Reijo Salonen and I had an enjoyable and lively session during our talks couple of weeks ago in Turku. His topic, “How to Successfully Fail in Drug Development” sparked a lot of interest!
Drug development is very challenging, and it starts from the beginning of the process. The striking finding is that more than 80% of results for target identification in academic laboratories are not replicated in an industry setting. Once a molecule is ready to go into man, 50% of drug candidates fail in Phase 3 clinical studies. Also, the external environment changes along the way, with competitors appearing, regulations changing, and key advocates leaving the company.
What can be done about it? Reijo discussed several options to improve the chances including using human in vitro data as much as possible, using adaptive clinical trial designs, getting an outside review of your projects and communicating with stakeholders every step of the way.
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