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Societal challenges of precision medicine : Bringing order to chaos

Salgado, Roberto; Moore, Helen; Martens, John W M; Lively, Tracy; Malik, Shakun; McDermott, Ultan; Michiels, Stefan; Moscow, Jeffrey A.; Tejpar, Sabine and McKee, Tawnya, et al. (2017) In European Journal of Cancer 84. p.325-334
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... (More)

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).

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published
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keywords
Assay validation, Biomarkers, Drug development, Preanalytical and analytical validation, Precision oncology, Regulatory sciences
in
European Journal of Cancer
volume
84
pages
325 - 334
publisher
IFAC & Elsevier Ltd.
external identifiers
  • scopus:85028944052
ISSN
0959-8049
DOI
10.1016/j.ejca.2017.07.028
language
English
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yes
id
1496e9fa-e58a-487c-8c18-23b301a5ba5e
date added to LUP
2017-10-06 11:29:55
date last changed
2018-10-21 04:50:52
@article{1496e9fa-e58a-487c-8c18-23b301a5ba5e,
  abstract     = {<p>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).</p>},
  author       = {Salgado, Roberto and Moore, Helen and Martens, John W M and Lively, Tracy and Malik, Shakun and McDermott, Ultan and Michiels, Stefan and Moscow, Jeffrey A. and Tejpar, Sabine and McKee, Tawnya and Lacombe, Denis and Becker, Robert and Beer, Philip and Bergh, Jonas and Bogaerts, Jan and Dovedi, Simon and Fojo, Antonio T. and Gerstung, Moritz and Golfinopoulos, Vassilis and Hewitt, Stephen M. and Hochhauser, Daniel and Juhl, Hartmut and Kinders, Robert and Lillie, Thomas and Herbert, Kim Lyerly and Maheswaran, Shyamala and Mesri, Mehdi and Nagai, Sumimasa and Norstedt, Irene and O'Connor, Daniel and Oliver, Kathy and Oyen, Wim J.G. and Pignatti, Francesco and Polley, Eric and Rosenfeld, Nitzan and Schellens, Jan and Schilsky, Richard and Schneider, Erasmus and Senderowicz, Adrian and Tenhunen, Olli and van Dongen, Augustinus and Vietz, Christine and Wilking, Nils},
  issn         = {0959-8049},
  keyword      = {Assay validation,Biomarkers,Drug development,Preanalytical and analytical validation,Precision oncology,Regulatory sciences},
  language     = {eng},
  month        = {10},
  pages        = {325--334},
  publisher    = {IFAC & Elsevier Ltd.},
  series       = {European Journal of Cancer},
  title        = {Societal challenges of precision medicine : Bringing order to chaos},
  url          = {http://dx.doi.org/10.1016/j.ejca.2017.07.028},
  volume       = {84},
  year         = {2017},
}