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Figure 0.18 Value chain of marine biotechnology in the area of pharmaceuticals Stage of production is part of original value chain of marine biotechnology Stage of production is not part of the original value chain of marine biotechnology Depending on the source and the novelty of the gained product, these first steps (“early drug discovery”) can be very complex. Value may be obtained by additional uses of the outcome of these steps, e.g. use of the products in other sectors, energetic use of the wastes and application of the process details to other biotechnological challenges. The second stage of the value creation process is that of preclinical research. This stage is followed by the clinical development of the active agent, which covers several phases in which people take part in tests to prove the effectiveness as well as the harmlessness of the active agent. Following on from the clinical development, testing and approval, is the commercialisation of the new active agent. For this to be successful, up scaling is required first to ensure that adequate volumes of the new active agent can be produced. Then the active agent can be marketed and sold as an intermediate product to the pharmaceuticals industry, which can use the active agent to launch new drugs onto the market and carry out long-term studies on possible side effects. The stages of value creation after the production and marketing of the active agent derived on the basis of marine biotechnology no longer form part of the original value chain of marine biotechnology as the marine resource is then no longer the focus of the value creation process. Individual pharmaceuticals companies can also be directly involved in the value creation process of marine biotechnology if, for example, they carry out independent research and development activities on marine organisms. All the major pharmaceutical firms (including Merck, Lilly, Pfizer, Hoffman-Laroche and Bristol-Myers Squibb) have marine biology departments146. However, only their marine activities (the size of which is seldom identifiable) should be accounted in the blue biotech sector. Potential products areas currently in research and development stage Because of the physical and chemical conditions in the marine environment, almost every class of marine organism possesses the capacity to produce a variety of molecules with unique structural features. These molecules offer an unmatched chemical diversity and structural complexity, together with a biological potency and selectivity. In recent years, the chemistry of natural products derived from marine organisms has become the focus of a much greater research effort. This is due, in a large part, to the increased recognition of marine organisms as a source for bioactive compounds with pharmaceutical applications or other economically useful properties. Additionally, nature is still the main source for new pharmaceuticals: 90 % of all drug have their origin in nature. The fact that marine resources are still largely unexplored has inspired many scientists to intensify their efforts by using novel technologies to overcome the inherent problems in discovering compounds which may have potential for further development as pharmaceuticals or as functional products. 146 European Commission, 2006, “Background paper No. 10 on marine biotechnology”. Annex to the Green Paper on Maritime Policy. 13p. Study in support of Impact Assessment work on Blue Biotechnology 119

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