Abstract

Even though the landscape has evolved sensitively during the last decades, the method of developing a drug - the technology - did not…or should not have changed. However, as mentioned in previous opinions, the emergence of startups in life sciences has left room for brilliant scientists and scientific managers. Nevertheless, it seems that for many of them, their time is spent focusing mainly on the science, which is not a bad thing of course, but entrepreneurs should also maintain the flame and passion in their technology. They seem to forget that more than one government agencies, such as FDA, EMA, Health Canada, and the drug development itself are highly conservative and are huge fans of the KISS (Keep It Super Simple and Safe or …Stupid) approach. For that reason, startups and scientific entrepreneurs should be well surrounded by seasoned drug developers. Science will never be better than regulatory requirements.

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