2018 Faculty

Karen Aitken
Associate Director of Start-Up & Regulatory
Syneos Health, Australia

Karen holds a Bachelor of Pharmacy and has held roles in clinical pharmacy and the pharmaceutical industry over 27 years. Currently, Karen is Associate Director of Site Start-Up and Regulatory at Syneos Health Australia and oversees the site activation stage of clinical trials across Australia and New Zealand. Karen advocates streamlining start-up processes and ensuring the conduct of trials in Australia and New Zealand is attractive to global sponsors.


Eleanor Allan
Quality Assurance & Training Consultant
Caledonian Clinical Training, Australia

Following graduation from the University of Aberdeen with an honours degree in Microbiology, Eleanor commenced work in the pharmaceutical industry and has worked in both pre-clinical drug development and clinical research roles since 1986. For the past 21 years she has specialised in clinical research training and quality assurance auditing. In October of 2000 she set up her own consultancy business, Caledonian Clinical Training, focussing on process improvement and quality management. She has trained and audited diverse groups including Sponsors, CROs, investigators, study coordinators, academic research groups and ethics committees both in Asia and Australia.


Helen Aunedi
Country Head, Clinical Operations
Roche, Australia

Helen Aunedi has over 25 years of experience working in the pharmaceutical/healthcare industry in the Asia Pacific region, with broad leadership experience in regional and local clinical operations, development, compliance, pharmacovigilance and training. She is currently the country head of country clinical operations for Roche Pharmaceuticals Australia, providing leadership and strategic direction and oversight for all clinical trials. Helen holds a Masters of Medical Science and Drug Development from The University of NSW, Masters of Arts in Psychology from The University of Sydney and is a Six Sigma Black Belt.


Dominic Bailey
CEO
Genesis Research Services, Australia

Dom has studied Nursing, Occupational Health and Safety and Clinical Trials Research at University and is a highly experienced healthcare professional having worked extensively in both public hospitals and private companies. Dom has conducted clinical research workshops, webinars and presentations locally and internationally on Quality Management, Social Media in Clinical Trials, Medical Device Studies, and Site Development. Over 5 years he has led the development of Genesis Research Services from a small clinical trials practice into a multi-service company that manages multiple specialist investigators, international modern recruitment services, a research network, a registry of over ten thousand trial participants and obtained ongoing ISO9001 Quality Management Accreditation for all aspects of the business. With a focus on business development, innovation and sustainability, Dom’s professional goal is to provide simple and valuable quality management for clinical research success.


Amy Behrakis
Clinical Team Leader, Clinical Development
Syneos Health, Australia

Amy Behrakis is currently a Clinical Team Leader in the Oncology and Haematology Business Unit of Syneos Health. She has over 17 years of experience in oncology clinical trials working in both global pharmaceutical companies and CROs. Her current role includes working within the Site ID team to identify suitable sites for new Oncology and Haematology studies in Australia and New Zealand. Amy is also the Catalyst Site Relationship Manager of the Catalyst Oncology Site Network in Australia and works within the Catalyst program to further strengthen site relationships and ensures continual process improvement and collaborative working approaches are fostered and developed to maximize efficiencies throughout the project life cycle. Amy holds a Bachelor of Science (Hons) in Pharmacology and has a keen interest in identifying and working with new sites particularly in the early phase oncology trial setting.


Carrie Bloomfield
Associate Director & Head of Clinical Research
GlaxoSmithKline, Australia

Carrie joined GSK Australia in February 2016 and has over 20 years’ experience in the clinical trials environment in both Clinical Research Organisation and Pharmaceutical companies. Prior to GSK, Carrie held various roles at IQVia (formerly, Quintiles) over 11 years with her last role being Head of Clinical Project Management, Australia and New Zealand. Throughout her career Carrie has held roles in Clinical Research, Clinical QA, Central Laboratory management and Project Management. More recently Carrie joined the Medicines Australia/Medical Technology Association of Australia R & D Taskforce where she holds co-chair responsibilities.


Russell Brown, PharmD, PhD
Clinical Trial Liaison, Site Engagement – Scientific Affairs
PRA Health Sciences, Australia

 

Radhika Butala
Manager, Clinical Trials Unit
Macquarie University, Australia

 

Dr. Simon Carson
Medical Director
Southern Clinical Trials Group, Ltd, New Zealand

Dr. Simon Carson has been the medical director of a primary health care based clinical trials unit since 2007. Together with Julia Mathieson, he established Southern Clinical Trials Group, comprised of 5 NZ sites with access to large primary care databases, in 2011.


Matthew Cook, PhD
Senior Clinical Site Monitor
Bristol-Myers Squibb, Australia

Matthew Cook is a Senior Clinical Site Monitor at Bristol-Myers Squibb Australia where he has worked since May 2015. Prior to this, he worked as a study coordinator on haematology, oncology, and phase I clinical studies. He has background in cell biology, working as a Research Associate/Specialist Scientist in both Australia and the United Kingdom. Matthew holds a PhD (Cell Biology), Bachelor of Science with Honours and a Graduate Certificate in Technology and Innovation Management all from the University of Queensland. Matthew has a strong focus on improving patient outcomes and on establishing strong relationships with clinical research sites.


Kelsey Dobell-Brown
Manager, Clinical Trials Support Unit
South West Sydney Local Health District (SWSLHD) & Ingham Institute, Australia

Kelsey Dobell-Brown is the current Manager for the Clinical Trials Support Unit at South West Sydney Local Health District (SWSLHD). She trained and worked as an ICU (cardio-thoracic) nurse before embarking on a diverse career in clinical trials at Liverpool Hospital, the Melanoma Institute, Campbelltown Hospital and the Ingham Institute. Kelsey was instrumental in establishing the SWSLHD Clinical Trials Support Unit which includes the establishment of a clinical trials finance officer and standard operating procedures. Across the South West there are currently 25 active clinical trial groups from 19 different specialty areas. In 2016/17 the District was involved in over 300 clinical trials. She also works with researchers across the District to instill a high standard of practice through onsite Good Clinical Practice (GCP) training and in assisting researchers with the navigation through the Ethics and Governance processes. Her role also provides a point of contact for clinical trials Sponsors, Investigators and supporting departments to ensure a streamlined approach to all aspects of clinical trial feasibility, application and ongoing management.


Suzanne Elliott
Clinical Trial Unit Manager
Gallipoli Medical Research Foundation, Australia

Suzanne Elliott joined the Foundation in November 2016 as the Clinical Trial Unit Manager. Suzanne has been involved in clinical research for over 25 years, with a doctorate in molecular oncology and post-doctorate in infectious/viral/cancer immunology clinical trials. She has a special interest in early phase drug development, Phase I clinical trials, working with a Phase I company for over a decade. She has qualifications in drug development and has extensive experience particularly in ethics and regulatory affairs and Good Clinical Practice. Suzanne’s focus is to provide a professional and supportive role to the Foundation’s clinical team in its aim to pursue clinical research excellence in emerging new therapies that may benefit our patients.


Lorena Figueroa
CCO Line Manager, Clinical Operations
Roche, Australia

Lorena has 20 years’ experience in roles such as Global Project Manager and People Manager, both in Pharma and Biotech. She spent almost 10 years managing clinical trials at a global level. Lorena joined Roche in 2015 as a clinical research manager responsible for managing a team of regional project managers, providing functional expertise and individual coaching to support the delivery of the highest quality and standard clinical studies as well as ongoing process improvement projects. Lorena is also a member of the e-label TransCelerate APAC working group and a subject matter expert in support of the implementation of SIP and IR initiatives at Roche. Lorena holds a degree of Pharmacy from the University of Buenos Aires and a diploma in Project Management from New England University.


Dr. David Fuller
Senior Vice President, Clinical Development
Syneos Health, Australia

Dr. Fuller currently holds the position of Senior Vice President, Clinical Development for Syneos Health and is qualified in both Medicine and Pharmacy. He commenced his career as a CRA for a major pharma company and now has and has over 30 years international experience including leadership of 4 product approvals. His R&D experience encompasses pre-clinical, clinical development, pharmacovigilance and medical and regulatory affairs with diverse therapeutic expertise spanning oncology, rheumatology, renal medicine, CNS, dermatology and infectious disease products. David also serves as a Board Director for Linear Clinical Research.


Michelle Gallagher
Managing Director
The Social Science, Australia

 

Chantal Gebbie
Information and Support Consultant
Cancer Council NSW, Australia

 

Angela Giagodi
Director
Creative Touch Coaching & Training, Australia

 

Siew Lee Goh, PhD
Director, Site and Patient Access
Syneos Health, Singapore

Siew Lee is currently a Director of Site and Patient Access for Syneos Health. She is responsible for delivering and implementing site relationship initiatives in Asia Pacific region in line with the company’s global strategy. Siew Lee is also responsible for regional oversight of site identification activities in APAC.


Mel Goldman
Business Development Manager
Genesis Research Services, Australia

 

Mel Grand, MHlthSc
Clinical Trials Manager, Radiation Oncology
Liverpool & Macarthur Cancer Therapy Centres, Australia

Mel is the Radiation Oncology Clinical Trials Manager at Liverpool and Campbelltown Hospitals in NSW, is employed by the Ingham Institute and has been in this position for over 3 years. Prior to this, Mel was a clinical radiation therapist and project manager of radiation oncology government-funded projects working for both TROG and RANZCR. Mel has experience with the development of investigator-initiated studies and is a current GCP trainer.


Zoe Harrison
Business Development Manager
CMAX, Inc., Australia

Zoe Harrison is the Business Development Manager at CMAX Clinical Research in Adelaide. Like many Australian clinical trial sites, CMAX continues to see strong demand for early phase trials from international sponsors. After joining CMAX as a Clinical Project Manager in 2010, Zoe transitioned across to the fast-paced area of business development over five years ago, and enjoys working with sponsors to support their clinical development programs. Zoe has 15 years of experience in clinical research and holds a Masters of Public Health and Masters of Health Management.


Cheryl-Ann Hawkins
Senior Clinical Research Nurse Consultant
Monash Health, Australia

 

Andrew HuxleyAndrew Huxley
Regional Director, Clinical Operations for Asia Pacific
Eli Lilly and Company, Australia

Andrew Huxley is currently the Regional Director of Clinical Operations for Eli Lilly within Asia Pacific. Through a number of roles Andrew has had over 15 years’ experience managing virtual teams and working with CROs in Asia Pacific and across the globe. In this most recent role, he has been responsible for leading a functional sourcing model and driving organisational change, which is intended to provide improved sense of partnership and customer focus. With a Bachelor of Science and MBA in Project Management and Marketing, Andrew is passionate about effectively integrating business with science. Other topics of interest include staff engagement, balanced scorecards and developing high performance teams.


Gina Kennedy
Clinical Operations Manager
Clinical Network Services, Australia

Gina has worked in the clinical trials industry for over 20 years, including pre-clinical laboratories, at site, in pharma and CROs. Her roles across the industry, including pharmacologist/scientist, study coordinator, CRA, project management, and various departmental management and mentoring roles. With Gina’s varied background of the industry she brings a holistic approach to managing clinical trials, and has a great understanding of all stakeholder perspectives and works to try to harmonise and align all stakeholders to better treat our families and friends.


Bill Lam
Director, Clinical Site Management
Pfizer, Australia

Bill Lam is director of the clinical site management team which delivers Phase 1-3 global clinical trials for Pfizer in Australia and New Zealand. He joined Pfizer Australia as associate medical director in 1999. Over the last 18 years, Bill has taken roles of increasing responsibility in global medical affairs and clinical development. Bill graduated in Medicine at the University of Bristol, United Kingdom, before receiving internal medicine training at Austin Health, Melbourne in Australia. Whilst being Fellow of Clinical Pharmacology at the University of Melbourne, he completed his PhD Medicine in the area of autonomic neuroscience. He was also a consultant clinical evaluator of pre-registered medicines for the Therapeutic Goods Administration.


Catherine Lee
Area Head, Global Clinical Site Management Asia
Pfizer, Taiwan

Catherine Lee is the Area Head of Global Clinical Site Management in Asia for Pfizer with over 24 years of experience in clinical research. Catherine is responsible for supervising the medical and operational resources in the Asia Pacific region, excluding Japan, to ensure effective delivery of key clinical site management milestones and overseeing the clinical/medical, operational and scientific oversight activities for Pfizer clinical trials. Catherine is a registered pharmacist with a Master's degree in Pharmacology and an EMBA. She is passionate about drug development and advance science with clinical research site to accelerate the availability of therapies for patients.


Marian Lieschke
Nurse Unit Manager, Cancer Clinical Trials
Peter MacCallum Hospital, Australia

 

Marie Luci
Clinical Trials Contracts Manager
Cancer Trials Australia, Australia

 

Angela Masterson
Director of Clinical Management
PPD, Australia

 

Julia Mathieson
Co-owner & Director of Clinical Trials
Southern Clinical Trials Group, New Zealand

Julia Mathieson has a background in primary health care nursing. She has been the clinical trials director of a primary health care based clinical trials unit since 2007. Julia established Southern Clinical Trials Group, comprised of 5 NZ sites with access to large primary care databases, with Simon Carson in 2011.


Chris McConachy, BSc
Associate Director, Customer Relationship Management - Asia Pacific
Covance, New Zealand

Chris entered the clinical research industry in 2006, and subsequently joined Covance in 2011. In addition to broad experience across Clinical Operations in Asia Pacific, Chris has specific experience in the support of international clients conducting Phase I research in Australia. Chris is currently Associate Director, Customer Relationship Management for Covance in Asia Pacific - providing oversight and facilitation of customer relationships with sponsors, key research sites, and partner Institutions.


Jenny McGrath
Senior Clinical Research Coordinator
Respiratory Clinical Trials Unit, Royal Adelaide Hospital, Australia

Jenny has an extensive background in clinical research and has worked in respiratory research since 1994. As a registered nurse these qualifications compliment her research achievements (Master in Science – Research). Jenny is part of the senior management team in RCTU. Her initiatives to RCTU and the running of the Unit include: Training and education of Clinical Research Coordinators (CRC). CRC education – in ICH GCP, respiratory diseases, respiratory therapies and their uses, and study subject advocacy, Jenny developed the first business plan for RCTU (in 2003). Jenny initiates governance and finance reviews (clinical trials budget negotiations) to ensure studies undertaken are able to be completed to a high clinical research standard within given timelines.


The Honourable Frank McGuire
Parliamentary Secretary for Health & Medical Research
Victorian Government, Australia

 

Sophie Mepham, PhD
National Research Manager
Genesis Cancer Care, Australia

Sophie has worked in clinical research since 1997 and is currently National Research Manager for GenesisCare, specialising in research that focuses on oncology and radiotherapy treatments. Sophie previously worked as Senior Manager, Translational and Clinical Research and for 3 years as the Head of the Clinical Trials Unit at Peter Mac, covering all specialities of oncology trials, from first in human, through to phase III. Before taking up this role in Australia, Sophie worked in the UK managing a haematology clinical trials unit for 8 years and then subsequently for 2 years as a Research & Development Manager for all clinical research across a large NHS hospital as part of the National Institute for Health Research (NIHR). She is an NIHR accredited GCP trainer and GCP program lead.


Matt Miller
Vice President of Global Patient Recruitment & Feasibility
StudyKIK, USA

Matt has been a leader in the use of digital and social media campaigns for patient recruitment on a single site and multi-site level with experience at a major CRO. He has developed cutting edge techniques to patient recruitment using social media for various therapeutic areas and disease states.


Tam Nguyen, PhD, MBA
EO Research
St. Vincent's Hospital Melbourne, Australia

Dr. Tam Nguyen is an experienced research administrator with previous clinical research experience in biomedical engineering at numerous teaching hospitals and medical research institutes across Australia. In the current role as a senior executive of research at St Vincent's Hospital Melbourne, he is responsible for research strategy, business development and administration. He has a double degree in Biomedical Engineering, a PhD in Biomechanics and an MBA in general management. Tam is an Adjunct Associate Professor at RMIT University and an Honorary Senior Fellow at the University of Melbourne. He is a fellow of the Australian Institute of Management and a member of the Australian Institute of Company Directors. Tam recently co-founded an investment fund supporting Australian biotech and medtech start-ups.


Majella O'Leary
Regional Clinical Site Lead
Pfizer, Australia

Majella O’Leary graduated with a BSc (Hons) and PhD in Pharmacology from University College Dublin, Ireland in 1993. Majella then completed 3 years of post-doctoral research at the Garvan Institute Medical Research, Sydney before joining the pharmaceutical industry as a clinical research associate in 1997. Majella has 21 years of industry experience, 19 of which have been with Pfizer where Majella has held positions of increasing responsibility including quality standards, project management and operations management. More recently, Majella was the Asia area head of the Pfizer Study Start-up Unit, and was the interim director of clinical site management before moving into her current position as regional clinical site lead overseeing studies within the Pfizer Oncology Portfolio.


Christine Pierre
President
Society for Clinical Research Sites, USA

Christine Pierre is the President of the Society for Clinical Research Sites (SCRS). She is internationally known for her expertise in clinical research site management and patient recruitment and retention for the clinical trials industry. In addition, she also addresses audiences around the world on issues pertaining to human subject protection, site operations and subject recruitment and retention. Her global reach has included presentations in Australia, Canada, Africa, Israel, and the United States.


Dr. Megan Robertson
Director of Research
St. Vincent's Hospital Melbourne, Australia

Dr. Megan Robertson is an alumna of the University of Melbourne where she completed a Bachelor of Medicine, Bachelor of Surgery (MBBS). She is the current Director of Research at St Vincent’s Hospital, Melbourne, and works as a Senior Intensivist at Epworth HealthCare, and Assistant Censor at the College of Intensive Care Medicine (CICM). Previously, she held positions as the Director of Professional Affairs, CICM, as the Executive Director of Research at Epworth HealthCare, and as the Co-Director of the Intensive Care Unit at Epworth Freemasons.


Natasha Rogic
Regional Site Advocate
Vertex Pharmaceuticals, Australia

Natasha Rogic is a clinical research professional with over six years’ experience in the Australian and New Zealand clinical trials industry. Natasha holds a Bachelor’s degree in Science (Pharmacology) from the University of Sydney and has therapeutic experience in Cystic Fibrosis, Oncology, Haematology, Neurology, Immunology and Rare Diseases. Currently serving as Regional Site Advocate and Regional Clinical Operations Study Lead at Vertex Pharmaceuticals, Natasha has also held the roles of Site Activation Manager, Clinical Research Associate and In-House Clinical Research associate at PRA Health Sciences and AstraZeneca. Natasha has a passion for improving patient outcomes and supporting clinical research sites by removing obstacles between study sponsor and investigative sites in addition to reducing site and patient burden.


Prudence Scott
Director of Medex Consulting & Medical Oncologist
Monash Medical Centre, Australia

Prudence Scott is a practising medical oncologist with expertise in cancer medicines regulation. From 2013-16, Prudence was Director of the Oncology/Haematology Evaluation Unit at the Therapeutic Goods Administration (TGA), Australia’s medicines and medical devices regulatory authority. After leaving the TGA, Prudence set up Medex Consulting, to provide expert advice to support the government’s commitment to undertake faster review processes for medicines meeting high unmet need. Making new cancer medicines available in Australia, and uncovering improved ways medicine regulators can facilitate this process, remains a key area of interest and focus. Prudence has a medical degree from Otago University in New Zealand, and completed a Master of Philosophy in Management Studies and a Doctor of Philosophy in Medicine (breast cancer research) at the Weatherall Institute of Molecular Medicine while a Rhodes Scholar and Nuffield Medical Fellow at Oxford University. Prudence is a Fellow of the Royal Australasian College of Physicians.


Gabriel Silver, BN, MHA
CRA/Feasibility, Recruitment & Site Engagement Lead APAC
Medpace, Australia

Gabriel is a passionate research professional with over 13 years of experience in Clinical Trials as both a Clinical Research Coordinator and a Clinical Research Associate (CRA). Holding a Bachelor of Nursing and Master of Health Sciences (Health Administration), he has a combined 18+ years of experience in leadership positions on numerous national and international clinical research executive committees and councils. Gab is currently combining his role as a CRA with oversight of feasibility, recruitment, and site engagement operations in the Asia Pacific Region for the Global CRO Medpace.


Kate Smith
Strategy & Site Alliance Director
IQVIA, New Zealand

With more than 18 years’ experience in Industry, Kate has a depth of experience in the management and execution of clinical trials, with a special interest in Early Phase Development. Kate has developed a close relationship with a network of Phase I centres throughout Asia Pacific, including both established Phase I network sites and sites that are new to Phase I delivery. In the past 2 years, Kate has worked extensively with regional operations teams throughout Asia Pacific, to streamline and innovate the delivery of ECD studies, ensuring best in class timelines and deliverables, coupled with highest quality study outputs. Kate’s years of experience in the industry allows her to provide whatever level of support is needed by the sites, while being able to offer Sponsors a custom built strategy for the delivery of their ECD studies. Kate has a Honours Degree in Pharmacology from the University of Otago in New Zealand, and has held roles both within Pharma and CRO in New Zealand, United Kingdom and Singapore.


Adam Stoneley
Clinical Trials Operations Manager
Icon Cancer Foundation, Australia

Adam is an experienced clinical operations manager with a demonstrated history of working in the hospital and healthcare industry. He is skilled in clinical research, life sciences, oncology, clinical data management, and clinical trials. He is a strong research professional with a Bachelor's degree focused in Health/Health Care Administration/Management from Queensland University of Technology.


Tina Sun
Head of Clinical Operations, Taiwan/Hong Kong
Eli Lilly and Company, Taiwan/Hong Kong

 

Mohan Vallipuram
Principal Consultant
PAREXEL, Australia

Mohan is a scientific expert with extensive experience in due diligence, development, registration and maintenance of therapeutic goods across a range of therapy areas covering non-prescription medicines (complementary, OTC), prescription medicines (generic, innovator) and medical devices. Mohan works with clients in Australia, Europe, USA, Asia, Middle East and South America.


Angela Watt, BSc (Hons), PhD, GDHSM
Director Research Governance & Ethics
Melbourne Health Office for Research, Royal Melbourne Hospital, Australia

 

Andrew Wear
Director, Medical Technologies & Pharmaceuticals
Department of Economic Development, Jobs, Transport & Resources, Australia

Andrew is the Director of the Medical Technologies and Pharmaceuticals branch at the Victorian Department of Economic Development, Jobs, Transport and Resources (DEDJTR), where he leasd the development of government policy aimed at growing the economic impact of this sector. In this role, he also has responsibility for Victorian government science and innovation policy. Before joining DEDJTR, Andrew was a Director at the Department of Premier and Cabinet, leading the provision of advice to the Premier in a variety of policy areas, including: education; justice; energy; water; agriculture; and environment. He has also worked in a variety of executive roles with the Department of Planning and Community Development, and Regional Development Victoria. In 2007, he undertook a secondment with the OECD's Local Economic and Employment Development Program in Italy.


Karen West
Executive Director, Clinical Development, Early Phase, APAC
Syneos Health, Australia

 

Elizabeth Wilson
Associate Director, Prime & Partner Sites ANZ
IQVIA, Australia

Elizabeth worked initially in hospital and retail pharmacy roles before moving to the biopharmaceuticals industry. She has since worked in various clinical development and management roles with Agenix Ltd, Progen Pharmaceuticals Industries Ltd, and QuintilesIMS. Elizabeth is currently Associate Director for Sites Relationships for IQVIA Australia-New Zealand. Elizabeth completed her degree in Pharmacy (University of Queensland) and has postgraduate qualifications in clinical pharmacy. She has spent more than 20 years focusing on clinical hospital pharmacy and drug development, particularly in the area of clinical cancer services for paediatric and adult patients. Her current role involves working with sites and sponsors to increase the speed and efficiency of patient recruitment and clinical research in Australia and New Zealand to bring new medicines to patients faster.