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Challenges with advanced therapy medicinal products and how to meet them.
Committee for Advanced Therapies (CAT); CAT Scientific Secretariat; Schneider CK, Salmikangas P, Jilma B, Flamion B, Todorova LR, Paphitou A, Haunerova I, Maimets T, Trouvin JH, Flory E, Tsiftsoglou A, Sarkadi B, Gudmundsson K, O'Donovan M, Migliaccio G, Ancāns J, Maciulaitis R, Robert JL, Samuel A, Ovelgönne JH, Hystad M, Fal AM, Lima BS, Moraru AS, Turcáni P, Zorec R, Ruiz S, Akerblom L, Narayanan G, Kent A, Bignami F, Dickson JG, Niederwieser D, Figuerola-Santos MA, Reischl IG, Beuneu C, Georgiev R, Vassiliou M, Pychova A, Clausen M, Methuen T, Lucas S, Schüssler-Lenz M, Kokkas V, Buzás Z, MacAleenan N, Galli MC, Linē A, Gulbinovic J, Berchem G, Fraczek M, Menezes-Ferreira M, Vilceanu N, Hrubisko M, Marinko P, Timón M, Cheng W, Crosbie GA, Meade N, di Paola ML, VandenDriessche T, Ljungman P, D'Apote L, Oliver-Diaz O, Büttel I, Celis P. Committee for Advanced Therapies (CAT), et al. Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Nat Rev Drug Discov. 2010. PMID: 20190786 Review.
[Clinical trials with advanced therapy medicinal products].
Schüssler-Lenz M, Schneider CK. Schüssler-Lenz M, et al. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):68-74. doi: 10.1007/s00103-009-0984-4. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010. PMID: 20011994 German.
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 P, Ferry N, Hystad M, Schüßler-Lenz M, Doevendans PA, Flory E, Beuneu C, Reischl I, Salmikangas P. Celis P, et al. Among authors: schussler lenz m. Transfus Med Hemother. 2015 May;42(3):194-9. doi: 10.1159/000382107. Epub 2015 Apr 28. Transfus Med Hemother. 2015. PMID: 26195933 Free PMC article.
Cell-based therapies for cardiac repair: a meeting report on scientific observations and European regulatory viewpoints.
Schüssler-Lenz M, Beuneu C, Menezes-Ferreira M, Jekerle V, Bartunek J, Chamuleau S, Celis P, Doevendans P, O'Donovan M, Hill J, Hystad M, Jovinge S, Kyselovič J, Lipnik-Stangelj M, Maciulaitis R, Prasad K, Samuel A, Tenhunen O, Tonn T, Rosano G, Zeiher A, Salmikangas P. Schüssler-Lenz M, et al. Eur J Heart Fail. 2016 Feb;18(2):133-41. doi: 10.1002/ejhf.422. Epub 2015 Oct 16. Eur J Heart Fail. 2016. PMID: 26470631 Free article.
Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies-the German Cancer Consortium approach.
Krackhardt AM, Anliker B, Hildebrandt M, Bachmann M, Eichmüller SB, Nettelbeck DM, Renner M, Uharek L, Willimsky G, Schmitt M, Wels WS, Schüssler-Lenz M. Krackhardt AM, et al. Among authors: schussler lenz m. Cancer Immunol Immunother. 2018 Apr;67(4):513-523. doi: 10.1007/s00262-018-2119-y. Epub 2018 Jan 29. Cancer Immunol Immunother. 2018. PMID: 29380009 Free PMC article. Review.
[Combination therapies in immuno-oncology: differentiated regulatory approaches].
Müller-Berghaus J, Sarac SB, Schüssler-Lenz M. Müller-Berghaus J, et al. Among authors: schussler lenz m. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2020 Nov;63(11):1388-1395. doi: 10.1007/s00103-020-03228-2. Epub 2020 Oct 21. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2020. PMID: 33084926 Free PMC article. Review. German.
12 results