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leaders in early phase clinical trials – a vital step in a healthier future ” NUCLEUS NETWORK COMPANY REPORT 2008

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Page 1: NUCLEUS NETWORK COMPANY REPORTsvc110.wic022v.server-web.com/Upload/Content/File... · Nucleus Network is Baker IDI’s independent clinical research company. Baker IDI Heart and Diabetes

“ leaders in early phase clinical trials – a vital step in a healthier future ”

NUCLEUSNETWORKCOMPANYREPORT2008

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COMPANY REPORT 2008 _ 01

02 Chairman’s Report

04 Chief Executive Officer’s Report

06 Baker IDI & Nucleus Network

07 About Us

09 Why Australia?

12 Education

14 Our Senior Clinical Research Team

17 Financials

CONTENTSWE HAVECEMENTEDOUR PLACE ASAUSTRALIA’SLEADINGEARLY PHASECLINICALTRIALSORGANISATION

“ service driven quality focused global perspective ”

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COMPANY REPORT 2008 _ 02

CHAIRMAN’SREPORT

“ nucleus network continues to confirm its place as an industry leader with strict adherence to the highest standards of clinical research, conducted in accordance with international regulatory requirements and expectations ”

Professor Garry Jennings AM

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COMPANY REPORT 2008 _ 03

CHAIRMAN’SREPORT

The clinical trials performed at Nucleus Network involve either healthy volunteers or patients with specific medical conditions. Their involvement ensures our work can continue and we are grateful for the time and effort of our participants, all of whom are performing an important community service. Without their support, new medicines would not reach the people who need them.

These clinical trials performed at Nucleus Network – both at our Prahran facility and at our facility at Austin Health, are conducted with an extraordinary degree of skill, expertise, care and diligence. The company continues to confirm its place as an industry leader with strict adherence to the highest standards of clinical research, conducted in accordance with international regulatory requirements and expectations. We are committed to best practice industry-wide and have expanded our training for researchers and medical staff involved in clinical trials both here and overseas. Chief executive Andrew Giddy has built a team of industry-leading professionals in the organisation with a wide range of skills. As such, the staff is able to assist biotechnology companies in the development of new therapies and first-in-man studies. In addition, offering both education and consulting services means the company and its staff are world-leaders in this area.

Once again, we’d like to thank our industry partners for their assistance and input: especially The Alfred Hospital, Austin Health and our partners on the Alfred Medical Research Education Precinct (AMREP) campus. We are grateful too for the tremendous support we receive from small and large pharmaceutical and biotechnology companies here and overseas. Their confidence is apparent in their repeat business and it is this confidence that has enabled us to grow into the world-class organisation we are.

We are proud to present you with our latest company report for Nucleus Network, a wholly owned subsidiary of Baker IDI Heart and Diabetes Institute.

In the last year, and despite some of the difficulties encountered in the international financial environment, Nucleus Network has continued to exceed all expectations of growth and remains the nation’s leading early phase clinical trials facility.

As you know, early phase clinical trials are a vital step in the process of bringing new and safe medicines to the community. Every medicine that is sold over the counter or by prescription has been through the most rigorous and thorough clinical testing to establish it both effective and safe for use. It is this critical process that is the work of Nucleus Network and the company has earned its international reputation for quality and skill in this area with a highly trained staff and standards that are second-to-none.

‘‘ nucleus network continues to exceed all expectations of growth and remains the nation’s leading early phase clinical trials facility ”

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COMPANY REPORT 2008 _ 04

CHIEFEXECUTIVEOFFICER’SREPORT

“ we have always believed that australia has the opportunity to continue to make important advances in clinical trials ”

Dr Andrew Giddy

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COMPANY REPORT 2008 _ 05

CHIEF EXECUTIVE OFFICER’SREPORT

At a time when businesses are downsizing we have continued to grow. This is evident not just in our increased capacity for clinical trials - with the $2.5 million purpose-built 16-bed clinical research centre at Austin Health opened in February 2008 – but with the growth in our education and consulting arms. We are also enjoying repeat business from new sponsors in our early phase clinical research. We have done this by adhering to the belief that bringing together a critical mass of expert clinical researchers, medical professionals and key opinion leaders builds strong industry relationships and important research alliances.

Nucleus Network has also been a strong contributor to the development of the clinical research environment and clinical research skills on a national basis. The second Clinical Research Excellence Conference (CRX08) was co-hosted by Nucleus Network and the University of Melbourne in Brisbane in August. The CRX conference brought together some 300 clinical researchers from across Australia with a special focus on indigenous health. Nucleus Network also continued to deliver our subsidised Good Clinical Practice training courses Australia wide and have now trained over 1000 public hospital and research institute staff in GCP. Nucleus Network has also been a significant contributor, along with other Alfred Medical Research Education Precinct (AMREP) partners (Monash & Alfred) to the Victorian Medical Insurance Authority (VMIA) Research Governance project that aims to provide increased skills and resources to the numerous Research Governance Office’s in Victoria’s public hospitals.

We have always believed that Australia has the opportunity to continue to make important advances in clinical trials. First-in-man testing of new medications is critical if we are to keep pace with medical discovery, with our population and their needs in times of health and in disease.

It was our aim to further develop Victoria and Australia’s capabilities in clinical research and to contribute internationally to the safest and smartest clinical research environment possible. It continues to be exactly what we strive for and work towards.

It was our aim when we started out as a new early phase clinical trials business to provide an unparalleled service to the pharmaceutical and biotechnology industries in Australia and overseas. We believed that Australia was yet to seize enough of the global market share of clinical research services and as a small fledgling company we sought to bring the highest quality, skills and expertise to every stage of early clinical trials.

This unwavering commitment to quality, safety and service, and a dedication to improved health for future generations and for people now, has seen us grow into a competitive, vibrant company which has increased its staff threefold and now provides clinical research support to an impressive range of Australian and international businesses. Our contribution was recognised last year when we were winners in the 2008 Governor of Victoria Export Awards, in the categories of Emerging Exporter and The Victorian Export Award for Innovation Excellence. We were also finalists for the Australian Export Awards.

‘‘ nucleus network has been a strong contributor to the development of the clinical research environment and research skills on a national basis ”

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COMPANY REPORT 2008 _ 06

BAKER IDI

Metabolism and Obesity

Understanding the complex relationship between physical activity, weight regulation and the genetic and environmental underpinnings of metabolism to address the causes and complications of metabolic disorders and obesity.

Diabetic Complications

Diabetes is a chronic, insidious disease on the rise in the community. Among its many debilitating complications are heart and vascular disease, kidney and eye disease. Understanding who is most at risk of the complications of diabetes and discovering ways to mitigate the effects of the disease is this team’s focus.

Vascular and Hypertension

This team brings together studies on high blood pressure, kidney disease, the neurobiology of the relationship between depression and heart disease as well as research into the damage to arteries caused by atherosclerosis, and the damage caused by heart attack.

Cardiology and Therapeutics

Heart failure, and how better to treat atrial fibrillation are among the research areas for this team. Both are increasing the health burden of communities. The focus is on taking laboratory findings and translating them into better drugs, surgical and therapeutic devices for people suffering from heart disease.

Health Services

A one-stop shop of complete patient care, diagnosis and advice is available under Baker IDI’s diabetes and heart clinics. Being at the frontline of disease care and managements ensures that our researchers understand not just the biology, but also the human effects of disease.

Nucleus Network is Baker IDI’s independent clinical research company. Baker IDI Heart and Diabetes Institute is an international leader in research on obesity, diabetes and heart disease. Our work extends from the laboratory to wide-scale community studies.

Newly created in 2008 from the merger of the Baker Heart Research Institute and the International Diabetes Institute, Baker IDI comprises six broad themes of research, each of which supports groups of scientists who work in the community as well as researchers who work in a laboratory setting. Bringing together basic scientists with epidemiologists ensures that our research is directly informed by community needs.

Research themes include:

Populations Studies and Profiling

This team works at understanding the prevalence of disease and disease risk in the population and improving health of the community. The focus is on prevention, education as well as the development of better profiling tools.

Baker IDI Heart & Diabetes Institute, AMREP Precinct

‘‘ our work extends

from the laboratory to

wide-scale community

studies ”

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COMPANY REPORT 2008 _ 07

Nucleus Network is a not-for-profit clinical research and education company wholly owned by Baker IDI Heart and Diabetes Institute. Nucleus Network’s not-for-profit status provides unique collaborations with hospital based principal investigators, individual researchers, medical schools and access to dedicated research precinct facilities and capabilities. The organisation is a centre for excellence in clinical research and is Australia’s leading Phase 1 clinical research organisation.

Nucleus Network operates two early phase clinical trial units at the Centre for Clinical Studies - a 30-bed early phase clinical research unit on the AMREP site as well as a 16-bed facility run at the Austin Hospital. These facilities are co-located with major teaching hospitals, are custom-designed to comfortably conduct early phase clinical trials and are staffed by leading professionals in the clinical research field. It is in these units that new drugs and compounds are administered to healthy volunteers in a strictly controlled environment, attended to 24 hours a day by Nucleus Network’s specially trained medical support staff. Participants in trials are watched closely for any reactions and have blood samples, blood pressure and other vital signs taken and carefully recorded at regular intervals. The information collected monitors and protects the participants’ health and also provides crucial information about the therapy under trial. These participant profiles inform the pharmaceutical company’s understanding of the drug and are a crucial part of the development of the therapy.

Burnet Tower, AMREP Precinct

NUCLEUS NETWORK

‘‘ nucleus network’s not-for-profit status

provides unique collaborations with

hospital based principal investigators,

individual researchers, medical schools

and access to dedicated research

precinct facilities and capabilities ”

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COMPANY REPORT 2008 _ 08

NUCLEUS NETWORK

The clinical trials performed at Nucleus Network involve either healthy volunteers or, sometimes, patients with specific medical conditions. We rely heavily on community involvement in this process, and are grateful for the time and effort offered by our volunteers, without whom new medicines would not reach the people who need them most.

As well as the clinical research activities, Nucleus Network provides a broad range of expertise on clinical research and product development in the global pharmaceutical, biotechnology and medical device industries. The company’s three core business activities comprise:

- Conduct of early phase clinical research;

- Clinical trial consulting services

- Education and training in Good Clinical Practice (GCP);

Clinical Trials Consulting, is a consultancy group geared toward the local Australian biotech market, to help companies go from pre-clinical studies into the clinic for the first time. Nucleus Network may start working with companies a year before they are ready to move to the clinic – eg providing preclinical gap analysis and assistance with writing drug brochures, generating clinical development plans and assistance to seek out grant funding. Through its involvement in world-class clinical trials for international sponsors, Nucleus Network is able to bring skills and experience to support local Australian biotech companies who are developing new medicines.

Nucleus Network Education collaborates with Australian and international education groups to provide globally recognised career development options for clinical research personnel. Clinical Researchers can access in-class room training and on-line training for Good Clinical Practice and recognition for continuing education.

‘‘ we rely heavily on community involvement

and are grateful for the time and effort

offered by our volunteers, without whom

new medicines would not reach the people

who need them most ”

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COMPANY REPORT 2008 _ 09

WHY AUSTRALIA?

The CTN system only requires an institutional ethics committee (IEC) approval, following review by the IEC scientific committee of the investigator’s brochure and the study protocol. It is therefore possible to obtain Ethics Review Committee approval within 30 days and then lodge a notification (CTN) to the TGA, with acknowledgement received within 7-10 days. The introduction of the CTN system to Australia has seen strong growth in the number of trials conducted, with around 2800 CTNs lodged in 2007.

This combination of research community and government support for clinical research in Australia is typical of the vibrant local biotech and pharmaceutical industry. This environment has resulted in a highly skilled, experienced and committed workforce of clinical researchers and medical staff, able to conduct trials according to the highest international standards and also able to provide training to the industry. An efficient regulatory system, the CTN process and the dedicated work of assiduous ethics committees underpins the quality of work and makes Australia the ideal location for clinical trials in an internationally competitive field.

‘‘ an efficient regulatory system, the clinical

trial notification process and the

dedicated work of assiduous ethics

committees underpins the quality of

work and makes australia the ideal

location for clinical trials in an

internationally competitive field ”

Australia’s biotech and pharmaceutical sector is a fast-growing industry, and there has been a steady growth in clinical trials in this country since the 1990s. There is much to recommend Australia as a site for clinical research, as an increasing number of companies, large and small, and both local and international, have discovered. A recent survey conducted by The Economist Intelligence Unit ranked Australia first against many other nations as a site for clinical trials due to three main factors:

- Low average cost of clinical trials

- Large number of recognised trial sites

- High percentage of clinical trials completed on time

The most interesting aspect of this benchmarking process was that Australia ranked relatively low in terms of numbers of trials conducted per capita of population. This strongly suggests there is significant additional capacity to undertake clinical trials in Australia, and Nucleus Network’s new facility at Austin Health is testimony to that potential for growth.

In addition to those benefits associated with conducting clinical trials in Australia, the recognition by both researchers and government that bench research must be translated to clinical application with benefits to the community has resulted in a renewed focus on supporting clinical trials. In 1991 the Australian pharmaceutical regulator, the Therapeutic Goods Administration (TGA) introduced the Clinical Trial Notification (CTN) scheme. This scheme allows clinical trials of unapproved medicinal products to be conducted without the need for regulatory review by the TGA. This is a significant boon to companies seeking to quickly complete research and testing.

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COMPANY REPORT 2008 _ 010

INTERNATIONAL CUSTOMER REVENUE

International Customers _ 75% Australian Biotechs _ 10% Consulting _ 10% Education _ 5% Grants & Subsidies _ 0%

INTERNATIONAL CUSTOMER SPREAD

Large Pharmaceutical Companies _ 52%

Small to Medium Pharmaceutical Companies _ 48%

EXPORTING TO THE WORLD

WINNERS AT THE 2008 GOVERNOR OF VICTORIA EXPORT AWARDS

Victorian Export Award For Innovation Excellence

Emerging Exporter Award

‘‘ service driven

quality focused

global perspective ”

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COMPANY REPORT 2008 _ 011

‘‘ australia’s biotech and pharmaceutical sector is a fast-growing industry, and there has been a steady growth in clinical trials in this country since the 1990s ”

CLINICAL TRIALS IN AUSTRALIA Clinical Trial Notification Applications

99.8% of trial sites are approved under Clinical Trial Notification

NUCLEUS NETWORK’S DUAL LOCALITY

Alfred Medical Research Eductaion Precinct Burnet Tower, AMREP Precinct, 89 Commercial Road Melbourne, Victoria, Australia 3004

Austin Centre for Clinical Studies Site Harold Stokes Building, 145 Studley Road Heidelberg, Victoria, Australia 3084

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COMPANY REPORT 2008 _ 012

Robyn Lichter Director of EducationNigel Wilcock Education Administration AssistancePeta Hamill Course Administrator

Clinical trials play a pivotal role in bringing new medication to appropriate patient groups, within clinical trials, patient protection is the focus of Good Clinical Practice (GCP). In this dynamic medical environment where regulations and methods evolve and change, regular training is essential in order that we work to the highest standard.

The education arm of the Nucleus Network business is committed to training staff in the clinical trials industry to raise the awareness and standard of GCP.

Nucleus Network Education offers both GCP training and certification programs. On completion of study course, certificates of attendance are provided. Courses are offered online or face-to-face and are designed around the schedule of the participant. There are several benefits to obtaining and maintaining certification. Certification assists the public, healthcare professionals and the industry itself by identifying standards for professional practice and provides confidence that those testing our future medicines do so as trained and competent professionals.

Between 2003 and 2008, Nucleus Network Education trained 1198 industry professionals across Australia and in New Zealand. These numbers have grown exponentially in the last two years with a significant expansion of the number of external clients trained. The certification exam program has been undertaken by 115 candidates with 110 candidates yielding more than 95% pass rate. Out of the 11 separate international exam cycles conducted since commencement of the exam program, Australia has achieved a 100% pass rate 5 times – with a complete pass rate in 2008! Nucleus Network itself, has had 20 members of staff, including the CEO and senior management, successfully complete the ACRP exam. Our organization aims to lead the Industry by example and support all clinical research organizations in Australia and New Zealand who endeavour to make the commitment to GCP standards.

EDUCATION

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COMPANY REPORT 2008 _ 013

EDUCATION

In 2007, in an expansion of its education resources, Nucleus Network Education partnered with global online training company ClinfoSource, based in Danville, California. In 2008 these courses were launched with users signing up and purchasing over 200 individual modules.

The Clinfosource-Nucleus Network Education partnership continues to offer online training for clinical trials professionals in the Australia-New Zealand region. The program provides clinical trial investigators, coordinators, research associates and others a solid and practical understanding of clinical trials conduct and management, and of the regulations and ethics central to the drug development process. This collaboration offers courses customised for the Australia-New Zealand region in the web-based format allowing convenient access to GCP training. These online courses also represent a greater depth and breadth to the current in-class GCP course. The high standard, accessible, affordable and flexible clinical research training format is designed to suit the pressures of busy dedicated personnel working in the clinical research area.

This year a substantial Learning and Development program was launched internally for Nucleus Network’s employees. This system enables management of comprehensive training requirements for each individual of the organisation’s ever-growing staff.

The activity in 2008 branched out from not only offering training to Industry but engaging in the development of capacity training on both a state and federal level. Through the Victorian Managed Insurance Authority (VMIA), Nucleus Network Education has developed processes and tools to assist governance offices. Likewise with involvement on the National R&D Task Force for Quality, Nucleus Network has collaborated to raise the standards of national competency.

In this manner, this division of Nucleus Network continues to support the safety of subjects volunteering for our clinical trials.

NUCLEUS NETWORK EDUCATION ACTIVITY 2008

Name of Course No. Registrants Location

GCP Courses for Research Professionals 16 341 incl. VIC, NSW, QLD, WA, SA, New Zealand

GCP Aspects 4 55 incl. VIC, NSW, QLD, WA

GCP Investigators 4 38 incl. VIC, NSW, QLD, WA

ACRP Exam Review Courses 3 43 incl. VIC, Singapore

ACRP Certification Exam - 20 - (Investigator, Coodinator or CRA)

National Conference 1 273 Brisbane

No – the number of times this course was conducted, ie. 16 times in Australia & New Zealand for GCP. Thus 27 events were conducted in total (one per fortnight) and with the two cycles of exams, four sites (Victoria x 2, Queensland x 2 and New South Wales x 1).

SUMMARY OF EDUCATION ACTIVITY 2005-08

In-Class Programs ** Online Programs *

Year GCP INV A CER Tools Pkgs Conf Users Modules

2005 52 - 22 - - - - - -

2006 187 - 24 8 - - - - -

2007 318 26 20 8 56 22 434 - -

2008 341 38 55 43 - 13 273 24 216

Total 898 64 121 59 56 35 707 24 216

GCP GCP for Research ProfessionalsGCP INV GCP for Physicians & InvestigatorsGCP A Originally GCP Practical Applications, from 2008 combined some

of ‘Tools’ to form GCP Practical Aspects for Clinical Research SitesTools Tools for Clinical Research Efficiency (John Rowell)CER Certification Review CoursePkgs Certifications Review Packages Conf Conference

In 2007 Nucleus Network, in collaboration with the University of Melbourne, created the conference concept CRX – Clinical Research Excellence. This was designed to be a forum to bring the countries investigators together with commercial sponsors and providers. The conference was touted a huge success and moved to Brisbane in 2008.

* Nucleus Network Education partners with ClinfoSource to offer web-based Good Clinical Practice courses to the research industry.

** Nucleus Network Education partners with the Association for Clinical Research Professionals (ACRP) to offer in-class programs for Good Clinical Practice to the research industry.

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COMPANY REPORT 2008 _ 014

A/Professor Kazuko Masuo Associate Medical DirectorCarolyn Stewart Director of Operations Centre for Clinical Studies AMREP siteRobin Luber Director of QualityDr Jacqui Waterkeyn Director of Operations Austin Centre for Clinical Studies

OUR SENIOR CLINICALRESEARCH TEAM

Dr Andrew Giddy Chief Executive OfficerLisa Nelson General ManagerCraig Rogers Chief Commercial OfficerMr Brian Motz Chief Financial / Administrative OfficerA/Professor Peter Hodsman Medical DirectorNucleus NetworkProfessor Albert Frauman Medical DirectorAustin Centre for Clinical Studies

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COMPANY REPORT 2008 _ 015

Mr Brian Motz Chief Financial Officer Chief Administrative Officer

Brian joined Nucleus Network in 2005 and he is a key member of the senior management team. He is responsible for most administration functions across the organisation including Finance, Human Resources and Payroll. Brian is a qualified member of the Institute of Chartered Accountants in Australia and Canadian Institute of Chartered Accountants.

A/Professor Peter Hodsman Medical Director Nucleus Network

As medical director for Nucleus Network, Associate Professor Peter Hodsman holds legal and ethical responsibility for all first-in-man drug trials conducted by the company. He also holds dual specialist recognition in medicine and clinical pharmacology.

Professor Albert Frauman Medical Director Austin Centre for Clinical Studies

Professor Albert Frauman holds the Chair in Clinical Pharmacology and Therapeutics at the University of Melbourne, is Director of Clinical Pharmacology and Therapeutics / Hypertension Services at Austin Health and Co-Director of the Victorian Toxicology Service. Albert has joined as our Austin Centre for Clinical Studies site Medical Director.

A/Professor Kazuko Masuo Associate Medical Director Nucleus Network

Dr. Kazuko Masuo is an experienced medical doctor with 29 years experience in clinical medicine and medical research. A certificated cardiologist, nephrologist and endocrinologist, and a fellow and a mentor of the American Heart Association, Kazuko graduated from Osaka University Medical School and completed her PhD in Japan. Kazuko has been an Associate Professor of Medicine at Osaka University Graduate School of Medicine, Japan from 1998.

OUR SENIOR CLINICALRESEARCH TEAM

Dr Andrew Giddy Chief Executive Officer

Andy joined Nucleus Network in 2005 from The Boston Consulting Group, where he spent five years as a strategy consultant to top Australian companies.

Prior to joining BCG, Andy spent nine years in the pharmaceutical industry and was Head of Clinical Development Operations at F. Hoffman-LaRoche AG (Roche) in Switzerland.

Andy is a registered Veterinary Physician and Surgeon and has a postgraduate diploma in Bioethics. He has attended executive programmes at both Columbia and London Business Schools.

Lisa Nelson General Manager

Lisa joined the company as one of the founding management executives. In this role, she provides strategic and financial oversight of Nucleus Network’s clinical development services and works closely with all our Sponsors. Lisa is also key in developing collaborations and business partnerships nationally and internationally with not-for-profit and independently owned clinical research organisations, academia, research institutes and health-care research organisations, a key strategy for success from Nucleus Network’s inception.

Craig Rogers Chief Commercial Officer

Craig is responsible for the development and implementation of commercial opportunities for Nucleus Network. His role includes negotiation and contracting of new studies, establishment and maintenance of master service agreements with existing clients and participation in the identification and development of vertical and horizontal growth opportunities.

Craig also reviews legal agreements for clinical trials and participation in external industry development groups.

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COMPANY REPORT 2008 _ 016

OUR SENIOR CLINICALRESEARCH TEAM

Carolyn Stewart Director of Operations Centre for Clinical Studies AMREP Site

Carolyn is responsible for overseeing functional managers responsible for recruitment, nursing, laboratory, pharmacy and data management in support of clinical studies being conducted at the Centre for Clinical Studies. Her key responsibilities are planning and implementing processes and business activities in accordance with approved procedures, legal, scientific, ethical and regulatory requirements.

Carolyn has over 20 years experience in clinical research with more than 15 years in the biopharmaceutical industry in various clinical operation roles with increasing responsibility. Carolyn has a broad experience in drug development within Australia as well as the US, UK and Eastern Europe.

Dr Jacqui Waterkeyn Director of Clinical Operations Centre for Clinical Studies Austin Site

Jacqui is Involved in the day-to-day management of all aspects of the Austin Centre for Clinical Studies Clinical Trial Unit. Her role involves an intimate knowledge of all clinical studies conducted at Austin Centre for Clinical Studies and managing the staff at all levels.

Jacqui has a Bachelor of Science degree with honours (UNSW, Sydney) and a PhD in infectious diseases from the University of Melbourne School of Veterinary Science.

Robin Luber Director of Quality

Robin is a quality systems professional with 17 years experience in various quality related roles within the pharmaceutical / life science industry. He has been the Quality Manager at Nucleus Network since April 2006.

Robin heads up the Quality Assurance department that provides QA services to the organisation with the primary responsibility of managing the company quality system for the benefit of both internal and external customers.

‘‘ our highly skilled, experienced and committed workforce of clinical researchers and medical staff has grown to over 80 full and part time employees ”

CLINICAL RESEARCH & MEDICAL STAFF

Full Time _ 52% Part Time _ 3% Casual _ 45%

CLINICAL RESEARCH & MEDICAL STAFF Rate of growth of permanent & casual staff since 2004

CLINICAL RESEARCH & MEDICAL STAFF

Existing _ 77% New in 2007-08 _ 23%

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COMPANY REPORT 2008 _ 017

FINANCIALS

Income Statement for the year ended 31 December 2008 2008 2007

Revenue Rendering of services 13,732,331 12,645,662 Rental income - 500 Finance income 30,780 32,471 13,763,111 12,678,633

Cost of services (8,147,406) (8,095,471)Gross profit 5,615,705 4,583,162

Other income 99,221 104,433

Marketing expenses (114,221) (53,415) Occupancy expenses (620,135) (384,434) Administrative expenses (including donations) (4,033,742) (3,090,030) Depreciation expense (529,789) (216,349) Loss on disposal of property, plant & equipment - (4,440)Surplus before tax & finance costs 417,039 938,927

Finance costs (85,370) (11,305)Surplus before income tax 331,669 927,622 Income tax expense - -Surplus after tax 331,669 927,622

Cash Flow Statement as at 31 December 2008 2008 2007

Cash flows from operating activitiesReceipts from customers (incl of GST) 14,814,931 12,459,585Payments to suppliers and employees (incl of GST) (13,683,574) (11,976,469)Interest received 30,780 32,471Borrowing costs (85,370) (11,305)Receipt of government grants 49,221 70,000Net cash flows from (used in) operating activities 1,125,988 574,282

Cash flows from investing activitiesProceeds on sale of property, plant & equipment - 928 Purchase of property, plant & equipment (577,420) (2,144,311) Purchase of investments (52,081) -Net cash flows from (used in) investing activities (629,501) (2,143,383)

Cash flows from financing activitiesProceeds from borrowings 250,00 800,000 Proceeds from borrowings from parent entity (112,978) -Net cash flows from financing activities 137,022 800,000

Net increase (decrease) in cash and cash equivalents 633,509 (769,101)Cash and cash equivalents at beginning of period 371,524 1,140,625Cash and cash equivalents at end of period 1,005,033 371,524

Balance Sheet as at 31 December 2008 2008 2007

ASSETS Current assets Cash & cash equivalents 1,005,033 371,524 Trade & other receivables 3,432,002 3,396,215 Prepayments 133,274 27,630Total current assets 4,570,309 3,795,369

Non-current assets Property, plant & equipment 2,305,918 2,258,287Investments 52,081 -Total non-current assets 2,357,999 2,258,287TOTAL ASSETS 6,928,308 6,053,656

LIABILITIES Current liabilities Trade and other payables 2,323,483 2,079,351 Interest-bearing loans & borrowings 360,000 360,000 Non-interest-bearing loans & borrowings 175,000 287,978 Provisions 496,307 408,475 Unearned revenue 688,918 766,223Total current liabilities 4,043,708 3,902,027

Non-current liabilities Interest-bearing loans & borrowings 690,000 440,000 Non-interest-bearing loans & borrowings - - Lease liability 172,709 13,285Provisions 56,165 64,287Total non-current liabilities 918,874 517,572TOTAL LIABILITIES 4,962,582 4,419,599

NET ASSETS 1,965,726 1,634,057

EQUITY Equity attributable to equity holders - - Retained surplus 1,965,726 1,634,057TOTAL EQUITY 1,965,726 1,634,057

The summary financial information provided has been extracted from the audited general purpose financial statements of Nucleus Network Limited. The summary financial information does not include all the information and notes normally included in a statutory set of financial statements. A full set of audited general purpose financial statements can be obtained by contacting the Company directly on +613 9076 8900.

The statutory financial statements (from which the summary financial information has been extracted) have been prepared in accordance with Australian Accounting Standards, which include Australian equivalents to International Financial Reporting Standard (‘AIFRS’). The statutory financial statements were audited by Ernst & Young Australia and their unqualified audit opinion is shown above and is contained in the statutory financial statements.

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AUDITOR’S REPORTS

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Nucleus Network Burnet Tower, AMREP Precinct

Business Address 5th Floor, Burnet Tower, AMREP Precinct 89 Commercial Road Melbourne, Victoria, Australia 3004

T +61 3 9076 8900 F +61 3 9076 8911 F +61 3 9076 8940

Mailing Address PO Box 6083 St Kilda Road Central Melbourne, Victoria, Australia 8008

Nucleus Network Harold Stokes Building, Austin Site

Business Address Austin Centre for Clinical Studies Levels 8 and 9, Harold Stokes Building 145 Studley Road Heidelberg, Victoria, Australia 3084

T +61 3 9496 6700 F +61 3 9496 6724

Mailing Address PO Box 5555 Heidelberg, Victoria, Australia 3084

W www.nucleusnetwork.com.au

Nucleus Network Ltd ABN 39 102 450 706 trading as Centre for Clinical Studies, Clinical Trials Consulting and Nucleus Network Education.