Position PaperSocietal challenges of precision medicine: Bringing order to chaos

•Premature rollout of assays and technologies without proper analytical validation is often done before it is clinically appropriate.•Expensive though non-fully validated technical solutions brings no added value to the health care systems.•The current process of developing and validating biomarkers and assays needs streamlining alongside the principles developed in this paper.•In the absence of regulatory framework for biomarker development, discipline and common sense processes and guidelines must be strictly followed.

The increasing number of drugs targeting specific proteins implicated in tumourigenesis and the commercial promotion of relatively affordable genome-wide analyses has led to an increasing expectation among patients with cancer that they can now receive effective personalised treatment based on the often complex genomic signature of their tumour. For such approaches to work in routine practice, the development of correspondingly complex biomarker assays through an appropriate and rigorous regulatory framework will be required. It is becoming increasingly evident that a re-engineering of clinical research is necessary so that regulatory considerations and procedures facilitate the efficient translation of these required biomarker assays from the discovery setting through to clinical application. This article discusses the practical requirements and challenges of developing such new precision medicine strategies, based on leveraging complex genomic profiles, as discussed at the Innovation and Biomarkers in Cancer Drug Development meeting (8th-9th September 2016, Brussels, Belgium).