Development of cell therapy medicinal products by academic institutes.
In the rapidly evolving fields of cellular immunotherapy, gene therapy and regenerative medicine, a wide range of promising cell therapy medicinal products are in clinical development. Most products originate from academic research and are explored in early exploratory clinical trials. However, the success rate toward approval for regular patient care is disappointingly low. In this paper, we define strengths and hurdles applying to the development of cell therapy medicinal products in academic institutes, and analyze why only a few promising cell therapies have reached late-stage clinical development. Subsequently, we provide recommendations to stakeholders involved in development of cell therapies to exploit their potential clinical benefit.
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
Sofieke
S
de Wilde
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
Henk-Jan
HJ
Guchelaar
Pharmacotherapeutic Group 3, Medicines Evaluation Board (MEB), Utrecht, The Netherlands.
Carla
C
Herberts
Department of Hematology, Royal Free Hospital & University College London, UK.
Mark
M
Lowdell
Technical University Munich, Faculty of Medicine, TUM Cells Interdisciplinary Center for Cellular Therapies, Munich, Germany.
Martin
M
Hildebrandt
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
Maarten
M
Zandvliet
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
Pauline
P
Meij
D000047:Academies and Institutes; D035843:Biomedical Research; D064987:Cell- and Tissue-Based Therapy; D006801:Humans; D014495:Universities