Challenges in advanced therapy medicinal product development: a survey among companies in Europe
RMT Ten Ham, J Hoekman, AM Hövels… - … Therapy-Methods & …, 2018 - cell.com
Advanced therapy medicinal products (ATMPs) hold promise as treatments for previously
untreatable and high-burden diseases. Expectations are high and active company pipelines …
untreatable and high-burden diseases. Expectations are high and active company pipelines …
Clinical development and commercialization of advanced therapy medicinal products in the European Union: how are the product pipeline and regulatory framework …
T Boráň, M Menezes-Ferreira, I Reischl… - Human Gene …, 2017 - liebertpub.com
The research and development of advanced therapy medicinal products (ATMPs) has been
active in Europe and worldwide during recent years. Yet, the number of licensed products …
active in Europe and worldwide during recent years. Yet, the number of licensed products …
Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive
R Maciulaitis, L D'apote, A Buchanan, L Pioppo… - Molecular Therapy, 2012 - cell.com
Advanced therapy medicinal products (ATMPs), defined as gene therapy medicinal products
(GTMPs), somatic cell therapy medicinal products, and tissue-engineered products (TEPs) …
(GTMPs), somatic cell therapy medicinal products, and tissue-engineered products (TEPs) …
Current landscape of clinical development and approval of advanced therapies
Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target
orphan diseases and high unmet medical needs. The uncertainty about the product's benefit …
orphan diseases and high unmet medical needs. The uncertainty about the product's benefit …
Advanced therapy medicinal products' translation in Europe: a developers' perspective
M Pizevska, J Kaeda, E Fritsche, H Elazaly… - Frontiers in …, 2022 - frontiersin.org
Advanced Therapy Medicinal Products (ATMPs) comprising cell, gene, and tissue-
engineered therapies have demonstrated enormous therapeutic benefits. However, their …
engineered therapies have demonstrated enormous therapeutic benefits. However, their …
Addressing pressing needs in the development of advanced therapies
D Morrow, A Ussi, G Migliaccio - Frontiers in bioengineering and …, 2017 - frontiersin.org
The commercial development of advanced therapy medicinal products (ATMPs) represents
great opportunity for therapeutic innovation but is beset by many challenges for its …
great opportunity for therapeutic innovation but is beset by many challenges for its …
Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption
C Eder, C Wild - Journal of market access & health policy, 2019 - mdpi.com
Background: The umbrella term ATMPs (Advanced Therapy Medicinal Products) comprises
cell therapies, gene therapeutics and tissue engineered products. After implementation of …
cell therapies, gene therapeutics and tissue engineered products. After implementation of …
Hurdles in clinical implementation of academic advanced therapy medicinal products: a national evaluation
S de Wilde, L Veltrop-Duits, M Hoozemans-Strik, T Ras… - Cytotherapy, 2016 - Elsevier
Background Since the implementation of the European Union (EU) regulation for advanced
therapy medicinal products (ATMPs) in 2009, only six ATMPs achieved marketing …
therapy medicinal products (ATMPs) in 2009, only six ATMPs achieved marketing …
Mitigating deficiencies in evidence during regulatory assessments of advanced therapies: a comparative study with other biologicals
M Elsallab, CA Bravery, A Kurtz… - … Therapy Methods & …, 2020 - cell.com
Advanced therapy medicinal products (ATMPs) comprising cell therapy, gene therapy, and
tissue-engineered products, offer a multitude of novel therapeutic approaches to a wide …
tissue-engineered products, offer a multitude of novel therapeutic approaches to a wide …
Advanced therapy medicinal products: current and future perspectives
Background: Advanced therapy medicinal products (ATMPs) are innovative therapies that
encompass gene therapy, somatic cell therapy, and tissue-engineered products. These …
encompass gene therapy, somatic cell therapy, and tissue-engineered products. These …