The project «EuroSkinGraft» deals with a novel generation of skin substitutes to clinically treat a broad spectrum of severe skin defects. EuroSkinGraft is coordinated by Prof. Dr. Ernst Reichmann, University of Zurich. TBRU is in this context in charge of Workpackage 4 and 9.
WP4 – The GMP production of denovoDERM and denovoSkin and their adaptation to clinical requirements. The main objective of WP04 is the GMP production of the two skin grafts, designated denovoDerm and denovoSkin. For Phase 1 and 2 clinical trials, safe and highly functional denovoDerm and denovoSkin are to be routinely produced under GMP conditions in the three clinical centres. Phase 3 clinical studies are envisaged thereafter. The major objectives of WP04 are:
- Objective 1: Establishing and optimizing the GMP-production process of denovoDerm and denovoSkin in a brand new GMP-facility.
- Objective 2: GMP production of the denovoDerm and denovoSkin for the Phase1 and Phase2 clinical trials.
- Objective 3: The permanent adaptation of the two types of skin substitutes, denovoDerm and denovoSkin to clinical requirements throughout the duration of the project.
- Objective 4: Transfer of the technology to produce the denovoDerm and denovoSkin to Partner 02 (VUA) and the Partner 03 (UKB), to enable these to produce the substitutes at place.
- Objective 5: Dissemination of the corresponding data and technology
WP9 – Project Management. The WP09 objectives are the effective management of the EuroSkinGraft project. To achieve this objective we will exercise the following tasks:
- Make sure that the participants achieve the objectives, complete the milestones in time and deliver the deliverables.
- Make sure that the consortium's contractual duties are carried out. Advise and guide the Participants to comply with the EU regulations and their contractual and legal requirements.
- Set-up an effective communication infrastructure and foster the integrative process within the consortium.
- Manage the processes for the capture and the protection of intellectual property, including confidential information and patents properly.
- Ensure that knowledge produced within the project is disseminated to the relevant target groups through the annual reports.