In the past four decades, the biopharmaceutical industry has undergone huge transformations after a long period of gradual changes. Although the industry was rather successful up to the 1970s as measured by the number of new medications, since then, despite the exponential growth of technological means, the industry finds itself in a crisis. This so-called innovation gap, which is clearly visible given the increasing spending on R&D while the number of new drugs on an annual basis has stagnated for the last 30 years, has stirred many discussions as to its causes.

This section attempts to describe the structural and cultural elements that arguably have had a strong contribution to the innovation gap, yet are difficult to quantify. Translational science, as a pharmaceutical discipline and mindset, has been pointed out as a significant element to regain profitability of R&D. With the wider use of biomarkers, success rates can improve by allowing for much earlier selection of successful projects that reveal clinical meaningful results.

The implementation of such new organizational structures accompanied by the introduction of modern technologies does not come without challenges. Companies and institutions need to acknowledge these challenges. Although it is not clear when we will arrive at a breakeven point, the industry must remain flexible in dealing with these rapid technological and social-economical changes and accept that shortcuts may be penalized by costly failures.