2019 Annual Report

YOUR PARTNER OF CHOICE FOR CLINICAL TRIALS 17 Years operating 30 Network members 1475 + Trials opened 9400+ Patients enrolled WESTERN AUSTRALIA

1 QUEENSLAND

4

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SOUTH 6 AUSTRALA NEW SOUTH WALES

7 2 3

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VICTORIA 9 10 11 14–29 13 12

2 | ANNUAL REPORT 2019 Our network members

1 Linear Clinical Research 17 Epworth Healthcare

2 Calvary Central Districts Hospital 18 Health

3 Lyell McEwin Hospital 19 Monash Health

4 The Tweed Hospital 20 Murdoch Children’s Research Institute

5 Coffs Harbour Health Campus 21 Olivia Newton-John Cancer Research Institute 6 Port Macquarie Base Hospital 22 Peninsula Health 7 Chris O’Brien Lifehouse 23 Peninsula Oncology Centre 8 Border Medical Oncology 24 Peter MacCallum Cancer Centre 9 Goulburn Valley Health 25 Royal Children’s Hospital 10 Bendigo Health 26 Royal Women’s Hospital 11 Ballarat Health Services 27 St Vincent’s Institute 12 Barwon Health 28 The Walter and Eliza Hall Institute 13 South West Healthcare of Medical Research

14 Alfred Health 29 Western Health 30 15 Austin Health 30 Auckland City Hospital 16 Cabrini Health

CONTENTS 5 Chairperson’s Report 6 Review of Operations 9 Management Reports 18 Board Sub-Committee Reports 20 Board of Directors 25 Corporate Governance 26 CTA Current Member Organisation Directory

2 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 3 4 | ANNUAL REPORT 2019 Chairperson’s Report

It is my pleasure to write my fourth Chairperson’s report, to preface the 2019 Cancer Trials Australia Annual Report. I thank my fellow Directors for their important contributions throughout 2019; Michelle Gallaher, Colin Nugent, John Seymour, Mark Shackleton, Craig Underhill and Zee Wan Wong, as well as our new Director Tim Murphy.

In 2019 CTA expanded its Membership base with the addition of Coffs Harbour, situated in the Mid North Coast Local Health District in NSW, as well as experienced further growth in both the number and scope of Service Agreements with our Members. Building on the back of growth over the previous three years, CTA service metrics grew further in 2019, once again breaking our year-on-year CEO Kurt Lackovic, now in his third year record in all key performance indicators. at CTA, and the entire CTA management Our growth continues into 2020, welcoming team have impressed with their ability to two additional Members in the first continue to grow CTA’s Membership and quarter alone. services, while simultaneously improving efficiency. I am particularly pleased with Throughout 2019 CTA continued to focus the strategic investment in information on ensuring the smooth administration management systems, as detailed further of an expanding trial portfolio across our into this report. Cancer Trials Australia is Membership. This is only possible through extremely well positioned to continue to nurturing strong links with both Sponsors provide value for money services to support and Contract Research Organisations, clinical trial activity across our growing and leveraging the significant value Membership. Our efforts help ensure offered through our expanding Tumour Australia remains a destination of choice Group network. for international clinical trial sponsors, CTA continued to take a leadership role at securing earlier access to novel therapies both national and international conferences, for Australian cancer patients. adding significant value to Australia’s clinical I would like to take the opportunity to trial sector. Our staff also represented congratulate both CTA management and all Members’ interest on a range of committees CTA staff, as well as acknowledge Network and advisory groups, including an Australian Member personnel for working hard to Clinical Trials Alliance reference group, ensure CTA’s ongoing success. CT:IQ, AusBiotech’s Clinical Trials Advisory Group and the BioMelbourne Network’s ANDREW SCOTT Clinical Trials Advisory Group. Board Chairperson

4 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 5 Review of Operations

I write my 2019 Review of Operations supported by CTA, amendments grew from home, under challenging 5%, clinical trial contracts grew 24%, and circumstances across the globe. CTA’s the CTA Finance team issued over 5,000 ability to adapt to changing operating invoices and administered more than $33M conditions over the past two months is a on behalf of our Members, up almost 40% testament to the character of our staff, on the previous year. This activity lead to as well as the investment of funds, effort the generation of a healthy surplus for and foresight made towards evolving our reinvestment to benefit our Members. Information Systems over recent years. Increased activity throughout 2019 The 2019 calendar year saw further growth necessitated additional staff, with our team at Cancer Trials Australia, both in CTA’s growing by seven employees across the year. Membership as well as in the delivery of We also implemented a change in structure, administrative services to our Members. with the creation of an additional Start- I am pleased that, despite the challenges Up team dedicated to our newest service presented by COVID-19 in 2020, two Members, enabling greater focus on the additional Members have been added in the establishment and refinement of processes first quarter of this year. at those sites.

New service agreements were executed in In 2018, CTA was pleased to announce 2019, and all expiring service agreements reaching an agreement with the Victorian were renewed throughout the year, Comprehensive Cancer Centre (VCCC) to highlighting the ongoing value-add CTA is provide Site Management Services for providing for our service Members. I look the VCCC’s Investigator Initiated Trial (IIT) forward to continuing to nurture strong Program. Throughout 2019 we executed relationships with all Members within our 11 individual agreements under this scheme, expanding network. ensuring a coordinated approach to the administration of Investigator Initiated After two retirements and one addition at Trials across VCCC Members, which will help Board level in 2018, there was only change in maximise benefits of clinician led research to 2019, with the Board welcoming Tim Murphy Victorian cancer patients. as an independent Director. I look forward to working closely with Tim and all other Board Toward the end of 2018, I was pleased members over the coming period. to announce a new project, funded by the VCCC’s Efficiency Program, providing Almost all CTA service metrics improved Victorian sites with an exciting opportunity across 2019; feasibilities grew 45%, there to implement the electronic document was a 14% increase in new trial activity management system, SiteDocs Portal, for

6 | ANNUAL REPORT 2019 oncology clinical trials. Throughout 2019 expansion of services offered, including we led the implementation of SiteDocs at for investigator initiated trials, (iv) strategic 17 Victorian sites, facilitating a reduction selection of additional Members, as well as in repetitive administration and providing (v) further enhancing our communication sponsors with a consistent mechanism to with Members, industry and government. ensure trial management and oversight. Nurturing tighter links with both State and Federal governments will allow CTA to add Management at CTA have expanded on their further value in the evolving Australian respective areas of responsibility further in clinical trial landscape. this report, covering Ethics and Governance Submissions, Budget and Contracts, Finance, Finally, I would like to take the opportunity Information Systems and Human Resources. to thank all CTA staff, as well as all Member personnel, for the hard work that is Cancer Trials Australia continues to focus essential to enable the CTA network to on (i) providing cost efficient and timely continue to flourish. services to our expanding Membership, (ii) strategic investment in information KURT LACKOVIC systems that support our Members, (iii) Chief Executive Officer

6 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 7 8 | ANNUAL REPORT 2019 Management Reports

Member Network There was a 45% increase in the number of feasibilities received from sponsors in 2019 CTA successfully coordinated 33 Tumour compared to 2018, reflecting both Australia’s Group meetings for the 10 Tumour attractiveness as a destination to conduct Streams and the Phase 1 Tumour Group. clinical trials and CTA’s increasing ability to New Tumour Group Chairpersons were support such trials. welcomed for the Gastrointestinal, Gynaecological, Haematological and Lung In October 2019, we held the Annual Tumour Groups. We thank the following CTA Research Managers meeting which enabled many of our metro, interstate and outgoing Chairpersons for their dedicated regional Member sites to come together time: Associate Professor Linda Mileshkin and discuss pertinent topics such as “How (Gynaecological TG Chair, 10 years), Dr to survive an FDA audit”, Teletrials, and the Sumi Ananda (Gastrointestinal TG Chair, development of a Research Governance nine years), and Dr Dishan Herath (Lung TG Toolkit. We thank the Research Managers Chair, six years) and welcomed the following and site staff for taking the time to ensure Investigators as new chairpersons: Dr Sumi the success of this annual forum. Ananda for Gynaecological, Dr Margaret Lee for Gastrointestinal, Dr Muhammad Our continued collaboration with the Alamgeer for Lung and Dr Chung Fong to Victorian Comprehensive Cancer Centre lead an additional Haematological (myeloid (VCCC) saw at least two major projects focussed) Tumour Group. Thank you to progress significantly in 2019; CTA service all the ongoing Tumour Group Chairs provision for 11 Investigator Initiated Studies, for supporting the growing CTA network some affording us the possibility of building throughout 2019. relationships with new departments such

THERE WAS A 45% &14% INCREASE IN THE NUMBER INCREASE IN NEW OF FEASIBILITIES RECEIVED TRIAL ACTIVITY FROM SPONSORS IN 2019

8 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 9 as Anaesthesia and Palliative Care, and the Our continued growth in recent years Teletrials Governance project, which saw necessitated a significant internal change, CTA charged with developing a streamlined with the creation of a new Start-Up team in model for Victoria, in conjunction with October. An additional Start-Up Manager, Hospital Research Office Representatives, Nicola Howell, was employed to focus VMIA and the DHHS. on CTA’s newest service Members and to assist in the establishment and refining of processes at each site. CTA’s expertise and Ethics and Governance advocacy will support and develop these Submissions sites as they increase their trial portfolios and expand their trial capabilities. There was a healthy 14% increase in new trial activity supported by CTA in 2019, and It has been demonstrated that regional amendments grew 5% in the same period; cancer patients lack access to quality we note that amendments required during clinical trials when compared to their the Start-Up process continued to be a key metropolitan patients. CTA responded to this factor influencing Start-Up timelines. inequity by specifically promoting regional cancer centres to our Sponsor network, via CTA’s support of non-oncology trials grew the development and publishing of site- further with services to departments outside specific brochures, in partnership with the of our traditional oncology indications now Regional Trials Network. The brochures underway for two Members, in addition highlight the site’s expertise and experience to our team supporting 16 non-oncology in clinical trials and outline the site facilities departments for Melbourne Health. and capacity.

OPEN TO ACCRUAL CANCER TRIALS CTA SUPPORTED START-UP ACTIVITY SUPPORTED BY CTA FOR CANCER TRIALS

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150150 22 5252 55

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00 2525 22 22 22 22 20152015 20162016 20172017 20182018 20192019

10 | ANNUAL REPORT 2019 2525 22 22 55 22 22 55 22 55 55 55 5252

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HAEHAE HAEHAE HAEHAE OTHEROTHER To conclude, many thanks to the staff of both increase in new study contract negotiations Start-Up teams, whose dedicated and expert undertaken across our service sites. work is very much appreciated. Whilst we are not employed in patient facing roles, we Our internal timeline targets for clinical trial maintain strong collaborative relationships contract negotiations were met or exceeded with our service Members that ensure a in the majority of cases with an average time positive contribution to overall clinical trial to approval of 81 days. Additionally, we found activity for our Members and for Australia. It that clinical trial contract negotiations were is rewarding to support our Members as they not a rate-limiting factor in overall study achieve great gains in their trial portfolios. approval timelines. We have been able to 250consistently maintain our timelines over the 22 JEN HAN years for a number of key reasons; we always Clinical Trials Start-Up 2 ensure that our service sites price within fair & Sponsor Relations Manager 25 market value, we always ensure that2 our 200 NICOLA HOWELL budget negotiations are transparent and, 25 Clinical Trials Start-Up Manager most importantly, our team has, over the 2 2 years, developed a high degree of expertise and knowledge, enabling CTA to negotiate 150 2 Budget52 and Contracts clinical trial budgets efficiently and effectively. 5 The CTA Budget and Contracts team As well as our core budget and contract successfully negotiated 179 clinical trial 100services, we continue to provide Principal contracts in the 2019 calendar year. This Investigators with assistance in preparing growth reflects a healthy 24% annual indicative budgets for their study grant

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0 25 2 2 2 2 2015 2016 2017 2018 2019 OPEN TO ACCRUAL CANCER TRIALS SUPPORTED BY CTA – BY PHASE

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10 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 11 transparent and upfront discussions, we have successfully been able to remove OUR TEAM HAS, OVER holdback fees from most of our Member THE YEARS, DEVELOPED site contracts and agree on fairer and more realistic payment terms. These changes A HIGH DEGREE will assist in overall site sustainability and OF EXPERTISE AND maintain positive cash flow, especially for KNOWLEDGE, ENABLING smaller, regional Members.

CTA TO NEGOTIATE Throughout 2019 we have also invested CLINICAL TRIAL more time and resources into managing our BUDGETS EFFICIENTLY data integrity processes. The Budget and AND EFFECTIVELY. Contracts, Finance and Information Systems teams have been working closely together to implement processes to improve the accuracy, timeliness and reporting of patient visit data to better inform our billing reports. By improving interrogation of the data collected, we have been able to determine common errors, recognise patterns and adjust guidance, and by working more closely with our Member sites, we have seen applications. We welcome the opportunity a significant improvement in data quality. to provide our expertise and support to our Our aim is to improve on this further in Member sites in this area and it is always a 2020, by providing Members with additional pleasure to hear when grant applications training and guidance. have been successful. Towards the end of 2019, we commenced Our work with the VCCC Investigator Initiated discussions with our service sites to obtain Trial program this year has provided us with the relevant legal and governance approvals the opportunity to negotiate contracts across to support the use of electronic signatures. multiple sites for various IITs. This has not CTA seeks to adopt electronic signatures only allowed us to gain exposure working as a standard for clinical trial agreement with departments outside our traditional execution, to reduce time spent with hard area of oncology but has also given us the copies in circulation, improve record-keeping opportunity to gain knowledge of practices in and more importantly reduce overall study other clinical trial disciplines, broadening our start up timelines. overall ability to negotiate more effectively. It has been a challenging and workload Over the last 12 months, we have been intensive year for the Budget and Contracts working closely with Sponsors to negotiate team. I would like to take this opportunity better payment terms for our Members. to thank the entire team for their continued Slow payments from Sponsors and CRO’s hard work and dedication. have been an operational concern for our Members for many years. We have found MARIE LUCI that site payments often end up arriving Clinical Trials Contracts Manager much later than agreed payment terms. Additionally, Sponsor and CROs that hold back a portion of site payments until study Finance closure (on average 10%) cause greater The Finance team has again achieved delays to the site being paid in full for an unqualified audit report, through work delivered. The good news is that management of excellent processes, systems most Sponsors and CROs have started to and reconciliations to meet audit standards. acknowledge these site challenges and have been working closely with CTA to address Throughout 2019, CTA Finance managed these payment issues. By conducting more the invoicing process for approximately

12 | ANNUAL REPORT 2019 450 commercially sponsored trials and on behalf of our sites, with no bad debts approximately 165 non-commercially recorded throughout the year. This service sponsored trials, across 15 of our Member is provided interest free to each of our full- sites including metropolitan sites: Peter service Member sites, significantly reducing McCallum Cancer Centre, The Royal Women’s their cash-flow risk. Hospital and The Royal Melbourne Hospital (PCCTU), Western Health, Cabrini Health, In addition, the CTA Finance team are Alfred Health and Epworth Healthcare along responsible for CTA payroll and salary with workload expanding to service a greater packaging arrangements. The Finance number of regional centres: Bendigo Health, team also prepare an annual budget, South West Healthcare in Warrnambool, 6+6 forecast, and support the Finance and The Tweed Hospital and Goulburn Valley Audit Board Sub Committee. Our main Health in . In late 2019, we workload and core function, however, also welcomed Barwon Health, who will continues to be the finance and associated transition all trials across to CTA for financial debtor collection services for clinical trials management early in 2020. conducted by our Members. We aim to ensure maximum revenue and timely Workload in the CTA Finance team increased invoicing on behalf of our Member sites, during 2019 with cash transfers to sites in accordance with contractual terms. increasing by 15% and the number of Contractual agreements with Sponsors invoices issued increasing by 14%. The CTA continue to be complex, with many different Finance team successfully transitioned to items to be tracked for invoicing purposes, MYOB in April 2019. This platform now tracks and our continued focus is to work with our all transactions within each clinical trial at Member sites to ensure accurate and timely a project level, thus reducing reliance on data entry, an area in which we have worked external spreadsheet tracking. together with the Budget and Contracts team and the Information Systems team As an additional benefit to our Member sites, to continue to finesse and improve on CTA has continued to use its cash to invest in these processes. sites by transferring funds to Members on a bi-monthly basis, irrespective of whether the I take this opportunity to thank my staff for invoice has been paid to CTA by the Sponsor. their excellent contribution throughout the This regular transfer of funds to our sites 2019 financial year. means that, in many cases, the site has been paid before CTA. CTA is well experienced MICHELLE BUTTON in debtor collection, managing this service Finance Manager

THROUGHOUT 2019, CTA FINANCE MANAGED THE INVOICING PROCESS FOR APPROXIMATELY & COMMERCIALLY450 165NON-COMMERCIALLY SPONSORED TRIALS SPONSORED TRIALS

12 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 13 Information Systems data, and identification of under-performing studies and data collection gaps. Two Factor Our previous Annual Report communicated Authentication (2FA) was enabled for all the launch of an internal project Power BI users, ensuring that the privacy management platform, Atlassian’s Jira, and security of this valuable data was for managing and tracking work in maintained. Our Power BI dashboards can progress across our Start-Up efforts in the draw together separate datasets arising Budgets and Contracts, and Ethics and from Jira, Velos eResearch, financial, and Governance teams. In 2019, the reach of this site-supplied datasets to provide a powerful tool extended further into covering Post- mechanism for analysis. Approval and Feasibility management. The success of this project led to the recruitment CTA extended and embedded our strategic of a full-time Project Officer to extend and information capability during 2019 with advance our capability. The anticipated the award of a new project grant to deploy additional benefits of having one database the site file document management collating all data across all teams is now system, SiteDocs Portal, to 17 sites that fall being fully realised, with extensive within the Victorian Comprehensive Cancer reporting now achievable, and further Centre Efficiencies Program. SiteDocs Portal feeding of this data into Power BI allows streamlined management of key dashboards for analysis at Member sites. regulatory documents between Sponsor This granular understanding of our work pharmaceutical companies and clinical trial product cycle informs future resource teams. Two Project Officers, employed by planning and trial portfolio management, CTA, were recruited to the project and an as well as a greater ability to analyse ambitious roll out plan commenced. At the bottlenecks and improve performance close of 2019, all 17 sites had been activated against strategic goals. 2020 will see and had made considerable progress in introduction of real-time reporting of this their implementation. The project promotes data to Member sites and automated linkage a consistent and harmonised approach to of the Jira dataset to external regulatory clinical trial documentation and public sources. ease of use to internal stakeholders and external Sponsors. In late 2019, an additional Our Member dashboard analytics tool, injection of funds was granted to extend the Microsoft’s Power BI, has grown in value, project to 2021, allowing inclusion of further providing Members with a much-needed sites and additional resourcing. mechanism to obtain trend analysis by year, team and disease indication over finance, Velos eResearch use continued to grow, timeline, patient accrual and study status with additional Member sites now serviced

14 | ANNUAL REPORT 2019 through this application. A number of application processes were rationalised, providing users with better performance.

Our website grew with the addition of regional site promotional material, and SiteDocs Portal training materials, and we released news posts throughout the year. We upgraded the website host and implemented additional security features to detect and prevent cyber threat. this, CTA conducted a phishing exercise to CTA made a significant change to our assess the ability for staff to recognise and network infrastructure in the adoption of appropriately respond to malware; all staff Office365 for our shared files in SharePoint passed this test. and OneDrive, Exchange365 email server and external full backup services. This allowed us Our laptop fleet grew to 17 units and an to effect stringent cybersecurity Advanced Endpoint Management tool was deployed Threat Protection protocols to further to these to ensure Windows update and Anti-virus compliance. We migrated protect our data. Of significant benefit over connection of our PC fleet to the PMCC IT on-premises Exchange servers (as found local area network and upgraded all desktop in traditional hospital IT environments), machines to Windows 10, which had a virus definitions are updated real-time from significant impact on speed and reduction Microsoft’s worldwide signalling rather than in cyber threat vulnerability. We deployed via scheduled updates – enabling the filtering Microsoft Teams as an intranet and added to adjust as new threats emerge. six workstations to accommodate our During 2019, two of our Members fell growing staff complement. We finalised an victim to the debilitating Emotet virus which Information Systems Strategic Plan which wiped out their email and file stores. Due was endorsed by the CTA Board in late 2019. to our protected independent Office365 I would like to thank all members of the environment, our own email and file Information Systems team and our external storage was unaffected, and all potential partners for their foresight and dedication to cross contamination of the virus into our improving CTA’s capability in this area. system was prevented. We were thus able to continue to service our Members with EMILY ENGLAND minimal interruption. As a direct result of Information Systems Manager

THIS ALLOWED US TO EFFECT STRINGENT CYBERSECURITY ‘ADVANCED THREAT PROTECTION’ PROTOCOLS TO FURTHER PROTECT our data

14 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 15 Human Resources relationships between teams, through a series of fun, but purposeful activities. Along At the conclusion of 2019, CTA employed with continued professional development, 36 staff (as well as several casuals), up from such activities are an important investment 29 staff at the start of the year. The major in maintaining staff engagement toward reason for this relatively large increase achieving CTA’s objectives. in staff numbers was the creation of new roles in response to growth at existing and We were pleased to be able to offer a new Member sites, as well as to capitalise one-year internship to an RMIT on opportunities arising from grants and Pharmaceutical Sciences Honours Program our investment in improved information student. Our student intern worked as a systems, with a focus on improving junior Ethics Submission Specialist and was processes and data integrity. ultimately successful in completing the requirements of their degree at the end Because of CTA’s growth over recent years, of their CTA placement. there was recognition of the need to extend our relatively flat organisational structure to Finally, an extensive review of our leave one that provided better career progression, policy was undertaken in 2019, to bring it both laterally and vertically. It was also into line with recent changes to legislation, necessary to build-in additional delegation, best practice guidelines and updated internal giving managers the opportunity to grow in procedures. their roles, and to more formally address 2019 was a very busy year in terms of succession planning. increased recruitment activity and internal The change in organisational structure job changes, ultimately positioning CTA for included the creation of a new team that a successful 2020 - one that will see more was established to implement best-practice opportunities arising both internally, for clinical trial processes at new service career progression, and externally, to lead Members. This saw the establishment of other projects within the sector, and to an additional management role, as well further diversify the types of services we can as additional senior supervisory roles, offer our Members. thus offering opportunities for increased SUSY MONTAGNER responsibility. The changes helped ensure a Human Resources Manager low staff turnover across 2019.

CTA held a successful team building event in the middle of the year, to introduce new staff to their team-mates, and further strengthen

THERE WAS RECOGNITION OF THE NEED TO EXTEND OUR RELATIVELY FLAT ORGANISATIONAL STRUCTURE TO ONE THAT PROVIDED BETTER CAREER PROGRESSION, BOTH LATERALLY AND VERTICALLY.

16 | ANNUAL REPORT 2019 16 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 17 Board Sub-Committee Reports

Finance and Audit increase of 22%, and the surplus for the year Sub-Committee Report was $525,106 (2018: $616,820). The quality of administration of clinical The Finance and Audit Sub-Committee trials by CTA will continue to be the focus (FASC) held four meetings throughout the for the FASC, to underpin CTA’s success year, as well as regular ongoing contact into the future. As was reported last year, and interaction with management. The investment in financial and other reporting FASC provided a rigorous review of systems has continued to drive greater operational and financial performance efficiencies and continuous improvement compared to budget, the company’s financial in reporting accuracy and relevance to position, cash flow, profit and loss, debtor stakeholders. A strong financial position management, balance sheet performance allows this improvement to continue into and all potential capital investment the years ahead. propositions. The FASC also considered potential internal and external risks to Strategic alliances and a focus on the business and assisted management in Government advocacy have continued to maintaining a current Risk Register. The ensure CTA is well positioned to add value Committee’s advice and recommendations to its Members. were provided to management and the CTA Board. Exchange rate uncertainties are essentially neutralised by contracts being written in The CEO, Dr Kurt Lackovic, and Finance local currency, together with a continued Manager, Michelle Button attended all FASC focus on cost management. meetings during the year and maintained their excellent standard of accurate financial The Company finished the year with a very information and reports. sound financial position, having $7.15M in cash reserves (2018 $6.23M). Total equity of The FASC assisted management in the $4.35M was recorded, an increase over 2018 preparation and presentation of the annual ($3.74M), driven by the impact of an increase budget and additional forecasts, particularly in net assets. The cash reserves continued with respect to business assumptions and to act as a buffer for timing of a cash flow potential risks. that remained unpredictable and to enable financing of site payments before sponsor Total clinical trials funding revenue payments were received, in an environment administered by the company for the year of sustained growth. This continues to be a was $33,912,908 (2018: $27,903,940) an significant financial benefit to CTA’s Members.

18 | ANNUAL REPORT 2019 With the uncertainties around future business Performance and forecasts resulting from disruption due to Remuneration COVID -19, it is reassuring to have these reserves in place. Sub-Committee Report The Performance and Remuneration Sub- The ratio of current assets to current Committee (PRSC) met twice in 2019, to liabilities was 1.67 (2018: 1.64), well above set CEO KPIs, subsequently review CEO the planned threshold of 1.25. Management performance against those KPIs, as well maintained strong control over debtors, as review policies associated with CTA which remains a challenge in a cost staff remuneration. The committee also competitive environment. oversaw the selection and appointment of CTA’s overall financial risk profile remained an additional independent Board member sound. CTA continues to remain income in 2019. Post completion of his MBA in tax exempt, as a charity under the 2018, Dr Lackovic undertook professional requirements of the Australian Charities development at Stanford in 2019, completing and Not-For-Profit Commission. a residential program ‘The Innovative Healthcare Leader’. Management is congratulated on yet another unqualified audit report, delivered The Committee was also pleased to receive by Deloitte; and the FASC wishes to again updates regarding professional development acknowledge the high accounting and for all CTA staff throughout 2019. financial management standards set by ANDREW SCOTT Michelle Button, Finance Manager, and Chairperson, Performance and Dr Kurt Lackovic, CEO. Remuneration Sub-Committee The Committee was pleased to advise the Board to accept the 2019 results and despite the potential challenges caused by the impact of COVID-19, CTA is well positioned to face 2020 with confidence under the leadership of Dr Kurt Lackovic and the entire management team.

COLIN NUGENT B COM, CA (SA), ACA Chairperson, Finance and Audit Sub-Committee

18 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 19 Board of Directors

PROFESSOR PROFESSOR JOHN SEYMOUR ANDREW SCOTT (CHAIR) MBBS, FRACP, PHD AM, MBBS, MD, FRACP, APPOINTED AS DIRECTOR: JUNE 2014 FAHMS, FAANMS, FAICD, DDU APPOINTED AS DIRECTOR: AUGUST 2015 Professor John Seymour AM is a clinical haematologist and Associate Director of Head, Tumour Targeting Laboratory, Olivia Clinical Research at the Peter MacCallum Newton-John Cancer Research Institute, 2015 Centre, and the Director of the integrated to present. Medical Director, Department Haematology Department of the Peter of Molecular Imaging and Therapy, Austin MacCallum Cancer Centre & the Royal Health, 2015 to present. Professor, Faculty Melbourne Hospital in Melbourne, Australia. of Medicine, , 2007 to present. Professor, School of Cancer After receiving his MB and BS degrees Medicine, , 2015 to from the University of Melbourne in present. Director, Australian Nuclear Science 1987, Professor Seymour completed a and Technology Organisation, 2008 to translational research fellowship at the MD present. Past-President, World Federation of Anderson Cancer Center in Houston, and Nuclear Medicine and Biology subsequently received their Distinguished Alumnus award in 2011. He also completed MEETINGS ATTENDED: PhD studies in the pathobiology of DIRECTORS 4 OF 4; PRSC 2 OF 2 haematopoietic growth factors at the Ludwig Institute for Cancer Research. Professor Seymour is a member of several national and international scientific committees including, Cancer Australia Advisory Groups, the Scientific Advisory Committee for the International Conference on Malignant Lymphoma, Medical Advisory Board of the Lymphoma Coalition, and the Board of Directors of the International

20 | ANNUAL REPORT 2019 Extranodal Lymphoma Study Group. He COLIN NUGENT served for more than a decade as Executive B.COM, MEMBER OF INSTITUTE member and Chairman of the major OF CHARTERED ACCOUNTANTS IN AUSTRALIA (CA) national clinical trials co-operative group in haematologic malignancies, the Australasian APPOINTED AS DIRECTOR: JUNE 2015 Leukaemia & Lymphoma Group. He is a Colin is a current member of the Australia frequent invited speaker nationally and & New Zealand Institute of Chartered internationally, is a member of numerous Accountants and owns a consulting practice professional societies, an Editor-in-Chief offering strategic and financial services of Leukemia & Lymphoma, and currently to the healthcare sector. Colin is a “Big 4” on the editorial boards of Blood, Journal trained Chartered Accountant, graduated of Clinical Oncology and the British Journal from the University of Cape Town and gained of Haematology. He has authored 20 book his CA (SA) membership. He obtained his chapters, >600 peer reviewed publications Australian ACA accreditation in 1983. Colin (with >30,000 literature citations), and >750 has extensive commercial and technical conference abstracts. experience across a broad range of national Actively involved in a broad range of and global companies. The last 25 years have collaborative research, Professor Seymour been spent in the Healthcare space with has been the principal investigator on companies such as Ipsen, Kendle (now INC >85 clinical trials and chief investigator Research), Medisence (Abbott Labs), holding on competitive grants awarded >AUD$95 financial, director and board positions in million funding in the last 10 years. In 2015 these and other organisations. he was awarded Membership of the Order MEETINGS ATTENDED: of Australia, and elected to the Australian DIRECTORS 4 OF 4; FASC 4 OF 4; PRSC 2 OF 2 Academy of Health and Medical Sciences for his contributions to the field. MEETINGS ATTENDED: DIRECTORS 3 OF 4

20 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 21 MICHELLE GALLAHER PROFESSOR MARK SHACKLETON DIP APP SCI (ORTH), GRAD DIP BUS, MBA, MBBS, PHD, FRACP GAICD, FELLOW AIM APPOINTED AS DIRECTOR: JULY 2017 APPOINTED AS DIRECTOR: SEPTEMBER 2015 Prof Mark Shackleton is the Director of Michelle is CEO of ShareRoot, an ASX Oncology at Alfred Health, a Professor of listed technology development company. Oncology at Monash University, a Victorian With over 25 years of experience in the Cancer Agency Clinical Research Fellow, biopharmaceuticals and healthcare sector Chair of Melanoma and Skin Cancer Trials and deep professional global networks, (the national co-operative trials group Michelle is a recognised, award-winning in cutaneous malignanacy), and Head of leader in the Australian innovation the Cancer Development and Treatment industries. Establishing The Social Science Laboratory at the Monash Central Clinical in 2014, selling to ShareRoot in April School at The Alfred. After training in medical 2018 and guiding a specialist application oncology and at the Ludwig Institute in of ShareRoot’s key platform technology, Melbourne, Dr. Shackleton undertook PhD Media Consent, in the medical sector, studies at the Walter and Eliza Hall Institute Michelle has a proven track record of of Medical Research and post-doctoral business building, creative disruption and work at the University of Michigan, USA. He commercialisation of technologies. Michelle was awarded the 2006 Victorian Premier’s is co-founder of the NFP company Women Award for Medical Research, a 2010 NHMRC in Science, Technology, Engineering, Achievement Award, a 2011 Pfizer Australia Mathematics & Medicine (STEMM) Fellowship, and in 2012 was awarded the Australia and is a recognised advocate for Australian Science Minister’s Prize for Life gender equality and diversity in STEMM Scientist of the Year. His laboratory focuses industries. Previously CEO of the Victorian on understanding mechanisms of cancer biotechnology industry association, Director initiation and propagation. of external relations at the Australian Stem MEETINGS ATTENDED: Cell Centre, Michelle is a non-executive DIRECTORS 2 OF 4 Director on a number of NFP and for profit organisations in the biotech, medical and health sector. Michelle holds an allied health qualification in Applied Science from La Trobe University as well as postgraduate qualifications in Business from RMIT University and Executive Leadership and GEMBA from Monash University. Michelle is also Telstra Victorian Business Woman of the Year and Entrepreneur of the Year in 2017 and was inducted into the Victorian Honour Roll for Women in 2018. MEETINGS ATTENDED: DIRECTORS 2 OF 4; FASC 3 OF 4

22 | ANNUAL REPORT 2019 DR. CRAIG UNDERHILL ASSOCIATE PROFESSOR ZEE WAN WONG MBBS, FRACP MBBS MRCP FAMS GDA FRCP FRACP MAICD APPOINTED AS DIRECTOR: JULY 2017 APPOINTED AS DIRECTOR: JULY 2018 Dr Craig Underhill is the Clinical Director Dr Zee Wan Wong commenced her current of Cancer Services at Albury Wodonga role as Head of the Oncology Unit at Health and Hume Regional Cancer Service Peninsula Health in August 2017. She holds Border East, has a conjoint appointment a joint appointment as Adjunct Clinical as a Senior Lecturer with the University of Associate Professor with Monash University. NSW Rural Clinical School Albury, Honorary Apart from being a member of the Monash appointment at Royal Melbourne Hospital Partners Comprehensive Cancer Consortium as Associate Medical Oncologist, is Chair and Executive and Governance committees, Cancer Advisor Cancer Executive Committee, Dr Wong is the Joint Clinical Director of Murrumbidgee Local Health Network, Southern Melbourne Integrated Cancer and the Regional Oncology Lead with the Services (SMICS), a Clinical Advisor for Cancer Victorian Comprehensive Cancer Centre. Council Victoria Clinical Network and Senior Dr Underhill completed his Bachelor of Lecturer at the Department of Rural Health, Medicine and Surgery in 1987 at Melbourne University of Melbourne Medical School. She University. He became a Fellow of the Royal is a current member of the Ethics Committee Australasian College of Physicians in 1997. In at Peninsula Health. the 1990’s Dr Underhill worked as the Senior Zee Wan obtained her postgraduate Clinical Research Registrar at Guy’s Hospital, medical qualifications at the Royal College London as well as the Peter MacCallum of Physicians (UK) before completing her Cancer Centre. Medical Oncology fellowship in the USA MEETINGS ATTENDED: in 2003. Thereafter, she was a Senior DIRECTORS 2 OF 4 Consultant at the National Cancer Centre, Singapore. She obtained her Medical Oncology Fellowship with the Royal Australasian College of Physicians in 2013. More recently, she completed a Specialist Certificate in Clinical Leadership at The University of Melbourne as well as the Executive Ready Program with Women & Leadership Australia. Previously, Zee Wan was the founding Clinical Director of the Oncology Unit at Goulburn Valley Health as well as the Clinical Director of West Hume Regional Integrated Cancer Services. She is a member of the AGITG Lower GI Working Party and also holds memberships with ASCO, ESMO, MOGA, COSA, BCT, ALTG and ANZGOG. She has numerous peer- reviewed publications and has presented at national as well as international oncology conferences. MEETINGS ATTENDED: DIRECTORS 3 OF 4

22 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 23 MR TIM MURPHY DR KURT LACKOVIC FAICD, M.MKG, BSC(HONS) PHD, MBA, GAICD APPOINTED AS DIRECTOR: AUGUST 2019 APPOINTED AS COMPANY SECRETARY: 30 JANUARY 2017 Tim is currently the General Manager - Blood Cancer Partnerships at Leukaemia Dr Kurt Lackovic has been CEO of Cancer Foundation and Chairman, ARMI at Monash Trials Australia since January 2017. He has University. He is a politically astute executive spent his entire career in medical research. with extensive experience working with His education includes a PhD in chemistry, the C-suite and the Boardroom to manage international post-doctoral experience in corporate issues in regulated environments. medical genomics and early stage drug Broad local and international (London, discovery. Kurt graduated from the Australia Brussels) experience in effective stakeholder Institute of Company Directors in 2014, engagement and political advocacy. and in March 2018 completed his MBA at Melbourne Business School, graduating on Strong background in high growth, merger, the Dean’s list. Dr Lackovic has published consolidation, and downsizing global and 20+ articles across multiple research areas, national business environments. Expertise in possesses extensive expertise in leading multiple sectors, especially healthcare. complex academic and clinical programs, has A passionate strategic thinker who develops strong connections to industry, and strategic high performing teams and works cross- linkages to senior executives in Government functionally to ensure the long-term viability and major teaching Hospitals. He is a of the organisation. member of the Licensing Executives Society of Australia and New Zealand, American A Fellow of the Australian Institute of Society of Clinical Oncology, Society for Company Directors with a Bachelor of Clinical Research Sites and AusBiotech’s Science (Hons) & Master of Marketing from Clinical Trial Advisory Group. He also sits on Melbourne Business School. the Boards of several NFPs. MEETINGS ATTENDED: MEETINGS ATTENDED: DIRECTORS 2 OF 2 DIRECTORS 4 OF 4; FASC 4 OF 4; PRSC 2 OF 2

24 | ANNUAL REPORT 2019 Corporate Governance

The Board focuses on the objectives and • Approves the business plan values for which CTA was created and that and budget remain important to its Members and • Approves significant stakeholders and thus ensures that Member corporate policies value is protected and enhanced. The Board supports the principles of the ASX Corporate The CEO is responsible for the day-to-day Governance Councils Principles of Good management of CTA with all powers and Corporate Governance and Best delegations authorised by the Board. Practice Recommendations. BOARD STRUCTURE CTA is not a listed company and as such is AND STANDARDS not required to report on these principles; however, the Board has applied the The Board comprises up to eight members. principles where relevant to a Not-For-Profit Five Board members are nominated by the company limited by guarantee. Member institutions and the Board appoints up to three Independent Directors. The The Board ensures that CTA management profiles and qualifications of the Directors and staff maintain regular reporting are detailed in this report. All Directors are practices and comply to the highest level of required to disclose to the Board any areas corporate ethics. The Board is comprised where they may have a Material Personal of Member and Independent Directors with extensive commercial and Member Interest. If issues arise at Board meetings organisation experience. The Directors they are dealt with according to The ensure they bring an independent judgment Corporations Act Cth (2001). to bear in decision-making. Management The CEO is responsible for implementing provides the Board and its sub-committees the corporate strategy approved by the with information in a form, timeframe and Board, execution of all operations and quality that enables them to effectively the management of staff, delivering the discharge their duties. objectives within the constraints of a In particular the Board: budget approved by the Board, and is • Appoints and manages the CEO assisted in the process by the Finance and • Approves corporate strategy Audit sub-committee.

24 | ANNUAL REPORT 2019 ANNUAL REPORT 2019 | 25 CTA CURRENT MEMBER ORGANISATION DIRECTORY

CANCER TRIALS AUSTRALIA MEMBER SITES Prof Danny Rischin Prof Mark Shackleton Peter MacCallum Cancer Centre Alfred Health Dr Stephen Begbie Dr Michelle Wilson Port Macquarie Base Hospital Auckland City Hospital Mr Ryan Hehir Dr Niall Tebbutt Royal Children’s Hospital Austin Health Assoc Prof Orla McNally Dr Stephen Brown Royal Women’s Hospital Ballarat Health Services Dr Sue-Anne McLachlan Dr Philip Campbell St Vincent’s Institute Barwon Health Dr Ian Collins Dr Rob Blum South West Healthcare Bendigo Health Prof Ehtesham Abdi Dr Craig Underhill The Tweed Hospital Border Medical Oncology Dr Anne-Laure Puaux Prof Gary Richardson The Walter and Eliza Hall Institute of Cabrini Health Medical Research Dr Emma Poland Dr Dishan Herath Calvary Central Districts Hospital Western Health Assoc Prof Lisa Horvath Chris O’Brien Lifehouse CURRENT TUMOUR GROUP CHAIRPERSONS Dr Karen Briscoe Assoc Prof Hui Gan Coffs Harbour Health Campus Brain Cancer Dr Nikolajs Zeps Dr Belinda Yeo Epworth Healthcare Breast Cancer Dr Babak Tamjid Dr Margaret Lee Goulburn Valley Health Gastro-Intestinal Cancer Mr Jayden Rodgers Assoc Prof Sumitra Ananda Linear Clinical Research Gynaecological Cancer Dr Rohit Joshi Dr Michael Dickinson Lyell McEwin Hospital Haematology – Lymphoma/Myeloma Dr Angela Watt Dr Chun Fong Melbourne Health Haematology – Myeloid/AML Dr Eva Segelov Prof Danny Rischin Monash Health Head and Neck Cancer Ms Carolyn Stewart Dr Muhammad Alamgeer Murdoch Children’s Research Institute Lung Cancer Dr Matthias Ernst Dr George Au-Yeung Olivia Newton-John Cancer Research Institute Melanoma Dr Zee Wan Wong Assoc Prof Jayesh Desai Peninsula Health Phase I Trials Dr Vinod Ganju Dr Ben Tran Peninsula Oncology Centre Uro-Oncology Cancer

26 | ANNUAL REPORT 2019 26 | ANNUAL REPORT 2019 P: 61 3 8559 7244 General enquiries: [email protected] www.cancertrialsaustralia.com

28 | ANNUAL REPORT 2019