EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells
Celis, Patrick, Farinelli, Giada, Hidalgo‐Simon, Ana, Meij, Pauline, Tihaya, Mara, Schüssler‐Lenz, Martina, Timón, Marcos
Published in British journal of clinical pharmacology (01.05.2024)
Published in British journal of clinical pharmacology (01.05.2024)
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EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B‐Cell Lymphoma
Papadouli, Irene, Mueller‐Berghaus, Jan, Beuneu, Claire, Ali, Sahra, Hofner, Benjamin, Petavy, Frank, Tzogani, Kyriaki, Miermont, Anne, Norga, Koenraad, Kholmanskikh, Olga, Leest, Tim, Schuessler‐Lenz, Martina, Salmonson, Tomas, Gisselbrecht, Christian, Garcia, Jordi Llinares, Pignatti, Francesco
Published in The oncologist (Dayton, Ohio) (01.10.2020)
Published in The oncologist (Dayton, Ohio) (01.10.2020)
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European regulatory experience with advanced therapy medicinal products
Barkholt, Lisbeth, Voltz-Girolt, Caroline, Raine, June, Salmonson, Tomas, Schüssler-Lenz, Martina
Published in Nature reviews. Drug discovery (01.01.2019)
Published in Nature reviews. Drug discovery (01.01.2019)
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The European Medicines Agency Review of Kymriah (Tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukemia and Diffuse Large B‐Cell Lymphoma
Ali, Sahra, Kjeken, Rune, Niederlaender, Christiane, Markey, Greg, Saunders, Therese S., Opsata, Mona, Moltu, Kristine, Bremnes, Bjørn, Grønevik, Eirik, Muusse, Martine, Håkonsen, Gro D., Skibeli, Venke, Kalland, Maria Elisabeth, Wang, Ingrid, Buajordet, Ingebjørg, Urbaniak, Ania, Johnston, John, Rantell, Khadija, Kerwash, Essam, Schuessler‐Lenz, Martina, Salmonson, Tomas, Bergh, Jonas, Gisselbrecht, Christian, Tzogani, Kyriaki, Papadouli, Irene, Pignatti, Francesco
Published in The oncologist (Dayton, Ohio) (01.02.2020)
Published in The oncologist (Dayton, Ohio) (01.02.2020)
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Paediatric Strategy Forum for medicinal product development of chimeric antigen receptor T-cells in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration
Pearson, Andrew Dj, Rossig, Claudia, Mackall, Crystal, Shah, Nirali N, Baruchel, Andre, Reaman, Gregory, Ricafort, Rosanna, Heenen, Delphine, Bassan, Abraham, Berntgen, Michael, Bird, Nick, Bleickardt, Eric, Bouchkouj, Najat, Bross, Peter, Brownstein, Carrie, Cohen, Sarah Beaussant, de Rojas, Teresa, Ehrlich, Lori, Fox, Elizabeth, Gottschalk, Stephen, Hanssens, Linda, Hawkins, Douglas S, Horak, Ivan D, Taylor, Danielle H, Johnson, Courtney, Karres, Dominik, Ligas, Franca, Ludwinski, Donna, Mamonkin, Maksim, Marshall, Lynley, Masouleh, Behzad K, Matloub, Yousif, Maude, Shannon, McDonough, Joe, Minard-Colin, Veronique, Norga, Koen, Nysom, Karsten, Pappo, Alberto, Pearce, Laura, Pieters, Rob, Pule, Martin, Quintás-Cardama, Alfonso, Richardson, Nick, Schüßler-Lenz, Martina, Scobie, Nicole, Sersch, Martina A, Smith, Malcolm A, Sterba, Jaroslav, Tasian, Sarah K, Weigel, Brenda, Weiner, Susan L, Zwaan, Christian Michel, Lesa, Giovanni, Vassal, Gilles
Published in European journal of cancer (1990) (01.01.2022)
Published in European journal of cancer (1990) (01.01.2022)
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Cell-based therapies for cardiac repair: a meeting report on scientific observations and European regulatory viewpoints
Schüssler-Lenz, Martina, Beuneu, Claire, Menezes-Ferreira, Margarida, Jekerle, Veronika, Bartunek, Jozef, Chamuleau, Steven, Celis, Patrick, Doevendans, Pieter, O'Donovan, Maura, Hill, Jonathan, Hystad, Marit, Jovinge, Stefan, Kyselovič, Ján, Lipnik-Stangelj, Metoda, Maciulaitis, Romaldas, Prasad, Krishna, Samuel, Anthony, Tenhunen, Olli, Tonn, Torsten, Rosano, Giuseppe, Zeiher, Andreas, Salmikangas, Paula
Published in European journal of heart failure (01.02.2016)
Published in European journal of heart failure (01.02.2016)
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Challenges with advanced therapy medicinal products and how to meet them
Schneider, Christian K, Salmikangas, Paula, Jilma, Bernd, Flamion, Bruno, Todorova, Lyubina Racheva, Paphitou, Anna, Haunerova, Ivana, Maimets, Toivo, Trouvin, Jean-Hugues, Flory, Egbert, Tsiftsoglou, Asterios, Sarkadi, Balázs, Gudmundsson, Kolbeinn, O'Donovan, Maura, Migliaccio, Giovanni, Ancāns, Jānis, Maciulaitis, Romaldas, Robert, Jean-Louis, Samuel, Anthony, Ovelgönne, Johannes H, Hystad, Marit, Fal, Andrzej Mariusz, Lima, Beatriz Silva, Moraru, Anca Stela, Turcáni, Peter, Zorec, Robert, Ruiz, Sol, Akerblom, Lennart, Narayanan, Gopalan, Kent, Alastair, Bignami, Fabrizia, Dickson, J George, Niederwieser, Dietger, Figuerola-Santos, María-Angeles, Reischl, Ilona G, Beuneu, Claire, Georgiev, Rosen, Vassiliou, Maria, Pychova, Alena, Clausen, Mette, Methuen, Taina, Lucas, Sophie, Schüssler-Lenz, Martina, Kokkas, Vasilios, Buzás, Zsuzsanna, MacAleenan, Niall, Galli, Maria Cristina, Linē, Aija, Gulbinovic, Jolanta, Berchem, Guy, Fraczek, Mariusz, Menezes-Ferreira, Margarida, Vilceanu, Nela, Hrubisko, Mikulás, Marinko, Petra, Timón, Marcos, Cheng, Wing, Crosbie, George Andrew, Meade, Nick, di Paola, Michelino Lipucci, VandenDriessche, Thierry, Ljungman, Per, D'Apote, Lucia, Oliver-Diaz, Olga, Büttel, Isabel, Celis, Patrick
Published in Nature reviews. Drug discovery (01.03.2010)
Published in Nature reviews. Drug discovery (01.03.2010)
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Book Review
Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies—the German Cancer Consortium approach
Krackhardt, Angela M., Anliker, Brigitte, Hildebrandt, Martin, Bachmann, Michael, Eichmüller, Stefan B., Nettelbeck, Dirk M., Renner, Matthias, Uharek, Lutz, Willimsky, Gerald, Schmitt, Michael, Wels, Winfried S., Schüssler-Lenz, Martina
Published in Cancer Immunology, Immunotherapy (01.04.2018)
Published in Cancer Immunology, Immunotherapy (01.04.2018)
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Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products
Jost, Nils, Schüssler-Lenz, Martina, Ziegele, Bettina, Reinhardt, Jens
Published in Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz (01.11.2015)
Published in Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz (01.11.2015)
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Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective
Salmikangas, Paula, Schuessler-Lenz, Martina, Ruiz, Sol, Celis, Patrick, Reischl, Ilona, Menezes-Ferreira, Margarida, Flory, Egbert, Renner, Matthias, Ferry, Nicolas
Published in Advances in experimental medicine and biology (01.01.2015)
Published in Advances in experimental medicine and biology (01.01.2015)
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Implications for blinding in clinical trials with THC-containing cannabinoids based on the CANNA-TICS trial
Müller-Vahl, Kirsten R., Jakubovski, Ewgeni, Fremer, Carolin, Lenz-Ziegenbein, Martina, Großhennig, Anika, Klages, Carolin, Koch, Armin, Haas, Martina, Pisarenko, Anna
Published in Frontiers in neuroscience (21.09.2022)
Published in Frontiers in neuroscience (21.09.2022)
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Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014
Celis, Patrick, Ferry, Nicolas, Hystad, Marit, Schüßler-Lenz, Martina, Doevendans, Pieter A., Flory, Egbert, Beuneu, Claire, Reischl, Ilona, Salmikangas, Paula
Published in Transfusion medicine and hemotherapy (01.01.2015)
Published in Transfusion medicine and hemotherapy (01.01.2015)
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Arzneimittelzulassung im Bereich seltener Erkrankungen: die europäische regulatorische Perspektive am Beispiel der Gen- und Zelltherapeutika
Schüßler-Lenz, Martina, Hofner, Benjamin
Published in Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen (01.09.2024)
Published in Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen (01.09.2024)
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Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe
Schuessler-Lenz, Martina, Herberts, Carla, Reischl, Ilona, Ruiz, Sol, Celis, Patrick, Beuneu, Claire, Kjeken, Rune, Timón, Marcos
Published in Advances in experimental medicine and biology (2023)
Published in Advances in experimental medicine and biology (2023)
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