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Balancing Open Source Stem Cell Science with Commercialization

Courtney, A   de Sousa, P   George, C   Laurie, G   Tait, J

Nature Biotechnology   29 (2) 115-116

February 2011   (First published online February 2011)

http://www.nature.com/nbt/journal/v29/n2/full/nbt.1773.html

The United Kingdom took an early lead in establishing regulations for research on human embryonic stem cells (hESCs) in a way that clearly serves the needs of the research community. However, the needs of those who will translate the basic research into therapies are not always aligned with those of basic researchers. In the United Kingdom, this has led to a paradoxical situation in which the regulations that favor basic research are restricting commercial investment.

Experience has shown that early-stage choices made in setting up regulatory systems in the life sciences can, in unanticipated ways, determine the eventual scope for innovation and the delivery of public benefits from scientific discoveries. An example is stem cell science and regenerative medicine therapies where, although the UK regulatory system has succeeded in facilitating basic stem cell research, downstream development of therapies must navigate an increasingly challenging regulatory system.