Infrastructure to produce Phase 2/3 radiopharmaceuticals
This initiative focuses on the centralized production of radiopharmaceuticals for clinical studies beyond phase 2, aiming to streamline development and accelerate patient access. The in-house development of radiopharmaceuticals is sufficient for early research phases, first in man and phase 1 clinical trials, but once a radiofarmaceutical reaches phase 2 or 3 clinical trials, the production capabilities of hospitals are too small for the amount of patients in these trials. By centralizing regulatory paperwork and production infrastructure, it reduces duplication across institutions, enables national‑level patient inclusion, and allows participation of peripheral hospitals. This approach shortens study timelines, lowers costs, and increases the attractiveness of promising radiopharmaceuticals for industrial investment. The initiative is currently in an early implementation phase, with key partners aligned and existing infrastructure identified for initial use. The initiative wants to demonstrate the feasibility using a case driven approach using Ga‑68‑labelled FAPI, with intellectual property held at Erasmus MC and applications in diseases with therapeutic potential. Funding opportunities, such as support from PharmaNL, are being explored to advance the next steps.