The first‐in‐human (FIH) clinical trial is an important milestone for each development program. For small (bio)pharma companies the FIH trial requires a significant investment, and every sponsor wants to make sure that all is well set for starting the trial. It is indisputable that successful execution of the FIH trials does require sponsors to coordinate the task with thorough consideration and planning across many disciplines.
Especially, selection of the starting dose requires a cross‐functional collaboration, where preclinical knowledge needs to be transformed into clinical applications. This step could become a large hurdle which could even retard the progress of the program, if planned and strategic alignments are not reached within the project team as well as adequate actions are not taken well in advance of the FIH trial.
Open Orphan (LON:ORPH) was founded in 2017, with the goal of rapidly building Europe’s leading pharma services company by a management team with extensive industry and financial expertise. The company comprises of two commercial specialist CRO services businesses (Venn Life Sciences and hVIVO) and is also developing a genomics data platform business (Genomic Health Data).
