Funding is undoubtedly one of the major challenges small and medium-sized companies face when developing a new therapy from the bench to the clinic and eventually to the market. Suitable partnerships and potential mergers and acquisitions are key drivers to take a drug development programme to the next stage. The investors in these programmes do so to gain a benefit, and this is often related to the potential returns upon successful completion of the programme or the platform of consideration.

Due diligence activities should be conducted to ensure the return on the investment is plausible and holds a level of risk the investor is willing to undertake. This article explores some of the main challenges in the due diligence task performed for a drug in early development and highlights key recommendations and example issues observed to allow for a successful due diligence activity that focuses on the major risks in completing drug development and eventual approval.