A management model in blood, tissue and cell establishments to ensure rapid and sustainable patient access to advanced therapy medicinal products in Europe
Delgadillo Duarte, Joaquin (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Kerkelä, Erja (Finnish Red Cross Blood Service (Finland))
Waters, Allison (Irish Blood Transfusion Service. National Blood Centre (Ireland))
van den Akker, Emile (University of Amsterdam)
Lechanteur, Chantal (Université de Liège)
Baudoux, Etienne (Université de Liège)
Gardiner, Nicola (St. James's Hospital (Dublín, Irlanda))
De Vos, John (Hôpital Saint-Eloi (França))
Vives Armengol, Joaquim (Universitat Autònoma de Barcelona. Departament de Medicina)

Fecha:	2023
Resumen:	Blood, tissue and cell establishments (BTCs) stand out in the management of donor selection, procurement and processing of all types of substances of human origin (SoHO). In the last decades, the framework created around BTCs, including hospitals and national health system networks, and their links to research, development and innovation organizations and agencies have spurred their involvement in the study of groundbreaking advanced therapy medicinal products (ATMP). To further improve strategic synergies in the development of ATMPs, it will be required to promote intra- and inter-European collaborations by creating an international network involving BTCs and major stakeholders (i. e. , research organizations, hospitals, universities, patient associations, public agencies). This vision is already shared with the European Blood Alliance, the association of non-profit blood establishments, with 26 member states throughout the European Union and European Free Trade Association states. Herein we present and analyze the "BTC for ATMP Development And Manufacture" (BADAM) model, an ethically responsible business model based on the values and missions of BTCs and their commitment to health equity, patient access and education (based on voluntary donation of SoHO to address unmet clinical needs, while contributing to training professionals and scientific literacy of our Society).
Nota:	Altres ajuts: acords transformatius de la UAB
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Advanced therapy medicinal product ; Blood establishment ; Business model ; Cell processing ; Clinical translation ; Donation ; Donor ; Regulatory development ; Substances of human origin ; Tissue bank
Publicado en:	Cytotherapy, Vol. 25 Núm. 12 (december 2023) , p. 1259-1264, ISSN 1477-2566

DOI: 10.1016/j.jcyt.2023.08.001

6 p, 681.8 KB

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