Societal challenges of precision medicine: Bringing order to chaos

Research output: Contribution to journalArticle


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).


  • Roberto Salgado
  • Helen Moore
  • John W M Martens
  • Tracy Lively
  • Shakun Malik
  • Ultan McDermott
  • Stefan Michiels
  • Jeffrey A. Moscow
  • Sabine Tejpar
  • Tawnya McKee
  • Denis Lacombe
  • Robert Becker
  • Philip Beer
  • Jonas Bergh
  • Jan Bogaerts
  • Simon Dovedi
  • Antonio T. Fojo
  • Moritz Gerstung
  • Vassilis Golfinopoulos
  • Stephen M. Hewitt
  • And 23 others
  • Daniel Hochhauser
  • Hartmut Juhl
  • Robert Kinders
  • Thomas Lillie
  • Kim Lyerly Herbert
  • Shyamala Maheswaran
  • Mehdi Mesri
  • Sumimasa Nagai
  • Irene Norstedt
  • Daniel O'Connor
  • Kathy Oliver
  • Wim J.G. Oyen
  • Francesco Pignatti
  • Eric Polley
  • Nitzan Rosenfeld
  • Jan Schellens
  • Richard Schilsky
  • Erasmus Schneider
  • Adrian Senderowicz
  • Olli Tenhunen
  • Augustinus van Dongen
  • Christine Vietz
  • Nils Wilking
External organisations
  • University of Antwerp
  • National Cancer Institute, USA
  • Erasmus University Medical Center
  • Wellcome Trust Sanger Institute
  • University of Paris-Sud
  • University Hospitals Leuven
  • European Organisation for Research and Treatment of Cancer
  • United States Food and Drug Administration
  • Karolinska University Hospital
  • MedImmune Limited, Cambridge
  • Columbia University
  • European Bioinformatics Institute
  • UCL Cancer Institute
  • Indivumed GmbH
  • National Cancer Institute at Frederick
  • Merck Sharp & Dohme Limited, UK
  • Duke University
  • Massachusetts General Hospital
  • Pharmaceuticals and Medical Devices Agency
  • European Commission
  • Medicines & Healthcare Products Regulatory Agency (MHRA)
  • International Brain Tumour Alliance (IBTA)
  • Institute of Cancer Research London
  • European Medicines Agency (EMA)
  • Mayo Clinic Minnesota
  • University of Cambridge
  • Antoni Van Leeuwenhoek Hospital
  • American Society of Clinical Oncology
  • Wadsworth Center for Laboratories and Research
  • Cerulean Pharma Inc.
  • Finnish Medicines Agency
  • Amsterdam UMC - Vrije Universiteit Amsterdam
  • Foundation Medicine, Inc.
  • Skåne University Hospital
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cancer and Oncology


  • Assay validation, Biomarkers, Drug development, Preanalytical and analytical validation, Precision oncology, Regulatory sciences
Original languageEnglish
Pages (from-to)325-334
JournalEuropean Journal of Cancer
Publication statusPublished - 2017 Oct 1
Publication categoryResearch