期刊
CYTOTHERAPY
卷 19, 期 2, 页码 293-298出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.jcyt.2016.10.017
关键词
affordability; cell and gene therapies; clinical trials commercialization; patient advocacy; regulation; reimbursement
Often, novel gene and cell therapies provide hope for many people living with incurable diseases. To facilitate and accelerate a successful regulatory approval and commercialization path for effective, safe and affordable cell and gene therapies, the involvement of patient advocacy groups (PAGs) should be considered early in the development process. This report provides a thorough overview of the various roles PAGs play in the clinical translation of cell and gene therapies and how they can bring about positive changes in the regulatory process, infrastructure improvements and market stability.
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