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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. Among authors: celis p. Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Nat Rev Drug Discov. 2010. PMID: 20190786 Review.
The advanced therapy classification procedure. Overview of experience gained so far.
Voltz-Girolt C, Celis P, Boucaumont M, D'Apote L, Pinheiro MH, Papaluca-Amati M. Voltz-Girolt C, et al. Among authors: celis p. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Jul;54(7):811-5. doi: 10.1007/s00103-011-1309-y. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011. PMID: 21698533 Review.
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. Among authors: celis p. 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 Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?
Boráň T, Menezes-Ferreira M, Reischl I, Celis P, Ferry N, Gänsbacher B, Krafft H, Lipucci di Paola M, Sladowski D, Salmikangas P. Boráň T, et al. Among authors: celis p. Hum Gene Ther Clin Dev. 2017 Sep;28(3):126-135. doi: 10.1089/humc.2016.193. Epub 2017 May 16. Hum Gene Ther Clin Dev. 2017. PMID: 28510497 Review.
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