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Overcoming the Translational Gap in Commercialisation of Stem Cell Therapy

Mittra, J   Lowrie, H   Tait, J   Mastroeni, M

REMEDiE Closing Conference: Bringing Regenerative Medicine to the Clinic: Trials and Tribulations in Europe and Beyond

University of the Basque Country, Bilbao, Spain

April 18 – 19 2011

The conference will announce the principal findings of the REMEDiE project which over the past three years has explored developments in the political, socio-economic, legal and bioethical domains in the field of regenerative medicine (RM), both in Europe and at the global level. Regenerative medicine involves the application of novel biomaterials - specifically cells (including stem cells), genes (via gene therapy) and biodegradable scaffolding materials, to achieve a regenerative effect, i.e. technologies aimed at stimulating or augmenting the human body's inherent capacity for self-repair.

Findings will be presented through an integrated series of presentations that cover these three domains and their implications for clinical translation, and for regulatory policy.

The key issues to be explored during the conference include:

• The geographical and technological stratification of the European RM sector, its diverse (and highly uneven) markets, innovation strategies and its implications for appropriate policy-making
• The distinctive innovation and governance model being developed in India, China and Japan
• The specific challenges associated with developing large-scale trials in the area and pressures towards harmonisation across Europe
• The emergence of indirect forms of commercialization of oöcytes for reproductive and research purposes and the regulatory challenges that need to be addressed here
• The emergence of distinctive and competing bioethical networks that frame RM in very different ways.