Background: Radiopharmaceutical development typically involves fragmented workflows across multiple institutions, creating barriers to clinical translation. We have established the integrated Radiopharmaceutical Sciences (iRPS) program within a comprehensive cancer centre, unifying target discovery, peptide optimization, radiochemistry, and clinical implementation under a single platform to accelerate theranostic development.
Methods: The iRPS platform combines four integrated components: (1) mRNA display technology for high-throughput target identification from 10¹² cyclic peptide libraries, (2) peptide structure-activity relationship platform for parallel optimization of lead compounds, (3) innovative structural modifications including constrained peptide design and novel chelator conjugation strategies, and (4) scalable clinical-grade radiochemistry achieving high radiochemical purity. Uniquely positioned within Peter MacCallum Cancer Centre, this platform enables seamless progression from bench discovery to bedside application, leveraging direct access to clinical expertise, patient populations, and imaging infrastructure.
Results: The integrated platform has produced >1000 peptides in the last two years and has led to the development of three novel optimized radiopharmaceutical candidates with sub-nanomolar affinities ready for clinical translation, supporting the world's largest hospital-based theranostic program with >1200 annual patient treatments. Clinical translation capabilities include first-in-human studies across multiple targets (¹⁶¹Tb-PSMA, ⁶⁸Ga-DPI-4452), 10+ active clinical trials, and regulatory-compliant manufacturing producing >1000 patient doses annually. The cancer centre environment provides real-time clinical feedback, enabling rapid optimization cycles and immediate clinical validation of new agents.
Conclusions: The iRPS platform demonstrates how integrated radiopharmaceutical development within a clinical cancer centre accelerates translation timelines while ensuring clinical relevance. This model bridges the traditional gap between academic discovery and clinical application, establishing a sustainable framework for next-generation theranostic development with direct patient impact and significant commercialization potential through industry partnerships.