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3rd – 4th October 2017 – PSCP/ ISCI Joint Workshop, Mercure St Pauls Hotel, Sheffield.

October 3, 2017

As a follow up to our workshop in Bar Harbor (Oct 2016), PSCP had the pleasuer of hosting and international delegation to discuss the “Significance of Genetic Variants for the use of Pluripotent Stem Cells in Regenerative Medicine” in Sheffield UK in October 2017. The meeting established the need and feasibility for setting up an ‘International Expert Group’ to collate and monitor the genetic and epigenetic variants that arise during hPSC culture and to provide a framework to facilitate risk assessment for clinical applications of hPSC derivatives. Participation included several public funding agencies, e.g. MRC (UK), NIH (USA), AMED (Japan) and CIRM (California), regulators from the FDA and MHRA, academic experts and product developers (both academic and industrial) from around the globe. There was general agreement that there is a need for an International Expert Group of the type proposed, but there were varying views on its remit and scope. A preliminary steering group has been formed to further develop this group and an invitation has been received for a member of the steering group to present at the 4th International Alliance for Biological Standardisation conference on Cell Therapy Manufacturing in Los Angeles, June 2018.

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