2006_Network_Navigating towards our future First report of ‘ The Navigator Network ’ on emerging issues in biotechnology and_Unknow

7/30/2019 2006_Network_Navigating towards our future First report of The Navigator Network on emerging issues in biot

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Navigating towards our future:

First report of The Navigator Network onemerging issues in biotechnology and

nanotechnology.

June 2006


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The Navigator Network

The journey so far

This is the first report of The Navigator Network an independent project set up andfunded by the Ministry of Research, Science and Technology (MoRST) to scan thehorizon for future developments in science and technology. Its aim is to support NewZealands readiness for the challenges and opportunities of new science andtechnology. It has a particular focus on biotechnology and nanotechnology.

The project, which runs for two years through to June 2007, is being managed by twoconsultants Dr Barbara Nicholas and Karen Cronin, with support from JaneCameron, a MoRST policy advisor with expertise in futurewatch.

It is generating a number of outputs, including the establishment of a network ofscientists and other experts around New Zealand with an interest in future watch;four scanning reports and workshops; commissioned think pieces on key issues;

and special topic events.These scanning reports, which may include issues that warrant a policy alert togovernment, will be provided to a Steering Committee chaired by , which includesrepresentatives from key government agencies and the science sector.

This is a public document which will be circulated within the policy sector and madeavailable more widely to members of the Navigator Network.

We want to emphasise that this report is a contribution to discussion. It does notrepresent Government policy or the views of the Ministry of Research, Science andTechnology. It provides an insight, from one scanning round, of some trends andissues. It does not aim to predict future science and technology; nor does itrecommend policy or funding priorities.

What next?

The Navigator Network is now into its second round of scanning and will be running afurther workshop in August 2006. We will be interested to track the trends we havealready identified, and looking for new discoveries and developments that surpriseus. We will be inviting a small group of people to join the scanning team at theworkshop to provide a diverse set of perspectives and enrich our explorations ofwhat these science and technology trends may mean for New Zealand. In particularwe hope to include people with interests in the future of agriculture, land use, theenvironment and nanotechnology.

The Navigator Network team is always interested to hear from people who would liketo participate in our project. We can be contacted through our web site atwww.navigatornetwork.net.nz .

Dr Barbara Nicholas

Karen Cronin

(June 2006)

Further copies of this report are available at www.navigatornetwork.net.nz/resources


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List of Contents:

Section 1 Introduction

1.1 Background

1.2 The scanning process

1.3 The content of this report

1.4 Caveat

Section 2 Summary of Scanning Observations (February-April 2006)

2.1 Industrial biotechnology

2.2 Health

2.3 Food and nutrition

2.4 Research tools and practice

2.5 Intellectual property

2.6 Molecular biology

2.7 Nanotechnology and new materials

2.8 Environment

2.9 The geo-political context

2.10 Manufacturing, business and marketing

2.11 Social change

Section 3 The first scanning workshop (May 2006)

3.1 Introduction

3.2 What are we scanning for?

3.3 Generic issues

Section 4 Observations on key trends and issues

4.1 Areas of rapid science advance

4.2 Emerging paradigms and conceptual shifts in science

4.3 Significance

Appendices

1. Contributors2. The Navigator Network Project team bio notes.


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Section 1: Introduction

1.1 Background

In 2005 the New Zealand Ministry of Research, Science and Technology () initiatedand funded a future watch project, subsequently named the Navigator Network. Thisis its first scanning report.

The purpose of the Network is to strengthen ways for New Zealand to foresee andmake timely responses to issues and opportunities in biotechnology andnanotechnology, and other emerging areas of science. It aims to:

Support discussion and a collective understanding of new and emerging

science and technologies, how they may influence New Zealands future, andwhat actions may be required to address their challenges and opportunities.

Gather, synthesise and share information and support linkages in theexchange and convergence of ideas between policy and sciencecommunities.

Support the development of a culture of early thinking across government andmore broadly.

Develop, apply and profile a New Zealand approach to environmentalscanning.

The Network is taking an innovative approach to future watch scanning, in that it is

essentially people-centred, relying on the intellectual and knowledge-creatingprocesses that occur when one brings well informed and reflective people together.The methodology involves gathering experts from different areas of practice, differentcommunities of interest, and different analytical frameworks, into a conversation. Thefocus is on the practice and outcomes of science, over a time frame that looks 15-30years ahead.

The Network aims to be a learning process both in how we carry out the scanningand the knowledge creation processes, and because we hope our work will take usto unexpected places and raise fresh questions.

1.2 The scanning process

The major stream of the Navigator project is the core scanning activity. Our processhas been to appoint a core group of scanners researchers and experts active andaware of developments in biotechnology, nanotechnology, and the social and politicalcontext for science (see Appendix 1). Their work is enriched and supplemented byscanning input from a number of government-funded agencies including, to date, sixgovernment departments with a direct interest in biotechnology, along with theBioethics Council and the Parliamentary Commissioner for the Environment.

The scanners are providing regular reports on their observations and reflections onkey developments in their areas of work. They are noting trends that may havesignificance for future directions, uptake, and responses to biotechnology andnanotechnology. The first round of scanning, in February April 2006, produced over

300 observations, which provided the base for this report and are summarised insection 2.


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Following an initial collation and analysis of observations, workshops are being heldwhere all scanners, and some additional invited people, reflect on the patterns of thereports, contribute further knowledge, and consider the possible significance andimplications of what has been noticed. We see this workshop activity as a centralfeature of the Network. It is where new knowledge is created and fresh questionsasked as people with different perspectives explore the issues together. It isessentially a dialogic process where participants enquire of one another, and cometo see the world differently.

The cycle of scanning observations, workshops, and reports will be repeated at 4-monthly intervals through to the end of the project in 2007.

1.3 The content of this report

This report is a summary of the first cycle of scanning. It builds on the Biotechnologyto 2025 Reportby the Ministry of Research Science and Technology, an in-depthscan published in January 2005. It provides a base-line for future scans over the next

year, as those of us in the project establish a common understanding of each othersareas of expertise and develop our skills in future watch. The report identifies sometrends that are at the edge of development and may not yet be widely known. We areidentifying both those things that are new, and those that are new to us.

In section 2 below we present a summary of the observations of the scanners.Several large areas were immediately obvious: the science associated with climatechange and energy sources; food and nutrition; personalised medicine; andemerging diagnostic and information technologies. We have made an initial note ofthese trends and our on-going scanning will enable a more nuanced reading of theirpossible trajectories. Over time, we may detect early signals of important newdevelopments in science and technology. On first sighting, their significance may not

be obvious. On the other hand, some of what we report may prove not to beimportant only time will tell. In the meantime we will include all the observations.

Section 3 is a summary of the discussion around these first results at our scannersworkshop in May 2006. The workshop enabled participants to progress theconversation from initial observations, to interpretation: what might this all mean forNew Zealand? The conversations were unpredictable - as we had hoped! Forinstance, there was a thoughtful discussion on the increasing internationalcommercialisation of science and its impact on the practice of science itself, and thepossible ramifications in New Zealand of the associated cultural changes in researchpractice.

In Section 4, we give our overview of the key trends and issues, and identify some

questions to take into the next cycle of reporting and interpretation. We do this in aspirit of enquiry. We are not setting out to make predictions or to map priorities. Muchof what these emerging areas of science and technology might mean for NewZealand will not be entirely clear until the future unfolds. But we hope to offer somequestions and insights? that will help us all to better engage with that future as wemeet it.

We hope that the reader will find this report useful. There may be examples that willreinforce or challenge existing assumptions, material that will provide input intostrategy, policy or decisions, and new patterns emerging as we look over a broadrange of trends, questions and insights that may themselves suggest alternativeframing of issues.


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1.4 CaveatIt is important to note the limitations of the scanning activity reported here, and toplace it in the context of the wider project.

The Navigator Network is required to pay particular attention to biotechnology andnanotechnology rather than all of science and technology. Furthermore, the scale ofthe project places significant constraints on the size of the core scanning group andthe number of scanning rounds we can complete in the time frame.

A strategic decision was taken early on to focus on those areas of biotechnology andnanotechnology that are likely to be the most significant to New Zealand forexample, agriculture, horticulture, food, health and environment and to appointscanners with that in mind. However, we were aware that we had thus excludedsome areas of the physical and social sciences and have therefore developed twoother activities to manage this:

a. In addition to our scanners, we will invite a wider group of people to each ofthe workshops to discuss the scanning reports. This means that the

interpretive (meaning-making) stage of the process will include a diverserange of scientific disciplines, and knowledge of the social and politicalcontext for science. It will also allow for cross fertilization between differentsectors and world views. We expect this to alert us to additional emergentareas of science, and their connections to different areas of activity in NewZealand. This may lead to additional commissioned work to analyse someissues in depth.

b. We are also developing strategies to track other areas that have beenbrought to our attention, and which we could not hope to cover fully in thecore scanning group. One topic is the rapidly developing field ofneuroscience. We are also planning a special event to look at trends aroundthe future of food, a key issue for New Zealand. Further information will bemade available over the next few months on the Navigator Network website :

www.navigatornetwork.net.nz


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Section 2: Summary of scanning

observations

This section is a summary of the 300+ observations made by the scanners in theperiod February April 2006 and submitted to the project team. It covers thefollowing key themes:

2.1 Industrial biotechnology

2.2 Health

2.3 Food and nutrition

2.4 Research tools and practice

2.5 Intellectual property

2.6 Molecular biology

2.7 Nanotechnology and new materials

2.8 Environment

2.9 The geo-political context

2.10 Manufacturing, business and marketing

2.11 Social change

Governments& highprofile investors arestarting to makesubstantialinvestments inbiofuel

developments.

2.1 Industrial Biotechnology

Biofuels believe the hype?

Biofuels developments have been in the news stimulated byrises in petrol prices, the growing consumption of fossil fuelsby China, the international drive for energy security, andgrowing international concern about climate change.

The rapid proliferation of information signalling heightenedgovernment and market interest has led some scanners toidentify this as a classic hype cycle in the making.

President Bushs State of the Union Address announcing afresh policy push (Advanced Energy Initiative) to replacemuch gasoline oil imports by bioethanol produceddomestically from agricultural waste. The president has askedCongress to increase its budget for biorefinery developmentfrom $90 million in 2006 to $150 million in 2007. Dept ofEnergy target of 30% by 2025.

Some of the worlds biggest investment names are lining upto invest in biofuel developments including Bill Gates privateinvestment company Cascade Investment purchasing $84million in newly issued Pacific Ethanol, and Richard Branson

plans to invest $300-400 million to produce and marketethanol.


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First moveradvantage:Countries to Watch Brazil & Spain.

Mascoma, a US based bioethanol start-up is the firstcompany to be funded entirely by venture capital with no Govtsubsidy. (There are also smaller initiatives such as SanFranciscos plan to generate methane from dog faeces.)

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Responses to biofuels will be influenced by developments inother fuel technologies, and social choices about these.Global electricity generation from small scale distributedsources overtook global production from nuclear plants in2006, thus providing a choice to nuclear for climate changemitigation. This is additional to carbon sequestration whereequipment is not expected to be commercialized for 10-20years.

Advances in ultra capacitor design and construction, usingvertically aligned single wall carbon nanotubes, has thepotential to enable ultracapacitors with energy storage

comparable to lithium batteries but with the benefits oftraditional ultracapacitors. Such battery technologies wouldsupport development of distributed energy networks.

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European Commission directives on renewable energy pointto an increasing European focus on biofuels. The SpanishGovernment in particular is prioritising investment inbiomass/biofuels R&D to meet a target of 5.83% of totaldomestic fuel consumption by 2010. Two major Spanishcompanies have also signed an agreement to build sixbiodiesel plants in Spain (raw material rapeseed andsunflower oils), expected to be operating by 2007-2008 thatwill produce 200,000 tons of biodiesel per year. This isreported to be the biggest undertaking in the biodiesel fieldworldwide.

The Brazilians are also moving to build a global bioethanolmarket building infrastructure at home, infrastructure andmarkets abroad and accelerating developments in othersugar producing nations by exporting technology andexpertise a global bioethanol industry based on tropicalsugar cane production may therefore become establishedmore quickly than that based on other crops.

In the short to medium term Brazil is the only country capableof cost-effectively sustaining the burgeoning internationalethanol market. For an international market to take root in thelonger term other sugar-producing countries will need toexpand their exports. If Brazil wants to benefit from adependable commodity futures market it is necessary forother producers to be opening up markets.

Brazils expansion strategy therefore also includes craftingdeals to help other countries build their biofuels programmes.

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Cutting edge R&D focus is on eNewZealandymes &bioprocessing

technologydevelopment &processconsolidation.

Tropical competitiveadvantage?

Questions of landuse?

Currently, ethanol production is predominantly based onsugar cane and corn. Internationally, a key R&D focus is onhow to harness waste products from these crops: cornstover, bagasse as well as woody biomass (ligno-cellulose) toproduce biofuel cost-effectively.

The current challenge for producing bioethanol is separatingthe sugars from the lignocellulose -- the combination of lignin,hemicellulose (C5 sugars), and cellulose (C6 sugars) thatform plant cell walls. Many technologies have beendeveloped to convert lignocellulose to sugars, but the costsare still high and sugar yields are low.

The real step change will occur with the consolidation of thehydrolysis, and C5 and C6 sugar fermentation steps intandem all are currently separate which will dramaticallyincrease yields.

Only four teams globally are currently capable of fermenting

C5 sugars to ethanol. The race is on to consolidate thebioconversion process.

Another key issue for biofuels is how to get the best netenergy and carbon balance. Shell oil has developed anenzyme that breaks down cellular walls such that bioethanolcan be produced with an energy input of only 10% of theenergy the resulting ethanol provides. Some currentprocesses based on corn require an energy input of up to80% of the energy they unlock when burnt as fuels.

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Significant competitive advantages lie in the tropics with landand the ability to grow 3 sugar cane crops per year comparedto temperate climates. The R&D focus is on breedingtransgenic sugar cane with reduced lignin and/or increasedcellulose as a target. Predictions of capability to produce22,000 litres of ethanol per hectare per year.

Salix or willow plants that can be coppiced are seen asproviding opportunities as a feedstock for NEW ZEALANDdomestic production with claims that it could yield 11-16 timesmore energy for every unit used to produce it.

There has been a chequered history of short rotation coppice

willow in the UK, where other crops are being investigated,including Miscanthus giganteus, a perennial grass.

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A conflict is emerging between the food industry and biodieselmanufacturers in Europe over rapeseed oil supply has beenescalated to the EU parliamentary level for members todecide the future of edible oil distribution. Is this trend ofcompeting food/fuel markets prescient of things to come?

There are however claims that by 2050 , through harvestingboth protein and cellulose from corn and switchgrass existing

agricultural land could both supply our food needs andreplace gasoline with ethanol.


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Emergingmetagenomicstechniques areproviding powerfultools forbioprospecting inunusualenvironments.However social,cultural and

commercialproblems remain.

The diffusion ofemerging

biotechnologicalapplications into

clinical use. The EMEA did not however, reject the applicationbecause of the way the drug was produced, but because ofthe way the drug was administered during clinical trials.

The use of biopharming has therefore, not been ruled out bya major regulator good news for New Zealand researchers

working in the field.--------------------------------------------------------------

Bioprospecting

An emerging Bioprospecting trend is the use of metagenomicstudies (the study of the collective genomes ofmicroorganisms within a given environment) of previouslyoverlooked environments to mine for novel micro-organismsand enzymes.

Recent examples include Venter et als study of the surfacewaters of the Sargasso Sea, and a New Zealand study on the

metagenomics of the microbial population of the bovinerumen.

The marine environment in particular is being touted as asource of untapped commercial potential.

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Concerns remain strong amongst developing nations andindigenous peoples about the social and cultural impacts andthe exploitation of bio-resources by commercial enterpriseswithout benefit sharing regimes.

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Diversa the worlds largest bioprospecting company hasrecently announced a restructuring to focus on buildingproduct sales rather than research due to limited success indeveloping commercial products. This may signal anincreasing reluctance for the private sector to invest inbioprospecting enterprises.

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2.2. Health

A number of challenges to the health system are possiblefrom emerging biotechnologies.

New diagnostic tools will reduce the need for largescale laboratory services. However, it is uncertain howrapidly high speed sequencing will be used in clinicalcare as opposed to research settings, and its effect onprovision of health care in the shorter term.

New treatments like targeted breast cancer drugHerceptin where social and political forces are drivingthe public demand for expensive new medicaltreatments.

Stem cell technologies. These promise new

treatments for disease, and the possibilities of organ


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healthcare systemsremains challenging

Social forces arestarting to come tobear on strugglinghealthcare systemsfor access to the firstwave of expensivepersonalisedmedicines.

regeneration.

Several of these biotechnologies have applications outside

health. Genetic technologies have already shifted genetictesting from the health to the social arena:

The UK forensic Science Service is running a pilot tosee if they can use DNA testing to discover a personssurname even if they have not given a DNA sample

People are using the technology to trace familyancestry, quite independent of health uses

Ancient DNA has been extracted from 3000 year oldskeletons of the first people to reach Vanuatu, toinform debates about the origins and migration path

of Pacific settlers Scientists are reporting being approached by athletes

and coaches keen to explore the possibilities of genetherapy to enhancement performance, and stem cellresearch may offer technologies that can enhance orextend human life span.

Commentators note the potential of enhancement therapiesto further extend the gap in wellbeing between rich and poor,and the need for public discussion to inform public policyabout this. (Wide discussion is also called for in anotheremerging area the creation of organisms with completely

synthetic genomes.)These developments will also require ashift in the expertise of health practitioners, who will becomecurators of masses of interlinked data and the controllers ofreal-time treatments and wellness adjustments.

Personalised Medicine up-take turbulence

There have been calls in both New Zealand and the UnitedKingdom recently for the personalised breast cancer drugHerceptin to be made more widely available to more patientsat earlier stages in the cancer process.

A woman in the UK has even recently won a court case

against the NHS to fund her course of Herceptin for her.Despite this precedent, primary care trusts in the UK will stillbe allowed to refuse access to the drug.

Healthcare systems are struggling with the high costsassociated with drugs prescribed by specific genotype, andwith smaller markets of users, . Herceptin , when it enteredthe marketplace (1998) was heralded as the advent ofpersonalised medicine.

Drug and biotech companies developing and marketing thesetypes of drugs are continuing to put premium prices on them.In spite of a number of competitor breast cancer drugs

emerging out of late-stage clinical trials, the costs are forecastto remain the same due to the market benchmark having


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The first generic

biological drug hasbeen approved byregulators. This willpotentially havedownstreamimplications on theaffordability of thistype of drug.

Dry pipelines &reporting issues inclinical trials areputtingpharmaceutical

companies underincreasingpressure

been set by Herceptin.

Other examples of personalised medicine are approachingcommercialisation.

In Australia, for example, a group have developed apersonalised diagnostic test for hypersensitivity to radiationpoisoning during cancer radiotherapy.

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The emergence of generic biological drugs

The European Medicines Agency (EMA) has recommendedthe approval of the first generic biotechnology drug markingthe first real threat to the nearly permanent franchise enjoyedby any biotechnology company that manages to take a drugsuccessfully to market. Intense lobbying is underway with

arguments against saying that the complexity of biologicaldrugs makes it difficult, if not impossible, to replicate themsafely.

A recent analysis of the impact that generic medications haveon market costs by the FDA shows that the arrival in themarket place of just two generic versions of a brand-namemedicine can nearly halve the price consumers pay. When abrand-name drug faces competition from just one genericcompetitor that challenger typically sells for 94% of cost of thebranded rival a second competitor drops the price to just52%.

Big Pharma - under increasing pressure?In the US and Europe, only 20-30 new drugs are approvedeach year and only one in four acts on targets not alreadyaddressed by existing drugs. The low number of candidatedrugs reaching the market indicates that pharmaceuticalproductivity has fallen to the point that new strategies arelikely to be required to sustain the industry. It signals a timeof potential change in the market and industry models ofsuccess.

Reviews suggest that there now good evidence for subtledistortion of the results of clinical trials by selective reporting

of data namely the suppression of negative results. Thishas lead to a call for comprehensive and compulsory trialregistration, thus making it harder for scientists to suppressnegative results.

The lack of vaccines for the developing world has prompted aproject Making markets for vaccines that aims to facilitatemarkets that will provide an incentive for companies to investin the R&D for suitable vaccines.

Manufacturing and Process Innovations

Molecular biological tools and techniques are emerging that

are beginning to provide greater certainty at the front-end ofthe drug development process and mitigating the risk ofcompounds failing downstream This could save estimated


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But bioprocessing

innovations andmolecular biologytools are beginningto have a positiveimpact on bottomlines.

costs of $500 million that can be lost if a drug fails at the lasthurdle.

Key techniques include RNAi for target validation, and geneand protein expression profiles providing early and moresensitive markers for toxicity of drug effects in pre-clinical andclinical studies.

Recent innovations in streamlining bio-manufacturingprocesses are also starting to reap rewards forpharmaceutical companies.

Bioinformatics advances have reduced the development timeof these processes from 12 months to 1-2 months. Theresulting productivity gains to pharmaceutical companies hasbeen significant, for example, the fermentation of Dormectin(a Pfizer developed drug) now yields in 4 months what it

previously took a year to produce, saving the company $100million per annum.

Drug Development Technology Trends

Dirty Drugs: rather than targeting one specific molecule, abetter way to treat complex disease such as cancer may be toaim for several targets at once. Specific drugs or magicbullet drugs (like Herceptin) only attack a single biologicaltarget at a time. One of the leading edge drugs of this type Gleevec, was designed to target a specific protein incancerous cells, specifically killing them while leaving normalhealthy cells unharmed. Subsequent studies have shown that

Gleevec is not as specific as it was first thought. Drugs whichtarget multiple points in a complex system could potentiallylead to better outcomes than focusing on a single target.

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A trial of a personalised vaccine against multiple sclerosiswas expected to begin in March 2006. This is a new approachto vaccine production. Blood is taken from MS patients toextract the immune cells that are attacking the persons brainand nerve cells. They are then weakened by radiation andreintroduced into the patient, whose immune systemrecognises the cells as damaged and attacks them. All

previous attempts to develop vaccines against MS havefailed.

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Implanted micro-fluidic devices for programmed long-termdrug delivery systems: it has been demonstrated for the firsttime (in a dog) that its possible using an implantedmicrofluidic device and wireless technology to actively controlthe release of drugs in the body over a prolonged period oftime.

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Gene Therapy

Recent studies have shown that gene therapy could


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There are concerns

about the dual usepotential of genetherapyapplicationsLowerregulatory hurdles incountries like Chinaare exacerbatingthis.

Commentators aredivided on the levelof risk associatedwith emergingzoonotic diseaseslike avianflumultidisciplinaryapproaches like theemerging field ofconservationmedicine may beginto provide greater

insights

significantly increase muscle mass, strength and endurance.Some scientists are now being approached by athletes andcoaches wanting to find out more about the technology.

Currently, in the high profile journal, Blood, around 15% ofscientific articles focus on gene therapy.

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A growing number of patients are heading to China forexperimental therapies. Several experimental biologicaldrugs pioneered by Western biotech companies that failed toreach US or European markets have recently been approvedin China. For example, the first commercial gene therapyapplication, Gendicine, for the treatment of cancer.

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A disease causing gene was silenced in monkeys using RNAitherapy delivered directly into the bloodstream. This is the

first example that shows systematic administration of RNAiworks in primates. In the study, the effect persisted for about11 days following a single dose of RNAi and no toxicity wasobserved over the period.

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Infectious Diseases

Scientists at the AAAS claim that the responsibility forincreasing risks of emerging epidemics from zoonoticdiseases lies with ongoing increase in intensive farming oflivestock, deforestation, ownership of exotic pets and global

travel and trade.-------------------------------------------------------------------------

Some commentators, however, are claiming the conditions foravian flu to mutate into a readily virulent transmissible humanflu are not present. One study infers that the 1918 epidemiconly materialised because the appalling health conditions inthe WWI trenches created the type of environment for thedisease to mutate into such a virulent form.

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Conservation medicine brings together veterinarians,

physicians, ecologists, and conservation professionals toexplore the relationships among animal, human, andenvironmental health and emerging infectious diseases: Withrecent cross-species epidemics, there is growing concern thatwe dont understand the dynamics of zoonotic transmission.Conservation medicine is concerned both with diseases thatthreaten endangered species, as well as how diseases aretransmitted between animals (including humans) and mayprovide insights into the emergence of zoonotic diseases.

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Malaria will become the super bug of the next decade

according to the World Bank.


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In two verysignificantbreakthroughsresearchers havegenerated areplacement organ a bladder from apatients owncellsand nano-structured scaffoldshave been used toregenerate nervetissue and restorevision to hamsters.

Two distinct trends

are emerging instem cell research:

1. The race toidentify anethical way tosource stemcells; &

2. rapid movingdiscoveriesimplicating stemcells in an

increasing rangeof biological &

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Regenerative Medicine

For the first time, a replacement organ has been generatedfrom a patients own cells. The neo-bladder was developedby researchers by extracting progenitor cells taken frompatients and adding them to a collagen scaffold thatencourages growth into the desired shape. Complete organdevelopment is expected when transplanted into the patient.Biotech company Tengion is currently working toward clinicaltrials of a neo-bladder. The technique relies on the patientproviding healthy progenitor cells. This may not be possible insome cases.

Clinical safety and effectiveness needs to be demonstrated.

Other organs or tissues will also need to be developed todemonstrate wider utility. More structured, denser organs likekidneys and hearts will be considerably more challenging.

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Nanotechnologies are also being applied to regenerativemedicine, and nano-structured scaffolds may contribute tothis field. A self-assembling peptide nanofiber scaffold helpsregenerate nerve axons and knit brain tissue together. Thetechnique was used to restore vision to hamsters. Repairingaxon damage is very difficult, this paper provides a potentiallynew method for repairing nerve damage. Further animal

testing is required before clinical trials could begin.

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Australian researchers have grown a mouse breast in vivofrom a single epithelial stem cell, providing some proof ofconcept for a method of tissue regeneration.

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Stem Cells

The testes have been identified by three research groups asa potential source of totipotent/pluripotent stem cells. In

theory, the reprogrammable testes cells could circumvent theethical difficulties of stem cell work that involves destroyinghuman embryos. It remains to be seen whether this will bepossible with humans.

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Embryonic stem-cell gametes may also have a role to play infertility treatment, providing a source of ova. Such ova couldalso be used in therapeutic cloning work.

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The concept that cancers may arise from self-renewable stem

cells has recently been resurrected with recent evidencesuggesting this may be case. If correct, then there are


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diseaseprocesses

Meanwhileconflicting nationalpolicies in embryonic

stem cell researchhave ledresearchers to formthe Hinxton Groupto attempt to furtherinternationalregulationdevelopment.

significant implications for the way that we assess cancer,and how we design treatment to attack these cells, as theymay be inherently resistant to the current therapeuticapproaches.

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According to new research in male rainbow trout, stem cellsare not sex-determined, despite their chromosomes whenplaced in either male or female hatchlings they differentiateinto sperm or (unexpectedly) eggs respectively. If this worksin other animals it would allow rapid production of inbred lineswhich can retain and hyper-express desirable phenotypes.This would be useful in animal biotechnology, especiallybiopharming applications.

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An international consortium on stem cells, ethics, and law

called the Hinxton Group has been convened and hopes tofurther the internationalisation of stem cell regulations. Thisincludes a recommendation that laws and regulations need tobe flexible in order to accommodate rapid scientific advanceas well as creating national and international HESC banksthat meet international quality standards.

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2.3 Food and Nutrition

In the area of food and nutrition, a number of social andscientific trends are coming together. These include:

The development of Culinology - a term coined todescribe the connection between food science and theculinary arts. It ranges from methods of moving bulkand convenience foods out of the commodity market,to efforts to widen peoples range of acceptable andinnovative foods. This sits alongside a move tofunctional foods, another approach to moving food outof the commodity market, as well a strategy toimprove human health

Significance of demographics to nutritional status. Forexample, malnutirion is already a rising issue in the

elderly, and likely to become a larger problem as theelderly population increases. This will be associatedwith rising health costs. (The aging population willalso increase demands for new technologies to assistwith care, especially if there is a shortage of care-givers - likely due to lack of interest and low pay).

Developing understanding of the relationshipsbetween genetics and environment as they relate tonutrition in the womb and during life, and consequenthealth and disease status

Greater awareness of the value of understanding food

and nutrition within an evolutionary context

Questioning of the significance of developments in


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New evidencesuggests thatgenetically, humanshave not evolved tocope with changingdietary patterns thatare increasinglyresponsible for therise of lifestylediseases this may

provide anoverarchinghypothesis currentlyabsent fromnutritional science

Research isidentifying a range offactors responsiblefor the obesityepidemic from sleepdeprivation to foetalnutrition to earlychildhood exposureto the microbial

world

Nutrition and food

food and nutrition for the distribution of health betweenbetter and worse off people

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Looking to the ancestral human diet?

Contemporary nutritional is heavily based on epidemiologicalresearch. Recent research, however, has reported that thehuman genome has hardly changed since the emergence ofmodern humans (50100,000 years ago). It is hypothesisedthat advances in traditional nutrition science would benefitfrom an intimate understanding of the ancestral human dietbecause genetically, humans remains adapted for the foodsconsumed then, rather than the diets often consumed today.

Modern nutritional science lacks a unifying hypothesis onwhich to build a dietary strategy. Some argue that anunderstanding of human evolutionary experience and it

relevance to contemporary nutritional requirements couldaddress the need for a unifying hypothesis.

Life-style diseases: Obesity

Several international studies are indicating that sleepdeprivation is linked with changes in appetite control andimmune function both of which are linked to lifestylediseases obesity and type II diabetes. A recent survey of10,000 NEW ZEALANDers shows that 37% never or rarelygot enough sleep.

Recent findings are also showing early life nutrition andexposure to out environment notably our exposure to the

microbial world -play a significant role defining our futurehealth status, including downstream propensity to lifestylediseases like obesity. For example, US based researchershave been raising germ free mice which can eat and eat andnot get fat compared to mice with normal gut bacteria thegerm-free mice ate 29% more food but had 42% less bodyfat.

Individuals with obesity, Type II diabetes and metabolicdisorders may have suffered from improper epigeneticprogramming during fetal and postnatal development due toinadequate maternal nutrition and metabolic disturbances

which transmitted these conditions to the next generation.

Scottish research has demonstrated both the difficulties andpossible impact of education programmes to increaseconsumption of fruit and vegetables in young people. Eatinghabits in young people have an impact throughout their lives.

Nutrigenomics

The disciplines of food science and human nutrition may beon the cusp of exploiting the wealth of information that hasbeen generated by the genomics (et al) explosion. There isincreasing understanding of the interactions between key

envioronmental factors that affect the genome, transcriptomeproteome and metabolome, and the effect of this life long


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science are goinggenomic

Functional foods is arapidly growingmarketinternationally

there are howeverpotential regulatoryand social hurdlesthat will need to beaddressed

GM plant and animalapplications areemerging withenhancedconsumer traitsleading somecommentators tospeculate that thismay improve the

technologysacceptability rating

interaction on an individuals health and disease status.

This has implications for New Zealand food industries bothin terms of commercial expectations from consumers andkeeping abreast of expectations in our key export marketsand emerging food manufacturing practice that is beginning to

incorporate these kind of developments into the manufactureof new food concepts.

Functional Foods

Functional foods are a rapidly growing area of research.Currently, functional foods markets are estimated to be a$US50 million industry, projected to increase to US167 millionby 2010.

Functional foods are sold as premium brands and research isalready indicating that families on restricted incomes are notable to buy products like heart-healthy margarines even if

they wish to. If more reliance is placed on functional foods totreat/prevent disease the health gap between rich and poorcould potentially widen.

Herbal and natural supplements are growing in popularity,but are not necessarily harmless, and there is little in the wayof safety testing. The inclusion of a bioactive factor in a foodproduct at high concentration could be considered as turningthe food product into a drug carrier. For example, deer velvetis currently being touted as a cure-all particularly for theelderly; however, deer velvet is also know to have high levelsof epidermal growth factor, a cytokine whose cellular receptoris directly correlated with many human cancers. At presentthe regulatory hurdles for such products is considerably lowerthan for example, drug development. This will have futureimplications for regulation and co-prescription with othermedications/functional foods and potential negative side-effects.

Where will functional foods stops and drugs begin?

Using GM to produce foods of greater health value?

Most transgenic traits in crops and animals to date have beenfor industrys benefit. (Round-up ready crops, delayedsenescence tomatoes, double muscling in livestock). Industry

has long hoped that products with consumer-friendly traits willswing public opinion. Were moving into a time where thatcherished assumption may well be tested.For example:

Pigs have been genetically modified to producehumanised omega-3 fatty acids. While this researchwas conducted primarily to study cardiovascularfunction (using pigs as a model for humans), there isthe potential that such animals could also eventuallybe introduced into the food chain. This would supporta trend of using GM to produce foods of greater healthvalue.

The fibre content of wheat has been increasedthrough the use of RNA interference to knock out a


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with consumers

Gene sequencingtechnologies areevolving rapidly

but is our ability tointerpret the data

deluge keepingpace?

Genetic diagnostictechnologies areevolving equallyrapidly withimplications for

pathogen testing inclinical practice and

wheat gene. The GM plants were used to producedthe desired trait, and confirm the effect and safety onrats.

The next step, however, is to find natural variants in wheatthat have a similar knockout and use these to producecommercial wheat varieties that are not geneticallymodified with higher fibre content. This may be a moreacceptable approach for society and consumers.

2. 4. Research tools and practice

Diagnostics & Gene Sequencing Technologies rapidadvances

A range of new DNA sequencing technologies are beingdeveloped. Technological improvements are occurring veryquickly (over a matter of months) enabling longer more

accurate reading of DNA sequences. There is no predictionas to when a $1000 genome will be achievable, but is beinganticipated. Some of the newer approaches such asnanopores are likely to be many years away fromcommercialisation.

Cheaper highly accurate, high throughput, longer readsequencing technologies will be used initially for researchpurposes. This will result in many more complete genomedata sets, as well as, for example, the enhanced ability toidentify individual genetic variations in populations (be theypeople or pathogens). However, this wealth of data will add to

the existing substantial challenges for methods to properlyanalyse such information.

Longer term as prices decrease such sequencing is beingpredicted to be used for individual patients as part of theirnormal diagnosis. However, to fully utilise this opportunityrequires a greater understanding of interactions betweengenes and the environment. This will take much longer todevelop (through well designed long term trials and focussedinterdisciplinary studies of specific diseases), so it will remainuncertain to what extent cheap sequencing technologies willhave on provision of health care in the near term.

Diagnostic technologies are also advancing rapidly. Examplesinclude:

A handheld diagnostic device has been developedwhich uses mRNA in saliva to identify diseases(including oral cancer with 94% accuracy on a sampleof 320, breast cancer and type II diabetes) in 20minutes. Still at early stage of development butpotential implications of widespread adoption aremanifold: eg. screening without the need for large-scale laboratory services, earlier, accurate diseasediagnostics.

Affymetrix recently released a high-density micro-array that identifies up to 8900 distinctive organisms in


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for biosecuritymanagement.

Advances in in-silicomodellingtechniques will haveimplications for waythat molecularbiology research isconducted in thefuture

ICT advances areproviding increasingopportunities forresearchers to workin new collaborativeways sharingdatasets and virtualwork spaces

a single experiment. This has implications for theincreased speed and accuracy of pathogen testing,will improve the diagnosis of disease, and help directspecific treatments in clinical situations.

ICT-Bio Convergence

In-silico modelling is becoming an increasingly powerful tool.Moores Law has brought us to the point where we have thecomputing power to build things as complex as those built bynatural selection.

Notable recent trends and achievements in this field:

researchers modelled every atom in a virussuspended in a drop of water for 50 nanoseconds andwere able to record previously unsuspected systemlevel behaviour.

computational vaccinology the use of computers to

design vaccine sequences. This approach is likelycomplement existing vaccine design strategies andcomputationally designed immunogens, in particular,may be synthesised in the lab and potentially be usedas vaccine candidates;

This has implications for molecular biology research. Will itco-exist in research with the wet lab in cooperation and/orcompetition?

DNA Computing

A molecular computer that uses enzymes to perform

calculations has been built by researchers in Israel. Enzymepowered computers could eventually be implanted into thehuman body and used to, for example, tailor the release ofdrugs to a specific persons metabolism.

Collaboration tools

Grid Computing is an emerging development in New Zealandbut is already established in Europe, US, Australia and someAsian countries. It achieves three goals access todatabases or applications that are available at different sites,distribution of complex computational tasks across the gridand enables e-collaboration. No one organisation has the

resources to deliver the diversity of databases andapplications required for the practice of modern science.Organisations are pooling resources for large pieces of kitand collections.

There is a trend away from the scientific paper as the officialunit of scientific output towards a more collaborative,dynamic way of reporting scientific results. The availability ofnew ways of interaction the social software and multi-useronline spaces or virtual worlds - will increasingly allowscientists to do science in new ways. Internet-only journalsand online early editions are early indicators of a sea-change

in science communications which will have larger effects.These trends may also be increasingly significant when we


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Big projects,generating massivedata sets to answerincreasingly complexresearch questionscan no longer beundertaken byindividual institutionsor even countries

Divergent trends: theuse of animals in

research elicitsstrong reactionsfrom a range ofquarters

viewed against a future when international travel is likely tobecome less convenient (security measures) and moreexpensive (rising costs of jet fuel).

Big Science

There are a number of multi-national research projects toanswer the hard questions generating massive data sets.These include:

Genetic Signposts: one of the biggest projects to identifythe genetic variations that predispose people to eightmajor diseases (TB, heart disease, Types I & II diabetes,bi-polar disorder and hypertension) has been funded bythe Wellcome Trust.

The collaboration brings together 24 leading geneticists tocollect and analyse the genetic make-up of 2000 affectedindividuals compared to 3000 control samples. It is hoped

that by identifying these genetic signposts thatresearchers will be able to understand which people aremost at risk and which genes are contributing to eachdisease.

The UK Biobankproject got underway in March 2006 withthe aim to gather, analyse and store the DNA of a millionvolunteers This is the first time a project of this magnitudehas been launched. Critics raise privacy concerns and therisk of misleading results and misuse of data.. Biobank UKis one of two huge medical research projects, both ofwhich hope to unravel the relationship between a personsgenetic make-up and environmental triggers of diseasestates. The US equivalent, announced in 2004 by theNational Genome Research Institute is still in the planningstages.

The Barcoding of Life Consortium using a smallfragment of mtDNA project to catalogue every species onearth. Implications for border security.

The use of animals in research

The UK government is considering radical changes in theregulation and reporting of animal experiments to make thesystem more accurately reflect the amount of suffering

animals experience in research . One of the new aspects ofthe system is the recording of the animals experienceretrospectively as opposed to the current system which onlyoffers prospective experience data , that is generalised andprovides no indication of the actual experience of the animals.

Hundreds of scientist and students have protested in favourof a new biomedical laboratory that supports the use ofanimals in research in Oxford, UK. This is the first march tosupport animal research by scientists in the face of thesometimes extreme tactics of animal rights protestors in theUK.

The denial of rights for animals is compared with humanslavery by an American Professor of Law, with a conclusion


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Paradigm Shift:

miRNA and the non-coding regions inDNA are playing anincreasingly centralrole

that the case for animals having the one right not to betreated as the property of humans is as strong as thatagainst slavery.

Meanwhile, engineers funded by the US military have createda neural implant designed to enable a sharks brain signals to

be manipulated remotely. The team has gained ethicalapproval to develop implants which monitor and influence thebehaviour of animals, from sharks and tuna to rats andmonkeys.

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2.5 Intellectual Property

The WAI262 claim hearings to the Waitangi Tribunal haveresumed after a four year break this relates to native floraand fauna and associated Maori Intellectual property rights.The new direction of the tribunal has angered the claimants,

who argue that the draft statement of issues ignores questionconcerning Maori world views and tino rangatiratanga overthe exploitation of natural resources.

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The US Supreme Court is considering the law on patentingnatural phenomena. Generally speaking a naturalphenomenon or law of nature can not be patented althoughprocesses which take advantage of the phenomenon or lawcan be. The Supreme Court is currently considering a case,Laboratory Corporation of America Holdings (LabCorp)against Metabolite Laboratories that could wreck havoc on

the patent world. A decision is expected by June 2006 onwhether it is legal to patent a biological relationship betweentwo substances. This strategy underpins the biotechnologyindustry and this case could have wide-ranging implications ifthe Court rules that it not legal to patent a biologicalrelationship between two substances.

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2.6. Molecular Biology

It aint junk - A paradigm shift in the making

Vast parts of the human genome that had previously been

considered junk, now have been shown to be expressed asRNA, but not converted into protein. MicroRNAs (miRNAs)are a class of non-coding RNAs that regulate the expressionof other genes. These small RNAs will have a central role incellular and developmental processes.

Already companies are producing specific miRNA arrayproducts. Existing biological data will need to be re-evaluatedin light of this new research.

People are also turning their attention to non-coding DNA.What does it do, or does it have some selective advantage, orplay some regulatory role? It is likely that non-coding DNA will

contain significant regulatory function. We already know thatmiRNAs play a role in gene regulation. It remains to be seen


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how much of a role other non-coding DNA plays. The keyissue here is that there is a potential paradigm shift in the air.Most eukaryotic genomes are made up of non-coding DNA.

If this truly plays a large role in biological function thenresearch emphasis will shift from genes to non-coding

regions.------------------------------------------------------------------------

Emerging areas to watch:

Synthetic Biology

Synthetic biology aims to create novel biological functionsand tools by modifying or integrating well-characterizedbiological components (i.e. genes, promoters) into higherorder genetic networks using mathematical modeling to directthe construction towards the desired end product. This is anarea being pushed forward by high profile research

proponents like Craig Venters work attempting to determinethe minimum number of genes required for a living organism.

Epigenetics and development

Epigenetics - the study of heritable traits and characteristicsthat are not encoded in sequences of DNA, but rather theinteractions between DNA and other molecules or by protein-protein interactions is advancing rapidly. Twin studies arestarting to unlock how epigenetic effects contribute to howdifferent phenotypes can originate from a common genotypeshowing that relatively small differences in epigenetic patternscan have a large impact on our ultimate phenotype. In theNew Zealand research context this has implications foranimal cloning research.

For mammals, the environment in the womb may haveconsiderable effects on genetic-coping mechanisms forpreparing offspring for the post-birth environment.

Comparative genomics

Comparative genomics is the analysis and comparison ofgenomes from different species. The purpose of which is togain a better understanding of how species have evolved andto determine the function of genes and non-coding regions of

the genome. This area of study is also starting to haveimplications for the comparative study of plant genomes.

Paleogenomics

A Canadian team has sequenced the DNA of a woollymammoth from a well-preserved sample from Siberia coupledwith a new PCR method. The team has been able to identifyalmost half of the DNA, and the DNA match with modernAfrican elephants was 98.55% - consistent with a divergencedate of 5-6 million years. This is a first for an extinct species,launching a new field paleogenomics.

Environment and evolutionA mimivirus has been discovered, larger than some bacteria,


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Regulatory systemdevelopments arenot keeping up withnanotechnologydevelopments

The liabilityconcerns of insurersare coupled withwhat is claimed asthe first nano-product recall

There is much hypesurroundingprojected industrygrowth but the rateof VC investmentcompared to publicfunding suggeststhat were still at thefundamentalresearch stage...

existing on the boundary between viruses and cellular lifeforms. Its discovery may call for a re-organisation oftaxonomy, advance study of evolution, and provide insightsinto self-organising construction at the large molecular level.

Bioinformatic techniques are being used to see if one can

predict the course of human influenza. While not yetsuccessful, if it could predict the evolution of an organism, thetechnique could be used to anticipate potential therapeutictherapies and vaccines.

The importance of collecting samples from populationsimpacted by pollution for taxonomic databases has beenrecognised.

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2.7. Nanotechnology and new materials.

The Context for Nanotechnology

No major jurisdiction has designed regulatory regimes fornanomaterials. The US patent office has issued thousands ofnanotech related patents with investment in nanotech R&Drunning at over $US10 billion a year. The US NSF expectsnanotech to account for commercial sales exceeding $US1trillion by 2011 & $US2.5 trillion by 2015. This may mean thatbecause nanotech regulation is moving slowly internationallyproducts will potentially be commercialised before beingadequately assessed for safety.

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First health related recall of a nanotech product: A bathroomcleaning product (Nano-Magic) was recalled in Germanyafter 70 people were reported to have had severe respiratoryproblems after using the product. Six were hospitalised. Thereport noted that it is not clear whether the product actuallycontains manufactured nanomaterials or the term was justused as a marketing tool.

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Insurers have been sufficiently concerned by the toxicity risksof nanomaterials that they have called for a new regulatoryframework based on the precautionary principle and

threatened to withdraw cover.----------------------------------------------------------------------

A report by Cientifica notes that Venture Capital investment innanotechnology is very small compared to public funding withthe conclusion that investors are not seeing large returns frommany of the existing nanotech companies.

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There appear to be increasing numbers of nanotech-relatedpatents being issued (in the US and elsewhere) that arebroad in scope. This is being referred to as a patent land-

grab and there is a concern that the scope of the patents willstifle innovation.


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Carbon Nanotubesand Quantum Dotsare the technologydevelopment areasto watch

The convergence ofnano andbiotechnologies arestarting to driveemerging healthcare innovations

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Nature Publishing Group has issued a Call for Papers for anew journal Nature Nanotechnolog,ysignalling greaterperceived value in the field. There is clearly enough qualityresearch and advertising revenue in this space to support

another top-class journal.------------------------------------------------------------------------

Wider social interest in nanotechnology is emerging. Forinstance, historians are becoming involved in understandingthe place of nanotechnology in society, with one projecttracking the history of nanotechnology as it emerges.

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Nanotechnology Technology Trends

Carbon nanotubes and quantum dots appear to be two areas

of nanotechnology application that are advancing rapidly.In the case of carbon nanotubes this will have implications forthe electronics, semiconductor and energy sectors. Notablebreakthroughs include:

IBM has succeeded in creating a test circuit toevaluate the performance of carbon nanotubes tocarry electrical current potential. This was previouslya technological bottleneck ,and has potentialimplications for materials and semiconductormanufacturing techniques and much smaller, fastercomputers.

Use of a catalyst using carbon nanotubes to convertchemical energy into electrical energy to develop fuelcell artificial muscles for humanoid robots (militaryapplications). Nanotubes could be used to storeelectrical energy potentially becoming a majoralternative to chemical batteries in 200 years(disruptive technology)

Quantum dots talking to each other by transmittinglight to each other in a coherent fashion. This lays thepathway for using quantum dots to transmit lightwaves in an arranged and flexible manner for use in

an optical quantum computer = faster computers usingoptics.

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Nano-bio convergence

The convergence of nano and biotechnologies is seen as afertile area for future innovations which will have implicationsfor areas like future healthcare applications.

Nano-medicine is the term being used for miniaturisation ofexisting tools which will lead to superior diagnostics andbiosensors, improved imaging techniques and innovative

therapeutics. The European Science Foundation recentlypublished a report outlining a roadmap in this area seen as


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Growing demands

for global resourcesis putting increasingpressure on theenvironment

a rapidly progressing field.

Other examples of bio-nanotechnology identified in thisscanning cycle include:

Electronic noses made from organic semi-conductors.

Biomimetics or the development of syntheticsystems based on information from biological systems notably, the use of marine diatoms to inform thedesign of nano-structured semi-conductor materials.

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New Materials

Researchers are working on self-organising materials, thatuse the methods by which nature assembles fundamentalmicrostrucutres to construct macro scale articles. This

promises mass production of articles with minimalenvironmental impact, and/or menotic replacement bodyparts.

Some materials are shifting in use thermoplastic materials(TP) are being used in new applications in aircraftconstruction. This signals the possibility of applications of TPin industrial areas, and also possibly in prosthetics.

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2.8. Environment and natural resources

Concern about the state of the planet is intensifying with

particular concern about biodiversity loss and on-going effectsof climate change. Infectious diseases are also threateningmany of the worlds staple food crops such as rice andsoybeans (a trend that appears to be increasing) withconsequences for yield and quality.

Social and political change is a significant drivers ofenvironmental change and risk, for example:

The 2006 Worldwatch State of the World reporthighlights the consequences were China and India tomatch even Japanese and European resource use they would consume the worlds entire annual supply

of oil and minerals

There is a projected increase in the number of vesselsmovements, with associated threats to biosecurity andcontainment

The US Bush administration has endeavoured 3times to relax US pollution regulation, but failed eachtime

A Danish conference claimed that growth in greenmarkets will not generate net economic growthbecause of decline in sunset industries, but that

growth could be gained from energy efficiency, cleantechnologies and public procurement. Econ-


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Recent researchsuggests-surprisingly - thatmethane is alsoproduced aerobicallyby plants...

innovation could be boosted by providing incentivesthrough subsidies and green taxation.

And there are issues specific to the New Zealandenvironment:

In the marine context, for instance, local responses tolegislative frameworks in aquaculture, development ofmarine reserves, and responses to the Seabed andForeshore Act

Influential commentators are noting how little it wouldtake to implode NEW ZEALANDs clean green image

The cost of cleaning up the eutrophication of theRotorua lakes has been estimated at $200 million, andthere is a long latent period until all effect of change inland use are realised

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Climate Change

Methane emissions

Methane is an important greenhouse gas and its atmosphericconcentration has tripled since pre-industrial times. Recentresearch is suggesting that plants also produce significantamounts of methane. These results are surprising methanewas not thought to be produced when oxygen is present. Theauthors calculate that this previously unidentified source ofmethane is of significant magnitude representing 10-30% ofcurrent annual methane emissions in strength and size if

further proven.If this evidence is borne out, it will have implications for NewZealand with methane from ruminants already producingthe bulk of our greenhouse gas emissions.

Commentators are suggesting that roughly doubling thefunding of research into ways of reducing methane emissionsfrom animals may well be the best investment New Zealandcould make towards greenhouse gas mitigation. New Zealandwill be a follower of R&D with respect to CO2 mitigation. NewZealand has expertise in ruminants and could potentiallymake a far greater contribution to this research than other

areas.

Modelling

Stabilising the atmospheric concentration of CO2 at 550ppmis feasible and while the modelling remains subject tosignificant uncertainty, there is an emerging consensus thatsuch a concentration would yield a global temperature rise of2 with a 20% chance of catastrophic effects.

Climate models for New Zealand are confirming earlyprojections that westerlies will increase, generating wetterconditions on the west coasts and drier east coast conditions.

The major impacts will be on agricultural patterns andelectricity generation.


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Ecosystems areunder pressurebutemerging monitoringtools may provide us

with the tools tounderstand systemdynamics in greaterdetail

Sea levels are expected to rise by several metres by the endof the century. Several papers by international teams suggestthat the earth may be warm enough by 2100 for widespreadmelting of the Greenland Ice Sheet and partial collapse of

Western Antarctic Ice Sheet. The research is based on paleo-climate data to determine how large the Greenland Ice Sheetwas during the last inter-glacial period 129,000 years agowhen sea levels were metres higher than they are today. Thiswill help to estimate the impacts future sea level rises withgreater certainty.

Regulation

California is set to become the first state in the US to enactlaws to ensure reductions in greenhouse gas emissions. If thebill passes other States are likely to follow suit and even ifnot, California law alone could assist in reducing the global

price of carbon credits and thus reduce NEW ZEALANDs billunder our Kyoto obligations.

Environmental impacts

Antarctic birds are breeding later in response to the changingclimate. Researchers suggest that that the declining quantityof sea ice in combination with the longer sea ice season havecaused declines krill and marine animals in early spring. Thiscould also have implications on fisheries and the ecology ofthe food chain in the Southern Ocean.

Energy use and sources

There is increasing interest in alternative energy sources anddistribution networks (see section 1 and international debateabout the role of nuclear power in managing environmentalrisk).

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Ecosystems/Biodiversity

The Millenium ecosystem report identified that over 60% ofecosystem services which support life on earth are degraded.These include:

Euoropean decline of butterflies, with indications thatbutterfly decline is worldwide

A major ecosystem shift has occurred in the NorthBering Sea

A 2005 report indicates that the number and size ofmarine dead-zones is increasing world-wide mostlyas a result of coastal run-off.

New ecological relationships continue to be uncovered

Researchers have discovered that a tree weta eatsfleshy seeds from a range of native plant species and

has a key role in seed dispersal.


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Sensor networksand metagenomicanalysis couldprovide the step

change that we needto measure andmonitorenvironmentalprocesses moreeffectively

The implications of declining weta species in relation toindigenous plants is uncertain but it serves to highlight thatthere is still much to learn about our indigenous eco-systemsand the webs that underlie it

Fungi such as mushroom are able to producemycelium that insects are attracted to and which cansubsequently kill the insects and their colony

Low dosages of toxins from algae bloom can havesignificant chronic or fatal effects on seal lions (untilnow low dosages were not thought to be a significanthealth risk)

New research suggest that mangroves contribute 10%of oceans dissolved organic carbon suggesting thatthey play a stronger ecological role than previously

believed.-------------------------------------------------------------------------

Emerging monitoring technology

Sensor Networks

Networks of tiny computers (sensor nets) are beingdeveloped to monitor a large number environmentalconditions over a large area in real time. This represents astep change in methods to measure and monitorenvironmental processes. It would provide much more dataon ecosystem conditions, so likely to have a similar influence

on environmental science as genomics and proteomics haveon genetics.

This will produce huge databases of information that arecontinually added to. If properly managed and exploited itwould substantially improve the understanding of someenvironmental processes.

Several companies are already producing such sensors, andthe US Ocean Observatories Initiative is creating a fibre opticgigabit carrier across the Pacific Ocean floor to handle thedata. Currently the sensors are being used on a small scalefor research purposes, and costs for sensors are high. Sensor

costs need to decrease substantially and this will require thatthe sensors also have commercial utility (for example inmineral and oil exploration).

A new application of remote sensing platforms reveals large-scale distribution of marine fishes. This method may replacetraditional fisheries survey methods.

Metagenomics

Metagenomics is the simultaneous collection of genetic datafrom many different species or variants in an environmentalsample. Traditionally community and ecosystem ecologists

studied their communities by looking at what organisms arepresent, their interactions and their contribution to the


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Truly sustainabledevelopment hasimplications forfuture farming andland managementpractices

The potentialelimination ofdisease causingprions in livestock byRNAi technology

could haveimplications for thedownstreammanagement ofdiseases like BSE

functionality of the community or eco-system.

With metagenomics it is possible to take this concept further.For example, if we are interested in eco-system function andhealth, then we can simply ask what genes are available inthe environment and from this infer the metabolic processes

that are in play. This, in turn, can be used to tell us about thetypes of chemical and biotic processes in the environment.

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Agriculture and farming practices

Environmental issues in food production are generatingconversations about:

Eco-farming: ways in which farmers can be helped toimprove soil quality and reduce use of water bytechniques such as crop rotation and organic farming

Relationships between initiatives in biofuel productionand food production

Long term connections between economics of foodproduction (particularly energy costs) and consumerprice

Concerns to link conservation agendas with biotechnologyand economic growth have been one driver behind aninitiative to resurrect the NEW ZEALAND flax industry withpossible health, fibre, craft and neutriceutical applications.

Parallel conversations try to anticipate the future forcommodity agriculture, and the place of biotech (in the form ofgm) in that future. The top 6 companies that dominate ag-biotech may further consolidate, but there will remaincommercial opportunities for smaller companies.

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Researchers in the US have demonstrated that they cannearly eliminate production of infectious prion proteins inlivestock using RNA interference (RNAi). This study extendsthe in vivo use of RNAi from mice to larger animals for thefirst time. This technique could potentially enable scientists togenetically engineer livestock that are resistant to prion-

caused diseases like BSE.With Sweden having just lost its BSE-free status, this leavesthe EU with no BSE-free countries and Australia and NewZealand are two of the few countries remaining with BSE-freestatus.

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2.9. The geo-political context

International Regulation

In a report published on 10 March, the European Commissionhas concluded that in view of the EUs limited experience with


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The release ofGMOs into theenvironmentremains contentious

at multi-lateral andindividual countrylevel

the cultivation of GM crops and the need to conclude theprocess on introducing national measures, there is no need,at this stage to legislate at the European level to create aframework for the national rules permitting the co-existence ofconventional or organic crops with GM crops in Europe.Before any final decision is taken, however, the Commissionwill engage in consultative process with stakeholders.

The Commission has reserved the right to decide whether thenational measures adopted are too strict and to take action iflegal measures are required. This has caused an outcryamongst environmentalists and GM-free supporters.

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The Parties to the Cartegena Biosafety Protocol agreed inMarch to new rules for the labelling of living modifiedorganisms (LMOs)

The Parties to the Convention on Biodiversity reaffirmed a2000 recommendation to Governments not to allow fieldtesting of GM sterility technologies until sufficient scientificdata is available to assess such proposals, and threw outproposed draft text (supported by NEW ZEALAND, Australiaand Canada) aimed at clearing the way for field testing.

Calls for greater caution with respect to the release of GMtrees have come from two UN bodies. In March, the Parties tothe Convention on Biodiversity called for greater precaution inthe assessment of applications for GM trees and this followedthe UNs Food and Agriculture Organisation (FAO) call inOctober for an international framework to assess the safety ofGM trees.

In February, Poland became the third country in Europe (afterGreece and Poland) to have all its regions declared GM Free.

In New Zealand, there is speculation that public attitudes maychange in response to gm applications in industrialbiotechnology and in improving the health benefits of food,and the potential to modify organisms without introducingDNA sourced from other organisms. Social research onpublic attitudes has been interpreted both to support andquestion that view.

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The Biological Weapons Convention (BWC) still lacks aprotocol to enforce it. Although it prohibits biological and toxinweapons, the absence of provisions to monitor and verifycompliance means the BWC is little more than a gentlemansagreement not to exploit biotechnology for hostile purposes.

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International R&D The continuing rise of Asia

Bilateral Agreements

US and Australia have both recently signed agreements withIndia with significant S&T components.


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Interest in the rapidlydeveloping Asiannations continues todrive S&T based bi-

lateral agreements

likewise Asiannations continue tomake massive publicR&D investments inthe biologicalsciences and

researchinfrastructure

During a recent visit by Australian PM. John Howard to Indiain March, six MOUs were signed including biotechnology andscience and technology. The Australia-India StrategicResearch Fund was launched with Australia providing $A20million (+$A5 million in merit based scholarships) over fiveyears for collaborative research projects and scientificsymposiums. India will match this funding.

Similarly, President Bush, on a recent visit to India launched a$US 100 million Knowledge Initiative on Agriculture. The 3year initiative hopes to revitalise the bi-lateral partnership onagricultural research and exchange including the promotion ofpublic private partnerships for commercialisation ofagricultural R&D in both countries. Biotech, pest management& sustainable water management are all priority areas.

The agreement has not met with support from all quarters inIndia with the Left claiming that the initiative will be driven by

the interests of US-led multinational corporations such asMonsanto and Walmart.

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R&D investments

Since selecting the Biomedical Sciences (BMS) as an area ofgrowth, the Singapore Government has invested significantresources to nurture the industrial, intellectual and humancapital of the BMS sector. This investment is fast showingdividends and the sector has been growing rapidly. However,after surging 33 per cent in 2004, the BMS sector grew 9.8per cent in 2005. Total output from pharmaceutical andmedical equipment plants hit S$18 billion in 2005, accordingto figures from the Singapore Economic Board and theAgency for Science and Technology Research (A*Star).A*Star is optimistic that Singapores biomedical sector is ontrack to achieve the 2015 target of S$25 billion inmanufacturing output, S$12.5 billion in value-added, and15,000 jobs.

The Japanese Council for Science and Technology Policy areabout to release their Third Science and Technology BasicPlan a five year blueprint for R&D investment and policy inJapan. The updated S&T plan aims to continue previous

policies of concentrated funding in four priority areas: the lifesciences, ICT, environmental sciences, and nanotechnologyand materials sciences.

The Government aspires to raise R&D expenditure to 1% ofGDP over the next five years. This translates to 25 trillion($US 214 billion) for R&D over the next 5 years.

Chinas development in science includes a noticeableincrease in the number of scientific and technical publicationsfrom that country.

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Growing painsaround resourceneeds coupled witha command andcontrol politicalsystem could makerapid changepossible

Sustainable development

China may take a lead in focused and effective sustainabledevelopment over the next decade many aspects ofChinese environment are in difficulty, and there areindications politicians are focused on the issue. The political

context could make rapid change possible. China is, forinstance, introducing new regulations in the allocation of freshwater, and producing monthly publications to promote organicproduction methods.

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2.10. Manufacturing, business and marketing

A number of social and demographic changes are likely toaffect markets and manufacturing. Smaller families andchanging demographics in developing countries may affect

the supply of labour in those places; different perceptions oflabour costs and exchange rates may

Documents

2006_Network_Navigating towards our future First report of ‘ The Navigator Network ’ on emerging issues in biotechnology and_Unknow