BioTechnology Australasian

VOLUME 26 • NUMBER 1 • March 2016 • Journal of AusBiotech Australia’s Biotechnology Organisation

AusBiotech and the Australian biotechnology industry celebrates 30 years What will Australian biotechnology look like over the next 30 years? Preview of AusMedtech 2016

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Book now to join us for the AusBiotech 30th year gala luncheon Celebrating the past, inspiring the future

Save the date Friday 15 July From 12 noon Melbourne

Enquiries Contact the AusBiotech Events Team [email protected] or 03 98281400

AusBioWELCOME AusBioWELCOME CEO and Chair report

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AusBioFEATURES AusBiotech’s 30th year

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Evolution of AusBiotech and Australian biotechnology

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Influential people in biotech

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Leading Australia’s industry organisation: a timeline

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Disrupting the paradigm

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Biotech – the last 30 years

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Biotech – the next 30 years

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Recollections of 30 years of biotechnology

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The people who founded Australia’s industry organisation; where are they now?

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What will Australian biotechnology look like over the next 30 years?

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The evolution of transgenic food

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Regenerative medicine – are we there yet?

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30 years of regenerative medicine in Australia

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Reflections from our members

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Harmonisation, risk and rigour

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The ASX-listed biotechnology sector

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AusBioFEATURES

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AusMedtech 2016 Australia’s medtech conference to convene in Adelaide

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South Australia: A hot spot for medtech companies

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Pulse of the industry – global medtech outlook

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AusBioNEWS

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China guide to support Australian medtech companies

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Why do academics feel they own quality?

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Student life – Career opportunities via networking

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AusBioEVENTS Opportunities to involve your company in the International BioFest 2016

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AusBiotech 2015 in Melbourne sets momentum for this year’s International BioFest 63 Tech Transfer Summit Australia

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AusBioSTOCK Stock 68 AusBioPEOPLE New member profiles

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Corporate, institute and associate members of AusBiotech

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AusBiotech staff and office bearers

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ISSN 1036 7128 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, transmitted in any form or by any other means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission in writing of the publishers. While every effort has been made to ensure the accuracy of the information in this publication, the publishers assume no responsibility for errors or omissions or any consequences or reliance on this publication. The opinions expressed in this publication do not necessarily represent the views of the editor or the publisher. © 2016

Australasian Biotechnology is the official journal of AusBiotech, Australia’s Biotechnology Organisation. Australasian Biotechnology reports on research and business news within the biotechnology arena. Publisher’s Disclaimer The information, opinions and advice in this journal are given in good faith and, while all care has been exercised to ensure that the information is accurate, no responsibility can be accepted for errors, or loss or damage from business decisions arising from the use of information contained in this publication, and the publishers hereby exclude all liability be it contractual tortious or otherwise.

AusBiotech Level 4, 627 Chapel Street, South Yarra, VIC, 3141 Tel: (03) 9828 1400, Email: [email protected], www.ausbiotech.org Editor Lorraine Chiroiu, Chief Industry Affairs Officer Tel: (03) 9828 1414, Email: [email protected] Editorial Coordinator Linda Edgerton, Communications Associate Tel: (03) 9828 1401, Email [email protected] Advertising Bookings and Enquiries - Tanya Daw, Tel: (03) 9828 1431, Email: [email protected] Advertising Submission - Andrew Jackson – Digital Image 161 Buckhurst St South Melbourne, 3205, Victoria, Tel: (03) 9690 1222, Email:26 [email protected] • Number 1 • March 2016 Australasian BioTechnology Volume

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CEO and Chair report

Dr Anna Lavelle

Welcome to the collector’s 30th anniversary edition of Australasian Biotechnology, marking the momentous occasion of three decades since the founding of the Australian Biotechnology Association (ABA), which 15 years ago became AusBiotech. So much has changed over the period; AusBiotech is hardly recognisable as the organisation that Martin Playne, the ABA’s founding Chairman, describes later in this edition – and yet this work was critical in laying the foundation of what we have achieved today. From its early focus on fermentation via biopharmaceuticals, medtech’s devices and diagnostics, cleantech’s biofuels, foodtech’s nutraceuticals and functional foods, biological remediation, agricultural and industrial biotech, Australia’s biotechnology industry has more recently evolved to encompass digital health and regenerative medicine. The Australian biotechnology industry and its industry association in their inexorable linkage have achieved a great deal in their relatively short and productive histories. As we look back over 30 years of the industry association and the industry’s successes and challenges in this edition, as well as the individuals whose dedication and vision made it happen, all indicators are that the sector is positioned to take its rightful place as a key contributor to Australia’s economy. We have just seen the results of 2015, when a record $1.1 billion in capital was raised, the deal flow provided plenty of excitement and the Federal Government has ignited the industry with

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Ms Julie Phillips

its attention on innovation and the launch of the National Innovation and Science Agenda (NISA) released in December. “ The [NISA] Agenda is part of the Government’s commitment to establishing Australia as a leading innovation system..” The Hon Malcolm Turnbull, Prime Minister The NISA delivered long-advocated-for gains for biotech, including:

• The new $250 million Biomedical Translation Fund to support commercialisation; • The ‘Same Business Test’ will be relaxed with a more flexible ‘predominantly similar business test’. This will allow a start-up to bring in an equity partner and secure new business opportunities without worrying about tax penalties; • Employee Share Schemes (ESS) were improved to limit the requirement for disclosure documents given to employees to be made available to the public. This will allow otherwise non-disclosing companies to offer shares to their employees without having to reveal commercially sensitive information to competitors. This will make ESS more userfriendly for innovative companies, allowing them to attract motivated staff without a substantial initial outlay; • Tax breaks for investors in early-stage innovative companies; • Benefits under the R&D Tax Incentive were retained;

AusBioWELCOME AusBiotech supported this in 2015 and:

• Hosted 78 events, including major conferences, investment and states-based events • Attracted 6,600 delegates • Made more than 24 submissions to governments and attended more than 100 meetings with various government departments and Parliamentarians. • Attended 42 consultations meetings • 104 newsletters • More than 240 media articles • Facilitated 2,465 partnering meetings, through business matching program and international delegations, and signed a deal for Australian biotechs to become part of the global 35,000+ directory. From the Chair, Julie Phillips For my part, I’m a relative newcomer to the AusBiotech Chairmanship, having held the position for just over a year; however I have been a supportive and active member for at least ten years. In that time, as the CEO of BioDiem, I have seen remarkable growth in and achievement by the organisation, notably its role in the delivery of the landmark R&D Tax Incentive in 2011. An important focus of AusBiotech has been to position biotechnology innovation as central to new job growth, increased productivity and as a revenue-driver for a thriving economy for the future, as Australia moves away from reliance on the traditional industries like mining and car manufacturing to seek more sustainable, hightech knowledge-based industries. The NISA proposals offer a chance for Australia to grow, not only its biotech companies with their world-class Australian-backed research, but also the ecosystem of service providers and facilities to provide technologies for a global market and jobs for our talented biotech professionals of today and the future. Through the efforts of our industry organisation we have been at the negotiating table to advocate successfully for the importance of our industry sectors. As an industry organisation we are well-regarded and the credit for this rests with the management and staff of AusBiotech and the countless hours of volunteering provided by members including the current and previous boards and committeees.

AusBiotech has worked extremely hard and achieved a significant amount. Specifically, our organisation has been instrumental in key policy developments. As many of you will know October 2015 marked CEO, Dr Anna Lavelle’s ten years at the helm of AusBiotech. Dr Lavelle sat down for an interview with Editor Paul Cross: this is reproduced below with the kind permission of Biotech Dispatch. The article provided a good snapshot of the past decade, from the perspective of AusBiotech’s leadership. Dr Lavelle joined AusBiotech just over ten years ago, having enjoyed a varied career up to that point as an academic and CEO of several organisations. “I’d had an eclectic background before AusBiotech, which probably made me perfect for the job, particularly when it came to leading organisations and understanding policy and stakeholder management,” she says. AusBiotech has grown in size and stature since she arrived at the organisation which was then located in the offices of former Australian biotechnology leader, Amrad. The Amrad name has gone and AusBiotech now occupies its own office in Melbourne. AusBiotech had four staff ten years ago and tight constraints on its financial resources, but strong membership loyalty, says Dr Lavelle. “I came from outside the ‘biotech family’, which ruffled some feathers but was probably best,” she says. AusBiotech is almost unique as an industry organisation, something that has become more apparent under Dr Lavelle’s leadership. Its membership represents a diverse range of interests, covering virtually every aspect of the biotechnology value chain from discovery through to commercialisation and even policy. This contrasts with many other industry organisations that tend to represent one aspect of a value chain. According to Dr Lavelle, this broad focus actually aids AusBiotech, ensuring its positions reflect the diverse nature of its membership and enhancing its credibility with stakeholders.

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AusBioWELCOME

AusBiotech Board: Dr Andrea Douglas, Mr Barry Thomas, Dr Anna Lavelle, Mr Lawrence Gozlan, Ms Michelle Burke, Mr Serg Duchini, Ms Serina Cucuzza and Ms Julie Phillips (Chair).

“What it means for AusBiotech is that we often play the role of ‘interpreter’ for different parts of the ecosystem, where people have stereotypical perceptions of certain parts of the sector. “Often it’s innocent misunderstandings of the sector that can be easily addressed,” she says, going on to describe it as one of the organisation’s most important functions. “There are very few people in Australia that have a detailed understanding of the ecosystem and the interdependence of its different components,” says Dr Lavelle. When it comes to measuring the success of her tenure at AusBiotech, Dr Lavelle says the focus should be on ‘level of impact’, particularly when it comes to the organisation’s relationships with stakeholders, notably Government, and ability to influence the environment. The organisation is also unique in the wide range of services it provides members. While other industry associations focus on policy and advocacy, AusBiotech has an additional strong focus on promoting the commercial interests of its members through its year long schedule of meetings and conferences. Dr Lavelle says the issues have evolved over the years. Ten years ago, she says the organisation 6

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was very strongly focussed on GM-related issues and running its annual conference. “Since then, we’ve really tried to focus on the main game – what’s the big picture? Post-GFC the priority for our members, and therefore our priority, was access to capital. “In 2007, Australian biotech companies raised just under $1 billion in capital. The next year that dropped to $183 million, so the ceiling just fell in on SME companies. “Our sole focus needed to be on this capital question and, given the urgency and potential impact, we needed to push aside some of the other policy areas we had been focussed on.” According to Dr Lavelle, the organisation started pursuing changes to address the problem, focussed on the R&D Tax Incentive. “It took over four years to get the R&D Tax Incentive through and finally passed into law. It required lots of negotiations, speeches, papers, but it has delivered through non-equity diluting capital to small companies exactly as envisioned. “It has been the most important thing and significant change in the past ten years.” Dr Lavelle has welcomed new Prime Minister Malcolm Turnbull’s stated support for innovation

AusBioWELCOME and Christopher Pyne’s appointment to a beefedup industry and innovation portfolio.

monetisation of intellectual property – they get the concept of shipping stuff to other countries.

“Mr Turnbull is the first Prime Minister to lead with innovation, starting with elevating the portfolio in Cabinet, so there is hope that we may now have a chance because the public statements being made represent a remarkable shift.

“But the value of an intellectual property deal with many hundreds of millions of dollars is often lost on them,” says Dr Lavelle. “There is an incorrect perception amongst some officials that this is a small and non-material sector for the economy.”

She told BiotechDispatch the Government’s challenge will be translating the early and strong vocal support for innovation into outcomes for the sector, pointing to its current commitment to cut the R&D Tax Incentive, having already capped claims under the program.

Dr Lavelle welcomes Mr Turnbull’s comments on the importance of translation.

“This was a transformative policy when it was introduced and we need Mr Turnbull and his Government to understand the negative impact on our sector of constant attempts to wind it back,” says Dr Lavelle. She also expresses concern at the potential for further changes to come out of the current review of tax, which is considering the R&D Tax Incentive. While Treasurer Scott Morrison recently announced that the Government was halting further work on the review, Dr Lavelle remains concerned. “What some Canberra-based officials don’t seem to understand is that a corporate tax reduction has no benefit for many biotech companies because they aren’t paying tax yet,” she says. “The other side is that they don’t understand the potential upside of the sector and the

“Clearly, there has been instruction we are now looking at innovation and the translation of the product of discovery into export income for Australia as an important economic driver into the future. “We have haemorrhaged opportunity at the walls of our universities in the past, there is no doubt about that, and it’s the systems that have allowed that to happen.” According to Dr Lavelle, the way universities and funded and academics are remunerated is holding back Australia’s ability to improve its performance in translational research. She also laments the lack of basic knowledge of what it takes to commercialise a product. “If we are going to get better at commercialisation, then we need to get better at building real linkages between the public and private sectors. It is not an option – it’s a priority.” See more at: http://biotechdispatch.com.au/dr-anna-lavelleon-ten-years-at-ausbiotech/#sthash.cda72BgT.dpuf

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AusBioFEATURE – AusBiotech’s 30th year

Evolution of AusBiotech and Australian biotechnology On the occasion of 30 years since the founding of the Australian Biotechnology Association, a reflection on the journey and the people who made it happen.

being organised every two years, primarily by the staff at the University of NSW, who had the first School of Biological Technology, which had been founded in 1968.

AusBiotech, Australia’s biotechnology organisation, is today a dynamic and wellconnected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural, environmental and industrial sectors. AusBiotech is dedicated to the development, growth and prosperity of the Australian biotechnology industry, by providing initiatives to drive sustainability and growth, outreach and access to markets, and representation and support for members nationally and around the world.

By 1976, CSIRO had started a biotechnology program, and become active in organising and attending conferences. It is therefore not surprising that it was CSIRO’s Dr Martin Playne who later in 1986 founded the Australian Biotechnology Association (ABA) and became its inaugural Chairman and Principal Executive Officer.

Our membership base includes biotechnology companies, ranging from start-ups to mature multinationals, research institutes and universities, specialist service professionals, corporate, institutional, individual and student members from Australia and globally. AusBiotech has representation in each Australian state providing a national network to support members and promote the commercialisation of Australian bioscience in the national and international marketplaces. Where it all began In 1986, biotechnology as a stand-alone discipline was slowly emerging and scientists were gathering in Australia, as it was in the US and in pockets around the world, to share information and further their research. Since the late ‘70s, small biotech conferences were 8

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From its humble beginnings as the ABA with 94 members, the organisation has worked to support and grow the industry, with many committed and visionary people as its champions. Dr Martin Playne tells how it all began: “In the ‘70s, there were a number of centres with some biotech activity, such as at the University of Queensland and companies such as Agen, MabCo, Fielders, Burns Philp, Websters, CSL, CSR and CUB all had R&D facilities and employed scientists, but the communication between scientists in those businesses and those in academia or government was very limited. The 6th biotech conference was held at the University of Queensland (UQ) in the winter of 1984. By this time, the accumulated funds from successive conferences amounted to several thousand dollars. It was obvious that there was a need to formalise the conferences into some sort of organisation, before the funds handed across casually to the next person fell into the wrong hands. Matters of liability and tax status were also a consideration. I contacted Professor Peter Gray at UNSW

AusBioFEATURE – AusBiotech’s 30th year and Prof Horst Doelle at UQ and the three of us agreed to put up a proposal at the coming conference in Brisbane in 1984 for the formation of an association.

The proposal said that “it is desirable that the use of the initials ABA be retained but with the inclusion of the word ‘industry’ or equivalent to reflect this increased importance.”

The evening time-slot in the conference program turned out to be a slightly unfortunate decision, as after the day’s conference proceedings had finished at 5.00pm, most of us spent the time before the 7.30 pm meeting in the University club bar!

This is also the time a decision was taken to employ an executive director with a view to working with the directors to “restructure” the ABA – and the hunt began that ended in the appointment of Anthony Coulepis.

Consequently, Horst, as conference host, had the unenviable and difficult job of controlling a meeting of some 200 attendees. Despite everyone being a bush-lawyer, we somehow ended up with the three of us being appointed by the throng to set up an association. The meeting was vocal in its belief that: (a) the inaugural working party members should come in equal numbers from the three states, Queensland, NSW and Victoria (b) the working party was to consist of two people from each state (c) the three of us were to nominate the others (d) the association should have a strong linkage with industry, as no-one wanted another scientific society, and we did not want to compete with bodies such as RACI, ASBMB, IChem Eng, or ASM. (e) many of us thought that the most important contribution an association could make was to provide a neutral forum for scientists, engineers and technologists from both commercial businesses, and from academia and CSIRO. And the transition from the ABA to AusBiotech in 2001 Fast forward 14 years and Dr Peter Riddles election to the ABA’s presidency in 2000, also marked the endorsement of the “general thrust” of the recently launched Steering Committee proposal, to strengthen the role of the ABA as an industry association, which was presented at the AGM. The restructuring proposal to “take the ABA to a new level” included a 100-page report from Buchan Communications Group, comprising of 59 considerations for members. While this included discussion on a change of name, AusBiotech was not yet in the running (and given records for 2001 are missing there is no explanation how the name can to be).

In his editorial in Australasian Biotechnology Nov/Dec 2000, Dr Martin Playne described the organisation as “a unique organisation - a hybrid of an industry association and a scientific society.” He said: “There is no doubt there is need for change, and a need for a professional executive in the ABA. The debate is most likely about the form it should take…” He went on that the Steering Committee have “been making strenuous efforts to ensure we retain all the benefits…while creating a new dynamic association to lead the way ahead for our industry sector.” At this time the industry was growing well with the global industry doubling in size between 1993 and 2000 and calculated to be worth over $US60 billion – a figure that seems quaint by today’s standards. The Australian had about 160 locally active biotechnology companies. The Deloitte Biotech Index at this time had 47 ASX-listed companies in its index and CSL made up more than 43% of the market capitalisation. Dr Peter Riddles said that the global growth of the industry is “so loud and clear that one does not need to be ‘visionary’ any more to see or understand what is required.” The decision to commission the proposal and establish the Steering Committee was made at the ABA2000 forum in the AGM. Former Director Stephan Wellink describes the events: “I was a member of ABA and was for some years, and got involved with some other members about taking ABA to next level. I flew down for an initial meeting in Melbourne where there was a debate about the organisation.” “The ABA’s future was put to a vote, to either remain the ABA or to change constitution and move to AusBiotech. As I recall, the directors asked the members for any other comments. I stood up and said I was voting for the future, not for the past. Then I was elected director.” AusBiotech officially came to be on 10 May 2001. Volume 26

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AusBioFEATURE – AusBiotech’s 30th year The Annual report 2001 said: “The next four key steps in the development of AusBiotech, and the challenge for the incoming AusBiotech Board, include the formulation of policies and their implementation, the strengthening of staff resources, the raising of Funds, and the implementation of effective management principles.” “With the continued implementation of AusBiotech’s 3-Year Business Plan, the organisation can only become stronger and contribute a vital role in the development of the Australian biotechnology industry.” Reflections from AusBiotech’s longest-serving Chair, Dr Deborah Rathjen Dr Deborah Rathjen was Chair of AusBiotech for six years (2008 - 2014) and steered AusBiotech through its most rapid change period. Her leadership was essential to securing the changes which added strength to the organisation. During this time, Dr Rathjen also successfully led her own company, Bionomics, to record deals. Dr Rathjen said: “During my tenure I saw significant transformation of both the industry and of AusBiotech. AusBiotech survived the financial crisis to become the sustainable, robust, industry representative that it is today with a strong voice. Our proudest achievement has been the role AusBiotech has played in championing the R&D Tax Incentive, which did not get up first time around. AusBiotech lobbied successfully amid an environment which had seen the canning of all industry innovation grants. Payments under this policy have continued to flow to the sector. The R&D Tax Incentive has been very well received by the industry and its intact preservation remains the number one public policy issue within the industry.” “Other highlights have been the current strategic plan for AusBiotech; the launch of AusEventsTM, a division of AusBiotech that is a professional conference organiser for life science and technology events; and investor conferences initiated and now global. Australian biotech has become more visible to off-shore investors as measured by overseas investment and participants and there has been a re- invigoration of relations with the Federal Government across clinical trials, work on biosimilars and other initiatives.”

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The Australian biotechnology industry today From fermentation to therapeutics, Australia’s biotechnology industry has come to encompass medtech’s devices and diagnostics, cleantech’s biofuels, foodtech’s nutriceuticals and functional foods, biological remediation, agricultural and industrial biotech, biologic medicines, biomarkers and much, much more… The Australian biotechnology industry and its industry association in their inexorable linkage have achieved a great deal in their relatively short and productive histories. In 2015, for the second consecutive year, Australian biotechnology ranked fourth in the world (Scientific American, Worldview Scorecard). Behind this impressive achievement is a vast group of Australian companies, working to translate our world-class research into medical therapies, medical devices, diagnostic, vaccines, and agricultural crops. Today the industry consists of an estimated 900 biotechnology companies (400 therapeutics and diagnostics and 500 – 900 medical technology companies) and employs in excess of 45,000 Australians. The 500+ Medical device companies in Australia, with a few exceptions are typically young and small, competing globally with large multinational companies for market share. The industry is advancing rapidly into new fields of science and engineering, with nanotechnology and other research developments facilitating new innovations in the biomedical sphere and an increasing convergence of physical and biological technology platforms. It is a highly innovative sector pushing the boundaries in advanced manufacturing, using highly skilled labour distributed to global production chains and specialised markets. The Australian industry is attracting significant deals. Highlights in 2015 included: Hatchtech signed a licensing deal worth up to AU$ 279 million for its Xeglyze head lice treatment. Starpharma signed a licensing deal worth up to AU$650 million with AstraZeneca for its dendrimer drug delivery platform and Fibrotech was purchased by Shire in a deal worth up to AU$600 million for new class of drugs to treat fibrosis. Spinifex was purchased by Novartis in a deal worth up to AU$1 billion, for its treatment of chronic pain in what has been described as the biggest deal on record in biotech and most successful venture capital exit in Australia’s history.

AusBioFEATURE – AusBiotech’s 30th year

Influential people in biotech In 2015, Scientific American Worldview: A Global Biotechnology Perspective named AusBiotech’s CEO Dr Anna Lavelle among the 100 most influential people in global life sciences, as determined through nominations and selections from an international panel of experts and peers. Julie Phillips, Chairman of AusBiotech Ltd, said, “It is a great honour for Anna to be recognised in this way, but especially to be the only Australian named in this global group of respected, visionary and eminent people. Also on the list was fellow geneticist Craig Venter, whose work to sequence the human genome is legendary in biotech circles, and the Bill and Melinda Gates to give you an idea of the calibre of the list. It reflects very well on AusBiotech, which has gone from strength-to-strength under Anna’s leadership, which also delivered to the industry the landmark reform, the Research and Development (R&D) Tax Incentive. Anna is quite rightly proud of her part in delivering this initiative and we each have much to thank her for – not the least of which is hundreds of millions of dollars returned to the sector in cash refunds under the R&D Tax Incentive. Anna is a talented, tenacious and dedicated advocate for our industry.” From Deborah Rathjen immediate-past Chairman of AusBiotech: “Anna is such a passionate person. Her commitment to the Australian life science and biotech sector is unwavering and she is absolutely focussed on ensuring that the industry has the right framework to operate successfully and we’ve seen a lot of advances under Anna’s leadership. Her dogged determination was particularly important through difficult times such as the GFC when

all the industry innovation programs were cut. She played a key role in keeping the sector moving forward even during this period. Anna is absolutely singled minded on ensuring the industry is soundly based and she has enabled our industry to take its place on the global stage. More importantly, Anna is a really delightful person to work with. She has a big heart, is truly compassionate and she’s always there to support the people around her, as much as we are here to support her.” Anna achieved 10 years service as AusBiotech’s CEO in June 2015. During 2015 AusBiotech’s COO, Glenn Cross, also achieved a decade of service to AusBiotech, its members and the industry. Together Anna and Glenn have re-visioned AusBiotech and seen exception growth. They have delivered a strong and influential network of biotech and medtech companies and related organisations and a better policy environment for Australian companies. Dr Deborah Rathjen was the longest-serving Chair of AusBiotech, serving six years from 2008 to 2014. She also represented AusBiotech as the Chair of the Pharmaceutical Industry Council. In 2015 Dr Rathjen was included in the Top 50 most influential Australian business women by The Australian newspaper. Dr Anna Lavelle said: “Deborah steered AusBiotech through its most rapid change period. Her leadership was essential to securing the changes which added strength to the organisation. Whilst successfully leading her own company, Bionomics.”

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AusBioFEATURE – AusBiotech’s 30th year Dr Martin Playne is the founder of the Australian Biotechnology Association (ABA), which is today known as AusBiotech. He was the number one member as well as the inaugural President and Chairman, and is an Honorary Life Member of AusBiotech. For 18 years Martin was editor of the ABA’s and AusBiotech’s publications, from 1986 to 2004. Dr Peter Riddles was President of the Australian Biotechnology Association (ABA) from 2000, when he chaired the Steering Committee that recommended and oversaw the transition to AusBiotech, and became the inaugural President of AusBiotech. He was elected as a Director of ABA in 1995 and continued to serve AusBiotech’s Board until 2004. Dr John Ballard is one of the founding leaders of Australia’s biotechnology industry and played a key role in setting up AusBiotech. He is cofounder and current Chairman of BioAngels and has taken particular interest in starting innovation centres and seed funding capital to support spin-out companies from universities and other public sector institutions. He was Managing Director and previously CEO of GroPep Ltd until 2002, positions he held since the inception of the company in 1988 and through its listing on the ASX in 2000. Dr Simon Carroll was a long-serving AusBiotech Board member, having been a passionate and active participant from the inception of AusBiotech until his retirement in 2010. It is widely recognised that he has been an overseer to the growth and development not only of AusBiotech as an organisation, but the wider biotechnology industry in Australia. The contribution made by Dr Paul Walton (1956 – 2013) to the AusBiotech board provided invaluable leadership to our industry and great support to his fellow board members. Paul joined the board of AusBiotech in 2010, while Senior Vice-President of Corporate Development at CSL, where he was responsible for corporate strategy, opportunities for corporate growth including mergers & acquisitions, and was Secretary of the CSL Board Innovation and Development Committee. Mr Leon Serry was the founder and managing director of Circadian. He has made an outstanding contribution to the Australian biotechnology industry and academic and 12

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commercial sector. Leon has pioneered the development of a vibrant Australian biotechnology industry based on innovative technology transfer from the Australian medical research community throughout the last 20 years, overcoming significant scepticism and numerous funding crises. A few years ago, Sir Gustav Nossal, AC, CBE described Leon as the father of the Australian biotechnology sector. Professor Maree Smith is an exceptional researcher capable of prolific discovery of novel therapeutics and able to achieve translation of these discoveries to clinical practice. Professor Smith’s passion to see more academic discoveries commercialised in Australia saw her lead the establishment of the Centre for Integrated Preclinical Drug Development (CIPDD)/ TetraQ at the University of Queensland to make it easier for academics to translate their own discoveries and for industry to access rare capabilities in Australia. Dr Chris Nave is a leader in commercialising early stage medical research technology in Australia. He drove the formation of The Medical Research Commercialisation Fund (MRCF) Collaboration in 2007 as an innovative collaborative approach to investing in early stage development and commercialisation opportunities emanating from Australian medical research institutes and allied research hospitals. Dr Greg Collier has played a significant role internationally and domestically in promoting Australia’s leadership in biotechnology development and commercialisation. Under Greg’s leadership ChemGenex was the first Australian company to submit a New Drug Application (NDA) to the US Food and Drug Administration for a cancer medicine. Dr Sue Meek AO has been the Chief Executive of the Australian Academy of Science since May 2008. She has over 30 years of experience working in a variety of capacities at the interface of industry, academe and government. Her particular interests are in promoting awareness and understanding of science and technology, and the formulation of policies and programs to stimulate the conduct and application of strategic research and development. Prior to her current position, Dr Sue Meek was Australia’s inaugural Gene Technology Regulator from December 2001.

AusBioFEATURE – AusBiotech’s 30th year AusBiotech, and the biotechnology industry more broadly, very much appreciates the role and support of state and federal governments. The following people have had the greatest positive impact on the sector. The Hon Peter Beattie for many years was one of biotechnology’s leading public advocate at home and overseas. Stephan Wellink said: “I was at BIO ’99 in Seattle when Peter and others effectively launched ‘Biotech Down Under’ to the world. It was the first time Australia presented a coordinated approach at an international biotechnology forum. Peter’s leadership ensured that other state and federal leaders looked on biotechnology as a serious contributor to society and important to the economy.” Among his many achievements, The Hon John Button (1933-2008) is particularly remembered for the factor ‘f’ pharmaceutical industry scheme and its subsequent successors, which had a massive impact both in terms of international pharmaceutical investing and forming partnerships with local firms. The Hon John Brumby made a significant contribution to biotechnology while in public office. He understood the importance of biotechnology and innovation to the economy. The Hon Ian McFarlane MP has held several ministries, including most recently Minister for Industry and Science (2014-2015) and Minister for Industry (2013-2014). As Minister for Industry, Tourism and Resources (2001-2007) his portfolio provided $20 million for a series of initiatives to develop Australia’s biotechnology sector and support for the development of a national approach to the industry. Dr Anna Lavelle said: “Premier Brumby’s first official function as Premier was to open the Australian Synchrotron, a major project that he was instrumental in attracting. He has demonstrated clearly, both as Victoria’s first Minister for Innovation and as Premier, a persistent and sophisticated support of biotechnology and we appreciate his leadership role.”

Among the many notable scientific discoveries, some have changed the world: Sir Gustav Nossal AC, CBE has made an enormous scientific contribution with his groundbreaking research work on the immune system, which earned him a knighthood in 1977. Gus Nossal ran Walter and Eliza Hall Institute of Medical Research in Melbourne for more than 30 years and in 1996 he was one of the founders of Foursight, a company providing advice on R&D and science to companies, investment institutions, academics and government. The Nossal Institute for Global Health, established in 2006, is named in honour of his commitment to translating medical research into health for all, and utilises the multi-disciplinary research and educational capabilities provided by the University of Melbourne to build and exchange knowledge to improve health in areas where it is most needed. Professor Graeme Clark AC profoundly changed lives for more than 350,000 people around the world with the development and commercialisation of the cochlear implant. Dr Elane Zelcer said: “It required extraordinary tenacity from Professor Clark and his team, management of the convergence of different technologies (medicine, engineering, electronics, materials), financing through a joint venture and knowledge of how to take a highly innovative product to market.” Ranking among Australia’s most successful biotechnology success stories is the work of Professor Ian Frazer AC and his team on the human papillomavirus vaccine for cervical cancer, Gardasil. From its origins in ground-breaking research at The University of Queensland (UQ), to its use in over 120 countries worldwide, it is saving the lives of 250,000 people every year. Dr Anna Lavelle said: “Professor Frazer’s leadership has demonstrated exceptional success in navigating the research, clinical trial and commercialisation pathways that are essential for success in this industry. Dr Barry Marshall AC won a Nobel Prize for discovering the bacteria that cause stomach ulcers believes the same bugs can be used to deliver vaccines that protect against swine flu and other diseases.

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AusBioFEATURE – AusBiotech’s 30th year Below, we remember some of the scientists and industry leaders who defined and shaped the industry. Emeritus Professor Nancy F Millis, AC, MBE (1922 – 2012) was an extraordinary woman and pioneer of early Australian biotechnology, and a Life Member of AusBiotech. Nancy Millis was one of the pioneers of the study of fermentation technology in Australia. Prof Millis’ areas of interest lie in the general field of biotechnology, more specifically in fermentation, wastewater and environmental biotechnology. She was a highly respected researcher, educator, and policy-maker who oversaw the development of science-based regulation of gene technology in Australia. The Millis Oration was named after Nancy and has been held annually at the AusBiotech national conference for over a decade. The Oration is a focal point of the annual industry gathering and is appropriately named in honour of this pioneer of Australia’s biotechnology industry. Professor Millis is one of only a handful of scientists to be honoured with her own “Australian Legends” postage stamp and in 2006 the bacterium Millisabrevis was named in recognition of her contribution to water microbiology. Paul Trainor AO (1927 - 2006) is remembered as the ‘father of Australia’s medical device industry.’ Marilyn Sleigh said: “He was the founder of the Nucleus Group whose companies (Cochlear, Telectronics) are the basis of Australia’s successful medical devices industry and the training ground for many of its successful executives.” Dr Andrew Baker (1961 - 2012) was a partner with GBS Ventures and had sat on the board of several biotechnology companies, including Hatchtech, Spinifex, Verva, Euthymics and Xenome. He led the initial GBS Venture Partners’ investment in Spinifex that, along with parallel investments from UIIT and Symbiosis, established the company and set Spinifex on the path to develop innovative pain medicines. He was a founding Board member of Spinifex Pharmaceuticals and Chairman through to December 2011. He had over 28 years’ experience in the pharmaceutical and biotechnology industries, and had worked for 14

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companies such as Genentech, Bayer and Johnson & Johnson. He was involved in founding of several listed companies and assisting them with commercial growth and product development, combining his scientific and industry expertise. Dr Geoff Grigg (1926 - 2008) former CSIRO Chief of the Divisions of Molecular Biology and Biotechnology, was way ahead of his time in seeing the commercial possibilities in bioscience and was instrumental in the foundation of companies in Australia and the UK that have been collectively valued at more than $1 billion (Bioclone, Peptech (Arana), Betapeptide and Human Genetic Signatures in Australia, and in the UK, Cambridge Antibody Technology and Domantis).” The late Dr David Evans AM was integral in the formation of Australia’s first university-based venture capital fund, Uniseed. David served as CEO of the Uniseed fund from its inception in late 2000 until June 2002, after leaving his position as Managing Director of UniQuest, where he worked from 1994 to 2000. He was later Executive Chairman of Magnetica from 2004 until 2009. In 2013, David was honoured with a Member of the Order of Australia “for significant service to science and innovation through commercialising and developing new technologies”. David helped to launch many innovations throughout his career. He also mentored many of the commercialisation professionals now leading Australia’s efforts to promote our innovation resources globally, including tech transfer specialists, venture capitalists, intellectual property advisors and researchers. Dr Paul Priscott (1950 – 2014) founded AMS Laboratories in 1996 in Sydney, to provide worldclass microbiological testing and consulting services for, amongst others, the pharmaceutical, biotechnology, medical device and cosmetic industries. Before founding AMS Laboratories, Dr Priscott held positions in commercial, academic, research and government laboratories. He was committed to science and the industry, and held membership and leadership of several committees and technical working groups of the TGA, ACCORD and Standards Australia. He was also an industry representative on the NATA Council and Convener of the Cosmetics and

AusBioFEATURE – AusBiotech’s 30th year Pharmaceuticals Special Interest Group (CAPSIG) of the Australian Society for Microbiology. Life sciences executive and medical imaging (echocardiograph) specialist, Barry Epstein (1951 – 2014), was Vice President Marketing of Proteomics International and a longtime supporter of the biotech sector in Western Australia, serving on the WA Branch Committee of AusBiotech in 2007. Dr Richard Lipscombe, Managing Director of Proteomics International, said: “Barry was an insightful and inspirational man who threw himself into projects with enthusiasm and positivity. His life science career spanned the globe and in Western Australia we reaped the benefit of that experience, exemplified by his passion for biomarker discovery and his crucial involvement in developing a molecular diagnostic test for kidney disease. Barry lived his life to the full, enjoying both travel and work until the very end, and he will be a motivation to us all to discover new ways to improve medical treatments. A marketing and business development expert with international and national experience in the biotechnology industry, Barry also worked in the not-for-profit sector and was involved in several multi-million dollar capital campaigns for Australian healthcare organisations. He was responsible for generating $20 million to establish the WA Institute of Medical Research and worked with the Board Chairman of Wesfarmers and other industry leaders and medical researchers for that purpose. Alan Woods (1926 – 2014) was a founding father of angel capital investment in the Australian biotechnology industry. He was a successful entrepreneur and together with family members built David Bull Laboratories, which was later sold to Faulding. He had an unusual mix of technical understanding, commercial savvy and vision which led him to become a founding investor in Biota Limited, one of Australia’s earliest biotech start-ups. This continued a legacy of his grandfather’s interest in influenza treatment, which never wavered. Alan not only invested in the sector but supported other entrepreneurs and for example, was crucial in the establishment of Medica Holdings Limited, a listed Pooled Development Fund. Medica went on to establish several other biotechnology companies.

Dr Michael Hirshorn OAM (1950 - 2011) was Director of Sydney-based Four Hats Capital and had a 30 year career of founding, building, managing industry heavyweights and investing in technology companies. He was a founder and CEO of Cochlear, and a founding director of ResMed and his contribution to the industry was highly respected. In 1988 he won BRW Businessman of the Year (Technology) for establishing Cochlear in the US Europe and Japan and in 2004 Mike was awarded an Order of Australia Medal for his work in commercialising medical technology. Dr Michael Dalling AM (1946 - 2010) was a pioneering biotechnology scientist and business leader. His contribution to research and development of biotechnology and its commercialisation in Australia was well known and highly respected. Michael had worked for many years on the transfer of gene-technology into floriculture, and headed, as MD, the first biotechnology company, Calgene Pacific which worked on producing the previously elusive ‘blue’ rose and carnation. The company later became Florigene, which commercialised the blue carnation. Michael led the Victorian Government’s Strategic Industry Research Foundation (SIRF) for many years, where he assisted Victoria’s manufacturing industries. Under his leadership, SIRF coordinated the creation of the Australian ‘concept’ car, pioneered the creation of value from research initiatives and developed a number of alternative business models, including ceramic fuel cells. While at SIRF, it was with his influence that Victoria became a major supporter of the Cooperative Research Centre (CRC) initiative commenced during the Hawke Government and which continues to this day. Alastair Lucas AO (1952 – 2015) was chairman of investment banking at Goldman Sachs Australia. He was the founding chairman of the MRFF Action Group, a coalition of stakeholder groups established to back creation of the Abbott Government’s $20 billion endowment fund for health and medical research. Mr Lucas was also chairman of the Burnet Institute from 2002-2014 and a Research Australia Director from 2012-2014. He was an insightful and active supporter of the Australia medical research and biotechnology sector. Volume 26

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AusBioFEATURE – AusBiotech’s 30th year Leading Australia’s industry organisation: a timeline 1985

1990 1991

1995 1996

2000

1985 - 1990

1994 - 1995

1999 – 2000

Inaugural President and Chairman of the ABA Council: Dr Martin Playne (CSIRO)

President: Dr David Fisher (Peptide Technology)

President: Dr Peter Rogers (CUB Brewtech)

1990 – 1991

1995 - 1996

President: Mr John Grace (Sirotech, CSIRO)

President: Dr John Smeaton (Bresatic Ltd)

1991 – 1992

1996 - 1997

President: Prof. Peter Gray (University of NSW)

President: Dr Graeme Woodrow (Biotech Australia)

1992 – 1993

1997

President: Prof.Neil Willetts (Biotech Australia)

President: Dr Ian Nisbet (CSL)

1993 – 1994

1997 - 1998

President: Prof. Milton Hearn (Monash University)

President: Prof. Joan Dawes (CRC for Biopharmaceutical Research; BioDiscovery Ltd)

1998 – 1999 President: Dr Anne Campbell (CRC Association)

1985

1990 1991

24 December 1985 the Australian Biotechnology Association is incorporated as company limited by guarantee. By April 1986 it had 94 members and the first elections were held 26 August 1986 with 331 members eligible to vote.

1995 1996

2000

The ABA’s first permanent employee: Barbara Arnold, Company Secretary, 1988 - 2000

April 1987: Membership exceeds 500 2000 46 ASX-listed companies with combined market cap of $14.3 billion, plus 151 private companies.

1985 10 ASX-listed companies (no market caps on record until 1989).

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AusBioFEATURE – AusBiotech’s 30th year 2001

2005 2006

2010 2011

2016

2004 – 2006

2014 – Current

Inaugural Chair of the AusBiotech Board: Professor Simon Carroll (Advanced Ocular Systems)

Chair: Julie Phillips (BioDiem Ltd)

2000 - 2004

2006 – 2008

Inaugural President of AusBiotech: Dr Peter Riddles (IMBcom)

Chair: Dr Susan Pond (Johnson & Johnson Research)

2008 – 2014 Chair: Dr Deborah Rathjen (Bionomics) AusBiotech’s longest-serving Chair

2005 – Current AusBiotech’s inaugural Chief Executive Officer, Dr Anna Lavelle, achieved 10 years service to AusBiotech in 2015 and was named among the 100 most influential people in global life sciences (Scientific American Worldview)

2001 – 2005 Executive Director: Dr Anthony Coulepis

2001 May 2001 the ABA becomes AusBiotech, after a vote at the 2000 AGM.

2005 2006

2010 2011

2004 Dr Martin Playne retires as Editor of Australasian Biotechnology (formerly ABA News) and after 18 years as Editor.

2016 2014 and 2015 Australia ranked fourth in the world for biotechnology innovation (Scientific American Worldview). AusBiotech has more than 3,000 members.

AusBiotech’s Chief Operations Officer, Mr Glenn Cross, achieved 10 years service to AusBiotech in 2015. 2005 Membership reaches 2,600 2011 111 ASX-listed companies with combined market cap of $39 billion, plus 1100 private companies. Volume 26

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2015 89 ASX-listed companies with combined market cap $50 billion, raised $1.1 billion in primary capital.

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AusBioFEATURE – AusBiotech’s 30th year

Dr Anna Lavelle, CEO, AusBiotech

Disrupting the paradigm Dr Anna Lavelle provides her views on the new thinking that is needed to enable Australians to realise the potential of biomedical healthcare. Over the years, I have publicly lamented the fact the innovation has always been a difficult ‘sell’. Not so anymore, it seems the entire country is on-board with the Federal Government’s innovation agenda. We too at AusBiotech have welcomed the focus on innovation and commend the Government for its foresight. However, in the discussions than have eschewed, it has become clear that there are widely differing views on what innovation is, what it could be and what it should be. While I will defer on my chosen definition, I contend that if we want to realise the benefits of our comparative advantage in biomedical

technology, our models for thinking and planning for our healthcare in the future must be disrupted. We need to apply innovative thinking to some key access issues. Innovation lives in the future and many find the future difficult to conceive and even more difficult to fund. The modern world is beset with issues of grave significance – from climate change, cleansing waste streams, food production and quality, alternative fuel developments, through to the ills experienced by ageing populations. Individuals alive today are part of an active revolution, which has taken the building blocks of biology and applied them to a wide range of important problems, especially in healthcare. Australia has a proud and long history in medical research, and boasts more Nobel laureates than

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AusBioFEATURE – AusBiotech’s 30th year any country on a per capita basis, with five living Nobel Prize winners. Australia is number four globally in the area of life sciences innovation. We are solving the technology issues and finding cures and treatments that 20 years ago we thought impossible, but our thinking in policy terms has not kept pace and remains rooted in outdated but familiar models and paradigms. My case-in-point is the Pharmaceutical Benefits Scheme (PBS). It’s a brilliant and popular scheme, no doubt, but it is the only ‘game in town’. If a product is not listed on the PBS, the product is in most cases unavailable to patients in Australia. Even if you’re willing and able to pay for it yourself, it’s unavailable. In this context the pressure on the Government and sponsors to list products is relentless and conversely the pressure on the Government to contain costs is also relentless. With the ‘face’ of personalised medicines changing rapidly to low volume, higher cost treatments, this is a pressure cooker in need of some innovative thinking to act as a valve. An example of innovative thinking was the establishment of the Medical Research Future Fund (MRFF), which was broadly welcomed as a visionary nation-building investment for Australia. It is the biggest medical research fund of its kind in the world and has clear and desirable benefits for Australia’s future in both improved medical outcomes and economic benefits. There are clear benefits from providing enabling support to health and medical research, including: a healthier and more productive workforce, which is especially important as we move to increase workforce participation among older Australians; a more efficient and continuously improving healthcare system; growing Australia’s medicines industry, already worth $4 billion in annual exports; and attracting private investment to Australia and creating high-value jobs. There is also a clear benefit in enabling better access to the new medicines and treatments. An example of the future of healthcare is Australian companies that are currently developing gene therapies that are personalised one-dose cures. Imagine the ability to cure a leukaemia in one dose. From a technology

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perspective, this is around the corner, but from a policy perspective, how does the patient get access? What is it worth to you if treatment can prevent years of therapy, years of pain, years of lost productivity, years of quality-of-life loss and years of not using the PBS? This example challenges all our current models and programs; from manufacturing to regulation, to clinical trials to listing on the PBS. This is where we need innovative ideas and bold policy. It is time we disrupted the paradigm and entered a discourse on options to fund our future healthcare in earnest. Perhaps we need a scheme that starts saving for healthcare from birth; or perhaps a private insurance option would work. This issue of innovation – both products and thinking - is one of national importance. It sits at the heart of what Australia will be in the future, of the life-span of Australians in the future and what we have to offer the world.

AusBioFEATURE – AusBiotech’s 30th year

Biotech – the last 30 years Dr Stewart Washer Chairman Orthocell (ASX:OCC) and Chairman Cynata (ASX:CYP) Someone at a party asked me recently what I did as a job. This was a hard one. I sit on a number of biotech boards surrounded by much smarter fellow Directors and brilliant CEOs who do all the hard work. What could I be adding to these companies to keep me around ? I came up with a glib very modest answer, “I predict the future”. The more I thought about this, the more I liked it. We all need to predict the future in the fast moving world of technology, otherwise we will be superseded or go down the wrong path. We may feel like the last guy to pay $425,000 for a Sydney taxi license in 2011…the year One BU (Before Uber). Stem Cells R Us I believe that art can sometimes predict the future, particularly science fiction. 1985 was a wonderful year in film with Back to the Future and Cocoon released. Cocoon was a film about a group of elderly residents from a retirement village who get their diseases cured and rejuvenated by swimming in a pool they discover inside a nearby disused holiday home infused with an Alien life force. OK, you probably see why I am not a movie reviewer now. However, it looks like these Aliens may have been using stem cells back then. We humans took another 14 years to isolate stem cells in 1998, when Prof James Thompson isolated human embryonic stem cells from a blastocyst, and are only just

now releasing our first stem cells medicines to the market. One of the most exciting areas in stem cells was the more recent discovery of Induced Pluripotent Stem Cells (iPSCs) by Prof Yamanaka in Japan and Prof James Thompson, once again taking a lead in stem cell research. The amazing thing about these stem cells is that they are very similar to embryonic stem cells but are produced from adult cells, blood or other cells using reprogramming techniques. No more need for controversial use of blastocysts/embryos. Show me your DNA DNA was also first used in a crime case in 1985. DNA fingerprinting developed by Prof Jeffreys (Uni Leicester) allowed a boy from Ghana to be legally reunited with his mother in the UK. Prof Jeffreys then went on to use his DNA technique to solve a number of murder cases and other crimes. Criminals of the world and unexpected Dads now both lived in fear. We have indeed seen some great advances in the past 30 years in biotech, however we have also seen a great deal of biotech that has been slower to develop then we first thought. Stem cells were going to make paralysed people walk and the human genome project was going to grant a range of immediate miracles. We have not seen these yet but we are making good progress.

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AusBioFEATURE – AusBiotech’s 30th year

Biotech – the next 30 years Gut Bugs Those of you who are as old as me may remember the 1978 audio tape of War of the Worlds accompanied with great music by the Moody Blues. At the end of the story, the Martians all die from the bacteria that inhabit the earth. We are saved by the bugs. We are actually inhabited by a multitude of bacteria, particularly in our gastrointestinal tract, that control our health far more than we imagined. In the future we will see a great outcome of the current efforts in directing our microbiome to improve our health. We will control a range of currently devastating inflammatory and autoimmune diseases using modified gut bacteria. This will represent a massive market and large pharma will move into this area soon. I think even mental health may benefit from this field, including depression. We may all be happy and slim in the future. Brain wave The next few decades will also create large advances in neurobiology and brain computer interface. There is significant funding going into these areas from the US and Europe currently. I would predict that we will see mind controlled

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computers soon. Early work has made some real advances here already. This will be interesting once mixed with a dose of Artificial Intelligence, Robotics, Drones and Virtual Reality. What an exciting time to be around! Grow me a new liver Studies to date on regenerative medicine have made good progress in using mesenchymal stem cells (MSCs) injected directly into the body against a range of diseases, including heart disease, stroke and Crohn’s disease. We will see these treatments approved and released to the market soon. I think beyond this we will see great advances in the treatment of a range of autoimmune diseases from stem cells. 3D printing of new organs is definitely an area to watch where living cells are printed onto a collagen scaffold and grown in a bioreactor. Let’s drink to that. The next 30 years will be amazing as nanotechnology also grows up and starts to play in biotech. I really think the era of the brain is upon us as well and we will see some really exciting breakthroughs. Here’s to a terrific 2016! Welcome to the future.

AusBioFEATURE – AusBiotech’s 30th year

Recollections of 30 years of biotechnology Dr Martin Playne, Founder and first President of the Australian Biotechnology Association (ABA), today known as AusBiotech, looks back over what has changed in the last 30 years, what new developments and discoveries have occurred in the biotechnology area, and what AusBiotech and its predecessor organisation, the ABA, have achieved over that time. A recent catalogue search of the State Library of Victoria using ‘biotechnology’ as the search term revealed over 1,000 entries. Searching for ‘Australian biotechnology’ showed 98 entries. However when one searched that same term for articles, then 11,000 entries are found. This alone indicates how established biotechnology has become in the last 30 to 50 years. I think it is also important to consider the mistakes and failures that have occurred in this broad industry sector of biotechnology, and where the industry body may have done things better or differently in the last 30 years. Biotechnologies or biological technology as it was known earlier goes back a long way to the making of cheeses and fermented milk and meat products, and alcoholic beverages in western society, and just as far back in Asian and African societies, with a huge range of fermented products. Once discovered, microbial fermentation was widely used to preserve foods through a natural acidification process. Indeed, such fermentation processes are still the basis for preservation of foods. In more recent times, it has been recognised that some natural fermentations can also provide the consumer with health benefits, e.g. the probiotics found in bio-yoghurts, and on the pharmacist’s shelf. Fermentation processes were also used to produce many amino acids, and antibiotics, and a number of chemical commodities. Fermentation is widely used to treat biological effluents and to produce methane. We scarcely think of these well-established processes as part of biotechnology because they are regarded as mature technologies. Yet, improvements to

such processes can immediately lead to high economic returns. Biotechnology became established as a research field in Australia in the late 1970s. At that time, a major part of the biotechnology research effort by CSIRO and the universities was connected to fermentation processes. This was reflected in the papers presented at that time in the bi-annual biotech conferences. Fermentation processes were also being developed to produce fuels from biological materials (starch wastes, wheat straw, bagasse, pig waste, forestry residues). The late 1970s were a time when there was an oil crisis. Sound familiar? Funding for such research virtually ceased by 1985, when the crisis had passed, although much progress had been made. The knowledge developed has gone unrecognised for the most part – it was published in pre-digital days and today’s computer searches do not find it. Monoclonal antibodies were ‘the talk of the town’ in the early 1980s, but in reality have taken a long time to become established commercial processes. Polyclonal antibodies were a separate story, as immunological products and techniques were becoming increasingly important in medicine. Volume 26

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AusBioFEATURE – AusBiotech’s 30th year Genetic technologies had only just started to have a commercial impact by 1975, following the unravelling of the secrets of DNA and the double helix in the late 1950s. Genetic manipulation of bacteria, yeasts and mammalian cell lines was very much the domain of the ‘gene jockeys’ in the higher echelons the biochemistry departments of elite universities. There was only a weak connection between the more industry-oriented biotech researchers and the more academic gene jockeys. Thus, up until about 1985, the use of genetic technologies in the old biotechnologies had scarcely occurred. Biotechnology was the province of the plant and microbial scientists and waste treatment engineers. The genetic studies were mostly slanted to the more profitable medical industries, due to researchers’ proximity to leading medical research institutes, such as Walter and Eliza Hall, the Florey and Garvan Institutes. In 1985, the connection was weak and this is reflected in the content of the biotechnology conferences of that time, and the main thrust of the then biotechnology association (ABA). Both sides of the equation had recognised the need for a rebalancing of effort, but it took time. The fermentation industries were realising the potential of genetic manipulation, as were plant industries, and the medical research fraternity were realising the need for biotechnology processes and the need to scale-up. Molecular biologicals had become almost by default some of the earliest medical products on the market using the new biotechnology. Much of their development was due to the development of scaled-up chromatographic methods and new membrane technologies for product separation and purification. Our 1993 survey of biotechnology in Australia (Fayle and Playne, 1993) showed that along with molecular biological companies, diagnostic companies were also a major component of the emerging biotechnology companies. Vaccine technology was well advanced in Australia, largely through the efforts of CSL. I believe that CSL can be credited for its efforts to commercialise medical research and link it strongly to biotechnology – its success stands out against that of the pack of smaller start-up

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companies. It indicates to me the need for the Australia Government to give long-term strong support to develop the larger research-oriented companies, such as occurred with CSL many years earlier. I would be remiss if I did not discuss the continuing embargoes by several States against genetically-manipulated crops (GMOs). The industry has failed quite badly in this area. Why? The original ABA formed a Genetic Release Sub-committee headed by Dr Sue Meek in its early years, it produced a number of explanatory leaflets on genetic manipulation for schools, and provided forums for issues to be debated. Perhaps we took a ‘too scientific’ approach rather than using media-based persuasion. The opponents to GMOs mostly had no science training and argued on the basis of scare tactics and falsehoods, they targeted conservative farmers and politicians and the organic lobby. One could say that so far they have won, despite overwhelming practical evidence of the benefits of most GMO crops – higher yield, greater pest resistance, and higher nutritive value. All tremendous benefits particularly to the poorer countries of the world, and all very necessary properties for an ever-growing world human population. We have achieved a great deal. The biotech organisation has grown from its first seven subscribers and no staff nor funds in 1985 to a highly successful AusBiotech in 2016, solidly funded, with some 3,000 members. It has evolved into a highly-successful representative and lobby group for the broad biotech industry, covering medical, veterinary, fermentation, agricultural and environmental industries successfully and incorporating the biotech instruments and equipment and the medical devices industries. My congratulations to all those involved in taking AusBiotech to this stage. Happy 30th Birthday. Reference Fail, D. and Playne, MJ (1993) Biotechnology in Australia in 1993 IN Australian and New Zealand Biotechnology Directory 3rd Ed (Eds: Playne, M and Arnold, B) (ABA, Melbourne) p 7- 14.

AusBioFEATURE – AusBiotech’s 30th year

The people who founded Australia’s industry organisation; where are they now? A look at the people who started the Australian Biotechnology Association and AusBiotech and what’s happened since. It’s been more than 30 years since the Australian Biotechnology Association (ABA) was established in December 1985 to provide a strong network of support and range of services for the biotechnology industry. Behind the scenes an active and dedicated group of people voluntarily worked together to make their vision a reality – a thriving biotechnology industry for Australia. Fifteen years later another group of equally dedicated people re-shaped the organisation and shepherded it in its transition to AusBiotech. Below we take a closer look at those past directors of both ABA and AusBiotech, featuring their career highlights during and since their roles with ABA and AusBiotech. The expertise and knowledge of past ABA and AusBiotech directors shows the breadth of experience that has led the organisation to becoming Australia’s biotechnology industry organisation. The first formal meeting of the ABA was held February 1986 in Melbourne. According to the first ABA Bulletin (May 1986) which later became Australasian Biotechnology, the ABA had 94 members and eight appointed directors on the inaugural Council. The Council also appointed three members as representatives of those states and territories not represented by directors. These appointments were made until official elections were held in August 1986 and included the following people… Dr Martin Playne (Chairman and President) Martin was the founder of the ABA and the number one member as well as the appointed Chairman and President for the first six years. Martin stepped down from the Board in 1991,

but has continued his involvement to this day. He was elected to the Board in the first elections in 1986 and appointed Chairman and President, continuing on the Board of Directors following ABA’s first board elections. For 18 years Martin was also Editor of the ABA’s and AusBiotech’s publications, from 1986 to 2004. Martin’s career began as a research scientist with CSIRO and from 1965 until 1977 he was involved in tropical pasture chemistry and ruminant nutrition in Townsville. He was then invited to join a new research team in Melbourne to develop liquid fuels from ligno-cellulosic biomass by fermentation. In 1982, funding for energy research ceased. He then focused on production of highvalue chemicals and polymers by microbial fermentation, before working on functional foods, including the production of oligosaccharides by enzymic synthesis, and the use of probiotic bacteria. His team developed improved new probiotic strains with good health efficacy. Three of these are available in the international marketplace. He left CSIRO in late 1999. Martin’s professional career included collaboration in the CRC on Food Innovation (CSIRO 3 Divisions, UNSW, DSM, Arnotts, Goodman Fielder, Burns Philp), and he was Program Leader with Probiotics in the CRC from 1994 until 1999. Martin says he likes to think of himself as a microbial biochemist with an international reputation and part of the international community of scientists. “I highly value the development of a good research team, run on democratic principles, supportive of and loyal to each other,” he says. Martin said the biotech organisation was established as “communication between scientists in those businesses and those in academia or government was very limited.” The ABA was to provide a neutral forum for scientists, engineers and technologists from both commercial businesses, and from academia and CSIRO, and it was also obvious that there

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AusBioFEATURE – AusBiotech’s 30th year was a need to formalise the emerging biotech conferences under some sort of organisation.” Martin was from 2000 to 2009 Director of Melbourne Biotechnology, a small consulting business providing services primarily in functional foods and specifically in probiotics and oligosaccharides as prebiotics – and closed the business in 2009. Since then he has continued to do some scientific writing and peerreview articles in international scientific journals in his retirement and enjoys doing historical research and writing, sailing, hiking, playing grandparent, gardening, and volunteering on a couple of committees. He published his first book on life in the colony of Port Phillip in 2014 (“Two Squatters”), and is currently writing a second book on the great will forgeries of 1844. Martin is an Honorary Life Member of AusBiotech (bestowed in 2000). Dr Peter Gray (former President) Peter was a founder of the Australian Biotechnology Association (ABA) and served as a Director from incorporation in 1985 until 1992, as VicePresident (1990) and as President from 1991- 1992. At the time that ABA was founded, Peter was an Associate Professor in the Department of Biotechnology at the University of New South Wales (UNSW), having returned a few years earlier from working in the US. Named as one of Australia’s 100 Most Influential Engineers on several occasions, Peter is a Fellow of the Australian Academy of Technology and Engineering (ATSE) and the Australian Institute of Company Directors. Peter is a member of the Boards of ATSE, Biopharmaceuticals Australia Pty Ltd, ACYTE Biotechnology Pty Ltd, ECI Inc in New York, and serves on a number of State and Federal Government Councils and Committees. Peter has had commercial experience in the USA working for Eli Lilly & Company and for the Cetus Corporation, and has previously held academic positions at University College London and at the University of California, Berkeley. Before joining the University of Queensland, he was the Professor of Biotechnology and Director 26

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of the Bioengineering Centre at UNSW, and a Senior Principal Research Fellow at the Garvan Institute of Medical Research in Sydney. He is an Honorary Professor at Fudan University, Shanghai, China, and is an Emeritus Professor at UNSW. He was appointed inaugural director of the Australian Institute for Bioengineering and Nanotechnology (AIBN) at the University of Queensland (UQ) in 2003. He and his colleagues have since built AIBN to an institute of almost 500 people with a culture of outcome-driven research excellence. Through his role with ATSE he has been championing the introduction of a metric to measure research engagement between public and private sector researchers in Australia, the ‘Research Engagement for Australia’ metric, REA. In December 2015 was appointed as the Acting President of ATSE. Mr Kevin Kirby Kevin continued as an elected ABA Director after the 1986 board elections until 1992. He was involved with research and development activities with CSIRO, including discovery of a process for sugar fermentation in low fibre crops into ethanol; development of batch and continuous pilot facilities for process evaluation; and design and pilot scale operation for wastewater treatment (anaerobic treatment of animal and industrial wastes to treat wastewater) and energy recovery in the form of biogas. Kevin’s projects included a two-stage anaerobic reactor for the treatment of low suspended solids wastewater; evaluation of hydrolysis of lactose from whey permeate; assessment of processes for the production of chemicals such as biotin, rutin, citric acid, riboflavin and insulin; development of a fermentation process for the production of the anti-cancer drug, Bleomycin, and the setting up for FDA approval of a 12,000 L production facility; and biotransformations for chemical synthesis. Kevin worked as a consultant and operative for IDT Australia and associated companies in the preparation of a 12,000 L fermenter facility at CSL for FDA approval and production of ‘Bleomycin’ for eventual export. He led a

AusBioFEATURE – AusBiotech’s 30th year consultancy with Bioplus Technologies to implement the two-stage anaerobic bioreactor for possible use with agricultural and industrial wastewater in Melbourne. Since retiring in 1994, he has devoted time to overseas travel, golf, lawn bowls, moving back to Queensland, home renovation, genealogy and keeping in touch with family and friends. Dr Merilyn Sleigh Merilyn continued as an elected ABA Director after the August 1986 elections until 1988. At the time of her election, she was a research scientist with the CSIRO, working with engineering mammalian cell lines for production of recombinant proteins. She also worked with CSIRO as a front-person in debates and public relations activities occurring during the first phase of public debate surrounding genetically modified organisms. In 1993 she became Research Director at Peptide Technology Ltd, one of Australia’s earliest listed biotech companies. Merilyn served as Dean of the Faculty of Life Sciences at the UNSW for four years, and in 2001 became CEO of EvoGenix, working with antibody engineering technology. She credits working with EvoGenix as a rewarding career experience. “The company developed its technology and product portfolio, acquired a US company, listed on the ASX and was eventually acquired by Peptech, which changed its name to Arana Therapeutics. The subsequent acquisition of Arana by Cephalon provided an attractive exit for EvoGenix investors and a welcome good news story for the industry.” Merilyn has consulted with companies and investors and currently works as a non-executive director across biotech, agricultural and food sectors. She has carried out advisory roles with CSIRO and the Garvan Institute and is currently a member of the Council of the University of Technology Sydney. At the time of incorporation, the Council appointed three state representatives:

Dr Sue Meek AO (SA) Sue joined the ABA in 1985 as its 30th member and was appointed as the ABA’s South Australian (SA) state representative. During this time she was consulting to the SA Government as Executive Officer of the SA Biotechnology Promotion. In 1988 she moved to Perth as the Manager for Biotechnology in the Technology and Industry Development Authority, and joined the Executive Committee of the ABA’s Western Australian (WA) state branch from 1998-2001. From 1991 to 1998 she chaired the WA Government’s Inter-Departmental Committee for Biotechnology Regulation and represented the State during two attempts (1993-5 and 1998-2000) to establish a national regulatory system. By then Sue was Executive Director of the Science and Technology Division in the Department of Commerce and Trade, and left to take up the appointment as the Australian Government’s inaugural Gene Technology Regulator in 2001. During her time in WA she was also a consultant to the Victorian Law Reform Commission for its 1989 report on Genetic Manipulation, prepared and presented the ABA’s submission to the House of Representatives Standing Committee on Industry, Science and Technology 1992 Inquiry into Genetically Modified Organisms, and served as Contributing Editor (Regulatory Issues) for Australasian Biotechnology from 1991-2001. She attended the 2001 national ABA meeting in Brisbane that voted for the decision to establish AusBiotech. In 2008 Sue was appointed to her current position as Chief Executive of the Australian Academy of Science. She is a Fellow of the Australian Academy of Technological Sciences and Engineering, a Director of Bioplatforms Australia Pty Ltd and the Australian Council of Learned Academies Secretariat Pty Ltd, and Chairs the Advisory Council of the International Life Sciences Institute’s Washington-based Centre for Environmental Risk Assessment. In 2013 she was appointed an Officer of the Order of Australia for distinguished services to science.

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AusBioFEATURE – AusBiotech’s 30th year Dr John Grace (President 1990 - 91) John was the second President of the ABA taking over from Dr Martin Payne in 1990, until 1991 and serving as a director from the formation of the ABA until 1992. He has been involved in the Biotech Industry since 1970, the old and the new. Prior to becoming President, he worked for Mauri Brothers and Thomson launching a new CSIRO based technology producing bacteria for cheese making. While President he held the position of Manager of the Sydney office of Sirotech, CSIRO’s commercialisation company specialising in the biotech area. He joined AMRAD, a biopharmaceutical company, as General Manager Business Development in 1987. He became CEO of AMRAD in 1990 and led the successful IPO that raised $70m in 1996. After stepping down from AMRAD in 2001 he has operated a consulting business and has been part-time CEO and director for a number of companies and government agencies. Currently he is the Chair of UniSA Ventures, a board member of the Polymers CRC and Chair of the ATSE Clunies Ross Award committee. He continues to advise researchers on the commercialisation of their research particular in biotech. Dr Peter Riddles (President 2000-04) Peter was President of the ABA from 2000, when he chaired the Steering Committee that recommended and oversaw the transition to AusBiotech, and became the inaugural President of AusBiotech. He was elected as a Director of ABA in 1995 and continued to serve AusBiotech’s Board until 2004. He was responsible for chairing the Forum at ABA2000 where the decision was made to appoint a Steering Committee to investigate the transition of the organisation. Peter retired as President of AusBiotech in November 2004 and was recognised by his efforts through Honorary Life Membership.

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Dr John Ballard John was the Vice President of ABA before its reshaping as AusBiotech. While with AusBiotech he held dual appointments of Managing Director of GroPep Limited and Chairman of PrimeGRO, guiding GroPep to a successful listing on the ASX. From 1991 until 1999 he was Director and CEO of the CRC for Tissue Growth and Repair. Trained in biochemisty, Dr Ballard has focused his research career on growth factors, particularly isolation, characterisation, and roles in protein accretion and metabolic regulation. John was a member of the Commonwealth Government’s Biotechnology Consultative Group and the SA Government’s Biotechnology Advisory Council, and filled roles as Board member of Flinders University’s Biotechnology Advisory Board and professor in biotechnology at the University of Adelaide. He is an inventor of many of GroPep’s patents and a recipient of several research awards including the Australian Society of Biochemistry and Molecular Biology’s Boehringer-Mannheim, LKB and Lemberg medals. He has served as Secretary and President of ASBMB and President of the Australian Perinatal Society. Since 2002, John has played a major role in establishing BioAngels, an angel investor group in SA, as well as national associations of angel investors. The goal of these organisations is to promote investments in early-stage companies and assist them through both financial support and active mentoring. He has been Chairman of the Australian Proteome Analysis Facility since 2005 and from 2007 until 2015 was chairman of the Melbourne-based biotech company AdAlta Pty Ltd, which is one of the 20 companies supported financially by the members of Bioangels. As a recognised pioneer of the industry and ongoing contributor, John was a recipient of the AusBiotech 2010 Chairman’s Excellence Award

AusBioFEATURE – AusBiotech’s 30th year Mr Scott Carpenter While serving as a founding Director of AusBiotech, Scott was employed by Aventis CropScience (which later became Bayer CropScience), in regulatory affairs for agricultural biotechnology. He served the Board until 2004 and was Chair of AusBiotech Victorian Branch from 2001 to 2003. Scott was involved in the commercial release of InVigor hybrid canola and LibertyLink cotton into the Australian agricultural system, and obtained a number of field trial approvals as well as food approvals for traits in canola, corn, cotton and soybean. Following a secondment to the US, Scott left Bayer CropScience for a role at AusBiotech as the program manager for agricultural, environmental and industrial biotechnology. While with AusBiotech, he was involved in a number of activities from events, submissions to governments and stakeholder engagement. After leaving AusBiotech in 2009, Scott joined the Defence Science and Technology Group (DSTG) as a business development manager for the Maritime Platforms Division. The focus of DSTG includes elements of biotechnology in a number of applications. In 2012 Scott joined Starpharma as a Director of Business Development, commercialising the Priostar® dendrimer platform focusing on crop protection (herbicides, insecticides and fungicides). Scott works with a number of partners globally including Adama, the largest generic manufacturer of crop protection products and provides input into Starpharma’s technical program. Dr Simon Carroll (Chair 2004 - 06) Simon was the longest serving AusBiotech Board member to date, having been a passionate and active participant from the inception of AusBiotech until his retirement from the Board in August 2010. During his tenure he served as Chair, taking the mantel from Peter Riddles in 2004 and later Deputy Chair. Simon was Chair of the organisation when Dr Anna Lavelle was

appointed at the first Chief Executive Officer in 2005. While with AusBiotech, Simon was commercial adviser to CSIRO, based in their Melbourne corporate office. His previous professional appointments with CSIRO involved commercial development activities in the area of biotechnology, and included co-ordinating CSIRO’s pharmaceutical and health research, representing CSIRO on various CRC boards of management and committees, as a director of various companies, as well as key account management with the major Australian pharmaceutical development companies. Prior to joining AusBiotech, Simon had worked as a clinical microbiologist before undertaking graduate studies in parasitology leading to a postdoctoral position in the US investigating developmental biology of parasites at the genetic level, along with other aspects of RNA control and metabolism. On returning to Australia in 1988, Dr Carroll took up a position at WEHI before joining AMRAD in 1991 where he worked in project evaluation, product development and manufacture, primarily in the biotech area. Simon is widely recognised as an overseer to the growth and development not only of AusBiotech as an organisation, but the wider biotechnology industry in Australia and was a recipient of the AusBiotech 2010 Chairman’s Excellence Award. In 2001, Simon moved to Perth as the inaugural Director of the Western Australian Biomedical Research Institute, a joint initiative of Curtin and Murdoch Universities and allied with the Chemistry Centre WA. For part of this time he served as WA Branch Committee Chair and initiated the Industry Development Officer program that serves the Branches of AusBiotech. In 2006 he joined Advanced Ocular System Limited, a public company serving as CEO. From 2008 to 2010 Simon was Chairman of CustomVis plc, a public company developing and marketing medical devices in the laser vision correction industry, while also being engaged as a consultant to the international pharmaceutical industry. In November 2010, Simon joined WA’s Scitech in Science Partnerships – a not-for-profit organisation that seeks to increase interest and participation by Western Australians in science

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AusBioFEATURE – AusBiotech’s 30th year and technology. Through this premier science communication centre, Simon coordinates WA’s National Science Week activities and Inspiring Australia program increasing the engagement and awareness of STEM for Australia’s future. Simon continues his interests in biomedical science through the not-for-profit cancer research and awareness foundation “Sock it to Sarcoma!” serving on the Board and Research Committee in collaboration with a number of key institutions in Perth. Dr Shanny Dyer Shanny was a founding Director until 2001, during which time she assisted in writing AusBiotech’s five-year business plan and organised the 2001 Commercialising Health Innovations Forum in Sydney. She was Business Development Manager at Biotech Australia and shortly after joined AVAX Australia as General Manager / Scientific Director. In 2001, Shanny was appointed AusBiotech’s NSW Branch Chair, undertaking programs later adopted by other states to develop knowledge and skills in product development and marketing. In 2003, she joined UTS as Director of Industry Engagement and Commercialisation, then became Investment Manager at private equity group Vericap Finance Limited. Shanny is a founding director of Seagull Technologies, an award-winning company that develops a noninvasive drug delivery system to the back of the eye. She is also co-inventor of Seagull’s patented intellectual property. She is a panellist for both NHMRC and ARC, assessing grant applications with a commercial focus. Shanny is currently Managing Director and Chairman of Wavefront Biometric Technologies Pty Ltd, developing innovative eye-based identity authentication solutions. She is also an independent board member of Bionic Vision Australia.

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Adjunct Prof David O. Irving Adjunct Professor David Irving is an executive in the life sciences sector with over 25 years’ experience in strategic research leadership with a passion for translating research findings into beneficial outcomes. David was one of the foundation directors of the AusBiotech Board where he served for eight years. He also served for several years as the NSW Branch Chair of AusBiotech and remains an active member of the organisation. He graduated from the Australian National University with a PhD in molecular biology/ biochemistry; has post-doctoral research experience with CSIRO and The Rockefeller University, New York, and is a graduate of the Australian Institute of Company Directors. He is currently Director, Research and Development, at the Australian Red Cross Blood Service (Blood Service), where he is responsible for the direction of all research and development conducted by the Blood Service across the country. He also has an appointment as an Adjunct Professor in the Faculty of Health, University of Technology, Sydney. Prior to joining the Blood Service, David was the inaugural CEO of the Diabetes Vaccine Development Centre (DVDC), a jointly supported initiative of the National Health and Medical Research Council and the New York-based Juvenile Diabetes Research Foundation International. Prior to that, David held executive management positions with Biotech Australia Pty Limited, Sydney and its successor companies where he held a variety of positions commencing as a research scientist and culminating in being appointed Director of Research and Business Development. From that base, he was involved in taking a spin-out company through IPO and became a Director of that company. After several iterations, that company is now trading successfully as a publicly listed company on the ASX.

AusBioFEATURE – AusBiotech’s 30th year David has extensive experience across commercial biotechnology, not for profit biomedical research and development and member based industry organisation sectors, built on a strong technical background. He has proven expertise in strategic planning, general management and interdisciplinary team leadership, marketing and financial management, management of stakeholder and investor relationships, international and local business development and project management as well as a strong track record in attracting research and development funding and investment from both public and private sources.

support capital raising using the Australian Small Scale Offerings Board. She joined Enabled Employment Pty Ltd as a non-Executive Director in 2015 and for the last two years has chaired both the Board and the Finance and Audit Committee of Good360 Australia Ltd, a startup charity based in Sydney. She is heavily involved in Canberra’s Griffin Accelerator as a mentor and also chairs Canberra Business Chamber’s Innovation Taskforce. Dr Elane Zelcer Elane served on the Board of the ABA from 1997 until the AusBiotech 2001 elections, assisting with the transition.

Dr Lyndal Thorburn An ABA Director from 1998 until 2001, Lyndal’s roles included development of the AusBiotech business model and federal government lobbying on behalf of the bioscience industry. She established the ABA’s Canberra region branch in 1999, and chaired this until 2002. During this time she also represented AusBiotech lobbying the Department of Foreign Affairs and Trade on trade-related aspects of intellectual property rights; the environment department on access to biological resources; Food Safety ANZ on labelling of GM foods; and various departments on the establishment of the then Office of the Gene Technology Regulator.

With a background in commercialisation and medical research, Elane works with organisations that are characterised by having the need for change or start-up strategies that involve significant risk management due to limited funding. These include start-up and early stage biotech/ medtech companies and universities – she provides strategy advisory and commercialisation services in life sciences, engineering and healthcare sectors. Elane is currently contracted by the Australian Government as a Commercialisation Adviser for Accelerating Commercialisation; prior to this, she was contracted to Commercialisation Australia.

While with AusBiotech, Lyndal was Managing Director of Advance Consulting & Evaluation, a consultancy specialising in bioscience commercialisation and industry policy. In 2004 she became Managing Director of Innovation Dynamics Pty Ltd (a merger of Advance Consulting with Aoris Nova Pty Ltd, which was led by Dr Kelvin Hopper). Innovation Dynamics became well known as the publisher of BioIndustry Review – Australia and New Zealand and as provider of business development services for life sciences start-ups and their investors. Lyndal later went on to be Nonexecutive Director and then Managing Director of Melbourne-based Neopec Pty Ltd.

Since 2001 Elane has applied her executive, board and advisory experience to private forprofit companies (various including Director at Immuron Ltd), non-profit sectors (CEO, Hadassah Australia Ltd; Director AUSiMED Ltd), universities (Executive Director, the Monash University STRIP), Independent Director Dairy CRC, and on various State and Federal government committees.

Since 2013, Lyndal has been working through her consultancy, now called Viria Pty Ltd, to

Prior to starting Thrombogenix, Elane was CEO of Montech Pty Ltd, Monash University’s

Her first start-up company was Thrombogenix, spun-out from Monash University in 1997 to focus on developing new anti-thrombotics for prevention of heart attacks and strokes. As CEO, Elane led the company through three capital raisings, raising more $15M.

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AusBioFEATURE – AusBiotech’s 30th year commercialisation company, where she worked with the University’s researchers to improve their understanding of the needs of businesses. Elane completed her BSc (Hons), PhD & Grad Dip Mktg at Monash and undertook postdoctoral studies in Canada and the United States. She returned to Australia to work with the multi-national pharmaceutical and diagnostics company Bayer Diagnostics (Australasia) Pty Ltd. AusBiotech held its first elections in November 2001. Peter Riddles, Tony Coulepis, John Ballard, Scott Carpenter, Simon Carroll and David Irving continued on the Board and the following were elected director: Dr Peter Devine Peter was a member of the AusBiotech Board until 2006 and also served on AusBiotech’s Queensland Branch committee prior to that, where he was involved in the creation of the “ClubBio” Queensland Conferences. After five years of service, Peter resigned from the AusBiotech Board to focus on his position as CEO of Uniseed, a venture fund operating at the universities of Queensland, Melbourne and NSW. Since then, Uniseed has made numerous investments in biotech-based technologies invented at these three universities, including three recent high profile biotech exits:

• Hatchtech – a company developing a new treatment for human head lice – asset sale to Dr Reddy’s Laboratories in September 2015 in a deal worth $US197 million; • Spinifex Pharmaceuticals – a pain drug developer – was sold to Novartis in June 2015 in a deal reported at $US700 million; and • Fibrotech – a company developing treatments for fibrosis – was acquired by Shire Pharmaceuticals in May 2014 in a deal worth up to $US557 million. Peter also served on the Board of Directors of these biotech companies. “These exits are particularly satisfying considering Uniseed was a founding investor in all of these companies, and it highlights the importance of early stage funding in the biotech sector” he said.

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“These exits validate the Uniseed model, where research organisations contribute the investment capital. Universities are logical investors at this early and risky seed stage, where the time to exit is long and truly patient capital is needed. As examples, Hatchtech took 15 years from Uniseed’s first investment to exit, Spinifex 10 years, and Fibrotech 8 years”. In December 2015, Uniseed announced that it had closed its third and largest fund of $50 million, with the addition of the University of Sydney and the CSIRO to the three existing Go8 university partners. Prior to joining Uniseed, Peter had worked at four Australian Biotechnology companies and at UniQuest, the commercial arm of the University of Queensland. These positions included roles as Vice President of Business Development at ASX-listed Progen, and as an investor and Commercialisation Manager at infectious disease diagnostics company PanBio, which was sold to Inverness Medical Innovations in 2007 for $40 million. Ms Samantha O’Connor Samantha (Sam) served on the AusBiotech Board until 2003 and on the NSW Branch as a Committee member. She began her role with AusBiotech while working with Pfizer Australia. Since Australia’s home-grown pharmaceutical industry was small at the time, she was asked to join the AusBiotech Board to provide a view into the role of the pharma industry in supporting the commercialisation of Australian research. During her time with Pfizer Australia, Sam led Pfizer’s investment program of building collaborations with the Australian medical research community, sourcing investment opportunities that strategically aligned with the company’s global research portfolio. Sam left her position on the AusBiotech Board when she moved to Pfizer’s UK operations in 2003 t o join Pfizer’s Worldwide Business Development team responsible for the acquisition and divestiture of products, technologies and intellectual property. Sam received her MBA during her time in the UK.

AusBioFEATURE – AusBiotech’s 30th year In 2011, Sam moved to Pfizer’s US operations in Cambridge, Massachusetts, where she resides today. Sam now heads up the strategy and business planning function for Pfizer’s Centers for Therapeutic Innovation (CTI), Pfizer’s innovative program translating leading science into clinical candidates through networked collaborations. Mr Stephan Wellink Stephan was involved with AusBiotech, from its inception until 2004. Stephan was the inaugural Principal Commercial Adviser of Agribusiness at CSIRO until 2001. His role at CSIRO included leading biotechnology-related activities in many parts of the world at a time when the organisation was grappling with international and cultural changes and unprecedented commercial activity. Stephan joined the University of Technology in Sydney (UTS) in 2001 as Director of Research and Innovation and led a significant change process until his departure in 2006. The work he led contributed to UTS growing its research activity in both scope and quality which is quite measureable today. In 2006 he established a consulting company that serves technology organisations, universities and government. Stephan’s expertise extends to the writing of large competitive grant applications, giving advice on corporate governance structures, strategic planning and strategic alliances. In recent years, he has designed and facilitated a number of successful events in the agrifood space covering areas such as big data, neuroscience, behavioural economics and leadership in innovation.

by John Larkin. He has written and will direct a documentary, which pays homage to The Mavis Bramston Show, the pioneering Australian satirical program of the 1960s. Life goes on… Dr Jonathan Wright Jonathan has an extensive background in developing and commercialising Australian medical technology and working with some of the great companies like ResMed and more recently Nanosonics. Prior to joining AusBiotech, where he served on the Board until 2003, he was Marketing Director with Johnson & Johnson Medical, focusing on new business/ technology development in Asia Pacific. He was a Board member of AusBiotech at its founding and at that stage was VicePresident Global New Business for ResMed. He left ResMed in 2003 to become CEO of Ambri, an ASX-listed biotechnology company commercialising pointof-care testing. Within two years he moved to a CEO position at SomnoMed and orchestrated market entry into the USA market. He established Biomed Device Marketing in 2006 and has since been involved in developing several major startups including Dosimetry & Imaging (UNSW) and more recently has served as a strategic consultant to Nanosonics.

In 2012, Stephan formed Inkwell Films, an independent film company. He was a producer on the animated short film, Woody, which won a number of international awards and was nominated for an AACTA in 2014. His latest films are documentaries: Rod Taylor: Pulling No Punches will premiere on Foxtel in early 2016 and Jerry Lewis: King of Comedy will premiere on ARTE, France, in March 2016. Stephan is working with Ben Lewin and Judi Levine (The Sessions) to develop The Shadow Girl, a feature film based on the award-winning novel

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INVESTMENT EVENTS SERIES 2016

SINGAPORE

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SINGAPORE BIOTECH INVEST will provide biotech and medtech companies with the opportunity to meet investors and discuss potential partnerships.

3 May 2016 Singapore Stock Exchange

ASIA

Biotech Invest 5-6 May 2016 Hong Kong Convention and Exhibition Centre

Now in its fourth year, ASIA BIOTECH INVEST will provide biotech and medtech companies with the opportunity to meet investors and discuss potential partnerships. The event will include a program of panel discussions, keynote speeches and company spotlight presentations.

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ausbiotechinvestment.com.au

AusBioFEATURE – AusBiotech’s 30th year

What will Australian biotechnology look like over the next 30 years?

Dr Alan Finkel AO Australia’s Chief Scientist Over the next 30 years I am confident that Australia will continue to invest in biotech and medical research at or above world-class levels. We will undoubtedly reap the returns and see the benefits in smarter industries, better health and a cleaner world. As Chief Scientist I want Australians to get excited about it all. But instead of trying to add here to the list of general aspirations I’ll confine myself to the area about which I am most familiar – neuroscience. The amazing thing about the human brain is that it is even more complex than the genome that defines it. Every time I read about advances in brain imaging technology, or techniques to reconstruct three dimensional connections between neurons, I am simultaneously staggered by the brilliance of the researchers and humbled by the realisation that we know so little. For the last two decades, I’ve looked back each year at all we’ve learned since Ramón y Cajal ushered in the era of cellular neuroscience with his elegant drawings of neurons in 1888. And every year, I estimate that we have probably only learned about 1% of what we need to know in order to understand the brain. For all the discoveries reported each year, I am not sure that we get any closer.

Because of the complexity of the brain and the miniscule scale of its neurons and their synaptic connections, the dream of implanting electric circuits 30 years from now to augment cognition or memory will remain a dream. But at least we will make progress in sensory prosthetics. In particular, I am confident that there will be bionic eyes bringing vision to the blind, even if the achieved perception will be far below the resolution and colour richness generated by an actual human eye. As for those people who are taking drugs hoping to extend their lives until computers are powerful enough to store their uploaded memories and personalities…. well, they’re on drugs. Any such upload process in 30 years from now will be destructive, meaning the donor will die irrespective of the success of the upload. If the upload works, the result will be woefully crude, leaving the uploaded personality in a vegetative state. On the bright side, the daunting complexity of the human brain is fantastic news for those contemplating entering neuroscience in the coming decades. There will be lots and lots to learn over the coming centuries. Let’s keep Australia at the centre of global progress.

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AusBioFEATURE – AusBiotech’s 30th year What will Australian biotechnology look like over the next 30 years?

Dr Andre Tan Recent PhD graduate Almost 30 years ago, the basic steps of polymerase chain reaction (PCR) were experimentally defined. This fundamental development in the amplification of DNA ushered in a new epoch in the biological sciences, and has transformed our understanding of nature and biology ever since. At that time, one could not have easily predicted the emergence of the gene sequencing capabilities we enjoy today. Similarly, it is difficult to predict where the frontier of science, both the global and Australasian biotechnology sector, will lie in 2046. However, the manner in which our region responds to global factors and events over this time will shape the sector’s development and outlook. Climate change remains the greatest threat to our planet, and the biotechnology sector will have a pivotal role in meeting the problems that are symptomatic of this immense challenge. Improving food security for the predicted global population of 9.6 billion people in 2050 through the use of genetically-modified organisms will be a difficult issue that will need to be navigated. The strength of our region’s advanced agricultural practices, coupled with robust debate, could see Australia and its neighbours lead the development of technologies and frameworks needed to ensure ample supply of food for local and export markets, as well as the ancillary expertise. Artificial intelligence is the quiet revolution that increasingly underpins the ability for data to be analysed and acted upon. In healthcare, being able to ask new, sophisticated questions of large datasets opens the door to new clinical trial designs and frameworks, as well as bringing the promise of personalised medicine closer to reality. The combination of favourable clinical 36

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trial environments, high-quality trial capabilities and a strong medical research ecosystem in Australia and New Zealand, coupled with maturing analytics capability presents as a significant growth opportunity the region is well placed to lead. Advanced manufacturing capabilities, such as 3D printing, will see the repackaging of old and existing business models not normally associated with manufacturing come to the fore. The increased customisation and sophistication of manufactured products will certainly lead to significant disruption – no area of manufacturing is immune. Many questions remain – will our region be a leader or a follower? Can we maintain sufficient manufacturing R&D capability to mitigate against disruption? Continued development of a capable workforce to meet these challenges and opportunities will be critical. Graduates seeking to participate require ever-broader skills and knowledge, and will need to commit to life-long technical and commercial upskilling for long-term career success. The full spectrum of primary to postgraduate training models (especially STEM) will need to adapt to fast-changing sector needs, as well as prepare the next generation of industry professionals. Though many have articulated various visions for how the region’s knowledge-based economy should look, commitment to bringing this vision to reality requires support from industry, educational institutes and governments. It is my hope that in another 30 years, I can look back at this speculative article and see that our sector has grown to meet these challenges to put us in strong standing beyond 2046.

AusBioFEATURE – AusBiotech’s 30th year What will Australian biotechnology look like over the next 30 years?

Dr Elizabeth Finkel Editor-In-Chief, Cosmos Magazine; Author of The Genome Generation Predict how Australian biotech will look in 30 years? That’s a tall order. Thirty years ago sequencing a single gene was a huge chore. What took us to the ‘omics’ era was the cross-fertilisation of PCR, highthroughput DNA sequencing techniques and supercomputing. Now add 3-D printing, stem cells, wafer-thin implantable silicon chips, RNAi, CRISPR – and that cross-fertilisation has become an orgy of innovation. It’s a brave soul who’ll predict what the fruits will be in 30 years. But the groundcover is being sewn today. The dream of personalised medicine will be realised with universal genome sequencing at birth, intelligent algorithms to decode what they mean, and implanted chips to monitor health. The well will be warned of impending diabetes, metabolic disease, kidney or liver failure, cancers, heart attacks and strokes. The sick will be fixed with artificial organs (scaffolds seeded with stem cells, augmented by circuitry), or by regenerating their own tissues – say worn-out knee joints – using a cocktail of growth factors. Cancer will be curable thanks to genome-correcting drugs based on RNAi and other epigenetic modifiers, or CRISPRlike techniques to edit out offensive mutations. Genome-editing will be used to repair embryos bearing mutations – and for those colonists headed off to Mars, there will be a special clause

allowing them to be enhanced: engineered to have stronger bones and be especially cancer and dementia resistant For those of us confined to Earth’s rules, memory chips built on the insights of today’s brain projects and brain-machine interfaces like the bionic eye, will fix dementia and enhance cognition. Will we be able to afford this medical revolution? We’re still in a muddle as to whether the costs of early screening and detection deliver a cost benefit or actually save lives. Perhaps by then, artificial intelligences will have worked this out. Meanwhile plant biotech will deliver super plants highly adapted to a warming resource-strained planet: they will use half the amount of water and nitrogen thanks to nitrogen fixing and waterefficiency genes. Masterful DNA editing will keep new varieties one step ahead of pests. It’s all possible… but the ultimate landscape is unpredictable. Not just because of technological disrupters. Public sentiment can make or break a technology. Market forces allow one technology to soar, another to die off. Natural or humanmade disasters concentrate the collective research mind. But then again, perhaps in 30 years’ time, artificial intelligence will have worked this all out as well.

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AusBioFEATURE – AusBiotech’s 30th year

The evolution of transgenic food Dr James D. Murray Department of Animal Science; Department of Population Health and Reproduction, University of California, Davis, USA; CSIRO Health and Biosecurity Business Unit, Australian Animal Health Laboratory, Geelong, Australia

Dr Tim Doran CSIRO Health and Biosecurity Business Unit, Australian Animal Health Laboratory, Geelong, Australia On November 19 2015, the United States Food and Drug Administration (US-FDA) approved AquaBounty Technologies Inc. application for the use of the AquAdvantage salmon for human consumption. The AquAdvantage salmon, an Atlantic salmon genetically engineered (GE) to express the Chinook salmon growth hormone gene and thus grow faster and more efficiently, was developed in 1992 (Du et al., 1992).These salmon are bred to be sterile and are farmed in land-locked aquaculture facilities with multiple barriers for physical containment. Scientists and scientific bodies have overwhelmingly welcomed the FDAs decision after extensive reviews of food and environmental safety and endorsed AquAdvantage salmon as a safe and more sustainable product than existing farmed salmon, which helps to relieve the pressure of overfishing on wild populations. This landmark decision by the US-FDA is the first approval of the use of a GE animal for food anywhere in the world. However, while this is certainly an important regulatory action, the implication of this decision worldwide for the development of GE animals, and possibly gene edited animals, for use in agriculture remains to be seen. To put this regulatory action into perspective one needs to remember that the first GE livestock (Hammer et al., 1985) and fish (Zhu et al., 1985) were reported in 1985. AquaBounty Technologies first approached the US-FDA for regulatory approval of the AquAdvantage salmon in 1995, but it was not until 2009 that the US-FDA issued Industry Guidance 187 (FDA 2009) outlining the process they planned to use to regulate GE animals. In 2010 the US-FDA announced that the AquAdvantage salmon was as safe to eat as conventionally grown Atlantic salmon, but a

further five years elapsed before approval was given. The world-wide regulatory dysfunction around GE animals for use in agriculture to produce food for human consumption has effectively limited advancement in this field and resulted in a cessation of work and capacity building in virtually all of the developed countries first associated with this technology (Australia, Canada, Germany, New Zealand, the United Kingdom, and the United States). For example, in the mid-1980s there were strong programs of research directed at developing transgenic livestock in Sydney, Adelaide and Melbourne, but by the late 1990s only the South Australian program was left and it was, and has continued to be, largely focused on xenotransplantation and the creation of bio-medical research models. The past decade has seen a growth in laboratories world-wide undertaking the creation of GE livestock for use in agriculture, but this new activity is almost exclusively limited to China, Brazil, and Argentina, with one new laboratory focused on GE chickens emerging in CSIRO. The CSIRO team is based at the Australian Animal Health Laboratory in Geelong where they are applying GE technology to health, welfare and food safety issues that impact poultry industries. They have been combining GE and gene silencing technology to develop avian influenza resilient chickens, and via collaborative Australian Poultry CRC projects have been developing precision genome engineering approaches to sex selection for the egg laying industry and the removal of allergens from eggs to provide safer food products for the growing number of Australians that are allergic to eggs. As noted above, the implication of the US-FDA decision to approve AquAdvantage salmon for Volume 26

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human consumption on the development of GE animals for use in agriculture is not clear. At present there appears to be little corporate support for using GE animals in agriculture and in the face of steep regulatory costs and longtime frames this single decision may not be sufficient to ease either of these burdens. The real impact at this point, and the one that may most affect Australia, is whether or not economies like China and India will now move forward more rapidly. Over the past decade China has put more resources into developing GE animals for agriculture than the rest of the world combined and India is now moving to establish laboratories in this area as well. Biotechnologies such as GE have an important role to play in the future of agriculture, including ensuring food safety and security, improving animal health and welfare, and enhancing the nutritional benefits of various foods. These benefits can be realised only through appropriate investment, which will occur only when the 40

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animal agriculture industries have confidence in a suitable, clear-cut, and timely regulatory process for those animals and food products. With many nations poised to take steps forward in deployment of animal biotechnology, harmonisation of regulations will be critical in a global trade environment. References Du, S.J., Gong, Z.Y., Fletcher, G.L., Shears, M.A., King, M.J., Idler, D.R. and Hew, C.L. (1992). Growth enhancement in transgenic Atlantic salmon by the use of an “all fish” chimeric growth hormone gene construct. Biotechnology (N Y) 10:176-81. FDA. (2009). Guidance 187: Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs. www.fda.gov/RegulatoryInformation/Guidances/ default.htm Hammer, R.E., Pursel, V.G., Rexroad, C.E. Jr., Wall, R.J., Bolt, D.J., Ebert, K.M., Palmiter, R.D. and Brinster, R.L. (1985). Production of transgenic rabbits, sheep and pigs by microinjection. Nature 1985 315:680-683. Zhu, Z., Li, G., He, L. and Chen, S. (1985). Novel gene transfer into the fertilized eggs of goldfish (Carassius auratus L. 1758). J. Appl. Ichthyol. 1:31-34.

AusBioFEATURE – AusBiotech’s 30th year

Regenerative medicine – are we there yet? Dr Peter French Director, BCAL Diagnostics Pty Limited All traditional cultures have some personification of the Divine Healer or miracle-working god. The ancient Greeks had Asclepius, the god of medicine. Whilst we are celebrating the rise of regenerative medicine over the past 30 years, the dream of regenerative miracles goes back at least 2000 years when Matthew wrote, “Jesus … said to them, “Go and report to John what you hear and see: the blind receive sight and the lame walk, the lepers are cleansed and the deaf hear, the dead are raised up ... “. Today many are putting their faith in the power of the stem cell to perform similar miracles. Is this faith well founded? Stem cell types Ever since we understood that there were stem cells that are capable of generating new differentiated cells and tissues, the possibility of repairing organs and tissues to perform healing miracles has excited scientists, doctors and the public alike. Initially much of the research utilised embryonic stem cells (ESCs), as these were considered to be the most flexible, being able to differentiate into ectodermal, mesodermal and endodermal tissue. However, there were, and still are, significant ethical issues with using human embryos as the source of these cells, as well as immunorejection complications, and as a result the widespread use of ESCs has not transpired. Inducing pluripotent cells directly from the patient’s own cells to generate tissue or cells would resolve most of the problems associated with using ESC, including the problems of immunorejection and the ethical issues. However these pluripotent stem cells are hard to identify and are apparently few in number. Adult stem cells such as bone marrow stem cells, mesenchymal stem cells, adipose stem cells and neural stem cells, and many others,

have been detected in tissues. Over the last ten years, adult stem cells have been the main focus of companies involved in developing stem cell-based therapies. Whilst using adult stem cells from a patient to treat that patient’s disease (autologous stem cell therapy) overcomes the ethical, immunorejection and abundance issues of the other stem cell types, there are still many challenges remaining. These include: how to control and regulate the process to successfully trigger differentiation into the desired cell type after the stem cells have been isolated; understanding the mechanism of action by which the stem cells exert their therapeutic effect; carving out a defensible patent position on a naturally occurring cell type to justify the significant investment involved in developing a human therapy; expanding the range of diseases that the adult stem cell can address, and developing a pricing model for a treatment that could be a single administration. Progress and challenges Progress has been made in many of these issues. Many companies have developed proprietary isolation and purification processes to identify and/or isolate specific adult stem cells from a patient and to transplant those cells back into the patient’s affected organ. However, it appears that in most cases the cells do not integrate into the tissue and regenerate new differentiated cells as first thought and hoped. Rather the cells tend to exert their effect via secreted “extrinsic factors” that stimulate the surrounding tissue to repair itself. These effects are therefore transient and may need re-administration in many cases. There is the possibility that there may be low level integration into the target tissue, and understanding how to address and overcome safety concerns associated with incomplete differentiation and improper integration of cells in damaged or diseased tissues during stem cell therapy remains a potential challenge. Combining gene and cell therapy The limitation with the use of autologous adult stem cells stems from the fact they are not useful in most cases for genetic-based diseases, as the patient’s own stem cells suffer the same genetic problem as those of the diseased tissues or organs. One potential solution to this is to

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AusBioFEATURE – AusBiotech’s 30th year combine stem cell therapy with gene therapy. Modification of a patient’s stem cells to knock down or delete a defective gene is possible with technologies such as CRISPR-Cas9, DNAdirected RNA interference (ddRNAi) or zinc finger nucleases. A private US company, Calimmune, is using ddRNAi to knock down the CCR5 HIV co-receptor in HIV patients’ CD34+ cells (hematopoietic stem cells). This would potentially result in the patient becoming resistance to infection with the virus, providing a potential single shot cure for HIV/AIDS. Stem cells could also be modified with conventional gene therapy to express a gene that is missing from the normal healthy genome. Each of these technologies has its advantages and disadvantages. The biggest challenge with using a gene therapy-modified stem cell therapy is that of the regulatory hurdle for the ultimate therapeutic product, with only one gene therapy product on the market in the Western world (uniQure’s Glybera approved in Europe for TTR-amyloidosis), speculated to cost 1 million Euros. A costly cure? Unlike previous exponents of medical miracles from ancient times, the current group of regenerative medicine companies are looking to return significant monetary rewards to their long-suffering investors. This indicates another challenge with new therapies that offer potential cures. If a single administration is sufficient to cure the disease, what would (and should) that cost? And who should pay? Various models have been proposed, but no consensus yet exists. One option is to treat a single treatment like an operation. After all, no-one wants to have an operation on a weekly or monthly basis for months or years. The cost of an operation can be very expensive, but people, and/or the government, are willing to pay to have the problem fixed. But is a single injection that can be performed in an outpatient department costing 1 million Euros seen as good value for money? The recent controversy over Gilead’s 12-week cure for hepatitis C that costs $1,000 per pill per day indicates that the public will have trouble swallowing (pun intended!) that level of cost, even for a cure. Then there have been proposals for some sort of annuity payment – amortised over months, or more likely, years. This is a challenge

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particularly in the US, where patients may switch health funds when changing jobs, and therefore creating an administrative nightmare. And what if there is a relapse and the patient refuses to pay? A lot more work is needed by companies, government, health funds and community groups to understand the best pricing mechanism to use in this brave new world of regenerative medicine. The future The pace with which regenerative medicine has moved over the past 30 years is astounding. I have no doubt that stem cell therapy, modified or not, will find a niche in the armamentarium of the medical profession in the short to medium term, and may well provide cures for disease that 30 years ago would seem to be miraculous. We are not there yet, however. Many challenges remain: some scientific, some technical, and some political. These will require a lot of hard work and clever thinking. As Prime Minister Malcolm Turnbull would probably say, “It is an exciting time to be an Australian (working in the field of regenerative medicine).” Dr Peter French was the CEO and Managing Director of Benitec Biopharma Limited from 2010-2015, and was the founder of Australia’s first stem cell storage company, Cryosite Limited. He is currently a Director of BCAL Diagnostics Pty Limited.

AusBioFEATURE – AusBiotech’s 30th year

30 years of regenerative medicine in Australia Dr Tim Oldham and Dr Dominic Wall Cell Therapies Pty Ltd Regenerative medicine, broadly defined as the use of human cells as therapeutic agents, is poised to transform health outcomes and become established as the fourth pillar of modern medicine. Australia has played an important role over the past 30 years and continues to contribute to international progress. The year 1986 saw the first peripheral blood haematopoietic stem cell apheresis and transplant to reconstitute an immune system after myeloablative chemotherapy in Germany.1 Royal Adelaide Hospital followed in 1987, however much of the pioneering work had been, and continued to be done, in Australia. 1973 had seen the installation of the first hospitalbased apheresis machine at St Vincent’s in Sydney whilst Ray Bradley and colleagues were elucidating the blood forming cells at Peter Mac.2 From 1983 onwards Chris Juttner with investigators at the IMVS in South Australia led the field in human haematological recovery with their work on blood stem cells34 and shortly after, the application of Don Metcalf’s research at WEHI resulted in world-first data from Melbourne and Adelaide confirming the clinical value of G-CSF for mobilisation of peripheral blood stem cells.5 So began Australian interests in what is now one of the hottest fields in regenerative medicine: cellular immunotherapy. The next 15 years though saw tissue engineering lead the way from bench to clinical practise. Research during the 1990s led ultimately to the formation of Clinical Cell Culture (1999, now Avita Medical), Polynovo (acquired by Clazada in 2009) and Celexcel (2004, now part of Admedus) all focussed on tissue repair (skin and cardiac

muscle). Several multinationals including Verigen brought autologous chondrocyte implants to Australia during the 2000s, and though Verigen has left, the scientists behind the technology persevered and formed Orthocell (2006) to focus on cartilage and tendon repair. Meanwhile the next great wave of regenerative medicine played out around mesenchymal stromal cells, which promise immune regulation as well as regenerative potential and have the advantage of expandability and apparent immune privilege. This offered the potential for large scale allogeneic production. Australia produced Mesoblast (2001, listed in 2004), now the largest MSC company globally), Regeneus (2007) and most recently Cynata (2013) who are exploiting the Nobel Prize winning discovery of reprogramming cells (induced pluripotent stem cells) to produce MSC’s at massive scale. But back to cellular immunotherapy. By 1999, scientists and clinicians at Peter Mac opened cGMP cell processing clean rooms that led to the formation of Cell Therapies P/L 2003, Australia’s first TGA accredited cell therapy CMO which was then producing immunotherapies on behalf of IDM S.A. from France, and then Prima Biomed’s dendritic cell vaccine that was in clinical trials in 2001-2015. By 2006, Peter Mac researchers had been able to genetically modify T-cells to express receptors targeting antigens on tumour cells –

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AusBioFEATURE – AusBiotech’s 30th year reprogramming immune cells to target cancer.6 This chimeric antigen receptor T-cell (CAR-T) approach is now revolutionising cancer treatment, achieving 90% durable complete response rates in the worst forms of leukaemia. Today, Peter Mac’s own CAR-T program is progressing toward its second clinical trials and the first patients in Australian arms of international CAR-T trials have undergone apheresis.

1. M Korbling, EJ Freireich, “Twenty-five years of peripheral blood stem cell transplantation”, 2011 Blood 117 (24), 6411-6416

Several nations are now making aggressive plays for leadership in regenerative medicine. Japan has created aggressive new regulatory pathways and Belgium, Canada, UK and California USA all have made $100m plus investment to fuel evidence based regenerative medicine industries. To be sure that Australian patients benefit from these revolutions in healthcare over the next 30 years, Australia must commit now to financing the research, clinical, regulatory and manufacturing infrastructure that will enable continued research leadership, as well as deployment of international advances.

4. To LB, Dyson PG, Juttner CA (1986) Cell-dose effect in circulating stem-cell autografting. Lancet 2: 404-5

2. Rosendaal M, Hodgson GS and Bradley TR (1976) Haemopoietic stem cells are organised for use on the basis of their generation-age. Nature 264, 68-9 3. To LB, Haylock DN, Kimber RJ, Juttner CA (1984) High levels of circulating haemopoietic stem cells in very early remission for acute non-lymphoblastic leukemia and their collection and cryopreservation. Br J Haematol 58:399-410

5. Sheridan WP, Begley CG, Juttner CA et al (1992) Effect of peripheral-blood progenitor cells mobilized by G-CSF on platelet recovery after high-dose chemotherapy Lancet 339:640-4. 6. Peinert, S, Prince, HM, Guru, PM, Kershaw, MH, Smyth, MJ, Trapani, JA et al. (2010). Gene-modified T cells as immunotherapy for multiple myeloma and acute myeloid leukemia expressing the Lewis Y antigen. Gene Ther 17: 678–86.

Brisbane 2 – 3 August 2016

Stamford Plaza, Brisbane

www.agfoodtech.com.au

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AusAg & Foodtech

AusBioFEATURE – AusBiotech’s 30th year

Reflections from our members Graham Gourlay Special Projects, Cystic Fibrosis Australia In 1986, I joined the Australian Biotechnology Association (ABA), as it was then called. I believe I am one of the original members of what is now known as AusBiotech. From the mid 1960s until the early 1980s, I worked for a company called Mauri Bros and Thomson (MBT) which was taken over by Burns Philp in 1982. One of MBT’s main products was bakers’ yeast which is grown in large aerated tanks. The process to produce bakers’ yeast was described as a type of fermentation technology, a term used prior to the word biotechnology being ‘invented’. As the area of biotechnology became increasingly important, Max Shaw, the Head of MBT Research Laboratories, worked with several other people (including Nancy Millis and Peter Rogers if I remember correctly) to organise the first Australian Biotechnology Conference in 1983, which was held at the company’s premises at North Ryde in Sydney. I understand that the ABA was ‘conceived’ at that first conference, even though it was not born until some three years later; a long gestation period! I retired as CSIRO Food and Nutrition Intellectual Property Manager five years ago but have retained my AusBiotech membership, mainly because of the networking and information sharing benefits. These continue to be very helpful in my on-going voluntary work with Cystic Fibrosis Australia, trying to identify new cystic fibrosis R&D opportunities and innovative ways to fund them.

Professor Tony Weiss University of Sydney and Scientific Founder of Elastagen Pty Ltd I am delighted to congratulate AusBiotech on its founding 30 years ago as the Australian Biotechnology Association. Over those three decades, attitudes have changed for the better. I reflect on my unusual combination of university

professor, innovator and biotechnology company founder. That would have been a rarity just a few years ago, certainly decades ago. Only recently did it become acceptable, even desirable, to talk about a harmony of excellence in fundamental science and commercialisation. I am glad times have changed. Innovation is in. Sitting at the interface between pure and applied is now desirable. I am grateful to AusBiotech for helping to drive this important agenda by championing a good environment for Australia’s fragile biotechnology industry and by contributing to Australia’s national development. Unfortunately the biotechnology industry in Australia is still fragile – so keep up the fine work AusBiotech!

Dr David Randerson Managing Director, Acuity Technology Management In 1986 Martin Playne invited me to join the editorial board of the Journal, a role I held with great pride for a decade as I watched the biotech booms come and go. At the time I was MD of one of the early-to-list, some would say “premature”, others “before its time”, biotechnology companies which I cofounded and listed on the second board of the ASX at the commencement of the year. It followed two years of exceptional effort to find investors interested in the potential of mammalian cells for production of recombinant proteins and monoclonal antibodies – the nub of modern biotechnology. I suspect the first biotech listing was Queensland Science and Technology Limited (fermentation technologies) in 1984; a further three listed in 1985, including Circadian Technologies and Biota; with seven in 1986. According to the Sydney Morning Herald (29 Feb 1988), by January 1987 there were 21 listed biotech companies with a total market capitalisation of $528 million (average $25 million) and by March 1988, following the October 1987 market crash, 22 companies had a combined capitalisation of $196 million (average $8.9 million). Of these companies, only three remain today, Circadian, IDT and Agen (as Agenix), although hardly recognisable from their prospectus descriptions,

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AusBioFEATURE – AusBiotech’s 30th year the others having failed (most), been acquired or merged, or morphed into other entities with changed focusses. As best I can determine only two products proposed in these 22 companies’ IPOs made it to market, Biota’s neuraminidase inhibitor and Agen’s D-dimer test. Running down the list it is clear that the majority obtained their core IP from publicly funded organisations and all had technologies far from commercialisation – attributes that may not be greatly different today. There were no IPOs in the sector between 1988 and 1994 when Hyal (to become Meditech and merge with Alchemia) and Norvet (now Novagen) listed. The boom time was 1996 to 2002, again to languish following the “tech-bubble” crash. The industry, however, the Journal and the Association survived these economic downturns. It would be interesting to compare outcomes and activities of the first wave with the second, 1994 to 2002, and the third, 2004 to 2008. Maybe I’ll find time for such an analysis when I retire

Leigh Farrell Chairman, d3 Medicine, LLC What a magnificent achievement; 30 years of influencing innovation policy and helping grow Australia’s biotechnology and medtech industries. From humble beginnings as the Australian Biotechnology Association of which I was a student member, Anna Lavelle and her professional team have become internationally recognised as advocates of the Australian biotechnology industry. As a result of numerous federal inquiries, Productivity Commission reviews and AusBiotech’s advocacy, Australia’s Federal Government has pleasingly reinforced the importance of our biotechnology industry to the Australian economy through policy initiatives including maintenance of the R&D Tax Incentive, establishing the $20 billion Medical Research Future Fund and $250 million Biomedical Translational Fund. These initiatives together with Australia’s favourable regulatory environment and Venture Capital Limited Partnership legislation should hopefully ensure that our excellence in medical research evolves to excellence in translational medicine, clinical pharmacology and early product development resulting in more value being retained by innovators before being sold to commercialisation partners. 46

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Barry Thomas Director Asia Pacific Cook Medical, Managing Director Cook Australia The biotech industry in Australia today is in a healthy position. This is largely due to the efforts of individuals that have worked to shape the industry, as well as policy that supports its growth. Australia has a strong history in innovation and has always been a fertile ground for the development of new ideas. Biotech, in particular, has been supported by policies that encourage innovation, such as the R&D Tax Incentive, which has paved the way for the growth of the sector. Australia was the first country in the world to introduce this kind of incentive, and at the time it was revolutionary. This is one of the main reasons why R&D is so strong in Australia today. However, while we have strong universities and research facilities to build on existing biotechnology, a key challenge facing the industry is getting this research to the commercialisation stage. There is widespread consensus that Australian policy has not kept pace with international markets, with a continued discord between R&D and commercialisation. One way to turn this around would be the introduction of a patent box-style tax measure. The Australian Innovation and Manufacturing (AIM) Incentive has been forward to the government as a potential model. It has been developed by Cook Medical together with other industry bodies including AusBiotech, Export Council of Australia, and Medical Technologies Association of Australia. The Incentive recommends that qualifying IP profit be taxed at a lower rate (10% is suggested) in order to encourage the commercialisation of R&D here in Australia. More than 10 countries around the world have introduced similar measures, including the UK and China, and the US is currently introducing something similar. The implementation of the AIM Incentive would create many more opportunities for the Australian biotech industry to develop and thrive in today’s competitive international market.

AusBioFEATURE – AusBiotech’s 30th year

Harmonisation, risk and rigour The real story of device regulation is what happens after product approval… requirements are actually far more closely aligned than is suggested by the differences in process. There are still local differences in detail, but it’s now possible to achieve regulatory approvals in a large number of markets based on a common Technical File and compliance with internationally accepted standards.

Arthur Brandwood CEO, Brandwood Biomedical It’s 1986:

• Cochlear has been going five years and has just obtained US FDA approval for the Bionic ear. It’s another five years before Peter Farrell is to leave UNSW to found ResMed. And some of the best pacemakers in the world are made in Sydney by Telectronics (sister to Cochlear). • TGA doesn’t exist. • A scandal is brewing about some heart valves… The regulatory success story of the past 30 years has been the rise of global harmonisation. Back in 1986 each national regulator pretty much did things their own way. Manufacturers had to deal with each independently according to unique local requirements. Then along came the grandiosely titled Global Harmonization Task Force and indeed the world was changed. The European Directives of the early 1990s propagated in whole or in part via the GHTF into the regulatory systems of Canada, Australia, Japan and many other markets, most recently ASEAN. Substantial parts have also found their way into China, Korea and parts of South America. The odd one out of course is the US FDA, but even FDA relies heavily on international standards and so underlying technical

But amongst all this international harmony, even a casual observer will have noticed the news coverage over the past couple of years debating the rigour of regulation. Depending on viewpoint regulators are accused of not doing enough, allowing unsafe devices to harm patients, or they are bureaucratic and getting in the way of innovation. Essentially it’s an argument about risk – which is always present in an imperfect world. Perhaps the more interesting lesson of the past 30 years is that it was ever thus. In the mid 1980s, around 40,000 Australians received a Bjork-Shiley mechanical heart valve. It later transpired that these valves were subject to catastrophic mechanical failure with disastrous results. A subset of valves assembled by a particular process worker were at much higher risk of failure and clinical advice was that those particular valves should be removed – involving a hazardous and life threatening replacement surgery. Unfortunately, the devices simply weren’t tracked well enough to tell which patient got which valve and the resulting furore led to the establishment of the TGA’s devices regulations. This and other high profile implant stories such as the Dow Corning silicone breast implants stimulated interest in implant tracking and establishment of postmarket registries including the Australian National Joint Replacement Registry. Years later that registry provided early detection of the failure of the ASR hip. This device, along with the PIP Breast Implant contributed to a public and political outcry which drove tightening of regulations around the world to mandate clinical trials for most high-risk devices.

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AusBioFEATURE – AusBiotech’s 30th year And so it goes around: whereas the process of premarket assessment has become more aligned, the level of scrutiny, the rigour of regulation actually varies in response to postmarket events. Each well-publicised failure brings a backlash and the premarket process becomes stricter by means of requirements for higher levels of evidence. So what do we know about postmarket device performance. Luckily the US FDA is pretty transparent about its regulatory process, publishing summaries of all approvals and 510(k) clearances, as well as an extensive set of postmarket databases. These are interesting because postmarket events reflect the types of technology of the day. For a device become noticed in the postmarket reports it has to be widely used and the technology to be sufficiently advanced or high risk that it doesn’t always work perfectly. A comparison of postmarket data in 1986 with the present day shows a startling shift in the nature of device technologies. Back in 1986, the top ten device types featuring in the FDA MDR database included four implants, Four hospital use instruments, glucose monitors and a contraceptive IUD.

The figures for 2015 are totally different. The same list today is quite different featuring glucose sensors, insulin pumps, ambulatory dialysis and portable oxygen. Devices have moved out of the hospital and into the home and are being used to treat chronic diseases, mainly diabetes. And we have gone digital: almost all of those top 10 devices are now clever computerised systems for monitoring the patient and delivering medicines. Regulators must also adjust. The risks of home use digital devices require quite different premarket approaches to assessment of hospital hardware and surgical implants. And what happened to Telectronics? The erstwhile flagship of the Australian device industry was itself closed after a widely publicised design fault in its pacing leads with its own tracking and explant challenges (although Telectronics’ worldleading pacemaker designs were acquired by St Jude and lived on). And the Telectronics engineers went on to work for Cochlear or ResMed or to found other medical device companies in Australia planting the seeds for future innovation.

Top ten devices most commonly reported to US FDA for postmarket events 1986 and 2015 1986

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2015

Implantable pacemaker

Insulin Infusion Pump, used with Invasive Glucose Sensor

Pacemaker electrode

General Purpose Infusion Pump

Continuous ventilator

Insulin Infusion Pump

Glucose test system

OTC Blood Glucose Test

Gas machine for anaesthesia

Glucose Sensor - Invasive

Silicone inflatable breast prosthesis

Artificial Pancreas Device System

General Purpose Infusion Pump

Peritoneal dialysis system

Biological Heart Valve

Portable oxygen generator

Diagnostic Intravascular Catheter

Automated external defibrillator

Contraceptive intrauterine device (IUD)

Picture archiving and communications system

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AusBioFEATURE – AusBiotech’s 30th year

The ASX-listed biotechnology sector Joanna Hill Financial Adviser, Baillieu Holst Ltd When I first started compiling the INDEX of ASXlisted healthcare companies for the AusBiotech Journal in 2004 there were few publications that provided potential investors with information that aggregated data in the ever-growing, new ASX listings in the healthcare sector. The industry can be broadly divided into five subsectors: Research & Development Biotechnology, Pharmaceuticals, Diagnostics, Devices, and Services. Many companies overlap these subcategories, sometimes changing their focus or making a transition from one subcategory to another. This has made it difficult to separate into distinct categories or clear subsectors of the Healthcare Index. The availability of data and analysis of the ASX listed biotechnology industry was relatively immature 20 years ago, despite the global successes of our well-known and highly-regarded international healthcare leaders, such as CSL, ResMed and Cochlear. The next Australian biotechnology success story listed on the ASX was Sirtex Medical, a biotechnology and medical device group. Sirtex is one of a rare Australian biotechnology company, listed in 2000, that delivered commercial outcomes from the sale of its SIR-Spheres microspheres for targeted radioactive treatment for liver cancer, enabling the company to reward patient investors with fully franked dividends since 2009. The ASX 200 Healthcare Index has always been dominated, and remains so today, by Australia’s largest global healthcare enterprise, CSL Ltd, previously the Commonwealth Serum Laboratories, first listed in June 1994 at AU$2.40 (77 cents in today’s terms). In 2007 CSL made a 3:1 share split, today the shares are trading at

above $100.00 each. If shareholders had kept the stock from the day of its IPO, the capital return on their initial investment (excluding dividends) would be approximately 13,000%. Such value appreciation is rare among blue-chip stocks. CSL’s market capitalisation today is approximately A$47 billion and together with the other Australian global successes, two medical device producers ResMed (market cap AU$11B), Cochlear (market cap AU$6B) and Sirtex Medical (market cap AU$2B) represents 62% of the ASX200 Healthcare Index. CSL’s current market cap puts it in ASX top 10 behind only the banks, Telstra, BHP and Wesfarmers. The Australian listed healthcare is a significant contributor, not only to Australian industries and employment, but significantly to wealth creation for the nation and its citizens. Australia has lacked, and still lacks, the necessary venture capital funding necessary for early stage, research and development projects. The lack of private funding to advance promising early stage development projects has led many industry leaders to seek funding in the much larger and more mature US market, hence Australia losing the benefit of future income from successful commercialisations of their products. Those who lacked access to overseas investment networks went to the Australian public market and listed on the ASX; The explosion of early stage listings in the early 2000s. Many listed far too early and were not able to secure on-going funding or a partner with deeper pockets. The secondary market, after the Initial Public Listing, new share issues provided the bulk of subsequent funding. The repeated dilution of existing shareholders, even when most participated in the new issues, made the investor weary of the biotechnology sector. In the early 2000s there were more than 60 biotechnology companies listed on the ASX with a market cap below AU$20M. Volume 26

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AusBioFEATURE – AusBiotech’s 30th year Since those early days the listed biotechnology sector has matured, the public has a greater understanding of the long-term investment horizon needed and the ongoing funding support required before commercialisation can be achieved, but never guaranteed. The most successful ASX listed companies have been able to access international investors and collaborate with global enterprises. As an illustration of what it takes to fund and to establish significant global networks with complimentary enterprises in order to progress early stage projects Mesoblast makes a very good case study. Mesoblast is one of a few Australian ASX listed biotechnology companies that has been very successful at attracting significant funding and collaboration with US companies in the promising field of regenerative medicine. Their proprietary patented technology in the use of adult stem cells, and a method associated with purifying and enriching Mesenchymal Precursor Cells have the potential as a treatment in many disease indications, including orthopaedic and cardiovascular. ASX and Nasdaq listed Mesoblast is recognised by many as a global leader in the promising field of stem cell therapies. In following Mesoblast’s progress and its successive capital raisings since listing in 2004, with a modest issue of 42 million shares at 50 cents each to raise AU$21 million, one can get a clear picture of how much time and funding is needed, before any commercial potential can be revealed, yet still cannot be guaranteed. Mesoblast made strategic purchase and partnership with US-based Angioblast Systems acquiring a 33.3% stake (for AU$10 million) to give it another spoke in exploring the therapeutic use of MPC, this time, in partnership with Angioblast, for cardiovascular diseases. Further funding from an NHMRC grant of AU$1.5 million and Commercial Ready Grant of AU$2.7 million in 2005 helped to cement the validity of Mesoblast’s endeavours in the minds of Australian investors. In 2005 Mesoblast appointed the Bank of New York to establish level 1 American Depository Receipt (ADR) program to give the company access to a larger and well informed American investor base. In September 2008 the FDA granted Angioplasty Systems Inc., Orphan Drug designation for the 50

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use of adult stem cells technology in patients with bone marrow transplant. Mesoblast was able to issue new shares and raise AU$17 million, increasing its shareholding of Angioblast to 39%. Increasing attention globally to the potential for the therapeutic use of adult stem cells, gave rise to significant deal making. In November 2008 US- based Osiris Therapeutics, a cellular and regenerative biotechnology company, received an upfront payment of US$130 million (with a potential deal value of US$1.38B) from Genzyme Corporation (acquired by Sanofi in 2011) for access to their adult stem cell technology platform. In March 2009 Mesoblast raised a further AU$10 million by issue of 15 million new shares, Angioblast too raised $10 million by issuing new shares, with Mesoblast retaining 38.5% but in 2010 Mesoblast raised AU$37 million, with a new and existing shareholder issue, to acquire all of Angioblast Sytems, a strategic acquisition that advanced Mesoblast’s as a global leader in advancing the development of the potential use of MPC in cardiovascular and orthopaedic diseases. In November 2010 Angioblast Systems (wholly owned by Mesoblast) received US Government US$1.2 million in grants under the qualifying Therapeutic Discovery Project. In December 2010 Mesoblast announced that it was to receive an upfront payment of US$130 fee from Cephalon Alliance and additional US$130 million for exclusive world-wide rights to selective Mesoblast products, and Cephalon to acquire a 19.9% stake in Mesoblast. In February 2011 Mesoblast had cash balance of $280 million, in March 2013 the company able to raise another $170 million to drive their advanced programs and in 2015 Mesoblast listed on the Nasdaq with a cash injection from new investors of US$83 million. Despite the long lead-time, capital raisings of more than $600 million, strategic acquisitions and significant partnerships Mesoblast has not yet commercialised its product to receive revenue and distribute profits to longstanding shareholders. Mesoblast is well-recognised as a global leader in regenerative medicine research and development, it holds a portfolio of patents that may make a significant contribution to future revenue streams.

AusBioFEATURE – AusMedtech 2016

Australia’s medtech conference to convene in Adelaide Following the success of AusMedtech 2015 in Melbourne, this year’s AusMedtech conference will move to the Adelaide Convention Centre to continue discussions about the issues and factors relevant to global medtech success. The conference, presented by AusMedtech with host partners BioSA and the Adelaide Convention Bureau, will celebrate the latest innovations in the sector, with a spotlight on South Australian ingenuity. AusBiotech’s annual AusMedtech event is Australia’s premier medtech conference for developers, manufacturers and suppliers of medical technology, from emerging companies, engineers and clinicians to commerciallysuccessful global companies involved in development of new medical devices and diagnostics. It provides the opportunity to come together and learn from colleagues who share the challenges associated with this sector. AusMedtech 2016 will feature a comprehensive program, trade exhibition, networking events and AusPartnering, our business matching program enabling delegates to schedule 30-minute meetings with other attendees. There will also be an opportunity for delegates to join a tour of the Medical Device Research Institute (MDRI) at Flinders University in Tonsley, to view some of the research, facilities and capabilities within the MDRI and meet academics driving the research. MDRI is also home to the award-winning Medical Device Partnering Program (MDPP), a unique model for collaboration between researchers, clinicians, end-users and industry, responding to industrydriven research problems and connecting ideas to develop innovative medical devices and assistive technologies. The tour is available to registered delegates only and RSVP is required.

A highlight on day one will be the plenary delivered by Stephen Tomisich, CEO of Trajan Scientific and Medical, who has seen the company grow from a new entrant to a wellestablished leader in the Australian medtech industry. Trajan has already made a significant breakthrough in its recent partnership with the University of Adelaide’s Institute for Photonics and Advanced Sensing (IPAS) by opening a new business unit at the University’s facilities focusing on instruments, sensors and devices. This milestone expands Trajan’s footprint outside their HQ in Melbourne and will drive collaboration with the University’s technical capabilities further assisting their vision to enhance human wellbeing. On day two, Dr Neal Fearnot, President, Cook Advanced Technologies and Vice President, Cook Group Incorporated, Cook Medical (USA), will present a plenary giving his expert view on the key issues facing the global medtech industry. Neal Fearnot’s focus at Cook Medical is the scientific and business potential of new medical technology and regulatory affairs policy worldwide. Among his experience of serving as founding President of three companies – MED Institute, Cook Biotech and Cook Advanced Technologies – Dr Fearnot has filed countless submissions to the US Government as well as providing input to the development of legislation in the US, Japan, India, Taiwan, Europe, Panama, Bahamas and Mexico. View the full AusMedtech 2016 program at ausmedtech.com.au

The AusMedtech 2016 program will address key commercial issues such as export opportunities, finance and investment, hot technologies and updates in the fields of IP, regulatory approvals, health economics and Australia’s Medtech reimbursement and sales networks.

Conference

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AusBioFEATURE – AusMedtech 2016

Pulse of the industry – global medtech outlook Gamini Martinus Australian Life Sciences Leader, Ernst & Young The global medical technology sector continues to face tepid growth and a dwindling pool of investors for early-stage companies. In the 12 months ending 30 June 2015, these obstacles were partially offset by a record number of initial public offerings and debt deals, a healthy market for mergers and acquisitions, and an increased emphasis on R&D spending. But, despite these gains, the medtech industry cannot afford complacency. The latest edition of Ernst & Young’s annual medical technology industry report, Pulse of the industry, found revenue for US and European public medtech companies increased just 2% in 2014 to US$341.8b – the second year of low, single-digit, top-line growth. Venture capital investment held steady, but the amount of money dedicated to early round investment dropped 19% to less than US$1.3b. The disparity between the ‘haves’ and the ‘havenots’ in medtech is growing increasingly stark. Despite the buoyant fundraising and deal-making environment that exists globally, there remains a persistent gap in the type of early-stage venture capital funding required to support an innovative medtech ecosystem.

across the entire life sciences sector, including medtech, biotechnology and pharmaceuticals. In this environment, the number of IPOs in the Australian sector as a whole remains limited – with just five deals announced in the last year, raising less than AU$50m. These challenges raise important questions about the long-term sustainability of the sector. Reigniting revenue growth will require a renewed focus on the development of breakthrough products and solutions that improve health outcomes. It is those innovations that will catalyse and sustain investor enthusiasm in the medtech industry. So it’s heartening to see that innovation is still firmly on the agenda of the Australian medtech sector. Larger medtech companies in particular are continuing to invest in R&D to expand their product range and global reach. Looking ahead, while there are significant opportunities to transform health care via medtech, delivering on this promise and accelerating growth beyond the single-digit revenue gains achieved in 2013 and 2014 will require a significant focus on and investment in innovation, right across the industry’s value chain. The views expressed in this article are the views of the author, not Ernst & Young. The article provides general information, does not constitute advice and should not be relied on as such. Professional advice should be sought prior to any action being taken in reliance on any of the information. Liability limited by a scheme approved under Professional Standards Legislation.

This lack of funding can be partially attributed to an increasingly uncertain reimbursement climate and the resulting pressure for companies to find new ways to demonstrate the value of their products. With its iterative product development cycle, medtech is particularly susceptible to value-based criticisms that may depress new product sales. As a consequence, organic growth has been difficult to achieve, particularly at the industry’s leading therapeutic device companies. Funding is stretched in the Australian market too, where the limited pool available is being spread

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South Australia’s medtech capabilities are growing... BioSA is a high-tech innovation initiative of the South Australian Government, helping South Australian medtech companies achieve success.

Contact us to find out more about our grant programs, industry assistance and business incubation. www.bioinnovationsa.com.au +61 8 8217 6400

AusBioFEATURE – AusMedtech 2016

South Australia: A hot spot for medtech companies

The BioSA Business Incubator, located close by in Thebarton, helps to facilitate commercialisation of research coming out of the precinct.

More and more medtech companies are reaping the benefits of being based in South Australia. Their success comes on the back of a longstanding SA Government commitment to support and grow the sector through a vision that combines research, education and industry. This commitment includes the creation of Adelaide BioMed City located at the west end of North Terrace, bringing together over $3 billion of public and private investment in research and patient care infrastructure. Collaboration between the already completed SA Health and Medical Research Institute (SAHMRI), the new Royal Adelaide Hospital and the state’s three universities offers a world-leading research, academic and clinical practice environment. Just three kilometres west of Adelaide BioMed City, researchers and innovators have long benefited from the start-up and commercial expertise based in the Thebarton Technology Precinct in the city fringe suburb. The Precinct co-locates around 30 life science/medtech companies as well as the BioSA Business Incubator and BioSA Tech Hub facility. In addition, just south of the CBD, Tonsley Park is growing a precinct for high-value industry, research, education and residential use. A new state government initiative aimed at boosting the presence and profitability of South Australia’s medical technology companies is a giant leap in the right direction too. The MedDev SA Alliance aims to help commercialise South Australia’s medical device resources by bringing together manufacturers, the state government, federal government and other key industry groups including BioSA and the Medical Device Partnering Program at Flinders University. Another government agency, Health Industries South Australia, attracts direct investment to the state and helps forge

partnerships between interstate and overseas companies and local life sciences clusters to assist them develop, test and translate new medical technology into clinical practice. An impressive number of South Australian medtech and biotech companies have experienced exceptional growth and success to date. Signostics, an innovator of highly miniaturised ultrasound devices, undertakes research and development in Adelaide and exports to countries around the world. Another success story is Jackson Care Technologies (JCT), a highly sought provider of cutting-edge communications for the healthcare sector. ASX-listed Reproductive Health Science (RHS) is also a notable inclusion. The developer of advanced patented single-cell genomic technologies has launched a product to improve IVF success rates through preimplantation genetic screening. The company has distributors in China, Russia, India, Israel, Turkey, Iran and South Africa and sells the product directly in other territories. These innovators are part of a growing number that have received assistance and funding from the SA Government (through BioSA and related initiatives) to become commercial entities. Dr John Greenwood AM is grateful for the encouragement, support and advantages that being based in South Australia has meant for his revolutionary products for burns victims. “South Australia has provided me with all of the necessary infrastructure, financial support and institutional encouragement to take an idea 10 years ago, and turn it into clinical products today,” he said. “Laboratory infrastructure and excellent animal research facilities allowed development and optimisation of our biodegradable skin graft alternatives. “BioSA provided essential support and capital to safeguard continuous progress. State government funding looks certain to drive commercialisation; and Royal Adelaide Hospital recognised the importance and potential of the work too.” South Australia is obviously, and uniquely, dedicated to nurturing and developing the medtech and biotech industries. This can only be great news for interstate and international innovators with the foresight to pounce on the opportunities this level of commitment brings.

The South Australian Health and Medical Research Institute forms part of Adelaide BioMed City

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AusBioNEWS

China guide to support Australian medtech companies AusBiotech has developed the ‘Guide for Australian medical technology companies seeking to engage in China’ (the China Guide), to support small to medium-sized Australian medical devices and diagnostics companies that are seeking to engage with and in China. The China Guide is part of a larger project that seeks to facilitate medical devices and diagnostics trade and partnership with China by breaking down the information barriers for Australian companies. This Guide and the broader project are supported with funding from the Australian Trade Commission as part of the Asian Business Engagement (ABE) Plan and will result in much-needed information about intellectual property (IP) management and the types of business structures suitable for Australian companies in China. As part of the “Medical diagnostics and devices to China” project, AusBiotech also produced an online ‘Directory of Australian medtech companies’ (the Directory) in Chinese and English to promote Australian Medtech companies in China. The Directory includes companies developing orthopaedic, neurology and cardiology devices as well as oncology and other diagnostics and wound care and hospital suppliers. Fifty Australian medtech companies opted to be included. The Directory is being supported by distribution in China via partner China BlueSky Partners and distributed to Chinese companies and organisations via industry bodies and Government departments in Beijing, Shanghai, Nanjing and Hong Kong. The Australian medical technology industry consists of an estimated 500 - 800 companies that are seeking opportunities in global markets and are increasingly seeking support to enter Asian markets, specifically China. Most of these companies are micro or small enterprises with a turnover of less than $2 million, with limited capability to assess overseas markets independently.

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The China Guide provides information about IP management, information on business structures, the business, cultural and regulatory context and other information that a medical technology company may consider when developing their business plan for China. The China Guide does not intend to take the place of professional advice, but it is intended as a starting point for Australian companies interested in China. China is one of the fastest-growing and remarkable medtech markets in the world. Its astonishing growth is largely attributable to the country’s increasing government spending, underpinned by robust economic growth, which has led to improved healthcare access and infrastructure, as well as the ongoing expansion of public insurance coverage and infrastructure for less developed parts of the country. Beyond the growth in government spending, patients’ ability to afford better medical care has increased - driven by the rapidly-increasing middle class - and an ageing population. It is also a complex and fast-changing environment, and most importantly it is a very different business environment to that of countries like Australia. The Guide is delivered via AusBiotech’s AusMedtech, the national industry group that represents the medical technology sector and is supported by generous in-kind support from major partners FB Rice and Deloitte. The project was informed by a select advisory committee of partners that also included: The Burnet Institute, Quintiles, L.E.K. Consulting, Admedus Ltd, Duncan Hart Consulting, China BlueSky Partners and Brandwood Biomedical. The Guide can be requested from [email protected] and the Directory can be found at www.ausmedtechdirectory.org.au.

AusBioNEWS

Why do academics feel they own quality? Prof Paul Wood Adjunct Professor in Biotechnology, Monash University With the recent Innovation statement we are again seeing the question raised about the risk this will pose to the independence, integrity and quality of research (9 December, Quinn Grundy, The Conversation). However this is only part of the story and unfortunately the other half gets little attention. Each week there are many publications in peer-reviewed quality journals with data and conclusions that will never be able to be reproduced. Very little of this is due to deliberate fraud, but more to experiments that lack all the necessary controls, are so customised in design that other labs won’t be able to repeat them or just lack the appropriate statistical power to be able to draw strong conclusions. Commercial science, conducted in highlyregulated industries such as the pharmaceutical industry, is done to a standard of quality not imaginable in an academic environment. International standards such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) are routine in industry, but seldom used in university research. If you use the analogy of submitting a scientific paper to a regulatory agency rather than a peer -reviewed journal, few academic papers would get published. Firstly, none of the scientific protocols have been reviewed and approved up front, the statistical analysis was not agreed to before the experiments were conducted (data mining is not allowed) and most critically none of the primary data was submitted for independent analysis.

significant capital to develop products based on this research. A paper by Begley and Ellis in Nature (vol 483 p531-533, 2012) examined this issue of reproducibility in the field of cancer research and concluded that some non-reproducible papers had spawned entire fields of research with hundreds of secondary publications. They suggested that the pressure on academics to publish could be one of the factors underlying the publication of erroneous, selective or irreproducible data. It is time for the academic community to embrace the value of working with industry. It is not just about the dollars that might be provided to universities, it is also about the focus on innovation, quality and real outcomes for the public who fund much of what universities do. Research Australia conducts annual national surveys that demonstrate a consistently high level of community support for health and medical research, but if questioned further it would be no surprise to find that diagnostics, therapies and access to clinical trials are the activities tax payers value most. There are potential risks associated with all collaborations, we just need to be aware of these, implement appropriate systems to manage these risks and accept that both academia and industry will benefit from a closer working relationship.

Cries of commercial interest are often heard when industry collaborates with universities, for example the observation that commercial studies more frequently yield positive outcomes is evidenced as subtle commercial bias; not evidence that many companies appreciate they have to conduct studies large enough to avoid false negatives. Freedom to publish is the catch-cry with little concern about patent considerations, which are vital if industry is to risk

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AusBioNEWS

Student life – Career opportunities via networking like an eternity as I stood alone amidst actively communicating individuals. But as it turned out, at that event I met my best local guide in the form of AusBiotech Membership Manager, Tanya Daw. Fortunately Tanya noticed me, spoke to me for a while, encouraged me and even introduced me to some professionals by saying some good things about me. I finally succeeded in having conversations with different people until the end of the event. This experience was the breakthrough that motivated me to never miss any networking events throughout my studies.

Ram Kishore Savana Project Engineer, Medical Devices, Protego Medical Pty Ltd. Master of Biotechnology, The University of Melbourne; AusBiotech student volunteer I recently completed a Master of Biotechnology, with a scholarship, from the University of Melbourne. The program is designed to equip biotechnology graduates with a range of management skills. During my masters, I made the most of the networking opportunities available to me, in particular as a student volunteer at AusBiotech’s major conferences. My story below might benefit some current students and job seekers in paving the way to their first job. Life in a competitive environment is not easy for a person who had never left India. Networking has been essential to building my career in Melbourne. I joined AusBiotech in August 2013, the third week of my masters’ study (also my third week in Melbourne) and attended my first event, Vic BioBeers, in the same week. Every minute felt

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Change is a process that requires effort, I had to break out of my comfort zone to actively communicate with professionals in the field (or at least try). After the first networking event, I had a good think about the night, discussed networking with friends and did research on the purpose of a business card. I then designed a card – I called it my ‘Student Networking Card’. It included a short summary of my background and skillset in bullet points on the back of the card. My business cards went with me anywhere and everywhere. Most of the people who’ve seen my card were surprised with the idea of having a mini-resume and appreciated my approach. This strategy worked very well and I started receiving calls from some professionals for a coffee and had discussions abut how we could help each other. Midway through my masters, I received opportunities from two start-ups – Research assistant at a stem cell research laboratory and an intern (Engineering/Science) position at a medical device company. I chose the latter one as I was more interested in gaining hands-on experience related to my course. The medical device company, Protego Medical, is a startup by Brandon Capital partners and has just one employee (CEO). My initial contract was for three months assisting with project management and device designing and manufacturing. As I continued to gain experience and develop my skillset, I became more confident in my work. I am working for the same company today, almost one and a half years later.

AusBioNEWS

I assisted the CEO in almost all the company activities that led it to reach its current stage – Proof of Concept study at a renowned hospital in Melbourne.

biotech students from Melbourne University who are members of AusBiotech were influenced by my approach and are currently participating in many of the events in and around Melbourne.

In addition to meeting my educational goals and internship targets, I continued taking part in AusBiotech events. I volunteered for six national and state-level conferences in two years. The increase in my LinkedIn contacts was directly proportional to the number of people I met via networking. If I count approximately, I met more than 400 new people in the biotech sector during my two years of Masters. I also shared my experience with fellow students during leisure time at the university and contributed significantly to the increase in number of students attending the networking events. More than half of the

Networking keeps students up-to-date with the biotech industry in Melbourne while also helping a few of the academic assignments. While students can aim to identify potential employers during the networking events, the employers can also identify some potential employees. Having seen a few others who followed this path of grabbing opportunities to gain work experience, I sincerely recommend every student to choose networking as one of their main approaches to land in their first job in the biotech sector. Thank you AusBiotech and Protego Medical!

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AusBioEVENTS

Opportunities to involve your company in the International BioFest 2016

Presenting three major conferences in one week, the International BioFest 2016 will be the largestever gathering of the life sciences in Australia, a not-to-be-missed opportunity to meet the entire biotech ecosystem in one place in one week. International BioFest 2016 is expected to attract over 2,500 delegates to attend the academic, industry and investor events in Melbourne from 24 – 27 October 2016. The event will be a celebration of Australian and international life sciences and highlight Melbourne as one of the world’s great biotech hubs.

IBS 2016, the 17th International Biotechnology Symposium and Exhibition, is a biennial gathering of the scientific and industrial communities of biotechnologists and green chemists comprising academics, researchers, students, company executives, government and entrepreneurs. The Symposium program will present the most advanced issues in biotechnology, green chemistry and its related fields, which will be discussed by a selected group of international speakers and lecturers. ibs2016.org

The International BioFest 2016 will comprise:

• IBS 2016, the 17th International Biotechnology Symposium and Exhibition • AusBiotech 2016, Australia’s life sciences conference • Australia Biotech Invest 2016, Australia’s life sciences investment showcase. For information about partnering with the International BioFest 2016 as a sponsor or exhibitor, please refer to the website. Contact Kirsty Grimwade, National Conference and Events Manager with any questions, email [email protected]. Opportunities are available to partner with the full BioFest or one of its conferences. Speaker abstracts are currently being invited for IBS 2016 (submissions close 1 April), please email [email protected] for further information. Providing outstanding networking opportunities, BioFest events will include a welcome reception, gala conference dinner, closing event and IBS handover. AusPartnering, AusBiotech’s business matching app, will enable delegates to schedule meetings with other attendees. The BioIndustry Exhibition Hall will showcase more than 150 companies.

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AusBiotech 2016 will be the latest instalment of AusBiotech’s national conference, the flagship event for Australia’s life sciences sector to gather, learn and connect. ausbiotechnc.org

Australia Biotech Invest 2016 is Australia’s annual life sciences investment showcase to promote investment in Australian biotech. australiabiotechinvest.com.au

INTERNATIONAL

BIOFEST 2016 24 - 27 October

Melbourne Convention Centre, Victoria

internationalbiofest.org

AusBioEVENTS

AusBiotech 2015 in Melbourne sets momentum for this year’s International BioFest AusBiotech 2015, held 7 -9 October at the Melbourne Convention Centre in Victoria, was another successful meeting of the Australian life sciences community, showcasing the expertise, research and technologies to further advance our leading biotech sector, which is currently ranked fourth in the world. The conference featured an outstanding lineup of Australian and international speakers covering a diverse range of topics relevant to the global life sciences industry, in areas including regenerative medicine, new markets, business development, access to capital, entrepreneurship, biotechnology investment and clinical trials. The new one-day Regenerative Medicine Symposium focused on science’s potential to deliver replacements for damaged tissue and organs, and how close we are to creating ‘made to order’ body parts. A range of experts – including researchers, ethicists, and biotechnology companies – discussed progress, developments and perspectives on regenerative medicine and stem cell therapies. AusPartnering, AusBiotech’s business matching program, again facilitates hundreds of meetings between conference participants. In 2016, the AusBiotech national conference will be part of the International BioFest, the largestever gathering in Australian life sciences, with three major conferences coming together in one week in one place as one integrated network. AusBiotech thanks all delegates, presenters, sponsors and exhibitors, in particular the Victorian Government for their exceptional support as co-host of AusBiotech 2015 and the upcoming AusBiotech 2016 national conference. Award presentations at AusBiotech 2015 The prestigious Johnson & Johnson Innovation 2015 Industry Excellence Awards were presented at the opening of AusBiotech 2015:

• Industry Leadership Award – Professor Maree Smith, Executive Director, Centre for Integrated Preclinical Drug Development (CIPDD)/TetraQ, University of Queensland • Emerging Company of the Year – Ellume Pty Ltd • Company of the Year – Spinifex Pharmaceuticals The awards recognise the leading lights of Australia’s world-class biotech, medical technology and healthcare sectors. Professor Maree Smith was recognised for her stellar career as a researcher – capable of prolific discovery of novel therapeutics – and her ability to achieve translation of these discoveries to clinical practice. Ellume Pty Ltd was named Emerging Company of the Year for its development of simple, highly sensitive and reliable diagnostics for infectious diseases, and by linking the results of those tools to optimal therapy. Spinifex Pharmaceuticals was awarded Company of the Year for its work as a pioneer in the development of new treatments for chronic pain – a debilitating and often poorly treated condition affecting millions of patients worldwide. The winner of the AbbVie Student Poster Award 2015 was announced at the official closing: Alistair Cole, a student in the Department of Anatomy and Neuroscience at the University of Melbourne, was named the winner of AbbVie Student Poster Award 2015. Mr Cole received the award for his poster presentation, ‘The role of Bone Morphogenic Protein signalling in oligodendrocyte differentiation and myelination.’ In layman’s terms, the research is an attempt to understand the factors involved in myelin repair in the brain and spinal cord.

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AusBioEVENTS

1

2

3

4

5

6

7

9

8

10

1 and 2. Welcome to AusBiotech 2015 3. Student volunteers at AusBiotech 2015 4. Delegates plan their session attendance 5. AusPartnering business matching 6. Richard Bolt, Secretary, Department of Economic Development, Jobs, Transport and Resources, Victorian Govenment, and Dr Anna Lavelle, CEO, AusBiotech 7. Emeritus Professor Alan Trounson, Founder, MIMR-PHI Institute of Medical Research 8. Prof Kevin Hindle, Chief Executive Officer, Mentor Entrepreneurship, and CoFounder IMENCA 9. Dr Dushyant Pathak, Associate Vice Chancellor, Office of Research Technology Management & Corporate Relations, University of California Davis 10. Professor Carola Vinuesa, Head, Department of Pathogens and Immunity, Australian National University College of Medicine, Biology and Environment.

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AusBioEVENTS

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12

13

14

15

16

SAVE THE DATE See you back in Melbourne for

AUSBIOTECH 2016

24 –26 OCTOBER 17

18

(part of the International BioFest 2016) Melbourne Convention Centre, Victoria For updates, bookmark ausbiotechnc.org and internationalbiofest.org

19

20

11. Julie Phillips, Chair, AusBiotech, welcomes delegates to the conference dinner. 12. The Johnson & Johnson Innovation 2015 Industry Excellence Awards were presented at the opening of AusBiotech 2015. L to R: Gavin Fox-Smith, Managing Director, Johnson & Johnson, with award winners Dr Sean Parsons, Managing Director, Ellume; Maree Smith; and Tom McCarthy, CEO, Spinifex Pharmaceuticals. 13. Lorraine Chiroiu, Chief Industry Affairs Officer, AusBiotech, and Rebecca Wilson, CEO, Buchan Consulting. 14. Dr Anna Lavelle, CEO, AusBiotech, was interviewed by Dr Fintan Walton, CEO of PharmaVentures, for Pharma TV. 15 – 17. BioIndustry Exhibition Hall. 18. Alistair Cole, winner of the AbbVie Student Poster Award 2015. 19. Abbvie Student Poster Award display 20. Dr Anne Lavelle (left) was presented with flowers by Dr Deborah Rathjen, to celebrate Anna’s 10 years leading AusBiotech.

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CO-ORGANISERS

HOST

Commercialising life science research

LICENSING PARTNERING TECHNOLOGY TRANSFER

12 – 13 April 2016 Customs House, Brisbane, QLD ttsglobalinitiative.com.au

AusBioEVENTS

Tech Transfer Summit Australia

TTS Australia 2016 will return to University of Queensland’s Customs House in Brisbane.

TTS Global Initiative and AusBiotech are pleased to announce the third annual Tech Transfer Summit (TTS) Australia, bringing together leading tech transfer professionals from Australia and the international community to help build expertise and relationships that enable successful tech transfer – that which results in the translation of research into products to benefit our community. The two-day event will return to the University of Queensland’s Customs House in Brisbane, with the continued support of our host partner UniQuest. Tech transfer activities are an essential component of the biotechnology sector and where many of Australia’s promising companies began. Tech transfer offices and the TTS Australia summits are already helping to bridge the gap between the world-class research going on in our universities and commercial success. Interactive presentations will highlight best practices, lessons learned and key issues such as licencing, strategic industry-research collaborations and commercial negotiation. Industry case studies will also be discussed. Engaging topics from TTS Australia 2015 to be further explored at this year’s summit include international business development of tech transfer, commercialisation trends in Australia, financing, reimbursement, valuing your opportunity, early-stage venturing and IP.

Glenn Cross, Chief Operations Officer at AusBiotech, addresses TTS Australia 2015.

Thank you to TTS Australia 2015 event partners Life Sciences Queensland, Johnson & Johnson Innovation, Fisher Adams Kelly, Watermark and Global Data, and particularly UniQuest, our host partner in both 2015 and 2016. TTS Australia is one chapter of a global initiative, with other summits in Europe and North America. The conference is organised by AusBiotech, via its AusEventsTM division. For updates about TTS Australia 2016, bookmark the website: ttsglobalinitiative.com.au.

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Number 1 • March 2016 Australasian BioTechnology

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AusBioSTOCK

INDEX by Joanna Hill

68

Issuer Name

ASX

Principal Activity

First List Date

AtCor Medical Holdings Limited

ACG

Developer & international marketer of Blood Pressure at the Heart device SphygmoCor

9-Nov-05

Alchemia Limited

ACL

Drug discovery & development Fondaparinux, antithrombotic; oncology compounds FAK pathway

Acrux Limited

ACR

Actinogen Ltd

Last Price $

Yr H $

30.1

0.16

0.35

0.10

-2

-8

3

23-Dec-03

2.3

0.01

0.01

0.00

-5

0

3

9.3

Transdermal drug delivery platform technology

29-Sep-04

111.6

0.66

1.14

0.57

7

10

12

6

ACW

Developer of lead candidate Xanamem for treatment of neurodegenerative dosorders uincl Alzheimer's

16-Oct-07

35.2

0.06

0.15

0.04

-1

-5

2

Anteo Diagnostics Limited

ADO

Multi-component coatings for solid phase of immunoassays for biomarker development

7-Apr-00

69.3

0.06

0.12

0.07

-1

-12

1

Adherium Ltd

ADR

Digital technologies - monitoring medication use in chronic respiratory conditions

26-Aug-15

57.3

0.57

0.72

0.48

0

0

0

Agenix Limited

AGX

ThromboView clot imaging diagnostics

2-Sep-92

2.7

0.02

0.03

0.01

-1

-2

1

Admedus Ltd

AHZ

Tissue engineering regenerative medicine & vaccine development for Herpes & HPV

24-Mar-04

100.1

0.46

1.03

0.50

-17

-3

19

Analytica Limited

ALT

eHealth devices. PericCoach System for Stress Urinary Incontienence

25-Oct-00

3.9

0.00

0.03

0.00

-1

-1

0

Allegra Orthopaedics Ltd

AMT

Prostetic Implants tools

5-Dec-07

16.0

0.25

0.05

0.02

-1

-6

6

Antisense Therapeitics ltd

ANP

Antisense Pharmaceuticals. (Psoriasis, MS)

20-Dec-01

9.4

0.05

0.04

0.01

0

2

4

Antara Lifesiences Ltd

ANR

Natural, plant based therapeutics for gastrointestinal diseases

16-Oct-14

50.9

1.49

1.80

0.42

-5

-28

15

Avita Medical Ltd

AVH

Tissue-culture, regenerative products treatemnt of wounds, scars & skin defects

11-Aug-93

55.9

0.11

0.12

0.06

-2

-5

1

Avexa Limited

AVX

R & D drugs for treatment of infectious diseases. HIVintergrase program & antibiotic-resistant bacterial infections.

29-Sep-04

3.0

0.04

2.63

0.75

-14

8

14

AirXpanders Ltd

AXP

Aeroform tissue expander for breast reconstruction

22-Jun-15

231.6

1.10

2.63

0.75

-3

8

14

Biotron Limited

BIT

Antiviral Drug developer, HIV & HCV

24-Jan-01

19.1

0.06

0.17

0.04

-1

-6

1

Benitec Limited

BLT

Gene Silencing Technology

17-Feb-97

19.0

0.12

1.00

0.11

-10

-1

21

Bone Medical Limited

BNE

Development & Commercialisation of therapeutics for bone & joint disease

24-Jan-85

1.5

0.01

0.02

0.01

0

-2

0

0

Bionomics Limited

BNO

Small molecule product developer in areas of cancer anxiety epilepsy & multiple sclerosis

21-Dec-99

153.9

0.33

0.59

0.27

-4

-8

0

0

Brain Resource Limited

BRC

Provider International Database for Human Brain Function

28-Aug-01

22.4

0.15

0.29

0.15

-2

-7

-5

Bioxyne Ltd

BXN

Developer of treatments for respiratory diseases

14-Dec-00

4.8

0.03

0.03

0.01

0

25

1

Cellmid Limited

CDY

"Midkine - novel cancer therapeutic and diagnostic target and anti-midkine antibodies with hybridoma cell lines and nucleotides. "

9-Dec-05

17.6

0.02

0.04

0.02

0

-5

0

Cogstate Ltd

CGS

Diagnostic & therapeutic products for neurodegenerative diseases (also Alzheimer's & Parkinson's)

13-Feb-04

66.5

0.60

0.70

0.14

0

0

9

Clover Corporation Limited

CLV

Refines & Supplies Natural Oils

30-Nov-99

51.2

0.31

0.60

0.14

0

0

17

Australasian BioTechnology Volume 26

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Yr L $

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Div (c)

0

0

0.5

AusBioSTOCK Issuer Name

ASX

Principal Activity

First List Date

Cochlear Ltd

COH

Manufacturer & Marketer Implants for Impaired Hearing

4-Dec-95

CSL Limited

CSL

Supply Blood Products & Vaccines

Cryosite Limited

CTE

Clinuvel Pharmaceuticals Limited

M Cap $m

Last Price $

Yr H $

5,918.6

102.49

107.25

76.73

296

35

316

210

8-Jun-94

47,392.1

102.72

108.68

85.40

415

25

571

171.4636

Collection, Processing & Long Term Storage Blood Stem Cells

9-May-02

8.9

0.19

0.44

0.19

1

20

7

1

CUV

Developer of treatment for UV-related skin disorders. Lead drug CUV1647 in Ph III clinical trial for the treatment of polymorphous light eruption (PLE)

13-Feb-01

158.2

3.70

3.64

2.50

-24

-15

25

Cyclopharm Limited

CYC

Manufacturer & distributor of radiopharmaceuticals, molecular imaging. Lead product Technegas (lung ventilation imaging drug)

18-Jan-07

35.8

0.61

0.70

0.40

6

11

11

Cynata Therapeutics

CYP

Large Scale production of mesenchymal stem cells

20-Dec-07

25.5

0.38

1.44

0.23

-6

-6

7

Dorsavi Ltd

DVL

Motion Analysis device technologies for clinical, elite sports & OHS

11-Dec-13

54.0

0.37

0.42

0.20

-11

0

0

Dimerix Ltd

DXB

Oraline' device for occupational & law enforcement multidrug tesing & Dimeris Ph2 ChronicKidney Disease & Diabetic Retinopathy

4-Feb-93

7.0

0.01

0.01

0.00

0

-4

1

Ebos Group Ltd

EBO

Distributor Healthcare products

6-Dec-13

2,148.7

14.80

14.20

8.95

63

0

53

41.6111

Ellex Medical Lasers Ltd

ELX

Production of Ophthalmic Instruments for Treatment Impaired Vision

12-Sep-94

74.3

0.73

0.90

0.27

2

0

18

0

Genera Biosystems Limited

GBI

Advanced Molecular Diagnostic Tests

11-Jun-08

24.9

0.26

0.36

0.20

-3

-9

-1

Gi Dynamics, Inc

GID

EndoBarrier, endoscopically delivered treatemnt for obese type 2 diabetes

7-Sep-11

9.4

0.02

0.32

0.02

-13

0

9

Genetic Technologies Limited

GTG

Genomics. Genetic Technology - Non-Coding DNA

30-Jul-87

32.6

0.02

0.06

0.02

-1

-2

1

IDT Australia Ltd

IDT

Manufacturer of Pharaceuticals & clinical trial management services

24-Sep-93

57.0

0.25

0.42

0.14

-1

-36

0

Innate Imunotherapeutics Ltd

ILL

Immunomodulator Microparticle technology

23-Dec-13

34.4

0.19

0.24

0.12

-3

-6

2

Immuron Ltd

IMC

Oral Immunotherapy treatments

30-Apr-99

24.0

0.36

0.58

0.15

-5

-8

6

Imugene

IMU

Immuno-oncology biopharma, gastric & breast cancer immunotherapies

2-Dec-93

17.3

0.01

0.02

0.01

0

-4

0

Impedimed Limited

IPD

Diagnostic devices: lymph oedema; muscle wasting; metabolic disorders

24-Oct-07

292.2

0.87

1.25

0.76

-7

-13

8

ITL Limited

ITD

Innovative Medical Devices Blood Collection and related markets

29-Oct-03

18.5

0.21

0.28

0.18

2

0

10

Invion Ltd

IVX

Clinical-stage developer for inlammatory respiratory diseases & high blood pressure

15-Feb-10

7.4

0.01

0.04

0.00

-2

0

0

LBT Innovations Limited

LBT

Automated preparation & streaking of microbiological specimens. MicroStreak automated routine agar plate processing

31-Jul-06

12.1

0.11

0.20

0.06

0

38

2

Living Cell Technologies Limited

LCT

Developer of live cell products for treatment of neurological and metabolic disorders

1-Sep-04

25.8

0.05

0.08

0.03

-2

-3

1

Lifehealthcare Group

LHC

Critical Care Medical Devices & Implatable devices

5-Dec-13

67.4

1.52

3.92

1.49

6

24

31

MedTech Global Ltd

MDG

Healthcare software solutions, clinical management, EMR capability, consultancy services

13-Aug-87

8.7

0.09

0.20

0.07

-3

-3

1

MediBio

MEB

Diagnostic tests for depression & other mental health disorders

29-Jan-01

19.1

0.24

0.49

0.20

-17

-1

-9

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Number 1 • March 2016 Australasian BioTechnology

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AusBioSTOCK

70

Issuer Name

ASX

Principal Activity

First List Date

Medigard Limited

MGZ

Medical Safety Devices. Lead products: retractable hypodermic syringes; blood collection device; IV cannula/catheter introducer device

5-Feb-04

Medical Australia Limited

MLA

Distributor of Medical devices, IV system, blood banking lab. collection of human & animal biologics

Mesoblast Limited

MSB

Monash IVF Group

Last Price $

Yr H $

1.4

0.02

0.11

0.01

-1

-2

-1

20-Dec-04

6.6

0.05

0.12

0.04

0

-28

3

Commercialisation of adult stem cell technology with specific application in the regeneration of bone & cartilage

16-Dec-04

665.2

1.92

4.22

1.14

-35

-5

-3

0

MVF

Reproductive, obstetric, gynaecological services; diagnostic & genetic testing

26-Jun-14

383.7

1.71

1.74

1.05

9

19

-46

7.7

Medical Developments International Limited

MVP

Medical & Veterinary Equipment. Lead Analgesic Agents (pre-hospital & emergency). Penthrox Inhaler.

15-Dec-03

259.7

4.69

4.50

1.70

2

274

0

2

Mayne Pharma Ltd

MYX

Branded & generic pharma products, oral drug delivery systems, complex oral dose forms

29-Jun-07

990.0

1.24

1.46

0.91

3

42

4

Nanosonics Limited

NAN

Disinfection & sterilisation technology, decontamination products to prevent spread of infections

17-May-07

531.6

1.86

2.05

1.16

-4

-51

15

Neuren Pharmaceuticals Limited

NEU

Bioharmaceutical therapies for brain injury, neurodegenerative & neurodevelopmental disorders

3-Feb-05

214.6

0.12

0.17

0.07

-1

0

1

Novogen Limited

NRT

Patents around ATM technology in cancer therapeutics

1-Sep-94

43.0

0.10

0.45

0.10

-3

0

9

NuSep Ltd

NSP

Cell & protein separation systems

14-May-07

2.3

0.01

0.05

0.01

-1

0

-1

OBJ Limited

OBJ

Magnetic micro-array drug delivery technologies

29-May-00

109.7

0.06

0.09

0.05

0

-41

0

Orthocell Ltd

OCC

Regenerative cellular soft tissue therapies for restoration of tendon, cartilage injuries

12-Aug-14

23.4

0.39

0.99

0.28

-5

-8

4

Optiscan Imaging Limited

OIL

Producer Optical Instruments Laser and Optical Fibre

8-Aug-97

4.5

0.02

0.09

0.02

-1

-3

0

Opthea Ltd

OPT

Biologics drugs for opthalmic diseases

18-Apr-91

58.6

0.19

0.28

0.07

-5

-30

15

Oncosil Medical Ltd

OSL

Medical Radiation treatments, OncoSil silicon & phosphorus beta emitter to be used as brachytherapy

15-Aug-05

67.5

0.16

0.28

0.07

-1

-26

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

33.9

0.23

0.85

0.19

-11

-2

14

Pharmaaust Ltd

PAA

Drug developer of synthetic compounds for treatment of human and canine cancers

2-Oct-01

10.2

0.12

0.32

0.07

-3

-4

4

Patrys Limited

PAB

Developer of natural human antibody based therapies including cancer

13-Jul-07

5.6

0.01

0.02

0.01

-1

Probiotec Limited

PBP

Distributor of prescription & OTC pharmaceuticals

14-Nov-06

25.9

0.47

0.55

0.15

-47

-1

40

Prana Biotechnology Limited

PBT

Commercialising research into age-related neuro-degenerative diseases inc. Alzheimer's, Crutzfeldt-Jacobs, MND, Parkinson's. Lead compound PBT in Ph2 clinical trials

28-Mar-00

47.0

0.09

0.26

0.07

-1

-8

7

PolyNovo Ltd

PNV

PolyNovo Biomaterials tissue engineering & Metabolic pharma

26-Nov-98

152.5

0.29

0.34

0.07

0

0

2

Phosphagenics Limited

POH

Vital Health Science. D & C patented phosphorylation technologies, nutraceuticals, dietary supplements, Vit E phosphate complex.

11-Aug-93

13.9

0.01

0.07

0.01

-2

0

2

0

Prima Biomed Ltd

PRR

Fund Biotechnology Research (inc. cancer immunotherapy, rheumatoid arthritis, vaccine technology preventing parasitic diseases in animals)

23-Jun-88

82.3

0.04

0.19

0.02

-2

0

0

0

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AusBioSTOCK Issuer Name

ASX

Principal Activity

First List Date

Prescient Therapeutics Ltd

PTX

Immunotherapeutic products for chronic infectious diseases & Co-X-Gene thechnology for cancer treatemnt

2-Jan-92

pSivida Corp.

PVA

Sustained -release micro-insert drug & biologics controlled-delivery products

Pharmaxis Ltd

PXS

Phylogica Limited

M Cap $m

Last Price $

Yr H $

8.1

0.09

0.13

0.05

-3

0

2

12-Jun-08

22.9

3.94

6.65

3.92

-86

-5

0

R & D & Commercialisation treatment autoimmune, chronic respiratory diseases (inc. MS, cystic fibrosis, rheumatoid arthritis)

10-Nov-03

80.9

0.25

0.42

0.08

6

4

11

PYC

Discovery & Development novel peptide therapeutics for treatment of Asthma, Stroke, Diabetes

30-Mar-05

24.0

0.01

0.04

0.01

0

-4

0

ResApp Health Ltd

RAP

Developer of SmartPhone Medical app for Respiratory diseases

12-Jan-05

63.0

0.13

0.17

0.02

0

0

0

Regeneus Ltd

RGS

Developer of adipose-derived cells with regenerative capacity for cell therapies

19-Sep-13

14.8

0.09

0.22

0.07

-3

-3

0

Reproductive Health Science

RHS

Developer of chromosomal abnormality embroy testing in IVF cycles

5-Mar-87

4.4

0.08

0.22

0.08

-1

-11

2

Resonance Health Ltd

RHT

MRI & tools for diagnosis and monitoring of liver diseases FerriScan & HepaFat

2-Jan-92

8.4

0.02

0.05

0.02

0

18

1

Resmed Inc

RMD

Developer Manufacturer Distributor Medical Equipment for Diagnosis and Management of Sleep Disordered Breathing

25-Nov-99

11,157.5

8.09

9.85

6.69

33

25

0

Rhinomed Limited

RNO

BreatheAssist technology nasal device for sport, sleep and drug delivery

21-Sep-07

14.9

0.02

0.06

0.02

-1

-2

0

RSH Respiri Ltd

RSH

Mobile health aplications for respiratory disorders

14-Jul-00

9.6

0.03

0.12

0.03

-2

-2

1

Reva Medical, Inc

RVA

Bioresorbable stent products, drug-eluting coronary scaffolding treatment for cardiovascular diseases

23-Dec-10

480.7

1.14

1.22

0.40

-23

-5

-17

Sonic Healthcare Limited

SHL

Diagnostic. Pathology & Radiology Services

30-Apr-87

7,527.3

18.38

23.73

16.84

93

20

-380

SciGen Limited

SIE

Development Marketing Sales Pharmaceuticals (inc. Sci-B-Vac Hepatitis B vaccine)

15-Nov-02

1.0

0.01

0.02

0.01

0

25

-15

Somnomed Ltd

SOM

Specialises in products for sleep apnoea. Lead product SomnoMed mandibular advancement splint (MAS)

27-Aug-04

139.3

2.66

3.18

2.24

1

211

25

Starpharma Holdings Limited

SPL

Global R & D Funding for Biotechnology.. Commercialisation Dendrimer Nanodrugs (inc. treatment STD)

28-Sep-00

212.9

0.62

0.98

0.43

-6

-10

14

Sirtex Medical Limited

SRX

R & D Novel Technology for Cancer Treatment (radioactive particles SIR-Spheres for liver cancer treatment)

24-Aug-00

1,832.8

32.00

41.33

14.80

86

37

149

Suda Ltd

SUD

Drug delivery OroMist, oro mucosal administration for off-patent drugs

24-Jan-02

31.9

0.03

0.05

0.02

0

-8

1

Simavita Ltd

SVA

Wireless sensor technology solution for assessment of urinary incontinence in the elderly

22-Feb-14

8.7

0.08

0.64

0.09

-12

-1

11

TBG Diagnosticas Ltd

TDL

Molecular Diagnostics

22-Dec-95

55.5

0.26

0.30

0.14

-9

-3

6

Tissue Therapies Limited

TIS

Developer biomedical tech. wound healing, tissue regeneration, cell culture; VitoGro platform tech. enhancing cell growth & migration

19-Mar-04

11.8

0.04

0.25

0.03

-5

-1

1

3D Medical Ltd

3DM

3D Printing & Holographic projection provider

30-Nov-05

21.4

0.06

0.20

0.05

-4

-2

1

Universal Biosensors Inc.

UBI

Specialist medical in vitro diagnostic tests for point-of-care; blood test C-reactive protein test

13-Dec-06

68.5

0.40

0.50

0.22

-4

-11

8

Uscom Limited

UCM

Develop Supply Operate Medical Equipment Ultrasonic Cardiac Output Monitor

10-Dec-03

16.0

0.17

0.22

0.13

-2

-11

0

Unilife Corporation

UNS

Injectable drug delivery, prefilled automatic needle retraction syringes, wearable, autoinjectors, ocular delivery systems

26-Jun-86

64.1

0.20

0.90

0.11

-26

-1

52

Volume 26

•

Yr L $

EPS c

PER

Asset B (c)

Div (c)

12.367

71

20

Number 1 • March 2016 Australasian BioTechnology

71

AusBioSTOCK Issuer Name

ASX

Principal Activity

First List Date

Viralytics Limited

VLA

Anti-cancer Virotherapy technology using naturally occurring Coxsackievirus and Echovirus. Lead product CAVATAK

15-Oct-86

Virtus Health Ltd

VRT

Assisted Reproductive Services, diagnostics, Day Hospitals

Vita Life Sciences Limited

VSC

Development & distribution of 'over the counter' medicines; complementary; alternative; dietary supplements; health foods

M Cap $m

Last Price $

Yr H $

Yr L $

EPS c

PER

Asset B (c)

Div (c)

153.1

0.67

0.93

0.31

-2

-29

12

11-Jun-13

480.4

6.01

7.95

4.55

38

16

-176

28

23-Aug-07

82.0

1.48

1.90

0.75

8

19

40

3.75

Figures displayed in above index were taken at the close of the ASX 29 February 2016.

Top performers quarter rolling March 2016 ASX Code

Company name

Quarterly Return %

PNV

Polynovo Limited

CGS

Top performers year rolling March 2016 ASX Code

Company name

Yearly Return %

63%

RAP

Resapp Health Ltd

209%

Cogstate Ltd

54%

PNV

Polynovo Limited

124%

RAP

Resapp Health Ltd

47%

CGS

Cogstate Ltd

120%

PBP

Probiotec Limited

45%

ANR

Anatara Ls Ltd

120%

ACL

Alchemia Limited

36%

AMT

Allegra Orthopaedics

114%

ANR

Anatara Ls Ltd

34%

PXS

Pharmaxis Ltd

101%

AXP

Airxpanders, Inc.

32%

PBP

Probiotec Limited

93%

RVA

Reva Medical, Inc

32%

MVP

Medical Developments

84%

PAA

Pharmaust Limited

30%

OPT

Opthea Limited

83%

NEU

Neuren Pharmaceut.

29%

BXN

Bioxyne Ltd

82%

VSC

Vita Life Sciences.

28%

ACL

Alchemia Limited

79%

BIT

Biotron Limited

28%

RVA

Reva Medical, Inc

77%

AGX

Agenix Limited

27%

ELX

Ellex Medical Lasers

76%

CUV

Clinuvel Pharmaceut.

26%

IMC

Immuron Limited

59%

PTX

Prescient Ltd

22%

OSL

Oncosil Medical

58%

MDG

Medtech Global

22%

IDT

IDT Australia Ltd

54%

OPT

Opthea Limited

20%

VLA

Viralytics Limited

52%

MVP

Medical Developments

20%

TDL

Tbg Diagnostics Ltd

50%

OBJ

OBJ Limited

20%

ACG

AtCor Medical

47%

NAN

Nanosonics Limited

19%

QRX

Qrxpharma Ltd

44%

LBT

LBT Innovations

41%

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.

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Australasian BioTechnology Volume 26

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Number 1 • March 2016

AusBioPEOPLE

New member profiles

TransPerfect Medical Device Solutions are designed to meet all of the content needs of today’s device maker, from start-up to global enterprise. Beginning with patented translation services (ISO 13485, ISO 14971-certified), through to e-clinical trials technology, and validated process automation and content management technology, TransPerfect offers the first comprehensive portfolio of integrated solutions for the medical device industry. Elliot Scott (Director – ANZ) T: +61 2 9264 0155 E: [email protected]

Bioactive Laboratories is an Australian agri-biotech company specialising in rare and endangered plant species for human health. Activities include drug and extract research, plant species cultivation and the commercialisation of optimised plant based medicines. Whilst our drug development collaborations with the Walter and Eliza Hall Institute and the Marshall Centre are advancing in the field of infectious diseases, Bioactive is continuing its early market entry with a first-in-class, gentle to the stomach, anti-inflammatory and pain relieving agent. A watershed year for Bioactive with TGA & FDA applications advanced; a US market entry is planned in the not too distant future for a novel mouth ulcer treatment & arthritis supplement. Rick Ferdinands Managing Director

Bosch a world leading innovative company renowned for its commitment to global quality, now offers to the Australian manufacturing industry the solutions to become more competitive in the global market through labour saving technologies utilizing flexible, scalable through innovative lean automation.

T: +61 (0)414 84 9990 E: [email protected] W: www.bioactivelab.com.au

With a breadth of industries and products that extend from the automotive industry, to healthcare, energy, power tools, household appliances and whitegoods. Bosch Manufacturing Solutions division is now working with Medical manufacturing industries throughout Australia and New Zealand offering services such as, Automation/Robotics, Test and Measurement systems, utilizing Process technologies in Laser Marking/Cutting, Vision systems, tightening systems, dispensing systems & ect. Our engineering services range from feasibility studies, workshops, lean equipment design, and Project management through to full system integrators. Bosch’s engineers from the Manufacturing Solutions division are highly skilled at understanding the entire lifecycle of a project, starting at its genesis. John Croft Business Development Manager Robert Bosch (Australia) Pty. Ltd RBAU/TEF Locked Bag 66 Clayton South Victoria 3169 Visitors: 1555 Centre Road, Clayton Victoria 3168

DEK Technologies develops cutting edge solutions across a diverse range of high technology sectors. With a global presence, unique business model and over 300 employees worldwide, DEK Technologies has successfully delivered services and products to multinational companies for over 15 years. We have extensive experience in embedded systems, real-time solutions, ASIC/ FPGA development, hardware design, fault tolerant systems and telecom and datacommunication. As a growing company, diversifying into different industries, we don’t merely apply stock solutions to complex challenges, but seek new ways to enhance the design approach and product performance. DEK Rechnologies Cnr Riggall St and Maldon St Broadmeadows VIC 3047 Melbourne Australia P: +61 3 9309 1808 E: [email protected] W: www.dektech.com.au

T: +61 (0)3 9541 7860 F: +61 (0)3 9541 7872 M: +61 (0)434 185 329 E: [email protected] W: www.bosch-manufacturingsolutions.com.au

Volume 26

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Number 1 • March 2016 Australasian BioTechnology

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AusBioPEOPLE

New member profiles (cont.)

Headquartered in Adelaide, Australia, Ellex designs, develops, manufactures and sells innovative product that help eye surgeons around the world to effectively and efficiently treat eye disease. Ellex is a world leader in this field. Ellex has ophthalmic lasers and devices that treat glaucoma, retinal disease primarily caused by diabetes, secondary cataract and vitreous opacities, as well as age-related macular degeneration. Sales and service directly to eye surgeons is conducted via subsidiary offices in Minneapolis, Lyon, Berlin and Tokyo. A network of more than 50 distribution partners around the world services other markets. Ellex expects to report a profit before tax (PBT) of $1.8m for the 6 months ended 30 December 2015. This represents a 38% increase on the PBT reported for the year ended 31 December 2014. Tom Spurling CEO

Celebrating 50 years of inspiring achievement, Flinders University enjoys a strong reputation for its excellence in teaching and research. The flagship Medical Device Research Institute (MDRI) has the expertise and capabilities to deliver innovative solutions to the medical and allied health sectors. With dedicated programs such as the Medical Device Partnering Program (MDPP), the Institute has formal avenues for collaborating with industry partners. Co-located with industry, and hosting a node of the National Medical Technologies and Pharmaceutical Industry Innovation Growth Centre (MTPConnect), the MDRI is expanding networks to further focus research in areas of priority. Capability within the Institute is varied and crossdisciplinary and our close connections to the clinical community ensure research is relevant and accessible.

P: 08 8104 5200 E: [email protected]

Carmela Sergi Institute Manager Medical Device Research Institute Flinders University, Tonsley Bldg 1 School of Computer Science, Engineering & Mathematics GPO Box 2100 ADELAIDE SA 5001 The National Trauma Research Institute works with organisations nationally and internationally to prevent and reduce the impact of severe injury. Through its recent integration with The Alfred Trauma Service, NTRI provides expertise in the treatment of traumatic injury and through evidence-based research, education, biotechnologies and systems development, NTRI facilitates and leads ongoing improvements in care of the injured. Biotechnologies, decision support, physiological monitoring, team communication and the subsequent reduction in errors of omission are the keys to improved trauma care. Currently involved in a number of biotechnology projects, more information about NTRI can be found at www.ntri.org.au. Professor Mark Fitzgerald Director National Trauma Research Institute (a department of Alfred Health and Monash University) Level 4, Burnet Building 89 Commercial Road Melbourne Victoria 3004 Australia T: +61 3 9076 8806 W: www.ntri.org.au E: [email protected]

T: +61 8 8201 2904 E: [email protected] W: www.flinders.edu.au/mdri

The Peter MacCallum Cancer Centre houses the largest group of laboratory-based cancer researchers in Australia working in close collaboration with clinical cancer experts. Many of our laboratories have pioneered new technologies that are open to licensing and further development. We offer industry a range of opportunities for collaborative or contract research and development. Our access to sophisticated animal models of cancer and a range of human tissue banks with associated clinical data, combined with the expertise of our internationally-renowned research and clinical staff, provides the ability for industry to be actively involved in novel research programs from the earliest stages. Dr Shari Lofthouse Head, Intellectual Property and Business Development T: (03) 9656 3647 E: [email protected] W: www.petermac.org

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AusBioPEOPLE

ResApp Health is developing smartphone medical applications for the diagnosis and management of respiratory disease. The technology is based on machine learning algorithms that use sound alone to diagnose and measure the severity of respiratory conditions without the need for additional hardware. ResApp has a multi-site clinical study underway and preliminary results demonstrated accurate diagnosis of the majority of childhood respiratory diseases. Approval has been recently received to extend the study to adults. Markets for ResApp’s technology include telehealth use, emergency department and regular clinic use, at-home use by consumers and use by aid and humanitarian organisations in the developing world. Dr Tony Keating CEO & MD E: [email protected] W: www.resapphealth.com.au

RSM is a full service national accounting firm delivering expert corporate financial and advisory accounting services to clients across diverse industry sectors. Around the world, RSM is the 7th largest global audit, tax and consulting network. Our onefirm structure enables our clients to more readily connect to our extensive national and international networks, expertise and industry experience. We boast a national network of 29 offices which, combined with over 90 years experience, has helped us develop an extensive understanding of Australian business trends and conditions. Our network across 110 countries and 730 offices enables clients to enjoy access to world’s best practice, insight and expertise. As a single firm, we provide strong service benefits to our clients.  Our structure enhances business efficiencies, reduces internal bureaucracy and underpins our client focused culture.  It also assists our clients in readily connecting to Partners and Senior Advisors, providing both leading advice and great value for money. Contacts: Stephen Carroll T: (08) 9261 9100 E: [email protected] Andrew Barker T: (08) 9261 9403 E: [email protected]

TruScreen offers the latest technology in cervical screening, provided real-time, accurate detection of pre-cancerous and cancerous cervical tissue. TruScreen comprises a hand-held wand and disposable single-use sensor which are gently moved over the surface of the cervix and which use low levels of electricity and light to examine the cervix. TruScreen has been evaluated in studies involving more than 10,000 women worldwide, and is proven as, or more, effective than top quality conventional Pap tests. In addition, TruScreen delivers its results instantly, at the point of care, eliminating the need for expensive supporting pathology infrastructure and the delay in results reporting that both PAP and HPV testing incur. Martin Dillion CEO Level 1, 1 Jamison St Sydney, NSW 2000 T: +61 2 9091 7475 E: [email protected] W: TruScreen.com

Alcidion is a leading provider of intelligent informatics for high performance healthcare that empowers clinicians with decision support tools to ensure the highest quality of care for their patients. By providing clinicians with decision support tools and making recommendations about patient care, patient flow and patient safety, organisational efficiency may be optimised and key clinical risks eliminated. Alcidion’s solutions target key problems for Emergency Rooms, Inpatient Services and Outpatient Departments and are built upon a next generation health informatics platform, which incorporates an intelligent EMR, Clinical Decision Support Engine & Electronic Smartforms. Alcidion Corporation Level 2, 40 Greenhill Road Wayville, SA 5034 T: +61 8 8208 4600 W: www.alcidion.com

Volume 26

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Number 1 • March 2016 Australasian BioTechnology

75

AusBioPEOPLE Corporate, institute and associate members of AusBiotech 3M Australia Pty Ltd AbbVie Pty Ltd Acrux Ltd

Business Events Sydney

Australian Synchrotron Co. Ltd

Celestino Pty Limited

Austrianova Singapore Pte Ltd

Actinogen Limited

Avatar Brokers Pty Limited

Adelaide Research & Innovation Pty Ltd

Baillieu Holst Ltd Baker IDI Heart and Diabetes Institute

Adherium Limited Admedus Limited

Bayer CropScience Pty Ltd

Agriculture Victoria Services Pty Ltd

Bellberry Limited

Ainscorp Pty Ltd

Benitec Biopharma Limited

AJ Park

Bio21 Molecular Science and Biotechnology Institute, University of Melbourne

Alcidion Corporation Pty Ltd (Australia)

Bioactive Laboratories Pty Ltd

Alexion Pharmaceuticals Australasia P/L

BioDiem Ltd

Allens Patent & Trade Mark Attorneys

Biointelect Pty Ltd

Alzhyme Pty Ltd AMGEN Australia Pty Ltd

Biomedical Research Victoria (BioMedVic)

AMS Laboratories Pty Ltd

BioMelbourne Network

Analytica Ltd

Bionics Institute

Anteo Diagnostics

Bionomics Ltd

Antisense Therapeutics Ltd

BioPacific Partners

ANU Connect Ventures Pty Ltd

BioPharmaceuticals Australia (BPA)

Bio-Link Australia

APC Technology Arnold Bloch Leibler AstraZeneca Pty Ltd ATP Innovations Pty Ltd Austanz Chitin P/L Australia China Business Council (ACBC) - Victoria

Australasian BioTechnology Volume 26

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

BioScience Managers Pty Ltd

CTX CRC Limited

Biotech Dispatch

Cure Brain Cancer Foundation

BioTech Primer Inc.

Curtin University - School of Biomedical Sciences

Biotron Limited Blueprint Life Science Group Brandon Capital Partners Brandwood Biomedical Pty Ltd Bristol-Myers Squibb (Australia) Pty Ltd

CV Laser Pty Ltd (CustomVis) Cyclopharm Limited Cynata Therapeutics Cystic Fibrosis Australia D3 Medicine Datapharm Australia Pty Ltd Davies Collison Cave

Brooker Consulting

Deakin Research Commercial

BTG Australasia P/L

Deloitte Touche Tohmatsu

Buchan Consulting

Department of Economic Development, Jobs, Transport and Resources

Burnet Institute •

Centre for Drug Candidate Optimisation

CSL Limited

Bosch Australia Pty Ltd

Australian Red Cross Blood Service (ARCBS)

Cellmid Limited

BioSA

Australian Institute for Bioengineering & Nanotechnology (AIBN)

Australian Proteome Analysis Facility (APAF)

Cell Therapies Pty Ltd

CSL Behring Australia

Biovite Australia Pty Ltd

Australian National University (ANU)

Calimmune Australia

Bioplatforms Australia Ltd

Australian Agricultural Company Limited (AACo)

Australian National Fabrication Facility (ANFF)

76

Australian Regenerative Medicine Institute

Number 1 • March 2016

AusBioPEOPLE Corporate, institute and associate members of AusBiotech Liberty Medical Pty Ltd (Hollister/Dansac)

Department of Science, Information Technology and Innovation (DSITI)

Genzyme - a Sanofi company

Department of State Growth (TAS)

Global Orthopaedic Technology

Lipotek Pty Ltd

Gold Coast Health and Knowledge Precinct Office

Logan Office of Economic Development

Golja Haines & Friend

M. H. Carnegie & Co.

Grant Thornton Australia Limited

M+W Group

Griffith Hack

Madderns Patent & Trade Mark Attorneys

DesignMedix, Inc. DibbsBarker Dimerix Limited DLA Piper Australia DorsaVi Pty Ltd EIB Insurance Brokers Pty Ltd

Global Kinetics Corporation Pty Ltd

Griffith University

Linear Clinical Research Ltd

MasterControl Inc.

Elastagen Pty Ltd

Heidrick & Struggles Australia Pty Ltd

Eli Lilly Australia Pty Ltd

Holman Webb Lawyers

Meat and Livestock Australia Ltd

Ellex Medical Lasers Limited

Houlihan² Patent & Trade Mark Attorneys

Medibio Ltd

Ellume ELSEVIER B.V. Eppendorf ERA Consulting (Australia) Pty Ltd Eskitis Institute Eskitis Institute, Griffith University EY 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

McCloud Consulting Group

Hydrix Pty Ltd

Medical Device Research Institute, Flinders University

ide

Medlab Clinical Ltd

IDT Australia Ltd

Medtronic Australasia Pty Ltd

Ikaria Australia (now part of Mallinckrodt Pharmaceuticals)

Melbourne Biotechnology

Immuron Limited Imugene Ltd INC Research Australia Pty Limited

Melbourne Convention Bureau (MCB) Melbourne School of Engineering Merck Sharp & Dohme

Informit

Mesoblast Limited

Innate Immunotherapeutics Limited

Minomic International Limited

Institute for Glycomics

Mobius Medical Pty Ltd

Inter-K Peptide Therapeutics (Inter-K Pty Ltd) Invion Limited

Minter Ellison Lawyers Monash Innovation Monsanto Australia Ltd. Morgans Financial Limited

IQ3 Corp Ltd

MPR Group Pty Ltd

IQnovate Life Science Organisation

Murdoch Childrens Research Institute

IQX Ltd

Murdoch University

Fusidium Pty Ltd

Johnson & Johnson Innovation

Gamma Vaccines Pty Limited

Johnson Matthey (Aust) Ltd

Gangneung City

Kain C+C Lawyers

Gangwon Province

King & Wood Mallesons

Garvan Institute of Medical Research

Korea Research Institute of Bioscience and Biotechnology

National Trauma Research Institute, Alfred Health and Monash University

GBS Venture Partners Pty Ltd

KPMG

Neoclinical

Genesearch Pty Ltd

La Trobe University Library

Neuren Pharmaceuticals Limited

Genetic Signatures

LBT Innovations Ltd

Neuroscience Trials Australia

Volume 26

•

Nanosonics Limited National Association of Testing Authorities Australia

Number 1 • March 2016 Australasian BioTechnology

77

AusBioPEOPLE Corporate, institute and associate members of AusBiotech Neurosciences Victoria Ltd New Venture Institute Newcastle Innovation Ltd Newline Australia Insurance Pty Ltd

Teva Pharmaceuticals Australia Pty Ltd

pSivida Corp

TGR Biosciences Pty Ltd

QBiotics Limited

The University of Queensland

QIAGEN Pty Ltd

The University of Western Australia

QIMR Berghofer Medical Research Institute

Nexvet Biopharma plc Norton Rose Fulbright Australia

Q-Pharm Pty Limited

Novartis Pharmaceuticals Australia Pty Ltd

Queensland University of Technology

Novo Nordisk Pharmaceuticals Pty Ltd

The Walter & Eliza Hall Institute of Medical Research THEMA Consulting Pty Ltd Therapeutic Innovation Australia

Quintiles Pty Ltd

Tissue Therapies Ltd

Novogen Limited

qutbluebox Pty Ltd

Trajan Scientific and Medical

Novotech

Regeneus Ltd

TransPerfect Translations Pty Ltd

Nucleus Network

ResApp Health Limited

TruScreen Pty Ltd

NZBIO

Research Australia Limited

UK Trade & Investment

OccuRx Pty Ltd

RSM Australia

UniQuest Pty Ltd

OFX

Russell Kennedy Pty Ltd

Universal Biosensors Pty Ltd

Omnigon Pty Ltd

Sanofi-Aventis

ONBoard Solutions Pty Ltd

SeerPharma Pty Ltd

University of Southern Queensland

OncoSil Medical Ltd

Sementis Limited

Opthea Pty Ltd

Seqirus Australia - a CSL Company

Orthocell

Shire Australia Pty Ltd

Osprey Medical

Sienna Cancer Diagnostics Ltd

Paranta Biosciences Limited

Simavita Pty Ltd

Patheon Biologics Pty Ltd

SiSU Wellness

Patrys Ltd

SMART Arm Pty Ltd

Peter MacCallum Cancer Centre

Southern Star Research Pty Ltd

Pfizer Australia

SpeeDx Pty Ltd

PharmAsia News

Spruson & Ferguson

Pharmaxis Ltd

St Vincent’s Hospital Melbourne

Phillips Ormonde Fitzpatrick

Starpharma Holdings Limited

Phosphagenics Limited

Suda Limited

Phylogica Ltd

SydPath

Planet Innovation Pty Ltd

Synchrotron Light Source Australia

PolyNovo Limited Prana Biotechnology Ltd

Talu Ventures

PresSura Neuro

Tasmanian Alkaloids

Pricewaterhouse Coopers

Telethon Kids Institute

Protagonist Pty Ltd

Terra Rossa Capital Pty Ltd

Proteomics International Laboratories Limited

78

Provectus Biopharmaceuticals, Inc.

Australasian BioTechnology Volume 26

Terragen Biotech Pty Ltd TetraQ •

Number 1 • March 2016

University of Sydney, Engineering and Information Technologies University of Western Australia University of Wollongong UNSW - School of Biotechnology and Biomolecular Sciences UNSW Innovations UoM Commercial Ltd US Studies Centre, University of Sydney Venture Valuation ViciBio Pty Ltd Viralytics Ltd Virtual Regulatory Solutions, Inc WATERMARK Patent & Trade Mark Att. West Pharmaceutical Services Western Sydney University World Courier (Australia) Pty Ltd Wrays

AusBioPEOPLE AusBiotech staff and office bearers CHAIR:

Ms Julie Phillips (BioDiem Ltd) Tel: (03) 9692 7240; Email: [email protected]

DIRECTORS:

Ms Michelle Burke (Bristol-Myers Squibb) Tel: (03) 8523 4200; Email: [email protected] Mr Lawrence Gozlan (Scientia Capital) Tel: (03) 9661 8274; Email: [email protected] Dr Andrea Douglas (CSL Limited) Tel: (03) 9389 1135; Email [email protected] Mr Barry Thomas (Cook Australia Pty Ltd) Tel: (07) 3434 6010; Email [email protected] Ms Serina Cucuzza (Burnet Institute) Tel: 03 9282 2204; Email [email protected] Mr Serg Duchini (Deloitte Touche Tohmatsu) Tel: (03) 9671 7376; Email [email protected]

Chief Executive Officer

Dr Anna Lavelle Tel: (03) 9828 1400; Email: [email protected]

Executive Assistant

Ms Jo Beamsley Tel: (03) 9828 1404; Email: [email protected]

Chief Operating Officer

Mr Glenn Cross Tel: (03) 9828 1402; Email: [email protected]

Chief Industry Affairs Officer

Ms Lorraine Chiroiu Tel: (03) 9828 1414; Email: [email protected]

Chief Finance Officer & Company Secretary

Mrs Penny Brassington Tel: (03) 9828 1455; Email: [email protected]

National Programs Manager

Dr Mick Blake Tel: (03) 9828 1425; Email: [email protected]

Member Services Manager

Ms Tanya Daw Tel: (03) 9828 1431; Email: [email protected]

National Conference and Events Manager

Ms Kirsty Grimwade Tel: (03) 9828 1406; Email: [email protected]

Events Manager

Ms Jessica Italiano Tel: (03) 9828 1456; Email: [email protected]

Project Manager

Ms Hayley Laing Tel: (03) 9828 1400; Email: [email protected]

Business Development Manager

Ms Mel Nelson Tel: (03) 9828 1400; Email: [email protected]

Web and Data Administrator

Ms Harshini Bellana Tel: (03) 9828 1432; Email: [email protected]

Events Coordinator

Ms Sienna Deano Tel: (03) 9828 1420; Email: [email protected]

Investment Events Coordinator

Ms Amelia Lundstrom Tel: (03) 9828 1435; Email: [email protected]

Accountant

Ms Crystal Tan Tel: (03) 9828 1408; Email: [email protected]

AP/NSW Representative

Mr Stephen Pattillo Tel: 0412 709 800; Email: [email protected]

COMMITTEE CHAIRS NSW Branch

Dr Phil Kearney (Merck Sharp & Dohme) Tel: (02) 9795 9842; Email: [email protected]

QLD Branch

Dr Ryan Parlett (Deloitte) Tel: (07) 3308 7358; Email: [email protected]

SA Branch

Mr Mathew Palmer (INC Research Australia Pty Limited) Tel: (08) 7202 1500; Email: [email protected]

TAS Branch

Dr Anthony Koutoulis (University of Tasmania) Tel: (03) 6226 2737; Email: [email protected]

VIC Branch

Dr Andrea Huggins (CSL Limited) Tel: (03) 9389 1318; Email: [email protected]

WA Branch

Mr Brian Leedman (ResApp Diagnostics) Tel: (08) 9443 4949; Email: [email protected]

ADVISORY GROUPS Chair, AusAg & Foodtech

Prof Paul Wood (IMNIS) Tel. 0409 098 949; Email: [email protected]

Chair, AusMedtech National Committee

Mr Warren Bingham (Clinical Genomics Technologies) Tel: 0419 144 836; Email: [email protected]

Chair, AusMedtech Regulatory Affairs Expert Panel

Mr Grant Bennett (Brandwood Biomedical) Tel: (02) 9906 2984; Email: [email protected]

Chair, AusMedtech IP Expert Panel

Dr Brett Lunn (FB Rice) Tel: (02) 8231 1019; Email: [email protected]

Chair, Stoma Industry Group

Dr Mick Blake (AusBiotech) Tel: (03) 9828 1425; Email: [email protected]

Chair, NSW AusMedtech

Ms Lis Boyce (Dibbs Barker) Tel: (02) 8233 9566; Email: [email protected]

Chair, VIC AusMedtech

Mr Ian Reilly (Altrutec) Tel: (03) 9888 3978; Email: [email protected]

Volume 26

•

Number 1 • March 2016 Australasian BioTechnology

79

Celebrating life sciences with 3 events in 1 week

24 – 27 October 2016 Melbourne Convention Centre, Melbourne, Australia

internationalbiofest.org Contact: [email protected]

IBS 2016

AusBiotech 2016 Australia’s Life Sciences Conference www.ausbiotechnc.org

IBS 2016 17th International Biotechnology Symposium and Exhibition www.ibs2016.org 24 – 27 October 2016

24 – 26 October 2016

Host

Supporting Partners

17th International Biotechnology Symposium and Exhibition

Australia Biotech Invest 2016 Australia’s Life Science Investment Showcase

www.ibs2016.org

www.australiabiotechinvest.com.au 26 – 27 October 2016