The Translational Mindset Is Essential for Taking Tissue-Engineered Therapeutics from Lab to Clinic

被引:2
作者
Tandon, Nina [1 ]
Bhumiratana, Sarindr [1 ]
机构
[1] EpiBone Inc, New York, NY 11226 USA
关键词
tissue engineering; translational development; therapeutics;
D O I
10.1021/acsbiomaterials.1c01396
中图分类号
TB3 [工程材料学]; R318.08 [生物材料学];
学科分类号
0805 ; 080501 ; 080502 ;
摘要
Many academic researchers are familiar with the technical challenges inherent in creating patient-specific, tissue-engineered therapeutics for clinical applications. However, for the potential of these products to mature into clinical practice and the profound possibilities to be realized, developers must apply not only technical expertise but also a comprehensive translational strategy.making a product marketable, scalable, manufacturable, and approvable by regulators, while providing genuine advantages to patients. Here, we provide a brief overview of three crucial steps for successful translation: adoption of a "translational mindset," consideration of three categories of core challenges (economic, regulatory, and manufacturing), and detailed planning at the earliest stages of development.
引用
收藏
页码:4629 / 4633
页数:5
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