Adam Steensberg Tad

Please cite this article in press as: Steensberg, A. Beyond biomarkers in drug discovery and d 1359-6446/ 2014 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.drudis.2014.12.009 market; this is no longer a certainty. Today, most new drugs compete against numerous therapies, including nonpharmaceutical options. To create new value these therapies need to provide benefits beyond existing therapies, and perhaps serve stakeholders differently to the prescribing physician and patient. Looking for new value, pharma organizations have invested in identifying patient subgroups with superior biological responses to a specific new molecular entity [1,2]. Numerous investments focus on identifying novel biomarkers and companion diagnostics for personalized medicine [1]. Astonishing technical developments (genomics, proteomics, metabolomics) have fueled biomarker research [3,4], but progress is slow [5]. Until the tools of research improve, pharma companies need other ways to boost pharmaceutical productivity and create value; modern design methods might serve this role. The pharma industry is not the first maturing industry to experience gradual commoditization, shifting customer requirements and pressures to increase productivity (information technologies once created value through technical performance, but now promote ease of use, mobility and connectivity). Complementary to finding biomarkers and companion diagnostics, one can create value by deeply understanding the context of use of new products. Personalized medicine which recognizes the individual characteristics of each patient certainly considers all the elements of patient care when tailoring individual treatment: usability, access, affordability, among others. Thus, knowledge and insights gained from humancentered research could provide keys for creating unique value. Because investments in personalized medicine are driven partly by new demands from consumers, taking a human-centered approach to value creation makes sense. Patients desire treatments that integrate into their lifestyles and serve their aspirations (Fig. 1). This is consistent with known hierarchies of need [6] where early solutions meet basic requirements. Today, there are many new needs and stakeholders: caregivers have important roles; new buyers seek sensible alternatives; physicians want patients to succeed (against burdens of training, complexity and adherence). In addition, health authorities can update standards for safety and efficacy. Adjacent to the insights for R&D provided by biomarkers, there are numerous human-centered insights that pertain to individuals, including knowledge of lifestyle preferences, care-giving