Theranostic Hub – The BioHub for Advanced Diagnostic and Theranostic
Hosting Entity: Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” IRST IRCCS
Mission and Strategic Focus
The Hub aims to accelerate precision oncology by integrating radiopharmaceutical production, multi-omics diagnostics, advanced imaging, and AI into a single, coordinated theranostic ecosystem that delivers personalized medicine.
CORE PILLARS:
- Integrated theranostics: Develoment and production of GMP (Good Manufacturing Practice) radiopharmaceuticals and combine them with omics and imaging data to guide diagnosis, therapy selection, and treatment monitoring.
- Data-driven precision medicine: Generation and integration of multi-omics, radiomics, and clinical data to create actionable diagnostic, prognostic, and predictive signatures.
- Translation to patients: Shortening the path from discovery to first-in-human studies through coordinated clinical, regulatory, and manufacturing workflows.
Through shared R&D platforms and biobanks, access to GMP infrastructures and digital tools, and structured technology transfer and international partnerships enabling multicentre innovation.
IMPACT:
- Technological: The Hub advances clinical-grade theranostics by enabling integrated development of radiopharmaceuticals, multi-omics biomarkers, and AI-based imaging tools, supporting validation and first-in-human studies.
- Economic/Industrial: The Hub supports SMEs and industry through access to GMP production, shared infrastructures, and technology transfer services, reducing development time and de-risking investment in precision medicine technologies.
- Social/Sustainability: The Hub improves patient outcomes and healthcare efficiency by enabling earlier diagnosis, personalized therapies, and optimized treatment monitoring, while reducing ineffective treatments and unnecessary procedures.
Infrastructure
Located in Meldola (FC), the BioHub hosts integrated infrastructures supporting the full theranostic pipeline, from radioisotope production and radiopharmaceutical manufacturing to advanced imaging, multi-omics analysis, and clinical application. The facilities enable prototyping, validation, and GMP (Good Manufacturing Practice) scale-up, accelerating translation from research to patient care.
KEY ASSETS:
- Radiopharmaceutical Production Facility (GMP compliant): end-to-end manufacturing of diagnostic and therapeutic radiopharmaceuticals.
- Cyclotron Facility: on-site isotope production (e.g. F-18, C-11, Ga-68, Lu-177).
- Hot Cells & Automated Radiochemistry: safe handling, synthesis, and labeling of radioisotopes.
- Quality Control & GMP Clean Rooms (Grade A/B/C/D): sterility, purity testing, and aseptic formulation.
- Advanced Diagnostic Imaging Facility: PET, SPECT, hybrid systems (PET-CT, PET-MRI), MRI, CT, and infusion suites.
- Omics & Translational Laboratories: genomics, proteomics, metabolomics, and bioinformatics for biomarker discovery.
- Radiomics & Imaging Genomics Laboratory: AI-based image analysis and multi-omics integration.
- Clinical Theranostics & Supporting Facilities: targeted radionuclide therapies, dosimetry, safety, logistics, and regulatory compliance.
OUR SERVICES
R&D and Innovation Support
- Tailored guidance for research and innovation projects
- IP consultancy and regulatory support compliant with IAEA, FDA, EMA, GMP, and ISO standards
Facility / Lab Access
- Access to shared laboratories, pilot lines, testbeds, GMP-compliant clean rooms, and state-of-the-art radiopharmaceutical, imaging, and multi-omics platforms.
Finance and Investment Support
- Assistance in identifying EU programmes, national and regional funding schemes
- Support in the identification of private investment opportunities
Technology Transfer Services
- Support for business plan development
- IP management
- Licensing
- Commercialization
- Networking with research and clinical partners
Training and Capacity Building
- Specialized programs to strengthen skills in research, entrepreneurship, and innovation
Internationalisation Support
- Global networking
- Participation in international conferences and fairs
- Matchmaking with key stakeholders.
Science communication
- Public engagement activities to increase awareness of biomedical innovation and its societal impact
INTERNATIONAL COLLABORATIONS & PARTNERSHIPS
International partnerships are essential to the BioHub’s growth, providing access to complementary expertise, advanced infrastructures, and European Union programmes, while supporting scaling, sustainability, and international visibility.
Collaborations enable joint research and innovation, technology transfer, skills exchange, and alignment with international regulatory and quality standards, accelerating translation from research to clinical and industrial impact.
KEY PARTNERSHIPS:
- McGill University – Canada
- Focus: big data, artificial intelligence, and precision medicine.
- Benefit for the Hub: strengthened capabilities in artificial intelligence–driven radiomics and multi-omics integration, increased competitiveness in international calls.
- Centre for Genomic Regulation (CRG) – Spain (research institute)
- Focus: functional genomics, systems biology, and translational research.
- Activities & outputs: framework agreement supporting joint publications, high-impact multinational projects, and researcher exchanges for advanced training.
- Benefit for the Hub: enhanced genomics expertise, skills development, and stronger positioning in competitive European research programmes.
INFORMATION REQUEST
MedTech Hub
Hub for Innovation in MedTech, 3D Bioprinting & Device Manufacturing
BioFood Hub
Hub for precision fermentation and sustainable food production
Translational Hub
Translational BioHub for innovative therapies
BioSpac-ER Hub
Biomaterials and Biolectronics Hub for One Health and Space
Theranostic Hub
The hub for combining therapeutic and diagnostic capabilities
BioHub on AI for Medicine
Hub for AI for medicine and multimodal bioinformatics
