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BioFirst NSW Biotechnology Strategy 2001 I present to you BioFirst, the New South Wales Biotechnology Strategy. Biotechnology is a science as old as the making of bread and the brewing of beer. However the current biotechnology revolution involves the study of the deepest structures of living things and applies what is learnt to achieving a range of environmental and human benefits. Biotechnology has already delivered unquestionable advances in the fields of human health and agricultural production. Through bioremediation and biological alternatives to pesticides, it is also benefiting the natural environment. The current debate about genetically modified organisms and stem cell research shows the ethical challenges we face with biotechnology research. Clearly, whatever their benefits, some processes – such as human cloning – will be unacceptable. Through the strategies outlined in BioFirst the benefits to the people of NSW will be maximised. The strategy will ensure that ethically and environmentally difficult issues are faced honestly and, if possible, resolved. BioFirst plays to NSW strengths. While ensuring a robust capability around the key technologies that underpin the biotechnology revolution, NSW will work with the Commonwealth Government, and with other States and Territories, to achieve an environment in which our biotechnology professionals – our scientists; technologists; and industrial, advisory and financial communities – can flourish. BioPLATFORM adds substantial new funds to the extensive support the Government already gives to biotechnology research and development. The BioBUSINESS component focuses the Government's approach to capitalising on opportunities for biotechnology-related development. A BioUNIT reporting directly to me will give leadership and coordination to the strategy. I commend BioFirst to you.

Bob Carr Premier Our community is currently sitting on the edge of an exciting new age of discovery in biotechnology. This age offers us enormous benefits in the fields of health and commerce – and also poses important ethical questions. It is essential that we embrace, as a community, both the benefits and the challenges that this period will offer us. This will require frank and constructive dialogue between all stakeholders at every level. NSW has many natural advantages as a centre for the development of biotechnology. It is already home to the lion’s share of biotechnology companies in Australia and enjoys a strong, vibrant and internationally regarded biomedical research community. Nevertheless, we can never allow ourselves to grow complacent – we must always believe that we can do better and achieve more. Our focus must be at the global level. We should look beyond our shores and seek to be world leaders in biotechnology. We can do this, and indeed we already are. BioFirst seeks to build upon our existing strengths while acknowledging that ongoing success demands renewed energy, investment, cooperation and above all – leadership. BioFirst will provide that leadership – I commend this strategy to you.

Craig Knowles Minister for Health Chair, NSW Cabinet Committee on Biotechnology Introduction – Biotechnology will be a driving force in economic development over the next decade.

Like the Information Technology (IT) revolution The biotechnology sector differs from other The BioFirst vision is to position NSW as a of the 1990s its impact will be broad, potentially developing industries in several important leading player in biotechnology to maximise affecting many aspects of everyday life. Health- respects. It relies on a number of resource- the social, environmental and economic benefits care, agricultural production and environmental intensive inputs, such as research infrastructure of biotechnology for the people of NSW remediation are all areas where biotechnology and a highly skilled workforce. The driving force and Australia. can bring substantial benefits. In addition, the for the development and application of new The NSW Government is committed to consolidating expansion of biotechnology industries will be technologies is largely economic. However, the and extending the State’s achievements by important in securing high growth in the NSW industry is characterised by long lead times enhancing its research and development (R&D) economy. Government must play an active role between research and product commercialisation. capacity, and by encouraging and promoting in promoting and monitoring the uptake and This increases the difficulty of attracting capital a dynamic, socially and ethically responsible development of this new technology. to support the development of new businesses. biotechnology industry. These developments also give rise to important For NSW to take a leading role in the balanced The BioFirst strategy is based on a broad definition issues for the community and Government. development of biotechnology will require the of biotechnology, and recognises that biotechnology For example, what research is ethical? How do combined efforts of the research, business, applications span a diverse range of industries. we balance the desirability of improving industry and government sectors. Research It also recognises that BioBUSINESS is frequently agricultural production with concerns about scientists, educational institutions, primary technology-driven – requiring investment in protection of the environment? The NSW producers, hospitals and health care workers, a strong BioPLATFORM and the establishment Government recognises that the acceptability biotechnology and other industry associations, of ways to support the commercialisation of new biotechnology products and research venture capitalists, the financial services industry of research. processes is a vital issue for the whole community. and the general community all have significant Government must seek to be a responsive and contributions to make. The NSW Government will BioFirst focuses on the key areas of: informed leader in this debate. take an active role in generating shared views and – ethics; responsible action. Finally, through the education – business; The biotechnology industry is characterised system it can ensure that young people are – research and service delivery; and by significant overlaps in the areas of research, adequately informed about biotechnology. – support and leadership. product development and commercialisation. Biotechnology is relevant to the following NSW BioFirst is a five-year strategy that sets out Government departments: Health, Agriculture, the NSW Government’s initiatives to promote Land and Water Conservation, State and biotechnology in NSW and ensure that Regional Development, Education and Training, community concerns are properly considered Information Technology, Forestry, Mineral as this exciting field advances. The strategy also Resources, Fisheries, Police and Treasury. recognises that given the significant extent of private investment in biotechnology, opportunities exist for industry/Government partnerships and industry supported initiatives.

04 13 29 BioPLATFORM BioUNIT

01 04 19 25 42 Foreword Introduction BioBUSINESS BioETHICS Appendices

32 50 Case Studies References

01 Foreword04 Introduction 13 BioPLATFORM 19 BioBUSINESS 25 BioETHICS 29 BioUNIT 32 Case Studies 42 Appendix A 50 Glossary of abbreviations 40 Testimonials Members of the NSW Ministerial and acronyms Advisory Council on Biotechnology 51 Glossary of 42 Appendix B biotechnology terms Organisations and individuals consulted 52 Notes 44 Appendix C Some Biotechnology pharmaceutical and related companies in NSW 49 Appendix D Key Acts, regulations and agencies involved in implementing the BioETHIC initiative

Contents The BioFirst vision – To position NSW as a leader in biotechnology and thus to maximise the social, environmental and economic benefits of biotechnology for the people of NSW and Australia.

What is biotechnology? Examples of Biotechnology Environment Biotechnology is the term for a group of Applications – detection, removal and treatment technologies that pursue the understanding Health of toxins in water, air, food and soil and use of organisms and biological processes – better and safer drugs – bioremediation of heavy metals, for health, social, environmental or economic – new and improved vaccines and diagnostic tests oils and chemicals applications or outcomes. The term ‘modern – new therapies for incurable diseases such as – conversion of waste into energy biotechnology’ distinguishes recent, purely diabetes mellitus, currently cancer and Food processing and beverages research-based activities from such traditional Parkinson’s disease – improved food safety and quality processes as fermentation (for example bread, – testing and treatment for genetic components – improved maturation and preservation cheese and beer-making) and animal and of disease techniques plant-breeding. Modern biotechnology includes techniques ranging from molecular and cellular Agriculture and aquaculture Marine biotechnology biology, biochemistry and immunology through – improved food storage and nutritional quality – new pharmaceuticals, enzymes and to biological applications of information – improved food safety biomolecular materials (for example, technology (IT). – higher yielding crops bioceramics) – improved identification and management – biomonitors (for example, using Benefits and Applications of agricultural pests and diseases bioluminescence) – isolation of naturally occurring products Biotechnology has already delivered significant – protecting crops against herbicide benefits ranging from cochlear implants and – domestication of wild plants a diagnostic test for Ovine Johne’s Disease – improved vaccines and diagnostic tests to DNA matching in criminal investigations. for animal diseases It can be applied in many ways to a variety of – improved animal welfare industry segments, significantly expanding their – new and improved varieties and capabilities and potential to deliver valuable management for aquaculture community benefits. Biotechnology has wide applications in health, agriculture and other Forestry fields, such as aquaculture, forestry, mining, – faster tree growth to achieve reafforestation manufacturing, environment, food and beverage – improved fibre and wood quality processing and marine biology. – disease resistance and saline tolerance – reduce environmental contamination in the production of paper products Mining – leaching of ores – mine site rehabilitation Manufacturing / bioprocessing – improved production of high-value products such as pharmaceuticals and flavours. – production of gas, liquid fuels and commodity chemicals

06 07 Industry structure Commercial scale NSW’s competitive strengths The enormous variety of biotechnology The global market for biotechnology is large The biotechnology industry presents NSW with applications is creating a complex industry and growing, showing similar trends to the excellent opportunities for growth. As Australia’s sector, which includes products ranging from IT industry of the 1990s. Global revenues for largest State, with Australia’s largest city and commodities through to high-value products biotechnology products and services are now pre-eminent financial centre as its capital, NSW and services.1 estimated at US$50billion per annum and has a range of strengths – in research, science growing at around 20 percent per annum2. and technology, industry, and science education – It includes established industries such as Between July 1998 and June 2000, United that underpin the development of biotechnology. traditional food processing and brewing States companies alone raised approximately companies as well as large, and typically multi- US$17billion in investment funding3. In the USA national, pharmaceutical companies. Important Strengths in research, science alone, approximately 300 new biotechnology- segments for NSW are formed by companies and technology based pharmaceuticals are presently undergoing in the areas of biomedical devices, biomaterials, NSW has a strong, diverse and geographically clinical trials. diagnostic and scientific instrumentation. distributed range of expertise, and an extensive Australian biotechnology companies have raised research infrastructure in health, agriculture, and Scientific development will lead to the identification over A$900 million in new capital since the education. There are 11 major teaching hospitals of new intellectual property (IP), some of which end of 1999. At the same time, there has been and their associated clinical research groups, will be commercialised. Over the next 5 years, a dramatic increase in the number of new and more than 30 health and medical research the industry is likely to see the growth of smaller, products being developed by the Australian institutes. There are nine Agricultural Centres of high-technology companies whose product biotechnology industry. Of the 546 disclosed Excellence, supported by 10 agricultural research developments and services will be based on products for which information is available, stations and a further 75 advisory offices located modern biotechnological applications. As the 51 percent are currently under development, throughout regional and rural parts of the State. sector develops, service and information companies 28 percent are on the market and 21 percent The Commonwealth Scientific and Industrial specialising in support for biotechnology are in clinical/field trials. The majority of these Research Organisation (CSIRO) has major Divisions companies will form and expand. products are in human health.4 of Animal Production, Energy Technology, Food Collaboration between smaller biotechnology Science, Molecular Science and Plant Industry Agriculture is the other major beneficiary of companies and large pharmaceutical companies in NSW. biotechnology. For example, NSW Agriculture will become a critical ingredient in creating scientists at Tamworth, in collaboration with the NSW has 11 universities including five in regional opportunities and generating economic value. CSIRO, have identified the osmo-regulator gene areas. There are a further two in the Australian Developments in this sector will be diverse (ORG), which induces drought-tolerance in plants. Capital Territory. In addition, several major and will extend beyond health and agriculture. ORG has been inserted into a wheat variety and national research facilities, including the They may include companies seeking to develop is currently being trialled in low rainfall areas of Australian Nuclear Science and Technology alternative fuels; to extract valuable biological NSW. Commercial release is expected this year. Organisation at Lucas Heights, contribute to compounds from waste streams; to recover ORG could also potentially be inserted into barley, this extensive capability. metals by bioleaching, and to remediate rice and other species. NSW has particular strengths in plant breeding, contaminants in soils and marine environments. The biotechnology sector is growing rapidly fermentation technologies, diagnostic and (14 percent growth in veterinary and pharmaceutical therapeutic devices, bioinformatics, proteomics, products; 21 percent growth in pesticides nanotechnology and clinical research. Twelve and agricultural chemicals) and continues to Cooperative Research Centre (CRC) headquarters outperform most other manufacturing industries.5 – across the agriculture, environment, waste management, health, conservation, and food A key objective of this strategy is to capture the industry sectors – are located in NSW, many economic value created in the biotechnology field in regional and rural areas. for NSW and Australia.

09 A total of 28 percent of all national expenditure NSW accounts for 23 percent of the biotechnology Strengths in science education Strengths in finance and by State and Territory Governments on R&D in component in Australia’s Gross Domestic Product NSW is a leader in school science education, corporate activity biotechnology-related fields occurs in NSW – the highest contribution of any Australian State with NSW students accounting for eight of NSW is one of Asia-Pacific's major economic (A$210 million) – compared with 20 percent or Territory. NSW’s exports include approximately the 13-strong Australian team at the Science forces, with an economy larger than that of in Victoria (A$147 million) and 24 percent in A$900 million of medicinal / pharmaceutical Olympiads 2000. Biology, chemistry and physics Singapore and comparable to that of Hong 6 Queensland (A$179 million). Thirty percent of products, placing this category among the State’s are covered at these annual Olympiads, at which Kong. Almost two-thirds of all multinational 13 Australian R&D expenditure in biotechnology top ten merchandise exports. Australian teams consistently win medals against corporations in Australia have their regional in higher education is in NSW (A$350 million) NSW accounts for 76 percent (39 of 51) competition from 80 countries. headquarters located in Sydney, and 50 percent – compared with 22 percent in Victoria and 17 of the members and affiliates of the Australian of Australia's top 500 companies have chosen percent in Queensland.7 Thirty six percent of all All NSW school science syllabuses include aspects Pharmaceutical Manufacturers’ Association. to locate in NSW. Australian private sector R&D in biotechnology- of biotechnology at the foundational level – The NSW pharmaceutical industry employs related ANZSIC fields is in NSW – about the same covering social and ethical considerations as well NSW received A$14.8 billion in new private over 11,500 people, and 14 of the top 20 as in Victoria and more than three times that as major developments and applications. investment in 1999–2000, accounting for pharmaceutical suppliers in Australia have chosen in Queensland.8 over one-third of the national total. The NSW Sydney as their base for regional operations.14 Technical and Further Education (TAFE) NSW provides an extensive range of educational and Government has AAA credit ratings from both Strengths in industry NSW has a growing number of business and training programs to support the development Standard & Poor’s and Moody’s agencies. NSW is home to over 150 companies in the technology/research parks, including the and growth of the State’s biotechnology industry Sydney is the business capital of Australia biotechnology, pharmaceutical and related Australian Technology Park (Eveleigh), Macquarie – including Diplomas of Laboratory Technology in and the hub of Australia’s IT and communication industries9 (see Appendix C). Over 40 percent Research Park (Macquarie University, North Ryde), Biological and Laboratory Testing; Pathology industries. It has the largest share of Australia’s of all biotechnology, pharmaceutical and related Riverside Corporate Park (Ryde), Frenchs Forest Testing; Process Manufacturing Testing; and Food financial and professional services sectors. companies in Australia are located in NSW, Business Park, the Industry Development Centre Testing. TAFE NSW works closely with industry The Reserve Bank, the Australian Stock Exchange, compared with 32 percent in Victoria and 11 (Newcastle) and Cellulose Valley Technology and other education and training providers to the Futures Exchange, the Securities Institute of percent in Queensland.10 11 NSW hosts about 60 Park (Lismore). A technology park has also develop optimum collaborative arrangements. Australia and the Australian Venture Capital percent of the biotechnology companies involved been established adjacent to the Australian Association have all chosen Sydney as their in the human biomedical sector in Australia’s Nuclear Science and Technology Organisation principal location. eastern States. The Deloitte Biotech Index of listed (Lucas Heights). companies for March 2001 lists 18 companies Sydney’s capital markets are robust, The Government is examining the feasibility of transparent and efficient. Access to capital that are either based in NSW or maintain establishing a Biomedical Business Park adjacent significant operations in NSW.12 and to professional services, particularly business to the Westmead Hospital / University of Western and legal services, is a key requirement for Sydney campus, as well as undertaking initial emerging biotechnology businesses. planning for a biomedical cluster in Northern Sydney, BioMed North. The NSW Government has already announced a partnership with the University of New South Wales (UNSW) to examine the feasibility of a biohub at the UNSW/Prince of Wales Hospital precinct.

10 11 BioPLATFORM

The BioPLATFORM program represents a major step by the NSW Government towards securing a premium position for NSW in the future international growth and development of biotechnology 13 BioPLATFORM – The substantial depth and diversity that already exists in NSW’s research, scientific and technological communities, and the State’s many areas of world-class performance, constitute tremendous ‘biotechnology assets’.

Rationale Outcomes of the This initiative will work in parallel with 2. Support key enabling technologies Functional genomics Bioinformatics The foundation for this development is BioPLATFORM program opportunities arising from the Centres of – ‘beyond genomics’ Functional genomics – the study of the function Bioinformatics is the computing capability to and significance of genes – seeks to explain not analyse large amounts of biological data about a geographically distributed system that The outcomes for NSW of the BioPLATFORM will Excellence in Biotechnology recommendations Delivery: NSW Agriculture, NSW Health incorporates major urban, regional and rural in the Commonwealth Government’s Backing only the genetic basis of health, but also the genes and proteins. This emerging industry be world-class technical capabilities that enable The key drivers of biotechnology come from centres. It is particularly strong in the agricultural Australia’s Ability package. interaction of genes with the environment to sector is an essential component of molecular the State to create and respond to opportunities advances in genomic research – research into the sciences and health and medical research. cause disease. NSW will strengthen its capabilities biotechnology, agriculture and health research. arising from biotechnology: A research and development cluster should genetic material of all organisms – and related This NSW infrastructure links with community in functional genomics, located in centres – growth in NSW’s research community, possess the following attributes: disciplines including functional and structural NSW Government will support increasing NSW’s activities and the work of industry. spread across the State, by building on existing together with appropriate infrastructure – clarity of purpose; genomics, proteomics, and bioinformatics. existing strengths in bioinformatics, which include: capabilities (plant, animal, micro-organic and capital assets; – capacity to attract and manage funding from This initiative will establish firm foundations for – the Australian National Genomics Information The NSW Government’s BioPLATFORM program and human). is designed to build on the State’s existing – an increase in the intellectual, biological a variety of sources; the key enabling technologies for applications Service (ANGIS); large and small-scale biotechnology research and economic wealth of NSW; and – close geographic location, close physical links in health, agriculture, the food industry, forestry, The NSW Government will support the – Entigen (previously eBioinformatics); infrastructure and to support key research – improved connection and responsiveness or demonstrated advantages from operation environmental management and the mining and establishment of a transgenic mouse and – the Animal Genetics and Breeding Unit scientists and technicians in their work. to Australian and NSW priorities for health, as a distributed system; process industries. mouse embryo storage facility that will be widely at Armidale; and BioPLATFORM is designed to secure a premium agriculture, aquaculture, forestry, – proximity to and/or established links with accessible to the research community. This facility – the recently launched Australian Centre for Key platform technologies will be supported, position for NSW in the future international and the environment. industry; will provide a primary resource to researchers to Advanced Computing and Communications including: growth and development of biotechnology. – established links with the community; facilitate the understanding of the function of (AC3) – a newly established facility at the BioPLATFORM strategic initiatives – proximity to and established links with Basic and structural genomics particular genes and to develop the ability to vary Australian Technology Park, which has three BioPLATFORM will: 1. Build the research community a teaching/tertiary hospital – facilitating access The NSW Government will work with the research gene expression in living systems. supercomputers, very large storage facilities and – extend the foundation for translating Delivery: NSW Agriculture, NSW Health to samples and clinical practices and the community to develop an optimal model to broadband connectivity. excellence in research into economic benefits; Protein analysis and proteomics application of ‘bench-to-bedside’ research; ensure the adequacy and critical mass of facilities – enable rapid uptake of new technology Sustaining the BioPLATFORM will depend Protein analysis and proteomics are essential Nuclear magnetic resonance – strong links with one or more universities; for research and training in basic and structural by the research community; and on strengthening the connections among the technologies for determining the functions of Nuclear Magnetic Resonance (NMR) techniques – established IT networks; genomics. This may comprise an advanced – realise the social benefits of biotechnology. various components of the biotechnology sector. genes and for uncovering changes in proteins are now an essential tool in food technology, – common and/or complementary research foci; research network. The Commonwealth initiatives A key underpinning of these initiatives will be that contribute to the many layers of complexity bioprospecting and diagnostic medicine, and – shared access to equipment that is operated for establishing world class Centres of Excellence Current initiatives supported by the NSW to build on existing capabilities, including NSW’s within biological systems. In most areas of underpin major advances in biotechnology. and maintained by dedicated technicians – in Biotechnology will be taken into account in the Government to be built upon in the substantial scientific expertise and research base. application, comparisons between healthy and Their uses include the development of for example, with access on a fee-for-service development of this model. BioPLATFORM program include: affected samples can identify targets for action. pharmaceuticals and the elucidation of the Encourage collaboration and alliances basis, especially for organisations that are not – the strategic development of research facilities BioPLATFORM will support and further NSW’s structure and function of gene products and Infrastructure funding will be used to encourage members of the cluster; to encourage the development of a critical leadership in protein analysis and proteomics. the way they operate in the cells. The NSW cooperation and alliances among researchers – shared business facilitation skills and business mass of research expertise; Government will contribute to the enhancement with common scientific interests and among support services; NSW has been a pioneer in this development and – securing large-scale infrastructure; and and coordinated use of NMR facilities in NSW. – strengthening NSW’s capabilities companies, both public and private, in the NSW – access to IP management and advice on already has several world-class facilities, including: in bioinformatics, proteomics and biotechnology industry. The establishment of commercialisation; – the Australian Proteome Analysis Facility, Ryde functional genomics. a limited number of research clusters in NSW, – cluster ‘badging’ – to facilitate the marketing (a Major National Research Facility); through a transparent and competitive process, of members’ capabilities; and – process development in Proteome Systems will build this capacity. – access to supercomputing facilities. Ltd; and – mass spectral analysis, post-translational analysis This initiative will make it easy for researchers and cellular metabolites at the Biomedical Mass in NSW to access the infrastructure, expertise Spectrometry Unit at UNSW (a Major National and support required to progress research. Research Facility). Core technologies could be located within clusters to facilitate greater access and efficient use of expensive equipment. Support for training in appropriate skills, and knowledge transfer through mentoring and professional interaction, will be essential elements of research clusters.

14 15 Workforce development In health, this will include the study of disease 4. Maintain and enhance research 5. Preserve the biological assets 6. Ensure a world-class, international Interaction and frequent contact with international The developments in biotechnology will require mechanisms and novel therapeutic approaches at facilities Delivery: NSW Agriculture, NSW Health focus and renewing research and peers is also an important requirement for a skilled workforce. Universities and Technical and the molecular level, and studies of the effect of Delivery: NSW Agriculture, NSW Fisheries, (for human tissue) development capability attracting and retaining high-quality researchers. Further Education (TAFE) have already responded genetic changes on pathology and physiology. NSW Health Delivery: NSW Agriculture, NSW Fisheries, NSW will provide support for international travel There is a need to ensure that NSW has an to this educational need to develop skilled This knowledge will also be applied to population NSW Health and communication to enable NSW researchers An asset strategy will be implemented that will adequate repository of genetic material for personnel to optimise the use of these enabling based studies, including genetic epidemiology (both public – and private-sector) to access world- maintain and enhance existing institutes and ongoing R&D. This is particularly important It is widely accepted that the future of NSW technologies. The NSW Government will work and in clinical trial settings. NSW has particular class institutions and participate in significant centres. This initiative will include the provision for valuable agricultural species, both plant biotechnology will require a dynamic community with key institutions to improve laboratory strengths in its NHMRC Clinical Trials Centre, international forums. This support will be of specific capital grants on a competitive basis and animal, and, where ethical, from native/ of top-class researchers, with the opportunity support for genetic sequencing, data the National Drug and Alcohol Research Centre, provided, in conjunction with existing bilateral to achieve physical consolidation of research endangered species and human materials, to build research programs in well supported management, bioinformatics, functional the National HIV Centre and the Institute funding programs, including those facilitating facilities and to promote the formation of including human tissue. Ready access to clean settings. The top three incentives for attracting genomics, and proteomics – with particular for International Health. This initiative will better engagement with Asia-Pacific partners. collaborative groups. There will be a strong propagation material – disease-free and of known overseas scientists on grant programs to Australia attention to empowering researchers and complement the NSW Government’s Build the focus on co-investment in the implementation composition – is essential for NSW agricultural are known to be: autonomy in setting research Recognition of our achievements and leaders technicians in their collection and interpretation Research Community initiative. of this initiative. industries to maintain their competitive edge and direction, research support and access to in science is crucial for the renewal and growth of data generated by genomic research. NSW is Australia’s largest agricultural producer, export markets. adequate/high-quality technical support services.15 of research capabilities in this State. NSW will The program will explore opportunities to attract The establishment of core capabilities at local and our future competitiveness will depend on promote wider awareness of the achievements of newcomers from other fields (for example, facilities will be critical for research groups to Under this initiative, a centrally held register The NSW Government will ensure the attraction the efficiency with which improved agricultural NSW scientists from within universities, institutes, mathematicians, statisticians and engineers) into maintain NSW’s international competitiveness. of repositories of genetic material and national of appropriate personnel by providing specific traits are identified, enhanced and transferred hospitals, Government and industry who have biotechnology. These capabilities will include access to core collections located in NSW will be compiled and ‘top-up’ funding for five emerging world-class to commercial cultivars. Biotechnology will gained national/international recognition within technologies such as transgenics, gene array, maintained. The register will be made available researchers per year, for three years each – 3. Support the key application areas of continue to improve the nutritional quality of their fields of endeavour. crystallography and monoclonal antibody to industry. sufficient to enable institutions to offer relocation human health and agriculture, including food, minimise the environmental impacts of development. In addition, collaboration will be expenses, world-competitive salaries, set-up 7. Focus on converging technologies aquaculture agriculture, and reduce the cost of production. The storage, cataloguing, and accessibility facilitated through state-of-the-art information budget and technical support during the Delivery: all NSW Government Departments Delivery: NSW Agriculture, NSW Fisheries, This initiative will support the establishment of of key collections will also be maintained. and communication linkages, such as Health establishment phase. These funds will be used NSW Health a multi-site agricultural genomics network with Specifically, this initiative will identify critical gaps Biotechnology is a data-intensive technology, SuperNet and TeleMedicine Strategies. to attract both expatriate Australians working critical mass in agricultural biotechnology. in the maintenance of unique genetic material resulting in several IT-related areas of convergence This initiative will support the continuing application overseas and international researchers to NSW These activities will take place in a number essential for crops of agricultural significance – for example, database management, data of biotechnology R&D to key areas of human to establish research programs. of regional nodes and field sites (including to NSW. storage, Internet usage, computation and health and agriculture, including aquaculture. Canberra, Narrabri, Orange, Sydney, Tamworth, This will be implemented in conjunction with visualisation (imaging). NSW already has strengths Wagga Wagga and Yanco) and will focus on existing competitive schemes such as the in electronics, engineering and IT, in developing crops that are important to NSW’s prosperity and NHMRC R Douglas Wright Awards, which provide novel devices and diagnostics (including for have national and international significance (for outstanding researchers at an early stage of product design), chemistry and nanotechnology. example, barley, canola, cotton, grain, legumes, their career with an opportunity for independent The NSW Government will provide seed grapes, rice, and wheat). research. Two of the five awardees must work funding to promote the convergence between in the area of ‘modern biotechnology’ as defined This initiative will also maintain NSW’s biotechnology (including bioinformatics) and in this strategy – one in bioinformatics, and capability in microbial genomics and its various other technologies, with particular focus on IT. no more than three in any one year in applications: the environment; processing; health/medical research. industrial chemicals; waste treatment and conversion; mine rehabilitation; and the production of medical/veterinary vaccines and medical/veterinary/plant diagnostic tests.

16 17 BioBUSINESS

Australia, and NSW in particular, has a foundation of world-class research strengths across the key life science fields of biotechnology, and some outstanding research organisations. 19 BioBUSINESS – If NSW is to become a leader in the emerging global biotechnology industry, it must be able to develop and successfully market its research outcomes by connecting with globally active enterprises.

Rationale Outcomes of BioBUSINESS Link to global business opportunities The NSW Government will enhance the business In his report Wills16 recognised that Australia The outcomes of the BioBUSINESS programs Biotechnology is an international revolution environment for larger biobusiness companies by has been traditionally very good at research but, will be: and, as links are forged amongst our research adopting the following initiatives. DSRD will work despite some outstanding success, on the whole – a significant increase in the size and number of community, strong global links for business with pharmaceutical companies to promote NSW has not been good enough at capturing the value biotechnology companies and biotechnology also need to be developed. as a base for regional headquarters, operating centres, R&D and production. Quality and of its IP. The fundamental research endeavour professionals in NSW; These links will be encouraged by supporting the professionalism in the NSW bio-manufacturing must therefore be complemented by a culture – increased opportunities for the attendance of NSW biotechnology companies at base (including its suppliers) will be encouraged that realises the value of discoveries made. commercialisation of research and the major international conferences and exhibitions in through further promotion of, and support for A flourishing industry sector is critical to obtain establishment of new companies; the USA, EU and Asia, and on-site visits to global training in, Good Manufacturing Practice and the economic benefit from research and – a consolidation of NSW’s position as the leading businesses. Opportunities for collaboration with Quality Accreditation. NSW is a recognised leader Government sectors. Australia – and NSW in location in Australia for biotechnology business other States and the Federal Government to in the development of device and diagnostic particular – already has a foundation of world- and the multinational pharmaceutical industry; promote an Australian presence at overseas technologies. NSW strength in this area will be class research strengths across the key life science – strengthened linkages between science, events will be explored. fields of biotechnology, and some outstanding technology and clinical expertise and with the promoted to attract businesses to establish in research organisations. NSW is also a significant manufacturing, business and financial sectors Linkages between NSW and California, Tokyo this State. and other centres under sister-state agreements generator of modern biotechnology IP. both within NSW and internationally; and 9. Support the biotechnology pipeline will be used to bring about cooperation between – increased exports and import replacement for to take basic research through The continued growth and development of our respective biotechnology industries and biotechnology products and services. development to commercialisation biotechnology should lead to the emergence encourage new commercial opportunities. of new products, companies and industries of Delivery: NSW Department of State and Regional major significance to the future economic and BioBUSINESS strategic initiatives This initiative will support applications by Development, with co-investors 8. Target world-class and export- NSW biotechnology companies to the new social health of Australia. The initiatives of the A key initiative will be to close the gap oriented products, services and Commonwealth Innovation Access Program, NSW Government’s BioBUSINESS program, between basic research and development to businesses with its focus on international access and are designed to widen and deepen the pool commercialisation. At one end Commonwealth of NSW biotechnology business, by: Delivery: NSW Department of State and Regional world-class expertise. Development and State programs support research in – better supporting the commercialisation of The NSW Government will continue to support universities and other institutions to generate products and services arising from the NSW Promote NSW’s biobusiness credentials the Australian Technology Showcase (ATS) and new knowledge. At the other end, industry and BioPLATFORM; This initiative will promote the attractiveness other promotional programs, by: the financial markets take on viable proposals – working with counterparts in the Federal of NSW as a desirable site to do business in – encouraging biotechnology companies through the commercialisation phase. Gaps in and other State Governments to grow the biotechnology. As Australia’s largest State with to become members of the ATS, which provides funding occur between the research and industry in Australia; Australia’s largest city and pre-eminent financial networking with local and international ‘investment-readiness’ stages. Often, early-stage – enhancing opportunities for small centre as its capital, NSW has a range of customers, assistance to enter new overseas assistance is required to meet non-research biotechnology businesses to grow and strengths – in research, science and technology; markets, and access to business support infrastructure costs for these new venture start- expand into international markets; and industry; science education. seminars targeted to the needs of technology ups. The Commonwealth Government is seeking – attracting new biotechnology investment companies; and NSW as a desirable location for biobusiness to reduce these gaps through the expanding into NSW. – supporting the activities of AusBiotech Ltd and and NSW biotechnology companies, will be Commercialising Emerging Technologies (COMET) other industry-related events. These new initiatives complement and build upon advanced by the NSW Government: Program and the new Biotechnology Innovation the successful business support programs that are – continuing to market and promote the State’s Fund (BIF). already in place and delivered by the Department competitive advantages for biotechnology of State and Regional Development (DSRD) companies; targeted at building the capacity of high growth, – increasing access to NSW companies and high potential companies. research institutions on the internet using portal systems; – continuing to showcase NSW as a major industry player in both national and international forums; and – co-investing in these initiatives with Austrade and Invest Australia.

20 21 Although the focus of commercialising Assist with non-research establishment costs Foster connections between investors and 10. Promote leadership and training biotechnology is on company formation and The New South Wales Department of State and biotechnology sector Delivery: NSW Department of Education development, other mechanisms – such as Regional Development will create a BioBUSINESS A broad strategic view will be taken in the design and Training, NSW Department of State licensing agreements, direct product sales expansion component within its Business of initiatives that aim to facilitate connection and Regional Development and strategic alliances – are relevant to the Expansion Program for delivery by skilled and between investors and the biotechnology sector. Professional Leadership Development Programs biotechnology industry. The type of commercial experienced business advisers, with biotechnology The initiatives will be developed taking into The NSW Government will establish Professional vehicle will vary from case to case. But ensuring backgrounds. This will assist biotechnology account sources of advice, professional assistance Leadership Development Programs (PLDPs), a stream of sufficient new quality business businesses with non-research establishment costs. and finance from both corporate and industrial with a focus on leaders of both start-ups and proposals, defined as ‘deal flow’, is of fundamental The program would complement the funding settings. Superannuation funds trustees and established entities from any segment of the importance. This will determine the current available from BIF, ATS and COMET and the others with critical decision-making roles biotechnology sector. This could include bringing and future environment for the biotechnology companies’ own contribution. Eligible expenditure will be included. The achievements of NSW’s together leaders of early stage biotechnology industry in NSW. could include recruitment and relocation biotechnology sector will be promoted through businesses to explore commercial growth issues expenses, legal fees, accounting, corporate the BioUNIT to the investment community. Commercialisation of biotechnology requires in cooperative learning groups. governance and reporting, and IP maintenance. more than the formation of start-up companies. Infrastructure support for start-up companies The PLDPs will: It requires skills to enter licensing agreements Management expenditure in companies Capital markets and industry are now becoming – provide mentoring, for example through and strategic partnerships. undertaking further innovation more active in seizing new, investment-ready a panel of experts who could act as DSRD will create a High Growth Bio component opportunities in biotechnology. In some cases this The NSW Government is proactively ensuring non-executive directors or business coaches within its High Growth Business Program. Funds is with the assistance of recent Commonwealth a sustainable funding pipeline for biotechnology for biotechnology businesses; will be applied to commercialisation expenditure incentives such as Innovation Investment Funds, to maximise benefits from the platform strategies – increase corporate governance skills in other than research. In newer companies, this Pooled Development Funds, and the Pharmaceutical through targeted assistance for the following start-ups, for example by working with the might include IP maintenance, accounting, market Industry Investment Program. Opportunities initiatives. Australian Institute of Company Directors; research and planning, pilot plant, prototyping, to leverage State Government investment with – seek to ensure that management and finance Support proof of concept administrative support, legal costs, and some sources of Commonwealth and private sector training in NSW is appropriately adapted The NSW Government will co-invest with either costs associated with gaining regulatory approvals. funding will be examined. for biotechnology, for example by working private sector funds (industry or finance) or the Eligibility requirements will be modelled on the Research ‘spin-out’ companies will be encouraged with business schools and the Securities proponent’s funds to contribute to the matching existing program, which includes a commitment to develop a business and industry focus. Institute of Australia; commitment of Commonwealth Government’s to either internationalisation or import-replacement A feasibility study will be specifically undertaken – liaise with the Australian Bankers Association new Biotechnology Innovation Fund (BIF). activity and a contribution by the companies to determine what infrastructure is required to launch a short Biotech for Bankers course for themselves. Through BIF a total of A$40 million over three to support research incubators in NSW. new players in the biotechnology sector; and years is available to successful applicants. The Outsourced Export Manager Program (OEMP) – ensure equity of access to leadership Promote export-readiness and reduce reliance These grants are to establish proof-of-concept will be adapted for biobusiness. The OEMP and training programs for biotechnology on imports and strategies for IP protection, business planning provides funds to eligible companies to obtain professionals in regional NSW, for example The global market for biotechnology products and market development studies. BIF applicants externally sourced advice on export strategies. through consultation with established providers and services is large and growing. There is an must provide dollar-for-dollar matching funds, of distance education. imperative for NSW to pursue export opportunities and State Government funds may be used to and to reduce reliance on imports. This initiative The role of education in ensuring the continued contribute to this purpose. will encourage biotechnology companies to growth of the biotechnology industry will be participate in the DSRD High Growth Business recognised through: and New Export Opportunities Programs. – seeking world’s best practice in the These programs will provide advice and assistance development of biotechnology education on issues facing fast-growing companies – for NSW school students; and particularly in preparing to enter export markets. – promoting achievements and successes in The initiatives will link with the Austrade Export the biosciences, with a view to encouraging Market Development Grants Program. people at all stages in the education system to choose a career in biotechnology.

22 23 BioETHICS

The challenge for Government is to optimise progress in medical and agricultural research and clinical practice so that the potential social, environmental and economic benefits can be made available to the community, while ensuring that appropriate ethical, safety and environmental standards are maintained 25 BioETHICS – There is growing community awareness of both the potential benefits of biotechnology applications – for example, in medicine, enhancing food quality and safety, waste management and environmental remediation – and the associated potential for unethical or high-risk conduct.

Rationale In undertaking this work, the initiatives will link Community attitudes to biotechnological The NSW Government will ensure that NSW’s – promote an equitable balance of benefits Access to biological resources The challenge for Government is to optimise with current developments in Commonwealth advances relate to issues of human and activities in biotechnology reflect community and risks; and Ownership of and access to biological resources, progress in medical and agricultural research biotechnology-related legislation and regulation environmental safety, and a range of questions values, particularly in relation to the ethics – ensure adequate consultation, advice and including plant and animal genetic resources, are and clinical practice so that the potential social, (for example, the Gene Technology Act), as well about the intrinsic ethics of some possible of genetic interventions in humans. In June 2001, monitoring of the bioethics agenda (including of strategic importance to NSW’s ability to develop environmental and economic benefits of as national guidelines (for example, the National applications – particularly the genetic the Council of Australian Governments agreed the activities of the Commonwealth’s Gene a competitive and sustainable biotechnology biotechnology can be made available to the Statement on Ethical Conduct in Research modification of humans. Broader ethical issues that all jurisdictions would achieve consistent Technology Ethics Committee) by establishing industry. This links to the germplasm initiatives in community, while ensuring that appropriate Involving Humans) and codes of conduct used by also arise, for example concerns relating to the approaches to the regulation of assisted expert groups as necessary, with advice from BioPLATFORM but focuses on IP, equity of access, ethical, safety and environmental standards professional bodies. allocation of resources, and equity of access to reproductive technology and related emerging the BioUNIT’s Bioethics Committee. trade and land management issues. The BioETHICs initiatives will be implemented the new technologies. human technologies. are maintained. 13. Develop and maintain NSW Market and trade issues within a complex State and Commonwealth The NSW Government will work with To deliver these objectives, Biotechnology Risk Management Plans NSW keeps abreast of international standards These matters do not fit neatly within legislative, organisational and regulatory context. the Commonwealth Government to: the NSW Government will: Delivery: NSW Agriculture, NSW Health including Codex Alimentarus, Biosafety Protocols either Commonwealth or State Government The key relevant Acts, regulations and agencies – assess the benefits, risks and associated and other relevant agencies, in collaboration to the UN Convention on Biological Diversity, jurisdictions. Rather, they require a coordinated are listed in Appendix D. – increase community awareness of the existing legislative and regulatory requirements for with the BioUNIT technical and trade agreements and other key and consistent approach. Accordingly, NSW will and future roles of traditional biotechnology, biotechnology involving plants, animals, market- and trade-related activities that will collaborate with the Commonwealth Government such as plant breeding, in our society; Develop and implement Biotechnology Risk BioETHICS outcomes humans and micro-organisms, on a case-by- impact on biotechnology in NSW. These will be and other States and Territories to ensure a sound – inform the community of new developments Management Plans for NSW, taking into account The outcomes of the bioethics program will be: case basis; monitored by the NSW Government (working national ethical framework for R&D in the relating to significant ethical, social, issues arising from the preceding initiatives, and – a rigorous, efficient and transparent regulatory – redress gaps where they are identified with industry associations) and communicated biotechnology sector. Consistency between environmental or legal implications giving particular attention to the following topics. system for biotechnology (particularly gene (for example through the emergence of through the communication initiative. Where Commonwealth and State/Territory regulation of biotechnology; technology) in NSW; new technologies). Where possible and Ethical evaluation and biological risk necessary or appropriate, the NSW biotechnology is desirable in this important area of social and – provide information about the benefits – a well informed community, and clear appropriate, this will include: This is the major source of community concern. sector will be encouraged and supported to take ethical policy. and risks of biotechnology and the related indications of community views on major – seeking consistent national legislation There is a need for both ethical evaluation and a proactive role in forging Australia’s position regulatory framework; Through its BioETHICS initiatives, the NSW bioethical issues; and and regulation; ongoing assessment of possible risks associated on these matters. – consult and liaise as widely as possible with the Government will proactively identify and manage – that the relevant agencies will have in place – ensuring linkage with existing mechanisms – for with, for example, research on human community on ethical issues – including Impacts on rural and regional NSW risks associated with biotechnology innovation. regularly updated Risk Management Plans, and example, by adopting NHMRC Guidelines; and embryos, the use of embryonic stem cells, consumer, scientific, health, environmental and Biotechnology is likely to bring substantial It will also engage with the community on associated Standard Operating Procedures to – building on a successful regulatory model – cloning, xenotransplantation, genetic screening, industry groups; benefits to communities and economies in rural biotechnology issues, promote informed debate deal with hazardous materials. such as the NSW Animal Research Act and gene therapy and engineering (somatic and – raise awareness and encourage discussion and regional NSW, particularly in agribusiness, and respond to community concerns in a timely its associated Review Panel mechanism, germline), the production of genetically modified of bioethical issues in NSW secondary schools; and to create associated opportunities for the manner. BioETHICS strategic initiatives or accreditation systems used elsewhere. foods, and the environmental effects of – when required, undertake or commission biotechnology industry. However there is a need 11. Promote informed community discussion – cooperate in the development of a nationally genetically modified agriculture. The BioETHICS initiatives focus on: research into ethical issues; and to minimise the potential for negative effects Delivery: BioUNIT in association with NSW consistent gene technology regulatory regime – promoting informed discussion on ethical – monitor public awareness and understanding For hazardous biological materials, risk (for example, on the viability of small farms) and Agriculture, the NSW Department of Education for genetically modified organisms (GMOs) and regulatory issues, and conducting proper of biotechnology-related issues. management plans and standard operating ensure equity of access for remote communities and Training and NSW Health – and in – plants, animals and micro-organisms; community consultation; procedures are already in place in relevant to new technologies. The risk management collaboration with the Commonwealth 12. Ensure a fair and responsible – establish procedures to ensure that existing – ensuring a fair and responsible regulatory agencies. These will be continually monitored planning process will identify and seek to address regulatory system regulations, legislation and enforcement system; and Community acceptance of the products of to ensure that new or revised plans are relevant issues for rural and regional NSW, Delivery: BioUNIT in association with relevant processes are responsive to new technologies; – developing and maintaining NSW Biotechnology ‘modern biotechnology’ will play a critical role developed in response to new risks. particularly in the agriculture and food industries. Risk Management Plans. in their successful application. It is therefore agencies and the Bioethics Committee – inform the NSW community of developments in bioethics, through the BioUNIT’s information imperative for the Government to consider and The NSW Government will cooperate with dissemination initiative; incorporate community views in regulating the the Commonwealth and other State/Territory biotechnology industry and its products. Governments to deliver a rigorous, efficient and transparent regulatory system for the biotechnology sector, which safeguards the community and environment against possible risks while acknowledging commercial considerations and community benefits.

26 27 BioUNIT

The NSW Government is providing high-level leadership to the State’s biotechnology sector. The Government’s commitment to implement, maintain and build on the BioFirst strategy over time is demonstrated by the establishment of the BioUNIT – a dedicated biotechnology unit accountable to the Premier. 29 BioUNIT – The BioUNIT will provide a locus of responsibility and expertise to assist the future development and growth of biotechnology in NSW.

Rationale BioUNIT outcomes – interface with the biotechnology sector – and – be supported in the leadership and Dissemination of information The NSW Government is providing high-level The outcomes from the BioUNIT will be: particularly with leaders and peak bodies such implementation of BioFirst by an Inter- A dedicated web portal will disseminate information leadership to the State’s biotechnology sector. – high level Government leadership driving as AusBiotech Limited (previously the Australian Departmental Coordinating Committee to all segments of the NSW biotechnology The Government’s commitment to implement, implementation and further development Biotechnology Association) – in the design, comprising representatives from NSW Health, industry, in order to improve communication maintain and build on the BioFirst strategy over of the BioFirst strategy; monitoring and delivery of programs; and the NSW Department of State and Regional between all biotechnology industry stakeholders. time is demonstrated by the establishment of – a rigorous evaluation of policy and regulatory – monitor the impacts on NSW of developments Development, the NSW Department of This will include the scientific and research the BioUNIT – a dedicated biotechnology unit framework and industry outcomes; affecting biotechnology, including emerging Education and Training, NSW Agriculture community, venture capital market, business accountable to the Premier. – engagement with the community on trade and regulatory frameworks. and Treasury. and investment sectors, Government and biotechnology-related issues; and members of the general community. The leadership provided through the BioUNIT will: Strategic policy framework A NSW Biotechnology Patron will be appointed – increased dialogue among all involved in – promote NSW as a competitive leader The BioUNIT will oversee the implementation and will report directly to the Premier. This will The web portal will be a ‘one-stop shop’ biotechnology – science, industry, business, in biotechnology, both nationally and of the BioFirst strategy and further develop the be a the part-time appointment of an for all biotechnology stakeholders. It will: finance, manufacturing, government internationally, and provide a primary point whole-of-Government approach by working eminent individual with broad experience and – maintain reference material, an up-to-date and the community. of contact for the biotechnology community; with Government, business and the community understanding of the sector, and a national biotechnology community contact list – ensure a coordinated approach to the to deliver strategy outcomes. It will coordinate profile and credibility within the biotechnology and a stakeholders’ database; development, funding and implementation BioUNIT strategic initiatives further biotechnology policy development in community. The Patron will chair the BioFirst and – promote the free exchange and use of data of biotechnology-related policy; 14. Establish a BioUNIT NSW, as it relates to Government departments BioETHICS Committees, traverse segments linking regarding industry composition, trends – give the broader community a common Delivery: The NSW Cabinet Office and the research, industry and investment sectors. to the NSW Government, increase cohesion and and performance; and identify needs. The Patron will be an advocate – work with key Government agencies to sponsor entry point into Government processes relating Advice and communication A key role for the BioUNIT will be to monitor for the NSW biotechnology industry and advise selected industry-driven events that foster to biotechnology; The BioUNIT will be an identifiable and and evaluate the implementation of BioFirst, the Premier, senior Ministers and Department awareness of, and networking within, the – signal the Government’s participation accessible hub for information about the NSW using quantitative measures where possible Heads (via the Inter-Departmental Coordinating biotechnology sector – with the objective of in international and national forums; and biotechnology sector, providing stakeholders (for example, FTE employment, export revenue Committee) as required. delivering world-class events on par with – raise the profile of biotechnology and the general community with contact, advice earned, citation indices). those held in the USA, the EU and Asia. in the research, business and investment and referrals relating to biotechnology activity 15. Monitor and communicate The BioUNIT will take a leadership role and be sectors and the broader community. and key developments. It will also provide developments responsible for driving the achievements of the information about biotechnology-related NSW Delivery: BioUNIT, working with relevant The BioUNIT will also evaluate the benefits gained BioETHICS initiatives through monitoring and Government programs. Government agencies where appropriate through the implementation of BioFirst. communicating developments, promoting Evaluation will involve a review of the strategy’s In particular, the BioUNIT will: leadership and facilitating a coordinated Research appropriateness, efficiency and effectiveness, – promote NSW biotechnology investment approach to bioethical issues. Empirical evaluation of performance will be partly based on the outcomes stated below. opportunities to the business and investment a key element in the implementation of BioFirst. Structure It will also benchmark NSW’s performance in community – within NSW, nationally The BioUNIT will work with key agencies to drive The BioUNIT will be established in The Cabinet biotechnology against that of comparable and internationally; the evaluation process, by: Office and be accountable to the Premier. economic regions in countries such as Canada, – work to broaden community understanding – auditing biotechnology R&D, training, clinical Ireland, Israel, Singapore and the USA. about biotechnology; In carrying out its functions, the BioUNIT will: and commercial activity in NSW; – keep abreast of the delivery of biotechnology – work with the Ministerial Advisory Council – using quantitative measures to monitor programs – including those of the OECD on Biotechnology; performance, especially of bioscience; and other international policy agencies, – be advised by a new reference group – reporting against health, agricultural, the Commonwealth Government, Australian on bioethical issues; and environmental and other biotechnology- State/Territory counterparts, State Veterinary related priorities and needs; and and Health Officers – and inform – tracking available performance indicators and the NSW biotechnology and general monitoring trade and regulatory developments, community as required; together with policy trends in other jurisdictions.

30 31 Australia Sydney

Location of key research organisations in New South Wales

32 33 BioFirst: Building on our success stories

Bioinformatics The Centenary Institute of Cancer The Cooperative Research Centre The Elizabeth Macarthur The Garvan Institute of The Hunter Medical Research Institute Bioinformatics, which underpins modern Medicine & Cell Biology for Cardiac Technology Agricultural Institute Medical Research The Hunter Medical Research Institute (HMRI) molecular life science research and education, The Centenary Institute of Cancer Medicine The Cooperative Research Centre for Cardiac Research scientists at the Elizabeth Macarthur The Garvan Institute of Medical Research is a strategic partnership between Hunter Health, is one of the newest areas of biotechnology. Its & Cell Biology (The Centenary Institute) is one of Technology (CRC-CT), the only hospital- Agricultural Institute (EMAI) near Camden (The Garvan) was established under its own The University of Newcastle and the business and industry potential is strong: recent research the independent medical research organisations headquartered CRC, was based at the Royal are engaged in biotechnological and molecular Act of NSW Parliament in1984. It is the civic communities of the Hunter Valley. Its aim estimates that the bioinformatics market will be supported by the NSW Government’s R&D North Shore Hospital to foster research leading to biological projects at an internationally largest medical research institute in NSW is to develop the Hunter region as a centre for worth at least US$1 billion by 2005 and will reach Infrastructure Grants Program. Its research the commercialisation of IP. competitive level. and a cornerstone of the St Vincent's knowledge-based enterprise. US$5.4 billion by 2010 – a tenfold increase from portfolio is specifically designed to complement Biotechnology Research Precinct. Its molecular In recognition of its initiative in establishing EMAI provides diagnostic, research and advisory Today HMRI unites and coordinates the activities its present base of US$468 million. In 2000 there the programs of other major NSW centres. and clinical programs focus on the genetic basis Elastomedic (now renamed AorTech Biomaterials), programs to the cattle, sheep, intensive livestock, of 300 researchers on six major sites. Their were 24 major bioinformatics companies The Centenary Institute has strong clinical links of diseases, including cancer, diabetes, arthritis, a high-tech biomaterials company, the CRC-CT cropping, horticultural and floricultural industries. activities presently attract approximately A$12 worldwide, and 42 other players. These numbers for translational research, and an established asthma, osteoporosis and mental illness. 17 received the 2000 CSIRO Medal for Business As NSW Agriculture’s leading research laboratory million per year in research funding, with will rise sharply. track record in both internationally recognised Excellence, and was ranked among the nation's for developing and applying biotechnology, it The Garvan is an international leader in forging considerable capacity for growth. NSW has the strongest and fastest growing research and commercial development. To date top-achieving CRCs by the CRCs Association, also provides cost-effective solutions in the innovative links with the pharmaceutical, HMRI is Australia's only regionally based, bioinformatics sector in Australia and the it has attracted over A$70 million in R&D funding. Canberra. surveillance, prevention, control and diagnosis biotechnology and finance industries. comprehensive, health and medical research Asia-Pacific. It is home to: CenTec Pty Limited was set up by the Centenary of animal and plant diseases, and in the rapidly Its commercial activities span material and institute. It covers the full spectrum of health and – Entigen Corporation (formerly eBioinformatics The CRC-CT sold its share in Elastomedic within Institute to streamline the commercial application of developing areas of food safety and intellectual property licenses, research medical research – from health service evaluation Pty Ltd) – Australia's first and largest 18 months, allowing it to return $A26 million its research portfolio. It is currently focused on nutraceuticals. collaborations and product development and public health, through clinical care and bioinformatics company cash to its Participating Institutions, among them developing bio-drugs/vaccines and platforms for partnerships. The Garvan has generated over diagnostics to basic biomedical science. – the Australian National Genomic Information two major hospitals. EMAI has extensive research links with monoclonal antibodies and gene therapy. A$16 million of revenue from commercialisation Infrastructure funding from NSW Health was an Service (ANGIS) – Australia's national universities via postgraduate research programs An 85% completion rate of industry-ready PhDs activities since 1996. This income has helped essential catalyst in HMRI's strategic planning to bioinformatics facility and collaborative research projects. It also has was another outstanding achievement of this CRC. leverage support from granting agencies and focus and capitalise on its particular strengths – – the Australian Proteomics Analysis Facility access to equipment and technologies located donors, accelerating further research progress. cancer; pregnancy and reproduction; vaccines and (APAF) at a number of other regional, national and immunity; asthma and respiratory disease; mental – the Clive and Vera Ramaciotti Centre for international institutes. The Garvan’s successful business initiatives are based on world-class medical research together health and neuroscience; cardiovascular disease Gene Function EMAI undertakes molecular-based research with its proactive process for identifying, and stroke; ageing; the social determinants of – the Australian Technology Park (ATP) – where to identify and characterise bacterial, fungal, viral evaluating and protecting the IP generated by health; health services research; and clinical trials. the commercialisation of biotechnology and and insect pathogens of plants and animals, and its researchers. This has helped create a portfolio IT is nurtured to reduce microbiological hazards in livestock and HMRI has pioneered an integrated research of over 30 patents and patent applications. – high-performance computing initiatives livestock products. model that emphasises: eg Vislab, Australian Centre for Advanced The completion of the human genome project – multidisciplinary research groups spanning Computing and Communications (AC3) has created rapid changes in the international public health, clinical care and basic science – bioinformatics undergraduate education biotechnology marketplace. Business models approaches to a common problem; and programs –the BSc (Bioinformatics) course that were successful only a few years ago are no – the integration of research with postgraduate at the (now in its fourth longer viable. Rather than licensing valuable IP and undergraduate training, health care year); and new courses at both the University early for short-term, rapidly diminishing financial delivery, commercial development of Western Sydney and the University of NSW returns, the Garvan is increasingly advancing and the community. partnerships with investors in order to create new HMRI's integration with the health service on one companies for developing technologies and hand and the business community on the other products to the more advanced stages required ensures that both the practical applications and by the global marketplace. By managing the the commercialisation potential of research attendant risks and focusing on long-term and findings are prioritised, with excellent results. potentially much larger returns, the Garvan is For example, HMRI researchers have shown that helping to develop a new model of a modern the introduction of an enzyme test for more research institute that links world's best medical accurately predicting the risk of preterm delivery research programs with strategic in pregnant women resulted in a 90% reduction commercialisation initiatives. in false diagnosis, substantially reducing the costs and inconvenience associated with unnecessary hospitalisation.

34 35 The New Children’s Hospital at Proteome Systems Ltd ResMed The Tamworth Centre The Victor Chang Cardiac Wagga Wagga Agricultural Institute Westmead Vector Production Facility Protein science has been less neglected in ResMed is a leading Australian respiratory for Crop Improvement Research Institute Molecular Biology Research Unit An essential requirement of gene therapy Australia than elsewhere in the world, with the medical device company, specialising in products The Tamworth Centre for Crop Improvement The Victor Chang Cardiac Research Institute Using the new scientific techniques of molecular research and clinical evaluation is the ability result that the world's first national proteomics for the diagnosis and treatment of sleep (TCCI) has a long history as a wheat breeding (VCCRI) is achieving ongoing success in biology, the Molecular Biology Research Unit at to transfer healthy genes into diseased cells facility was built at Macquarie University in 1996. disordered breathing (SDB). centre. It maintains the Australian Winter Cereal commercialising its R&D into heart disease and the Wagga Wagga Agricultural Institute (WWAI) Proteome Systems Ltd (PSL), one of the world’s has achieved rapid progress with the facilities and tissues. This is achieved with gene transfer In 1999 and 2000, ResMed made Fortune’s Collection and coordinates the national durum heart transplantation. Such commercialisation first dedicated proteomics companies, was spun currently available. Further investment in this formulations known as vector stock. Top 100 Fastest Growing Companies in America wheat and chickpea programs and the NSW is an essential component of the business of out of that facility in 1999. research will ensure that WWAI maintains its and, for the past four years, ResMed has lucerne improvement program. TCCI also research institutes in the new millennium. In 1999, researchers at The New Children’s position as a leading institution in the area of Proteomics can substantially reduce the time been on the Forbes list of the 200 Best Small participates in major interstate soil management Hospital at Westmead identified the need The VCCRI currently has three provisional patents plant improvement for more sustainable and it takes to develop new products and processes Companies in America – the most recent ranking and farming systems research programs. for an Australian/NSW vector production facility. in place, and one full patent. The full patent profitable farming systems. At that time clinicians and researchers in Australia in biotechnology. Proteomics is currently was 34. Ninety of TCCI’s 140 staff members are directly (shared with other research groups) relates used in drug discovery, disease diagnosis and The WWAI Molecular Biology Research Unit imported vector stock from America at a high ResMed manufactures nasal systems for the involved in research into plant breeding and to a specific gene. The provisional patent topics characterising desirable traits in plants, animals aims to: cost. Following a modest financial investment, home treatment of SDB, with a range of sustainable agriculture. Genetics, microbiology relate to cell growth inhibition, muscle cell and micro-organisms. – develop novel genotypes that will enhance hospital staff can now produce vector stock ventilatory support systems for the treatment and biochemistry account for approximately differentiation and the role of 'junk DNA'. the profitability and sustainability of crop locally for a fraction of the cost of importing Since 1999 PSL has been assembling a definitive of adult patients with respiratory insufficiency 40% of research time. Research areas include: Research continues into these projects, and production; and the stock from overseas, making it more readily proteomics platform by building strategic alliances or respiratory failure. ResMed also manufactures – plant breeding (durum wheat, chickpea, commercial development will be investigated – achieve a broader understanding of the genetic available to Australian researchers and clinicians. with major corporations (including Sigma and air delivery systems (eg nasal masks, headgear faba bean, lucerne, canola, barley); at the end of 2001. – plant pathology and soil microbiology; and mechanisms controlling expression of qualitative NSW is unique in Australia and the Asia Pacific Millipore of the USA, and Shimadzu of Japan). and tubing to connect the system to the patient) In 2001 the VCCRI has attracted interest – biochemistry – food products and pesticide and quantitative traits in crop plants. region for being the first to establish a facility The Proteomics Alliance – an alliance with Sigma plus humidifiers and other accessories aimed in commercial collaborations from three resistance mechanisms in insects. to produce high-grade vector stock for the local and Shimadzu driven by PSL – is now beginning at improving patient comfort, convenience separate companies in Australia and the USA. A group of four scientists and two technicians research community. The New Children's Hospital to be publicised. PSL’s proteomics platform (an and compliance with therapy. The company TCCI’s plant breeding programs (undertaken The collaborations, which range from micro-array is working to meet these objectives by producing at Westmead Vector Production Facility has the integrated set of new instrumentation, kits and also markets a growing range of sleep in collaboration with commercial partners) have development to embryonic stem cell technology doubled haploids, constructing genome maps capacity to produce sufficient vector stock to consumables linked by the use of informatics) laboratory products. released 10 new varieties during the last three and gene therapy, are expected to earn using molecular techniques and validating the will shortly be marketed for US$1.5–2 million. qualitative and quantitative effects of genes in meet the current needs of researchers and Strategic alliances with other market leaders years, raising over A$700,000 in gross royalties. A$250,000 in the first year and provide extensive It is expected that the first proteomic platforms field trials. clinicians across Australia. – for example, with the Icelandic company In 2000 it received approximately A$1.75 million benefits downstream. will be sold as an early access system to the US Flaga hf., whose multi-channel sleep recording in external funding for biotechnology research. The molecular marker-based analyses are being by the end of 2001. The VCCRI is currently investigating the commercial equipment complements ResMed's innovative development of a cardiac diagnostic device with used to fast-track the selection of plants for: The platform will also be offered to universities range of diagnostic devices – enable ResMed an estimated initial value of A$300,000–400,000. – tolerance to nutrient toxicities, with multiple and research institutes across Australia. to offer a comprehensive suite of products. The VCCRI and its researchers expect to sell the sources of resistance to diseases/pests; – resistance to pests and diseases that are not Obstructive Sleep Apnoea (OSA) affects rights to this technology within the next six yet present in Australia; and millions of people worldwide. Its prevalence months. The resulting commercial income earned – quantitative (multi-gene) traits (eg malting is comparable to that of asthma or diabetes, by the Institute will be re-invested into ongoing quality plus grain quality in barley). but awareness is low and only around 5% of employment and research within the VCCRI. sufferers are diagnosed and treated. However, understanding of the morbidity and mortality caused by SDB is increasing, together with recognition of the association between SDB and common diseases such as chronic obstructive pulmonary disease, stroke, and cardiac disease. As a result, SDB is one of the fastest growing segments of the respiratory industry. ResMed is moving quickly to seize these exciting opportunities by developing algorithm-based software and related hardware to treat SDB.

36 37 Biometrics Research Unit Xcelerator Ltd – Bioentrepreneur Bioremediation DNA Testing in NSW Policing The Australian Technology Park (ATP) Crop improvement programs rely on breeders Xcelerator is a professional biobusiness incubator Xcelerator’s Bioentrepreneur business unit Bioremediation is an application of biotechnology As part of the move to intelligence-driven The ATP is a focus for incubation and breeding assessing the genetic merits of breeding and that provides complete support to start-up develops and presents continuing education that cleans up contaminated waste sites and policing, DNA testing for the investigation of for start-up companies. It has functioned unique lines, based on the timely and accurate companies working in the biotechnology sector, workshops on business development for those mitigates the impact of environmental accidents serious offences, often called ‘the fingerprints of successfully as an incubator for about 40 analysis of yield and quality data. They also rely within an environment and infrastructure that working in the life sciences. As well as servicing such as oil spills. the 21st Century’, has been introduced into NSW. companies in the IT and electronics / engineering on the results of such analyses being reported nurture sound development and rapid growth. a gap in the market, Bioentrepreneur fulfils This application of biotechnology will be used to areas. Their development has led to several In NSW the latest innovations in design and in a uniform and appropriate manner. Xcelerator is currently the only privately funded Xcelerator’s commitment to developing, educating find and convict the guilty, to clear up unsolved prominent high value companies. environmental technology were used to create incubator of its type operating in Australia. and growing the life sciences biobusiness sector crimes and to acquit or free the innocent. Blood, Since 1986 the Biometrics Research Unit at the the Millennium Parklands out of wasteland in The Biomedical Building currently contains in Australia in line with world’s best practice. semen, sweat, a flake of skin or even an eyelash WWAI has been developing advanced statistical Xcelerator has three key aspects to its business: Homebush Bay, Sydney, in time for the 2000 Johnson & Johnson Research as a major tenant, An online resource for biobusiness startups has taken from a crime scene may be used to catch methodologies for improving the response – Biobusiness incubation Olympic Games. plus Aoris Nova, IPC Firefly, and Clinsoft. Other been established at www.bioentrepreneur.net the offender. to selection for yield and other traits. These Xcelerator offers a range of facilities, professional companies elsewhere in the ATP have interests in As part of the bioremediation strategy, methodologies now form the basis of the services and skills to assist both early stage Companies currently in incubation Under legislation that commenced on 1 January the biomed area and would benefit through the contaminated waste found at Homebush Bay analysis and reporting of the majority of crop biotechnology start-up companies and existing at Xcelerator include: 2001, police may take saliva or hair samples from: major development in the area. In particular, the was relocated and contained into four managed, improvement data in Australia. They have also companies entering the expansion phase. At its – Biotechnology Frontiers (BTF) Pty Ltd – persons arrested for or suspected of committing strengths of the ATP in electronics and IT will consolidated mounds. The fill was then capped been widely adopted overseas, through joint premises located in the 'Biohub' at North Ryde, offering a range of products designed a crime; prisoners serving sentences for offences influence intake to the park in areas such as with one metre of clay and landscaped to create ventures with CIMMYT (Mexico) and it provides office space, wet lab space, meeting specifically to facilitate rapid, accurate carrying terms of five years or more; or persons medical diagnostics, biomedical devices and natural looking hills. Leachate – contaminated Rothamsted (UK). facilities, communications infrastructure and other testing for Cryptosporidium and Giardia who voluntarily provide samples. DNA data that bioinformatics. Bioinformatics already has in environmental samples waste water from the fill – is collected by drains Recent achievements of the WWAI Biometrics shared resources, access to mentors, access to has been collected are matched against all other a presence in the Park through Epigen with – Asia-Pacific Clinical Pty Ltd – a consulting dug into the clay and removed for treatment. Research Unit include: business development networks and facilitation crimes on the DNA database. potential use of the AC3 Supercomputer. company providing a range of development This ensures that people, plants and animals are – developing a unified model to examine of access to capital. and consulting services in the biomedical protected from exposure to pollution. Excess A package of stringent safeguards against abuse genotype by environment interactions; – Commercialisation and advisory services and discovery life sciences. It offers a broad non-contaminated waste was formed into five of the system has been introduced including – releasing a statistical analysis computer package Xcelerator assists biotechnology businesses with spectrum of services to the international Millennium Markers shaped as geometric cones. oversight of the legislation by the Ombudsman, (together with its commercial partner VSN (UK)); all aspects of commercialisation – from project pharmaceutical, biotechnology and medical an independent custodian of the DNA database, – developing an integrated relational database A series of irrigation and habitat ponds have been evaluation, due diligence and business planning device industries, designed to enable them and criminal penalties for misuse of the database. for crop improvement programs; constructed as part of the Millennium Parklands through to introductions to potential investors. to gain entry into the Asian and Pacific – developing an integrated relational database Wetlands Corridor. The three main irrigation healthcare market for molecular mapping in barley; and It can also assist investors by evaluating the potential ponds play an integral role in the Wetlands – implementing and developing a fully efficient of opportunities within the biotechnology sector. Corridor water harvesting and irrigation scheme, quantitative trait loci analysis that detects key storing stormwater run-off and recycling it for markers more accurately. irrigation, greatly reducing the demand for potable water on site. The smaller ponds have been planted with native freshwater plants and provide successful wetlands habitats for birds and aquatic fauna. Bioremediation is also being put to work in rural NSW, where about 1,600 abandoned cattle tick dips sites contaminate the soil with arsenic and organochlorines. NSW Agriculture researchers at the Wollongbar Agricultural Institute have identified a combination of bacteria that can break down the dip chemicals. This has proven successful in small batches. A commercial partner has been identified and trials are planned to undertake batches of several tonnes of contaminated soil.

38 39 Views from within the NSW biotechnology sector

‘Biotechnology has had ‘Biotechnolology is a ‘We are now in ‘Most developments ‘Our aim is to ‘With more of its the initiatives because ‘The potential for ‘The completion ‘There are great ‘One of the key ‘Initially this may an enormous impact global industry and the most exciting phase in agriculture and formulate an integrated technical and human of the obvious benefits turning biotechnology of the first “draft” opportunities presented platforms for change not involve genetic on viral diseases. All Sydney, the capital of of the biotechnology agribusiness occur strategic plan for resources located for growing the skills towards positive of the human genome by the new revolution in the medical research engineering but common viral genomes New South Wales is revolution in cancer. incrementally, and are the development of in regional and rural base, business potential environmental sequence represents in biotechnology but it sector revolves around techniques will be used have now been Australia's global city, Biotechnology has based on technological core research and areas than any other and employment for protection is significant. the culmination of two will take skill, resources, the creation of critical for gene discovery, use sequenced. Knowing and gateway to the the produced spectacular advances made biotechnology centres State, NSW has an the region. A good As we look to tackle decades of exciting vision and tenacity if mass among its of genetic markers in the sequence of key rest of the world.Sydney advances in in response to the in conjunction unprecedented example is the the next generation research which has we are to exploit them. scientists. Given that variety development human viruses has is Australia's leading understanding the competitive pressures with industry opportunity to harness overwhelming support of tough environmental changed forever With strategic one of the primary and the creation allowed the cloning centre for business and structure and function of a world market. and Government the potential of for Hunter Medical issues, whether they concepts of investment now, objectives of science of new products. of important viral financial services, of the human genome, Modern biotechnology partnerships by sharing regional communities Research Institute by be in remediating pharmaceutical Australia has the is to sponsor individual Application of proteins for use in including venture and of the biological presents the opportunity the expertise, resources for research and the people of the contaminated sites or development and necessary skills to investigator-initiated, biotechnology in diagnosis and vaccines. capital. It is also home building blocks that for a steep change and infrastructure development, Hunter.’ turning waste to useful preventative medicine. compete in several curiosity-driven varietal improvement The first recombinant of the Australian Stock determine essential in agriculture and within the network. particularly in the products such This paradigm shift areas of the new fundamental research, will ensure faster DNA vaccine, Hepatitis B, Exchange. differences between agribusiness – in It is clearly an ultimate areas of health and Professor John Rostas as composts, soil in medical research has technology. However, it is now critical that development and has been enormously cancer cells and normal production efficiencies, goal to bring novel agriculture. The Director, Hunter Medical conditioners or energy, spawned the the competition is we garner these skills greater certainty. New ‘The interaction successful and of great cells. Now these the quality and diversity drugs and devices challenge is to establish Research Institute biotechnology brings development of strong and the window into an overall framework products and variety between the our importance as more advances are being of products and in that will benefit organisations that will opportunities for a biotechnology industry of opportunity is of infrastructure and types will ensure a biotechnology research than 200 million people converted into “smart” the environmental the community into harness this local innovation and and has fundamentally limited, if we are to be commercialisation greater product range capacity, and the access are infected with drugs that specifically impacts of agriculture. the market. support and resource ‘Biotechnology has promoting altered the relationships successful and enjoy support. The concept and cement the industry’s to capital that Sydney Hepatitis B worldwide cripple the process The world must work base. The establishment potential to reduce sustainability. between academic the benefits to of “clustering” will place as an important provides will be the key and this virus causes of unchecked cell its way through Professor Carol Pollock of research and significantly the research and industry. mankind – the greatly enhance food producer. to turning basic and ‘One of the NSW liver cancer. proliferation, invasion the accompanying Co-ordinator, BioMed technology hubs –- current reliance on significant economic research interaction applied research into Environment Protection ‘Australia, by virtue of ‘Failure to adequately and spread into social issues in North either clustered around chemicals, providing returns and employment and, most importantly, ‘New antivirals commercial products Authority’s important its excellent educational invest in biotechnology other tissues that an objective way a geographic centre or new and long-term opportunities – that will create major cost- are constantly being and outcomes that will approaches is working standards, outstanding will see the Australian characterises cancer in order to realise distributed throughout solutions to agronomic certainly follow.’ saving efficiencies and produced by small, benefit the people of to turn business health care system and industry quickly lose its development. Drugs the promised benefits. ‘Use of biotechnology a region or the State problems and offers greater effectiveness.’ start-up biotechnology New South Wales and innovation towards strong agricultural base, competitive advantage like Herceptin NSW, as the country’s will assist Australia’s and coordinated substantial benefits Professor Denis Wade AM companies (often built Australia.’ environmental is well placed to play in the marketplace to for the treatment leading State, is animal industries to as a network – offers to the environment. Chair, Innovation Council Peter J Wills, AM around individual protection and a significant role major competitors such of breast cancer and must remain in remain free from disease an arrangement that ‘Biotechnology offers of New South Wales researchers and then Cr Lucy Turnbull reducing risks to public in this worldwide as USA, China and and STI571 in the the vanguard of these threats such as foot is flexible and dynamic, huge opportunities for sold on to large Deputy Lord Mayor health. We also want development, as well as Japan and some large treatment of leukaemia, exciting developments.’ and mouth disease. can readily incorporate controlling serious soil- ‘The biotechnology pharmaceutical the to encourage new being at particular risk private companies that are just two examples centres for key borne diseases in revolution has already companies) – for ‘Biotechnology will biotechnology if we fail to proactively have already embraced of these designer drugs Dr John Keniry platform technologies cotton such as fusarium begun to impact example, many anti HIV be essential in the approaches to be incorporate these rapidly the technology.’ of unprecedented Chairman, and fits well with the wilt. on rice industries drugs and also the “L” ‘The biotech sector development of new designed in a way that developing technologies specificity and potency.’ Ridley Corporation notion of encouraging throughout the world. Dr Laurie Lewin drugs for treatment is set to provide diagnostic tests used ‘The new approach is scientifically sound, into the fabric of our collaboration and Australia must lead in of hepatitis B.’ venture capital business for disease surveillance to controlling these and protects the diverse activities. Director CRC Professor Michelle resource sharing. This application of these with more exciting and monitoring. types of diseases environment and for Sustainable Haber model is especially ‘By Australian standards techniques to remain Rice Production. Professor opportunities than the and pests could have human health in an Director, Children’s Cancer ‘Maintaining a disease suitable for regional NSW has an established competitive in the Tony Cunningham Internet ever could. a huge impact open and transparent Institute Australia free dairy industry will communities. If these R&D reputation production and Director, The Westmead Australia enjoys some on Australia’s other manner.’ for Medical Research ensure our export communities are and importantly, marketing of rice – an Millennium Institute clusters of world-class cropping industries, markets continue to actively involved in the a strong track record industry largely based excellence in this including pulse, cereal Kerry Schott grow, returning process, they will in entrepreneurial in NSW and worth over sector; let’s grasp and coarse grains.’ Chair, NSW Environment valuable export embrace approaches to add value $600 million with more the opportunity now. Protection Authority earnings to Australia.’ and support to our research.’ than $400 million in Policy makers should John Grellman export sales each year. unapologetically back Chairman of the Board Winston Watts Professor John Shine this sector in as a of Cotton Seed Chief Executive Officer, The Garvan Institute “winner” for Australia.’ Distributors Ltd and cotton NSW Dairy Farmers’ grower, Merah North Bill Ferris AO Association. Executive Chairman, Castle Harlan Australian Mezzanine Investments Pty Limited 40 41 Appendix A Appendix B

Members of the NSW Ministerial Advisory Organisations and individuals consulted Professor Richard Christopherson Dr David Harrison Professor Carol Pollock Ms Sarah Tritsch Caplan Council on Biotechnology The Strategy was developed by an Inter- The University of Sydney Former CEO, Biotech Australia P/L Royal North Shore Hospital The Cabinet Office Chair Departmental Working Group chaired by Professor Gary Cobon Dr T J Higgins Professor Bill Rathmill Ms Rowena Tucker Councillor Lucy Turnbull Associate Professor Steven Boyages NSW Health Australian Proteome Analysis Facility CSIRO Division of Plant Industries Quality Wheat Care CRC Ltd NSW Health Deputy Lord Mayor, City of Sydney Council With assistance from Dr Lindsay Cook Dr Kelvin Hopper Dr Julio Rebeiro Councillor Lucy Turnbull Representatives Dr Kate Grenot NSW Agriculture Aoris Nova P/L Sigma Aldrich P/L City of Sydney Council Dr Kelvin Hopper Director, BCP Investments Pty Ltd Managing Director, Aoris Nova Pty Ltd Ms Lisa Corbyn Professor Stephen Hunyor Mr Stephen Robinson Mr Brian Waddington The following individuals and organisations NSW Environment Protection Authority Cardiac Technology Centre Start Up Australia P/L NSW Treasury Professor Rick Kefford were consulted and/or provided submissions Department of Medicine, Westmead Hospital during the preparation of this Strategy. The NSW Dr Bill Cowie Dr David Irving Professor John Rostas Dr Denis Wade Government thanks them for their contributions. NSW Health Biotech Australia P/L Hunter Medical Research Institute Johnson & Johnson Research P/L Dr John Keniry Chairman, Ridley Corporation Mr Jan Aalders Professor Tony Cunningham Professor Lesley Johnson Professor Peter Rowe Dr Bradley Walsh NSW Department of Information Westmead Millennium Institute University of Technology, Sydney Children's Medical Research Institute Australian Proteome Analysis Facility Professor Stephen Leeder Technology and Management Chair Research & Development & Advisory Ms Karen Dado Professor Rick Kefford Ms Susan Ryan AO Ms Carolyn Walsh Committee NSW Health Mr Geoff Allen Pricewaterhouse Coopers The Westmead Millennium Institute Australian Institute of The Cabinet Office NSW Fisheries Superannuation Trustees Mr Michael Reid Ms Mary Darwell Dr John Keniry Associate Professor Tony Weiss Director-General, NSW Health Dr Dave Anthony The Cabinet Office Ridley Corporation Mr Glen Sanford The University of Sydney Auscott Limited Deloitte Touche Tohmatsu Professor John Rostas Dr Shanny Dyer Professor Stephen Leeder Mr Robert Wheeler Director, Hunter Medical Research Institute Dr Claire Baxter Avax Australia P/L The University of Sydney Dr Helen Scott-Orr NSW Department of Information NSW Innovation Council NSW Agriculture Technology and Management Dr Bernadette Tobin Mr Walter Edgar Ms Catherine Livingstone Director, Plunkett Centre for Ethics in Healthcare Professor Jim Bishop MicroMedical Industries Ltd Company Director, Dr Richard Sheldrake Dr Keith Williams Sydney Cancer Centre former CEO Cochlear Limited NSW Agriculture Proteome Systems Limited Professor Denis Wade Mr Mario Falchoni Chairman & Managing Director, Associate Professor Steven Boyages Office of the Minister for Health Dr Tim Littlejohn Ms Jeanette Sheridan Johnson & Johnson Research Pty Ltd NSW Health Entigen Pty Ltd NSW Health Dr Leigh Farrell Dr Mark Bradley Johnson and Johnson Research P/L Professor John Mattick Professor John Shine AO Xcelerator P/L Institute For Molecular Bioscience, Garvan Institute of Medical Research Ms Lynette Foulkes Queensland Dr Samuel Breit New South Wales Department of State and Dr Barry Slobedman St Vincent's Hospital Regional Development Dr Calum McKinley The Westmead Millennium Institute Allcofell Mr Jamie Callachor Dr Peter French Dr Nigel Steele-Scott New South Wales Department of State St Vincent's Hospital Mr David Michaels CSIRO Division of Plant Industries and Regional Development NSW Department of Education and Training Professor Robert Graham Professor Collin Sullivan Mr Peter Carre Victor Chang Cardiac Research Institute Dr David Mitchell ResMed Limited WebHub Ltd Parallel Biotechnologies Pty Ltd Professor Peter Gray Ms Linda Taylor Professor David Celermajer The University of Sydney Mr Andrew O’Connor The Cabinet Office Royal Prince Alfred Hospital The Cabinet Office Professor Michelle Haber Dr Lyndal Thorburn Professor John Chalmers AC Children’s Cancer Institute Australia Dr Greg Pearce Advance Consulting and Evaluation Pty Ltd The Institute for International Health for Medical Research Pharmacia Australia P/L Dr Bernadette Tobin Mr Bruce Christie Plunkett Centre for Ethics in Healthcare Elizabeth Macarthur Agricultural Institute

42 43 Appendix C

Some biotechnology, pharmaceutical Ag-food Diagnostics and biologicals 3M Pharmaceuticals Pty Limited Thornleigh Pharmaceutical and Human Therapeutics and related companies in NSW18 This sector covering both plant and animal This sector has similarities to the Pharmaceutical Abbott Australia Pty Limited Kurnell Pharmaceutical and Human Therapeutics The following table shows examples of (livestock and domestic animals) biotechnology and Human Therapeutics Sector. The focus is on biotechnology, pharmaceutical and related ranges from traditional plant breeding techniques diagnosis of disease rather than its treatment. Acyte Biotechnologies Pty Limited Randwick Pharmaceuticals and Human Therapeutics companies currently operating in NSW, showing to the application of modern biotechnology Examples include diagnostic tests for infectious Agenix Limited North Ryde Pharmaceuticals and Human Therapeutics their primary location and sector (based on techniques, such as genetic engineering, to plant diseases, genetic markers, toxins in foods their primary area of specialty) and animal breeding and health. It also includes and genetic testing for parentage or forensic AiMazePty Ltd Eveleigh Clinical and/or Specialist Services biotechnology for the production of food and purposes. Newer developments include DNA- Alcon Laboratories (Australia) Pty Limited Frenchs Forest Pharmaceutical and Human Therapeutics Note on Sectoral Classifications. ingredients and food processing technologies, based microchip diagnostics. It also includes the There is no generally acceptable system of such as fermentation. extraction or production of biological molecules Allergan Australia Pty Limited Gordon Pharmaceutics and Human Therapeutics classification for the biotechnology industry. and substances, such as plasma, ant-bodies and Allied Biotechnology Pty Limited Maryong Ag-food (animal/veterinary) The categories used here are not definitive but Biomedical Technology proteins for use in diagnostics or as inputs to the attempt a broad classification of biotechnology This sector includes biomedical devices and Pharmaceutical and Human Therapeutics sector Alphapharm Pty Limited Glebe Pharmaceutical and Human Therapeutics and related businesses in NSW in order to implants for therapeutic or diagnostic uses in AMBRI Pty Limited Ryde Platform Technology underscore the diversity of the industry in human or animal health. These uses may be Platform Technology NSW. The main sectors may be broadly therapeutic or diagnostic. The closely related area This sector covers more fundamental AMGEN Australia Pty Limited North Ryde Pharmaceuticals and Human Therapeutics classified as follows: of scientific and medical instrumentation includes techniques, with broad applicability across Aoris Nova Pty Ltd Eveleigh Other the development of products and services – for many biotechnology sectors or applications. Pharmaceuticals and Human Therapeutics example, gene-sequencing machines, used for Developments in bioinformatic, proteomic and Aortech Biomaterials Pty Ltd Chatswood Biomedical Technology This sector ranges from small local companies research and development and specialist services. separation technologies may be included here AP Clinical Pty Ltd North Ryde Clinical and/or Specialist Services involved in the development and manufacture as well as biosensor or nanotechnologies. of a wide range of pharmaceutical products Clinical and Specialist Services Similarly, this field may also cover biological Applied Horticultural Research Pty Ltd Maianbar Ag-food (plant) to the large, mature and typically multinational Many biotechnology companies provide specialist systems or classes of molecules, which may be ARCH Clinical Research Pty Ltd Swansea Clinical and/or Specialist Services pharmaceutical companies. services – for example services for high through- used in many widely diverse applications. put screening for new drugs; the analysis of Arrow Pharmaceuticals Pty Ltd Roseberry Pharmaceuticals and Human Therapeutics The sector also includes the smaller, high gene and protein sequences and computer-based Environment and/or Industrial technology biotechnology companies whose Arrow Scientific Pty Ltd Leichhardt Clinical and/or Specialist Services prediction of structure/ function relationships This sector includes the conversion of biomass product developments and services are based (linking fields such as functional genomics, into alternative fuels, the production of fine- ASTA Medical Australasia Pty Limited Parramatta Pharmaceuticals and Human Therapeutics on more recently evolved technologies such pharmacogenetics and bio-informatics); and chemicals and polymers from biomass feedstock as recombinant DNA technologies (cloning), AstraZeneca Pty Ltd North Ryde Pharmaceutical and Human Therapeutics the conduct of clinical trials for testing new by fermentation and the extraction of valuable molecular and cellular biology, biochemistry, drug candidates. biologicals from waste streams. A related area Australian Biologicals Registry Pty Ltd (Cryosite) Sydney Clinical and/or Specialist Services immunology, protein engineering and other is the use of biotechnology for the management technologies. This sub-sector represents the Australian Radioisotopes Pty Ltd Lucas Heights Pharmaceuticals and Human Therapeutics of wastes and pollution and also the extraction leading edge of the modern biotechnology and processing of minerals. Aventis Pharma Pty Ltd Lane Cove Pharmaceuticals and Human Therapeutics industry. AVT Holdings Limited Chatswood Pharmaceuticals and Human Therapeutics There also a growing sub-sector of biotechnology companies working in the personal and health AVAX Australia Pty Ltd Chatswood Pharmaceuticals and Human Therapeutics care industries and markets, for example, AWT Pty Limited Ryde Environment and/or Industrial vitamins, alternative medicines, and nutraceuticals. Aza Research Pty Ltd Ryde Pharmaceuticals and Human Therapeutics Bayer Australia Limited Pymble Pharmaceutical and Human Therapeutics Becton Dickinson Pty Ltd North Ryde Biomedical Technology

44 45 Beta Peptide Foundation Pty Ltd Balmain Diagnostics and Biologicals Gradipore Ltd Frenchs Forest Platform Technology Bio-Care Technology Pty Ltd Somersby Ag-food (plant) Heart Assist Technologies Pty Limited Crows Nest Biomedical Technology Biochemical Veterinary Research Pty Ltd Mittagong Ag-food (animal/veterinary) Heart Research Developments Pty Limited Camperdown Pharmaceutical and Human Therapeutics Bioclone Australia Pty Ltd Marrickville Diagnostics and Biologicals Hoechst Marion Roussell Australia Pty Limited Lane Cove Pharmaceuticals and Human Therapeutics Biodiagnostics Pty Ltd Gordon Diagnostics and Biologicals Human Genetic Signatures Pty Ltd North Ryde Diagnostics and Biologicals Boehringer Ingelheim Pty Limited North Ryde Pharmaceuticals and Human Therapeutics Human Therapeutics Limited Roseville Pharmaceuticals and Human Therapeutics Bioenterprises Pty Ltd Roseville Pharmaceuticals and Human Therapeutics Hydragen Pty Limited Enmore Clinical and/or Specialist Services Bioquest Limited Ryde Diagnostics and Biologicals ICON Clinical Research Pty Limited North Ryde Clinical and/or Specialist Services Bio-Rad Pty Ltd North Ryde Medical technology ICP Firefly Pty Ltd Eveleigh Clinical and/or Specialist Services Biosignal Pty Limited Randwick Platform Technology Instore Biotechnologies Pty Ltd East Ryde Clinical and/or Specialist Services Biospecialties Australia Pty Ltd Mayfield Pharmaceuticals and Human Therapeutics International Animal Health Products Pty Ltd Huntingwood Agri-food (animal/ veterinary) Biotech Australia Pty Limited Roseville Pharmaceuticals and Human Therapeutics IRM Technologies Pty Ltd (Inhalix) Camperdown Biomedical Technology Biotel Pty Limited Rydalmere Biomedical technology Janssen-Cilag Pty Ltd Lane Cove Pharmaceuticals and Human Therapeutics Boots Healthcare Australia Pty Limited Ryde Pharmaceuticals and Human Therapeutics Johnson and Johnson Research Pty Ltd Eveleigh Pharmaceuticals and Human Therapeutics BTF Pty Limited Ryde Platform Technology Jurox Pty Limited Rutherford Agri-food (animal/ veterinary) Burns Philp and Company Limited Sydney Agri-food (plant) Knoll Australia Pty Limited Lane Cove Pharmaceuticals and Human Therapeutics C-Qentec Diagnostics Pty Limited Epping Diagnostics and Biologicals Lundbeck Australia Pty Ltd Castle Hill Pharmaceuticals and Human Therapeutics Cellabs Pty Ltd Brookvale Diagnostics and Biologicals Meddicoll Pty Ltd Ryde Diagnostics and Biologicals Clover Corporation Limited North Sydney Pharmaceuticals and Human Therapeutics Medtronic Australasia Pty Ltd Gladesville Biomedical Technology Cochlear Limited Lane Cove Biomedical Technology Merck Sharp and Dohme (Australia) Pty Ltd Granville Pharmaceuticals and Human Therapeutics Corbett Research Pty Ltd Mortlake Biomedical Technology Micromedical Pty Ltd Chatswood Biomedical Technology Cottee Pharmaceuticals (Australia) Pty Limited Frenchs Forest Pharmaceuticals and Human Therapeutics Mundipharma Pty Limited Sydney Pharmaceuticals and Human Therapeutics Cotton Seed Distributors Pty Ltd Wee Waa Ag-food (plant) Narhex Operations Pty Ltd Avalon Pharmaceuticals and Human Therapeutics Covance Pty Ltd North Ryde Clinical and Specialist Services National Diagnostic Products (Australia) Pty Ltd Gordon Diagnostics and Biologicals CroMedica Pty Limited Carlingford Clinical and Specialist Services Neomedix Systems Pty Ltd Mona Vale Biomedical Technology Cyanamid Agriculture Pty Limited Baulkham Hills Ag-food (animal/ veterinary) New England Pharmaceuticals Pty Ltd Armidale Ag-food (animal and veterinary) Delpharm Consultants Pty Limited Crows Nest Clinical and Specialist Services Novapharm Research (Australia) Pty Ltd Roseberry Diagnostics and Biologicals Deltapine Australia Pty Limited Narrabri Ag-food (plant) Novartis Animal Health Australasia Pty Ltd Pendle Hill Ag-food (animal/veterinary) Diagnostic Technology Pty Limited Pymble Biomedical Technology Novartis Australia Pty Limited Pendle Hill Pharmaceuticals and Human Therapeutics EIDN Pty Limited Randwick Environment and/or Industrial Novartis Crop Protection Australasia Pty Ltd Pendle Hill Ag-food (plant) Eli Lilly Australia Pty Ltd West Ryde Pharmaceuticals and Human Therapeutics Novartis Pharmaceuticals Australasia Pty Ltd North Ryde Pharmaceuticals and Human Therapeutics ENGENEIC Pty Ltd North Ryde Pharmaceuticals and Human Therapeutics NovoNordisk Pharmaceuticals Pty Limited North Rocks Pharmaceuticals and Human Therapeutics Enretech Australasia Pty Limited Moss Vale Environment and/or Industrial Novogen Limited Ryde Pharmaceuticals and Human Therapeutics Enterix Pty Ltd Ryde Diagnostics and Biologicals Novotech Communications Pty Limited Pyrmont Clinical and/or Specialist Services Entigen Pty Limited Eveleigh Platform Technology NSL Health Limited Castle Hill Pharmaceuticals and Human Therapeutics Ferring Pharmaceuticals Pty Ltd Gordon Pharmaceuticals and Human Therapeutics Nucleics Pty Ltd Randwick Platform Technology Fort Dodge Australia Pty Limited Castle Hill Ag-food (animal/veterinary) Nulite Pty Ltd Hornsby Biomedical Technology Fucell Pty Limited Kingsford Platform Technology Objectivision Pty Ltd Double Bay Biomedical Technology G2 Therapies Limited Darlinghurst Pharmaceuticals and Human Therapeutics Omnicare Clinical Research Pty Ltd North Ryde Clinical and/or Specialist Services Gammasonics Institute for Medical Research Pty Ltd Five Dock Biomedical Technology Organon (Australia) Pty Ltd Lane Cove Pharmaceuticals and Human Therapeutics Genetic Technologies Corporation Pty Limited Willoughby Clinical and/or Specialist Services Organon Teknika (Australia) Pty Limited Baulkham Hills Pharmaceuticals and Human Therapeutics Genset Pacific Pty Ltd Lismore Diagnostics and Biologicals Otsuka Pharmaceutical Australia Pty Ltd Pymble Pharmaceuticals and Human Therapeutics Genzyme Australasia Pty Ltd Castle Hill Pharmaceuticals and Human Therapeutics Pan Pharmaceuticals Limited Moorebank Pharmaceuticals and Human Therapeutics Goodman Fielder Limited Sydney Ag-food (plant) Panacea Clinical Research Pty Ltd Strawberry Hills Clinical and/or Specialist Services

46 47 Parallel Biotechnologies Limited Turramurra Platform Technology Parke Davis Pty Ltd Caringbah Pharmaceuticals and Human Therapeutics Peptech Animal Health Limited North Ryde Ag-food (animal/veterinary) Peptech Limited North Ryde Pharmaceuticals and Human Therapeutics Pfizer Pty Limited Ryde Pharmaceuticals and Human Therapeutics Appendix D Pharmacia Australia Pty Limited Rydalmere Pharmaceuticals and Human Therapeutics Pharmatox Pty Ltd Dural Clinical and/or Specialist Services Phytotherapy Technology Pty Ltd Randwick Pharmaceuticals and Human Therapeutics PI2 Limited Roseville Pharmaceuticals and Human Therapeutics Polartechnics Ltd Sydney Biomedical and Technology Probe Pharmaceuticals Australia Pty Ltd North Sydney Pharmaceuticals and Human Therapeutics Probiotec Ltd Surrey Hills Pharmaceuticals and Human Therapeutics Proteome Systems Limited North Ryde Platform Technology Psiron Ltd North Ryde Diagnostics and Biologicals PsyGene Pty Ltd Darlinghurst Pharmaceuticals and Human Therapeutics PWV Medical Pty Ltd West Ryde Biomedical Technology Key Acts, regulations and agencies NSW – Animal Research Act 1985 Quintiles Pty Ltd North Sydney Clinical and/or Specialist Services involved in implementing the BioETHICS initiatives – Pesticides Act 1999 ResMed Ltd North Ryde Biomedical Technology Commonwealth – Plant Diseases Act 1924 (as amended 2000) Rhone-Poulenc Rorer Australia Pty Limited Baulkham Hills Pharmaceuticals and Human Therapeutics – Gene Technology Act (2001, pending): Office of the Gene Technology Regulator, – Stock Diseases Act 1923 (as amended 1999) Roche Diagnostics Australia Pty Ltd Castle Hill Diagnostic and Biologicals associated Committees (Technical, Consultative, – Stock Chemical Residues Act 1975 Roche Products Pty Limited Dee Why Pharmaceuticals and Human Therapeutics Ethics) and Institutional Biosafety Committees (regulation of genetic modification) (as amended 1999) Sanofi-Synthelabo Australia Pty Limited Lane Cove Pharmaceuticals and Human Therapeutics – Therapeutic Goods Act 1987: Therapeutic – Stock Medicines Act 1989 Schering Pty Ltd Alexandria Pharmaceuticals and Human Therapeutics Goods Administration (regulation of therapeutic drugs/devices) – Human Tissue Act 1983 Schering-Plough Pty Limited Baulkham Hills Pharmaceuticals and Human Therapeutics – ANZFA Act 1991: Australian and New Zealand – Public Health Act 1991 Searle Crows Nest Pharmaceuticals and Human Therapeutics Food Authority (regulation of processed food products) – Contaminated Land Management Act 1997 Serono Australia Pty Limited Frenchs Forest Pharmaceuticals and Human Therapeutics – Quarantine Act 1908: Australian Quarantine Sirtex Medical Limited North Ryde Pharmaceuticals and Human Therapeutics and Inspection Service (regulation of imported products) Solvay Biosciences Pty Ltd Pymble Pharmaceuticals and Human Therapeutics – Wildlife Protection (Regulation of Imports and Southern Cross Laboratories Pty Limited Dural Clinical and/or Specialist Exports) Act 1982: Environment Australia (regulation of imported species, organisms SSH Medical Limited Lidcombe Biomedical and Technology and certain products) Stantex Pty Ltd Five Dock Biomedical Technology – National Occupation Health and Safety Commission (regulation of chemicals) Starrate Pty Limited Bethungra Ag-food (animal/veterinary) – National Registration Authority (regulation Sunscreen Technologies Pty Limited North Sydney Pharmaceuticals and Human Therapeutics of agrochemicals) – National Health and Medical Research Symbiotic Research Pty Limited Eveleigh Clinical and/or Specialist Services Council Act, 1992: NHMRC Australian Health TA Med Pty Ltd Northbridge Pharmaceuticals and Human Therapeutics Ethics Committee – Australian Code of Practice for the Care Technico Pty Ltd Bowral Ag-food (plant) and Use of Animals for Scientific Purposes, TECRA Pty Ltd North Ryde Diagnostics and Biologicals 1997: NHMRC – IP and copyright legislation The Brain Resource Company Ltd Westmead Biomedical Technology Virbac (Australia) Pty Ltd Peakhurst Ag-food (animal/veterinary) Vita Medical Limited Lucas Heights Biomedical Technology Wyeth Australia Pty Limited Baulkham Hills Pharmaceuticals and Human Therapeutics Yates Botanicals Pty Ltd Tuggerah Ag-food (plant)

48 49 Glossary of abbreviations and acronyms Glossary of biotechnology terms

ANZSIC Australian and New Zealand Standard Industrial Classification bioinformatics: The use of computing deoxyribonucleic acid (DNA): The chemical nanotechnology: Functioning devices with technologies to discover and manage systematic compound that constitutes the hereditary material moving parts that are only molecules in size, ATP Australian Technology Park biological information by translating genetic and of living organisms, ie the genetic code. The DNA such as a biosensor with a tiny molecular switch BIF Biotechnology Innovation Fund Progam protein data into manageable forms that can be in human beings is grouped into approximately as its central component analysed and interpreted, often in conjunction 35,000 genes BioSS Biomathematicians and Statistics Scotland nuclear magnetic resonance (NMR): with rapidly growing databases functional genomics: The study of the A technique that provides information on the CIMMYT International Maize and Wheat Improvement Center biomass: All the living organisms of a particular functional consequences for a cell or organism structural behaviour of complex molecules in their COMET Commercialising Emerging Technologies Program region, considered collectively of the presence, absence or modification environments of a gene CRC Cooperative Research Centre bioprospecting: The practice of screening nutraceutical: A plant or natural product that samples of plants, animals and microorganisms gene: The carrier of hereditary characteristics, when consumed orally, confers a health benefit CSIRO Commonwealth Scientific and Industrial Organisation (often collected from the wild) for active chemical a piece of DNA that codes for the production protein: A complex organic compound composed DSRD New South Wales Department of State and Regional Development compounds or molecules that can be developed of a particular molecule (usually a protein) of numerous amino acids. Proteins occur in all into patented and marketable commodities used to make a part of machinery or tissue FTE Full time equivalent employee living organisms and their production is coded of an organism biotechnology: The understanding and use of for by genes GMO Genetically Modified Organism biological processes and organisms for health, genetically modified organism (GMO): proteome: As the genome is the genetic IP Intellectual property social, environmental and economic applications An organism in which the genome has been complement of an organism, so the proteome or outcomes modified in some way in order to alter the IT Information technology is the complement of all proteins in an organism. characteristics of the organism biotechnology industry: A collection of Proteins may differ in the sequence of their amino NHMRC National Health and Medical Research Council industries – eg pharmaceutical, food processing, genome: The collection of all the genes in a cell acids or in chemical modifications which result in OECD Organisation for Economic Cooperation and Development plant and animal agriculture, environmental in an organism changed properties that can be identified management or minerals processing – which PLDP Professional Leadership Development Program genomics: The study of the organisation, proteomics: the high-throughput separation, utilise some of the techniques of biotechnology structure and control of genes identification and characterisation of proteins R&D Research and development (for a more complete definition, see page --) from a biological sample – a complementary genotype: The entire genetic constitution STEC Shiga Toxin Escherichia coli cell: The smallest structural unit of living technology to genomics, but starting with the of an individual organisms that is able to grow and reproduce protein rather than the gene TGA Therapeutic Goods Administration independently gene therapy: Treating, diagnosing or transgenic: The introduction of a modified gene preventing disease by introducing specific clone: A group of individual organisms (or cells) from one organism into another alterations in the genetic material of the produced from one individual cell through asexual human body vector: The agent used to carry new genes processes that do not involve the interchange or into cells combination of genetic material. The word ‘clone’ genetically modified organism (GMO): may be used as a noun or a verb. An organism in which characteristic/s have xenotransplantation: The implantation been altered by a modification of the genome of an organ or limb from one species to cytotechnology: ‘diagnostic cytopathology’ (for example, by the introduction of a modified another organism in a different species. = Involves the interpretation of cells that gene from another organism) When performed in animals ‘rejection’ of the spontaneously exfoliate or are removed from transplant by the recipient’s immune system tissues by abrasion or fine needle aspiration, germplasm: The total genetic variability of an is a common response. eg specimens from the cervix (Pap tests), breast, organism, represented by the total available pool thyroid, lymph node, liver, etc of germ cells or seed monoclonal antibody: A highly specific antibody that is derived from only one clone of cells

50 51 Notes

1 Ernst & Young et al. 2001, Benchmarking study 15 Commonwealth of Australia 1998, Health of research and development costs in selected and Medical Research Strategic Review, segments of Australian biotechnology. Discussion Paper.

2 US Bio via Commonwealth of Australia 1999, 16 Peter Wills AM, Health and Medical Research Developing Australia's Biotechnology Future. Strategic Review, 1999.

3 www.bioworld.com 17 Frontline Research, 2000.

4 Ernst & Young, Commonwealth of Australia 18 BioAccent Pty Ltd, Directory of NSW Bioscience and Freehills June 2001, The Australian based Companies, February 2001, Australian Biotechnology Report 2000. Pharmaceutical Manufacturers Association, website, www.apma.org.au, July 2001, Australian 5 Australian Pharmaceutical Manufacturers Biotechnology Directory, AusBiotech Limited Association, Facts Book 1999–2000. 2001, and Department of State and Regional 6 ibid. Regional Development internal documents.

7 Australian Bureau of Statistics 1998–99, I The sector classification is broadly based unpublished data. on the report Benchmarking Study of R&D Costs in Selected Segments of the Australian 8 Australian Bureau of Statistics, Cat. no. 8104.0, Biotechnology, January 2001, Ernst & Young, ABS, Canberra. The Hay Group and the Strategic Industry 9 Ernst & Young, Commonwealth of Australia Research Foundation for Invest Australia. and Freehills, op. cit.

10 ibid.

11 Ernst & Young 1999, Australian Biotechnology Report.

12 Deloitte Biotech Index, March 2001, 5th Edition

13 Australian Bureau of Statistics 2000, unpublished data.

14 Australian Pharmaceutical Manufacturers Association, op. cit.

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