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.
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.
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