Marine Report

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					     Opportunities for Marine Biotechnology
            Application in Ireland



  This is a variation of the CIRCA Report “A Comparative Study of
Marine Biotech RTD and Industrial Development Strategies” (delivered
                   June 2004) designed for publication




                        Prepared for
                   Marine Institute




    The CIRCA Group Europe Ltd.

    January 2005




                                        The CIRCA Group Europe Ltd.
                                           26 Upper Pembroke Street
                                                    A Comparative Study of Marine Biotech RTD and Industrial Development Strategies



                                                                              Table of Contents


                1.      Introduction .............................................................................................................................. 1

                2.      Methodology............................................................................................................................. 3
                         2.1    Objectives........................................................................................................................................ 3
                         2.2    Review of National and Regional Activities and Programmes........................................................ 3
                         2.3    Identification of ‘Model’ Marine Biotech Companies..................................................................... 4
                         2.4    Workshop ........................................................................................................................................ 4
                         2.5    Analysis, and Preparation of Final Report ..................................................................................... 4

                3.      Approaches to Marine Biotech Development ....................................................................... 5
                         3.1    Background to Marine Biotech Activities........................................................................................ 5
                         3.2    International Cooperation in Marine Biotech................................................................................. 5
                         3.3    Organisation of Marine Biotech within National R&D Systems..................................................... 6
                         3.4    European Commission Support for Marine Biotechnology............................................................. 7

                4.      National Programmes, Strategies and Activities.................................................................. 8
                         4.1    Australia.......................................................................................................................................... 9
                         4.2    Canada .......................................................................................................................................... 11
                         4.4    Norway .......................................................................................................................................... 16
                         4.5    United States ................................................................................................................................. 18
                         4.6    Countries without Formal Marine Biotechnology Programmes ................................................... 20

                5.      Marine Biotech Industry ........................................................................................................ 27
                         5.1    Bioprospecting/bioscreening for Novel Compounds..................................................................... 27
                         5.2    Improving the Production of Marine Organisms .......................................................................... 30
                         5.3    Production of Novel Foods, Feeds and Nutraceuticals................................................................. 34
                         5.4    Diagnostics and Biosensors .......................................................................................................... 38

                6.      Marine Biotech Clusters ........................................................................................................ 43

                7.      Discussion and Recommendations ..................................................................................... 45
                         7.1    Overall Findings and Discussion .................................................................................................. 45
                         7.2    An Irish Marine Biotechnology Initiative...................................................................................... 46
                         7.3    Marine Biodiscovery or BioProspecting ....................................................................................... 48
                         7.4    Genomics of Marine Organisms.................................................................................................... 51
                         7.5    Fish Vaccines ................................................................................................................................ 52
                         7.6    Diagnostics & Biosensors ............................................................................................................. 52
                         7.7    Production of Novel Foods, Feeds and Nutraceuticals................................................................. 53
                         7.8    The Role of International Collaboration....................................................................................... 54
                         7.9    Summary of Recommendations ..................................................................................................... 54


APPENDICES

Appendix 1: Abbreviations used........................................................................................................................................ 56
Appendix 2: People consulted during study ...................................................................................................................... 58
Appendix 3: Briefing Note from DFO (Canada) for Canadian Minister for Fisheries..................................................... 60
Appendix 4: Marine Biotechnology research and expertise in Irish Universities and Institutes of Technology and their
            related expertise in the fields of Biotechnology ............................................................................................ 64
Appendix 5: Note from Prof. Michael Guiry & Dr. Gerd Koennecker on the potential for novel flora/fauna in Ireland’s
            marine environment. Pers. Comm................................................................................................................ 73
Appendix 6: Marine Biotechnology Companies cited and website addresses................................................................... 75
                               A Comparative Study of Marine Biotech RTD and Industrial Development Strategies




1.     INTRODUCTION
Ireland has a significant marine resource and is actively working to optimise the use of this resource for
national economic and social benefit. One of the ways in which Ireland can both utilise this resource,
but also protect and conserve it, is through the use of biotechnology. Marine biotechnology may be
defined, for the purposes of this study, as the application of biological technologies to marine
environment, materials and organisms so as to:

       •    Find new information, organisms, genes, biomarkers, biochemical processes and
            biomolecules of importance to industry, nutrition, medicine and the environment.

       •    Use marine biological agents to provide products or processes of relevance to medicine, the
            environment or industry.

The study is being conducted at an opportune time: Ireland’s scientific and technological infrastructure
is currently being dramatically upgraded, and the Marine sector and its support infrastructure is also
being extensively reviewed and expanded. This period of change is an appropriate time to consider new
opportunities, and to undertake the infrastructural and funding changes required to address them.

Biotechnology is not a sector of industry, but is rather a set of technologies which are fundamentally
changing a wide range of industry sectors. The major impacts of biotech are currently being seen in the
Healthcare and Agricultural sectors, but other sectors are being increasingly impacted, including
Forestry, Food, Fisheries (including aquaculture) and Environmental services.             The range of
applications of biotechnologies within these sectors, and their combined potential for economic benefit,
have been widely publicised and will not be repeated here.

Because of the enormous potential of biotechnology, many countries have taken specific actions to
ensure that their industries and citizens obtain the benefits of biotechnology. Biotechnology
development programmes have been initiated to varying degrees in most developed countries over the
last few decades, and now exist in most EU countries. These programmes differ between countries in
their strategic purpose, sectoral focus or mechanisms. They also vary in their degree of success. In
general, however, national or regional biotech programmes take the form of investment in biotech
expertise and research and Development (R&D); and/or investment in the infrastructural and support
needs of biotech industry (capital, R&D supports, staffing, regulatory environment and so on). One of
the potential areas for application of biotechnology is in the marine sector. The wide range of potential
commercial applications is outlined in Section 6.

The marine sector is at an interesting stage in its development. Marine fish stocks are declining and
traditional fishing is expected to contribute a declining proportion of fish in the future. The UN Food
& Agriculture Organisation (FAO) has warned that about 47 percent of the main stocks of wild fish are
fully exploited and catches have reached, or are very close to, their maximum sustainable limits 1.

1
     FAO's State of World Fisheries and Aquaculture 2002 report (SOFIA).

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                               A Comparative Study of Marine Biotech RTD and Industrial Development Strategies



FAO predicts that world fish catch production will stagnate by 2015-2030. On the other hand,
aquaculture is growing more rapidly than all other animal food producing sectors; its contribution to
global supplies of fish, crustaceans and molluscs increased from approx 4 percent of total production in
1970 to 29 percent in 2001 3, and is expected to continue this trend. Technologies to improve
aquaculture production, and to better manage stocks of wild species, and the environment in which they
survive, will therefore be essential. Biotechnology has much to contribute to these objectives.

Despite this promise, marine biotechnology had not to date been a major area of investment worldwide
until recently. The major investors have been the USA and Japan, particularly Japan (see 4.3). Even
the USA, which is a world leader in biotechnology, has invested less than 1 percent of its total
biotechnology research and development budget to marine biotechnology 2. This may be because the
commercial opportunities are less available, or less obvious, to potential investors. As one commentator
observed ‘commercial success stories in biotechnology are familiar. But commercial success stories in
marine biotechnology are far less familiar and far fewer’ 3.

There are several other reasons why marine biotech has not historically attracted significant attention or
investment. The marine sector has always been perceived as an industry engaged in harvesting natural
resources. Unlike agriculture it has not relied on a long-term investment in resource maintenance. In
addition, the population and industries of the marine sector have been associated with relatively poor
areas – as compared to other industries. These are perhaps additional reasons why marine biotechnology
has not really attracted the attention of biotech investors – or has not been perceived as an industry with
great potential.

To summarise all of the above, the international marine sector is in a period of significant change: fish
production is changing from ‘hunting’ to ‘farming’; and underwater technology, remote sensing, and
chemical and analytical methods are providing information on hitherto unexplored marine resources.
The opportunities within the marine sector are becoming more diverse, as are the technologies which
will be required to meet the technical challenges. Biotechnology is one of the major technologies which
will be required.

Ireland is in a good position to build a biotech-based marine activity.

Although Ireland has had a formal biotech programme since 1987, the investment in biotech was
minimal until 1998 when an investment of €2.5 billion in national R&D development commenced. The
national objective to make Ireland a research-intensive economy is now being realised through a series
of programmes including the Programme for Research in Third Level Institutions (PRTLI) 4 in which
over €600m was invested; Science Foundation Ireland in which €710m was invested, and various other
initiatives. This investment is laying down a foundation of expertise and facilities on which future Irish
sectoral economies will be based.




2
    Turning to the Sea: America’s Ocean Future (1999): www.publicaffairs.noaa.gov/oceanreport
3
    Rita Colwell. “Fulfilling the promise of biotechnology” Biotechnology Advances 5226 (2002)
4
    Programme for Research in Third Level Institutions: €610m – see www.hea.ie

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                                 A Comparative Study of Marine Biotech RTD and Industrial Development Strategies



In considering Ireland’s strategic position to undertake a marine biotech programme, the assets include
a relatively strong (and rapidly growing) research base, and a high output of trained graduates. The
Irish biotech research community is very open to participation in new areas of research effort, including
marine opportunities. There is also a small cohort of marine and biotech 5 companies that could exploit
marine biotech.

This study is an input into the process of defining an appropriate Marine Biotech Programme for
Ireland. Its overall purpose is to look at approaches to marine biotech R&D and industry development in
other countries and assess what Ireland can learn from these experiences.


2.       METHODOLOGY

2.1         Objectives

The overall objective of the study was to identify what Ireland might learn from other country’s
experiences of marine biotechnology. Specifically the objectives are:

      1. To identify programmes and strategies aimed at developing marine biotech R&D capability,
         and industrial activity, in countries and regions comparable to Ireland.

      2. To analyse the current R&D specializations within such programmes and the basis of their
         choice as programme priorities.

      3. To review the development of marine biotech companies and clusters arising from such
         programmes and to identify the major areas of commercial activity, including the companies
         that are active in this field.

      4. To suggest potential lessons for Ireland arising from this analysis.


2.2         Review of National and Regional Activities and Programmes

To assess how Ireland might approach Marine Biotechnology, it is useful to look at the experiences and
activities of other countries (or regions) with formal marine biotech programmes, or with other relevant
forms of local or national strategies or initiatives. This involved searches of specialist databases,
websites and published literature and ‘grey literature’ defining national activities. In addition marine,
and biotech experts in different countries were consulted about national and international initiatives in
their area (see Appendix 2). Our external expert, Prof. Jan A. Olafsen provided many contacts through
his involvement in several multinational programmes and activities in the area.

Where such relevant activities exist, further analysis is provided.



5
      There are approx 60 biotech companies on the island of Ireland, employing about 4,000 (CIRCA Report for InterTrade
      Ireland. Mapping the BioIsland 2003)

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                             A Comparative Study of Marine Biotech RTD and Industrial Development Strategies




2.3       Identification of ‘Model’ Marine Biotech Companies

A separate analysis was conducted to identify international companies that exploit ‘marine
biotechnology’. It is difficult to be very precise in classifying companies in this way. This is because
biotechnology is often used by industry in combination with other technologies. To ensure that all
relevant companies were included in the analysis, a broad view was taken. Companies in the marine
sector which have a significant reliance on biotechnology were included. In particular, companies in
the following areas were sought:

      •   Biodiscovery: companies which use marine materials or organisms as a source of compounds
          for screening for novel chemicals for use as pharmaceuticals, adhesives, or ingredients for a
          huge range of industrial and other applications. This is also sometimes called bioprospecting.

      •   Products or processes for improving the production of marine organisms through
          enhancing healthcare, breeding or yield of marine fish and shellfish stocks.

      •   Production of novel foods, feeds and nutraceuticals using biotech applications, including
          upgrading of fish quality, utilisation of fish waste, and development of nutraceutical products
          from marine sources.

      •   Diagnostics & Biosensors for the assessment of the quality of marine products or for
          assessment of environmental quality or management of marine environments.

The activities of these companies are noted in the report and their websites are listed in Appendix 6.


2.4       Workshop

As part of the process of defining national priorities in the area of marine biotechnology, the Marine
Institute organised a workshop on 16th & 17th February in Dublin. The attendees were all invitees and
included international and Irish individuals involved in many aspects of marine biotechnology.

The workshop was structured so that the international attendees could provide views on (a) activities in
their own countries and (b) views on the future of the area, and suggestions as to where Ireland might
prioritise. In the final session break-out groups reported on their views on opportunity areas for
Ireland; and the R&D resource and expertise requirements to address these needs.


2.5       Analysis, and Preparation of Final Report

Where national or regional programmes and strategies were identified, they were analysed so as to
define ideas and approaches with a relevance to Ireland. Marine industrial activity in the different
countries was also assessed, particularly to identify regions or cities where clusters of marine
biotechnology industry were growing. A report was then prepared by the CIRCA team, which also
took account of the views from the Marine Biotechnology Workshop (see 2.4). The abbreviations used
are in Appendix 1, and the list of people consulted is in Appendix 2.



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3.       APPROACHES TO MARINE BIOTECH DEVELOPMENT

3.1         Background to Marine Biotech Activities

Europe has a high degree of marine biodiversity in widely different marine habitats ranging from the
Arctic to the Mediterranean and from the deep sea to varied coastal areas and fjord systems. The
research needs and interests of European countries and regions are therefore diverse, and are addressed
through a wide range of marine biology programmes, stations and research vessels. Despite the
diversity, Europe’s marine biologists nevertheless operate within an established framework of
international cooperation (see 3.2).

Interest in marine biology in Europe has been closely related to marine resource utilization. For
instance, the aquaculture industry has urgent needs for new feed formulations, and for disease
prevention methods. This has created an increased focus on R&D to underpin potential solutions, e.g.
understanding lipid metabolism, and also the molecular biology of diseases, fish resistance mechanisms
etc. However, there are wide differences between the research needs of shellfish aquaculture in South
Europe, and of the rapidly growing finfish aquaculture and related industries in the North. Interest in
other areas, such as marine bioactive compounds (Bioprospecting), has been more limited, but is now
increasing.


3.2         International Cooperation in Marine Biotech

The degree of international cooperation in marine sciences is striking, but perhaps not surprising given
that marine habitats are not usually restricted to national boundaries. Aquaculture related sciences also
have excellent collaborative networks, some of which are industry-driven. However, within marine
biotechnology as such there is a relative lack of cooperation. This could be due to its relative novelty, or
to the relative lack of success-stories - and thus an uncertainty about the viability of industries.

Whereas there are extensive contacts between European groups, it is not an area of research that has
been particularly well coordinated in the past. The Marine Board of the European Science Foundation
(ESF) has described EU marine R&D research groups as “excellent but sub-critical” 6. This group has
called for a European Network promoting dissemination of marine biotech discoveries, and Research/
Industry collaboration to screen compounds of marine origin. Because of the complexity of scientific
collaboration in Europe there is a need for information-providers and networking. Also there is a need
to increase mobility, particularly among young scientists, in order to better utilize the infrastructures and
biological models that are already present at the marine biological stations.




6
      Navigating the Future- II - Integrating Marine Science in Europe. ESF March 2003.

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                               A Comparative Study of Marine Biotech RTD and Industrial Development Strategies




Among the R&D collaborative organisations which address these needs are:

        •    European Society for Marine Biotechnology 7 (ESMB) which has been in existence since
             1995. It is an academic organisation which aims to stimulate marine biotechnological
             research, and to promote European and international co-operation and information exchange
             in marine biotechnological research and education.

        •    ScanBalt NorFa Marine Biotech Network 8 which is particularly of relevance to marine
             biotechnology in the Nordic and surrounding countries. ScanBalt is a cooperation initiative
             among 11 Nordic and Baltic countries in all areas of R&D. It currently has several specialist
             networks which are the specific nodes for cooperation. One of these, the Marine Biotech
             Network, aims to become a Nordic – Baltic platform for communication and cooperation in
             marine biotechnology. The objective is to strengthen the quality of research, improve shared
             use of marine research infrastructures, set up joint training courses, and disseminate
             information between participants.

Both ESMB and ScanBalt will help to promote mobility, and will also take a part in cooperation in
higher education within marine biotechnology. Since most actors in Marine Biotech are based in
universities or research institutes, such networks will intensify their cooperation. In the case of the
Scanbalt NorFa network, it is the ambition to also involve commercial actors and thus strengthen public
private cooperation. This network will also support the Nordic Council vision of developing Nordic
arenas for knowledge exchange and scientific networks. It will thus function as a body for inter-Nordic-
European cooperation and as a link to international Marine Biotechnology activities.


3.3         Organisation of Marine Biotech within National R&D Systems

Marine biotechnology combines technologies and expertise from the field of biotechnology with needs,
opportunities and expertise from the marine sector. It is an interface between two well-developed areas
of R&D activity. Those involved may have entered from a background of marine R&D, or from some
area of biotechnology R&D.

In a similar fashion, the identification of relevant marine biotechnology activities is complicated by the
fact that they can be found within widely different parts of national R&D infrastructure. In short,
biotechnology may be a topic with national marine science/fisheries R&D programmes; or marine
activities may be a component of national biotechnology R&D programmes.

For example, marine species may be included as target species in programmes of genome sequencing or
mapping. Alternatively there may be an aquaculture R&D programme which involves genome
sequencing. Similarly, national health or biotechnology programmes may fund biodiscovery activities
which screen compounds from marine sources; alternatively, national marine programmes may fund
biodiscovery programmes. In all of these cases the technical objectives and outcomes are identical, but
the management context is very different.


7
      www.esmb.org
8
      www.scanbalt.org/sw409.asp

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                           A Comparative Study of Marine Biotech RTD and Industrial Development Strategies




3.4       European Commission Support for Marine Biotechnology

The nature of marine biotechnology, i.e. its need for trans-national activity, and the existing culture of
international collaboration make it an ideal area in which to implement the ‘European Research Area’
concept. However, marine S&T has been a reducing priority within recent Framework Programmes. It
was not included as a specific topic area in Framework 6, despite significant lobbying by several
countries, including Ireland.

Under the 5th Framework Programme, there were 121 Marine projects funded in the sub-programme on
Energy, Environment and Sustainable Development. Of these, 8 had a biotechnology component or
approach. In the sub-programme on Quality of Life, 230 marine-related projects were funded, of which
57 involved a biotechnology approach or technique.

Of the above 65 biotechnological projects, the sub-areas of interest were:

      Area                        %      Examples
      Food & Feed                 12     Alternative fish-feeds; Novel food-uses of seaweed
      Fish Health                 33     Fish vaccines and therapies
      Diagnostics                 14     Health, and environmental monitoring assays

      Genetic Assessment          26     Genetics of fish quality, etc
      Other biotech               15


Irish partners were involved with 61 of the 230 marine R&D projects and approximately 16 percent of
these had a biotechnological component.

The projects in which Irish partners were involved included:
   • Food colours from seaweed
   • Genetic markers (mackerel)
   • Sea lice resistance
   • Peptide vaccines (salmon)
   • Stress genes expression (trout)
   • Immune response genes (salmon)
   • Biologic sensor for water pollution
   • Surfactant from seaweed
   • Biological tags and genetic markers (herring)
   • By-products from cod

Although it is not a specific topic in Framework Programme 6, support for aspects of Marine biotech is
provided in this programme. A project which may be specifically mentioned is a major Marine
Genomics project has been funded as a Network of Excellence. The formal title is “Implementation of
high-throughput genomic approaches to investigate the functioning of marine ecosystems and the
biology of marine organisms”. The network involves 330 scientists in 16 EU countries and will examine
the genomes of species including algae, microorganisms, fish and shellfish. Experts in genomics,
proteomics and bioinformatics from several EU Centres of Excellence in genomics have been
networked with marine biologists who can make use of genomics data. There is no Irish partner in this
programme.

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4.       NATIONAL PROGRAMMES, STRATEGIES AND ACTIVITIES

This section reviews and analyses the extent and nature of formal R&D programmes and activities in
the area of marine biotechnology in EU and other countries with a relevant marine background. The
objective was to identify programmes which specifically focus on marine biotechnology, and to assess
the motivation, purpose and mechanisms employed. What were sought were not individual research
projects, but rather planned programmes of activity designed to achieve results of strategic or economic
relevance to the country or region. As noted in 3.3, marine R&D activities may be found within any of
the many organisations that are active in the marine and biotech communities. Note also that further
information on industrial development initiatives in some of these countries is provided in sections 5
and 6.

The basic finding of the study is that few countries have formal comprehensive programmes or
strategies for marine biotech. Nevertheless, most countries do conduct marine biotech research.
However this research is usually conducted within programmes which do not highlight biotechnology as
their purpose. Indeed, the US Agency National Marine Fisheries Service is significantly using
biotechnology in its laboratories, but does not mention the word ‘biotechnology’ anywhere in its
research strategy document (see 4.5). As another example, Iceland does not identify marine biotech as a
national priority, but biotechnology is significantly used within its fisheries research (see 4.6.5).

Because of the diversity of funding systems for R&D within the countries assessed, it was not possible
to find international comparative statistics on marine biotechnology funding. It is a category of research
that can be funded from many sources within each country, and statistics on total expenditure in
individual countries have not been drawn up.

The countries with significant coordinated biotech programmes which include marine applications,
include Norway, Australia, and Japan. The USA and Canada have both outlined the value and
opportunities which may derive from marine biotech, but have not initiated a single coordinated
programme in the area. Nevertheless, in each case there is significant activity in each of these countries
within different R&D agencies, and in universities. In both cases there are individual states or
provinces which have defined marine biotech as priorities for development.

The most common R&D themes within these marine biotech programmes are below, in approximate
order of their importance within national activities:

     1. BioDiscovery or BioProspecting Initiatives: i.e. programmes or projects which support the
        search for useful compounds from extracts of marine organisms. Examples include Australia,
        Japan and Germany.

     2. Genomics of aquaculture species: research to understand the genetic metabolism of farmed
        stock so as to improve healthcare, reproduction, yield or other traits. Examples include France,
        Australia, and Norway.



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      3. Genomics of wild species: research to understand the population dynamics, migration patterns,
         and distribution of wild species; and also to provide genetic markers to prevent poaching,
         validate product description of fish etc. Examples include Canada, USA, UK and Norway.

      4. Food Safety: research to detect shellfish and fish-borne human pathogens and other hazards,
         and to develop methods to prevent their occurrence. Examples include USA and Australia.

      5. Environmental Research. Research to understand marine ecosystems and to develop
         diagnostics which can be used to monitor environmental quality, production capacity and their
         safety for fish and for humans. Australia and USA are examples here.

These themes, locally refined to suit national expertise, economic needs and marine habitat, will be seen
to recur in many of the national Marine Biotech activities presented below.

Those countries with significant national programmes or strategies are presented in 4.1.to 4.5, while
other countries are outlined in 4.6.


4.1        Australia

The Australian National Biotechnology Strategy was launched in July 2000 with funding of €17.6m
million over three years (2001–2004) for a wide range of targeted initiatives. In January 2001, a further
€38.5m was contributed to the overall programme through the ‘Backing Australia’s Ability’ initiative.
In May of 2004 this initiative was further extended to 2011 9 and further funding was provided. The
planned spend on Australian S&T development under these programmes (2001 to 2011) is €4.8 billion.
The research in the current (2003-2006) Research Plan period addresses the priorities of
Environmentally Sustainable Australia, Promoting and Maintaining Good Health, Frontier Technologies
for Building and Transforming Australian Industries, and Safe-guarding Australia. In pursuance of
these objectives, the programme particularly focuses on the application of biotechnology in
environmental management, and in the pharmaceutical, forestry, fisheries, aquaculture and agriculture
sectors. One of the strategies adopted is to work with sectoral interests to identify their resource needs
in biotechnology, including the utilization of ‘endemic and exotic biological resources’.

In the area of Marine Biotechnology, the major strategic partner is the Australian Institute of Marine
Science (AIMS) 10 which was established to assist in the management of the marine environment and
marine resources. Priorities for AIMS in their 2003-6 strategic plan include:

      •   Sustainable development of aquaculture industries

      •   Use of marine genetic resources for pharmaceutical and commercial applications.




9
     Backing Australia’s Ability – Building Our Future through Science & Innovation. see http://backingaus.innovation.gov.au
10
     Further information on AIMS is at: www.aims.gov.au/

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The Institute employs more than 160 staff and has an organisational structure divided into three science
groups and various support sections. The AIMS Research plan for 2003-2006 defines three priorities,
one of which is Marine Biotechnology. Three research teams within the Marine Biotechnology Group
address this priority:

    1. Bioactive Molecule Discovery: This is a multi-disciplinary team of marine biologists,
       biochemists, marine microbiologists, natural products chemists, pharmacologists, and
       information technicians. They are engaged in extracting molecules from marine organisms and
       materials and screening them for medical, industrial and other uses. Molecules with potential
       application are licensed to industry for further assessment and development. AIMS has a
       collection of 8,000+ extracts of macroscopic marine organisms which are preserved, catalogued
       and available for novel chemical discovery. AIMS has a collection of over 9,000+ isolates of
       marine microorganisms, cryopreserved and ready for molecular, taxonomic, and metabolite
       analysis. A sub-set of these microbes has already been used to develop a library of 5,000
       extracts for new chemical screening or for novel enzyme discovery. The chemical and bioassay
       data is in a relational database which provides the opportunity for rational discovery.

    2. Bio-innovation: This group is mainly staffed by eco-toxicologists, biochemists, microbiologists
       and geneticists, who have a wide-ranging role in identifying novel applications for marine
       organisms, and also novel solutions for certain marine problems. These include new
       technologies for water quality assessment, for detection of aquatic toxins and contaminants, for
       marine disease and pest diagnostics, and for the evaluation of environmental stress in sentinel
       marine organisms.

    3. Tropical Aquaculture: The priority here is “developing technology to enhance sustainable
       tropical aquaculture production for industry and the community". Production systems for
       sponges, prawns and lobster are in development.

AIMS are also developing new collection techniques to allow access to previously unattainable habitats
and taxonomic groups. Culture methods for novel organisms are also being developed to facilitate scale-
up of organisms which produce bioactive compounds that prove difficult to synthesise.

AIMS have also developed significant experience in the area of biodiscovery management and their
publications note the wide range of competence required. The scientific expertise required includes:
taxonomy, marine ecology, database design and data mining, cell culture of both microbes and tissues,
gene discovery, expression of proteins from cloned genes, biomolecule purification and identification.
It also requires management expertise in IP management, licensing and other interactions with industry,
start-up formation, and significant interaction with other stakeholders in the marine sector.




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                      Some highlights of AIMS Research Programmes 2003

         !    Over 180 macro-organism extracts showing activity, and 60 micro-organisms showing anti-
              microbial activity against pathogens, including E. coli, S. aureus or C. albicans, were
              discovered.

         !    Two active anti-cancer lead compounds were placed in pre-clinical trials, as part of a
              collaboration with the US National Cancer Institute. Both of these active compounds were
              isolated from sponges found in Western Australian and New South Wales

         !    Over 400 new extracts with potential as anti-tumour agents were isolated from marine
              organisms and sent to NCI for screening. These extracts had a high hit rate with many
              selected for more detailed investigation against NCI’s ‘60 human tumour cell line’.

         !    Research funded by a research partner, Nufarm agrichemical company, yielded 30 new
              lead compounds exhibiting specific C4 plant herbicidal activity.




4.2          Canada

Although there is no formal national programme for Marine Biotechnology, Canada has a strong
interest in application of biotechnology in the marine sector, and has invested widely in marine
biotechnology initiatives at both Federal and Provincial level. The major emphasis has been on using
genetic information to manage, conserve and improve fish stocks. Extraction of useful compounds,
particularly nutritional products, has also been pursued.

Fisheries and Oceans Canada (DFO) 11 is the federal government department mainly responsible for
marine activities. Their applications of biotechnology 12 include:

     •       Defining the genetic profiles of commercially valuable species for stock identification
     •       Harvest management
     •       Preserving the genetic diversity of endangered species
     •       Selecting broodstock for aquaculture development
     •       Identification and control of aquatic animal diseases
     •       Monitoring recovery of wild and fisheries habitats
     •       Assessing potential environmental impacts of transgenic fish.

In fish processing there are further applications for diagnostic test usage, fish processing, and waste
utilisation. DFO are actively considering the relevance of biotechnology to their areas of responsibility
and activity. They have already issued a public statement as to what they see as the role of
biotechnology for marine science (see Appendix 3).


11
      www.dfo-mpo.gc.ca
12
      CIRCA communication with Fisheries & Oceans Canada, Jan. 2004

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DFO have conducted a review of national biotechnology activities and in 2004 they were planning 13 to
develop their genomics and biotechnology initiatives in 4 main areas:

     •   Genetic profiling for sustainable management of marine resources
     •   Aquatic animal health
     •   Transgenic fish regulatory science
     •   Aquatic environmental health and remediation.

The details of these themes and the management structure for their implementation are currently being
finalized. The current DFO Science programmes essentially focus on:

     •   Environmental research to provide a scientific foundation for the conservation and protection of
         fish and fish habitat, and the protection of marine ecosystems and
     •   Research to support the fisheries (including aquaculture) industry. The ‘Aquaculture
         Collaborative Research and Development Program’ provides funding for aquaculture R&D
         projects proposed by industry and private proposers. Other projects are also conducted at a
         provincial level on local issues.

The National Research Council of Canada (NRC) is another key player in marine biotechnology in
Canada. The NRC Biotech Strategy is implemented through six Strategic groups, including the
Institute for Marine Biosciences (www.imb.nrc.ca) in Halifax, Nova Scotia. NRC also manages the
Genomics and Health Initiative (GHI) which is implemented in all the NRC institutes across Canada.

The IMB Research programmes are organised into four main themes:

     •   Aquaculture Production/Aquaculture Nutrition (including research on genomics of flounder,
         halibut and other fish species)
     •   Natural Toxins and Shellfish. The IMB is a major centre for research in this area and can
         identify every known marine toxin.
     •   Aquatic Animal Health (e.g. Furunculosis, Sea-lice and environmental issues)
     •   Mass Spectrometry/Proteomics Technologies

Genome Canada (www.genomecanada.ca) is the federal funding organization for genomics research in
Canada and has many programmes on a range of organisms of commercial or other interest. Some of
the funding for genome research is directed towards marine biotechnology, but it is not a specific
priority of this agency. Two projects of specific relevance are:

     •   PLEUROGENE - a €2.5m collaborative project supported by Genome Canada and Genoma
         España (The Spanish genomics Programme) to study the genomics of two commercial flatfish,
         i.e, Atlantic halibut and Senegal sole. The objective is to better understand some of the
         reproductive, nutritional and growth characteristics of these species so as to make them more
         amenable for aquaculture.
     •   Genomics Research on Atlantic Salmon (GRASP) – a €3.9m genome mapping project of
         Atlantic Salmon (See section 5.3). The specific purpose is to identify genes related to immune
         response to pollution, parasitism and stress, and also genes related to sex determination.


13
     CIRCA correspondence with Peggy Tsang, DFO

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A further relevant Canadian genomics project, although not funded by Genome Canada is:
     •    Aeromonas Salmonicida Genomics. The Institute for Marine BioSciences 14 is conducting
          several genomics projects of marine significance. One of these is the assembly and annotation
          of the genome sequence of Aeromonas salmonicida the bacterium which is the causative agent
          of the salmon disease Furunculosis. The project seeks to identify genes linked to virulence in A.
          salmonicida.

At provincial level, the most active province has been the Atlantic coastal province of Nova Scotia,
which has the advantage of the presence of a federal Institute for Marine Biosciences (IMB) (see above)
and also a centre of Genome Canada. Nova Scotia is also home to several successful marine biotech
companies including Ocean Nutrition (see page 37). The development of a cluster of marine biotech
companies in Halifax is further described in Section 6. New Brunswick and Newfoundland are also
actively applying biotechnology to improve their already significant marine industries.




         Genomics research for healthy oceans, sustainable fisheries and aquaculture

     Marine genomics research at Fisheries and Oceans Canada (DFO) is transforming commercial
     fisheries management, aquaculture development and ocean protection strategies. Unlocking the
     genetic secrets of fish and other aquatic organisms will help to:

               •     Identify, track and protect vulnerable species;
               •     Protect the biological diversity of our oceans;
               •     Minimize the impact of disease outbreaks; and
               •     Increase productivity of aquaculture.

     What is marine genomics?
     Marine genomics is the science of identifying and recording the structure and function of selected
     genes in fish, shellfish, marine mammals, aquatic plants and other organisms. Like a fingerprint
     or a barcode, each living organism has a unique DNA sequence that identifies it. DFO scientists
     use this barcode to distinguish individuals as well as populations that share similar genetic
     patterns.

     The result? More complete and reliable science information about how marine species live and
     breed, and how they are affected by environmental changes, such as a rise in ocean
     temperature, or by human activities like fishing and oil spills. All this information translates into a
     better ability to support sustainable fisheries and aquaculture and ensure healthy oceans.

                                                      Extract from Public information brochure by DFO - Canada




14
      www.imb.nrc.ca/research/index.html

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4.3        Japan

Japan sees biotechnology as one of the ‘transformative’ technologies that are of crucial strategic
importance to its economic future. So as to ensure that Japan’s agencies and industry are well
coordinated in their development of biotechnology, Prime Minister Koizumi created a Biotechnology
Strategy Council in the summer of 2002. This group acts an advisory committee and reports directly to
his Office.

An explicit goal behind the creation of the council was to develop a strategic vision for the life sciences
sector in Japan. One objective was to develop a single biotechnology development plan which would
coordinate the wide range of government R&D and other initiatives in the field of life sciences. In
December 2002 the Japan BioStrategy Council published a policy document 15, which has now been
accepted and is being implemented. The Strategy has been called the ‘b-Japan Plan’ to emphasise the
parallels with the country’s IT Strategy or ‘e-Japan Plan’.

This plan, which cover all aspects of biotech R&D, Industry development, education and public
information, emphasises marine biotech in many of its recommendations and proposals. Specific areas
of marine R&D specified in the plan include:

      •   “ We will search for functional properties that marine organisms... possess and elucidate
          expression mechanisms ... and structure of useful constituents.

      •   We will search for DNA markers concerning resistance to disease, quality, stress-resistance
          and high functionality in major agricultural products… and growth and resistance to diseases
          in marine products ...(and)… effective breeding systems to utilize these markers.

      •   In the food and agricultural, forestry and marine products industry, a sector with little R&D
          investment compared to other industries, in order to promote the creation of new industries…
          we will strengthen exchanges of people between industry, schools and government. At the same
          time, we will also implement a fusion of interdisciplinary research, in which researchers will
          participate from independently administered corporations, universities, and private enterprises,
          and where research based on ingenious ideas of young researchers can be aimed at creating
          biotech venture businesses”

Although this plan has brought a new impetus and focus to biotech, marine biotech was already in
progress. Indeed, Japan was one of the first countries to establish marine biotechnology as a national
priority, and it has been making significant investment since the 1980s, particularly in the area of
biodiscovery. Several countries have programmes which focus on marine macrobiota (particularly
sponges, crustacea and mollusca) as the source of useful metabolites. However, the major focus of the
Japanese programme has been on the screening of marine micro-organisms, particularly bacteria. This


15
      Biotechnology Strategy Guidelines, Japan Biotechnology Strategy Council 2002

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is consistent with Japanese R&D and industrial strengths in programmes which seek to exploit
organisms from other environments for commercial activity.

The government agencies which have sponsored marine biotech initiatives include:

          The Ministry of International Trade and Industry (MITI) has been the major player. In
          1988 it formed the Marine Biotechnology Institute Co Ltd, (MBI)16 jointly with 24 private
          Japanese companies. In return for the investment, the consortium companies get priority access
          to IP deriving from the programme. MBI carries out its activities through MITI's Research
          Centre for the Industrial Utilization of Marine Organisms, which has built two biotechnology
          centres to conduct mainly basic research on collecting marine organisms and screening them for
          useful chemicals. Marine micro-organisms have been the major focus of this research. The
          programme has required significant basic research to culture, identify and classify these
          organisms. These organisms have not been widely studied elsewhere, and most are entirely
          new species. The research has resulted in a collection of 20,000 strains of microorganisms,
          including 1,000 microalgal cultures. Through a related research programme, MBI is also
          screening extracts from these organisms for compounds of therapeutic or industrial interest.
          The microorganisms are also screened as potentially useful for environmental decontamination
          and pollution abatement.

          The Ministry of Agriculture, Forestry and Fisheries (MAFF) focused on the more
          "traditional" areas of fisheries and aquaculture: including methods to culture marine organisms
          in Japanese waters and development of technology to use fish and shellfish wastes.
          Biotechnology also plays a role in this area.

          The National Research Institute of Aquaculture (NRIA) conducts basic and applied research
          oriented towards expanding the fish farming industry and fish production. Both salt-water and
          fresh water species are being studied. Once again, biotechnology plays a role in some of the
          approaches adopted in this programme.

          The Science and Technology Agency (STA) funds the Japan Marine Science and Technology
          Centre (JAMSTEC) whose mission is to support fundamental research contributing to the
          greater use of the oceans. JAMSTEC's marine biotechnology activities focus on using
          submarine technology to study.

      •   Physiology, ecology and culture methods for deep sea organisms
      •   The use of the deep sea for culture of organisms
      •   New technology for culture of algae in the deep sea with artificial light
      •   Technology to explore and culture deep-sea organisms that live in special conditions such as
          extreme pressure or temperature environments.




16
     http://cod.mbio.co.jp/mbihp/e/organization_e.php

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4.4        Norway

Fisheries is a very important sector of the Norwegian economy: a total of 27,000 fishermen are employed
on the high seas, a further 14,000 are employed in aquaculture related industries, while fish processing
employs an additional 11,000. The export value of Norwegian fisheries and fishery products was
approximately €3.82 billion in the year 2000 and it is reported as potentially reaching over €17 billion by the
year 2020. This sector is seen as a vital part of Norway’s industrial future as their oil revenues gradually
stagnate and decline.

Norway has developed a national plan for Functional genomics which is very significantly directed
towards exploiting marine opportunities. The plan – FUGE - arose from a proposal by a range of
Norwegian R&D interests made in 2001 17. This proposal noted that “Increasing Norwegian research
capacity in functional genomics is also a prerequisite for further development in the marine resource
sector…” and “ … FUGE will play a role in establishing the research basis needed to promote further
development of the aquaculture industry, optimal utilization of marine resources, and the creation of a
biomarine industrial cluster in Norway”.

The proposal was accepted by the Norwegian Government and the FUGE Programme was initiated in
2002, managed by the Norwegian Research Council. It was initiated in 2002 with the intention that it
would run for 10 years with an evaluation in 2007. The national funding commitment to FUGE in
2003 was approx €17.5m, and it was planned to double this budget from other sources.

FUGE will apply genomics to ‘basic biological, medical and marine research’. The inclusion of
marine as a specific area of application of the national genomics programme is significant. The plan for
the marine application of genomics, according to the Action Plan 18, is that ‘FUGE will play a role in
establishing the research base needed to promote further development of the Aquaculture industry and
optimal utilisation of marine resources’.

There are specific goals for this process in the plan which specifies:

       •    By the end of 2005 genomics will be integrated into research in bioprospecting
       •    By the end of 2006, there will be a solid national foundation for research into marine
            functional genomics directed towards mapping the genetic components for growth rates,
            flavour, reproductive success and disease resistance of fish species that are strategically
            important to Norway
       •    By the end of 2006 better systems for the production of fish feed will be developed

The implementation of the FUGE action plan emphasises international collaboration with researchers in
relevant laboratories in EU and elsewhere.



17
      FUGE – Functional genomics in Norway – a national plan. Research Council of Norway 2001
18
      www.forskningsradet.no/fag/andre/fuge/english/documents.html



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In addition to the Genomics initiative, Norway has four universities pursuing marine science including
marine biotechnology: in Oslo, Bergen, Trondheim and in the Arctic at Tromsø. There are also several
marine research institutes, such as the Institute of Marine Research in Bergen and the Norwegian
Institute of Fisheries and Aquaculture in Tromsø. In addition, large-scale aquaculture stations are
located near Bergen, at Sunndalsøra and in Tromsø. There is also a research station at Ny Ålesund on
Spitsbergen at 79° N.

The creation of a Research Council for Fisheries resulted in the establishment, in the early 1970s, of two
national institutions in Tromsø: The Norwegian College of Fishery Science (part of the University of
Tromso), and the Applied Norwegian Institute of Fisheries and Aquaculture Research. This later
resulted in the establishment of a national centre of marine biotechnology involving these institutions in
Tromsø. Since then Tromsø has seen the development of a research park and a regional programme
focused on marine biotechnology: Marine Biotechnology in Tromsø (MABIT) 19. Several small
companies (such as Biotec ASA) have spun off from this activity and a small cluster has developed.
This is further described in Section 6. A BioProspecting-program, marine biobank and modern
screening facilities are now being developed.

Marine biotechnology has also been a priority area at the University of Trondheim, with research
focusing on marine microbes, fish spoilage and seaweed research, which has been a research focus for
more than 50 years. The current research priority within this research programme is marine
polysaccharides/hydrocolloids. This activity has also seen the spin-off of several companies.

Bergen with the University, the Marine Institute, and (formerly) several institutes associated with
fisheries and aquaculture, is a cluster of marine science and developing companies. In the mid 1990s an
international marine molecular biology centre (The SARS Centre) was established in Bergen, and is
devoted mainly to marine developmental biology.

Marine Biotechnology at the University in Oslo operates within the University of Oslo, The
Agricultural University at Ås, and the Norwegian College of Veterinary Medicine. The latter college
has a relatively high activity within the Norwegian Salmon Genome Project, funded by the Research
Council of Norway, which supports 13.5 positions. It also involves a range of academic and industry
collaborators in Norway and the EU. The objective is to combine research in molecular
genetics/molecular biology with bioinformatics to increase knowledge on the biology of Atlantic
salmon.

The Research Council and the Ministry of Fisheries have specifically supported marine biotechnology,
but recent programs are now focused on biotechnology and marine science/aquaculture, respectively.

Finally, it should be noted that plans are underway to launch a major and wide national program/effort
under several Ministeries. Not details of this plan are yet available.



19
     5-year programme est. in 1998 by Min. of Fisheries. Further details of this and other NO programmes at
     http://odin.dep.no/archive/kufvedlegg/01/03/243BR050.pdf

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4.5        United States

The USA is the world leader in biotechnology R&D and industry. More than 885,000 people are
employed in the life sciences. The USA is also a world leader in Marine Sciences Research, and has
several of the most significant international Marine Research centres specialising in this area. Among
these may be particularly mentioned:

      •   Scripps Institute of Oceanography 20;
      •   Woods Hole Oceanographic Institution 21
      •   Centre for Marine Biotechnology at the University of Maryland 22.

With this combination of leadership, it might be expected that marine biotechnology would be a
significant area of activity. Indeed, marine biotechnology was one of the topics included in the National
Science Council’s 1995 report on “Biotechnology for the 21st Century: New Horizons” 23 and it has
been a specific topic in many other policy statements since then. However, despite the many positive
references in federal policy statements, there is no single programme which deals with marine
biotechnology in all of the United States. One reason for this may be that the US pre-eminence in
other areas of biotechnology, particularly healthcare and agriculture, has meant that these areas have
been seen as more attractive areas for investors, both public and private.

Among the US agencies with specific responsibility for aspects of marine activity, there has been
activity in biotechnology. In 1999 the National Oceanic and Atmospheric Administration (NOAA)
produced a report on “Turning to the Sea: America’s Ocean Future”. This report contained
recommendations towards a US Oceans policy. Among these were a series of Marine Biotech priorities
including environmental assessment of potential biotech applications, and marine biodiscovery.

A subsidiary of NOAA, and a major funder and coordinator of US Marine research is the Sea Grant
Programme 24. This programme is seen as a partnership between government, academia, industry, and
scientists. Biotechnology is one of 10 thematic areas of Sea Grant activity. It is not, however, a priority
theme. The Sea Grant objective in this area is “to identify and catalyse research applying new marine
biotechnologies to improve and protect human and environmental health in coastal America, and to
create economic benefits nationwide by fostering the development of novel industrial processes and
products.”

The Sea Grant Programme funds research, training and education for sustainable exploitation of the
Great Lakes and ocean waters. The Sea Grant programme in Marine Biotechnology, which has been in
place since the early 1990s, has funded hundreds of projects in every area of marine biotechnology in
over 200 universities and institutions. Although the specific funding levels are not available, there is a
significant federal investment in this area.

20
      http://sio.ucsd.edu/
21
      www.whoi.edu/
22
      www.umbi.umd.edu/~comb
23
      www.nalusda.gov/bic/bio21/aqua.html
24
      www.nsgo.seagrant.org/

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The National Marine Fisheries Service (NMFS), which is another agency within NOAA, is responsible
for the science-based management, conservation, and protection of living marine resources within US
waters. This agency is also using biotechnology in its research programme, although there is no specific
mention of biotechnology as a priority theme within their current NMFS Strategic Plan for Fisheries
                          25
Research (February 2004) . Among the specific applications are:

     •    Within a research theme to investigate the abundance and life history of fish stocks, there will
          be significant use of DNA analysis to assess stock movements and origins.
     •    In aquaculture research, molecular biology techniques will be used to assess genetic heritage of
          farmed salmon and other species; and to identify species, stocks, and individuals.
     •    In aquaculture research, methods to identify and control pathogenic microorganisms will be
          developed. This will involve conducting genetic studies of the pathogens, characterizing host-
          pathogen interactions, and developing sensitive molecular techniques.
     •    In food safety, research will identify and characterize key virulence determinants that enable
          Vibrio vulnificus to cause human infections, using comparative genomics and other molecular
          genetic means.

At State level, many states have undertaken the following:

     •    Florida has established a Centre of Excellence in BioMedical and Marine Biotechnology with
          the objective to focus on discovery of new drugs from marine resources. This programme will
          be conducted in association with industry partners. 26

     •    Hawaii has funded some activities in training and research on marine bioproducts engineering.

     •    Maine has defined a ‘Marine Industry & Technology Fund’ 27 and has established a ‘Small
          Industry Growth Fund’ in which one of the eligible areas is Marine Sciences and
          Biotechnology.

     •    Maryland has created the University of Maryland Biotechnology Institute with the specific
          mission to promote the development of biotechnology. One of its centres, mentioned above is
          the Marine Biotechnology Centre which is a major state resource in marine biotech
          development.

     •    Mississipi has an S&T driven economic development plan managed by Mississippi Technology
          Alliance. This organisation has identified marine science as a technology cluster targeted for
          growth.

     •    South Carolina has provided funding for development of Marine genomics expertise at the
          Medical University of SC.

25
     NMFS strategic plan for fisheries research 2004. NMFS F/SPO-61
26
     see www.floridabiotech.org/
27
     see www.marinebiotech.org/

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4.6       Countries without Formal Marine Biotechnology Programmes

Many countries do not have formal national programmes, but nevertheless have activities designed to
develop aspects of marine biotechnology. These activities provide ideas from which Ireland might
learn, and also provide indications on the priority areas for investment in marine biotechnology.
Activities in a range of countries, are briefly described in this section.

4.6.1     Denmark
While there are no specific support grants or strategies aimed at marine biotechnology research in
Denmark, there are some companies very active in marine biotechnology (see Section 6) and also a
number of strong research groups with activities in marine biotech – particularly seafood processing,
microbiology and aquaculture related research.

A secretariat and incubator facility has been established in Copenhagen under the administration of
“Medicon Valley”, which handles a number of cooperative efforts within medical sciences and
biotechnology. The Medicon Valley concept28 may also help to provide the link between the different
biotechnology disciplines (biotechnologies) required to sustain a marine biotech effort.

Copenhagen also hosts the headquarters of the International Council for the Exploration of the Sea
(ICES), and is thus in a useful position to form links between research activities within fisheries and
marine biology. The “Seafood Plus” project is also lead from Denmark. This is an EU integrated
project involving 70 partners. It is aimed at fulfilling the consumer’s need for healthy seafood products.

4.6.2     France
Institut Français de Recherche pour l'Exploitation de la Mer (IFREMER) 29 is the major French agency
involved in marine research, but it has no specific Marine Biotechnology policy. Neither is there a
marine focus within the major national biotech activities run by a range of other French RESEARCH
agencies.

However, there are several significant research sub-programmes of relevance. France launched a
"Genomique Marine" or Marine genomics programme in 2003. This involved the creation of the
“Institute de la Genomique Marine” to promote genome sequencing projects. The 4-year French
programme is coordinated in Roscoff by CNRS, and funded by the French Ministry of Research. It also
involves collaboration with IFREMER and other regional and academic collaborators. One of the
specific priorities for CNRS at Roscoff is researching the expression of proteins from marine organisms.
This is intended to a major areas of interest in the future and one in which they would welcome
collaboration from Irish laboratories.




28
     www.medicanvalley.com/
29
     www.ifremer.fr

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As well as funding research (approx. € 1.2-1.5m per year), the programme will also encourage
commercialisation of the results. The first R&D proposals to this programme were submitted in Sept.
2003.

The Institute de la Genomique Marine laboratory is the French partner in a European Framework
Network of Excellence Project (NoE) (see 5.1) and will provide the French contribution for much of the
research that has been proposed within the NoE.

The Marine Station of Concarneau 30 has a major R&D programme in fish waste upgrading. They have
established a group of French laboratories consisting of Concarneau, IFREMER (Nantes), University of
La Rochelle, University of Quimper, and University of South Brittany (Lorient). The objective is the
production of tailor -made peptides by enzymatic hydrolysis of fish, mollusc and crustacean wastes. The
current emphasis is on functional peptides for nutraceutical use. They collaborate with a French
company CTPP (Boulogne) for commercialisation of the technology. This research also has
international collaborations: e.g. it is part of a joint Franco-Norwegian project; it is a sub-component of
the FP6-funded project SEAFOOD-plus; and also funded by an Interreg-funded project VALBIOMAR
(with Spain, Scotland, Portugal).

4.6.3      Greece
In 2003 the National Centre for Marine Research and the Institute of Marine Biology of Crete were
merged to create the Hellenic Centre for Marine Research (HCMR) 31. This centre is described as “a
multi-site organisation created to integrate government-funded marine science research in Greece”.
One of the aims of HCMR is the promotion of biotech and biopharmaceutical research. One of the
Institutes which make up HCMR is the Centre for Marine Biology and Genetics, whose major focus is
on exploration of marine biodiversity.

4.6.4      Germany
Although Germany does not have a formal federal Marine Biotechnology programme, there are several
regional programmes and activities of relevance.

BIOTECmarin 32 is a Centre of Excellence in Marine Biotechnology involving five Universities and
the DAR Mannheim. The centre focuses on research in marine animals (primarily sponges) and their
associated microorganisms (bacteria/fungi), which are known to produce highly selective and potent
bioactive compounds. These compounds are assessed for their potential healthcare applications. It also
has an associated spin-off company BIOTECmarin GmbH.

The BOSMAN projects 33 (BOreal Sponges-Sources of MArine Natural Products) I & II investigate
the industrial applicability of natural products derived from boreal sponges and associated
microorganisms. Symbiotic bacteria living within sponge community have proven to be a source of
novel compounds for therapeutic discovery programmes. BOSMAN is part of the "Marine Natural

30
     www.mnhn.fr/mnhn/conc/index.htm
31
     www.hcmr.gr
32
     www.biotecmarin.de/.
33
     http://www.geowiss.uni-hamburg.de/i-bioge/english/projekte_e/bosman2_e.htm

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Product Research" programme of the Federal Ministry of Education, Research and Technology (GBF)
and commenced in 1999. BOSMAN I involved multidisciplinary research groups from different
German universities. The scientific disciplines involved include geobiology, sponge and
microbiological taxonomy and natural product chemistry. BOSMAN II continued the work on finding
sponge species and extracting useful compounds. However, it has also taken the next steps by starting
screen extracts, fractions and isolated compounds for specific biological activity. Project researchers
have developed new bioassays for this purpose. It has also started the process of identifying
pharmacological effects of sponge extracts, fractions and isolated compounds, and also the isolation of
useful enzymes from sponges and their associated bacteria.

Lower Saxony also managed a Marine Biotechnology programme, which was funded by the
Volkswagen Foundation (Volkswagen Stiftung e.V.) and managed by German Research Centre for
Biotechnology (Gesellschaft für Biotechnologische Forschung: GBF) 34. The major focus was on
extracting and screening biologically active compounds from marine organisms. Nineteen work groups
from different universities and research institutes participated in this joint project, which ran over a five
year period ending in 2002. The GBF team isolated many new bacteria and a series of promising
extracts, some with potential pharmaceutical qualities, are now being tested more thoroughly.

4.6.5       Iceland
Iceland’s biotech R&D priority is healthcare, and particularly human genomic analysis. The Iceland
development agency ‘Invest in Iceland published a report 35 in 2003 which outlined national
biotechnology policy. The major national objective in Biotech is to develop a biotech-based healthcare
industry. Iceland has one significant advantage in this area in that it has both a well-documented
genealogical population database, and also a very complete health database. The combination of these
two represents an ideal situation in which to conduct genomic research. As a result the company
Decode has been established.

The report notes the opportunities which may arise from healthcare applications of natural resources,
including marine biota, but this is not a priority area of biotech development.

Although it is not a national biotech priority, marine biotechnology is a priority within fisheries
research. The major marine R&D agency is the Icelandic Fisheries Laboratories (IFL) 36. IFL's
research priorities are on “biotechnology, new processing technology, aquaculture, the processing and
improved quality of chilled seafood products and the safety and wholesomeness of marine seafood. In
the fields of biotechnology and new processing technology, the goal is to utilize biotechnology in
developing new products from seafood. Emphasis is placed on research on proteins and their
processing from marine catches and their potential use as wholesome bio components, flavouring or
other blending substances in food production, dietary supplements, herbal medicines and other
medicinal products.” 37



34
     www.gbf.de/index_err.html
35
     Research environment for the health related industries in Iceland
36
       www.rfisk.is/english/about/
37
      Icelandic Fisheries Laboratories: Annual Report 2003

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In 2002, the Ministry of Fisheries (which is responsible for IFL) initiated the ‘Added Value of Seafood’
(AVS) fund to promote projects which focus on increasing the export value of seafood products. A part
of this fund is dedicated to biotechnology because “marine biotechnology is one of the areas expected to
give some added value to seafood export from Iceland within five to ten years time” 38.

There are already several companies in Iceland that specialise in development of products based on
marine material (see page 37). According to one such company Primex (see Table 6) “The interest in
increasing the value of catches, the importance of the marine industry in Iceland and the wealth of
useable material available make Iceland an attractive option for companies specialising in this
promising field ” 39

4.6.6     Israel
None of the researchers contacted were aware of any national strategic effort in Marine Biotech in
Israel. “The work going in Israel is either funded through various national or bi-national granting
programs, European consortia, or various industrial grants, but to my knowledge there is no special
effort in marine biotech.” 40 The major relevant institution is Israel Oceanographic and Limnological
Research (IOLR) 41, which is a research institution dedicated to aquatic research, and particularly to
developing methodologies and technologies for sustainable use of coastal, marine and freshwater
resources. IOLR has several projects of relevance to marine biotechnology, in particular Algal
bioadhesives 42. See page 36 for information on Nature Beta Technologies Ltd.

4.6.7     Italy
There is a range of marine biotech R&D activities in progress, but there is no significant central
coordination of these activities, and no national programme. The major marine R&D institute is Istituto
di Scienze Marine 43 (ISMAR) which is affiliated to the main Italian Agency for Research – Consiglio
Nazionale delle Ricerche (CNR). The Stazione Zoologica, based in Naples also has effective
programmes in developmental biology and molecular evolution. Neither these institutes, nor CNR in
general, has any central programme in marine biotechnology, although there are individual projects of
relevance to the field.

4.6.8     Netherlands
Within the main R&D agency NWO, there are four programs that fund different aspects of the marine
life sciences:

     •   Netherlands Geosciences Foundation (GOA)
     •   Netherlands Organization for Scientific Research (SLW)
     •   Commission for Antarctic Research
     •   Netherlands Foundation for the Advancement of Tropical Research WOTRO.



38
     Pall Gunnar Palsson, Icelandic Fisheries Laboratories: Personal Communication
39
     Research environment for the health related industries in Iceland. Invest in Iceland Agency. October 2003.
40
     Prof. David Gutnick – Dept. Molecular Microbiology & Biotechnology – Tel Aviv University
41
     http://marine.ocean.org.il/index.html
42
     http://algal-adhesives.ocean.org.il/
43
     www.ismar.cnr.it/

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None has a specific focus on marine biotechnology and there is no central programme in this area. The
Netherlands also has an excellent national programme for genomics research – The Netherlands
Genomics Initiative44. Although this agency funds a wide range of genomics activities, no marine
organisms are included in any of their genomic centre research programmes.

One activity worth noting as an example of R&D coordination is the Netherlands Marine Life Sciences
Platform45. This was established in 1995 with the purpose to “bring scientists together in order to
strengthen research in marine biological processes in the broadest sense of the word. This includes:

     •   oceanic, coastal, estuarine, rocky shores and coral reef research
     •   interactions among all relevant subdisciplines
     •   collaboration between individuals and institutions, at both the national and international levels.

The hallmark of the platform is thus to network scientists and create a higher visibility of marine
biological research within the larger context of Dutch science“.

4.6.9     New Zealand
Marine research investment in New Zealand averaged NZ$63m (€33.4m) in the years 2002 and 2003 46.
However, despite the significant activity in marine R&D, marine biotechnology would not appear to be
a major priority. A report entitled ‘Marine Research in New Zealand’ published in 2003 does not
distinguish Marine Biotechnology as a specific area of R&D activity in New Zealand. However, it
estimates that approximately 24 percent of national funding was spent on “Understanding biological
systems” and a further nine percent on “Aquaculture and BioActives”. Biology and related disciplines
are estimated to represent 27 percent of the total skills base associated with the total spend.

Biotechnology development programmes in New Zealand were also assessed to establish whether they
contained any focus on the marine sector. A major review of NZ biotechnology 47 published in 2003
does not highlight the life science base in marine biotech as a major strength for the country. The report
does note that the ‘unique biological base’ in New Zealand in marine and terrestrial life, is an ‘area
where there is an opportunity to build competitive advantage’. However, there is no apparent
programme planned to exploit this opportunity. A report on the biotech industry in New Zealand 48
published in 2001, hardly mentions the marine sector.

There is a small cluster of marine / marine biotechnology companies in Nelson. This is further
discussed in Section 6.     In essence, although New Zealand has a major marine resource, marine
biotechnology research is not a major area of activity within the biotechnology community in New
Zealand. Equally, biotechnology is not perceived within the marine community as a means of major
development for the sector. In this respect it is somewhat similar to Ireland.


44
     www.genomics.nl/international.htm
45
     www.bio.vu.nl/vakgroepen/thb/users/mlp/
46
     Marine Research in New Zealand: A Survey & Analysis. NZ Ministry of Research, S&T. July 2003.
47
     Growing the Biotech sector in NZ: A Framework for action. Biotechnology Taskforce. May 2003.
     www.biospherenz.com/download/biotech_taskforce_report.pdf
48
     An Initial Survey of the Biotechnology Industry in New Zealand. Industry New Zealand; June 2001.
     www.industrytaskforces.govt.nz/biotech/documents/

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4.6.10 Poland
There is one small Department of Genetics and Marine Biotechnology in the Institute of Oceanology in
Gdynia 49, which is part of the Polish Academy of Sciences. However, there is no formal programme or
strategy on marine biotechnology.

4.6.11 Spain
The National Research Council (CSIC) has several R&D Centers that conduct Marine Science and/or
Biotechnology 50.     Although several of these are high quality activities of direct relevance to
commercial biotech, these activities are not coordinated as elements of a central marine biotech activity.
However, the recent change in Government has resulted in a restructuring of S&T administration and a
promise of increasing R&D budgets until 2008. Note also the activities of Pharmamar (see page 28)
who are a major company in marine biodiscovery.

4.6.12 Sweden
The major focus of Swedish biotechnology is healthcare technology development and
commercialisation and most of the national initiatives support this focus. No marine activities were
found in a search of the major agencies dealing with Swedish biotech i.e. Swedish Institute for Food and
Biotechnology; Bio Sweden; Stockholm BioScience Initiative; Medicon Valley (see Denmark Section).

There are three marine research centres in Sweden: Stockholm Marine Research Centre (SMF) in
Stockholm university; Göteborg University Marine Research Centre and Umeå Marine Sciences Centre.
The marine centres work as umbrella organisations for all marine research in Sweden. Marine
Biotechnology is not a major focus

Among the marine biotech activities that should be mentioned are:

The Wallenberg Foundation has provided $5.33 million for a collaboration between University of
Bergen (Norway), the University of Maryland (US) and Goteborg University in Sweden to develop
education and research activities in marine biotechnology. This will include environmental solutions,
advance procedures in aquaculture, improving cultivating farm-raised seafood, and training of current
and future scientists in applying biotechnology-based solutions to prevent and control diseases of
marine plant and animal life.

The MarEGene project is a joint Swedish/Danish project which studies the genetic response of marine
organisms to environmental damage 51. It involves an integrated study of ecology and evolution of
marine life in the Skagerrak and Kattegat to identify genes relevant to understanding the response of
marine organisms to stress, and to use this understanding to support sustainable development.




49
     www.cbmpan.gdynia.pl.
50
     www.csic.es - Spanish national research institute.
51
     http://biologi.uio.no/cees/maregene/I3/Overview.jpg

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4.6.13 UK
A report entitled ‘A Study into the Prospects for Marine Biotechnology Development in the UK’ 52 was
published in Jan 2005 and again highlighted the opportunities in the sector. The report, which was
commissioned by several interested marine bodies and funded by the Department of Trade & Industry,
recommends that the emerging industry should make more integrated use of different UK R&D funding
sources, and the new initiatives offered by Government, to promote innovation. It also emphasises the
need for coordination among the various agencies in the sector.

The major UK activities in the marine sector are in Scotland, where there is an active biotech strategy
run by Scottish Enterprise 53. Although this strategy targets five lead sectors, Marine biotech is not one
of the priorities. However, Scottish Enterprise does collaborate with Highlands and Islands Enterprise
to implement a marine strategy in this region. This programme is not formally available at the moment
but is expected to become available during 2004.

The major location of activity in Scotland is at Dunstaffnage, which is home to the Scottish Association
for Marine Science (SAMS) (formerly the Scottish Marine Biological Association). This station
conducts a wide range of marine studies. Of particular relevance is the recent establishment of the
European Centre for Marine Biotechnology (ECMB). The ECMB conducts its own commercial marine
biotechnology research, which is associated with the research activity within SAMS. It also functions as
an incubator for both SAMS and other business ventures. It provides access to modern laboratory
facilities and office space for marine biotech companies. However, the objective is to develop the
centre and area as a major centre for marine biotech activity.

A ‘Marine Foresight Panel’ is currently studying the future marine needs and opportunities for the UK.
A Marine Biotechnology Group (MBG) has been established by this panel as a task team and ‘charged
with developing the context for development of the nascent field of marine biotechnology in the United
Kingdom’. They have commissioned a report on the legal framework for the development of UK
marine biotechnology by reference to domestic, European Union and international law. This report,
entitled, A Study into the Legal Framework for Marine Biotechnology Development in the United
Kingdom was published in March 2004.

The outcome of this foresight exercise will clearly be a major indicator of the future direction of UK
Marine Biotechnology.

In the area of genomics, three UK Universities, in collaboration with the ARK-Genomics IGF Centre
(Roslin), Qiagen Ltd. and Marine Harvest (a division of Nutreco) are studying gene regulation in
Atlantic salmon. The project is funded by a UK research council and will link closely with the salmon
farming industry through Scottish Quality Salmon, which represents the producers of 65 percent of
Scottish farmed salmon. The primary goal is to identify the salmon genes and metabolic pathways
influencing traits that are important in terms of (a) efficiency and sustainability of farm production, (b)
welfare of farmed stocks, and (c) quality and nutritional value of salmon.


52
     This report by BioBridge Ltd can be viewed at: www.dti.gov.uk/sectors_biotechnology.html
53
      www.scottish-enterprise.com

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5.     MARINE BIOTECH INDUSTRY

This section reviews the current areas of activity of marine biotech industry by looking at the range of
activities of the companies that comprise the sector. Some of the major biotechnologies are reviewed to
assess (a) their application in the marine sector and (b) the nature and existence of companies exploiting
these applications. The four areas of commercial activity addressed in this section are:

       •     Bioprospecting/bioscreening for novel compounds
       •     Improving the production of marine organisms
       •     Production of novel foods, feeds and nutraceuticals
       •     Diagnostics & Biosensors

There are other applications for biotechnology in the marine sector, but they are smallscale and arguably
have little essential connection with their marine origin. Phytoplankton, for instance, secrete skeletal
structures composed of Silica in a huge variety of shapes and complexity. Understanding how this is
done could be the basis for novel microfabrication technologies of the future. To quote one source “…
it is conceivable that, in the future, biological systems will not only be used to construct individual
molecular size components,... but will also be involved in their production and control” 54.


5.1        Bioprospecting/bioscreening for Novel Compounds

Drug development is a hugely complex process which is longer, more costly and more highly regulated
than product development in any other industrial sector. The classical cycle for drug development
starts with the identification of a molecule which has some promise of pharmaceutical activity. Modern
techniques have vastly improved the mechanisms for screening candidate compounds for therapeutic
efficacy. Novel compounds from a wide range of biological sources are put through these ‘High-
throughput’ drug-screening programmes in the hope that some activity may be found.

If the molecule proves effective and safe, and is feasible to
                                                                                 ‘The ocean represents a virtually
manufacture, it will then be tested on patients suffering from                untapped resource for the discovery of
the target condition or disease. Only 1 molecule in 10,000                     novel chemicals with pharmaceutical
                                                                                            potential’
will pass through all of the phases of assessment and finally
                                                                            ‘Understanding the Ocean’s role in Human
reach the market. The entire process, commonly known as                     Health’ National Research Council (USA) 1999
the drug pipeline, can take 10 years to complete and can cost
up to $800m.

Perhaps the clearest evidence of the complexity and unpredictability of this process is the relatively
empty pipeline of many of the major pharmaceutical companies. Failures of promising drugs at late
stages in the clinical trial process can cause major changes in the fortunes of pharmaceutical companies,
and dramatic reductions in their share value.         Drug companies are therefore constantly seeking

54
      Lowe,C.(2000) Nanobiotechnology: fabrication & applications of chemical & biological nanostructures. Curr. Opinion in
      Struct. Biology 2000, 10:428–434

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candidate compounds to assess in their drug discovery programmes. Because of the diversity of unmet
medical needs for drugs, there is also a huge range of screening programmes in which candidate
compounds may be tested.



                                     Case Study: Pharmamar
                            – A specialist Marine Biodiscovery company

            PharmaMar, founded in 1986, is one of Spain's main biopharmaceutical
            companies, and a world leader in sourcing anti-tumour compounds from marine
            organisms. The company has evaluated substrates from e.g. sea squirts,
            sponges and Cnidarios (soft corals). It has established a library of over 40,000
            marine samples that are screened for potential as anti-cancer medicines. From
            these, 150 compounds have shown potential, and over 500 patent applications
            have been submitted or granted. Ten of these compounds are in preclinical
            development as anti-cancer therapies, and 3 in clinical trial. These are:

                   •    YondelisTM (Phase II) extracted from a tunicate, Ecteinascidia
                        turbinata
                   •    Aplidin® (Phase II) extracted from a tunicate Aplidium albicans
                   •    Kahalalide F (Phase I) extracted from a mollusc Elysia rufescens.

            Because of their potency, relatively small amounts of these compounds are
            needed. PharmaMar's strategy is therefore to produce the compounds itself. It is
            in the process of registration for marketing authorization in EU and the USA. It
            plans to market its own products in Europe, and licence to 'Big Pharma' for
            marketing elsewhere.



Marine plants, animals and bacteria are a major potential source of such candidate compounds. The
range of application of novel compounds from marine sources is immense. Mayer & Hamann (2003)
report that in the year 2000 alone, 78 marine chemicals were reported in the literature as having
therapeutic potential 55. In addition to pharmaceutical use, they may be used in foodstuffs (see section
6.3 below), adhesives, paints and many other applications.

The reason for this variety of novel compounds is that the oceans contain a range of extreme
environments (heat, salinity, pressure etc) in which organisms have evolved mechanisms for survival.
Marine ecosystems contain organisms which are unique. In other words no organisms closely related to
them are found in freshwater or on land. The less organisms are related, the more likely it is that they
have developed quite different cellular chemicals, metabolic pathways, storage products, and protection
mechanisms. The wealth of unique organisms in the sea therefore include many which have unique
metabolic processes. These processes produce new biologically active molecules, and these are the
source of the untapped potential of useful chemicals that the oceans possess.

Significant sources of unique biological material exist in Irish waters which could be explored for such
compounds. “The seaweed flora of Ireland is about 450 species… Ireland benefits from its position; the
fauna is a mixture of Boreal/Northern species and a strong element of Lusitanian/Mediterranean

55
     A.M.Mayer & H.T.Hamann (2003) Marine Pharmacology in 2000. 10.1007/s10126-003-0007-7

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species. The varied coastline and close proximity of open Atlantic waters allow for the presence of
stenothermal species and communities. Whilst the inshore fauna is very rich in species (the Greater
Galway Bay area alone including about 1500 species), the fauna of the continental slope is by far the
most diverse. Single samples may contain as many as fifty different species if the substrate is suitable.
…. Ireland has the most extensive still intact coral reefs along the Western European seaboard outside
Norway... (and) is well placed, with the highest density and diversity between 300-1200 m.” 56

This is further discussed in section 7.3.

As noted in the earlier sections, many research projects are in progress in many countries to identify and
screen these marine compounds. This process of extraction and screening is known as bioprospecting
or biodiscovery. In addition to the research institutions involved in such research, there are also
specialist companies with the same goals. A list of sample companies is in Table 1.

The commercial strategy of these companies varies, but the usual business plan is to identify a source of
candidate compounds and to conduct preliminary screening. If initial screening suggests that the
compound has some efficacy in a particular application, further rounds of screening will be conducted
to further assess the level and range of efficacy. As there is an immense range of potential therapeutic
and chemical applications for each compound, each one can potentially be put through a wide range of
testing. Because of the specialist nature of the tests used, institutions and companies will usually
specialise in a particular area of testing (e.g. Anti-microbials, anti-cancer, cardiac, neurological etc)

Compounds with potential in a particular application are generally licensed to major pharma or
chemical industry at some stage in the screening process. The ‘finding’ company or organisation will
make an agreement with the company on fees and royalties. Some of the screening companies may
choose to keep some of the compounds for further in-house development. This may be with a view to
licensing at a later stage, or to developing their own products. An alternative model pursued by other
biodiscovery companies is to operate on behalf of the major industries on a contract basis, i.e. they are
contracted to provide an agreed number of new compounds per year (or per source) for testing in the
client’s laboratories. In this case royalties may not be paid, but the finding fee will be higher.

Bioprospecting involves a vast array of sources or materials, and an equally vast range of potential
applications. All approaches to bioprospecting must therefore have a focus or speciality. The usual
bases are:

     •   Those that have access or expertise relevant to a particular source of material (e.g. one type of
         organism, a waste source, area etc): e.g. BIOTECmarin GmbH focuses on novel materials
         from marine sponges and associated microorganisms; several companies focus on deriving
         useful compounds from fish and shellfish waste because of the ready availability of this
         material.




56
     Prof Mike Guiry & Dr. Gerd Koennecker, NUIG (Pers. Comm.) see Appendix 5.

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      •     Those that have a competence in screening for compounds useful for a particular application,
            e.g. Pharmamar (Spain) focus on anti-cancer compounds, which they source from a range of
            marine animals; several companies (Nautix, Plastimo etc) focus on antifouling compounds.

It should be noted that there are many companies which are not marine specialist companies, but which
have major screening programmes for useful compounds from any source. Most of these companies
will include marine compounds in their programmes. These companies have not been included here.




                   Case Study: Drugs from marine sources - Elan & Ziconotide

 Elan is currently developing ziconotide for treatment of severe pain. Ziconotide is the synthetic form
 of the conotoxin omega-conopeptide MVIIA, found in the venom of the fish-eating marine snail,
 Conus magus. This snail is one of over 500 species of cone snail whose venoms provide a rich
 source of natural peptides that can modulate selected ion channel function. Ziconotide is a selective
 N-type voltage-sensitive calcium channel (VSCC) blocker with analgesic and neuroprotective
 properties in laboratory animals. The drug has performed well in clinical trials and Elan is reported to
 be planning a launch in early 2005.




  Table 1:       Companies involved in discovery and/or screening for useful compounds from
                 marine sources.
 Company                           Location          Products
 Integrin                          UK                Pharmaceuticals
 Biotec Pharmacon                  Norway            Pharmaceuticals (Immunomodulators; enzymes)
 Nautix                            France            Antifouling compounds for paints
 Plastimo                          France            Antifouling compounds for paints
 Kolorian                          France            Antifouling compounds for paints
 BIOTECmarin GmbH                  Germany           Compounds from marine sponges and symbionts
 Pharmamar                         Spain             Anti-cancer compounds from marine organisms
 BioDiscovery NZ                   New Zealand       Pesticidal and anti-microbial compounds




5.2         Improving the Production of Marine Organisms

Although man has been consuming marine products since pre-history, culturing and management of
marine organisms is still a poorly developed field. With increasing human population and reducing
stocks of wild fish and shellfish, farming of seafood is likely to be an increasing activity. Using
biotechnology to improving production of farmed or harvested seafood is therefore receiving increasing
attention.

The major commercial opportunities arising in this area are: (a) development and production of
healthcare products (vaccines & therapeutics) for farmed fish; and (b) new strains of farmed fish with
improved characteristics in growth rate, feed conversion, disease resistance or quality.




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Fish Health: Disease is a persistent problem for fish-farming operations. As further wild species are
farmed it is likely that the range of diseases encountered will increase. Farmed fish, like any other
animals maintained at high densities, are prone to infectious disease. They are also susceptible to
parasites, such as lice. Diseases of farmed salmonids include bacterial, viral and protozoan diseases. In
the early years of fish farming, bacterial diseases were controlled through the use of antibiotic products.
However, antibiotic use is no longer acceptable due to cost and environmental restrictions. Vaccines
are currently the preferred solution for control of many fish diseases, and there is extensive research in
progress to develop new, more effective and multivalent vaccines for the major diseases of farmed fish.
Vaccine introduction has therefore been rapid within the fish-farming sector. However, introduction of
new farmed species will probably bring new diseases, and therefore new requirements for further
vaccine development. Ongoing research in Ireland into the genetic basis of disease resistance (e.g.
through the EU Salimpact Project) may also offer an opportunity to better understand the nature of both
disease resistance and susceptibility.
This in turn may assist in the rearing of                    Fish Vaccine Companies
disease resistance strains of cultured
                                             The international market for fish vaccines is of the order of
marine organisms.                            €60 million. The companies operating in this market
                                             generally originated as small companies, often spin-offs
                                             from research groups which developed the early vaccines.
The major diseases affecting the Irish
                                             However, within the last decade the major healthcare
industry are now nearly all viral as         companies have bought all of these pioneer companies.
bacterial diseases can be largely            The market is now dominated by Intervet (NL) which owns
                                             Norbio (Norway); Novartis which owns AquaHealth Ltd.
controlled through vaccines and, to a        (Canada); Schering Plough (US) which owns Aquaculture
lesser extent, antibiotics. Better           Vaccines Ltd.; and Alpharma (US) which has its production
                                             in Norway.
treatments and prophylactics are
available also for lice. Viral diseases,
particularly Infectious pancreas necrosis and Pancreatic disease, are the greatest health threat to the Irish
industry at the moment and vaccines have so far proved disappointing.

Research into vaccines for new diseases, and improved delivery mechanisms for vaccines, must
continue. However, the opportunities for Ireland to gain economic advantage within a small market
which is already dominated by multinational companies (See inset above), are not obvious.


 Table 2: Fish Vaccine Products
                               Existing Products                     Products in Development

                                  Furunculosis                Motile Aeromonad Septicaemia
                                     Vibriosis                       Bacterial Cold Water disease
     Bacterial
                                  Winter Ulcer                           Columnaris disease
     Diseases
                                  Hitre Disease                       Bacterial Kidney Disease

                                                                          Pancreas Disease
                       Infectious Pancreatic Necrosis (IPN)
                                                                       Spring Viraemia (Carp)
                          Viral Haemorrhagic Septicaemia
                                                                  Grass Carp Haemorrhagic Disease
  Viral Diseases             Infectious Salmon Anaemia
                                                                     Infectious Salmon Anaemia
                        Infectious Haematopoietic Necrosis
                                                                        Viral Nervous Necrosis

                                                                                Sea Lice
     Parasitic                                                       Proliferative Kidney Disease
     Diseases                                                         White Spot (Icth Infection)




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 Table 3: Companies involved in Aquaculture Vaccines or Therapeutic technologies
 Company                            Location                  Products

 Intervet Norbio                    Norway                    Fish vaccines and endocrine products

 Alpharma                           US & NO                   Fish Vaccines (et al)

 Aqua Health Ltd                    Canada                    Fish Vaccines

 Schering Plough                    USA                       Fish Vaccines


Fish Breeding & Stock Management: One of the likely trends in aquaculture is the introduction of
further species and strains as farmed stock. Cod and Halibut, for instance, are recent additions to the
farmed species in Europe. Despite the rapid growth in aquaculture, only 29 species account for 78
percent of production 57. In addition, only a very small proportion of the output of aquaculture is from
genetically enhanced stock.

A likely approach to increasing aquaculture production is by providing high genetic merit fish strains
with improved characteristics such as growth rate, feed utilization, disease resistance and meat quality.
It is likely that these improved strains will be ‘high-merit’ for only one of these characteristics and that
fish-farmers will choose their strain according to need.

Because of the size and anatomy of fish, genetic markers are commonly used to tag young fish in
breeding programmes. There is therefore an existing pool of genetic information on commercial strains.
Understanding the genetic determinants of merit factors in fish will provide a significant base on which
to achieve improvements.

In shellfish, there has been little genomic activity to date. There are many reasons for this, including the
fact that cross-breeding of shellfish strains is less likely to be conducted, due to the perils of introducing
‘non-native’ strains into aquaculture areas. Most of the cultured shellfish are essentially wild and
genomic activity has centred on genes related to improving their domestication. In the USA, a
Molluscan Broodstock Programme has been established by USDA to “benefit the west coast shellfish
industry through conservation, genetic improvement, and wise management of genetic resources of
molluscan shellfish resources” 50. The goals are “to establish a repository for molluscan shellfish
germplasm, to establish breeding programs for commercial production of molluscan shellfish, and to
establish a resource center for the industry, researchers, and other interested parties in the U.S. and
abroad”58. Oysters from this programme have shown average yields that are 9.5 percent greater than
wild stock. Spat from these strains were used in 2002 by commercial oyster hatcheries in the Western
USA 59.

Genetic information also has other practical applications for commercial aquaculture. There is a high
consumer and regulatory interest in the traceability of foodstuffs. This interest can also extend to


57
     Data for 2000: FAO's State of World Fisheries and Aquaculture 2002 report (SOFIA).
58
     Aqualculture Magazine Vol 26(2) Mar/April 2000
59
     Ann. Rept. Oregon Agric. Expt Station 2002; & Coastal Oregon Marine Expt. Station 2002/03.

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aquaculture products. One of the leading companies in the field of genetic identification and tracking of
food origin is Identigen Ltd 60, based in Dublin. The company has received queries about the use of
their technology in tracking fish products.

The major genomic R&D effort worldwide is towards identifying useful genetic traits and using this
information to select and breed strains with these traits. While there is much research in progress in
academic and institutional laboratories, the major players in aquaculture genetics are the commercial
aquaculture companies. An example is the Norwegian company Genomar, which produces strains of
Tilapia with enhanced genetic characteristics. In Ireland, Nutreco 61 run a genetic improvement
programme in Atlantic salmon both for their own internal production (Ireland & Scotland) and for the
sale of superior eggs and smolts for Ireland, Scotland and Chile. This programme combines DNA
marker technology to identify fish to their parents, and traditional breeding technology to select
broodstock with superior genetic merit for growth, maturation and quality traits (fat, colour, texture).
A similar programme is in progress in Chile (Marine Harvest Chile) using three different strains of
Atlantic salmon and in Marine Harvest Norway with two strains of Atlantic salmon (collaboration with
Genomar). The longest running breeding programme in salmon aquaculture is that run by the
Norwegian company, AquaGen, whose strain of salmon are now in their 8th generation.

Disease resistance is not a goal for Marine Harvest as it is too difficult to measure (i.e. it is expensive
and also risky to conduct challenge tests) and it takes two generations to really make improvements in
breeding (8 years). In general vaccine companies can provide a quicker solution than breeding.
However, this view is changing with the increasing threat of viral diseases that are not so amenable to
vaccines. In the opinion of Marine Harvest, viral resistance is a preferred priority for a biotech-based
breeding programme, as ‘traditional’ breeding is too slow.

Another approach is to use genetic engineering to incorporate the desired traits. It is unlikely that
genetically modified strains will be publicly acceptable in Europe in the near future. The Scottish
policy 62 on this technology is that GM currently “plays no part in Scottish commercial aquaculture
production. The industry considers, however, that, were the public perception of transgenic to change,
it could not ignore the potential of the technologies”. This view is likely to be repeated throughout
Europe. However, in some countries genetically modified strains of fish are already undergoing trials.
For instance AQUA Bounty Canada produce GM salmon modified to increase growth rate.

In summary, biotech techniques can be used to identify genes which are related to desirable traits (fast
growth, disease resistance, flavour etc.) and this information can be used to improve aquaculture either
by providing information which will guide improvement in husbandry practices; by identifying genes
which can guide classic breeding programme; or by identifying genes which can be engineered into GM
aquaculture species.




60
     www.identigen.com
61
     Information from Ashley Norris, Marine Harvest/Nutreco, Ireland
62
     A Strategic Framework for Scottish Aquaculture: Scottish Executive Env. & Rural Affairs Dept March 2003

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 Table 4: Companies involved in aquaculture breeding or genetic enhancement programmes
 Company                                      Location              Species of interest
 Marine Harvest/Genomar                       Norway                Tilapia, Salmon
 AQUA Bounty Canada                           Canada (NFL)          Engineered salmon & other fish spp.
 SalmoBreed as                                Norway                Salmon and rainbow trout
 Aquagen                                      Norway                Salmon & rainbow trout




                                        360
                                                       1,028          Northwest
                                617                                   West
                                                                      Southwest
                                                                      Southeast
                                                         358
                                                                      East
                                      1,136




Figure 1: Waste materials (tonnes) from Irish crab and prawn landings & imports in 2000. (From Report on
Disposal & re-utilisation of fish & fish processing waste. Nautilus Consultants 2003 (for Marine Institute)).


5.3        Production of Novel Foods, Feeds and Nutraceuticals

A significant current driver of food choice among consumers is health, and marine products have the
advantage of being perceived as ‘natural’ and therefore healthy by many consumers. A major concern
of marine food producers is to ensure that this status is retained. Research into establishing the health
potential of marine foods, and validating the claims of those already on the market, is therefore a
priority. Related research needs include techniques to ensure traceability of marine products to their
point of origin, and also to understand the determinants of quality in farmed species.

Because of the high consumer priority on health, functional foods (defined as foods which confer
benefits in addition to their nutritive value) and dietary supplements are product areas in which marine
resources have a high potential. The benefits of functional foods include enhancement of digestive
ability, gut immunity, calcium metabolism etc. Dietary supplements include a wide range of vitamins,
minerals etc which can also confer a range of health benefits.

Several classical functional foods and dietary supplements (fish oils, carrigeenans) are already of marine
origin and there is potential for more.

Marine food is currently not a major component of the Irish food industry. According to Bord Bia
estimates, fish exports in 2002 were valued at €380m or 5.5 percent of total food & drink exports. It is
worth noting that Ireland’s total output of aquaculture products is about 30,000 tonnes p.a., whereas
Nutreco 63 (a Norwegian/Dutch aquaculture company) produces 150,000 tonnes 64. Competition from

63
     www.nutreco.com
64
     Data from Enterprise Ireland

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these large-scale producers, and a rising cost base, suggests that Ireland must aim at higher-value
products from marine sources. These could include both consumer food products (prepared meals etc),
and also functional foods and other dietary and cosmetic products. Marine biotech has a major
potential role in the development of the latter products.

A wide range of companies are involved in investigating and implementing processes to extract marine
compounds for food and other wider nutritive purposes. While the potential for discovery of useful
compounds is as great as that described in 6.1 above, there are certain areas of concentration that can be
defined. These are:

      •    Chitin and related compounds from shellfish waste
      •    Omega 3 and other fatty acids from fish oils
      •    Alginates, carrigeenans etc from marine algae

In this section, the major concentration is on companies that specialise in marine food & feeds.
However, it is useful to note that major food and biochemical companies are also major processors and
users of marine raw materials for food use. These include major multinationals such as BASF,
Novozymes, Degussa, and FMC Biopolymers. There are also companies such as Indena (Italy) which
specialise in plant extracts and also use marine plants for part of their production. These companies
employ a huge range of processes and use materials from a very wide range of marine and non-marine
sources. They could not be regarded as marine biotech companies and are therefore not listed in the
tables below. Nevertheless they are of major importance as users of marine food ingredients that may
be discovered in the future.

Chitin and related compounds: A significant set of companies is involved in production of chitin
and/or related compounds, mainly from prawn or shrimp shells (see Table 6). Chitin is a high-mw
polymer of N-acetyl-D-glucosamine and resembles cellulose in its solubility and low chemical
reactivity. Chitin is easily obtained from crab or shrimp shells by removal of proteins and the
dissolution of the calcium carbonate. This treatment produces 70 percent deacetylated chitosan. The
extent of chitin waste available in Ireland is shown in Figure 1 and the process for production of
chitosan is shown in Figure 2. Chitin and chitosan (and derivatives) have an immense range of uses in
healthcare (bone therapies, wound dressings, pharmaceutical coatings, prebiotics, contact lenses),
photographic coatings, cosmetics, nutritional products, environmental engineering (absorptive capture
of metals and dyes) and many other products.

The companies in this sector generally specialise in production of particular derivatives of chitin (i.e.
chitosan, chitin, glucosamine etc), or in grades of these products for different markets (i.e. for
processing, laboratory reagents, therapeutic uses etc). For instance Glucomed plan to produce a
pharmaceutical grade of glucosamine to promote cartilage regeneration and treatment of osteoarthritis;
Biohenk (a joint venture between Henkel KGaA and BioChem AS), specialises in production of
chitosan for the cosmetic market; and Vanson Halosource specialises mainly in chitin derivatives for
water and air purification applications. All produce from the same source material, which is prawn
shells.



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Omega 3 and other fatty acids: There is also a wide range of companies which produce omega 3 and
other fatty acids from fish or fish waste. These are used either as pharmaceutical products or food
supplements. These include Pronova Biocare (Norway); Lýsi hf. (Iceland). The Norwegian company
Natural AS is also involved in development of Omega 3 oils for the fish-farming industry. Research on
the mechanisms of action of fish oils is still in progress and there are still developmental opportunities
for dietary supplement products in this area.

Alginates, carrigeenans and other products: Other companies produce alginates, carrigeenans and
other food ingredients from marine algae (Table 5). These are widely used in the food and drink
industry as binders and thickeners in a huge range of products. In Ireland companies in this business
include Arramara Teo. (Galway) and Kerry Algae.

Some companies are now applying new technologies to improve the processes for alginate production,
and to identify and develop new potential products. A range of traditional and technology-based
companies in the algal sector are listed in the Surialink website 65.

Some products (alginates, carrigeenans) are derived from algae which are cultivated for the purpose,
while others (e.g. chitin and some fish oils) are derived from waste by-products.

Marine by-products are a major potential source of material for bio-production of a variety of useful
materials, including feed and food ingredients. The volume of waste from fisheries is approximately 20
percent of total fish production. There have been many initiatives to derive value from this waste, both
for environmental and economic reasons. Biotechnology provides technologies which can be applied to
this task. Biotechniques can be used both in identifying useful components and also in processes for
waste utilisation.


                          Case Study: Beta carotene from marine algae

 NATURE BETA TECHNOLOGIES (NBT) LTD. was founded to commercialise the algal research at the
 Weizmann Institute of Science in Israel. The company mass cultivates Dunaliella, an algal species
 originally discovered in the Dead Sea. The algae are the richest source of the carotenoid, beta
 carotene which has been shown to be an important natural anti free radical and anticancer agent. NBT,
 which is now owned by Nikken Sohonsha (Japan), grows the algae in large open ponds and harvests it
 by centrifugation. The algae are then dehydrated into a dry powder, containing the essential stereo-
 isomers of beta carotene used in health foods, pharmaceuticals and cosmetics. The dried product is
 sent to Japan where it is formed into tablets and packaged.


A further area of opportunity for marine extracts is in animal feeds. Fish meal is already used for farm
animals and further sources for animal feeds are being sought. However, a particular area of
opportunity is the development of fish-feed products. An insufficient supply of feed with an appropriate
fat composition threatens the future growth of the fish-farming industry. There is an opportunity for
both agriculture and other industries to develop and produce fish feed with the required quality and
composition. Among the companies which have products in this area are Biotech Pharmacon, which
produces ingredients for fishfeed (see section 6.1).

65
     www.surialink.com/communities/INDEX.ASP

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     Table 5: Companies producing nutritional or reagent products from marine sources
     Company                     Location              Products
     Lysi hf.                    Iceland               Omega 3 fatty acids & other marine lipids
     ProBio Nutraceuticals       Norway                Omega 3 fatty acids & marine anti-oxidants
     Maritex                     Norway                Omega 3 fatty acids & nutritional ingredients
     NFL Aqua Products.          Canada                Nutraceutical & food products from seaweed
     Markmar ehf                 Iceland               Marine food & nutraceutical products
     BlueBioTech Int.            Germany               Algal culture for feeds and extracts
     Eximo                       Norway                DNA & Marine Lecithin from Herring Milt
     NorthIce                    Iceland               Flavourings from cold-active enzymes in shrimp
     Ocean Nutrition             Canada                Omega 3 fatty acids & nutritional ingredients
     Biotech Pharmacon           Norway                Ingredients for fish-feed
     Nature Beta Technol.        Israel                Beta-carotene from cultured algae
     Acadian Seaplants           Canada                Range of algal-based food, feed and health products


In Norway over 550,000 tonnes of fish by-products are produced annually, of which about 150,000
tonnes are dumped into the sea. RUBIN 66 is a foundation established in Norway in 1992, and works
for increased and more profitable utilisation of by-products from the fisheries and fish farming in
Norway. It is funded by the Norwegian Research Council, the Norwegian Fishermen’s Association
(NF) and the Norwegian Seafood Association (FHL). The objectives are to achieve total utilization of
Norwegian fish waste and to increase the value added of marine by-products to more than €570m. This
exceeds the current export value of traditional fish fillet.

     Table 6: Companies producing chitin & related products from marine sources
     Company                   Location                Products
     Primex                    Iceland                 Seafood flavours & chitin
     Biohenk                   Norway                  Chitosan
     Glucomed AS               Norway/Iceland          Pharma grade glucosamine from chitin waste
     APT Ltd.                  Canada                  Chitin & medical derivatives
     Vanson HaloSource         USA                     Chitin & Chitosan derivatives
     France Chitine            France                  Chitin & Chitosan derivatives
     Dalwoo-ChitoSan           Korea                   Chitin & Chitosan derivatives




66
      see www.rubin.no/eng/



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                               Figure 2: Preparation of chitin and chitosan



5.4      Diagnostics and Biosensors

Diagnostics and Biosensors are products (and /or services), which detect and measure specific indicators
of health, environmental status, quality etc. Examples include products for detection of diseases, or for
specific indicators of pollution or product quality. Such products are widely used in many areas,
particularly human and animal healthcare.

An example of diagnostic assay usage is in algal toxin detection. Some algal blooms produce toxins that
accumulate in shellfish and are harmful, even lethal, to humans when ingested. Government agencies
throughout the world monitor shellfish harvesting sites to determine levels of these toxins in the fish or
in the producing waters. Shellfish farmers and seafood processors also monitor their materials to ensure
the safety of their products.



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The use of diagnostic products in the Marine sector is now a basic management requirement and can be
categorised in the following areas:

Fisheries and Fish Farm Management: Producers, particularly those involved with farmed fish, must
avoid disease so as to maintain optimal fish growth or loss of fish stock. Bacterial and viral infections in
fish cause loss of stock or poor product quality. Routine monitoring of various diseases will therefore be
conducted. These will include bacterial, viral, fungal, protozoan or other diseases depending on the fish
species being farmed and the location of the farm. In addition, farmers will monitor the water quality
in the area of their farm both to ensure regulatory compliance (See below) and also for management
purposes. In wild fishery management, genetic diagnostic testing is being increasingly used to assess
genetic identity of wild fish as a means of monitoring stock movement, and of monitoring crossbreeding
with farmed fish. Research to determine the sequence of fish genomes will be of use in isolating and
characterising beneficial fish genetic traits (e.g. genes that influence the growth of fish, or their
resistance to infection). This information can be used to improve fish breeding (by recombinant or
classical breeding methods), or to monitor stock movements and interbreeding. Finally, this technique
is also used to detect poaching of fish; and to verify the use of particular fish species in processed
products. These developments will have an influence on the fish products of tomorrow and will require
a wider range of assays and test procedures to monitor brood stock for future fish production.

Regulatory Requirements: Government agencies have in place many regulations governing the
quality of marine products and environments. Diagnostic testing is required to prove compliance with
these standards. For instance, in the export of shellfish, the molluscs must be harvested in waters that
are within certain limits of algal toxin concentrations. Diagnostic tests are carried out by Government
laboratories to ensure that these seafood products comply with International or European legislation.
Other similar testing is carried out as part of the normal process of fish and shellfish production. Table
7 shows the range of testing which may be required by fish and/or shellfish processors.




       Case Study: Aquaculture Diagnostics - Jellett Rapid Testing Ltd. (Canada)

  Jellett Rapid Testing Ltd., Nova Scotia, Canada (www.jellettbiotek.ca) develops and sells Rapid
  Diagnostic Tests for marine biotoxins. Marine biotoxins can be lethal to consumers of shellfish.
  The products are user friendly, antibody based rapid screening tests designed to provide early
  indications of marine biotoxins in water or in shellfish. They are available for the two major algal
  toxins:

        •    Paralytic Shellfish Poison (PSP)
        •    Amnesic Shellfish Poison (ASP)

  These qualitative tests can detect toxins in shellfish tissue, phytoplankton or in water samples in 20
  minutes. The PSP test is based on antibodies which were developed through collaborative
  research with the National Research Council. The company is now working on further assays for
  aquaculture health management.




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Processor and Retailer Requirements: An increasing proportion of fish and shellfish is now sold as
packaged prepared foods. Apart from the testing required by local and state health and environmental
agencies, producers must also comply with testing regimes imposed by the large retailing chains.
Routine quality testing of products in the processing environment is therefore of benefit to the food
processor. These tests may be similar to the regulatory tests, but additional tests are often also required
(see Table 7). Seafood manufactures have to ensure the quality of their products and carry out strict
testing protocols to determine any microbial contamination that may cause human disease on
consumption, or result in product deterioration. Examples include tests for Listeria and Salmonella. Fish
freshness and the determination of maximum shelf storage times are also of interest to the producers.

 Table 7: Analytical tests performed in Aquaculture QC laboratories
 Microbiological Assays (indicators of disease and/or freshness)
      !       Total Viable Count; E. coli & coliforms
      !       Tests for: Staphylococcus aureus. Salmonella spp.
 Chemistry Assays (indicators of contamination and/or freshness)
      !       Levels of: Salt, Mercury, Sulphur Dioxide
      !       TVBN (Total Volume Basic N)
      !       Radionuclides & Pesticide Residues
      !       Histamine
      !       Other Freshness / Sensory tests (dependent on retailer requirements)
      !       Product Shelf-life tests (dependent on retailer requirements)


The Diagnostic Business: Many commercial opportunities exist in diagnostic products and services.
A report conducted by CIRCA for BIM in 200267 showed that 25 analytical labs offer services to the
seafood processing industry. Each of these offers one or more of the tests listed in Table 7. Several of
the larger seafood processors also have their own laboratories to perform this service. In general, such
services must be locally provided, due to the logistics of shipping samples and returning the results
within the necessary short period.

A wide range of diagnostic companies manufacture the commercial assays and instruments used by
these laboratories. There are 22 companies in Ireland (north & south) which manufacture diagnostic
products 68. However, it should be noted that the diagnostic business is hugely diverse both in terms of
product technologies, and also product applications. The major technologies used in these assays are:

          •    Clinical Chemistry: Some test procedures consist of direct chemical tests or enzymatic
               assays. These tests owe little to biotechnology.

          •    Immunoassays: These tests involve the use of antigens and antibodies to determine specific
               targeted analytes. These are classical biotech products and are increasingly used in a very
               wide range of formats.




67
     Feasibility of a National Seafood Technology Service. CIRCA Group for BIM. Unpublished 2002
68
     Mapping the BioIsland: CIRCA Report for InterTrade Ireland 2003

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      •      DNA Tests: These assays involve analysis of DNA patterns and are used to detect micro-
             organisms, or to identify fish or shellfish with particular genetic sequences.

      •      BioSensors: Sensors use a variety of technologies and are mainly differentiated from the
             above by the fact that they generate an electronic signal. Biosensors use a biological ‘front
             end’ to detect the target. This could be an antibody, DNA probe or other mechanism. The
             device will also include a phase whereby the detection is converted to an electronic signal.

Diagnostic and biosensor products are therefore not all biotech-based, but the vast majority are, and
biotechnological methods are generally the basis of the new products coming into use.

At the moment it would appear that none of the Irish diagnostic companies produce tests of relevance to
the marine sector. However, there is significant expertise in diagnostic methods, and also research into
fish diseases which may produce the markers of fish disease on which future diagnostics will be
produced. There may be an opportunity for some of the existing companies to develop products in this
area. The only constraints to this possibility would appear to be market considerations. At the moment
the market is small and widely spread, and product margins in the seafood business are low. It is
therefore not an ideal market for diagnostics producers. Nevertheless, there are firms that exist in these
markets (see Table below) and opportunities may exist.

 Table 8: Companies involved in Diagnostic and/or Biosensor products of relevance to the
           marine sector
 Company                    Location       Products
 Biosense                   Norway         Assays for food, water and environmental testing Integrin
 Aquatic Diagnostics        UK             Fish pathogen and immune response assays
 Diagxotics Inc.            USA            Finfish and Shellfish pathogen assays
 Genomar                    Norway         DNA typing for traceability of fish products
 Jellett Rapid Testing      Canada         Algal Toxin assays
 Biosense                   Norway         Assays for food, water and environmental testing Integrin




               Case Study: Fish Disease Diagnostics - Aquatic Diagnostics Ltd.

          Aquatic Diagnostics Ltd. (ADL) develops and markets monoclonal antibodies and DNA
          probes for detection of fish pathogens. It was established in 2001 as a spin-out from
          the Institute of Aquaculture at the University of Stirling, UK. The antibodies are used in
          rapid tests of relevance to fish health management.

          They are available for detection of specific pathogens, and also for assessment of the
          immune response of various farmed fish species.




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The use of diagnostics and/or biosensors in the marine sector will occur in the following areas:

      •    Disease detection. Farmed species have specific diseases whose effects or causes may be
           detectable from water or specimen sampling.
      •    Management support. Assays are available to assess the physiological condition of farmed
           species (e.g. smoltification, detection of larvae etc).
      •    Breeding support. The use of genetic tests to determine traits associated with fish health
           and the determination of brood stock.
      •    Determination of water quality. Assays will continue to be required by industry and
           regulators to ensure compliance with water quality directives, and for fisheries management
           purposes.
      •    Seafood Traceability. Consumer demands for food quality has created a demand for assays
           to genetically track seafood to its point of origin. This is particularly true of farmed seafood.

Despite the apparent wide range of applications, the commercial opportunities for development and
manufacture of kits for the marine sector is limited as the volume of testing remains at a low level.
Individual tests or assays are generally commercialised through existing diagnostic companies,
particularly those interested in the food or wider veterinary sector.




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6.     MARINE BIOTECH CLUSTERS

Irish biotechnology and marine communities are small in relation to the international scene. It will be
necessary to develop mechanisms to overcome the difficulties created by this small scale. Developing
optimal levels of interaction between companies and organisations is one approach. Such interaction is
recognised as being critical to the success of biotechnology industry worldwide. Synergy is created
when biotechnology companies co-exist.         For that reason, companies tend to spring up around
technology sources, such as universities. These companies benefit from the existence of the university
facilities and expertise, but also from each other. In the right circumstance, the interchange of ideas,
resources, contacts and business between these companies can be a major advantage.

Clusters improve competitiveness in three ways 69;

     1. Improve productivity through improved access to specialised suppliers, skills and information.

     2. Innovation is given more importance as the need for improvement in processes of production is
        highlighted. And firms working together can satisfy this need.

     3. Once established, clusters will grow as a result of the creation of new firms and the entrance of
        new suppliers.

Clusters with a marine focus or connection exist in several countries and regions:

In Norway, a biomarine industrial cluster was one of the potential outputs envisaged by the authors of
the FUGE proposal 70 (see also 5.5).     This cluster was seen as involving several major groups of
players: “food producers (the fish farming industry, breeding organizations, the fish feed industry, the
food processing industry and an appurtenant logistics industry), biotech industry (a growing number of
small and medium-sized biotechnology companies with top-notch professional know-how),
pharmaceutical enterprises and equipment suppliers.”

Norway has several towns which have de facto clusters including Tromsø (which has seven specialist
marine companies and several R&D institutions, and a specific programme for local R&D funding –
MABIT (see 4.13).

In Nova Scotia, there are also a significant number of marine biotech companies and institutions. A
report71 by AEGIS Consulting for the Atlantic Canada Opportunities Agency (ACOA) suggests that
there is a potentially viable marine biotech cluster in Halifax. The core of this cluster consists of only
three companies and two research institutions (Dalhousie University and NRC – Institute for Marine
Biosciences). However, it is also noted that a wider cluster exists which consists of 17 components

69
     Porter M.E., Clusters of innovation initiative: San Diego, New York 2001
70
     FUGE – Functional genomics in Norway – a national plan. Research Council of Norway 2001
71
     Nova Scotia Marine Biotechnology – Strategic Cluster Review. Prepared for ACOA by Aegis Management Consulting.
     2.2003.

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(companies, universities and institutions) in Halifax and its hinterland. The report notes several
problems that the potential cluster must address to become fully functional. These include:

      •    Communication: It will be necessary to develop greater linkages between the cluster
           organisations and between the cluster and many other relevant national and international
           organisations.
      •    Intellectual Property: Transfer of IP from local technology developers must be improved
           so as to ensure an effective transfer of IP from the developing institutions to the user
           companies.
      •    Leadership: The report suggests that there is no leader or champion for a biotech cluster
           and that steps should be taken to encourage the emergence of a spokesperson for the players
           in the cluster.
      •    Cluster Flagships: It is also suggested that one agency should take the lead as a source of
           the resources and facilities required by the cluster partners, and also that a major biotech
           company should be encouraged to establish part of its operation in Nova Scotia.

The report concludes that Halifax has an excellent opportunity to develop a marine biotech cluster based
on its existing companies and research institutes.

Also in Canada, St John’s, Newfoundland has the companies and institutions necessary to develop a
cluster, and an agency BioEast which is actively promoting the development of a marine biotech sector.
Whether an effective cluster exists is not clear.

Another interesting cluster concept is that developed in Nelson, New Zealand. The local regional
development organisation, Canterbury Development Corporation 72 has developed the concept of a
nutraceutical cluster involving organisations developing, producing or marketing nutraceuticals from a
range of sources. The cluster is called “Canterbury and Nelson New Zealand Nutraceuticals Cluster”
and one of the sub-clusters is on marine nutraceuticals. It involves 18 organisations in a range of
activities relevant to nutraceutical, including three R&D institutions.

The TRIDENT network, which is run in Ireland by the Marine Institute could be an effective force in
creating linkages with the cluster management, and constituent companies, in the Atlantic Arc Regions.
The areas of interest of Trident include:

      •    Biotechnology and bio-active compounds
      •    Sea product processing development and aquaculture

At the moment, Ireland does not have specialist companies in this area which could create an effective
cluster. However, it is clear that Galway is the most likely location for an effective cluster given the
location of several R&D institutions in the area.




72
     www.cdc.org.nz/main/clusters/

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7.    DISCUSSION AND RECOMMENDATIONS

7.1       Overall Findings and Discussion

The overall finding of the study is that several areas of marine biotechnology present potential
opportunities for Ireland. This assessment is based on the analysis of activities in other countries, the
activities undertaken by marine biotech companies worldwide; the current status of biotech and marine
science expertise in Ireland; and the overall national S&T infrastructure developments. Specific points
that emerge from the study, and which are relevant to the discussion of the recommendations are.

      •    Biotechnology has many current and potential economic applications in the marine sector.
           Changes in fisheries, aquaculture and drug discovery are likely to increase the need and
           opportunity for the application of biotech in the sector.

      •    Few countries have as yet developed national R&D programmes to exploit these
           opportunities. Nevertheless, research projects in individual areas of marine biotech are
           being widely conducted in many countries.

      •    Ireland has biotech expertise within several S&T institutions which can support a national
           effort in marine biotechnology. National capability in biotechnology research will increase
           as a result of current national investment in expertise (e.g. through SFI) and research
           facilities (through PRTLI). This national capability can be applied to the marine
           opportunities if there is an appropriate programme to highlight the opportunities, to provide
           the specific supports required, and to manage the inter-disciplinary activities that will be
           needed.

      •    Of particular significance is the fact that SFI is engaged in attracting international expertise
           in biotechnology to Irish institutions. The opportunity therefore exists to attract high quality
           researchers who could embellish the expertise required to support specialised elements of a
           marine biotech effort. This could be critical to the realisation of some of the
           recommendations.

      •    In addition to the availability of suitable R&D support for a national effort in marine biotech,
           there is also significant support for the commercialisation of the output of such research.
           Funding and support for the transfer of research outputs, and also for the creation and growth
           of viable new marine biotech companies is available from EI and other agencies.

      •    Despite the existence of research expertise, Ireland is not involved in many of the existing
           international collaborative activities, which will be valuable sources of information and data.
           This lack should be addressed in any future programme.




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Based on these findings, it is considered that certain areas of marine biotech present significant
opportunities for Ireland. These opportunities are discussed below, and a series of recommendations are
made. These recommendations do not represent all of the possible areas of marine biotech application.
However, they are considered to be the higher priority actions that arise from the reviews and
discussions which were conducted. In summary, they seek to develop a national programme which
has wide participation from the various relevant agencies and institutions (7.2); and to also ensure that
this expertise is fully involved in international activities which can contribute to the overall programme
objectives (7.8).

The major areas of marine biotech application are in drug discovery (7.3) and genomics (7.4). The
areas of fish vaccines (7.5) and diagnostics (7.6) are also considered, as both are significant areas of
commercial biotech activity. In both cases only a limited R&D effort is considered justified. Further
approaches to maintaining fish and shellfish health are vital however, and will likely arise from the
additional information on physiology, nutrition and genetics that will arise from genomics and related
studies.

The final area of potential application is food and nutraceuticals (7.7). However, it is considered that
the range of food sources and applications involved is too extensive to be adequately considered within
this study. The relevance of marine biotech to the development of novel foods and feeds is, however,
undoubted.


7.2       An Irish Marine Biotechnology Initiative

One of the objectives of this study was to analyse marine biotechnology programmes in other countries
and to gain insights from the experiences and practices of these programmes. However, the study
suggests that very few countries have formal and comprehensive marine biotech programmes in place.
The exceptions are Australia, Canada, USA and Japan. This is disappointing in relation to the overall
purpose of the study as there are few major programmes from which Ireland might draw lessons or
ideas. However, it is clear from the study context that the lack of formal programmes should not be
interpreted as a lack of interest, or of perceived opportunity, in marine biotechnology. All of the policy
analyses that have been reviewed suggest that marine biotech is an area of major opportunity in certain
sub-sectors (see below).

The major areas of activity in Marine Biotechnology within the countries evaluated were:

      •   BioDiscovery or BioProspecting Initiatives: the search for useful compounds from extracts of
          marine organisms.
      •   Genomics of aquaculture species: understanding the genetic metabolism of farmed stock so
          as to improve healthcare, reproduction, yield or other traits.
      •   Genomics of wild species: research to understand the population dynamics, migration patterns,
          and distribution of wild species; and also to provide genetic markers to prevent poaching,
          validate product description of fish etc.
      •   Food Safety: research to detect shellfish and fish-borne human pathogens and other hazards,
          and to develop methods to prevent their occurrence.

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    •   Environmental Research. Research to understand marine ecosystems and to develop
        diagnostics to monitor environmental quality and safety.

The first three of these are significant elements of the future of biotechnology application in marine
institutions worldwide. Biodiscovery has the advantage that it matches a world need for new drugs,
and marine resources are both unexplored and also sufficiently novel to offer real prospects for new and
useful compounds. National activities in marine biodiscovery are likely to grow as the existing
programmes show positive results.

Genomics programmes for economically important species (either wild or farmed) are also likely to
expand significantly as the genomic information on a wider range of fish species increases, and as the
technology for easier use of gene-based detection and analysis improves. Aquaculture has a need for a
greater range of species which can be farmed. Genomics offer the possibility to understand important
aspects of the metabolism of candidate species. Similarly, genomics offers a means to establish much
of the information required to better conserve wild species. This includes migration routes, stock
origins etc.

It is in the above areas that major directed programmes of biotech research might be expected to arise in
different countries.

In the other areas of application, i.e. Food Safety and Environmental research, it is likely that
biotechnology will be one of several technologies applied within research in these fields. There is
therefore less need for specific biotech-based programmes in these areas.

One feature of research programmes in genomics, and particularly in biodiscovery, is the need for a
high degree of collaboration between different organisations. This may be one reason for the lack of
formal programmes in these areas in a wider range of countries. Because a wide range of expertise and
facilities is required to conduct a biodiscovery programme, it is often more convenient to conduct such
programmes as collaborative activities among different institutions rather than to formalise them within
one institution.

Within Ireland no single institution has all of the capabilities to undertake all elements of a marine
biotech programme. Nevertheless, there is interest in a marine biotech initiative within several Irish
R&D and development institutions (SFI, EI, IDA and several universities). It is also clear that several
of these institutions have elements of the expertise and facilities required to undertake a national
programme, and are keen to play a role in whatever future activities might arise. It is therefore
suggested that the Marine Institute should undertake the role of coordinator of a marine biotech
initiative which is a collaborative activity between several institutions. The challenge for the Marine
Institute will be to create an infrastructure and environment in which this expertise can cooperate in
synergy.




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In addition to the Marine Institute, the institutions that clearly have roles to play in such an initiative
include:

A range of R&D Researchers within Irish Universities and ITs have experience and expertise in
many of the areas outlined in this report. Some of this expertise is outlined in Appendix 4. Irish
expertise of relevance to a Marine Biotech initiative exists within several different sectors of Irish R&D.
These include:

      •    Marine biology: Irish marine biologists are mainly based within NUIG, UCC and GMIT,
           and also within the Marine Institute itself, although scattered expertise is also found in other
           institutions. The current focus within academic marine research is primarily on
           environmental and ecological issues, and on issues related to management of wild and
           cultivated food species.
      •    Biotechnology: This is now a major sector of Irish R&D activity and expertise is spread
           throughout almost every R&D institution. Many areas of biotechnology are potentially
           relevant to a marine initiative.
      •    Bio/chemistry: A discovery programme will require expertise in chemistry, and the
           equipment for extraction, identification etc of compounds from marine sources.

Science Foundation Ireland (SFI) has a mandate to enhance the scale and quality of research in
Ireland. Biotechnology is one of their priorities. SFI could assist in the development of a Marine
Biotech initiative by funding a high-quality research activity in a relevant and underpinning area. The
specific process would require the identification of a leading researcher with relevant expertise.

Enterprise Ireland: have a target for establishment of biotech start-ups, and also a variety of
programmes to support applied R&D and the commercialisation of its output. Assistance in
commercialisation will be a requirement in many of the potential areas of activity which might be
contained within an initiative.


7.3       Marine Biodiscovery or BioProspecting

All of the indications are that a marine biodiscovery initiative is a clear opportunity for Ireland. Ireland
has a marine resource of unusual organisms which are likely to express valuable molecules. In addition,
we have, or are already building, much of the expertise necessary to exploit this resource.
Bioprospecting is, of course, a speculative activity as the name implies, but the potential rewards are
high. The area of biodiscovery is also relevant to Ireland’s aspirations to develop indigenous biotech
industry, and possibly to also provide additional anchors for our FDI Pharmaceutical industry.

Among the positive aspects of this area of activity is the fact that Irish agencies and industry already
have many of the elements required to implement a biodiscovery programme. While there are some
missing elements, they are within our capacity to develop. The overall requirements are:




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       a.         Access to a source of organisms or materials. (Box 1 in Figure 3.) This source could
                  be a particular group of organisms; or an ecological system existing under extreme
                  conditions; or a source of waste with a high level of bio compounds.

                  Ireland’s seabed has several unusual, if not unique, sources of organisms, including
                  carbonate mounds and cold-water reefs. There are indications from international
                  sources that marine algae, protists, and invertebrates would be a rich source of novel
                  compounds. This is because of their high degree of unrelatedness to other organisms.
                  Furthermore, temperate organisms are likely to produce more usable toxins than
                  tropical organisms. These sources could be explored for useful compounds. There are
                  several Irish R&D groups with competence in the taxonomy and ecology of marine
                  groups, particularly algae. These include the Martin Ryan Institute in NUIG 73and the
                  Department of Zoology Ecology & Plant Science, UCC 74.

       b.         Competence in identification, extraction etc of compounds from organisms. (Box 2
                  in Figure 3.) This may be chemical or biochemical competence, depending on the
                  purpose of the screening and the nature of the source.

                  Ireland already has considerable competence in chemistry and biochemistry. Among
                  the sources of such competence is the Centre for Synthesis & Chemical Biology 75
                  (CSCB), which is part of the Conway Institute in UCD. Application of CSCB and
                  other expertise to biodiscovery is very feasible.

       c.         Competence and Facilities for screening compounds for usefulness in a particular
                  pharmaceutical, chemical or other application. (Box 3 in Figure 3)

                  Ireland has some competence in screening of compounds, and existing companies with
                  an interest in this activity. Recent investment by HEA and SFI has created research
                  groups with expertise in several disease and metabolic areas. There are clear
                  advantages to associating a discovery programme with research groups with relevant
                  clinical and biological competence. However, as described in 6.1, it is not feasible for
                  one organisation to screen compounds for all potential applications. Agreements with
                  companies and institutions worldwide to screen compounds for further uses would be a
                  part of the process.

       d.         Pharmaceutical companies with the capability of further developing candidate
                  compounds as marketable products. Ideally these companies should be locally
                  based, so as to ensure the optimal economic benefit from the programme. However,
                  economic returns may also be achieved through license and royalty agreements with
                  such companies overseas. Licensing of compounds to companies is a normal process
                  in these circumstances, while the possibility of developing some local companies for

73
     http://mri.nuigalway.ie/
74
     www.ucc.ie/acad/departments/zeps/pages/profile.htm
75
     www.ucd.ie/conway/html/homepage/cscb_conway.htm

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                some applications is also feasible. It may be feasible to form commercial companies,
                with VC funding, to conduct such screening. This has been done in other countries.
                This would depend on the expertise, forms of supports available, and the access to
                compounds that was available to the companies.

                While Ireland has a significant pharmaceutical manufacturing industry, bioprospecting
                activities are of interest to the discovery function within these companies. The presence
                of these companies in Ireland may therefore not be of direct relevance to a biodiscovery
                initiative.

In summary, establishment of a biodiscovery programme is a potentially feasible area of
investment within a national Marine biotech initiative. Further strategic assessment will be required
to define specific aspects of such a programme including: the organisms or materials which would be
prioritised as the material source; the primary purpose of the screening; availability of partners for
further screening etc.

A biodiscovery programme would in essence be a virtual institute with geographically dispersed units.
It would require a strong central management team. This would be required both to ensure appropriate
interaction and understanding between the different functions (see Fig 3) and also to manage the IP and
commercialisation process.

A major output of the research would be patent submissions on the molecules identified. Pharmamar,
for instance (see Case Study on page 28) has submitted over 500 patents in the past 18 years. A
specialist IP activity would be required (with agreement from all of the relevant parties) to ensure
protection of the programme outputs during patenting and licensing, and possibly other
commercialisation stages.

         Figure 3: Schematic of the elements of an Irish Marine Biodiscovery function


                                Biodiscovery management function




                  1.                           2.                           5….
             Collection of              Characterisation              Screening for
                                                                                 4.
           marine organisms              of compounds               specific clinical, or
                                                                          Screening for
             and primary                and preliminary                  reagent 3.
                                                                       specific clinical, or
                                                                               Screening for
             extraction of                 screening                   applications
                                                                              reagent
                                                                            specific clinical, or
             compounds                                                     applications
                                                                                  reagent
                                                                                applications




                                              Licensing to Irish or overseas industry




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7.4         Genomics of Marine Organisms

A programme in the genomics of organisms of economic importance to the Irish marine sector is a
strategic requirement for Ireland. Understanding the genomics of aquaculture organisms, particularly in
relation to their disease resistance, growth, survival etc, are fundamental requirements for maintenance
of a viable aquaculture industry. Such a programme would therefore be a long-term investment from
which specific benefits can be foreseen. These could include:

        •     An ability to precisely identify strains, or even individuals, of fish or shellfish. This
              information can be used for stock management, traceability of foodstuffs, prevention of
              poaching, and for a range of other management purposes. For instance, as new strains of
              commercial fish and shellfish stocks become more common, it may become necessary to
              distinguish these stocks from each other.
        •     Identification of beneficial genes that can be used to guide breeding programmes for high-
              merit stocks.
        •     Improved husbandry practices for fish and shellfish farming based around better
              understanding of disease transmission, food/health interactions, fish behaviour etc. Breeding
              for stock with a reduced stress response, for instance, would be of significant benefit to
              producers.
        •     New markers of disease, health status, reproductive condition etc that could be the basis of
              new diagnostic tests.
        •     New therapeutics or nutrients relevant to the maintenance of health among cultivated species.
        •     Based on extensive research on the ranching of species like salmon, to develop predictive
              and sustainable models to guide and enhance the ranching of additional marine food
              organisms.

Ireland should seek to develop a programme in the genomics of organisms of strategic importance
to the marine sector. Ireland already has competence in several of the requirements for a programme
in this area. There is a well-recognised competence in salmonid population genetics, and in fish
genetics and genomics, within the Marine Institute and their collaborators.

The major advances in aquaculture breeding and genetics are being made in the commercial sector.
Some of the relevant companies are listed in Table 4. One of these companies, Marine Harvest, is also
present in Ireland and is a significant part of national competence in this area, and an appropriate partner
for any national effort in this area. Goals and limitations for the future of fish production will also
largely be set by the aquaculture industry.

Within the universities, there are also several research groups with a competence in fish genetics and/or
genomic analysis. These include the laboratories of Dr Dan Bradley in Trinity College 76; of Prof. Tom
Cross, Department of Zoology Ecology & Plant Science, University College Cork 77; and Dr Andy

76
      www.tcd.ie/Genetics/staff/Dan_Bradley.html
77
      www.ucc.ie/acad/departments/zeps/pages/profile.htm

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Ferguson 78, Dept of Biology & Biochemistry, Queen’s University, Belfast. There are also other Irish
R&D groups with an expertise in human genomics. In short, there is a wide competence in genomics,
as well as several groups with the specific competence to take part in such a programme. It is
suggested that involvement of groups with existing experience in human or animal genomics is
preferable to attempting to introduce genomic competence into a marine science group.

Development of a programme in this area would require the broadening of the sphere of Irish genomic
competence to a wider range of aquaculture organisms. For practical purposes, it would be necessary to
involve a range of Irish institutions (particularly the Marine Institute) and several university research
groups. It would also be strategically useful, if not essential, to develop collaboration with one or more
of the genomic programmes underway in other countries (see sections 4 and 7.2).

The recommended structure for a Marine Genomics programme is through a series of independent
projects in the genomics of particular organisms. This programme would be centrally managed
(probably by the Marine Institute) so as to ensure adequate interaction among the R&D groups, and
between the R&D groups and potential users of the resulting information. The central coordinator
would also be involved in promoting international collaboration by the research groups involved.


7.5        Fish Vaccines

In any aquaculture programme, health is a major issue. There are several approaches to health
maintenance in aquaculture: one approach is the development of fish vaccines. This is already a proven
approach and many vaccines are in widespread use. Ireland has also had past experience in this field.



While Ireland does have some competence in vaccines, investment in a programme of fish vaccine
research would only seem warranted where Irish stock was subject to a disease for which no vaccine
was likely to be developed elsewhere. The fish vaccine market is relatively small (approx $60m) and is
dominated by 4 companies which are owned by major healthcare industries (see section 6.2). The
opportunity to develop significant Irish commercial activity from a vaccine research programme is not
obvious. Vaccine research is therefore not a recommended area for investment.


7.6        Diagnostics & Biosensors

Despite the fact that diagnostics, and increasingly biosensors, are a major area of international R&D and
commercial activity, there is only a small number of companies and research groups which specialise in
diagnostics for marine applications. These are described in 6.4. Most diagnostic technology is
developed for other purposes and then applied to marine needs. The major applications in the marine
sector are in testing of water (for pathogens, algal toxins, pollutants etc): fish and shellfish stock (for
disease indications or pathogens) and fish and shellfish muscle (for disease indications, freshness,
contaminants etc). A wide range of diagnostic technologies is already available to perform these tests,



78
      www.qub.ac.uk/bb/prodohl/TroutConcert/Research/aferguson.htm

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and virtually all of these techniques are also used in human or other assays. In other words, the marine
sector does not generally require unique diagnostic approaches to fulfil its needs.

With regard to commercial diagnostic activity, the overall market for specialist diagnostics for
aquaculture or fisheries use is small, and potential customers are widely distributed. Consequently it
has not been an attractive area for diagnostics companies to date.

The opportunity or need for a diagnostic or biosensor programme solely for marine applications is
therefore small. The technologies employed in the tests used are virtually all identical to those used in
human and/or veterinary diagnostics. An exception is algal toxin detection, which requires specific
chemical assays.

It is suggested that an Irish programme in the area of diagnostics or biosensors for marine applications
is not required or justified. These needs, however, can generally be met through funding of directed
research projects.

However, while investment in a diagnostic R&D programme is not considered justified, needs and
opportunities for diagnostic products will occasionally arise. Research in genomics, biodiscovery etc.
will inevitably identify useful markers of disease, metabolic status, pollution etc that may become the
basis of useful diagnostic assays. There may also be an occasional need for specific tests for detection
of locally specific diseases, pollutants or contaminants. The Marine Institute can ensure that such needs
and opportunities are within the scope of the Marine R&D programmes. Given the existence of several
diagnostic companies in Ireland, it should also be ensured that there is an active process to inform
relevant industry of these opportunities, and to support their commercialisation.


7.7      Production of Novel Foods, Feeds and Nutraceuticals

Marine foods will benefit from R&D activities in several areas:
     •    Genomics research will benefit food production and quality by identifying the genes for food
          quality characteristics and allowing breeders to enhance fish strains possessing these genes.
     •    Diagnostic and biosensor developments will enhance the ability to detect and prevent or
          reduce pollutants, contaminants and other problems affecting food quality
     •    Genomics research will also assist in the development of markers that can be used in tracing
          fish products to their source of origin, thereby providing additional security for the
          consumer.

There are also other potential areas in which biotechnology could play a role in marine foods and feeds.
These include the so-called functional foods, which are foods that have a health benefit beyond their
nutritional content. There are many functional foods that derive from marine sources. Examples include
prebiotic and probiotic products based on fish oils, algae or other marine sources. They are further
discussed in 6.3. Some of these opportunities are dependent on economic factors, e.g. the quantities
and value of the source materials available for extraction of potential products, and the logistics of their
coastal or ocean locations. The detailed analysis required to establish the sources of functional food
materials available from Irish waters was outside the scope of this report. It is clear, however, that this

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is a field of work in which there is little research activity in Ireland. It may be an opportunity area, and
further analysis is warranted to define this potential.


7.8         The Role of International Collaboration

A particular feature of marine science activities is the high level of international collaboration involved.
This was discussed in 3.2. In most countries, the expertise required to run a comprehensive programme
on marine biotechnology will exist within a combination of marine and biotech institutions. As one
source 79 notes: “Marine biotechnology initiatives exist within small, but excellent, groups at national
universities and marine institutes throughout Europe. …They are employed at an extraordinarily varied
group of organisations. Finding each other and coordinating thus becomes a complicated task”.

Ireland is no exception in this regard and it will probably be necessary to fill gaps in Irish expertise and
facilities by developing collaborative agreements with overseas groups. In conducting the study many
international groups were keen to discuss Ireland’s approach to marine biotech and openly indicated
their interest in collaboration.

In the development of an Irish initiative, there are two roles for international collaboration:

     (a) The major role is to provide required expertise or resources. For instance, a biodiscovery
         programme will require a range of screening expertise which cannot all be met nationally.
         Equally, a genomics programme will require a high level of international collaboration. The need
         is for very specific expertise which will be defined by the needs of the project, and is less likely
         to be addressed through generic international collaborative agreements. It is recommended that
         relevant international partners be sought to fill specific gaps in the expertise or facility
         needs of elements of a national Marine Biotech Initiative.

     (b) A second role is the general need to enhance expertise and activity by involvement in
         collaborative R&D activities. Ireland is not involved in some of the more significant activities
         underway in this area, particularly in marine genomics. It is recommended that one element
         of a national Marine biotech initiative should be the promotion of Irish involvement in
         international (particularly EU) projects and activities. This should be addressed as a means
         to develop expertise in relevant areas, and also to gain access to the significant body of shared
         information available on marine organisms.


7.9         Summary of Recommendations

       1. A Marine Biotechnology Initiative will require the expertise and facilities of many Irish
          institutions if the required resources are to be brought together. The Marine Institute should
          undertake the role of coordinator of a marine biotech initiative as a collaborative activity
          between several institutions. See 7.2 for discussion.
       2. It is recommended that a biodiscovery programme is a feasible area of activity within a national
          Marine Biotech initiative and should be assessed in detail. See 7.3 for discussion.
       3. A programme in the genomics of organisms of strategic importance to the marine sector is also
          a potential area of activity within a national Marine Biotech initiative. See 7.4 for discussion.


79
       Scanbalt Marine Biotech Network – see www.scanbalt.org/sw267.asp

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    4. A formal programme in diagnostics and biosensors for marine applications is not considered
       justified. However, the Marine Institute should maintain a watching brief on the needs and
       opportunities that may arise in this area and deal with them through existing R&D programmes.
       See 7.6 for discussion.
    5. It is recommended that relevant international partners be sought to fill specific gaps in the
       expertise or facility needs of elements of a national Marine Biotech Initiative. See 7.8 for
       discussion.
    6. It is recommended that one element of a national Marine biotech initiative should be the
       promotion of Irish involvement in international (particularly EU) projects and activities. See
       7.8 for discussion.




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                             Appendix 1: Abbreviations used




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                                Abbreviations used


AIMS           Australian Institute of Marine Sciences (www.aims.gov.au/)
BIM            Bord Iascaigh Mhara – Irish Sea Fisheries Board (www.bim.ie)
CNRS           Centre Nationale de la Recherche Scientifique
DFO            Fisheries and Oceans Canada
DNA            Deoxyribonucleic acid – the biochemical basis of genes
EI             Enterprise Ireland (www.enterprise-ireland.com)
ERA            European Research Area
ESF            European Science Foundation
ESMB           European Society for Marine Biotechnology
EST            Expressed Sequence Tag
EU             European Union
FAO            Food & Agriculture Organisation (of the United Nations)
FUGE           Functional Genomics Project (Norway) – see 5.5
GBF            Gesellschaft für Biotechnologische Forschung (www.gbf.de)
GM             Genetically Modified
GRASP          Genomics Research on Atlantic Salmon Project
HEA            Higher Education Authority (www.hea.ie)
ICES           International Council for the Exploration of the Sea
IDA            Industrial Development Authority, Ireland (www.ida.ie)
IFL            Icelandic Fisheries Laboratories (www.rfisk.is/english/about/)
IFREMER        Institut Français de Recherche pour l'Exploitation de la Mer
IP             Intellectual Property
IT             Institute of Technology
MABIT          Marine Biotechnology in Tromsø
MITI           Ministry of International Trade & Industry (Japan)
NOAA           National Oceanic and Atmospheric Administration (USA)
NoE            Network of Excellence (Project type within Framework 6)
NUIG           National University of Ireland, Galway
PRTLI          Programme for Research in Third Level Institutions
QTL            Quantitative Trait Loci
RTD            Research & Technological Development
SFI            Science Foundation Ireland (www.sfi.ie)
TCD            Trinity College Dublin
UCC            University College Cork
UCD            University College Dublin
USDA           United States Department of Agriculture
VC             Venture Capital




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                      Appendix 2: People consulted during study




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                                  People consulted during Study80
Prof. Carmen Alvarez            Universidad de Malaga                                    Malaga, Spain
Dr. Chris Battershill           Institute of Marine Science                              Australia
Dr Dan Bradley                  Dept. Genetics, Trinity College                          Ireland
Dr Mark Cantley                 European Commission - DG Research                        Brussels, Belgium
Mercedes Careche                Instituto del Frío (CSIC),                               Spain
Dr. J. Mark Cock                CNRS-Goëmar-UPMC, Station Biologique,                    Roscoff, France
Børge Damsgaard                 Fiskeriforskning                                         Norway
Dr Robert Devlin                Dept. Fisheries & Oceans                                 Vancouver, Canada
Dr. José Antonio                Center of Marine Biotechnology, University
                                                                                         Maryland, USA
Fernández-Robledo               of Maryland Biotechnology Institute
Shaul Freireich                 Office of Chief Scientist                                Israel
Dr Paul Galvin                  Nat. Microelectronics Research Centre                    Cork, Ireland
Dr Barbara Girard               BioSeas Partnership, Newfoundland                        Canada
Jóhannes Gíslason               Primex                                                   Iceland
Ronan Gormley                   Teagasc: National Food Centre                            Ireland
Prof. Michael Guiry             Martin Ryan Centre, NUI Galway                           Galway, Ireland
Prof. David Gutnick             Dept. of Molec. Microbiol. & Biotechnology,              Tel Aviv Univ. Israel
Jeff Howarth                    Highlands & Islands Executive                            Scotland
Ir. P.J.M. Keet                 Min. of Agriculture, Nature and Food Quality             Netherlands
Prof. Bernard Kloareg           Station Biologique de Roscoff                            Roscoff, France
Dr. Ben F. Koop                 University of Victoria                                   BC, Canada
Yves le Gal                     MNHN                                                     France
Dr. Hans Lehmann                National Contact Point, DLR                              Bonn, Germany
Deirdre Lyons                   IDA-Ireland                                              Dublin, Ireland
Francisco Bas Maestre           Vitalia Consulting                                       Madrid, Spain
Dr Douglas McKenzie             Integrin Advanced Biosystems Ltd                         Scotland
Dr. Marinus Meiners             Univ. Applied Sciences, Wilhelmshaven                    Germany
Dr Pierre Meulien               Dublin Molecular Medicine Centre                         Ireland
Denis O’Riordan                 Kerry Foods                                              Ireland
Páll Gunnar Pálsson             Icelandic Fisheries Laboratories                         Reykjavik, Iceland
Dr Ena Prosser                  Biotechnology Directorate, Enterprise Ireland            Dublin, Ireland
Dr. Zuzana Smolenicka           International Marine Centre - IMC,                       Torregrande, Italy
Dr Wouter Spek                  Netherlands Genomic Initiative                           Netherlands
Peggy Tsang                     Aquaculture Science, Fisheries & Oceans                  Canada
Dr Vicky Webb                   Nat. Inst. of Water & Atmospheric Research               New Zealand



 80
      A workshop on Marine Biotechnology in February 2004 (organised by MI) also provided inputs to the study

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     Appendix 3: Briefing Note from DFO (Canada) for Canadian Minister for
                                   Fisheries




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                ROLE OF BIOTECHNOLOGY IN FISHERIES AND OCEANS CANADA
                                              (Information Only)


  SUMMARY
        •     Fisheries and Oceans Canada (DFO) is using biotechnology for establishing
              genetic profiles of commercially valuable species for stock identification,
              harvest management, preserving the genetic diversity of endangered species,
              selecting broodstock in aquaculture development, identification and control of
              aquatic animal diseases, monitoring recovery of habitat and assessing potential
              environmental impacts of transgenic fish.

        •     Biotechnology is a new way of doing business, in federal government
              departments as well as in the scientific communities, which will lower
              operational costs and keep DFO Science in the forefront of innovation.

        •     The regions are organized into centres of expertise to develop the platform
              technologies, which will be used in as many day-to-day operations as possible.


Background

    !       Biotechnology at DFO can be described as the use of the knowledge of DNA (genetic
            materials) structures and functions of marine organisms, to answer questions of what is
            happening to our marine resources.

    !       DNA sequences are like barcodes which identify the products for sale at department stores.
            DFO scientists are making DNA sequences to produce barcodes (DNA probes) for marine
            species. By using this innovative tool on samples of undigested blood or scales, one can
            identify individuals, species and populations of fish by matching samples to a databank of these
            DNA sequences.
    !       Before the development of the DNA probes, scientists relied on time-consuming live captures
            of huge numbers of organisms, which could then be tagged, released and eventually recovered.

    !       By charting each species genetically, population by population, scientists can better assess
            which populations can support fisheries and how to prevent the loss of genetic diversity in
            designing breeding programs. Endangered species can be identified and protected in marine
            protected areas to ensure the genetic variability each species needs to survive and thrive.

    !       DFO scientists also use DNA analyses in supportive breeding (salmon enhancement) and
            selective breeding (aquaculture) programs. In Atlantic salmon enhancement, DNA
            fingerprinting is used to trace adults, progeny and returnees in order to determine the success of
            different enhancement strategies. In Pacific salmon aquaculture, DNA analysis is used to check
            genetic diversity in aquaculture strains and to distinguish wild from cultured salmonids.

    !       Biotechnology methodologies are used to evaluate the effectiveness of sterilization of male and
            female salmonids to prevent breeding of escaped farm fish with wild fish stocks.

    !       During the 2002 MSX oyster disease outbreak in the province of Nova Scotia, DFO scientists
            used a newly developed molecular test to differentiate between MSX and SSO infections in
            oysters. Subsequently, control measures were concentrated on areas affected by the more


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        pathogenic MSX infections and the economic impact of culture operation closures was limited
        to these areas. As a result of the Canadian experience, the OIE (Office International des
        Epizooties) reference laboratory is revising the molecular confirmation as the international
        standard for the diagnosis of MSX and SSO infections in oysters.

    !   Knowing the genetic profiles of sockeye salmon populations returning to the Fraser River and
        analyzing the daily population mix during the 2002 season, allowed the fisheries authority to
        temporarily close the fishery on days when the late run appeared earlier than expected. The late
        run was associated with high spawning mortality. The closure minimized the pressure on this
        population and preserved the genetic diversity of sockeye in the Fraser River.

    !   Enforcement officers are using DNA technique in forensic analysis to identify confiscated
        products and trace them to their species or stock of origin. This acts as a strong deterrent
        against poaching or illegal harvesting and improves the enforcement of regulations and
        protection of marine resources.

    !   Genetic analysis is used in conjunction with other information – such as traditional ecological
        knowledge, satellite tagging studies and aerial surveys – to distinguish stocks of fish and marine
        mammals in the Canadian Arctic. This is helping the Freshwater Institute scientists understand
        the properties of each stock before providing advice regarding harvest limits to fishery co-
        management boards.

    !   The Centre for Oil and Gas Environmental Research is developing new sensitive, cost-effective
        and rapid assays, based on recent advances in biotechnology, for monitoring recovery in habitat
        quality.

    !   DFO transgenic fish research has produced genetically modified salmon that are reared in
        contained, land-based facilities. The DFO-developed transgenic salmon strains are used to
        obtain factual information on performance characteristics and fitness parameters, for the
        assessment of potential impacts that escaped genetically modified fish may have on wild
        populations. This serves as the science base for the regulation of transgenic fish under the
        Fisheries Act. The transgenic strains are also used by other federal regulatory authorities for
        food safety assessments.

    !   Understanding the genetic blueprint of living marine organisms forms a powerful base to
        develop applications and to seek solutions for a wide range of challenges. The department’s
        core expertise is concentrated at these specialized research centres -- the Pacific Biological
        Station and the West Vancouver Laboratory in the Pacific Region; the Bedford Institute of
        Oceanography in the Maritimes Region and the Gulf Fisheries Centre in the Gulf Region. The
        applications developed are then transferred to other laboratories and integrated into day-to-day
        operations. The adoption of the biotechnology applications will grow as the technology
        continues to mature and costs decline.

    !   DFO works in partnership with Canadian organizations (such as the University of British
        Columbia, University of Victoria, Dalhousie University, the National Research Council of
        Canada, Genome Canada, the Fredericton Research and Productivity Council), and research
        institutes in other countries, to share knowledge and expertise in this fast-evolving field.

    !   DFO, the Canadian Food Inspection Agency, Health Canada, Environment Canada and other
        federal government departments are working together to maintain efficient coordination in the
        federal biotechnology regulatory system.

    !   Through these activities, DFO is contributing to the Canadian Biotechnology Strategy (CBS) a
        horizontal initiative, aimed at ensuring that biotechnology continues to enhance Canadians’
        quality of life in terms of health, safety, the environment and social and economic development.


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Key Messages

    !   The medical and agricultural sectors have made tremendous advances using biotechnology.
        The marine science sector is benefiting from these technological breakthroughs.

    !   DFO scientists are applying proven leading edge biotechnology techniques to marine science
        operations.

    !   Biotechnology is bringing savings on operations. Genetic analyses are carried out in high
        throughput automated systems which can provide vast amount of scientific information in real
        time.

    !   The genetic information is taking some of the guesswork out of determining stock status and
        results in better science advice for sustainable resource use. There is also great potential to
        improve aquaculture practices, fisheries management, habitat management, and managing
        species at risk.

    !   Biotechnology is transforming marine science in the same way it has revolutionalized medicine
        and agriculture. Molecular assays are becoming the standard in many operations. It is essential
        for DFO to move forward to maintain the credibility nationally and internationally.

    !   The Science Sector is ensuring that the core expertise matches the emerging needs and that the
        expertise is deployed efficiently in well-structured partnerships for optimal leveraging of
        external resources.




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 Appendix 4: Marine Biotechnology research and expertise in Irish Universities
    and Institutes of Technology and their related expertise in the fields of
                               Biotechnology




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   Marine Biotechnology research and expertise in Irish Universities and Institutes of
         Technology and their related expertise in the fields of Biotechnology

Trinity College, Dublin

In the area of marine biotechnology, the college has projects on

Genetic diversity in Atlantic salmon populations

This work investigates the levels of genetic variation between and within wild and farmed Atlantic
salmon populations using microsatellite DNA genotypes.

It also has an interest in Aquatic microbiology concerning the public health aspects and spoilage in fish,
and carries out chemical analysis, water and effluent analysis for the food industry, and drug
manufacturing sectors. Comparative bioavailability studies are undertaken for drug companies and
development of new and the reformulations of existing products are undertaken.

Others research areas that could contribute to marine biotechnology expertise include:

    !   The development of novel and efficient strategies for exploiting the biosynthetic potential of
        transgenic chloroplasts.
    !   Phytochemical and biological evaluation of medicinal plants as potential sources of novel
        bioactive compounds, especially with anti-inflammatory, anti-cancer, anti-malarial and anti-
        acetylcholine esterase activities.

In the biotechnology field the university has expertise in:

    !   Development of novel anti-cancer drugs
    !   Development of new or improved vaccines
    !   Anti-viral immunity
    !   Viral vectors for vaccine construction, as gene therapy agents, and as cancer therapy agents
    !   Aspects of Drug Delivery System
    !   Application of computational modelling to augment the drug design process

The National Pharmaceutical Biotechnology Centre, is situated at TCD and has research projects in
the fields of

        Inflammation & Cancer,
        Neurobiology & Ageing,
        Vaccine R&D,
        Pharmaceutics & Pharmaceutical Chemistry.


University College Dublin

In the area of marine biotechnology, the college has projects on

Automated identification and characterisation of marine microbial populations.

The project will develop and apply automated techniques for identifying phytoplankton and bacterial
populations based on optical properties measured by analytical flow cytometry (AFC).




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Microbiological safety of heat treated vacuum packed shellfish products
The project included an examination of pre-processed mussels for the presence of bacterial pathogens,
the survival of pathogens or indicators when inoculated into shellfish and then processed, and the
development of a Polymerase Chain Reaction (PCR) method for the detection of hepatitis A virus in
shellfish.

In the general biotechnology field the university has expertise in
     ! Quality assurance in water microbiology
     ! Bacterial gene expressionIn-vitro tests for drug allegernicity
     ! ELISA methods and immunofluorescence microscopy
     ! Development of immunosensors and immunoassays
     ! Molecular cloning and characterization of the genesConformational transitions of polymers and
         protein folding
     ! Enzyme-based biosensor
     ! Biodegradable polymers for controlled biological release.


Also contributing to the development of the Biotechnology infrastructure at NUI, Dublin, is

The Conway Institute:

Its research programme is centred for scientific, management and reporting purposes on three research
disciplines, the activities of each being coordinated through a dedicated centre and reporting to the
Conway Institute Board of Management. The overriding goal of the Conway Institute’s research
programme is to identify novel therapeutic targets in human and animal diseases by integrating and
focusing the activities in these disciplines on four areas:

    •   Cancer Biology
    •   Infection, Inflammation and Immunity
    •   Neuroscience
    •   Vascular Biology

Centre for Synthesis and Chemical Biology

Chemical biology incorporates research that provides an understanding of the chemical basis of biology,
development and use of biological tools for chemistry, development and use of chemical tools for
biology and medicine. Expertise within the centre encompasses these areas with a specific emphasis in
bioactive molecule design and synthesis; synthetic and biosynthetic methodology development,
analytical, computational, structural and supramolecular chemistry.

Centre For Integrative Biology

The Centre for Integrative Biology (CIB) brings together a critical mass of multidisciplinary
researchers from 5 Faculties in UCD with a clear strategy for using the techniques of functional
genomics and proteomics in a fully integrative way with cellular, whole animal and computational
models to identify new therapeutic targets.

The Dublin Molecular Medicine Centre

The research programme at the DMMC is being carried out in state-of-the-art laboratory research
facilities, which are networked to new Genome Resource Units on the sites of their major teaching
hospitals. These facilities also accommodate technology platforms in genome scanning, transcriptomics,
bioinformatics and computational biology, and nanofluidics, and the Gene Archive of Ireland. The



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cross-institutional collaboration between clinicians and scientists may accelerate the developments of
novel therapeutic targets.

The National Agricultural & Veterinary Biotechnology Centre, is situated at the University and has
expertise in Vaccines, Immunoassays, Receptor Cloning, and Plant Biotechnology

Dublin City University

While the University does not have a direct involvement with Marine Biotechnology, there is expertise
that could contribute to the area. For example:

    !   Biodegradation of toxic waste - pure and mixed microbial cultures
    !   Bioaugumentation of waste treatment systems / bacterial survival
    !   In vitro toxicity testing
    !   Animal cell culture
    !   Developments of novel antibody and cell based sensor systems
    !   Development of environmental indicators
    !   Development of yeast expression systems for extracellular production of heterologous proteins
    !   cell growth morphology and resistance to toxins
    !   Applications of recombinant DNA technology in immunodiagnostics.

There are also a number of Centres of excellence in the Biotechnology field:

National Cell and Tissue Culture Centre (NCTCC)

The National Cell and Tissue Culture Centre’s research and services include:

Multidrug resistance, Monoclonal and polyclonal antibody development, In vitro models for
invasiveness and metastasis, Apoptosis and cell cycle, Cellular differentiation, In vitro screening of
pharmacological agents, Cell Therapy and Tissue Engineering.

National Centre for Sensor Research (NCSR)

The National Centre for Sensor Research’s research programme covers a broad spectrum of activities
from fundamental investigations to applied research in the applications areas of food safety, biomedical
diagnostics, process control and environmental monitoring.
The research structure of the NCSR focuses on three priority research themes:

    !   Photonics
    !   Life Sciences and Health
    !   Nanotechnology & Microsystems

National Institute for Cellular Biotechnology (NICB)

The National Institute for Cellular Biotechnology is a multidisciplinary centre of research excellence in
Fundamental and Applied Cellular Biotechnology, Molecular Cell Biology and Biological Chemistry.

Areas of interest include:

    !   Cellular Differentiation, Regulation & Engineering
    !   Microbial Pathogenicity & Fermentation
    !   Target Validation/Functional Genomics
    !   Molecules for Life: Synthesis & Fermentation




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NUI, Maynooth

In the area of Marine Biotechnology, the Biology department has had research experience in

    !   The molecular systematics of sponges.
    !   Microsatellite PCR typing of the sea louse.

The university also has a number of Institutes and laboratories with expertise in biotechnology, these
include:

    !   Bioinformatics Laboratory
    !   Institute of Bioengineering & Agroecology
    !   Institute of Immunology
    !   Immunovirology Group
    !   National Institute for Cellular Biotechnology

Together with Trinity College Dublin (TCD), and University College Cork (UCC), NUI Maynooth is
part of the Institute of Biopharmaceutical Sciences, whose Core Technologies are Mass Spectrometry ,
Proteomics, genomics, bioinformatics and Organic synthesis.


University of Limerick

While the University of Limerick does not have a major focus in the Marine Biotechnology field, its
academic staff has research expertise in related areas, these include:

    !   Biosensors
    !   Characterization & application studies of enzymes
    !   Studies of food borne pathogens and
    !   Analysis of antibiotic resistance from food sources
    !   Functional Food Ingredients
    !   Aquatic fungi
    !   Development of alternative adsorbents for organic compounds in aqueous environments

University College, Cork

UCC has a number of projects and expertise in the area of Marine Biotechnology, some of these are:

    !   The study of effects of macroalgal blooms.
    !   Diagnostic techniques for the detection of the protozoan parasite Bonamia ostreae
    !   Enzyme detection in the hemolymph of the flat oyster Ostrea edulis
    !   The interrelation of growth and disease resistance of different populations of juvenile Atlantic
        halibut
    !   Tissue culture methods suitable for the Pacific Oyster
    !   In vitro and in vivo toxicology in mussels.
    !   Amperometric immunosensors for detection of shellfish poisoning
    !   Stress studies in the great scallop Pecten maximus
    !   Sulphate-reducing bacteria from deep sediment layers of the Pacific Ocean
    !   Study of gene transfer in aquatic habitats
    !   Responses of bivalve molluscs to heavy metals
    !   Antifouling technology
    !   Interactions between freshwater cyanobacteria and the freshwater mussel
    !   Studies to investigate the potential environmental and biological factors that lead to mass
        mortality of C. gigas



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    !   Most of these projects are conducted by the Department of Zoology, Ecology & Plant Sciences
        (ZEPS), together with the Aquaculture Development Centre (ADC). These institutions have an
        established track record in the following areas of marine biotechnology:
    !   fish nutrition, growth and physiology;
    !   molecular genetics of salmonids and marine fish (including gadoids and pleuronectids);
    !   vaccine development /immunology in finfish;
    !   diseases of cultured shellfish.

UCC’s Environment Research Institute has projects in

    !   Amnesic Shellfish Poisoning and Toxicity (ASP) in cultured shellfish.
    !   The rates of Cyanobacterial feeding by zebra mussel (Dreissena polymorpha) and its impact on
        growth, survival and toxin uptake and release in Irish Freshwaters
    !   In Vitro enabling technologies for use in aquatic toxicology

The university also has comprehensive research programmes in the general field of Biotechnology,
incorporating Genomics, proteomics, genetics, molecular biology and in particular, Food biotechnology.

Areas of interest include:
   ! Apoptosis, cancer and degenerative diseases
   ! Probiotics
   ! Signalling pathways involved in the pathogenesis of disease.
   ! Cellular signalling in normal and diseased tissue.
   ! Drug target discovery, validation and assay development
   ! Development of prototype instrumentation, assay tools and integrated systems for in vitro
        diagnostics, high throughput screening, sensing, cell-based assays
   ! Biotic stresses in plants and the use of stress markers to improve transformation efficiencies.
   ! Tissue culture and the use of medicinal plants to treat human diseases
   ! Molecular detection of pathogens.

The University has other biotechnological research organisations, for example:

BioScience Institute.

BIOMERIT Research Centre.

National Food Biotechnology Centre, whose research themes include:
Functional Foods, Novel Antimicrobial Agents, Probiotics, Food Safety and Food ingredient Research.

NUI, Galway

NUIG has a major research theme in the field of Marine science and a number of project are related to
Marine Biotechnology at various laboratories within the institution:

The Irish Seaweed Centre

Projects include:

Extraction of a novel surfactant from sustainable kelp.
A surface-active agent has been extracted from Laminaria digitata, which has the potential to replace
common surfactants in personal care, cleaning and de-greasing products.




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An enzyme-screening project of macroalgae to identify key enzymes required for carbohydrate
biosynthesis.
The aim is to produce bioactive carbohydrate anti-tumour, anti-viral, immunostimulatory agents,
pesticides, nutraceuticals and biopharmaceuticals.

Iodide uptake and efflux by Laminaria
A project on studying the iodine content, chemical composition and mechanisms of control of iodide
uptake and efflux by Laminaria, and to utilise the seaweed model to provide information for therapeutic
potential in utilising radio iodide in the treatment of breast and other cancers.

Marine algae as a novel, sustainable organic supplement in fish feed for salmonid aquaculture
This project will build research capacity by establishing nutritive value and overall suitability of a range
of seaweeds as supplement in fish feed for salmonid aquaculture.

Commercial cultivation of Carrageen Moss
The commercially important seaweed Chondrus crispus will be cultivated using novel cultivation
methods, to outgrow to a commercial size at sea.

National Diagnostics Centre
Projects include:

A Functional Genomics Approach to Measuring Stress in Fish Aquaculture
The aim of this study is to identify in fish candidate genes associated with resistance to stress conditions
and thus provide the physiological and genetic basis for new marker-assisted selection strategies. A
related project studies the isolation of genes involved in the regulation of the immune system in
commercially important salmonid species

Regulation of acute phase response (APR) proteins in Rainbow Trout during exposure to a
confinement stressor.
This project investigates whether the APR can also be induced in Rainbow Trout by the confinement /
overcrowding stress of the aquaculture environment.

Molecular Biology of Wild Atlantic Salmon.
The major objective of the programme is to create the first comprehensive database of gene expression
profiles and functional information associated with embryo development, smoltification and sexual
maturation in wild Atlantic salmon. A related project studies the thyroid stimulating hormone (TSH)
and its role in smoltification in Atlantic salmon

Development of a pathogen epitope predication program, and evaluation of its usefulness in
designing fish vaccines.
The main objective of the project is to study the peptide binding specificities of fish major
histocomaptibility complex (MHC) class I molecules. Such knowledge will help to develop a pathogen
epitope predictions programme and evaluate its usefulness in designing a viral pathogen peptide-
vaccine.

The development of assay systems for the detection of algal toxins in shellfish.
The initial approach was to develop and validate a cytotoxicity assay and further studies are now been
undertaken to a panel of immunoassays for an increasing range of algal toxins that are being found
worldwide. Related work aimed at the detection of the toxin-producing species is being carried out in
collaboration with the Martin Ryan Institute.




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Other marine biotechnology research activities at the university relate to:

    !   Developmental role of vertebrate IGF signalling (zebrafish).
    !   Gene expression in larval Arctic charr
    !   Gene expression in the blastula stage of Atlantic salmon
    !   Fish diseases and vaccines,
    !   Antimicrobial agent and susceptibility testing
    !   Microbial communities of the Deep Ocean and hydrothermal vents.
        Aquatic pollutants and microbial communities.
        Phytoplankton ecology
    !   Sea Lice Resistance to Chemotherapeutants

The University also has biotechnological expertise in

    !   Cellular responses to environmental agents.
    !   Expression of Recombinant Proteins
        Gene Mapping (Microsatellite Markers)
    !   Cellular responses to DNA damage
    !   Innate and acquired immune responses.
    !   Differential gene expression
    !   Enzyme electrodes
    !   Anaerobic digestion
    !   Microbial physiology and pathogenic mechanisms
    !   Microarray development.
        Microbial nucleic acid based diagnostics development
    !   Food-borne pathogens,
    !   Antibiotic Resistance,
    !   Virulence and Pathogenesis

The following institutions at NUIG are relevant to the biotechnology area:

The Martin Ryan Institute
The Institute is currently active in the following research areas:
Marine Botany, Marine Microbiology, Oceanography: Physical and Chemical, Meteorology, Marine &
Estuarine Zoology

National Centre for Biomedical Engineering Science.
Research themes include
Control of Genome Stability, Gene therapy, Biomechanics, and Molecular cell biology

Regenerative Medicine Institute
The goal of REMEDI is to explore the synergies of gene therapy and adult stem cell therapy to promote
tissue repair and regeneration, and is active in Molecular Biology and Gene Expression research.




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Marine Biotechnology Research at Institutes of Technology

The Irish Institutes of Technology have an active and growing research activities in the area of Marine
biotechnology. Examples of the research projects at these institutions include:

Letterkenny IT:

    !   Crustean waste processing (Chitin) for use as a biological control agent and as a heavy metal
        adsorbent.
    !   Molecular biology methods for detection and identification of bivalve larvae
    !   DNA biosensors for detection of planktonic larvae of king scallop.
    !   Extraction and analysis of shellfish toxins (Domoic Acid)

Tralee IT:

    !   Development of new alginate based materials.

Cork IT:

    !   Development of methods for norovirus detection (Food Safety).
    !   Isolation and characterisation of shellfish toxins related to Food poisoning.
    !   In vitro and in vivo bioassays for assessing the impact of chemicals (endocrine disrupting
        compounds in fish and their environment.

Waterford IT:

    !   Marine microbial biocatalysis; biochemistry and molecular genetics of enzymes in cyanide and
        nitrile metabolism.

Galway-Mayo IT:

    !   Molecular methods for determination of the dynamics of mussel settlement.
    !   Allozyme markers for genetic stock identification (Blue Whiting)

Dublin IT:

    !   Tissue culture techniques and biomarkers for stress / damage in Trout, flounder and mussel.
    !   Development of fluorescence methods for the detection of algal species.
    !   Proteomics studies on skin mucus proteins during smoltification of Salmon.




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Appendix 5: Note from Prof. Michael Guiry & Dr. Gerd Koennecker on the potential for
              novel flora/fauna in Ireland’s marine environment. Pers. Comm.




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Note from Prof. Michael Guiry & Dr Gerd Koennecker on the potential for novel
flora/fauna in Ireland’s marine environment. Pers. Comm.


Flora

The seaweed flora of Ireland is about 450 species, a considerable portion of the 600 or so species
reliably reported for Britain & Ireland (Hardy & Guiry, 2003) including coldwater species, temperate
species and warm-water species. The University herbarium at NUI, Galway includes a reference
collection of about 12,000 specimens. NUI, Galway is also the home of several experts on green, red
and brown algae (Professor Michael Guiry and Dr Fabio Rindi) and phytoplankton (Dr Robin Raine).
The Martin Ryan Institute is home to AlgaeBase, the only Global Species Database held in Ireland.

Fauna

Ireland has a rich and varied fauna, probably in excess of 3000 species which has been accurately listed
only in selected areas. There is still scope for a substantial number of new species to be discovered and
described, particularly in the Porifera (Sponges). Zoogeographically, Ireland benefits from its position;
the fauna is a mixture of Boreal/Northern species and a strong element of Lusitanian/Mediterranean
species. The varied coast line and close proximity of open Atlantic waters allow for the presence of
stenothermal species and communities absent for example from the Irish Sea. Whilst the inshore fauna
is very rich in species (the Greater Galway Bay area alone including about 1500 species), the fauna of
the continental slope is by far the most diverse, and differs significantly from that found inshore. Single
samples may contain as much as fifty different species or more if the substrate is suitable. Such
substrates are for example Lophelia pertusa (Cold Water Coral) reefs, or gravel found along the
continental slope which is vastly extended around the Porcupine Bank to the west of Ireland. Ireland has
the most extensive still intact coral reefs and thickets along the Western European seaboard outside
Norway, these are limited, sparse and under intense pressure in areas west of Scotland, and in future
may be protected even from scientific investigations. There is evidence of aequatorial submergence in
sponges, e.g. species which are found at a couple of hundred metres of Northern Norway are found at
around 2000metres near the Azores. Ireland is well placed, with the highest density and diversity
between 300-1200 m.

References

Hardy, F.G. & Guiry, M.D. (2003). A Check-list and Atlas of the Seaweeds of Britain and Ireland. pp. x
+ 435. London: British Phycological Society.
http://mri.nuigalway.ie/databases.html
http://www.algaebase.org




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   Appendix 6: Marine Biotechnology Companies cited and website addresses




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                Marine Biotechnology Companies cited and website addresses
 Alpharma                           www.alpharma.com
 APT Ltd.                           www.aquaculture.co.il
 AQUA Bounty Canada                 www.aquabounty.com
 Aquagen                            www.aquagen.com
 Aqua Health Ltd                    www.aquahealth.co.uk
 Aquatic Diagnostics                www.aquaticdiagnostics.com
 Arramara Teo.                      www.arramara.ie
 BioDiscovery NZ                    www.biodiscovery.co.nz
 Biohenk                            http://home.c2i.net/w-200778/officialstuf/bh_history.htm
 Biosense                           www.biosense.com/
 BIOTECmarin GmbH                   www.biotecmarin.de
 Biotec Pharmacon                   www.biotec.no
 Diagxotics Inc.                    www.diagxotics.com
 Elan                               www.elan.com
 Eximo                              www.eximo.no
 France Chitine                     www.france-chitine.com
 Genomar                            www.genomar.com
 Glucomed AS                        www.glucomed.com
 Identigen                          www.identigen.com
 Integrin                           www.integrin.co.uk
 Intervet Norbio                    www.intervet.no
 Jellett Rapid Testing Ltd.         www.jellettbiotek.ca
 Kerry Algae                        www.kerryalgae.ie
 Kolorian                           www.kolorian.com
 Lysi hf.                           www.lysi.is
 Maritex                            www.maritex.com
 Markmar ehf                        www.markmar.is
 Marine Harvest                     www.marineharvest.com
 Nature Beta Technologies           www.matimop.org.il/newrdinf/company/c1206.htm
 Nautix                             www.nautix.com
 Natural AS                         www.natural.no
 NFL Aqua Products                  www3.nf.sympatico.ca/napi
 NorthIce                           www.northice.com
 Nutreco                            www.nutreco.com
 Pharmamar                          www.pharmamar.com
 Plastimo                           www.plastimo.fr
 Primex                             www.primex.is
 ProBio Nutraceuticals              www.probio.no
 Pronova Biocare                    www.pronovabiocare.com
 SalmoBreed as                      www.salmobreed.no
 Schering Plough                    www.spaquaculture.com/
 Vanson HaloSource                  www.halosource.com




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