2026 RWE4Decisions Symposium: Optimising RWE to Deliver Value in Healthcare

Karen Facey worked as a statistician in the pharmaceutical sector and UK medicines regulation, before becoming founding Chief Executive of the first national HTA agency in Scotland. Since 2003, Karen has been an independent HTA consultant with special interests in RWD, rare diseases and patient involvement.

She is passionate about holistic HTA to determine value and use of health service data to improve patient care. Karen also works with the University of Oxford as a Senior HTA Advisor in the IHI Guidelines for RWE Generation project and with Utrecht University in the SUSTAIN HTA Coordinating Support Action.

Hans-Georg Eichler is the Consulting Physician of the Association of Austrian Social Insurance Institutions. He was the Senior Medical Officer of the European Medicines Agency for over 14 years, and Professor and Chair of clinical pharmacology at the Medical University of Vienna. In 2011, he was a Visiting Scholar at MIT, where he participated in the NEW Drug Development ParadIGmS Initiative (NEWDIGS), focused on enhancing the capacity of the global biomedical innovation system to sustainably deliver new, better, affordable therapeutics to the right patients faster.

Dr. Eichler is also a lead co-author of a publication focused on the role of RWE in access and reimbursement decisions for personalized medicines, recently published in the Clinical Pharmacology and Therapeutics (CP&T) Journal.

Dr. Roisin Adams is Head of HTA Strategy and External Engagement for the NCPE. Dr. Adams led the HTA team for a number of years before being seconded to the HSE to lead a new unit tasked with overseeing and managing high cost drugs in acute hospitals. Dr. Adams is the elected Chair of the Health Technology Assessment Coordination Group which is the governance body responsible for the EU HTA Regulation. 

She also co- chairs the HTA domain of the BeNeLuxA initiative and is a Director on the Board of the International Horizon Scanning Initiative. She has been awarded a number of grants from the Health Research Board to examine health preferences in Ireland.

Her areas of interest include methods for preference elicitation, combining different data for evidence synthesis and reimbursement mechanisms for high-cost drugs.

She has held advisory positions for Department of Health, the Health Information and Quality Authority and policy direction at EU level.

Kristin Thompson is Investment Director on the Innovation Investment team, a role she has held since September 2024. She was previously Chief Operating Officer at eureKARE, where she invested in more than 10 companies and held several board positions. An American with an international career spanning the US, Spain, Germany and France, Kristin began her career as a researcher working on novel modalities including AAV and Lentivirus, mRNA translation modifiers, CRISPR-Cas and 3D cell systems. Her translational research also was in collaboration with PTC Therapeutics and Boehringer Ingelheim.

She subsequently moved into Business Development, focusing on in- and out-licensing, corporate restructuring and strategic partnerships, before transitioning to venture capital.

Kristin holds a degree in Biology from the University of North Carolina at Chapel Hill and a PhD in Molecular Medicine from the University of Ulm, Germany.

Dr. Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), a position he holds since 2010. He also works as a lawyer for the law firm Novacos and advises pharmaceutical and biotech companies in regulatory and pricing & reimbursement decisions from a EU and German law perspective. From 2008 to 2013, he was the head of the Brussels office of the German Pharmaceutical Industry Association (BPI).

Dr. Natz also worked in the field of competition law with the European Commission and in the pharmaceutical industry. He was a research assistant at Duke University (USA) where he dealt with international pharmaceutical law.

Wim van Harten is Research Group Leader of the Technologies and Services in Oncology programme at the Netherlands Cancer Institute (NKI) and Professor of Quality Management of Health Care Technology at the University of Twente. Following his medical training, he spent seven years working in Cameroon before specialising in public health and health administration. He subsequently completed a PhD in Quality Management and held senior leadership positions in Dutch healthcare, including serving on the Executive Board of the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital and as CEO of Rijnstate Hospital. Professor van Harten is the former President of the Organisation of European Cancer Institutes (OECI) and a recognised expert in health technology assessment, healthcare innovation, cancer rehabilitation, and value-based oncology. His research focuses on improving the affordability, accessibility, and evaluation of cancer care technologies, including the use of real-world evidence to inform healthcare decision-making.

Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV).
Niklas is the Co-Chair of the HTAR Coordination Group with special expertise in pharmaceutical products. He was the Chair of the Consortium Executive Board for EUnetHTA21 (2021-2023) as well as the Chair of the EUnetHTA JA 3, Executive Board between 2018 and 2021.
Niklas has been working with pricing and reimbursement since 2001. He has held positions as medical assessor, project leader, Head of the Department for New Submissions (between 2009 and 2014) and he is now the Chief Pharmacist.
Niklas has a broad experience of different aspects of value-based evaluation and over time has seen the increasing importance for health technology assessment (HTA) both across health care systems and on local level to prepare accurate decision making.
Among Niklas special interests have been the early development of joint scientific advice in 2009 and onwards (pilots both nationally with MPA and on European level with EMA) and strategic discussions about RWD.

Eric is a Senior Health Economist leading the OECD’s work in Digital Health, bringing together policy guidance for digital tools, integrated data, and responsible analytics including artificial intelligence. In that role, he is accountable for measuring and evolving the OECD’s Recommendation on Health Data Governance (2017) and supporting digital health policy that provides data protection (e.g. security and privacy) and timely access to quality data to optimize the use of data for information, insights, and impact among individuals, health workers, policy makers, researchers, and innovators.

Prior to joining the OECD, Eric led the Secretariat for a pan-Canadian Health Data Strategy, bringing together experts and governmental leaders from across Canada to establish an integrated health data ecosystem that makes better use of data for health systems, public health, population health, research, and care. Eric authored the Pan-Canadian Heath Data and Information Governance Framework and Toolkit and has taught courses in data science, health data governance, and privacy.

Nienke Schutte is Head of the Innovation in Health Information Systems Unit at Sciensano, the Belgian institute for health research and public health. She holds a PhD in behavioural genetics and has worked across academic, hospital, and public health research settings. Since joining Sciensano in 2018, she has played a leading role in advancing health information systems, data governance, and the secondary use of health data for research and policy-making.

Dr. Schutte has been actively involved in several major European initiatives, including the Population Health Information Research Infrastructure (PHIRI) and TEHDAS2, supporting the development and implementation of the European Health Data Space (EHDS). Her work focuses on improving the quality, interoperability, discoverability, and reuse of health data to enable evidence-based decision-making and strengthen public health systems across Europe

Christian Dehlendorff is a biostatistical chief consultant at the Danish Medicines Council, where he has been working since September 2021. He has more than 15 years of experience working with real-world data and evidence primarily within register-based epidemiology and in recent years also experience in how real-world data can be used in health technology assessments.

Prior to his current position, he was employed at the Danish Cancer Society Research Center from 2011-2021 and was head of statistics from 2018. He was also employed as external associate professor at the Technical University of Denmark.Christian has a Master of Science in engineering from the Technical University of Denmark with a focus on statistics and data analysis. He received his PhD from the Technical University of Denmark in 2010. He has authored 150+ scientific publications, in particular within pharmaco-(cancer)epidemiology.

Christian also holds a position as an external associate professor at the University of Copenhagen.

Diana Sinkevich is Vice President of Market Access EU & International and Global HEOR within the Global Rare Diseases Unit at Chiesi Group. In this role, she leads market access, value strategy, health technology assessment, and evidence generation activities across Europe and international markets, supporting access to innovative therapies for people living with rare diseases. Prior to joining Chiesi, she worked in life sciences consulting, including at IQVIA, where she focused on integrating patient perspectives into clinical development and translating clinical trial and real-world evidence into actionable insights for healthcare decision-makers.

Diana is actively involved in international policy and research initiatives, including the ISPOR Emerging and Orphan Therapies Special Interest Group and the EFPIA HTA Working Group, contributing to discussions on evidence generation, health technology assessment, and equitable access to rare disease treatments.

She holds degrees in Economics and Finance from Bocconi University and a master’s degree in Biotechnology from Johns Hopkins University

Dorota Religa, MD, PhD, is Professor of Geriatrics at Karolinska Institutet and Senior Consultant at Karolinska University Hospital, Stockholm, Sweden.

She serves as Director of the Swedish Registry for Cognitive/Dementia Disorders (SveDem), where she leads initiatives to improve dementia care, quality monitoring, and research through nationwide real-world data.

Her work focuses on dementia, cognitive disorders, aging, and the use of registry data to support evidence-based healthcare and research.

Shaun Rowark has worked in UK healthcare data space for over a decade, starting out as a data analyst in hospital trusts to now being an associate director at NICE, providing strategic leadership in healthcare data analytics to enable the dynamic use of health data for Health Technology Assessment and guideline development.
He is focused on delivering innovative analytical solutions to embed real-world evidence in decision-making and influence best practice.
Shaun holds a master’s degree in health informatics from University College London.

Shaun holds a Master’s degree in health informatics from University College London.

ing Wang-Silvanto is a health economist and real-world evidence expert with extensive experience in health economics and outcomes research (HEOR), evidence generation, and market access across the pharmaceutical industry. She currently serves as Senior Director, Global Value Evidence at Astellas Pharma and is an active member of the Observational Health Data Sciences and Informatics (OHDSI) community, a global collaborative that develops open-source solutions for large-scale observational health research.

Throughout her career, Dr. Wang-Silvanto has held senior leadership roles in HEOR and evidence generation across Europe and global markets, supporting the translation of clinical and real-world data into evidence that informs healthcare decision-making. Her work focuses on leveraging real-world evidence, advanced analytics, and emerging technologies, including artificial intelligence, to improve the assessment of healthcare interventions and support patient access to innovative therapies.

She is also a published contributor to research exploring the application of AI and data science methodologies within evidence generation and health outcomes research.

aunya Dover is Director of Science and Methods at Canada’s Drug Agency (CDA-AMC), where she leads work across health technology assessment (HTA) methods, real-world evidence, ethics, equity, and scientific advice. She provides strategic leadership in advancing evidence appraisal and methodological innovation to support evidence-informed healthcare decision-making in Canada.

Prior to joining CDA-AMC, Saunya spent more than a decade in clinical and health research, including paediatric rare disease research and evidence generation. Her work focuses on strengthening the use of real-world evidence and ensuring rigorous, transparent, and patient-centred approaches to healthcare decision-making.

Tonya Winders is President and Acting CEO of the Global Allergy & Airways Patient Platform (GAAPP), a global network representing patient organisations and individuals living with allergy, asthma, and other airway diseases. With more than 25 years of experience in the allergy and respiratory health sector, she is a recognised advocate for patient-centred care and improved access to effective treatments.

Tonya serves on several international expert panels, including the Global Initiative for Asthma (GINA), and has authored numerous peer-reviewed publications. Through her work with GAAPP, she champions the integration of the patient voice into healthcare policy, research, and decision-making to improve outcomes for people living with respiratory and immunological conditions worldwide

Karen Facey worked as a statistician in the pharmaceutical sector and UK medicines regulation, before becoming founding Chief Executive of the first national HTA agency in Scotland. Since 2003, Karen has been an independent HTA consultant with special interests in RWD, rare diseases and patient involvement.

She is passionate about holistic HTA to determine value and use of health service data to improve patient care. Karen also works with the University of Oxford as a Senior HTA Advisor in the IHI Guidelines for RWE Generation project and with Utrecht University in the SUSTAIN HTA Coordinating Support Action

Hans-Georg Eichler is the Consulting Physician of the Association of Austrian Social Insurance Institutions. He was the Senior Medical Officer of the European Medicines Agency for over 14 years, and Professor and Chair of clinical pharmacology at the Medical University of Vienna. In 2011, he was a Visiting Scholar at MIT, where he participated in the NEW Drug Development ParadIGmS Initiative (NEWDIGS), focused on enhancing the capacity of the global biomedical innovation system to sustainably deliver new, better, affordable therapeutics to the right patients faster.

Dr. Eichler is also a lead co-author of a publication focused on the role of RWE in access and reimbursement decisions for personalized medicines, recently published in the Clinical Pharmacology and Therapeutics (CP&T) Journal

Ashley Jaksa is Principal, Research Partnerships at Pedestal Health where she leads the strategic growth of research collaborations.

Her role centers on developing and executing high-impact research partnerships with pharmaceutical, biotechnology, and other stakeholders to redefine how retrospective and prospective data are used to advance disease research and treatments.

Prior to joining Pedestal Health, Ashley held roles at Aetion, CVS Health, and Context Matters, where she contributed to the evolution of evidence generation strategies across the healthcare ecosystem.

Her research focuses on improving the use of real-world evidence (RWE) in regulatory, payer, and health technology assessment (HTA) decision-making. She has presented her work at leading conferences including ISPOR, HTAi, and AMCP, and her research has been published in a range of peer-reviewed journals. Ashley holds a Bachelor’s degree from the University of Michigan and a Master of Public Health from Yale University.

Ashley is an active contributor to the RWE community, serving on ISPOR’s Real-World Evidence and RWE4Decisions Steering Committees, SustainHTA’s Advisory Council, AMCP’s RWE Research Initiative, and the Editorial Board of the Journal of Comparative Effectiveness Research. She is also a former Chair of ISPOR’s Real-World Evidence Subject Matter Interest Group.

François Houÿez is Director of Treatment Information and Access and Health Policy Advisor at EURORDIS-Rare Diseases Europe, where he leads work on access to therapies and health policy for people living with rare diseases. A patient advocate since the early 1990s, he has played a pioneering role in ensuring that the patient voice is represented in regulatory and health technology assessment (HTA) decision-making across Europe and heard by industry.

François represents EURORDIS at the European Medicines Agency (EMA), the HTA Stakeholder Network, and the ACT EU initiative. He also serves on the Executive Board of the GetReal Institute, supporting the integration of real-world evidence into healthcare decision-making. Through his work, he helps advance equitable access to treatments and strengthens patient involvement across the medicine’s lifecycle.

Klaus Pugner is Head of Global Payer Evidence Planning and HTA at Takeda, with more than 20 years of experience in health economics, pricing, reimbursement, health technology assessment (HTA), and real-world evidence. He has led the development of global value dossiers, HTA strategies, pricing and reimbursement frameworks, and market access capabilities supporting the launch of innovative medicines across international markets.

Throughout his career, Klaus has built and led regional and global HEOR, market access, and HTA teams, with a particular focus on translating evidence into successful access strategies for patients and healthcare systems.

Laura Batchelor is Managing Partner of FIPRA Public Affairs and Head of its Healthcare & Lifesciences Practice, as well as a member of the FIPRA Network Advisory Board. She has over 25 years’ experience advising on EU and national government relations, while driving FIPRA’s growth in Brussels. Her expertise spans pharmaceuticals, medical devices and the broader life sciences sector, alongside trade, competition and security.

Laura specialises in developing strategies that identify common ground between public and private interests, supporting policy-driven growth and market access, and has advised on the creation of multi-stakeholder coalitions that have shaped policy thinking and political action at European and national level. Earlier in her career, she spent a year in Washington, DC, building partnerships and business for the FIPRA Network, followed by five years in the UK.

She is a Founder and Board Member of W@Lifesciences and serves on the Board of the British Chamber of Commerce to the EU and Belgium