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Call: Call for Project proposals within personalised medicine (NordicPerMed)


The submission deadline for this call has passed
Application deadline
04.09.2018 13:00
Full call title

Innovations in Personalised Medicine: Towards implementation of personalised medicine in health care

Who can apply?

The following applicants from the Nordic countries can apply for funding (the Nordic countries are defined here as Denmark, Finland, Iceland, Norway, Sweden):

  • Research organisations including academic research and research institutes
  • Public organisations including hospitals, regulatory agencies, municipalities etc.
  • Small-, medium- and large private enterprises
  • Patient organisations
Background

The Swedish Governmental Agency for Innovation Systems (Vinnova), the Icelandic Centre for Research (RANNÍS), Innovation Fund Denmark, Innovaatiorahoituskeskus Business Finland and the Research Council of Norway, in collaboration with NordForsk, are launching a call for proposals for funding of trans-Nordic projects aimed at implementation of personalised medicine in health care.

Personalised medicine* (PM) is an interdisciplinary field that will drive the health research and innovation agenda for years to come. Research and innovation in this area is moving rapidly, but in a rather fragmented fashion. The implementation of personalised medicine in health care is moving forward in areas such as cancer, where most successful opportunities have been identified, but progress is slow within most other indication areas.

Partnerships and innovation networks are needed to encourage cross-disciplinary and cross-border collaboration in order to advance the field. It is of the utmost importance that research, industry, health care sectors and society jointly address challenges related to regulatory and legal frameworks, policy, payment mechanisms and health economics, etc., to overcome barriers to the implementation of PM.

This call is specifically aimed at developing innovations** related to the implementation of personalised medicine for citizens and health care systems. It is intended to build on strengths and synergies between the Nordic countries.

* In this call the definition of personalised medicine as set by the European Commission is used:
Personalised medicine refers to a medical model using characterisation of individuals' phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention.”

** Innovation in this context is defined as new products, services, markets, processes or organisational models that create financial benefits or are of value to society.

The overall objectives of NordicPerMed are:

  • To promote new, personalised medicine approaches for more effective and sustainable health care for the benefit of patients, citizens and society;
  • To improve the Nordic position in personalised medicine through research and innovation that builds on Nordic strengths;
  • To increase collaboration between companies, research-performing organisations and public-sector organisations (hospitals and relevant agencies) and civil society;
  • To promote Responsible Research and Innovation* (RRI) perspectives in personalised medicine within a Nordic context, including diversity, inclusion, openness and transparency;
  • To contribute to the action plan of the EU initiative International Consortium for Personalised Medicine (ICPerMed).**

* For further explanation of RRI, see e.g.: Indicators for promoting and monitoring Responsible Research and Innovation and A framework for Responsible Innovation - under BIOTEK2021, IKTPLUSS, NANO2021 and SAMANSVAR.

** ICPerMed is a communication and support action (CSA) funded by the European Commission to promote personalised medicine activities. 

Thematic framework

The overall purpose of this call is to focus on the key elements that will bring PM to the patient/citizen. The patient/citizen perspective should therefore be included in all parts of the grant application.

Although generation of new biomarker and health care data is an important aspect of PM, this call seeks to intensify the emphasis on the next steps in the value chain to make it possible to bring improved PM treatments to the patients within a sustainable health care system.

Thus, the main focus should be on use of data already available within the health care system, such as existing omics, imaging, clinical and other healthcare data, rather than on generating new basic data. The broader societal impact of implementing PM is significant. Ethical and RRI perspectives are therefore very important in PM and should be taken into consideration at all stages.

It is expected that this initiative will significantly advance PM activities related to the following three topics:

  • Data: Knowledge generation and value creation in relation to the use of existing omics and health-related data at the Nordic level for PM purposes, thereby generating new PM hypotheses to be tested in the clinic, for example. In addition, support for the development of data management practices (access, quality and harmonisation supporting Nordic and international research and innovation.
  • Clinical trial/regulatory: Development and implementation of solutions to overcome clinical and regulatory challenges related to PM.
  • Health economics: Research and development of health economics models that are useful in a PM setting.

The call is intended to fund research and innovation projects. Project proposals under this call are expected to address one or more of the three topics within the thematic framework.

Data:

There is currently much focus on the generation of omics data on a broader patient and population scale. In addition, attempts are being made to bring available patient health care data into formats which, together with omics data, may open up for new PM opportunities. These endeavours are hampered by major hurdles such as difficulties in accessing sensitive data across borders and use of different data formats in healthcare.

The Nordic countries, with a total population of 26 million people, have a rather unique position in this context. They share similar health care systems, cultural backgrounds and high ethical standards. Most importantly, the health care and register data that have been collected for decades constitute an exceptional data resource and facilitate the use of much larger data sets at the Nordic level than at national level. This provides a unique opportunity to contribute to the development of PM.

Project proposals submitted under this call may build both on established collaborations between institutions across the Nordic countries over time and on ongoing related data projects to provide a good basis for supporting data sharing in a constructive way.

Projects are expected to build on Nordic strengths and synergies and utilise cross-Nordic omics and health care data in order to identify potential PM opportunities across relevant indications to be tested in a clinical setting.

Proposed activities in the project proposals should include deliverables regarding how learning obtained from this call can be used to streamline use of data across borders as well as suggestions for future harmonisation of data management, in both a Nordic and a broader European perspective.

Clinical trials/regulatory:

Conventional clinical development models are coming under pressure as new PM opportunities emerge from progress in research utilising omics, imaging and health-related data. In a PM setting, regular clinical development and pivotal studies are often rather complicated and challenging.

Several factors add complexity to PM clinical trials. The segmentation into smaller patient groups typically increases costs and diminishes the final market, patient recruitment becomes more challenging and often more countries and sites need to be involved. One way of solving this has been introduced in the PM cancer field using a more dynamic development process. This was largely possible due to the characteristics of the patient populations in this field (terminal patients, short-term treatments, specific mutations etc). When moving to other indications, in particular chronic diseases, innovative thinking within clinical development is needed to bring true PM into reality. Using the Nordic countries as a single area for patient recruitment may facilitate faster recruitment and allow access to larger study populations.

Faster access to patients through innovative clinical development models is closely linked to the regulatory process of approval of new PM treatments. A much more dynamic interplay between clinical development and regulatory approval is needed to bring the PM treatments to the patients within a reasonable timeframe and at an acceptable cost. It is strongly encouraged to involve regulatory authorities as well as patient organisations when considering new regulatory pathway and processes.

Clinical studies under this topic may include exploratory trials to e.g. test new PM hypotheses or new suggested biomarkers or repurposing of known treatments but cannot include large pivotal studies for e.g. new drug or biomarker validation due to prohibitively high costs. Project proposals under this topic are expected to address these clinical/regulatory challenges. When suggesting new PM-based clinical trials, proposals for methods to ensure faster access to patients may be included.

Health economics:

Various factors, e.g. development of new expensive treatments and demographic changes, have put our health care systems under pressure. The economic burden can be expected to increase over the coming years. Unless new and innovative health care models are developed, PM-based treatments may exacerbate cost-related problems in our health care systems, since an increasing number of specialised treatments will be required for an increasing number of smaller patient populations. In turn, this may influence the distribution of health care resources between different groups of patients and have broader societal consequences. Various solutions have been suggested, e.g. value-based pricing, specific pricing and reimbursement policies in areas with small volumes such as rare diseases and stratified medicines, as well as patient involvement in pricing and reimbursement decision-making.

Project proposals under this topic are expected to address these health economics challenges and propose solutions relating to the specific indication area covered by the proposal.

Financial framework

The total budget for this call is EUR 14.9 million

The projects awarded support will be funded through a virtual common pot, which means that the national funding agencies will fund their respective participants in the funded projects. The participants are therefore strongly advised to consult their respective funding agencies for further guidance (see also Annex 1 to this document).

The total expected funding available per project is in the order of EUR 1-3 million for a duration of up to 4 years. The amount of funding available per project partner is subject to national rules and regulations.

Eligibility criteria
  • All project participants must be legal entities in their respective countries.

  • The Project Leader must be based in an entity in one of the co-funding countries (Denmark, Finland, Iceland, Norway, Sweden).

  • Projects must consist of participants from at least three countries, at least two of which must be from co-funding countries. Participants from non-funding countries may participate in projects by providing their own financing as long as the overall aim is to pursue the goals of this call. Letters of commitment are required from all participants in the proposal stage.

  • Applicants must comply with national rules (see Annex 1).

  • All proposals must be written in English and submitted via the NordForsk application portal.

Further requirements
  • All applicants must be active in areas relevant for the call within their respective countries.

  • Projects funded under this call are recommended to make contact with the Nordic e-Infrastructure Collaboration aimed at supporting Nordic data sharing on sensitive data when relevant.

  • Projects should be based on the principles of Responsible Research and Innovation (RRI) and applications must include information on RRI-related aspects. Funded projects are expected to take part in workshops or similar events on RRI topics arranged by the Call Committee.

  • The application must describe considerations relating to ethical dilemmas and associated questions of relevance to the project. Specific ethical considerations that will be of relevance after the project is completed should also be discussed. Applications are not expected to propose final solutions to current or especially future ethical dilemmas but should include a description of the steps that will be taken to maintain high ethical standards now and in the future.

  • In line with its gender policy, NordForsk and the funding agencies work to promote gender balance among project participants as well as gender perspectives within the research and innovation activities as important aspects of research quality. All projects that receive funding must describe gender balance in the project and explain how the project incorporates or gives consideration to gender perspectives.

  • Proposals must include plans for contributing to open science in accordance with Science Europe's Principles for the Transition to Open Access to Research Publications.

  • Proposals must describe how data management will be aligned with the FAIR data principles (Findable, Accessible, Interoperable, Re-usable, see e.g. the H2020 guidelines).

Assessment criteria

The proposals will be evaluated by a panel of international expert using the following criteria:

1. Excellence and relevance in relation to call

  • Relevance to the thematic framework of the call; clear description of the medical and technical needs and challenges

  • Scientific quality of the project; state-of-the-art of the research, clarity and pertinence of objectives, knowledge generation

2. Innovation quality of the project

  • The potential of the project to provide new PM solutions and/or to add value to existing PM solutions in health care.

  • Potential of the project to lead to the development of new treatments/product/services/processes and their possibility of reaching a market.

  • Competitive advantage of the product/services/processes developed in the project.

  • Involvement of end-users, e.g. patients, health care providers and professionals, and companies.

3. Quality in implementation of the project

  • Feasibility of the project; clearly described plans with objectives, milestones and deliverables.

  • Necessary and complementary key qualifications of the project participants and quality and competence of the project consortium to meet the objectives of the proposal, including a relevant mix of different actors from academia, research institutes, companies and the public sector.

  • Clarity of plans for utilisation of results from the project, including introduction in health care, IPR strategies, etc.

  • Feasibility of budget in relation to project plan.

  • Risk assessment; availability of resources, risk management describing threats and opportunities.

4. Nordic and international impact of the project

  • Potential of the project to add value for society, citizens and patients.

  • Potential to provide Nordic added value, i.e. that Nordic collaboration generates more value than would be the case through national activities alone.

  • Potential of the project to contribute to a stronger international position for the Nordic countries within PM.

In addition, the Call Committee will assess the strategic relevance of the proposals to the call according to the following criteria:

  • Alignment of the proposals with overall objectives of NordicPerMed.

  • A balanced portfolio of funded projects with respect to the three thematic areas of the call and disease indications.

  • A balanced distribution of projects and participants across co-funding countries.

  • A balanced distribution of budgets between sectors (academia, SME, industry, public sector).

Processing of proposals

Proposals should be submitted electronically through the NordForsk Application Portal no later than 4 September 2018 at 13:00 CEST. Proposals must be submitted in English. No attachments to the proposals are allowed, unless specifically requested in the application form. The application form is based on the eligibility criteria and assessment criteria stated above and can be found in its complete form at NordForsk Application Portal. To access the application form, you must register as a user at NordForsk Application Portal and create a draft application.

An eligibility check of submitted proposals will be carried out by the NordForsk administration and the national funding organisations according to the eligibility criteria described above and national eligibility criteria described in the annex.

All eligible proposals will be evaluated by a panel of international experts using the criteria above. A Call Committee, specifically appointed by the funding parties to implement the call, will take strategic considerations (as outlined above) into account in addition to the expert evaluation for the final recommendation on funding.

The NordForsk Board will make the final funding decision with respect to the NordForsk share of the budget, based on the recommendation of the Call Committee. The national funding agencies correspondingly make the final funding decision with respect to the national contributions, based on the recommendation of the Call Committee. Funded projects will need to enter into separate agreements with relevant national funding agencies that will provide funding to the specific project. Therefore, participants must submit separate national applications to national agencies according to local national rules (see Annex 1).

NordForsk's Guidelines on Impartiality will be applied throughout the entire evaluation and funding process.  Applicants will be notified in writing of the outcome of the funding decision. The national funding agencies will execute their respective funding processes according to local national rules and processes. Start-up of projects awarded funding is expected to take place in Q1 2019.

Each party and all individuals with access to documents and information regarding projects shall treat this as confidential information, in particular in relation to protecting business-critical information of private sector participants.

Management of funded projects

A consortium agreement regulating the rights and obligations of the various institutions/partners involved in the project must be agreed upon by the project participants for funding to be paid out, but projects can start earlier. A model template for consortium agreements will be made available via the NordForsk portal.

The Project Leader will be responsible for submitting annual progress reports and a final report to NordForsk describing the overall progress and final result of the project. In addition, national reports have to be sent to the respective national funding agencies according to national rules. The projects are expected to participate to a reasonable extent in meetings, conferences and other events arranged within the framework of this call. The Project Leaders are responsible for the implementation of human resource strategies for researchers in keeping with the basic principles of the EU Charter for Researchers and the EU Code for the Recruitment of Researchers, where applicable.

Responsible adviser for national funding agencies:

See Annex 1

Applicants are advised to consult funding agencies prior to submitting the application

Responsible advisers for NordForsk:

Maria Nilsson, Special Adviser
E-mail: maria.nilsson@nordforsk.org
Phone: +47 993 80 264

Marianne Aastebøl Minge, Senior Adviser
E-mail: marianne.minge@nordforsk.org
Phone: +47 936 02 527

Technical support

For technical support, please contact: support@nordforsk.org or +47 905 51 520

Max applied amount (EUR)
3000000
Appendices
NordForsk, Stensberggata 25, 0170 Oslo, Tlf: +47 476 14 400, E-post: support@nordforsk.org, Organisasjonsnummer: 971 274 255