Overcoming Challenges Facing Advanced Therapies in the EU Market

被引:105
作者
Abou-El-Enein, Mohamed [1 ,2 ]
Elsanhoury, Ahmed [1 ]
Reinke, Petra [1 ,2 ]
机构
[1] Charite, Berlin Brandenburg Ctr Regenerat Therapies BCRT, D-13353 Berlin, Germany
[2] Charite, Dept Nephrol & Internal Intens Care, D-13353 Berlin, Germany
关键词
GENE THERAPIES; CELL; CANCER; HIV;
D O I
10.1016/j.stem.2016.08.012
中图分类号
Q813 [细胞工程];
学科分类号
100113 [医学细胞生物学];
摘要
While advanced therapy medicinal products offer great clinical promise, most EU-approved products have not achieved satisfactory commercial performance. Here we highlight a number of issues that prevent current products from obtaining commercial success and pitfalls that developers must overcome in future product development.
引用
收藏
页码:293 / 297
页数:5
相关论文
共 10 条
[1]
Putting a price tag on novel autologous cellular therapies [J].
Abou-El-Enein, Mohamed ;
Bauer, Gerhard ;
Medcalf, Nicholas ;
Volk, Hans-Dieter ;
Reinke, Petra .
CYTOTHERAPY, 2016, 18 (08) :1056-1061
[2]
Gene therapy: a possible future standard for HIV care [J].
Abou-El-Enein, Mohamed ;
Bauer, Gerhard ;
Reinke, Petra .
TRENDS IN BIOTECHNOLOGY, 2015, 33 (07) :374-376
[3]
The business case for cell and gene therapies [J].
Abou-El-Enein, Mohamed ;
Bauer, Gerhard ;
Reinke, Petra .
NATURE BIOTECHNOLOGY, 2014, 32 (12) :1192-1193
[4]
A roadmap toward clinical translation of genetically-modified stem cells for treatment of HIV [J].
Abou-El-Enein, Mohamed ;
Bauer, Gerhard ;
Reinke, Petra ;
Renner, Matthias ;
Schneider, Christian K. .
TRENDS IN MOLECULAR MEDICINE, 2014, 20 (11) :632-642
[5]
The Impact of Market Volatility on the Cell Therapy Industry [J].
Brindley, David A. ;
Reeve, Brock C. ;
Sahlman, William A. ;
Bonfiglio, Greg A. ;
Davie, Natasha L. ;
Culme-Seymour, Emily J. ;
Mason, Chris .
CELL STEM CELL, 2011, 9 (05) :397-401
[6]
Gene therapies: the challenge of super-high-cost treatments and how to pay for them [J].
Carr, David R. ;
Bradshaw, Steven E. .
REGENERATIVE MEDICINE, 2016, 11 (04) :381-393
[7]
Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries [J].
Gammie, Todd ;
Lu, Christine Y. ;
Babar, Zaheer Ud-Din .
PLOS ONE, 2015, 10 (10)
[8]
Therapeutic cancer vaccine survives biotech bust [J].
Ledford, Heidi .
NATURE, 2015, 519 (7541) :17-18
[9]
Stem Cell Therapies in Clinical Trials: Progress and Challenges [J].
Trounson, Alan ;
McDonald, Courtney .
CELL STEM CELL, 2015, 17 (01) :11-22
[10]
Commercialization of cellular immunotherapies for cancer [J].
Walker, Anthony ;
Johnson, Robert .
BIOCHEMICAL SOCIETY TRANSACTIONS, 2016, 44 :329-332