Societal challenges of precision medicine: Bringing order to chaos

doi:10.1016/j.ejca.2017.07.028

. 2017 Oct:84:325-334.

doi: 10.1016/j.ejca.2017.07.028. Epub 2017 Sep 4.

Societal challenges of precision medicine: Bringing order to chaos

Collaborators, Affiliations

Collaborators

IBCD-Faculty:
Robert Becker¹², Philip Beer¹³, Jonas Bergh¹⁴, Jan Bogaerts¹⁵, Simon Dovedi¹⁶, Antonio T Fojo¹⁷, Moritz Gerstung¹⁸, Vassilis Golfinopoulos¹⁹, Stephen Hewitt²⁰, Daniel Hochhauser²¹, Hartmut Juhl²², Robert Kinders²³, Thomas Lillie²⁴, Kim Lyerly Herbert²⁵, Shyamala Maheswaran²⁶, Mehdi Mesri²⁷, Sumimasa Nagai²⁸, Irene Norstedt²⁹, Daniel O'Connor³⁰, Kathy Oliver³¹, Wim J G Oyen³², Francesco Pignatti³³, Eric Polley³⁴, Nitzan Rosenfeld³⁵, Jan Schellens³⁶, Richard Schilsky³⁷, Erasmus Schneider³⁸, Adrian Senderowicz³⁹, Olli Tenhunen⁴⁰, Augustinus van Dongen⁴¹, Christine Vietz⁴², Nils Wilking⁴³

Affiliations

¹ EORTC Pathobiology Group, Belgium; Department of Pathology GZA, Antwerp, Belgium; Breast Cancer Translational Research Laboratory, Jules Bordet Institute, Belgium.
² National Cancer Institute Biorepositories and Biospecimen Research Branch (BBRB), Rockville, MD, USA.
³ Department of Medical Oncology, Erasmus MC Cancer Institute and Cancer Genomics Netherlands, Erasmus University Medical Center, Rotterdam, The Netherlands.
⁴ Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, US National Cancer Institute, Rockville, MD, USA.
⁵ Investigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
⁶ Wellcome Trust Sanger Institute, Cambridge, UK.
⁷ Service de Biostatistique et D'Epidémiologie, Gustave Roussy, CESP, INSERM, Univ. Paris-Sud, Univ. Paris Saclay, Villejuif, France.
⁸ National Cancer Institute, Cancer Therapy Evaluation Program, Rockville, MD, USA.
⁹ Molecular Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium.
¹⁰ Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, Diagnostic Biomarkers and Technology Branch, National Cancer Institute, Bethesda, USA.
¹¹ EORTC Headquarters, Brussels, Belgium. Electronic address: denis.lacombe@eortc.be.
¹² US Food and Drug Administration (FDA), Silver Spring, MD, USA.
¹³ 14M Genomics, Medical Genomics, Hinxton, Cambridge, UK.
¹⁴ Karolinska Institutet and University Hospital, Stockholm, Sweden.
¹⁵ EORTC Headquarters, Statistics Department, Brussels, Belgium.
¹⁶ MedImmune, Oncology, Cambridge, UK.
¹⁷ Columbia University Medical Center, New York, USA.
¹⁸ European Bioinformatics Institute EMBL-EBI, Cancer Genome Project, Hinxton, UK.
¹⁹ EORTC Headquarters, Medical Vice Director, Brussels, Belgium.
²⁰ National Cancer Institute (NCI), Bethesda, MD, USA.
²¹ UCL Cancer Institute, Dept. of Oncology, London, UK.
²² Indivumed GmbH, CEO, Hamburg, Germany.
²³ Frederick National Laboratory for Cancer Research, Laboratory of Human Toxicology and Pharmacology, Frederick, MD, USA.
²⁴ Merck Sharp & Dohme Limited, Global Clinical Development, London, UK.
²⁵ Duke University Medical Center, Surgery Department, Durham, NC, USA.
²⁶ Massachusetts General Hospital, Cancer Center, Charlestown, MA, USA.
²⁷ National Cancer Institute (NCI), National Institutes of Health (NIH) OCCPR, National Cancer Institute (NCI), Bethesda, MD, USA.
²⁸ The University of Tokyo and Pharmaceuticals and Medical Devices Agency, Companion Diagnostics Working Group, Tokyo, Japan.
²⁹ European Commission, Innovative and Personalised Medicine, Brussels, Belgium.
³⁰ Medicines & Healthcare Products Regulatory Agency (MHRA), Licensing Division, London, UK.
³¹ International Brain Tumour Alliance (IBTA), Chair and Co-Director, Tadworth, Surrey, UK.
³² The Institute of Cancer Research, Sutton, UK.
³³ European Medicines Agency (EMA), London, UK.
³⁴ Mayo Clinic, Rochester, USA.
³⁵ University of Cambridge, Cancer Research UK Cambridge Institute, Cambridge, UK.
³⁶ The Netherlands Cancer Institute - Antoni Van Leeuwenhoek-ziekenhuis, Amsterdam, The Netherlands.
³⁷ American Society of Clinical Oncology (ASCO), Office of the CEO, Alexandria, VA, USA.
³⁸ New York State Department of Health, Wadsworth Center, Albany, NY, USA.
³⁹ Cerulean Pharma Inc., Clinical Department, Waltham, MA, USA.
⁴⁰ Finnish Medicines Agency, Oulu, Finland.
⁴¹ VU University Medical Center Amsterdam, Dept. of Radiology & Nuclear Medicine, Amsterdam, The Netherlands.
⁴² Foundation Medicine, Inc., Regulatory Affairs, Cambridge, MA, USA.
⁴³ Skane University Hospital, Lund, Malmo, Sweden.

PMID: 28865260
PMCID: PMC7888555
DOI: 10.1016/j.ejca.2017.07.028

Societal challenges of precision medicine: Bringing order to chaos

Roberto Salgado et al. Eur J Cancer. 2017 Oct.

. 2017 Oct:84:325-334.

doi: 10.1016/j.ejca.2017.07.028. Epub 2017 Sep 4.

Authors

Collaborators

IBCD-Faculty:
Robert Becker¹², Philip Beer¹³, Jonas Bergh¹⁴, Jan Bogaerts¹⁵, Simon Dovedi¹⁶, Antonio T Fojo¹⁷, Moritz Gerstung¹⁸, Vassilis Golfinopoulos¹⁹, Stephen Hewitt²⁰, Daniel Hochhauser²¹, Hartmut Juhl²², Robert Kinders²³, Thomas Lillie²⁴, Kim Lyerly Herbert²⁵, Shyamala Maheswaran²⁶, Mehdi Mesri²⁷, Sumimasa Nagai²⁸, Irene Norstedt²⁹, Daniel O'Connor³⁰, Kathy Oliver³¹, Wim J G Oyen³², Francesco Pignatti³³, Eric Polley³⁴, Nitzan Rosenfeld³⁵, Jan Schellens³⁶, Richard Schilsky³⁷, Erasmus Schneider³⁸, Adrian Senderowicz³⁹, Olli Tenhunen⁴⁰, Augustinus van Dongen⁴¹, Christine Vietz⁴², Nils Wilking⁴³

Affiliations

¹ EORTC Pathobiology Group, Belgium; Department of Pathology GZA, Antwerp, Belgium; Breast Cancer Translational Research Laboratory, Jules Bordet Institute, Belgium.
² National Cancer Institute Biorepositories and Biospecimen Research Branch (BBRB), Rockville, MD, USA.
³ Department of Medical Oncology, Erasmus MC Cancer Institute and Cancer Genomics Netherlands, Erasmus University Medical Center, Rotterdam, The Netherlands.
⁴ Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, US National Cancer Institute, Rockville, MD, USA.
⁵ Investigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
⁶ Wellcome Trust Sanger Institute, Cambridge, UK.
⁷ Service de Biostatistique et D'Epidémiologie, Gustave Roussy, CESP, INSERM, Univ. Paris-Sud, Univ. Paris Saclay, Villejuif, France.
⁸ National Cancer Institute, Cancer Therapy Evaluation Program, Rockville, MD, USA.
⁹ Molecular Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium.
¹⁰ Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, Diagnostic Biomarkers and Technology Branch, National Cancer Institute, Bethesda, USA.
¹¹ EORTC Headquarters, Brussels, Belgium. Electronic address: denis.lacombe@eortc.be.
¹² US Food and Drug Administration (FDA), Silver Spring, MD, USA.
¹³ 14M Genomics, Medical Genomics, Hinxton, Cambridge, UK.
¹⁴ Karolinska Institutet and University Hospital, Stockholm, Sweden.
¹⁵ EORTC Headquarters, Statistics Department, Brussels, Belgium.
¹⁶ MedImmune, Oncology, Cambridge, UK.
¹⁷ Columbia University Medical Center, New York, USA.
¹⁸ European Bioinformatics Institute EMBL-EBI, Cancer Genome Project, Hinxton, UK.
¹⁹ EORTC Headquarters, Medical Vice Director, Brussels, Belgium.
²⁰ National Cancer Institute (NCI), Bethesda, MD, USA.
²¹ UCL Cancer Institute, Dept. of Oncology, London, UK.
²² Indivumed GmbH, CEO, Hamburg, Germany.
²³ Frederick National Laboratory for Cancer Research, Laboratory of Human Toxicology and Pharmacology, Frederick, MD, USA.
²⁴ Merck Sharp & Dohme Limited, Global Clinical Development, London, UK.
²⁵ Duke University Medical Center, Surgery Department, Durham, NC, USA.
²⁶ Massachusetts General Hospital, Cancer Center, Charlestown, MA, USA.
²⁷ National Cancer Institute (NCI), National Institutes of Health (NIH) OCCPR, National Cancer Institute (NCI), Bethesda, MD, USA.
²⁸ The University of Tokyo and Pharmaceuticals and Medical Devices Agency, Companion Diagnostics Working Group, Tokyo, Japan.
²⁹ European Commission, Innovative and Personalised Medicine, Brussels, Belgium.
³⁰ Medicines & Healthcare Products Regulatory Agency (MHRA), Licensing Division, London, UK.
³¹ International Brain Tumour Alliance (IBTA), Chair and Co-Director, Tadworth, Surrey, UK.
³² The Institute of Cancer Research, Sutton, UK.
³³ European Medicines Agency (EMA), London, UK.
³⁴ Mayo Clinic, Rochester, USA.
³⁵ University of Cambridge, Cancer Research UK Cambridge Institute, Cambridge, UK.
³⁶ The Netherlands Cancer Institute - Antoni Van Leeuwenhoek-ziekenhuis, Amsterdam, The Netherlands.
³⁷ American Society of Clinical Oncology (ASCO), Office of the CEO, Alexandria, VA, USA.
³⁸ New York State Department of Health, Wadsworth Center, Albany, NY, USA.
³⁹ Cerulean Pharma Inc., Clinical Department, Waltham, MA, USA.
⁴⁰ Finnish Medicines Agency, Oulu, Finland.
⁴¹ VU University Medical Center Amsterdam, Dept. of Radiology & Nuclear Medicine, Amsterdam, The Netherlands.
⁴² Foundation Medicine, Inc., Regulatory Affairs, Cambridge, MA, USA.
⁴³ Skane University Hospital, Lund, Malmo, Sweden.

PMID: 28865260
PMCID: PMC7888555
DOI: 10.1016/j.ejca.2017.07.028

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.

PubMed Disclaimer

Conflict of interest statement

None declared.

Cited by

Identification and Validation of Key Genes Related to Lipophagy in Osteoporosis.
Hu Y, Zuo M, Wu Y, Yang Y, Shi X, Zhang Q, Wu J, Xie R, Bi Y, Lin B, Mo C. Hu Y, et al. Orthop Res Rev. 2025 Jul 22;17:341-359. doi: 10.2147/ORR.S518036. eCollection 2025. Orthop Res Rev. 2025. PMID: 40727594 Free PMC article.
Views of European Drug Development Stakeholders on Treatment Optimization and Its Potential for Use in Decision-Making.
Saesen R, Lejeune S, Quaglio G, Lacombe D, Huys I. Saesen R, et al. Front Pharmacol. 2020 Feb 5;11:43. doi: 10.3389/fphar.2020.00043. eCollection 2020. Front Pharmacol. 2020. PMID: 32116718 Free PMC article.
Steps forward for cancer precision medicine.
Salgado R, Moore H, Martens JWM, Lively T, Malik S, McDermott U, Michiels S, Moscow JA, Tejpar S, McKee T, Lacombe D; IBCD-Faculty. Salgado R, et al. Nat Rev Drug Discov. 2018 Jan;17(1):1-2. doi: 10.1038/nrd.2017.218. Epub 2017 Nov 24. Nat Rev Drug Discov. 2018. PMID: 29170471
Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence.
Olaghere J, Williams DA, Farrar J, Büning H, Calhoun C, Ho T, Inamdar MS, Liu D, Makani J, Nyarko K, Ruiz S, Tisdale J, McCune JM, Boadi E, Reagan-Udall Foundation For The Fda. Olaghere J, et al. Biomedicines. 2025 Mar 20;13(3):758. doi: 10.3390/biomedicines13030758. Biomedicines. 2025. PMID: 40149734 Free PMC article.
The Biomarker Toolkit - an evidence-based guideline to predict cancer biomarker success and guide development.
Savva KV, Kawka M, Vadhwana B, Penumaka R, Patton I, Khan K, Perrott C, Das S, Giot M, Mavroveli S, Hanna GB, Ni MZ, Peters CJ. Savva KV, et al. BMC Med. 2023 Oct 4;21(1):383. doi: 10.1186/s12916-023-03075-3. BMC Med. 2023. PMID: 37794461 Free PMC article.

See all "Cited by" articles

References

1. Council conclusions on personalised medicine for patients (2015/C 421/03). Notices from European Union Institutions, Bodies, Offices and Agencies.
1. Lacombe D, Tejpar S, Salgado R, Cardoso F, Golfinopoulos V, Aust, et al. European perspective for effective cancer drug development. Nat Rev Clin Oncol 2014;11:492–8. - PubMed
1. Conley BA, Doroshow JH. Molecular analysis for therapy choice: NCI MATCH. Semin Oncol 2014;41:297–9. - PubMed
1. Donahue RN, Lepone LM, Grenga I, Jochems C, Fantini M, Madan RA, et al. Analyses of the peripheral immunome following multiple administrations of avelumab, a human IgG1 anti-PD-L1 monoclonal antibody. J Immunother Cancer 2017;5:20. - PMC - PubMed
1. Teutsch SM, Bradley LA, Palomaki GE, Haddow JE, Piper M, Calonge N, et al. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative: methods of the EGAPP Working Group. Genet Med 2009;11:3–14. - PMC - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

Grants and funding

LinkOut - more resources

Full Text Sources
Other Literature Sources
- The Lens - Patent Citations Database
- scite Smart Citations

[1] Council conclusions on personalised medicine for patients (2015/C 421/03). Notices from European Union Institutions, Bodies, Offices and Agencies.

[2] Council conclusions on personalised medicine for patients (2015/C 421/03). Notices from European Union Institutions, Bodies, Offices and Agencies.

[3] Lacombe D, Tejpar S, Salgado R, Cardoso F, Golfinopoulos V, Aust, et al. European perspective for effective cancer drug development. Nat Rev Clin Oncol 2014;11:492–8. - PubMed

[4] Lacombe D, Tejpar S, Salgado R, Cardoso F, Golfinopoulos V, Aust, et al. European perspective for effective cancer drug development. Nat Rev Clin Oncol 2014;11:492–8. - PubMed

[5] Conley BA, Doroshow JH. Molecular analysis for therapy choice: NCI MATCH. Semin Oncol 2014;41:297–9. - PubMed

[6] Conley BA, Doroshow JH. Molecular analysis for therapy choice: NCI MATCH. Semin Oncol 2014;41:297–9. - PubMed

[7] Donahue RN, Lepone LM, Grenga I, Jochems C, Fantini M, Madan RA, et al. Analyses of the peripheral immunome following multiple administrations of avelumab, a human IgG1 anti-PD-L1 monoclonal antibody. J Immunother Cancer 2017;5:20. - PMC - PubMed

[8] Donahue RN, Lepone LM, Grenga I, Jochems C, Fantini M, Madan RA, et al. Analyses of the peripheral immunome following multiple administrations of avelumab, a human IgG1 anti-PD-L1 monoclonal antibody. J Immunother Cancer 2017;5:20. - PMC - PubMed

[9] Teutsch SM, Bradley LA, Palomaki GE, Haddow JE, Piper M, Calonge N, et al. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative: methods of the EGAPP Working Group. Genet Med 2009;11:3–14. - PMC - PubMed

[10] Teutsch SM, Bradley LA, Palomaki GE, Haddow JE, Piper M, Calonge N, et al. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative: methods of the EGAPP Working Group. Genet Med 2009;11:3–14. - PMC - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Societal challenges of precision medicine: Bringing order to chaos

Collaborators

Affiliations

Societal challenges of precision medicine: Bringing order to chaos

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Abstract

Conflict of interest statement

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Related information

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources