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AustralasianBioTechnology 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

years Book now Save the dateto join us for the Friday 15 July AusBiotech From 12 noon 30th year gala Melbourne luncheon Enquiries Celebrating Contact the AusBiotech the past, Events Team inspiring the [email protected] or 03 98281400 future

AusBioWELCOME21 AusBioWELCOME 435 CEO and Chair report 43 863 AusBioFEATURES 11 AusBiotech’s 30th year 16 Evolution of AusBiotech and Australian biotechnology 19 Influential people in biotech 21 Leading Australia’s industry organisation: a timeline 22 Disrupting the paradigm 23 Biotech – the last 30 years 25 Biotech – the next 30 years 35 Recollections of 30 years of biotechnology 39 The people who founded Australia’s industry organisation; where are they now? 41 What will Australian biotechnology look like over the next 30 years? 43 The evolution of transgenic food 45 Regenerative medicine – are we there yet? 47 30 years of regenerative medicine in Australia 48 Reflections from our members Harmonisation, risk and rigour The ASX-listed biotechnology sector AusBioFEATURES 51 AusMedtech 2016 55 Australia’s medtech conference to convene in Adelaide 57 South Australia: A hot spot for medtech companies Pulse of the industry – global medtech outlook AusBioNEWS 58 China guide to support Australian medtech companies 59 Why do academics feel they own quality? 60 Student life – Career opportunities via networking AusBioEVENTS Opportunities to involve your company in the International BioFest 2016 62 AusBiotech 2015 in Melbourne sets momentum for this year’s International BioFest 63 Tech Transfer Summit Australia 67 AusBioSTOCK Stock 68 AusBioPEOPLE 73 New member profiles 76 Corporate, institute and associate members of AusBiotech 79 AusBiotech staff and office bearers ISSN 1036 7128 All rights reserved. No part of this AusBiotech Level 4, 627 Chapel Street, South Yarra, VIC, 3141publication may be reproduced, stored in a retrieval system, Tel: (03) 9828 1400, Email: [email protected], www.ausbiotech.orgtransmitted in any form or by any other means, electronic,mechanical, photocopying, recording or otherwise, without Editorthe prior permission in writing of the publishers. While Lorraine Chiroiu, Chief Industry Affairs Officerevery effort has been made to ensure the accuracy of the Tel: (03) 9828 1414, Email: [email protected] in this publication, the publishers assume noresponsibility for errors or omissions or any consequences Editorial Coordinatoror reliance on this publication. The opinions expressed in Linda Edgerton, Communications Associatethis publication do not necessarily represent the views of the Tel: (03) 9828 1401, Email [email protected] or the publisher. © 2016 Advertising Bookings and Enquiries - Tanya Daw, Australasian Biotechnology is Tel: (03) 9828 1431, Email: [email protected] the official journal of AusBiotech, Australia’s Biotechnology Organisation. Advertising Submission - Andrew Jackson – Digital Image Australasian Biotechnology reports on 161 Buckhurst St South Melbourne, 3205, Victoria, Tel: (03) 9690 1222, research and business news within the VoluEmmeail2: 6and• reNwu@mdbigeirta1l-i•mMagaer.cchom20.a1u6 Australasian BioTechnology biotechnology arena.Publisher’s Disclaimer The information, opinions and advice in thisjournal are given in good faith and, while all care has been exercised toensure that the information is accurate, no responsibility can be acceptedfor errors, or loss or damage from business decisions arising from the useof information contained in this publication, and the publishers herebyexclude all liability be it contractual tortious or otherwise. 3

AusBioWELCOMECEO and Chairreport Dr Anna Lavelle Ms Julie PhillipsWelcome to the collector’s 30th anniversary its attention on innovation and the launch of theedition of Australasian Biotechnology, marking National Innovation and Science Agenda (NISA)the momentous occasion of three decades since released in December.the founding of the Australian BiotechnologyAssociation (ABA), which 15 years ago became “ The [NISA] Agenda is part of theAusBiotech. Government’s commitment to establishing Australia as a leading innovation system..”So much has changed over the period;AusBiotech is hardly recognisable as the The Hon Malcolm Turnbull, Prime Ministerorganisation that Martin Playne, the ABA’sfounding Chairman, describes later in this edition The NISA delivered long-advocated-for gains for– and yet this work was critical in laying the biotech, including:foundation of what we have achieved today. • The new $250 million Biomedical TranslationFrom its early focus on fermentation via Fund to support commercialisation;biopharmaceuticals, medtech’s devices anddiagnostics, cleantech’s biofuels, foodtech’s • The ‘Same Business Test’ will be relaxed withnutraceuticals and functional foods, biological a more flexible ‘predominantly similar businessremediation, agricultural and industrial biotech, test’. This will allow a start-up to bring inAustralia’s biotechnology industry has more an equity partner and secure new businessrecently evolved to encompass digital health opportunities without worrying about taxand regenerative medicine. The Australian penalties;biotechnology industry and its industryassociation in their inexorable linkage have • Employee Share Schemes (ESS) wereachieved a great deal in their relatively short and improved to limit the requirement for disclosureproductive histories. documents given to employees to be made available to the public. This will allowAs we look back over 30 years of the industry otherwise non-disclosing companies to offerassociation and the industry’s successes shares to their employees without having toand challenges in this edition, as well as the reveal commercially sensitive information toindividuals whose dedication and vision made competitors. This will make ESS more user-it happen, all indicators are that the sector is friendly for innovative companies, allowingpositioned to take its rightful place as a key them to attract motivated staff without acontributor to Australia’s economy. substantial initial outlay;We have just seen the results of 2015, when • Tax breaks for investors in early-stagea record $1.1 billion in capital was raised, the innovative companies;deal flow provided plenty of excitement and theFederal Government has ignited the industry with • Benefits under the R&D Tax Incentive were retained;4 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioWELCOMEAusBiotech supported this in 2015 and: AusBiotech has worked extremely hard and achieved a significant amount. Specifically, our• Hosted 78 events, including major conferences, organisation has been instrumental in key policy investment and states-based events developments. As many of you will know October 2015 marked CEO, Dr Anna Lavelle’s ten years at• Attracted 6,600 delegates the helm of AusBiotech.• Made more than 24 submissions to Dr Lavelle sat down for an interview with Editor governments and attended more than 100 Paul Cross: this is reproduced below with the meetings with various government departments kind permission of Biotech Dispatch. The article and Parliamentarians. provided a good snapshot of the past decade, from the perspective of AusBiotech’s leadership.• Attended 42 consultations meetings Dr Lavelle joined AusBiotech just over ten• 104 newsletters years ago, having enjoyed a varied career up to that point as an academic and CEO of several• More than 240 media articles organisations.• Facilitated 2,465 partnering meetings, through “I’d had an eclectic background before business matching program and international AusBiotech, which probably made me perfect delegations, and signed a deal for Australian for the job, particularly when it came to leading biotechs to become part of the global 35,000+ organisations and understanding policy and directory. stakeholder management,” she says.From the Chair, Julie Phillips AusBiotech has grown in size and stature since she arrived at the organisation which wasFor my part, I’m a relative newcomer to the then located in the offices of former AustralianAusBiotech Chairmanship, having held the biotechnology leader, Amrad.position for just over a year; however I have beena supportive and active member for at least ten The Amrad name has gone and AusBiotech nowyears. In that time, as the CEO of BioDiem, I have occupies its own office in Melbourne.seen remarkable growth in and achievement bythe organisation, notably its role in the delivery of AusBiotech had four staff ten years ago and tightthe landmark R&D Tax Incentive in 2011. constraints on its financial resources, but strong membership loyalty, says Dr Lavelle.An important focus of AusBiotech has been toposition biotechnology innovation as central to “I came from outside the ‘biotech family’, whichnew job growth, increased productivity and as ruffled some feathers but was probably best,” shea revenue-driver for a thriving economy for the says.future, as Australia moves away from relianceon the traditional industries like mining and car AusBiotech is almost unique as an industrymanufacturing to seek more sustainable, high- organisation, something that has become moretech knowledge-based industries. apparent under Dr Lavelle’s leadership.The NISA proposals offer a chance for Australia Its membership represents a diverse range ofto grow, not only its biotech companies with their interests, covering virtually every aspect of theworld-class Australian-backed research, but also biotechnology value chain from discovery throughthe ecosystem of service providers and facilities to commercialisation and even policy.to provide technologies for a global market andjobs for our talented biotech professionals of This contrasts with many other industrytoday and the future. organisations that tend to represent one aspect of a value chain.Through the efforts of our industry organisationwe have been at the negotiating table to According to Dr Lavelle, this broad focus actuallyadvocate successfully for the importance of our aids AusBiotech, ensuring its positions reflect theindustry sectors. As an industry organisation we diverse nature of its membership and enhancingare well-regarded and the credit for this rests its credibility with stakeholders.with the management and staff of AusBiotechand the countless hours of volunteering providedby members including the current and previousboards and committeees. Volume 26 • Number 1 • March 2016 Australasian BioTechnology 5

AusBioWELCOMEAusBiotech Board: Dr Andrea Douglas, Mr Barry Thomas, Dr Anna Lavelle, Mr Lawrence Gozlan, Ms Michelle Burke, Mr Serg Duchini, Ms Serina Cucuzza andMs Julie Phillips (Chair).“What it means for AusBiotech is that we often was very strongly focussed on GM-related issuesplay the role of ‘interpreter’ for different parts of and running its annual conference.the ecosystem, where people have stereotypicalperceptions of certain parts of the sector. “Since then, we’ve really tried to focus on the main game – what’s the big picture? Post-GFC“Often it’s innocent misunderstandings of the priority for our members, and therefore ourthe sector that can be easily addressed,” she priority, was access to capital.says, going on to describe it as one of theorganisation’s most important functions. “In 2007, Australian biotech companies raised just under $1 billion in capital. The next year that“There are very few people in Australia that have dropped to $183 million, so the ceiling just fell ina detailed understanding of the ecosystem and on SME companies.the interdependence of its different components,”says Dr Lavelle. “Our sole focus needed to be on this capital question and, given the urgency and potentialWhen it comes to measuring the success of her impact, we needed to push aside some of thetenure at AusBiotech, Dr Lavelle says the focus other policy areas we had been focussed on.”should be on ‘level of impact’, particularly whenit comes to the organisation’s relationships with According to Dr Lavelle, the organisation startedstakeholders, notably Government, and ability to pursuing changes to address the problem,influence the environment. focussed on the R&D Tax Incentive.The organisation is also unique in the wide “It took over four years to get the R&D Taxrange of services it provides members. While Incentive through and finally passed into law. Itother industry associations focus on policy and required lots of negotiations, speeches, papers,advocacy, AusBiotech has an additional strong but it has delivered through non-equity dilutingfocus on promoting the commercial interests of capital to small companies exactly as envisioned.its members through its year long schedule ofmeetings and conferences. “It has been the most important thing and significant change in the past ten years.”Dr Lavelle says the issues have evolved over theyears. Ten years ago, she says the organisation Dr Lavelle has welcomed new Prime Minister Malcolm Turnbull’s stated support for innovation6 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioWELCOMEand Christopher Pyne’s appointment to a beefed- monetisation of intellectual property – they getup industry and innovation portfolio. the concept of shipping stuff to other countries.“Mr Turnbull is the first Prime Minister to lead with “But the value of an intellectual property deal withinnovation, starting with elevating the portfolio in many hundreds of millions of dollars is often lostCabinet, so there is hope that we may now have on them,” says Dr Lavelle. “There is an incorrecta chance because the public statements being perception amongst some officials that this is amade represent a remarkable shift. small and non-material sector for the economy.”She told BiotechDispatch the Government’s Dr Lavelle welcomes Mr Turnbull’s comments onchallenge will be translating the early and strong the importance of translation.vocal support for innovation into outcomes forthe sector, pointing to its current commitment to “Clearly, there has been instruction we are nowcut the R&D Tax Incentive, having already capped looking at innovation and the translation of theclaims under the program. product of discovery into export income for Australia as an important economic driver into the“This was a transformative policy when it was future.introduced and we need Mr Turnbull and hisGovernment to understand the negative impact “We have haemorrhaged opportunity at the wallson our sector of constant attempts to wind it of our universities in the past, there is no doubtback,” says Dr Lavelle. about that, and it’s the systems that have allowed that to happen.”She also expresses concern at the potentialfor further changes to come out of the current According to Dr Lavelle, the way universitiesreview of tax, which is considering the R&D Tax and funded and academics are remunerated isIncentive. holding back Australia’s ability to improve its performance in translational research.While Treasurer Scott Morrison recentlyannounced that the Government was halting She also laments the lack of basic knowledgefurther work on the review, Dr Lavelle remains of what it takes to commercialise a product.concerned. “If we are going to get better at“What some Canberra-based officials don’t seem commercialisation, then we need to getto understand is that a corporate tax reduction better at building real linkages betweenhas no benefit for many biotech companies the public and private sectors. It is notbecause they aren’t paying tax yet,” she says. an option – it’s a priority.”“The other side is that they don’t understand See more at: http://biotechdispatch.com.au/dr-anna-lavelle-the potential upside of the sector and the on-ten-years-at-ausbiotech/#sthash.cda72BgT.dpuf Volume 26 • Number 1 • March 2016 Australasian BioTechnology 7

AusBioFEATURE – AusBiotech’s 30th yearEvolution of AusBiotech and AustralianbiotechnologyOn the occasion of 30 years since the being organised every two years, primarily by thefounding of the Australian Biotechnology staff at the University of NSW, who had the firstAssociation, a reflection on the journey and School of Biological Technology, which had beenthe people who made it happen. founded in 1968.AusBiotech, Australia’s biotechnology By 1976, CSIRO had started a biotechnologyorganisation, is today a dynamic and well- program, and become active in organisingconnected network of over 3,000 members and attending conferences. It is thereforein the life sciences, including therapeutics, not surprising that it was CSIRO’s Dr Martinmedical technology (devices and diagnostics), Playne who later in 1986 founded the Australianfood technology and agricultural, environmental Biotechnology Association (ABA) and becameand industrial sectors. AusBiotech is dedicated its inaugural Chairman and Principal Executiveto the development, growth and prosperity Officer.of the Australian biotechnology industry, by From its humble beginnings as the ABA with 94providing initiatives to drive sustainability and members, the organisation has worked to supportgrowth, outreach and access to markets, and grow the industry, with many committedand representation and support for members and visionary people as its champions. Dr Martinnationally and around the world. Playne tells how it all began:Our membership base includes biotechnology “In the ‘70s, there were a number of centres withcompanies, ranging from start-ups to mature some biotech activity, such as at the Universitymultinationals, research institutes and of Queensland and companies such as Agen,universities, specialist service professionals, MabCo, Fielders, Burns Philp, Websters,corporate, institutional, individual and student CSL, CSR and CUB all had R&D facilities andmembers from Australia and globally. employed scientists, but the communicationAusBiotech has representation in each Australian between scientists in those businesses and thosestate providing a national network to support in academia or government was very limited.members and promote the commercialisation The 6th biotech conference was held at theof Australian bioscience in the national and University of Queensland (UQ) in the winter ofinternational marketplaces. 1984. By this time, the accumulated funds from successive conferences amounted to severalWhere it all began thousand dollars. It was obvious that there was aIn 1986, biotechnology as a stand-alone need to formalise the conferences into some sortdiscipline was slowly emerging and scientists of organisation, before the funds handed acrosswere gathering in Australia, as it was in the casually to the next person fell into the wrongUS and in pockets around the world, to share hands. Matters of liability and tax status wereinformation and further their research. Since also a consideration.the late ‘70s, small biotech conferences were I contacted Professor Peter Gray at UNSW8 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearand Prof Horst Doelle at UQ and the three of The proposal said that “it is desirable thatus agreed to put up a proposal at the coming the use of the initials ABA be retained butconference in Brisbane in 1984 for the formation with the inclusion of the word ‘industry’ orof an association. equivalent to reflect this increased importance.”The evening time-slot in the conference program This is also the time a decision was taken toturned out to be a slightly unfortunate decision, employ an executive director with a view toas after the day’s conference proceedings had working with the directors to “restructure”finished at 5.00pm, most of us spent the time the ABA – and the hunt began that endedbefore the 7.30 pm meeting in the University in the appointment of Anthony Coulepis.club bar! In his editorial in Australasian BiotechnologyConsequently, Horst, as conference host, had Nov/Dec 2000, Dr Martin Playne described thethe unenviable and difficult job of controlling organisation as “a unique organisationa meeting of some 200 attendees. Despite - a hybrid of an industry association andeveryone being a bush-lawyer, we somehow a scientific society.”ended up with the three of us being appointed He said: “There is no doubt there is need forby the throng to set up an association. change, and a need for a professional executiveThe meeting was vocal in its belief that: in the ABA. The debate is most likely about(a) the inaugural working party members should the form it should take…” He went on that come in equal numbers from the three states, the Steering Queensland, NSW and Victoria Committee have “been making strenuous efforts(b) the working party was to consist of two to ensure we retain all the benefits…while people from each state creating a new dynamic association to lead(c) the three of us were to nominate the others the way ahead for our industry sector.”(d) the association should have a strong At this time the industry was growing well with linkage with industry, as no-one wanted the global industry doubling in size between 1993 another scientific society, and we did not and 2000 and calculated to be worth over $US60 want to compete with bodies such as RACI, billion – a figure that seems quaint by today’s ASBMB, IChem Eng, or ASM. standards. The Australian had about 160 locally(e) many of us thought that the most important active biotechnology companies. The Deloitte contribution an association could make Biotech Index at this time had 47 ASX-listed was to provide a neutral forum for scientists, companies in its index and CSL made up more engineers and technologists from both than 43% of the market capitalisation. commercial businesses, and from academia Dr Peter Riddles said that the global growth of and CSIRO. the industry is “so loud and clear that one does not need to be ‘visionary’ any more to see orAnd the transition from the ABA to AusBiotech understand what is required.”in 2001 The decision to commission the proposal andFast forward 14 years and Dr Peter Riddles establish the Steering Committee was made atelection to the ABA’s presidency in 2000, also the ABA2000 forum in the AGM.marked the endorsement of the “general thrust” Former Director Stephan Wellink describes theof the recently launched Steering Committee events: “I was a member of ABA and was forproposal, to strengthen the role of the ABA some years, and got involved with some otheras an industry association, which was presented members about taking ABA to next level. I flewat the AGM. down for an initial meeting in Melbourne whereThe restructuring proposal to “take the ABA to there was a debate about the organisation.”a new level” included a 100-page report from “The ABA’s future was put to a vote, to eitherBuchan Communications Group, comprising remain the ABA or to change constitution andof 59 considerations for members. While this move to AusBiotech. As I recall, the directorsincluded discussion on a change of name, asked the members for any other comments.AusBiotech was not yet in the running (and I stood up and said I was voting for the future,given records for 2001 are missing there not for the past. Then I was elected director.”is no explanation how the name can to be). AusBiotech officially came to be on 10 May 2001. Volume 26 • Number 1 • March 2016 Australasian BioTechnology 9

AusBioFEATURE – AusBiotech’s 30th yearThe Annual report 2001 said: “The next four The Australian biotechnology industry todaykey steps in the development of AusBiotech, From fermentation to therapeutics, Australia’sand the challenge for the incoming AusBiotech biotechnology industry has come to encompassBoard, include the formulation of policies medtech’s devices and diagnostics, cleantech’sand their implementation, the strengthening biofuels, foodtech’s nutriceuticals and functionalof staff resources, the raising of Funds, and foods, biological remediation, agriculturalthe implementation of effective management and industrial biotech, biologic medicines,principles.” biomarkers and much, much more… The“With the continued implementation of Australian biotechnology industry and its industryAusBiotech’s 3-Year Business Plan, the association in their inexorable linkage haveorganisation can only become stronger and achieved a great deal in their relatively short andcontribute a vital role in the development of the productive histories.Australian biotechnology industry.” In 2015, for the second consecutive year, Australian biotechnology ranked fourth in theReflections from AusBiotech’s longest-serving world (Scientific American, Worldview Scorecard).Chair, Dr Deborah Rathjen Behind this impressive achievement is a vastDr Deborah Rathjen was Chair of AusBiotech for group of Australian companies, working tosix years (2008 - 2014) and steered AusBiotech translate our world-class research into medicalthrough its most rapid change period. Her therapies, medical devices, diagnostic, vaccines,leadership was essential to securing the changes and agricultural crops.which added strength to the organisation. During Today the industry consists of an estimated 900this time, Dr Rathjen also successfully led her biotechnology companies (400 therapeutics andown company, Bionomics, to record deals. diagnostics and 500 – 900 medical technologyDr Rathjen said: “During my tenure I saw companies) and employs in excess of 45,000significant transformation of both the industry and Australians.of AusBiotech. AusBiotech survived the financial The 500+ Medical device companies in Australia,crisis to become the sustainable, robust, industry with a few exceptions are typically young andrepresentative that it is today with a strong voice. small, competing globally with large multi-Our proudest achievement has been the role national companies for market share. TheAusBiotech has played in championing the R&D industry is advancing rapidly into new fields ofTax Incentive, which did not get up first time science and engineering, with nanotechnologyaround. AusBiotech lobbied successfully amid an and other research developments facilitatingenvironment which had seen the canning of all new innovations in the biomedical sphere andindustry innovation grants. Payments under this an increasing convergence of physical andpolicy have continued to flow to the sector. The biological technology platforms. It is a highlyR&D Tax Incentive has been very well received by innovative sector pushing the boundaries inthe industry and its intact preservation remains advanced manufacturing, using highly skilledthe number one public policy issue within the labour distributed to global production chainsindustry.” and specialised markets.“Other highlights have been the current strategic The Australian industry is attracting significantplan for AusBiotech; the launch of AusEventsTM, deals. Highlights in 2015 included: Hatchtecha division of AusBiotech that is a professional signed a licensing deal worth up to AU$ 279conference organiser for life science and million for its Xeglyze head lice treatment.technology events; and investor conferences Starpharma signed a licensing deal worthinitiated and now global. Australian biotech up to AU$650 million with AstraZeneca forhas become more visible to off-shore investors its dendrimer drug delivery platform andas measured by overseas investment and Fibrotech was purchased by Shire in a dealparticipants and there has been a re- invigoration worth up to AU$600 million for new class ofof relations with the Federal Government across drugs to treat fibrosis. Spinifex was purchasedclinical trials, work on biosimilars and other by Novartis in a deal worth up to AU$1 billion,initiatives.” 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.10 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearInfluential people in biotechIn 2015, Scientific American Worldview: A Global all the industry innovation programs were cut.Biotechnology Perspective named AusBiotech’s She played a key role in keeping the sectorCEO Dr Anna Lavelle among the 100 most moving forward even during this period. Annainfluential people in global life sciences, as is absolutely singled minded on ensuring thedetermined through nominations and selections industry is soundly based and she has enabledfrom an international panel of experts and peers. our industry to take its place on the global stage. More importantly, Anna is a really delightfulJulie Phillips, Chairman of AusBiotech Ltd, said, person to work with. She has a big heart, is truly“It is a great honour for Anna to be recognised in compassionate and she’s always there to supportthis way, but especially to be the only Australian the people around her, as much as we are herenamed in this global group of respected, visionary to support her.”and eminent people. Also on the list was fellowgeneticist Craig Venter, whose work to sequence Anna achieved 10 years service as AusBiotech’sthe human genome is legendary in biotech CEO in June 2015.circles, and the Bill and Melinda Gates to giveyou an idea of the calibre of the list. It reflects During 2015 AusBiotech’s COO, Glenn Cross,very well on AusBiotech, which has gone from also achieved a decade of service to AusBiotech,strength-to-strength under Anna’s leadership, its members and the industry. Together Anna andwhich also delivered to the industry the landmark Glenn have re-visioned AusBiotech and seenreform, the Research and Development (R&D) exception growth. They have delivered a strongTax Incentive. Anna is quite rightly proud of her and influential network of biotech and medtechpart in delivering this initiative and we each have companies and related organisations and a bettermuch to thank her for – not the least of which policy environment for Australian companies.is hundreds of millions of dollars returned tothe sector in cash refunds under the R&D Tax Dr Deborah Rathjen was the longest-servingIncentive. Anna is a talented, tenacious and Chair of AusBiotech, serving six years from 2008dedicated advocate for our industry.” to 2014. She also represented AusBiotech as the Chair of the Pharmaceutical Industry Council.From Deborah Rathjen immediate-past Chairman In 2015 Dr Rathjen was included in the Top 50of AusBiotech: “Anna is such a passionate most influential Australian business women byperson. Her commitment to the Australian The Australian newspaper.life science and biotech sector is unwaveringand she is absolutely focussed on ensuring Dr Anna Lavelle said: “Deborah steeredthat the industry has the right framework to AusBiotech through its most rapid changeoperate successfully and we’ve seen a lot of period. Her leadership was essential to securingadvances under Anna’s leadership. Her dogged the changes which added strength to thedetermination was particularly important organisation. Whilst successfully leading herthrough difficult times such as the GFC when own company, Bionomics.” Volume 26 • Number 1 • March 2016 Australasian BioTechnology 11

AusBioFEATURE – AusBiotech’s 30th yearDr Martin Playne is the founder of the Australian commercial sector. Leon has pioneeredBiotechnology Association (ABA), which is today the development of a vibrant Australianknown as AusBiotech. He was the number one biotechnology industry based on innovativemember as well as the inaugural President and technology transfer from the Australian medicalChairman, and is an Honorary Life Member of research community throughout the last 20 years,AusBiotech. For 18 years Martin was editor of the overcoming significant scepticism and numerousABA’s and AusBiotech’s publications, from 1986 funding crises. A few years ago, Sir Gustavto 2004. Nossal, AC, CBE described Leon as the father of the Australian biotechnology sector.Dr Peter Riddles was President of the AustralianBiotechnology Association (ABA) from 2000, Professor Maree Smith is an exceptionalwhen he chaired the Steering Committee that researcher capable of prolific discovery of novelrecommended and oversaw the transition to therapeutics and able to achieve translation ofAusBiotech, and became the inaugural President these discoveries to clinical practice. Professorof AusBiotech. He was elected as a Director of Smith’s passion to see more academicABA in 1995 and continued to serve AusBiotech’s discoveries commercialised in Australia sawBoard until 2004. her lead the establishment of the Centre for Integrated Preclinical Drug Development (CIPDD)/Dr John Ballard is one of the founding leaders TetraQ at the University of Queensland to makeof Australia’s biotechnology industry and played it easier for academics to translate their owna key role in setting up AusBiotech. He is co- discoveries and for industry to access rarefounder and current Chairman of BioAngels and capabilities in Australia.has taken particular interest in starting innovationcentres and seed funding capital to support Dr Chris Nave is a leader in commercialisingspin-out companies from universities and other early stage medical research technologypublic sector institutions. He was Managing in Australia. He drove the formation of TheDirector and previously CEO of GroPep Ltd until Medical Research Commercialisation Fund2002, positions he held since the inception of the (MRCF) Collaboration in 2007 as an innovativecompany in 1988 and through its listing on the collaborative approach to investing in earlyASX in 2000. stage development and commercialisation opportunities emanating from Australian medicalDr Simon Carroll was a long-serving AusBiotech research institutes and allied research hospitals.Board member, having been a passionateand active participant from the inception of Dr Greg Collier has played a significant roleAusBiotech until his retirement in 2010. It is internationally and domestically in promotingwidely recognised that he has been an overseer Australia’s leadership in biotechnologyto the growth and development not only of development and commercialisation. UnderAusBiotech as an organisation, but the wider Greg’s leadership ChemGenex was the firstbiotechnology industry in Australia. Australian company to submit a New Drug Application (NDA) to the US Food and DrugThe contribution made by Dr Paul Walton Administration for a cancer medicine.(1956 – 2013) to the AusBiotech board providedinvaluable leadership to our industry and great Dr Sue Meek AO has been the Chief Executivesupport to his fellow board members. Paul joined of the Australian Academy of Science sincethe board of AusBiotech in 2010, while Senior May 2008. She has over 30 years of experienceVice-President of Corporate Development at CSL, working in a variety of capacities at the interfacewhere he was responsible for corporate strategy, of industry, academe and government.opportunities for corporate growth including Her particular interests are in promotingmergers & acquisitions, and was Secretary of awareness and understanding of science andthe CSL Board Innovation and Development technology, and the formulation of policiesCommittee. and programs to stimulate the conduct and application of strategic research andMr Leon Serry was the founder and managing development. Prior to her current position,director of Circadian. He has made an Dr Sue Meek was Australia’s inaugural Geneoutstanding contribution to the Australian Technology Regulator from December 2001.biotechnology industry and academic and12 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearAusBiotech, and the biotechnology industry Among the many notable scientificmore broadly, very much appreciates the role discoveries, some have changed the world:and support of state and federal governments.The following people have had the greatest Sir Gustav Nossal AC, CBE has made anpositive impact on the sector. enormous scientific contribution with his groundbreaking research work on the immuneThe Hon Peter Beattie for many years was one system, which earned him a knighthood in 1977.of biotechnology’s leading public advocate at Gus Nossal ran Walter and Eliza Hall Institute ofhome and overseas. Medical Research in Melbourne for more than 30 years and in 1996 he was one of the foundersStephan Wellink said: “I was at BIO ’99 in Seattle of Foursight, a company providing advice onwhen Peter and others effectively launched R&D and science to companies, investment‘Biotech Down Under’ to the world. It was the institutions, academics and government.first time Australia presented a coordinatedapproach at an international biotechnology forum. The Nossal Institute for Global Health,Peter’s leadership ensured that other state and established in 2006, is named in honour of hisfederal leaders looked on biotechnology as a commitment to translating medical research intoserious contributor to society and important to health for all, and utilises the multi-disciplinarythe economy.” research and educational capabilities provided by the University of Melbourne to build andAmong his many achievements, The Hon John exchange knowledge to improve health in areasButton (1933-2008) is particularly remembered where it is most needed.for the factor ‘f’ pharmaceutical industry schemeand its subsequent successors, which had a Professor Graeme Clark AC profoundlymassive impact both in terms of international changed lives for more than 350,000 peoplepharmaceutical investing and forming around the world with the development andpartnerships with local firms. commercialisation of the cochlear implant.The Hon John Brumby made a significant Dr Elane Zelcer said: “It required extraordinarycontribution to biotechnology while in public tenacity from Professor Clark and his team,office. He understood the importance of management of the convergence of differentbiotechnology and innovation to the economy. technologies (medicine, engineering, electronics, materials), financing through a joint venture andThe Hon Ian McFarlane MP has held several knowledge of how to take a highly innovativeministries, including most recently Minister for product to market.”Industry and Science (2014-2015) and Ministerfor Industry (2013-2014). As Minister for Industry, Ranking among Australia’s most successfulTourism and Resources (2001-2007) his portfolio biotechnology success stories is the work ofprovided $20 million for a series of initiatives Professor Ian Frazer AC and his team on theto develop Australia’s biotechnology sector human papillomavirus vaccine for cervical cancer,and support for the development of a national Gardasil. From its origins in ground-breakingapproach to the industry. research at The University of Queensland (UQ), to its use in over 120 countries worldwide, it isDr Anna Lavelle said: “Premier Brumby’s first saving the lives of 250,000 people every year.official function as Premier was to open theAustralian Synchrotron, a major project that Dr Anna Lavelle said: “Professor Frazer’she was instrumental in attracting. He has leadership has demonstrated exceptionaldemonstrated clearly, both as Victoria’s first success in navigating the research, clinicalMinister for Innovation and as Premier, a trial and commercialisation pathways that arepersistent and sophisticated support essential for success in this industry.of biotechnology and we appreciate hisleadership role.” 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. Volume 26 • Number 1 • March 2016 Australasian BioTechnology 13

AusBioFEATURE – AusBiotech’s 30th yearBelow, we remember some of the scientists companies such as Genentech, Bayer andand industry leaders who defined and shaped Johnson & Johnson. He was involved in foundingthe industry. of several listed companies and assisting them with commercial growth and productEmeritus Professor Nancy F Millis, AC, MBE development, combining his scientific and(1922 – 2012) was an extraordinary woman and industry expertise.pioneer of early Australian biotechnology, and aLife Member of AusBiotech. Dr Geoff Grigg (1926 - 2008) former CSIRO Chief of the Divisions of Molecular Biology andNancy Millis was one of the pioneers of the study Biotechnology, was way ahead of his time inof fermentation technology in Australia. Prof seeing the commercial possibilities in bioscienceMillis’ areas of interest lie in the general field of and was instrumental in the foundation ofbiotechnology, more specifically in fermentation, companies in Australia and the UK that havewastewater and environmental biotechnology. been collectively valued at more than $1 billionShe was a highly respected researcher, educator, (Bioclone, Peptech (Arana), Betapeptide andand policy-maker who oversaw the development Human Genetic Signatures in Australia, and inof science-based regulation of gene technology the UK, Cambridge Antibody Technology andin Australia. Domantis).”The Millis Oration was named after Nancy and The late Dr David Evans AM was integral in thehas been held annually at the AusBiotech national formation of Australia’s first university-basedconference for over a decade. The Oration is a venture capital fund, Uniseed. David served asfocal point of the annual industry gathering and is CEO of the Uniseed fund from its inception in lateappropriately named in honour of this pioneer of 2000 until June 2002, after leaving his position asAustralia’s biotechnology industry. Managing Director of UniQuest, where he worked from 1994 to 2000. He was later ExecutiveProfessor Millis is one of only a handful Chairman of Magnetica from 2004 until 2009.of scientists to be honoured with her own In 2013, David was honoured with a Member of“Australian Legends” postage stamp and the Order of Australia “for significant service toin 2006 the bacterium Millisabrevis was science and innovation through commercialisingnamed in recognition of her contribution and developing new technologies”.to water microbiology. David helped to launch many innovationsPaul Trainor AO (1927 - 2006) is remembered throughout his career. He also mentored many ofas the ‘father of Australia’s medical device the commercialisation professionals now leadingindustry.’ Marilyn Sleigh said: “He was the Australia’s efforts to promote our innovationfounder of the Nucleus Group whose companies resources globally, including tech transfer(Cochlear, Telectronics) are the basis of Australia’s specialists, venture capitalists, intellectualsuccessful medical devices industry and the property advisors and researchers.training ground for many of its successfulexecutives.” Dr Paul Priscott (1950 – 2014) founded AMS Laboratories in 1996 in Sydney, to provide world-Dr Andrew Baker (1961 - 2012) was a partner class microbiological testing and consultingwith GBS Ventures and had sat on the board services for, amongst others, the pharmaceutical,of several biotechnology companies, including biotechnology, medical device and cosmeticHatchtech, Spinifex, Verva, Euthymics and industries. Before founding AMS Laboratories,Xenome. He led the initial GBS Venture Dr Priscott held positions in commercial,Partners’ investment in Spinifex that, along academic, research and government laboratories.with parallel investments from UIIT and He was committed to science and the industry,Symbiosis, established the company and set and held membership and leadership of severalSpinifex on the path to develop innovative pain committees and technical working groups ofmedicines. He was a founding Board member the TGA, ACCORD and Standards Australia. Heof Spinifex Pharmaceuticals and Chairman was also an industry representative on the NATAthrough to December 2011. He had over 28 Council and Convener of the Cosmetics andyears’ experience in the pharmaceutical andbiotechnology industries, and had worked for14 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearPharmaceuticals Special Interest Group (CAPSIG) Dr Michael Hirshorn OAM (1950 - 2011) wasof the Australian Society for Microbiology. Director of Sydney-based Four Hats Capital and had a 30 year career of founding, building,Life sciences executive and medical imaging managing industry heavyweights and investing(echocardiograph) specialist, Barry Epstein in technology companies. He was a founder(1951 – 2014), was Vice President Marketing and CEO of Cochlear, and a founding directorof Proteomics International and a longtime of ResMed and his contribution to the industrysupporter of the biotech sector in Western was highly respected. In 1988 he won BRWAustralia, serving on the WA Branch Committee Businessman of the Year (Technology) forof AusBiotech in 2007. establishing Cochlear in the US Europe and Japan and in 2004 Mike was awarded an OrderDr Richard Lipscombe, Managing Director of of Australia Medal for his work in commercialisingProteomics International, said: “Barry was an medical technology.insightful and inspirational man who threw himselfinto projects with enthusiasm and positivity. Dr Michael Dalling AM (1946 - 2010) wasHis life science career spanned the globe and a pioneering biotechnology scientist andin Western Australia we reaped the benefit of business leader. His contribution to researchthat experience, exemplified by his passion for and development of biotechnology and itsbiomarker discovery and his crucial involvement commercialisation in Australia was well knownin developing a molecular diagnostic test for and highly respected. Michael had worked forkidney disease. Barry lived his life to the full, many years on the transfer of gene-technologyenjoying both travel and work until the very end, into floriculture, and headed, as MD, the firstand he will be a motivation to us all to discover biotechnology company, Calgene Pacific whichnew ways to improve medical treatments. worked on producing the previously elusive ‘blue’ rose and carnation. The company laterA marketing and business development expert became Florigene, which commercialised thewith international and national experience in blue carnation.the biotechnology industry, Barry also workedin the not-for-profit sector and was involved in Michael led the Victorian Government’sseveral multi-million dollar capital campaigns Strategic Industry Research Foundation (SIRF)for Australian healthcare organisations. He was for many years, where he assisted Victoria’sresponsible for generating $20 million to establish manufacturing industries. Under his leadership,the WA Institute of Medical Research and worked SIRF coordinated the creation of the Australianwith the Board Chairman of Wesfarmers and ‘concept’ car, pioneered the creation of valueother industry leaders and medical researchers from research initiatives and developed a numberfor that purpose. of alternative business models, including ceramic fuel cells. While at SIRF, it was with his influenceAlan Woods (1926 – 2014) was a founding father that Victoria became a major supporter of theof angel capital investment in the Australian Cooperative Research Centre (CRC) initiativebiotechnology industry. He was a successful commenced during the Hawke Government andentrepreneur and together with family members which continues to this day.built David Bull Laboratories, which was later soldto Faulding. He had an unusual mix of technical Alastair Lucas AO (1952 – 2015) was chairmanunderstanding, commercial savvy and vision of investment banking at Goldman Sachswhich led him to become a founding investor Australia. He was the founding chairman of thein Biota Limited, one of Australia’s earliest MRFF Action Group, a coalition of stakeholderbiotech start-ups. This continued a legacy of groups established to back creation of thehis grandfather’s interest in influenza treatment, Abbott Government’s $20 billion endowmentwhich never wavered. Alan not only invested in fund for health and medical research. Mr Lucasthe sector but supported other entrepreneurs was also chairman of the Burnet Institute fromand for example, was crucial in the establishment 2002-2014 and a Research Australia Directorof Medica Holdings Limited, a listed Pooled from 2012-2014. He was an insightful and activeDevelopment Fund. Medica went on to establish supporter of the Australia medical research andseveral other biotechnology companies. biotechnology sector. Volume 26 • Number 1 • March 2016 Australasian BioTechnology 15

AusBioFEATURE – AusBiotech’s 30th yearLeading Australia’s industry organisation: a timeline1985 1990 1991 1995 1996 2000 2 1985 - 1990 1994 - 1995 1999 – 2000 President: Inaugural President and President: Dr Peter Rogers Chairman of the ABA Dr David Fisher (CUB Brewtech) Council: (Peptide Dr Martin Playne (CSIRO) Technology) 1990 – 1991 1995 - 1996 President: President: Mr John Grace Dr John Smeaton (Sirotech, (Bresatic Ltd) CSIRO) 1991 – 1992 1996 - 1997 President: President: Dr Prof. Peter Gray Graeme Woodrow (University (Biotech Australia) of NSW) 1992 – 1993 1997 President: President: Prof.Neil Willetts Dr Ian Nisbet (Biotech (CSL) Australia) 1993 – 1994 1997 - 1998 President: Prof. President: Prof. Milton Hearn Joan Dawes (CRC for (Monash Biopharmaceutical Re- search; BioDiscovery Ltd) University) 1998 – 1999 President: Dr Anne Campbell (CRC Association)1985 1990 1991 1995 1996 2000 20 24 December 1985 the The ABA’s first permanent employee: Barbara Arnold, Company Secretary, 1988 - 2000 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. April 1987: Membership exceeds 500 2000 46 ASX-listed1985 companies with10 ASX-listed companies combined market(no market caps on record cap of $14.3 billion,until 1989). plus 151 private companies.16 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th year0 2001 2005 2006 2010 2011 2016s 2004 – 2006 2014 – Inaugural Chair of the Current 2000 - 2004 AusBiotech Board: Chair: Inaugural President Professor Simon Carroll Julie Phillips of AusBiotech: (Advanced Ocular Systems) (BioDiem Ltd) Dr Peter Riddles (IMBcom) 2006 – 2008 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)d) 2001 – 2005 Executive Director: Dr Anthony Coulepis00 2001 2005 2006 2010 2011 2016 May 2001 the 2004 Dr Martin Playne 2014 and 2015 Australia ABA becomes retires as Editor of ranked fourth in the world AusBiotech, Australasian Biotechnology for biotechnology innovation after a vote at (formerly ABA News) and (Scientific American the 2000 AGM. after 18 years as Editor. 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 2015 111 ASX-listed 89 ASX-listed companies with companies with combined market combined market cap of $39 billion, cap $50 billion, plus 1100 private raised $1.1 billion companies. in primary capital. Volume 26 • Number 1 • March 2016 Australasian BioTechnology 17



AusBioFEATURE – AusBiotech’s 30th yearDr Anna Lavelle, CEO, AusBiotechDisrupting the paradigmDr Anna Lavelle provides her views on the technology, our models for thinking and planningnew thinking that is needed to enable for our healthcare in the future must be disrupted.Australians to realise the potential of We need to apply innovative thinking to some keybiomedical healthcare. access issues. Innovation lives in the future and many find the future difficult to conceive andOver the years, I have publicly lamented the fact even more difficult to fund.the innovation has always been a difficult ‘sell’.Not so anymore, it seems the entire country is The modern world is beset with issues of graveon-board with the Federal Government’s significance – from climate change, cleansinginnovation agenda. waste streams, food production and quality, alternative fuel developments, through to the illsWe too at AusBiotech have welcomed the focus experienced by ageing populations. Individualson innovation and commend the Government for alive today are part of an active revolution,its foresight. However, in the discussions than which has taken the building blocks of biologyhave eschewed, it has become clear that there and applied them to a wide range of importantare widely differing views on what innovation is, problems, especially in healthcare.what it could be and what it should be. Australia has a proud and long history in medicalWhile I will defer on my chosen definition, I research, and boasts more Nobel laureates thancontend that if we want to realise the benefitsof our comparative advantage in biomedical Volume 26 • Number 1 • March 2016 Australasian BioTechnology 19

AusBioFEATURE – AusBiotech’s 30th yearany country on a per capita basis, with five living perspective, this is around the corner, but fromNobel Prize winners. Australia is number four a policy perspective, how does the patient getglobally in the area of life sciences innovation. access? What is it worth to you if treatment can prevent years of therapy, years of pain, yearsWe are solving the technology issues and finding of lost productivity, years of quality-of-life losscures and treatments that 20 years ago we and years of not using the PBS? This examplethought impossible, but our thinking in policy challenges all our current models and programs;terms has not kept pace and remains rooted in from manufacturing to regulation, to clinical trialsoutdated but familiar models and paradigms. to listing on the PBS.My case-in-point is the Pharmaceutical Benefits This is where we need innovative ideas and boldScheme (PBS). It’s a brilliant and popular policy. It is time we disrupted the paradigm andscheme, no doubt, but it is the only ‘game in entered a discourse on options to fund our futuretown’. If a product is not listed on the PBS, the healthcare in earnest. Perhaps we need a schemeproduct is in most cases unavailable to patients that starts saving for healthcare from birth; orin Australia. Even if you’re willing and able to pay perhaps a private insurance option would work.for it yourself, it’s unavailable. This issue of innovation – both products andIn this context the pressure on the Government thinking - is one of national importance. It sitsand sponsors to list products is relentless and at the heart of what Australia will be in the future,conversely the pressure on the Government to of the life-span of Australians in the future andcontain costs is also relentless. With the ‘face’ what we have to offer the world.of personalised medicines changing rapidlyto low volume, higher cost treatments, this isa pressure cooker in need of some innovativethinking to act as a valve.An example of innovative thinking was theestablishment of the Medical Research FutureFund (MRFF), which was broadly welcomed as avisionary nation-building investment for Australia.It is the biggest medical research fund of its kindin the world and has clear and desirable benefitsfor Australia’s future in both improved medicaloutcomes and economic benefits.There are clear benefits from providing enablingsupport to health and medical research,including: a healthier and more productiveworkforce, which is especially important aswe move to increase workforce participationamong older Australians; a more efficient andcontinuously improving healthcare system;growing Australia’s medicines industry, alreadyworth $4 billion in annual exports; and attractingprivate investment to Australia and creatinghigh-value jobs.There is also a clear benefit in enabling betteraccess to the new medicines and treatments.An example of the future of healthcare isAustralian companies that are currentlydeveloping gene therapies that are personalisedone-dose cures. Imagine the ability to curea leukaemia in one dose. From a technology20 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearBiotech – the last 30 yearsDr Stewart WasherChairman Orthocell (ASX:OCC) and Chairman Cynata (ASX:CYP)Someone at a party asked me recently what now releasing our first stem cells medicines toI did as a job. This was a hard one. I sit on a the market. One of the most exciting areas innumber of biotech boards surrounded by much stem cells was the more recent discovery ofsmarter fellow Directors and brilliant CEOs who Induced Pluripotent Stem Cells (iPSCs) by Profdo all the hard work. What could I be adding to Yamanaka in Japan and Prof James Thompson,these companies to keep me around ? I came once again taking a lead in stem cell research.up with a glib very modest answer, “I predict the The amazing thing about these stem cells is thatfuture”. The more I thought about this, the more they are very similar to embryonic stem cells butI liked it. We all need to predict the future in the are produced from adult cells, blood or other cellsfast moving world of technology, otherwise we using reprogramming techniques. No more needwill be superseded or go down the wrong path. for controversial use of blastocysts/embryos.We may feel like the last guy to pay $425,000for a Sydney taxi license in 2011…the year Show me your DNAOne BU (Before Uber). DNA was also first used in a crime case in 1985.Stem Cells R Us DNA fingerprinting developed by Prof Jeffreys (Uni Leicester) allowed a boy from Ghana to beI believe that art can sometimes predict the legally reunited with his mother in the UK. Proffuture, particularly science fiction. 1985 was a Jeffreys then went on to use his DNA techniquewonderful year in film with Back to the Future to solve a number of murder cases and otherand Cocoon released. Cocoon was a film about crimes. Criminals of the world and unexpecteda group of elderly residents from a retirement Dads now both lived in fear.village who get their diseases cured andrejuvenated by swimming in a pool they discover We have indeed seen some great advances in theinside a nearby disused holiday home infused past 30 years in biotech, however we have alsowith an Alien life force. OK, you probably see seen a great deal of biotech that has been slowerwhy I am not a movie reviewer now. However, to develop then we first thought. Stem cells wereit looks like these Aliens may have been using going to make paralysed people walk and thestem cells back then. We humans took another human genome project was going to grant a14 years to isolate stem cells in 1998, when range of immediate miracles. We have not seenProf James Thompson isolated human embryonic these yet but we are making good progress.stem cells from a blastocyst, and are only just Volume 26 • Number 1 • March 2016 Australasian BioTechnology 21

AusBioFEATURE – AusBiotech’s 30th yearBiotech – the next 30 yearsGut Bugs computers soon. Early work has made some real advances here already. This will be interestingThose of you who are as old as me may once mixed with a dose of Artificial Intelligence,remember the 1978 audio tape of War of the Robotics, Drones and Virtual Reality. What anWorlds accompanied with great music by exciting time to be around!the Moody Blues. At the end of the story, theMartians all die from the bacteria that inhabit the Grow me a new liverearth. We are saved by the bugs. We are actuallyinhabited by a multitude of bacteria, particularly Studies to date on regenerative medicine havein our gastrointestinal tract, that control our health made good progress in using mesenchymalfar more than we imagined. In the future we will stem cells (MSCs) injected directly into the bodysee a great outcome of the current efforts in against a range of diseases, including heartdirecting our microbiome to improve our health. disease, stroke and Crohn’s disease. We willWe will control a range of currently devastating see these treatments approved and released toinflammatory and autoimmune diseases using the market soon. I think beyond this we will seemodified gut bacteria. This will represent a great advances in the treatment of a range ofmassive market and large pharma will move into autoimmune diseases from stem cells. 3D printingthis area soon. I think even mental health may of new organs is definitely an area to watch wherebenefit from this field, including depression. We living cells are printed onto a collagen scaffoldmay all be happy and slim in the future. and grown in a bioreactor. Let’s drink to that.Brain wave The next 30 years will be amazing as nanotechnology also grows up and starts toThe next few decades will also create large play in biotech. I really think the era of the brainadvances in neurobiology and brain computer is upon us as well and we will see some reallyinterface. There is significant funding going into exciting breakthroughs. Here’s to a terrific 2016!these areas from the US and Europe currently. Welcome to the future.I would predict that we will see mind controlled22 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearRecollectionsof 30 years ofbiotechnologyDr Martin Playne, Founder and first President such processes can immediately lead to highof the Australian Biotechnology Association economic returns.(ABA), today known as AusBiotech, looks backover what has changed in the last 30 years, Biotechnology became established as a researchwhat new developments and discoveries have field in Australia in the late 1970s. At that time, aoccurred in the biotechnology area, and what major part of the biotechnology research effortAusBiotech and its predecessor organisation, by CSIRO and the universities was connectedthe ABA, have achieved over that time. to fermentation processes. This was reflected in the papers presented at that time in the bi-annualA recent catalogue search of the State Library biotech conferences. Fermentation processesof Victoria using ‘biotechnology’ as the search were also being developed to produce fuelsterm revealed over 1,000 entries. Searching for from biological materials (starch wastes, wheat‘Australian biotechnology’ showed 98 entries. straw, bagasse, pig waste, forestry residues).However when one searched that same term The late 1970s were a time when there wasfor articles, then 11,000 entries are found. This an oil crisis. Sound familiar? Funding for suchalone indicates how established biotechnology research virtually ceased by 1985, when thehas become in the last 30 to 50 years. crisis had passed, although much progress had been made. The knowledge developedI think it is also important to consider the has gone unrecognised for the most part – itmistakes and failures that have occurred in this was published in pre-digital days and today’sbroad industry sector of biotechnology, and computer searches do not find it.where the industry body may have done thingsbetter or differently in the last 30 years. Monoclonal antibodies were ‘the talk of the town’ in the early 1980s, but in reality haveBiotechnologies or biological technology as taken a long time to become establishedit was known earlier goes back a long way to commercial processes. Polyclonal antibodiesthe making of cheeses and fermented milk and were a separate story, as immunologicalmeat products, and alcoholic beverages in products and techniques were becomingwestern society, and just as far back in Asian increasingly important in medicine.and African societies, with a huge range offermented products. Once discovered, microbialfermentation was widely used to preservefoods through a natural acidification process.Indeed, such fermentation processes are stillthe basis for preservation of foods. In morerecent times, it has been recognised that somenatural fermentations can also provide theconsumer with health benefits, e.g. the probioticsfound in bio-yoghurts, and on the pharmacist’sshelf. Fermentation processes were also usedto produce many amino acids, and antibiotics,and a number of chemical commodities.Fermentation is widely used to treat biologicaleffluents and to produce methane. We scarcelythink of these well-established processes aspart of biotechnology because they are regardedas mature technologies. Yet, improvements to Volume 26 • Number 1 • March 2016 Australasian BioTechnology 23

AusBioFEATURE – AusBiotech’s 30th yearGenetic technologies had only just started to companies. It indicates to me the need for thehave a commercial impact by 1975, following Australia Government to give long-term strongthe unravelling of the secrets of DNA and support to develop the larger research-orientedthe double helix in the late 1950s. Genetic companies, such as occurred with CSL manymanipulation of bacteria, yeasts and mammalian years earlier.cell lines was very much the domain of the ‘genejockeys’ in the higher echelons the biochemistry I would be remiss if I did not discuss thedepartments of elite universities. There was continuing embargoes by several Statesonly a weak connection between the more against genetically-manipulated crops (GMOs).industry-oriented biotech researchers and the The industry has failed quite badly in this area.more academic gene jockeys. Thus, up until Why? The original ABA formed a Genetic Releaseabout 1985, the use of genetic technologies in Sub-committee headed by Dr Sue Meek in itsthe old biotechnologies had scarcely occurred. early years, it produced a number of explanatoryBiotechnology was the province of the plant leaflets on genetic manipulation for schools,and microbial scientists and waste treatment and provided forums for issues to be debated.engineers. The genetic studies were mostly Perhaps we took a ‘too scientific’ approachslanted to the more profitable medical industries, rather than using media-based persuasion.due to researchers’ proximity to leading medical The opponents to GMOs mostly had no scienceresearch institutes, such as Walter and Eliza training and argued on the basis of scare tacticsHall, the Florey and Garvan Institutes. In 1985, and falsehoods, they targeted conservativethe connection was weak and this is reflected farmers and politicians and the organic lobby.in the content of the biotechnology conferences One could say that so far they have won, despiteof that time, and the main thrust of the then overwhelming practical evidence of the benefitsbiotechnology association (ABA). Both sides of most GMO crops – higher yield, greaterof the equation had recognised the need for pest resistance, and higher nutritive value.a rebalancing of effort, but it took time. The All tremendous benefits particularly to thefermentation industries were realising the poorer countries of the world, and all verypotential of genetic manipulation, as were plant necessary properties for an ever-growingindustries, and the medical research fraternity world human population.were realising the need for biotechnologyprocesses and the need to scale-up. We have achieved a great deal. The biotech organisation has grown from its first sevenMolecular biologicals had become almost by subscribers and no staff nor funds in 1985default some of the earliest medical products to a highly successful AusBiotech in 2016,on the market using the new biotechnology. solidly funded, with some 3,000 members.Much of their development was due to the It has evolved into a highly-successfuldevelopment of scaled-up chromatographic representative and lobby group for the broadmethods and new membrane technologies biotech industry, covering medical, veterinary,for product separation and purification. fermentation, agricultural and environmental industries successfully and incorporating theOur 1993 survey of biotechnology in Australia biotech instruments and equipment and the(Fayle and Playne, 1993) showed that along medical devices industries. My congratulationswith molecular biological companies, diagnostic to all those involved in taking AusBiotech tocompanies were also a major component of this stage. Happy 30th Birthday.the emerging biotechnology companies. ReferenceVaccine technology was well advanced inAustralia, largely through the efforts of CSL. Fail, D. and Playne, MJ (1993) Biotechnology in Australia inI believe that CSL can be credited for its efforts 1993 IN Australian and New Zealand Biotechnology Directoryto commercialise medical research and link it 3rd Ed (Eds: Playne, M and Arnold, B) (ABA, Melbourne) pstrongly to biotechnology – its success stands 7- 14.out against that of the pack of smaller start-up24 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearThe people who founded Australia’sindustry organisation; where arethey now?A look at the people who started the Australian but has continued his involvement to this day.Biotechnology Association and AusBiotech and He was elected to the Board in the first electionswhat’s happened since. in 1986 and appointed Chairman and President, continuing on the Board of Directors followingIt’s been more than 30 years since the Australian ABA’s first board elections. For 18 years MartinBiotechnology Association (ABA) was established was also Editor of the ABA’s and AusBiotech’sin December 1985 to provide a strong network publications, from 1986 to 2004.of support and range of services for thebiotechnology industry. Behind the scenes an Martin’s career began as a research scientist withactive and dedicated group of people voluntarily CSIRO and from 1965 until 1977 he was involvedworked together to make their vision a reality – in tropical pasture chemistry and ruminanta thriving biotechnology industry for Australia. nutrition in Townsville. He was then invited to joinFifteen years later another group of equally a new research team in Melbourne to developdedicated people re-shaped the organisation liquid fuels from ligno-cellulosic biomass byand shepherded it in its transition to AusBiotech. fermentation. In 1982, funding for energy research ceased. He then focused on production of high-Below we take a closer look at those past value chemicals and polymers by microbialdirectors of both ABA and AusBiotech, featuring fermentation, before working on functional foods,their career highlights during and since their roles including the production of oligosaccharideswith ABA and AusBiotech. by enzymic synthesis, and the use of probiotic bacteria. His team developed improved newThe expertise and knowledge of past ABA probiotic strains with good health efficacy.and AusBiotech directors shows the breadth Three of these are available in the internationalof experience that has led the organisation marketplace. He left CSIRO in late 1999.to becoming Australia’s biotechnologyindustry organisation. Martin’s professional career included collaboration in the CRC on Food InnovationThe first formal meeting of the ABA was held (CSIRO 3 Divisions, UNSW, DSM, Arnotts,February 1986 in Melbourne. According to the Goodman Fielder, Burns Philp), and he wasfirst ABA Bulletin (May 1986) which later became Program Leader with Probiotics in the CRCAustralasian Biotechnology, the ABA had 94 from 1994 until 1999. Martin says he likes tomembers and eight appointed directors on the think of himself as a microbial biochemist withinaugural Council. The Council also appointed an international reputation and part of thethree members as representatives of those states international community of scientists. “I highlyand territories not represented by directors. value the development of a good researchThese appointments were made until official team, run on democratic principles, supportiveelections were held in August 1986 and included of and loyal to each other,” he says.the following people… Martin said the biotech organisation was Dr Martin Playne (Chairman established as “communication between and President) scientists in those businesses and those in academia or government was very limited.” Martin was the founder of The ABA was to provide a neutral forum for the ABA and the number one scientists, engineers and technologists from both member as well as the appointed commercial businesses, and from academia and Chairman and President for the CSIRO, and it was also obvious that there first six years. Martin stepped down from the Board in 1991, Volume 26 • Number 1 • March 2016 Australasian BioTechnology 25

AusBioFEATURE – AusBiotech’s 30th yearwas a need to formalise the emerging biotech of the Bioengineering Centre at UNSW, and aconferences under some sort of organisation.” Senior Principal Research Fellow at the Garvan Institute of Medical Research in Sydney. HeMartin was from 2000 to 2009 Director of is an Honorary Professor at Fudan University,Melbourne Biotechnology, a small consulting Shanghai, China, and is an Emeritus Professorbusiness providing services primarily in at UNSW.functional foods and specifically in probioticsand oligosaccharides as prebiotics – and He was appointed inaugural director of theclosed the business in 2009. Since then he has Australian Institute for Bioengineering andcontinued to do some scientific writing and peer- Nanotechnology (AIBN) at the University ofreview articles in international scientific journals Queensland (UQ) in 2003. He and his colleaguesin his retirement and enjoys doing historical have since built AIBN to an institute of almost 500research and writing, sailing, hiking, playing people with a culture of outcome-driven researchgrandparent, gardening, and volunteering on a excellence. Through his role with ATSE he hascouple of committees. He published his first book been championing the introduction of a metric toon life in the colony of Port Phillip in 2014 (“Two measure research engagement between publicSquatters”), and is currently writing a second and private sector researchers in Australia, thebook on the great will forgeries of 1844. ‘Research Engagement for Australia’ metric, REA. In December 2015 was appointed asMartin is an Honorary Life Member of AusBiotech the Acting President of ATSE.(bestowed in 2000). Mr Kevin Kirby Dr Peter Gray (former President) Kevin continued as an elected ABA Director after the 1986 Peter was a founder of the board elections until 1992. Australian Biotechnology He was involved with research Association (ABA) and served and development activities with as a Director from incorporation CSIRO, including discovery of a in 1985 until 1992, as Vice- process for sugar fermentation President (1990) and as in low fibre crops into ethanol; President from 1991- 1992. development of batch and continuous pilot facilities for process evaluation; and design andAt the time that ABA was founded, Peter was pilot scale operation for wastewater treatmentan Associate Professor in the Department of (anaerobic treatment of animal and industrialBiotechnology at the University of New South wastes to treat wastewater) and energy recoveryWales (UNSW), having returned a few years in the form of biogas.earlier from working in the US. Kevin’s projects included a two-stage anaerobicNamed as one of Australia’s 100 Most Influential reactor for the treatment of low suspendedEngineers on several occasions, Peter is a Fellow solids wastewater; evaluation of hydrolysis ofof the Australian Academy of Technology and lactose from whey permeate; assessment ofEngineering (ATSE) and the Australian Institute processes for the production of chemicals suchof Company Directors. Peter is a member of the as biotin, rutin, citric acid, riboflavin and insulin;Boards of ATSE, Biopharmaceuticals Australia development of a fermentation process for thePty Ltd, ACYTE Biotechnology Pty Ltd, ECI Inc in production of the anti-cancer drug, Bleomycin,New York, and serves on a number of State and and the setting up for FDA approval of a 12,000Federal Government Councils and Committees. L production facility; and biotransformations forPeter has had commercial experience in the USA chemical synthesis.working for Eli Lilly & Company and for the CetusCorporation, and has previously held academic Kevin worked as a consultant and operative forpositions at University College London and at the IDT Australia and associated companies in theUniversity of California, Berkeley. preparation of a 12,000 L fermenter facility at CSL for FDA approval and production ofBefore joining the University of Queensland, he ‘Bleomycin’ for eventual export. He led awas the Professor of Biotechnology and Director26 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearconsultancy with Bioplus Technologies to Dr Sue Meek AO (SA)implement the two-stage anaerobic bioreactorfor possible use with agricultural and industrial Sue joined the ABA in 1985 as itswastewater in Melbourne. 30th member and was appointed as the ABA’s South AustralianSince retiring in 1994, he has devoted time to (SA) state representative. Duringoverseas travel, golf, lawn bowls, moving back this time she was consulting toto Queensland, home renovation, genealogy the SA Government as Executiveand keeping in touch with family and friends. Officer of the SA Biotechnology Promotion. In 1988 she moved to Perth as the Dr Merilyn Sleigh Manager for Biotechnology in the Technology and Industry Development Authority, and joined Merilyn continued as an elected the Executive Committee of the ABA’s Western ABA Director after the August Australian (WA) state branch from 1998-2001. 1986 elections until 1988. At the time of her election, From 1991 to 1998 she chaired the WA she was a research scientist Government’s Inter-Departmental Committee with the CSIRO, working with for Biotechnology Regulation and represented engineering mammalian cell lines the State during two attempts (1993-5 andfor production of recombinant proteins. She also 1998-2000) to establish a national regulatoryworked with CSIRO as a front-person in debates system. By then Sue was Executive Directorand public relations activities occurring during of the Science and Technology Division in thethe first phase of public debate surrounding Department of Commerce and Trade, and leftgenetically modified organisms. to take up the appointment as the Australian Government’s inaugural Gene TechnologyIn 1993 she became Research Director at Peptide Regulator in 2001.Technology Ltd, one of Australia’s earliest listedbiotech companies. During her time in WA she was also a consultant to the Victorian Law Reform Commission for itsMerilyn served as Dean of the Faculty of Life 1989 report on Genetic Manipulation, preparedSciences at the UNSW for four years, and in 2001 and presented the ABA’s submission to thebecame CEO of EvoGenix, working with antibody House of Representatives Standing Committeeengineering technology. She credits working with on Industry, Science and Technology 1992 InquiryEvoGenix as a rewarding career experience. “The into Genetically Modified Organisms, and servedcompany developed its technology and product as Contributing Editor (Regulatory Issues) forportfolio, acquired a US company, listed on the Australasian Biotechnology from 1991-2001.ASX and was eventually acquired by Peptech, She attended the 2001 national ABA meetingwhich changed its name to Arana Therapeutics. in Brisbane that voted for the decision toThe subsequent acquisition of Arana by Cephalon establish AusBiotech.provided an attractive exit for EvoGenix investorsand a welcome good news story for the industry.” In 2008 Sue was appointed to her current position as Chief Executive of the AustralianMerilyn has consulted with companies and Academy of Science. She is a Fellow of theinvestors and currently works as a non-executive Australian Academy of Technological Sciencesdirector across biotech, agricultural and food and Engineering, a Director of Bioplatformssectors. She has carried out advisory roles with Australia Pty Ltd and the Australian Council ofCSIRO and the Garvan Institute and is currently Learned Academies Secretariat Pty Ltd, anda member of the Council of the University of Chairs the Advisory Council of the InternationalTechnology Sydney. Life Sciences Institute’s Washington-based Centre for Environmental Risk Assessment. InAt the time of incorporation, the Council 2013 she was appointed an Officer of the Orderappointed three state representatives: of Australia for distinguished services to science. Volume 26 • Number 1 • March 2016 Australasian BioTechnology 27

AusBioFEATURE – AusBiotech’s 30th year Dr John Grace Dr John Ballard (President 1990 - 91) John was the Vice President John was the second President of ABA before its reshaping of the ABA taking over from Dr as AusBiotech. While with Martin Payne in 1990, until 1991 AusBiotech he held dual and serving as a director from the appointments of Managing formation of the ABA until 1992. Director of GroPep Limited and Chairman of PrimeGRO, guiding GroPepHe has been involved in the Biotech Industry to a successful listing on the ASX.since 1970, the old and the new. Prior tobecoming President, he worked for Mauri From 1991 until 1999 he was Director andBrothers and Thomson launching a new CSIRO CEO of the CRC for Tissue Growth and Repair.based technology producing bacteria for cheese Trained in biochemisty, Dr Ballard has focusedmaking. While President he held the position his research career on growth factors, particularlyof Manager of the Sydney office of Sirotech, isolation, characterisation, and roles in proteinCSIRO’s commercialisation company specialising accretion and metabolic regulation.in the biotech area. He joined AMRAD, abiopharmaceutical company, as General Manager John was a member of the CommonwealthBusiness Development in 1987. He became CEO Government’s Biotechnology Consultative Groupof AMRAD in 1990 and led the successful IPO and the SA Government’s Biotechnology Advisorythat raised $70m in 1996. Council, and filled roles as Board member of Flinders University’s Biotechnology AdvisoryAfter stepping down from AMRAD in 2001 he has Board and professor in biotechnology at theoperated a consulting business and has been University of Adelaide.part-time CEO and director for a numberof companies and government agencies. He is an inventor of many of GroPep’s patents and a recipient of several research awardsCurrently he is the Chair of UniSA Ventures, including the Australian Society of Biochemistrya board member of the Polymers CRC and and Molecular Biology’s Boehringer-Mannheim,Chair of the ATSE Clunies Ross Award LKB and Lemberg medals. He has served ascommittee. He continues to advise researchers Secretary and President of ASBMB and Presidenton the commercialisation of their research of the Australian Perinatal Society.particular in biotech. Since 2002, John has played a major role in Dr Peter Riddles establishing BioAngels, an angel investor group (President 2000-04) in SA, as well as national associations of angel investors. The goal of these organisations is to Peter was President of the ABA promote investments in early-stage companies from 2000, when he chaired and assist them through both financial support the Steering Committee that and active mentoring. He has been Chairman of recommended and oversaw the Australian Proteome Analysis Facility sincethe transition to AusBiotech, and became 2005 and from 2007 until 2015 was chairman ofthe inaugural President of AusBiotech. He the Melbourne-based biotech company AdAltawas elected as a Director of ABA in 1995 and Pty Ltd, which is one of the 20 companiescontinued to serve AusBiotech’s Board until supported financially by the members of2004. He was responsible for chairing the Forum Bioangels.at ABA2000 where the decision was made toappoint a Steering Committee to investigate the As a recognised pioneer of the industry andtransition of the organisation. Peter retired as ongoing contributor, John was a recipient of thePresident of AusBiotech in November 2004 and AusBiotech 2010 Chairman’s Excellence Awardwas recognised by his efforts through HonoraryLife Membership.28 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th year Mr Scott Carpenter appointed at the first Chief Executive Officer in 2005. While serving as a founding Director of AusBiotech, Scott While with AusBiotech, Simon was commercial was employed by Aventis adviser to CSIRO, based in their Melbourne CropScience (which later became corporate office. His previous professional Bayer CropScience), in regulatory appointments with CSIRO involved commercialaffairs for agricultural biotechnology. He served development activities in the area ofthe Board until 2004 and was Chair of AusBiotech biotechnology, and included co-ordinatingVictorian Branch from 2001 to 2003. CSIRO’s pharmaceutical and health research, representing CSIRO on various CRC boardsScott was involved in the commercial release of management and committees, as a directorof InVigor hybrid canola and LibertyLink cotton of various companies, as well as key accountinto the Australian agricultural system, and management with the major Australianobtained a number of field trial approvals as pharmaceutical development companies.well as food approvals for traits in canola, corn,cotton and soybean. Prior to joining AusBiotech, Simon had worked as a clinical microbiologist before undertakingFollowing a secondment to the US, Scott left graduate studies in parasitology leading to aBayer CropScience for a role at AusBiotech postdoctoral position in the US investigatingas the program manager for agricultural, developmental biology of parasites at the geneticenvironmental and industrial biotechnology. level, along with other aspects of RNA control and metabolism. On returning to Australia inWhile with AusBiotech, he was involved in a 1988, Dr Carroll took up a position at WEHInumber of activities from events, submissions before joining AMRAD in 1991 where he workedto governments and stakeholder engagement. in project evaluation, product development andAfter leaving AusBiotech in 2009, Scott joined manufacture, primarily in the biotech area.the Defence Science and Technology Group(DSTG) as a business development manager Simon is widely recognised as an overseer to thefor the Maritime Platforms Division. The focus growth and development not only of AusBiotechof DSTG includes elements of biotechnology as an organisation, but the wider biotechnologyin a number of applications. industry in Australia and was a recipient of the AusBiotech 2010 Chairman’s Excellence Award.In 2012 Scott joined Starpharma as a Directorof Business Development, commercialising In 2001, Simon moved to Perth as the inauguralthe Priostar® dendrimer platform focusing Director of the Western Australian Biomedicalon crop protection (herbicides, insecticides Research Institute, a joint initiative of Curtinand fungicides). Scott works with a number and Murdoch Universities and allied with theof partners globally including Adama, the Chemistry Centre WA. For part of this time helargest generic manufacturer of crop protection served as WA Branch Committee Chair andproducts and provides input into Starpharma’s initiated the Industry Development Officertechnical program. program that serves the Branches of AusBiotech. In 2006 he joined Advanced Ocular System Dr Simon Carroll Limited, a public company serving as CEO. (Chair 2004 - 06) From 2008 to 2010 Simon was Chairman of CustomVis plc, a public company developing Simon was the longest serving and marketing medical devices in the laser AusBiotech Board member to vision correction industry, while also being date, having been a passionate engaged as a consultant to the international and active participant from the pharmaceutical industry. inception of AusBiotech until his retirement from the Board In November 2010, Simon joined WA’s Scitechin August 2010. During his tenure he served as in Science Partnerships – a not-for-profitChair, taking the mantel from Peter Riddles in organisation that seeks to increase interest and2004 and later Deputy Chair. Simon was Chair participation by Western Australians in scienceof the organisation when Dr Anna Lavelle was Volume 26 • Number 1 • March 2016 Australasian BioTechnology 29

AusBioFEATURE – AusBiotech’s 30th yearand technology. Through this premier science Adjunct Prof David O. Irvingcommunication centre, Simon coordinates WA’sNational Science Week activities and Inspiring Adjunct Professor David Irving isAustralia program increasing the engagement an executive in the life sciencesand awareness of STEM for Australia’s future. sector with over 25 years’ experience in strategic researchSimon continues his interests in biomedical leadership with a passion forscience through the not-for-profit cancer research translating research findings into beneficialand awareness foundation “Sock it to Sarcoma!” outcomes. David was one of the foundationserving on the Board and Research Committee directors of the AusBiotech Board where hein collaboration with a number of key institutions served for eight years. He also served for severalin Perth. years as the NSW Branch Chair of AusBiotech and remains an active member Dr Shanny Dyer of the organisation. Shanny was a founding He graduated from the Australian National Director until 2001, during University with a PhD in molecular biology/ which time she assisted in biochemistry; has post-doctoral research writing AusBiotech’s five-year experience with CSIRO and The Rockefeller business plan and organised the University, New York, and is a graduate of the 2001 Commercialising Health Australian Institute of Company Directors.Innovations Forum in Sydney. She was Business He is currently Director, Research andDevelopment Manager at Biotech Australia and Development, at the Australian Red Crossshortly after joined AVAX Australia as General Blood Service (Blood Service), where he isManager / Scientific Director. responsible for the direction of all research and development conducted by the Blood ServiceIn 2001, Shanny was appointed AusBiotech’s across the country. He also has an appointmentNSW Branch Chair, undertaking programs later as an Adjunct Professor in the Faculty of Health,adopted by other states to develop knowledge University of Technology, Sydney.and skills in product development and marketing. Prior to joining the Blood Service, David wasIn 2003, she joined UTS as Director of Industry the inaugural CEO of the Diabetes VaccineEngagement and Commercialisation, then Development Centre (DVDC), a jointly supportedbecame Investment Manager at private equity initiative of the National Health and Medicalgroup Vericap Finance Limited. Shanny is a Research Council and the New York-basedfounding director of Seagull Technologies, an Juvenile Diabetes Research Foundationaward-winning company that develops a non- International. Prior to that, David held executiveinvasive drug delivery system to the back of the management positions with Biotech Australia Ptyeye. She is also co-inventor of Seagull’s patented Limited, Sydney and its successor companiesintellectual property. She is a panellist for both where he held a variety of positions commencingNHMRC and ARC, assessing grant applications as a research scientist and culminating in beingwith a commercial focus. appointed Director of Research and Business Development. From that base, he was involvedShanny is currently Managing Director and in taking a spin-out company through IPOChairman of Wavefront Biometric Technologies and became a Director of that company. AfterPty Ltd, developing innovative eye-based several iterations, that company is now tradingidentity authentication solutions. She is also successfully as a publicly listed company onan independent board member of Bionic the ASX.Vision Australia.30 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearDavid has extensive experience across support capital raising using the Australian Smallcommercial biotechnology, not for profit Scale Offerings Board. She joined Enabledbiomedical research and development and Employment Pty Ltd as a non-Executive Directormember based industry organisation sectors, in 2015 and for the last two years has chairedbuilt on a strong technical background. He both the Board and the Finance and Audithas proven expertise in strategic planning, Committee of Good360 Australia Ltd, a startupgeneral management and interdisciplinary team charity based in Sydney. She is heavily involvedleadership, marketing and financial management, in Canberra’s Griffin Accelerator as a mentormanagement of stakeholder and investor and also chairs Canberra Business Chamber’srelationships, international and local business Innovation Taskforce.development and project management as wellas a strong track record in attracting research Dr Elane Zelcerand development funding and investment fromboth public and private sources. Elane served on the Board of the ABA from 1997 until the Dr Lyndal Thorburn AusBiotech 2001 elections, assisting with the transition. An ABA Director from 1998 until 2001, Lyndal’s roles included With a background in development of the AusBiotech commercialisation and medical business model and federal research, Elane works with organisations that are government lobbying on behalf characterised by having the need for of the bioscience industry. She change or start-up strategies that involveestablished the ABA’s Canberra region branch significant risk management due to limitedin 1999, and chaired this until 2002. During this funding. These include start-up and earlytime she also represented AusBiotech lobbying stage biotech/ medtech companies andthe Department of Foreign Affairs and Trade on universities – she provides strategy advisorytrade-related aspects of intellectual property and commercialisation services in life sciences,rights; the environment department on access engineering and healthcare sectors.to biological resources; Food Safety ANZ onlabelling of GM foods; and various departments Elane is currently contracted by the Australianon the establishment of the then Office of the Government as a Commercialisation Adviser forGene Technology Regulator. Accelerating Commercialisation; prior to this, she was contracted to Commercialisation Australia.While with AusBiotech, Lyndal was ManagingDirector of Advance Consulting & Evaluation, Since 2001 Elane has applied her executive,a consultancy specialising in bioscience board and advisory experience to private for-commercialisation and industry policy. In 2004 profit companies (various including Directorshe became Managing Director of Innovation at Immuron Ltd), non-profit sectors (CEO,Dynamics Pty Ltd (a merger of Advance Hadassah Australia Ltd; Director AUSiMED Ltd),Consulting with Aoris Nova Pty Ltd, which universities (Executive Director, the Monashwas led by Dr Kelvin Hopper). Innovation University STRIP), Independent DirectorDynamics became well known as the publisher Dairy CRC, and on various State and Federalof BioIndustry Review – Australia and New government committees.Zealand and as provider of business developmentservices for life sciences start-ups and their Her first start-up company was Thrombogenix,investors. Lyndal later went on to be Non- spun-out from Monash University in 1997 toexecutive Director and then Managing Director focus on developing new anti-thromboticsof Melbourne-based Neopec Pty Ltd. for prevention of heart attacks and strokes. As CEO, Elane led the company through threeSince 2013, Lyndal has been working through capital raisings, raising more $15M.her consultancy, now called Viria Pty Ltd, to Prior to starting Thrombogenix, Elane was CEO of Montech Pty Ltd, Monash University’s Volume 26 • Number 1 • March 2016 Australasian BioTechnology 31

AusBioFEATURE – AusBiotech’s 30th yearcommercialisation company, where she worked “These exits validate the Uniseed model, wherewith the University’s researchers to improve their research organisations contribute the investmentunderstanding of the needs of businesses. capital. Universities are logical investors at this early and risky seed stage, where the time toElane completed her BSc (Hons), PhD & Grad exit is long and truly patient capital is needed.Dip Mktg at Monash and undertook post- As examples, Hatchtech took 15 years fromdoctoral studies in Canada and the United Uniseed’s first investment to exit, Spinifex 10States. She returned to Australia to work with the years, and Fibrotech 8 years”.multi-national pharmaceutical and diagnosticscompany Bayer Diagnostics (Australasia) Pty Ltd. In December 2015, Uniseed announced that it had closed its third and largest fund of $50AusBiotech held its first elections in November million, with the addition of the University of2001. Peter Riddles, Tony Coulepis, John Ballard, Sydney and the CSIRO to the three existingScott Carpenter, Simon Carroll and David Irving Go8 university partners.continued on the Board and the following wereelected director: Prior to joining Uniseed, Peter had worked at four Australian Biotechnology companies and at Dr Peter Devine UniQuest, the commercial arm of the University of Queensland. These positions included roles Peter was a member of the as Vice President of Business Development AusBiotech Board until 2006 at ASX-listed Progen, and as an investor and and also served on AusBiotech’s Commercialisation Manager at infectious Queensland Branch committee disease diagnostics company PanBio, which prior to that, where he was was sold to Inverness Medical Innovations in involved in the creation of the 2007 for $40 million.“ClubBio” Queensland Conferences. Ms Samantha O’ConnorAfter five years of service, Peter resigned fromthe AusBiotech Board to focus on his position Samantha (Sam) served on theas CEO of Uniseed, a venture fund operating at AusBiotech Board until 2003the universities of Queensland, Melbourne and and on the NSW Branch as aNSW. Since then, Uniseed has made numerous Committee member. She beganinvestments in biotech-based technologies her role with AusBiotech whileinvented at these three universities, including working with Pfizer Australia.three recent high profile biotech exits: Since Australia’s home-grown pharmaceutical industry was• Hatchtech – a company developing a new small at the time, she was asked to join the treatment for human head lice – asset sale to AusBiotech Board to provide a view into the role Dr Reddy’s Laboratories in September 2015 in of the pharma industry in supporting a deal worth $US197 million; the commercialisation of Australian research.• Spinifex Pharmaceuticals – a pain drug During her time with Pfizer Australia, Sam developer – was sold to Novartis in June 2015 led Pfizer’s investment program of building in a deal reported at $US700 million; and collaborations with the Australian medical research community, sourcing investment• Fibrotech – a company developing treatments opportunities that strategically aligned with the for fibrosis – was acquired by Shire company’s global research portfolio. Sam left Pharmaceuticals in May 2014 in a deal worth her position on the AusBiotech Board when up to $US557 million. she moved to Pfizer’s UK operations in 2003 t o join Pfizer’s Worldwide Business DevelopmentPeter also served on the Board of Directors of team responsible for the acquisition andthese biotech companies. divestiture of products, technologies and intellectual property. Sam received her MBA“These exits are particularly satisfying during her time in the UK.considering Uniseed was a founding investorin all of these companies, and it highlights theimportance of early stage funding in the biotechsector” he said.32 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearIn 2011, Sam moved to Pfizer’s US operations by John Larkin. He has written and will directin Cambridge, Massachusetts, where she a documentary, which pays homage to Theresides today. Sam now heads up the strategy Mavis Bramston Show, the pioneering Australianand business planning function for Pfizer’s satirical program of the 1960s. Life goes on…Centers for Therapeutic Innovation (CTI),Pfizer’s innovative program translating leading Dr Jonathan Wrightscience into clinical candidates throughnetworked collaborations. Jonathan has an extensive background in developing and commercialising Australian Mr Stephan Wellink medical technology and working with some of the great companies like ResMed and more recently Stephan was involved with Nanosonics. AusBiotech, from its inception until 2004. Prior to joining AusBiotech, where he served on the Board until 2003, he was Marketing Stephan was the inaugural Principal Commercial Adviser Director with Johnson & of Agribusiness at CSIRO Johnson Medical, focusinguntil 2001. His role at CSIRO included leading on new business/ technologybiotechnology-related activities in many parts development in Asia Pacific.of the world at a time when the organisation wasgrappling with international and cultural changes He was a Board member ofand unprecedented commercial activity. AusBiotech at its founding and at that stage was Vice-Stephan joined the University of Technology in President Global New BusinessSydney (UTS) in 2001 as Director of Research for ResMed. He left ResMed inand Innovation and led a significant change 2003 to become CEO of Ambri, an ASX-listedprocess until his departure in 2006. The work biotechnology company commercialising point-he led contributed to UTS growing its research of-care testing.activity in both scope and quality which is quite Within two years he moved to a CEO positionmeasureable today. at SomnoMed and orchestrated market entry into the USA market.In 2006 he established a consulting company thatserves technology organisations, universities and He established Biomed Device Marketing ingovernment. Stephan’s expertise extends to the 2006 and has since been involved in developingwriting of large competitive grant applications, several major startups including Dosimetry &giving advice on corporate governance Imaging (UNSW) and more recently has servedstructures, strategic planning and strategic as a strategic consultant to Nanosonics.alliances. In recent years, he has designed andfacilitated a number of successful events inthe agrifood space covering areas such as bigdata, neuroscience, behavioural economics andleadership in innovation.In 2012, Stephan formed Inkwell Films, anindependent film company. He was a produceron the animated short film, Woody, which wona number of international awards and wasnominated for an AACTA in 2014. His latestfilms are documentaries: Rod Taylor: Pulling NoPunches will premiere on Foxtel in early 2016and Jerry Lewis: King of Comedy will premiereon ARTE, France, in March 2016. Stephanis working with Ben Lewin and Judi Levine(The Sessions) to develop The Shadow Girl, afeature film based on the award-winning novel Volume 26 • Number 1 • March 2016 Australasian BioTechnology 33

INVESTMENT EVENTS SERIES 2016SINGAPORE SINGAPORE BIOTECH INVEST will provide biotech and medtech companies with the opportunity toBiotech Invest meet investors and discuss potential partnerships.3 May 2016Singapore Stock ExchangeASIA Now in its fourth year, ASIA BIOTECH INVEST will provide biotech and medtech companies with the opportunityBiotech Invest to meet investors and discuss potential partnerships. The event will include a program of panel discussions,5-6 May 2016 keynote speeches and company spotlight presentations.Hong Kong Convention ausbiotechinvestment.com.auand Exhibition CentreContact Amelia LundstromInvestment Events Coordinator| [email protected]| +61 3 9828 1435INVESTMENTEVENTSSERIES 2016

AusBioFEATURE – AusBiotech’s 30th yearWhat will Australian biotechnology looklike over the next 30 years?Dr Alan Finkel AO Because of the complexity of the brain and the miniscule scale of its neurons and their synapticAustralia’s Chief Scientist connections, the dream of implanting electric circuits 30 years from now to augment cognitionOver the next 30 years I am confident that or memory will remain a dream. But at leastAustralia will continue to invest in biotech and we will make progress in sensory prosthetics.medical research at or above world-class levels. In particular, I am confident that there will beWe will undoubtedly reap the returns and see bionic eyes bringing vision to the blind, even ifthe benefits in smarter industries, better health the achieved perception will be far below theand a cleaner world. As Chief Scientist I want resolution and colour richness generated by anAustralians to get excited about it all. But actual human eye.instead of trying to add here to the list of generalaspirations I’ll confine myself to the area about As for those people who are taking drugs hopingwhich I am most familiar – neuroscience. to extend their lives until computers are powerful enough to store their uploaded memories andThe amazing thing about the human brain is personalities…. well, they’re on drugs. Anythat it is even more complex than the genome such upload process in 30 years from nowthat defines it. Every time I read about advances will be destructive, meaning the donor will diein brain imaging technology, or techniques to irrespective of the success of the upload. If thereconstruct three dimensional connections upload works, the result will be woefully crude,between neurons, I am simultaneously staggered leaving the uploaded personality in a vegetativeby the brilliance of the researchers and humbled state.by the realisation that we know so little. On the bright side, the daunting complexityFor the last two decades, I’ve looked back each of the human brain is fantastic news for thoseyear at all we’ve learned since Ramón y Cajal contemplating entering neuroscience in theushered in the era of cellular neuroscience with coming decades. There will be lots and lots tohis elegant drawings of neurons in 1888. learn over the coming centuries. Let’s keepAnd every year, I estimate that we have probably Australia at the centre of global progress.only learned about 1% of what we need toknow in order to understand the brain. For allthe discoveries reported each year, I am notsure that we get any closer. Volume 26 • Number 1 • March 2016 Australasian BioTechnology 35

AusBioFEATURE – AusBiotech’s 30th yearWhat will Australian biotechnology look like over the next 30 years?Dr Andre Tan trial environments, high-quality trial capabilities and a strong medical research ecosystemRecent PhD graduate in Australia and New Zealand, coupled with maturing analytics capability presents as aAlmost 30 years ago, the basic steps of significant growth opportunity the region ispolymerase chain reaction (PCR) were well placed to lead.experimentally defined. This fundamentaldevelopment in the amplification of DNA ushered Advanced manufacturing capabilities, suchin a new epoch in the biological sciences, and as 3D printing, will see the repackaging of oldhas transformed our understanding of nature and existing business models not normallyand biology ever since. At that time, one could associated with manufacturing come to the fore.not have easily predicted the emergence of the The increased customisation and sophisticationgene sequencing capabilities we enjoy today. of manufactured products will certainly lead toSimilarly, it is difficult to predict where the frontier significant disruption – no area of manufacturingof science, both the global and Australasian is immune. Many questions remain – will ourbiotechnology sector, will lie in 2046. However, region be a leader or a follower? Can we maintainthe manner in which our region responds to sufficient manufacturing R&D capability toglobal factors and events over this time will shape mitigate against disruption?the sector’s development and outlook. Continued development of a capable workforceClimate change remains the greatest threat to meet these challenges and opportunities willto our planet, and the biotechnology sector will be critical. Graduates seeking to participatehave a pivotal role in meeting the problems that require ever-broader skills and knowledge,are symptomatic of this immense challenge. and will need to commit to life-long technicalImproving food security for the predicted global and commercial upskilling for long-term careerpopulation of 9.6 billion people in 2050 through success. The full spectrum of primary tothe use of genetically-modified organisms will postgraduate training models (especiallybe a difficult issue that will need to be navigated. STEM) will need to adapt to fast-changingThe strength of our region’s advanced agricultural sector needs, as well as prepare the nextpractices, coupled with robust debate, could generation of industry professionals.see Australia and its neighbours lead thedevelopment of technologies and frameworks Though many have articulated various visionsneeded to ensure ample supply of food for for how the region’s knowledge-based economylocal and export markets, as well as the should look, commitment to bringing this visionancillary expertise. to reality requires support from industry, educational institutes and governments. It is myArtificial intelligence is the quiet revolution that hope that in another 30 years, I can look backincreasingly underpins the ability for data to be at this speculative article and see that our sectoranalysed and acted upon. In healthcare, being has grown to meet these challenges to put usable to ask new, sophisticated questions of in strong standing beyond 2046.large datasets opens the door to new clinicaltrial designs and frameworks, as well as bringingthe promise of personalised medicine closer toreality. The combination of favourable clinical36 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearWhat will Australian biotechnology look like over the next 30 years?Dr Elizabeth FinkelEditor-In-Chief, Cosmos Magazine; Author of The Genome GenerationPredict how Australian biotech will look in allowing them to be enhanced: engineered to30 years? That’s a tall order. have stronger bones and be especially cancer and dementia resistantThirty years ago sequencing a single genewas a huge chore. What took us to the ‘omics’ For those of us confined to Earth’s rules,era was the cross-fertilisation of PCR, high- memory chips built on the insights of today’sthroughput DNA sequencing techniques and brain projects and brain-machine interfacessupercomputing. Now add 3-D printing, stem like the bionic eye, will fix dementia andcells, wafer-thin implantable silicon chips, RNAi, enhance cognition.CRISPR – and that cross-fertilisation has becomean orgy of innovation. It’s a brave soul who’ll Will we be able to afford this medical revolution?predict what the fruits will be in 30 years. We’re still in a muddle as to whether the costs of early screening and detection deliver a costBut the groundcover is being sewn today. benefit or actually save lives. Perhaps by then,The dream of personalised medicine will be artificial intelligences will have worked this out.realised with universal genome sequencing atbirth, intelligent algorithms to decode what they Meanwhile plant biotech will deliver super plantsmean, and implanted chips to monitor health. highly adapted to a warming resource-strainedThe well will be warned of impending diabetes, planet: they will use half the amount of watermetabolic disease, kidney or liver failure, cancers, and nitrogen thanks to nitrogen fixing and water-heart attacks and strokes. efficiency genes. Masterful DNA editing will keep new varieties one step ahead of pests.The sick will be fixed with artificial organs(scaffolds seeded with stem cells, augmented It’s all possible… but the ultimate landscape isby circuitry), or by regenerating their own tissues unpredictable. Not just because of technological– say worn-out knee joints – using a cocktail of disrupters. Public sentiment can make or break agrowth factors. Cancer will be curable thanks technology. Market forces allow one technologyto genome-correcting drugs based on RNAi to soar, another to die off. Natural or human-and other epigenetic modifiers, or CRISPR- made disasters concentrate the collectivelike techniques to edit out offensive mutations. research mind.Genome-editing will be used to repair embryosbearing mutations – and for those colonists But then again, perhaps in 30 years’ time,headed off to Mars, there will be a special clause artificial intelligence will have worked this all out as well. Volume 26 • Number 1 • March 2016 Australasian BioTechnology 37

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AusBioFEATURE – AusBiotech’s 30th yearThe evolution of transgenic foodDr James D. MurrayDepartment 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, AustraliaDr Tim DoranCSIRO Health and Biosecurity Business Unit, Australian Animal Health Laboratory,Geelong, AustraliaOn November 19 2015, the United States Food further five years elapsed before approvaland Drug Administration (US-FDA) approved was given.AquaBounty Technologies Inc. application forthe use of the AquAdvantage salmon for human The world-wide regulatory dysfunction aroundconsumption. The AquAdvantage salmon, an GE animals for use in agriculture to produceAtlantic salmon genetically engineered (GE) to food for human consumption has effectivelyexpress the Chinook salmon growth hormone limited advancement in this field and resultedgene and thus grow faster and more efficiently, in a cessation of work and capacity buildingwas developed in 1992 (Du et al., 1992).These in virtually all of the developed countries firstsalmon are bred to be sterile and are farmed in associated with this technology (Australia,land-locked aquaculture facilities with multiple Canada, Germany, New Zealand, the Unitedbarriers for physical containment. Scientists and Kingdom, and the United States). For example,scientific bodies have overwhelmingly welcomed in the mid-1980s there were strong programsthe FDAs decision after extensive reviews of of research directed at developing transgenicfood and environmental safety and endorsed livestock in Sydney, Adelaide and Melbourne,AquAdvantage salmon as a safe and more but by the late 1990s only the South Australiansustainable product than existing farmed program was left and it was, and has continuedsalmon, which helps to relieve the pressure to be, largely focused on xenotransplantationof overfishing on wild populations. and the creation of bio-medical research models. The past decade has seen a growthThis landmark decision by the US-FDA is the in laboratories world-wide undertaking thefirst approval of the use of a GE animal for food creation of GE livestock for use in agriculture,anywhere in the world. However, while this is but this new activity is almost exclusively limitedcertainly an important regulatory action, the to China, Brazil, and Argentina, with one newimplication of this decision worldwide for the laboratory focused on GE chickens emergingdevelopment of GE animals, and possibly gene in CSIRO. The CSIRO team is based at theedited animals, for use in agriculture remains Australian Animal Health Laboratory in Geelongto be seen. where they are applying GE technology to health, welfare and food safety issues that impact poultryTo put this regulatory action into perspective one industries. They have been combining GE andneeds to remember that the first GE livestock gene silencing technology to develop avian(Hammer et al., 1985) and fish (Zhu et al., 1985) influenza resilient chickens, and via collaborativewere reported in 1985. AquaBounty Technologies Australian Poultry CRC projects have beenfirst approached the US-FDA for regulatory developing precision genome engineeringapproval of the AquAdvantage salmon in 1995, approaches to sex selection for the egg layingbut it was not until 2009 that the US-FDA issued industry and the removal of allergens from eggsIndustry Guidance 187 (FDA 2009) outlining to provide safer food products for the growingthe process they planned to use to regulate GE number of Australians that are allergic to eggs.animals. In 2010 the US-FDA announced thatthe AquAdvantage salmon was as safe to eat As noted above, the implication of the US-FDAas conventionally grown Atlantic salmon, but a decision to approve AquAdvantage salmon for Volume 26 • Number 1 • March 2016 Australasian BioTechnology 39

AusBioFEATURE – AusBiotech’s 30th yearhuman consumption on the development of animal agriculture industries have confidenceGE animals for use in agriculture is not clear. in a suitable, clear-cut, and timely regulatoryAt present there appears to be little corporate process for those animals and food products.support for using GE animals in agriculture and With many nations poised to take stepsin the face of steep regulatory costs and long- forward in deployment of animal biotechnology,time frames this single decision may not be harmonisation of regulations will be critical insufficient to ease either of these burdens. a global trade environment.The real impact at this point, and the one thatmay most affect Australia, is whether or not Referenceseconomies like China and India will now moveforward more rapidly. Over the past decade Du, S.J., Gong, Z.Y., Fletcher, G.L., Shears, M.A., King, M.J.,China has put more resources into developing Idler, D.R. and Hew, C.L. (1992). Growth enhancement inGE animals for agriculture than the rest of the transgenic Atlantic salmon by the use of an “all fish” chimericworld combined and India is now moving to growth hormone gene construct. Biotechnology (N Y)establish laboratories in this area as well. 10:176-81.Biotechnologies such as GE have an important FDA. (2009). Guidance 187: Regulation of Geneticallyrole to play in the future of agriculture, including Engineered Animals Containing Heritable Recombinant DNAensuring food safety and security, improving Constructs. www.fda.gov/RegulatoryInformation/Guidances/animal health and welfare, and enhancing the default.htmnutritional benefits of various foods. Thesebenefits can be realised only through appropriate Hammer, R.E., Pursel, V.G., Rexroad, C.E. Jr., Wall, R.J.,investment, which will occur only when the 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. 1:31-34.40 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearRegenerative have been detected in tissues. Over the lastmedicine – are ten years, adult stem cells have been the mainwe there yet? focus of companies involved in developing stem cell-based therapies. Whilst using adult stemDr Peter French cells from a patient to treat that patient’s disease (autologous stem cell therapy) overcomes theDirector, BCAL Diagnostics Pty Limited ethical, immunorejection and abundance issues of the other stem cell types, there are still manyAll traditional cultures have some personification challenges remaining. These include: how toof the Divine Healer or miracle-working god. control and regulate the process to successfullyThe ancient Greeks had Asclepius, the god of trigger differentiation into the desired cellmedicine. Whilst we are celebrating the rise of type after the stem cells have been isolated;regenerative medicine over the past 30 years, understanding the mechanism of action bythe dream of regenerative miracles goes back which the stem cells exert their therapeuticat least 2000 years when Matthew wrote, effect; carving out a defensible patent position“Jesus … said to them, “Go and report to on a naturally occurring cell type to justify theJohn what you hear and see: the blind receive significant investment involved in developingsight and the lame walk, the lepers are cleansed a human therapy; expanding the range ofand the deaf hear, the dead are raised up ... “. diseases that the adult stem cell can address,Today many are putting their faith in the power and developing a pricing model for a treatmentof the stem cell to perform similar miracles. that could be a single administration.Is this faith well founded? Progress and challengesStem cell types Progress has been made in many of these issues.Ever since we understood that there were Many companies have developed proprietarystem cells that are capable of generating new isolation and purification processes to identifydifferentiated cells and tissues, the possibility of and/or isolate specific adult stem cells from arepairing organs and tissues to perform healing patient and to transplant those cells back intomiracles has excited scientists, doctors and the patient’s affected organ. However, it appearsthe public alike. Initially much of the research that in most cases the cells do not integrate intoutilised embryonic stem cells (ESCs), as these the tissue and regenerate new differentiatedwere considered to be the most flexible, being cells as first thought and hoped. Rather the cellsable to differentiate into ectodermal, mesodermal tend to exert their effect via secreted “extrinsicand endodermal tissue. However, there were, factors” that stimulate the surrounding tissue toand still are, significant ethical issues with using repair itself. These effects are therefore transienthuman embryos as the source of these cells, and may need re-administration in many cases.as well as immunorejection complications, and There is the possibility that there may be lowas a result the widespread use of ESCs has not level integration into the target tissue, andtranspired. Inducing pluripotent cells directly from understanding how to address and overcomethe patient’s own cells to generate tissue or cells safety concerns associated with incompletewould resolve most of the problems associated differentiation and improper integration of cellswith using ESC, including the problems of in damaged or diseased tissues during stemimmunorejection and the ethical issues. However cell therapy remains a potential challenge.these pluripotent stem cells are hard to identifyand are apparently few in number. Combining gene and cell therapyAdult stem cells such as bone marrow stem The limitation with the use of autologous adultcells, mesenchymal stem cells, adipose stem stem cells stems from the fact they are not usefulcells and neural stem cells, and many others, 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 Volume 26 • Number 1 • March 2016 Australasian BioTechnology 41

AusBioFEATURE – AusBiotech’s 30th yearcombine stem cell therapy with gene therapy. particularly in the US, where patients may switchModification of a patient’s stem cells to knock health funds when changing jobs, and thereforedown or delete a defective gene is possible creating an administrative nightmare. And whatwith technologies such as CRISPR-Cas9, DNA- if there is a relapse and the patient refuses todirected RNA interference (ddRNAi) or zinc finger pay? A lot more work is needed by companies,nucleases. A private US company, Calimmune, government, health funds and community groupsis using ddRNAi to knock down the CCR5 to understand the best pricing mechanism to useHIV co-receptor in HIV patients’ CD34+ cells in this brave new world of regenerative medicine.(hematopoietic stem cells). This would potentiallyresult in the patient becoming resistance to The futureinfection with the virus, providing a potentialsingle shot cure for HIV/AIDS. Stem cells could The pace with which regenerative medicine hasalso be modified with conventional gene therapy moved over the past 30 years is astounding. Ito express a gene that is missing from the normal have no doubt that stem cell therapy, modified orhealthy genome. Each of these technologies has not, will find a niche in the armamentarium of theits advantages and disadvantages. The biggest medical profession in the short to medium term,challenge with using a gene therapy-modified and may well provide cures for disease that 30stem cell therapy is that of the regulatory hurdle years ago would seem to be miraculous. We arefor the ultimate therapeutic product, with only not there yet, however. Many challenges remain:one gene therapy product on the market in the some scientific, some technical, and someWestern world (uniQure’s Glybera approved in political. These will require a lot of hard workEurope for TTR-amyloidosis), speculated to cost and clever thinking. As Prime Minister Malcolm1 million Euros. Turnbull would probably say, “It is an exciting time to be an Australian (working in the field ofA costly cure? regenerative medicine).”Unlike previous exponents of medical miracles Dr Peter French was the CEO and Managing Director offrom ancient times, the current group of Benitec Biopharma Limited from 2010-2015, and wasregenerative medicine companies are looking the founder of Australia’s first stem cell storage company,to return significant monetary rewards to their Cryosite Limited. He is currently a Director of BCALlong-suffering investors. This indicates another Diagnostics Pty Limited.challenge with new therapies that offer potentialcures. If a single administration is sufficient tocure the disease, what would (and should) thatcost? And who should pay? Various modelshave been proposed, but no consensus yetexists. One option is to treat a single treatmentlike an operation. After all, no-one wants tohave an operation on a weekly or monthly basisfor months or years. The cost of an operationcan be very expensive, but people, and/orthe government, are willing to pay to have theproblem fixed. But is a single injection that can beperformed in an outpatient department costing1 million Euros seen as good value for money?The recent controversy over Gilead’s 12-weekcure for hepatitis C that costs $1,000 per pill perday indicates that the public will have troubleswallowing (pun intended!) that level of cost, evenfor a cure. Then there have been proposals forsome sort of annuity payment – amortised overmonths, or more likely, years. This is a challenge42 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th year30 years of muscle). Several multinationals including Verigenregenerative brought autologous chondrocyte implants tomedicine in Australia during the 2000s, and though VerigenAustralia has left, the scientists behind the technology persevered and formed Orthocell (2006) to focusDr Tim Oldham and on cartilage and tendon repair.Dr Dominic Wall Meanwhile the next great wave of regenerative medicine played out around mesenchymalCell Therapies Pty Ltd stromal cells, which promise immune regulation as well as regenerative potential and haveRegenerative medicine, broadly defined as the advantage of expandability and apparentthe use of human cells as therapeutic agents, immune privilege. This offered the potentialis poised to transform health outcomes and for large scale allogeneic production. Australiabecome established as the fourth pillar of modern produced Mesoblast (2001, listed in 2004), nowmedicine. Australia has played an important the largest MSC company globally), Regeneusrole over the past 30 years and continues to (2007) and most recently Cynata (2013) who arecontribute to international progress. exploiting the Nobel Prize winning discovery of reprogramming cells (induced pluripotent stemThe year 1986 saw the first peripheral blood cells) to produce MSC’s at massive scale.haematopoietic stem cell apheresis andtransplant to reconstitute an immune system But back to cellular immunotherapy. By 1999,after myeloablative chemotherapy in Germany.1 scientists and clinicians at Peter Mac openedRoyal Adelaide Hospital followed in 1987, cGMP cell processing clean rooms that led to thehowever much of the pioneering work had been, formation of Cell Therapies P/L 2003, Australia’sand continued to be done, in Australia. 1973 first TGA accredited cell therapy CMO which washad seen the installation of the first hospital- then producing immunotherapies on behalf ofbased apheresis machine at St Vincent’s in IDM S.A. from France, and then Prima Biomed’sSydney whilst Ray Bradley and colleagues were dendritic cell vaccine that was in clinical trials inelucidating the blood forming cells at Peter 2001-2015. By 2006, Peter Mac researchers hadMac.2 From 1983 onwards Chris Juttner with been able to genetically modify T-cells to expressinvestigators at the IMVS in South Australia led receptors targeting antigens on tumour cells –the field in human haematological recovery withtheir work on blood stem cells34 and shortly after,the application of Don Metcalf’s research at WEHIresulted in world-first data from Melbourne andAdelaide confirming the clinical value of G-CSFfor mobilisation of peripheral blood stem cells.5So began Australian interests in what is now oneof the hottest fields in regenerative medicine:cellular immunotherapy.The next 15 years though saw tissue engineeringlead the way from bench to clinical practise.Research during the 1990s led ultimately to theformation of Clinical Cell Culture (1999, nowAvita Medical), Polynovo (acquired by Clazada in2009) and Celexcel (2004, now part of Admedus)all focussed on tissue repair (skin and cardiac Volume 26 • Number 1 • March 2016 Australasian BioTechnology 43

AusBioFEATURE – AusBiotech’s 30th yearreprogramming immune cells to target cancer.6 1. M Korbling, EJ Freireich, “Twenty-five years of peripheralThis chimeric antigen receptor T-cell (CAR-T) blood stem cell transplantation”, 2011 Blood 117 (24),approach is now revolutionising cancer treatment, 6411-6416achieving 90% durable complete response ratesin the worst forms of leukaemia. Today, Peter 2. Rosendaal M, Hodgson GS and Bradley TR (1976)Mac’s own CAR-T program is progressing toward Haemopoietic stem cells are organised for use on theits second clinical trials and the first patients in basis of their generation-age. Nature 264, 68-9Australian arms of international CAR-T trials haveundergone apheresis. 3. To LB, Haylock DN, Kimber RJ, Juttner CA (1984) High levels of circulating haemopoietic stem cells in very earlySeveral nations are now making aggressive remission for acute non-lymphoblastic leukemia and theirplays for leadership in regenerative medicine. collection and cryopreservation. Br J Haematol 58:399-410Japan has created aggressive new regulatorypathways and Belgium, Canada, UK and 4. To LB, Dyson PG, Juttner CA (1986) Cell-dose effect inCalifornia USA all have made $100m plus circulating stem-cell autografting. Lancet 2: 404-5investment to fuel evidence based regenerativemedicine industries. To be sure that Australian 5. Sheridan WP, Begley CG, Juttner CA et al (1992) Effectpatients benefit from these revolutions in of peripheral-blood progenitor cells mobilized by G-CSFhealthcare over the next 30 years, Australia must on platelet recovery after high-dose chemotherapy Lancetcommit now to financing the research, clinical, 339:640-4.regulatory and manufacturing infrastructure thatwill enable continued research leadership, as well 6. Peinert, S, Prince, HM, Guru, PM, Kershaw, MH, Smyth,as deployment of international advances. 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. Brisbane2 – 3 August 2016Stamford Plaza, Brisbanewww.agfoodtech.com.au Host AusAg & Foodtech Industry Body44 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearReflections from our membersGraham Gourlay professor, innovator and biotechnology company founder. That would have been a rarity just a fewSpecial Projects, Cystic Fibrosis Australia years ago, certainly decades ago. Only recently did it become acceptable, even desirable, to talkIn 1986, I joined the Australian Biotechnology about a harmony of excellence in fundamentalAssociation (ABA), as it was then called. I believe science and commercialisation. I am glad timesI am one of the original members of what is now have changed. Innovation is in. Sitting at theknown as AusBiotech. interface between pure and applied is now desirable. I am grateful to AusBiotech for helpingFrom the mid 1960s until the early 1980s, I to drive this important agenda by championingworked for a company called Mauri Bros and a good environment for Australia’s fragileThomson (MBT) which was taken over by Burns biotechnology industry and by contributing toPhilp in 1982. One of MBT’s main products was Australia’s national development. Unfortunatelybakers’ yeast which is grown in large aerated the biotechnology industry in Australia is stilltanks. The process to produce bakers’ yeast fragile – so keep up the fine work AusBiotech!was described as a type of fermentationtechnology, a term used prior to the word Dr David Randersonbiotechnology being ‘invented’. Managing Director, Acuity TechnologyAs the area of biotechnology became increasingly Managementimportant, Max Shaw, the Head of MBT ResearchLaboratories, worked with several other people In 1986 Martin Playne invited me to join the(including Nancy Millis and Peter Rogers if editorial board of the Journal, a role I held withI remember correctly) to organise the first great pride for a decade as I watched the biotechAustralian Biotechnology Conference in 1983, booms come and go. At the time I was MD of onewhich was held at the company’s premises at of the early-to-list, some would say “premature”,North Ryde in Sydney. I understand that the ABA others “before its time”, biotechnologywas ‘conceived’ at that first conference, even companies which I cofounded and listed on thethough it was not born until some three years second board of the ASX at the commencementlater; a long gestation period! of the year. It followed two years of exceptional effort to find investors interested in the potentialI retired as CSIRO Food and Nutrition Intellectual of mammalian cells for production of recombinantProperty Manager five years ago but have proteins and monoclonal antibodies – the nub ofretained my AusBiotech membership, mainly modern biotechnology.because of the networking and informationsharing benefits. These continue to be very I suspect the first biotech listing was Queenslandhelpful in my on-going voluntary work with Science and Technology Limited (fermentationCystic Fibrosis Australia, trying to identify new technologies) in 1984; a further three listedcystic fibrosis R&D opportunities and innovative in 1985, including Circadian Technologiesways to fund them. and Biota; with seven in 1986. According to the Sydney Morning Herald (29 Feb 1988),Professor Tony Weiss by January 1987 there were 21 listed biotech companies with a total market capitalisation ofUniversity of Sydney and Scientific $528 million (average $25 million) and by MarchFounder of Elastagen Pty Ltd 1988, following the October 1987 market crash, 22 companies had a combined capitalisationI am delighted to congratulate AusBiotech on of $196 million (average $8.9 million). Of theseits founding 30 years ago as the Australian companies, only three remain today, Circadian,Biotechnology Association. Over those three IDT and Agen (as Agenix), although hardlydecades, attitudes have changed for the better. recognisable from their prospectus descriptions,I reflect on my unusual combination of university Volume 26 • Number 1 • March 2016 Australasian BioTechnology 45

AusBioFEATURE – AusBiotech’s 30th yearthe others having failed (most), been acquired Barry Thomasor merged, or morphed into other entities withchanged focusses. As best I can determine only Director Asia Pacific Cook Medical,two products proposed in these 22 companies’ Managing Director Cook AustraliaIPOs made it to market, Biota’s neuraminidaseinhibitor and Agen’s D-dimer test. Running down The biotech industry in Australia today isthe list it is clear that the majority obtained their in a healthy position. This is largely duecore IP from publicly funded organisations and to the efforts of individuals that have workedall had technologies far from commercialisation – to shape the industry, as well as policy thatattributes that may not be greatly different today. supports its growth.There were no IPOs in the sector between 1988and 1994 when Hyal (to become Meditech and Australia has a strong history in innovationmerge with Alchemia) and Norvet (now Novagen) and has always been a fertile ground for thelisted. The boom time was 1996 to 2002, again development of new ideas. Biotech, in particular,to languish following the “tech-bubble” crash. has been supported by policies that encourageThe industry, however, the Journal and the innovation, such as the R&D Tax Incentive, whichAssociation survived these economic downturns. has paved the way for the growth of the sector.It would be interesting to compare outcomes and Australia was the first country in the world toactivities of the first wave with the second, 1994 introduce this kind of incentive, and at the timeto 2002, and the third, 2004 to 2008. Maybe I’ll it was revolutionary. This is one of the mainfind time for such an analysis when I retire reasons why R&D is so strong in Australia today.Leigh Farrell However, while we have strong universities and research facilities to build on existingChairman, d3 Medicine, LLC biotechnology, a key challenge facing the industry is getting this research to the commercialisationWhat a magnificent achievement; 30 years stage. There is widespread consensus thatof influencing innovation policy and helping Australian policy has not kept pace withgrow Australia’s biotechnology and medtech international markets, with a continued discordindustries. From humble beginnings as the between R&D and commercialisation.Australian Biotechnology Association of whichI was a student member, Anna Lavelle and her One way to turn this around would be theprofessional team have become internationally introduction of a patent box-style tax measure.recognised as advocates of the Australian The Australian Innovation and Manufacturingbiotechnology industry. (AIM) Incentive has been forward to the government as a potential model. It has beenAs a result of numerous federal inquiries, developed by Cook Medical together withProductivity Commission reviews and other industry bodies including AusBiotech,AusBiotech’s advocacy, Australia’s Federal Export Council of Australia, and MedicalGovernment has pleasingly reinforced the Technologies Association of Australia.importance of our biotechnology industry to the The Incentive recommends that qualifying IPAustralian economy through policy initiatives profit be taxed at a lower rate (10% is suggested)including maintenance of the R&D Tax Incentive, in order to encourage the commercialisation ofestablishing the $20 billion Medical Research R&D here in Australia. More than 10 countriesFuture Fund and $250 million Biomedical around the world have introduced similarTranslational Fund. These initiatives together with measures, including the UK and China, andAustralia’s favourable regulatory environment and the US is currently introducing something similar.Venture Capital Limited Partnership legislation The implementation of the AIM Incentive wouldshould hopefully ensure that our excellence create many more opportunities for the Australianin medical research evolves to excellence in biotech industry to develop and thrive in today’stranslational medicine, clinical pharmacology competitive international market.and early product development resulting inmore value being retained by innovators beforebeing sold to commercialisation partners.46 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearHarmonisation, risk and rigourThe real story of device regulation is what happens afterproduct approval…Arthur Brandwood requirements are actually far more closely aligned than is suggested by the differences in process.CEO, Brandwood Biomedical There are still local differences in detail, but it’s now possible to achieve regulatory approvals inIt’s 1986: a large number of markets based on a common Technical File and compliance with internationally• Cochlear has been going five years and has accepted standards. just obtained US FDA approval for the Bionic ear. It’s another five years before Peter Farrell is But amongst all this international harmony, even to leave UNSW to found ResMed. And some of a casual observer will have noticed the news the best pacemakers in the world are made in coverage over the past couple of years debating Sydney by Telectronics (sister to Cochlear). the rigour of regulation. Depending on viewpoint regulators are accused of not doing enough,• TGA doesn’t exist. allowing unsafe devices to harm patients, or they are bureaucratic and getting in the way of• A scandal is brewing about some heart innovation. Essentially it’s an argument about risk valves… – which is always present in an imperfect world. Perhaps the more interesting lesson of the pastThe regulatory success story of the past 30 30 years is that it was ever thus.years has been the rise of global harmonisation.Back in 1986 each national regulator pretty In the mid 1980s, around 40,000 Australiansmuch did things their own way. Manufacturers received a Bjork-Shiley mechanical heart valve.had to deal with each independently according It later transpired that these valves were subjectto unique local requirements. Then along came to catastrophic mechanical failure with disastrousthe grandiosely titled Global Harmonization results. A subset of valves assembled by aTask Force and indeed the world was changed. particular process worker were at much higherThe European Directives of the early 1990s risk of failure and clinical advice was that thosepropagated in whole or in part via the GHTF into particular valves should be removed – involvingthe regulatory systems of Canada, Australia, a hazardous and life threatening replacementJapan and many other markets, most recently surgery. Unfortunately, the devices simply weren’tASEAN. Substantial parts have also found tracked well enough to tell which patient gottheir way into China, Korea and parts of South which valve and the resulting furore led to theAmerica. The odd one out of course is the US establishment of the TGA’s devices regulations.FDA, but even FDA relies heavily on internationalstandards and so underlying technical 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. Volume 26 • Number 1 • March 2016 Australasian BioTechnology 47

AusBioFEATURE – AusBiotech’s 30th yearAnd so it goes around: whereas the process The figures for 2015 are totally different.of premarket assessment has become more The same list today is quite different featuringaligned, the level of scrutiny, the rigour of glucose sensors, insulin pumps, ambulatoryregulation actually varies in response to dialysis and portable oxygen. Devices havepostmarket events. Each well-publicised failure moved out of the hospital and into the homebrings a backlash and the premarket process and are being used to treat chronic diseases,becomes stricter by means of requirements mainly diabetes. And we have gone digital:for higher levels of evidence. almost all of those top 10 devices are now clever computerised systems for monitoringSo what do we know about postmarket device the patient and delivering medicines.performance. Luckily the US FDA is pretty Regulators must also adjust. The riskstransparent about its regulatory process, of home use digital devices require quitepublishing summaries of all approvals and different premarket approaches to assessment510(k) clearances, as well as an extensive set of hospital hardware and surgical implants.of postmarket databases. These are interestingbecause postmarket events reflect the types And what happened to Telectronics?of technology of the day. For a device become The erstwhile flagship of the Australiannoticed in the postmarket reports it has to be device industry was itself closed after awidely used and the technology to be sufficiently widely publicised design fault in its pacingadvanced or high risk that it doesn’t always work leads with its own tracking and explantperfectly. A comparison of postmarket data in challenges (although Telectronics’ world-1986 with the present day shows a startling shift leading pacemaker designs were acquiredin the nature of device technologies. by St Jude and lived on). And the Telectronics engineers went on to work for Cochlear orBack in 1986, the top ten device types featuring ResMed or to found other medical devicein the FDA MDR database included four implants, companies in Australia planting the seedsFour hospital use instruments, glucose monitors for future innovation.and a contraceptive IUD.Top ten devices most commonly reported to US FDA for postmarket events 1986 and 2015 1986 2015Implantable pacemaker Insulin Infusion Pump, used with Invasive Glucose SensorPacemaker electrode General Purpose Infusion PumpContinuous ventilator Insulin Infusion PumpGlucose test system OTC Blood Glucose TestGas machine for anaesthesia Glucose Sensor - InvasiveSilicone inflatable breast prosthesis Artificial Pancreas Device SystemGeneral Purpose Infusion Pump Peritoneal dialysis systemBiological Heart Valve Portable oxygen generatorDiagnostic Intravascular Catheter Automated external defibrillatorContraceptive intrauterine device (IUD) Picture archiving and communications system48 Australasian BioTechnology Volume 26 • Number 1 • March 2016

AusBioFEATURE – AusBiotech’s 30th yearThe ASX-listed biotechnology sectorJoanna Hill above $100.00 each. If shareholders had kept the stock from the day of its IPO, the capital returnFinancial Adviser, Baillieu Holst Ltd on their initial investment (excluding dividends) would be approximately 13,000%. Such valueWhen I first started compiling the INDEX of ASX- appreciation is rare among blue-chip stocks.listed healthcare companies for the AusBiotechJournal in 2004 there were few publications that CSL’s market capitalisation today isprovided potential investors with information that approximately A$47 billion and together with theaggregated data in the ever-growing, new ASX other Australian global successes, two medicallistings in the healthcare sector. device producers ResMed (market cap AU$11B), Cochlear (market cap AU$6B) and Sirtex MedicalThe industry can be broadly divided into (market cap AU$2B) represents 62% of thefive subsectors: Research & Development ASX200 Healthcare Index. CSL’s current marketBiotechnology, Pharmaceuticals, Diagnostics, cap puts it in ASX top 10 behind only the banks,Devices, and Services. Many companies overlap Telstra, BHP and Wesfarmers. The Australianthese subcategories, sometimes changing listed healthcare is a significant contributor, nottheir focus or making a transition from one only to Australian industries and employment, butsubcategory to another. This has made it difficult significantly to wealth creation for the nation andto separate into distinct categories or clear its citizens.subsectors of the Healthcare Index. Australia has lacked, and still lacks, the necessaryThe availability of data and analysis of the ASX venture capital funding necessary for early stage,listed biotechnology industry was relatively research and development projects. The lack ofimmature 20 years ago, despite the global private funding to advance promising early stagesuccesses of our well-known and highly-regarded development projects has led many industryinternational healthcare leaders, such as CSL, leaders to seek funding in the much larger andResMed and Cochlear. The next Australian more mature US market, hence Australia losingbiotechnology success story listed on the ASX the benefit of future income from successfulwas Sirtex Medical, a biotechnology and medical commercialisations of their products. Those whodevice group. Sirtex is one of a rare Australian lacked access to overseas investment networksbiotechnology company, listed in 2000, that went to the Australian public market and listeddelivered commercial outcomes from the sale on the ASX; The explosion of early stage listingsof its SIR-Spheres microspheres for targeted in the early 2000s. Many listed far too early andradioactive treatment for liver cancer, enabling were not able to secure on-going funding or athe company to reward patient investors with fully partner with deeper pockets. The secondaryfranked dividends since 2009. market, after the Initial Public Listing, new share issues provided the bulk of subsequent funding.The ASX 200 Healthcare Index has always The repeated dilution of existing shareholders,been dominated, and remains so today, by even when most participated in the new issues,Australia’s largest global healthcare enterprise, made the investor weary of the biotechnologyCSL Ltd, previously the Commonwealth Serum sector. In the early 2000s there were more thanLaboratories, first listed in June 1994 at AU$2.40 60 biotechnology companies listed on the ASX(77 cents in today’s terms). In 2007 CSL made with a market cap below AU$20M.a 3:1 share split, today the shares are trading at Volume 26 • Number 1 • March 2016 Australasian BioTechnology 49

AusBioFEATURE – AusBiotech’s 30th yearSince those early days the listed biotechnology use of adult stem cells technology in patientssector has matured, the public has a greater with bone marrow transplant. Mesoblast wasunderstanding of the long-term investment able to issue new shares and raise AU$17 million,horizon needed and the ongoing funding support increasing its shareholding of Angioblast to 39%.required before commercialisation can beachieved, but never guaranteed. Increasing attention globally to the potential for the therapeutic use of adult stem cells, gave riseThe most successful ASX listed companies have to significant deal making. In November 2008been able to access international investors and US- based Osiris Therapeutics, a cellular andcollaborate with global enterprises. regenerative biotechnology company, received an upfront payment of US$130 million (with aAs an illustration of what it takes to fund and potential deal value of US$1.38B) from Genzymeto establish significant global networks with Corporation (acquired by Sanofi in 2011) forcomplimentary enterprises in order to progress access to their adult stem cell technologyearly stage projects Mesoblast makes a very platform.good case study. In March 2009 Mesoblast raised a furtherMesoblast is one of a few Australian ASX listed AU$10 million by issue of 15 million new shares,biotechnology companies that has been very Angioblast too raised $10 million by issuing newsuccessful at attracting significant funding shares, with Mesoblast retaining 38.5% but inand collaboration with US companies in the 2010 Mesoblast raised AU$37 million, with apromising field of regenerative medicine. Their new and existing shareholder issue, to acquireproprietary patented technology in the use of all of Angioblast Sytems, a strategic acquisitionadult stem cells, and a method associated with that advanced Mesoblast’s as a global leaderpurifying and enriching Mesenchymal Precursor in advancing the development of the potentialCells have the potential as a treatment in many use of MPC in cardiovascular and orthopaedicdisease indications, including orthopaedic and diseases. In November 2010 Angioblast Systemscardiovascular. (wholly owned by Mesoblast) received US Government US$1.2 million in grants under theASX and Nasdaq listed Mesoblast is recognised qualifying Therapeutic Discovery Project.by many as a global leader in the promising fieldof stem cell therapies. In following Mesoblast’s In December 2010 Mesoblast announced that itprogress and its successive capital raisings since was to receive an upfront payment of US$130 feelisting in 2004, with a modest issue of 42 million from Cephalon Alliance and additional US$130shares at 50 cents each to raise AU$21 million, million for exclusive world-wide rights to selectiveone can get a clear picture of how much time Mesoblast products, and Cephalon to acquireand funding is needed, before any commercial a 19.9% stake in Mesoblast. In February 2011potential can be revealed, yet still cannot be Mesoblast had cash balance of $280 million, inguaranteed. Mesoblast made strategic purchase March 2013 the company able to raise anotherand partnership with US-based Angioblast $170 million to drive their advanced programsSystems acquiring a 33.3% stake (for AU$10 and in 2015 Mesoblast listed on the Nasdaqmillion) to give it another spoke in exploring the with a cash injection from new investors oftherapeutic use of MPC, this time, in partnership US$83 million. Despite the long lead-time,with Angioblast, for cardiovascular diseases. capital raisings of more than $600 million,Further funding from an NHMRC grant of strategic acquisitions and significant partnershipsAU$1.5 million and Commercial Ready Grant Mesoblast has not yet commercialised its productof AU$2.7 million in 2005 helped to cement to receive revenue and distribute profits to long-the validity of Mesoblast’s endeavours in the standing shareholders.minds of Australian investors. In 2005 Mesoblastappointed the Bank of New York to establish level Mesoblast is well-recognised as a global1 American Depository Receipt (ADR) program leader in regenerative medicine research andto give the company access to a larger and well development, it holds a portfolio of patentsinformed American investor base. that may make a significant contribution to future revenue streams.In September 2008 the FDA granted AngioplastySystems Inc., Orphan Drug designation for the50 Australasian BioTechnology Volume 26 • Number 1 • March 2016