Description :

Call for Proposals for Multinational and Translational Research Projects on Bidirectional Brain-Body Interactions

Maintenance, improvement, and restoration of human brain health are of fundamental importance and a worldwide priority. It has become increasingly evident that bidirectional communication between the central nervous system and the body has significant implications for maintaining both homeostatic and brain function. Abnormalities in brain–body interaction linked to genetic, environmental or lifestyle factors encompass a wide range of conditions affecting millions worldwide. Dysregulation of the brain-body axis can potentially contribute to or exacerbate various neurological and psychiatric disorders. The estimated prevalence can vary significantly depending on factors such as geographic location, population demographics, and advancements in medical diagnosis.

The study of bidirectional interactions between the central nervous system and the body is an emerging field of research that holds the potential to enhance our understanding of often overlooked pathophysiological processes involved in common neurological and psychiatric disorders. Expanding our current knowledge in this area is crucial as it serves as the initial step towards the development of therapeutic and preventive approaches aimed at preserving and improving brain health on a global scale.

The 'Network of European Funding for Neuroscience Research' (NEURON) has been established under the ERA-NET scheme of the European Commission (www.neuron-eranet.eu). The ERA-NET NEURON aims to coordinate and optimize research efforts and funding programmes of its partner countries/regions in the field of mental, neurological, and sensory disorders. Under the umbrella of NEURON, a joint transnational call (JTC 2024) in the field of bidirectional brain-body interactions will be launched in 2024.

Description :

LifeArc announces £5 million drug repurposing programme for motor neuron disease

• LifeArc is launching new £5m programme to help find new treatments for motor neuron disease (MND).
• The programme is seeking applications from the international MND research community for research projects looking at repurposed drugs and drug combinations to tackle the neurodegenerative condition.
• The programme will verify the potential effectiveness of promising treatments to improve their chance of success in clinical trials in unique offering in fight against MND.
• Funding is part of LifeArc’s multi-million pound Motor Neuron Disease Translational Challenge to make MND treatable by 2030 and ultimately find a cure.
• MND is a neurodegenerative condition that affects the brain and nerves causing weakness, loss of movement and is currently fatal.

LifeArc announced today that it will commit £5 million in grant funding to find new treatments for motor neuron disease (MND) as part of a drug repurposing programme to tackle the high failure rate in MND clinical trials.

Currently, potential treatments for MND, including repurposed drugs, have failed to show beneficial effects in patients and the failure rate for treatments in clinical trials for MND remains very high. LifeArc aims to improve the success rate of clinical trials by funding pre-clinical research studies on repurposed drugs that show potential and, uniquely, verify that they could be effective in treating MND.

International research teams in academia and small and medium-sized enterprises (SMEs) are eligible to take part in the programme, with funding of up to £750,000 per project available. To be considered eligible for funding, applicants must have identified a new repurposed drug with experimental evidence that shows it has potential for treating MND.

The chosen projects will benefit from LifeArc’s deep expertise, advice and mentorship in translational research, its drug-repurposing know-how and access to its collaborative network of project partners. This is all part of the charity’s aim to support the next generation of translational scientists and give projects the best chance of success.

This funding call is part of LifeArc’s Motor Neuron Disease Translational Challenge to make the condition treatable by 2030 and ultimately find a cure. Breaking the research deadlock in MND is a key priority for the charity and forms part of the Challenge’s £50 million investment to accelerate the translation of scientific discoveries into new breakthroughs to transform how MND is detected, treated, and managed.

Currently, around half of those diagnosed with MND die within two years and six people are diagnosed with MND every day in the UK. The condition currently affects around 5,000 people in the UK and more than 330,000 worldwide. There are currently no treatments that can cure the condition and the only licensed drug for MND in the UK has a modest effect on extending life.

Dr Paul Wright, Head of LifeArc’s MND Translational Challenge, said: “We are fortunate to have exceptional research in the MND community both in the UK and further afield but despite this, most clinical trials using repurposed drugs fail due to lack of effectiveness. Improving confidence in drug repurposing requires more robust preclinical research, meaning that repurposed drug candidates are progressed into trials with sufficient evidence to predict they could benefit someone living with MND. To achieve our ambition of making MND treatable by 2030, we need to start with better decision making at the pre-clinical stage to demonstrate as early as possible that a repurposed drug candidate has the potential to deliver improvements for patients.”

David Setters, MND campaigner and co-founder of Patients United to End MND, said: “This major initiative gives the MND community another boost as we build on recent exciting progress in research. While the development of new therapies remains crucial, the key benefit of repurposing is a shorter trial timescale given that the drugs will have already passed safety tests. The increased prospect of access to more trials in the relatively near future not only brings hope to patients, but also a heightened sense of “self-worth” by being involved in research. Those of us living with this brutal condition greatly appreciate the considerable funding and impetus that LifeArc has brought to MND research in recent years. The team’s focus on translational research to accelerate the arrival of meaningful treatments combined with a desire to harness emerging discoveries from around the world, as with this new programme, gives us a real lift.”

Dr Jane Haley MBE, Director of Research at MND Scotland, added: “Motor neuron disease is rapid, brutal and terminal, and people with MND don’t have time to wait, so it is important that all avenues to possible new treatments are explored. Repurposing of existing licenced medicines is one way of speeding up the process of finding effective treatments. It’s been tried very successfully in cancer, where it has delivered many new treatments for patients, so it is important that MND researchers learn from their successes. We welcome LifeArc’s £5 million investment in this area – it is about time there was a world without MND, and this can only be achieved through research.”

Dr Brian Dickie MBE, Director of Research Development at the MND Association, said: “This exciting new funding call will provide a real shot in the arm for the research community, catalysing the translation of the vast new knowledge gained about MND in recent years and feeding the pipeline of repurposed drug candidates available for clinical trials.”

Jessica Lee, Director of Research at My Name’5 Doddie Foundation, said: “MND research is at a tipping point; we have never known more about the biology underpinning MND and our research community is collaborating like never before. We now need urgent and coordinated investment to drive forward the search for new treatments. We are pleased to welcome LifeArc’s new funding call which could bring new treatments to people living with MND in years, not decades, and we look forward to supporting the programme in any way we can.”

The funding call will be underpinned by the Guiding principles for drug discovery and development in amyotrophic lateral sclerosis white paper that is also being published today. This is the output of a year-long project that has brought together leading researchers, clinicians, industry experts and people living with MND to outline an agreed approach to reduce the risk of clinical trials of new treatments through an enhanced evidenced-based approach to pre-clinical research.

Researchers interested in applying for funding are encouraged to join a webinar about the project taking place in February 2024 and can register here.

A parallel funding scheme to support data science and AI/machine learning approaches to repurposed drug candidate identification in MND will also be made available through the programme. LifeArc will fund up to five bioinformatic projects that aim to exploit MND data sets with up to £100,000 available per project over 12 months.

Description :

Aims of the call

• to support translational research projects that combine innovative approaches in the field of nanomedicine and
• to encourage and enable transnational collaboration between academic research (public and private partnership i.e. research teams from universities, higher education institutions, public research institutions) and clinical/public health research (research teams from hospital, healthcare settings and other healthcare organisations) or R&D activities from industrial enterprises (all size). The participation of Medical Doctors and clinicians is strongly encouraged. SMEs (Small and Medium-size Enterprises) are also strongly encouraged to participate.

Project proposals will address multidisciplinary and translational research. The applications must cover at least one of the following nanomedicine areas that are of equal relevance for this call:

a) Regenerative medicine

b) Diagnostics

c) Nanotherapy

Proposals may include, but are not limited to the identification, characterisation and validation of biomarkers, early diagnosis, convergence of nanotechnology and stem cell technology, cell biology applied to nanomedicine, multimodal imaging agents or techniques, point of care diagnostics (on site sensors), standardised procedures for preparation & characterisation of drug delivery systems, green production processes for nanomedical products, nanoparticles for hyperthermia, regenerative, gene or cell therapies using nanotechnology. Pre-clinical and clinical studies are eligible subject to national/regional regulations.

In order to use nanomedicines/nanodevices in clinical practice, additional advances and further understanding are, therefore, still needed and achievable. The aim of the call is to advance nanomedicine toward any translational focus with anticipated impact relative to the risk and investment. The call also invites applications that focus on improving outcomes e.g. improve the current drug development process, consistency and reproducibility studies, studies such as safety surveillance, studies to support use in special populations.

For a better understanding of the objectives and a more efficient evaluation, applicants are asked to specify in which of the two categories described below the project falls, according to its Technology Readiness Levels (TRL), i.e. its degree of innovation and expected time to market:

1. Innovation applied research projects: Proof of concept projects for innovative applications with analytical/experimental research and/or implementation and integration of components and test in laboratory and/or animal models. Safety and nanotoxicity should be taken into account when relevant. The viability of a path that may lead the experimental and/or analytical results (for TRL 3) and/or demonstrators (for TRL 4) to a future application at medium/long term shall also be demonstrated
2. Projects with high potential of applicability at short/medium term: Projects closer to the market for the validation of demonstrators and prototypes in a realistic laboratory (for TRL 5) and/or relevant simulated operational field environment (for TRL-6). The viability of a path that may lead the validated systems and results to real products shall be demonstrated. Industrial engagement is crucial in this type of projects. Medical regulatory aspects have to be properly considered.

At the end, projects should fall within, but are not limited to, TRL 3-6, although for being realistic and coherent with the characteristics of the call, projects should propose advancements for a maximum of two TRL levels during their lifetime. TRL level must be understood as the level achieved by the end of the three-year-project.  Industry engagement should be appropriate for the TRL range being investigated.

Exclusion: proposals based on nanoscale naturally occurring processes or structures and proposals focus on KET without nanotechnologies.

General conditions for application

The duration of the projects will be 36 months.

Joint research proposals may be submitted by applicants belonging to one of the following categories (according to national/regional regulations; certain categories may not be eligible for funding by a specific funding organisation, please see Annex I of the call text):

• A. Academia – research teams working in universities, other higher education institutions or research institutes.
• B. Clinical/public health sector – research teams working in hospitals/public health and/or other health care settings and health organisations.
• C. Enterprises – private companies of all sizes.
• and D. Operational stakeholders – e.g. patient advocacy organisations, municipalities and local governments, local/national NGO’s. In line with the concept of RRI, operational stakeholders should be in a position to provide useful knowledge to the consortium, ensure the consortium’s research is useful and translatable to their (or other) organizational contexts, and/or influence decision making or create change within their organisations. Operational stakeholders should be engaged in the research process from conception of the study to dissemination.

Size of the consortium

Each application must include partners from at least two of the three categories A, B and C. The number of participants and their research contribution should be appropriate for the aims of the transnational research project and be reasonably balanced in terms of international participation. Each transnational collaborative project should represent the critical mass to achieve ambitious scientific goals and should clearly demonstrate an added value from working together. It is important to integrate partners from the category D in line with the aims of the proposal.

Only transnational projects will be funded. The following conditions apply to the composition of consortia:

• Minimum of three eligible and a maximum of five eligible partners from at least three different countries participating in the call (see list above).
• The maximum number of eligible partners can be increased up to six or seven (see table below) if they include one or two partners, respectively, from the following participating countries: Latvia, Lithuania, Slovakia, Türkiye.
• No more than two eligible partners from the same country participating in the call will be accepted within one consortium.
• Maximum of two collaborators per consortium. Collaborators are self-funded partners: i.e. partners that do not request funds in this Joint Transnational Call provided by one of the participating funding organisations (i.e. partners from non-funding countries or partners which are not fundable according to national/regional regulations of the participating funding organisations).

There will be a two-step submission and evaluation procedure for joint applications, i.e. pre-proposals and full proposals, and the full proposal review process will be complemented by a rebuttal stage. For both submission steps, one joint proposal document (in English) shall be prepared by the partners of a joint transnational proposal and must be submitted on the electronic submission system by the project coordinator.

Call timeline

Further information

Description :

*Please note the dates for call launch and deadlines are not official yet. We will modify them as soon as this information is available.

IHI published draft information on future call topics a few months ahead of the official call launch. The aim is to give you additional time to find or build a consortium and prepare a strong proposal.

Note that as draft topics are still under development, the texts may change considerably between the versions published here and the call launch, and you should always check the final, approved topic texts once the calls are launched.

Topics:

• Improving clinical management of heart disease from early detection to treatment
• User-centric technologies and optimised hospital workflows for a sustainable healthcare workforce
• Clinical validation of biomarkers for diagnosis, monitoring disease progression and treatment response

The topics are currently under consultation with the States’ Representatives Group (SRG) and the Science and Innovation Panel (SIP). They may therefore change considerably between the versions published here and the call launch, and applicants should check the final, approved topic texts once the calls are launched.

Description :

*Please note the dates for call launch and deadlines are not official yet. We will modify them as soon as this information is available.

IHI published draft information on future call topics a few months ahead of the official call launch. The aim is to give you additional time to find or build a consortium and prepare a strong proposal.

Note that as draft topics are still under development, the texts may change considerably between the versions published here and the call launch, and you should always check the final, approved topic texts once the calls are launched.

Topics:

• Support healthcare system resilience through a focus on persistency in the treatment of chronic diseases
• Development of practical guidance and recommendations for using real world data/real world evidence in healthcare decision-making

The topics are currently under consultation with the States’ Representatives Group (SRG) and the Science and Innovation Panel (SIP). They may therefore change considerably between the versions published here and the call launch, and applicants should check the final, approved topic texts once the calls are launched.

Description :

FIGHT KIDS CANCER is thrilled to announce that its next call opening on September 1st, 2023 will be exclusively dedicated to research on paediatric brain tumours.

In order to substantially support this disease area, which is in dire need for new treatments, FIGHT KIDS CANCER decided to give more flexibility to the applying teams by increasing the possible amount available and duration per grant application:

• For clinical trials:
  o    Up to 5 years
  o    Up to 5 million euros
• For translation research projects:
  o    Up to 4 years
  o    Up to 2 million euros

As flexibility is the key motivation for the modification of the grants' duration and amount, the FKC Funders wants to stress the fact that applicants should apply for what they need and not refrain from applying for smaller amounts or shorter projects such as primer/ preliminary studies, projects or programmes grants.

Each project will be evaluated on its merit alone. Shorter, high-risk high gain projects are as welcome as are biology companion projects. Translational projects applying for longer duration or higher amounts will be expected to facilitate collaboration across institutions and borders within Europe to meet the FKC selection criteria.

FIGHT KIDS CANCER aims to catalyse and support pan-European leading-edge research initiatives in paediatric cancer to develop innovative approaches to improve the outcome for all children and adolescents with cancer. This call will cover the following non-exclusive objectives:

• Realise the real impact on young patients,
• Improve survival rates and reduce toxicity to restore young patients to full health after treatment,
• Advance fundamental knowledge of paediatric malignancies,
• Support improved interdisciplinary research, methods and collaborations for tackling the issues of today,
• Strengthen collaboration and the development of scientific capacity across Europe.

FIGHT KIDS CANCER aims towards overcoming the structural lack of research dedicated to paediatric cancers by ensuring a recurring endowment that will be granted to the best European research projects every year. An additional ambition is to foster closer working ties between clinical and laboratory researchers.

How to submit an expression of interest?

We invite you to consult the guidelines of the call here, also available on the submission platform.

The following template is to be used to submit your Expression of Interest.

The deadline to submit your expression of interest to the FKC paediatric brain tumours call is the 17^th of October 2023 at 16:00 CEST.

The submission platform guidelines can be downloaded here

Description :

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 most of the following expected outcomes:

• The scientific and clinical communities make effective use of state-of-the-art information, data, technologies, tools and best practices to underpin the development of the diagnostics, and as such can also facilitate the development of effective therapeutics and/or preventive strategies.
• The scientific and clinical communities advance the field through a better understanding of mechanisms underlying brain disorders at the molecular, cellular and systemic level.
• The scientific and clinical community make wide use of newly established and where relevant open access databases and/or integrate them with existing infrastructures for storage and sharing of collected data according to FAIR principles, thereby encouraging further use of the data.
• Policymakers, funders, scientific and clinical communities, patient organisations, regulators and other relevant bodies are informed of the research advances made, while health professionals envisage use of the biomarker tests for early detection of the disorder and for guiding patients in the selection of personalised treatments/interventions.
• Patients and caregivers are sufficiently engaged with the research, which also caters for their needs.

Scope:

Treatments for some high-burden brain disorders are potentially on the horizon. Consequently, many patients and citizens will want to know if they are eligible for these treatments. For some disorders, a definitive diagnosis is difficult, expensive and time-consuming. Simple blood or other fluid-derived (e.g. saliva, urine, sweat) tests for markers that may indicate early signs of the disorder, and which can be deployed for widespread clinical use are needed.

The brain disorders within the scope of this topic fall under two categories, namely those listed under chapters six and eight of the International Classification of Diseases. Proposals in the area of mental disorders are encouraged.

Proposals should address all of the following aspects:

• Proposals should aim to validate biomarkers that can reliably confirm early stages of the human brain disorder and guide treatment/ intervention selection.
• Proposals should aim to provide evidence supporting the regulatory acceptance of the biomarkers.
• Exploitation of existing data, biobanks, registries and cohorts is expected, together with the generation of new key data.
• Inclusion of patients or patient organisations in the research is strongly encouraged, as to ensure that their views are considered.
• Sex and gender aspects, age, socio-economic, lifestyle and behavioural factors should be taken into consideration in the study.
• To enable sharing of samples, quality data and advanced analytical and digital tools, consideration should be made for using infrastructures already developed at the European^[6] or national level.
• To enable the management of brain disorders, consideration should be made in demonstrating the gained cost efficiency.
• SME participation is encouraged.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

Description :

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:

• A diverse and comprehensive EU landscape of multi-country adaptive platform trials (i.e. able to study multiple interventions in a disease or condition in a perpetual manner, thus allowing modification to the trial after its initiation without undermining its validity and integrity) that assess vaccines and therapeutics for infectious diseases, and have the capacity to pivot rapidly in the case of epidemic or pandemic health threats.
• Innovative and improved design of clinical studies, suited for pandemic preparedness, is available for the clinical research community, taking into account the high safety standards in the European regulatory environment.
• Trial sites across multiple countries have the capacity to deliver robust clinical evidence in a diverse European population, using harmonised research methods, data collection and analysis.

Scope:

As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally. Health threats are expected to arise due to among others, climate change, and thus a need for proactive approaches to ensure timely availability of medical countermeasures during disease outbreaks is anticipated. The conduct of perpetual adaptive platform trials, with the in-built agility to pivot when an epidemic strikes, is key to be prepared for infectious disease epidemics or pandemics.

This topic aims to provide funding to adaptive clinical platform trials that may be implemented routinely outside of an epidemic or pandemic context, but that are designed to be ready for the timely assessment of novel diagnostics, therapeutics or vaccines in the face of an epidemic or pandemic.

Proposals should develop the wide range of elements needed to sustain multi-country adaptive platform trials, including the trial implementation capacity, laboratory analysis capacity, and a harmonised approach to the collection, storage, sharing and analysis of FAIR data.

Proposals should ensure timely engagement with regulatory authorities and bodies. Proposals should consider the European regulatory environment and take full use of the European capacity to deliver quality trials, including the possibility for registration of new medical products. Proposals should strengthen the leading role of the EU in clinical research preparedness for future epidemics and pandemics.

The proposals should address the following areas:

• Development of robust clinical evidence that contributes to the knowledge base for the diagnosis, treatment and prevention of infectious diseases. Sex, gender, age, ethnicity and socio-economic factors should be taken into account.
• Known hurdles related to ethical, administrative, regulatory, legal and logistical aspects should be anticipated and addressed to the extent possible, in order to avoid such barriers when the trial needs to pivot in response to an epidemic or pandemic.
• Engagement with clinical researchers and biostatisticians, to increase capacity for the design and implementation of adaptive platform trials across Europe.

Collaboration and coordination with existing adaptive platform trials in the EU is expected, where relevant, as well as with the coordination mechanisms established under topic HORIZON-HLTH-2023-DISEASE- 3.05 and with the European Medicines Agency (EMA). Collaboration and coordination with other organisations and other regional and global initiatives, such as Global Health EDCTP3 Joint Undertaking, the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R), the European Pandemic Preparedness Partnership and the European Health Preparedness and Emergency Response Authority (HERA) should be envisaged. International cooperation is encouraged.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

Description :

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 most of the following expected outcomes:

• Health policymakers are aware of the healthcare interventions (pharmacological, non-pharmacological or technological interventions; including preventive and rehabilitative actions) that are identified as working best for the specific population groups from the point of view of safety, efficacy, patient outcomes, adherence, quality of life, accessibility, and (cost-) effectiveness.
• Health professionals have access to and use the improved clinical guidelines on the optimal treatment of patients and prevention of diseases e.g. through vaccines. Considerations made in the guidelines include the harmonisation and standardisation of care for high burden diseases or conditions throughout Europe, as well as possible individualised needs of patients.
• The scientific and clinical communities make effective use of state-of-the-art information, data, technologies, tools and best practices to develop interventions that are sustainable.
• Citizens, patients, prescribers, and payers receive more accurate information on available healthcare interventions via ad hoc communication platforms.
• The scientific and clinical communities make wide use of the newly established open access databases and/or integrate them with existing open access infrastructures for storage and sharing of collected data according to FAIR^[1] principles.

Scope:

Effective, affordable and accessible healthcare for diverse population groups is challenging and complex. For example, specific needs underlie the delivery of effective preventive actions and therapeutic treatments to a rapidly growing elderly population, often presenting comorbidities and associated polypharmacy. The paediatric population, including children born preterm, has also its specific needs in specially adjusted therapeutics and early interventions to address emerging health and developmental problems. Similar to the elderly population, the paediatric population is often excluded from many clinical trials that generate the evidence base for healthcare interventions. Women, including pregnant women, are also often under-represented in clinical studies and access to quality healthcare is frequently inadequate. Other population groups with limited access to quality healthcare and/or under-representation in clinical studies include low-income groups, and refugees. Intersectionality within these groups also needs consideration.

Proposals should address most of the following:

• Compare the use of currently existing (pharmacological, non-pharmacological and technological) healthcare interventions in specific population groups (or selected subgroups). While there is no restriction on diseases or conditions, preference will be given to proposals focusing on interventions with high public health relevance.

• Ensure acceptability and sustainability of the healthcare intervention through early involvement of ‘end users’ (e.g. patients, care providers) in the design of the study (integrating patient valued outcomes) and, where possible, in the research process including implementation. Additionally, proposals should take into account the diversity of health systems in different regions of Europe to allow large-scale uptake.

• Consider involving HTA bodies in order to create synergies and accelerate the practical implementation of the results. Where relevant, existing work of EU-funded projects such as EUnetHTA should be also taken into account.

• Consider issues of particular relevance for the target populations, for example, multimorbidity, complex chronic conditions, polypharmacy, substance misuse, vaccine efficacy, compliance, age, gender specificities and diseases with high societal burden (including but not limited to e.g. musculoskeletal diseases and mental health disorders). Special consideration should be given to fulfilling all ethical requirements.

• For the chosen population, assess clinical and safety parameters, as well as health and socio-economic outcomes (e.g. quality of life, patient mortality, (co)morbidity, costs, and performance of the health system). Agreed core outcome sets (COS) should be used as endpoints in conditions where they already exist, in other cases, efforts should be made to agree on such COS. Consider using new instruments and methods for determining the burden of disease and for evaluating the effects of the interventions. Low-cost innovations should also be considered.

• Inclusion of patient organisations and associations of caregivers and other healthcare professionals is recommended.

• Clinical trials, including pragmatic clinical trials, observational studies, use of existing health data in different study designs, creation of large-scale databases and performing meta-analyses may be considered for this topic. Use of existing data should always be considered to add value, increase quality and increase implementation speed of the study. Regarding databases, sustainability after the proposed action's end also needs to be considered.

• The proposed research needs to take into account sex and gender aspects.

The Commission will ensure an overall coordination mechanism between the projects funded under this topic to catalyse the exchange of knowledge, as well as the development and adoption of best practices. Proposals are expected to budget for the attendance to regular meetings. Projects resulting from this call will be invited to share and discuss their case studies amongst themselves and with relevant stakeholders at the EU level, and necessary resources should be allocated to this task.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

Description :

IHI call 5 is a single-stage call with topics on the 3Rs, theranostics, stroke management and synthetic data.

Topics

• Topic 1: Accelerating the implementation of New Approach Methodologies and other innovative non-animal approaches for the development, testing and production of health technologies
• Topic 2: Development and proof of principle of new clinical applications of theranostics solutions
• Topic 3: Improved prediction, detection, and treatment approaches for comprehensive stroke management
• Topic 4: Maximising the potential of synthetic data generation in healthcare applications

For full details of the topics, including the budget breakdown, click on the links above (which take you directly to the relevant page of the Funding and Tenders Portal) or read the call text.

Indicative budget

• The maximum financial contribution from IHI JU for these topics is: EUR 115 million
• Industry / contributing partner contributions: Applicant consortia should ensure that out of the total project budget, at least 45 % needs to be covered by contributions provided by project participants

How to apply

All documents relating to the call can be found via the Funding and Tenders Portal and the IHI call documents page. We advise you to read these documents, in particularly the guide for applicants, carefully.

Proposals must be submitted via the electronic submission system of the Funding and Tenders Portal. To start submitting your proposal, simply click on the relevant topic above - this will take you directly to that topic's page on the portal. Once there, scroll down and click on 'Start submission'.

To submit a proposal via the electronic submission system, you will need to have an EU Login account and ensure that your organisation is registered as a beneficiary.

Description :

IHI call 4 is a two-stage call with topics on the 3Rs, patient-centric blood sample collection, clinical trials, and the environmental impacts of healthcare.

Topics

• Topic 1: Expanding translational knowledge in minipigs: a path to reduce and replace non-human primates in non-clinical safety assessment
• Topic 2: Patient-centric blood sample collection to enable decentralised clinical trials and improve access to healthcare
• Topic 3: Inclusive clinical studies for equitable access to clinical research in Europe
• Topic 4: Establishing novel approaches to improve clinical trials for rare and ultra-rare diseases
• Topic 5: Safe & sustainable by design (SSbD) packaging and single use device solutions for healthcare products
• Topic 6: Sustainable circular development and manufacturing of healthcare products and their quantitative environmental impact assessment

For full details of the topics, including the budget breakdown, click on the links above (which take you directly to the relevant page of the Funding and Tenders Portal) or read the call text.

Indicative budget

• The maximum financial contribution from IHI JU for these topics is: EUR 83 350 000 million
• Industry / contributing partner contributions: EUR 85 076 000 million

How to apply

All documents relating to the call can be found via the Funding and Tenders Portal and the IHI call documents page. We advise you to read these documents, in particularly the guide for applicants, carefully.

Proposals must be submitted via the electronic submission system of the Funding and Tenders Portal. To start submitting your proposal, simply click on the relevant topic above - this will take you directly to that topic's page on the portal. Once there, scroll down and click on 'Start submission'.

To submit a proposal via the electronic submission system, you will need to have an EU Login account and ensure that your organisation is registered as a beneficiary.