The Italian Nanomedicine Platform (INP) aims to establish a solid technical and scientific foundation for the development of advanced and precision medicine products in the therapeutic, diagnostic, and preventive fields, aligning with leading European technological platforms. INP is essential for fostering collaboration across various universities and centers of excellence, promoting high-value research and applied innovation. By integrating expertise in areas ranging from basic research, chemistry, and formulation to preclinical testing, INP facilitates the progression of projects towards higher TRL levels. The platform brings together disciplines such as physics, engineering, biomedicine, and regulation to develop innovative strategies, positioning INP as a key player in international research. Additionally, INP emphasizes cross-sectoral expertise in regulatory and safety requirements, ensuring successful translation into clinical and industrial contexts.
AIMS
- The Italian Nanomedicine Platform (INP) aims to create a technical-scientific foundation for products in advanced and precision medicine for therapeutic, diagnostic, and preventive applications.
- The platform fosters collaboration between universities and centers of excellence, promoting research with both applied and non-applied objectives.
- INP coordinates and shares knowledge across multiple disciplines, from basic research to chemistry, formulation, and preclinical testing, to reach high Technology Readiness Levels (TRL).
- Expertise from various fields, including physics, engineering, biomedical sciences, and legislation, are integrated into nanomedicine projects.
- INP supports researchers in developing innovative medical solutions, such as drug delivery systems, diagnostic tools, medical devices, and regenerative medicine.
- The platform includes regulatory, technological, and safety expertise to ensure product approval and market entry.
- INP focuses on creating a transversal planning system with impacts on technology transfer, industrial production, healthcare, and education.
- INP aims to train specialized professionals for the growing nanomedicine sector.
ORGANIZATION
In line with European Technology Platform for Nanomedicine, INP will be organized in WGs with dedicated AIM and initially coordinated by prof. Giovanni Tosi (University of Modena and Reggio Emilia).
Working Groups – Italian Nanomedicine Platform
WG 1 – Nanotherapeutics and Nanodiagnostics
Scope
The “Nanotherapeutics and Nanodiagnostics” Working Group focuses on the development of therapeutic and diagnostic nanosystems addressing unmet clinical needs. The WG covers the full spectrum of advanced nanomedicine approaches with a strong emphasis on translational impact.
Main Topics
Nanoformulations, drug delivery systems, nanodiagnostics, gene and mRNA therapy, targeting strategies, combined drug/device systems, nanotheranostics.
Objectives
- Map competencies, technologies, and infrastructures with Technology Readiness Levels (TRL) between 2 and 6.
- Identify and promote synergies among universities, research centers, clinical institutions, and industry.
- Foster joint project proposals and targeted collaborations for the development and testing of innovative nanomedicine solutions.
WG 2 – Regenerative Medicine
Scope
The “Regenerative Medicine” Working Group addresses the application of nanotechnologies to tissue regeneration and tissue engineering.
Objectives
- Build an interdisciplinary network involving biologists, pharmacologists, clinicians, and engineers.
- Coordinate research activities on scaffolds, nanofibers, biomaterials, and combined or self-repair systems.
- Promote collaboration with IRCCS and university hospitals to facilitate clinical translation.
WG 3 – Bio/NanoMaterials
Scope
The “Bio/NanoMaterials” Working Group is dedicated to the design, synthesis, and characterization of bio- and nano-hybrid materials for therapeutic, diagnostic, and regenerative applications.
Objectives
- Define shared standards for material synthesis and characterization.
- Map materials and technologies with potential TRL ≥ 3.
- Support scalability and foster interaction with the “Regulatory and Industrial Transfer” Working Group.
WG 4 – Clinical Translation
Scope
The “Clinical Translation” Working Group aims to bridge the gap between preclinical research and clinical application of nanomedicine-based solutions.
Objectives
- Identify priority clinical needs and relevant validation models.
- Promote multicenter studies and translational validation pathways.
- Integrate preclinical data with personalized and precision medicine approaches.
- Address clinical and regulatory requirements from the earliest stages of project development.
- Actively involve clinicians, IRCCS, and hospitals belonging to excellence and reference networks.
WG 5 – Preclinical Evaluation and Safety
Scope
The “Preclinical Evaluation and Safety” Working Group focuses on proof-of-concept efficacy, toxicology, and safety assessment of nanosystems in clinically relevant disease models, within a regulatory framework.
Objectives
- Collaborate closely with the “Physico-chemical Characterization” Working Group.
- Establish a shared database of in vitro and in vivo models with clinical relevance.
- Map GLP-certified laboratories available at the national level.
- Define common standards and reproducibility procedures.
- Integrate complementary in vitro and in silico models.
WG 6 – Physico-chemical Characterization
Scope
The “Physico-chemical Characterization” Working Group is dedicated to advanced physico-chemical characterization of nanomaterials and nanosystems.
Objectives
- Implement harmonized characterization protocols at the national level.
- Promote sharing of infrastructures and analytical instrumentation.
- Support all Working Groups in material validation and data quality assurance.
- Identify and share priorities in assay cascades aligned with regulatory needs (e.g. ISPRA, JRC).
WG 7 – Regulatory and Industrial Transfer
Scope
The “Regulatory and Industrial Transfer” Working Group acts as an interface between research, industry, and regulatory authorities (EMA, AIFA, Farmindustria), supporting technology transfer and innovation uptake.
Objectives
- Identify regulatory barriers and propose guidelines for nanotechnology-based products.
- Support development pathways from TRL 6 to TRL 9.
- Facilitate public–private partnerships and spin-off creation.
- Integrate expertise on regulatory requirements for approval dossiers of new drugs, innovative formulations, and medical devices.
WG 8 – Educational and Training
Scope
The “Educational and Training” Working Group focuses on advanced education and capacity building in nanomedicine and nanotechnologies.
Objectives
- Develop continuous training programs in nanomedicine and related technologies.
- Integrate early-career researchers, PhD students, and postdocs into WG activities.
- Support and coordinate summer schools, interdisciplinary courses, and European exchange and training programs in collaboration with ETPN and other platforms.
