The current state of advanced therapy medicinal products in the Czech Republic

Z Kočí, T Boráň, P Krůpa, Š Kubinová - Human Gene Therapy …, 2018 - liebertpub.com
Advanced therapy medicinal products (ATMPs) represent a new generation of
biopharmaceuticals that comprise gene therapy medicinal products (GTMPs), somatic cell …

Advanced therapy medicinal products: current and future perspectives

E Hanna, C Rémuzat, P Auquier, M Toumi - Journal of market access & …, 2016 - mdpi.com
Background: Advanced therapy medicinal products (ATMPs) are innovative therapies that
encompass gene therapy, somatic cell therapy, and tissue-engineered products. These …

Challenges with advanced therapy medicinal products and how to meet them

Nature reviews Drug discovery, 2010 - nature.com
Advanced therapy medicinal products (ATMPs), which include gene therapy medicinal
products, somatic cell therapy medicinal products and tissue-engineered products, are at the …

Development of advanced therapy medicinal products: a case for early scientific advice

M Brunner, B Jilma - Clinical Pharmacology: Current Topics and Case …, 2016 - Springer
Advanced therapy medicinal products (ATMPs)–gene therapy medicinal products, somatic
cell therapy medicinal products and tissue-engineered products–are currently the most …

(Committee for Advanced Therapies (CAT), CAT Scientific Secretariat), Challenges with advanced therapy medicinal products and how to meet them

CK Schneider, B Flamion, I Haunerova… - Nature Reviews. Drug …, 2010 - ikee.lib.auth.gr
Advanced therapy medicinal products (ATMPs), which include gene therapy medicinal
products, somatic cell therapy medicinal products and tissue-engineered products, are at the …

Development of Advanced Therapy Medicinal Products—a case for early scientific advice

B Jilma - Clinical Pharmacology: Current Topics and Case …, 2010 - Springer
Abstract Advanced Therapy Medicinal Products (ATMPs)—gene therapy medicinal products,
somatic cell therapy medicinal products, and tissue engineered products—are currently the …

A comprehensive resource on EU regulatory information for investigators in gene therapy clinical research and advanced therapy medicinal products

O Cohen-Haguenauer - Human Gene Therapy, 2013 - liebertpub.com
Gene and cell therapy medicinal products are new and innovative medicinal products. In the
European Union (EU), they are classified as biological medicinal products according to …

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) …

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 …

[HTML][HTML] Regulatory framework for advanced therapy medicinal products in Europe and United States

C Iglesias-López, A Agustí, M Obach… - Frontiers in …, 2019 - frontiersin.org
Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative
therapies. The European Union (EU) and the United States (US) are fostering their …