Deadline: 15-Mar-23
The European Commission (EC) is accepting proposals for Strengthening the European translational research ecosystem for advanced therapy medicinal products (ATMPs) for rare diseases.
Scope
The overall aim of this topic is to optimise and streamline the future development of ATMPs and other related innovative therapeutic modalities for rare diseases by strengthening the ecosystem that facilitates the transition of early pre-clinical proof-of-concept research to clinical development. This topic focuses on the scientific, technological and regulatory barriers that are limiting translational research into rapid and cost-effective development of ATMPs and other related innovative therapeutic modalities for rare diseases.
Funding Information
The check will normally be done for the coordinator if the requested grant amount is equal to or greater than EUR 500 000, except for:
- public bodies (entities established as a public body under national law, including local, regional or national authorities) or international organisations; and
- cases where the individual requested grant amount is not more than EUR 60 000 (lowvalue grant).
Expected Outcomes
- Research and innovation (R&I) actions to be supported under this topic must work towards results that contribute to all the following expected outcomes.
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A sustainable network of centres of excellence, that should:
- advance the most promising, impactful, translatable, quality-controlled technologies that address the bottlenecks in the development of ATMPs and other related innovative therapeutic modalities such as the use of messenger RNA (mRNA), or nucleic acids and nanoparticle (NPs) delivery for gene editing;
- make these technologies accessible to all actors involved in the development of ATMPs and other related innovative therapeutic modalities, including the research community, academia, clinics, small to medium-sized enterprises (SMEs), healthcare professionals, biotech, medical technology and pharmaceutical companies, and patients;
- share information, processes and methods, and build capacity in science and technology, and regulatory awareness of ATMPs, including the ability to assist industrial and academic developers of ATMPs in their translational research.
- Consensus reached on quality standards (e.g. of analytical methods) and translation process by the ATMP community at large that support the timely and robust development of ATMPs and other related innovative therapeutic modalities.
- Strengthened interactions with regulators to enable a more streamlined and transparent regulatory pathway that will optimise and speed up the development and delivery of ATMPs and other innovative therapeutic modalities for rare diseases for the benefit of patients, carers, healthcare systems and society.
- Improved technologies/processes, analytic tools, methods including non-clinical methods, and assays useful for the development of ATMPs and other related innovative therapeutic modalities, beyond those targeting rare and ultra-rare diseases.
Eligibility Criteria
To be eligible for funding, applicants must be established in one of the eligible countries, i.e.:
- the Member States of the European Union, including their outermost regions;
- the Overseas Countries and Territories (OCTs) linked to the Member States;
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eligible non-EU countries:
- countries associated to Horizon Europe;
- low- and middle-income countries.
For more information, visit European Commission.