Lew Sheiner spent a 7‐month sabbatical stay in the company where I was working as a Clinical Pharmacologist 15 years ago. After this, he wrote a key paper entitled ‘Learning versus confirming in clinical drug development’ [1]. Lew foresaw that in the not‐too‐distant future, pharmaceu‐ tical companies would not only sell drugs with printed labeling but drugs with a software to guide the prescribers on the key elements to iden‐ tify the right drug, the right dose in the right patient with the right disease as guided by the right biomarkers! He already had in mind the concept of per‐ sonalized healthcare (PHC) and was already pro‐ moting the idea that PHC should be thought of at the same time as the target selection is defined. As always, Lew demonstrated his vision‐ ary skills... but we are not yet completely there! Very sadly, Lew died too early in 2004. In direct heritage with Lew Sheiner, the more recent paper from Lalonde et al. on model‐based drug development (MBDD) is highlighting the need for clinical pharmacologists to influence and lead drug‐development by using model‐ based drug development principles [2]. By sum‐ marizing MBDD in an excellent statement: “Models are essentially the knowledge reposi‐ tory for the data that are generated in clini‐ cal development programs”, Richard Lalonde underlines the possibilities for models to inte‐ grate knowledge on drug projects that could become drug products. However, we again have to realize that those data are mainly biomarkers. So, biomarkers are key to improving drug development but it is also important to ensure that they are appropriately used, in other words, that there is an integrated interpretation of what they mean. In this issue of Biomarkers in Medicine, several aspects of the challenges that biomarkers and integration by clinical pharmacology science are posing will be discussed. First, Dominic G Spinella (Biomarkers in clinical drug development: realizing the promise [3]) will review the variety of new technologies and approaches that have been attempted by the pharmaceutical industry, which were expected to bring ‘revolution’. But rather than revolu‐ tion, it was evolution and sometimes evolu‐ tion might be better than revolution. However, recently we have seen new positions such as ‘Translational Medicine Leaders’ joining our drug‐development teams. This is a big challenge for our clinical pharma cology colleagues but as described above by Richard Lalonde, they themselves evolved to become ‘knowledge inte‐ grators’ by developing their skills to be able to combine those new biomarkers into meaningful decision criteria markers. Clearly, the new early development teams now have more people on board, such as translational medicine leaders, biomarker and experimental medicine leaders and ... clinical pharmacologists!