As a pandemic hub, the «Centro nazionale anti pandemico-CNAP» focuses on the development and production of vaccines and monoclonal antibodies for the treatment of emerging epidemic and pandemic diseases. For these activities, the Fondazione Biotecnopolo will make use of first- and second-level spoke centers, as well as pathogen sequencing networks, ensuring the necessary interactions with centers involved in the development of vaccines according to the One Health model.
The «Centro nazionale anti pandemico» (CNAP – National Pandemic Center) performs its functions within the initiatives of the «Innovative Health Ecosystem» intervention of the National Plan for Investments complementary to the National Recovery and Resilience Plan (NRRP).
The national preparedness activity of the CNAP aims at:
- investigating, mapping and reducing the risk of emerging infectious diseases;
- mitigating, preventing and detecting potential outbreaks;
- monitoring, in the presence of epidemic emergencies, the degree and impact that the health crisis causes in different sectors, including non-health sectors;
- maintaining and encouraging multidisciplinary and interdisciplinary research activities toward particular pathogens with epidemic and pandemic potential;
- encouraging the implementation of programs for research, innovation and technology transfer to the production system in the field of biotechnology applications aimed at human health protection, with special focus on new vaccines and monoclonal antibodies against emerging infectious diseases and their clinical development until their safety and initial efficacy are demonstrated;
- encouraging research on solutions to antibiotic resistance;
- developing and producing pilot batches for emergency use;
- ensuring liaisons with government agencies responsible for national and foreign security.
Through the CNAP, the Fondazione Biotecnopolo is required to identify the national intervention strategy to address future epidemics through the following macro areas:
- research, development, testing, pilot and small-scale production of mRNA vaccines;
- research, development, testing, pilot and small-scale production of vaccines against antibiotic-resistant (AMR) bacterial pathogens based on reverse vaccinology;
- development of technologies to support the evolution of vaccines and monoclonal antibodies and anything else useful and necessary to counter pandemics;
- other useful initiatives in pursuit of the above purposes.
The CNAP makes use of research laboratories, pilot development and production facilities and other technical and scientific expertise to support its research and development activities, as well as a network for conducting clinical trials in coordination with the Italian Drug Agency.
The CNAP is committed to producing the doses needed for clinical trials and for initial use and emergency intervention. The pilot plant has the capacity for the development, scale-up, production, filling and release for clinical use of vaccines and drugs. Using a structurally organized network of collaborations, it designs, implements and coordinates clinical trials.
The CNAP has its own highly qualified expertise in the following fields: virology, bacteriology, molecular biology, RNA, structural biology, advanced materials for vaccine and monoclonal delivery, data science to analyze molecular structures of antigens and RNA, genomes, and imaging. Some of the expertise can be acquired through collaborations with centers of excellence identified for the purpose.
In conjunction with national security authorities, the CNAP also performs functions to enforce, implement, and monitor biosafety and biosecurity measures to ensure the protection of personnel and the environment.
Finally, the CNAP will ensure coordination with the activities of the National Centers contemplated in the investment of the National Recovery and Resilience Plan for the following topics: «Gene Therapy and Drug Development with RNA Technology» and «High Performance Simulation, Computing and Data Analytics».