Societal challenges of precision medicine: Bringing order to chaos

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Bibtex

@article{1496e9fae58a487c8c1823b301a5ba5e,
title = "Societal challenges of precision medicine: Bringing order to chaos",
abstract = "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).",
keywords = "Assay validation, Biomarkers, Drug development, Preanalytical and analytical validation, Precision oncology, Regulatory sciences",
author = "Roberto Salgado and Helen Moore and Martens, {John W M} and Tracy Lively and Shakun Malik and Ultan McDermott and Stefan Michiels and Moscow, {Jeffrey A.} and Sabine Tejpar and Tawnya McKee and Denis Lacombe and Robert Becker and Philip Beer and Jonas Bergh and Jan Bogaerts and Simon Dovedi and Fojo, {Antonio T.} and Moritz Gerstung and Vassilis Golfinopoulos and Hewitt, {Stephen M.} and Daniel Hochhauser and Hartmut Juhl and Robert Kinders and Thomas Lillie and Herbert, {Kim Lyerly} and Shyamala Maheswaran and Mehdi Mesri and Sumimasa Nagai and Irene Norstedt and Daniel O'Connor and Kathy Oliver and Oyen, {Wim J.G.} and Francesco Pignatti and Eric Polley and Nitzan Rosenfeld and Jan Schellens and Richard Schilsky and Erasmus Schneider and Adrian Senderowicz and Olli Tenhunen and {van Dongen}, Augustinus and Christine Vietz and Nils Wilking",
year = "2017",
month = "10",
day = "1",
doi = "10.1016/j.ejca.2017.07.028",
language = "English",
volume = "84",
pages = "325--334",
journal = "European Journal of Cancer",
issn = "1879-0852",
publisher = "IFAC & Elsevier Ltd.",

}