Key Speakers

Ann Single

Ann Single is the Coordinator for the Patient Voice Initiative, a multi-stakeholder patient-led not for profit working to ensure patients are seen, heard and valued in healthcare decision-making, especially in health technology assessment (HTA). She’s worked in patient involvement in HTA for more than 20 years, first directing it within Scotland’s HTA agency and then sharing and developing good practice in HTAi’s Patient and Citizen Involvement Interest Group. After Chairing this group of 300 multi-stakeholder members in 43 countries for four years, in 2023 she became its Outgoing Chair and HTAi’s first Vice President from the patient community sector. Ann co-edited the book Patient Involvement in Health Technology Assessment (2017) and is a faculty member member of the International Patient Advocacy Management Masters Course at Rome’s Catholic University (Università Cattolica del Sacro Cuore). Her must recent peer-reviewed paper considers cases of patients involved at the organisational level of HTA bodies. She currently serves as a consumer representative on the Australian Government’s HTA Policy and Methods Review Reference Committee.

Professor Karen Woolley

Professor Karen Woolley is honoured to be a Life Member of ARCS and served ARCS as a Director and Chair of the Board.

As a bereaved parent, clinical trial participant, and caregiver to immediate family members with acute and chronic conditions, Karen’s lived experience has motivated her to work with patients - as partners - in her medical communications career. With patient leaders in the Asia Pacific, European, and North American regions and her medical communication colleagues, she has conducted, presented, and published award-winning research on the ethical and effective involvement of patients in publications. This research has led to practical outcomes with the co-creation of free, evidence-based, online resources for plain language summaries of publications (www.envisionthepatient.com/plstoolkit) and for patient authorship www.patientauthorship.com/). Karen is a Professor at two universities, she has served on the Boards of government hospital and healthcare services (serving 400,000 patients) and not-for-profit research and medical communication associations, she has authored the Good Publication Practice 3 guidelines, prepared Position Statements on the ethical use of professional medical writers for European, American, and international not-for-profit associations, and served on the Editorial Board for an international research integrity journal. To renew her energy, she surfs, runs, cycles, and stairclimbs with (mostly) willing family and friends.

Dr Lisa Eckstein

Dr Lisa Eckstein is the Director of Philanthropic Activities for Bellberry Ltd and the CT:IQ Programme Director. Her previous role was as a senior lecturer in the faculty of Law at the University of Tasmania, where she chaired the Tasmania Health and Medical Human Research Ethics Committee and published on the regulation of clinical trials, genomic privacy, and consent. Prior to academia, Lisa worked as a legal officer for the Australian Law Reform Commission and for state and federal health departments.

Matt Dun

Dr Matt Dun is Professor of Paediatric Haematology/Oncology Research at the University of Newcastle (UON) and Hunter Medical Research Institute (HMRI), and a National Health and Medical Research Council (NHMRC) Investigator.In addition, Dr Dun is the Director of Brain Cancer Research - HMRI Precision Medicine Research Program, Paediatric Stream Leader - MHF Centre for Brain Cancer research, Executive of Pediatric Neuro-Oncology Consortium (PNOC) DMG Therapeutic Advisory Committee (DMG-TGA) and member of the Australian New Zealand Childhood Haematology Oncology Group (ANZCHOG) CNS Tumour Committee. Throughout his career, Dr Dun has been decorated by 35 national and international awards for his paediatric cancer research. Notably, in 2019, he was named the NSW Premier’s Outstanding Cancer Research Fellow, and in 2020 received an Australian Institute of Policy and Science Young Tall Poppy Award. In 2022 he received an International DIPG ‘Big Hero’ Award (Washington D. C.) and was named as the University of Newcastle, College of Health, Medicine, and Wellbeing, Mid-Career Researcher of the year. In 2023, Matt was named the Lake Macquarie Ambassador (Citizen of the Year), awarded the ChadTough Defeat DIPG ‘Spirit Award’ (Michigan), the PNOC ‘Basic Science Trailblazer’ award (San Francisco), the International DIPG Symposium 2023 ‘Innovator Award’ (Lexington) and finally named the HMRI Directors ‘Midcareer-Researcher of the Year’.

Karen Lee

Karen is a corporate and privacy lawyer with over 15 years of experience. She is a qualified lawyer in Australia, New York and England and Wales and has been a legal business partner for medical devices, pharmaceutical, and financial services clients in Australia and Hong Kong. Karen has advised on AI, ethics and governance framework development, training and rollout and been the legal lead on machine learning projects in predictive medicine and clinical studies. She has led privacy reform and regulatory change projects from a legal perspective for ASX-listed and international organisations. Her experience includes advising the board on directors’ duties and advising senior management on regulatory investigations, the adoption of emerging technology and digital platforms, management of business assets including data, and data breach preparation and responses. In 2023, Karen was a speaker on AI at the Australasian Institute of Digital Health’s AI+ Care conference in Brisbane and co-led a Generative AI Masterclass at the Association of Corporate Counsel’s National Conference in Canberra. She is currently the Chair of the Association of Corporate Counsel Australia’s Legal Technology and Innovation Committee and a member of the Australian Institute of Digital Health NSW Branch committee.

Andrew Wiltshire

Andrew’s Career in Healthcare spans 35 years. In his current role Andrew has responsibility for Healthcare Policy, supporting AWS public policy teams across the APAC regionPreviously Andrew led the Health Economics, Market Access, Policy and Government and Stakeholder Relations functions for Medtronic in Australia and New Zealand, in addition to coordinating Government Affairs for the APAC region.Before that Andrew had a variety of roles within Healthcare organisations across business and functional leadership. In addition to his Medtech experience, Andrew started his career as a Registered Nurse and has worked in the Pharmaceutical Industry as well as a brief stint in the Hospitality Industry. He holds an MBA from the University of New England and a BA in Media from Griffith University. He is an ARCS Australia Board Member and is Chair of the MTAA Digital Health Advisory Group and Co-Chair of the US-ASEAN Business Council Digital Health Committee.

Michelle Gallaher

Michelle is an award-winning health technology entrepreneur with a particular interest in artificial intelligence, clinical trials and ethics. Recently commencing as the inaugural CEO of Cerulea Clinical Trials, a not-for-profit spin out from the Centre for Eye Research Australia, Michelle’s current focus is on building a world-leading ophthalmic clinical trials company specialising in gene therapy trials, medical devices and applying emerging AI-enabled efficiency solutions that will improve outcomes and reduce costs. Commencing in allied health, Michelle’s career spans clinical and administrative roles in public and private healthcare, commercial and executive roles within biotech, pharmaceutical, and medical organisations, as well as and leading a biotech peak-body. Michelle moved from the corporate world to found her first startup in 2014, successfully selling that business three years later, going on to found AI health tech company Opyl Ltd in 2019 (ASX:OPL). During COVID, Michelle designed and directed the successful build of Opyl’s two technology platforms; Opin, to accelerate recruitment of patients to trials, and TrialKey, an AI tool that predicts the outcomes of trials and optimises trial designs so they are more likely to succeed. The appropriate application of AI in healthcare and the role of ethics and digital leadership in technology development is a key issue that Michelle is renowned for as a key opinion leader and advocate. Michelle is an experienced non-executive director on several boards and is co-founder of not-for-profit advocacy organisation, Women in STEMM Australia. Michelle is a Victorian Honour Roll for Women inductee, Victorian Telstra Businesswoman and Entrepreneur of the Year, and a winner of Westpac’s 200 Businesses of Tomorrow. Michelle has an undergraduate degree in applied science, postgraduate qualifications in business and product management, a Global Executive MBA, is a graduate of the Institute for Company Directors and a Fellow of the Australian Institute for Management. Michelle hates cricket and always has.

Farah Magrabi

Farah Magrabi is a Professor of Biomedical and Health Informatics at the Australian Institute of Health Innovation, Macquarie University. She has a background in Electrical and Biomedical Engineering, and has worked as a health services researcher for 20 years. At the Australian Institute of Health Innovation, she leads research to improve the clinical safety and effectiveness of digital health and AI technologies for clinicians and consumers. Professor Magrabi is co-chair of the Australian AI Alliance’s Working Group on safety, quality and ethics; and an advisor to the Australian Digital Health Agency.

Fiona Mccormack

Fiona McCormack is the Director of the Devices Emerging Technology Section within the Medical Devices Surveillance Branch at the TGA. Fi’s background is a Medical Scientist, and she has worked in various technical roles within the TGA for the past 18 years. Fi has extensive regulatory and technical knowledge across multiple areas, including in vitro diagnostics (IVDs) and medical devices, software and AI-based products, quality management systems, auditing and the certification of device manufacturers.

Chris Burns

Christopher Burns (B.Sc. (Hons) PhD FRACI FRSC GAICD) – CEO and Managing Director Chris is an experienced drug discovery leader having worked in various roles in pharma, biotech and academia for over 30 years. After completing a Ph. D. in Organic Chemistry at the University of Melbourne, Chris undertook postdoctoral studies in the USA before moving to Pfizer UK, as a senior scientist. After 5 years he returned to Australia as a Research Fellow at the University of Sydney with the CRC for Molecular Engineering and Technology and after two years moved to the biotechnology company Ambri as Head of Chemistry. Chris then moved to the Melbourne-based biotech Cytopia as Head of Medicinal Chemistry and later as Research Director. Over this time he led teams in the discovery of two anti-cancer agents that entered clinical trial (including the drug momelotinib which was recently approved by the US FDA). Chris was subsequently recruited to the Walter and Eliza Hall Institute of Medical Research in Melbourne as a Laboratory Head before taking on executive and leadership roles with a number of privately-held biotechnology companies in Melbourne including Certa Therapeutics and MycRx. Dr Burns is the inventor on over 30 patents and a co-author on over 65 scientific publications, and is a Fellow of the Royal Society of Chemistry (UK) and the Royal Australian Chemical Institute. He was the recipient of the 2022 Adrien Albert Award - the premier award of the MCCB Division of the Royal Australian Chemical Institute which is given for sustained, outstanding research in the field of medicinal chemistry or chemical biology. Dr Burns is a founder of Amplia Therapeutics and originally served as a Non-Executive Director from 2018 and was subsequently appointed as Chief Executive Officer and Managing Director in December 2022.

Anne-Maree Englund

Anne-Maree is passionate about the potential of innovative technologies to improve health outcomes. An engineer by trade, she also has a masters in public policy, and combines a thorough knowledge of product development with a strong understanding of the broader health and innovation policy landscape. She started her career at the medical device innovator Cochlear, has been the Operations Manager at health IT startup Humanetix, and also spent several years as Policy Manager at pharmaceutical company MSD. She is currently Head of Strategic Policy Implementation at Medicines Australia.

Tiff Boughtwood

Tiffany Boughtwood is the Managing Director of Australian Genomics, an Australian Government initiative supporting genomic research and its translation into clinical practice through broad engagement and a collaborative national approach. Tiffany has 25 years’ experience in molecular biology and management: leading academic and diagnostic genomic programs; collaborating internationally in genetic and genomic research; and consulting in health genomic implementation. She served on the World Economic Forum Global Future Council for Biotechnology and the WHO Collective Global Network for Rare Disease, and advised the initiation of the UAE Genomic Program. Tiffany is a member of the WHO Technical Advisory Group on Genomics and is a Director of the Childhood Dementia Initiative.

Warick Shaw

20+ years of experience across roles in Regulatory, Quality, Project Management, Customer Solutions & Market Access in Regulatory Agencies and MedTech, Pharmaceutical and Cell & Gene organisations.

International Speakers

Hamish King, Chief Operating Officer, Cisema (Hong Kong)

Hamish King is CEO at Cisema, a China-focused CRO and regulatory consultancy founded in Munich and Beijing in 2002. A lawyer by training - admitted in Hong Kong and NSW, Australia - Hamish previously worked with UK Magic Circle Firm Linklaters in Hong Kong, and has over 10 years' experience in the legal and regulatory fields. He has obtained the RAC and CFA qualifications. Regularly writing articles and speaking on China market access and regulatory pathways, he currently lives in Hong Kong.

Michelle Lott (USA)

Michelle Lott is founder and principal of leanRAQA (leanraqa.com). She's supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services – and grief counseling(!), because dealing with regulators can be emotionally draining. Her clients delegate those things to her, so they can focus on winning in the marketplace. Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP). She serves as mentor in residence for several medical device incubators and guest lectures on regulatory affairs at the Atlantic Technological Institute of Galway and John Hopkins, among others. She holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.

Dr Robert McDowall (UK)

Bob McDowall is an analytical chemist with over 50 years’ experience including 15 years working in the pharmaceutical industry and over 30 years’ working for the industry as a consultant. Bob has been involved with the automation of laboratories and validation of computerised systems for over 35 years. He edited the first book on Laboratory Information Management Systems (LIMS) in 1987 and is the 1997 LIMS Awardee. Bob is also is the author of two editions of a book on the validation of chromatography data systems and one on data integrity and data governance for regulated laboratories. He writes the Questions of Quality column for LCGC International and Focus on Quality column for Spectroscopy. Bob was a subject matter expert input and review contributor to the GAMP Records and Data Integrity Guide and two of the data integrity Good Practice Guides.

Dr Pedro Franco (London)

Pedro Franco has an extensive educational background, holding a degree in Pharmaceutical Science (PharmD) from the University of Lisbon, a Master's in Organic Chemistry (M.Sc) from the New University of Lisbon in collaboration with Imperial College in London, a PhD in Orphan drugs and Rare diseases from the University of Sheffield, and an Executive MBA from Business Bayes School at City University in London. He also completed his music studies in Cello at Lisbon Conservatory.

Currently, Pedro serves as the Head of Europe Global Regulatory and Scientific Policy at Merck KGaA, focusing primarily on regulatory intelligence, strategy, and policy. He also serves as the liaison for the China and Latam regions concerning regulatory and policy topics.

Prior to his role at Merck, Pedro worked at the European Medicines Agency for 12 years in various roles and departments, with a focus on regulatory affairs, international collaboration, assessment, authorization of medicines, orphan drugs, pediatrics, peer review, quality, and strategy. Before that, he was employed at INFARMED, the Portuguese national competent authority, as a pharmaceutical assessor. Earlier in his career, he worked as a postgraduate research fellow in the area of toxicology, carcinogenic chemistry, and drug development.

Dr Tiina Palomaki (Finland)

Dr Tiina Palomäki holds a PhD in genetics. She has been working as a Director, Principal consultant at Cencora Pharmalex, Munich Germany since 2022, and she is specialized in scientific and strategic consulting for cell and gene therapies as well as biotechnological products. Prior to joining Cencora Pharmalex Dr Tiina Palomäki worked as a senior researcher at the Finnish Medicines Agency, the National Competent Authority in Finland, where she was responsible for preclinical aspects of advanced therapy medicinal products and biotechnological products 2006-2022. She has hold positions at the EMA (European Medicines Agency) Committee for advanced therapies (CAT), the Cell-based product working party, and the Gene therapy working party. Prior to joining the Finnish medicines agency, she worked 13 years in academic research in the field of stem cells, molecular and cellular biology. She graduated from the University of Helsinki 1993, and made her PhD and a post doc in the Dept of Biosciences in the University of Helsinki.

Phil Tregunno

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products.

Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has also led international projects to develop and deliver tools for global pharmacovigilance, which are now being used for surveillance internationally.

Key Speakers

International Speakers

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