Marian Adikari, LLB, BSc
Manager, Site Contracts
Marian Adikari, LLB, BSc
Manager, Site Contracts
Clinical research professional and qualified lawyer with 10+ years of site contracting experience, including 3+ years of line management of site contract managers. Highly experienced in all aspects of site contracting (including study grants). Also has a strong science background (majoring in Physiology).
Mazen Amatoury, BSc (Hons)
Senior Clinical Research Associate
With a background in scientific research in a hospital setting and >6 years experience in the pharmaceutical industry as a CRA, Mazen has a passion for promoting patient safety and data integrity in clinical trials. Over the past 2 years, he has led the expansion of the medical surplus recovery program, ‘Kits4Life’, to Australia and is calling all pharmaceuticals and CROs to make lab kit donation an Industry standard, to help patients in need and divert waste from landfill. To learn more about Kits4Life, Mazen will be at the Bayer booth #3 along with not-for-profit partner, Medishare.
SVP, Global Study Operations & Expansion
Founder & CEO
Maree Beare, a recognized leader in the fields of HealthTech, Femtech, and Biotech, has made significant contributions to the industry. Her innovative approach and disruptive solutions have garnered attention, earning her a place on Forbes’ prestigious list of top 50 Healthtech disruptors. As the founder and CEO of Clinials, Maree Beare is revolutionizing the clinical trials market, a sector valued at $47 billion. Recognizing the inefficiencies and challenges in the study participant recruitment process, Maree embarked on a mission to provide a more effective and streamlined approach. Clinials, a unique participant recruitment platform, utilizes the power of AI to enable pharmaceutical researchers to communicate complex medical information to patients, improve candidate selection, expedite clinical trial timelines, and offer comprehensive multi-site analytics. Additionally, Maree Beare is a driving force behind Wanngi, a health management platform, and a Biotech company. Her dedication to the advancement of HealthTech, Femtech, and Biotech is evident in her unwavering commitment to bringing life-saving medicines to market. Maree’s passion and expertise have allowed her to address the persistent challenges within the clinical trials landscape. With a staggering 80% failure rate for trials despite substantial budgets, Maree’s visionary leadership has the potential to reshape the industry and significantly impact the lives of patients worldwide. Through her ventures, Maree Beare continues to push the boundaries of innovation in HealthTech, Femtech, and Biotech, ensuring that individuals receive access to more effective treatments sooner and contributing to the advancement of medical research and patient care.
Janelle Bowden, PhD
Managing Director and Consultant
Janelle Bowden, PhD, is a scientist by training and has 20+ years of experience working in and around clinical trial operations in Australia and overseas, for sponsors, sites, and as a consultant. Janelle has a passion for creating more inclusive, accessible trials, and supporting greater consumer participation and involvement in research. Janelle’s social enterprise, AccessCR, provides clinical trial and consumer engagement products and services to organisations involved in research, so as to deliver on its mission to support, build capacity in, connect and advocate for the needs of people looking for, taking part in and contributing to medical research and clinical trials – the Community and Consumer Research Workforce (CCReW).
CEO & Founder
Evrima Techologies, Australia
Experienced patient recruitment specialist with strong project management and digital marketing expertise across various therapeutic areas and trial phases. Client-focused and driven to achieve innovative solutions.
Katrina Brosnan, RN
Principal Policy Officer
The Australian Teletrial Program, Queensland Health, Australia
Katrina trained as a Registered Nurse, specialising in Intensive Care. After twenty years in the clinical environment, she became involved in clinical trials – initially in Dementia. She has worked in research administration – across both research ethics and research governance roles, and as a research development officer, and started working as a Principal Policy Officer in the Office of Health and Medical Research, Queensland Health (now known as the Office of Research and Innovation) in 2010. Katrina steps back into clinical work periodically to maintain her currency of practice both clinically and in the clinical trials space, working in Cardiology Research and Clinical Trials, and Acute Stroke Clinical Trials. Katrina joined the Australian Teletrial Program in 2021 as Principal Policy Officer.
Principal Project Officer
Shelley comes from a animal science background, and has spent the last decade working in clinical trials. coordinating international early phase trials in ophthalmology and oncology. Passionate about the importance of clinical trials in supporting high quality healthcare she moved into a role at the NSW Ministry of Health. Since starting she has delivered several large scale clinical trial initiatives within the public sector, and is currently coordinating the complex implementation of a CTMS software system to support clinical trial delivery across all NSW public hospitals.
Radhika Butala, MIPH
Clinical Trial and Research Manager
Westmead Private Hospital, Ramsay Healthcare, Australia
Radhika is a passionate Clinical Researcher and Site Advocate with over 17 years of experience and expertise from Trial Coordination to Trial Unit establishment. She has diverse clinical trial expertise in interventional and device studies spread across multiple therapeutic areas along with operational and managerial experience in the public, private, commercial and academic sectors within the clinical research industry and the Australian Healthcare sector. She is passionate about collaborating, educating and championing young people to seek careers in clinical research. She is currently the Clinical Trial and Research Manager at Westmead Private Hospital in Sydney, a part of the Ramsay Healthcare Group, where she is setting up a new clinical trials unit.
Joshua Carey, Master of Clinical Nursing (Quality and Safety), BN
Emeritus Research, Australia
Joshua has worked in the healthcare sector for over 8 years, beginning as a Registered Nurse in 2014, before moving to Clinical Trials as Research Nurse/Study Coordinator in 2018. While Working in Clinical Trials he realised he was drawn to quality control projects, later making the decision to pursue this avenue in a Masters Degree in Clinical Nursing (Quality and Safety). After achieving his degree, Joshua moved into a Quality Associate Role in a Phase 1 trial centre, before taking on his current Quality Specialist role at Emeritus Research.
Business Development Manager
Mia brings experience from both the technology and site sides of the clinical research industry. Leading site sales at CRIO, Mia helps to equip research sites with a software that replaces pen-and-paper data collection processes. Prior to CRIO, Mia worked at a site network conducting Phase II-IV clinical trials. This multifaceted background allows her to bring a unique perspective to the work she does with sites.
Maria Cecilia L. Castillo
Senior Director, Quality Assurance
PPD, part of Thermo Fisher Scientific, Australia
Cecilia is a wife and mother to three beautiful children and consider her family her greatest blessing and source of motivation. She lost her father to cancer as a teenager soon after she entered university in 1994 – a time of limited treatment options for Acute Lymphocytic Leukemia. Having realized the impact of this situation, it inspired her to pursue a science degree and join the clinical research industry; first as a study coordinator, then as a CRA, Regulatory Affairs and ClinOps leader, and then into Quality. This work is personal, knowing her work can help patients and their families enjoy life to the full. She is currently the global head of Audit Management in PPD, part of Thermo Fisher Scientific, leading 58 Quality professionals across 20+ countries, delivering best in class billable and non-billable drug development services to Pharma, Biotech, and Government clients. She is known for collaborative leadership, leading change and transformations, and consistent delivery of business targets. Cecilia was previously a college instructor and is a teacher by heart. One of her greatest joys is to see people grow in their personal and professional lives – a most rewarding and a constant source of encouragement for a dedicated leader and mentor. Her goal is to have continuous development professionally and in personal life; influence people around her to find meaningful purpose in life, passion for excellence, and serve others.
Bosco Chan, MPhil
Senior Country Trials Manager
Bosco is a Senior Country Trials Manager for Pfizer Australia Pty Ltd, with over 17 years of project management, line management and international drug development experience across Australia, New Zealand, Hong Kong SAR China and the United Kingdom.
Dora Charalambous, PhD, MBA
Senior Director, Project Delivery
PPD, part of Thermo Fisher Scientific, Australia
Dora Charalambous is a Senior Director and the APAC oncology lead for Project Delivery at PPD, part of Thermo Fisher Scientific. Dr Charalambous has over 25 years of clinical operations experience across a wide variety of therapy areas and has held senior operational leadership roles from both CRO and sponsor side. Her current focus is on supporting the successful delivery of oncology programs across the biotech sector, including advanced therapies in early development. Dr Charalambous holds a medical research PhD from Monash University and MBA from Melbourne Business School.
Julie Charlton, RN
Site Care Partner
Julie Charlton is a Site Care Partner with Pfizer. Having started her career as a nurse, Julie has over 20 years of experience across clinical sites, ethics, research governance, collaborative research and industry. With extensive knowledge across all phases of research, she has end-to-end expertise across multiple disciplines including oncology, intensive care, vaccines, respiratory, haematology, heart failure, rare diseases, and GMO research.
Julie spent 10 years as a research governance manager across multiple institutions in Sydney, and provides a unique and pragmatic approach to implementing GMO studies across Australia. Motivated by equitable health care, Julie focusses on process improvements and practical solutions to drive positive patient outcomes.
Hiram Chipperfield, PhD
Beyond Drug Development, Australia
Hiram Chipperfield is a Principal Consultant at Beyond Drug Development where he provides product development and regulatory affairs support, with a focus on early-phase clinical trials. He has over 10 years industry experience working on a range of advanced therapies from preclinical development through to marketing authorisation. Beyond Drug Development is an integrated product development team dedicated to early-stage therapeutics development, with a primary focus on advancing innovative products from small to medium biotechnology and pharmaceutical companies worldwide. Hiram is the current chair of the Beyond Drug Development IBC and was previously a member of the BioDesk IBC. During his tenure on these IBCs, he has reviewed 20+ Australian GMO clinical trial licence applications. He has a scientific background with a PhD from the University of Queensland, followed by academic and commercial research in Boston and Singapore. Prior to joining Beyond, Hiram held roles in a regulatory affairs consulting firm, a global diagnostics company and a regional CRO.
Patricia (Trish) Church
Site Excellence Partner
Trish started her career in clinical research as a Research Nurse in a Phase I unit in Edinburgh, Scotland before joining the pharmaceutical industry as a CRA in 1997. Since then, Trish has held numerous roles supporting sites and sponsor companies across most areas of clinical research. Her current role is with Pfizer as a Site Excellence Partner where her focus is quality, including oversight of the monitoring function.
Chief Commercial Officer
Matt has worked in the medical and clinical research industry since 2000 across Asia Pacific, Europe and North America. In 2015 he founded Paratus Clinical and attained capital funding for the new company, of which he is now a Director and Chief Commercial Officer. Paratus Clinical has a network of dedicated research sites across the east coast of Australia and has conducted over 100 trials.
Senior Operations Manager, AUS/NZ
Icon Group, Australia
Rebecca has over 10 years’ experience in the clinical research space, having held numerous roles across quality, governance, and clinical operations. With a strong interest in early phase oncology trials and a dedication to improving the execution of trials. Rebecca leads Icon’s Research Coordination with efficiency. Managing an experienced team, she is focused on improving the planning and execution of Icon global clinical trials program whilst maintaining the highest quality of patient safety.
Chief Executive Officer
Emeritus Research, Australia
Cheryl commenced her Clinical Research career in 2002 when employed by Monash Health’s Haematology Research Unit as a Clinical Trials Coordinator. She soon took on the role of Manager. To widen her understanding of the whole process of Clinical Trial approvals, she spent a year as a member of the Monash Health HREC. In September 2015 she was given the honour of being appointed the MHTP Clinical Trials Centre Manager, consolidating her clinical management skills. In October 2018 Cheryl joined Emeritus Research as Operations Manager, introducing new roles to allow for growth and efficiency. In June 2021 she was appointed CEO and is looking forward to cementing Emeritus Research’s place in the industry as the gold standard clinical trials site. Clinical Trials have opened the world for Cheryl. The girl from small town middle America has travelled to 4 continents with her roles within research. She loves a good laugh, sneezes very loudly and has learned that “Great Things Never Come From Comfort Zones”. (Author Unknown).
Lestter Cruz Serrano, M.D., BCMAS
Head of Medical Affairs and Global Site Engagement Lead
Cognizant Technology Solutions, USA
Dr. Lestter Cruz Serrano is the Global Head of Medical Affairs in Cognizant Life Sciences group. He is also the global lead for Site Engagement for Shared Investigator Platform (SIP) driving regional site adoption with groups in US, Canada, EU, ASIA-PAC and LATAM. He has led Cognizant’s efforts, in close collaboration with SIP Sponsors, to assist the most prestigious & large Academic Medical Centers around the world to adopt SIP. Prior to this role, Dr. Cruz worked at CHI Health, where he led the Hematology and Oncology studies for the NIH Cooperative Group and Pharmaceutical Trials. He has also worked at Nebraska Medicine & the University of Nebraska Medical Center where he conducted phase II & III clinical trials for Diabetic, Endocrinology, Metabolic and Cardiovascular patients. He received his M.D. degree from the UAG School of Medicine and trained as a Family physician. He is a Board-Certified Medical Affairs Specialist and currently is working on his MBA.
Jhodie Duncan, PhD
General Manager of Research and Partnerships
Latrobe Regional Hospital, Australia
Dr. Jhodie Duncan is currently working at Latrobe Regional Hospital as the General Manager of Research and Partnerships in the Research Unit. With a strong sense of teamwork, relationship building and community engagement she is excited to be working towards improving health outcomes for the Gippsland community. Jhodie has over 20 year’s research experience having completed her PhD at the University of Melbourne in the field of developmental neuroscience, after which she was awarded a CJ Martin Fellowship to undertake post-doctoral training at Boston’s Children’s Hospital/Harvard Medical School. In 2009 Jhodie returned to Australia and received a Future Fellowship and ARC grant to work at the Florey Institute of Neuroscience and Mental Health in the field of addiction neuroscience and act as lab head for the “adolescent inhalant abuse” laboratory. Jhodie joined the team at Latrobe Regional Hospital in 2020 as Research Manager and has vast experience in both pre and clinical research, supervising students, leadership, mentoring and acting on committees. In 2023 she was promoted to General Manager of Research and Partnerships providing oversite to a growing Research Unit focused on expansion of clinical trials and teletrials regionally. Her accolades include over 50 publications, presentation of 35 seminars and contribution to the activation of over 20 clinical trials at Latrobe Regional Hospital via the development of strong collaborative partnerships.
Louretta Dwyer, EEN CCRC
Dedicated Clinical Research Coordinators, Australia
With a background in Nursing where a passion for patient care and the desire to facilitate the availability of improved treatment options began, Louretta embarked on a 20-year-long career in Clinical Research. She completed Clinical Research Coordinator Certification with ACRP and worked as a Clinical Research Coordinator at a large Clinical Research site specialising in Pain Medicine before managing an Endocrinology Clinical Research Centre. Having worked on some 40+ pharma and device trials, juggling the overlapping clinical, administrative, and business aspects of the role, it was clear how complex AND how vitally important the role of CRC is. With resourcing a concern industry wide and unwavering determination to see Australia feature on the global clinical trials stage, a team of Dedicated Clinical Research Coordinators (DCRC) to support the successful completion of clinical trials, commenced. Dedicated CRC’s can be found working quietly behind the scenes, sometimes remotely, to relieve some of the pressure on site staff and collaborate with CRO’s and study Sponsors in achieving excellent clinical trial results. DCRC’s may also be seen at sites where we focus on safety and wellbeing of patients while working hard to foster a collaborative work environment with our colleagues. All DCRC’s are Nurses Registered with AHPRA, with an average of 25 years clinical experience in General Medicine, Orthopaedics, Respiratory, Renal, ICU, Surgical suite, Trauma, and others. DCRC’s can administer medications and will undertake protocol specific training as required and delegated by PI. All have ICHGCP Certification, thrive on teamwork, always uphold professionalism and act with compassion and respect toward patients and their families.
Marina Dzhelali, Post Grad Nursing Science Degree
Research Manager/GCP Auditor
Medical Research Institute of New Zealand (MRINZ), NZ
Marina Dzhelali works as a Research Manager in Medical Research Institute of NZ and as a QA Manager in Pharmasols Ltd. Born in Russia, raised in Ukraine and having worked professionally in USA and NZ for last 24 years, Marina has research experience in many clinical areas and is a current member of the NZACREs Executive Board. Living in one of the Wellington suburbs allows her to enjoy combination of suburban and semirural life style, with husband, kids and animals around. Favourite past time is to curl on the sofa with Agata Christie book and an apple!
Lisa Eckstein, S.J.D
Dr Lisa Eckstein is the CT:IQ Programme Director and Director of Philanthropic Activities for Bellberry Ltd. She also holds a position as Senior Lecturer in Law in the Faculty of Law at the University of Tasmania where her research focuses on ethical and legal issues associated with clinical research and innovative technologies. Lisa has previously completed a Doctor of Juridical Science at Georgetown University Law Centre and a post-doctoral fellowship in the Department of Bioethics at the National Institutes of Health.
Suzanne L. Elliott, PhD, BAppSc; Grad Dip (Drug Dev)
Associate Director of Clinical Trials
Gallipoli Medical Research Foundation, Australia
Suzanne is the Greenslopes Private Hospital’s Gallipoli Medical Research Foundation’s (GMRF)-Associate Director of Clinical Trials, overseeing 21 research staff in cancer, liver and respiratory trials. Previous roles included Operations Manager, Scientific Officer and Deputy CEO of Q-Pharm, a Brisbane-based, Early-Phase clinical trial site company, and with the CRC-Vaccines, Vaccine Solutions and the QIMR Berghofer Regulatory Affairs Manager involving investigator initiated immunotherapy trials in for Hodgkin’s Disease, prostate cancer and melanoma and vaccines in malaria. She has UNSW Drug Development qualifications and Good Clinical Practice accreditation. Suzanne has adjunct biomedical academic roles at both UQ and QUT and contributes to various committees for QUT, UQ, Praxis Australia, and other NHMRC ethics working groups with special interests in early phase adaptive drug design, malaria challenge studies, vaccine studies and research ethics.
Tahli Fenner, PhD
Director of Risk Management
Department of Health, Australia
Dr Tahli Fenner is the Director of the Risk Management Section, within the Pharmacovigilance Branch of the TGA, which is responsible for managing the clinical trial notification and approval schemes, as well as the pharmacovigilance and Good Clinical Practice inspection programs and risk management plan evaluation. Dr Fenner joined the TGA after completing her PhD in synthetic organic chemistry. She has worked across many different areas within the TGA and the Department of Health, since starting out in medicines evaluation. Her more recent roles within the TGA have included leading the teams responsible for managing medicines scheduling and expert advisory committees.
Shelley Firth, RN, BSN
Trial Advancement Manager
Emeritus Research, Australia
Shelley Firth is the Trial Advancement Manager at Emeritus Research a dedicated private clinical trials site in both Melbourne and Sydney. Shelley has held many leadership positions in Oncology and Clinical Trials, with over 15 years of experience within the public hospital and private sector. Shelley is committed to the implementation of new and efficient approaches in all aspects of clinical trials, resulting in positive outcomes for patients. Shelley is a registered nurse with a Bachelor of Nursing and has a post graduate certificate in Oncology/Palliative care nursing.
Patient Centricity / Decentralised Clinical Trial Lead
Megan has 16 years of clinical trials experience working in a range of roles within IQVIA and within the clinical research industry. Megan’s current role involves developing and implementing bespoke Patient Centric and Decentralized Clinical Trial (DCT) solutions. Prior to this, Megan has overseen the implementation of remote monitoring solutions, managed the CRA Development Program and worked in Quality Management.
Brayden Fraser, MSc
Chief Development Officer
Emeritus Research, Australia
Brayden is currently the Chief Development Officer at Emeritus Research, a dedicate private clinical trials site in both Melbourne and Sydney. As part of his role, he oversees the Business Development, Recruitment and Study Start-Up (trial advancement) functions of all Emeritus Research sites.
Diana Foster, PhD
Total Diversity, USA
Dr. Diana L. Foster currently serves as the Chief Executive Officer for Total Diversity Clinical Trial Management. She has worked with Total Diversity since inception and has guided Total Diversity as it has become a full-service contract research organization.
Danielle French, BA (Hons)
Senior Project Manager
Ramsay Health Care, Australia
Danielle French is Senior Project Manager working across Ramsay Health Care and the Ramsay Hospital Research Foundation. Danielle has worked at Ramsay Health Care since 2015 after moving to Australia from the UK. Her work includes research and patient reported measure project implementation and managing Ramsay’s compliance with the National Clinical Trials Governance Framework. Motivated by improving patient outcomes, , she is passionate about delivering meaningful projects and understanding how clinical data can be used to provide better care.
Kathryn Gamble, BA Health Science, Grad. Cert. Business Law
Senior Clinical Operations Lead
Kathryn Gamble is a Senior Clinical Operations Lead at Roche Pharmaceuticals Australia. Her pharmaceutical career has spanned over 17 years and has included the coordination of multiple ethical review panels, Clinical Research Monitoring, and all aspects of Study Start-up. Her educational foundation in Health Science, and more recent studies in Law, drive her passion to ensure that the rights and needs of patients are front-of-mind in the development of Clinical Trial Informed Consent forms. Her career has included several collaborations with global colleagues for Consent related process and system development. Locally, she is recognised as SME for Informed Consent at Roche Australia, and has contributed on national initiatives, such as the CT:IQ InFORMed project.
Rick Greenfield, BBA-IS
Founder & Chief Strategy Officer
RealTime Software Solutions, USA
|Rick has 20+ years of experience in the Clinical Research industry. He was part owner & helped build one of the largest multi-specialty research sites in the US. His goal is to continue to build innovative systems for sites, Sponsor & CROs to contribute to operational excellence in clinical trials.|
Melissa Groom, RN
Senior Nurse Program Manager, Research Nursing & Phlebotomy Regional Specialist
Melissa Groom is an accomplished Senior Nurse Program Manager and Research Nursing and Phlebotomy Specialist in Australia at IQVIA.
With a career spanning 10+ years across a multiple positions in healthcare and industry, supported by a diverse range therapeutic area experience with a specialised focus in oncology and haematology, she has consistently demonstrated a passion for advancing patient health outcomes.
Combining her clinical background with a comprehensive knowledge of program management, Melissa has successfully led and overseen numerous complex patient support and education programs, alongside decentralised clinical trials. Melissa currently oversees IQVIA’s in home decentralised trial offering across Australia and played a pivotal role in shaping the landscape of decentralised clinical trials home service. Melissa possesses a profound understanding of the unique challenges and opportunities presented by decentralised trials, ensuring seamless implementation and execution.
Drawing from her background across multiple settings, Melissa brings a compassionate and patient-centric approach to all aspects of her work. Passionate, driven, and results-oriented, Melissa is proud to be at the forefront of advancing healthcare through progressive patient support programs and decentralised trial approaches.
Anne Gunner, MBBS; FANZCA (Pt I)
Paratus Clinical Research, Australia
Dr Anne Gunner graduated from Sydney University in 1989. Her medical career has been largely hospital based, working extensively in the fields of Anaesthetics, Intensive Care and Critical Care, as well as medical education and general medicine, before venturing into the world of Clinical Trials. Other jobs include mother, farmer, cheese maker and local witch doctor, covering anything from delivering alpacas to treating kids who’ve fallen head first into the washing machine. She has published in both medical journals and literary magazines, as well as self-publishing two novels and some poetry collections. Her ambition is to be 80 and happy.
Senior Clinical Research Manager
Senior Clinical Research Manager Janssen Australia. With over 25 years of Pharmaceutical industry expertise, Samantha has worked in research, quality and training roles across sponsors and CROs. Samantha is currently responsible for Early Development trials in Janssen Australia. She has a passion for collaborative research, promoting Australia and New Zealand sites as the best options for global development studies.
Site Relationship Partner
Over 15 years of experience across Site, CRO and Pharma.
Cheryl-Ann Hawkins, RN, MHA
Chief Operating Officer
Emeritus Research, Australia
Cheryl-Ann Hawkins is the Chief Operating Officer at Emeritus Research. She has enjoyed working in many leadership positions in both Clinical Trials and Oncology in a career spanning 30 years. Her expertise is in Oncology, first in human, vaccine and GMO’s. Cheryl-Ann is focused on the practicalities of protocols and the impact on resources at site level. Implementation of innovative approaches of clinical trial delivery to ensure optimal efficiencies at site level is her priority. Cheryl-Ann is solutions oriented and thrives in the challenging clinical trial environment to ensure success for both sponsors and clinical trial participants. Cheryl-Ann is a Registered Nurse with a Bachelor of Nursing, has completed a post graduate diploma in Oncology/Palliative care nursing, a Master’s degree in Health Administration and a post graduate certificate in Cancer Research.
Antonio Hellebuyck, MMedSc, PMP
Senior Director of Project Delivery
PPD, part of Thermo Fisher Scientific, Australia
Antonio is a Senior Director of Project Delivery, within the Vaccines Therapeutic unit at PPD, part of Thermo Fisher Scientific. Within this role, Antonio serves as an Oversight Director on various vaccine trials supporting and guiding global project managers and project teams and is an SME and escalation point in APAC on vaccine project related matters at PPD. Antonio is a motivated, customer-focused and solution orientated and has more than 20 years of experience in the clinical research industry including clinical operations, project management, oversight, and business development. He has deep experience in leading global clinical trials in various indications (including healthy volunteers, vaccine and GMO trials) and leading teams to successful project delivery. Antonio holds a bachelor’s degree in medical science and a Master of Medical Science degree in Drug Development from the University of New South Wales. Antonio is also a certified project management professional (PMP) since 2017.
Stephanie Henderson, BSc (Hons)
Team Leader, Ethics and Governance
Cancer Trials Australia
Stephanie Henderson is currently the Team Leader – Ethics and Governance at Cancer Trials Australia based at the Peter MacCallum Cancer Centre. She has completed a Bachelor of Science (Hons, first class) from the University of Melbourne. Stephanie has extensive experience in writing, amending and adapting consent forms for interventional and registry based clinical trials. Her ethics experience includes submitting to a variety of public and private Adult and Children HRECs throughout Australia. She is interested in creating a consent form template that puts the participant at the forefront and improves the overall consent process.
Malisha Hettiarachchi, MSc
Senior Research Associate
Malisha Hettiarachchi is a Senior Clinical Research Associate at MSD. With over 10 years in the healthcare industry starting off as a clinical research coordinator at site to working as a research professional in the pharma industry across Australia and New Zealand. She has managed clinical trials with a broad therapeutic base and phases according to local regulations and, ICH- GCP guidelines. Malisha holds a Bachelor of Science in Biomedical sciences, and Master of Science in Biomedical Science from the University of Auckland.
Taneen Hisgrove, MAICD
Executive, Site Advocate
Senior leader with 15+ years in Asia Pacific developing strategy and driving operational delivery to by bring potentially life-saving or life changing medication to market faster. Experienced in building, managing, and growing operational teams across both the APAC region and globally. Skilled in developing, planning, and implementing transformational delivery models and successful integrations. I am privilege to have the platform to engage and collaborate with the site community globally and locally, to have time to listen and understand the challenges that will allow industry to work together to find solutions to support sites and expand patient’s access to clinical trials. I truly believe that ‘Patient centricity starts with Site Centricity’.
Business Operations Manager (Oncology & Haematology)
Linear Clinical Research, Australia
I’m the Business Operations Manager at Linear Clinical Research. With a primary focus on early phase clinical trials for oncologic and haematology malignancies, I bring seven years of experience in the clinical trial field. At Linear Clinical Research, I oversee a diverse portfolio of more than 100 clinical trials, ensuring smooth operations and compliance with regulatory requirements. I Collaborate closely with a dedicated team, I play a role in developing strategic plans that guide successful trial execution from study start up to study close. Through effective communication and a collaborative approach. Building strong relationships is essential in my role. I actively engage with researchers, CROs, pharmaceutical companies, and vendors to foster partnerships and establish Linear Clinical Research as a trusted clinical trial site.
To remain at the forefront of clinical research, we place a strong emphasis on continuous professional and company growth. We proactively explore opportunities to leverage software and technology, seeking innovative solutions that can enhance our site operations and ultimately benefit the treatment of our patients. Above all, my driving force is the desire to improve patient outcomes. I am deeply passionate about making a meaningful impact in the lives of individuals affected by oncologic and haematology malignancies. Through hard work and innovative approaches, My objective is to make a valuable contribution towards delivering optimal care and a diverse array of treatment options to patients. As a proud member of the dynamic team at Linear Clinical Research, I am committed to advancing the field of early phase clinical trials.
Associate Director Business Unit Operations
Syneos Health, Australia
Gjorgina a highly experienced Project and Operations leader with a product development mindset that has spent over 15 years working across Pharmaceuticals and Clinical Research Organisations bringing innovative products to market that help patients with unmet needs. Gjorgina has spent the last 3 years implementing and overseeing vaccine clinical trials, including a COVID-19 candidate during the pandemic and several others since across Australia and New Zealand, and she understands the unique requirements and challenges these trials pose for study teams.
Clinical Trial Unit Manager (Operations)
Gallipoli Medical Research Foundation, Australia
Vanessa has been in the Clinical Trial Industry for 20 years; 13 years CRO + 7 years at a Trial Site. Having first being exposed to CTMS at Novotech back in 2015 (Oracle) supporting the Project Managers and CRAs with CTMS Study builds and finance issues as the Clinical Project Specialist. She was hired at Gallipoli to implement a CTMS in 2016, a site that is a busy CTU with key opinion leaders in Oncology, Respiratory and Liver research. We first implemented IBM “Merge”, then moved to Advarra’s Clinical Conductor. Her focus was on team uptake and moving away from all things excel!
Senior Clinical Research Manager
Senior Clinical Research Manager at Janssen responsible for managing business operations, study feasibility and strategic site management across Australia and New Zealand.
Gina Kennedy, MS, Pharmacology
Senior Clinical Operations, Manager
Gina has over 25yrs in the clinical trials industry. She started in pre-clinical research, working in London UK and Australia. After being exposed to the benefits of clinical trials, Gina became a Study Coordinator and then moved into industry. Gina has worked in Pharmaceutical Companies and CROs. Currently Gina is Snr Clinical Operations Manager at ICONS Strategic Solutions (FSP). Gina is enthusiastic about the current changes seen in the industry. She is excited by the opportunities present to the Australian diverse population via remote access and eDevices. Gina believes Australia has a great opportunity to lead in the changing environment and build a strong workforce across all stakeholders.
Vice President of Strategy and Special Projects
Kent brings more than 30 years of experience in IT and clinical development from executive roles with Eli Lilly and Medidata Solutions. She has served on the SCRS Leadership Council for seven years, and is also a board director with Circuit Clinical and current Chair of the Association of Clinical Research Organizations (ACRO).
Research Operations Manager
The Kinghorn Cancer Centre, Australia
Robert has over 25 years of clinical and research experience. Since 2005, Robert has worked in roles such as Research Coordinator and Senior Clinical Research Associate for both academic and commercial institutions, in Australia and overseas. Robert has worked as the Research Operations Manager at The Kinghorn Cancer Centre since 2011. Leading a dynamic clinical trials department, Robert is responsible for building site capabilities and the rapid expansion of the centres Phase I unit as part of the NSW NECTA collaboration. He currently manages a large portfolio Phase I – III Industry trials, as well as developing and managing multi-centred national & international Investigator led research.
Rebecca Komesaroff, BBiomedSc(Hons), BSc
Clinical Trials Assistant
Murdoch Children’s Research Institute, Australia
Rebecca is a Clinical Trials Assistant at Murdoch Children’s Research Institute (MCRI) with almost two years of experience in clinical research. She is committed to working collaboratively with a diverse range of healthcare professionals to improve paediatric health outcomes and quality of life. In 2022, Rebecca participated in the Victorian Comprehensive Cancer Centre (VCCC) Alliance SKILLED Clinical Trials Assistant Internship where she undertook a Consumer Engagement Survey Study. The Survey Study examined the opinions and attitudes of parents, patients, and clinicians towards an animated information and consent video. Rebecca is passionate about understanding the information needs of children, culturally and linguistically diverse communities, and those with hearing difficulties. Specifically, she hopes to contribute to the development of novel communication strategies that optimise information access, build trust, and increase healthcare equity. Rebecca’s interest in clinical research was sparked during her Honours degree in the Department of Biochemistry & Molecular Biology at Monash University where she investigated the link between mutated Tuberous Sclerosis Complex (TSC) genes and TSC disease presentation.
Alison Lai, MSc (Med)
Senior Clinical Operations Manager, ANZ
Alison Lai is a Senior Clinical Operations Manager at MSD. Alison has enjoyed a career spanning 25 years in clinical trials within both Pharma and CROs. Alison holds a Bachelor of Science in Chemistry and Biochemistry, from the University of Newcastle and a Master of Science in Medicine from the University of Sydney.
Adrian Lanzillotti is an accomplished professional with nearly a decade of experience in patient recruitment for clinical trials. With expertise in the clinical research industry, Adrian excels in delivering value through partnerships. Within his role as General Manager at Clinibase, Adrian has been instrumental in the significant growth of the business and has delivered successful patient recruitment campaigns, ensuring the timely enrolment of qualified participants. His strategic approach and deep understanding of the industry has contributed to the effectiveness of numerous trials. Adrian’s strong communication and collaboration skills have fostered productive relationships with colleagues, clients, and stakeholders. His ability to work well with others has been instrumental in achieving positive outcomes.
Sharon Lee, RN, PhD Candidate
Clinical Research Manager
Western Sydney Local Health District, Australia
Sharon Lee (Clinical Research Manager, Western Sydney Local Health District) has over 23 years research experience across both investigator-initiated studies and pharmaceutical sponsored clinical trials. Sharon has extensive experience with ethics and governance applications processes and regulations. She is a Transcelerate accredited ICHGCP trainer. In her current role she assists researchers with protocol design and development, ethics and governance applications, budget negotiations, contract reviews and data collection ensuring ethical standards are maintained. She is also currently enrolled in a PhD (Faculty of Medicine and Health, University of Sydney) investigating research capacity of allied health, nursing and medical professionals.
Martin Lim, MS, MBA
Co-founder and CEO
ONWARD Health Research, Singapore
Martin Lim is the co-founder and CEO of ONWARD Health Research, a Singapore-based technology and services company advancing clinical research in ASEAN and beyond, beginning with Indonesia. Prior to founding ONWARD Health Research, Martin spent five years as the president and COO of a multispecialty clinical research site network supporting clinical trials for over 50 physicians in Southern California where he was responsible for business development, contract and budget negotiations with sponsors, finances and human resources. Additionally, Martin spent over 12 years in healthcare software in roles spanning from software implementation to product/project management and sales. Eight years of this was as the head of product management at a software company that grew from two customers to the world’s largest electronic medical records system for organ and tissue donation during his tenure. Martin began his career as a clinical research coordinator, running cardiology, radiology and oncology clinical trials at two major academic medical centers in Southern California.
Martin holds a BS in biology from UC Irvine, MS in physiology from Georgetown University and an MBA from the UCLA Anderson School of Management.
University of the Sunshine Coast, Australia
Director of a university network of clinical trial sites in Queensland which has 75 staff, conducts 30 new trials each year across vaccines, early phase confinement, chronic diseases, cancer, and devices.
Health Consumer Expert
Sarah Lukeman is a cancer survivor, clinical trial participant and experienced health consumer advocate and representative. She is Co-Deputy Chair of Cancer Voices NSW and has been on their Executive Committee since 2017. Sarah was the Community Engagement Coordinator for the Hunter Cancer Research Alliance (HCRA) for 2 years, where she supported consumers and researchers to work together through training, mentoring and administrative support. She is a consumer buddy for a number of discovery science cancer researchers in NSW and Victoria and is on the organising committee of the NSW Cancer Conference. Sarah is regularly invited to speak on Consumer Involvement in Research (CIR) and has co-designed and copresented intermediate training on CIR for Health Consumers NSW. Sarah is consumer representative on several committees in the Hunter New England Local Health District; the NSW Regional Health Partners (NSWRHP) Community Advisory Committee; the Women’s Health Research, Translation and Impact Network (WHRTN) Workforce Development Committee; and Chairs the Centre for Women’s Health Research (CWHR) Consumer and Community Involvement Committee. Sarah has been a member of the Clinical Trials: Thinking Smarter (CT:IQ) Steering Committee since 2021 and consumer representative on their InFORMed and Beyond the Form projects. Sarah served a term as elected Councillor for Singleton Shire Council and is a graduate of the Australian Institute of Company Directors. She trained as a Chemical Engineer, worked in the mining industry, and is a Tai Chi instructor. She lives in regional NSW and advocates for equitable access to healthcare and a just transition for mining communities. Sarah feels privileged to have grey hair and wrinkles and to have seen her daughters grow up.
Peter Lynch, BSc, JD
PPD, part of Thermo Fisher Scientific, Australia
Over 20 years of experience in Regulatory Affairs in Australia, including both TGA and Sponsor work experience. Currently lead the PPD Regulatory Affairs function in Australia and New Zealand, which forms part of the global PPD Regulatory Affairs department of more than 400 staff across 40 countries. PPD Australia RA team is currently assisting a number of clients with maintaining compliance with the gene technology regulations in Australia including submission of GMO licence application to OGTR and approved licence management at Australia trial sites including interactions with local IBCs and site staff.
Nora Maher, CHES
Senior Clinical Trial Coordinator
Macquarie University Hospital Clinical Trials Unit, Australia
Nora has a Bachelor of Science in Community Health Education and has been a Certified Health Education Specialist (CHES) for ten years. She started her career in bone marrow transplant and cellular immunotherapy patient education, teaching nutrition classes and developing materials for patients and their families. In her current role as a trial coordinator at Macquarie Uni, she liaises between patients and families, investigators, and sponsors to provide patients the opportunity to receive novel and life-saving treatment. Although Nora’s focus is oncology, she also dabbles in devices, cardiology, lymphedema, ophthalmology, and whatever else is thrown her way. When not seeing patients, she mentors new staff and develops standardized training for the unit.
Andrew McFadzen, BN
Clinical Trials Network Manager
Ramsay Health Care, Australia
Andrew McFadzen is the Clinical Trials Network Manager for Ramsay Health Care tasked with the national management of the 20 Clinical Trials & Research Units within the Ramsay Health Care Network. With experience of over a decade in clinical nursing in Hematology & Oncology, he is passionate in supporting site activities to see research translate in improved patient treatments and outcomes to improve their overall quality of life. Over the last 14 years he has focused his career on the development & growth of Clinical Trials Units in both the public & private health sector from establishment. Andrew is involved in a number of quality improvement projects to assist Ramsay CTRU sites deliver best practice and standards of care for their participants in Clinical Trials & Research within the Australian landscape.
Jenny McGrath, RN, MSc, CCRC
Clinical Research Lead
Royal Adelaide Hospital, Australia
Jenny has an extensive background in Clinical Research having worked at the RCTU for over 20 years. As a Registered Nurse these qualifications compliment her research achievements (master’s in science – Research) and she is a valuable resource for all RCTU staff. 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) in ICH GCP, Respiratory diseases, Respiratory therapies and their uses as well as study software during the course of studies. Jenny developed the first business plan for RCTU in 2003. Jenny is instrumental in creating business opportunities and is central to the Ethics and Governance of the RCTU as well as a resource to other units within CALHN. Jenny has been instrumental in bringing the Clinical Trials Centre to the RAH and the Clinical Trials Management System to CALHN.
Anu Mehra, MPH
Clinical Operations Manager
An accomplished professional in the pharma industry over the past 20 years in the APJ region, experienced in the Clinical Research field. Holding a bachelor’s degree in Alternative Medicine from Mumbai, India & a Masters degree in Public Health from University of Western Sydney, I have a keen interest in learning about inventions & new advances in the medical field. Over the years, I’ve had the opportunity to work on significant clinical research projects including trials in Oncology with Keytruda which has helped thousands of patients suffering from cancer. I currently work as a Clinical Operations Manager at MSD overseeing multiple projects in Operations for start-up with focus on Budgets and Contracts.
Eman Nafea, MPharmSci, MHM, PhD
Director, Australian Clinical Trials Education Centre (A-CTEC
Australian Clinical Trials Education Centre (A-CTEC), Australia
Dr Eman Nafea has 20-year experience in academia, translational research and clinical research education. Eman’s current focus is on enhancing clinical research quality through competency-based education and training. Her projects aim to build workforce capacity and capability in the clinical research industry in Victoria and Australia. With the support of the Victorian Research Translation Centres Collaborative (VRTCC), she is currently directing the first Australian Clinical Trials Education Centre (A-CTEC). A-CTEC vision is to build the capacity and capability of the Australian clinical trials workforce through easy access to world-class education and training opportunities, at no cost to the end user Eman has been leading clinical trials education and training at Peter MacCallum Cancer Centre (PMCC), and VCCC Alliance SKILLED internship program over the last 5 years. She is certified by The International Board of Certified Trainers (IBCT) and holds a Master’s degree in Pharmaceutical Sciences & PhD degree in Biomedical Engineering with research expertise in innovative drug delivery for treatment of challenging diseases. She has completed her Master of Health Management at in 2020 and is affiliated Assistant Professor of Pharmaceutics overseas.
Tam Nguyen, PhD, MBA
Deputy Director of Research, Associate Professor
St Vincent’s Hospital Melbourne, Australia
Associate Professor Tam Nguyen has over 20 years of working in clinical trials, health and medical research and research management sector including tertiary teaching hospitals, medical research institutes and universities across Australia.
Tam is the deputy director of research at St Vincent’s Hospital Melbourne, responsible for research strategy, research development and innovation. Tam serves as non-executive director and advisor to several medtech and health tech start-ups and scale ups. He holds academic appointments with Melbourne Medical School, Monash Medical School and RMIT University and is a Fellow of the Royal Society of Public Health, Australian Institute of Managers and Leaders and Australasian Research Management Society.
Tam is a co-editor of a recently published book– Artificial Intelligence in Medicine (by Springer Nature).
Clinical Trials Business Improvement Lead
Monash Health, Australia
Skye is a clinical research professional with 8 years experience working in public and private health service organisations. Currently, she is the Clinical Trials Business Improvement Lead at Monash Health and responsible for implementing the National Clinical Trials Governance Framework. With academic qualifications in Arts, Science, Bioethics and Public Health, Skye has an interest in innovations that can improve the clinical research experience for both researchers and participants. Skye has been a team lead on the InFORMed project since it commenced in 2021.
Director, Head of Site Management
Kate Pascall has more than 20 years’ experience in the pharmaceuticals industry. Kate started her career in clinical research as a Clinical Research Associate for SmithKline Beecham in 1998. Since then Kate has held various positions in industry; Study Manager (GSK), Project Manager (Kendle), Clinical Operations Manager and Head of Clinical (AstraZeneca), Independent Contractor (KESH Consulting) and Associate Director, Site Management at IQVIA.
Since 1 Feb 2021 Kate was appointed Director, Site Management for IQVIA based in Sydney. Her talented team of CRAs, CTAs and line managers deliver full service clinical trial monitoring operations in Australia. Originally from the UK, Kate relocated to Australia in 2003 and has worked in CROs and Pharma companies in both Countries. Kate’s background is in Pharmacology, completing a PhD in neuro-pharmacology in 1998 at the University of Portsmouth, UK.
Linny Kimly Phuong
Founder & Board Director (Chair)
The Water Well Project, Australia
Dr Linny Kimly Phuong is the Founder and Board Director Chair of The Water Well Project. Linny is the daughter of refugees. Her parents were Vietnamese Boat People are migrated to Australia in 1979 after being granted refugee status by the United Nations Humanitarian Program. Outside of The Water Well Project, Linny is a Paediatric Infectious Diseases Physician and PhD candidate with the University of Melbourne Department of Paediatrics studying invasive pneumococcal infections in children. Personally, Linny has received recognition with awards for her work with The Water Well Project including the Australian Medical Association- Doctor in Training of the Year Award (2017), Victorian Premier’s Volunteer Champions’ Award- Leadership category (2016) and Young Australian of the Year- Victorian State Finalist (2013).
Emma Priest, RN, PgDip
Lead Clinical Research Nurse for Neurosurgery Unit
St. Vincent’s Hospital, Australia
Emma is a Registered nurse at St Vincent’s Hospital Melbourne. In her 21 year career at SVHM she has been the lead Clinical Research Nurse for the Neurosurgery unit for the last 7 years. Since commencing her career at St Vincent’s, she has worked in several areas of the hospital including the Emergency Dept. where she completed her post-graduate studies through Melbourne University and the Elective Surgery Management Team where she managed the Neurosurgery elective surgery waiting list. This then led her into her current research role, where her research work has contributed to multiple publications. Emma is inspired by her role because ‘Every standard therapy/treatment we use in medicine today started as a clinical trial and now I have the opportunity to work with new therapies that may become standard treatments in the future.’
Executive Vice President, Strategic Site Solutions
Transformative Pharmaceutical Solutions, USA
Jeff has 16 years of experience in the Life Sciences industry. At TPS, he leads the Site Solutions function, with the overall responsibility of delivering these solutions. Prior to joining TPS, Jeff served as the Vice President of MediSync Clinical Research, a network of clinical trialsites. At MediSync, he was responsible for building and managing the business unit including sites operational oversight, sponsor relationships, trial quality, safety and performance, and MediSyncs’ profit and loss. Prior to joining MediSync, he was a Clinical Research Associate at Medpace Inc.
Teresa Ringeri, RN Div.1; BAppSc(Psych); BNurs
Business Development Manager
Southern Star Research, Australia
Experienced Project Manager, Trial Advancement Team Manager, Business Development Manager and Senior Clinical Research Coordinator with a demonstrated history of working in the pharmaceuticals industry. Skilled in Good Clinical Practice (GCP); Project management at site and CRO; setting up and running clinical trials including budgets/contracts, PICFs, HREC, governance, vendors, essential documents; 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. Always ready and keen to learn anything new, develop a broader skill set, and to always progress both professionally and personally.
Keith Roffey, OAM
National Manager, MediShare
Rotary Australia World Community Services, Australia
Keith Roffey’s background, spanning a career of 52 years before retirement in 2014 is Project Management and business owner in the Retail and Museum fit out industry. He became a Rotarian in 2001, on becoming a member he realised a long-term goal to expand his interests outside of his industry.
Keith feels being a Rotarian is rewarding and gives a greater purpose as a citizen. He respects Rotary for its ideals and the greater focus on global humanitarian issues whilst still encouraging service to our local communities.
Keith served as Governor of D9690 2012 – 2013, D9675 Polio Eradication sub-Committee Chair 2013 – 2015, D9675 Council on Resolutions & Council on Legislation Representative 2017 – 2020 and currently The District Rotary Foundation Chair D9675 2021 – 2024.
Beyond Club & District his responsibilities have been Committee Member Zones 7B & 8 Membership Development Plan, RI Membership Assistant Coordinator Zone 8, Board member of Rotary Australia World Community Service (RAWCS) as National Manager of the In-kind Donations Activities 2014 – 2021.
As well as the District Rotary Foundation Chair, Keith continues to manage the RAWCS project MediShare, working with a range of partners, government & not-for profit organisations providing disadvantaged communities with recovered usable medical equipment and resources who face difficulties obtaining the affordable goods they need.
Kamini R. Rowjee, MBL, BSc(Hons), BSc
PPD, part of Thermo Fisher Scientific
Kamini is an Associate Director at PPD; overseeing Project Delivery, and managing diverse teams and clients. The underlying philosophy that guides her decisions is a strong focus on quality, relationship building and empowering others to do more, achieve more and become independent. She thrives on leading by example, working collaboratively and this drives her in the continuous pursuit of excellence in her field. She is passionate about serving others to do and be better.
Senior Project Manager
PPD, part of Thermo Fisher Scientific, Australia
Debbie is a Senior Project Manager with more than 20 years of experience in the clinical research industry. Her depth of experience managing global clinical trials consists of all phase I, II and III trials across the therapeutic areas of oncology, paediatrics and vaccines. She currently specialises in respiratory and infectious diseases and recently managed COVID-19 treatment and vaccine trials. Her career highlight is managing a phase I, first in human trial for an antibiotic agent funded by a US agency where she discovered her passion in product development.
Jaspreet Sidhu, RN, Grad Dip (Crit Care), MHSc (Nursing), MBA Exec
Project Lead, National Clinical Trials Governance Framework
Alfred Health, Australia
Jaspreet is the Project Implementation Lead for the NCTGF at Alfred Health in Victoria. Jaspreet has a background in critical care nursing and has been involved in clinical trials and research for over a decade. Commencing with clinical trial coordination at a site, supporting clinicians conduct trials from concept to outcome and translation into practice, managing large international clinical trials and associated sub-studies, to designing bespoke quality management frameworks for organisations and training in quality systems in clinical trials and research, Jaspreet is a passionate advocate for embedding clinical trials into clinical care. Jaspreet is excited about the future where people are informed and every patient is informed and has access to a clinical trial as part of their healthcare options, regardless of where they live.
Elena Sklavenitis, MBMSc, BSc
Site Activation Partner Team Lead
Elena is the APAC Site Activation Partner Team Lead for Pfizer that is focused on driving clinical trials throughout their lifecycle, with specialization in start up, ethics and governance. She is involved in numerous workstreams within start-up operations, dedicated to uncovering efficiencies in clinical trial processes across Australia, New Zealand , North America and Europe, including being the Pfizer ANZ representative for the Shared Investigator Platform (SIP). She is passionate about the value of strong teamwork, and its necessity in the success of clinical trials.
Director of Operations
PPD, part of Thermo Fisher Scientific, Australia
Kathryn Speed is the Director of Operations and Country Head for Australia at PPD, part of Thermo Fisher Scientific which is a large global Clinical Research Organisation. Originally starting out as a Registered Nurse, at the turn of the Millennium she stumbled across a Study Co-ordinator role which she held for 6 years until moving to Pharma as a CRA. Having now held a variety of roles in the Clinical Research industry over more than 23 years across both Australia and New Zealand, Kathryn is passionate about advancing treatments for the benefit of all patients and her team, who are an integral part of this advancement, reaching their full potential.
Helen Stevens, RN
Clinical Nurse Consult-Early Drug Development
Parkville Clinical Trials Unit, Australia
25 plus years of Oncology/ Haematology /Apheresis nursing experience across three major teaching hospitals. Involvement in FIH and Early Phase Drug Development trails since 2006 across both haematology and medical oncology. Currently Clinical Nurse Consultant for Early drug Development within in the Parkville Clinical Trial Unit. Role involves . Involvement in the phase 1 clinic established to facilitate patient selection and education around the role of early phase trials as a clinical treatment option Assist staff allocated to manage early phase trials with activation of studies at site . Assess Operational challenges and clinical logistics for early phase trials. Including early review of draft protocols. .Standardize processes within the trial unit for complex drug administration . Assist with the Integration of clinical trials requirements into the Electronic medical record system. .clinical trial liaison with internal hospital departments Current Committee positions Site Research Nursing representative on the: Clinical Trial Experts Council for Roche Research Nurse Representative: HREC Committee at Petermac SOP committee member at PCCTU.
Carolyn Stewart, MMSc (Drug Development)
Business and Operations Manager, Melbourne Children’s Trials Centre
Murdoch Children’s Research Institute, Australia
Carolyn Stewart is the Business and Operations Manager of the Melbourne Children’s Trials Centre (MCTC) which is a collaboration between The Royal Children’s Hospital, Murdoch Children’s Research Institute, and the University of Melbourne. MCTC supports all types of clinical research ranging from trials of novel therapeutic agents to large public health prevention trials and aims for excellence in the design and conduct of clinical trials and leadership in paediatric health research. Carolyn has a master’s degree in Medical Sciences (Drug Development) from the University of New South Wales and has more than 35 years’ trials experience within both the healthcare and the pharmaceutical industries. She has worked in various clinical and operational management roles and has experience in all phases of clinical trials in a broad range of therapeutic areas.
Vivien Sutton, PhD
Chair, Peter Mac Clinical trials IBC
Peter MacCallum Cancer Centre, Australia
Dr Vivien Sutton has a PhD in Immunology and has over 35 years’ experience as a laboratory-based research scientist, specialising in cancer immunology, cell biology and gene technology. Her main research interest has been cytotoxic T cells and how they kill either virus infected or cancer cells. Vivien has been at Peter Mac since 2000 as a senior research fellow in the Cancer Immunology program. During this time, she has also served as a member, and for the last 15 years, Chair, of the Peter MacCallum Cancer Centre Institutional Biosafety Committee (PeterMac IBC) and the Austin Health IBC since 2005. Due to the rapid expansion of clinical trials using genetically modified therapeutics, a second IBC was established at Peter Mac in 2020. Vivien took on the additional role of Biosafety specialist, to oversee all pre-clinical laboratory and clinical research at the VCCC and is Chair of the Peter Mac Clinical Trials IBC.
Tina Thorpe, RN, PGDip Genetic Counselling, PGCert Clin Rsch (Oncology), PGCert ICU
Research Nurse Manager (ANZ)
Illingworth Research Group, Australia
Tina’s career in the medical field spans more than 25 years. As a Registered Nurse, she has gained extensive expertise in various domains, including general medical care, rural nursing, and critical care units such as Cardiothoracic Intensive Care Unit (ICU), trauma ICU, and pediatric ICU. Over fifteen years ago, Tina made a pivotal transition into the Clinical Trials industry, taking on the role of a site study coordinator at Peter MacCallum Cancer Centre. This decision opened new avenues for her to contribute to the advancement of medical knowledge and patient care. With a deep commitment to research, Tina joined Illingworth Research Group as a Research Nurse specializing in home visits 5+ years ago. Since then she has progressed through various positions, including Country Coordinator and Project Manager, and currently holds the role of Research Nurse Manager for ANZ (Australia and New Zealand). Tina has completed postgraduate studies in ICU, genetic counselling, and Clinical Research (Oncology). Tina’s primary focus lies in providing patient-centric, site-friendly, and solution-focused approaches to clinical trials. She firmly believes that by supporting research nurses and fostering a commitment to delivering- care, we can contribute to positive change in the healthcare industry and ultimately better patient outcomes.
David Vulanco, LCSW, MBA, CIP, RAC, ACRP-CP
Honorary President, Vice President, Clinical Research Compliance & Integrity
SCRS, HCA Healthcare
David is a well-known thought leader and change agent in the clinical research industry through numerous associations, boards, initiatives, publications, presentations and contributions. A native of New Orleans, he has a Master’s degree in both Social Work and Business Administration and maintains the additional credentials of Certified IRB Professional (CIP), Regulatory Affairs Certification (RAC) and Fellow for the Association of Clinical Research Professionals (FACRP). Among other things he is the a Vice President for Clinical Research Compliance & Integrity for HCA Healthcare, providing research-related compliance and strategy consultation to their portfolio of hospitals, physician practices and healthcare technology companies. He also currently serves as the Honorary President for the Society for Clinical Research Sites (SCRS) and President of the Music City Angels. David and his wife are empty-nesters living south of Nashville, Tennessee where they involve themselves in work, family life as well as other charitable and entrepreneurial opportunities.
Jason Wagstaff, BS
Jason Wagstaff is the CEO of Clinibase Pty Ltd. Clinibase are focussed on driving Clinical Trial Recruitment and digital transformation of Clinical Trials throughout Australia. Jason has more than a decade’s experience in senior management roles throughout the infrastructure and health care spheres. He has delivered solution and service outcomes for clients in mission critical environments and has a passion for growing and focusing companies to deliver to these outcomes.
Nicola Ware, BSc (Hons), MBA, GAICD
Director, Research, Innovation & Integrated Care, Ramsay Health Care
Ramsay Health, Australia
Nicola Ware is the Director of Research, Integrated Care & Innovation for Ramsay Health Care Australia and the CEO of the Ramsay Hospital Research Foundation. In this role, Nicola oversees the development & implementation of research within Ramsay, the operations of our Clinical Trials Network and the development of new models of integrated care or other strategic initiatives that are focused on the improvement of healthcare outcomes for patients. Throughout her career, Ms Ware has been involved in laboratory based research, clinical research and implementation research, holding senior management roles at Victor Chang Cardiac Research Institute, Melanoma Institute Australia & Neuroscience Research Australia. She has extensive experience in Strategy, Innovation, Research Management as well as management of non-profit organizations.
Julia Warning, PhD
Principal Policy Officer
NSW Health, Australia
Dr Julia Warning is the Principal Policy Officer, Advanced Therapeutics within the NSW Office for Health and Medical Research. Dr Warning has significant experience and expertise in developing, implementing and evaluating policies and programs that support and accelerate advanced therapeutics research, manufacture and translation. She works closely with NSW Health branches, divisions and agencies in establishing statewide service delivery models for advanced therapeutics. Dr Warning is also a member of NSW governance overseeing the design and delivery of infrastructure such as the $126.4M NSW viral vector manufacturing and $96M RNA pilot manufacturing facilities. She is passionate about engaging with research, clinical and consumer communities to increase safe and timely access to advanced therapeutics and ultimately improve patient outcomes.
Elizabeth Ann Wilson, BPharm PGradDip Clin Pharm
Director Strategic Site Relationships
Current responsibility • Director of Prime and Partner Sites ANZ. ANZ lead for Early Phase Cancer trials and Strategic Relationships IQVIA ANZ Profile Overview • 27 years of clinical trials & drug development experience • Hospital Pharmacist with therapeutic specialty in paediatric & adult cancers • Project Management experience in Australian ASX listed Biotech company • Clinical Operations director experience focused on development of oncology portfolio – Australian listed Biotech company • Highly skilled at developing long-term key opinion leader relationships, with a developed network in research environments. Areas of Expertise • Worked on all sides of trial landscape – sponsor/site/CRO so can bring a balanced approach • Project Management • Line Management – multiple roles • Site Management – liaison/educator/support • Relationship Management • Broad therapeutic knowledge including – haematology/oncology/palliative care/general medicine/hepatology/VTE/neurology • Drug development from FIH Phase I through to Phase III trials • ICH-GCP/Decentralized trials/education of multiple players in clinical trial ecosystem Passion • Passion is working with sites and sponsors to increase the speed and efficiency of patient recruitment and clinical research within ANZ to bring new medicines to patients faster.
Anne Woollett, BEd, RN
Alfred Health, ANZ
Anne Woollett, Clinical Trials Director, TrialHub. Alfred Health Anne is Director of Clinical trials Trial Hub, at the Alfred. In this role she is responsible for the establishment of the TrialHub Directorate and the development and implementation of the federally funded TrialHub initiative to the improve access and increase participation in clinical trials for people in outer metropolitan regional and rural communities, as well as oversight and harmonisation of clinical trials at The Alfred. Anne has over 30 years’ experience working in a broad range of fields in oncology clinical trials including clinical trials development, processes and governance at local, state and national levels. She has worked in and with many different governance structures including networks, multi-service collative ventures and academic health centres as well as commercial and investigator-led research including Victorian Comprehensive Cancer Centre, University of Melbourne, The Australian & New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group, the Australian Clinical Trials Alliance (ACTA), Peter Mac Callum and Barwon Health. Anne holds voluntary positions on numerous advisory committees including the Victorian Clinical- Trial Education Centre, VCCC and the Regional Trials Network.