Stem cells and their potential to address significant unmet medical needs have been the focus of growing media attention. Scientific understanding of stem cells, including induced pluripotent stem cells, has been advancing rapidly, and commercial interest in these therapies has grown alongside it. However, the relative novelty of this therapeutic area, coupled with a fast pace of scientific development, means that the regulatory framework for these therapies and the avenues for protecting these products with patents and other intellectual property are less well understood than for more traditional therapies such as small molecules and antibodies. In Part One of this two-part series, panelists discussed the regulatory landscape for these products and the latest legal trends and issues affecting this increasingly important therapeutic area, with a special emphasis on the US and China.
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