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[CAR-T, in-house models for national networks, and hospital exception: perspectives in Italy.]
1Università LUISS Guido Carli, Roma; Agenzia Italiana del Farmaco (AIFA), Roma*.
Abstract:
The article reconstructs the current status and development prospects of CAR-T therapies. It further explores the legitimacy of some production and administration paths of these therapies by national networks of hospital centers equipped with cellular workshops, according to an "in-house" model. Specific attention is paid to CAR-T produced in the context of clinical trials and according to the so-called "hospital exception", disciplined in Italy by a ministerial decree adopted in 2015 aiming at guaranteeing sustainability and accessibility of these innovative advanced therapies.
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