Proof-of-Concept Efficacy Clinical Study
Regulatory Strategy with Scientific Input
Regulatory Operations
Need
- Approached by Japanese pharmaceutical company with an antiviral product intended to treat and prevent influenza, seeking approval for proof-of-concept (PoC) efficacy clinical study
- Assistance required for interactions with European agency to ensure efficient review of protocol and general clinical development plan
Approach
- Reviewed non-clinical data and non-clinical development program
- Prepared briefing package for scientific advice meeting with national European agency
- Liaised with European agency and ensured timely submissions for scientific advice meeting
- Coordinated European agency meeting with the client and managed all oral and written communications between the Japanese client and European agency
Benefits
- Extensive review of all submission information from the Celerion team enabled on-time and effective input from a European agency on the timing and acceptability of a proof-of-concept efficacy study, and acceptability of development plan allowed quick and immediate go-ahead decision for the client