Case study
Overview
TFS was selected by this small European biotech company to develop provide full service support during the development of their genetically modified bacteria producing human proteins for improving wound healing. This ongoing study is a phase 1/2a study investigating the topical efficacy of the investigational medicinal product (IMP).
The phase 1 part is a multi-centre, open-label, non-randomized, uncontrolled dose-finding study. Each cycle of treatment lasted 2 weeks with 3 administrations of IMP per week on alternate days. Treatment cycles were sequentially administered, without treatment breaks. The actual treatment duration with IMP depended on the level of healing during treatment and was to be discontinued once the target ulcer was completely closed or when 3 cycles of treatment were completed (6 weeks of treatment). Extension of treatment beyond 3 cycles (6 weeks) was allowed on a case-by-case basis for maximum of additional 2 cycles (4 weeks).
Challenges
Germany
- Very high Investigator Fees
- Sites’ interest low due to study complexity – specific sites searched (having phase 1 unit & capacity/experience to deal with IMP)
- Late changes to exploratory objectives, requiring retrospective data collection close to DBL
- Regulatory challenges – close contact with competent authority (CA) necessary
- Crucial for client to deliver Top Line Results according to agreed and communicated timelines
Poland
- Complex and long registration process for Genetic Engineering Unit (GEU) – close contact with authorities (Ministry of Environment) and sites
- Sites identification was difficult due to study complexity – specific sites searched (having phase 1 unit & capacity/experience to deal with IMP)
