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Title:

Advanced Therapy Medicinal Products and the Changing Role of Academia.

Document type:
Review; Journal Article; Review
Author(s):
Priesner, Christoph; Hildebrandt, Martin
Abstract:
Academic institutions coin the ATMP landscape but do not possess an industry-like capacity to vigorously pursue the full developmental pathway to marketing authorization. At the same time, industry has fostered clinical trials with ATMPs, brought the first products to marketing authorization, and defined novel modes of interaction with academia. A regulatory niche for local manufacturing of ATMPs within an academic institution had been foreseen in Regulation (EU) 1394/2007 under the term "Hospit...     »
Journal title abbreviation:
Transfus Med Hemother
Year:
2022
Journal volume:
49
Journal issue:
3
Pages contribution:
158-162
Fulltext / DOI:
doi:10.1159/000524392
Pubmed ID:
http://view.ncbi.nlm.nih.gov/pubmed/35813600
Print-ISSN:
1660-3796
TUM Institution:
Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie
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