PSY166 - MARKET ACCESS TRENDS FOR ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPS) IN EUROPE [PDF]
Value in Health, 2018 R. Dellamano +4 more
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Advanced therapy medicinal products (ATMPs) & GMP : 10 years after
, 2019 We review the GMP/regulatory experience with advanced therapy medicinal products (ATMPs) approximately 10 years after EC regulation 1394/2007, aka the ATMP regulation applied. Particularly, we discuss practical issues which have arisen during this period
Jossen, Valentin +3 more
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An Analysis of Monitoring Solutions for CAR T Cell Production
Healthcare Technology LettersThe chimeric antigen receptor T cell (CAR T) therapy has shown remarkable results in treating certain cancers. It involves genetically modifying a patient's T cells to recognize and attack cancer cells.
Arber Shoshi +10 more
doaj +1 more source
The issue of heterogeneity of MSC-based advanced therapy medicinal products–a review
Frontiers in Cell and Developmental BiologyMesenchymal stromal stem cells (MSCs) possess a remarkable potential for numerous clinical applications due to their unique properties including self-renewal, immunomodulation, paracrine actions and multilineage differentiation.
Ana Bajc Česnik +2 more
doaj +1 more source
PDG89 ADVANCED THERAPY MEDICINAL PRODUCT (ATMP) MARKET ACCESS - A CONTINUING CHALLENGE [PDF]
Value in Health, 2019 C. Watson, K. Cadwell
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REGULATORY CONSIDERATIONS FOR ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPS): GLOBAL PERSPECTIVES
Advanced Therapy Medicinal Products (ATMPs), including gene therapy medicinal products, somatic cell therapy medicinal products, tissue-engineered products, and certain combined advanced therapies, represent a major transformation in modern medicine. Unlike conventional small-molecule medicines, ATMPs frequently involve living cells, genetic material ...
Kshitija Jeetesh Shinde +1 more
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European Journal of HistochemistryDeveloping cellular therapies is not straightforward. This presentation summarizes the experience of academic stem cell investigators working in different clinical applications and aiming to share insight into what could be useful to consider, in light of the current situation regarding advanced therapies.
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Pricing Pressures And Market Access Outcomes Of Advanced Therapy Medicinal Products (Atmps) In The Eu5 [PDF]
Value in Health, 2017 MJ Jenkins, P Borga, A Ribeiro
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PNS136 Use of Real-World Evidence in Advanced Therapy Medicinal Product (ATMP) HTA Decisions [PDF]
Value in Health, 2020 C. Watson, G. Jones, R. Miller
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Challenges in Advanced Therapy Medicinal Products Development: A survey amongst companies in Europe
, 2018 Advanced Therapy Medicinal Products (ATMPs) hold a promise as treatments for previously untreatable and high burden diseases. Expectations are high and active company pipelines are observed, yet only ten market authorizations were approved in Europe. Our
ten Ham, R.M.T. +5 more
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