Advancing promising results from Pillar II collaborative research through the innovation journey

Expected Outcome:

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

• Research and Innovation (R&I) solutions funded under Horizon Europe Pillar II are further advanced along the innovation pathway towards uptake and deployment in the EU and/or Associated Countries, including their translation into high value products, services, processes or business models, strengthening the capacity of European public and private organisations to use innovative solutions.

• End users[1] and market actors actively co-develop and validate highly innovative solutions in real-world settings, ensuring demand-side needs are integrated, helping to de-risk the innovation journey.

• The EU and Associated Countries benefit from accelerated commercialisation, adoption and deployment of Horizon Europe results, thereby reinforcing societal benefits, sustainable competitiveness, resilience and strategic autonomy of the Union.

Scope:

Projects funded under Horizon Europe’s Pillar II generate a wealth of high potential innovative results. Even though such results are many times successfully translated into used solutions, there is a need to increase the efficiency of the R&I investments and foster more uptake of promising results into innovative solutions. If more results[2] were converted into innovative products, processes, services, practices, business models or other novel solutions, they would strongly contribute to European societal benefit, sustainable competitiveness, prosperity, clean transformation, wellbeing or strategic autonomy.

This topic aims at supporting actions that bring solutions generated by Pillar II closer to production and adoption by testing and validating them in real world settings, taking into consideration societal needs, cultural diversity and responsible innovation.

Consortia do not necessarily have to include beneficiaries from the previous grant(s) but must own or have access to the knowledge assets, including intellectual property, where relevant, as stipulated in the specific conditions of this topic. Applicants should justify the proposed composition of the consortium and how it brings the necessary expertise and results ownership. Proposals may also build on complementary background results from closely related EU actions or national/regional projects contributing to the same innovation pathway, provided that these complementary results strengthen the market-readiness and deployment potential of the main result of the Horizon Europe project.

Applicants should evidence that the proposed activities start beyond the laboratory or research environment and should focus on prototyping, testing, demonstrating, piloting, large-scale product validation and market replication under real-world conditions.

Proposals should focus on innovation activities that cover the later stages of development, including the use of research and technology infrastructures[3] where relevant, should cover more than one of the following activities:

• Validation and Testing activities: This could include refining or piloting of prototypes through iterative testing, ensuring they meet the required regulatory or other standards before moving forward; testing to gain approval from potential users, or trial in real-world settings, including to understand user preferences and/or optimise outcomes; stress testing for technical feasibility to ensure the robustness of solutions at scale.

• Commercialisation aspects: This could include activities around regulatory compliance standardisation or certification, development of business or pricing strategies and planning for market entry.

• Scaling and Operations: This could include activities around large scale validation such as interoperability and/or standardising processes for quality assurance and control; preparations for supply chains and operational readiness; planning for ramping up manufacturing or delivery.

• Stakeholder, User and Market Readiness: This could include activities that involve engaging users/customers through co-creation and iterative feedback mechanisms to refine products and strategies, and to ensure that the proposed solutions are aligned with industrial and/or societal needs, concerns and expectations.

• Deployment and Investment Bridging: This could include partnering activities to expands market reach and securing the required investment commitment for the next phase by EU or national deployment programmes or investment funds.

Proposals should clearly outline which wider impact can be expected if the project succeeds, along with convincing Key Performance Indicators or a similar framework to measure and follow up the project impact. Impacts do not have to be only monetary but can also consist of other kinds of societal benefits and impacts on wellbeing, clean transformation, resilience or strategic autonomy etc. To assess the value for investment, proposals should specify, with metrics where relevant, all the following:

• Describe the expected scale and significance[4] of the identified wider impacts.

• Include a business plan or exploitation strategy (including risks and mitigation) that will be further developed during the project. Proposals should identify the beneficiary(ies) (e.g. industry, company, public authority, etc.) responsible for the scaling-up of the solutions. The exploitation strategy should envisage a first deployment in the EU and/or Associated Countries.

• End users should be represented as a beneficiary within the consortium (and identified in the proposal) to test the feasibility of the solution and to ensure that the innovations developed meet the specific needs and requirements of the demand. To support the expected outcomes of the topic, additional end users beyond the project consortium can be subcontracted for further testing and validation activities.

The maximum project duration should not exceed 3 years.

If the activities to be carried out under the proposal are relevant and align with STEP[5] eligibility, (i.e. digital and deep tech, clean and resource efficient tech and biotech) proposals should demonstrate how they contribute to either: i) bringing innovative, cutting-edge technologies with strong economic potential to the internal market, or ii) reducing or preventing the Union’s strategic dependencies.

Where relevant, applicants envisaging to include clinical studies[6] should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.

Technology Readiness Level - Technology readiness level expected from completed projects

The starting TRL for proposals based on results generated within a project funded under Cluster 3, 4, 5 or 6 should be TRL 6. For proposals based on results generated within a project funded under Cluster 1 or 2, the proposed activities must start beyond the laboratory or research environment and focus on prototyping, testing, demonstrating, piloting, large-scale product validation and market replication under real-world conditions. In case of proposals that are based on results generated within more than one projects, the Cluster of the primary project -as stated by the applicants in their proposal- will be the Cluster to be considered.

[1] Within this topic end users can be both public and private entities.

[2] The term 'results' means any tangible or intangible effect of a given action, such as data, knowhow or information, whatever its form or nature and whether or not it can be protected, as well as any rights attached to it, including intellectual property rights (patents, copyright, trademarks, etc.).

[3] The catalogue of European Strategy Forum on Research Infrastructures (ESFRI) research infrastructures portfolio can be browsed on the ESFRI website: https://ri-portfolio.esfri.eu

[4] Scale refers to the breadth or magnitude of an innovation's reach (e.g., the number of users, industries, or markets affected); significance refers to its importance or transformative effect (e.g., whether it represents an incremental improvement or a fundamental shift in how a problem is solved or a need is met).

[5] https://strategic-technologies.europa.eu/about_en

[6] A clinical study covers clinical studies/trials/investigations/cohorts and is defined as any systematic prospective or retrospective collection and analysis of health data obtained from individual patients or healthy persons in order to address scientific questions related to the understanding, prevention, diagnosis, monitoring or treatment of a disease, mental illness, or physical condition. It includes but it is not limited to clinical studies as defined by Regulation 536/2014 (on medicinal products), clinical investigation and clinical evaluation as defined by Regulation 2017/745 (on medical devices), performance study and performance evaluation as defined by Regulation 2017/746 (on in-vitro diagnostic medical devices).

From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS - https://euclinicaltrials.eu). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data.

Applicants are encouraged to consider the latest innovations and advances in the clinical trial design and research methods in order to evaluate promising interventions allowing shorter development timings. Applicants are also encouraged to follow the World Health Organization (WHO) guidance for best practices for clinical trials (https://www.who.int/publications/i/item/9789240097711).