2019 Faculty

Gail Adinamis
CEO & Founder
GlobalCare Clinical Trials, USA

Gail Adinamis is founder and CEO of GlobalCare Clinical Trials, a global patient-centric service organization that conducts study visits at patients’ homes or alternate settings via a global network of ambulant healthcare providers to support traditional, virtual or hybrid studies. Adinamis has 40 years of comprehensive global clinical trials experience including over 12 years of global trials management at Abbott Laboratories and Astellas Pharma US. She established the clinical trials divisions for three national home infusion companies and served as president of those wholly-owned subsidiaries. She was founder, President and CEO of an independent ambulant care service company for clinical trials prior to establishing GlobalCare Clinical Trials in 2010. Adinamis is active in many industry associations and has been an invited speaker at several industry conferences and recipient of numerous awards and recognitions including twice being among INC 5000’s fastest growing private companies, CEO and International Game Changer of the Year, and among the top 50 fastest growing Woman-owned companies in 2018 and 2019.

Deama Amr, PhD
Clinical Research Manager
Medtronic, Australia

Dr Deama Amr is a Clinical Research Manager for Medtronic Australasia’s Cardiac and Vascular Group, successfully supporting the business in establishing a clinical trial presence in Australia and New Zealand. Over the past five years, Dr Amr has identified barriers to the implementation of global clinical trials in the region, expanding the footprint of the clinical trial portfolio from two, to more than 12, during this timeframe. Her work has been rewarded through multiple company awards related to streamlining and expanding clinical trials in ANZ; and she has also been recognised for her fierce leadership of the ANZ Chapter of the Medtronic Women’s Network from 2016-2018. Before the move to the medical device industry, Dr Amr, completed a PhD in Pharmacology from the University of Sydney, and joined industry based clinical trials through the National Centre for HIV, Epidemiological & Clinical Research (NCHECR). From there she worked with Abbott Australasia on project management and clinical trial execution on a number of their therapeutic areas, including HIV, Rheumatoid Arthritis and Psoriasis, before moving to the George Institute to lead the APAC clinical operations of a number of Cardiovascular trials.

Niharika Anand, MBA
Site Relationship Manager
IQVIA, Australia

Niharika worked initially at Alfred Hospital as a Clinical Study Coordinator within Monash Alfred Psychiatry Research Centre for 1 year before moving to the biopharmaceuticals industry. She has since worked in various clinical development and management roles with Amgen Australia and IQVIA. Niharika is currently Prime Site Relationship Manager, for Sites Relationships for IQVIA Australia-New Zealand. 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. Niharika completed her Bachelor of Science from Monash University, majoring in Pharmacology and Biochemistry and then her Honours Degree in Neuroscience from University of Melbourne. She has spent more than 8 years focusing on clinical hospital research and drug development, particularly in the area of cardiology, psychiatry, CNS diseases, and endocrine illnesses. In her role as within IQVIA, Niharika has worked in project management and clinical operations roles, working within focused group and supporting the wider organisation with process improvement. In other roles she has held clinical research associate role, regulatory and start up positions as well as clinical specialist positions.

Effie Atkins
Clinical Trial Patient

Diagnosed with liver cancer, Effie’s life was turned around when she agreed to participate in a phase 1b trial at the Monash Health Translation Precinct. Her liver tumour has shrunk, and over 2 years later she remains in good health. She has met many others with similar stories. Recently Effie discovered that, with more support for such trials, many more patients could benefit from similar clinical trials and research to find improved treatments could advance much faster. Today, Effie works to spread the word, gain support in her own community, and eliminate key funding bottlenecks. She works with Monash Health to raise funds to help cancer patients who have exhausted all other treatment options.

Shivani Arora
Site Start Up & Regulatory Specialist II, Clinical Solutions
Syneos Health, Australia

Shivani specializes in Clinical study start-up and site liaison. She has a total 14 years of experience in fields like clinical research, banking, writing and training. Shivani has been working as a CRO for the last 5 years. Communication, multi- tasking and organisational skills are core strengths.

Bernadette Aliprandi-Costa, PhD
Manager, Safety and Quality Improvement Systems and Intergovernmental Relations
Australian Commission on Safety and Quality in Health Care, Australia

Bernadette is the Manager, Safety and Quality Improvement Systems and Intergovernmental Relations at the Australian Commission on Safety and Quality in Health Care (the Commission). The Commission is an Australian government agency funded by the Council of Australian Governments (COAG) that leads and coordinates national improvements in safety & quality of health care based on best available evidence. The Commission works in partnership with the Australian Government, state and territory governments, private sector, patients, clinicians, managers and health care organisations. Bernadette holds a PhD in health outcomes research from the University of Sydney, and has published widely on systems of care and the management of acute coronary disease. Her doctoral research focused on reporting hospital performance nationally using outcomes data to calculate the composite of evidence-based quality indicators. Bernadette has lead programs of work in the health care sector developing quality reporting frameworks; designing and implementing system and quality performance reporting programs; designing and managing clinical quality registries and designing and implementing government funding models in the research and vocational educational and training sectors. Currently, Bernadette is leading the development and implementation of the National Clinical Trials Governance Framework, a key element of the Encouraging more Clinical Trials in Australia initiative, on behalf of the Australian Government Department of Health and all states and territories.

Zoe Armstrong, BSc (Biotechnology)
Clinical Research Director ANZ
MSD, Australia

Zoe began her career in the pharmaceutical industry 20 years ago at MSD. She started in clinical operations as a CTC then CRA, moving through various functional roles including, project mgt and line mgt for 10 years. In 2009 Zoe assumed the role of research director for Australia and NZ and supported the clinical operations team through the subsequent merger with Schering Plough and the combination of Aus and NZ into one cluster ANZ. For the last 9 years Zoe has led research operations as CRD across ANZ. From 2013-2015, Zoe also lead the ASEANZ cluster where she assumed responsibilities for countries across South East Asia in addition to ANZ. Now she manages a broad team of 144 people across ANZ and offers unique insight into the opportunities and challenges with leading clinical trials across countries and diverse cultures. Zoe holds a BSc (Biotechnology) from the University of Technology Sydney.

Georgina Arnold, BSc Biomedical Technology
Clinical Research Director for South East Asia
MSD, Australia

Georgina joined MSD in 2004 and is now the Clinical Research Director for SEA. Within this role, she leads, manages and oversees all aspects of MSD’s clinical operations across the cluster (Philippines, Vietnam, Singapore, Thailand, Malaysia and India).
Georgina offers over 20 years of industry experience in both APAC and Europe across different phases of clinical trial, therapeutic areas, and in CRO and Pharma environments.

Sophy Athan, BA, MA, Grad Dip Lib, Grad Dip Lib Soc Pol
Chair CCAC
VCCC, Australia

I have been a consumer leader and advocate for the last 17 years. I became first involved with health because of my role as a carer to 2 family members. I have been on a numerous committees in the acute sector and in the primary sector. Over the last 3 years I have become involved more closely with research and education on committees and also on research grants. I am the Chair of the Health Issues Centre (Victorian Peak Consumer Organisation), AHPRA CRG, EMPHN CRG, Victorian Clinical Council member, Chair of Cancer Consumer Advisory Committee of the VCCC plus others. I am passionate and committed to improving quality and safety outcomes for patients and one way to achieve this is to involve patients/consumers in research and clinical trials. I have undertaken a number of consumer leadership courses and have a commitment to improving access and equity to all aspects of health.

Helen Aunedi, MMedSc, MA
Country Head, Country Clinical Operations
Roche, Australia

Helen Aunedi is the Country Head of Country Clinical Operations for Roche (Pharmaceuticals) Australia, a position she has held since 2015. She directly leads and manages the affiliate clinical operations team and contributes to the Asia Pacific and global Country Clinical Operations Function. The Roche team actively supports and is implementing TransCelerate initiatives globally including Australia. Helen is a co-chair of the, Medicines Australia Research and Development Taskforce –an industry working group tasked with improving conditions for clinical trials in Australia. Helen has over 27 years in the pharmaceutical/healthcare industry and broad leadership experience in regional and local clinical operations in Asia Pacific.

Dom Bailey, MClinTRes; MOHS; B.Nurs,
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.

Wayne Baker
Greenphire, USA

As Greenphire’s Chief Commercial Officer, Wayne is responsible for the global commercial strategy of the rapidly growing organization, including the execution of sales and marketing programs. Wayne is a proven strategic sales executive with more than 25 years of commercial experience in technology and life science industries. Prior to joining Greenphire in 2016, Wayne served in numerous senior leadership roles at Advanced Health Media (AHM), a leading global provider of SaaS-based solutions designed to manage compliant interactions with healthcare professionals and organizations. During his tenure, Wayne helped establish AHM as the market leader, playing an integral role in the organization’s 1500 percent revenue growth during a four-year period. Earlier in his career, Wayne gained sales leadership and industry experience at Parametric Technology Corporation (PTC) and Brent International. He earned his bachelor’s degree in Chemical Engineering from Drexel University. Wayne resides in the Philadelphia area with his wife and four children.

Carrie Bloomfield, MBA, BAppSci
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.

Charlotte Bradshaw
CEO & Founder
Evrima Technologies, Australia

Charlotte is the CEO & Founder of Evrima Technologies. She has 8 years's industry experience having managed patient recruitment for a leading clinical research company and run a consulting company to service clinical trial organisations with digital marketing solutions. She has a strong background in marketing, project management and business development and has worked across a wide range of industries including clinical research, professional services and market research. She is passionate about finding innovative solutions to customer problems and helping get new medicines to market for those who need them.

Kate Burbury, MBBS(Hons), FRACP, FRCPA, DPhil
Consultant Haematologist, Deputy CMO
Peter MacCallum Cancer Centre, Australia

Kate is a Consultant Haematologist, Deputy Chief Medical Officer, Chair of Senior and Junior Medical Staff at Peter MacCallum Cancer Centre. In addition, the institutional Lead for Digital Health, CML/MPN, Thrombosis/Haemostasis service and peri-operative/rehabilitation programmes. She is a clinician researcher, responsible for the strategic direction of clinical trials and research innovations, as well as their translation and implementation into clinical practice. With an extensive clinical and research portfolio, designed and implemented key Phase I, II & III clinical trials, including investigator-initiated trials, across various cancers and anticancer therapies. As a national and international expert in haematological malignancies influenced fundamental clinical-research strategies to focus on important areas of clinical unmet need and through cooperative networks facilitated and coordinated translation of these findings into real-world clinical practice and policy development. She has an extensive listed of publications, submitted and invited presentations at National and International scientific meetings, editorial board member of international journals and a regular reviewer of many journals. Kate is an active member of numerous professional and scientific committees, where her scope of influence extends to guidance for clinical care, research and trial strategies, education and training, policy development.

Emma Burt
Clinical Trial Participant

Emma was diagnosed with Ovarian Cancer in 2015 at the age of 32. After exhausting all current available curative treatment options, with no successful outcomes, she looked into Clinical Trails whilst undergoing palliative treatment in 2016. After a waiting period, Emma was accepted and invited to participate in a Phase 1B trial at the Monash Health Translation Precinct in July 2016. Three years later her results are a miracle of science. Emma shares her patient experience in an endeavour to help improve care and pathways for future patients.

Radhika Butala, MIPH
Manager, Clinical Trials Unit
Macquarie University, Australia

I’ve been in the Clinical Research Industry for more than 15 years now, having worked across different streams in both Drug and Device trials. In 2013 I started the  Clinical Trials Unit for the Faculty of Medicine and Health Sciences at Macquarie University in Sydney, Australia.  In the past 5 years the CTU has grown to a 18 member strong team that currently coordinates over 50 trials spread across various clinical streams. I’ve been an active member of the SCRS ASIA-Pac summit from its inception in 2014 and am always keenly interested in incentives that benefit site metrics.

Michelle Button
Finance Manager
Cancer Trials Australia, Australia

Michelle has 15 plus years of experience working as the Finance Manager for Cancer Trials Australia. This involves extensive experience on behalf of both public and private member sites, in tracking and billing for both sponsored and non-sponsored cancer clinical trials.

Lee Byrne, BA, GradDip.Journ, MA
Communications Manager
Victorian Comprenhensive Cancer Center, Australia

A successful track record in delivering complex communication strategies and campaigns, particularly in integrating content and audience segmentation across multiple platforms. Lee Byrne has nearly 20 years’ experience in a range of sectors, including education, government, science and health, both here and in the UK. She has a reputation for achieving solutions through a collaborative approach, incorporating stakeholder management and engagement opportunities. In her most recent appointments, Lee has delivered organisational change, increased staff engagement, managed development of inactive websites, connected and engaging social media accounts, facilitated strategic collaboration opportunities and developed leading teams. Lee currently works for the Victorian Comprehensive Cancer Centre (VCCC), with a focus on increasing access, participation and workforce capability in cancer clinical trials. The VCCC is a multi-site, multi-disciplinary alliance of 10 leading research, academic and clinical institutions working together to identify and fill gaps and unmet needs, to benefit the critical mass and improve outcomes for Victorian cancer patients.

Carlos China, MD
Site Operations Relationship Lead
Pfizer, Australia

Dr. Carlos China is a Board-Certified Dermatologist from Brazil. He worked at Royal Prince Alfred Hospital in Sydney and then moved to The Woolcock Institute of Medical Research as Investigator. Besides several studies he was also co-responsible for setting up a phase 1 and conducted FIH studies. He is working at the Pharmaceutical Industry in Clinical Research roles since 2012 and at Pfizer for the last 4 years.

Katherine Clark, PhD
Director of Licensing & Certification
Australian Government Department of Health

Katherine has a PhD in Cell Biology from Flinders University of South Australia and worked for over ten years in Medical Research, most recently at the University of Cambridge. Katherine joined the TGA in 2002 and has worked for the last 12 years as a GMP inspector for biological manufacturers performing GMP inspections in Australia and internationally. Katherine is currently the Director of the Licensing and Certification section in the Manufacturing Quality Branch of the TGA and is the Project Manager for the implementation of the Good Clinical Practice Pilot Inspection Program.

Ryan Clarke
Manager, Clinical Operations
Bristol-Myers Squibb, Australia

Ryan joined BMS in December of 2009 as a clinical site monitor and moved to a clinical site manager role in 2015. Ryan has worked in all areas of clinical trial research across a wide range of therapeutic areas but has a passion for early clinical development. Ryan moved into line management in July 2018 as a manager of clinical operations and has enjoyed the challenge of motivating his team to drive clinical trial execution. Ryan holds a bachelor of Health Sciences from Latrobe University (2005) and a Bachelor of Pharmaceutical Sciences from RMIT University (2009).

Cheryl Coleman, RN
Operations Manager
Emeritus, Australia

After a long and varied nursing career, Cheryl was employed by Monash Health’s Haematology Research Unit, in 2002, and spent 13 years with them as a Coordinator and Unit Manager. She led Haematology Research to became one the largest and most productive trial units within the network. In 2015, Cheryl was given the honour of being appointed the MHTP Clinical Trials Centre Manager. Coordinating the opening of the Centre, and building its exceptional team, was a highlight of her career. For 3 years she was able to work closely with the multiple trial units within Monash Health but also with trialists from Monash University and the Hudson institute. Cheryl accepted the Operations Manager position at Emeritus Research in 2018, where she is proud to work with an exceptional, innovative, nimble and growing team. She has learned that “Great things never come from comfort zones!” (Author Unknown)

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.

Nikki Cross, BSc PGdip (Resp Science)
Research Coordinator (Site Study Start Up & Finance)
Alfred Health, Australia

Nikki has 20 years experience in Clinical Research, starting in Respiratory Medicine as a diagnostic scientist, then in Medical Oncology for the past 18 years. She was the site manager in Medical Oncology Research at Alfred Health for the past 18 years, developing extensive experience in the study start up processes at site level. Nikki’s current role is managing site start-up and finance in Oncology clinical trials at Alfred Health.

Kyle Cunningham
Chief Product Officer
Greenphire, USA

As Chief Product Officer, Kyle leads the strategic direction of Greenphire’s solution development, ensuring that our product innovation roadmap is constantly evolving to solve relevant healthcare industry problems - ultimately creating value for sponsors, CROs, clinical research sites and study participants. Kyle has two decades of experience across multiple industries and in a variety of roles spanning innovation, operations management and client experience. Prior to joining Greenphire, Kyle worked for SEI Investments (Europe) where he managed product and service innovation for global asset management.

Stella Davis
Manager, Clinical Operations
Parexel, Australia

Successful, team-orientated Clinical Operations Manager with over 12 years' experience in clinical research. Based in Melbourne, Stella has worked as a leader/manager for over 8 years. Broad background in project management with strong competencies in both communication and leadership. Diverse therapeutic area with primary focus in Oncology and leading teams both locally as well as globally.

Madeleine Do, BSc
Senior Global Trial Manager
Janssen Cilag, Australia

With a passion for problem-solving and creative solutions, Madeleine Do has worked within the Clinical Research industry for close to 20 years, across the Asia Pacific and European regions. As a Global Project Manager at Janssen, she continues to seek innovative approaches whilst striving to simplify the complexity of clinical trial protocols. Madeleine would like to further deepen her understanding of the challenges faced by Patients and Investigator Sites and build partnerships to bring forward creative solutions and positive outcomes for all. Outside of work, you'll find Madeleine with a camera in hand for a spot of nature photography and spending time with her family on the beach.

Dr. Tim Dyke, BVSc PhD MBA GAICD
Executive Coach
AltusQ Pty Ltd Australia

Tim helps people and businesses to help themselves – to develop and grow towards where they need to grow – aiming to reach new heights. To give passion to their strategy and to give strategy to their passion. Following a life in veterinary practice, academia and government, Tim turned his mind and business efforts to coaching people and also consults in research ethics, integrity and govenance. His passion is ‘the accidental leader’ – the scientist / practitioner / clinician who is promoted to a manager role – where soft skills are essential.

Suzanne Elliott, BAppSc, PhD, Grad Dip (Drug Dev), ACRP-CCRC
Clinical Trial Manager
Gallipoli Medical Research Foundation, Australia

Suzanne is Clinical Trial Manager for the Greenslopes Private Hospital’s Gallipoli Medical Research Foundation’s (GMRF). Suzanne has over 25 years experience in drug development and clinical trials in Australian hospitals, Medical Research Institutes and early Phase clinical trial companies. Suzanne has over 9 years working as a Medical Laboratory Scientist, with a PhD in molecular haematology/oncology and post doctorate experience and regulatory affairs roles in research and ethics oversight, project management and development in the areas of infectious disease and immuno-oncology/immunotherapy vaccines in the areas of EBV diseases (Glandular Fever, Hodgkin’s Lymphoma, Post transplant lymphoproliferative disease), prostate, melanoma and malaria, including Human Malaria Challenge Models. As Deputy CEO, Chief Scientific Officer and Operations Manager of Q-Pharm Pty Limited, Suzanne provided scientific, ethics and regulatory submissions, and clinical trial oversight for early phase drug and vaccine investigational products, including GMO products. Suzanne is an QUT Adjunct Associate Professor and participates in Steering Committees and Industry groups.

Lorena Figueroa, B.Pharm
Country Clinical Operations Leader
Roche, Australia

Lorena is passionate about harnessing people's talents and strengths in order to bring hope to patients through efficient delivery of quality clinical trials. She strives to create an environment of trust, collaboration and adaptability where people feel encouraged to be authentic and supported to excel.
Current Role Lorena joined Roche in 2015 as a Country Clinical Operations Leader, managing a team Regional Project Managers support the delivery of clinical trials and process improvement projects. Lorena is a member of the e-label transcelerate APAC working group representing Roche. Experience Lorena has 20 years’ experience as Global Project and People Manager, both in Pharma and Biotech. Lorena holds a degree of Pharmacy from the University of Buenos Aires and a diploma in Project Management from UNE. Personal note / Fun fact Lorena is interested in mindfulness and regularly practices yoga, meditation and Reiki and is currently learning pottery.

Diana Foster, PhD
Vice President, Strategy and Special Projects

Diana Foster, PhD, is the Vice President of Strategy and Development for the Society for Clinical Research Sites and is responsible for building relationships with industry that help amplify the voice of the clinical research site. She is a recognized expert in the intricacies of site management and an innovator in the use of strategic marketing tactics. Diana has designed and facilitated site management and patient recruitment trainings across the globe.

Dr. David Fuller, MBBS, B.Pharm (Hons)
Senior Vice President, Clinical Development
Syneos Health, Australia

Dr Fuller has over 30 years international experience successfully developing & securing regulatory approvals of new clinical products. He is qualified in Medicine and Pharmacy and for the last 9 years has specialized in early phase healthy volunteer and oncology trials. David has had direct leadership roles in four product approvals (US/EU) with multiple FDA & EMA interactions and has designed and executed multiple Phase I-III studies (US, EU, Asia) for both orphan and major market products. His therapeutic experience includes oncology, infectious disease products, CNS / analgesia, rheumatology/inflammation, renal medicine, dermatology and gastroenterology.

Melanie Gentgall, RN, CCRA,Cert V1 TAE
PRAXIS, Australia

Melanie has spent the last 20 years of her career within the Australian Clinical Trials environment and has seen it progress from a fledgling industry to its current advanced and exciting network across Australia. She is a passionate and dedicated research advocate who is committed to improving access to education and training of the highest quality for the entire Australian research sector. This is made possible through her current role as founding CEO of PRAXIS Australia, a NFP education provider fast becoming a leader in the Australian sector through various models including itsvariosu workshops and its flagship training model, Research Essentials.

Angela Giagodi, BSc (Hons), Cert IV
Creative Touch Coaching & Training, Australia

Angela Giagodi is a Certified Learning & Development Consultant, Coach and Clinical Research Specialist. She has a Bachelor of Science (Hons) from University of Sydney, a Certificate IV in Training and Assessment from University of Technology Sydney, Certificate in Coaching from NeuroLeadership Institute and international DISC certification from Thomas International. Angela has a special interest in Neuroscience, Leadership and helping people and organisations perform at their full potential. She has over 23 years’ industry experience and has worked in a variety of roles at the local, regional and global level. In January 2015, Angela established Creative Touch Coaching and Training as a consultancy business which works directly with customers to provide customised solutions. Through her consultancy business, Angela has worked with her customers to develop and deliver Training and Coaching solutions as well as Clinical Research Services and Specialised Projects by combining her Clinical and Learning and Development expertise.

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

Siew Lee received her Bachelor of Science (Hons) in Biochemistry and Microbiology & Immunology and Master of Science in Biochemistry from Dalhousie University in Canada and her Doctor of Philosophy in Experimental Medicine from McGill University in Canada. She is currently holding a position as Director, Site and Patient Access at Syneos Health in Singapore. She is responsible for delivering and implementing site relationship initiatives in Asia Pacific region in line with the company’s global strategy.

Melinda Goldman, BBus
Business Development Manager
Genesis Research Services, Australia

Melinda Goldman is the Business Development Manager at Genesis Research Services. Her role includes sourcing new clinical trials for the site, managing financial activities, and leading the recruitment services department to offer progressive multi-site participant recruitment options. Mel is also a consultant for Praxis, developing and facilitating business essentials workshops.

Cheryl-Ann Hawkins, RN, MHA, BAppSc (Nursing), PGDip (Oncology/Palliative Care) Gradcert (Onc. Research)
Clinical Research Manager. Oncology
Alfred Health, Australia

Cheryl-Ann Hawkins is currently the Clinical Research Manager of Oncology at Alfred Health. She is the Australian Ambassador for the Society for Clinical Research Sites (SCRS) and Chair of SCRS AsiaPac Summit 2019. Cheryl-Ann has a keen interest in supporting study sites and improving processes to ensure sites can cope with the demands of providing clinical trials to patients. She has worked in various leadership Oncology nursing roles in a career spanning 25 years. Over the past 15 years she has focused her career on early phase/first in human drug trials, recently moving into her research manager role to broaden her management experience. Cheryl-Ann completed a post graduate diploma in Oncology/Palliative care nursing in 1996, a Master degree in Health Administration in 2004 and a post graduate certificate in Oncology Research in 2012. Cheryl-Ann holds an affiliate position with Monash University/ Monash Partners educating and certifying researcher in Good Clinical Practice (GCP).

Kylie Hewitt, PhD
Senior Country Manager
PPD, Australia

Kylie Hewitt, Bsc Hons PhD Associate Director SEA ANZ, SIA, PPD I received my Bsc Hons in 1999 and completed a PhD in Biochemistry and Molecular Biology in 2003, Monash University. Continued research at the University of Birmingham from 2004 -2007, focusing on obesity and hormones. Then joining the University of WA as a Research Associate genetic epidemiology research in the therapeutic area of cancer (Mesothelioma, Prostate, Breast, Brain and Skin cancer) 2007 to 2008. From 2008 to 2011 I worked on phase II and III multi-site clinical trials in the therapeutic area of Oncology as Study Coordinator at Peter MacCallum Cancer. Joining PPD in 2011 as a submission specialist and in 2013 the start-up manager for Australia New Zealand, since then I have taken start up activities in managing Singapore, Malaysia & the Philippines.

Andrew HuxleyAndrew Huxley, MBA
Regional Director, Site Engagement- Asia Pacific
Eli Lilly, Australia

Andrew Huxley is currently the Regional Director of Site Engagement 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.

Adriana Ioan, MD
Site Oversight and Operations Relationship Lead
Pfizer, New Zealand

I am a medically qualified doctor with 16 years clinical experience and 8 years worked in oncology (specialized in Lung Cancer), and I joined the Pharma industry in 2005 and worked since then in various roles in oncology and hematology. I joined Pfizer clinical development in 2013, initially as a regional medical monitor for oncology studies, then an regional clinical site lead covering Australia, and currently I am one of the clinical site leads for ANZ, based in Auckland.

Nick Karrasch
Trialfacts, Australia

CEO of Trialfacts with over 13 years’ experience in clinical trial recruitment, Nick’s passion lies in making recruitment predictable. Through Trialfacts, Nick has successfully recruited over 10,000 patients into hundreds of studies, in a reliable and predictable manner. Trialfacts seeks to have a lasting positive impact on the healthcare industry by bridging the gap between sponsors, CROs, research sites and grant-funded researchers, and people willing to volunteer and contribute to research.

Gina Kennedy, MS
Senior Clinical Operations Manager
Covance, 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.

Rachelle Kirk-Burnnand,,BSc, PGDip
Clinical Operations Lead
Syneos, Australia

Rachelle is a Clinical Operations Lead in Early Phase Development group at Syneos Health. She is currently involved in Phase I studies conducted throughout APAC and Europe. Rachelle has over 12 years Global experience in a clinical research organization’s, biotechnology and Men’s Health research as a Project Manager, a Senior Clinical Research Associate and Clinical Research Associate working across studies in Phase I, II, and III.

Kimberly Kundert, RN, BSN
VP, Operations
VirTrial, USA

Kim Kundert is an experienced research executive and currently VP of Clinical Operations for VirTrial. Prior to VirTrial, she served as the SVP of Operations for Radiant Research/Synexus, the largest site network in the world. Kundert was responsible for overseeing operations and performance of 84 research sites across the US. In her 19 years at Radiant, Kundert helped develop a platform of standardization across the network sites and had some hand in approximately 10,000 trials. Kundert has served on pharmaceutical advisory boards and CRO planning committees to provide input on protocol development and enrollment strategies from a site’s perspective. Kundert is a winner of two Stevie Awards for women in Business- Best Executive in Service Businesses in 2011, Silver Stevie for Female Executive of the Year in 2012. Kundert graduated Summa Cum Laude from Arizona State University with a bachelor’s degree in Nursing.

Bill Lam, MBChB, PhD
Director, Clinical Site Management
Pfizer, Australia

Bill Lam is Director, Clinical Site Management, Pfizer Australia & New Zealand. He joined Pfizer Australia as Associate Medical Director in 1999. Over the last 18 years, Bill has taken up roles of increasing responsibility in Medical Affairs and Clinical Development. Bill moved to Pfizer HQ, New York in 2004 as Regional Medical Director of Japan/Asia in cardiovascular medicine. In 2009, he became the Clinical Development Lead of Emerging Markets for medicines in the treatment of heart & thromboembolic diseases, pain, Alzheimer’s disease, and haemophilia. In 2012, Bill was the Medical Affairs Lead of Asia, leading medical affairs initiatives for Pfizer’s innovative compound portfolio in internal medicine, inflammation & immunology and rare diseases. Bill has recently returned to Australia to lead the Global Clinical Site Management team who delivers Phase 1-3 global clinical trials in Australia and New Zealand.

Kurt Lackovic, PhD, MBA, GAICD
Cancer Trials Australia, Australia

Dr. Lackovic has led Cancer Trials Australia (CTA) through significant growth over the past two years. As CEO of CTA, he is responsible for the development and implementation of CTA’s strategy, including business development and stakeholder engagement, as well as general operations. He has spent his entire career in medical research. His education includes a PhD in chemistry, post-doctoral placements in medical genomics and early stage drug discovery, as well as an MBA from Melbourne Business School, where he graduated on the Dean’s list. Dr Lackovic has published 23 peer-reviewed articles across diverse medical research areas, possesses extensive expertise in leading complex academic and clinical programs, strong connections to industry, and strategic linkages to senior executives in Government and major teaching Hospitals. He is a member of the Licensing Executives Society of Australia and New Zealand, American Society of Clinical Oncology, Society for Clinical Research Sites and AusBiotech’s Clinical Trials Advisory Group.

Ben Laverty, BSc
Director, ANZ Clinical Site Management
IQVIA, Australia

Ben has over 20 years' experience working in the pharmaceutical industry. He commenced his career at Pfizer as a drug metabolism and pharmacokinetics specialist working in pre-clinical and early clinical drug candidate optimisation. Ben has held clinical roles as a CRA, Clinical Project Manager and CRA/CPM Line Manager of global and APAC trials. At IQVIA Ben leads a team of Line Managers, CRAs and CTAs overseeing the delivery of >180 clinical trials across Australia and New Zealand.

Marian Lieschke, RN
Parkville Cancer Clinical Trial Unit, Australia

Marian Lieschke trained as an Oncology Nurse at the Royal Marsden. After moving to Australia, she worked extensively as a Clinical Oncology Research Nurse becoming the Manager of the Royal Melbourne Hospital Oncology Clinical Trials Unit in 2004. She was appointed as the Manager of the Parkville Cancer Clinical Trials Unit (PCCTU) in 2016, bringing the trial units of RMH , the Peter MacCallum Cancer Centre and the Royal Women's Hospitals together as a single unit to serve the Precinct, a unit which now employs nearly 100 staff. Marian has held positions in the Victorian Association of Research Nurses and the Cancer Council of Victoria Clinical Trials Professionals Group and currently chairs the VCCC committee on Building Workforce Capacity. Marian is passionate about Clinical trials as an alternate clinical pathway for patients, about education for Clinical trial staff and for improving the Clinical trial industry by increasing conversation with global Pharmaceutical companies.

Lucas Litewka, BAppSci, MBA
USC Clinical Trials, Australia

Lucas joined the University of the Sunshine Coast (USC), as the inaugural Director of the Clinical Trials Centre in 2015. The primary focus of this role was to take a greenfield opportunity and create an industry-focused Clinical Trials Centre on the Sunshine Coast and extend a network of activities across Queensland. Lucas has demonstrated his effectiveness as a member of a high performance leadership team in the formulation, development and implementation of critical business strategies both at Board level and within organisations on senior leadership teams. He has a sound understanding of the Hospital, Health, University and Research sectors, along with the ability to understand and interpret government policy to align with the organisation’s business strategy and the ability to build strong relationships across all levels in an ethical and sustainable manner. He has been recently appointed to join the Health Care Committee of the Australian Advisory Board on Technology and Healthcare Competitiveness.

Lauren Macnaughton
Site Engagement Manager
Lilly, Australia

Lauren Macnaughton currently leads the Site Engagement Teams for Australia, New Zealand and India at Eli Lilly. These teams are responsible for partnering with clinical trial sites to execute clinical research projects across a variety of therapeutic areas. She has over 14 years' experience in clinical research across a variety of project and people leadership roles at local, regional and global levels. Lauren is passionate about making a difference in the lives of patients by facilitating access to innovative treatment options through clinical trials. Lauren holds a Bachelor of Science in Molecular Biology & Genetics from the University of Sydney.

Robin Marcus, RN, BSN
Chief Strategy Officer
GlobalCare Clinical Trials, USA

Robin Marcus is Chief Strategy Officer with GlobalCare Clinical Trials. Over the past 28 years Robin has become known as an innovative healthcare executive focused on operationalizing new products and services. Her talents have been leveraged with companies of all sizes including Caremark, Mediware, Home Healthcare Laboratory of America, and Integrity Health Care. She began her professional career as an Oncology and Bone Marrow Transplant Nurse in San Francisco after receiving her BA from University of California San Diego and her BSN from The University of San Francisco.

Gordan McGurk, PhD
Director, OmniAdvisory Consulting
Chair Human Research Ethics Committee, Royal Brisbane and Women's Hospital, Australia

Gordon is Director of OmniAdvisory Consulting and specialises in areas of clinical trials strategy development; human and animal ethics; research governance; corporate governance; and research integrity. He is also the chairperson of the Royal Brisbane and Women’s Hospital (RBWH) Human Research Ethics Committee (HREC), the UQ HREC ‘A’, and a member of the Townsville Hospital and Health Service HREC. Much of Gordon’s expertise was gained while working at the National Health and Medical Research Council on projects related to improving clinical trials in Australia. He holds a PhD in Genetics from the University of Edinburgh. He is a Fellow of the Governance Institute of Australia and Graduate of the Australian Institute of Company Directors. His current work involves optimizing clinical trials research at the RBWH.

Bonnie McLeod, BHlthSc, PgDHlthMgt
Senior Contract Specialist
PPD, Australia

I have been lucky enough to work many roles in the research world. I started my career in Western Australia and spent many years as a Study Coordinator in both the Oncology and Haematology fields. After correcting one too many e/CRFs and SAE reports, I had the opportunity to work as a Governance Officer/Coordinator at Royal Perth Hospital and Fiona Stanley. I started in my governance role at a time when even the concept of an ‘RGO’ was still a new word, so I really did learn from the ground up (we all did)! After spending a ‘gap’ year as a CRA, these days, I am based at PPD Australia Pty Ltd, as a Contract Specialist. This is certainly a role I really enjoy, (perhaps it’s my love of numbers; card game anyone)? Fun fact: I am serial potato chip eater and connoisseur!

Clara Mena, BBiotech
Budget & Contracts Specialist
Cancer Trials Australia, Australia

Clara Mena is a Budget and Contracts Specialist at Cancer Trials Australia where she has worked since 2017. Prior to this, she worked as a Clinical Research Associate at inVentiv Health Clinical and PAREXEL. Clara has a strong focus on establishing strong relationships with sites and sponsors and improving overall study start up timelines. Clara holds a Bachelor of Biotechnology.

Sophie Mepham, PhD
National Research Manager
Genesiscare, Australia

Sophie has worked in clinical research since 1997 and is currently National Research Manager for GenesisCare, specialising in research that focuses on Theranostics, medical 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 has a PhD in Oncology/Immunology and is an NIHR accredited GCP trainer and GCP program lead.

Dan Milam
Vice President Global Engagement

With over twenty years of experience working in the pharmaceutical, CRO, and site sectors, Dan has gained a wide perspective and understanding of the needs of the industry as a whole that aid to facilitate and build strong alliances. His focus is on expanding SCRS’ global footprint and the inclusion of all industry stakeholders in SCRS initiatives with the goal to foster sustainability for clinical research sites.

Megan Morrison, BMedSci (Hons), M.B.A
Clinical Country Head
Covance, Australia

Megan Morrison is an experienced Country Head with 18 year’s experience working within the industry. Megan has a strong medical science and business acumen and has held roles that vary from local responsibly, to APAC responsibilities and Australian and New Zealand figure head. She has worked across universities, pharamecutical companies and international and regional CROs. Currently she is clinical Country Head at Covance.

Eman Nafea, MSc, PhD
Clinical Trials Education, Training & Development Manager
Parkville Cancer Trials Unit, Australia

Eman has nearly 20-years' experience in academic and adult education in pharmacy, biomedical engineering and clinical research. She has research expertise in innovative drug delivery systems for treatment of challenging diseases. She is currently progressing with her Masters of Health Management at UNSW and is affiliated Assistant Professor of Pharmaceutics overseas. Eman has proficiency in Australian legislation and regulation of clinical trials and medical research by previously working in Sydney Children’s Hospital Network and The Royal Children’s Hospital Melbourne. In 2017, she has joined Parkville Cancer Clinical Trials Unit to establish the role of Clinical Trials Education, Training & Development Manager. Her main focus is on enhancing clinical trial quality through competency-based education and training programs for site staff at all levels. She is concurrently working with the Victorian Comprehensive Cancer Centre as a consultant to develop education projects aiming to build workforce capacity and capability in the clinical trial industry in Victoria.

Sumith Nawaratne, PhD, BSc (Hons)
Senior Project Manager
PRA Health Sciences, Australia

Sumith holds a BSc (Hons) from Monash University in Pharmacology and a PhD from the Victorian College of Pharmacy/Austin Hospital in Clinical Pharmacology and Pharmacokinetics. He has been engaged in clinical research, project management, pharmacovigilance, clinical training, clinical compliance and medical marketing for the last 22 years. In that time, he has worked for CSL, PPD, Mayne Pharma, Hospira Australia and Clinuvel Pharmaceuticals. He was also the project manager for the Australia Thai HIV vaccine Consortium, for which he was responsible for the GLP, GMP and GCP development of two HIV vaccine candidates. He has experience in all areas of pharmaceutical/biotechnology product development from conception to market approval and medical marketing, with his strength in clinical development.
During his time in the pharmaceutical industry, he has held concurrent appointments as a Senior Fellow in both the Radiology and Microbiology/Immunology departments of Melbourne University and was an ARCS Board member. He is a current member of the Australian Institute of Company Directors and a Fellow of the Australian Institute of Project Managers. He completed his role as the Director for Clinical Research & Compliance at Clinuvel Pharmaceuticals, responsible for all global clinical research activity for the lead product, SCENESSE®. In October 2014, SCENESSE® was approved by the EMA . This work was also published in the New England Journal of Medicine July 2015.

Maureen Nicholls, BSc Pharmacy
Country Clinical Operations Leader
Roche, Australia

I started out my career as a pharmacist working in retail and hospitals and discovered clinical trials when I moved to Australia. I have now worked in the Pharmaceutical industry for 19 years both in a CRO and Pharma and have been fortunate enough to work with amazing people who are dedicated to helping patients get access to life changing medicines. I have held a number of different positions and currently really enjoy managing a team of experienced project managers managing trials across Asia Pacific. I am passionate about people and patients and consider myself lucky to be able to work in this industry doing so much great work.

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.

Nicola Norton, RN
Clinical Project Lead
Linear Clinical Research, Australia

Qualified as a Registered Nurse in the UK and spent most of my nursing career in Theatre and Elective Orthopaedics. I moved across into Clinical Research in 2000 and worked for a CRO(LCG Bioscience) initially as a Research Nurse progressing up to a Senior Study Coordinator. After 7 years I then went to work for Glaxo Smith Kline based at their Clinical Trial Facility, based in Cambridge as a Study Manager. In 2016 I emigrated to Perth where I currently work for Linear Clinical Research as a Clinical Project Lead managing Early Phase Trials covering a variety of therapeutic areas.

Rachael Nowak, BSc (Hons)
Senior Clinical Research Associate II/Clinical Lead
Syneos, Australia

I have over 9 years of clinical research experience and have worked with a range of Sponsors on a variety of studies including; industry sponsored trials (big pharma through to small start-ups), Investigator Initiated studies and in international collaborative research organisations.

Catherine O'Mahony
Managing Director
On Q Recruitment Pty Ltd, Australia

Catherine O’Mahony is the Founder and Managing Director of On Q Recruitment, a leading provider of recruitment services across the Australian Life Sciences industry. Catherine has qualifications in Applied Biology & Marketing and before commencing her recruitment career 25 years ago, she worked for 5 years in the Pharmaceutical, Environmental & Food industry in Australia & Ireland. She founded On Q in 1999 and today leads a team of 10 highly passionate professionals assisting clients ranging Pharma, CROs, Medical Research Institutes & Government in scientific, technical and medical assignments.

Casey Orvin

Casey Orvin is President of the Society for Clinical Research Sites (SCRS). With nearly 20 years of experience working with the site community, Orvin previously served as Executive Vice President of Business Development for Synexus, and Vice President of Marketing and Sponsor Recruitment for Clinical Research Advantage.
Orvin is a champion for clinical research sites with experience creating outreach programs, developing key partnerships, and generating study opportunities for hundreds of clinical research sites globally. He is an active community member and dedicated volunteer in the Phoenix area where he lives with his wife and three children.

Resh Padilla, PMP, MBA
Project Director
PRA Health Sciences, Australia

Over 21 years experience in pharmaceutical and clinical R&D roles including project management, clinical development, quality assurance, manufacturing, medical, regulatory affairs, sales and marketing. Has worked in the Philippines, Singapore, Japan and Australia and has extensive experience across the rest of Asia and the US. Mentored and provided senior oversight to several project teams. Thrives in a fast-paced deadline-driven environment and has cross-functional expertise in all phases of drug development from pre-clinical to post-marketing. Widely experienced in therapeutic areas such as oncology, cardiology, infectious disease, respiratory, immunology, dermatology and neurology. Involved in CRO process development in Japan.

Sarah Poriters
Country Clinical Operations Leader
Roche, Australia

I have worked in clinical research for more than a decade, starting as a Study Coordinator at a small private practice working in HIV. I joined Roche in 2010 and have worked as a CTA, CRA, Project Manager and Clinical Research Manager. Working within our Oncology team I have a particular focus on lung and breast cancer. Recently I’ve been supporting our team members who are implementing the Teletrial model on their studies and I am very excited about this opportunity to bring trials to patients in rural Australia.

Heike Raunow, MPH, RN
Manager, Clinical Trials Unit
Western Health, Sunshine Hospital, St. Albans (Australia)

Heike trained as a registered nurse, specialised initially as a cancer nurse and then as research nurse. She holds a Master in Public Health as well as a Diploma in Management. Heike has worked in various roles as Research nurse, Team leader and Research manager across all phases of clinical trials across the areas of Oncology/Haematology/ BMT and Intensive care. Currently Heike manages the clinical trials unit at Sunshine Hospital - Western Health.

Amanda Rangel, MS, CCRC
VP of Business Development
VirTrial, USA

Amanda has spent 15 years in the clinical research industry serving a variety of functions including clinical research coordinator, patient recruitment and engagement specialist, business development, and head of operations for a US based site network. Most recently, Amanda served as Sr. Director, Global Business Development for Synexus, the largest site network in the world. Amanda is now fortunate to help lead VirTrial's integration of telehealth into the clinical research industry.

Teresa Ringeri, RN Div.1; BAppSc(Psych); BNurs
Business Manager, Senior Clinical Research
Emeritus Research, Australia

Experienced Senior Clinical Research Coordinator and Business Manager at Emeritus Research, which is a dedicated Clinical Research Centre. Has worked in the pharmaceutical clinical trials industry for over 8 years and recently moved into the Business Manager position, which involves managing studies from the point of feasibility, and assessing their suitability for our site, up until the point of Site Initiation Visit. Skilled in Good Clinical Practice (GCP); setting up and running clinical trials; maintaining excellent relationships with clients, study participants and staff; Mentoring; Leadership; and Business Development. Strong research professional with a Bachelor of Nursing/Bachelor of Applied Science from Deakin University. Loves being at the forefront of cutting edge clinical trials that provide new treatment options and benefits for trial participants.

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, BSc
Regional Lead
Vertex Pharmaceuticals, Australia

Natasha Rogic is a clinical research professional with approximately seven 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 various companies. 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.

Mark Rosenthal, PhD, MBBS, FRACP
Parkville Cancer Clinical Trial Unit, Australia

Professor Mark Rosenthal trained as a Medical Oncologist in Melbourne and Sydney, Australia. He was awarded a Doctorate of Philosophy for a thesis examining the molecular genetics of colon cancer conducted at the Ludwig Institute for Cancer Research. (1992-1996). He completed post-graduate training at New York University Medical Centre, New York, USA (1996-98) was a Senior Staff Specialist in the Department of Medical Oncology, Royal Melbourne Hospital (1998-2016) and Professor Director of the Department from 2006-2016. He was Chairman and Chief Medical Officer of Cancer Trials Australia (2006-2016) and was Chairman of the Cooperative Trials Group for Neuro-Oncology (COGNO) from 2007-16. In 2016 he was appointed as: Senior Staff Specialist in the Department of Medical Oncology at the Peter MacCallum Cancer Centre, Director of the Parkville Cancer Clinical Trials Unit and Clinical Trials Lead for the Victorian Comprehensive Cancer Centre. His major interests include: neuro-oncology and early phase clinical trials.

Dhanusha Sabanathan, PhD, MRes,MMed, MBBS
Oncologist, Nepean Blue Mountains Local Health District (NBMLHD)
Clinical Trials Fellow, Macquarie University, Australia

Kylie Shackleton, RN
Deputy Manager
Parkville Cancer Clinical Trials Unit

Kylie Shackleton is the Deputy Manager of the Parkville Cancer Clinical Trials Unit (PCCTU) located in Melbourne Australia. The PCCTU is an integration of the Medical Oncology and Haematology Cancer Trials Units of Peter MacCallum Cancer Centre, The Royal Melbourne Hospital and the Royal Women’s Hospital. It is the largest cancer trials unit in Australia with over 100 staff providing support for over 70 clinicians to undertake cancer trials. The PCCTU has a strong focus on highly specialized and complex trials including early drug development. Kylie brings nearly twenty years of oncology research nursing experience to her recent appointment as Deputy Manager of PCCTU. Before moving to the PCCTU, Kylie worked in investigator initiated trials at the Walter and Eliza Hall Insititute, where she helped establish a role for Venetoclax in the treatment of breast cancer.

Vicki Sproule, RN
National Lead Clinical Research Coordinator
Genesis Care

Vicki is a registered nurse that has been working in clinical trials for the past 15 years and is currently the National Lead Clinical Research Coordinator for Genesis Care. Vicki has worked across both the public and private sectors at a site level as well as from a sponsor perspective with a collaborative group and pharmaceutical company. Prior to working in research Vicki worked as an RN in a vaiety of roles. Vicki is passionate about ongoing education for research staff and this is a focus of her current role with Genesis Care.

Helen Stevens, RN
Clinical Nurse Consult-Early Drug Development
Parkville Clinical Trials Unit

Helen Stevens has 20 plus years of Oncology/ Haematology /Apheresis nursing experience across three major teaching hospitals. She is a Senior Research Nurse for Oncology/Haematology clinical trial across a range of tumour types, and clinical phases including First in Human Phase 1 trials. Helen is Involved in the development of a Phase 1 outpatient’s clinic, at the Royal Melbourne Hospital, as a tertiary referral centre to assess patients with advanced cancer suitability for trials and arrange pre testing for mutation panels. She is a Senior Research nurse involved in a pilot study for Risk –based monitoring in a Phase 1 setting during early implementation of RBM. Currently Clinical Nurse Consultant-Early Drug Development Clinical Trials at the Parkville clinical trials Unit.

Carolyn Stewart, MMedSc
Business and Operations Manager
Melbourne Children's Trials Center, Australia

Carolyn began working at the Melbourne Children’s Trials Centre (MCTC) in April 2014. In her current role as Business and Operations Manager, Carolyn is responsible for the management, operation and administration of MCTC services relating to clinical trial activities within the Melbourne Children’s campus. Carolyn has a Masters of Medical Sciences (Drug Development) from the University of New South Wales and has more than 20 years’ experience in clinical research primarily within the biopharmaceutical industry. She has worked in various clinical and operational roles, including 12 years at Amgen Australia Pty Ltd as a Clinical Research Manager and 7 years at Nucleus Network Limited early phase clinical trial unit. Carolyn has experience in all phases of clinical drug development in a broad range of therapeutic areas within Australia, Europe and the US.

Adam Stoneley, BBus
Research Operations Manager
Icon Group, Australia

Adam Stoneley is the Research Operations Manager for the Icon Group, and is a firm advocate of the Group’s simple vision to deliver the best care possible to as many people as possible, as close to home as possible. Icon’s research activities are coordinated centrally from the Brisbane headquarters with clinical trials underway at 9 satellite outpatient clinics across Australia. With support from the Icon Group and embracing innovations such as tele-trials and satellite site supervision plans, Adam is keen to have most of Icon’s 30 clinics across Australia providing clinical research opportunities to the wider community and servicing patient populations with unmet needs.

Courtney Thornely, BSc
Program Manager
Victorian Comprehensive Cancer Centre, Australia

A passionate and committed healthcare professional with an array of experience in both clinical and translational research in oncology, culminating in an extensive working knowledge of both the healthcare and academic sectors. As a professional, Courtney Thornely takes a continuous approach to evaluation and is constantly seeking agile ways to improve processes and procedures; achieving mutual satisfaction of all parties involved. A strategic thinker, Courtney enjoys the opportunity to apply experience and knowledge for continuous improvement, and uses these skills as a program manager to further develop engaging communication and beneficial relationships to build trust with key stakeholders and opinion leaders.

Robert Tobler, B. App Sc.
Team Leader/Senior Study Coordinator
Parkville Cancer Clinical Trials Unit (Peter Mac), Australia

Rob Tobler trained as a Radiation Therapist at QUT, Brisbane and worked in this field for 5 years at a number of regional centres across Australia. In 2013, Rob became a study coordinator at Barwon Health, Geelong, and joined PCCTU in January 2017. He is currently a Senior Study Coordinator and the team leader for the Head & Neck/Upper GI/cSCC medical oncology tumour stream team at PCCTU. His interest areas include quality improvement and site process efficiencies through technology.

Michelle Tuer, BHA, MPH
Therapeutic Area Leader - Oncology
Roche Australia

Michelle joined Roche in 2002 and has extensive experience is various functional and leadership roles in Australia, United Kingdom & the USA. Having returned to Australia last year, she is now the Therapeutic Area Leader for Oncology and leads a broad operations team to deliver on clinical trials in Australia and the Asia-Pacific region. She has strong partnering experience and is passionate about cross industry collaboration to improve patient access and bring innovative solutions to how we conduct our trials. Prior to joining Roche, Michelle held a number of business management and financial positions in the NSW public health care system.

Fiona Tuthill
Research Business Manager
Border Medical Oncology Research Unit, Australia

Fiona Tuthill joined the BMO Research Unit in 2010 after returning to her home town and a new career in Cancer Clinical Trials Management. Fiona has over 25 years' experience in financial and project management in the private sector, having spent the previous 15 years as a Director in Structured Finance at Société Générale a major French Investment Bank. Fiona has been able to bring a fresh prospective to Clinical Trials Management and its financing.

Dorothy Ugaddan, B. Sci.
Senior Clinical Manager-Clinical Management
PPD, Australia

My professional career started in the Philippines in 2000 where I have gained experience in the CR Industry as CRA for Pharmaceutical company. I have gone to a CRO approximately 3 years later, moved up to ranks as SR CRA and had the opportunity to not only monitor in my home country but including Singapore and Malaysia. I managed phases II to IV clinical trials in various therapeutic areas including Psychotic and Mood disorders, Haematology, Oncology, Cardiology and Infectious Diseases. Sponsored by PPD Australia in 2007 as a SCRA initially and was promoted as an Associate Clinical Manager in 2013. In the role, I am leading and supporting the successful delivery of the Clinical Management goals and objectives while building a motivated, productive and collaborative team. Supporting and coaching individuals achieve their personal career goal. I also work closely with project teams specifically focusing on providing local guidance and support they achieve recruitment targets whilst maintaining quality at site.

Tamara Waddell, PhD
Senior Clinical Manager
PPD Australia, Australia

Tamara is an experienced Clinical Research Industry professional, with 18 years' experience managing and monitoring clinical trials in both the CRO & Pharmaceutical environment. Currently responsible for line management of Clinical Management staff at PPD Australia, with a key focus on end results using metrics and KPIs to manage performance. She also supports the oversight of Australian Clinical Operations, collaborating with senior management on strategic planning, resourcing and business development. Prior to PPD, Tamara worked in project management and has extensive experience managing trials in a wide variety of therapeutic areas across the Asia Pacific region. Her education includes a PhD in Cardiovascular Physiology and a Bachelor of Science (with Honours). Tamara strives for personal and professional development, and contributes to initiatives that enhance PPD’s business objectives.

Karen West
Executive Director, Clinical Development
Syneos Health, Australia

Karen heads up the early phase operations for Syneos Health in APAC and also oversees the management of the external phase I units in Europe. Karen has over 25 years’ experience in the pharmaceutical industry including pharma and local and global CROs. Karen has held a number of positions within clinical operations, project management, training, business development, strategy and executive management. Karen has worked in all phases of clinical development from proof of concept and phase I through to large scale phase III and IV studies. Karen has managed staff regionally and locally and has extensive clinical operations management experience having been responsible for over 150 clinical staff in 11 countries within Asia Pacific.

Kevin Wightman, BSc (Hons)
Director of Business Development
Illingworth Research Group, Australia

20+ years experience in leading Pharma, CRO and eClinical Solutions including Clinical Operations, Regulatory Affairs, Corporate Development, Business Development and Senior Management roles.

Elizabeth Wilson, BPharm, PGDipClinPharm
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.

Felicity Wilson
Study Start Up Manager
Roche, Australia

Clinical Operations Manager in pharmaceuticals with over 10 years' clinical trial experience including 6 years in Study Start Up. I lead a highly engaged team of Study Start Up Specialists at Roche Products who have implemented novel submission strategies such as direct sponsor submissions. My mission is to achieve positive business outcomes through realising people's potential. I do this through my coaching, learning, strategic and agility capabilities. I am motivated by my team creating hope and clinical trial opportunities for patients in need of enhanced treatment options.

Anne-Marie Woods, RN
CCTC Manager
Austin Cancer Clinical Trials Centre, Australia

Anne-Marie is a registered nurse with 20yrs experience conducting Oncology/Haematology clinical trials within the public health sector. She is currently the Manager of Cancer Clinical Trials (CCT) at Austin Health. Anne-Marie is passionate about promoting excellence, quality and efficiency in
research practices through collaboration, innovation and engaged leadership. Prior to her current role she was the CCT Quality Portfolio Coordinator, a unique and highly successful clinical site position offering support across the department, enhancing quality in all areas of clinical trial management operations.

Christine Zahren, BSN, RN, MAppSC (Acu)
Director, White Coats Foundation
Business Development Manager, ClinTrial Refer, Australia

Christine has a background in nursing with over 25yrs experience in the healthcare Industry. She has worked in various areas including aged care, acute care, rehabilitation medicine, dermatology specialist clinics, and surgery. Christine has extensive experience as a clinical trial nurse coordinator, and spent 5 years managing the Dermatology Clinical Trials Unit at the Skin & Cancer Foundation Inc in Victoria. She also holds a Master of Applied Science in Chinese Medicine (Acupuncture). Christine joined the ClinTrial Refer team in August 2019 following a merger between her company ‘Clinical Trials Connect’ and ‘ClinTrial Refer’. The move was part of a joint vision to provide a central hub where people could access current clinical trial information. Christine is also the Co-founder and Director of the White Coats Foundation which is a NFP dedicated to supporting the discovery of better health through awareness. She also works one day a week as a Trials Strategy and Development Consultant at The Skin & Cancer Foundation Inc.

Professor John R. Zalcberg OAM, MB BS, PhD, FRACP, FRACMA, FAHMS, FAICD
Head, Cancer Research Program
Monash University, Australia

Professor Zalcberg is currently the Head of the Cancer Research Program as well as NHMRC (MRFF) Practitioner Fellow in the School of Public Health and Preventive Medicine at Monash University - currently overseeing the establishment and activities of clinical quality registries across various tumour types. He is also the inaugural Tony Charlton Chair of Oncology at Alfred Health as well. He was previously the Director, Division of Cancer Medicine, at the Peter MacCallum Cancer Centre in Melbourne from 1997 to 2014 as well as their Chief Medical Officer from 2007 to 2013. He is the current Chair of the Australian Clinical Trials Alliance and serves on the Board of the Australian Red Cross Blood Service. He is immediate past Chair of the Board of AGITG after serving in this role for over 15 years and a past Board Member of Cancer Trials Australia and past Co-Chair of the Cancer Drugs Alliance. Previous positions also include Board Member of the NSW Cancer Institute, President of the Clinical Oncological Society of Australia. He received a Medal of the Order of Australia Award (OAM), the 2011 Cancer Achievement Award from the Medical Oncology Group of Australia and the 2015 Tom Reeve Award for outstanding contribution to cancer care from the Clinical Oncological Society of Australia (COSA). In 2014 the AGITG announced the annual “John Zalcberg OAM Award for Excellence in Australasian Gastro-Intestinal Trials Group (AGITG) Research” in his honour. He has over 280 articles published in peer-reviewed journals and has received funding in excess of $54m over the course of his career.