Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine
Rapid and continuing advances in biomarker testing are not being matched by uptake in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. The potential that...
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-02-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/13/3/583 |
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| author | Denis Horgan Gennaro Ciliberto Pierfranco Conte Giuseppe Curigliano Luis Seijo Luis M. Montuenga Marina Garassino Frederique Penault-Llorca Fabrizia Galli Isabelle Ray-Coquard Denis Querleu Peter Riegman Keith Kerr Hein Van Poppel Anders Bjartell Giovanni Codacci-Pisanelli Jasmina Koeva-Balabanova Angelo Paradiso Zorana Maravic Vassiliki Fotaki Nuria Malats Chiara Bernini Simonetta Buglioni Alastair Kent Elisabetta Munzone Ivica Belina Jan Van Meerbeeck Michael Duffy Beata Jagielska Ettore Capoluongo |
| author_facet | Denis Horgan Gennaro Ciliberto Pierfranco Conte Giuseppe Curigliano Luis Seijo Luis M. Montuenga Marina Garassino Frederique Penault-Llorca Fabrizia Galli Isabelle Ray-Coquard Denis Querleu Peter Riegman Keith Kerr Hein Van Poppel Anders Bjartell Giovanni Codacci-Pisanelli Jasmina Koeva-Balabanova Angelo Paradiso Zorana Maravic Vassiliki Fotaki Nuria Malats Chiara Bernini Simonetta Buglioni Alastair Kent Elisabetta Munzone Ivica Belina Jan Van Meerbeeck Michael Duffy Beata Jagielska Ettore Capoluongo |
| author_sort | Denis Horgan |
| collection | DOAJ |
| description | Rapid and continuing advances in biomarker testing are not being matched by uptake in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. The potential that genomics has brought to biomarker testing in diagnosis, prediction and research is being realised, pre-eminently in many cancers, but also in an ever-wider range of conditions—notably <i>BRCA1/2</i> testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, the implementation of genetic testing in clinical routine setting is still challenging. Development is impeded by country-related heterogeneity, data deficiencies, and lack of policy alignment on standards, approval—and the role of real-world evidence in the process—and reimbursement. The acute nature of the problem is compellingly illustrated by the particular challenges facing the development and use of tumour agnostic therapies, where the gaps in preparedness for taking advantage of this innovative approach to cancer therapy are sharply exposed. Europe should already have in place a guarantee of universal access to a minimum suite of biomarker tests and should be planning for an optimum testing scenario with a wider range of biomarker tests integrated into a more sophisticated health system articulated around personalised medicine. Improving healthcare and winning advantages for Europe’s industrial competitiveness and innovation require an appropriate policy framework—starting with an update to outdated recommendations. We show herein the main issues and proposals that emerged during the previous advisory boards organised by the European Alliance for Personalized Medicine which mainly focus on possible scenarios of harmonisation of both oncogenetic testing and management of cancer patients. |
| first_indexed | 2024-03-09T06:04:24Z |
| format | Article |
| id | doaj.art-74b76549363c4c63953a57c663011df2 |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-09T06:04:24Z |
| publishDate | 2021-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-74b76549363c4c63953a57c663011df22023-12-03T12:05:58ZengMDPI AGCancers2072-66942021-02-0113358310.3390/cancers13030583Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised MedicineDenis Horgan0Gennaro Ciliberto1Pierfranco Conte2Giuseppe Curigliano3Luis Seijo4Luis M. Montuenga5Marina Garassino6Frederique Penault-Llorca7Fabrizia Galli8Isabelle Ray-Coquard9Denis Querleu10Peter Riegman11Keith Kerr12Hein Van Poppel13Anders Bjartell14Giovanni Codacci-Pisanelli15Jasmina Koeva-Balabanova16Angelo Paradiso17Zorana Maravic18Vassiliki Fotaki19Nuria Malats20Chiara Bernini21Simonetta Buglioni22Alastair Kent23Elisabetta Munzone24Ivica Belina25Jan Van Meerbeeck26Michael Duffy27Beata Jagielska28Ettore Capoluongo29European Alliance for Personalized Medicine, Avenue de l’Armee/ Legerlaan 10, 1040 Brussels, BelgiumIRCCS Istituto Nazionale Tumori “Regina Elena”, Via Elio Chianesi, 53, 00128 Rome, ItalyDipartimento di Scienze Chirurgiche Oncologiche e Gastroenterologiche, University of Padova, Via Giustiniani 2, 35128 Padova, ItalyDepartment of Oncology and Hemato-Oncology, University of Milano and European Institute of Oncology, IRCCS, 20139 Milano, ItalyPulmonary Department, Clínica Universidad de Navarra, Calle Marquesado de Sta. Marta, 1, 28027 Madrid, SpainCenter for Applied Medical Research (CIMA), Schools of Sciences and Medicine, University of Navarra, Av. de Pío XII, 55, 31008 Pamplona, SpainS.S. Oncologia Medica Toraco Polmonare, Fondazione IRCCS Istituto Nazionale dei Tumori Via Giacomo Venezian, 1, 20133 Milano, ItalyDepartment of Pathology and Tumor Biology, University of Clermont-Auvergne, 49 bd François Mitterrand, 63001 Clermont-Ferrand, FranceAssociazione aBRCAdaBRA Onlus Via Volontari Italiani del Sangue, 32, 90128 Palermo, ItalyMedical Oncology Department, Centre Leon Bérard & Université Claude Bernard Lyon, 69008 Lyon, FranceSurgery Department, Institut Bergonié Cancer Center, Centre Léon Bérard Cheney D- 2 ème étage -28 Rue Laennec, 69373 Lyon, FranceDepartment of Pathology, Josephine Nefkens Institute, Erasmus Medical Center, Be 235b, Dr Molwaterplein 50, 3015 Rotterdam, The NetherlandsDepartment of Pathology, University of Aberdeen, King’s College, Aberdeen AB24 3FX, UKDepartment of Urology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, BelgiumDepartment of Urology, Skane University Hospital, Box 117, 221 00 Lund, SwedenDepartment of Medical and Surgical Sciences and Biotechnology, University of Rome, “la Sapienza”, Piazzale Aldo Moro, 5, 00185 Roma, ItalyBulgarian Association for Personalised Medicine, 45 Bacho Kiro Str., 1202 Sofia, BulgariaScientific Directorate, IRCCS Istituto Tumori Giovanni Paolo II, Viale Orazio Flacco, 65, 70124 Bari, ItalyDigestive Cancers Europe, Rue de la Loi 235, 1040 Brussels, BelgiumDigestive Cancers Europe, Rue de la Loi 235, 1040 Brussels, BelgiumCIBERONC, Av. Monforte de Lemos, 3-5, 28029 Madrid, SpainEuropean Alliance for Personalized Medicine, Avenue de l’Armee/ Legerlaan 10, 1040 Brussels, BelgiumIRCCS Istituto Nazionale Tumori “Regina Elena”, Via Elio Chianesi, 53, 00128 Rome, ItalyIndependent Patient Advocate, 14 Farthing Road Downham Market, Norfolk PE38 0AF, UKDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141 Milano, ItalyKUZ-Coalition of Association in Healthcare, Trpimirova 11, 10000 Zagreb, CroatiaThoracic Oncology-MOCA, University Hospital Antwerp, Wilrijkstraat 10, 2650 Edegem, BelgiumUCD School of Medicine, Conway Institute of Biomolecular and Biomedical Research, University College Dublin, Belfield, Dublin 4, IrelandMaria Skłodowska-Curie Institute of Oncology, Wawelska 15 B, 00-001 Warszawa, PolandDepartment of Molecular Medicine and Medical Biotechnologies, University of Naples Federico II, 80131 Naples, ItalyRapid and continuing advances in biomarker testing are not being matched by uptake in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. The potential that genomics has brought to biomarker testing in diagnosis, prediction and research is being realised, pre-eminently in many cancers, but also in an ever-wider range of conditions—notably <i>BRCA1/2</i> testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, the implementation of genetic testing in clinical routine setting is still challenging. Development is impeded by country-related heterogeneity, data deficiencies, and lack of policy alignment on standards, approval—and the role of real-world evidence in the process—and reimbursement. The acute nature of the problem is compellingly illustrated by the particular challenges facing the development and use of tumour agnostic therapies, where the gaps in preparedness for taking advantage of this innovative approach to cancer therapy are sharply exposed. Europe should already have in place a guarantee of universal access to a minimum suite of biomarker tests and should be planning for an optimum testing scenario with a wider range of biomarker tests integrated into a more sophisticated health system articulated around personalised medicine. Improving healthcare and winning advantages for Europe’s industrial competitiveness and innovation require an appropriate policy framework—starting with an update to outdated recommendations. We show herein the main issues and proposals that emerged during the previous advisory boards organised by the European Alliance for Personalized Medicine which mainly focus on possible scenarios of harmonisation of both oncogenetic testing and management of cancer patients.https://www.mdpi.com/2072-6694/13/3/583Europe’s Healthcare SystemsbiomarkersoncogenomicsHRDcancers |
| spellingShingle | Denis Horgan Gennaro Ciliberto Pierfranco Conte Giuseppe Curigliano Luis Seijo Luis M. Montuenga Marina Garassino Frederique Penault-Llorca Fabrizia Galli Isabelle Ray-Coquard Denis Querleu Peter Riegman Keith Kerr Hein Van Poppel Anders Bjartell Giovanni Codacci-Pisanelli Jasmina Koeva-Balabanova Angelo Paradiso Zorana Maravic Vassiliki Fotaki Nuria Malats Chiara Bernini Simonetta Buglioni Alastair Kent Elisabetta Munzone Ivica Belina Jan Van Meerbeeck Michael Duffy Beata Jagielska Ettore Capoluongo Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine Cancers Europe’s Healthcare Systems biomarkers oncogenomics HRD cancers |
| title | Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine |
| title_full | Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine |
| title_fullStr | Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine |
| title_full_unstemmed | Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine |
| title_short | Bringing Onco-Innovation to Europe’s Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine |
| title_sort | bringing onco innovation to europe s healthcare systems the potential of biomarker testing real world evidence tumour agnostic therapies to empower personalised medicine |
| topic | Europe’s Healthcare Systems biomarkers oncogenomics HRD cancers |
| url | https://www.mdpi.com/2072-6694/13/3/583 |
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