Educational Symposia

* Program subject to change

Tue 30 Nov14:00 - 15:30Educational SymposiaAMR and Pull Incentives: Still a Vision or Becoming a Reality in Europe?

Antimicrobial resistance (AMR) is a global issue and poses a serious threat to the effective prevention and treatment of infections caused by bacteria, viruses, and fungi. Whilst appropriate initiatives such as stewardship are useful to restrict their use to instances where treatment options are limited, there are challenges in supporting the development of new antibiotics. The introduction of incentives aims to encourage innovation and the development of new antibiotics. Push incentives directly lower the R&D cost of developing a new antimicrobial, while pull incentives, such as value-based pricing and reimbursement initiatives, improve commercial prospects . The objective of this symposium is to provide information on the conceptual role and types of pull incentives in incentivising R&D, to discuss pull incentive initiatives implemented to date, and to increase understanding of how these can be most effectively developed and implemented at country level, based on experiences across Europe.

SponsorShionogiModerators

Christine Årdal, MBA, PhD

Norwegian Institute of Public Health, Oslo, Norway

Christine Årdal MBA PhD has worked for over 20 years on access to medicines through different sectors. At the Norwegian Institute of Public Health, her research focuses on the policy aspects of antimicrobial access and innovation. Årdal was the co-lead of the research and innovation work package for the European Union’s Joint Action on Antimicrobial Resistance and Healthcare-Associated Infections (EU-JAMRAI), detailing European strategies to implement mechanisms to increase antibiotic access and innovation. She was also a co-lead in the DRIVE-AB research project, with a focus to stimulate innovation, the sustainable use, and the equitable availability of novel antibiotics to meet unmet public health needs.

Speakers

James Anderson, MSc MBA

The International Federation of Pharmaceutical Manufacturers and Associations, Maidenhead, United Kingdom

James joined the IFPMA as Executive Director of Global Health in January 2021, where he is responsible for leading the work on priorities in global health. This includes industry’s policy and advocacy on pandemic preparedness, antimicrobial resistance (AMR) and global access to medicines and vaccines. In his previous role as Head of Corporate Government Affairs at GSK, James led GSK’s strategic engagement with the UK Government and was a member of the Life Science Strategy Board and Vice-Chair of Business at OECD’s Healthcare Committee. He led GSK’s work on AMR and advised on AMR policy development at the WHO, UN, EU Commission and National Governments. He was also in the Founding team of the AMR Action Fund and led the development of the Davos Declaration and UNGA Industry AMR Roadmap.

Timo Minssen, LL.Lic., LL.M., M.I.C.L., Dipl. Jur.

University of Copenhagen, Lund, Sweden

Professor Timo Minssen is the Founder and Managing Director of the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen. He is also a senior consultant at the Swedish Law firm X-officio Advokat AB. Holding law & life science-related LL.M. & LL.D./Jur. Dr. degrees, he specializes in IPRs, antitrust, and regulatory law in the health & life science sectors. He is the new chair of the International Network for AMR Social Science (INAMRSS). Moreover, he collaborates on several research projects scrutinizing regulatory challenges posed by new health technologies and health threats with inter alia Harvard Law School, Harvard Medical School, the University of Cambridge, and the Max Planck Institute for Innovation and Competition.

Lotte Steuten, Prof. PhD, MSc

OHE, City, University of London, London, United Kingdom

Lotte Steuten, PhD, is Vice-President and Head of Consulting at the Office of Health Economics and Honorary Visiting Professor at City, University of London, UK. After graduating cum laude with her PhD from Maastricht University, the Netherlands, Lotte has been active in the health economics and HTA field for >15 years in various academic roles and executive functions (non-profit and for-profit). Lotte’s research speciality is decision analysis, focusing on the development and application of health economic analysis and health technology assessment (HTA), with the aim to accelerate patient access to high value health care services and treatments. She has co-authored >100 journal publications and reports. To translate research into better decisions, she works effectively with pharmaceutical industry, technology assessors, payers and policy makers, (academic) researchers, clinical and patient representatives as well as capital investors. Her international career-path, including the UK, the US and the Netherlands, has provided her with deep insights in the fundamental differences and commonalities between the role of health economic research and HTA policies and practices in different healthcare systems. In her current role at the Office of Health Economics she is responsible for the research-led consulting program, maintaining OHE's stellar reputation for objective, innovative and high-quality research and analysis globally, and meeting its charitable objectives. Before joining OHE, Lotte worked as an Associate Member at the Fred Hutch Cancer Research Institute and Associate Professor at the University of Washington, Seattle (US), where she currently holds affiliate appointments. Prior to that she co-founded Panaxea, a healthcare research consultancy, and served as its CEO and CSO from 2010 to 2018. As an active member of ISPOR for over 10 years, Lotte serves at the Board of Directors, is Co-Chair of the Virtual ISPOR Europe 2021 meeting, and contribute(d) to their various Taskforces, Shortcourses, Committees, and diversity initiatives.

Wed 1 DecHealth Technology Assessment: The New Frontier for Gene Therapies in EuropeLive

Economic evaluation studies may underestimate the value of innovative cell and gene therapies in rare diseases, impacting on Health Technology Assessment (HTA) frameworks, market access and pricing decisions. This symposium will explore the complexities involved in evaluating and valuing gene therapies, to enable patient access to these novel therapies in the European region. Panelists will discuss the affordability challenge posed by novel single-dose treatments, such as gene therapies, compared to chronic therapies historically reimbursed in Europe. They will explore the evolution of the reimbursement landscape for cell and gene therapies in Europe and reflect on the drug value evidence-based challenges for novel therapies such as gene therapy, including how to value benefits beyond quality of life and survival.

SponsorNovartis Gene TherapiesModerators

Omar Dabbous, MD, MPH

Novartis Gene Therapies, Inc., Bannockburn, IL, USA

Speakers

Michael Drummond, MCom, DPhil

University of York, York, YOR, United Kingdom

Michael Drummond, BSc, MCom, DPhil is professor of Health Economics and former Director of the Centre for Health Economics at the University of York. His particular field of interest is in the economic evaluation of health care treatments and programmes. He has undertaken evaluations in a wide range of medical fields including care of the elderly, neonatal intensive care, immunization programmes, services for people with AIDS, eye health care and pharmaceuticals. He is the author of two major textbooks and more than 650 scientific papers, and has acted as a consultant to the World Health Organization and the European Union. He has been President of the International Society of Technology Assessment in Health Care, and the International Society for Pharmacoeconomics and Outcomes Research. In October 2010 he was made a member of the National Academy of Medicine in the USA. He has advised several governments on the assessment of health technologies and chaired one of the Guideline Review Panels for the National Institute for Health and Care Excellence (NICE) in the UK. He is currently Co-Editor-in-Chief of Value in Health and has been awarded 3 honorary doctorates, from City University (London), Erasmus University (Rotterdam) and the University of Lisbon.

J.-Matthias Graf von der Schulenburg, PhD, MD

Leibniz University Hannover, Hannover, Germany

J.-Matthias Graf von der Schulenburg is editor in chief of the European Journal of Health Economics and the Health Economics Review. He teaches risk and insurance and health economics at the Leibniz University Hannover. For his research, he has received the Alexander von Humboldt Award 1990 and the American Risk and Insurance Award in 1992. He is member of the Academy of Sciences and Literature,Mainz and the European Academy for Sciences and Arts.

Mondher Toumi, MD, MSc, PhD

Aix Marseille University, Marseille, France

Professor Mondher Toumi is a MD by training and holds two MSc in Biostatistics, and in Biological Sciences (option pharmacology) and a PhD in Economic Sciences. He is professor of Public Health at Aix-Marseille University. After working for 12 years as a research manager in the Department of Pharmacology at the University of Marseille, he joined the Public Health Department in 1993. In 1995, he entered the pharmaceutical industry and worked there for 13 years. Mondher Toumi was appointed global vice president at Lundbeck A/S in charge of health economics, outcome research, pricing, market access, epidemiology, risk management, governmental affairs, and competitive intelligence. In 2008, he founded Creativ-Ceutical, an international consulting firm dedicated to support health industries and authorities in strategic decision-making. In February 2009 he was appointed professor at Lyon I University in the Department of Decision Sciences and Health Policies. The same year, he was appointed director of the chair of Public Health and Market Access. He launched the first European University Diploma of Market Access (EMAUD) an international course already followed by more than 350 students. Additionally, he recently created the Market Access Society to promote research and scientific activities around market access, public health and health economic assessment. Since 2009, he also chaired the Annual Market Access Day, a purely academic event. He is editor in chief of the Journal of Market Access and Health Policy (JMAHP), which is PubMed index. Since September 2014, he joined the research unit EA3279 of the Public Health Department, at Aix-Marseille University (France) as full professor. Mondher Toumi is also visiting professor at Beijing University (Third Hospital). He has been an active member of ISPOR from its creation. He served as co-chair of the Research Review Committee ISPOR Europe in 2012 and 2013. He contributed to Short Courses in ISPOR Asia and Europe. He is member of the Editorial Board of Value and Outcome Spotlight. From 2010 he contributed to ISPOR conferences with more than 196 posters and podium presentations and 11 issue panels and workshops. He co-Chaired two consecutive SIGs on orphan drugs. He also supported ISPOR African and Nigerian Chapter. He is a recognized expert in health economics and an authority on market access and risk management. He has more than 200 scientific publications and oral communications and has contributed to several books. He just finished a book on Market Access soon to be available.

Thu 2 DecEarly-Stage Treatment in Oncology: How Can We Break the Access Logjam?Live

Early-stage treatments in neoadjuvant and adjuvant settings carries hope for many cancer patients: improved patient-relevant outcomes, curative potential, and prolonged survival effects have motivated attempts to try and treat patients earlier. As earlier treatment options are being considered, the use of endpoints other than overall survival has increased in recent years. For instance, between 2014 and 2016, nearly 75% of the European Medicines Agency’s approvals for oncology medicines were based on randomized controlled trials with disease-relevant endpoints. As the value and conditions around the acceptability of these endpoints remain contested, it is imperative to understand if, and how, access to early-stage cancer treatment is affected by the use of non-OS, disease-relevant endpoints. How do different countries in Europe take these endpoints into account, and what are best practices to ensure safe and timely access of neoadjuvant and adjuvant cancer treatments for patients?

SponsorMSDModerators

Duane Schulthess, BA, MBA

Vital Transformation, Wezembeek Oppem, VBR, Belgium

Duane Schulthess is the Managing Director of Vital Transformation, a consultancy focused on quantifying and defining innovation and value in the health-care sector. His 2019 BMJ publication titled “Are CAR-T therapies living up to their hype?” is considered a ground-breaking analysis in the field of real-world evidence, and has been cited in presentations by the European Medicines Agency and EUnetHTA. Previously, Duane was the EMEA Head of Corporate Development of The Wall Street Journal, and the Commercial Director of Science|Business. He is a senior associate of the UK’s Royal Society of Medicine.

Speakers

Oriana Ciani, PhD

SDA Bocconi School of Management, Milan, MI, Italy

Oriana Ciani is Associate Professor of Practice at SDA Bocconi in Milan. She holds a MSc in Biomedical Engineering from Politecnico di Milano and postgraduate degree in Healthcare Management from Bocconi University. She received her PhD from the University of Exeter with a thesis focusing on the evaluation of surrogate end points. She has been 2020 Fulbright Research Scholar at Yale School of Medicine and Yale School of Public Health. Oriana's research interests are centred on the use of evidence synthesis techniques to inform policy decisions, health technology assessment (HTA) and healthcare policies evaluation.

Marcin Czech, PhD

Institute of Mother and Child at Warsaw University of Technology, Warsaw, MZ, Poland

Marcin Czech is a full professor and head of the Department of Pharmacoeconomics at the Institute of Mother and Child in Warsaw, President of ISPOR, Poland Chapter, former Undersecretary of State/ Vice Minister at the Ministry of Health. He is the author of over 250 articles and reports in the field of management, health economics, pharmacoeconomics and quality of life. A medical doctor by education, specialist in epidemiology and specialist in public health, holding PhD degrees in medicine and management, MBA; completed postgraduate studies in Health Economics, Leadership Academy and university trainings.

Miguel Korte, Ph.D.

MSD, Kenilworth, NJ, USA

My brief education summary: - German Pediatric Hematology-Oncology Pediatrician: (Schwerpunkt Kinder- Hämatologie und-Onkologie). Certified by Bezirksärztekammer Rheinhessen, Mainz, Germany - MAY 2009 - PhD approved with “magna cum laude”. Certified by the Johannes Gutenberg-University, Mainz, Germany. Titel: „ Possibilities and therapeutic implications of cytologic findings in Pediatrics (with special reference to pediatric hematology and oncology) “. DEC 2008 - German Pediatrician: (Facharzt für Kinderheilkunde und Jugendmedizin). Certified by „Bezirksärztekammer Rheinhessen“. Mainz, Germany - 21.MAR.2007 - German MD Certification (Approbation als Arzt). Certified by „Landesamt für Soziales, Jugend und Versorgung Rheinland-Pfalz“. Koblenz, Germany - 20.MAR.2006 - Chief of Resident: Completed Pediatrics Residency Chief Program at the José de San Martín University Hospital of the University of Buenos Aires (UBA) School of Medicine (JUN 2000 – MAY 2001). - Pediatrician: Certificate as Pediatrician by the University of Buenos Aires, School of Medicine (NOV 2001). - Pediatrician: Certificate as Pediatrician by the Argentine Pediatric Society (DEC 2000) - Residency: Completed Pediatrics Residency Program at the José de San Martín University Hospital of the University of Bs. As. (UBA) School of Medicine (JUN 1997 – MAY 2000) University: MD - University of Salvador (USAL), Buenos Aires November 1996 I am a dynamic and driven leader, entrepreneurial mindset and passion for innovation with demonstrated success collaborating across functions and geographies. Decisive, intelligent risk taker and resourceful problem solver who inspires change through influence. Strong sense of ethic and integrity and the desire for impact. Adaptable, organized and data-driven with a strategic vision of the evolving oncology field.

Michele Pistollato, PhD

Charles River Associates, London, LON, United Kingdom

Michele Pistollato is a Principal at Charles River Associates. He specialises on policy topics in Life Sciences, ranging from value assessment and pricing dynamics for pharmaceuticals to public policy issues regarding specific therapy areas, such as oncology, cardiovascular diseases and rare diseases. Recent work includes research analyses on the consequences of price transparency for pharmaceuticals, the ideal environment for a well-functioning European HTA process and the challenges for oncology combinations.