Work Plan
Overall, 9 work packages (WPs) will work together to ensure the success of the project.
The development of the novel multifunctional biomaterials will occur in WP1 Design and optimization of multifunctional biomaterials (WP lead: CIBER) and WP2 Physicochemical characterization tools and definition of critical quality attributes (CQA) (UM & IT).
The efficacy of the novel biomaterials will be evaluated using in vitro and ex vivo models for antimicrobial and wound healing capacity in WP3 Efficacy evaluation (in vitro, ex vivo, in vivo) (CH).
The most promising candidates in terms of physicochemical characteristics, antimicrobial, and wound healing activity will be scaled up and manufactured considering GMP in WP4 Scale up and CMC (MyB).
These systems will have the required quantity and quality to carry out the in vivo evaluation of efficacy and toxicology, in mouse models (WP3 and WP5 Biocompatibility and safety evaluation (IMI)), according to the regulatory guidance provided by WP6 Regulatory aspects and ethics (ASPH).
Work packages dedicated to regulatory aspects, business case and exploitation and stakeholder involvement (WP6, WP7 Business Development and Exploitation (NT & HCELL), WP8) will be focused to the translation from research to commercialization.
All these WPs will closely collaborate with WP8 Dissemination, Communication and Stakeholder involvement (BNN).
Coordination activities will be performed in WP9 Project and Data Management (CIBER).
