Mon 13 Nov
8:30 - 9:45
Plenary Session
European Health Data Space – RWE Put to Work for Public Health
Digital Conference Pass
Establishing a European Health Data Space (EHDS) giving citizens easy access to their own health care records also holds a potential for RWE generations via secondary use of such data. The session will explore the political vision and realities of EHDS including discussion and challenges related to any opt-in or opt-out options. We will hear patients’ views both regarding the utility of an EHDS as well as issues related to data privacy. Pathfinder projects like Towards European Health Data Space, TEHDAS, will shed light on the challenges with bringing numerous and often diverse data sources together on one platform, and the European Medicines Agency will present their vision and concrete examples of RWE in the regulatory decision-making process.
Moderators
Steffen Thirstrup, MD, PhD, CMO
European Medicines Agency, Amsterdam, Netherlands
Steffen Thirstrup is a medical doctor and board-certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine with special emphasis on adult respiratory medicine. Additionally, Dr. Thirstrup was appointed adjunct professor in pharmacotherapy at the Faculty of Health Sciences, University of Copenhagen, in 2012.
From 2004-09 Steffen Thirstrup worked at Danish Medicines Agency first as the Danish member of CHMP at the European Medicines Agency (EMA) for five years including 10 months as joint CHMP- and CAT-member, followed by a short period as head of Danish Institute for Rational Pharmacotherapy dealing with HTA and best practice guidelines for primary care. In 2011 Prof. Thirstrup rejoined the licensing division at the Danish Medicines Agency acting as Head of Division for Medicines
Assessment and Clinical Trials. During this period Prof Thirstrup co-chaired the European Commission’s working group on market access for biosimilars medicinal products and acted as key scientific contact for the managing entity of the IMI beneficiaries for the PROTECT collaboration (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium).
In March 2013, Prof Thirstrup joined the pharmaceutical consultancy company NDA Group AB as a full- time medical advisor on NDA’s regulatory advisory board. In April 2014 Prof Thirstrup was appointed as director for the Regulatory Advisory Board at NDA Regulatory Services Ltd.
Since June 2022 Prof Thirstrup has been the Chief Medical Officer at the European Medicines Agency, Amsterdam, The Netherlands
Speakers
Markus Kalliola, MSc, MSocSc
The Finnish Innovation Fund Sitra, Helsinki, Finland
Markus Kalliola is the project director in Health data 2030 project in The Finnish Innovation Fund Sitra and the coordinator of Joint Action Towards The European Health Data Space (TEHDAS). Prior to Sitra he worked in the European Commission in DG Health and food safety where he was responsible of the cross-border healthcare IT projects. Mr. Kalliola has vast experience in data economy and in the next years he will work towards healthier and fairer data economy for Europe as well as towards more competitive health data ecosystem in Finland.
Mr. Kalliola holds a positions of trust in
• HMA-EMA joint big data steering group,
• HMA-EMA Darwin EU advisory board
• DNV Digital health advisory board
• EDAH advisory board
• HealthHub Finland EDIH advisory board
• Steering group for the secondary use of health data in Finland
Trine Pilgaard, MSc
Pfizer, Ballerup, 84, Denmark
Trine Pilgaard, Director, Market Access at Pfizer Aps. is a Global Market Access Leader with more than 15 years of experience working in the pharmaceutical industry. Trine started her career at the World Health Organization, working in the pharmaceutical department, where she co-led and co-authored the EU-funded Pharmaceutical Pricing & Information Project (PPRI). She then moved to Novo Nordisk, where she had various roles within Global Market Access, amongst others, working to support the launch of new assets within hemophilia. After Novo Nordisk, Trine joined the Global Leadership team at Lundbeck, responsible for launching their new schizophrenia product. Today, Trine heads-up Pfizer Aps’s Market Access department, ensuring access and reimbursement of Pfizer’s products in Denmark & Iceland. Trine’s department is responsible for Health Technology Assessments, Health Economics, Market Access, Outcomes Research, Real-World Evidence, pricing, and tenders. In addition to her role as Director, Market Access at Pfizer, Trine is active in the Danish Trade Association and part of the committee of Hospital Medicines. Trine holds a Master in Public Health Science from the University of Copenhagen and furthermore a Master in Health Services Management from the University of London School of Hygiene and Tropical Medicines / London School of Economics. Trine is especially interested in the generation of Real-World Evidence and has, throughout her career, published +10 peer-reviewed full-scale publications.
Andrzej Rys, MSc
European Commission, Brussels, Belgium
Patrice Verpillat, MD, MPH, PhD
European Medicines Agency, Amsterdam, Netherlands
Dr. Patrice Verpillat is the Head of the Real World Evidence (RWE) Workstream at the European Medicines Agency (EMA). He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research, access and life-cycle product management.
Dr. Verpillat has published over 70 articles in Medline referenced journals. He has been involved in many organisations such as ENCePP, ICH M14 working group, European pharma association (efpia) and ISPE.
Petra Wilson, PhD
Health Connect Partners, FTI Consulting, Brussels, Belgium
Petra Wilson is co-founder and managing director of Health Connect Partners, a boutique consultancy which focusses primarily on helping clients understand the European health policy environment. In addition, Petra is acts as EU Policy Advisor to HIMSS and FTI Consulting and is a member of the team at the Institute for Innovation through Health Data, focusing on data governance. Alongside these roles Petra serves on the WHO’s Digital Health Technical Advisory Group; is a Board Member of the European Association for the Study of Diabetes (EASD), and serves on the Ethics Boards of several EU funded projects. Petra holds a Doctorate in Public Health Law from Oxford University, she has British and Belgian nationality and and works in English, German and French.
Petra’s professional experience includes eight years in the European Commission, where she focussed particularly on the use of information society technologies in healthcare; seven years as Senior Director of Connected Health at Cisco, where Petra’s team supported clients in making best use of new communications technologies to drive safer and more efficient access to healthcare. Petra also has deep experience of the health services sector, having worked on both the patient and provider side as CEO of the International Diabetes Federation; as well as experience in academia having been member of the teaching staff of both the law school and medical school of Nottingham University
Tue 14 Nov
The New Pharma Legislation Proposal: The Good, the Bad or the......
Digital Conference Pass
After long and difficult negotiations, the EC adopted a proposal for the revision of the EU pharmaceutical legislation at the last possible moment to allow a decision on the implementation during the current legislative period. This proposal is the outcome of a process initiated in November 2020 aiming to create a future proof regulatory framework and at supporting the industry in promoting research and technologies that reach patients to fulfill their therapeutic needs while addressing market failures.
4 core pillars were identified in 2020
• Ensuring access to affordable medicines for patients, and addressing unmet medical needs (in the areas of antimicrobial resistance and rare diseases, for example)
• Supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the development of high quality, safe, effective and greener medicines
• Enhancing crisis preparedness and response mechanisms, diversified and secure supply chains, addressing medicines shortages
• Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.
This panel will discuss whether these original intentions are still sufficiently reflected in the latest proposal after several rounds of consultations of different Stakeholder groups and revisions. The group will also discuss how and where HEOR might help with identified shortcomings or omissions in the new proposal as identified by the panel.
Moderators
Anja Schiel, PhD
Norwegian Medicines Agency (NoMA), Oslo, 02, Norway
Anja Schiel works as Special Adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects at the Norwegian Medicines Agency. She has been Chair of EMA’s Biostatistics Working Party 2017 – 2019 and from 2019 – 2022 she was Chair of the Scientific Advice Working Party (SAWP) at EMA. She continues currently as alternate member at the SAWP and is member of the new Methodology Working Party (MWP) recently established at EMA.
She has been heavily involved in EUnetHTA JA3 and its successor, EUnetHTA 21 with a particular focus on parallel EMA-HTA scientific advices.
Speakers
Gloria Ghequiere, MEUS
Belgium Federal Government, Brussels, Belgium
Neil Grubert, MA
Independent, Basildon, United Kingdom
Denis Lacombe, MD
European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium
Denis Lacombe graduated with his MD from the University of Marseilles (France) in 1988 and obtained a Master Post-Doctoral Fellowship at The Roswell Park Cancer Institute (Buffalo, NY USA) for research in pharmacology and pharmacokinetics from 1989 to 1991. From 1991 to 1993, he worked as a Clinical Research Advisor in charge of the development of a new drug in oncology in the pharmaceutical industry. Dr Lacombe joined the EORTC in 1993 as a research fellow and quickly became a very active and productive Clinical Research Physician involved in the conduct of clinical research from protocol development through publication for a number of oncology indications from phase I to phase III. Dr Lacombe contributed to the strategic evolution of the EORTC pan-European clinical and translational research infrastructure as well as developing partnerships with multiple stakeholders. Dr Lacombe rose to the position of Director EORTC Headquarters in 2010, was appointed Director General in April 2015 and Chief Executive Officer in June 2021. In his current position, Denis Lacombe leads all activities promoting the EORTC as a major European organization in Cancer Clinical and Translational Research, including scientific activities, public relations and mediumterm strategies as defined by the EORTC Board as well as internal and external communications. Dr Lacombe is the author of well over 150 peer reviewed publications and communications.
Yannis Natsis, MA, BA
European Social Insurance Platform (ESIP), Brussels, Belgium
Yannis Natsis is the Director of the European Social Insurance Platform (ESIP), the umbrella organisation bringing together 45 national statutory social security institutions from 18 countries. ESIP is the voice of social protection and security in Europe or as Yannis puts it one of Europe’s truest treasures.
He has more than 10 years of experience in EU advocacy and policymaking. Prior to joining ESIP in February 2022, he led the advocacy for better and affordable medicines at the European Public Health Alliance (EPHA). In May 2019, he was appointed by EU Member States to the Management Board of the European Medicines Agency (EMA), a position he held until December 2021. Additionally, Yannis has been a Board member of the European Health Forum Gastein (EHFG), the leading EU health policy platform since 2018.
Yannis previously worked for the TransAtlantic Consumer Dialogue (TACD) focusing on health and pharmaceutical policies. From 2006-2010, he was an investigative reporter for Greece's award-winning TV news programme "Fakeli" and a contributor to one of Greece’s most respected dailies “Kathimerini”.
He has a Master's degree in International Conflict Analysis from the University of Kent, UK and a Bachelor's degree in European Studies from Pantion University of Social and Political Sciences, Athens, Greece. A Greek national, he is fluent in Greek, English and French.
Johan Pontén, MA
Medicine Evaluation Committee (MEDEV), Stockholm, Sweden
Johan Pontén is Senior Manager of International Affairs at The Dental and Pharmaceutical Benefits Agency in Sweden since 2014. He is since 2021 co-chair of the Medical Evaluation Committee, MEDEV, a network of 22 national authorities from 18 Member States and Norway bringing together all the relevant institutions (national HTA agencies and social health insurers-payers) responsible for the assessment, pricing and reimbursement of medicines in Europe. He has also supported the FINOSE collaboration between Nordic HTA agencies from the start in 2017. He has had a career in the Swedish Public Service and holds a Master in Pedagogic Leadership.
Wed 15 Nov
11:30 - 12:45
The Calm Before the Storm? Delivering the New Reality for EU HTA
Digital Conference Pass
EU collaboration has been in the planning by HTA agencies for over 16 years. Since the adoption of the EU HTA Regulation in January 2022, it will become the new way of working for all stakeholders from January 2025. Whilst the Regulation covers many facets, most of the activity, and arguably the most publicly visible component, will be the Joint Clinical Assessments (JCAs). In little over 12 months from now, the first technologies mandated by the new Regulation will be starting their pathways through a JCA. Health Technology Developers & other Stakeholders are already planning for the initial assessments.
The plenary will discuss what the stakeholders require of each other, and together how they can address the anticipated challenges to ensure a smooth adoption of the new Regulation. The discussion will identify the benefits and risks of the new approach, demonstrating what will be required to turn the rhetoric into action. Will the regulation simply result in a re-engineering of the flow of information from developers to decision makers, or is it an opportunity for Europe to have a strategic input to the development of innovative technologies. The plenary will consider what will be required to ensure the new regulation, and specifically the JCAs, deliver the promised efficiencies resulting in better access for patients.
We will discuss:
From The European Commission – What contribution the Commission require from stakeholders to develop the Implementing Acts, to ensure the Regulation is operational & fit for purposeFrom an EU HTA perspective : what the EU Coordination Group require from industry and Member States to make JCA implementation a successFrom an innovator perspective : what technology developers require to be able to re-engineer their internal processes to meet the requirements of the new Regulation and transformed National processesFrom a Member State perspective : what they require from Industry and expect from the EU process to ensure efficiency & predictability in their local processesFor the Patient : What are the opportunities for patients from the new Regulation? What happens to the patient voice in member state processes if given a voice ‘in Europe’?
Moderators
Adrian Griffin, MSc
Johnson & Johnson, Buckinghamshire, United Kingdom
Adrian has worked in the life sciences industry for over 25 years, predominantly in the fields of health economics, outcomes research, and reimbursement policy, with experience across the pharmaceutical, medical device, and diagnostic sectors. His present role is Vice President, HTA and Access Policy at Johnson & Johnson. Adrian graduated in Medicinal Chemistry from University College London, obtained a post-graduate teaching qualification from Oxford University, and a MSc in Health Economics at City University, London.
Speakers
Roisin Adams, MPharm, MSc., PhD
National Centre for Pharmacoeconomics, Dublin, Ireland & Discipline of Pharmacology and Therapeutics, Trinity College Dublin, Dublin, Ireland
Greg Rossi, PhD
AstraZeneca, Cambridge, United Kingdom
Greg Rossi, Ph.D., is the Senior Vice President responsible for the Oncology Business Unit in Europe and Canada at AstraZeneca. He received his doctorate in Biochemical Engineering from University College London (UCL) and has worked since then in the biotechnology/pharmaceutical industry in the clinical development and commercialisation of oncology therapeutics.
Over the last 25 years, Greg has worked in a number of national (US and UK), regional (Europe) and global roles for Amgen, Genentech, Roche and finally AstraZeneca. Before taking over the management of the Europe and Canada oncology business at AstraZeneca, Greg was responsible for leading the global DNA damage response (DDR) portfolio as well as the global Immuno-Oncology franchise.
Bettina Ryll, MD, PhD
Melanoma Patient Network Europe, and Past Chair of the Patient Advocates Working Group, European Society for Medical Oncology, Uppsala, Sweden
Dr. Ryll holds a medical degree from the Free University of Berlin, Germany, and a PhD in Biomedical Sciences from University College London, UK. After losing her husband to Melanoma, she founded the Melanoma Patient Network Europe and developed a special interest in patient-centric clinical research and innovation, innovative trial designs and novel drug development concepts. Between 2019 and 2021, she was member of the first EU Cancer Mission Board where her particular interest has been how to best leverage the potential of personalized medicine for patients and society through novel forms of collaboration and the support of health policy and governance. Currently, she works as strategist at SIR, Stockholm School of Economics' Research Institute for Mission Zero Cancer, an innovation ecosystem in health financed by Vinnova, Sweden's innovation agency.
Jose Valverde, MD
European Commission, Brussels, Belgium
Dr. Valverde graduated from the University of Seville in 1991 with a degree in medicine and surgery. He specialised in Emergency and Casualty Medicine (1993) and Family and Community Medicine (2012).
He works at the European Commission, DG-CNECT, Unit H.3 eHealth, Wellbeing and Ageing as Policy & Programme Officer, based in Luxembourg. Currently Team Leader of the “1 Million Genomes” Initiative, PO for 8 H2020 funded research projects and Topic Coordinator for Call SC1-DTH-11-2019. Dr. Valverde is also an active member of the European Advisory Committee on Health Research (EACHR) of WHO-Europe.
Previous positions:
Director of the Andalusian Agency for Health Technology Assessment (2000-2004);
International & Research Advisor at the Cabinet of the Andalusia Regional Minister for Health (2004-2006);
Scientific Officer at the European Commission Joint Research Centre (2006-2009);
Director General of the Spanish National Centre for Accessibility Technologies (2010-2011); and
Andalusian Regional Health Department as senior emergency & casualty physician, coordinator, regulator and researcher (2011-2018, 1995-2000).
Dr Valverde´s research has focused on eHealth including Personal Health Systems, Health 2.0, mHealth, and European healthcare systems enabled through Information Society Technologies. Another related research line is on accessibility technologies for active and healthy ageing.
