Biomarkers and personalized medicine: current status and further perspectives with special focus on dermatology

Abstract

Biomarkers are of increasingly high importance in medicine, particularly in the realm of 'personalized medicine'. They are valuable for predicting prognosis and dose selection. Moreover, they may be helpful in detecting therapeutic and adverse responses and in patient stratification based on efficacy or safety prediction. Thus, biomarkers are essential tools for the selection of appropriate patients for treatment with certain drugs to and enable personalized medicine, that is 'providing the right treatment to the right patient, at the right dose at the right time'. Currently, there are six drugs approved for dermatological indications with recommended or mandatory biomarker testing. Most of them are used to treat melanoma and human immunodeficiency virus infection. In contrast to the few fully validated biomarkers, many exploratory biomarkers and biomarker candidates have potential applications. Prognostic biomarkers are of particular significance for malignant conditions. Similarly, diagnostic biomarkers are important in autoimmune diseases. Disease severity biomarkers are helpful tools in the treatment for inflammatory skin diseases. Identification, qualification and implementation of the different kinds of biomarkers are challenging and frequently necessitate collaborative efforts. This is particularly true for stratification biomarkers that require a companion diagnostic marker that is co-developed with a certain drug. In this article general definitions and requirements for biomarkers as well as for the impact of biomarkers in dermatology are reviewed and opportunities and challenges are discussed.

Skin Pigmentation Genetics for the Clinic

“…With such rapid progress in our understanding of the human genome, they may be challenged by the new understanding of the genetics underlying these phenotypes [17] that must be incorporated into the clinic encompassing the move toward personal or precision medicine [18] . Network of pigmentation gene interaction in the melanocyte and the keratinocyte.…”

Advances in precision medicine — time for a new journal

“…Many more types can be defined by their specific application. Table 2 gives a summary on the different purposes of modern biomarkers related to pharmacotherapy [5] . At present, there are approximately 50 drugs approved in the EU [5] with a recommended or mandatory required biomarker determination either for efficacy or side effect prediction, and considerably more than 137 in the USA as of November 2015 [6] .…”

“…The prospect of Table 1. Attempts to define personalized medicine (adapted after Landeck et al 2015 [5] )…”

Collaboration for success: the value of strategic col-laborations for precision medicine and biomarker discovery

“…It represents one of the most important trends in medicine [1] . Owing to biological variability, often only a subset of patients may benefit from a particular therapy.…”

“…Also BM may serve as surrogate markers for clinical endpoints, shortening the product development period and saving costs. As a consequence, BM are of increasing importance in medicine and drug discovery [1,4] . [2] .…”