Towards a European production of stable isotopes for novel nuclear medicine therapies (SAMIRA/ERVI)

Expected Outcome: the project results are expected to contribute to the following outcomes: support for the development of EU production of stable isotopes that are essential for the manufacturing of radionuclides used in novel nuclear medicine therapies; strengthening of the resilience and security of the EU medical radioisotope supply chain by securing access to source materials, reducing dependence on third countries and enhancing industrial-scale production (including the sourcing of stable isotopes); leveraging of the knowledge and expertise of nuclear scientists, physicists and engineers in order to develop and optimise the processes for the EU-based production of stable isotopes, while contributing to Europe’s Beating Cancer Plan and implementing the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA). Scope: radiological and nuclear technologies are integral to modern healthcare. They play a crucial role in cancer care – from early detection and diagnosis to treatment and palliative support. They also support the diagnosis and management of a wide range of other conditions (including cardiovascular and neurological diseases). Each year, patients throughout the EU benefit from the application of nuclear medicine in the diagnosis and treatment of cancer and other serious conditions. Innovations such as targeted radionuclide therapy (also known as radioligand therapy) are reshaping medicine by enabling more precise and personalised treatment. Medical radioisotopes are essential both for diagnostics and for an expanding array of therapeutic applications (particularly in oncology). The EU’s supply of innovative radiopharmaceuticals for cancer therapy faces growing risks due to uncertainties over the availability of rare stable isotopes that are imported from Russia. One key concern is the availability of precursor materials for medical radioisotope production (particularly Yb-176, which is essential for innovative medicines in the EU). The EU’s reliance on Russia for Yb-176 and other stable isotopes is a strategic vulnerability. Reducing dependence on foreign suppliers and diversifying the supply chain will enhance the EU’s resilience and security of supply. This action aims to mitigate supply risks by establishing the secure and sustainable production of stable isotopes. These include Yb-176, which is essential for Lu-177 manufacturing and is the main component of radiopharmaceuticals like Lutetium-177-PSMA (used to treat prostate cancer) and Lutetium-177 Dotatate (used in therapies against neuroendocrine tumours). The production of other stable radioisotopes to produce emerging alpha and beta emitters for targeted radiotherapy is considered in this call (e.g. Gadolinium (Gd) essential for Terbium (Tb) isotopes manufacturing). This will widen the portfolio of therapeutic radioisotopes and theragnostic pairs of radioisotopes in order to provide patients with personalised options in nuclear medicine for both diagnostics and therapy. A key objective is to develop innovative, scalable and cost-effective methods for producing stable isotopes (particularly Yb-176), thereby reducing dependency on external suppliers and enhancing strategic autonomy. Ensuring a consistent and reliable isotope supply will enhance nuclear medicine therapies, thus benefit patients while strengthening the EU’s long-term resilience in the field. Interdisciplinary collaboration will be essential in achieving this goal. The initiative should also foster partnerships with industry, policymakers and healthcare professionals, thus ensuring a comprehensive approach that aligns production capacity with clinical and commercial needs. Engaging stakeholders throughout the nuclear medicine value chain will enhance feasibility, scalability and market integration. In addition to securing isotope supply, this action should stimulate innovation, attract investment and drive economic growth, thus reinforcing the EU’s leadership in nuclear medicine while also creating new opportunities in the sector. This action should focus on closer-to-the-market activities (including prototyping, testing, demonstrating, piloting and scaling up new or improved products or processes). Proposals may include limited R&D activities. Activities are expected to focus on technology readiness levels 5 to 7 (indicative but not mandatory, depending on the innovative potential of the field). The Commission recommends that consortia should use the JRC’s services where appropriate. The JRC may participate in the preparation and submission of the proposal. The JRC would bear the operational costs for its own staff and research infrastructure operational costs. The JRC’s facilities and expertise are listed in General Annex H to this work programme.

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