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Australian academy of Technological sciences and engineering (ATSE)
Number 150
June 2008
Australia’s biomedical
technology climate
Contributors discuss our research culture and
outcomes, medical technology prospects, specific
product research, biopharmaceuticals, funding
issues, and the journey from research to market
FOCUS www.atse.org.au
Contents
5
12 Raising capital for our
medical technologies
and therapeutics
14 Doing less, but doing
Great research it better
– how about some
outcomes? 16 The journey from research
By Peter Andrews to market with biomedicals
19 Biopharmaceuticals:
7
filling the gaps in
Australia’s capabilities
22 Emissions trading needs
technology investment
Medical technology: 23 Structural issues limit
prospects for the energy technology R&D
21st century
By Graeme Clark 24 Urgent action needed
on innovation
10
25 A globally trading,
technology-based
Australia?
26 Five innovation giants
Biomolecular win 2008 ATSE Clunies Ross
engineering: Awards
exploiting biological 28 Extreme Science takes
switches Brisbane by storm
By Anton Middelberg
30 DSTO: a Century of public
and private impacts
Cover: The essence of biomedical technology – the science starts in
the laboratory. 32 ATSE in focus
Photo: Office of the Queensland Chief Scientist
ATSE is an independent body of eminent Australian engineers and scientists
established to promote the application of scientific and engineering knowledge to
practical purposes. ATSE Focus is produced to serve this goal.
Opinions expressed in this publication are those of the authors, and do not necessarily
reflect the views of ATSE. Material published in Focus may be reproduced provided
ATSE Focus is produced to stimulate discussion and appropriate acknowledgement is given to the author and the Academy.
public policy initiatives on key topics of interest Chief Executive Officer: Dr Trevor Evans
to the Academy and the nation. Many articles are Editor: Bill Mackey
Technical Consultant: Dr Vaughan Beck FTSE
contributed by ATSE Fellows with expertise in these
areas. Opinion pieces on topics of national interest, Australian Academy of Technological Sciences and Engineering (ATSE)
particularly the Academy’s key interest areas – climate Address: Ian McLennan House, 197 Royal Parade, Parkville Victoria 3052
change, water, energy and education – will be Postal Address: PO Box 355, Parkville Victoria 3052
considered for publication. Items between 800 and Telephone: 03 9340 1200
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1500 words are preferred. Please address comments, Email: editor@atse.org.au
suggested topics and article for publication to
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editor@atse.org.au. ABN 58 008 520 394
Print Post Publication No 341403/0025
Deadline for the receipt of copy for next edition of ISSN 1326-8708
Focus is 11 July 2008 Design and production: Coretext 03 9670 1168 www.coretext.com.au
FOCUS www.atse.org.au 
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Biomedical Technology
Great research – how about
some outcomes?
Australia needs more spin-out companies coming out of its universities and
research institutes, and more of these companies developing into big ones
By Peter Andrews
A
chief.scientist@qld.gov.au productive life due to disease and injury and 70 per
ustralia’s biomedical research base is outstand- cent of all health care costs due to disease. Productivity
ing by any measure – creativity, originality, losses amount to three times as much again.
publications in the world’s best journals, even These are problems that should be susceptible to
Nobel Prizes – and there is every reason to our research. By and large, chronic diseases are prevent-
suppose that it will become better yet. able, and even those that cannot be prevented can be
Major investments by Federal and State govern- treated much more economically and effectively if de-
ments, particularly in Queensland and Victoria, dur- tected early.
ing this decade are already paying handsome dividends What do we need to do? First, let’s tackle our ma-
through the attraction and retention of internation- jor challenge: the risk factors driving our unacceptably
ally acclaimed researchers, the establishment of vibrant high levels of chronic disease.
and iconic new research institutes, and the building of By and large, Australian adults are overweight,
knowledge-intensive industries. consume too much alcohol but not enough fruit and
So, how is it that health costs are climbing, Indig- vegetables, and do not get enough exercise. More than
enous Australians are dying 17 years younger than the 20 per cent still smoke. In lower socioeconomic groups,
rest of the population and biotechnology companies remote communities and among Indigenous Austral-
are stagnating? What do we have to do to see serious ians the prevalence of these risk factors is higher and so
social and commercial returns from our investment in are the levels of chronic disease.
health and medical research? It is known that the elimination of these risk factors
In my view, we need to ramp up our investment can lead to a decade or more of increased life expect-
in translational R&D, using our outstanding research ancy. What is not known is how to devise and imple-
base as the engine to generate more effective health care ment programs at the community, workplace or health-
services and a stronger life sciences industry. services level that will enable Australians to make the
Let’s start with the social issues. It is often said that transition to healthier lifestyles.
every dollar invested in medical research saves $5 in The answers to these questions do not lie in conven-
health costs. But, despite our considerable investments tional biomedical research. Rather, we need to build
in health and medical research, Australia’s health bill on our biomedical research base, and integrate it with
has risen from 5.4 per cent of GDP in 1971 to 9 per research in the social sciences. We need to expand our
cent in 2006. In the US, which has by far the largest investment at the interface of the medical and social
medical research budget on the planet, the correspond- sciences.
ing increase has been from 7 per cent to 15 per cent. Second, let’s take the opportunity provided by our
What is driving this increase? In large measure, it is biomedical research base to lead the way in the predic-
chronic disease. According to the Australian Institute tion and early detection of chronic disease.
of Health and Welfare, 77 per cent of Australians have The $1000 genome is fast approaching reality, and
at least one chronic disease condition. Worse, 10 per will enable genetic predisposition to disease to be pre-
cent of children under 14, and 80 per cent of adults dicted at birth. At the same time, the identification of
over 65, have three or more such conditions. In total, biomarkers in blood will enable the rapid, early and
these conditions account for 80 per cent of the loss of inexpensive detection of chronic disorders, and the
FOCUS www.atse.org.au 
Biomedical Technology
advent of pharmacogenomics will ensure that patients and revenues and employee numbers have jumped by
receive drugs individually tailored to the underlying a factor of six.
causes of their disease. How can we maintain this momentum? Basically
Again, these advances will not be the province of we need two things: more companies spinning out of
biomedical research alone, but of collaborative efforts our universities and biomedical research institutes, and
at the interface of information technology, genomics, more of those small emerging companies being con-
biochemistry and nanotechnology. Investment at these verted into big ones.
interfaces, and their intersection with clinical science, Almost all of Australia’s biomedical research is con-
will be the key to translating research excellence into ducted in public-sector research organisations, but we
practical health outcomes. offer these organisations and their researchers little or
How about the commercial side? The global phar- no incentive to translate their research into commercial
maceutical industry is worth more than US$500 bil- outcomes.
lion a year, with faster growth and higher rates of return If we want our biomedical research community to
than most other knowledge-intensive industries. The go beyond excellent teaching and research, we need
growth rate of the biotechnology industry is higher to provide an additional stream of funding that ena-
again, and more than half of all new drugs reaching the bles them to do so. And we need to provide incentives
market are now products of biotechnology. – such as relief from capital gains tax – that will encour-
age individuals, such as the Fellows of ATSE, to invest
Almost all their capital and experience in facilitating the process.
of Australia’s Even then, a further step is required. Australian
biomedical biotechnology companies are commonly listing at one-
research is tenth of the market capitalisation of their US counter-
conducted in parts, and raise one-tenth as much money. They are be-
public-sector ing set up to fail.
research One of the few factors that has historically helped
organisations, but them compete internationally – AusIndustry’s Com-
we offer these mercial Ready – fell victim to the razor gang in the May
organisations Federal Budget. It will be vital that a successor scheme
and their is rapidly identified, ideally by extending the R&D Tax
researchers little Offset to enable tax loss companies to claim a rebate
or no incentive equivalent to their entitlements under the R&D Tax
to translate their Concession, but without the current counterproductive
research into restrictions on group turnover and R&D expenditure.
commercial The bottom line? We need to maintain our very
outcomes. strong track record in fundamental research, but add
real muscle to our ability to translate it into social and
Recognising this trend, the international pharma- commercial outcomes. We need to invest more in re-
ceutical industry is presently outsourcing more than 40 search at the interfaces between biomedical, social and
per cent of its R&D, compared with four per cent in clinical sciences, and we need to invest in the processes
the early 1990s. Indeed, Queensland clinical-trial com- that will convert the results of our biomedical research
panies are anticipating that revenues from international into companies, and companies into industries. t
pharmaceutical companies will reach $60 million by Professor Peter Andrews AO FTSE is an eminent
2010, and the overall market value of the State’s bio- Queensland scientist and bio-entrepreneur whose role as
Queensland Chief Scientist involves advising government
technology industry is projected to be $20 billion, with on policy and economic development issues associated
annual revenues of $4 billion, by 2025. with science, research and innovation. Author of more than
100 publications and inventor on two patents, he has led
Is this plausible? multifunctional scientific teams at research institutions in
From a standing start a decade ago, Queensland’s Victoria and Queensland. Professor Andrews has been at the
forefront of initiatives to develop the Australian biotechnology
biotechnology industry now has about two dozen industry and is an active participant in the commercialisation
drugs from local biotechnology companies in clinical of Australian science and research. Since 1985, he has founded,
co-founded or been a director of more than 10 scientific
trials. In 10 years the number of publicly listed biotech- companies. He currently serves as a director of two Australian
nology firms in Queensland has risen from two to12, biotechnology companies.
www.atse.org.au FOCUS
Biomedical Technology
Medical technology:
prospects for the 21st century
There is a veritable smorgasbord of small technologies
that could be developed for health care
By Graeme Clark
gclark@bionicear.org
Small technologies are defined at both a nanoscale and
microscale. According to the national standards, nano is
from 1nm (one nanometre, equal to one-billionth of a
metre) to 100nm, and micro is above that length.
N
anoscience is essentially physics and chemistry
at sizes that are not well understood. With
bio-applications, physicists and chemists copy
and learn from biology and, in turn, this helps
us to learn more about biology. But very importantly
this knowledge can be used in health care and to cor-
rect disease.
The big challenge is to determine what small tech-
nologies are most suited for a range of possible medical
applications. There are nanobiomaterials, nanobiotech- Graeme Clark
nology and nanobionics, as well as nanobiomechanics, peated stressing, such as with pacemakers, or as delivery
biofuel cells and MEMS (micro-electro-mechanical vehicles for radioisotopes for cancer.
systems) – and many more. A nanobiointerface is one where the material con-
Biomaterials are the basis of many developments. nects to the surface of the cell and influences its func-
Bionics (biology and electronics) refers to the transfer tion. The materials can also be made to conform to the
of electrical charge to and from biological systems, or shape of cells and proteins. This will allow greater at-
the release of agents that facilitate this transfer: Biofuel tachment of the cells to the polymers for control of the
cells are being developed at a nano/micro level and can biological reactions.
be used in the body for bionics and other applications Biomembranes can be made with porous elements
where electrical charge is required. that can let larger molecules pass through more readily
There are a number of basic elements of nanobio- than smaller molecules. It could be very important in
materials. When reduced in size, particles can change the body for the differential release of hormones – for
their function; most often the particles can be used as example, insulin in diabetes – and there could be feed-
drugs or trophic agents. back from blood glucose levels to control the pore size.
Nanobioparticles are used with arterial stents to Drug and cell-delivery systems can involve biode-
reduce post-operative stenosis. But more research is re- gradable polymers. The drugs and cells may be incor-
quired to reverse the disease process. porated within the material during curing. An example
Nanocomposites are synthesised by dispersing very of a biodegradable polymer is polyurethane. There is
small inorganic materials in polymers with dendritic- great versatility in the chemistry to vary the mechani-
like chains. Due to mixing at a molecular level they cal properties, porosity and integration with biological
have properties that are superior to either constituent. materials.
They have application in the body where there is re- With drug delivery, the agents are presently re-
FOCUS www.atse.org.au 
Biomedical Technology
Professor Clark and his team at work.
leased by passive processes. Drugs may also be assem- and this is matched to a sensor, then transduced and
bled rather than incorporated during the curing pro- analysed by the computer to produce a map of the pa-
cess. Frank Caroso, from the University of Melbourne, tient’s DNA.
has shown that drug-containing capsules can be made Biochips will be used to analyse blood from a pa-
from a spherical core. It is coated with alternate layers tient, where the chip determines their genetic make-up
of polymers that are positively and negatively charged. or diseased state within minutes. This will be made pos-
The core of the capsule is removed, leaving a polymer sible because the chip will be linked by a high-speed data
scaffold; the scaffold can be opened with changes in cable to a central computer where all the analyses will
pH, and the drug incorporated and then later released. be performed. This will mean that doctors in country
Nanobiotechnology applies in particular to the de- areas will be able to use special diagnostic equipment
velopment of nanomaterials for molecular biology, and and be guided in the management of patients, without
genetics procedures in particular. This is done through having to send them to the city.
creating biochips for the analysis of DNA, RNA, genes Nanobionics may also lead to drug and cell-deliv-
and proteins. Most is presently done in vitro with the ery systems with the use of electro-active polymers. The
polymerase chain reaction to amplify the genetic mate- drugs and cells may be incorporated within the mate-
rial under investigation. Real-time analyses are coming rial during the curing, or assembled together in stages.
onto the market. When polypyrrole is oxidised it loses an electron to
With nanobiotechnology, for example, a template become positively charged. This enables it to attract
for the amino acid sequences for the DNA is created and incorporate the negatively charged component of
www.atse.org.au FOCUS
Biomedical Technology
a protein or a living cell. The protein, or a nerve growth This costs the Australian taxpayer $1.7 billion dollars
factor, can then be released by the passage of an electri- annually. Our research has commenced to analyse the
cal current to neutralise that attraction. EEG activity and predict when a seizure is about to
Carbon nanotubes have great potential. They are happen. Electrodes in the brain will be used then to
very thin (1/10,000 the diameter of a human hair), reverse the seizure. To do so safely will require the use
conduct electricity and are strong. They have potential of nanobionics to ensure that the electrode surfaces and
application in a number of areas of medicine, including impedance is minimal.
heart valves and stents. Many areas of nanobionics will require electrical
An example of a biosensor developed through charge, and batteries made from nanomaterials will be
nanobionics is a 2 × 2-millimetre silicon chip attached implantable and self-sustaining. The cell will be fuelled
to the skin to measure body temperature. The chip con- by the body’s metabolic processes for the transformation
tains a temperature sensor in an integrated circuit. A of two redox reactions for glucose and oxygen. The use
lithium, thin-film battery supplies the very low level of of electrodes at a nanoscale is also more efficient.
power required by the circuit and the signal processing Advances in medical devices such as catheters, guide-
and transmission electronics, and an antenna sends the wires, stents, pacemakers and other invasive products
data by radio signals (radio-frequency transmission) to have enormously improved diagnostic and therapeutic
a monitor, either in the hospital ward or central nursing practices in medical care. However, the benefits of cath-
station, when the chip is queried. eters and other invasive devices are often limited by the
There is now considerable optimism that science occurrence of infections associated with the devices, even
and new technologies can make a major difference to when the best aseptic techniques are practiced.
health care. This applies in particular to the restoration Each year, as many as two million hospital patients
of body function and the control of disease. in the US develop nosocomial infections, that is
The first application for nanobionics with spinal infections which are a result of treatment in a hospital
cord repair is in chronic cases. This may be with cyst or health care unit, but secondary to the patient’s
formation or avulsion of the anterior rami of the motor original condition. Approximately 80 per cent of the
nerves. 80,000 annual deaths in this country from nosocomial
The lateral corticospinal tract is the main motor infections are device-related. One possible way of
pathway for the control of movement and scaffolds of preventing these infections is to use biodegradable
electro-active polymer, loaded with growth or inhibi- polymer and infiltrate it with antibiotic. Furthermore,
tory factors, as well as stem cells, could help bridge the cells that defend against infection can be incorporated
gap. It has also been shown that electrical currents will into the material.
help guide the spinal nerves to the right location, so the The estimated worldwide market for biomaterials is
scaffolds could incorporate conducting components. about $35 billion, with a predicted growth rate of 12 per
Adult stem cells can be also used and harvested from cent a year. Biomaterials and medical devices represent a
the fat, muscle and bone marrow and incorporated into fast-emerging market of about US$260 billion.
the scaffold. Most recently cells have been taken from Australia can still play a significant role in this mar-
umbilical cord blood and shown to be effective. ket, underpinned by strategic research. t
Nanobionics can help improve coronary artery Professor Graeme Clark is Laureate Professor Emeritus at
stents and reduce complications. Initially a stent is the University of Melbourne, Founder and Director Emeritus of
the Bionic Ear Institute, Senior Scientist at St Vincent’s Hospital,
inserted into the artery and expanded. Some 800,000 Melbourne, and Professor at the University of Wollongong.
angioplasties (mostly with stenting) are carried out in He initiated research at the University of Sydney, then led the
crucial research at the University of Melbourne and the Bionic
the US each year. In up to 30 per cent of these the artery
Ear Institute which resulted in the multi-channel cochlear
eventually becomes clogged again, so there is a great implant (bionic ear) for people with severe to profound hearing
loss. The device, developed industrially by Cochlear Ltd, is the
need to incorporate drug-eluting material that prevent
first clinically successful method of restoring brain function,
restenosis. and the first advance in helping deaf children to communicate,
Epilepsy affects up to two per cent of the world’s in the past 200 years. It was the first cochlear implant of any
type to be approved by the US Food and Drug Administration
population and one-third do not respond to medication. as safe and effective for use on children.
Letters to the Editor
ATSE Focus welcomes letters from readers in response to articles. Please keep letters brief to enhance publication
prospects. Longer letters may be run as contributed articles. Please address to editor@atse.org.au
FOCUS www.atse.org.au 
Biomedical Technology
Biomolecular engineering:
exploiting biological switches
Many medications, such as anti-cancer drugs, are not water soluble and thus
difficult to deliver into the human body. This is where biocompatible peptide
surfactants, such as Pepfactant®, have a role to play
By Anton Middelberg
M
a.middelberg@uq.edu.au made of 20 amino acids linked together in a specific
edical technology spans a range of length coded sequence. By changing the information sequence
scales, from the smallest pharmaceutical we can change the function, allowing technological de-
drug that interacts with the body’s pro- sign. But what are the rules that link surface behaviour
teins, through to engineered devices and, to amino acid sequence? In exploring this basic ques-
ultimately, infrastructure for healthcare. All of these tion, my PhD students and I made a very interesting ob-
technologies function because they detect an input and servation – some peptide surfactants behaved like real
change an output. detergents at the interface, while others behaved more
Although macroscopic switches that change health like food proteins and formed a mechanically strong
outcomes at the device and infrastructure level are visi- interfacial gel. Intrigued, I asked why. Significantly,
ble, the molecular-scale switches occurring at the protein I also asked whether we could create another switch,
and cell level are often invisible and poorly understood. this time within the plane of the interface. Could we
Yet at the dawn of the 21st century our understand- switch the interfacial behaviour between detergent and
ing of biological systems is exploding along with our gel states, in real time and in response to input switches
enhanced ability to quantitatively assess molecular- that were technologically meaningful? In other words,
scale events. Armed with this new capability, we are could we switch the character of the peptide at the in-
presented with an unparalleled opportunity to engineer terface without changing its sequence?
new medical technology, as well as an increasing ability Working with postdoctoral colleague Annette Dex-
to cleverly innovate across diverse Australian industries ter, I solved this challenge to create a peptide surfactant,
ranging from food to mining. or Pepfactant®, that we could switch between the two
A unique example of biology-inspired technology interfacial states in response to a change in solution pH.
is a new family of surfactants, or detergent-like mole- We have subsequently built a family of these molecules
cules, invented at the University of Queensland, called and elucidated design rules so that Pepfactant® proper-
Pepfactants®. ties can be tailored for specific applications. Using neu-
About 10 years ago, while looking at the comput- tron science, in conjunction with another postdoctoral
er-based structure of a protein, I realised that it had a colleague, Lizhong He, we have shown that in the gel
small region that could switch between two states. In state the peptide forms a molecularly thin film that has
one state this peptide (or small protein) looked like a mechanical properties similar to collagen. This collagen-
surfactant, having distinct hydrophilic and hydropho- like film helps stabilise foams and emulsions, while the
bic regions, while in the other state it resembled a small, switch allows us to turn off the stabilisation, at will.
disorganised polymer. Laboratory synthesis and testing In 2006 Pepfactants® won a TechConnect Emerg-
proved that it did seek out air-water and oil-water inter- ing Technology Award (TETA) in Boston, USA
faces, and that on a molar basis its surface activity was (www.nsti.org/news/item.html?id=72). Only three
superior to conventional detergents. The natural two- TETA awards, in three different categories of open
state biological switch resulted in a molecule with ex- international competition, were made – winners were
cellent detergent-like properties at an interface coupled ranked highest in terms of IP strength, value proposi-
with the superior solution behaviour of a polymer. tion and market potential. The technology also won
Proteins in nature carry information – they are the 2006 University of Queensland $100,000 Business
10 www.atse.org.au FOCUSBiomedical Technology
Plan Competition, under the leadership of PhD stu- The approach of using simple cell factories and
dent Andrew Malcolm, and has been used to establish well-established process technology will drive down
the first invested spin-out company from the Austra- the cost of virus-like particle vaccines, opening oppor-
lian Institute for Bioengineering and Nanotechnology tunities for the treatment of disease in the developing
(www.pepfactants.com.au). world. Moreover, molecular control of the particle
In medical terms, many important medications, surface suggests that it may be possible to develop new
such as anti-cancer drugs, are difficult to deliver into vaccines, without necessitating radical re-design of the
the human body because they do not dissolve in wa- manufacturing process.
ter. Biocompatible peptide surfactants can address this This approach promises a rapid-response vaccine
problem by dissolving the drugs into tiny oil droplets technology platform, and we have started to explore its
that are then stabilised by the gel-like film, which may utility in vaccine design,
also sense changes in pH that occur near or in a cell. specifically in response to
But applications go beyond the medical into fields the threat of pandemic in-
as diverse as mining and functional foods. For example, fluenza. Such an approach
minerals flotation controls foam using dilution with would overcome perceived
water – an increasingly scarce resource. We wonder and real limitations inher-
whether simple foam collapse using a change in pH can ent in using eggs for vac-
give environmental benefit. cine manufacture.
In terms of foodstuffs, switching off the surfactant There is an increasing
behaviour can ease processing during, for example, ice- awareness that Australian
cream manufacture. Then switching on the gel state competitiveness will increas- Anton Middelberg and Lizhong He prepare
can stabilise the ice-cream microstructure, replacing fat ingly require innovation a Pepfactant® sample for characterisation
using the neutron reflectometer SURF at the
with air. This paradigm of processing a well-behaved both in terms of knowledge Rutherford Appleton Laboratory, UK.
material and then switching on the desired strong ma- production and its exploi-
terial properties through a change in solution proper- tation. The opportunities Further reading:
ties is exactly what a spider does when it spins silk. emerging as a result of better Proceedings of the National Academy of
The molecular basis for the Pepfactant® interfacial understanding of biologi- Sciences, USA, 97(10), 5054-5059 (2000)
switch is rather simple. Certain amino acids bind metal cal processes and systems, Nature Materials, 5(6), 502-506 (2006)
ions, and binding can crosslink adjacent peptides at the including their ability to Science, 319, 1178-1179 (2008)
interface and change interfacial charge structure, lead- switch between distinct Journal of the Royal Society Interface,
ing to a gel state. Changing the pH changes binding states, provide a rich source 5(18), 47-54
strength and allows the linked peptide structure to be for potential innovation in
mobilised. This is the basis for a generic switch of tech- medical and non-medical fields.
nological value and we are now exploring its value in Such innovation, at least in this case, has been facili-
other systems, including viral vaccines. tated by flexible research funding associated with a Fed-
Vaccines have had a huge impact on human health, eration Fellowship, which has allowed particular themes
and great interest in virus-like particles has recently de- and ideas to be followed in a strategic manner, and to be
veloped following the successful launch of vaccines for developed in response to initial results obtained. Such
cervical cancer. Virus-like particles are well tolerated flexibility is rare in modern technological research, and
and appear to the immune system to be an authentic my team and I are grateful to the Australian Research
virus, yet do not carry a payload of viral nucleic acid. Council for encouraging us to follow our ideas. t
In effect, they resemble a Trojan horse and the immune
system mounts an appropriate defence, ignorant of the Professor Anton Middelberg FTSE is an Australian
Research Council Federation Fellow and Professor of Chemical
fact that the vessel is, in fact, empty. and Biomolecular Engineering at the University of Queensland.
Recently we have shown that it is possible to use His research focuses on the science of chemical self-assembly
processing, with the ultimate aim of defining new functional
microbial cell factories to produce virus proteins at products and new process routes for the manufacture of
very high levels, and in very simple biotechnological existing products. Professor Middelberg has previously held
tenured academic positions at Adelaide and Cambridge
processes. After purification using unit operations al- Universities, a Fulbright fellowship at Berkeley, and was
ready in widespread industrial use, the protein can be elected Fellow of Selwyn College Cambridge and Fellow of the
Cambridge-MIT Institute. His awards included the Brodie and
assembled into non-infectious, virus-like nanoparticles Shedden-Uhde medals of the Institution of Engineers Australia,
by metal-ion switching of self-assembly. and he has published more than 150 refereed papers.
FOCUS www.atse.org.au 11Biomedical Technology
Raising capital for our medical
technologies and therapeutics
Australian governments have supported medical research for some time now and
in a few areas we do have a worldwide reputation for ‘punching above our weight’
By Carrie Hillyard
A
carrie_hillyard@cmcapital.com nuation funds to guarantee continued funding.
ustralia’s governments have been support- It will take a few more years of operation for these
ing medical research for a considerable time returns to be comparable with those in countries with a
and we now have a worldwide reputation in a more established VC industry or, indeed, with the pri-
few areas, where we punch above our weight. vate equity industry in Australia, which is much more
There has been a recent emphasis on biotechnology and mature.
on growing an Australian industry to support future jobs The continued support of the superannuation in-
growth. This has led to a greater awareness, more com- dustry is also being compromised by current financial
mercial activity from the research institutions and sig- market conditions, which have dramatically cut the
nificant growth in new and expanded research facilities, value of their listed assets, skewing the percentage allo-
particularly in Queensland and Victoria. It has resulted cation of funds in alternative assets such as VC.
in increasing numbers of companies and, with the aid
of the pre-seed investment funds, more qualified invest- Sourcing the money
ment opportunities, with a better understanding of the So we now have VC, but how many of the start-up
important factors in growing a biotechnology company. hopefuls can get funded?
The answer is about two per cent – although the suc-
Venture capital cess rate from research groups with solid reputations is
A few years ago, the IR&D board posed the questions: higher. There are now seed funds that can invest up to a
‘Why are we not commercialising some of the inven- $1 million in a project or start-up company and, while
tions from our institutions?’ and ‘Why can’t we access there are only a handful of early stage VC funds able to
superannuation money for early stage companies?’ The support the growth of medical technology or pharma-
answer to both was that there was no venture capital ceutical development companies, these can invest up to
(VC) industry in Australia. $10 to $15 million per company. Additionally, a handful
The government had tried to develop programs of US funds have made investments in Australian compa-
previously without much success and a new approach nies alongside local managers who they know and trust.
was needed, which took the form of the Innovation In- The sort of company that will get funded is likely to
vestment Funds (IIF). have some good management, although often the team
This scheme was a relatively ‘hands off ’ approach will only be filled out when funding is secured. It will
to encourage private or institutional investors prepared have a clear barrier to the entry of competitors – usually
to invest in first-time funds managers. Its intent was to patented technology – and a solid plan to get its prod-
kick-start a VC industry, which could harness superan- ucts developed and tested in a clinical setting.
nuation money to be invested in commercialising tech-
nologies from our research institutions. The pitfalls …
The IIF has begun to achieve its objective, with the Companies looking for an investor should think about
first licensed managers accessing institutional money for the value a particular investor brings. It is important
their subsequent funds, which are investing in early stage for the company to do some homework on the investor
companies. Australia’s VC industry is now maturing, but – after all, the board member appointed by the VC firm
has yet to provide the consistent returns to the superan- may be working with the company for some years. It is
12 www.atse.org.au FOCUSBiomedical Technology
also essential, if several investors are involved, that the investor coming in – needs to be sufficient to undertake
investee knows that these investors have the same goals the safety and early efficacy trials.
for the company. A company has to have a very clear and realistic
Many a company has rued the day it accepted money business plan, which takes into account these various
from an investor only to find that the new investor had funding rounds.
completely different ideas about its investment. This can
lead to a dysfunctional board or, in one case, a complete To list … or not to list
restart for the company when an investor packed up its In the early stages, it is possible to find friends, family
bat and ball and demanded its money back. and ‘angel’ investors, although this is much easier with
Venture investors usually invest in the field of exper- information than medical technologies. There are also
tise of their staff and provide their industry networks, pre-seed and commercialisation funds available.
advisers, operational expertise and management skills Later, the choice is venture investors, listing on the
– as well as money. They will almost always take a board Australian Securities Exchange (ASX) or, possibly, an
seat. It is important to find a syndicate of like-minded international exchange. In Australia, where the market
investors with deep pockets, as medical technology is used to funding small mining explorations, biotech-
is likely to need a lot of development capital and the nology companies have listed straight out of the uni-
investors must be able to fund the company through versity without looking for VC investors.
several rounds. Listing brings its own issues, including the need for
Each round should raise enough to take the com- the CEO to be diverted by analyst briefings and inves-
pany to the next milestone that will add value. A rule tor relations, to provide a constant stream of announce-
of thumb might be a ‘seed’ round (just out of the re- ments to investors and additional costs. It is much
search organisation), which should be enough to get harder to find subsequent rounds of funding, unless the
to a compound or device that works in animals and is company is close to product with good news flow, par-
ready for formal preclinical studies. The series A should ticularly when, as currently, the financial markets lose
be enough to get the product to regulatory (preferably confidence and many companies struggle along with
US Food and Drug Administration (FDA)) approval small market capitalisations, ignored by both industry
to do the first trials. Series B – usually priced by a new analysts and investors.
Manufacturing product at Pharmaxis.
FOCUS www.atse.org.au 13Biomedical Technology
As a strategy for raising capital after a couple of A lot of things have changed in the 10 years that venture
rounds of VC funding, ASX listing has proved success- funding has been available for early stage medical technol-
ful and companies, such as Pharmaxis, have been able ogy and pharmaceutical development. A number of VC-
to raise very large amounts of capital to fund the late- funded companies have reached the stage when their first
stage clinical development of their lead products. products have been approved and are being launched.
However, even late-stage-listed product develop- There is now seed and early stage venture money avail-
ment companies can be affected by the vagaries of the in- able and companies can access up to about $30 million
ternational financial markets and investor sentiment and from Australian VC syndicates and introduced US funds.
those that do not plan to raise money when the market While listing seemed an easy option for many early
is positive towards growth stocks can be left without suf- stage companies a few years ago, these companies are now
ficient funding or having to accept big discounts in order struggling to find further capital. Listing is a strategy bet-
to find capital. ter suited to companies with products in late-stage devel-
opment and a planned flow of news to investors. t
Non-dilutive funding Dr Carrie Hillyard FTSE is a co-founder of CM Capital
The May Federal Budget delivered a blow to companies Investments, where she is responsible for the Life Sciences
group. CM manages over $260 million in three funds directed
planning to access AusIndustry’s Commercial Ready at life sciences and telecommunications technologies. She has
scheme, which was axed without warning, severely af- experience through the complete product cycle, from basic
research in cancer and endocrinology at the Royal Postgraduate
fecting potential R&D funding. Medical School, London University, to products on the
The R&D Tax Offset assists companies spending less market at Agen Biomedical. She has mentored entrepreneurs,
consulted to the biotechnology industry, research institutions
than $1 million on R&D. Project funding is available from and commercialisation bodies and served on a number of
overseas granting agencies, and Australian companies have government committees including the IR&D board and Tax
Concession Committee. Dr Hillyard is a member of the board of
benefited from the Gates Foundation, the US Department CathRx Ltd, the Mater Medical Research Institute and a member
of Defence and National Institutes of Health. of the Queensland Government’s Smart State Council.
Frank Fell, Indigenous Training and Development Specialist, Weipa
Introducing the new
face of the global
leader in aluminium
Actually, the faces are the same but we Its global bauxite and alumina business
have a bigger story to tell. is based out of Brisbane, Queensland.
In 2007 Rio Tinto Aluminium and Alcan The Queensland based operations
joined together to create Rio Tinto Alcan. provide the business with strengths in
bauxite extraction, alumina refinery
With a history stretching back fifty years
operations and project development.
in Queensland we thought it was time to
update you on who we are today. Our Queensland mining, refining and
smelting operations are important to
Quick Facts
the future growth of Rio Tinto Alcan.
• Number one in aluminium based on The business has recently announced
current production expansions for the Yarwun alumina
• Number one in bauxite based on refinery, near Gladstone, as well as
current production continuing to expand production
• Strong growth pipeline through the capacity at the Weipa bauxite mine on
value chain Cape York.
Rio Tinto Alcan (RTA) is the global leader
To learn more about the world’s biggest
in aluminium with large, long life, low
aluminium company visit:
cost assets worldwide.
The newly expanded product group has www.riotinto.com/riotintoalcan
operations in 61 countries and regions
around the world.Biomedical Technology
Doing less,
but doing it better
In the past, Australia’s early lead in a new field was often lost because research
teams could not match the size and funding of overseas groups, with which they
were competing. However, all this is changing
By Merilyn Sleigh
mjsleigh@gmail.com side the US – a remarkable achievement considering
Australia’s role as a performer of the still small relative size of our research community.
biomedical research
Australia’s contribution to the international biomedi- Potential for future biomedical
cal research effort has been marked by a number of research – doing less but doing
high-profile discoveries. it better
Past successes have included development of Co- Research Australia has suggested that Australia has
chlear’s bionic ear device, first cloning of three of the relative strengths in areas such as:
major factors involved in blood cell formation, a pio- ¢ development of medical devices and biomaterials;
neering position in stem cell research, discovery of the ¢ stem cell science and tissue replacement, together
role of bacteria in stomach ulcers, and development of with increasing expertise in clinical evaluation in
Relenza, the first rationally designed small molecule these areas;
drug based on protein structure. ¢ immunology – a traditional research strength; and
Each of these achievements has sprung from the vi- ¢ cancer research, both at a fundamental level and via
sion of an outstanding individual or small team, and has access to extensive tissue libraries, documented pa-
drawn from an extensive background of medical research tient cohorts and a twin registry.
funded over many years, largely from public sources. While this is not a comprehensive list, it highlights
Over the past 20 years we have seen concentration the potential to further build our edge in selected areas,
of much of Australia’s biomedical research effort into taking advantage of available government support, as
a number of high-profile research institutes. Following well as increasing funding from donor, commercial and
two major reviews of medical research, there has been international sources.
a significant increase in National Health and Medical Current support covers the spectrum from basic
Research Council (NHMRC) grants, with a tripling in research (NHMRC) through to commercial develop-
funding between 2001 and 2007, and further increases ment, including the Cooperative Research Centres
foreshadowed. As well, there is an increasing aware- Program (researcher-industry linkages), the P3 pro-
ness that excellent research requires state-of-the-art gram to assist pharmaceutical company development
infrastructure, provision of which has further focused in Australia, and incentives for venture capital.
activities in major centres (somewhat to the detriment Continuing investment in infrastructure will in-
of smaller research groups and many universities). crease the competitiveness of our biomedical research,
In the past, early leadership in a new field was often and broaden the skills and capabilities available to turn
lost because Australian research teams could only infre- discoveries into products in Australia.
quently approach the size and level of funding of overseas
groups, with which they were competing. However, the Discovery to profits – the rise of
emergence of larger and better-funded research institutes, biomedical technology industries
along with their increasing capability in commercialising The initial emphasis for Australian biotechnology was
important discoveries, is changing this situation. on agriculture (based on the relative strength of this
Australian research teams are now the largest recip- sector), rather than pharmaceuticals and diagnostics.
ients of US National Institutes of Health funding out- However, biomedical technology is the major focus
FOCUS www.atse.org.au 15Biomedical Technology
of today’s industry in Australia, as it has been from the ed the Nucleus Group in the 1960s to take Australian-
start in the US. manufactured medical products to world markets. This
The sector is now well-established and healthy, al- group spawned a number of successful companies, in-
though still vulnerable to stock market fluctuations, cluding Cochlear, Ausonics and Telectronics. As well, it
but small in international terms. It is around one-tenth generated competitive activity in adjunct areas, such as
the size of the industry in the US, based on measures biomaterials, and a cohort of commercially experienced
such as investment and employment, and much smaller individuals. Many of these are now the CEOs driving
in terms of revenues. the continued expansion and maturity of Australia’s
The local industry is also much less mature than that medical device sector, which has established capabilities
of the US. For example, the peak period for new company across the full range from discovery to marketing.
formation in the US was 1981-87 – in Australia it peaked
more than 10 years later, in 2001. We presently have three Opportunities and challenges
to four times more companies than can be reasonably sup- for the future
ported from available investment capital, suggesting that With the biomedical technology industry in Australia
further consolidation of the industry is overdue. lagging some five to 10 years behind its US counter-
US biotechnology is characterised by many com- part, further maturation following the pathway already
panies in the therapeutics sector generating revenues trodden in the US, is needed.
(more than US$70 billion in 2006), while in Australia, We can expect:
companies such as Pharmaxis and Cellestis are only just ¢ more company consolidation – companies more ad-
beginning to bring their products to the market. vanced and closer to revenues on ASX listing, with
The more successful Australian companies have an expectation of greater venture capital investment
developed business strategies to cope with local defi- prior to their initial public offering (IPO);
ciencies in markets and supply of capital. Some have ¢ strategies to grow companies more rapidly and over-
come competitive disadvantages, such as distance
Australian research teams are now the largest from customers, through international acquisitions
recipients of US National Institutes of Health and more realistic (internationally competitive, often
funding outside the US – a remarkable internationally sourced) levels of investment; and
achievement considering the still small relative ¢ successful companies moving further along the val-
size of our research community. ue chain from discovery through to manufacturing
and marketing, leading to significant revenues from
focused on one, or a small number of, niche products, a marketed products.
high-risk, but potentially high-return strategy. Others Continued government support is needed to main-
spread risk by developing technologies with wide ap- tain competitive advantage through an excellent re-
plication, such as in drug delivery, or by partnering later search base, and for research infrastructure, providing a
development of their products with large pharmaceu- focus for clustering of researchers and industry to maxi-
tical or diagnostic companies, more along the lines of mise the benefits from public and private investment.
companies in the US. The biomedical technology sector provides excel-
Although Australia was a follower in setting up a lent opportunities for the future, as a source of wealth
biotechnology industry, it was an early achiever in the based on intellectual – rather than resource – capital.
field of medical devices, and export earnings of estab- Increasing success by local companies and acceleration
lished companies, such as Resmed and Cochlear, are in areas of competitive advantage should provide the
substantial. There are currently about 600 medical de- impetus for expanding investment opportunities and
vice companies in Australia, with 30 listed on the ASX continued sector development. t
and annual revenues of about $900 million. Dr Merilyn Sleigh has just completed six years as Managing
The market capitalisation of listed device compa- Director of antibody therapeutics company EvoGenix Ltd,
successfully building the company from its start-up stage,
nies is greater than $9 billion (about 90 per cent of this through listing on the ASX, to its recent merger with Peptech
attributable to Resmed and Cochlear), compared with Ltd to form Arana Therapeutics. At earlier stages in her career
she was a senior researcher and manager with CSIRO, Director
a market capitalisation for all biotechnology compa- of Pharmaceutical Research with Peptech and Dean of the
nies, excluding CSL, of $5.5 billion. Faculty of Life Sciences at the University of New South Wales.
She is now working as a non-executive company director in
Leadership in the medical device sector resulted the broad life sciences sector, and an adviser to biotechnology
from the visionary approach of Paul Trainor, who found- companies and their investors.
16 www.atse.org.au FOCUSBiomedical Technology
The journey from research
to market with biomedicals
Starting with the end in mind is a key to the challenges
of biomedical product commercialisation
By Deborah Rathjen
M
drathjen@bionomics.com.au now ranks sixth in league tables of worldwide biotech-
y career in the biotechnology industry nology. Our late start has impacted commercialisation
started in 1988, when I joined Australian success to date, but with continued emphasis on the
biotechnology company Peptech to initi- skills required and sufficient capital to support inno-
ate a new research program focused on an vative product commercialisation, this lag in skills and
extremely perplexing – yet exciting and completely fasci- the flow-on effect to outcomes can be remedied.
nating – molecule involved in fighting infection and can- Among the enabling technologies to come to the
cer: the cytokine, tumour necrosis factor alpha (TNF). fore has been that of genomics. The sequencing of the
Before joining Peptech I had become aware of the human genome led to a dramatically increased amount
tremendous growth in start-up biotech companies in of capital available for the discovery of new treatments
the US, many of whom were engaged in research at the for major diseases, as hopes rose that a new era had be-
very cutting edge of my chosen field of cytokine biol- gun in the treatment and prevention of disease. But the
ogy, and presenting many opportunities for young bio- perception is that commercialisation of the outcomes
medical scientists to pursue productive careers within of this research has lagged.
industry. I was excited by the prospects. The lengthy time to market for any new and in-
Some 20 years down the track much has changed, novative product in a heavily regulated environment
with significant advancements in enabling technolo- remains extremely challenging. However, many new
gies giving rise to new therapeutic approaches generat- target-based therapies are now in clinical development,
ing blockbuster revenues for both pharmaceutical and with excellent prospects for commercialisation.
biotechnology companies. There has been an explosion On average, drug companies spend about 40 per
of start-up companies within Australia and the nation cent of their R&D budget on clinical trials but, de-
pending on the age and size of the company, this could
be significantly more. The amount of capital required,
combined with the time to market and the associated
regulatory hurdles, and the sheer technical risk, means
The lengthy time to market
for any new and innovative
product in a heavily regulated
environment remains extremely
challenging.
Deborah Rathjen
FOCUS www.atse.org.au 17Biomedical technology
that the commercialisation of biomedical products re- We were successful in identifying key regions of
quires long-term strategic thinking and commitment the molecule of commercial interest and filed a patent
– by companies, investors and governments. application on 7 August 1988. As a late entrant to the
I will illustrate these points using two examples field it was important for us to understand the competi-
from my experience. tive landscape and delineate the novelty and inventive-
ness of our work. It was an extremely large patent filing,
The commercialisation of with a long list of claims!
anti-TNF products: patent wars Time marched on and the patent filings we made
In facing up to the challenges of biomedical product in 1988 successfully passed through the examination
commercialisation, starting with the end in mind is par- phases, despite the crowded TNF patent space, until
ticularly important – even critical – as evidenced by the the granting of the patent in Europe was opposed by
development and commercialisation of products that BASF Knoll.
modulate/inhibit the activity of the cytokine TNF. Following written argument moved back and forth
Product development in this field required strate- several times, and several meetings with BASF Knoll,
gic filing of patent rights in a crowded area to provide a we eventually ended up before the European Patent Of-
basis for revenue generation for products with a myriad fice for a hearing and decision in 1999.
of potential therapeutic applications. To cut a long story short, a small Aussie biotech pre-
The primary role of TNF is the regulation of im- vailed and subsequently gained access to significant rev-
mune cells, but it also exerts effects on other cell types, enue streams from both Humira (a BASF Knoll/Abbott
including the endothelial cells that line blood vessels. product) and ultimately Remicade (a Centocor/Johnson
Dysregulation and, in particular, overproduction of & Johnson product) – both blockbuster drugs.
TNF have been implicated in a variety of human dis-
eases, including Crohn’s Disease and rheumatoid ar- New treatments for cancer:
thritis, as well as cancer. target-based drug discovery
The science of TNF had its beginning more than Until recently, anti-cancer drug discovery involved the
100 years ago in the anti-tumour properties of Coley’s screening of large, unselected libraries of compounds
toxins, and in the molecular age in discoveries made against tumour cell lines in vitro. Active agents were
in the late 1960s, mid-1970s and mid-1980s. TNF is then tested in a range of animal models before clinical
a complicated molecule – a homotrimer exerting its development commenced.
pleiotropic effects through two receptors, and with This undirected approach was lengthy and ineffi-
receptor engagement activating multiple intracellular cient and, as a consequence, expensive – paclitaxel, for
signalling pathways. example, took 30 years to progress from bench to clinic.
It was, and still remains, a molecule of significant The recent focus on target-based (genomics-identi-
commercial interest. Today the revenues generated by fied) drug discovery has resulted in a dramatic increase
blockers/modulators of TNF, including the antibod- in the number of new anti-cancer agents in development.
ies Remicade® and Enbrel®, is approximately US$8.5 Targeted anti-cancer agents offer the prospect for reduced
billion and they have application in the treatment of a side-effects, and thus a broader therapeutic index. These
broad range of autoimmune diseases. therapies also offer the opportunity for combined treat-
By the late 1980s the TNF patent literature was ex- ment modalities with conventional cytotoxic agents.
tensive and covered the molecule and variants as well One of a new class of targeted therapies known as
as monoclonal antibodies. Our working hypothesis was vascular disrupting agents (VDAs) is being developed
that TNF’s many functions could be segregated in mo- by Bionomics. The molecule we call BNC105, which is
lecular terms by defining key sites on the molecule. We now in clinical trial in patients with advanced cancer,
set about investigating this hypothesis by raising a large represents an interesting case study in taking the fruits
antibody library, both monoclonal and polyclonal anti- of academic research (initiated at the Research School
bodies, to the whole molecule and to isolated peptide of Chemistry, ANU) into a privately held biotech start-
fragments. Then we mapped sites of recognition, using up ( Melbourne-based Iliad Chemicals), and into clini-
a range of epitope mapping techniques, which we then cal development (by ASX-listed Bionomics, following
linked to a range of TNF actions, including tumour cell its acquisition in 2005 of Iliad).
killing and the induction of clotting factors on the sur- Importantly for patients, BNC105 has an extremely
face of endothelial cells. u more on page 20
18 www.atse.org.au FOCUSYou can also read
