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1. Tackling the implementation gap for the uptake of NGS and advanced molecular diagnostics into healthcare systems

Author

Horgan, Denis, Van den Bulcke, Marc, Malapelle, Umberto, Troncone, Giancarlo, Normanno, Nicola, Capoluongo, Ettore D., Prelaj, Arsela, Rizzari, Carmelo, Trapani, Dario, Singh, Jaya, Kozaric, Marta, Longshore, John, Ottaviano, Manuel, Boccia, Stefania, Pravettoni, Gabriella, Cattaneo, Ivana, Malats, Núria, Buettner, Reinhard, Lekadir, Karim, de Lorenzo, Francesco, Hofman, Paul, and De Maria, Ruggero

Published
2024
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2. Demographic Analysis of Cancer Research Priorities and Treatment Correlations

Author

Horgan, Denis, primary, Bulcke, Marc Van den, additional, Malapelle, Umberto, additional, Normanno, Nicola, additional, Capoluongo, Ettore D., additional, Prelaj, Arsela, additional, Rizzari, Carmelo, additional, Stathopoulou, Aliki, additional, Singh, Jaya, additional, Kozaric, Marta, additional, Dube, France, additional, Ottaviano, Manuel, additional, Boccia, Stefania, additional, Pravettoni, Gabriella, additional, Cattaneo, Ivana, additional, Malats, Núria, additional, Buettner, Reinhard, additional, Lekadir, Karim, additional, de Lorenzo, Francesco, additional, Alix-Panabieres, Catherine, additional, Badreh, Sara, additional, Solary, Eric, additional, De Maria, Ruggero, additional, and Hofman, Paul, additional

Published
2024
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3. Aligning Cancer Research Priorities in Europe with Recommendations for Conquering Cancer: A Comprehensive Analysis

Author

Horgan, Denis, primary, Bulcke, Marc Van den, additional, Malapelle, Umberto, additional, Normanno, Nicola, additional, Capoluongo, Ettore D., additional, Prelaj, Arsela, additional, Rizzari, Carmelo, additional, Stathopoulou, Aliki, additional, Singh, Jaya, additional, Kozaric, Marta, additional, Dube, France, additional, Ottaviano, Manuel, additional, Boccia, Stefania, additional, Pravettoni, Gabriella, additional, Cattaneo, Ivana, additional, Malats, Núria, additional, Buettner, Reinhard, additional, Lekadir, Karim, additional, de Lorenzo, Francesco, additional, Blanc, Patricia, additional, Alix-Panabieres, Catherine, additional, Badreh, Sara, additional, Hofman, Paul, additional, Solary, Eric, additional, and De Maria, Ruggero, additional

Published
2024
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4. Mobilising Collaboration among Stakeholders to Optimise the Growing Potential of Data for Tackling Cancer

Author

Horgan, Denis, primary, Van den Bulcke, Marc, additional, Malapelle, Umberto, additional, Normanno, Nicola, additional, Capoluongo, Ettore D., additional, Prelaj, Arsela, additional, Rizzari, Carmelo, additional, Stathopoulou, Aliki, additional, Singh, Jaya, additional, Kozaric, Marta, additional, Dube, France, additional, Ottaviano, Manuel, additional, Boccia, Stefania, additional, Pravettoni, Gabriella, additional, Cattaneo, Ivana, additional, Malats, Núria, additional, Buettner, Reinhard, additional, Lekadir, Karim, additional, de Lorenzo, Francesco, additional, Alix-Panabieres, Catherine, additional, Badreh, Sara, additional, Hofman, Paul, additional, De Maria, Ruggero, additional, and Solary, Eric, additional

Published
2023
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5. Framework for Adoption of Next-Generation Sequencing (NGS) Globally in the Oncology Area

Author

Horgan, Denis, primary, Hamdi, Yosr, additional, Lal, Jonathan A., additional, Nyawira, Teresia, additional, Meyer, Salomé, additional, Kondji, Dominique, additional, Francisco, Ngiambudulu M., additional, De Guzman, Roselle, additional, Paul, Anupriya, additional, Bernard, Branka, additional, Reddy Nallamalla, Krishna, additional, Park, Woong-Yang, additional, Triapthi, Vijay, additional, Tripathi, Ravikant, additional, Johns, Amber, additional, Singh, Mohan P., additional, Phipps, Maude E., additional, Dube, France, additional, Rasheed, Hadi Mohamad Abu, additional, Kozaric, Marta, additional, Pinto, Joseph A., additional, Doral Stefani, Stephen, additional, Aponte Rueda, Maria Eugenia, additional, Fujita Alarcon, Ricardo, additional, and Barrera-Saldana, Hugo A., additional

Published
2023
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6. Empowering quality data – the Gordian knot of bringing real innovation into healthcare system

Author

Horgan, Denis, primary, Hamdi, Yosr, additional, Lal, Jonathan A., additional, Nyawira, Teresia, additional, Meyer, Salomé, additional, Kondji, Dominique, additional, Francisco, Ngiambudulu M., additional, De Guzman, Roselle, additional, Paul, Anupriya, additional, Nallamalla, Krishna Reddy, additional, Park, Woong-Yang, additional, Triapthi, Vijay, additional, Tripathi, Ravikant, additional, Johns, Amber, additional, Singh, Mohan P., additional, Phipps, Maude E., additional, Dube, France, additional, Abu Rasheed, Hadi Mohamad, additional, Kozaric, Marta, additional, Pinto, Joseph A., additional, Stefani, Stephen Doral, additional, Aponte Rueda, Maria Eugenia, additional, Alarcon, Ricardo Fujita, additional, and Barrera-Saldana, Hugo A., additional

Published
2022
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7. The gaps between the new EU legislation on in vitro diagnostics and the on-the-ground reality

Author

Horgan, Denis, primary, Plebani, Mario, additional, Orth, Matthias, additional, Macintyre, Elizabeth, additional, Jackson, Stan, additional, Lal, Jonathan A., additional, Dube, France, additional, Kozaric, Marta, additional, Tumiene, Birute, additional, Salgado, Roberto, additional, Schalken, Jack A., additional, Capoluongo, Ettore D., additional, and Carnielli, Marta, additional

Published
2022
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8. Fighting Cancer around the World: A Framework for Action

Author

Horgan, Denis, primary, Mia, Rizwana, additional, Erhabor, Tosan, additional, Hamdi, Yosr, additional, Dandara, Collet, additional, Lal, Jonathan A., additional, Domgue, Joel Fokom, additional, Ewumi, Oladimeji, additional, Nyawira, Teresia, additional, Meyer, Salomé, additional, Kondji, Dominique, additional, Francisco, Ngiambudulu M., additional, Ikeda, Sadakatsu, additional, Chuah, Chai, additional, De Guzman, Roselle, additional, Paul, Anupriya, additional, Reddy Nallamalla, Krishna, additional, Park, Woong-Yang, additional, Tripathi, Vijay, additional, Tripathi, Ravikant, additional, Johns, Amber, additional, Singh, Mohan P., additional, Phipps, Maude E., additional, Dube, France, additional, Whittaker, Kate, additional, Mukherji, Deborah, additional, Rasheed, Hadi Mohamad Abu, additional, Kozaric, Marta, additional, Pinto, Joseph A., additional, Doral Stefani, Stephen, additional, Augustovski, Federico, additional, Aponte Rueda, Maria Eugenia, additional, Fujita Alarcon, Ricardo, additional, and Barrera-Saldana, Hugo A., additional

Published
2022
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9. Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring

Author

Horgan, Denis, primary, Čufer, Tanja, additional, Gatto, Francesco, additional, Lugowska, Iwona, additional, Verbanac, Donatella, additional, Carvalho, Ângela, additional, Lal, Jonathan A., additional, Kozaric, Marta, additional, Toomey, Sinead, additional, Ivanov, Hristo Y., additional, Longshore, John, additional, Malapelle, Umberto, additional, Hasenleithner, Samantha, additional, Hofman, Paul, additional, and Alix-Panabières, Catherine, additional

Published
2022
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10. Tackling Mantle Cell Lymphoma in Europe

Author

Horgan, Denis, primary, Walewski, Jan, additional, Aurer, Igor, additional, Visco, Carlo, additional, Giné, Eva, additional, Fetica, Bogdan, additional, Jerkeman, Mats, additional, Kozaric, Marta, additional, da Silva, Maria Gomes, additional, and Dreyling, Martin, additional

Published
2022
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11. European Health Data Space—An Opportunity Now to Grasp the Future of Data-Driven Healthcare

Author

Horgan, Denis, primary, Hajduch, Marian, additional, Vrana, Marilena, additional, Soderberg, Jeannette, additional, Hughes, Nigel, additional, Omar, Muhammad Imran, additional, Lal, Jonathan A., additional, Kozaric, Marta, additional, Cascini, Fidelia, additional, Thaler, Verena, additional, Solà-Morales, Oriol, additional, Romão, Mário, additional, Destrebecq, Frédéric, additional, and Sky Gross, Edith, additional

Published
2022
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12. Tackling Thyroid Cancer in Europe—The Challenges and Opportunities

Author

Horgan, Denis, primary, Führer-Sakel, Dagmar, additional, Soares, Paula, additional, Alvarez, Clara V., additional, Fugazzola, Laura, additional, Netea-Maier, Romana T., additional, Jarzab, Barbara, additional, Kozaric, Marta, additional, Bartes, Beate, additional, Schuster-Bruce, James, additional, Dal Maso, Luigino, additional, Schlumberger, Martin, additional, and Pacini, Furio, additional

Published
2022
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13. How Can the EU Beating Cancer Plan Help in Tackling Lung Cancer, Colorectal Cancer, Breast Cancer and Melanoma?

Author

Horgan, Denis, primary, Baird, Anne-Marie, additional, Middleton, Mark, additional, Mihaylova, Zhasmina, additional, Van Meerbeeck, Jan P., additional, Vogel-Claussen, Jens, additional, Van Schil, Paul E., additional, Malvehy, Josep, additional, Ascierto, Paolo Antonio, additional, Dube, France, additional, Zaiac, Michael, additional, Lal, Jonathan A., additional, Kamińska-Winciorek, Grażyna, additional, Donia, Marco, additional, André, Thierry, additional, Kozaric, Marta, additional, Osterlund, Pia, additional, Dumitrascu, Dan Lucian, additional, and Bertolaccini, Luca, additional

Published
2022
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14. Making Sure That Orphan Incentives Tip the Right Way in Europe

Author

Horgan, Denis, primary, Koeva-Balabanova, Jasmina, additional, Capoluongo, Ettore, additional, Jagielska, Beata, additional, Cattaneo, Ivana, additional, Kozaric, Marta, additional, Tumiene, Birute, additional, El Ahl, Jean-Paul, additional, Lal, Jonathan A., additional, Kalra, Dipak, additional, and Malats, Núria, additional

Published
2022
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15. Towards Better Pharmaceutical Provision in Europe—Who Decides the Future?

Author

Horgan, Denis, primary, Spanic, Tanja, additional, Apostolidis, Kathi, additional, Curigliano, Giuseppe, additional, Chorostowska-Wynimko, Joanna, additional, Dauben, Hans-Peter, additional, Lal, Jonathan A., additional, Dziadziuszko, Rafal, additional, Mayer-Nicolai, Christine, additional, Kozaric, Marta, additional, Jönsson, Bengt, additional, Gutierrez-Ibarluzea, Iñaki, additional, Fandel, Marie-Helene, additional, and Lopert, Ruth, additional

Published
2022
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16. Meeting the Need for a Discussion of Unmet Medical Need

Author

Horgan, Denis, primary, Borisch, Bettina, additional, Eliasen, Bogi, additional, Kapitein, Peter, additional, Biankin, Andrew V., additional, Gijssels, Stefan, additional, Zaiac, Michael, additional, Fandel, Marie-Helene, additional, Lal, Jonathan A., additional, Kozaric, Marta, additional, Moss, Barbara, additional, De Maria, Ruggero, additional, Geanta, Marius, additional, Nowak, Frédérique, additional, Montserrat-Moliner, Antoni, additional, and Riess, Olaf, additional

Published
2022
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17. Empowering quality data – the Gordian knot of bringing real innovation into healthcare system.

Author

Horgan, Denis, Hamdi, Yosr, Lal, Jonathan A., Nyawira, Teresia, Meyer, Salomé, Kondji, Dominique, Francisco, Ngiambudulu M., De Guzman, Roselle, Paul, Anupriya, Nallamalla, Krishna Reddy, Park, Woong-Yang, Triapthi, Vijay, Tripathi, Ravikant, Johns, Amber, Singh, Mohan P., Phipps, Maude E., Dube, France, Abu Rasheed, Hadi Mohamad, Kozaric, Marta, and Pinto, Joseph A.

Subjects
LITERATURE reviews, DATA quality, INDIVIDUALIZED medicine, BUILDING permits, MEDICAL care
Abstract

The introduction of Personalised Medicine (PM) into healthcare systems could benefit from a clearer understanding of the distinct national and regional frameworks around the world. Recent engagement by international regulators on maximising the use of real-world evidence (RWE) has highlighted the scope for improving the exploitation of the treasure-trove of health data that is currently largely neglected in many countries. The European Alliance for Personalised Medicine (EAPM) led an international study aimed at identifying the current status of conditions. A literature review examined how far such frameworks exist, with a view to identifying conducive factors – and crucial gaps. This extensive review of key factors across 22 countries and 5 regions revealed a wide variety of attitudes, approaches, provisions and conditions, and permitted the construction of a comprehensive overview of the current status of PM. Based on seven key pillars identified from the literature review and expert panels, the data was quantified, and on the basis of further analysis, an index was developed to allow comparison country by country and region by region. The results show that United States of America is leading according to overall outcome whereas Kenya scored the least in the overall outcome. Still, common approaches exist that could help accelerate take-up of opportunities even in the less prosperous parts of the world. [ABSTRACT FROM AUTHOR]

Published
2023
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18. How Can the EU Beating Cancer Plan Help in Tackling Lung Cancer, Colorectal Cancer, Breast Cancer and Melanoma?

Author

Horgan, Denis, Baird, Anne Marie, Middleton, Mark, Mihaylova, Zhasmina, Van Meerbeeck, Jan P, Vogel-Claussen, Jens, Van Schil, Paul E., Malvehy, Josep, Ascierto, Paolo Antonio, Dube, France, Zaiac, Michael, Lal, Jonathan A., Kamińska-Winciorek, Grażyna, Donia, Marco, André, Thierry, Kozaric, Marta, Osterlund, Pia, Dumitrascu, Dan Lucian, Bertolaccini, Luca, Horgan, Denis, Baird, Anne Marie, Middleton, Mark, Mihaylova, Zhasmina, Van Meerbeeck, Jan P, Vogel-Claussen, Jens, Van Schil, Paul E., Malvehy, Josep, Ascierto, Paolo Antonio, Dube, France, Zaiac, Michael, Lal, Jonathan A., Kamińska-Winciorek, Grażyna, Donia, Marco, André, Thierry, Kozaric, Marta, Osterlund, Pia, Dumitrascu, Dan Lucian, and Bertolaccini, Luca

Abstract

Cancer is the second leading cause of mortality in EU countries, and the needs to tackle cancer are obvious. New scientific understanding, techniques and methodologies are opening up horizons for significant improvements in diagnosis and care. However, take-up is uneven, research needs and potential outstrip currently available resources, manifestly beneficial practices—such as population-level screening for lung cancer—are still not generalised, and the quality of life of patients and survivors is only beginning to be given attention it merits. This paper, mainly based on a series of multistakeholder expert workshops organised by the European Alliance for Personalised Medicine (EAPM), looks at some of those specifics in the interest of planning a way forward. Part of this exercise also involves taking account of the specific nature of Europe and its constituent countries, where the complexities of planning a way forward are redoubled by the wide variations in national and regional approaches to cancer, local epidemiology and the wide disparities in health systems. Despite all the differences between cancers and national and regional resources and approaches to cancer care, there is a common objective in pursuing broader and more equal access to the best available care for all European citizens.

Published
2022

19. European Health Data Space-An Opportunity Now to Grasp the Future of Data-Driven Healthcare

Author

Horgan, Deni, Hajduch, Marian, Vrana, Marilena, Soderberg, Jeannette, Hughes, Nigel, Omar, Muhammad Imran, Lal, Jonathan A, Kozaric, Marta, Cascini, Fidelia, Thaler, Verena, Solà-Morales, Oriol, Romão, Mário, Destrebecq, Frédéric, Sky Gross, Edith, Cascini, Fidelia (ORCID:0000-0001-6499-0734), Horgan, Deni, Hajduch, Marian, Vrana, Marilena, Soderberg, Jeannette, Hughes, Nigel, Omar, Muhammad Imran, Lal, Jonathan A, Kozaric, Marta, Cascini, Fidelia, Thaler, Verena, Solà-Morales, Oriol, Romão, Mário, Destrebecq, Frédéric, Sky Gross, Edith, and Cascini, Fidelia (ORCID:0000-0001-6499-0734)

Abstract

The May 2022 proposal from the European commission for a 'European health data space' envisages advantages for health from exploiting the growing mass of health data in Europe. However, key stakeholders have identified aspects that demand clarification to ensure success. Data will need to be freed from traditional silos to flow more easily and to cross artificial borders. Wide engagement will be necessary among healthcare professionals, researchers, and the patients and citizens that stand to gain the most but whose trust must be won if they are to allow use or transfer of their data. This paper aims to alert the wider scientific community to the impact the ongoing discussions among lawmakers will have. Based on the literature and the consensus findings of an expert multistakeholder panel organised by the European Alliance for Personalised Medicine (EAPM) in June 2022, it highlights the key issues at the intersection of science and policy, and the potential implications for health research for years, perhaps decades, to come.

Published
2022

20. The gaps between the new EU legislation on in vitro diagnostics and the on-the-ground reality.

Author

Horgan, Denis, Plebani, Mario, Orth, Matthias, Macintyre, Elizabeth, Jackson, Stan, Lal, Jonathan A., Dube, France, Kozaric, Marta, Tumiene, Birute, Salgado, Roberto, Schalken, Jack A., Capoluongo, Ettore D., and Carnielli, Marta

Subjects
INDIVIDUALIZED medicine, TIME perspective, CONSUMERS, DEADLINES
Abstract

The background to this debate is now well-known: an EU policy decision to tighten controls on the devices and diagnostics sector led to the adoption of a regulation in 2017 with a schedule for implementation over coming years – a timetable extended still further by last-minute legislation in early 2022, to provide the sector and regulators with more time to adapt to the changes. Discussions among experts organised in April by the European Alliance for Personalized Medicine (EAPM) exposed continuing challenges that cannot be fully resolved by the recent deferral of implementation deadlines. One salient problem is that there is little awareness of the In Vitro Diagnostic Regulation (IVDR) across Europe, and only limited awareness of the different structures of national systems involved in implementing IVDR, with consequent risks for patient and consumer access to in vitro diagnostics (IVDs). The tentative conclusion from these consultations is that despite a will across the sector to seek workable solutions, the obstacles remain formidable, and the potential solutions so far proposed remain more a matter of aspirations than of clear pathways. [ABSTRACT FROM AUTHOR]

Published
2023
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21. Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring

Author

Denis Horgan, Tanja Čufer, Francesco Gatto, Iwona Lugowska, Donatella Verbanac, Ângela Carvalho, Jonathan A. Lal, Marta Kozaric, Sinead Toomey, Hristo Y. Ivanov, John Longshore, Umberto Malapelle, Samantha Hasenleithner, Paul Hofman, Catherine Alix-Panabières, Horgan, Deni, Čufer, Tanja, Gatto, Francesco, Lugowska, Iwona, Verbanac, Donatella, Carvalho, Angela, Lal, Jonathan A., Kozaric, Marta, Toomey, Sinead, Ivanov, Hristo Y., Longshore, John, Malapelle, Umberto, Hasenleithner, Samantha O., Hofman, Paul, and Alix-Panabières, Catherine

Subjects
liquid biopsy, treatment, Leadership and Management, Health Policy, healthcare, Health Informatics, personalized medicine, legislation, diagnosi, governance, Health Information Management, technology, cancer, policy framework, implementation, diagnosis
Abstract

Liquid biopsy (LB) is a minimally invasive method which aims to detect circulating tumor-derived components in body fluids. It provides an alternative to current cancer screening methods that use tissue biopsies for the confirmation of diagnosis. This paper attempts to determine how far the regulatory, policy, and governance framework provide support to LB implementation into healthcare systems and how the situation can be improved. For that reason, the European Alliance for Personalised Medicine (EAPM) organized series of expert panels including different key stakeholders to identify different steps, challenges, and opportunities that need to be taken to effectively implement LB technology at the country level across Europe. To accomplish a change of patient care with an LB approach, it is required to establish collaboration between multiple stakeholders, including payers, policymakers, the medical and scientific community, and patient organizations, both at the national and international level. Regulators, pharma companies, and payers could have a major impact in their own domain. Linking national efforts to EU efforts and vice versa could help in implementation of LB across Europe, while patients, scientists, physicians, and kit manufacturers can generate a pull by undertaking more research into biomarkers.

Published
2022
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