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Pharmaceutical clinical pipeline The current clinical pipeline includes more than 10 marine natural products (or derivatives thereof) in different phases of the clinical pipeline mostly for targeting cancer. However, only one European company (PharmaMar) is active in the clinical development. The clinical pipeline is a very late stage in the development of drugs requesting significant amounts of money and effort. This stage is characterised by medical chemistry researching “druggability”, development of processes for supply of the compounds and clinical trials. For Blue Biotechnology, the sustainable supply of the compounds by biotechnological means is a major research and development area. Pharmaceutical preclinical pipeline The preclinical pipeline continues to supply several hundred novel marine compounds every year and those continue to feed the clinical pipeline with potentially valuable compounds. From a global perspective, the European marine pharmaceutical pipeline remains very active, and has sufficient momentum to deliver several additional compounds to the market in the coming years. In the last 20 years, the marine pharmaceutical preclinical pipeline involved research with more than 1,000 marine chemicals which demonstrated antibacterial, anticoagulant, anti-inflammatory, antifungal, anthelmintic, antiplatelet, antiprotozoal, and antiviral activities; actions on the cardiovascular, endocrine, immune, and nervous systems; and other miscellaneous mechanisms of action.147 MedTech R&D pipeline The situation is even more complex, when evaluating the medical devices pipeline. Some recent examples of demonstrators gained high interest and public awareness, e.g. sinusitis destabilising agents containing the enzyme nuclease NucB from marine resources or chitosan containing wound healings. Chitosan marine biopolymers are used as pharmaceutical ingredients and as supplements for medical devices. For the latter, BASF and the Norwegian company Seagarden signed a contract to transfer the Chitosan marine biopolymers business in 2012 from BASF’s Cognis to the biotechnology specialist. However, these examples do not describe the full pipeline and the expected potential for products in this area, as the possible products are very divers. In research stage, many activities deal with wound healing (e.g. wound covers), alternative disinfectants (being more environmentally friendly and avoiding resistance development) and with coatings for artificial bones that enhance biocompability. Landscape of Marine Biotechnology infrastructures and technologies in the health sector Marine biotechnology in the health sector takes place in four types of environments:  especially in the field of health (which has extended funding pathways), an active group of universities and public research institutes is spread all over Europe covering mainly the first steps of the value chain of the health sector, which are fundamental research (biodiscovery, biology of marine organisms for targeted isolation) and applied research (lead structure development, process design, semi-synthesis, preclinical development);  Numerous start-up and small companies are concentrating on medical device product development and take part in academia-SME cooperation products for early drug discovery;  Very few medium-size companies (more than 50 employees) dedicated to marine biotechnology development have been identified at the European level. 147 Mayer, A.M.S., A.D. Rodriguez, Orazio Taglialatela-Scafati and N. Fusetani.. MARINE DRUGS 11:2510-2573, 2013. Published July 16, 2013 and available at http://www.mdpi.com/1660-3397/11/7/2510 120 Study in support of Impact Assessment work on Blue Biotechnology Table 0.9 Phar Clinical Status Co Phase III Phase II (Sal Phase I a) The marine pharm b) Ongoing clinical/to 148 http://marinepharmac

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