Biotherapeutics to accelerate wound healing in patients with diabetes
| Reference number | |
| Coordinator | Uppsala universitet - Institutionen för medicinsk cellbiologi |
| Funding from Vinnova | SEK 2 300 000 |
| Project duration | September 2015 - September 2017 |
| Status | Completed |
Purpose and goal
In this project activities to execute activities for a first clinical proof of concept was included. During the project the biotherapeutics was classified an advanced therapeutic medical product as compared to a medical device meaning that the required documentation and safety data is considerably higher though with a higher reward. We are currently systematically working through the safety packages.
Expected results and effects
The result of the activities we have performed during the last two years, relating to this project but also to the whole project have taken the project significantly forward, from research stage to commercial drug development. In this project there was five work packages and they were fully or partly completed. In addition many more activities were performed, e.g. built a team, started ilya Pharma, established an execution plan and raised private capital.
Planned approach and implementation
The ATMP classification had the implication that the activities to reach clinical proof of concept are significantly more extensive as compared to if the product was classified as an advanced medical device. There are now three senior very experienced regulatory consultants experts in development of biological drugs tied to the project. The funding needed to reach the clinical data have been assessed based in the new information and the project is divided into smaller risk-limiting steps.