To date, the project is proceeding overall as planned with a few deviations. The deviations were all solved during the first reporting period. The work in the first half of the project is primarily analytical technology transfer and validation of the research production process in preparation for the production of product required for the toxicology studies. The project is managed by Karin Agerman who coordinates all the work performed by the team and by subcontractors. The quality of the clinical activities (including preparation of the clinical trial) is secured by an on-going scientific and clinical management. A scientific advisory board, assembled in November 2018, evaluated the pre-clinical program, identifying gaps in the current data in preparation for the first clinical study. Additionally, a clinical advisory board met in April 2019, in London, where the clinical study design was reviewed. CombiGene received valuable feedback which will guide us in the planning and execution of the clinical trial. The critical risks affecting the project have been identified, assessed and analysed in order to mitigate the impact and ensure the overall efficiency and continuity of the project activities. In the first reporting period, CombiGene did not encounter any problems related to project management. CombiGene invested in additional human resources, hiring new consultants and strengthening the board with one new team member. Throughout the year CombiGene’s team has been actively disseminating and communicating the results and progress of the work to various groups of stakeholders. Members of the CombiGene team delivered numerous presentations and speeches during side events and scientific conferences.
In the second reporting period, the project has been further delayed. CombiGene encountered difficulties in the execution of Task 2.4 which impacted the timeframe of the remaining tasks in WP2 and WP3. The impact of this deviation was immediately assessed and corrective actions were implemented. Apart from the deviation in Task 2.4 the pace of work in PR2 was significantly impacted by the Covid-19 pandemic and imposed national regulations, recommending work from home as well as associated closure of clinics and laboratories. To mitigate the impact of Covid-19 pandemic and associated country lockdowns, the team held numerous video conference meetings, instead of in-person meetings. New communication channels and procedures were established to continue the work as planned, despite the difficulties.
Although CombiGene experienced these delays the project moved forward and delivered promising outcomes and lessons learned by the team. Work in WP3 was initiated and the CROs for the planned studies were selected. Three pre-clinical preparatory studies were completed and a draft Study Protocol for tox and biodistribution study was prepared. Dialogues, on study design and interest to participate in the first clinical study, were initiated with KOLs. Members of the CG team delivered numerous presentations and speeches during side events and scientific conferences. CombiGene has presented the project and its underlining research at more than ten conferences and clinical events.
