Speakers
Rui Santos Ivo
President, Executive Board, INFARMED - National Authority of Medicines and Health Products, Portugal
Niklas Hedberg, MPharm
HTACG Co-Chair & Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Chair of the EUnetHTA Executive Board and the TLV lead partner in EUnetHTA WP 3 Evaluation. Niklas has been working with pricing and reimbursement since 2001. Niklas started as a medical assessor and project leader in the agency, he was the Head of the Department for New Submissions between 2009 and 2014 and is since in his current position. 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.
Flora Giorgio, MPharm
Head of Unit Medical Devices, DG SANTE – Medical Products and Innovation, European Commission, Belgium
Flora is a pharmacist by training. She is heading the team of Health Technology Assessment at the European Commission in DG Health (SANTE), Unit "Medical devices and health technology assessment". The team is responsible for the Legislative Proposal on HTA, for the Secretariat to the HTA Network, and oversees the activities of the Joint Action EUnetHTA. Flora joined the EC in 2006 in DG CNECT, she worked in the ICT for the Health Unit. Before joining the EC she was the Secretary General of the PGEU, the European Association of Community pharmacists and also worked in a community pharmacy.
Michael Berntgen, PhD
Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
Michael Berntgen, Head of Scientific Evidence Generation at the EMA, Amsterdam, oversees robust medicine development. Collaborating with stakeholders, the department provides scientific advice, supports pediatric and orphan diseases, and manages the PRIME scheme. Michael, a pharmacist with a PhD, worked in pharmaceutical regulatory affairs in Germany and the UK from 1999 to 2006. Joining BfArM in 2006, he moved to EMA in 2007, holding various positions until becoming Head of the department in March 2020.
Valentina Strammiello, MA
Director of Programmes, European Patients' Forum, Belgium
Valentina Strammiello is currently the Director of Programmes at the European Patients Forum where she has been working for the past ten years. She oversees the EPF project portfolio and represents EPF in HTA and health data related activities.Before joining EPF, Valentina worked as freelance OSINT analyst on Security and Energy issues. Self-trained in website management and web 2.0 applications, she is among the founders of ecpa2.0 (European Centre for Public Affairs 2.0), a forum of young professionals in Public Affairs. She holds a BA in International Relations and a Master’s Degree in European Studies.
Ansgar Hebborn, PhD, MBA
Head - Access Policy Affairs Europe, F. Hoffmann-La Roche AG, Switzerland
Ansgar Hebborn is Roche Pharma's Head of Access Policy Affairs Europe. He represents Roche in relevant industry associations e.g. in Brussels as the chair of EFPIA’s European HTA Working Group. During the past few years, he has taken an active role as advisor and stakeholder representative in various HTA collaboration networks e.g. 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.
Milena Richter
Head of EU Office, Sanofi, Belgium
Claudine Sapède, PharmD
Director, Global HTA Policy, NOVARTIS INTERNATIONAL, Switzerland
Claudine Sapède is Director, Global HTA Policy at Novartis. In this role, she focuses on value assessment, HTA and reimbursement decision-making approaches and their impact on patient access to innovative treatments. She engages with internal and external stakeholders involved in shaping HTA, pricing and reimbursement decisions. Claudine is currently a member of the EFPIA market access and HTA working groups, leading the workstream related to the implementation of the EU HTA Reg. Prior to this, she had different roles in the field of pricing and market access, at country and global levels. Her career of over 20 y in the pharma sector spans the full spectrum of evidence generation, value demonstration, MA strategies, pricing, and policy.
Inka Heikkinen, MBA, MSc
Regulatory Policy Lead, Lundbeck, Denmark
Inka has been involved very closely in HTA Regulation implementation at EFPIA since the very beginning. She leads EFPIA workstream around regulatory-HTA interaction and Joint Scientific Consultation, with extensive work on defining industry positions and thinking around the future processes and system on Marketing Authorisation review process and Joint Clinical Assessment. As her day job, she leads R&D and regulatory policy strategy and operational excellence at Lundbeck, working with senior leaders defining and advocating for policies that optimizes the environment for future health technologies. Inka holds master degrees on health economics and in policy, an Executive MBA degree with specialisation in finance.
Lara Wolfson
AVP & Head, HTA Statistics, MSD Switzerland, Switzerland
Lara Wolfson, PhD, is the Associate VP and Head of HTA Statistics at MSD in Zurich, Switzerland. Leading a team of 75+ statisticians, she pioneers quantitative solutions for Health Technology Assessment (HTA) challenges. Lara's career spans roles at Merck, Janssen, and the World Health Organization, focusing on vaccines, epidemiology, and health economics. She also taught at Brigham Young University and the University of Waterloo. Dr. Wolfson co-leads the HTA ESIG of EFSPI and holds MS and PhD degrees in Statistics from Carnegie Mellon University, with an undergraduate background from Simon Fraser University.
Session Chair Invited
, Switzerland
Maya Matthews
Head of Unit State of Health, European Semester, Health Technology Assessment, European Commission , Belgium
Maya Matthews is the Head of Unit for State of Health in the EU at the European Commission's DG SANTE. She joined in 2008 and previously worked at the EU's Delegation to the UN in Geneva. Maya has experience in health issues, consulting on reproductive health, HIV prevention, and Tuberculosis. She holds a BA in Human Sciences from Oxford University and a Masters in Health Promotion Sciences from the London School of Hygiene and Tropical Medicine, where she also conducted research from 1993-1995.
Dirk Van Den Steen
HTA Deputy Head of Unit, European Commission, Belgium
Roisin Adams
Deputy Head, National Centre for Pharmacoeconomics (NCPE), Ireland
Maggie Galbraith
, French National Authority for Health (HAS), France
As project manager at the French National Authority for Health (HAS) Maggie is the HAS representative to the EUnetHTA 21 Committee for Scientific Consistency and Quality (CSCQ) and is involved in developing guidelines for patient and HCP involvement. During EUnetHTA JA3 she managed daily operations of the Early Dialogues Secretariat and patient involvement in this activity.She previously managed European Commission funded projects on patient safety (EUNetPaS, PASQ) and Alzheimer’s disease (ALCOVE), all coordinated by HAS. Previously, she worked in technology development at a large US hospital developing evidence-based patient solutions.She holds a Master’s degree in Public Affairs and a Bachelor of Arts in Russian and Political Science.
Anne Willemsen, MSc
Senior Project Manager, Joint Production Co-Lead Partner - Pharmaceuticals, ZIN - National Health Care Institute, Netherlands
Anne holds double Masters Degrees in Health Sciences, specialising in both Health Technology Assessment and Health Policy. This led her through research and project management roles within the Dutch National Healthcare Institute (Zorginstituut Nederland) since 2016 and she lead the EUnetHTA 21 Joint Clinical Assessment (JCA) Secretariat. Since April 2023, she is the co-chair of the HTA Coordination Group Subgroup on JCA under the HTA Regulation.
James Ryan, MSc
Director, Global HTA Policy , AstraZeneca (Global), UK, United Kingdom
James Ryan is an experienced health economist with over 25 years of experience in both medical devices and medicine HTA, working across academia and consultancy, as well as country and global industry roles. Currently Director for Global HTA Policy, HTA and Modelling Science at AstraZeneca, James blends his passion for policy, and evidence, leading a team of HTA experts delivering global payer evidence for HTA bodies for AstraZeneca’s oncology portfolio. He represents AstraZeneca at the HTAi Global Policy Forum, as well as at European Federation of Pharmaceutical Industries and Associations (EFPIA) HTA Working Group, where he co-leads the methodology workstream as the biopharmaceutical industry prepares for the EU HTA Regulation.
Steffen Thirstrup, MD, PhD
Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s biosimilar market access group. An adjunct professor at the University of Copenhagen, Dr. Thirstrup has authored over 40 publications and co-edited a key Danish pharmacology textbook. He divides his time between Amsterdam and Værløse, Denmark.
Marcus Guardian
COO EUnetHTA 21, General Manager - Heads of HTA Agencies Group, EUnetHTA, Netherlands
Based on the educational background in international law and diplomatic studies, Marcus has forged a career in network development, strategic guidance, and policy management. In 2016, he accepted the Chief Operating Officer position at EUnetHTA Joint Action 3 and now continues with EUnetHTA 21 Consortium. He also leads work of the Heads of HTA Agencies Group and supports the Chairs in processes of the strategic decision making, preparing European HTA landscape for the EU HTA Regulation. Moreover, in 2018 Marcus launched the International Horizon Scanning Initiative, building a global database of pharmaceutical products in development combined with novel data-modelling tools that support member state healthcare product negotiation potential.
Bettina Ryll
Member of the First EU Cancer Mission Board, MPNE, Vision Zero Cancer, Sweden
Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered risk/ benefit assessment tools. She lectures and advises on patient-centric drug development, member of ASCO and ISPOR and current chair of the ESMO Patient Advocacy Working Group.
Beate Wieseler
Head of Department, Institute for Quality and Efficiency in Health Care , IQWiG, Germany
Beate Wieseler is Head of the Department of Drug Assessment at the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG). At IQWiG she is responsible for the scientific assessment of pharmaceuticals, the development of assessment methods as well as in the Institute’s collaboration with German and international external parties. Prior to joining IQWiG in 2005, Beate Wieseler worked in clinical research and regulatory affairs for about 10 years. Beate Wieseler holds a Diploma in Biology from the University of Bonn and a Dr. rer. nat. from the University of Freiburg, Germany.
Robin Doeswijk
Head of European Affairs, European Hematology Association, Netherlands
Robin Doeswijk is Head of European Affairs at the European Hematology Association (EHA), which brings together and represents hematologists – clinicians, diagnosticians, researchers – from across Europe and beyond. With a background in International Relations (MA, University of Utrecht) and public affairs, Robin oversees EHA’s policy, advocacy and regulatory work as well as its partnerships and alliances. He is active on several BioMed Alliance committees and taskforces (co-leading the alliance on HTA) and a member of the EMA HCP Policy Officers Group. EHA strongly supports harmonised EU-level HTA as an important step towards improving affordable and equal access to innovative therapies for patients throughout Europe.
Alexander Natz, JD
Secretary General, European Confederation of Pharmaceutical Entrepreneurs, Belgium
Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements & licensing of pharmaceuticals. He has also worked in the field of competition law with the EC & in the pharma industry. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.
Anja Schiel, PhD
Special Advisor, Lead Methodologist/Statistician; NOMA, Norwegian Medical Products Agency (NOMA), Norway
Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006, worked several years as Post-Doc at the University of Leiden and later at the University of Oslo, before starting at the Norwegian Medical Products Agency (NOMA) in 2012. At NOMA she is working as Lead Methodologist both on regulatory and HTA projects. She has been Chair of EMA’s Biostatistics Working Party (2017 – 2019) and during 2019 – 2022 she was Chair of EMA’s Scientific Advice Working Party (SAWP). She has been involved in EUnetHTA JA3 and its successor, EUnetHTA 21, with particular focus on parallel EMA-HTA scientific advice (joined scientific consultations).
Adam Parnaby
Senior Director, Market Access Policy, Bristol Myers Squibb, Belgium
Adam has 18 years of experience in the pharma industry and started his career as an academic health economist. Previously, he was Director of Pricing and Market Access for Celgene’s Oncology portfolio in the EMEA region. Prior to joining Celgene, he worked in Health Economics and Market Access roles at GSK, Pfizer and Sanofi. He is currently Vice-Chair of the EFPIA Health Technology Assessment Working Group and plays a significant role in the evolving HTA environment. He currently works on a range of topics including HTA Policy, Payer evidence development, Pricing Models to support patient access to innovative therapies. He is actively engaged in the debate around healthcare sustainability.
Sara Torgal, MPharm
Global Regulatory Policy Lead, DIA, Switzerland
Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.
Antonella Cardone
Director, Cancer Patients Europe, Belgium
Antonella Cardone is the CEO of Cancer Patients Europe, a pan-European all-cancer patient association. She's a Patient Advocacy Expert and Advisor to the Board of Pancreatic Cancer Europe (PCE), uniting physicians, patients, politicians, journalists, academia, and industry, and she is a member of Inspire2Live. Antonella led the European Cancer Patient Coalition and served as Executive Director of the Fit for Work Global Alliance. With 25 years of nonprofit experience in health, social, and employment sectors, she also directed the Global Smoke-free Partnership of the American Cancer Society. Antonella holds Master's degrees in Science and Business Administration. She has been on the Boards of All.Can and PCE, where she was vice-chair.
Rasmus Syberg Hazelton, MSc
Senior Advisor International Affairs, Amgros, Denmark
Rasmus Syberg Hazelton is an International Affairs Senior Advisor at Amgros – the centralized procurement body for medicines for public hospitals in Denmark. Rasmus is responsible for Amgros international collaboration and international collaboration partners in the EU and Nordic Pharmaceutical Forum. Having 5 years of experience from the Danish Ministry of Health's Office for Pharmaceutical Policy Rasmus has an in-depth knowledge of the Danish health and pharmaceutical policy as well as the Danish priorities internationally. Current focus areas: Health politics, EU Pharma Strategy, HTA and New Pharmaceuticals.
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