TBVI provides a range of key services to support the R&D efforts of its consortium members and other partners. These include:
Project identification, design and development
TBVI initiates new projects when new funding opportunities arise. In line with it’s R&D strategy, TBVI sets the main parameters for the design of the project and actively reaches out to partners and links them to relevant key stakeholders to initiate new collaboration. It then works closely with partners to develop full project proposals.
TBVI manages and coordinates projects supporting partners with all administrative, financial and legal requirements for a grant or project.
TBVI mobilises resources for the TBVI consortium, for its individual members and for other partner vaccine developers. Resource mobilisation activities are focused on traditional as well as innovative funding sources involving governments, foundations and private sector partners.
Knowledge development, exchange, and networking
To optimise the discovery and development of new TB vaccines and biomarkers, TBVI facilitates and supports the generation of new knowledge and exchange among R&D partners. TBVI creates an enabling environment for consortium members to promote knowledge sharing through scientific meetings and workshops, publication in scientific and non-scientific journals, formal and informal networking.
Technical support for product and clinical development
To move a good scientific idea or novel concept into a useful product, TBVI provides technical support for product and clinical development. TBVI’s Product & Clinical Development Team (P&CDT), comprised of independent, top vaccine R&D experts, is charged with furthering the development of the candidates prioritised by the TBVI portfolio management process. P&CDT advises and guides vaccine researchers and developers while they move their candidates from concept to clinical development. P&CDT supports the definition of a final target product profile (TPP) and the development of subsequent plans for product development, characterisation and clinical testing.
P&CDT experts provide the following services to support, advise and guide vaccine researchers and developers:
- identifying vaccine candidates and the needs to enter into focused preclinical development;
- addressing production issues, cGMP requirements, product specifications;
- advising on animal studies and specific preclinical development requirements to move the candidates forward;
- assisting in the preparation of vaccine candidates for the subsequent phases of clinical trials;
- assisting in meeting regulatory requirements;
- planning and preparation of clinical studies;
- providing expertise to evaluate clinical test sites;
- establishing partnerships with clinical investigators;
- guidance during Phase I, II or III clinical trials.