Optimising bench science to withstand regulatory scrutiny

Abstract

The EU commission has on numerousoccasions acknowledged that SMEs and research spinoffs are an intellectual driving force within the EU. The EU commission has also provided numerous funding initiatives to foster academic pursuit per se as well as state of the art research having a commercial/commercialisation prospect. However, translation of bench science to the clinic is a huge endeavour, where academics are seldom prepared for the challenges they face when taking laboratory findings to commercialisation (this would include also patent application and status). Furthermore, a proportion of drug discovery efforts fall through at the Regulatory approval process stage, and, although “unquantifiable”, it is assumed that during negotiations between academic spinoffs and start-ups with angel investors and the pharmaceutical industry, a devaluation of the academic work might occur. One of the reasons might be that academic efforts and scientific data generated do not withstand regulatory scrutiny. This aspect is not surprising since there is an un-heightened awareness of pharmaceutical regulatory concepts within academia.