Pilot actions for follow-on funding: Leveraging EU-funded collaborative research in regenerative medicine

Expected Outcome

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

• The overall competitiveness of the EU biotechnology sector is strengthened through the further development of closer-to-deployment health innovations.
• The EU benefits from greater impact of the EU’s Research and Innovation (R&I) Framework Programmes through successful leveraging of previous EU funding in the field of regenerative medicine.
• EU innovators secure further funding to finalise the last stages of development.
• Patients benefit faster from solutions that improve their health and wellbeing.

Scope

R&I is essential for economic growth and boosting the competitiveness of the EU's life sciences sector. Through the Horizon 2020 and Horizon Europe Framework Programmes, the EU has supported projects that significantly impact our health by fostering scientific discoveries and developing new solutions. Transformational health innovations, such as mRNA vaccines, highlight the importance of collaboration among businesses, research institutions, and healthcare providers. Furthermore, sustained funding throughout the entire value chain is crucial for maximising impact and ensuring more products reach patients faster. The main aim of this topic is to pilot a follow-on funding mechanism, supporting the stepwise development of biotech innovations through collaboration, resulting from previously supported EU R&I actions in the field of health. This topic contributes to strengthening the R&I ecosystem within the EU and supports the implementation of the “Strategy for European Life Sciences”[1]. Given the importance of biotechnology as a critical technology[2], this topic aims to ensure that promising research results are efficiently taken further along the value chain, speeding the time to market or patient through stepwise funding and increasing the EU’s competitiveness. The chosen area of focus is regenerative medicine as it has the potential to heal or replace tissues and organs damaged by age, disease, or trauma, as well as to normalise congenital defects. Proposals should focus on prototyping, demonstrating and validating health innovations from TRL 5, moving beyond early-stage research to clinical development, testing, or eventual large-scale manufacturing. The previously funded EU research on which the proposal is build should be applicable to the field of regenerative medicine and should have clear exploitation potential and/or socio-economic benefits for the patients.

Applicants are expected to:

• Demonstrate in their proposal that the health product, therapy or service, has been successfully validated at preclinical level in the prior EU funded project and provide justification of the innovation potential with qualitative and quantitative data (e.g. publications, patent/trademark/design applications, spin-out/start-up track record, regulatory procedures, venture capital pitches, funds raised etc).
• Justify the proposed composition of the consortium and explain how this differs from the previous grant, and demonstrate how the health product, therapy or service to be developed further qualifies as regenerative medicine.
• Demonstrate adequate protection of the idea or Intellectual Property Rights or ensure freedom to operate until full deployment.
• Have a clear vision on the intended pathway to patients and/or route to market, including regulatory compliance. This includes defining specific milestones together with concrete and verifiable Key Performance Indicators (KPIs) to assess progress towards the market or healthcare settings.
• Identify the target patient group(s) (how many patients to be treated during the project and the potential patient population that could benefit) and product development milestones including a financial plan (for each milestone).

In the case of innovations with commercial potential, proposals should present the investor and market readiness towards commercialisation and deployment (market research, value proposition, business case and business model, prospects for growth, intellectual property protection, competitor analysis etc.) as well as aspects of regulation, certification and standardisation and reimbursement.

In the case of innovations with evidenced limited commercial potential but high patient benefit, proposals should contain a deployment and sustainability plan including aspects related to regulations, certification and standardisation and patient access through healthcare providers.

Proposals should take into account sex, gender, age and other relevant socio-demographic variables to ensure the scientific robustness, clinical value and applicability of the targeted regenerative medicine innovation.

Applicants should provide details of their clinical studies[3] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.

[1] https://research-and-innovation.ec.europa.eu/strategy/strategy-research-and-innovation/jobs-and-economy/towards-strategy-european-life-sciences_en; https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1686

[2] Commission Recommendation on critical technology areas for the EU's economic security for further risk assessment with Member States: https://defence-industry-space.ec.europa.eu/system/files/2023-10/C_2023_6689_1_EN_annexe_acte_autonome_part1_v9.pdf

[3] Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application.