USC Clinical Trials Centre Advisory Committee

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USC Clinical Trials Centre Advisory Committee

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The University of the Sunshine Coast (USC) Clinical Trials Centre Advisory Committee has been established to support development, strategic positioning, and to provide stakeholder consultation and feedback. The University of the Sunshine Coast Clinical Trials Centre is honoured to have the expert support and guidance from our distinguished USC Clinical Trials Centre Advisory Committee members.

Will Delaat AM

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Will Delaat AM has over 40 years’ experience in the global Pharmaceutical Industry, working as a senior executive in sales, marketing and business development roles in Europe and Australasia. He retired from the position of Managing Director of Merck, Sharp & Dohme (Australia/NZ) in 2008. He is currently Chairman of EnGeneIC Ltd, an unlisted Australian Biotech company specialising in cancer therapeutics, and non-executive Director of Pharmaxis Pty Ltd, an ASX listed pharmaceutical company. He is also Chairman of PreNotion Ltd, an IT start-up company in health informatics.

Will served as Independent Chairman of Medicines Australia, the peak body representing the innovative pharmaceuticals industry in Australia, from 2008-11, and Chairman of the Pharmaceuticals Industry Council.

He has been appointed to various Government councils and advisory boards, as well as sitting on not-for-profit boards. Will holds a Batchelor of Science (Hons.), Physiology & Chemistry, from the University of London, and is a graduate of the Australian Institute of Company Directors.

He was awarded the Order of Australia (AM) in 2012 for services to the Pharmaceutical Industry, to the development of health policy and reform, and to the community.

Miriam Dwyer

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Miriam Dwyer is a highly accomplished senior executive board director with exposure to a range of complementary fields within the primary health sector and a demonstrated focus on clinical research and efficacy trials. She has performed the essential role of Chief Executive Officer within the Gallipoli Medical Research Foundation (a Not for Profit research facility based at Greenslopes Private Hospital) since 2011. The position enables Miriam to combine her passion for the operational practicalities of medical research with the accomplished discipline of sound corporate governance to ensure the Foundation’s enduring commitment to its publics.

Miriam’s steadfast loyalty to improving the lives of current and former serving members of the Australian Defence Force through advancements in specialised physical rehabilitation and psychological intervention has been further reinforced by her directorial contribution to Mates4Mates commencing in 2013.

A native of the Emerald Isle, Miriam’s tertiary qualifications include a Bachelor of Science degree majoring in Microbiology and Biochemistry attained in her homeland. Her post-graduate studies illustrate an enthusiastic quest for knowledge and dedication to a range of topics including leadership, corporate governance, compliance, clinical research, strategy and planning and risk mitigation.

Miriam is a member of the Australian Institute of Company Directors. She is in high demand both nationally and internationally as a public speaker providing a trusted expert opinion across the primary healthcare spectrum with a deliberate leaning towards clinical research and medical advancements in the treatment of chronic disease.

Kevin Hegarty

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Kevin Hegarty has served in senior positions in Queensland Health since joining the organisation in 1995. He was first appointed to a Chief Executive level position in 2001 at the then Rockhampton Health Service District. Kevin then commenced as the Chief Executive of the Sunshine Coast in December 2003. Since this time he has been the Chief Executive in a number of iterations of health district structures.

As Chief Executive, Kevin has been directly involved in the planning and associated activity for the development of the Sunshine Coast Public University Hospital ($1.8 billion new tertiary hospital to be completed by the end of 2016), since first announced in 2005. This will be the first hospital under a Public Private Partnership procurement process in Queensland.

Kevin is committed to a devolved management structure with clinician engagement as a feature. He believes such structures facilitate high quality care delivered in an efficient and sustainable manner. He is also committed to working with other key organisations within the health sector and has a particular interest in research and education.

Kevin is an Associate Fellow of the Australian College of Health Service Management and a Member of the Australian Institute of Company Directors.

Dr Mark Holmes

Dr Mark Holmes is a Senior Lecturer, Nutritional Biochemistry and Discipline Leader, Biomedical Science with the University of the Sunshine Coast. Mark was educated in Perth and completed a PhD in metabolic biochemistry at the University of Western Australia in 1991. After completing his PhD, Mark took up a lecturing position at Central Queensland University (CQU), Rockhampton, where he taught basic science, clinical biochemistry and sports biochemistry to nursing and human movement students for seven years.

In 1998, Mark moved to the Sunshine Coast and took up a lecturing position in nutritional biochemistry at USC. He was promoted to Senior Lecturer in 1999. Mark's research interests now lie principally in the area of molecular epidemiology, nutrition and lipid metabolism. His research group is currently developing methods for the determination of selected biomarkers of dietary lipid intake and cardiovascular disease (CVD) risk in venous and capillary blood. These blood biomarkers will be used in research projects designed to assess the influence of dietary lipid intake on the premature development of CVD in the human population.

Mitch Kirkman

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Mitch Kirkman is the Development Quality Assurance Manager at Novartis Pharmaceuticals Australia Pty Limited. Mitch has more than 20 years’ experience in the management of global drug development with both large pharmaceutical companies and as a local managing director of a global contract research organisation (CRO). Mitch has been active in engaging with government, health jurisdictions, researchers and consumers on initiatives to keep Australia globally competitive in regards clinical trials. Originally qualifying as a hospital pharmacist, Mitch joined the pharmaceutical industry in 1988 and has worked as a CRA, Clinical Research Manager, Training Manager, Quality Manager and CRO Managing Director. He has also managed the set-up of data management, statistical services and health economic services within a CRO. He joined Novartis in 2001 and currently acts as a local expert for Novartis’ global clinical development quality assurance group. Although primarily focused on global clinical trials conduct he has more recently had a key role in a number of large and complex local Australian Novartis studies that have achieved publication in key global journals. In 2004, he was founding Chair of the Pharmaceuticals Industry Council (PIC) R&D Taskforce which championed a number of initiatives to develop streamlined ethical approval, develop standardised clinical trial agreements and streamline adverse event reporting to investigators and ethics committees. He continues as a member of the PIC R&D Taskforce and is currently a member of a number of government reference groups including the 2015 IHPA clinical trial cost reference group and the Government’s trial portal steering committee. In 2008, he was awarded the Pat Clear Award (Medicine Australia’s top award for contribution to the pharmaceutical industry) for spearheading the pharmaceutical industry’s efforts to achieve nationally standardised regulations of clinical research in Australia. During 2008/2009 he was appointed a clinical trial expert member of the Pharmaceutical Industry Strategy Group (PISG) by then Industry Minister Carr and during 2009/2010, Mitch was the industry member of the Clinical Trial Action Group (CTAG) formed by Minister’s Carr and Roxon.

Dr Carlo Maccarrone

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Carlo Maccarrone has 25 years’ experience in the pharmaceutical industry and is currently the Associate Director, Clinical Research at GSK Australia. In this role he has management responsibility for a team of clinical research professionals that conduct clinical trials from Phases I-IV in Australia and New Zealand. He has experience working across a broad range of therapeutic areas which span GSK’s medicines and R&D pipeline.

Carlo trained as a pharmacist before completing a Master of Pharmacy degree in cardiovascular pharmacology at the Victorian College of Pharmacy (Monash University), and a PhD at Melbourne University in the Department of Clinical Pharmacology, Austin Hospital. He began his career in academic research before joining the pharmaceutical industry where he has held a variety of positions in Clinical Research, Pharmaceutical Development and Academic Research Alliances.

Carlo has been active contributor to a number of government and industry committees that aim to improve the clinical research environment in Australia. His goal is to ensure that Australia remains globally competitive in R&D which benefits patients, researchers, healthcare and the Australian pharmaceutical industry.

Carlo is the Co-Chair of the Pharmaceutical Industry R&D Taskforce, Fellow of ARCS Australia, and a Director of the ARCS Board.

Dr Scott Snyder (Chairperson)

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Dr Scott Snyder is currently the Pro Vice-Chancellor (Corporate Services) at the University of the Sunshine Coast. In this role, he has responsibility for most University administrative functions and infrastructure projects. Prior to moving to the University in July 2014, Scott held a number of senior roles at Charles Darwin University over a ten year period. This included overseeing establishment and operation of the University’s administration as Executive Director and Chief Operating Officer, and having responsibility for the University’s response to the challenges of a deregulated sector as Pro Vice-Chancellor (Strategy and Planning). Scott has also had an academic career as a researcher, academic, head of school, and executive dean, working in Australia and Japan.

Oliver Steele

Hugo Stephenson

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Hugo Stephenson is a medical doctor, biotech services entrepreneur and founder of businesses that include MediGuard, the largest online medication monitoring service serving almost 3M patients, Health Research Solutions, an Australian CRO focused on late phase research (acquired by Quintiles in 2002) and MedSeed, a 1990s pioneer of hospital and GP decision support software in the Asia/Pacific region. Hugo is currently chairman of DrugDev, a global provider of technologies that help doctors, patients and researchers do more clinical trials together.

Hugo served as Senior Vice President at Quintiles from 2002 to 2011, establishing Quintiles’ global late phase operations, in-house CRA capability through global project coordination centers, and distributed drug safety operation across Asia, Europe and the United States. Hugo is passionate about organizations that think out of the box to improve life, and has a wide range of interests that include early biotech, consumer health, high power rocketry, metal sculpture and riding motorcycles. Hugo was named in the PharmaVoice 100 in 2010.

Dr Mason Stevenson

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Dr Mason Stevenson has 28 years’ experience as a general practitioner, the majority on the Sunshine Coast. He has held senior roles within medical associations since 1996 and owned and managed medical practices since 1990, and is currently a member of the Sunshine Coast Hospital and Health Board.

Mason began his medical career in Melbourne after completing a Bachelor of Medicine and Bachelor of Surgery at Monash University in 1983. He completed his internship and Junior Resident Medical Officer training at the Queen Victoria Medical Centre in 1985. Once completed, Mason worked as a doctor for the Melbourne Doctors After Hours Cooperative for a number of years before joining the Glen Waverley Medical Centre in Melbourne as a Principal General Practitioner (GP) Assistant in 1988.

In 1990, Mason moved to the Sunshine Coast, Queensland to open and work in his own solo practice as GP, Suncoast Medical Centre, Peregian Beach. Mason received his Vocational Registration – General Practitioner in 1996. This same year he became an owner in a group GP practice with three other doctors, Suncoast Medical Centre, Coolum Beach, and Treasurer of the Sunshine Coast Division of General Practice. His role as Treasurer lasted for two years, and he is still a member of Focus Health (formerly the Sunshine Coast Division of General Practice).

Between 1996 – 2004 while in ownership of the Suncoast Medical Centre, Mason also held the positions of:

  1. Sunshine Coast Local Medical Association (SCLMA) – Treasurer (1998 – 2000) and President (2000 – 2002)

  2. Australian Medical Association of Queensland – Treasurer, (2002 – 2004)

  3. AMA Federal Councillor (Queensland rep) including Finance Committee and Council of General Practice (2004 – 2007).

From 2004 until 2010, Mason worked as a GP subcontractor for the Suncoast Medical Centre Coolum Beach. He also held executive positions within medical associations including:

  1. Sunshine Coast Local Medical Association – President (2007 – 2008, 2010 – 2011)

  2. AMA Qld – Treasurer (2006 – 2008)

  3. AMA Qld – President elect, President and past President (2009 – 2011).

Since 2010, Mason has worked as a GP subcontractor for Noosaville Seven Day Medical Centre, while continuing in executive positions within medical associations including:

  1. Executive Member, AMA Federal Council of General Practice (2007 – 2012)

  2. Vice-President (2011–2012) and Executive Member (2012 – present), Sunshine Coast Local Medical Association

  3. GP Representative Councillor for AMA Qld Branch (2001 – present).

Elizabeth Wilson

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Elizabeth Wilson worked initially in hospital and retail pharmacy roles before moving to the pharmaceutical industry and worked in various clinical development and management roles with Agenix Ltd, Progen Pharmaceuticals Industries Ltd and Quintiles. Elizabeth is currently the Australia and New Zealand Sites Relationship Manager for Quintiles. Quintiles Transnational, is a Fortune 500 company and the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 32,000 employees conducting business in approximately 100 countries.

Elizabeth completed her degree in Pharmacy (University of Queensland) and has postgraduate qualifications in clinical pharmacy. She has spent many years focusing on clinical hospital pharmacy and drug development particularly in the area of Clinical Cancer Services for both paediatric and adult patients. Her main focus in her current role is to work in clinical trials with sponsors and sites to help bring new pharmaceutical product entities to patients within Australia and New Zealand.

Dr Karen Woolley

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Karen Woolley is currently the Division Head, Envision Pharma Group and a member of the Sunshine Coast Hospital and Health Board. Karen is highly respected around the world as a leader and innovator in the field of medical writing. These qualities and her mandate for ethical medical writing practices led to her appointment as a Director of the International Society for Medical Publication Professionals and Chair of its first Asia-Pacific Advisory Committee. A popular and sought-after speaker, her international standing as a medical writer was acknowledged in 2009 when she was the first non-American keynote conference speaker in the 70-year history of the American Medical Writers Association. Karen has extensive experience writing a broad range of regulatory and educational documents and she is a Certified Medical Publication Professional. She takes great satisfaction in putting ‘pen to paper’, and embodies and inspires ProScribe’s commitment to excellence in medical communication. Karen has spent the last 25 years immersed in medical writing and clinical research within academia and the pharmaceutical industry. An adjunct professor at the University of Queensland and at the University of the Sunshine Coast, she lectures in medical writing and drug development. Karen’s business ethics and acumen have been recognised by winning one of Australia’s most prestigious business awards (Telstra Business Women of the Year Award; Queensland, Business Owner). Karen is one of the few women in Australia to have served as a Director on the boards of multi-million dollar organisations in the not-for-profit and for-profit sectors.

Karen completed her BHMS (Ed) Hons at the University of Queensland in Australia and her PhD (Medical Science) at McMaster University in Canada. She is a Life Member of ARCS Australia, having served as President and Chair of the Board, and is also an Honorary Fellow of the American Medical Writers Association. Karen is also active within the Drug Information Association, serving on the on the Core Committee of the Medical Writing Special Interest Area Community and being the first person to lead medical writing workshops for the China affiliate of the Drug Information Association.

Lucas Litewka

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Lucas Litewka joined USC in January 2015 as the inaugural Director, USC Clinical Trials Centre. Lucas is a Director and Board Member of ARCS Australia Ltd, a professional development association for people working in the development of therapeutic goods. Lucas was previously the Clinical Trials Business Development Manager at St Vincent’s Hospital Melbourne within the research directorate where he provided centralised expertise to over a dozen decentralised clinical trial units within the hospital. As a Senior Medical Scientist, Lucas worked on a broad portfolio of clinical neurological research.

Julianne Bernhagen (Executive Officer)

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Julianne Bernhagen is a Project Manager within the USC Executive Projects Unit and is responsible for managing specific executive projects; coordinating the unit’s project management systems and processes; and contributing to nominated executive projects.

The projects, which may be at planning and development, funding submission or implementation stage, deliver a range of strategies and continuous business improvements for the sustainability and development of the University and/or the effective and efficient operation of the Executive Projects Unit.

Julianne previously worked as Consultant and Proprietor of JB-HR Consulting Pty Ltd providing human resource management, employee relations, organisational development, and change management services to higher education, local government, government owned corporations, and not for profit organisations.

Throughout the past 20 years, she has held Human Resources and leadership roles with Maroochy Shire Council, University of the Sunshine Coast, University of Southern Queensland, and Queensland University of Technology.

Julianne attended primary and secondary school on the Sunshine Coast, and initially joined the University as part of the planning team in 1995.

Julianne was USC’s inaugural Human Resources Manager and elected USC general staff member on the University Council.

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