Registered Members    Remember credentials In July 2005, in the context of the fourth and final Call for Proposals of the European Commision’s 6th Framework Programme (FP6), a research topic entitled “Application of post-genomics to xenotransplantation research” was included in the thematic priority area 1: “Life sciences, genomics and biotechnology for health”. This thematic priority is considered strategically important for Europe since life sciences and biotechnology are viewed as critical research areas that may contribute significantly to the Lisbon Objective of the European Union, i.e. for Europe to become the most competitive knowledge-based economy in the world by 2010. From a scientific standpoint, the overall objective of this thematic priority is to apply the knowledge generated in sequencing the human genome (and the genomes of many other species) with the aim of improving human health and to stimulate industrial and economic growth. Indeed, the major emphasis of the proposed research must be to develop basic scientific knowledge through to its application (“translational” approach). The funding instrument selected by the European Commission to promote a xenotransplantation research programme was that of an Integrated Project. Typically, these EC-funded projects involve 15 – 20 partners that undertake to work together in a collaborative programme with support spread over four or five years. In addition to the groups selected for their scientific expertise, the Commission stipulates that partners who are experts in ethical, social and regulatory issues should be included in the Project. Many first-class investigators from European research centres with excellent track records in xenotransplantation research could have taken part in this research initiative. However, collaborators were necessarily limited by stringent Commission requirements. The structure of such EC research projects is bound by specific definitions and with clear funding limits. (Indeed, the funding provided must be considered as a contribution to the research, and does not cover all costs.) Amongst the requirements that each successful application must comply with, the following are of critical importance: • Commitment to promote integration of research capacities (public and private) across Europe to increase coherence and achieve   critical mass; • Allocation of at least 15% of the budget to (“high-tech”) small and medium enterprises (SMEs); • Involvement of all key stakeholders [including appropriate industry, healthcare providers and physicians, policymakers, regulatory   authorities, patient associations, and experts on ethical matters, etc.] in implementing the theme. The proposed transdisciplinary   collaboration between all stakeholders must ensure that due account is taken of the ethical and societal concerns, our obligations   towards future generations and the rest of the world; • Ensuring that new knowledge is disseminated and translated into new therapies and clinical practice; • A very high ethical profile of the research proposed for funding. In this light, it became apparent that in order to enable the involvement of ALL the different stakeholders (including experts in ethics, law and social sciences and SMEs), only a limited number of the many excellent academic/private research groups in Europe could have joined any collaborative research effort submitted to the Commission. Indeed, designing the Integrated Project eventually submitted to the Commission for evaluation was a very difficult task. The decision was made to allocate all the resources available for this research project to the generation of a “super-engineered” pig, i.e. a pig with a newly generated genotype, able to improve the efficacy and safety profile of xenotransplantation. In addition, the programme was designed to provide a strong ethical, social (especially regarding communication with the public) and regulatory framework for xenotransplantation research (and, possibly, its future clinical application). With these goals in mind, the XENOME project was born. This research effort includes 22 academic/private institutions across 11 countries, with a fairly balanced representation of the different EU countries and funding distribution between academic and private entities. The key areas of research to be pursued within XENOME include immunology, safety, genetic engineering, physiology, ethics, social and regulatory aspects of xenotransplantation. For financial and ethical reasons, in vivo pre-clinical studies will be confined to the assessment of efficacy of renal, islet and neuronal xentransplantation. In October 2006, the Commission officially approved the funding of the XENOME Consortium. The Padua Medical Centre will serve as the co-ordinating body of this EU research effort. This website, constantly updated, will provide clear information on the rationale behind the project; outline the Work Package structure of XENOME and explain how these Work Packages interact and complement each other; explain why this project requires the use of large mammalian species; and will outline the steps put in place to minimise the use of such animals. In addition, the website will also include a section dedicated to frequently asked questions. In conclusion, following renewed interest in xenotransplantation worldwide, the XENOME Consortium represents the instrument through which the EU will be present in this field over the next 5 years. XENOME’s mission is to bring xenotransplantation closer to its clinical application. XENOME is eager to expand its collaborations with other European and non-European groups. Only through close interactions between scientists and world-wide collaboration will xenotransplantation research be able to approach the bedside.