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Societal challenges of precision medicine: Bringing order to chaos

2017; Elsevier BV; Volume: 84; Linguagem: Inglês

10.1016/j.ejca.2017.07.028

1879-0852

Roberto Salgado, Helen M. Moore, John W.M. Martens, Tracy Lively, Shakun Malik, Ultan McDermott, Stefan Michiels, Jeffrey A. Moscow, Sabine Tejpar, Tawnya C. McKee, Denis Lacombe, Robert Becker, Philip Beer, Jonas Bergh, Jan Bogaerts, Simon J. Dovedi, Antonio Tito Fojo, Moritz Gerstung, Vassilis Golfinopoulos, Stephen M. Hewitt, Daniel Hochhauser, Hartmut Juhl, Robert J. Kinders, Thomas Lillie, Kim Lyerly Herbert, Shyamala Maheswaran, Mehdi Mesri, Sumimasa Nagai, Iréne Norstedt, Daniel O’Connor, Kathy Oliver, Wim J.G. Oyen, Francesco Pignatti, Eric C. Polley, Nitzan Rosenfeld, Jan H.M. Schellens, Richard L. Schilsky, Erasmus Schneider, Adrian M. Senderowicz, Olli Tenhunen, Augustinus van Dongen, Christine Vietz, Nils Wilking,

CAR-T cell therapy research

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).