NSC-Reconstruct Workshop #2
Our project addresses issues of critical importance for driving the development of the novel cell therapy products developed within NSC-Reconstruct by organising a series of workshops for the efficient translation of stem cell derived products. They are organized in collaboration with leading international experts and involve a carefully selected panel of speakers with expert knowledge in each field. The goal is to provide a high-level forum for discussion of technical, regulatory and ethical challenges facing our work.
Workshop #2 addresses the regulatory and ethical issues related to the development and clinical use of next generation cell therapy products. This workshop is organised with the purpose of exploring and seeking expert advice on the following issues, essential for the use of the new cell therapy products in clinical trials:
(i) What are the most appropriate assays for genetic testing of cells going to the clinic? And at what stage of manufacturing should the testing be done?
(ii)Which genetic variants are acceptable and which are unacceptable in a clinical cell product, and how does this relate to the disease being treated?
(iii)Which QC assays are most appropriate to define composition, potency and safety of the cell product, as well as its properties post-grafting?
(iv)What are the most important ethical issues to be considered in the planning for a clinical trial using hPCS-derived cell products?
CHECK OUT THE PROGRAM OF THE EVENT
Workshop #2 addresses the regulatory and ethical issues related to the development and clinical use of next generation cell therapy products. This workshop is organised with the purpose of exploring and seeking expert advice on the following issues, essential for the use of the new cell therapy products in clinical trials:
(i) What are the most appropriate assays for genetic testing of cells going to the clinic? And at what stage of manufacturing should the testing be done?
(ii)Which genetic variants are acceptable and which are unacceptable in a clinical cell product, and how does this relate to the disease being treated?
(iii)Which QC assays are most appropriate to define composition, potency and safety of the cell product, as well as its properties post-grafting?
(iv)What are the most important ethical issues to be considered in the planning for a clinical trial using hPCS-derived cell products?
CHECK OUT THE PROGRAM OF THE EVENT
