nucleus network. australia s clinical research centre. company report 2006

Transcription

1 nucleus network. australia s clinical research centre. company report 2006

2 company report nucleus network has now fulfilled its objective of providing a clinical trials platform for victoria with the unit at the alfred hospital working at full capacity and plans for an additional facility at austin health now under way. nucleus network: australia s clinical research centre chairman s report Nucleus Network has now fulfilled its objective of providing a clinical trials platform for Victoria with the unit at The Alfred Hospital working at full capacity and plans for an additional facility at Austin Health now under way. Early phase clinical trials, such as those conducted by Nucleus Network, require an extraordinary degree of skill, expertise, care and diligence. Nucleus Network is an industry leader, following strict adherence to the highest standards of clinical research, conducted in accordance with international regulatory requirements and expectations. The company is also committed to best practice clinical research and regularly provides training for researchers and medical staff around the country who are involved in trials. This commitment to excellence and safety has been the key to the remarkable success of this company since its inception. Under the leadership of chief executive officer Andrew Giddy, Nucleus Network has collected a staff with a wide variety of skills, able to assist biotechnology companies in the development of new therapies and conduct first-in-man studies. None of this could occur; however, without the tremendous support we have received from our partners, especially The Alfred Hospital, which provides the clinical milieu to which activities of this kind are best suited. Similarly, the cooperation of Monash University, another partner, has been instrumental to our success. But most important of all is the tremendous support we have received from small and large pharmaceutical companies, both here and overseas. With their confidence, Nucleus Network has evolved into the truly world-class organisation it is today, one of which all of us can feel proud. Clinical trials is the fastest-growing area in biopharmaceutical development and Australia is fortunate in being able to become a leader in this field. A novel regulatory system, the CTN process and the dedicated work of assiduous ethics committees has underpinned the quality of our work and helped Nucleus Network become an internationally competitive early phase clinical trials facility. Professor Garry Jennings AM

3 company report ceo s report In a very successful year for the company, 2006 saw Nucleus Network achieve increased financial stability through strong growth in commercial operations. Importantly, Nucleus has also decreased its overall risk level in a number of key ways: rigorous standards and unparalleled quality of service to clients has resulted in repeat work from six of the top 10 global pharmaceutical companies. to accommodate this expansion, our employee headcount doubled in 2006 to over 50 permanent staff. nucleus network: australia s clinical research centre A greater depth of staff (a 50 per cent increase on 2005) has enabled the core business to support specialised areas such as a technical laboratory; volunteer recruitment, screening and medical support; The development of a new Quality Management System has boosted quality standards through the introduction of internal audits and vendor assessment programs; The implementation of a risk management system and risk register has allowed the identification of all areas of risk and the application of best practice quality standard procedures at the earliest stage in the cycle of trials, and A greater spread of customers across all operations means that no one client represents more than 17 per cent of revenue. These rigorous standards and unparalleled quality of service to clients has resulted in repeat work from six of the top 10 global pharmaceutical companies. To accommodate this expansion, our employee headcount doubled in 2006 to over 50 permanent staff. Eighty per cent of this growth was funded from business and contracts from major off-shore customers. The growth in our overseas client base is significant as the local biotechnology sector in Australia is not sufficiently large enough to exclusively support a Phase I unit such as Nucleus. Importantly, however, this local industry continues to benefit from the experience and infrastructure Nucleus Network is developing through our work with big, international pharmaceutical and biotechnology companies. This company growth makes Nucleus, one of only four specialist Phase I research units in Australia, a productive and profitable partner on the Alfred Medical Research Education Precinct (AMREP). To date, our core business has brought over $1.5 million in contracts to other AMREP site partners. With the attention we have shown to the most important areas of the company our safety record and procedures are exceptional, as witnessed by strong repeat business we expect this healthy growth to continue and for benefits to be felt by the whole research and education precinct. Dr. Andrew Giddy

4 04 company report who and what we are why australia? Phase I drug trials, where a new drug therapy is tested in a healthy volunteer, are an integral part of the pharmaceutical industry, and the only way that new therapies and treatments can be introduced into the health system. Nucleus Network, located in the Burnet Tower on the AMREP site is a centre for excellence in clinical research and one of Australia s leading Phase 1 clinical research facilities. This not-for-profit business, a wholly-owned subsidiary of another AMREP partner, the Baker Heart Research Institute, operates a 24-bed early phase clinical research unit, with significant expansion planned in It is here 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. Volunteers 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 gathered monitors and protects the volunteer s health and also provides crucial information about the therapy being trialled. These volunteer profiles inform the pharmaceutical company s understanding of the drug and are a vital part of its development. In addition to its clinical research activities, Nucleus Network provides a broad range of expertise on clinical research and product development on the global pharmaceutical, biotechnology and medical device industries. Its three core business areas are: Conduct of Phase I-IV studies, with particular focus on early phase studies Education and training on Good Clinical Practice (GCP) Clinical trial consulting services nucleus network divisional highlights Centre for Clinical Studies CCS conducted 28 studies in ethics submissions were sent to the Alfred Research Ethics Committee in 2006, with 31 approved. Four studies did not proceed and nine approvals are pending International clients generated export revenues of more than $6 million. Successful conduct of six first-in-man studies Clinical Trials Consulting Consulted to over 14 Australian and NZ biotechnology companies Seven of these consulting projects have led to trials planned or conducted in the CCS unit Nucleus Network Education Delivered 257 training days 26 new Nucleus staff trained in Good Clinical Practice (GCP) Nucleus Network is an industry leader, following strict adherence to the highest standards of clinical research, conducted in accordance with international regulatory requirements and expectations. The company is also committed to best practice clinical research and regularly provides training for researchers and medical staff around the country who are involved in trials. In 2006, Nucleus Network subsidised GCP training for 150 students in Victoria. Australia is an excellent location for conducting clinical research and has a vibrant biotech and pharmaceutical sector. Australian biotech, medical device and pharmaceutical companies seek synergies with international partners and embrace collaboration with academia and industry. The Australian health care system has a mix of public and private sector providers for delivering health services. The quality of health provided is high in both sectors and is supported by a federal Medicare system. The system aims to give universal access to health care while allowing choice for individuals through a substantial private sector involvement in delivery and financing. Major hospitals in both private and public sectors exhibit a strong commitment to medical research and many are experienced clinical trial sites which provide sponsors access to GCP trained study/site personnel. A focus on medical research has produced an environment that is strongly supportive of clinical research with support seen at the public, institutional and government levels. Stemming from generations of researchers and an outstanding reputation for clinical research, Australia is becoming a popular destination for conducting clinical trials. The recognition by researchers and government that bench research must be translated to clinical application 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 allowed clinical trials of unapproved medicinal products to be conducted without the need for regulatory review by the TGA. 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 resulted in strong growth in the number of trials undertaken in Australia, with around 2,500 CTNs lodged in Many large pharmaceutical companies discovered Australia in the 1990s and this led to a steady growth in clinical trial numbers. The development of the biotech industry in Australia paralleled this growth in off-shore studies and has resulted in a strong development of the early stage clinical trials market. With the implementation of the European Union directive on clinical trials, the phase I sector has become the fastest growing area of trial activity. australia was ranked first 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 the bench marking was that Australia was ranked relatively low in terms of numbers of trials conducted per capita of population. This strongly suggests that there is significant additional capacity to undertake clinical trials in Australia. Source: The Economist Intelligence Unit. *The higher the individual country s score for an individual indicator, the better the ranking.

5 06 company report recent studies - biologicals and peptides (abbreviated list) description A randomised, double-blind, placebocontrolled, ascending dose study to evaluate the safety, pharmacokinetics and efficacy of a new biological after multiple dose administration in subjects with moderate to severe psoriasis. A phase I, randomised double-blind, placebo-controlled, single dose, dose escalation study of a new monoclonal antibody in healthy volunteers. A phase I, single-center, randomised, single-blind, placebo-controlled, single-dose, dose-escalation study to evaluate the tolerability, safety, and pharmacokinetics of an intravenous infusion of a novel anti-inflammatory administered to healthy adult male volunteers. Single ascending dose study in healthy volunteers followed by a multiple dose study in mild to moderate asthmatics. Single ascending dose in healthy volunteers followed by a multiple dose study in Type 2 diabetics. Single ascending dose study in healthy volunteers with a new biological. no. of subjects subjects 20 Psoriasis Patients with >10% BSA & Naive Males 24 Mild to Moderate Asthmatics 40 Volunteers 16 Type 2 and Mild to Moderate Asthmatics and Type 2 63 therapeutic area route of administration compound type Dermatology S.C. Injection New Rheumatology S.C. Injection New Respiratory Infusion New Asthma IV New Diabetes Oral New Peptide Rheumatoid Arthritis regulatory intention TGA / nucleus network activities Protocol Preparation, IB preparation, IV TGA / a dedicated clinical trial facility for world-class clinical research. recent studies - chemical entities (abbreviated list) A phase I, single centre, double-blind, placebo-controlled, escalation single oral dose safety and tolerability trial with a new chemical entity for RSV. 72 Females Virology Oral New / TGA A bioequivalence trial of oral and intravenously administered chemotherapy agent in oncology patients. A pharmacokinetic and bioavailability study of a new treatment for cystic fibrosis using normal subjects. 6 Patients with Primary CNS Malignancies. 16 Females Oncology Infusion and Oral Approved Respiratory Inhaled New Use of an Existing / TGA / TGA Located within a tertiary teaching hospital within a medical precinct. There are five research institutes on site and between 2000 and 3000 medical professionals and researchers on this precinct. 5th Floor, Burnet Tower, AMREP Precinct 89 Commercial Road Melbourne, Victoria, Australia 3004 A phase I, single-centre, placebo controlled, dose-escalating study of the safety and pharmacokinetics of new peptide drug in healthy volunteers and exercise/diet controlled type 2 diabetics Type 2 Exercise/ Diet Controlled Type 2 Diabetes Oral- Suspension New TGA Protocol Preparation IEC Submission A double-blind, randomised, placebocontrolled, single and multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of a new migraine drug in healthy male japanese subjects 16 Japanese 8 Caucasian Male Japanese and Weight and Aged Matched Caucasians Neurology Oral New Japanese Ministry of Health Single ascending dose study in healthy male volunteers with a new topical anaesthetic agent. 35 Pain (Neuralgia, neuropathic pain) Topical New TGA/

6 08 balance sheet as at 31 December ASSETS Current assets Cash & cash equivalents 1,140, ,040 Trade & other receivables 1,532, ,099 Prepayments 21,931 - Total current assets 2,694,882 1,021,139 Non-current assets Property, plant & equipment 335, ,738 Total non-current assets 335, ,738 TOTAL ASSETS 3,030,575 1,296,877 LIABILITIES Current liabilities Trade and other payables 1,477, ,896 Interest-bearing loans & borrowings - - Non-interest-bearing loans & borrowings 287,978 - Provisions 238, ,371 Unearned revenue 292, ,000 Total current liabilities 2,297,153 1,198,267 Non-current liabilities Non-interest-bearing loans & borrowings - 226,463 Provisions 26,987 9,191 Total non-current liabilities 26, ,654 TOTAL LIABILITIES 2,324,140 1,433,921 NET ASSETS 706,435 (137,044) EQUITY Equity attributable to equity holders - - Retained surplus (accumulated deficit) 706,435 (137,044) TOTAL EQUITY 706,435 (137,044) income statement for the year ended 31 December Jan Jan Dec Dec months 18 months Revenue Rendering of services 8,709,786 2,589,655 Rental income 23,000 14,080 Finance income 15,896 12,298 8,748,682 2,616,033 Cost of services (5,617,496) (1,360,489) Gross profit 3,131,186 1,255,544 Other income 147, ,733 Marketing expenses (56,218) (179,119) Occupancy expenses (340,120) (243,603) Administrative expenses (2,037,455) (2,204,182) Surplus/(deficit) before tax & finance costs 844,464 (747,627) Finance costs (985) (114) Surplus/(deficit) before income tax 843,479 (747,741) Income tax expense - - Surplus/(deficit) after tax 843,479 (747,741) cash flow statement as at 31 December 2006 Cash flows from operating activities Receipts from customers (incl of GST) 9,239,976 2,049,272 Payments to suppliers and employees (incl of GST) (8,220,108) (3,510,114) Interest received 15,896 12,297 Borrowing costs (985) (114) Receipt of government grants 75,046 1,438,482 Disbursement of government grants to Members - (952,600) Net cash flows from (used in) operating activities 1,109,825 (962,777) Cash flows from investing activities Purchase of property, plant & equipment (141,755) (23,725) Acquisition of business from parent entity - (1) Net cash flows from (used in) investing activities (141,755) (23,726) Cash flows from financing activities Proceeds from borrowings from parent entity 61, ,463 Net cash flows from financing activities 61, ,463 Net increase (decrease) in cash and cash equivalents 1,029,585 (760,040) Cash and cash equivalents at beginning of period 111, ,080 Cash and cash equivalents at end of period 1,140, ,040 this not-for-profit, wholly-owned subsidiary of the baker heart research institute, operates a 24-bed early phase clinical research unit, with significant expansion planned in nucleus network: australia s clinical research centre

7 5th Floor, Burnet Tower, AMREP Precinct 89 Commercial Road Melbourne, Victoria, Australia 3004 Mailing Address PO Box 6083 St Kilda Road Central Melbourne. Victoria, Australia 8008 Contact Numbers Headquarters (Melbourne) Fax Fax Inquire about volunteering for a trial Phone contactus@nucleusnetwork.com.au