title: Overcoming Challenges Facing Advanced Therapies in the EU Market.
abstract: 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.
authors: Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité - Universitätsmedizin Berlin, 13353 Berlin, Germany; Department of Nephrology and Internal Intensive Care, Charité - Universitätsmedizin Berlin, 13353 Berlin, Germany. Electronic address: mohamed.abou-el-enein@charite.de.
authors: Mohamed
authors: M
authors: Abou-El-Enein
authors: Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité - Universitätsmedizin Berlin, 13353 Berlin, Germany.
authors: Ahmed
authors: A
authors: Elsanhoury
authors: Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité - Universitätsmedizin Berlin, 13353 Berlin, Germany; Department of Nephrology and Internal Intensive Care, Charité - Universitätsmedizin Berlin, 13353 Berlin, Germany.
authors: Petra
authors: P
authors: Reinke
mesh_terms: D005062:European Union; D015316:Genetic Therapy / Q000191:economics*; D006801:Humans; D040541:Marketing; D009965:Orphan Drug Production / Q000191:economics; D010820:Physicians; D012015:Reference Standards; D012307:Risk Factors; D012926:Social Control, Formal; D023822:Tissue Engineering / Q000191:economics*