Catalysing the journey from discovery to clinical impact
NIVI Development is the translational arm of the Novo Nordisk Foundation Initiative for Vaccines and Immunity (NIVI). Our role is to catalyse the journey from scientific discovery to clinical impact, ensuring that promising vaccine candidates can traverse the ‘valleys of death’ between early research and clinical development.
As part of NIVI’s broader vision to develop new or improved vaccines against respiratory pathogens, our mission is to enable the development of vaccines that generate robust, durable, and broad protection in the airways. We achieve this by combining our in-house vaccine development expertise with strategic external collaborations across the public and private sectors.
Combining in-house expertise with a strong partnership network
We advance promising new vaccine candidates that either originate from the NIVI Research Center or are developed through new strategic partnerships. Our capabilities are complemented by a network of external partners across academia, biotech, CROs, CMOs, clinical trial sites, and industrial collaborators.
In-House Capabilities
- Project and portfolio management
- Preclinical and clinical vaccine development
- CMC and regulatory
- Business development
External Partnerships
- Access to new technologies and vaccine platforms
- Technology transfer and manufacturing capabilities
- Clinical trial infrastructure
- Specialized scientific, clinical, and regulatory expertise
Strengthening infrastructure for vaccine innovation
Our impact extends beyond advancing individual vaccine candidates. NIVI Development also plays a role in strengthening the scientific, translational, clinical, and regulatory infrastructure required to develop innovative vaccines against respiratory pathogens.
Through our work in preclinical and early-phase clinical development, we generate new data, insights, and development approaches that can inform future NIVI programmes and benefit the broader vaccine research ecosystem.
NIVI Development contributes by
- De-risking innovative vaccine concepts and development strategies
- Establishing new alliances that bring together strengths from the public and private sectors
- Building translational and clinical infrastructure that can advance promising vaccine candidates and improve understanding of mucosal immunity mechanisms
Streamlined vaccine development pathways
Our project management and business development expertise ensure streamlined, end-to-end vaccine development pathways, from early discovery through Phase 1 and Phase 2 clinical development.
Once NIVI has a promising lead vaccine candidate supported by early clinical data, the full vaccine package – including intellectual property, preclinical and clinical data, and manufacturing know-how – is out-licensed to a commercial or manufacturing partner for further development, large-scale manufacturing, and market access under global access and revenue-sharing agreements. Any revenue generated is reinvested in NIVI.
Strategic partnerships & alliances
NIVI Development builds strategic partnerships with academic groups, technology developers, CROs/CMOs, clinical partners, and industry experts to extend and complement our in-house capabilities.
These alliances enable access to advanced vaccine technologies and platforms, efficient technology transfer and GMP manufacturing scale-up, design and oversight of clinical trials, and provide specialised expertise.
Through this partnership model, NIVI Development can establish new consortia tailored to oversee the clinical and manufacturing programmes for each vaccine candidate.
Innovative clinical trials
NIVI Development works with clinical partners to oversee Phase 1 and Phase 2 clinical trials of promising vaccine candidates.
Our clinical trials focus on innovative clinical concepts and endpoints that enhance understanding of vaccine mechanisms of action and mucosal immunity, contributing to NIVI’s broader focus on immunity against respiratory pathogens.