A university cyclotron network with shared regulatory files for new tracers
Most new cancer imaging agents and radioactive drugs start in university hospitals. A network sharing production, quality files and regulatory paperwork would get them into multi-centre trials years faster.
Overview
Academic radiopharmacy has repeatedly produced the agents the field now runs on (PSMA ligands and FAPI tracers from Heidelberg, DOTATATE from Basel and Rotterdam) but each centre re-creates production, quality control and regulatory documentation. A funded network of university cyclotrons and radiopharmacies would share drug master files, validated synthesis modules, GMP quality systems and a common clinical trial application template, so a tracer validated in one centre can be adopted in ten within months. It would also provide isotope purchasing at scale (gallium-68 generators, lutetium-177, actinium-225 allocation) for academic trials.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
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