HTA/Payers and Ministries of Health | Insurer | Clinician | Patient Representative | International Organisation | Academics | Analytics Expert | Industry | RWE4Decisions Secretariat
HTA/Payers and Ministries of Health
Belgium
Jo De Cock
Senior Adviser, National Institute of Health and Disability Insurance (INAMI-RIZIV)
Jo De Cock is the former CEO of INAMI-RIZIV. Prior to this, he was Deputy Director/Councillor for social affairs in the office of the Belgian Prime Minister (1985-1993) and then became adjunct general administrator of the National Social Security Office (1993-1995). Since its creation in 2019, Jo De Cock has been closely involved in the International Horizon Scanning Initiative, an independent entity legally registered at RIZIV/INAMI and a spin-off of the BeNeLuxAI initiative. Jo has driven forward a series of multi-stakeholder roundtables to consider use of RWE to ensure short term affordability, long-term sustainability and optimal patient care.
Belgium
Diane Kleinermans
President of the Commission of Drugs Reimbursement, National Institute of Health and Disability Insurance (INAMI-RIZIV)
Diane Kleinermans has been appointed President of the Commission of Drugs Reimbursement at the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV), after having served as an internal expert to the Commission since 2008, being amongst others in charge of orphan drugs assessments. From 2015 to 2020, she was advisor to the Belgian Minister of Public Health and Social Affairs Maggie De Block, focusing on drug policy, clinical trials and the BeNeLuxA/ IHSI initiatives. Diane started her career as a GP in Brussels. Until 2007, she worked with the pharmaceutical industry in R&D in Belgium and abroad; she worked amongst other for Pfizer, Novartis Opthalmics and GSK. Diane has been closely involved in the multi-stakeholder roundtables considering the use of RWE to ensure short term affordability, long-term sustainability and optimal patient care.
Canada
Laurie Lambert
Lead RWE, Canadian Agency for Drugs and Technologies in Health (CADTH)
Dr Lambert obtained a Masters and PhD in Public Health, Research Methods and Biostatistics from the University of Western Australia and a scholarship from Australia’s National Health and Medical Research Council was awarded for her doctoral work. Dr. Lambert was the coordinator of the Cardiovascular Evaluation Unit at INESSS for 16 years. She became the Lead for Real World Evidence at CADTH in August 2020. Dr Lambert believes multi-stakeholder collaboration and measurement of structures, processes and outcomes in the real-world setting will result in a variety of benefits for patients, care providers, decision-makers, and the health system.
Finland
Piia Rannanheimo
Chief Specialist, Finnish Medicines Agency (Fimea)
Piia Rannanheimo is a pharmacoeconomist at the Finnish Medicines Agency (Fimea). She joined Fimea’s HTA-team in 2010. With a background in Pharmaceutical Sciences, Rannanheimo has contributed to numerous national, Nordic and European HTAs and worked as a visiting researcher at CADTH and Center for Health Economics at University of York. She also serves as an expert for the Council for Choices in Health Care in Finland. She’s also been a member in several working groups led by the Ministry of Social Affairs and Health in Finland, covering rational use of medicines, HTA, RWD and data management. Currently, she’s working as a project manager in a work that that aim’s in the establishment of national medicinal product data repository.
Portugal
Cláudia Furtado
Head of Health Technology Assessment, Pricing and Reimbursement Division (DATS) and the Information and Strategic Planning Division, Portuguese National Authority for Medicines and Health Products (INFARMED)
Cláudia Furtado is the head of Health Technology Assessment, Pricing and Reimbursement Division (DATS) as well of the Information and Strategic Planning Division (DIPE) at INFARMED, the Portuguese National Authority of Medicines and Health Products. As head of DATS, she is responsible for HTA evaluation, pricing and reimbursement of medicines, medical devices and health products, and for managed entry agreements. As head of the DIPE, she oversees monitoring of health consumption and expenditure and the definition and evaluation of policy measures. In addition to her role at INFARMED, she is an assistant professor at the Portuguese National School of Public Health (Universidade NOVA de Lisboa).
Spain
Carlos Martín Saborido
Advisor at the National Health and Pharmacy General Directorate, Spanish Ministry of Health
Carlos Martín Saborido is a Health Economist working on HTA evaluations since 2007, first in Spain HTA Agencies, then in the UK for NICE, and then later on at the Joint Research Centre (European Commission) and now at the Spanish Ministry of Health as an Assessor in the area of Health Economics and RWE to support decisions. His work focuses on giving advice for the economic evaluation of health technologies and the analysis of data from the VALTERMED RWE database. Since 2019, Saborido has been working on the collection of data on use of drugs to generate evidence to support funding and reimbursement decisions.
Sweden
Niklas Hedberg
Chief Pharmacist, Swedish Dental and Pharmaceuticals Benefits Agency (TLV)
Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). Niklas is the Chair of the Consortium Executive Board for EUnetHTA21. He was the Chair of the EUnetHTA Executive Board between 2018 and 2021. Niklas has been working with pricing and reimbursement since 2001. He has held positions as medical assessor and 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 an onward (pilots both nationally with MPA and on European level with EMA) and strategic discussions about RWD.
Insurer
Austria
Hans-Georg Eichler
Consultant Physician, Association of Austrian Social Insurance Institutions
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.
Clinician
Switzerland
Matti Aapro
Director, Genolier Cancer Centre, Switzerland
Matti Aapro is member of the Board of Directors of the Genolier Cancer Center, Genolier, Switzerland and Immediate Past-President of the European Cancer Organisation. Dr. Aapro is Executive Board member of All.Can and President of Sharing Progress in Cancer Care (SPCC), both not-for-profit associations. He serves the International Society for Geriatric Oncology (SIOG) as Executive Board Member. He is past-President of the Multinational Association for Supportive Care in Cancer (MASCC). He continues to collaborate with the European School of Oncology (ESO) where he an Executive member. He is member of the Board of the French-speaking Society for Supportive Care (AFSOS), as well as Advisor to the Japanese Association for Supportive Care in Cancer (JASCC). He has been member of the Board of the European Organization for Research and Treatment of Cancer (EORTC) and of the Board of the European Society of Medical Oncology (ESMO). He received his medical degree from the Faculty of Medicine, University of Geneva, Switzerland and was a fellow at the Arizona Cancer Center in Tucson, Arizona, USA. He was the founding chair of the Medical and Radiation Therapy Department at the European Institute of Oncology in Milan. His main interests are Breast Cancer, Cancer in the Elderly, Supportive care and access to treatment.
Patient Representative
EURORDIS-Rare Diseases Europe
EURORDIS-Rare Diseases Europe is a non-governmental patient-driven alliance of patient organisations and individuals active in the field of rare diseases that promotes research on rare diseases and commercial development of orphan drugs.
Chris Sotirelis
Patient Advocate for the Thalassaemia Community
Chris Sotirelis, PhD, is a patient advocate representing the Thalassaemia community and Rare Diseases, active at national and international level over many years. In his capacity as EMA patient expert in the Committee for Advanced Therapies, he has been directly involved in developments of regulatory policy focusing on the new paradigms for ATMPs and PRIME. A long term supporter of the creation of new innovative frameworks for the collection of Real World Evidence for regulatory approval and access and reimbursement. As CAT member, he has participated in many ATMP Marketing Authorisation and PRIME eligibility evaluations, and a number of EMA guidelines on ATMPs, Orphan Similarity, Significant Benefit, GCP and GLP.
He has been directly involved, with HTA Parallel Scientific Advice sessions, in European payer led projects with MEDEV and the Mechanism of Coordinated Access (MOCA), as well as at the UK national level with MHRA, NICE and NHSE Specialised Commissioning. He has been part of RWE4Decisions from its inception, as well as its predecessor Trust4RD.
He has been directly involved, with HTA Parallel Scientific Advice sessions, in European payer led projects with MEDEV and the Mechanism of Coordinated Access (MOCA), as well as at the UK national level with MHRA, NICE and NHSE Specialised Commissioning. He has been part of RWE4Decisions from its inception, as well as its predecessor Trust4RD.
International Organisation
Eric Sutherland
Senior Health Economist, Organisation for Economic Co-operation and Development (OECD)
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.
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.
Academics
Italy
Entela Xoxi
Pharmacologist, Università Cattolica del Sacro Cuore, Italy
Ten years at Italian Medicines Agency (AIFA): Health technical officer pharmacologist (2007 – 2012) and AIFA’s Registries Co-Ordinator (2013 – 2016). IT member at EU Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) & IT member for “Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States”. IMI ROADMAP Regulatory‐HTA‐Payer EXAG Member (2017 – 2018) and IMPACT HTA WP10 partner (2018 – 2021). Expertise in regulatory science, post-marketing patient registry, managed entry agreements’ implementation. Since 2017 Lecturer with Collaboration Agreement for Research Projects at Catholic University Sacro Cuore Rome (Italy), and consultancy activities.
Analytics Expert
USA
Ashley Jaksa
Market Access Scientific Strategy Lead, Aetion, US
Ashley Jaksa is Market Access Scientific Strategy Lead at Aetion. She focuses on collaborating with decision-makers to enhance their use of RWE and setting methodological guidance for RWE generation. She also works with Aetion’s biopharma clients on incorporating RWE in their global market access strategy. She is passionate about determining how to get the best therapies to the right patients at the right time through the use of the best evidence. Previously, she led analytic services at Context Matters where she consulted with biopharma clients on designing and executing analytic projects. She has presented her research at numerous international conferences including ISPOR, HTAi, and AMCP, and published her findings in various peer-reviewed publications. She holds a bachelor’s degree from the University of Michigan-Ann Arbor and a MPH from Yale University.
Industry
Alexander Natz
Secretary General, EUCOPE
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.
Alison Horsfield
Global Strategy & Innovation Director, Oncology Market Access, AstraZeneca
Ali has had a variety of marketing roles in the Pharmaceutical industry, with a focus on oncology. In recent years she has worked in the field of market access, and is currently concentrating on helping AstraZeneca to contribute to the evolution of value based health care, including developing the enablers of value-based agreements and novel payment models, and the definition and generation of relevant stakeholder evidence. She is based in the UK and has spent time working in Australia, Japan and German.
Christophe Sauboin
Director, Global Market Access Excellence, Boehringer Ingelheim
Christophe Sauboin is Director of Global Market Access Excellence at Boehringer Ingelheim. Prior to this, he held key positions at GlaxoSmithKline ad Director of Value Evidence/Market Access in Belgium and Director of Health Economics in Nairobi, Kenya, shaping global market access strategies, engaged with payers, developed new approaches, and disseminated best practices in Health Technologies Assessment. He also served as an Evaluation Expert at Aide a la Decision Economique and holding positions at Groupe One and Handicap International.
Ansgar Hebborn
Head of European Access Policy Affairs, Hoffmann-La Roche AG
Ansgar Hebborn is Roche Pharma’s Head of European Access Policy. In this role, he focuses on evidence development and HTA, pricing and reimbursement decision making frameworks and their impact on patient access and biopharmaceutical innovation. He has taken an active role as advisor and stakeholder representative in various HTA collaboration networks including EU HTA Network, EUnetHTA and the HTAi Policy Forum Committee, and also has been involved in the foundation of other initiatives in this field e.g. the Green Park Collaborative, the HTAi Asia Policy Forum and SwissHTA. In an earlier role as health economist and outcomes research specialist for Roche in the US, he has gathered extensive experience with real-world data research.
Karl Arnberg
Director of Access and Evidence Policy, Novartis
Karl holds a position as Director Access and Evidence Policy at Novartis’ headquarters in Basel. Prior to joining Novartis, he worked 14 years in roles with increasing responsibility at the Dental and Pharmaceutical Benefits Agency in Sweden (TLV). Throughout his career, Karl has been keen to explore how to improve the understanding of the value medicines can bring to patients, healthcare systems and society. His current role as Novartis involves bringing alignment across functions on issues related to evidence and access to medicines – including data privacy, methodological advancements, and long-term sustainability of healthcare systems.
With a background in economics, Karl is particularly interested in the role of incentives to improve the efficiency of healthcare systems and its actors.
With a background in economics, Karl is particularly interested in the role of incentives to improve the efficiency of healthcare systems and its actors.
Andre Vidal Pinheiro
Vice-President – Head of Patient Value & Access EUCAN, Global Pricing & Access, Takeda
Andre Vidal Pinheiro is Takeda’s Head of Patient Value & Access for Europe and Canada. From informing Takeda’s product development plans that meet HTA-grade evidence requirements, to partnering with stakeholders for value-based healthcare solutions development, Andre and his team focus on accelerating and broaden access of Takeda’s innovative therapies to patients. Andre has been with Takeda since 2017 in multiple global and regional market access roles, and before that with Pricing & Market Access consultancy firms, giving him breadth of experience across several disease areas and therapy lifecycles. A scientist by training (and at heart), Andre holds a PhD in Biochemistry and a degree in Applied Chemistry. He is passionate about combining evidence-based decision-making, clinical development, public health & policy, the power of data, and pragmatism for the benefit of patients, caregivers and society as a whole.
Adam Heathfield
Senior Director, Global Health and Value Innovation Centre, Pfizer
Adam is part of Pfizer’s Global Access Innovation Centre, specialising in new access approaches for the company’s pipeline programs and external collaborations in novel contracting and Value Based Healthcare. Adam has worked at Pfizer for nearly 20 years, with responsibilities including HTA policy, rare diseases and orphan medicines, R&D policy and adaptive licensing. Prior to Pfizer Adam worked for the UK Prime Minister’s Strategy Unit, the House of Lords Science and Technology Committee and as an academic researcher. He is based in the UK.
RWE4Decisions Secretariat
Laura Batchelor
Project Lead, FIPRA
Laura is a Managing Director of FIPRA International and leads the healthcare practice. Over the past 20 years, Laura has advised individual companies, trade associations and NGOs to deliver legislative and policy change at European and national level. Laura has advised on the creation of a number of multi-stakeholder groups focused on access to innovative medicines, and policy recommendations derived from these consensus-building initiatives have been tabled for consideration by member states, referenced by the OECD and acknowledged by patients groups for thought leadership.
Karen Facey
Senior Advisor HTA, FIPRA / RWE4Decisions Facilitator
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 consultant on health policy, HTA and patient involvement. She is passionate about holistic HTA to determine value and use of health service data to improve patient care. Karen is lead co-author of the paper on ‘RWE to Support Payer/HTA Decisions about Highly Innovative Technologies in the EU – Actions for Stakeholders’. She has just completed EC-funded research in the IMPACT HTA project developing tools to support OBMEA.
François Meyer
Special Advisor HTA, FIPRA
François joined the management team of HAS in 2005, leading the setup of the HTA Division across key areas like pharmaceuticals, medical devices, interventional and diagnostic procedures, and public health programs. He expanded HAS’s role in economic analysis within France’s HTA field. He then focused on international cooperation, serving on the HTAi Board for two terms, coordinating EUnetHTA activities, and representing HAS in projects including Post Launch Evidence Generation with HTA-EMA cooperation. Before joining HAS, François held management roles at the French Medicines Agency (now ANSM). He was active at the EMA, serving on the Committee for Orphan Medicinal Products.