Immuno-oncology: AgBiotech: AusMedtech 2016:

Transcription

Volume 26 | Number 2
Australasian
BioTechnology
The journal of
Immuno-oncology:
changing the cancer care landscape
AgBiotech:
20 years of GM crops
AusMedtech 2016:
event recap
PRINT POST APPROVED 100022288
Look South
A place where world-leading researchers come
together in first-class facilities to address
some of the world’s grand challenges.
Our Vision
Our Team
Adelaide Enterprise
www.adelaide.edu.au/enterprise
Research Collaborations & Partnerships
www.adelaide.edu.au/research-partnerships
2561-2
Research Strategy Adelaide Research for Impact
www.adelaide.edu.au/research
CRICOS 00123M
The University of Adelaide works closely with government,
industry and the community to translate cutting edge research
into innovative products and services that deliver positive
impacts around the globe. Innovations as diverse as biofuel
made from microalgae, improving IVF success and drought
resistant crops are changing our lives for the better. If you are
interested in incorporating novel and applied research thinking
into your organisation’s innovation ecosystem then look
south, to the University of Adelaide.
AusBiotech Welcome
CHAIR AND CEO
REPORT
As we reach mid year, during our 30th anniversary
celebrations, AusBiotech has much to share with
you as evidence that Australia’s largest life sciences
network and industry advocate is just getting
warmed up.
AusBiotech was pleased to announce the appointment of
Executive Media as the official publisher of this journal,
Australasian Biotechnology, and this is the first edition
resulting from the partnership. As a highly-regarded
publisher with over 40 years’ experience, Executive Media
is ideally positioned to engage members, stakeholders,
investors and government on the biotechnology industry
in Australia.
The journal began as the Australian Biotechnology
Association Bulletin in May 1986 and it later became the
Australian Journal of Biotechnology in 1987, and then
Australasian Biotechnology in 1992. It is fitting that this
new chapter in its history commence at the mid point of
AusBiotech’s 30th year.
The journal will have some new features, such as the
new-look masthead, but continues to be published
three times a year (March, July and October) and carry
regular features, such as this Chair and CEO report, and
AusBioSTOCK, an exclusive report from Baillieu Holst
Stockbroking’s Joanna Hill.
Australia is among the world leaders for biotechnology,
boasting the largest listed biotechnology sector (as a
proportion of GDP) in the world. The combined market
cap of 46 responding companies was $48.6 billion and the
industry is expected to create 213 new jobs this year.
Julie Phillips
Australian life sciences companies have
attracted more than $2 billion in deal
flow over the last 18 months, which is
bolstering confidence and showing that
success is not theoretical
Australian life sciences companies have attracted more than
$2 billion in deal flow over the last 18 months, which is bolstering
confidence and showing that success is not theoretical.
The Survey, now in its sixth year, was open to all ASXlisted and unlisted biotechnology companies. Forty four
companies responded and 60 companies participated in
roundtable discussions held around Australia between
February and March 2016.
Key findings of the survey:
•
Confidence remains strong and sets some records.
Companies planning to increase their staff this year are
at an all-time high; 70 per cent of companies intend to
hire staff this year (up from 64 per cent last year and
69 per cent in 2014), with 30 companies intending
to recruit to 213 identified new roles. 41 per cent of
respondents said the environment was conducive to
growing a biotechnology company, up from 16 per cent
last year.
The 2016 AusBiotech CEO Industry Position Survey was
launched on 31 May and confirmed biotechnology’s
central position in Australia’s post mining–boom
economic transition.
The Survey, conducted by AusBiotech with support from
Grant Thornton and a contribution from Novotech, revealed
key themes surrounding the industry’s value to the Australian
economy; business sentiment; finance, investment, listing
and costs; and government policy.
Dr Anna Lavelle
•
All eyes on the R&D Tax Incentive.
The R&D Tax Incentive was confirmed as the most
significant government program for promoting innovation
in the private sector, and plays a pivotal role in motivating
and attracting research, development and clinical trials
to be conducted in Australia. The preservation of the
program remained clearly the most commonly cited,
unprompted concern for the industry’s future.
Australasian BioTechnology | Volume 26 | Number 2
1
AusBiotech Welcome
•
AusBiotech launched the Australian Life
Science Innovation Directory in May this
year, in order to connect the industry by
offering a fully searchable platform with
access to information on biotechnology
and life science companies and
organisations in Australia
•
Smart science needs smart money.
Access to capital for companies developing new
technologies remains a critical issue. The number of
companies planning to raise capital dropped slightly to
40 per cent, down from the same position last year (48
per cent).
•
Policy stability is key.
The constant reviews, threats and tweaks to industry
support programs are unsettling for biotechnology
developers that have long development cycles, and
they undermine business confidence.
AusBiotech is preparing for the highlight of the year, the
International BioFest 2016, which will be the largest ever
gathering in Australian life sciences, with three major
conferences coming together in one week, in one place, as
one integrated network. For 30 years, the annual AusBiotech
conference has brought together the entire biotechnology
‘ecosystem’ to share challenging and informative ideas, and
progress their biotechnology development work—and this
year will see a greater event.
International BioFest 2016 is expected to attract over 2500
delegates to attend the academic, industry and investor
events at the Melbourne Convention Centre from 24– 27
October 2016. Special deals are available for more than one
event or the whole event. Earlybird discounts end in mid
July, so there is benefit in planning early for this not-to-bemissed event, which will comprise:
•
IBS 2016, the 17th International Biotechnology
Symposium and Exhibition
•
AusBiotech 2016, Australia’s life sciences conference
2
Australia Biotech Invest 2016, Australia’s life sciences
investment showcase.
For further information, please visit the International BioFest
2016 website at internationalbiofest.org, where you can also
access the three individual events’ websites.
This event will be the first time the International
Biotechnology Symposium and Exhibition (IBS 2016),
has been held in Australia. IBS is the most representative
biotechnology event at the global level, at which
participants congregate from academia and industry, to
explore the advances and frontiers of science, as well as
applied biotechnologies. IBS presents and promotes the
contribution that chemistry provides to the development of
biotechnological research and industry.
The symposium program will include topics such as
agribusiness; industrial and environmental biotechnology;
pharmaceutical, medical and molecular; bioenergy and
biorefinery; the bio-economy, policy and investment; and
biosensors and nanotechnology.
AusBiotech launched the Australian Life Science Innovation
Directory in May this year, in order to connect the industry
by offering a fully searchable platform with access to
information on biotechnology and life science companies
and organisations in Australia.
Integrated within the larger Biotechgate global life science
database, which includes more than 38,000 company
and organisation profiles, the Directory is designed to
help promote the growth and potential of Australian
biotechnology on a global scale.
Members of AusBiotech have received an exclusive profile
that will help communicate each organisation’s valuable
contribution to Australian biotechnology and life sciences,
including:
•
an extended profile to display tailored company
information
•
a login to customise company information
•
endorsement from the AusBiotech logo.
To use the Directory, simply visit www.ausbiotech.org/
directory. You can search by sector, indications, product
phase, and many other categories with the comprehensive
search form and automated alerts.
AusBiotech Welcome
AUSBIOTECH BOARD
Julie Phillips
Chairman
AusBiotech Ltd
CEO and Executive Director
BioDiem Ltd
Tel: 03 9692 7240
Michelle Burke
Director, External Affairs
Bristol-Myers Squibb
Tel: 03 9213 4000
Lawrence Gozlan
Chief Executive Officer
Scientia Capital
Tel: 03 9661 8274
Dr Andrea Douglas
Vice President, R&D Strategy
and External Affairs
CSL Limited
Tel: 03 9389 1135
Dr Anna Lavelle Chief Executive Officer
AusBiotech Ltd Tel: 03 9828 1404
Barry Thomas
Managing Director
Cook Australia Pty Ltd
Tel: 07 3434 6010
Serina Cucuzza
Manager, Commercial Development
& Industry Engagement
Burnet Institute
Tel: 03 9282 2204
Serg Duchini
Partner, Leader Speciality
Taxes & Co. Director
Deloitte Touche Tohmatsu
Tel: 03 9671 7376
AusBiotech staff list
Chief Executive Officer Dr Anna Lavelle Events Manager
Vincent Portier
Chief Operations Officer Glenn Cross Project Manager
Hayley Laing
Executive Assistant
Jo Beamsley Business Development Manager
Mel Nelson
Chief Industry Affairs Officer Lorraine Chiroiu
Web & Data Administrator
Harshini Bellana
Chief Finance Officer & Company
Secretary
Penny Brassington
Events Co-ordinator
Sienna Deano
Events Co-ordinator
Amelia Lundstrom
National Programs Manager
Helen Arthur
Media and Communications Officer
Kristen Goodgame
Member Services Manager
Tanya Daw
Accountant
Crystal Tan
National Conference and
Events Manager Kirsty Grimwade
Representative, Asia Pacific and NSW,
Business Development
Stephen Pattillo
3
CONTENTS
WELCOME
IMMUNO-ONCOLOGY
1
32
Immunotherapy to treat AFL star’s melanoma,
by Giulia Heppell
34
Immunotherapy overview
AusBiotech Chair and CEO report, by Julie
Phillips and Dr Anna Lavelle
3
AusBiotech Board
NEWS
8
Industry news
AUSMEDTECH 2016
16
22
AusMedtech 2016: Australia’s medtech conference
Helping clinicians to develop innovative medical devices, by Dr Olivia Lockwood, SA Health
26
Technology convergence: the impact of digital
technology on treatment and patient interaction, by Murdoch Childrens Research Institute staff Anita Petris, Phoebe Macleod and Dr James Dromey.
38
Cancer immunotherapy comes of age (finally!),
by Dr Ian Nisbet, Afandin Pty Ltd
41
Next-generation DNA vaccine targets HPV
tumour cells, by Eden Cox
43
Combination therapies with immune checkpoint inhibitors, by Dr Jamie Lopez, Peter MacCallum Cancer Centre
45
Outpacing cancer: an interview with Josie Downey, MSD
AGBIOTECH
28
Shifting gears: how the changing landscape of Australian manufacturing can benefit
the medtech industry, by Peter Roberts,
Australian Manufacturing Forum
50
GM and the community: a call to action, by Rob Neely, Integrated Animal Health
SPONSORED ARTICLES
4
6CSL
30
Bosch Australia
12MSD
36
Monash University
14Bio-Link
47
Anteo Technologies
20
The IQ Group Global
62
Davies Collison Cave
24
McCloud Consulting Group
Contents
53
20 years growing GM crops: regulation, not science, has curtailed the benefits of our experience, by Matthew Cossey, CropLife Australia
56
Biotechnology and beef tenderness: 1995 to today, an interview with Dr Gregory Harper, Agriculture Research and Development
59
AusBiotech Business Solutions Program
IP LAW
60
Gene Genie: the judicial revolution in biotech IP, by
Prof Matthew Rimmer, Queensland University of
Technology
STOCK
64
Biotechnology stock index, by Joanna Hill, Baillieu Holst
PEOPLE
69
71
New member profiles
Corporate members
Australasian Biotechnology is
the official journal of AusBiotech,
Australia’s Biotechnology
Organisation. Australasian
Biotechnology reports on research
and business news within the
biotechnology arena.
AusBiotech: Level 4, 627 Chapel Street, South Yarra VIC 3141
Tel: 03 9828 1400 | Email: [email protected] | Web: www.ausbiotech.org
Published by: Executive Media ABN 30 007 224 204
430 William Street, Melbourne VIC 3000 | Tel: (03) 9274 4200 | Fax: (03) 9329 5295
Email: [email protected] | Web: www.executivemedia.com.au
Editor: Eden Cox | Graphic Designer: Robert Smith
The editor, publisher, printer and their staff and agents are not responsible for the accuracy or
correctness of the text of contributions contained in this publication, or for the consequences
of any use made of the products and information referred to in this publication. The editor,
publisher, printer and their staff and agents expressly disclaim all liability of whatsoever nature
for any consequences arising from any errors or omissions contained within this publication,
whether caused to a purchaser of this publication or otherwise. The views expressed in the
articles and other material published herein do not necessarily reflect the views of the editor
and publisher or their staff or agents. The responsibility for the accuracy of information is that of
the individual contributors, and neither the publisher nor editors can accept responsibility for the
accuracy of information that is supplied by others. It is impossible for the publisher and editors
to ensure that the advertisements and other material herein comply with the Competition and
Consumer Act 2010 (Cth). Readers should make their own inquiries in making any decisions,
and, where necessary, seek professional advice. © 2016 Executive Media Pty Ltd. All rights
reserved. Reproduction in whole or part without written permission is strictly prohibited.
5
SPONSORED CONTENT
100 YEARS OLD AND JUST
GETTING STARTED
CSL employees in 1920 packing a mixed bacterial vaccine to help combat the Spanish influenza pandemic in Australia
CSL was established in 1916 by the Australian
Government to ensure that the isolated nation
had reliable access to life-saving biological
products. One hundred years later, it has
become Australia’s largest and most successful
biotechnology company, with substantial in-house,
onshore translational research and development
capabilities.
We have evolved from being a company that largely brought
international discoveries to Australians to one that translates
its own early research into commercial medicines for patients
around the globe. In 1994, CSL spent less than US$20
million on research and design (R&D). In 2016, we will spend
close to US$600 million.
R&D represents both the past and the future of CSL, and
today, our future has never looked brighter.
Our mission is to broaden the pool of life-saving, lifechanging medicines by bringing more new products and
technologies to market, particularly for patients with rare and
serious diseases. In order to do this, we maintain a robust
R&D pipeline—beginning with early-stage research—so
that we have new products to launch next year, and the
year after, and a decade from now. And we employ a high-
A6
performance, dedicated staff comprising some of Australia’s
best and brightest researchers.
In April 2016, on our 100th birthday, we announced the
establishment of the CSL Centenary Fellowship Program.
This $25-million commitment is intended to formally pay
tribute to CSL’s origins by supporting Australia’s scientific
community, as well as helping to foster future research
excellence. We plan to award two long-term, high-value
fellowships each year, for 10 years, to support mid-career
Australian scientists to pursue world-class research.
We keep our global R&D function headquartered in Australia
because we believe that Australia’s medical research
community is world class, and a rich source of potential new
discoveries to address the world’s unmet medical needs.
We have also announced the establishment of the CSL
Global Hub for Research and Translational Medicine, which
will be housed at the University of Melbourne’s Bio21
Institute. We will be doubling the number of CSL research
scientists based there, and we are intending to use the Bio21
facility as an expanded base for new research collaborations,
in both Australia and in other parts of the world.
We are CSL. And we are just getting started…
Spanish flu vaccine
1919
Diphtheria toxin-antitoxin
1920
Insulin
1923
Tiger snake antivenom
1930
Tetanus vaccine
1938
Blood-typing sera
1939
Influenza virus vaccine
1942
Penicillin
1944
CSL CENTENARY FELLOWSHIPS
Call for Applications
Blood plasma therapies
1952
Diptheria, tetanus, whooping cough vaccine
1953
Polio vaccine
1956
Asian flu pandemic vaccine
1957
Plasma-derived clotting factor for haemophilia
1961
Rh(D) Immunoglobulin for newborns
1966
Hong Kong flu pandemic vaccine
1968
Funnel web spider antivenom
1981
Q fever vaccine
1989
The CSL Centenary Fellowships support world-class
medical research in Australia.
Each fellowship is valued at $1.25 million over
five years. Australian medical researchers working
on early stage or translational research with a
focus on rare and serious diseases, immunology
or inflammation are invited to apply for these
competitively-selected grants.
Applications for the first two fellowships, to
commence in January 2017, are now open and
will close on July 31st.
Plasma therapies for global markets
2000
Seasonal flu vaccine for global markets
2002
National HPV vaccine program for girls
2007
For further information and to apply please visit:
www.cslfellowships.com.au
We are CSL. And we are just getting started.
Next generation IV immunoglobulin
2007
H1N1 (Swine) flu vaccine
2009
Next generation subcutaneous immunoglobulin
2010
National HPV program for boys
2013
Adjuvanted seasonal flu vaccine
2015
Novel recombinant clotting factors for haemophilia
2016
CSL100.com.au
CSL Limited, ABN 99 051 588 348, 45 Poplar Road, Parkville Victoria 3052 Australia. OCH OPRH0014 04/16
News
INDUSTRY NEWS
Admedus wins manufacturer of the year at 2016 Manufacturers’ Monthly Endeavour Awards
On 12 May 2016, Admedus was chosen from more than 40 other finalists to take out the
major award of Manufacturer of the Year. Admedus was also awarded ‘Most Innovative
Manufacturing Company’ for its work in the research, manufacture and export of its lead
regenerative tissue product CardioCel®, which is undertaken at the company’s state-of-theart bio-manufacturing facility in Malaga, Western Australia.
Admedus’s state-of-the-art bio-manufacturing facility was officially opened in August
2014 in order to support global demand for the company’s lead regenerative tissue
product CardioCel.
CardioCel is developed using a high-tech engineering process called ADAPT®, whereby
scientists treat a piece of animal pericardium (the heart-covering membrane) to remove all
RNA, DNA and remnants of cells to produce an off-the-shelf, ready-to-use collagen bioscaffold that functions like human tissue.
University collaboration launched to discover new medicines
Victorian Premier Daniel Andrews has announced a new $80-million collaboration between
Monash University and the University of Melbourne in the field of biomedical research. The
Victorian Government will contribute $10 million towards the $60 million needed to get the
enterprise underway, with the two universities having already committed $50 million.
The new enterprise will be owned jointly by the two universities, but will be
independently governed by a board. It has the aim of bringing the advanced
commercialisation skills and funding needed to successfully address the early-stage
‘valley of death’ that faces new discoveries.
In a statement, the universities said the enterprise is expected to generate about $360
million in activity, support new companies, increase investment and exports, and create
specialised jobs in the sector.
Applications open for CSL fellowship
CSL is now calling for applications for the first two inaugural fellowships under the recently
announced $25-million program for early-stage and translational research in Australia. Two
five-year fellowships are to be awarded each calendar year for 10 years. The total value
of each award is $1.25 million, paid in annual instalments of $250,000 to the employing
university or medical research institute.
The grants are available to outstanding Australian researchers seeking to consolidate their
career and undertake medical research in an Australian academic institution. Applicants
must be mid-career Australian citizens (or permanent residents) working in early-stage and
translational research. Preference is expressed for a focus on rare and serious diseases,
immunology, or inflammation.
Applications for the first two CSL Centenary Fellowships close on 31 July 2016. Successful
applicants will be announced on 30 September.
Established in 2016 as the government-owned Commonwealth Serum Laboratories, today
CSL operates in more than 30 countries, manufactures across three continents, and employs
more than 16,000 people.
‘CSL may be one hundred years old, but we are just getting started,’ says CEO Paul
Perreault.
8
News
Worldview ranks Australia in top five for third year
Scientific American Worldview: A Global Biotechnology Perspective has launched its eighth
annual scorecard at the BIO International Convention in San Francisco, confirming that
Australia has held its place in the top five countries for the third consecutive year.
The report said: ‘It might be down under geographically, but Australia finished in the
scorecard’s top five for the past three years. It also produced the 12th highest output on the
Nature Index 2015 Global’.
AusBiotech’s attraction of industry-building conferences was noted in the report: ‘Experts
around the world recognise the biotechnology opportunities in this country, as some events
demonstrate. In October 2016, for example, Australia will host BioFest 2016, which is billed
as “the largest-ever gathering in Australian life sciences, with three major conferences
coming together in one week, in one place, as one integrated network”’.
Australia ranked fifth this year, measured by IP protection, intensity (ranked #3), enterprise
support, workforce/education (ranked #4), productivity (ranked #2), policy and stability.
Australia also ranked in the global top three on four indicators:
•
#3 Greatest public company revenues
•
#2 Most public companies
•
#2 Most public company employees
•
#2 Largest biotech public markets.
20 Years of GM crops in Australia
This year marks 20 years of Australian farmers growing genetically modified (GM) crops.
CropLife says an independent report released by Graham Brookes, of United Kingdombased PG Economics, has outlined the significant economic and environmental benefits
experienced by farmers.
The ‘Adoption and Impact of Genetically Modified (GM) Crops in Australia: 20 Years’
Experience’ report provides insights into the reasons why many farmers in Australia have
adopted, and continue to increasingly use, crop biotechnology since it became commercially
available 20 years ago.
Matthew Cossey, CropLife Australia CEO, says the report provides evidence that ‘statebased moratoria on GM crop cultivation serve no purpose other than to stifle innovation and,
in some cases, act as a political football for people who blatantly refuse to acknowledge the
real-world benefits GM crops provide to farmers and the nation.
‘GM cotton is credited as being the saviour of Australia’s cotton industry, with Australian
farmers among the first in the world to plant GM cotton seeds in 1996… It’s about time state
policy settings are supportive of Australian farmers and their right to choose to reap the wellestablished benefits of GM crops.’
Business agreement signed by European and Australian life sciences organisations
At the 2016 BIO International Convention in San Francisco, six organisations representing
health clusters and life sciences in Australia and Europe signed a business development
agreement that aims to accelerate business results and assist small to medium-sized
enterprises to enter new markets.
Two Australian organisations—BioSA and Health Industries South Australia—signed on
behalf of more than 100 health industries companies and research bodies based locally in
South Australia. Other signatories included organisations from the Auvergne-Rhone-Alpes
region in France, Bavaria in Germany, Catalonia in Spain and Piedmont in Italy.
Marco Baccanti, chief executive of Health Industries South Australia, said that the
cooperative effort is set to deliver real, practical results for companies and research
organisations in the region. South Australian companies will also benefit by creating networks
in European markets, a development that is highly significant to the growing health and life
sciences sector in Adelaide. Job creation and professional collaboration, as well as exports
and commercial opportunities are also foreseen for the South Australian sector following
the agreement. BioM CEO Professor Dr Horst Domdey also commented that a smoother
exchange of academic and clinical research will be made possible through the agreement.
9
News
Pfizer Australia to change hands
Melissa McGregor will succeed David Gallagher as leader for Pfizer Australia following
Gallagher’s promotion and relocation to Ireland.
Before his relocation to Australia, Gallagher led Pfizer for 13 years in his native Ireland, where
he also served as president of the Irish Pharmaceutical Healthcare Association, a researchbased industry association.
Speaking of his colleague’s departure, regional president of International Developed Markets
Richard Blackburn said that Gallagher had brought professionalism and dedication to serving
patients, and that he is held in high regard by colleagues in Australia and New Zealand,
adding also that the company looks forward to seeing McGregor build upon Gallagher’s
strong legacy.
McGregor is also an experienced Pfizer veteran, having worked for 18 years in various roles
including sales, marketing and training. For the last two years, she has also bolstered her
experience with Pfizer New Zealand as country manager. McGregor commented that she looks
forward to ensuring that the company continues to deliver for the patients who count on it.
Retiring CEO and co-founder predicts growth for LBT Innovations
‘Although this will be my final letter to you as the chief executive of LBT Innovations, I enter
my retirement with tremendous confidence that the company I co-founded will only continue
to grow and prosper,’ said CEO and co-founder Lusia Guthrie to shareholders upon her
retirement last month.
Brent Barnes will succeed Guthrie, and was welcomed enthusiastically by the retiring CEO for
his previous experience with Cochlear. Guthrie said that Barnes has a strong IT background
and a capacity for hard work, along with impressive vision for the company’s future.
Guthrie added that Barnes, who will begin his tenure on 8 August, joins LBT at a critical point
in the company’s development. Guthrie will continue in a consulting role to assist transitional
arrangements for the new CEO.
Barnes said, ‘I’m thrilled to be joining LBT Innovations at such a critical period for the
company. APAS® is close to market and LBT has tremendous opportunities to further exploit
its innovative digital imaging platform, including WoundVue®.’
Two external companies have also reportedly approached LBT to discuss the possibility of
collaborating to further commercialise LBTs MicroStreak technology into new international markets.
Success in laser trials for early age-related macular degeneration
Ellex Medical Lasers, a world-leader in medical technologies for the diagnosis and treatment
of eye disease, has announced progress in a clinical trial of its 2RT retinal rejuvenation laser
treatment for intermediate stage age-related macular degeneration. The Adelaide-based
company has completed an interim review of the initial participants in its clinical trial.
Following the interim review, Ellex will be able to continue the trial to its full course until at
least April 2018.
Ellex CEO Tom Spurling said the company was happy to report that the trial passed this
important milestone, and that the analysis revealed a meaningful difference in drusen
progression and retinal sensitivity between the two groups, one of which received sham
treatment and the other 2RT treatment. Spurling added that the trial also demonstrated a
good safety profile.
The trial is sham-controlled, double-masked and randomised, and is being conducted over
six sites, including five Australian sites and one in Northern Ireland.
The trial comprises 292 participants, the latest having been recruited and randomised in
April 2015. Each participant will undergo a comprehensive review every six months over 36
months, with the review period coming to an end in April 2018.
The leader of Ellex’s Laser trials is Professor Robyn Guymer, MBBS, PhD, FRANZCO, an
internationally renowned retinal professor currently based at Melbourne’s Centre for Eye
Research Australia.
10
News
Immuron announces increase in recruitment
Immuron has announced that its 50 per cent recruitment milestone has been reached for its
IMM-124E Phase II clinical trial for the treatment of non-alcoholic steatohepatitis. 60 patients
have been successfully randomised to date, and overall, 25 patients have successfully
completed treatment.
Patients eligible for the clinical trial are randomised into three groups, and receive a
600-milligram or 1200-milligram dose of IMM-124E, or placebo, three times a day. Immuron
has also announced that the treatments have not produced any significant negative effects.
‘This is a significant milestone for the company, and a great achievement by the team,’
reported Head of Medical for Immuron Dan Peres. ‘We continue to work with our study sites
to find ways to accelerate recruitment.
‘IMM-124E has several advantages over our competitors, including a great safety profile,
which provides a compelling option for our PIs and their patients,’ continued Peres.
Recruitment is expected to be finalised by the end of the year. To date, Immuron has
28 active study clinical study sites in the United States, Israel and Australia, and the
company has identified two additional United States sites, which will begin enrolment
this month.
Developments in research targeting Zika virus
Biotron has announced positive results from tests involving two compounds targeting the
Zika virus. The Zika virus has been identified in more than 40 countries, including 20 in the
Americas and many in the Pacific, and has been confirmed as a Public Health Emergency of
International Concern by the World Health Organization. Brazil experiences the worst of the
virus, with an estimated one million people currently infected.
The Zika virus is contracted after being bitten by an infected mosquito, and common
symptoms include conjunctivitis, fever, joint pain and rash. Symptoms are often mild;
however, the virus presents a serious threat during pregnancy. It has been associated with
the serious birth defect microcephaly, as well as other serious brain defects. Currently, no
approved vaccine or treatment is available.
Biotron, which is based in Sydney, exported compounds to an independent screening facility
in the United States for screening against the virus. According to a statement made by
Biotron, ‘One compound showed activity in the first round of screening and this result has
been confirmed in repeat assays. In a subsequent round of screening, a second compound
has also shown to inhibit replication of Zika virus’.
This is an important development for Biotron, and has prompted positive responses
from investors. Managing director Dr Michelle Miller remarked that the results so far
are encouraging, adding that they demonstrate the robustness of Biotron’s library of
compounds, and approach to drug development. A treatment for the Zika virus would be a
large valuation driver for Biotron.
Starpharma, a Victoria-based developer of dendrimer products for pharmaceutical,
life science and other applications, has also made promising developments in the
treatment of the Zika virus. Its VivaGel active, astodrimer sodium (SPL7013), has
demonstrated antiviral activity against the virus in laboratory studies, which have
shown near-complete antiviral protection at SPL7013 concentrations considerably
lower than that of the VivaGel condom (marketed in Australia as the Dual Protec
condom by Ansell).
11
SPONSORED CONTENT
A 100-DAY
BIOTECH PLAN
ideas for an incoming industry minister
BY DR PHIL KEARNEY, DIRECTOR, LICENSING & EXTERNAL RESEARCH, MSD
After the longest election campaign in 50 years,
readers of Australasian Biotechnology are probably
thinking, ‘what now for biotech?’
With a new Cabinet to be sworn in soon, we can anticipate
that the Minister for Industry, Innovation and Science will want
to engage biotech leaders, bed down worthy reforms and
build long-term foundations for a thriving biotech sector.
The Minister might consider the following four ideas for the
100-day plan.
Call an international investors’ forum
In January, Prime Minister Malcolm Turnbull, the Hon. Scott
Morrison MP and other government leaders met with 50
global fund managers at the Sydney Opera House. The A50
Australian Economic Forum, convened with global bank
Citi, aimed to reverse the declining share of investment
funds that Australia has received since the end of the mining
boom. It gave government the chance to showcase our
strengths as an open, stable and innovative economy, and
hear views on the policy settings that could encourage
greater investment.
In the keynote address to the forum, Morrison discussed
the government’s National Innovation and Science Agenda
(NISA), noting that it ‘was a deliberate statement not of
just policy detail, but government intent…to spark a fire
amongst the innovators around this country [and] say that
you are a key part of this country’s future’.
12A
AusBiotech welcomed the new
funding, tax and institutional
policies announced in NISA,
and the related proposals in
Labor’s FutureSmart policy
platform. Maximising the
benefit of these new policies
to Australian biotech will
require the full awareness and
engagement of international
investors and commercial
partners with a specific interest
in the biosciences.
The government has always
Dr Phil Kearney
been well represented at
international biotech events
like the annual BIO conference. The industry minister should
consider hosting a local forum so that selected investors can
discuss opportunities for bioscience investment in Australia,
and explore what steps could be taken to further encourage
commercialisation of Australian research.
This forum could also help in identifying investment partners
for translational research funds. It would also assist the
National Health and Medical Research Council (NHMRC) and
other granting bodies to identify the kind of development
work that would best meet the needs of global investors.
Finally, it would help other partnering institutions to identify
participants for initiatives to build linkages between industry
and academia.
SPONSORED CONTENT
Investors participating in the A50 Australian Economic Forum in January
Support clinical trial reform
Red-tape reduction is another policy objective with strong
bipartisan support. Although both Labor and Liberal
governments have recognised clinical trial reform as a critical
priority for years, streamlining clinical trial approvals has
proved challenging. It was therefore heartening to see the
state and federal health ministers’ communiqué on clinical
trials from the April 2016 Council of Australian Governments
(COAG) meeting in Perth.
The communiqué noted the importance of clinical trials in
advancing clinical practice and stimulating innovation. It
tasked the Australian Health Ministers’ Advisory Council
(AHMAC) with improving the efficiency of trials, to better
engage sponsors and improve trial start-up times and
outcomes. The industry minister is well placed to support
these efforts, and ensure that they lead to practical
improvements and the clinical trial administration through the
Clinical Trials Advisory Committee, which advises both health
and industry departments.
Cut TGA red tape
Another positive development in the build-up to the
election was the commitment of $20 million to implement
recommendations from the Expert Review of Medicines
and Medical Device Regulation. These include the
implementation of new approval pathways that could
accelerate the registration process, giving patients earlier
access to life-saving medicines, and reducing the cost and
administrative burden for companies.
Given the critical importance of timely and predictable
regulatory review to biotech and innovative pharmaceutical
companies alike, the industry minister should support the
timely implementation of these reforms. The Medicines
Industry Forum, which is scheduled to meet after the
election, would present a good opportunity to keep industry
abreast of developments on this.
Ask for a briefing on the PBAC guidelines
A final action for the new industry minister would be to
request a briefing on the proposed new Pharmaceutical
Benefits Advisory Committee (PBAC) guidelines, which will be
implemented shortly after the election. The guidelines include
new provisions that could seriously compromise the valuation
of innovative therapies, significantly reducing the incentive to
bring new medicines to market in Australia. These provisions
have implications that go well beyond the health portfolio,
and need whole-of-government consideration.
MSD and other innovative pharmaceutical companies
are actively involved in translational research, clinical
development and commercialisation in Australia. Together,
innovative pharmaceutical companies invest more than
$1 billion in Australian research and development, employ
14,000 Australians directly, and underwrite thousands more
jobs in universities and research institutions. The industry is
well placed to support the deeper integration of Australian
science into global markets, as well as the significant
employment and economic benefits that this will generate.
There has never been a more exciting time to be involved in
biotech research, commercialisation and policymaking, and
the industry minister will play a critical role in facilitating the
relationships and reforms that will help the sector reach its
full potential.
13B
SPONSORED CONTENT
REALISING VALUE FROM
BIOTECHNOLOGY
Investment into scientific innovation has
thankfully become an important focus for
Australia. The launch of the National Science
and Innovation Agenda and the creation of the
Biomedical Translation Fund are particularly
encouraging for our sector. To capitalise on
these opportunities, it becomes paramount to
focus on the ‘business of biotech’.
The health and economic benefits of biotechnology are
inextricably linked to its commercialisation, rather than
translation per se. Biotechnology is a challenging business,
and it requires specialised capabilities, experienced insights
and significant capital. Australian innovators typically must
engage with global partners to realise maximum value from
their intellectual property.
All too often, biotech innovators, understandably, focus
their limited resources on what they do best—innovation,
preclinical and clinical development—with the underlying
assumption being ‘build it, and they will come’. Their
somewhat vague business goal is to ‘partner with Big
Pharma’ after positive efficacy trials.
It is a risky strategy. Patents are filed, dollars are invested,
and even significant milestones are achieved before anyone
answers (or sometimes even asks) ‘how are we going to sell
this technology, and to whom are we going to sell it?’ Unless a
real-time commercial expert is onboard—someone currently in
the business of doing deals with or for actual biotech buyers—
the answers to these questions tend to involve guesswork and
speculation. As partnering is on the critical path to realisation of
value from biotechnology, the cost of leaving these questions
unanswered cannot be underestimated.
The technology and intellectual property
come first, but without experienced and
effective business development, even good
biotechnology often won’t sell itself-and
certainly not at an optimum price
14A
At Bio-Link, we believe that the best way to realise maximum
value from biotechnology is to engage early and often with
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be interested and what will motivate them to do a deal. We
call this ‘commercial outreach’. The commercial intelligence
acquired through this process is typically invaluable, and
prospective partner engagement invariably identifies at
least a few well-qualified companies as potential licensing
partners. Engagement with multiple prospects fosters crucial
competitive tension to optimise licensing terms, and may
also be leveraged to attract and negotiate more favourable
deal terms from investors. The technology and intellectual
property come first, but without experienced and effective
business development, even good biotechnology often
won’t sell itself—and certainly not at an optimum price.
We specialise in the commercialisation of biotechnology,
though our niche expands into a range of complementary
activities. When it comes to evaluating science, exploring
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AusMedtech
AUSMEDTECH 2016:
AUSTRALIA’S MEDTECH
CONFERENCE
More than 250 delegates from interstate and
overseas gathered in Adelaide from 10–11 May this
year to attend the 2016 AusMedtech conference.
Supported by BioSA and the Adelaide Convention
Bureau, and hosted by the Adelaide Convention
Centre, this year’s AusMedtech Conference
featured the largest line-up to date, and showcased
a wide range of national and international products
servicing the medical technology (medtech) field.
16
The Australian medtech industry is one of the nation’s
fastest-growing and evolving sectors. Having experienced
vigorous growth in recent years, in no small part propelled
by research developments and innovations in the biomedical
sphere, there is now an established community of more
than 1000 companies, which are mostly start-ups, operating
within Australia’s medtech industry.
The annual AusMedtech conference, celebrating its ninth
year in 2016, is a vital forum that brings together the medical
AusMedtech
AusMedtech 2016 Conference Dinner, supported by Cook Medical
devices and diagnostics sector to support the growth
of Australian medical technology around the globe. As
AusBiotech’s medical device and diagnostics conference,
the event is evidence that AusBiotech is working to connect
and grow the Australian medtech industry.
The two-day program featured six plenary sessions and 58
speakers, and hosted six breakout panel discussions, which
explored key topics affecting the industry, such as building
success within the Australian market, global challenges,
digital and telehealth, incubation and the start-up space,
government initiatives, investment and investor relations,
and regulatory issues.
Kick-starting the conference was Dr Anna Lavelle, CEO
of AusBiotech, who welcomed attendees to the exciting
two-day event. Following Dr Lavelle was the opening
address by the Hon. Kyam Maher MLC, South Australian
Minister for Employment, Minister for Aboriginal Affairs and
Reconciliation, Minister for Manufacturing and Innovation,
Minister for Automotive Transformation, and Minister for
Science and Information Economy. According to Maher,
‘Innovation in our high-value industries has never been
more important. The major challenges facing traditional
manufacturing in South Australia have led to greater focus
on developing future growth industries, such as medical
technologies’.
Following these opening addresses were plenary sessions
that explored the current trends in the sector, as well as the
challenges that are faced by the medical technology industry.
The ‘Incubating your way to success’ session had industry
experts explore the pathway from bench to business
success, a challenging journey with many fundamental areas
of business that need to be supported and considered,
and that are often outside the design of the technology
that has been created. This session was chaired by Warren
Bingham, Clinical Genomics, and featured Petra Andren,
ATP Innovations (and her case study, ‘From Incubation to
Commercialisation’); Dr Olivia Lockwood, Flinders University
(and her case study ‘Helping clinicians commercialise their
inventions’); and Greg Eaton, Greg Eaton and Associates
(who spoke on the topic ‘When it doesn’t go to plan… what
does it look like?’).
‘Shifting gears: How the changing landscape of Australian
manufacturing can benefit the medtech industry’, explored
the skills and capabilities of Australian manufacturers that
are transferable to the medical devices industry, and what
value and opportunities they represent. The session was
chaired by Peter Roberts, journalist and founder of the
Australian Manufacturing Forum, and featured discussion
from John Croft Robert Bosch (Australia) Pty Ltd, Bosch
Australia Manufacturing Solutions; Andrew Richards, SMR
Technologies; Grant Tinney, Precise Advanced Manufacturing
Group; and Shay Wilkinson, Cook Medical Pty Ltd.
The final panel of the day, ‘AusMedtech start-up showcase’,
looked at some of Australia’s latest medtech start-ups. This
session was chaired by Warren Bingham, Clinical Genomics,
In the first breakout session, Stephen Tomisich, CEO, Trajan
Scientific and Medical, presented on the topic ‘Building
a sustainable Australian scientific and medical device
company’, while Joanna Batstone, of IBM Research Australia
and IBM Australia and New Zealand, detailed the company’s
current and future efforts in the digital health arena.
Day one of the conference also featured various breakout
sessions, including ‘Technology convergence’, an
interactive panel discussion that explored the impact of
digital technology on the treatment of, and interaction
with, patients, which was chaired by Peter Bradley, LBT
Innovations Ltd, and featured Fred Blochlinger, Outerspace
Design; Dr James Dromey, Murdoch Childrens Research
Institute; Bronwyn Le Grice, Fidere Group Pty Ltd; and Sam
Holt, GP2U.
Dr Anna Lavelle, CEO, AusBiotech, and the Hon. Kyam Maher MLC, Minister
for Employment, Minister for Aboriginal Affairs and Reconciliation, Minister
for Manufacturing and Innovation, Minister for Automotive Transformation,
Minister for Science and Information Economy, Government of South Australia.
17
AusMedtech
and featured Dr John Cross, Expia; Dr Peter French,
BCAL Diagnostics; Dr Mark McEwen, FBE Pty Ltd; Dr Paul
Pers, FORE cms; and Dr Tori Wade, Netcare Resources.
The second and final day of the conference started with
a bang, with delegates attending the Australian National
Fabrication Facility (ANFF) business breakfast, which
provided updates on the new technologies evolving
from the research sector, such as nano-medicine and
biophotonics sensors.
The breakfast was chaired by Dr Warren McKenzie, ANFF,
and featured discussion by Professor Mark Hutchinson, ARC
Centre of Excellence for Nanoscale BioPhotonics, University
of Adelaide; and Professor Nico Voelcker, UniSA node
leader, ARC Centre of Excellence in Convergent Bio-Nano
Science and Technology, University of South Australia. The
breakfast also included a question and answer session on
how companies can engage with Australian researchers to
bring such technologies to market, which was chaired by
moderator Dr Stuart Hazell, Fusidium.
Following the breakfast, Neal Fearnot, Cook Advanced
Technologies and vice president, Cook Group
Incorporated, Cook Medical (USA), presented on key
issues for the global medtech industry. This was followed
by Natasha Gulati, Frost & Sullivan, whose session topic
was an outlook on the telehealth market in Australia.
Conference highlights
•
Joanna Batstone, VP and lab director, IBM
Research Australia, who detailed IBM’s current
and future efforts in digital health
•
Lee Hickin, Microsoft’s commercial lead for
Internet of Things, exploring what we can
predict about the direction of health IT by
looking at emerging platforms and infrastructure
•
Neal Fearnot, president, Cook Advanced
Technologies and vice president, Cook Group
Incorporated, Cook Medical (USA), who
provided an overview of key issues in the global
medtech industry
•
Stephen Tomisich, CEO, Trajan Scientific and
Medical, speaking on how to build a sustainable
Australian scientific and medical device
company.
Key conference topics
•
building successful medical device companies in
Australia
•
advances in the space of digital health
•
capital-raising and government initiatives
Delegates were then able to network with exhibitors, before
returning for mid-morning panel sessions. Glenn Cross,
AusBiotech, chaired the ‘Medtech investment’ session,
which had experts in the field exploring the sources of
capital that have opened up, and those that have dried up.
These experts included Thomas Mechtersheimer, Passion
Investment Group; Graydon Smith, AusIndustry; Matt
McNamara, BioScience Managers; and Jarred Shein, M.H.
Carnegie & Co. •
the Australian start-up space. ‘Medtech exports—leveraging Australia’s Free Trade
Agreements (FTAs)’ was another discussion, which was
chaired by Brendan Mason, SinoSA, and Richard Barrett,
MedDev SA Alliance. The panel members included Liu
Bing, Austrade, and Tracy Colgan, Kamsky Associations
Inc, and provided vital information on how to export
medical technologies using Australia’s recently enacted
free-trade agreements.
Other conference discussions included ‘New Federal
Government initiatives’, and ‘Investor Relations’, which
both featured the expert opinions of those working in these
areas, before the conference convened for lunch and more
networking opportunities.
After lunch, two more panel discussions were held. Option
one was on ‘United States patentable subject matter’, which
had chair Martin Pannall, Madderns Patent & Trade Mark
Attorneys lead a discussion with Brett Lunn, AusMedtech
Intellectual Property Expert Panel; Robert Kramer, Finnegan
(USA); and Derek Minihane, Cochlear Limited, on how what
constitutes eligible subject matter for patents is in flux in the
United States in a way that risks invalidating many valuable
existing patents, and a flight of investment capital from the
medical and biotech sectors.
18
Additional networking
•
tours of Flinders University’s Medical Device
Research Institute, Tonsley
•
the AusMedtech Cook Conference Dinner
•
the Australian National Fabrication Facility
(ANFF) Business Breakfast
•
AusMedtech 2016 Closing Reception.
The second panel explored the topic of regulation
of emerging technologies, a discussion led by Grant
Bennett, Brandwood Biomedical Pty Ltd, and involving Lusia
Guthrie, LBT Innovations Ltd; Neal Fearnot, Cook Advanced
Technologies and Cook Group Incorporated, Cook
Medical (USA); Yasushi Murayama, INFOSERVICE Group
and TÜV SÜD Japan Ltd; and Simranjit Singh, Quintiles,
who all shared their experiences of innovator pathways in
international markets in Asia and the United States.
After a quick afternoon tea, two keynote addresses
remained: ‘Digital Health’, chaired by Dr James
Dromey, Murdoch Childrens Research Institute; and
featuring Lee Hickin, Microsoft; and Dr Adrian Nowitzke,
Telstra Health, which discussed what we can predict from the
emerging software platforms, hardware and infrastructure
that are supporting these changes. The traditional wrap-up
session summarised the main outcomes raised during the
conference, and looks ahead to AusMedtech 2017.
Read ahead in this edition of Australasian Biotechnology for
further insights by AusMedtech 2016 conference presenters
Dr Olivia Lockwood, Dr James Dromey and Peter Roberts.
AusMedtech
1.
3.
2.
4.
5.
6.
7.
6.
8.
9.
1. The Hon. Jack Snelling MP, Minister for
Health, Minister for the Arts, Minister for Health
Industries; 2.Neal Fearnot, president, Cook
Advanced Technologies and vice president,
Cook Group Inc, Cook Medical (USA); Dr
Meera Verma, acting CEO, BioSA; and Dr
James Dromey, general manager business
development & strategy, Murdoch Childrens
Research Institute; 3. Stephen Tomisich, CEO,
Trajan Scientific and Medical; 4. Lee Hickin,
Commercial Lead for Internet of Things,
Microsoft; 5. Marco Baccanti, chief executive,
Health Industries SA; 6. Lunch at AusMedtech; 7.
Joanna Batstone, vice president, IBM Research,
CEO; 8. Networking event; 9. Dr Anna Lavelle,
Katrine Hildyard and Dr Meera Verma
19
SPONSORED CONTENT
ERADICATING DISEASE
THROUGH CAPITAL INVESTMENT
iQX Limited is a listed investment company and
fund manager that supports physicians, scientists
and entrepreneurs who are developing innovationbased businesses across the life science sector.
iQX believes that discoveries in the laboratory will translate
into novel therapeutics, diagnostics and medical devices.
iQX helps to drive the development of leading innovations
through a unique network of medical, scientific and
investment knowledge and expertise aimed at sourcing
ground-breaking opportunities and pairing them with the
appropriate capital through bespoke investment products.
iQX is part of the wider iQ Group Global Companies leading
Australia to the forefront of international biotechnology
research and commercialisation. This relationship expands
the group’s client base and development capability by
combining a deep understanding of life science with access
to major international capital markets.
iQX has established a compelling portfolio of investment
products through the inception of the iQ Series 8 Fund,
an Early Stage Venture Capital Limited Partnership
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The first product in the iQ Series 8 Fund range is a closedend, six- to seven-year term, A$100-million Life Science
Fund (Global) ESVCLP LP. This series is predominantly
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In September 2015, Innovation Australia granted the Fund
conditional registration as an ESVCLP LP. The iQ Series 8
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in a biologic compound, introducing a novel approach to
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This asset will benefit from the synergies provided by the
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Leading the development and commercialisation of a
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20
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AusMedtech
HELPING CLINICIANS TO DEVELOP
INNOVATIVE MEDICAL DEVICES
BY DR OLIVIA LOCKWOOD, TECHNICAL MANAGER, STATEWIDE RESEARCH AND TEACHING, SA
BIOMEDICAL ENGINEERING, SA HEALTH
The SA Biomedical Research and Teaching (R&T)
team members are the go-to gadget gurus,
using cutting-edge technology to find innovative
solutions to problems faced by clinicians and
medical researchers within SA Health and Flinders
University, School of Medicine. The R&T team has
mechanical, electronic, software and biomedical
expertise, accumulated during more than 30 years
creating medical devices, from original concept and
prototyping, through to clinical trial.
The team’s work is very diverse, and the solutions provided
have many local, national and international benefits.
Such solutions include improved standards of health care
through innovative medical device design; improved staff
safety through innovative solutions to mitigate or reduce
workplace injuries; the facilitation of groundbreaking
research by developing technology to make medical
research possible; and the creation of intellectual property
with commercial potential.
Dr Olivia Lockwood
Innovative medical device development model
to regulatory requirements. The service has expertise in
medical standards and regulations, medical device design,
repairs, maintenance and installations, and is involved from
device purchase, all the way through to disposal. There are
biomedical engineering departments within all major public
hospitals, plus a mobile team for the country and community
(rural and remote), dental, and pathology health services
located throughout the state.
The SA Biomedical Engineering Research and Teaching
team provides a unique service within the Australian public
health system. The team operates within an innovative
model, which promotes and enhances medical device
development for the state. This model is based on
partnering biomedical engineers with clinical and research
staff. The clinical and research staff know the clinical needs,
and ensure a patient focus, while the engineers provide the
biomedical expertise and technology solutions to solve the
problem. This leads to the creation of innovative medical
devices solving identified clinical needs.
Due to the role that SA BME plays in SA Health, the
engineers have a close working relationship with a wide
range of clinical and research staff. This places SA BME in a
very unique and ideal position, whereby it can engage with
clinical and research staff to discuss their needs, problems
or visions for better health care. When there is an identified
clinical or research need, the R&T team works collaboratively
with staff to understand the problem, identify their needs,
evaluate possible solutions and develop the medical
devices. This is a very streamlined path for medical device
research and innovation.
Integrated model of service
The devices developed by this model are very diverse
and demonstrate innovations. Some examples include the
following:
The R&T team is part of the South Australian Government’s
SA Biomedical Engineering (SA BME) statewide service. SA
BME regulates access of medical devices into SA Health,
ensuring that all medical devices used within the hospital
are safe, suitably designed for medical use and conform
22
•
Fluid Warmer: a non-powered, portable device that
saves lives at accident scenes by quickly warming blood
before delivery to hypothermic victims.
AusMedtech
AirGuards have been installed at major hospitals in Adelaide
•
•
•
•
•
Air Guard: a safeguard measure to reduce the incidence
of oxygen and air outlet mix-up within clinical areas,
thereby reducing the use of air when oxygen is required.
SA Health (FMC, RGH, TEQH and RAH sites) have
these devices installed and 11,400 units have been sold
internationally. At FMC, the incidence of incorrect air
use dropped from 12 cases to three in two years after
air guards were introduced.
Hip Implant Remover: developed to allow surgeons to
use a new surgical approach to hip implant removal
through the manufacture of a novel, custom-made
orthopaedic tool, preventing the need for a more
invasive surgical alternative.
Sonographer Safety: research to understand the causes
of, and possible solutions to eliminate, musculoskeletal
workplace injuries experienced by sonographers when
scanning patients.
Heel Pressure Relief System: a pressure ulcer care
tool used to reduce ulcer formation, while providing a
solution that is comfortable and usable by patients.
Quantifiable Blood Flow: a Doppler flow meter with a
unique ability to measure blood flow into transplanted
tissues in the leg, which allows researchers to gather
evidence to reduce the number of bed-stay days from
the current average of seven to three days.
Commercial potential
The medical devices developed by the R&T team have
commercial potential. To maximise this and enhance the
R&T medical device model, Flinders Biomedical Enterprises
(FBE) Pty Ltd was created in 2007. FBE is owned by the
Flinders Medical Centre Foundation. FBE provides a vehicle
to commercialise the medical devices developed by the
R&T team. Over the last eight years, FBE has successfully
commercialised the Fluid Warmer and Air Guard, making the
innovative outcomes of the R&T team available worldwide.
Medical device clinical trials
A very important part of medical device development is
clinical trials. The R&T is ideally positioned to run medical
device clinical trials with:
•
expertise in designing and running clinical trials
•
experience in writing and negotiating the ethics
application approval process
•
access to animal and clinical trial facilities
•
access to a wide range of patient types
•
one ethics application for all trials in SA Health.
While private pharmaceutical clinical trial facilities in South
Australia are prominent, there are limited options in the
state for medical device clinical trial services that industry
can use. SA Biomedical, through FBE Pty Ltd, is looking at
facilitating clinical trials for the medical device industry in
South Australia.
The SA BME R&T medical device model allows the
incubation of innovation by assisting clinical and research
staff to convert their inventions into medical device
realities—a need that will grow with more medical device
industries taking advantage of South Australia’s focus in the
medical techology space.
23
SPONSORED CONTENT
MCCLOUD CELEBRATES
FIVE YEARS
This year, Australian CRO McCloud Consulting
Group (MCG) celebrated its five-year anniversary.
From its humble beginnings with two staff
members working from home in early 2011, the
company has grown to a 12-person, full- service
data management and biostatistics team working
at the company’s beautiful corporate headquarters
in Belrose, Sydney. The company boasts more than
160 years of combined experience, several studies
submitted to health authorities, many statistical
training courses and publications in some of the
world’s best journals.
Company Director Philip McCloud reflects on some of the
highlights: ‘For me, it’s the variety of the services we have
provided over the years that has been so exciting. From
building and maintaining high-quality clinical databases,
attending health authority meetings on behalf of a sponsor,
analysing clinical trial data and explaining the results, to
tailoring a study design to meet the complex needs of a
sponsor – we’ve had a chance to do it all. Every day brings a
new challenge, and it keeps us all motivated and excited’.
One of the greatest achievements for the MCG statistics
team over the past few years has been providing
statistical analytics to iconic Australian company Spinifex
Pharmaceuticals. MCG supported the development of
Spinifex’s drug EMA401 in peripheral neuropathic pain by
performing the statistical analysis of its Phase II trial data,
leading to publication in The Lancet and one of Australia’s
24A
largest ever corporate buyouts—when Novartis acquired
Spinifex in 2015.
A high point for the data management team has been to
become expert users of the cost-effective, high-quality
clinical database system ‘OpenClinica’. This has allowed
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but do not have the in-depth skills and training required
to collect it in a compliant manner, and cannot afford the
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Using this cost-effective, high-quality solution has also
had significant flow-on savings for clients in their statistics
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and this saves us time’. MCG Lead Data Manager Jill
Schaefer agrees: ‘You can’t retrospectively add integrity
to the data, so it’s important the data are recorded,
handled and stored from the beginning in a way that allows
accurate reporting, interpretation and verification’. Data
inconsistencies are routinely identified and queried by MCG
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the data to be clean and complete when it comes time to do
the statistical analysis. This saves a lot of money during the
analysis phase and leads to more rigorous results.
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AusMedtech
TECHNOLOGY CONVERGENCE
The impact of digital technology on treatment and
patient interaction
BY ANITA PETRIS, PROJECT MANAGER DIGITAL HEALTH; PHOEBE MACLEOD, LEGAL AND
BUSINESS DEVELOPMENT MANAGER; AND DR JAMES DROMEY, GENERAL MANAGER BUSINESS
DEVELOPMENT AND STRATEGY, MURDOCH CHILDRENS RESEARCH INSTITUTE
The PEERS assessment tool for children
The use of digital technology in health is becoming
ubiquitous. The rapid rise in wearables, along with
the growing consumer interest in managing and
tracking one’s health, is now a major worldwide
trend. This is changing how consumers access and
interact with health care, and is leading to greater
participation in the control and management of
their own health, as highlighted in Eric Topol’s
book The Patient Will See You Now: The Future of
Medicine is in Your Hands. In this article, we outline
how digital technology is affecting treatment and
patient interaction, and how it is opening up new
models of research and clinical care.
26
The interaction of people with technology is a rich fount
of information that can be captured, analysed and acted
upon. Mobile technology has enabled patients to report
personal health information, such as answering questions
in real time and capturing objective data through the use
of technologies. The research and clinical community is
becoming increasingly engaged in patient-reported data,
particularly when the collected data can be used to inform
a clinical decision—for example, adjusting treatment
according to the patient response.
As an example, the Murdoch Childrens Research Institute
(MCRI) recently released a mobile application called Saliva
Tracker to help parents and caregivers of children with
cerebral palsy to track how a child is progressing on their
AusMedtech
prescribed medication for dribbling. Dribbling is a significant
factor impeding the successful integration of individuals
with disabilities into home, school and community life.
Saliva Tracker enables parents to participate in their child’s
treatment by collecting data outside of the clinic, and
providing valuable feedback to their specialist on whether
the prescribed treatment is working, or if a different
approach is required.
The use of technology allows for frequent, real-time
feedback, as well as the benefit of enriched data sets and
automated analytics, while enabling increased compliance
and compliance reporting through push notifications
and reminders. Our focus group research during the
development of Saliva Tracker reinforced the growing trend
of patients wanting to be more involved in their health
care, as well as highlighting how technology can provide a
powerful medium.
Patient-reported data is also being used in large population
health studies, facilitated through technology like Apple’s
ResearchKit, and online and social media channels. These
enable new ways to recruit participants, and provide
insights that may help uncover new and more accurate
risk predictors, as well as early interventions for noncommunicable diseases. For example, the Health eHeart
Study in the United States—which is currently being
undertaken by the University of California, San Francisco,
in collaboration with the American Heart Association—is
crowdsourcing its study participants. By inviting people
to use smart phones and sensors to collect a broad range
of data, including on sleep, diet, activity and physical
measurements, researchers are aiming to predict the
likelihood of the development of heart disease. Researchers
are also taking the potential application of technology one
step further by investigating ways that technology can be
used to improve cardiovascular health, and encourage
people to live a more heart-healthy lifestyle.
The demand for greater access to high-quality health care
outside of hospitals and clinics, continuity of care and
the evolution of technology is resulting in a shift towards
distributed care. Telehealth and advances in communication
technology have given us the ability to extend medical
expertise beyond the hospital and clinic, and out into the
community. Consumer demand for convenient access to
medical care has also spawned a number of health tech
startups, with telehealth platforms like Australian companies
GP2U, HealthKit and Telstra’s ReadyCare.
Technology is also enabling a stepped care approach
to patient treatment, where the degree of intervention
and treatment can be stepped up or down based on the
patient’s need. This has been particularly effective in treating
mental health conditions, and drug and alcohol addiction.
Technology-enabled regular monitoring of interventions and
treatments of patients in their day-to-day environments has
yielded more ‘reliable’ data that isn’t influenced by visits to
the clinic.
This has opened up the possibilities for use in patient
screening, and in early detection and intervention. For
example, MCRI is developing a clinically validated digital
assessment tool for psychologists, educators and health
professionals to identify social problems in children and
adolescents to enable early intervention and targeted
treatment for patients. Called PEERS (paediatric evaluation
of emotions, relationships and socialisation), this tool has the
ability to individually characterise a patient’s social strengths
and weaknesses that will directly inform tailored treatment and
early interventions.
The use of technology in mental health is yielding positive
results, with many patients feeling more comfortable reporting
their health information through an app or web tool than via a
face-to-face consultation with their health professional.
Today, we are having numerous encounters with technology
and its use in the management and maintenance of our
health. In future, there is the real possibility that we will view
technology as therapeutic in the same way that we would a
drug. Development is already underway for the use of digital
games as a therapeutic for conditions such as Alzheimer’s
disease, attention deficit hyperactivity disorder (ADHD) and
schizophrenia. Virtual reality technology is currently being
used in the real estate industry for house viewing, and
even in criminal trials to recreate crime scenes for jurors. Its
potential application in surgical training, patient education,
pain management and mental health are areas of interest for
health tech companies.
A number of recent research studies have indicated that
some people relate better to an avatar when discussing
mood and feelings than to a clinician. This provides an
opportunity for meaningful data to be collected and the use
of artificial intelligence (AI) to deliver targeted treatment;
patients can receive immediate personalised care at a time
of their choosing.
The role of technology in patient treatment, and in how
patients interact with the healthcare system and manage
their own health, is increasing. To date, this has largely been
driven by consumer technology companies. It is critical that
the use of technology in health care is evidence-based,
and has been demonstrated in clinical trials and studies to
have health benefits and clinical utility. It is only then that
we will see large-scale acceptance by patients, the medical
profession, investors and government.
27
AusMedtech
SHIFTING GEARS:
How the changing landscape of Australian manufacturing
can benefit the medical techology industry
BY PETER ROBERTS, JOURNALIST AND FOUNDER,
AUSTRALIAN MANUFACTURING FORUM
28
AusMedtech
For medical technology industries, there may be a
silver lining to the dark cloud that is hanging over
Australia’s manufacturing sector, but it does not
make up for the damage being wrought on the
country’s industrial capacity.
During AusMedtech 2016 in Adelaide earlier this year,
delegates gathered in the state that is feeling the brunt of
a worrying de-industrialisation of Australia. South Australia,
traditionally a manufacturing state, is reeling from the
decision by GMH to cease car manufacturing at Elizabeth
in 2016, taking with it numerous automotive suppliers that
either can’t or won’t diversify to survive.
On top of that, the primary steel blast furnace operated by
Arrium at Whyalla is under threat, with the company under
voluntary administration, and uncertainty hangs over the
state’s naval shipbuilding sector.
South Australia is suffering the most from a shrinking of
manufacturing from 25 per cent of gross domestic product
(GDP) as recently as the 1980s, to 6.2 per cent today. While
this still represents more than $106 billion in annual output,
there is no doubt that much has been lost. Entire industries
have closed, and in many key sectors, there are only one or
two companies still in business.
Sydney’s Silanna Semiconductor, for example, is Australia’s
only large-scale manufacturer of the silicon chips that are
at the heart of all modern products and services, including
medical devices. Silanna is known for designing and
manufacturing the communications chips on board NASA’s
Mars Curiosity Rover.
The operations of companies like Silanna bode well for
the capability available to the medical technology sector
from among our estimated 2500 small and medium-sized
enterprises (SMEs) operating globally. But this is sadly still
a small number for a nation that boasts the world’s 13thlargest economy, and one of the most successful.
In the past, the car industry, linked as it is to global supply
chains, brought skilled people, new technologies, cuttingedge manufacturing techniques, and advanced management
ideas to Australia. The country, and the medical technology
sector that has often recruited from the automotive
companies, will have to find a new source of new ideas when
GMH, Ford and Toyota exit in 2017.
Our observations are that the medical
devices industry is still a very labourintensive industry, and can benefit
from increased levels of automation
and technology
But speakers at the
AusMedtech session
‘Shifting Gears’ do
show that, in the short
term at least, medical
technology companies
can still draw on
car companies for
inspiration.
Robert Bosch is the
cornerstone supplier to
car making in Australia,
engineering and making most of
Peter Roberts
the onboard computers that make up a
high proportion of the value of a car. John Croft, business
development manager at Robert Bosch, told AusMedtech
that the company was investing $50 million to give itself
a new future in Australia by providing high-technology
automation solutions and advanced business processes.
‘Our expertise is gained from decades of automotive product
development and manufacturing,’ Croft says. ‘This is important
because automotive is a highly mature industry with very
small margins for error, high levels of scale and an absolute
requirement for quality processes. A lot of these requirements
can be transferred to other manufacturing industries.’
Bosch manufactures millions of diodes—a simple
semiconductor device—at its Melbourne factory each
year. More typical of its future operations is the work it
is doing with Shay Wilkinson, process engineering team
leader at Cook Medical in Brisbane, to identify improved
manufacturing systems and processes. Cook manufactures
in-vitro fertilisation (IVF) needles and aortic stents used to
ward off heart failure.
Croft says, ‘Our observations are that the medical devices
industry is still a very labour-intensive industry, and can
benefit from increased levels of automation and technology’.
Bosch is not alone among automotive players that are
diversifying for the future.
Grant Tinney chairs Precise Advanced Manufacturing Group,
which offers industry advanced manufacturing services, such
as additive machining and fabrication. He told AusMedtech
that Precise also assists companies, research organisations
and inventors to take their medical device or technology
concept from idea to commercial success.
Andrew Richards, product marketing manager at SMR
Technologies, also outlined changes to his business, which
is part of a global group that manufacturers exterior mirrors
for cars and commercial vehicles. Services include providing
end-to-end product design, engineering, production and
logistics solutions.
‘The company has been, and continues to be, driven by
research, development and commercialisation of innovative
new technologies and products.’
Peter Roberts is a former managing editor at the Australian
Financial Review and BRW, and founder of the Australian
Manufacturing Forum networking group, which can be found
on Linkedin.
29
SPONSORED CONTENT
BOSCH AUSTRALIA
MANUFACTURING SOLUTIONS
Australian manufacturing is the subject of intense
government and media scrutiny. Manufacturing
now accounts for approximately six per cent of
GDP from 12 per cent in the early 2000s. And this
is before the impending cessation of high-volume
vehicle manufacturing in Australia.
However, any developed economy needs to be diverse and
not reliant on one single industry, so manufacturing is still very
important. Despite the doom and gloom associated with automotive
manufacturing, there are still pockets of success in traditional and
new industries.
The Australian Industry Group performance index is reporting seven
consecutive months of increased growth from late 2015 to now.
At Bosch, we recognise that in order to maintain a sustainable
manufacturing sector, we need to continue to invest in new
technologies, processes and services. Our group, Bosch Australia
Manufacturing Solutions, was set up to support Australian
companies to gain efficiencies and productivity, and to introduce
new technologies to the market.
Our expertise is gained from decades of automotive product
development and manufacturing. This is important because
automotive is a highly mature industry with very small margins for
error, high levels of scale and an absolute requirement for quality
processes. A lot of these requirements can be transferred to other
manufacturing industries.
We have been able to help this transfer of expertise and have
been involved in multiple industries, including medical device
manufacturing and agriculture. Both these industries can benefit
from improved efficiencies and productivity.
In agriculture, connectivity and the internet of things (IoT) is top of
mind. However, automated solutions are also required to keep up with
the projected scale that new harvesting solutions will bring. Bosch is
confident in the development of this industry and has recently invested
in a Tasmanian agriculture technology company.
We are already working in the highly specialised medical device
industry in Australia, which is already globally competitive. Besides
a few large companies, such as Cochlear, Cook Medical and
ResMed, most companies in the industry are young and small but
have the potential to grow significantly with the right technology.
30
A
The medical device industry in Australia is highly specialised, but
there are more than 500 companies operating in it—in comparison,
the automotive supply chain is approximately 700 companies large.
Besides the few large companies, most medical device companies
are young and small, and compete globally.
On 19 February this year, we introduced an important part of our
technology suite, the APAS mobile collaborative robot. APAS
is a family of automation solutions designed for the flexible,
networked, smart factories of the future. APAS can be used safely
in collaboration with staff and without guarding due to its sensitive
sensor skin, which prevents direct contact.
Systems like the APAS robot are a step towards making our industry
sustainable. Investment in these technologies and processes can
make already competitive companies and industries world class.
John Croft
Business Development Manager
[email protected]
www.bosch-manufacturingsolutions.com.au
Bosch Australia
Manufacturing Solutions
Your partner in automation and robotics
APAS assistant
collaborative robot
The APAS assistant is a versatile automatic
production assistant. As an intelligent and
intrinsically safe robot system, the APAS
assistant allows direct collaboration with
people without expensive additional
shielding. This is made possible by the
unique sensor skin, which covers the robot
arm of the APAS assistant and which reacts,
as soon as somebody approaches.
With a breadth of industries and products that extend from the automotive industry, to
medical, pharmaceutical, healthcare, food, energy, power tools, household appliances and
whitegoods. With a strong history in supplying equipment to the automotive supply chain,
Bosch Manufacturing Solutions now delivers into a diverse range of Industries.
Automation
Assembly Line, Assembly Equipment, Material Handling,
Axis /Robotics & Jigs & Fixtures
Test & Measurement
Product Test Systems, Communication Interfaces, Data Analysis & Data Acquisition
Process Technology
Dispensing Systems, Riveting, Tightening Systems & Vision Systems
Engineering Services
Feasibility studies, Lean equipment design, Project Management,
System Integrators
The standardized production assistants APAS assistant, APAS inspector and APAS flexpress,
as a stand-alone solution or in a manufacturing island, are designed for: ad-hoc small series
production, semi-automation, pilot production for safeguarding a process, agile engineering
with early interim results and quality tests.
To find out more contact John Croft
(61) (0) 434 185 329 M
(03)9541 5086 T
[email protected] E
bosch-manufacturingsolutions.com.au W
Immuno-oncology
IMMUNOTHERAPY TO TREAT
AFL STAR’S MELANOMA
BY GIULIA HEPPELL
Cancer cell and lymphocytes
32
Immuno-oncology
Hawthorn star player Jarryd Roughead has commenced
12 months of immunotherapy to treat cancer.
Jarryd Roughead will be receiving treatment for four small
melanoma spots on his lungs—a recurrence of melanoma that
was surgically removed from his lip last year—at Melbourne’s
world-renowned Peter MacCallum Cancer Centre, with
specialist Professor Grant McArthur leading his case.
In a press conference held in May, Hawthorn club doctor
Michael Makdissi revealed the star player’s recent diagnosis.
‘Jarryd has had a recurrence of his melanoma,’ Makdissi said.
‘He’s been feeling perfectly well, so it’s come as a bit of a
surprise to us. He has four small spots on his lung. He had
a biopsy last week on one of those spots, and it confirmed
the diagnosis of melanoma. It’s a serious problem, but we’re
optimistic of a good outcome.
‘Jarryd met with Grant McArthur and his team at Peter Mac,
who are world experts in this area, and he’ll be starting immune
therapy next week. That will go for a period of 12 months.’
Speaking about his diagnosis, Roughead revealed, ‘When
you hear they are on organs it’s a little bit scary, but I feel
fine... It’s not as if I’m home or bedridden’.
While chemotherapy and radiotherapy are the most
common—and most aggressive—forms of medical therapies
used to treat cancer, Roughead will be undergoing
immunotherapy, the latest cancer treatment often claimed to
be revolutionary, which doesn’t have the usual side effects of
its traditional counterparts.
Treatment for Roughead comprises four infusions of the
immunotherapy drug three weeks apart, before progressing
to an infusion every
second week. This
treatment not only
provides a very
good prognosis for
survival, but it could also
fundamentally change the
way that cancer is treated.
According to Makdissi, ‘It’s
really changed the landscape of
melanoma therapy. We go there
expecting a really good result’.
Professor Grant McArthur leads the
team responsible for Roughead’s
cancer treatment at Peter
McCallum Cancer Centre
Immunotherapy is a treatment that stimulates the body’s
immune system to destroy the cancer. Immunotherapies
are thought to work by slowing the growth and spread
of cancerous cells, and by boosting the immune system’s
natural defences to fight and destroy existing cancer cells.
There are a number of different types of immunotherapies
available, including treatments using monoclonal antibodies,
nonspecific immunotherapies and cancer vaccines.
The immune system is a powerful tool, and immunotherapy
is set to play a huge role in cancer treatment in the future,
particularly in melanoma, where the revolutionary treatment
has had a big impact on patient survival in cases where other
therapies have failed.
In the following pages of this edition of Australasian
Biotechnology, we feature contributions from immunooncology experts Dr Jamie Lopez, Peter MacCallum Cancer
Centre; Dr Ian Nisbet, Cancure; Josie Downey, MSD; and
David Rhodes, Admedus.
33
Immuno-oncology
IMMUNOTHERAPY OVERVIEW
Monoclonal antibodies (mAbs) are manufactured in a
laboratory, and are designed to work in the same way
that natural antibodies do—identifying and fighting
foreign antigens and targets from the body, such as
bacteria, viruses and other substances.
Interestingly, mAbs can be designed to alter cancer cells
in different ways. These are by:
•
attaching to cancer cells in order to signal the
immune system to destroy that cell
•
slowing the growth of cancer cells by blocking the
parts of the cell that enable them to grow
•
delivering radiotherapy to cancer cells without
damaging healthy cells—this is achieved by
attaching radioactive molecules to antibodies, which
can also be used to diagnose some cancers by
flagging where cancer cells exist in the body
•
carrying drugs, such as chemotherapy, directly to
cancerous cells.
In contrast, non-specific immunotherapies refer to the
use of cytokines—proteins produced by white blood
cells in order to control the immune system and its
responses. These non-specific immunotheraphies use
cytokines to help the body’s immune system to destroy
the cancer cells.
Melanoma cells
remembers them. This vaccine-induced memory allows
the immune system to react quickly to infections already
encountered, allowing it to prevent another attack and
protect the body.
There are two types of cancer vaccines:
•
preventative (prophylactic)—intended to prevent
the development of cancer in healthy patients.
These vaccines are only useful for cancers that are
developed through infection (such as HPV)
•
treatment (therapeutic)—intended to treat an
existing cancer by strengthening the immune
system’s natural response against the cancer.
The types of cytokines being produced include:
•
interferons: these help the immune system to slow
the growth of cancer cells
Treatment cancer vaccines are classified as
immunotherapy.
•
interleukins: these can increase the production of
white blood cells and antibodies in order to fight
cancer
At this stage, there are three preventative cancer
vaccines available:
•
hematopoietic growth factors: can be used to
counteract some chemotherapy side effects.
The last type of immunotheraphy is cancer vaccines.
Vaccines, simply put, boost the immune system’s
natural instinct to fight against ‘foreign invaders’, such
as infectious agents that may cause disease and illness.
When a foreign ‘threat’ invades the body, the immune
system recognises and destroys it. It then stores this in its
memory in order to prevent future attacks.
Vaccines take advantage of this natural defence.
The majority of vaccines are created using harmless
and inactive versions of the microbes—either killed
or weakened microbes, or parts of them—that do
not cause diseases, but are still able to stimulate the
immune system’s natural fight instinct. When a vaccine
is administered, the immune system responds to
these microbes, eliminates them from the body, and
34
•
Gardasil—for people aged nine to 26 to prevent:
• cervical, vaginal, and vulval cancers in girls and
women
• anal cancer in women and men
• genital warts in men and boys
•
Cervarix—also protects against HPV, and is used in
the prevention of cervical cancer in females aged 10
to 25
•
hepatitis B vaccination—prevents hepatitis B
infection (HBV), which can cause liver cancer if the
infection is long lasting.
In comparison, most cancer treatment vaccines are only
available through clinical trials; however, in 2010, the
United States FDA approved sipuleucel-T (Provenge) for
men with metastatic prostate cancer. This treatment is
not available in Australia at this time.
At INC Research,
helping our clients
develop the medicines
patients need is
important to us.
Our Biotechnology
Solution is critical in
our mission to support
patient access to
treatment.
INC Therapeutic
Expertise
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specific needs.
Our unique operating
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aligned, inclusive of
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Our tailored approach
offers fit-for-purpose early
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expertise, pricing proposals
and contracting, and endto-end development and
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For more information
about INC Research’s
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© 2016 INC Research, LLC THE-0516-10025
SPONSORED CONTENT
TRANSFORMING BIOMEDICAL
DISCOVERY AT MONASH
Monash University has a long track record of
commercialising technology and innovation that
brings new products and services to the market.
Examples such as Monash IVF, Relenza™ and
Axiron™ were all developed at Monash and
commercialised with local partners such as Biota
and Acrux. These developments rely on both
world-leading science for their initial generation,
and working with industry partners to get them to
the market.
Over the past five years, Monash has invested significantly
in its researchers, to both recruit the best and provide them
with the best equipment and facilities to be truly world class.
As a result, Monash is consistently ranked in the top 100
universities globally, and ranked equal fourth in Pharmacy
and Pharmacology, and 39th in Medicine in 2016 (QS World
University Ranking by subject).
At the same time, there is an increasing emphasis on working
more closely with industry, both for commercialising research
and to ensure from the earliest stages that research is
informed by current industry issues. This has resulted in an
increase of over 40 per cent in industry income since 2011
across the Faculty of Medicine, Nursing and Health Sciences,
and the Faulty of Pharmacy and Pharmaceutical Sciences.
Equally important are the relationships that have developed
with companies such as Pfizer, Janssen, Regeneron, Novo
Nordisk, Servier, Capsugel and GSK.
Monash is now looking to deliver greater benefits to society
through a series of initiatives that will increase engagement
with industry and opportunities for commercialisation.
This has been highlighted in Focus Monash, the university
strategy that has enterprise and engagement embedded as
one of four key priorities.
Monash Biomedicine Discovery Institute
The new Monash Biomedicine Discovery Institute (BDI) is
positioning Monash University at the forefront of medical
discovery, research translation and industry engagement.
The Monash BDI is part of the three-institute Discovery
Precinct, alongside the Australian Regenerative Medicine
Institute (ARMI) and the Monash Institute of Cognitive and
Clinical Neurosciences (MICCN).
researchers, but as is the case in many universities, they
have been, to a degree, siloed in discipline-focused
departments. We saw an opportunity to cluster research into
Discovery Programs that tackle global health problems, and
at the same time better align our research with our clinical
programs and industry needs’.
BDI director Professor John Carroll led the BDI’s formation in
2015, commenting that, ‘Monash has exceptional biomedical
Monash University has longstanding translational research
partnerships with Monash Health and Alfred Health,
36
A
SPONSORED CONTENT
representing one of the largest and fastest-growing patient
populations in Australia. ‘Bringing clinical expertise,
patient cohorts and samples within reach of BDI scientists
will accelerate translation of early-stage research’, says
Professor Carroll.
The BDI brings together more than 100 research teams
of 700 researchers and 270 PhD students from multiple
disciplines into six health-focused Discovery Programs:
Cancer, Cardiovascular Disease, Development and Stem
Cells, Infection and Immunity, Metabolic Disease and
Obesity, and Neuroscience. Critically, these programs
have been configured to align with clinical imperatives and
the needs of our industry partners rather than traditional
academic disciplines. The research is underpinned by the
Monash Technology Research Platforms; a strong network of
more than 24 platforms ranging from antibody production,
molecular profiling, drug optimisation and structural biology,
and many more.
‘The scale of the BDI provides greater scope for our scientists
to work together and create insights at the intersection of
diseases,’ says Professor Carroll. ‘It also provides a strong
platform to work with clinicians and collaborate with local
and international companies earlier in the research process.’
Already, the BDI discovery engine is powering the innovation
pipeline, with close to 20 therapeutic opportunities under
development and translation.
Monash Innovation
Monash Innovation was established in 2015 to improve
the commercialisation outcomes from Monash University.
Led by Dr Alastair Hick, who has over 15 years of global
commercialisation experience, Monash Innovation is
committed to making an impact by getting technologies
developed and put to use. This focus on impact and finding
the right path for each opportunity is the key to successful
commercialisation.
Dr Hick is convinced that working with the BDI will be
transformational for commercialisation at Monash. ‘We
are not driven primarily by income, but impact. However,
if we do enough good-quality deals, we will make a
significant return for the university and our researchers.
I have no doubt that the quality of the opportunities for
commercialisation and collaboration in the BDI is the equal
of anywhere, and my team are excited about bringing
researchers together with our industry partners to deliver
real-world impact’, says Dr Hick.
Monash Innovation is developing a team capable of
delivering on this vision: a team that has real deal-making
experience and can flourish at the interface between
research and industry. They also have access to additional
funding that is often necessary to develop commercially
viable opportunities. Monash has developed the Monash
Research Impact Fund (MRIF), which invests in promising
opportunities based on market feedback from potential
commercial partners.
‘Access to MRIF funding is often crucial to our ability to
develop opportunities to a stage where commercial partners
or investors will commit. We are also working on a number
of other large-scale funding and investment initiatives that
will transform our ability to develop the innovation coming
from the BDI much further and much faster than we have
ever been able to do before. We are at the turning point
for innovation—with greater industry interest at the stage of
discovery, strong government initiatives for supporting and
funding innovation and entrepreneurship, and new venture
funds and angel investors with a range of investment models
providing us with more choices. We look forward to working
with our industry partners to turn our discoveries into the
next generation of therapeutics, diagnostics and devices’,
says Dr Hick.
To learn more about the Biomedicine Discovery Institute,
visit www.monash.edu/discovery-institute, or contact Monash
Innovation at [email protected].
Web: monash.edu/discovery-institute
Email: [email protected]
B
37
Immuno-oncology
CANCER IMMUNOTHERAPY
COMES OF AGE (FINALLY!)
BY DR IAN NISBET, AFANDIN PTY LTD
T cell attacking cancer
38
Immuno-oncology
‘Immuno-oncology’ is the current buzzword in
cancer treatment, with drugs like pembrolizumab
(KEYTRUDA®) and nivolumab (Opdivo®) providing
exciting new treatment options for an expanding
range of tumour types, including melanoma and
lung cancer. The ability to activate the immune
system to kill cancer cells has become a focus area
for oncology drug discovery and development.
Manipulation of the immune system to control cancer is not
a new concept; however, the idea can be traced back to at
least the 1890s, when William Coley began treating patients
with a preparation from streptococcal cultures (Coley’s toxins)
to stimulate immune activity. The use of the BCG (Bacillus
Calmette-Guérin) vaccine for the treatment of bladder cancer
was an ultimate outcome from Coley’s original concept.
Despite these early hints of efficacy, enthusiasm for immune
system involvement in (and control of) cancer has waxed and
waned over the subsequent years.
In the 1960s and the following decades, tumour immunology
again came to the fore as a result of studies into the rejection
of tumour transplants. It became clear that the immune
system had an ability to distinguish ‘normal self’ from ‘tumour
self’, and a number of tumour-associated antigens (TAAs)
were identified. This opened up the prospect of immunising
against cancer and, during the following years, development
of the first generation of cancer vaccines, which, at best,
yielded anecdotal evidence for patient benefit.
The modern era of cancer immunotherapy began with the
advent of recombinant DNA technology and the emergence
of the biopharmaceutical industry. Early initiatives included
the development of immune-stimulating cytokines, such as
the interferons (for example IFN-a, IFN-g) and interleukins (for
example IL-2). Although these drugs were approved for use
in niche cancer (and other) indications, their severe side effect
profiles and limited efficacy meant that the early expectations
for these drugs as the ‘silver bullets’ for the treatment of
cancer were never realised.
High-priced therapies (often at a cost
of more than $100,000 per patient per
annum per drug) create challenges for the
healthcare system
Over the same period, advances in DNA sequencing provided
new insights into cancer cell biology, and provided the
impetus for a new generation of therapeutic cancer vaccines.
Throughout the 1990s and into the 2000s, multiple variations
on the cancer vaccine theme (whole cells plus or minus
immune-stimulating cytokines, cell lysates, subunit vaccines,
DNA vaccines, et cetera) have
been taken into the clinic.
These products have
generally shown excellent
safety profiles, and
occasionally evidence for
the induction of relevant
immune responses, but
they have rarely shown
any meaningful efficacy.
The sole exception was
Dendreon’s sipuleucel-T
(Provenge®) for the treatment of
Dr Ian Nisbet
advanced prostate cancer, which
was successful in gaining market
approval in the United States and European Union, but was
a commercial disaster. The failure of multiple cancer vaccines
over the past 20 years has dampened enthusiasm for cancer
therapeutic vaccines (at least for the time being).
In contrast to the experience with cancer vaccines, the use
of antibodies as effector molecules, receptor antagonists
or drug-targeting agents has blossomed since the
1990s. Drugs such as rituximab (Rituxan®), trastuzumab
(Herceptin®), cetuximab (Erbitux®) and many others have
become established as standards of care across a range
of tumour types. While not necessarily acting strictly as
immunotherapies, these products have a demonstrated the
power of leveraging one arm of the immune system (the
humoral arm) for the treatment of cancer.
More recently, a greater understanding of the ways that
tumour cells evade and block the immune system has opened
up new treatment paradigms. Thanks to the pioneering work
of James Allison, chairman of Immunology at The University
of Texas MD Anderson Cancer Center in Houston, Texas, and
others, we now appreciate the complexity of the relationship
between cancer cells and the immune system. We now
know that cancer cells can deactivate killer T cells through
checkpoint pathways; that they can block T cell infiltration by
the expression of galectins and other inhibitory molecules;
and that they can downregulate the expression of MHC class
1 molecules, and thereby make themselves largely invisible
to the immune system. Clearly, cancer cells can manipulate
the immune system not to kill them, and understanding the
protection mechanisms has provided opportunities for drug
developers to out-manipulate the manipulators.
KEYTRUDA®, Opdivo® and YERVOY® are known as
checkpoint inhibitors (they block checkpoint pathways).
KEYTRUDA® and Opdivo® block PD1-PDL1 signalling
between tumours and immune cells, while YERVOY® blocks
a separate tumour cell/T cell engagement pathway (namely
CTLA4-CD28). In doing so, these antibodies release a cancerinduced ‘handbrake’ on the immune system, resulting in
dramatic anti-tumour responses. In melanoma, previously
unheard-of response rates of around 30 per cent have
been achieved in late-stage patients. As impressive and
unprecedented as these response rates are, there is clearly
substantial room for improvement—a 30 per cent response
rate still means that the majority of patients are not deriving
benefit from the treatment.
39
Immuno-oncology
So, where to from here? It is
reasonable to argue that we are still in
the early stages of the
immuno-oncology revolution
One way that is being actively explored to increase response
rates is for immunotherapies to be used in combination with
themselves, or with other therapies. Again in melanoma,
the combination of Opdivo® with YERVOY® has pushed
response rates into the 50 per cent and above range;
however, the extra activity comes at a cost—both financially
and clinically. High-priced therapies (often at a cost of
more than $100,000 per patient per annum per drug) create
challenges for the healthcare system. For the individual,
doubly activating the immune system increases the
incidence and severity of side effects: particularly debilitating
inflammatory conditions, such as inflammatory bowel disease.
The immune system is a powerful beast, and there are good
reasons why it is subject to natural control mechanisms such
as checkpoints.
On the treatment horizon is a range of cellular therapies,
which represent another dimension of the immuno-oncology
arsenal. It is now possible to engineer and expand T cells
targeting specific TAAs by transfecting the cells with chimeric
antigen receptors (CARs) to create CAR-T cells. These cells do
not need to be activated through the normal T cell activation
pathways; they are ready to seek out and destroy tumour
cells expressing the cognate TAA. In clinical trials in patients
with rare leukaemias, such as acute lymphoblastic leukaemia
(ALL), response rates of 95 per cent have been achieved
using CD19-targeted CAR-T cells in patients who have failed
all existing therapies. To describe this as unprecedented is a
gross understatement! However, despite such extraordinary
results (and the associated optimism and hype), the CAR-T
approach is yet to prove itself in other tumour types,
particularly solid tumours.
40
Finally, another form of cellular immunotherapy that is
beginning to gain momentum is to leverage the innate immune
system, particularly through the activity of natural killer (NK)
cells. Mechanisms for the activation of endogenous NK cells
are being explored, as is the infusion of exogenous NK cells. In
some ways, this brings the field of immuno-oncology full circle.
It is now known that bacterial cell components are natural
activators of the immune system (through, for example, binding
of bacterial DNA to toll-like receptors on immune cells), and
it is quite likely that the occasional beneficial effects obtained
with ‘Coley’s toxins’ were due, at least in part, to non-specific
stimulation of innate immunity.
So, where to from here? It is reasonable to argue that we are
still in the early stages of the immuno-oncology revolution. It is
also reasonable to argue that prior oncology drug development
efforts (whether successful or not) needs to be reconsidered
in light of treatments such as checkpoint inhibitors. It is likely
that treatments like cancer vaccines, and even chemotherapy,
may be much more effective in the context of an immune
system ‘with the handbrake released’. Similarly, other emerging
approaches, such as oncolytic viruses, need to be assessed in
combination with checkpoint inhibitors. There is a huge amount
of work to be done, both pre-clinically and clinically.
One thing seems certain: after a gestation period of more than
a century, manipulating and using the immune system to treat
existing disease, as well as to prevent disease recurrence, will
finally be entrenched as a central feature of cancer therapy.
Dr Ian Nisbet is a partner in the biotechnology consulting
company Afandin Pty Ltd. He is actively involved in cancer
drug development, with multiple companies; he is the parttime CEO of Cancure Pty Ltd, which is developing a portfolio
of cancer drugs that includes both immunotherapies and
targeted therapies; he is a co-founder and executive director
of Senz Oncology Pty Ltd, which is developing a small-molecule
treatment for acute myeloid leukaemia (AML); he is a co-founder
and corporate adviser to Cartherics Pty Ltd, which is developing
a next-generation CAR-T platform; and he is chairman of
vivoPharm Pty Ltd, a preclinical contract research organisation
that specialises in cancer pharmacology. He is also an Industrial
Fellow at the Australian Institute for Bioengineering and
Nanotechnology (AIBN) at the University of Queensland.
ERBITUX® IS A REGISTERED TRADEMARK OF ELI LILLY AND COMPANY.
HERCEPTIN® IS A REGISTERED TRADEMARK OF GENENTECH USA, INC.
KEYTRUDA® IS A REGISTERED TRADEMARK OF MERCK AND CO.
OPDIVO® AND YERVOY® ARE REGISTERED TRADEMARKS OF BRISTOL-MYERS SQUIBB
COMPANY.
PROVENGE® IS A REGISTERED TRADEMARK OF DENDREON CORP.
RITUXAN® IS A REGISTERED TRADEMARK OF BIOGEN, INC.
Immuno-oncology
NEXT-GENERATION DNA
VACCINE TARGETS HPV
TUMOUR CELLS
BY EDEN COX
41
Immuno-oncology
In 2006, Professor Ian Frazer won the Australian
of the Year award for his research that led to the
Gardasil vaccine, which provides immunity from
some human papillomavirus (HPV) strains and
associated cervical cancers. Working with Admedus
Ltd (ASX: AHZ), Prof Frazer is now developing a
next-generation DNA vaccine technology, which,
if successful, will target and clear HPV-positive
tumour cells in people who are already infected.
Gardasil is a very effective vaccine, and take-up in Australia
has been strong, at approximately 70–75 per cent; however,
despite selling more than $1 billion annually, 2014 data out
of the United States indicates that only around 40 per cent
of that country’s eligible population has been vaccinated
with Gardasil. This is also despite the 79 million people in
the United States who are infected with HPV, and the further
14 million people contracting the virus each year.
Research by the United States’ National Cancer Institute
shows that high-risk HPV types cause approximately five per
cent of all cancers worldwide. In addition to cervical cancer,
HPV is believed to be responsible for 90 per cent of anal
cancers; 71 per cent of vulva, vaginal and penile cancers;
and 72 per cent of oropharyngeal cancers.
These figures, and the limited uptake of prophylactic
vaccines, have presented a great need for a therapeutic
vaccine to treat people already infected with HPV and
suffering from HPV-related cancers.
Dr David Rhodes, Admedus’s chief scientific officer, says
that studies show that cancerous cells express less of the L1
protein that is key in the Gardasil vaccine. So, in developing
the patented DNA platform technology for the delivery of a
HPV therapeutic vaccine, Frazer and Admedus have optimised
a different set of HPV genes for the safe and efficient
production of antigens in the body’s cells. These antigens
then stimulate the body’s immune cells and alert them to its
presence, which, in turn, enables them to mount a defence
against the HPV-infected cells that carry these antigens.
Admedus has conducted several animal studies with the
HPV vaccine candidate, and has shown that the therapeutic
vaccine produces strong cytotoxic T lymphocyte (CTL)
responses. HPV-positive tumour cells were injected into
animals, and only vaccinated animals prevented tumour
growth, while non-vaccinated animals had uncontrolled
tumour growth. In more than 87 per cent of the animals,
there was no tumour 50 days post treatment. The
effectiveness of the vaccine in this challenge model is a
significant advance on published results.
Admedus is tracking towards its first HPV vaccine clinical
study this year, following the expected successful
completion of preclinical studies. As part of the Phase Ib
clinical study, the company will look at the safety of the
vaccine, as well as efficacy data in the study participants.
‘Due to previous experience with the DNA vaccine platform
in other areas, this program, once initiated, was able
to rapidly progress into animal models and into formal
42
Dr David Rhodes
Prof Ian Frazer
preclinical studies. As such, the HPV program has only been
in development for relatively few years,’ says Rhodes.
Admedus believes that should the vaccine prove successful,
it will offer a simpler, more effective treatment for cervical
and other HPV-associated cancers, greatly improving the
outlook for diagnosed patients, and potentially making such
cancers a thing of the past.
The potential applications for the novel DNA vaccine
technology are promising, with indications that, alone
or in conjunction with other therapies, it may be able
to treat a range of other viruses and cancers, as well as
bacterial infections.
In addition to a HPV therapeutic vaccine, Admedus is also
using the novel DNA vaccine technology to target the herpes
simplex virus 2 (HSV-2). Admedus’s HSV-2 program has
already completed a successful Phase I study in uninfected
participants, with results indicating no safety issues. And,
importantly, 19 out of 20 study participants showed a T cell
response to the vaccine antigen. This is an early indicator of
the vaccine’s ability to generate an immune response.
The HSV-2 vaccine Phase II study—undertaken with the
primary outcome being assurance that the vaccine is safe
in people who are already infected with the virus—revealed
no safety issues among participating patients, according to
results released in March this year. Study participants had a
marked decrease in viral lesions (outbreaks), with a drop of
more than 90 per cent in the monthly rate versus baseline.
The average number of days HSV-2 was detected in patients
was also reduced versus baseline.
‘Admedus is now on track to initiate the first clinical
study with the HPV vaccine this year after anticipated
successful completion of preclinical studies,’ says
Rhodes. ‘As part of the Phase Ib clinical study, the
company will look at the safety of the vaccine, as well as
efficacy data in the study participants.’
Admedus will also examine other outcomes after
vaccination, including a reduction of the symptoms and viral
flares that are related to HSV-2 lesion outbreaks and other
immunologic markers.
‘Programs like Gardasil and others really show how
researchers and companies can, and must, combine
effectively to commercialise these technologies.’
Immuno-oncology
COMBINATION THERAPIES
WITH IMMUNE CHECKPOINT
INHIBITORS
BY DR JAMIE LOPEZ, PETER MACCALLUM CANCER CENTRE, MELBOURNE
Despite decades of work that has contributed
to our fundamental understanding of cancer
immunology, it has only been in recent years
that we have seen this translate into effective
cancer treatments. The unprecedented success
of immune checkpoint inhibitors, such as PD-1/
PD-L1 and CTLA-4 antibodies, has ushered in a
new era of cancer treatments, with improved
response rates compared with standard-ofcare chemotherapeutics. These therapies work
by boosting the host’s natural cancer immune
surveillance. While initial clinical trials with
immunotherapeutic drugs have focused on
cancers with a high mutational load and higher
immune infiltrates, such as melanoma and lung
cancer, many other cancers are now being actively
assessed, such as renal, breast, head and neck, and
haematological malignancies.
Immune checkpoint inhibitors and immune agonists
dominate pharma pipelines, and considerable effort has
focused on developing the next blockbuster drug by
identifying novel cell surface checkpoint targets that are
amenable to biologics. Notwithstanding the success of
these new therapies, still little is known about why some
patients respond while others don’t. Rational combination
therapies of immunotherapies with conventional and
targeted treatments offer hope for improved response rates
among patients. These new combination approaches are
supported by a growing appreciation for how these existing
treatments engage the immune system, and their potential
to synergise with immunotherapies to prolong long-term
cancer immunity.
Chemotherapeutics has been a
mainstay in cancer treatment
for decades. Toxicity
remains a problem, and
therefore better use
of chemotherapies
through immunotherapy
combination approaches
may serve to reduce
toxicities, and improve
the patient’s quality of
life. A proper evaluation of
the effect of chemotherapies
on the immune system has
Dr Jamie Lopez
only taken place relatively
recently. Chemotherapies have been shown to improve
the recognition of tumours by the innate immune system
through upregulation of natural killer (NK) cell activation
ligands of the surface of tumour cells. Furthermore,
immunogenic cell death as a consequence of chemotherapy
treatment also elicits an adaptive immune response;
immature dendritic cells engulf dying tumour cells, and
therefore tumour antigens (neoantigens).
These antigens are presented to CD8+ killer T cells to
promote an adaptive immune response following dendritic
cell maturation. Doxorubicin and cyclophosphamide
have been shown to prime the immune system through
immunogenic cell death, a process that can be enhanced by
combination with immune checkpoint blockade. Non–small
cell lung cancer clinical trials using the ipilimumab (CTLA-4
antibody) combination with the frontline platinum-based
chemotherapies, Paclitaxel and Carboplatin are now being
assessed to determine whether such combination therapies
improve patient outcomes.
43
Immuno-oncology
A cytotoxic lymphocyte killing a tumour cell. Dr Jamie Lopez
Radiation therapy has been shown to induce tumour
regression both within and distal to the irradiation volume.
The systemic effect of radiation treatment, beyond killing
cancer cells directly exposed to the radiation, was thought
to occur through the induction of host anti-cancer immune
responses. The pro-immunogenic effects of radiation therapy
can lead to increased neoantigen expression on tumour
cells, and improved T cell–based immune responses that
can contribute to the control and/or elimination of cancer
cells. These immune stimulatory effects of radiation therapy
have been shown to promote the therapeutic activity of
immunotherapy. Enthusiasm for radioimmunotherapy as
a combined treatment modality for cancer care is well
reflected by their rapid translation into the clinic.
Targeted small-molecule therapies have provided
survival benefit over conventional therapies, and their cell
permeability properties offer an advantage over many of
the immune-modulating biologics that are only effective
against surface targets; however, high rates of relapse are
inevitable with targeted therapies due to the emergence
of drug-resistant pathways. Historically, targeted therapies
have been thought to work exclusively by blocking the
tumour’s oncogenic driver. Any additional effects on the
immune system have been overlooked, since traditional
patient-derived xenograft mouse models use animal models
deficient in an immune system.
Syngeneic models have uncovered an unappreciated
requirement for the immune system in some targeted
therapies. Vemurafenib, a small-molecule inhibitor of the
most common BRAF activating mutation V600E, has been
shown to increase CD8+ T cell infiltration into the tumour
site, which suggests that using this in combination with
immunotherapies may offer a two-pronged approach: 1)
disarm the tumour from the inside and impair its growth;
and 2) enhance the underlying anti-tumour activity of the
adaptive immune response.
The full therapeutic benefit of cancer
immunotherapy will likely be realised
when used in combination with these
conventional anti-cancer treatments
44
Combining immunotherapies with epigenetic modifying
therapies is gaining traction in the clinic for a number of
solid cancers. Epigenetic therapies such as the histone
deacetylase inhibitors (HDACi) have traditionally focused
on haematological cancers, where they have been most
effective as single agents. A number of preclinical studies
in mouse models of blood cancer have demonstrated that
the immune system is required for their efficacy. There is
growing evidence to suggest that epigenetic therapies
can be used to render solid cancers more immunogenic,
either through priming the immune system or alleviating the
tumour’s immunosuppressive environment.
A number of trials are now underway testing immune
checkpoint inhibitors with epigenetic therapies in various
solid cancers, including a Phase II trial to assess the DNA
hypomethylating reagent Azacitidine with PD-1 therapy
Pembrolizumab in advanced colon cancer. Dosing regimens
will also be an important factor in such studies, since it is
thought that initial dosing with the epigenetic modifying
therapy will be more beneficial as it acts to prime the
patient’s immune response, before subsequent immune
boosting by the checkpoint inhibitors.
Rational combinations, in addition to more effective dosing
regimes, using the new class of immunotherapies have
the potential to improve the immune system’s anti-tumour
response, improve treatment efficacy and lead to better
patient outcomes; however, a major challenge will be reducing
the potential adverse effects observed with each respective
therapy—including immunotherapies as they target important
immune regulatory pathways critical to the maintenance of
normal immune homeostasis. The success of immunotherapies
has led cancer researchers and oncologists to reassess the
contribution of the immune system in all cancer treatments,
including conventional chemotherapies, radiotherapy
and targeted therapies. The full therapeutic benefit of
cancer immunotherapy will likely be realised when used in
combination with these conventional anti-cancer treatments.
Australia has made a number of seminal contributions to the
field of cancer immunology, and immunology more broadly.
Pharma is now looking to the immunologists for new clues
on how to control the inherent anti-tumour properties of
the immune system, and boost the antigenicity of tumours.
The Peter MacCallum Cancer Centre’s move to the newly
established Victorian Comprehensive Cancer Centre this
year will mark a new era in cancer treatment for Australian
cancer patients. This presents opportunities to explore
new areas of research in immuno-oncology, develop these
projects through commercial partnerships and ultimately
translate these findings into the clinic.
Immuno-oncology
OUTPACING CANCER
An interview with Josie Downey, MSD
Cancer immunotherapy is a breakthrough that
is providing much hope for patients with the
greatest needs. MSD is advancing a broad and
fast-growing clinical development program for its
immunotherapy medicine KEYTRUDA®.
The success of KEYTRUDA is as much about regulatory
innovation as it is about scientific innovation. Regulatory
approval for KEYTRUDA was secured in Australia in record
time, an achievement made possible by MSD’s recognition
of the drug’s importance to the Australian population, and
the willingness and commitment of the Therapeutic Goods
Administration to complete the registration process as
quickly as possible.
For an inside look at
immuno-oncology in
Australia, Australasian
Biotechnology
speaks with Josie
Downey, MSD’s
director of Oncology
Business Unit, who
is responsible for a
number of marketed
products, as well as the
launch of new products,
including immuno-oncology
drugs like KEYTRUDA.
Josie Downey
45
Immuno-oncology
What is the current state of immuno-oncology in Australia?
Research in the area of immuno-oncology is changing
the way cancer is treated, and MSD’s immuno-oncology
development program is one of the fastest-growing in the
industry. KEYTRUDA, the company’s anti-PD-1 therapy, was
registered by the Therapeutic Goods Administration for the
treatment of advanced metastatic melanoma. Australia was
the first country in the world to register KEYTRUDA for the
first-line treatment of unresectable or metastatic melanoma
in adults.
What are the challenges and opportunities in the development
of new immunotherapy drugs?
Cancer is a complex disease, and MSD is investing
significant resources in the development of innovative
oncology medicines to help people with cancer. Over the
past decade, scientific research has led to the discovery of
new pathways and treatments, such as the PD-1 pathway
and anti-PD-1 therapies, that harness the power of the
body’s own immune system to help fight cancer. We believe
this approach can have an impact on survival expectations
for many cancer patients. The KEYTRUDA clinical
development program includes more than 30 tumour types
in more than 270 clinical trials, including in excess of 100
trials that combine KEYTRUDA with other cancer treatments.
How do collaborations emerge in immunotherapy, and what do
you believe is the value of these?
Our strategy begins with building a foundation with
monotherapy, in refractory settings and then in earlier
stages, and looking thoughtfully at combinations (with
standard of care, emerging approaches and other
immunotherapy agents). Our goal in combining KEYTRUDA
with other therapies is to improve outcomes while
maintaining tolerability and open new treatment paths
for a broader range of patients that may not respond
to monotherapy treatment. We have a strong scientific
rationale for each of the combination studies that we choose
to undertake based on biological hypotheses and what we
have seen preclinically. We are open to partnerships and
collaborations with academia, other companies, investigators
and large cooperative groups. To date, a significant
proportion of the more than 100 combination trials that are
already underway are through collaborations or partnerships. Australia was the first country in
the world to register KEYTRUDA for the
first-line treatment of unresectable or
metastatic melanoma in adults
46
Can you discuss some recent research and developments that
MSD has been undertaking in immunotherapy?
At this year’s meeting of the American Society of Clinical
Oncology in early June, researchers presented data from
studies of KEYTRUDA as monotherapy, and in combination
with other therapies, in more than 15 different cancers.
These included melanoma and non small–cell lung cancer, as
well as bladder, colorectal, esophageal, gastric, head, neck
and renal cancers, lymphoma and multiple myeloma. Firsttime presentation of findings for KEYTRUDA were presented
in new tumour types, including cervical, endometrial,
pancreatic, salivary and thyroid. What do you believe is in store for the future of immunooncology, and what is the key to ensuring commercial
success?
MSD is rapidly advancing the KEYTRUDA clinical trial
program because we believe that it has the potential to
become an integral part of cancer treatment, either as
monotherapy or as combination therapy, for many different
types of cancer where innovative treatments are greatly
needed. Additionally, we have a number of promising new
immuno-oncology candidates moving through early-phase
development. We are moving at an unprecedented pace
because we need to do everything possible to help outpace
cancer. We are working quickly, smartly and collaboratively
to accelerate the drug development process, and the speed
with which we can bring new hope to people with cancer.
SPONSORED CONTENT
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ANTEO BECOMING GLOBAL
GAME CHANGER
Nanoglue technology and offshore acquisition excites
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Anteo Diagnostics
is on the cusp of
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The combination of a major offshore acquisition, new
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Chaired by finance
innovator Mark
Bouris, Anteo has
achieved several key
milestones in the past
12 months. The goal is
to quicken technology
commercialisation, enter
Joe Maeji
new markets such as
batteries, and capitalise on Anteo’s recently acquired global
sales channel.
‘After more than a decade of development, our nanoglue
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In January 2016, the ASX-listed company concluded the
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DIAsource CEO Dr Jef Vangenechten was appointed group
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Institutional investors are backing Anteo. It was announced
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component of the DIAsource ImmunoAssays acquisitions,
and to provide working capital.
A
‘This is a pivotal phase for Anteo,’ says Dr Joe Maeji, Anteo
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Exceptional technology driving Anteo
Anteo’s technology has huge application. Its patented
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Anteo’s initial focus is the in vitro diagnostics (IVD)
market, the largest of medtech sub-sectors, and forecast
to be worth $70 billion by 2017. The IVD market is
expanding quickly as an ageing global population, growth
in emerging markets and development of point-ofcare testing requires faster, cheaper and more accurate
laboratory test results.
47
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patent could provide an automatable, effective sample
pre-treatment that mitigates interference without affecting
laboratory workflows.
Anteo is developing a patent portfolio for effective
enrichment or removal of desirable or undesirable materials
in both life science and large-scale industrial applications.
‘Our technology could dramatically simplify many
purification processes such as wastewater treatment,’ says Dr
Maeji. ‘We are receiving excellent feedback on our concept
from stakeholders in this market.’
Batteries is another large opportunity. The $30-billion
lithium-ion battery market is expected to be growing
strongly as demand for innovative energy solutions booms.
Preliminary research shows that Anteo’s nanoglue technology
can be easily implemented in the battery manufacturing process
between the raw materials and electrode manufacturing states to
improve efficiencies in battery capacity, charging time and life.
Studies have shown that Anteo’s polymeric technology,
Coupling Kits, improves diagnostic tests and is a faster,
cheaper and easier alternative to incumbent technologies.
It can transform the way scientists work by saving them
hours in reagent preparation time and, being water based, it
reduces the amount of hazardous materials they work with.
‘Anteo’s nanometre-thin metal-ion polymer binders,
primers and coatings for nanomaterials are a breakthrough
technology,’ says Dr Maeji. ‘It is effectively a universal
surface-coating solution that can be applied to almost any
range of synthetic surfaces and used as binders, primers and
coatings across industry. Its potential applications go well
beyond the life sciences sector.’
Leveraging a unique platform into new applications
Anteo believes the platform technology can be applied to
bio/separations, medical devices and batteries, in addition
to life sciences research and development.
In April 2015, Anteo announced a patent filing in the field
of bioseparations, which is a key process in many industries,
including the growing immunoassay market. Worldwide,
around 10 billion immunoassays that run each year are
susceptible to sample-specific interference, which can result
in bad test results and poor patient outcomes. Anteo’s
48
Anteo has three patent applications directed at the energy
sector. ‘The recent PCT filing is an important milestone in
our commercialisation activities in the industrial area,’ says
Dr Maeji. ‘We will be interacting with potential partners over
the next six to nine months.’
Dr Maeji says there are a lot of commonalities between
nanomaterials used in life sciences research and in lithiumion batteries, as well as other energy areas, electronics and
industrial coatings, among others. ‘Since we are binder and
coating specialists, energy storage is a natural progression for
our metal-ion polymer technologies,’ he says.
The IVD market is expanding quickly
as an ageing global population, growth
in emerging markets and development
of point-of-care testing require faster,
cheaper and more accurate laboratory
test results
B
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Allan Wong, Process Development Scientist, Anteo
Dr Maeji says multi-point binding that can break and reform is a
‘self-healing coating’ and can prevent fragmentation of siliconbased anodes that swell three to four times during charge
and discharge cycles. Commercialisation of these anodes that
have more than 10 times the energy storage density of current
graphite-based anodes is being hindered by these current
limitations. ‘We also believe Anteo coatings can help resolve
the stability problems of new generation cathode materials.’
Preliminary research shows that
Anteo’s nanoglue technology can be
easily implemented in the battery
manufacturing process between the raw
materials and electrode manufacturing
states to improve efficiencies in battery
capacity, charging time and life
Investors are interested in Anteo’s potential in energy
storage. Anteo successfully completed a $1-million equity
placement in May 2015 to enhance its Anteo Energy
division. The company said: ‘The level of enthusiasm shared
by our investors for the potential of Anteo Energy, driven by
the data, now gives us the ability to fast-track our program
for the use of nanoglues in batteries. This is potentially a
very large market opportunity for Anteo’.
C
Global reach to commercialise Anteo technology
Anteo’s full acquisition of DIAsource is a critical part of its
strategy. DIAsource develops, makes, markets and distributes
clinical diagnostic products in the field of endocrinology. It
services customers in 75 countries and sells products directly
and through a global network of 90 main distributors and 40
original equipment manufacturer partners.
DIAsource is performing strongly: revenue was €14.1 million
($21.7 million) in 2015 and it achieved its ninth consecutive
quarter of revenue growth (9 per cent over 2015) in March
2016 with sales of €3.8 million.
The deal transitions Anteo towards a cash flow–positive
organisation with significant earnings upside. It also provides
Anteo with an experienced, globally networked sales team
that dovetails with its scientific strengths, a strategic location
in Europe, and a range of additional commercialisation
opportunities for its metal-ion polymer technology.
‘There is a tremendous opportunity to leverage its product
range and capabilities through DIAsource’s supply chain,’
says Dr Maeji. ‘Anteo also gains access to a large production
capability that will allow us to manufacture products at scale.
Effectively, this acquisition fast-tracks Anteo’s capabilities
in production and commercialisation in the diagnostics
and life sciences global market. It would have taken years
and significant further investment for Anteo to build these
capabilities on its own.’
The key pieces in Anteo’s strategy—to apply core
technology into new application areas and create new
business opportunities—are rapidly coming together. ‘It’s
been a long journey, but Anteo is in the right place at the
right time,’ says Dr Maeji. ‘We are determined to capitalise
on all the hard work over the past decade and ensure our
technology, which has almost limitless potential across
industry, benefits more customers.’
To learn more about Anteo Diagnostics, visit www.anteodx.com.
49
Agbiotech
GM AND THE COMMUNITY
A call to action
BY ROB NEELY, FOUNDER AND EXECUTIVE DIRECTOR,
INTEGRATED ANIMAL HEALTH
GM can help the world’s population to be safer and healthier
50
Agbiotech
A recent mega study in the United States, ‘Genetically Engineered Crops: Experience and Prospects,’ has proven the safety
of GM crops
Over the last decade, we have seen a tectonic shift
in public opinion in two critical areas of agricultural
biotechnology. On the one hand, the public has
been convinced that genetic modification (GM) of
plants is a bad thing, while on the other, it applauds
the efforts of fast-food retailers and supermarkets
to eliminate antibiotics from the food chain due to
fears of antimicrobial-resistant superbugs.
Where is the logic in this thinking? Isn’t the GM of plants—
designed to decrease the use of insecticides and pesticides,
and to reduce the impact of drought through carefully
selecting plants that are hardier and naturally more insectresistant—a good thing, and if so, where does this fear of
GM crops arise?
As the founder of an animal health company built on the
back of a ‘natural is better’ approach, I have worked with the
human biotech industry for the last six or seven years, with
the view of taking novel therapies destined for humans and
creating animal health products from them.
Well before the general public was aware that farmers
were treating animals prophylactically with antibiotics (as
growth promoters), my team was looking at ways in which
biotechnology could be used to produce similar outcomes,
naturally, by hyper-stimulating the immune system.
A recent mega study in the United States, ‘Genetically
Engineered Crops: Experience and Prospects,’ has proven
the safety of GM crops, and while it may have unknowns
attached to it, so did the microwave oven and air travel
when they were first introduced. So, why has the weight
of public opinion come down so heavily against GM now,
while being equally strongly supportive of antimicrobialresistance mitigation?
My view is that it’s the same
answer: powerful lobby
groups combined with
the widespread use (and
ubiquity) of social media.
The lobby groups have
been successful in
portraying one form of
biotechnology as ‘good’
and the other as ‘bad’, if
not ‘evil’. Increasingly, we are
seeing ‘non GM’ labels on foods
Rob Neely
and feeds everywhere; there is clearly
commercial impact. For example, our stockfeed company
just went through and received organic certification for
several of its dairy inclusion products, but we had to prove
that we had no GM material involved in the raw materials.
Lobby groups have been around for a very long time, but
generally they have been confined to the halls of power—in
ivory towers or, indeed, in parliaments. What’s different
these days is the power of social media and its role in
shaping public opinion. This happens in the form of tweets,
Facebook posts, YouTube videos or Snapchats in bite-sized
pieces, which rarely, if ever, tell the whole story. Fear drives
a lot of traffic, and traffic is power—enormous power that
is almost instantaneous in nature—but unfortunately, more
often than not, there is very little basis in real science.
Agricultural biotechnology needs to understand this.
The scare campaign perpetrated by the ‘ban genetic
modification’ social media set is one reason there is so
much disdain for GM. The same campaign against antibiotic
resistance has already been fought and won, but animal
health was quick to act, and responded by being proactive
rather than reactive.
51
Agbiotech
It’s a juxtaposition that the industry needs to understand.
If you were to ask the public, would they support genetic
modification that would cure a disease in babies? I bet
you that almost 100 per cent of the public would approve;
however, if you instead asked them if they were willing to
eat GM food, I bet most would say no.
The biotech industry needs to understand that good science
is not always understood, and that the public doesn’t
read peer-reviewed journals to critically evaluate scientific
methods. Scientists use a language that members of the
public don’t understand, in order to describe results the
public doesn’t understand, and they then get upset when
fake science is spread via tweets or reposted for thousands
of connected users to see and share.
In Australia alone, there are apparently 15 million unique
users on Facebook each week. Clearly, Facebook is not a
scientific peer-reviewed journal, but it should be looked
upon as a ‘peer review app’. The agricultural biotech (plant)
industry needs to bring itself up to speed with public
sentiment and begin to look at strategies to change or align
it with the animal biotech industry, in order to capitalise on
the decades of science behind GM.
I suspect that the resistance to genetically modified
organisms (GMOs) has come about because while the
science seems easy to understand for scientists, the non-
scientific community has made up its own versions of the
science, in part because they don’t understand scientific
jargon, or just don’t trust the multinational companies that
have put hundreds of millions of dollars into the research
and development (R&D) of GM.
As a result, the ‘science’ has become an easy target
for ‘keyboard warriors’ to disparage. This has created
an overwhelmingly strong consumer sentiment—and,
increasingly, farmer sentiment—that GM food is bad,
when, in fact, it can help the industry, and thus the world’s
population, to be safer and healthier.
Australia needs a strategic panel to investigate how to
engage the community, take real action and get the
truth out there using simple concepts and a significant
educational campaign that doesn’t preach, but rather
shares—through tweets, posts, videos and snaps.
Rob Neely founded Integrated Animal Health (IAH) in Australia
three years ago after amalgamating a group of animal health
biotech licences that he owned. Having grown up on a dairy and
become an entrepreneur at a young age, Neely charted a path
in animal health when he established a boutique, yet nationally
distributed, horse feed brand in Australia in 2001. Unknown at
the time, the brand became a disruptor in a rather staid industry,
and he still owns the horse feed company today.
Rob Neely will be speaking at the Ag & Foodtech Symposium
2016, to be held in Brisbane from 2–3 August.
Brisbane
2 – 3 August 2016
Stamford Plaza, Brisbane
www.agfoodtech.com.au
Host Industry Body
52
Major Partners
Agbiotech
20 YEARS GROWING GM CROPS
Regulation, not science, has curtailed the benefits
of our experience.
BY MATTHEW COSSEY, CHIEF EXECUTIVE OFFICER, CROPLIFE AUSTRALIA
Matthew Cossey
In 2009, the European Joint Research Centre (JRC) surveyed the public and private sector plant
biotechnology product pipelines. This resulted in a report that predicted new traits that would come to
market by 2015, including additional ‘first generation traits’ that protect plants from pests and diseases,
but also ‘second generation traits’ that result in consumer benefits from increased nutritional value in crops.
53
Agbiotech
While the JRC predicted 91 new GM events on the markets
by 2015, we only saw 16.
This begs the question: where did we fail? Was it a science
issue? Were researchers not able to develop and deliver
on the new traits and crops? Interestingly, of the 91 new
events predicted, nearly two-thirds of them were already in
the advanced development stage in 2008, so it was not the
science holding us back.
2008 Status of GM events and predictions for 2015 from the Institute for
Prospective Technology Studies, Joint Research Commission, European
Commission http://ipts.jrc.ec.europa.eu/publications/pub.cfm?id=2420
The unfortunate reality is that access to biotechnology
innovation, and the significant benefits that it could have
delivered, fell well short of the JRC predictions, and
completely unnecessary costly government regulation is
the prime cause of this failure. The JRC had predicted that
91 new events would be commercialised by 2015, and by
2014 there were only 16 new events: a mere 17 per cent
of what was predicted. In spite of the significant annual
growth in genetically modified (GM) crop adoption (currently
approximately 18 million farmers in 28 countries), we have
still not seen the predicted introduction of new crops; 80
per cent of the major GM events are still in four major field
crops: soy, corn/maize, cotton and canola.
We have also not seen the predicted introduction of new
traits, including new combinations of stacked traits—85 per
cent of traits on the markets are still herbicide tolerant or
insect resistant.
What is more, the growth we had expected to see in public
sector–developed products has hardly materialised. Seventyfive per cent of commercialised products are still coming
from the leading private sector technology developers.
In a 2012 Phillips McDougall survey of the major private
sector technology developers, it was found that, on average,
it costs US$136 million over 13.1 years to develop a biotech
crop and take it to market. The majority of this cost and time
was concentrated in the regulatory science and registration
part of the product time line.
The reality is that it is not an issue of technology developers
being unable to deliver on innovation, but is rather that the
regulatory system is failing to deliver the innovation to farmers.
In this time line to commercialisation, we have seen that
the most time-consuming and resource-intensive part of
getting a new GM trait to market is actually outside of the
technology developer’s control. Technology developers
have improved the science of plant biotechnology so that
they can efficiently create new traits and events; it is the
regulatory science and registration aspects of the product
time line that are holding up new innovations getting
into the hands of farmers. The cost and time involved in
regulatory science and registration has increased by 50 per
cent over the last decade.
What is truly shocking is that for those countries that import
crops for use as food or animal feed, which should require
a much less substantial regulatory dossier, the time lines for
approval are increasing! For cultivating countries that benefit
the most from the technology, approval time lines have
remained flat or have slightly improved.
All in all, it is the regulatory system, not the science, that is
failing to deliver innovations in plant biotechnology to farmers.
Table 1: Number of Commercial GM events: 2008 and 2014. Note: Commercial means approved and marketed in at least one country.
54
Agbiotech
Table 2: Events in Commercial GM crops by trait: 2008 and 2014. Commercial means approved and marketed in at least one country.
Are the days of science-based regulatory systems over?
Trait
In many countries around the world, regulatory decisions are
increasingly influenced by protectionism, trade manipulation,
and ideology such as the anti-science and anti-multinational
company movements perpetuated by ideologues and activists.
Increase in
farm income
2015
Increse in farm
income 19962015
GM herbicide-tolerant
cotton
10.2 (13.6)
101.6 (136.2)
GM herbicide-tolerant
canola
16.6 (22.2)
73.8 (98.9)
GM insect-resistant
cotton
47.9 (64.1)
849.6 (1138.5)
Totals
74.7 (99.9)
1025.0 (1373.6)
In some countries (albeit not in Australia), regulators
consider more than just the safety of products, taking into
account socio-economic impacts, equality of technology
impacts, and ethical and spiritual values—and these nonscience considerations are preventing innovation from
getting into the hands of farmers, and helping to make an
impact on food security.
Globally, regulatory systems are failing to deliver such
innovation to farmers. For example:
•
authorisation time lines for cultivation and import are
increasing
•
the backlog of pending submissions is increasing
•
regulatory decisions will become more complicated as
new plant breeding innovations are introduced.
Australia has been lucky enough to have access to GM crop
innovations for 20 years. During this time, the technology
has provided significant economic and environmental
benefits to Australian farmers, and the public at large.
Australia’s cotton and canola growers have gained $1.37
billion worth of extra income, and have produced an
additional 226,000 tonnes of canola that would not have
been produced if conventional technology had been used.
Table 3: Farm income benefits from growing GM crops in Australia 1996–
2015: million US $ (Aus $ million in brackets)
Note: All values are nominal. Farm income calculations are net farm income
changes after inclusion of impacts on yield, crop quality and key variable
costs of production (for example, payment of seed premia, impact on crop
protection and weed control expenditure).
There are three actions that need to be taken to fully realise
the potential of the plant biotechnology pipeline, and to
ensure that the regulatory delays we have experienced over
the last two decades do not hold back the next 20 years of
adoption of the technology:
•
There is the need to engage with policymakers to
reduce the boundaries to entry through regulatory
reform (currently all but multinational companies are
largely excluded from the regulatory system).
•
The technology has allowed Australia’s farmers to reduce
their use of insecticides and herbicides by 22 million
kilograms of active ingredient, equal to a 26 per cent
improvement in the environmental impact associated with
pesticide use on these two crops (cotton and canola).
There is the need to educate stakeholders about the
true barriers to new innovation.
•
There is the need to look for opportunities for public–
private partnerships to deliver advances in agricultural
biotechnology to wider groups of farmers.
The reduced use of pesticides has also resulted in a saving of
nearly 27 million litres of fuel use, with 71.5 million kilograms
less carbon dioxide being released into the atmosphere.
The future of agricultural biotechnology is bright, but only
if the science is allowed to prevail, and public policy and
regulation is based on facts, not activist falsehoods.
55
Agbiotech
BIOTECHNOLOGY AND BEEF
TENDERNESS: 1995 TO TODAY
In the mid 1990s, Dr Gregory Harper was
investigating the factors that affect the
tenderness of Australian beef, and the way in
which biotechnology might be applied in order
to produce meat to market specifications. Dr
Harper—then at CSIRO Division of Tropical
Animal Production at the Tropical Beef Centre in
Rockhampton, Queensland—outlined his research
in an article published in 1995 in Australasian
Biotechnology (Volume 5, Number 3).
Now executive director of the Victorian Government’s
Agriculture Research and Development, Dr Harper revisits
his research in an interview with Australasian Biotechnology
to discuss the influence that biotechnology has had on meat
tenderness over the last 20 years, and how it compares with
his expectations in the 1990s.
How has biotechnology affected consistency in beef tenderness
in Australia over the last 20 years?
Biotechnology has had less impact on beef tenderness over
the last 20 years than I had originally thought it would. It has
had some impact…but I think I was more optimistic than I
really should have been. Of course, biotechnology has had
a significant impact on animal health through vaccines and
drugs, and biotechnology has helped to reduce the off-site
impacts of cattle feedlots and piggeries, but tenderness?
Not so much.
When considering the technological factors that affect meat
tenderness (rate of chilling, anatomical features, processing
techniques, et cetera), what has changed since the mid 1990s?
When you think about where we were back in 1995 when
I wrote that review, we had a rudimentary understanding
of where meat tenderness as a trait was going to go.
Ultimately, variation in meat tenderness has been minimised
56
through a mixture of sciencebased interventions in
processing, as well as a
process management
system approach [Meat
Standards Australia
(MSA): a beef, lamb
and sheepmeat quality
program]. We have,
however, had some
outstanding advances
in genetic improvement.
Who would have thought,
when I wrote the article in
Dr Gregory Harper
1995, that we’d only just begun
to see the revolutions in animal genetics that were coming
downstream from the human genetics revolution? We’d only
just started to understand that we could identify the genes
and gene regulatory networks that underpin such complex
characteristics as tenderness.
How have research efforts progressed since 1995 in the quest
to define biochemical markers for tough meat?
What I imagined in 1995 was the opportunity to use
biochemical and gene markers to identify potentially tough
meat in the living animal. To some extent, through the
understanding of the functions of calpain and calpastatin,
the lysosomal enzymes, and also connective tissue, we were
developing a mechanistic model for post-rigor tenderisation.
We also developed an understanding of how glycogen
depletes and changes the colour of muscle and meat. All
of these things helped us to identify the components of
tough meat, and what contributed to its variation across
the population of animals and carcasses. But, ultimately,
biotechnology wasn’t needed to get there. As I said,
biotechnology ended up contributing more to animal
genetics per se, and that contributed to the toughness/
tenderness problem and solution.
Agbiotech
genes to a point of whole-genome sequencing as it occurs
In the four phases of the beef production process that you
now, in the context of the Angus breed, in particular.
outlined in 1995 (breed, nutrition and management; slaughter
Industry is doing its best to move past pedigrees and
and deboning; post-slaughter processing; and valuation and
progeny tests, to whole-genome scans and phenotype
predictions. Innovations in the sequencing of genomes
marketing), you identified aspects of each phase that would
and the assessment of variation, made initially for human
benefit from biotechnological improvements. Can you outline
application, have revolutionised animal breeding systems.
what these were and whether any of these improvements have Still, there is more to come.
Have the genes or gene products that determine the rate or
now been made?
The area in which the most advances have been seen is in
form of muscle development been identified since the ‘90s?
the breeding, and that has been through the development
of gene tools, such as gene markers initially, and ultimately
through the development of things like whole-genome
selection. It’s systems like this, where the technologies that
have underpinned high-throughput gene sequencing and
high-throughput genomic analysis, that have enabled us to
accelerate genetic selections in all species: most specifically,
the bovine species.
The trait that has been most affected by genetic selection
technologies is the marbling trait within red meat, which
is the accumulation of fat within the grain of meat. While
back in the early 1990s we thought that this trait was really
controlled by nutrition alone, we worked out that it is largely
driven by genetics, and we quickly moved past candidate
By the time we were in the 2000s, we were identifying
gene markers and single genes that we thought accounted
for variation with complex traits, and those were being
commercialised in the marketplace. Whole-genome
sequencing and analytical technologies quickly made gene
marker tests obsolete and the patents of limited value.
How has selective breeding for beef tenderness progressed?
Selective breeding for beef tenderness has been much less
an issue than I had imagined it would be in 1995. This has
really been the result of a whole-of-supply-chain analysis
reflecting that animal breed, plus pre-slaughter stress,
plus aspects of how the animal is grown, plus the way it is
processed as meat, all packaged up within a standardisation
57
Agbiotech
system, such as MSA, has delivered the goods. The proof of it
all has recently been summarised in an audit of red meat quality
right across Australia. We have come a long way, indeed.
How has mechanisation and automation affected meat
tenderness over the last 20 years?
There is no question that automation has also contributed
to the delivery of better-quality red meat, as more accurate
cutting lines facilitate great control around chilling and
ageing, for example.
Have biosensor technologies played a role?
Biosensors have not really taken us far in this area. They
were an attractive concept, but have played no role. Back
in 1995, I imagined greater cost reductions in biochemical
testings: I didn’t imagine that gene sequencing costs would
shrink so radically.
Are blood-based gene tests for tenderness now in use?
Likewise, blood-based gene tests for tenderness were
commercialised for a number of years in the early 2000s
by organisations such as Genetic Solutions and Pfizer, but
ultimately, that technology was rendered obsolete by the
whole-genome sequencing and the multi-gene marker
technologies, such as gene panels.
Has research into muscular dystrophy using the MDX mouse
shed any light on genetic/biological markers for meat
tenderness?
It has been valuable to look at aspects of genetic
polymorphism, such as what you see in muscular dystrophy
of the MDX mouse. In the early 2000s, a lot of work was done
around the callipyge breed of sheep and the Belgian blue
breed of cow as opportunities to increase the efficiency of
growth by genetic or exogenous means. The impact of these
discoveries in the Australian market or global context has
been minor. Likewise, these gene and regulatory networks
could have been the target of gene editing, but we are yet to
see such applications. Perhaps callipyge-derived muscle cells
are the best ones to use for in-vitro meat production.
In pursuit of meat tenderness, has the addition of enzymes to
meat been successfully implemented?
In pursuit of tenderness, again I think that understanding
the enzymes that were involved in the meat tenderisation
after slaughter generated some value in terms of our stock
of knowledge, but larger strides were made from good oldfashioned control and optimisation of individual steps in the
growth, development, slaughter, and post-slaughter arena.
What role has biotechnology played in regards to the
classification of meat at the marketing stage of meat
production?
Biotechnology has played no role in the classification
of meat at the marketing stage. It has, to some extent,
underpinned the perceived value of Angus, and when we
look around the marketplace for meat at the moment, we
58
know about the brands like Angus. Generic animal breed
names like Wagyu have had incredible impact in the fastfood market and also the gourmet meat market. All of that
has been underpinned by technologies around selection and
identification, which we could regard as biotechnologies,
but reduced to the simplest of practices in selection and
optimisation of meat quality.
Has community acceptance of such technologies improved
since the ‘90s?
I think that consumer acceptance has taken quite a dive,
even though we have some marvellous technologies
available to us, such as trans-genetic or gene edited–type
technologies for achievement of disease resistance in
animals, or even feed efficiency–type traits. I think that
consumer acceptance of animals that are in any way
modified remains low. So, I think the biggest impact of the
biotechnologies is going to be in the breeding and selection
of animals.
How has labelling legislation responded to meat science
developments over the last 20 years?
The MSA system has given us spectacularly improved quality,
and I think ‘trace back’—the capacity for individuals and
brands to trace problems in the meat supplier all the way from
an Asian consumer back to a farm, or an individual feedlot—
has certainly developed over the last 20 years, as have other
aspects of animal production, such as animal welfare, and the
verification of breed type or country of origin.
As a result, these now underpin truly enormous diversification
of animal production in Australia and have also underpinned
the Australian red meat breeding market specifications
around the world. The markets have grown enormously in this
time, in both sophistication and in volume.
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IP Law
GENE GENIE
The judicial revolution in biotech IP
BY PROF MATTHEW RIMMER, INTELLECTUAL PROPERTY AND INNOVATION LAW, FACULTY OF LAW,
QUEENSLAND UNIVERSITY OF TECHNOLOGY (QUT)
Over the past few years, there have been some
dramatic developments in intellectual property (IP) and
biotechnology. In landmark rulings in gene patents in
superior courts in the United States and Australia, as well
as a significant settlement in Canada, the judiciary has
sought to draw tighter boundaries around what can be
protected as an invention under patent law. The superior
courts have been keen to emphasise that mere products
of nature, abstract ideas, and intellectual information
cannot be protected under patent law. This has caused
some consternation among the commercial providers of
medical diagnostics, the pharmaceutical industry and the
biotechnology sector. The judicial revolution in IP and
biotechnology will have an impact in agriculture, medicine,
health care and clean technologies.
United States
In 2013, the Supreme Court of the United States rejected
Myriad Genetics’ patent claims to isolate genes related to
breast and ovarian cancer on the grounds that they were
products of nature. This ruling sought to demarcate the
scope of patentable subject matter in new technologies.
The precedent has been applied in a number of cases by
lower courts. In 2016, the United States Court of Appeals
for the Federal Circuit ruled against Australian company
Genetic Technologies, finding that its patent for methods
of detecting genetic variations was invalid. This ruling is
significant given that Genetic Technologies has been Myriad
Genetics’ exclusive licensee of genetic testing in Australia
and New Zealand, and has faced controversy over patent
claims in non-coding and genomic mapping.
Australia
In October 2015, the High Court of Australia handed down
a landmark decision, ruling unanimously in favour of Yvonne
D’Arcy in her challenge against Myriad Genetics’ patents on
genetic testing for breast and ovarian cancer.
Reading the Myriad Genetics’ patent claims, Chief Justice
French, and Justices Kiefel, Bell and Keane, were concerned
about the chilling effect of broad, over-reaching claims:
‘Claims 1 to 3 include the products of applying any process,
known or unknown, to the cells of a human being, which
extracts or replicates from them nucleotides, which code for
mutant or polymorphic BRCA1 in the sequences specified
in the patent, whether or not the isolate contains other
components and sequences.’
Chief Justice French and his colleagues concluded that its
60
patentability would not serve the
purposes of the concept of
‘manner of manufacture in
s 18(1)(a) of the Act or of
the Act itself’. IP Australia
has sought to develop
new patent examination
guidelines in the wake of
this decision.
Canada
In Canada, the Children’s
Hospital of Eastern Ontario
(CHEO) launched a legal
Prof Matthew Rimmer
challenge against gene patents
in order to protect patient care. It stated, ‘Our clinicians
and scientists believe that no-one should be able to patent
human DNA…. [because] it would be like patenting water or
air’. CHEO hoped that Canada would follow Australia’s lead
after the ruling of the High Court of Australia: ‘The ruling
sets a significant international trend and CHEO is optimistic
about its own legal challenge to gene patents in Canada,
which was launched in November 2014.’
In the end, CHEO and patent holders reached settlement;
Transgenomic agreed to provide CHEO and other Canadian
public-sector laboratories and hospitals with the right to
test Canadians for the long QT syndrome on a not-for-profit
basis. Debate continues about whether this settlement is a
positive solution to the conflict over gene patents.
Conclusion
Superior courts in the United States, Australia, and Canada are
now taking a stricter approach to IP and biotechnology, and
the judiciary seeks to delineate unpatentable biotechnology
subject matter. While the Supreme Court of the United States
has explored the notion of ‘products of nature’, the High
Court of Australia has emphasised that purely intellectual
information is not patentable. IP disputes will have significant
impact on patient care, research freedom, access to health
care, innovation and commercialisation. There are also major
implications for the biotechnology industry in medicine,
diagnostics, agriculture and the environment. Rather than
focusing on gene patents, the industry will have to instead
focus upon downstream inventions.
Professor Matthew Rimmer is a leader of the QUT Intellectual
Property and Innovation Law research program, and a member
of the QUT Digital Media Research Centre, the QUT Australian
Centre for Health Law Research, and the QUT International Law
and Global Governance Research Program.
Nurture
your
innovation
Your IP is the core of your business. We want to help you grow and flourish…
Some of Australia’s most successful companies in the life sciences sector have relied on DibbsBarker
to help them grow from start-ups to global success stories.
Whether you need help with R&D contracting, commercialisation and licensing transactions, clinical
trials and regulatory, branding and trade marks, or patent strategy and defence, local or global, we
understand the journey you’re on. We’ll collaborate with you to deliver advice and support that fits
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Contact us to learn more.
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T +61 7 3100 5137
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www.dibbsbarker.com
SPONSORED CONTENT
Image: University of Michigan School of Natural Resources & Environment CC-BY 2.0: flickr.com/photos/snre/6946913891/
THE MEANING OF
MYRIAD
BY MARK ROBERTS, PARTNER, DAVIES COLLISON CAVE
Before you can qualify for patent protection in
Australia, and before you need to worry about
the normal requirements of novelty and inventive
step, you must have an invention that falls within
the categories of technology that are generally
considered patentable—that is, there needs to
be patentable subject matter. The requirement
for patentable subject matter is governed by
subsection 18(1)(a) of the Patents Act 1990,
which specifies that in order to qualify for patent
protection in Australia, an invention must be
a ‘manner of manufacture’ within the meaning
of Section 6 of the Statute of Monopolies. The
Statute of Monopolies is a United Kingdom act
from 1624. While it may seem rather strange for
the current Australian patent legislation to refer
to a requirement under a British act from the early
17th century, this has, in fact, served Australia well
because the patentable subject matter test has
been flexible enough to adapt to the previously
unimaginable advances in technology of the 20th
and 21st centuries.
62
A
The landmark High Court
of Australia decision of
1959 in National Research
Development Corporation
v Commissioner of Patents
([1959] 102 CLR 252) (NRDC),
which related to a method of
removing weeds from a crop
using a selective herbicide,
gave rise to a simple test to
determine when a manner
of manufacture exists. In the
Mark Roberts
NRDC case, the High Court
determined that in order to meet the manner of manufacture
requirement, an invention must relate to an artificially created
state of affairs that is of economic significance. Under this
test, Australia has been able to reward and incentivise
innovation in a range of new areas, including internet-related
technologies and biotechnology.
In October 2015, however, the High Court issued a decision in
D’Arcy v Myriad Genetics Inc. ([2015] HCA 35) (Myriad). In this
dispute, breast cancer survivor Yvonne D’Arcy sought revocation
of the Myriad patent claims directed to isolated nucleic
acids encoding mutant or polymorphic forms of the BRCA1
polypeptide that are markers for breast cancer. The revocation
action was run solely on the ground that those patent claims
SPONSORED CONTENT
did not constitute a manner of manufacture and were therefore
not eligible for patent protection. Ironically, other claims in the
patent directed to methods of diagnosis and diagnostic kits were
not challenged, with the result that whatever the outcome of the
case, the commercial activities of Myriad and its licensee GTG
would not be affected by the decision.
In a surprising and complex decision, the court found that
although the claimed isolated nucleic acids are chemically
distinct from nucleic acids that exist in nature, when properly
construed, the claims in dispute related merely to information.
The court went on to reason that as this information exists in
nature, it was not made and therefore could not be considered
a manner of manufacture. The court outlined a challenging
six-step test for determining manner of manufacture in relation
to new technology areas along the following lines (which
unfortunately will be difficult for lower courts, practitioners and
the industry to understand and apply).
Would the decision to uphold the patent to the invention as
claimed:
•
give rise to a large new field of monopoly protection
with potentially negative effects on innovation?
•
have a chilling effect on activities beyond those formally
the subject of the exclusive rights granted to the patentee?
•
involve assessing important and conflicting public and
private interests?
•
enhance or detract from the coherence of the law
relating to inherent patentability?
•
be consistent or inconsistent with (1) Australia’s
obligations under international law and (2) patent laws
of other countries?
•
best be left for the legislature?
If any of these questions are answered in the affirmative, then the
claims in question do not constitute a manner of manufacture.
Following the High Court decision in Myriad, IP Australia
has altered its examination guidelines and has indicated that
claims directed to the following subject matter will no longer
be accepted:
Isolated, naturally occurring nucleic acid molecules, whether:
•
DNA or RNA
•
human or non-human
•
coding or non-coding.
Claims to the following are excluded from patentability
where they merely replicate the genetic information of a
naturally occurring organism: •
complementary DNA and synthetic nucleic acids
•
probes and primers
Image: wheatfields CC-BY 2.0: flickr.com/photos/wheatfields/2074121298/
•
isolated interfering/inhibitory nucleic acids.
Claims directed to the following subject matter are
still considered by IP Australia to meet the manner of
manufacture requirement:
•
naturally occurring isolated bacteria
•
naturally occurring isolated virus
•
isolated polypeptides
•
synthesised or modified polypeptides
•
isolated polyclonal antibodies
•
monoclonal antibodies
•
isolated cells
•
isolated stem cells
•
chemical molecules purified from natural sources
•
transgene comprising naturally occurring gene
sequences
•
vectors, microorganisms, animals and plants comprising
a transgene.
It is going to be very interesting to see how lower court
judges interpret the Myriad decision. In the meantime,
while the IP Australia guidelines are a relatively sensible
interpretation of a very complex decision, it will take some
time before the full implications of the Myriad decision
are realised.
63
B
AusBioSTOCK
INDEX
BY JOANNA HILL, FINANCIAL ADVISER,
BAILLIEU HOLST
Issuer Name
ASX
Principal Activity
First List Date
M Cap $m
Last Price $
Yr H $
Yr L $
EPS c
PER
Asset B (c)
AtCor Medical
Holdings Limited
ACG
Developer & international marketer
of blood pressure at the Heart device
SphygmoCor
9-Nov-05
26.2
0.12
0.35
0.11
-2
-6
3
Alchemia Limited
ACL
Drug discovery & development
Fondaparinux, antithrombotic; oncology
compounds FAK pathway
23-Dec-03
2.6
0.01
0.02
0.00
7
0
10
9.3
Acrux Limited
ACR
Transdermal drug delivery platform
technology
29-Sep-04
117.4
0.71
1.02
0.57
8
8
13
6
Actinogen Ltd
ACW
Developer of lead candidate Xanamem
for treatment of neurodegenerative
disorders, incl. Alzheimer’s
16-Oct-07
43.1
0.07
0.10
0.04
-1
-6
2
Anteo Diagnostics
Limited
ADO
Multi-component coatings for solid
phase of immunoassays for biomarker
development
7-Apr-00
42.0
0.04
0.12
0.04
-1
-7
0
Adherium Ltd
ADR
Digital technologies for monitoring
medication use in chronic respiratory
conditions
26-Aug-15
56.7
0.49
0.72
0.43
-4
0
22
Agenix Limited
AGX
ThromboView clot imaging diagnostics
2-Sep-92
1.4
0.01
0.03
0.01
-1
-2
0
Admedus Ltd
AHZ
Tissue engineering regenerative
medicine & vaccine development for
herpes & HPV
24-Mar-04
55.9
0.30
0.98
0.28
-16
-2
12
Analytica Limited
ALT
eHealth devices. PericCoach system for
stress urinary incontinence
25-Oct-00
13.0
0.01
0.02
0.00
-0
-1
0
Allegra Orthopaedics
Ltd
AMT
Prosthetic implants tools
5-Dec-07
9.6
0.15
0.05
0.02
-3
-6
4
Antisense
Therapeitics ltd
ANP
Antisense Pharmaceuticals. (Psoriasis,
MS)
20-Dec-01
5.5
0.03
0.04
0.01
1
2
3
Antara Lifesiences Ltd
ANR
Natural, plant-based therapeutics for
gastrointestinal diseases
16-Oct-14
49.5
1.25
1.80
0.70
-5
-23
26
Avita Medical Ltd
AVH
Tissue-culture, regenerative products
treatment of wounds, scars & skin
defects
11-Aug-93
48.5
0.09
0.15
0.06
-2
-5
2
Avexa Limited
AVX
R & D drugs for treatment of infectious
diseases. HIVintergrase program &
antibiotic-resistant bacterial infections
29-Sep-04
2.6
0.02
2.63
0.75
-24
8
1
AirXpanders Ltd
AXP
Aeroform tissue expander for breast
reconstruction
29-Sep-04
223.4
0.90
2.63
0.75
-7
8
11
Biotron Limited
BIT
Antiviral drug developer, HIV & HCV
24-Jan-01
17.9
0.05
0.14
0.04
-1
-5
1
Benitec Limited
BLT
Gene silencing technology
17-Feb-97
13.5
0.09
1.00
0.09
-17
-1
19
Bone Medical Limited
BNE
Development & commercialisation of
therapeutics for bone & joint disease
24-Jan-85
2.1
0.03
0.05
0.02
0
0
0
Bionomics Limited
BNO
Small molecule product developer in
areas of cancer, anxiety, epilepsy &
multiple sclerosis
21-Dec-99
144.3
0.30
0.59
0.27
-4
-8
0
Brain Resource
Limited
BRC
Provider International Database for
Human Brain Function
28-Aug-01
20.2
0.14
0.28
0.10
-2
-5
-4
Bioxyne Ltd
BXN
Developer of treatments for respiratory
diseases
14-Dec-00
5.5
0.03
0.03
0.01
0
14
0
Cellmid Limited
CDY
Midkine–novel cancer therapeutic and
diagnostic target and anti-midkine
antibodies with hybridoma cell lines
and nucleotides
9-Dec-05
27.9
0.03
0.04
0.02
-0
-6
0
Cogstate Ltd
CGS
Diagnostic & therapeutic products
for neurodegenerative diseases (also
Alzheimer’s & Parkinson’s)
13-Feb-04
89.5
0.78
0.85
0.19
0
Clover Corporation
Limited
CLV
Refines & supplies natural oils
30-Nov-99
65.2
0.40
0.60
0.16
0
64
Div (c)
0
0
0
9
0
17
0.75
AusBioSTOCK
Issuer name
ASX
Principal activity
First list date
Cochlear Ltd
COH
Manufacturer & marketer implants for
impaired hearing
4-Dec-95
M cap $m
6,861.7
Last price $
Yr H $
Yr L $
EPS c
PER
Asset B (c)
Div (c)
120.25
124.95
76.73
296
41
316
210
CSL Limited
CSL
Supply blood products & vaccines
8-Jun-94
48,836.9
108.82
117.61
85.40
415
26
571
171.464
Cryosite Limited
CTE
Collection, processing & long-term
storage blood stem cells
9-May-02
8.7
0.19
0.33
0.18
1
29
7
1
Clinuvel
Pharmaceuticals
Limited
CUV
Developer of treatment for UV-related
skin disorders. Lead drug CUV1647 in
Phase III clinical trial for the treatment
of polymorphous light eruption (PLE)
13-Feb-01
202.0
4.29
5.00
2.50
-24
-18
25
Cyclopharm Limited
CYC
Manufacturer & distributor of
radiopharmaceuticals, molecular
imaging. Lead product Technegas (lung
ventilation imaging drug)
18-Jan-07
49.5
0.90
0.89
0.40
9
10
20
Cynata Therapeutics
CYP
Large-scale production of mesenchymal
stem cells
20-Dec-07
20.7
0.28
0.95
0.23
-7
-4
9
Dorsavi Ltd
DVL
Motion analysis device technologies for
clinical, elite sports & OHS
11-Dec-13
40.5
0.27
0.42
0.25
-11
0
0
Dimerix Ltd
DXB
Oraline device for occupational &
law enforcement multi-drug testing &
Dimeris Ph2 chronic kidney disease &
diabetic retinopathy
4-Feb-93
11.8
0.01
0.01
0.00
-0
-4
0
1
Ebos Group Ltd
EBO
Distributor healthcare products
6-Dec-13
2,289.4
15.13
15.70
8.95
68
0
26
40.986
Ellex Medical Lasers
Ltd
ELX
Production of ophthalmic instruments
for treatment of impaired vision
12-Sep-94
110.7
0.95
1.06
0.29
2
0
19
0
Factor Therapeutics
Ltd
FTT
Developer biomedical technology,
wound healing, tissue regeneration,
cell culture; VitoGro platform tech.
enhancing cell growth & migration
19-Mar-04
26.1
0.04
0.08
0.03
-5
-1
1
Genera Biosystems
Limited
GBI
Advanced molecular diagnostic tests
11-Jun-08
19.1
0.18
0.34
0.17
-3
-7
-2
Gi Dynamics, Inc
GID
EndoBarrier, endoscopically delivered
treatment for obese type 2 diabetes
7-Sep-11
11.3
0.03
0.17
0.02
-508
0
0
Genetic Technologies
Limited
GTG
Genomics. Genetic Technology - NonCoding DNA
30-Jul-87
30.9
0.02
0.04
0.02
-0
-5
1
IDT Australia Ltd
IDT
Manufacturer of pharmaceuticals &
clinical trial management services
24-Sep-93
53.7
0.25
0.42
0.22
-1
-35
0
Innate
Imunotherapeutics
Ltd
ILL
Immunomodulator Microparticle
technology
23-Dec-13
56.0
0.29
0.34
0.11
-3
-11
2
Immuron Ltd
IMC
Oral immunotherapy treatments
30-Apr-99
20.4
0.26
0.57
0.22
-5
-5
3
Imugene
IMU
Immuno-oncology biopharma, gastric &
breast cancer immunotherapies
2-Dec-93
13.9
0.01
0.01
0.01
-0
-4
0
Impedimed Limited
IPD
Diagnostic devices: lymph oedema;
muscle wasting; metabolic disorders
24-Oct-07
347.4
0.92
1.25
0.77
-7
-14
8
ITL Limited
ITD
Innovative medical devices blood
collection and related markets
29-Oct-03
14.2
0.19
0.28
0.15
2
0
10
Invion Ltd
IVX
Clinical-stage developer for
inflammatory respiratory diseases &
high blood pressure
15-Feb-10
6.2
0.00
0.03
0.00
-1
0
0
LBT Innovations
Limited
LBT
Automated preparation & streaking of
microbiological specimens. MicroStreak
— automated routine agar plate
processing
31-Jul-06
19.5
0.17
0.20
0.06
3
5
7
Living Cell
Technologies Limited
LCT
Developer of live cell products
for treatment of neurological and
metabolic disorders
1-Sep-04
37.2
0.07
0.09
0.03
-2
-5
1
Lifehealthcare Group
LHC
Critical care medical devices &
implantable devices
5-Dec-13
70.0
1.65
3.60
1.26
6
26
31
MedTech Global Ltd
MDG
Healthcare software solutions,
clinical management, EMR capability,
consultancy services
13-Aug-87
8.0
0.08
0.15
0.07
-2
-3
-1
MediBio
MEB
Diagnostic tests for depression & other
mental health disorders
29-Jan-01
32.5
0.29
0.49
0.19
-12
-2
0
0
0.25
12.5
65
AusBioSTOCK
Issuer name
ASX
Principal activity
First list date
Last price $
Yr H $
Yr L $
EPS c
PER
Asset B (c)
Medigard Limited
MGZ
Medical safety devices. Lead products:
retractable hypodermic syringes; blood
collection device; IV cannula/catheter
introducer device
5-Feb-04
M cap $m
3.5
0.04
0.08
0.01
0
-17
-1
Medical Australia
Limited
MLA
Distributor of medical devices, IV
system, blood banking lab collection of
human & animal biologics
20-Dec-04
5.5
0.04
0.08
0.04
-4
-1
2
Mach7 Tech Ltd
M7T
Imaging IT solutions: 3D printing &
holographic projection provider
30-Nov-05
18.5
0.04
0.13
0.04
-4
-1
1
Mesoblast Limited
MSB
Commercialisation of adult stem cell
technology with specific application in
the regeneration of bone & cartilage
16-Dec-04
402.3
1.04
4.06
1.02
-35
-3
-3
0
Monash IVF Group
MVF
Reproductive, obstetric, gynaecological
services; diagnostic & genetic testing
26-Jun-14
427.2
1.84
1.93
1.05
10
18
-43
7.7
Medical
Developments
International Limited
MVP
Medical & veterinary equipment. Lead
Analgesic Agents (pre-hospital &
emergency). Penthrox Inhaler.
15-Dec-03
347.8
6.20
6.85
2.10
2
363
0
2
Mayne Pharma Ltd
MYX
Branded & generic pharma products,
oral drug delivery systems, complex
oral dose forms
29-Jun-07
1,223.2
1.49
1.68
0.93
3
50
4
Nanosonics Limited
NAN
Disinfection & sterilisation technology,
decontamination products to prevent
spread of infections
17-May-07
642.2
2.21
2.59
1.16
-4
-60
15
Neuren
Pharmaceuticals
Limited
NEU
Biopharmaceutical therapies for
brain injury, neurodegenerative &
neurodevelopmental disorders
3-Feb-05
96.2
0.06
0.13
0.05
-1
0
1
Novogen Limited
NRT
Patents around ATM technology in
cancer therapeutics
1-Sep-94
42.1
0.10
0.30
0.10
-3
0
9
NuSep Ltd
NSP
Cell & protein separation systems
14-May-07
3.4
0.01
0.04
0.01
-1
0
-1
OBJ Limited
OBJ
Magnetic micro array drug delivery
technologies
29-May-00
141.6
0.08
0.11
0.05
-0
-46
1
Orthocell Ltd
OCC
Regenerative cellular soft tissue
therapies for restoration of tendon,
cartilage injuries
12-Aug-14
18.0
0.29
0.99
0.28
-4
-7
0
Div (c)
0
0
Opthea Ltd
OPT
Biologics drugs for opthalmic diseases
18-Apr-91
68.3
0.19
0.28
0.07
-1
-30
13
Oncosil Medical Ltd
OSL
Medical Radiation treatments, OncoSil
silicon & phosphorus beta emitter to be
used as brachytherapy
15-Aug-05
54.5
0.12
0.28
0.08
-1
-19
2
Osprey Med Inc
OSP
AVERT™ Plus System, to reduce
dye (contrast) usage in coronary &
peripheral angiographic procedures,
preventing induced nephropathy (CIN).
Limb Recovery™ System, percutaneous
technology to deliver targeted doses of
antibiotics to the lower limb in patients
with diabetes
2-May-12
31.6
0.21
0.85
0.19
-11
-2
10
Pharmaaust Ltd
PAA
Drug developer of synthetic
compounds for treatment of human and
canine cancers
2-Oct-01
7.5
0.08
0.20
0.07
-2
-4
3
Patrys Limited
PAB
Developer of natural human antibody
based therapies, including cancer
13-Jul-07
3.7
0.01
0.01
0.01
-1
Probiotec Limited
PBP
Distributor of prescription & OTC
pharmaceuticals
14-Nov-06
27.5
0.52
0.57
0.19
9
6
44
Prana Biotechnology
Limited
PBT
Commercialising research into agerelated neuro-degenerative diseases
inc. Alzheimer’s, Crutzfeldt-Jacobs,
MND, Parkinson’s. Lead compound
PBT in Ph2 clinical trials
28-Mar-00
52.3
0.11
0.18
0.06
-1
-7
7
PolyNovo Ltd
PNV
PolyNovo Biomaterials tissue
engineering & Metabolic pharma
26-Nov-98
13.69
0.25
0.34
0.08
-0
0
2
Phosphagenics
Limited
POH
Vital Health Science. D & C patented
phosphorylation technologies,
nutraceuticals, dietary supplements, Vit
E phosphate complex
11-Aug-93
16.4
0.01
0.03
0.01
-2
0
1
0
Prima Biomed Ltd
PRR
Fund Biotechnology Research (inc.
cancer immunotherapy, rheumatoid
arthritis, vaccine technology preventing
parasitic diseases in animals)
23-Jun-88
88.7
0.04
0.09
0.04
-4
0
1
0
Prescient
Therapeutics Ltd
PTX
Immunotherapeutic products for
chronic infectious diseases & Co-XGene thechnology for cancer treatment
2-Jan-92
9.6
0.08
0.13
0.04
-3
0
2
66
0
0
AusBioSTOCK
Issuer name
ASX
Principal activity
Yr H $
Yr L $
EPS c
pSivida Corp.
PVA
Sustained-release micro-insert drug &
biologics controlled-delivery products
First list date
12-Jun-08
M cap $m
23.8
Last price $
4.08
6.65
3.50
-86
PER
-5
Asset B (c)
0
Pharmaxis Ltd
PXS
R&D & commercialisation treatment
autoimmune, chronic respiratory
diseases (inc. MS, cystic fibrosis,
rheumatoid arthritis)
10-Nov-03
82.5
0.26
0.42
0.19
4
6
8
Phylogica Limited
PYC
Discovery & development novel
peptide therapeutics for treatment of
asthma, stroke and diabetes
30-Mar-05
28.1
0.01
0.02
0.01
-0
-4
0
ResApp Health Ltd
RAP
Developer of smartphone medical app
for respiratory diseases
12-Jan-05
177.0
0.37
0.49
0.02
-1
0
1
Regeneus Ltd
RGS
Developer of adipose-derived cells with
regenerative capacity for cell therapies
19-Sep-13
31.3
0.15
0.20
0.07
-2
-9
3
Reproductive Health
Science
RHS
Developer of chromosomal abnormality
embryo testing in IVF cycles
5-Mar-87
8.0
0.14
0.21
0.08
-3
-5
2
Resonance Health Ltd
RHT
MRI & tools for diagnosis and
monitoring of liver diseases, FerriScan
& HepaFat
2-Jan-92
6.8
0.02
0.05
0.01
-0
-170
1
Resmed Inc
RMD
Developer, manufacturer, distributor
of medical equipment for diagnosis
and management of sleep disordered
breathing
25-Nov-99
11,650.5
8.28
8.46
6.94
34
24
0
Rhinomed Limited
RNO
BreatheAssist technology nasal device
for sport, sleep and drug delivery
21-Sep-07
13.8
0.02
0.05
0.02
-1
-2
0
RSH Respiri Ltd
RSH
Mobile health applications for
respiratory disorders
14-Jul-00
15.6
0.04
0.07
0.03
-2
-2
0
Reva Medical, Inc
RVA
Bioresorbable stent products, drugeluting coronary scaffolding treatment
for cardiovascular diseases
23-Dec-10
427.0
1.00
1.28
0.40
-33
-3
-29
Sonic Healthcare
Limited
SHL
Diagnostic pathology & radiology
services
30-Apr-87
8,671.2
20.91
23.73
16.84
93
22
-380
SciGen Limited
SIE
Development marketing sales
pharmaceuticals (inc. Sci-B-Vac
Hepatitis B vaccine)
15-Nov-02
.5
0.01
0.02
0.01
0
3
-20
Somnomed Ltd
SOM
Specialises in products for sleep
apnoea. Lead product SomnoMed
mandibular advancement splint (MAS)
27-Aug-04
182.6
3.33
3.39
2.23
1
264
25
Starpharma Holdings
Limited
SPL
Global R&D funding for biotechnology.
Commercialisation Dendrimer
Nanodrugs (inc.treatment STD)
28-Sep-00
238.6
0.68
0.98
0.54
-6
-11
14
Sirtex Medical Limited
SRX
R&D novel technology for cancer
treatment (radioactive particles SIRSpheres for liver cancer treatment)
24-Aug-00
1,494.8
25.94
41.33
25.98
86
30
149
Suda Ltd
SUD
Drug delivery OroMist, oro mucosal
administration for off-patent drugs
24-Jan-02
22.8
0.02
0.05
0.02
0
-8
0
Simavita Ltd
SVA
Wireless sensor technology solution for
assessment of urinary incontinence in
the elderly
22-Feb-14
5.2
0.05
0.59
0.03
-12
0
5
Div (c)
12.255
71
20
TBG Diagnosticas Ltd
TDL
Molecular diagnostics
22-Dec-95
43.5
0.26
0.30
0.14
-7
-3
4
Universal Biosensors
Inc.
UBI
Specialist medical in vitro diagnostic
tests for point-of-care; blood test
C-reactive protein test
13-Dec-06
51.8
0.31
0.50
0.24
-4
-8
8
Uscom Limited
UCM
Develop supply operate medical
equipment—ultrasonic cardiac output
monitor
10-Dec-03
26.6
0.24
0.28
0.13
-2
-13
2
Viralytics Limited
VLA
Anti-cancer Virotherapy technology
using naturally occurring Coxsackievirus
and Echovirus. Lead product CAVATAK
15-Oct-86
227.9
0.92
1.12
0.52
-4
-22
20
Virtus Health Ltd
VRT
Assisted reproductive services,
diagnostics, day hospitals
11-Jun-13
526.0
6.80
7.29
4.55
38
18
-176
28
Vita Life Sciences
Limited
VSC
Development & distribution of ‘over the
counter’ medicines; complementary;
alternative; dietary supplements; health
foods
23-Aug-07
77.2
1.35
1.90
0.75
8
17
40
3.75
67
AusBioSTOCK
This quarter’s top 20 ASX healthcare sector performers
ASX CODE
Company Name
Quarter Rolling Return %
ALT
Analytica Limited
110
SIE
SciGen Limited
69
CYC
Cyclopharm Limited
49
POH
Phosphagenics Ltd.
49
CDY
Cellmid Limited
46
IIL
Innate Immuno
41
PBT
Prana Biotechnology
36
VLA
Viralytics Limited
36
LCT
Living Cell Tech.
35
RAP
Resapp Health Ltd
32
SOM
SomnoMed Limited
29
MEB
Medibio Limited
28
RSH
Respiri Limited
27
CGS
Cogstate Ltd
26
MGZ
Medigard Limited
24
UCM
Uscom Limited
23
AMT
Allegra Orthopaedics
22
MVP
Medical Developments
22
BXN
Bioxyne Ltd
20
ELX
20
This year’s top 20 ASX healthcare sector performers
ASX CODE
Company Name
Year Rolling % Return
RAP
Resapp Health Ltd
284
ACL
Alchemia Limited
139
CGS
Cogstate Ltd
122
PBP
Probiotec Limited
112
ELX
106
PNV
Polynovo Limited
102
LBT
LBT Innovations
101
MVP
Medical Developments
94
CLV
Clover Corporation
92
OPT
Opthea Limited
84
BXN
Bioxyne Ltd
73
RVA
Reva Medical, Inc
72
IIL
Innate Immuno
58
AXP
Airxpanders, Inc.
48
CYC
Cyclopharm Limited
47
MYX
Mayne Pharma Ltd
41
COH
Cochlear Limited
40
OBJ
OBJ Limited
40
LCT
Living Cell Tech.
39
CUV
Clinuvel Pharmaceut.
37
Data current at 27 June 2016. This information which has been collated by company reports released to the ASX contains general information only and does
not constitute financial product advice. Baillieu Holst Stockbroking Ltd and AusBiotech make no assertions as to the merits of any investment opportunities in
the companies referred to in these articles.
68
People
NEW MEMBER PROFILES
China Bioengineering Technology Group Limited (CBT)
China Bioengineering Technology Group Limited (CBT) is situated in Hong Kong Science and Technology Park. It is a high-tech professional
body comprising biomedical science and precision medicine, as well as big data access, statistics and analysis. Our company possesses
independent intellectual property right for gene test technology and biomedical data analysis platform.
CBT pioneers the application of genes on people’s daily personal medication, disease prevention, nutrition and exercise, intelligence
development, and other related domains in Hong Kong and China.
Dr Jay Liang China
Bioengineering Technology Group Limited
T: (852) 2208 7904
E: [email protected]
W: www.cbtgene.com.hk
Efic
When Efic helps you grow, it helps Australia grow. Efic is committed to unlocking finance for export success. As Australia’s export finance
agency, Efic delivers simple and creative solutions for Australian companies—to enable them to win business, grow internationally and
achieve export success. Through its loans, guarantees, bonds and insurance products, Efic has helped many Australian exporters and
subcontractors to take advantage of new contract opportunities that may otherwise have been out of reach.
T: 1800 093 724
W: www.efic.gov.au
GO Resources Pty Ltd
GO Resources Pty Ltd is a private Australian clean technology business established in 2013 to focus on the sustainable production and supply
of renewable and biodegradable raw materials for use in industrial and oleochemical markets.
GO Resources has the exclusive, worldwide licence to commercialise a super high oleic (SHO) safflower plant that produces uniquely super
high levels of oleic acid (>92 per cent) in its seed. This is the world’s highest-grade plant-derived oil for industrial use.
Mr Michael Kleinig
T: +61 425 761 997
Gold Coast Health and Knowledge Precinct
Located in Australia’s emerging global city, the Gold Coast Health and Knowledge Precinct is a 200-hectare health innovation hub offering
unparalleled commercial opportunities for business location, research collaboration, investment and growth. Already home to a world-class
university, public teaching hospital and private hospital, the Precinct offers exclusive access to research and development partnerships, and
generous financial incentives from all levels of government. It’s a vibrant and innovative community where people can live, learn and work.
Diane Dixon
Project Director
W: www.gchkp.com.au
Macquarie University
Macquarie University is a vibrant hub of intellectual thinkers, serving the world through discovery, knowledge sharing, innovation and deep
partnerships. We are home to Australia’s first and only fully owned, not-for-profit hospital on a university campus. Macquarie is also home to
the Australian Hearing Hub, a unique, world-class facility focused on collaborative research into hearing and communication. Our facilities and
people give Macquarie unparalleled flexibility to deliver translational biotechnology solutions.
Dr Lisa Rodgers
Corporate Engagement Manager
T: +61 2 9850 4595
W: www.mq.edu.au
69
People
Shelston IP
With a rich history spanning 155 years, and specialist teams of patent attorneys, trademark attorneys and IP lawyers, Shelston IP is a leading
intellectual property (IP) firm in Australasia. Our tagline, ‘Mind to Market’, reflects a crucial difference between Shelston IP and other firms.
It encapsulates our thorough understanding of the processes involved in converting ideas and innovations into intellectual assets, and our
appreciation of what it takes to successfully commercialise those assets.
Dr Michael Christie
The Queensland Alliance for Agriculture and Food Innovation (QAAFI)
The Queensland Alliance for Agriculture and Food Innovation (QAAFI) is a research institute dedicated to improving the competitiveness
and sustainability of Queensland’s tropical and subtropical agriculture and food sectors through high-impact science. QAAFI is a research
collaboration between The University of Queensland (UQ) and the Queensland Government, bringing together senior agricultural scientists in
the regions across Queensland, where they are well-placed to understand industry needs and develop the best scientific solutions.
Margaret Puls
Marketing and Communications Manager
W: www.qaafi.uq.edu.au
Wellspect HealthCare
Wellspect HealthCare is a knowledgeable innovator of urology and surgery products and services. We aim to make a real difference,
shown in our focus to pioneer quality solutions that improve outcomes. Our LoFric intermittent catheters are the world’s first single-use
hydrophilic catheter and remain the gold standard. Our iconic Bellovac®, Exudrain® and Kilroid ® deliver dependable performance every
day. DENTSPLY Sirona, as our parent company, gives customers the assurance of working with a globally responsible healthcare leader.
P: 1800 622 492
W: www.wellspect.com.au
AusBiotech’s fully searchable directory offers access to
information on biotechnology and medical technology
companies and organisations in Australia.
ausbiotech.org/directory
70
People
CORPORATE
AUSBIOTECH MEMBERS
3M Australia Pty Ltd
AbbVie Pty Ltd
Acrux Ltd
Actinogen Limited
AdAlta Pty Ltd
Adelaide Research & Innovation Pty Ltd
Adherium Limited
Admedus Limited
Agriculture Victoria Services Pty Ltd
Ainscorp Pty Ltd
AJ Park
Alcidion Corporation Pty Ltd (Australia)
Alexion Pharmaceuticals Australasia P/L
Allens Patent & Trade Mark Attorneys
Alzhyme Pty Ltd
AMGEN Australia Pty Ltd
Analytica Ltd
Anatara Lifesciences
Anteo Diagnostics
Antisense Therapeutics Ltd
ANU Connect Ventures Pty Ltd
Arnold Bloch Leibler
AstraZeneca Pty Ltd
ATP Innovations Pty Ltd
Austanz Chitin P/L
Australia China Business Council (ACBC) Victoria
Australian Agricultural Company Limited
(AACo)
Australian Institute for Bioengineering &
Nanotechnology (AIBN)
Australian National Fabrication Facility
(ANFF)
Australian National University (ANU)
Australian Proteome Analysis Facility (APAF)
Australian Red Cross Blood Service (ARCBS)
Australian Regenerative Medicine Institute
Australian Synchrotron Co. Ltd
Avatar Brokers Pty Limited
Baillieu Holst Ltd
Baker IDI Heart and Diabetes Institute
Baxalta Australia Pty Ltd
Bayer CropScience Pty Ltd
BCAL Diagnostics Pty Ltd
Bellberry Limited
Benitec Biopharma Limited
Bio21 Molecular Science and Biotechnology
Institute, University of Melbourne
Bioactive Laboratories Pty Ltd
BioDiem Ltd
Biointelect Pty Ltd
Bio-Link Australia
Biomedical Research Victoria (BioMedVic)
BioMelbourne Network
Bionics Institute
Bionomics Ltd
BioPacific Partners
BioPharmaceuticals Australia (BPA)
Bioplatforms Australia Ltd
BioSA
BioScience Managers Pty Ltd
Biotech Dispatch
BioTech Primer Inc.
Biotechnique Pty Ltd
Biotron Limited
Biovite Australia Pty Ltd
Bioxyne Limited
Blueprint Life Science Group
Bosch Australia Pty Ltd
Brandon Capital Partners
Brandwood Biomedical Pty Ltd
Bristol-Myers Squibb (Australia) Pty Ltd
Brooker Consulting
BTG Australasia P/L
Buchan Consulting
Burnet Institute
Business Events Sydney
Calimmune Australia
Celestino Pty Limited
Cell Therapies Pty Ltd
Cellmid Limited
Centre for Drug Candidate Optimisation
Children’s Medical Research Institute
China Bioengineering Technology Group
Limited
Chubb Insurance Company of Australia Ltd
Clarity Pharmaceuticals
Clinical Genomics Technologies Pty Ltd
Clinical Network Services (CNS) Pty Ltd
Clinical Research Corporation
Cochlear Limited
Coloplast Pty Ltd
Compounds Australia
ConvaTec (Australia) Pty Ltd
Cook Australia Pty Ltd
CPR Pharma Services Pty Ltd
CSIRO
CSL Behring Australia
CSL Limited
CTX CRC Limited
Cure Brain Cancer Foundation
Curtin University - School of Biomedical
Sciences
CV Laser Pty Ltd (CustomVis)
Cyclopharm Limited
Cynata Therapeutics
D3 Medicine
Datapharm Australia Pty Ltd
Davies Collison Cave
Deakin Research Commercial
DEK Technologies
Deloitte Touche Tohmatsu
Department of Economic Development,
Jobs, Transport and Resources
Department of Science, Information
Technology and Innovation (DSITI)
Department of State Growth (TAS)
DesignMedix, Inc.
DibbsBarker
Dimerix Limited
DLA Piper Australia
DorsaVi Pty Ltd
EFIC - Export Finance and Insurance
Corporation
EIB Insurance Brokers Pty Ltd
Elastagen Pty Ltd
Eli Lilly Australia Pty Ltd
Ellex Medical Lasers Limited
Ellume
ELSEVIER B.V.
Eppendorf
ERA Consulting (Australia) Pty Ltd
Eskitis Institute, Griffith University
Eurofins | ams
EY
Factor Therapeutics
FB Rice
Fisher Adams Kelly Callinans
Fitgenes Australia Pty Ltd
Flanders Investment & Trade - Embassy of
Belgium
Franke Hyland
Freehills Patent Attorneys
French Embassy, Trade Commission Business France Australia & New Zealand
Frost & Sullivan (Australia) Pty Ltd
Fusidium Pty Ltd
Gamma Vaccines Pty Limited
Garvan Institute of Medical Research
GBS Venture Partners Pty Ltd
Genesearch Pty Ltd
Genetic Signatures
Genzyme - a Sanofi company
Global Kinetics Corporation Pty Ltd
Global Orthopaedic Technology
GO Resources Pty Ltd
Gold Coast Health & Knowledge Precinct
Golja Haines & Friend
71
People
Grant Thornton Australia Limited
Griffith Hack
Griffith University
Heidrick & Struggles Australia Pty Ltd
Holman Webb Lawyers
Houlihan² Patent & Trade Mark Attorneys
Hydrix Pty Ltd
ide
IDT Australia Ltd
Ikaria Australia (now part of Mallinckrodt
Pharmaceuticals)
Immuron Limited
Imugene Ltd
INC Research Australia Pty Limited
Innate Immunotherapeutics Limited
Institute for Glycomics
Inter-K Peptide Therapeutics (Inter-K Pty
Ltd)
Invion Limited
iPug Pty Ltd
IQ3 Corp Ltd
IQnovate Life Science Organisation
IQX Ltd
Johnson & Johnson Innovation
Johnson Matthey (Aust) Ltd
Kain C+C Lawyers
King & Wood Mallesons
KPMG
LBT Innovations Ltd
Liberty Medical Pty Ltd (Hollister/Dansac)
Linear Clinical Research Ltd
Lipotek Pty Ltd
Logan Office of Economic Development
M. H. Carnegie & Co.
M+W Group
Macquarie University - Faculty of Science
and Engineering
Madderns Patent & Trade Mark Attorneys
MasterControl Inc.
McCloud Consulting Group
Meat and Livestock Australia Ltd
MedAdvisor Ltd
Medibio Ltd
Medical Device Research Institute, Flinders
University
Medlab Clinical Ltd
Medtronic Australasia Pty Ltd
Melbourne Convention Bureau (MCB)
Melbourne School of Engineering
Merck Sharp & Dohme
Mesoblast Limited
Minomic International Limited
Minter Ellison Lawyers
Mobius Medical Pty Ltd
Monash Innovation
Monsanto Australia Ltd
Morgans Financial Limited
MPR Group Pty Ltd
Murdoch Childrens Research Institute
Murdoch University
Nanosonics Limited
72
National Association of Testing Authorities
Australia
National Trauma Research Institute, Alfred
Health and Monash University
Neoclinical
Neuren Pharmaceuticals Limited
Neuroscience Trials Australia
Neurosciences Victoria Ltd
New Venture Institute
Newcastle Innovation Ltd
Newline Australia Insurance Pty Ltd
Norton Rose Fulbright Australia
Novartis Pharmaceuticals Australia Pty Ltd
Novo Nordisk Pharmaceuticals Pty Ltd
Novogen Limited
Novotech
Nucleus Network
NZBIO
OccuRx Pty Ltd
OFX
Omnigon Pty Ltd
ONBoard Solutions Pty Ltd
OncoSil Medical Ltd
Opthea Limited
Orthocell
Osprey Medical
Paranta Biosciences Limited
Patheon Biologics Pty Ltd
Patrys Ltd
Peter MacCallum Cancer Centre
Pfizer Australia
PharmaSynth
Pharmaxis Ltd
Phillips Ormonde Fitzpatrick
Phosphagenics Limited
Phylogica Ltd
Planet Innovation Pty Ltd
PolyNovo Limited
Prana Biotechnology Ltd
PresSura Neuro
Pricewaterhouse Coopers
Protagonist Pty Ltd
Proteomics International Laboratories
Limited
Provectus Biopharmaceuticals, Inc.
pSivida Corp
QBiotics Limited
QIAGEN Pty Ltd
QIMR Berghofer Medical Research Institute
Q-Pharm Pty Limited
Queensland Alliance for Agriculture & Food
Innovation (QAAFI)
Queensland University of Technology
Quintiles Pty Ltd
qutbluebox Pty Ltd
Regeneus Ltd
ResApp Health Limited
Research Australia Limited
Research, Innovation & Commercialisation
(RIC), University of Melbourne
REVOX Sterilization Solutions
RSM Australia
Russell Kennedy Pty Ltd
Sanofi-Aventis
SeerPharma Pty Ltd
Sementis Limited
Seqirus Australia - a CSL Company
Shelston IP
Shire Australia Pty Ltd
Sienna Cancer Diagnostics Ltd
Simavita Pty Ltd
SMART Arm Pty Ltd
Southern Star Research Pty Ltd
SpeeDx Pty Ltd
Spruson & Ferguson
St Vincent’s Hospital Melbourne
Starpharma Holdings Limited
Suda Limited
SydPath
Synchrotron Light Source Australia
Talu Ventures
Tasmanian Alkaloids
Telethon Kids Institute
Terra Rossa Capital Pty Ltd
Terragen Biotech Pty Ltd
TetraQ
Teva Pharmaceuticals Australia Pty Ltd
TGR Biosciences Pty Ltd
The University of Queensland
The University of Western Australia
The Walter & Eliza Hall Institute of Medical
Research
THEMA Consulting Pty Ltd
Therapeutic Innovation Australia
Trajan Scientific and Medical
TransPerfect Translations Pty Ltd
TruScreen Pty Ltd
UK Trade & Investment
UniQuest Pty Ltd
Universal Biosensors Pty Ltd
University of Southern Queensland
University of Sydney, Engineering and
Information Technologies
University of Western Australia
University of Wollongong
UNSW - School of Biotechnology and
Biomolecular Sciences
UNSW Innovations
Vectus Biosystems Limited
Venture Valuation
Viralytics Ltd
Virtual Regulatory Solutions, Inc
Volpara Solutions Limited
WA Health Translation Network (WAHTN)
WATERMARK Patent & Trade Mark Att.
Wellspect HealthCare
West Pharmaceutical Services
Western Sydney University
World Courier (Australia) Pty Ltd
Wrays
Celebrating
life sciences CONFERENCE
MAJOR
INTERNATIONAL
with 3 events
in 1 week
Celebrating
life sciences
with 3 events in 1 week
24 – 27 October 2016 Melbourne, Australia
Presented by
internationalbiofest.org
@AusBiotech
#BioFest16
IBS
2016
17th International
Biotechnology
Symposium and Exhibition
Australia’s Life Sciences
Conference
ausbiotechnc.org
#AusBio16
Supporting
Partners
ibs2016.org
#IBS2016
17th International
Biotechnology
Symposium
and Exhibition
www.ibs2016.org
Australia’s Life Science
Investment Showcase
australiabiotechinvest.com.au
#AusBioInv

Immuno-oncology: AgBiotech: AusMedtech 2016:

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