung lebenswissenschaftlicher Verwertungsideen, vorzugsweise aus den Bereichen „Therapeutika“, „Diagnostika“, „Plattformtechnologien“ und „Forschungswerk­zeuge“, von ihrer konzeptionellen Ausgestaltung bis hin zur Überprüfung der Machbarkeit („Proof-of-Principle“, abgekürzt „PoP“) und möglicher Verwertungsoptionen.

Antragsberechtigt sind Hochschulen und außeruniversitäre Forschungseinrichtungen. Die Zuwendungen werden im Wege der Projektförderung als nicht rückzahlbare Zuschüsse gewährt. Das Antragsverfahren für die Sondierungsphase ist zweistufig angelegt. Das Antragsverfahren für die Machbarkeitsphase ist einstufig angelegt.

Frist: Die förmlichen Förderanträge sind dem Projektträger jeweils bis spätestens 15. Februar eines jeden Jahres vorzulegen

Zur Ausschreibung

EKFS: Schlüsselprojekte / Key Projects

Mit dieser Fördermaßnahme fördert die Stiftung Projekte, die das Potenzial aufweisen, grundlegende für ein ganzes Forschungsfeld richtungweisende Entdeckungen zu zeitigen. Dies kann z. B. sein:

  • der Nachweis eines bisher fehlenden Kausalzusammenhangs,
  • das Testen einer bisher nicht da gewesenen oder nicht bearbeitbaren Hypothese,
  • das Infrage-Stellen einer bisher allgemein akzeptierten Theorie, ein „proof of principle“ oder eine “first in man” Untersuchung eines innovativen Interventionsansatzes,
  • oder auch eine klinische Studie, die das Potential hat, Leitlinien entscheidend zu verändern (ausgenommen pharmazeutische Phase III-Studien).

Anträge können von Wissenschaftlerinnen und Wissenschaftlern gestellt werden, die in ihrem Forschungsgebiet international ausgewiesen sind und auf einschlägigen Gebieten herausragend veröffentlicht haben. Sowohl Personal- als auch Sachmittel können beantragt werden, die für die Umsetzung des geplanten Projekts notwendig und wissenschaftlich wohl begründet sind. Die Mittelvergabe erfolgt in einem zweistufigen Verfahren.

Frist: Die Anträge können jederzeit gestellt werden.

Zur Ausschreibung

The Foundation’s aim with this funding measure is to find projects that have the potential to lead to fundamental discoveries that are groundbreaking for an entire field of research. This could be, for example:

  • evidence of a causal connection that was previously lacking,
  • testing of a previously non-existent or unworkable hypothesis,
  • questioning of a previously generally accepted theory, a “proof of principle” or a “first-in-man” examination of an innovative intervention approach,
  • or even a clinical trial that has the potential to significantly transform guidelines (with the exception of phase III pharmaceutical trials).

Applications can be made by scientists who have gained international recognition in their area of research and who have had outstanding publications in relevant fields. Both human and material resources may be applied for as necessary and scientifically justified for implementation of the planned project. The funds shall be allocated in a two-stage procedure.

Deadline: Applications can be submitted at any time

More information

DSHF: Klinische Forschung und Grundlagenforschung zu Herz-Kreislauferkrankungen

Die Deutsche Stiftung für Herzforschung (DSHF) fördert klinische Forschung und Grundlagenforschung zu Herz-Kreislauferkrankungen. Zu unserer Freude stellen wir fest, dass sich die Deutsche Stiftung für Herzforschung immer mehr im Bewusstsein der Öffentlichkeit etabliert. Die bislang publizierten Forschungsergebnisse sind vielfach exzellent und in Fachkreisen hoch gelobt. In der Regel finanziert die Stiftung Projekte in der Größenordnung von 70.000 EUR und einer Laufzeit von bis zu zwei Jahren. Gerade vielen jüngeren Forschern wird so eine Zukunftsperspektive geboten, indem hier die nötige Anschubfinanzierung gegeben und ihnen so der oft schwierigen Weg in die Wissenschaft geebnet wird. Die Stiftung legt ausdrücklich Wert darauf, gerade auch patientennahe Forschung zu fördern. Sie unterstützt Projekte, von denen erwartet wird, dass die Ergebnisse in Zukunft einer breiten Öffentlichkeit zugute kommen werden.

Finanziert werden:

  • Forschungsaufträge im Bereich Grundlagenforschung
    (Gebiete: Vorbeugung, Diagnostik, Therapie, Nachbehandlung)
  • Klinische Studien
  • Wissenschaftliche Personalstellen oder Hilfskräfte für einen bestimmten Zeitraum

Die Deutsche Stiftung für Herzforschung erwartet von den geförderten Forscherinnen und Forschern eine gewisse Mitarbeit dabei, die Ergebnisse der Öffentlichkeit zugänglich zu machen – in einer für Laien verständlichen Form sowie für die interessierte Fachwelt.

Frist: Jederzeit

Zur Ausschreibung

Deutsche Herzstiftung: Projektförderung

Die Deutsche Herzstiftung finanziert Projekte in der Größenordnung von 40.000 Euro bis 70.000 Euro. Bewerben können sich Ärztinnen und Ärzte bis zum Alter von 40 Jahren, die in Deutschland ein patientennahes Forschungsprojekt auf dem Gebiet der grundlagenbezogenen und klinischen Forschung im Bereich der Vorbeugung, der Diagnostik, der Therapie und der Nachbehandlung von Herz- und Kreislauf-Erkrankungen durchführen. Die Projektdauer sollte 2 Jahre nicht überschreiten. Das Forschungsvorhaben darf nicht der Zusatz- oder Zwischenfinanzierung der Stelle des/der Antragstellers/Antragstellerin dienen.

  • Forschungsaufträge im Bereich Grundlagenforschung (Gebiete: Vorbeugung, Diagnostik, Therapie, Nachbehandlung)
  • Klinische Studien
  • Wissenschaftliche Personalstellen oder Hilfskräfte für einen bestimmten Zeitraum

Frist: Jederzeit

Zur Ausschreibung

DIVI Stiftung: Förderstipendium

Die DIVI Stiftung vergibt ein Förderstipendium in einer Höhe von bis zu 10.000 Euro in Form einer einmaligen finanziellen Zuwendung zur Unterstützung von klinischen und wissenschaftlichen Projekten in der Intensivmedizin und Notfallmedizin. Die finanzielle Zuwendung des Stipendiums dient als Beitrag für Sachmittel und/oder Aufwendungen zur Implementierung und Realisation von wissenschaftlichen Aktivitäten für Nachwuchswissenschaftler (Alter unter 40 Jahren).

Der/die Bewerber/-in sollte Mitglied der DIVI oder einer medizinisch-wissenschaftlichen Gesellschaft sein, die Intensivmedizin und Notfallmedizin als einen der fachlichen Schwerpunkte ausweist bzw. Mitglied der DIVI ist.

Im Hinblick auf die Förderung und Weiterentwicklung der klinischen und medizin-technischen Forschung in der Intensivmedizin und Notfallmedizin unterstützt die DIVI Stiftung insbesondere folgende Themen:

  • angewandte Grundlagenforschung
  • Evaluation pathophysiologischer Grundlagen und prognostischer Kenngrößen
  • Verbesserung technologischer Prinzipien und Verfahren
  • Entwicklung neuer Therapiestrategien
  • Förderung von Kommunikationstechniken im Bereich der Notfallmedizin und des Rettungswesens

Über die Stipendienvergabe entscheidet ein Komitee der DIVI Stiftung.

Frist: Der Einsendeschluss für die Bewerbung ist immer der 30. September des jeweiligen Kongressjahres

Zur Ausschreibung

DFG: Klinische Studien

Das Programm Klinische Studien umfasst die themenunabhängige und zeitlich begrenzte Durchführung eines Vorhabens in der patientennahen klinischen Forschung. Gefördert werden interventionelle klinische Studien, zu denen Klinische Machbarkeitsstudien (Phase II) und Klinische Interventionsstudien (Phase III) zählen. Ziel dieser Förderung ist das Erbringen eines Wirksamkeitsnachweises eines therapeutischen, diagnostischen oder prognostischen Verfahrens. Für alle Studien ist eine hohe wissenschaftliche Qualität und Originalität sowie klinische Relevanz erforderlich. Ebenfalls gefördert werden Klinische Beobachtungsstudien, sofern mit der Beobachtungsstudie eine hoch relevante Fragestellung behandelt wird, deren Beantwortung nachweislich nicht mit einem interventionellen Design möglich ist. Gefördert werden: Personal, wissenschaftliche Geräte, Verbrauchsmaterial, Reisen und sonstige Kosten. Die Förderdauer von Klinischen Machbarkeitsstudien beträgt maximal 36 Monate, Fortsetzungsanträge sind nicht vorgesehen. Es gilt ein einstufiges Antragsverfahren. Die Förderdauer von Klinischen Interventionsstudien und Klinischen Beobachtungsstudien liegt zunächst bei maximal 36 Monaten. Für länger angelegte Studien kann im Anschluss ein Fortsetzungsantrag gestellt werden. Es gilt ein zweistufiges Antragsverfahren.

Frist: keine, Antragseinreichung jederzeit möglich

Zur Ausschreibung

Preise / Prizes

Deutsche Herzstiftung: Wilhelm P. Winterstein-Preis

Der Förderpreis der Deutschen Herzstiftung ist nach seinem Stifter, Wilhelm P. Winterstein, benannt. Es gibt nichts Gutes, außer man tut es, begründete Wilhelm P. Winterstein seinen Entschluss, gemeinsam mit seiner Frau Ursula den jährlichen Förderpreis der Herzstiftung zu spenden. Er ist mit 10.000 Euro dotiert.

Prämiert werden Forschungsarbeiten auf dem Gebiet der Herz-Kreislauf-Erkrankungen, bevorzugt aus einem patientennahen Forschungsbereich.

Frist: Jährlich im März

Zur Ausschreibung


Kontakt

Maria Moynihan, stv. Leitung ZFF
Wollweberstraße 1
17489 Greifswald
Telefon +49 3834 420 1176
Telefax +49 3834 420 1189
maria.moynihanuni-greifswaldde