Study Start Up
Study Start Up
Felicity has 15 years experience in the pharmaceutical and non-for-profit health care sectors in various clinical operations and project management roles. For the last 4 years, she has been leading the Study Start Up Team for Roche Australia. Felicity’s mission is to achieve positive business outcomes through people capability. She does this through her coaching, strategic and agility strengths. Felicity is a qualified coach, facilitator and has a degree in Applied Science (Health Information Management).
My mission is to achieve positive business outcomes through people capability. I do this through my coaching, strategic and agility strengths.
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.
Zoe Armstrong, BSc
Clinical Research Director
Zoe began her career in the pharmaceutical industry 22 years ago at MSD, holding a variety of roles in clinical operations. For the last 12 years Zoe has led research operations as CRD across ANZ for MSD. From 2013-2015, Zoe also lead the ASEANZ cluster where she assumed responsibilities for countries across South East Asia in addition to ANZ. Zoe now manages a broad team of 140 people across ANZ and offers unique insight into the opportunities and challenges with leading clinical trials across countries and diverse cultures. Zoe is currently the co-lead of Transcelerate across ANZ and is a member of the Australian Research Development Task Force (RDTF). Zoe holds a BSc (Biotechnology) from the University of Technology Sydney.
Helen Aunedi, MMedSc, MA
Country Head, Country Clinical Operations
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.
Senior Operations Manager, Research Coordination and Quality
Senior Manager, Communications & Engagement
TransCelerate BioPharma Inc.
Brian currently manages communication and engagement efforts for TransCelerate membership, including leadership from 20 pharmaceutical companies. With a focus on raising awareness of solutions globally, Brian oversees the activities of a member network that spans more than 30 countries. Through the course of his career, Brian has focused on communications within healthcare, a passion that began as he worked within a hospital system to lead marketing and communications efforts for new practices, treatments, and physicians within the hospital. Since then, Brian has a proven record of success in the design and hands-on management of brand marketing, employee relations, and public relations campaigns across varying industries with a focus on patient-oriented health care.
Suzanne Elliott, BAppSC, PhD, Grad Dip (Drug Dev), ACRP-CCRC
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 18 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, 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.
Lorena Figueroa, BPharm
Country Clinical Operations Leader & Agile Coach
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.
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 & Special Projects
Society for Clinical Research Sites, USA
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.
Kirsten Gibson, MS
Director of Improvement Service, Quality and Patient Safety
Tasmania Health Service, Royal Hobart Hospital, Australia
Kirsten is the Director of Improvement – Quality and Patient Safety Service for the Royal Hobart Hospital. Kirsten oversees accreditation, risk management, quality improvement, consumer engagement and auditing. She has a background in process improvement and project management with a Masters in Health Promotion Management. Prior to relocating to Tasmania in early 2019, Kirsten worked for a large healthcare start up focussed on helping clients succeed within valued based care ultimately to change the health of the nation by changing the way healthcare is delivered.
Research Governance Project Coordinator
Department of Health, Tasmania, Australia
Tanya Harley is the Research Governance Project Coordinator for the Department of Health in Tasmania. Tanya has been both an ethics officer and governance officer for several health services in Western Australia, implementing the WA Research Governance Policy Framework back in 2011. She worked as a Research Governance Officer to establish the research governance office at Fiona Stanley Hospital, as well as holding a Senior Policy Officer within the WA Department of Health, Research Development Unit. Whilst with the WA Department of Health, she worked on the development of the WA ICT system used to manage ethics and governance processes and trained staff in the use of the system. Somewhere in between she worked in Safety and Quality and has been an Accreditation Coordinator and a Risk Manager. In September 2018 she came for a short holiday here in Tasmania and after returning to WA started looking for jobs and within a week saw this role advertised. It was a sign!
Outside work, she and her partner run a growing and successful distillery!
Executive Director, Clinical Operations
My passion is to bring potentially life saving or life changing medication to market faster. My current role in Startup Integration and Performance is a wonderful platform, as I drive APAC and Global startup performance, technologies and innovations that will result in accelerating sites moving through start up and being ready to enroll. My prior broader experience in Clinical Management focused on working with sites and clients to drive patient recruitment, timely and high quality data collection and audit readiness. My experience and expertise bring to life end to end delivery.
Chung Y. Hsu, MD, PhD
China Medical University Hospital, Taiwan
Chung Y. Hsu, MD, PhD Chair Professor, Graduate Institute of Clinical Medical Science, China Medical University (2008-) Principal Investigator, Ministry of Health Clinical Trial and Research Center of Excellence (2010 -) Principal Investigator, Taiwan Stroke Registry (2006 -) Principal Investigator, SPAD, Pass, EXTEND International (Taiwan sites), ATACH-II (Taiwan sites), TASTE (Taiwan sites), STOP-AUST (Taiwan sites), STOP-MSU (Taiwan sites), PISA (under planning), DIRECT-SAFE (under planning), VRST (under planning). Taiwan Ambassador, Society for Clinical Research Sites (2016-) Member, Translational Medical Research Program Review Committee, Academia Sinica (2019 – 2021)
Gina Kennedy, MS
Snr. Clinical Operations Manager/Country Lead
Gina is passionate about improving processes, building a strong knowledge base and empowering my team to achieve excellence. She has over 22 years experience within the clinical trials industry, spanning all phases of clinical research, from pre-clinical to phase IV trials. Working across the industry, including, data management, as a study coordinator, CRA, regional project manager, and managing a clinical trials unit at site level and Line Management, in, both CRO and Pharmaceutical industries, has provided a broad perspective and understanding of all stakeholders.
Gina is currently chairperson of Society of Clinical Research Sites, ANZ Site Solutions Summit organising class committee.
Robert Kent, RN, BN
Manager of Clinical Research
Kinghorn Cancer Center, Australia
Robert has 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.
Sunil Kumar, BS (Medicine)
Sunil Kumar is a medical doctor by training and a clinical researcher for more than 17 years across SMO, Pharma and CRO sectors with experience in various disciplines like site management, site selection, clinical monitoring, project management, feasibility & clinical Informatics and is currently overseeing investigator payments as an Associate Director at Syneos Health and is based in Hyderabad India. In his career beginning 2003, he has extensive experience of oncology, CNS, infectious diseases and cardiology trials establishing long standing collaborations with Investigators and study teams in various leading capacities across all global regions. In addition, he has been particularly investing in line management, people management, teaching, mentoring and initiating process improvements to enhance professsional development of his team. Sunil had participated 2019 SCRS Summit in Melbourne and enjoyed every bit of it, interacting and building networks with sites, CROs and Sponsors and is very happy to be back in this space, though in a virtual capacity. Sincerely hope to participate in person next time and wish great success for this summit this year.
Marian Lieschke, RN
Parkville Cancer Trials Unit, Australia
Marian Lieschke trained as a an Oncology Nurse at the Royal Marsden. After moving to Australia, she worked extensively as a Clinical Oncology Research Nurse becoming the 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 Womens 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.
Adviser, Educator, Advocate and Innovator
Clinical Innovation Partners, USA
Craig Lipset is an advisor, educator, advocate and innovator focused on innovative solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the Decentralized Trials & Research Alliance, Vice Chair of the MedStar Health Research Institute, Vice President of the Foundation for Sarcoidosis Research and on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University, and Adjunct Instructor in the Center for Health + Technology at University of Rochester.
Jenny McGrath, RN, MSc
Clinical Research Project Lead
Royal Adelaide Hospital, Australia
Jenny has extensive background in Clinical Research and has worked in Respiratory Research since 1994. As a Registered Nurse these qualifications compliment her research achievements (Master in Science – Research). Jenny is part of the senior management team in RCTU. Her initiatives to RCTU and the running of the Unit include: Training and education of Clinical Research Coordinators (CRC). CRC education – in ICH GCP, respiratory diseases, respiratory therapies and their uses, and study subject advocacy, Jenny developed the first business plan for RCTU (in 2003). Jenny initiates governance and finance reviews (clinical trials budget negotiations) to ensure studies undertaken are able to be completed to a high clinical research standard within given timelines.
Jenny is a member of the International Site Advocacy Group for Investigator Payments with the Society of Clinical Research Sites (SCRS). She has undertaken a role on the Advisory committee for PRAXIS and is on the steering committee for Asia-Pac for SCRS.
Tam Nyguen, FRSPH, FAIM, PhD, MBA
Deputy Director of 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.
Society for Clinical Research Sites, USA
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.
Aparajeeta Priyadarasini, MS
Senior Solutions Consultant
Medidata, a Dassault Systèmes company, Sinapore
Aparajeeta Priyadarasini has over 14 years of experience in healthcare and life sciences industry. She has held various roles in global pharmaceutical companies and contract research organization, covering clinical research, biotechnology, medical device.
Teresa Ringeri, RN, Div.1;BAppSC(Psych);BNurs
Business Manager, Senior Clinical Research
Emeritus Research, Australia
After working as a nurse for a short time, Teresa moved to clinical trials at Emeritus Research in April 2011 and fell in love with the field and the benefits it provides to participants, the relationships it can build with trial participants and other people in the research field, as well as the amazing career opportunities. Teresa started off as a Trial Coordinator in 2011, took a break to have her two beautiful children, moving to a Senior Trial Coordinator in 2017 and then Business Manager in Oct 2018 to work in feasibilities and start-up activities, business development, IIS development and staff mentoring.
Outside of working in trials, Teresa loves her time with family and friends, fitness training and participating in fitness events and challenges.
Adam Stoneley, BBus
Research Innovation & Operations Team Manager
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.
Kevin Wightman, BSc
Senior Director of Business and Corporate Development
Illingsworth Research Group, Australia
Pty Ltd (A Syneos Health Company)
With more than 25 years working in the clinical trials industry in leading Pharma, CRO, Site, and Patient Centric solutions providers in Australia, NZ and the UK, Kevin is passionate about improving the way clinical trials are delivered to better meet patients’ needs. As a former ARCS Board Director and current member of the Board of Middlemore Clinical Trials Trust, Kevin brings unique experience, networks and insights from both industry and site perspective. In his current “day job”, leading Illingworth Research Group’s expansion in the Asia Pacific region, Kevin continues to follow his passion as a genuine “patient pioneer”, working to make clinical trials more accessible and less burdensome for patients and their families and carers, while focusing his business goals on providing Sponsors, CROs and Sites with innovative and robust patient centric solutions. Kevin originally graduated in Pharmacology from Nottingham University in the UK and has worked in Australia for over 20 years, living in Melbourne’s Bayside with his family and two dogs. He enjoys travel and especially the opportunity to sample new and exotic cuisine and of course good wines, wherever his travels take him!
Elizabeth Wilson, BAppSC, PhD, Grad Dip (Drug Dev), ACRP-CCRC
Prime Site Director
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 now IQVIA. 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.