Presentation shares insights from stem cell investigators on challenges in developing advanced therapy medicinal products, highlighting GMP practices and trial design.
Developing cellular therapies is not straightforward. This presentation summarizes the experience of academic stem cell investigators working in different clinical applications and aiming to share insight into what could be useful to consider, in light of the current situation regarding advanced therapies. These include 1) choosing the stem cell type and assessing a platform of technologies possibly common to multiple products, 2) familiarity with GMP manufacturing, reagent validation, and supply chain management, 3) product delivery issues and the additional regulatory challenges, 4) the relationship between clinical trial design and preclinical studies, and 5) the market approval requirements, scalability, pathways, and partnerships needed.
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