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2. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Sánchez-Montalva, Adrian, Estevez, Ana Belén, Sánchez, Àlex, Sanjuan, Anna, Sena, Elena, Granados, Emma, Arévalo de Andrés, Esther, Nuñez, Fátima, Arteaga, Gara, Fuentes Ruiz, Gabriela Perez, Fernández, Guillermo, Rivera-Esteban, Jesus, Comella, Joan, Ramos-Quiroga, Josep Antoni, Genescà, Joan, Espinosa, Juan, Pericàs, Juan Manuel, Murcia, Lada, Cash-Gibson, Lucinda, de Valles Silvosa, Maria, Barroso de Sousa, María Fernanda, Sánchez-Maroto Carrizo, Olga, Ibañez-Jiménez, Pol, Augustin, Salvador, Perez-Hoyos, Santiago, Rodríguez-Navarro, Sarai, Muñoz-Martínez, Sergio, Serres, Silvia, Kalko, Susana, Michon, Amelie, Ussi, Anton, Lydall, Ben, van de Ketterij, Edwin, Quiles, Ignacio, Carapina, Tamara, Kumaus, Constantin, Ramazanova, Dariga, Meyer, Elias Laurin, Koenig, Franz, Roig, Marta Bofill, Brunner, Martin, Posch, Martin, Krotka, Pavla, Zehetmayer, Sonja, Carton, Charlotte, Legius, Eric, Begum, Amina, Pariante, Carmine, Worrell, Courtney, Lombardo, Giulia, Sforzini, Luca, Brown, Mollie, Gullet, Nancy, Amasi-Hartoonian, Nare, Ferner, Rosalie, Kose, Melisa, Spitaleri, Andrea, Ghodousi, Arash, Di Serio, Clelia, Cirillo, Daniela, Cugnata, Federica, Saluzzo, Francesca, Benedetti, Francesco, Scarale, Maria Giovanna, Zini, Michela, Rancoita, Paola Maria, Alagna, Riccardo, Poletti, Sara, Dhaenens, Britt, Van Der Lei, Johan, de Steenwinkel, Jurriaan, Moinat, Maxim, Oostenbrink, Rianne, Hoogendijk, Witte, Hölscher, Michael, Heinrich, Norbert, Otte, Christian, Potratz, Cornelia, Zocholl, Dario, Kulakova, Eugenia, Tacke, Frank, Brasanac, Jelena, Leubner, Jonas, Krajewska, Maja, Freitag, Michaela Maria, Gold, Stefan, Zoller, Thomas, Chae, Woo Ri, Daniel, Christel, Kara, Leila, Vaterkowski, Morgan, Griffon, Nicolas, Wolkenstein, Pierre, Pais, Raluca, Ratziu, Vlad, Voets, David, Maes, Christophe, Kalra, Dipak, Thienpoint, Geert, Deckerck, Jens, Lea, Nathan, Singleton, Peter, Viele, Kert, Jacko, Peter, Berry, Scott, Parke, Tom, Aydin, Burç, Kubiak, Christine, Demotes, Jacques, Ueda, Keiko, Matei, Mihaela, Contrino, Sergio, Röhl, Claas, Cordero, Estefania, Greenhalgh, Fiona, Jarke, Hannes, Angelova, Juliana, Boudes, Mathieu, Dressler, Stephan, Strammiello, Valentina, Anstee, Quentin, Gutierrez-Ibarluzea, Iñaki, Otte, Maximilian, Heimbach, Natalie, Hofner, Benjamin, Burgwinkel, Cora, Kaestel, Hue, Hees, Katharina, Nguyen, Quynh, Prieto-Alhambra, Daniel, Tan, Eng Hooi (Cheryl), Raviglione, Mario, de Colombani, Pierpaolo, Villa, Simone, Maron, Eduard, Evans, Gareth, Savitz, Adam J., Van Dessel, Ann, Duca, Anna, Kaminski, Anne, Wouters, Bie, Porter, Brandon, Charron, Catherine, Spiertz, Cecile, Zizzamia, Christopher, Millar, Daniel, Hasselbaink, Danny, Orr, David, Kesters, Divya, Hubin, Ellen, Davies, Emma, Didden, Eva-Maria, Guz, Gabriela, Verstraete, Evelyn, Mao, Gary, Capuano, George, Martynowicz, Heddie, De Smedt, Heidi, Larsson, Ingela, Bruegelmans, Ines, Coste, Isabelle, Gonzalez Moreno, Jesus Maria, Niewczas, Julia, Xu, Jiajun, Rombouts, Karin, Woo, Katherine, Wuyts, Kathleen, Hersh, Kathryn, Oldenburg, Khrista, Zhang, Lingjiao, Schmidt, Mark, Szuch, Mark, Todorovic, Marija, Mangelaars, Maartje, Grewal, Melissa, Sandor, Molli, Di Prospero, Nick, Van Houten, Pamela, Minnick, Pansy, Bastos, Polyana, Patrizi, Robert, Morello, Salvatore, De Wilde, Severijn, Sun, Tao, Kline, Timothy, de Marez, Tine, Mielke, Tobias, Reijns, Tom, Popova, Vanina, Flossbach, Yanina, Tymofyeyev, Yevgen, De Groote, Zeger, Sverdlov, Alex, Bobirca, Alexandra, Krause, Annekatrin, Bobrica, Catalin, Heintz, Daniela, Magirr, Dominic, Glimm, Ekkehard, Baffert, Fabienne, Castiglione, Federica, Caruso, Franca, Patalano, Francesco, Bretz, Frank, Heimann, Guenter, Carbarns, Ian, Rodríguez, Ignacio, Ratescu, Ioana, Hampson, Lisa, Pedrosa, Marcos, Hark, Mareile, Mesenbrink, Peter, Penna, Sabina Hernandez, Bergues-Lang, Sarah, Baltes-Engler, Susanne, Arsiwala, Tasneem, Mondragon, Valeria Jordan, Guo, Hua, Da Costa, Jose Leite, Burman, Carl-Fredrik, Kirk, George, Aaes-Jørgensen, Anders, Dirach, Jorgen, Kjær, Mette Skalshøi, Martin, Alexandra, Hristov, Diyan, Rousseaux, Florent, Hittel, Norbert, Dornheim, Robert, Evans, Daniel, Sykes, Nick, Couvert, Camille, Leuven, Catherine, Notelet, Loïc, Gidh-Jain, Madhavi, Jouannin, Mathieu, Ammour, Nadir, Pierre, Suzanne, Haufe, Volker, Dong, Yingwen, Dubanchet, Catherine, de Préville, Nathalie, Baltauss, Tania, Jian, Zhu, Shnider, Sara, Bar-El, Tal, Bakker, Annette, Nievo, Marco, Iloeje, Uche, Conradie, Almari, Auffarrth, Ece, Lombard, Leandra, Benhayoun, Majda, Olugbosi, Morounfolu, Seidel, Stephanie S., Gumí, Berta, Guzmán, Claudia García, Molero, Eva, Pairó, Gisela, Machin, Núria, Cardelús, Raimon, Ramasastry, Saira, Pelzer, Saskia, Kremer, Andreas, Lindfors, Erno, Lynch, Chris, Spiertz, Cécile, Machín, Núria, and Pericàs, Juan M.

Published
2024
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3. The Rare Disease Moonshot: Paradigms Shift, Translational Medicine, and Regulatory Science for the World's Rarest Conditions.

Author

Ollivier, Cécile, Corriol‐Rohou, Solange, del Álamo, Marta, Favresse, Roseline, Kostenzer, Johanna, Boudes, Mathieu, Ussi, Anton E., Viel, Klaus, Linden, R. Michael, and Chlebus, Magda

Subjects
CLINICAL trials, DRUG accessibility, RESEARCH & development projects, ARTIFICIAL intelligence, BUSINESSPEOPLE, DRUG delivery systems
Abstract

The article discusses the Rare Disease Moonshot initiative, which aims to address the gaps and challenges in therapeutic development for the world's rarest conditions. It emphasizes the importance of public-private partnerships and collaboration to accelerate research and deliver safe and effective medical products. The initiative focuses on integrating regulatory science, developing sustainable infrastructures, and de-risking investments to support the development of new treatments and cures for rare and ultra-rare diseases. The authors highlight the need for multistakeholder collaborations and the dissemination of recommendations to maximize the benefits of the initiative for patients with rare diseases. [Extracted from the article]

Published
2024
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4. A call to action for translational sciences in COVID-19 and future pandemics

Author

Wan, Kanny K., Davis, Danielle, Lee, Taylor N., Ford-Scheimer, Stephanie L., Andreu, Antonio L., Bietrix, Florence, Bryans, Justin, Castro, Marco T., Chiba, Nobuyoshi, Faupel-Badger, Jessica M., Haynes, Brittany, Hirasawa, Ryutaro, Morel, Carlos M., Souza, Thiago Moreno L., Morrow, David, Munro, Trent, Newman, Stuart, Ussi, Anton E., Zorzal, Poliana B., Hall, Matthew D., Lo, Donald C., and Cutillo, Christine M.

Published
2022
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5. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Koenig, Franz, primary, Spiertz, Cécile, additional, Millar, Daniel, additional, Rodríguez-Navarro, Sarai, additional, Machín, Núria, additional, Van Dessel, Ann, additional, Genescà, Joan, additional, Pericàs, Juan M., additional, Posch, Martin, additional, Sánchez-Montalva, Adrian, additional, Estevez, Ana Belén, additional, Sánchez, Àlex, additional, Sanjuan, Anna, additional, Sena, Elena, additional, Granados, Emma, additional, Arévalo de Andrés, Esther, additional, Nuñez, Fátima, additional, Arteaga, Gara, additional, Fuentes Ruiz, Gabriela Perez, additional, Fernández, Guillermo, additional, Rivera-Esteban, Jesus, additional, Comella, Joan, additional, Ramos-Quiroga, Josep Antoni, additional, Espinosa, Juan, additional, Pericàs, Juan Manuel, additional, Murcia, Lada, additional, Cash-Gibson, Lucinda, additional, de Valles Silvosa, Maria, additional, Barroso de Sousa, María Fernanda, additional, Sánchez-Maroto Carrizo, Olga, additional, Ibañez-Jiménez, Pol, additional, Augustin, Salvador, additional, Perez-Hoyos, Santiago, additional, Muñoz-Martínez, Sergio, additional, Serres, Silvia, additional, Kalko, Susana, additional, Michon, Amelie, additional, Ussi, Anton, additional, Lydall, Ben, additional, van de Ketterij, Edwin, additional, Quiles, Ignacio, additional, Carapina, Tamara, additional, Kumaus, Constantin, additional, Ramazanova, Dariga, additional, Meyer, Elias Laurin, additional, Koenig, Franz, additional, Roig, Marta Bofill, additional, Brunner, Martin, additional, Krotka, Pavla, additional, Zehetmayer, Sonja, additional, Carton, Charlotte, additional, Legius, Eric, additional, Begum, Amina, additional, Pariante, Carmine, additional, Worrell, Courtney, additional, Lombardo, Giulia, additional, Sforzini, Luca, additional, Brown, Mollie, additional, Gullet, Nancy, additional, Amasi-Hartoonian, Nare, additional, Ferner, Rosalie, additional, Kose, Melisa, additional, Spitaleri, Andrea, additional, Ghodousi, Arash, additional, Di Serio, Clelia, additional, Cirillo, Daniela, additional, Cugnata, Federica, additional, Saluzzo, Francesca, additional, Benedetti, Francesco, additional, Scarale, Maria Giovanna, additional, Zini, Michela, additional, Rancoita, Paola Maria, additional, Alagna, Riccardo, additional, Poletti, Sara, additional, Dhaenens, Britt, additional, Van Der Lei, Johan, additional, de Steenwinkel, Jurriaan, additional, Moinat, Maxim, additional, Oostenbrink, Rianne, additional, Hoogendijk, Witte, additional, Hölscher, Michael, additional, Heinrich, Norbert, additional, Otte, Christian, additional, Potratz, Cornelia, additional, Zocholl, Dario, additional, Kulakova, Eugenia, additional, Tacke, Frank, additional, Brasanac, Jelena, additional, Leubner, Jonas, additional, Krajewska, Maja, additional, Freitag, Michaela Maria, additional, Gold, Stefan, additional, Zoller, Thomas, additional, Chae, Woo Ri, additional, Daniel, Christel, additional, Kara, Leila, additional, Vaterkowski, Morgan, additional, Griffon, Nicolas, additional, Wolkenstein, Pierre, additional, Pais, Raluca, additional, Ratziu, Vlad, additional, Voets, David, additional, Maes, Christophe, additional, Kalra, Dipak, additional, Thienpoint, Geert, additional, Deckerck, Jens, additional, Lea, Nathan, additional, Singleton, Peter, additional, Viele, Kert, additional, Jacko, Peter, additional, Berry, Scott, additional, Parke, Tom, additional, Aydin, Burç, additional, Kubiak, Christine, additional, Demotes, Jacques, additional, Ueda, Keiko, additional, Matei, Mihaela, additional, Contrino, Sergio, additional, Röhl, Claas, additional, Cordero, Estefania, additional, Greenhalgh, Fiona, additional, Jarke, Hannes, additional, Angelova, Juliana, additional, Boudes, Mathieu, additional, Dressler, Stephan, additional, Strammiello, Valentina, additional, Anstee, Quentin, additional, Gutierrez-Ibarluzea, Iñaki, additional, Otte, Maximilian, additional, Heimbach, Natalie, additional, Hofner, Benjamin, additional, Burgwinkel, Cora, additional, Kaestel, Hue, additional, Hees, Katharina, additional, Nguyen, Quynh, additional, Prieto-Alhambra, Daniel, additional, Tan, Eng Hooi (Cheryl), additional, Raviglione, Mario, additional, de Colombani, Pierpaolo, additional, Villa, Simone, additional, Maron, Eduard, additional, Evans, Gareth, additional, Savitz, Adam J., additional, Duca, Anna, additional, Kaminski, Anne, additional, Wouters, Bie, additional, Porter, Brandon, additional, Charron, Catherine, additional, Spiertz, Cecile, additional, Zizzamia, Christopher, additional, Hasselbaink, Danny, additional, Orr, David, additional, Kesters, Divya, additional, Hubin, Ellen, additional, Davies, Emma, additional, Didden, Eva-Maria, additional, Guz, Gabriela, additional, Verstraete, Evelyn, additional, Mao, Gary, additional, Capuano, George, additional, Martynowicz, Heddie, additional, De Smedt, Heidi, additional, Larsson, Ingela, additional, Bruegelmans, Ines, additional, Coste, Isabelle, additional, Gonzalez Moreno, Jesus Maria, additional, Niewczas, Julia, additional, Xu, Jiajun, additional, Rombouts, Karin, additional, Woo, Katherine, additional, Wuyts, Kathleen, additional, Hersh, Kathryn, additional, Oldenburg, Khrista, additional, Zhang, Lingjiao, additional, Schmidt, Mark, additional, Szuch, Mark, additional, Todorovic, Marija, additional, Mangelaars, Maartje, additional, Grewal, Melissa, additional, Sandor, Molli, additional, Di Prospero, Nick, additional, Van Houten, Pamela, additional, Minnick, Pansy, additional, Bastos, Polyana, additional, Patrizi, Robert, additional, Morello, Salvatore, additional, De Wilde, Severijn, additional, Sun, Tao, additional, Kline, Timothy, additional, de Marez, Tine, additional, Mielke, Tobias, additional, Reijns, Tom, additional, Popova, Vanina, additional, Flossbach, Yanina, additional, Tymofyeyev, Yevgen, additional, De Groote, Zeger, additional, Sverdlov, Alex, additional, Bobirca, Alexandra, additional, Krause, Annekatrin, additional, Bobrica, Catalin, additional, Heintz, Daniela, additional, Magirr, Dominic, additional, Glimm, Ekkehard, additional, Baffert, Fabienne, additional, Castiglione, Federica, additional, Caruso, Franca, additional, Patalano, Francesco, additional, Bretz, Frank, additional, Heimann, Guenter, additional, Carbarns, Ian, additional, Rodríguez, Ignacio, additional, Ratescu, Ioana, additional, Hampson, Lisa, additional, Pedrosa, Marcos, additional, Hark, Mareile, additional, Mesenbrink, Peter, additional, Penna, Sabina Hernandez, additional, Bergues-Lang, Sarah, additional, Baltes-Engler, Susanne, additional, Arsiwala, Tasneem, additional, Mondragon, Valeria Jordan, additional, Guo, Hua, additional, Da Costa, Jose Leite, additional, Burman, Carl-Fredrik, additional, Kirk, George, additional, Aaes-Jørgensen, Anders, additional, Dirach, Jorgen, additional, Kjær, Mette Skalshøi, additional, Martin, Alexandra, additional, Hristov, Diyan, additional, Rousseaux, Florent, additional, Hittel, Norbert, additional, Dornheim, Robert, additional, Evans, Daniel, additional, Sykes, Nick, additional, Couvert, Camille, additional, Leuven, Catherine, additional, Notelet, Loïc, additional, Gidh-Jain, Madhavi, additional, Jouannin, Mathieu, additional, Ammour, Nadir, additional, Pierre, Suzanne, additional, Haufe, Volker, additional, Dong, Yingwen, additional, Dubanchet, Catherine, additional, de Préville, Nathalie, additional, Baltauss, Tania, additional, Jian, Zhu, additional, Shnider, Sara, additional, Bar-El, Tal, additional, Bakker, Annette, additional, Nievo, Marco, additional, Iloeje, Uche, additional, Conradie, Almari, additional, Auffarrth, Ece, additional, Lombard, Leandra, additional, Benhayoun, Majda, additional, Olugbosi, Morounfolu, additional, Seidel, Stephanie S., additional, Gumí, Berta, additional, Guzmán, Claudia García, additional, Molero, Eva, additional, Pairó, Gisela, additional, Machin, Núria, additional, Cardelús, Raimon, additional, Ramasastry, Saira, additional, Pelzer, Saskia, additional, Kremer, Andreas, additional, Lindfors, Erno, additional, and Lynch, Chris, additional

Published
2024
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6. Potential business model for a European vaccine R&D infrastructure and its estimated socio-economic impact

Author

Jungbluth, Stefan, primary, Martin, William, additional, Slezak, Monika, additional, Depraetere, Hilde, additional, Guzman, Carlos A., additional, Ussi, Anton, additional, Morrow, David, additional, Van Heuverswyn, Fran, additional, Arnouts, Sven, additional, Carrondo, Manuel J. T., additional, Olesen, Ole, additional, Ottenhoff, Tom H.M., additional, Dockrell, H. M., additional, Ho, Mei Mei, additional, Dobly, Alexandre, additional, Christensen, Dennis, additional, Segalés, Joaquim, additional, Laurent, Fabrice, additional, Lantier, Frédéric, additional, Stockhofe-Zurwieden, Norbert, additional, Morelli, Francesca, additional, Langermans, Jan A.M., additional, Verreck, Frank A.W., additional, Le Grand, Roger, additional, Sloots, Arjen, additional, Medaglini, Donata, additional, Lawrenz, Maria, additional, and Collin, Nicolas, additional

Published
2023
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8. Recommendations for robust and reproducible preclinical research in personalised medicine

Author

PERMIT group, Fosse, Vibeke, Oldoni, Emanuela, Bietrix, Florence, Budillon, Alfredo, Daskalopoulos, Evangelos P, Fratelli, Maddalena, Gerlach, Björn, Groenen, Peter M A, Hölter, Sabine M, Menon, Julia M L, Mobasheri, Ali, Osborne, Nikki, Ritskes-Hoitinga, Merel, Ryll, Bettina, Schmitt, Elmar, Ussi, Anton, Andreu, Antonio L, McCormack, Emmet, PERMIT group, Fosse, Vibeke, Oldoni, Emanuela, Bietrix, Florence, Budillon, Alfredo, Daskalopoulos, Evangelos P, Fratelli, Maddalena, Gerlach, Björn, Groenen, Peter M A, Hölter, Sabine M, Menon, Julia M L, Mobasheri, Ali, Osborne, Nikki, Ritskes-Hoitinga, Merel, Ryll, Bettina, Schmitt, Elmar, Ussi, Anton, Andreu, Antonio L, and McCormack, Emmet

Abstract

BACKGROUND: Personalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals. The concept brings new challenges to the translational step, both in clinical relevance and validity of models. We have developed a set of recommendations aimed at improving the robustness of preclinical methods in translational research for personalised medicine.METHODS: These recommendations have been developed following four main steps: (1) a scoping review of the literature with a gap analysis, (2) working sessions with a wide range of experts in the field, (3) a consensus workshop, and (4) preparation of the final set of recommendations.RESULTS: Despite the progress in developing innovative and complex preclinical model systems, to date there are fundamental deficits in translational methods that prevent the further development of personalised medicine. The literature review highlighted five main gaps, relating to the relevance of experimental models, quality assessment practices, reporting, regulation, and a gap between preclinical and clinical research. We identified five points of focus for the recommendations, based on the consensus reached during the consultation meetings: (1) clinically relevant translational research, (2) robust model development, (3) transparency and education, (4) revised regulation, and (5) interaction with clinical research and patient engagement. Here, we present a set of 15 recommendations aimed at improving the robustness of preclinical methods in translational research for personalised medicine.CONCLUSIONS: Appropriate preclinical models should be an integral contributor to interventional clinical trial success rates, and predictive translational models are a fundamental requirement to realise the dream of personalised medicine. The implementation of these guidelines is ambitious, and it is only through the active involvement of all relevant stakeholde

Published
2023

9. Recommendations for robust and reproducible preclinical research in personalised medicine

Author

IRAS OH Toxicology, PERMIT group, Fosse, Vibeke, Oldoni, Emanuela, Bietrix, Florence, Budillon, Alfredo, Daskalopoulos, Evangelos P, Fratelli, Maddalena, Gerlach, Björn, Groenen, Peter M A, Hölter, Sabine M, Menon, Julia M L, Mobasheri, Ali, Osborne, Nikki, Ritskes-Hoitinga, Merel, Ryll, Bettina, Schmitt, Elmar, Ussi, Anton, Andreu, Antonio L, McCormack, Emmet, IRAS OH Toxicology, PERMIT group, Fosse, Vibeke, Oldoni, Emanuela, Bietrix, Florence, Budillon, Alfredo, Daskalopoulos, Evangelos P, Fratelli, Maddalena, Gerlach, Björn, Groenen, Peter M A, Hölter, Sabine M, Menon, Julia M L, Mobasheri, Ali, Osborne, Nikki, Ritskes-Hoitinga, Merel, Ryll, Bettina, Schmitt, Elmar, Ussi, Anton, Andreu, Antonio L, and McCormack, Emmet

Published
2023

10. Together4RD position statement on collaboration between European reference networks and industry.

Author

Hedley, Victoria, Bolz-Johnson, Matt, Hernando, Ines, Kenward, Rosalind, Nabbout, Rima, Romero, Clara, Schaefer, Franz, Upadhyaya, Sheela, Arzimanoglou, Alexis, Dollfus, Hélène, Leroux, Dorothée, Scarpa, Maurizio, Verloes, Alain, Daria Julkowska, Rath, Ana, Ussi, Anton, Mimouni, Yanis, Cuisenier, Morgane, Chalandon, Anne-Sophie, and Digneffe, Toon

Subjects
RARE diseases, INFRASTRUCTURE policy, RESEARCH & development, EXPERTISE
Abstract

Notwithstanding two decades of policy and legislation in Europe, aimed to foster research and development in rare conditions, only 5–6% of rare diseases have dedicated treatments. Given with the huge number of conditions classed as rare (which is increasing all the time), this equates to major unmet need for patients (over 30 million in the EU alone). Worryingly, the pace of Research and Innovation in Europe is lagging behind other regions of the world, and a seismic shift in the way in which research is planned and delivered is required, in order to remain competitive and—most importantly—bring meaningful, disease-altering treatments to those who desperately need them. The European Reference Networks (ERNs), launched in 2017, hold major potential to alleviate many of these challenges, and more, but only if adequately supported (financially, technically, and via robust policies and infrastructure) to realise that potential: and even then, only if able to forge robust collaborations harnessing the expertise, resources, knowledge and data of all stakeholders involved in rare disease, including Industry. To-date, however, ERN-Industry interactions have been largely limited, for a range of reasons (concerning barriers both tangible and perceived). This Position Statement analyses these barriers, and explains how Together4RD is seeking to move the needle here, by learning from case studies, exploring frameworks for collaboration, and launching pilots to explore how best to plan and deliver multistakeholder interactions addressing real research needs. [ABSTRACT FROM AUTHOR]

Published
2023
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11. Tackling the translational challenges of multi-omics research in the realm of European personalised medicine: A workshop report

Author

Oldoni, Emanuela, primary, Saunders, Gary, additional, Bietrix, Florence, additional, Garcia Bermejo, Maria Laura, additional, Niehues, Anna, additional, ’t Hoen, Peter A. C., additional, Nordlund, Jessica, additional, Hajduch, Marian, additional, Scherer, Andreas, additional, Kivinen, Katja, additional, Pitkänen, Esa, additional, Mäkela, Tomi Pekka, additional, Gut, Ivo, additional, Scollen, Serena, additional, Kozera, Łukasz, additional, Esteller, Manel, additional, Shi, Leming, additional, Ussi, Anton, additional, Andreu, Antonio L., additional, and van Gool, Alain J., additional

Published
2022
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13. Tackling the translational challenges of multi-omics research in the realm of European personalised medicine : A workshop report

Author

Oldoni, Emanuela, Saunders, Gary, Bietrix, Florence, Garcia Bermejo, Maria Laura, Niehues, Anna, 't Hoen, Peter A C, Nordlund, Jessica, Hajduch, Marian, Scherer, Andreas, Kivinen, Katja, Pitkänen, Esa, Mäkela, Tomi Pekka, Gut, Ivo, Scollen, Serena, Kozera, Łukasz, Esteller, Manel, Shi, Leming, Ussi, Anton, Andreu, Antonio L, van Gool, Alain J, Oldoni, Emanuela, Saunders, Gary, Bietrix, Florence, Garcia Bermejo, Maria Laura, Niehues, Anna, 't Hoen, Peter A C, Nordlund, Jessica, Hajduch, Marian, Scherer, Andreas, Kivinen, Katja, Pitkänen, Esa, Mäkela, Tomi Pekka, Gut, Ivo, Scollen, Serena, Kozera, Łukasz, Esteller, Manel, Shi, Leming, Ussi, Anton, Andreu, Antonio L, and van Gool, Alain J

Abstract

Personalised medicine (PM) presents a great opportunity to improve the future of individualised healthcare. Recent advances in -omics technologies have led to unprecedented efforts characterising the biology and molecular mechanisms that underlie the development and progression of a wide array of complex human diseases, supporting further development of PM. This article reflects the outcome of the 2021 EATRIS-Plus Multi-omics Stakeholder Group workshop organised to 1) outline a global overview of common promises and challenges that key European stakeholders are facing in the field of multi-omics research, 2) assess the potential of new technologies, such as artificial intelligence (AI), and 3) establish an initial dialogue between key initiatives in this space. Our focus is on the alignment of agendas of European initiatives in multi-omics research and the centrality of patients in designing solutions that have the potential to advance PM in long-term healthcare strategies.

Published
2022
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14. Evaluating Translational Methods for Personalized Medicine—A Scoping Review

Author

Fosse, Vibeke, Oldoni, Emanuela, Gerardi, Chiara, Banzi, Rita, Fratelli, Maddalena, Bietrix, Florence, Ussi, Anton, Andreu, Antonio L, McCormack, Emmet, The Permit Group, and Unión Europea. Comisión Europea. H2020

Subjects
Medicine (miscellaneous), Translational models, Preclinical models, Personalized medicine, Stratified treatment selection
Abstract

The introduction of personalized medicine, through the increasing multi-omics characterization of disease, brings new challenges to disease modeling. The scope of this review was a broad evaluation of the relevance, validity, and predictive value of the current preclinical methodologies applied in stratified medicine approaches. Two case models were chosen: oncology and brain disorders. We conducted a scoping review, following the Joanna Briggs Institute guidelines, and searched PubMed, EMBASE, and relevant databases for reports describing preclinical models applied in personalized medicine approaches. A total of 1292 and 1516 records were identified from the oncology and brain disorders search, respectively. Quantitative and qualitative synthesis was performed on a final total of 63 oncology and 94 brain disorder studies. The complexity of personalized approaches highlights the need for more sophisticated biological systems to assess the integrated mechanisms of response. Despite the progress in developing innovative and complex preclinical model systems, the currently available methods need to be further developed and validated before their potential in personalized medicine endeavors can be realized. More importantly, we identified underlying gaps in preclinical research relating to the relevance of experimental models, quality assessment practices, reporting, regulation, and a gap between preclinical and clinical research. To achieve a broad implementation of predictive translational models in personalized medicine, these fundamental deficits must be addressed. This research was funded by the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 874825. Sí

Published
2022

16. CORBEL Sustainability plan for extended BMS RI Innovation Office

Author

Abuja, Peter M., Carapina, Tamara, de Kort, Martin, Fauvel, Anne-Charlotte, Tieken, Chris, Ussi, Anton, and Wagstaff, Nigel

Subjects
Biomedical Research Infrastructures, Industry collaboration
Abstract

In this deliverable proposals are outlined to continue some of the Innovation Office activities of CORBEL beyond the formal termination of the project. Based on the breakdown of requests and other activities handled during the project and taking account of resources available options have been developed to provide Help Desk support for innovation as well as continuing the web portal and innovation email facilities and providing training and other materials. Opportunities to link into new initiatives will be pursued for mutual benefit. Relationships with other CORBEL work package products will be taken into account to simplify access to information and resources and to continue to share best practices post CORBEL.

Published
2020
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17. Clinical characteristics of COVID-19 in older adults. A retrospective study in long-term nursing homes in Catalonia

Author

Santaeugènia, Sebastià [0000-0002-2725-4065], Almirante, Benito [0000-0002-1189-2361], Meis-Pinheiro, Uxío, López Seguí, Francesc, Walsh, Sandra, Ussi, Anton, Santaeugènia, Sebastià, García-Navarro, José Augusto, San-José, Antonio, Andreu, Antoni L., Campins, Magda, Almirante, Benito, Santaeugènia, Sebastià [0000-0002-2725-4065], Almirante, Benito [0000-0002-1189-2361], Meis-Pinheiro, Uxío, López Seguí, Francesc, Walsh, Sandra, Ussi, Anton, Santaeugènia, Sebastià, García-Navarro, José Augusto, San-José, Antonio, Andreu, Antoni L., Campins, Magda, and Almirante, Benito

Abstract

The natural history of COVID-19 and predictors of mortality in older adults need to be investigated to inform clinical operations and healthcare policy planning. A retrospective study took place in 80 long-term nursing homes in Catalonia, Spain collecting data from March 1st to May 31st, 2020. Demographic and clinical data from 2,092 RT-PCR confirmed cases of SARS-CoV-2 infection were registered, including structural characteristics of the facilities. Descriptive statistics to describe the demographic, clinical, and molecular characteristics of our sample were prepared, both overall and by their symptomatology was performed and an analysis of statistically significant bivariate differences and constructions of a logistic regression model were carried out to assess the relationship between variables. The incidence of the infection was 28%. 71% of the residents showed symptoms. Five major symptoms included: fever, dyspnea, dry cough, asthenia and diarrhea. Fever and dyspnea were by far the most frequent (50% and 28%, respectively). The presentation was predominantly acute and symptomatology persisted from days to weeks (mean 9.1 days, SD = 10,9). 16% of residents had confirmed pneumonia and 22% required hospitalization. The accumulated mortality rate was 21.75% (86% concentrated during the first 28 days at onset). A multivariate logistic regression analysis showed a positive predictive value for mortality for some variables such as age, pneumonia, fever, dyspnea, stupor refusal to oral intake and dementia (p<0.01 for all variables). Results suggest that density in the nursing homes did not account for differences in the incidence of the infection within the facilities. This study provides insights into the natural history of the disease in older adults with high dependency living in long-term nursing homes during the first pandemic wave of March-May 2020 in the region of Catalonia, and suggests that some comorbidities and symptoms have a strong predictive value for mo

Published
2021

19. Biomarker Research and Development for Coronavirus Disease 2019 (COVID-19): European Medical Research Infrastructures Call for Global Coordination

Author

Oldoni, Emanuela, primary, van Gool, Alain, additional, García Bermejo, Laura, additional, Scherer, Andreas, additional, Mayrhofer, Michaela Th, additional, Florindi, Francesco, additional, Demotes, Jacques, additional, Kubiak, Christine, additional, Fauvel, Anne-Charlotte, additional, Bietrix, Florence, additional, Ussi, Anton, additional, and Andreu, Antonio L, additional

Published
2020
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22. The Fundamental Characteristics of a Translational Scientist

Author

Gilliland, C. Taylor, primary, White, Julia, additional, Gee, Barry, additional, Kreeftmeijer-Vegter, Rosan, additional, Bietrix, Florence, additional, Ussi, Anton E., additional, Hajduch, Marian, additional, Kocis, Petr, additional, Chiba, Nobuyoshi, additional, Hirasawa, Ryutaro, additional, Suematsu, Makoto, additional, Bryans, Justin, additional, Newman, Stuart, additional, Hall, Matthew D., additional, and Austin, Christopher P., additional

Published
2019
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23. Biomarker Research and Development for Coronavirus Disease 2019 (COVID-19): European Medical Research Infrastructures Call for Global Coordination.

Author

Oldoni, Emanuela, Gool, Alain van, Bermejo, Laura García, Scherer, Andreas, Mayrhofer, Michaela Th, Florindi, Francesco, Demotes, Jacques, Kubiak, Christine, Fauvel, Anne-Charlotte, Bietrix, Florence, Ussi, Anton, and Andreu, Antonio L

Subjects
BIOMARKERS, RESEARCH, WORLD health, CONCEPTUAL structures, INTERPROFESSIONAL relations, COVID-19 testing, COVID-19 pandemic
Abstract

An effective response to the coronavirus disease 2019 (COVID-19) pandemic requires a better understanding of the biology of the infection and the identification of validated biomarker profiles that would increase the availability, accuracy, and speed of COVID-19 testing. Here, we describe the strategic objectives and action lines of the European Alliance of Medical Research Infrastructures (AMRI), established to improve the research process and tackle challenges related to diagnostic tests and biomarker development. Recommendations include: the creation of a European taskforce for validation of novel diagnostic products, the definition and promotion of criteria for COVID-19 samples biobanking, the identification and validation of biomarkers as clinical endpoints for clinical trials, and the definition of immune biomarker signatures at different stages of the disease. An effective management of the COVID-19 pandemic is possible only if there is a high level of knowledge and coordination between the public and private sectors within a robust quality framework. [ABSTRACT FROM AUTHOR]

Published
2021
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25. Addressing Pressing Needs in the Development of Advanced Therapies

Author

Morrow, David, Ussi, Anton, and Migliaccio, Giovanni

Subjects
reimbursement mechanisms, funding models, manufacturing technology, Bioengineering and Biotechnology, regulatory pathway, advanced therapy medicinal product
Abstract

The commercial development of advanced therapy medicinal products (ATMPs) represents great opportunity for therapeutic innovation but is beset by many challenges for its developers. Although the ATMP field continues to progress at a rapid pace, evidenced by the increasing number of clinical trials conducted over the past few years, several factors continue to complicate the introduction of ATMPs as a curative treatment for multiple disease types, by blocking their translational pathway from research to the patient. While several recent publications (Trounson and McDonald, 2015; Abou-El-Enein et al., 2016a,b) as well as an Innovative Medicines Initiative consultation (IMI, 2016) this year have highlighted the major gaps in ATMP development, with manufacturing, regulatory, and reimbursement issues at the forefront, there remains to be formulated a coherent strategy to address these by bringing the relevant stakeholders to a single forum, whose task it would be to design and execute a delta plan to alleviate the most pressing bottlenecks. This article focuses on two of the most urgent areas in need of attention in ATMP development, namely manufacturing and reimbursement, and promotes the concept of innovation-dedicated research infrastructures to support a multi-sector approach for ensuring the successful development, entry, and ensuing survival of ATMPs in the healthcare market.

Published
2017
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28. Bridging the translational innovation gap through good biomarker practice

Author

van Gool, Alain J., primary, Bietrix, Florence, additional, Caldenhoven, Eric, additional, Zatloukal, Kurt, additional, Scherer, Andreas, additional, Litton, Jan-Eric, additional, Meijer, Gerrit, additional, Blomberg, Niklas, additional, Smith, Andy, additional, Mons, Barend, additional, Heringa, Jaap, additional, Koot, Wim-Jan, additional, Smit, Martin J., additional, Hajduch, Marian, additional, Rijnders, Ton, additional, and Ussi, Anton, additional

Published
2017
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31. Putting translational science on to a global stage

Author

Gilliland, C. Taylor, primary, Zuk, Dorit, additional, Kocis, Petr, additional, Johnson, Mike, additional, Hay, Stewart, additional, Hajduch, Marian, additional, Bietrix, Florence, additional, Aversa, Gregorio, additional, Austin, Christopher P., additional, and Ussi, Anton E., additional

Published
2016
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32. EATRIS, a European initiative to boost translational biomedical research

Author

van Dongen, Guus AMS, Ussi, Anton E, de Man, Frank H, and Migliaccio, Giovanni

Subjects
Review Article
Abstract

Recent advances in molecular and cellular biology have facilitated the discovery of the key molecular drivers of major diseases. This knowledge raised some optimism in the beginning of this century, yet its impact on disease prevention, diagnosis and targeted intervention remains low. At the same time the pharmaceutical industry is facing the dual challenges of a dwindling drug pipeline and ever increasing cost of drug development. It is against this background that a number of European countries decided to establish EATRIS, the European Advanced Translational Research InfraStructure in Medicine. EATRIS aims for faster and more efficient translation of basic research into innovative products, by providing academia and industry access to the state-of-the-art expertise and highly capital-intensive facilities residing in Europe's top translational research centers and hospitals. To this end, EATRIS formed product groups that provide translational services in the fields of development and supply of (1) molecular imaging and tracing, (2) vaccines, (3) biomarkers, (4) small molecules and (5) advanced therapeutic medicinal products. Herein we describe the background, goals, functions and structure of EATRIS. As an example, it will be described how EATRIS centers involved in imaging and tracing might contribute to more efficient drug development and personalized medicine.

Published
2013

33. Boost to translational medicine in Europe

Author

Migliacco, Giovanni, de Man, Frank H., and Ussi, Anton E.

Subjects
Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

Next week will mark the launch of the European Infrastructure for Translational Medicine (EATRIS; see go.nature.com/3li8fs). EATRIS aims to help clients (industry, small enterprises, funding organizations and academic institutions) to [...]

Published
2013

36. Biotech and SME Needs and Service Gaps in Relation to Research Infrastructures: Survey Report

Author

Daban, Montserrat, Ruiz, Maria, Ussi, Anton, Fauvel, Anne-Charlotte, Tieken, Chris, Keidong, Eliis, de Kort, Martin, and Andreu, Antonio

Subjects
biotech, Horizon 2020, translational medicine, EATRIS-Plus, SME, research infrastructure, personalised medicine, biomedical industry, public-private partnerships, bioclusters, multiomics, 3. Good health
Abstract

EATRIS-Plus is a flagship project aiming to consolidate our infrastructure’s capacities in the field of personalised medicine. One of the main objectives of the project is to accelerate outreach to SMEs and build long-term engagement with bioclusters. In order to be able to reach more potential industry users and further diversify EATRIS’ revenue streams, this task will pilot a collaboration programme with Biocat (comprising 1,060 companies, 580 of which biotech, medtech and pharma). Activities designed to raise the profile of the research infrastructure (RI) towards industry associations and their member companies will be evaluated, with impactful activities to be further expanded to other cluster regions. As one of the first activities, Task 6.2 - Accelerate outreach to SMEs: build long-term engagement with bioclusters aimed to further these efforts, Biocat has now performed a survey of SMEs’ needs in relation to infrastructure support and access to academic expertise and high-end facilities. The results and discussion are summarised in this Deliverable 6.1. The results of the survey will help EATRIS-Plus consortium partners refine their engagement strategy towards SMEs., EATRIS-Plus project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 871096

38. EATRIS, a European initiative to boost translational biomedical research.

Author

van Dongen GA, Ussi AE, de Man FH, and Migliaccio G

Abstract

Recent advances in molecular and cellular biology have facilitated the discovery of the key molecular drivers of major diseases. This knowledge raised some optimism in the beginning of this century, yet its impact on disease prevention, diagnosis and targeted intervention remains low. At the same time the pharmaceutical industry is facing the dual challenges of a dwindling drug pipeline and ever increasing cost of drug development. It is against this background that a number of European countries decided to establish EATRIS, the European Advanced Translational Research InfraStructure in Medicine. EATRIS aims for faster and more efficient translation of basic research into innovative products, by providing academia and industry access to the state-of-the-art expertise and highly capital-intensive facilities residing in Europe's top translational research centers and hospitals. To this end, EATRIS formed product groups that provide translational services in the fields of development and supply of (1) molecular imaging and tracing, (2) vaccines, (3) biomarkers, (4) small molecules and (5) advanced therapeutic medicinal products. Herein we describe the background, goals, functions and structure of EATRIS. As an example, it will be described how EATRIS centers involved in imaging and tracing might contribute to more efficient drug development and personalized medicine.

Published
2013

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