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The session was organised by Emerging Biopharmaceutical Enterprises EBE ; , the biopharmaceutical arm of EFPIA. The EU's orphan system is aimed at increasing interest in developing treatments for diseases that affect fewer than 5 in 10, 000 of the EU's population. But getting designated as an "Orphan Medicinal Product" can seem a long and complicated road if you are not familiar with the specific procedures that have to be followed. The desire to increase awareness, knowledge and understanding prompted EBE to ask all the interested stakeholders to come together. The workshop aimed to increase understanding of the EU's incentives system for developing treatments for rare, or "orphan", diseases and to help companies to use the system to its best effect. The dedicated tutorial session, the first of its kind, was coordinated by the Emerging Biopharmaceutical Enterprises EBE ; group, and comprised expert attendees from the European Medicines Agency, as well as the Committee for Orphan Medicinal Products COMP ; , national governments and more seasoned experts from companies that have used the system successfully in the past. More than 50 representatives from the biopharmaceutical sector came together to benefit from the instruction and experience from the experts. The aim was not simply to talk but also to discuss, to ask practical questions and to make recommendations in order to facilitate the procedure for the smaller and newer companies, in a very interactive and relaxed environment. The face-to-face, personal contacts gave a surprisingly informal and constructive feel to the entire day. Plus, of course, the workshop provided the opportunity "to hear first-hand from companies. 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For example, if two NICUs use different treatment strategies on babies with the same medical condition, but some babies started out sicker that others, there is no way to accurately assess whether the treatments were used effectively, and which of the treatments was most effective. To permit fair comparisons, it is essential to have an objective way to measure severity of illness. Spinal transection at T4 in the rat produced a marked increase in the contractile response of second-order mesenteric arteries to electrical stimulation of the perivascular sympathetic nerves. This change was attributable to increased 1-adrenoceptor activation and was correlated with an increased sensitivity to the 1-adrenoceptor agonist PE. The latter appeared to be due to a decrease in PE removal by the neuronal NE Table 2. Properties of concentration-response relations for PE with and without DMI and decadron. 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Embryonic stem cells ES cells ; arise from the cells of the inner cell mass of the embryo blastocyst ; . These embryonic cells have the capability to form all the different cell types and organs in the body. The cell lines so formed can give rise to new cells indefinitely. These cells can be cryopreserved and cultured again on thawing. The cells ES cells ; are pluripotent i.e. they have greater potential for differentiation than multipotent adult stem cells. As ES cells appear to be able to become any kind of tissue, once the mechanisms for differentiation are understood, then provision of banks of skin, bone, liver etc. tissues could be available to replace individual organs. Also, the use of embryonic stem cells for toxicological purposes has great potential and offers scientific advantages over the use of animal cells tissues, as they are not reliable models for predicting human embryotoxic responses. The potential for use of ES cells in regenerative medicine has yet to be realised but experts believe the scope of stem cell applications is enormous. Stem cell culture banks have been set up in the UK, USA and Germany thus alleviating the constant need to use further embryos to generate stem cells. It should be noted that although German law prohibits the production of embryonic stem cells it does permit their importation. A list of specific examples of potential applications of pluripotent stem cell research is contained in Appendix X. A high level expert group from the European Science Foundation has considered the subject of stem cell research and has stated in a report dated August 2002 that: "There are two major considerations concerning this topic. Firstly, the scientific study of human stem cells is at such an early stage that it is necessary to carry out experiments on cells obtained from embryos and adults in parallel. Secondly, the legislative situation governing work in this field differs considerably between countries represented in the European Science Foundation. The medical potential of stem cell therapy is obvious. Therapy using stem cells for diseases that involve the degeneration of defined cell types, such as diabetes, Parkinson's disease or Huntington's chorea, could become available within the foreseeable future. Stem cell therapy for diseases that affect whole organs or complex tissues is and phenoxybenzamine. Total mobility of unliganded receptors. Thus, it appears that not only degradation but also tighter association with a nuclear compartment can account for the reduced levels of receptor in HSB extracts in the presence of full antiestrogens or Ral. Taken together, these observations suggest that the dramatically reduced transcriptional activity of ER in the presence of Ral versus OHT in HepG2 cells result from much lower levels of functional nuclear receptors even in the absence of degradation or relocalization to the cytosol. In support of this hypothesis, our results indicate that all H12 mutants with increased agonist activity in the presence of Ral had increased solubility in high salt buffer in HepG2 cells. The same correlation was established in the presence of ICI182, 780. Similar results were obtained in transiently transfected HeLa cells, although transcriptional activity in the presence of all antiestrogens was weaker in HeLa cells data not shown ; . Note also that gains in transcriptional activation were not limited to our synthetic reporter vector, as increased transcription of the endogenous estrogen target gene TFF1 in the presence of Ral or ICI182, 780 was observed in MDA-MB-231 cells stably transfected with the L539A mutant. Together, these results suggest that the decreased concentration of high-salt extractable receptor contributes to the transcriptional inhibition observed in HepG2 cells in the presence of either Ral or of ICI182, 780. The increase in the fraction of mobile receptors observed in FRAP experiments with mutant receptors that have increased solubility and transcriptional activity further suggests that immobilization of the receptor is due to tighter interaction with a nuclear component responsible for poor extraction in high salt buffer and inactivity of the receptor. 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