Sun 9 Nov
8:00 - 12:00
Advanced Patient-Reported Outcomes
Session Type: Short Course
Topics: Patient-Centered Research
Level: Advanced
Separate registration required.
This course provides an in-depth discussion of the steps needed to successfully implement patient-reported outcomes (PRO) measurement within the drug development program to generate data to support patient-centered value messages. Formulation of a successful PRO strategy requires an understanding of PRO instrument selection, psychometric evaluation, data capture, and interpretation to negotiate regulatory, reimbursement, and market access drug development hurdles. Judging PRO instrument quality and appropriateness can be challenging.
The course will present the key elements to consider at each step in reviewing and selecting PRO measures and determining the need for new instruments. In addition, participants will gain a better understanding of regulatory expectations for qualitative and quantitative evidence to support the quality of PRO measures and aspects to consider when interpreting meaningful change. The course will include interactive discussions of PRO success stories and common pitfalls to watch out for during PRO implementation in clinical trial programs.
Participants will gain the knowledge and skills required to take on a more active and confident role in the PRO strategy and implementation process.
PREREQUISITE: This course assumes that participants will have a basic knowledge of key PRO-related concepts (eg, health-related quality of life, symptoms, impacts, a general knowledge of the PRO development steps, and a working knowledge of PRO measurement within clinical programs).
Speakers
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Rebecca Crawford, MA
RTI Health Solutions, Manchester, United Kingdom
Ms. Crawford has 13 years of experience providing consultative support to pharmaceutical companies with a focus on the development of patient-reported outcome (PRO) measurement strategies to best meet the needs of their clinical trial programs.
Ms. Crawford has developed, culturally adapted, and validated clinical outcome assessment measures, including PROs for several different therapeutic areas. Ms. Crawford has expertise in research design and in the application of both traditional and innovative qualitative research methods, including the collection and analysis of social media data to provide insights into the patient disease and treatment experience.
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Shanshan Qin, PhD
RTI Health Solutions, Durham, NC, United States
Shanshan Qin, PhD, received her training on Qualitative Methodology (including statistic inference and estimation, traditional and modern testing theories, structural equation modeling, and mixed and mixture modeling) at University of Georgia. She has 10 years of experience as a psychometric analyst and statistic consultant and has been working on psychometric evaluation of clinical outcome assessments (COAs) and support of regulatory review of COA labeling claims in various therapeutic areas, including dermatology, gastroenterology, diabetes, oncology, ophthalmology, and mental disorder. She is an experienced programmer of SAS, R, and IRT PRO.
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Lynda Doward, MSc
RTI Health Solutions, Manchester, United Kingdom
Ms. Doward has over 30 years of experience conducting patient-centered outcomes research including the provision of strategic advice to pharmaceutical companies in the incorporation of the patient voice into drug development programs. Ms. Doward is an expert in the development of clinical outcome assessment (COA) strategies including the development of patient-centered clinical trial endpoints, the implementation of patient-reported and other COA outcome measures in clinical trial programs, and the inclusion of PRO and other COA value messages at key drug development hurdles. Ms. Doward has extensive experience in supporting pharmaceutical clients in their COA-related submissions to regulatory agencies in Europe and the US and advises on health-utility measurement strategies for reimbursement agencies in Europe. Ms. Doward has led the development of over 40 COA questionnaires that have been adapted and validated for use in over 60 languages worldwide.
Ms. Doward currently serves on the ISPOR COA Special Interest Group (leadership committee) and the ISPOR Patient Council (member) and was a member of the leadership committee of the completed ISPOR Good Research Practices Task Force for the measurement of health state utilities in clinical trials. Ms. Doward has acted as a consultant to the World Health Organization and has served as a Research Advisor to the UK Department of Health, and medical charities in the United Kingdom.
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Nicholas J. Rockwood, PhD
RHI Health Solutions, Bend, OR, United States
Nicholas Rockwood, PhD, is a senior psychometrician in the Patient-Centered Outcomes Assessment group with RTI Heath Solutions and has been working on psychometric evaluations of clinical outcome assessments. Prior to joining RTI-HS, Dr. Rockwood was an assistant professor within the School of Behavioral Health at Loma Linda University, where he conducted quantitative research, taught doctoral-level statistics courses, and provided statistical consulting services to medical and behavioral health faculty and researchers. His statistics and psychometrics research, which has been published in top psychometrics journals such as Psychometrika and Multivariate Behavioral Research, broadly focuses on the development and evaluation of generalized latent variable modeling methods (eg, item response theory, multilevel modeling, structural equation modeling).
Developing Decision-Grade Real-World Evidence
Session Type: Short Course
Topics: Real World Data & Information Systems
Level: Intermediate
Separate registration required.
In this course, participants will be introduced to the principles of what makes real-world evidence (RWE) decision-grade, including an extended example. In the first half of the course, will review the most recent RWE frameworks and guidelines, and examine case studies in which RWE was used in regulatory and HTA approval. The second half of the course is an extended example in which participants will examine a study that could support an indication expansion, and interactively discuss how choices made in the design and implementation may affect the meaning and interpretability of results.
PREREQUISITE: Students are expected to be familiar with relevant concepts and methodologies for analyzing real-world data.
Speakers
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Jeremy Rassen, ScD
Aetion, Inc., New York, NY, United States
Jeremy A. Rassen, MS, ScD is a pharmacoepidemiologist with 25 years of academic and industry experience. He is cofounder, president, and chief technology officer at Aetion, a healthcare technology company that delivers real-world evidence for life sciences companies, payers, and regulatory agencies. Prior to founding Aetion, Dr. Rassen was assistant professor of medicine at Harvard Medical School, where he focused on methods to improve the quality and validity of real-world data studies. He also worked in Silicon Valley in a variety of tech companies. Dr. Rassen received his bachelor’s degree in computer science from Harvard College and his master’s and doctorate degrees in Epidemiology from the Harvard TH Chan School of Public Health.
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Shirley Wang, PhD
Brigham & Women's Hospital, Harvard Medical School, Boston, MA, United States
Dr. Wang is an associate professor at Brigham and Women’s Hospital, Harvard Medical School and lead epidemiologist for the Food and Drug Administration’s (FDA) Sentinel Innovation Center. She leads the Meta-Research in Pharmacoepidemiology program, with recent projects aimed at improving the transparency, reproducibility, and robustness of evidence from healthcare databases (www.repeatinitiative.org) and informing when and how real-world evidence studies can draw causal conclusions to inform regulatory or other healthcare decision-making (www.rctduplicate.org). She is currently PI on multiple NIH R01s and is also funded by FDA. Her methods work has received 3 awards from international societies.
Health Economic Modeling in R: A Hands-on Introduction
Session Type: Short Course
Topics: Economic Evaluation
Level: Introductory
Separate registration required.
This highly practical course will outline the computational and transparency advantages of using R, for those used in health economic modelling using Microsoft Excel. This course explores the use of R for health economic modelling in the context of health economics and outcomes research (HEOR) and faculty will guide the participants through practical examples of HEOR. The faculty are expert speakers who have diverse experience in academia, national Health Technology Assessment agencies (NICE, NCPE), and industry. The faculty will lead participants through practical examples of health economic modelling including using R for Markov models from deterministic analysis through to probabilistic sensitivity analysis and EVPI. Additional useful packages for modelling using R will also be discussed. All sessions will interchange between descriptive lectures and hands-on exercises. Participants will be provided with materials, including model examples in R and information on where to go for further learning. This course is designed for those with some familiarity with modelling techniques, such as the concepts of discrete time cohort Markov models and probabilistic sensitivity analysis, but familiarity with R coding is not required. Attendees will require a laptop with RStudio (v1.1.0 or higher) and R (v4.2.1 or higher) downloaded and installed.
Speakers
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Felicity Lamrock, PhD
Queen's University Belfast, Belfast, Ireland
Dr. Felicity Lamrock is a senior lecturer in Data Analytics at Queen’s University Belfast. She is currently the Director of the Northern Ireland Centre for Health Analytics and Decision Science (NI-CHADS) with a focus on the analysis of health data for decision modelling. Current projects include a range of disease areas including cancer, rare diseases, diabetes, COVID-19, and cardiovascular disease. Felicity was previously a statistician at the National Centre for Pharmacoeconomics (NCPE) working with a team of pharmacists and clinicians on Health Technology Assessments to advise the Health Service Executive on the recommendation of new drug therapies in Ireland. She remains involved with NCPE as a statistical advisor and is exploring how Northern Ireland could benefit from more decision modelling/pharmacoeconomic assessment.
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Gianluca Baio, PhD
University College London, London, United Kingdom
Gianluca is professor of Statistics and Health Economics in the Department of Statistical Science at University College London. He graduated in Statistics and Economics from the University of Florence, Italy and then completed a PhD program in Applied Statistics again at the University of Florence, after a period at the Program on the Pharmaceutical Industry at the MIT Sloan School of Management, Cambridge (USA). He worked as a research fellow and then Lecturer in the Department of Statistical Sciences at University College London, UK. His main interests are in Bayesian statistical modelling for cost effectiveness analysis and decision-making problems in the health systems, hierarchical/multilevel models and causal inference using the decision-theoretic approach. Gianluca leads the Statistics for Health Economic Evaluation research group within the department of Statistical Science, whose activity revolves around the development and application of Bayesian statistical methodology for health economic evaluation, eg, cost-effectiveness or cost-utility analysis. He also collaborates with the UK National Institute for Health and Care Excellence (NICE) as a scientific advisor on Health Technology Appraisal projects. He has developed and maintains several R packages, many specifically devoted to health economic evaluation, including BCEA, survHE and missingHE.
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Howard Thom, BA, MSc, PhD
Bristol Medical School : Population Health Sciences, Bristol, United Kingdom
Howard Thom has worked for over 10 years developing health economic models in R. These have been in many disease areas, including heart disease, stroke, physiotherapy, mental health, rheumatology, dermatology, and oncology. His methodological interests are structural uncertainty, value of information analysis, and the use of R for efficient modelling. He founded and co-chairs the R for Health Technology Assessment (HTA) scientific committee, organizing annual workshops on the use of R in HTA. He currently works at both the University of Bristol and at Clifton Insight, giving him the perspective of both commercial consulting and academia.
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Rose Hart, BSc, PhD
Dark Peak Analytics, Sheffield, United Kingdom
Rose Hart is a health economist with over 8 years of consultancy experience, specialising in health economic modelling and the development of advanced, reproducible tools in R and R Shiny. She has particular expertise in health technology assessment, early modelling, and value communication, and is known for building scalable solutions that integrate economic and statistical methods. Rose is passionate about embedding emerging technologies and efficient coding practices into modelling workflows.
Introduction to Applied Generative AI for HEOR
Session Type: Short Course
Topics: Methodological & Statistical Research
Level: Introductory
Separate registration required.
The rapid advancement in generative artificial intelligence (Gen AI) presents an opportunity for transformative potential in the field of Health Economics and Outcomes Research (HEOR). This course provides an introductory understanding of generative AI models with a particular focus on large language models (LLMs), which are revolutionizing the field of HEOR. Participants will be provided with an overview of the most appropriate ways to access LLMs, going beyond the use of chatbots. Further, they will be given insights into how to use prompt engineering to conduct scientific research and gain an understanding on issues pertaining to privacy and security when using Gen AI for HEOR. Participants will further explore specific applications of these models for conducting robust scientific HEOR research in systematic literature review (SLR), real-world evidence analysis, and economic evaluation. The course aims to equip participants with the knowledge to begin to use generative AI techniques for specific HEOR contexts and to appreciate how these innovative approaches can enhance HEOR activities. Practical exercises using Python and relevant AI frameworks will be incorporated for participants to follow along. Participants who wish to gain hands-on experience are required to bring their laptops with Python installed.
PREREQUISITES: Students should have a general understanding of common HEOR concepts such as SLRs and cost-effectiveness models. Knowledge of Python or similar programming languages such as R is considered a benefit, but not required.
Speakers
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Sven L Klijn, MSc
Bristol Myers Squibb, Princeton, NJ, United States
Sven Klijn is director at Bristol Myers Squibb in the Global HEOR Economic & Predictive Modeling group, where he leads the innovative modeling agenda in hematology and cell therapy. In addition, Sven has an active role in providing modeling education and masterclasses at international congresses. He has widely published on innovative methods, especially in the field of survival extrapolation and Generative AI. Sven has training in public health and health economics and previously had various roles in CROs related to health economic modeling.
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William Rawlinson
Estima Scientific, London, United Kingdom
Will is a senior health economist at Estima Scientific holding a degree in Physics and Philosophy from the University of Oxford. Will has 4 years’ experience developing cost-utility models and has specialized in applications of generative AI to health economic modelling. Will has published on the automation of R modelling using large language models (LLMs), and more recently has focused on applications of LLMs to Excel modelling and model reporting.
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Tim Reason, MSc
Estima Scientific, South Ruislip, United Kingdom
Tim Reason is co-founder of Estima Scientific and specializes in AI and evidence synthesis, having spent 15 years in the field of HEOR and technology. Tim is managing director of Estima, driving business activities, innovation and strategy for the company. Tim’s specializes in the intersection of HEOR, software development and AI to drive better outcomes for patients. Tim is the lead author on 2 seminal papers in AI for HEOR, showing that AI can be used to automate health economic modelling and NMA.
Risk-Sharing/Performance-Based Arrangements in Developing Countries
Session Type: Short Course
Topics: Health Policy & Regulatory
Level: Intermediate
Separate registration required.
During recent years, Managed Entry Agreements (MEAs) have become instrumental in ensuring the access of innovative medicines. This course is designed for healthcare professionals (including public decision-makers, academia, and industry) involved in pricing and reimbursement decisions who are wishing to understand the applicability and technical aspects of managed entry agreements (MEAs) in countries with severe economic constraints and explicit cost-effectiveness criterion. The topic will be introduced with key features of pricing and reimbursement systems in representative countries to understand why special methods are needed to facilitate evidence-based reimbursement policies of new health technologies. Faculty will present an economic model to explain the methodology and implications of managed entry agreements in cost-effectiveness and budget impact analysis. Participants will then have the opportunity to apply what they have learned through a hands-on exercise on making pricing and reimbursement decisions. A decision algorithm will be presented to support evidence and value-based policy decisions of high-cost new technologies. A series of password protected economic models will add more and more complexity to a pragmatic case study on a new pharmaceutical product in oncology. To close the course faculty will lead a discussion on the applicability of a pragmatic decision tool illustrating the pros and cons of different managed entry agreements and their usefulness in CEE settings. Participants who wish to gain hands-on experience must bring their laptops with Microsoft Excel for Windows installed.
Speakers
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Bertalan Németh, PhD
Syreon Research Institute, Budapest, Hungary
Bertalan Németh, PhD, graduated from the Corvinus University of Budapest (MSc in Quantitative economics and Operation research), the Eötvös Loránd University (Pharmaceutical economics and drug policies), and the Semmelweis University School of PhD Studies. Between 2010 and 2015 he was a health economist at the Hungarian HTA office. Since August 2015 Bertalan has been a senior health economist, and since 2019 a Principal Researcher at Syreon Research Institute. Bertalan is responsible for strategic consulting, and he is involved in various projects that include modelling, economic evaluation in health, health technology assessment and health statistics as well. Bertalan was the president of the ISPOR Hungary Chapter and was the chair of the ISPOR CEE Consortium. He was a participant in the international EUnetHTA project, the ISPOR HTA Roundtable Europe, and the Scientific Committee of the META Conference. Bertalan was also a faculty member of the global ISPOR HTA Training and was the module leader of Health Technology Assessment for the MSc program at Eötvös Loránd University.
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Rok Hren, MSc, PhD
Hren & Partner d.o.o., Ljubljana, Slovenia
Rok Hren has more than 15 years of commercial experience in pharmaceutical industry and more than 12 years on a board level in both (1) line management, which has included full P&L responsibility for operations in Slovenia and Romania, and (2) leadership regional functions in Central and Eastern Europe. He regularly presents on the topic of pharmaceutical economics and policies at conferences in Europe and is well experienced in healthcare media business.
He received his PhD in Physiology and Biophysics from Dalhousie University, Canada and MSc in International Health Policy (Health Economics) with Distinction from London School of Economics and Political Science, UK while he was a post-Doctoral Fellow at Nora Eccles Harrison Cardiovascular Research and Training Institute, University of Utah Medical School, USA. He is also an assistant professor at the University of Ljubljana and past president of the ISPOR Slovenia Regional Chapter. In total, his publications gathered 300/394 citations (excluding self-citations) in WoS/Scopus (as of September 10, 2016).
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Katarzyna Kolasa, PhD
Kozminski University, Warsaw, Poland
Driven with passion to improve healthcare, Katarzyna has focused her academic and business career on health economics.
She has been working with multiple pricing and reimbursement challenges worldwide for the last 25 years, while holding various regional and global leadership positions at Astra Zeneca, BMS, Biogen Idec, Lundbeck, GE Healthcare, Straub Medical, BD, and the Swedish County Council of Kalmar. Katarzyna is mentor and consultant to start ups involved in the development of innovative medical devices and digital health solutions from both Holland and Poland.
Since 2000, she has been an academic teacher and supervisor for over 30 MBA and PhD students. In partnership with the Polish Medical Research Agency, Deloitte Digital and the Polish Central Hospital of Ministry of Interior Affairs, she founded the first Digital Health 6 months educational program designed for digital transformation leaders working in the healthcare sector. Katarzyna developed an innovative Master Program Health Economics & Big Data (HEBDA) with the first edition being financed by EU Power Grant 2018 as well.
She is the founder of the Global Special Interest Group Digital Health and short courses “The Role of Digital Endpoints in the Value Generation for Health Technologies”, “Risk-Sharing/Performance-Based Arrangements in Developing Countries” for ISPOR, The Professional Society for Health Economics and Outcomes Research. She is currently a member of the ISPOR Education Council and a previous member of the ISPOR Health Science Policy Council as well.
Katarzyna has dedicated her academic research towards methodological advancements into the value assessment of pharmaceuticals, medical devices, and digital health solutions. Passionate about Big Data, she led the first project of machine learning adaptation for the optimal utilization of CT scanners granted by the Polish Ministry of Health. Since January 2022, she is the leader of AI special interest group at the Polish Chamber of Physicians. With the patronage of the Polish Parliamentary Commission for Innovation & Digitalization, she organized the first dialog about the societal preferences towards the adoption of AI in the healthcare in Poland.
Being a coauthor of more than 50 IF publications, she has presented her research at more than 60 international scientific conferences. As of 2022, Google Scholar reports over 730 citations to her work.
8:00 - 17:00
Reimbursement Systems for Pharmaceuticals in Europe
Session Type: Short Course
Topics: Health Policy & Regulatory
Level: Intermediate
Separate registration required.
Pharmaceutical reimbursement systems in Europe are complex, diverse, and heterogeneous, shaped by national policies, healthcare priorities, regulatory frameworks and underlying epistemological choices. This short course offers an in-depth exploration of these systems, focusing on the decision-making processes that determine whether and how new medicines are reimbursed or accessible across key European markets.
Unlike marketing authorization for pharmaceuticals (mainly regulated at the European level by EMA), pricing and reimbursement decisions in Europe are managed by individual member states. Health care services are generally covered by a single public health insurer operating under the Ministry of Health supervision. As a monopoly buyer (monopsony), this situation provides a leading position for the public health insurer to set reimbursement conditions. On the other side, pharmaceutical companies may be in a monopoly situation with a single provider or very few for the same medicinal class. Therefore, based on each country’s set of regulations, processes, and values, wide variations exist in pricing and reimbursement decisions of pharmaceuticals driven by power positions and desirability of new products. This course is essential for professionals involved in market access, health economics, regulatory affairs, and policymaking, providing the tools and knowledge needed to navigate the evolving landscape of pharmaceutical reimbursement in Europe.
Speakers
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Mondher Toumi, PhD
Inovintell, Luxembourg, Luxembourg
Professor Mondher Toumi is an MD by training and holds 2 MSc in Biostatistics, and in Biological Sciences (option pharmacology) and a PhD in Economic Sciences. He is a 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. He launched the first European University Diploma of Market Access (EMAUD), an international course already followed by more than 500 students. Additionally, he recently created the Market Access Society to promote research and scientific activities around market access, public health and health economic assessment. He is chief editor of the Journal of Market Access and Health Policy (JMAHP).
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 a visiting professor at Beijing University (Third Hospital).
In June 2022 Mondher Toumi founded InovIntell, an international venture dedicated to AI in life sciences.
He is a recognized expert in health economics and an authority on market access and risk management. He published more than 200 scientific publications and authored or co-authored several books predominantly in the fields of market access and health economics.
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Frank-Ulrich Fricke, PhD
Nuremberg, Germany
Frank-Ulrich Fricke is a professor of health economics at the Technische Hochschule Nürnberg Georg Simon Ohm and an impartial member of the arbitration board on drug prices in the German healthcare system (Schiedsstelle nach § 130b SGB V) since 2011. He has served as a faculty dean since 2017. After studying business administration and a PhD in economics, Frank-Ulrich worked in industry and in consulting for several years. Main areas of interest have been market access, pricing and reimbursement, health policy and health economic evaluations. Frank-Ulrich is a member of several national as well as international professional associations.
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Maarten Jacobus Postma, PhD
Professor Maarten J. Postma holds the chair Global Health Economics at the University Medical Center Groningen (UMCG) and the faculty of Economics & Business, both at the University of Groningen. Also, he is Prof in Pharmacoeconomics at the Departments of Pharmacy at the University of Groningen, Pharmacology at the Airlangga University (Surabaya, Indonesia) and Pharmaceutical Care Innovation at Universitas Padjadjaran (Bandung, Indonesia).
He did his MSc in econometrics and his PhD in health economics. He specifically leads a team of 100 staff, PhD and post-doc researchers in health and pharmacoeconomics, contributing to many international research networks and scientific communications. He specializes in the role of pharmacoeconomics/health economics in the reimbursement process. He serves (served) on various committees advising the Dutch government on reimbursement of drugs and vaccines. Also, he is an advisor to various health economics consultancy companies and pharmaceutical companies worldwide, Ministries of Health in neighboring countries, member of editorial boards of scientific journals (eg, Value in Health), on advisory boards for pharmaceutical companies and expert consultant for WHO. He is a member of the UK’s Joint Committee of Vaccination & Immunization since 2014.
He has almost 1000 peer-reviewed international publications, an H-factor of 100 and extensive teaching/lecturing experience (Groningen, Amsterdam, Utrecht, Heidelberg, Bielefeld, Ankara, Sofia, various universities in Indonesia, JoBurg, Moscow and Hanoi). He ranks 2nd (1st) most innovative (health) economist of the Netherlands. He attracted 25 EU-projects, 10 WHO-projects, various national projects from the National Institute of Public Health and the MoH, projects from NGOs and multiple projects from pharma, aggregating over 25 million EUR of funds for university in the last decade. His research often features in newspapers and Dutch television. He is involved in 5 spin-off consultancy companies from the University in various roles, inclusive director, shareholder and advisor. He was listed as the second most innovative economist of the Netherlands for 2024.
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Keith H Tolley, BA, MPhil, MPP
Tolley Limited, Buxton, United Kingdom
Keith has over 35 years’ experience in health economics across academia (University of York - Centre for Health Economics and University of Nottingham, UK 1987-1997), for several pharmaceutical companies, including GSK, Pfizer, and Ortho Biotech (1997-2005), and in consultancy as a Director at Mapi (Adelphi) Values and now Tolley. He has direct experience of HTA as performed by NICE and SMC, and reimbursement and pricing issues around Europe. Keith has managed and strategically contributed to company submissions to NICE and SMC across a range of disease areas. He has also reviewed and been involved in the development of health economic models for NICE and SMC and other HTA bodies and has reviewed economic models for their suitability (eg, structure, data inputs) for drug reimbursement purposes.
Keith is also a health economics assessor with the SMC, a position he has held since 2005, having previously been an industry representative on the NDC. In 2013, Keith also became an assessor for the All Wales Medicine Strategy Group (AWMSG) and has provided expert advice as part of the NICE Early Scientific Advice Program.
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Krzysztof Kloc
United States
Krzysztof Kloc is senior principal consultant in pricing, reimbursement, and market access (PRMA), vice head of the PRMA department, and co-founder of Clever-Access. Based in Krakow, Poland, he holds a master’s degree in applied biotechnology and has over 15 years of experience in market access and health technology assessment. Krzysztof has been engaged in consultancy projects in Poland related to the introduction and revisions of the Reimbursement Act, as well as in international projects, including stakeholder and pathway mapping, positioning and pricing strategy, evidence generation plans, and value communication. He was a speaker at the HTA Symposium in Krakow and is an active trainer for the International Market Access Upper Degree (IMAUD).
13:00 - 17:00
Budget Impact Analysis II: Practical Steps to Building a BIA and Enhanced Applications
Session Type: Short Course
Topics: Economic Evaluation
Level: Intermediate
Separate registration required.
This course presents an overview of budget impact analysis, the 6-step approach to developing budget impact analyses, and various practical applications. The course will review the basics of budget impact analysis, interpretation of results, and simplicity versus accuracy and face validity. Technical topics will include static versus dynamic budget impact models, considerations for device and diagnostic technologies, and realistic features such as patient copayments and use of generics. The instructors will walk through two different budget impact analyses programmed in Excel (one static and one dynamic) and work with participants during hands-on exercises to enhance these models. The Excel-based budget impact models used for the course will be provided to participants in advance of the presentation. This course is designed for those who are interested in learning the basics of budget impact analysis and desire exposure to these analyses in Excel. Participants who wish to gain hands-on experience must have Microsoft Excel for Windows installed on their computers.
PREREQUISITE: Working knowledge of Microsoft Excel is required.
Speakers
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Stephanie Earnshaw, PhD
RTI Health Solutions, Pittsboro, NC, United States
Stephanie Earnshaw has performed health outcomes and health services research for 30+ years. Her research focuses on applying decision-analysis techniques (e.g., decision trees, Markov processes, simulation) to industry-related issues and health care problems. In addition to developing budget-impact and cost-effectiveness models to support health technologies for the pharmaceutical, biotechnology, and diagnostic and medical device industry, she has developed innovative mathematical models using these methods to determine pricing strategy, predict clinical outcomes, allocate resources, and cost care pathways particularly in support of medical diagnostics.
Dr Earnshaw received her PhD in Industrial Engineering at North Carolina State University and is a member of ISPOR and the Institute for Operations Research and Management Sciences. She has presented her work at professional conferences and has published in several peer-reviewed journals. She has presented workshops and various courses on decision-analytic modeling techniques for pharmaceutical companies and organizations such as ISPOR, the Academy of Managed Care Pharmacy (AMCP), and the Centers for Disease Control and Prevention (CDC). Dr. Earnshaw has served on the ISPOR Board of Directors and as Chair of the Audit Committee and Educational Council. She has held an Adjunct Faculty appointment at the University of North Carolina’s Eshelman School of Pharmacy, Division of Pharmaceutical Outcomes and Policy, is honored as a Distinguished Alumni in Industrial and Systems Engineering at North Carolina State University and is one of the lead authors of “Budget-Impact Analysis of Health Care Interventions: A Practical Guide.”
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Anita Brogan, MSc, PhD
RTI Health Solutions, San Diego, CA, United States
Anita Brogan has 20+ years of experience in using analytical techniques to assess and present the health and economic impact of emerging pharmaceutical and biotechnology interventions. She has led the development of user-friendly and transparent cost-effectiveness, cost-utility, and cost-consequence models; budget-impact models; resource allocation models; and infectious disease transmission models programmed in Microsoft Excel and other platforms. She has experience with numerous types of modeling procedures, including Markov and other stochastic models, simulation, regression, linear and nonlinear programming, and various types of sensitivity analysis. Dr. Brogan has developed models and analyses in the areas of HIV, hepatitis C, RSV, Ebola, influenza, cystic fibrosis, bone health, mental health, women’s health, oncology, osteoporosis, chronic pain, age-related macular degeneration, hospital-acquired infection, financial portfolio optimization, and vehicle routing.
Dr. Brogan holds a PhD in Operations Research from the University of North Carolina. She has presented workshops and short courses on decision-analytic modeling techniques in a variety of venues, including meetings of ISPOR and the Academy of Managed Care Pharmacy (AMCP). Dr. Brogan has held an adjunct professorship at the Fermanian School of Business at Point Loma Nazarene University. She is also a co-author of the book “Budget-Impact Analysis of Health Care Interventions: A Practical Guide.”
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Thor-Henrik Brodtkorb
United States
Thor-Henrik Brodtkorb, PhD, is executive director in Health Economics at RTI Health Solutions (RTI-HS). He holds a PhD in Health Technology Assessment from the University of Linköping and has been with RTI-HS for 12 years. He has been teaching courses in decision-analytic modeling at Linköping University as well as presented workshops and short courses on decision- analytic modeling techniques for organizations such as Pharma Industry Sweden, Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), and ISPOR.
At RTI-HS, Dr. Brodtkorb leads the development of cost-effectiveness, cost- utility, cost-consequence, and budget-impact models for pharmaceutical, device, and diagnostic technologies. These models have been used to support reimbursement decisions in more than 15 European countries including NICE in UK, SMC in Scotland, TLV in Sweden, and NOMA in Norway. He has developed models and analyses in the areas of oncology, alcohol dependence, major depressive disorder, Alzheimer’s disease, dermatology, multiple sclerosis, cardiology, orthopedics, and asthma. His research has been presented at professional conferences and published in peer-reviewed journals. He is also a co-author of the book “Budget-Impact Analysis of Health Care Interventions: A Practical Guide.”
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Ashley Davis, PhD
RTI Health Solutions, Research Triangle Park, NC, United States
Ashley Davis is a senior director within the Health Economics division at RTI Health Solutions (RTI-HS). She holds a PhD in Industrial Engineering and Management Sciences from Northwestern University and has been with RTI- HS for 10 years. She has presented short courses on budget impact modeling techniques in a variety of venues, including meetings of The Professional Society for Health Economics and Outcomes Research (ISPOR).
In her role at RTI-HS, Dr. Davis uses analytical methodologies to evaluate the clinical and economic value of upcoming pharmaceutical products and changes to healthcare policies. She has developed user-friendly and transparent cost- effectiveness, cost-utility, and cost-consequence models; budget-impact models; resource allocation models; and infectious disease transmission models programmed in Microsoft Excel and other platforms. She has experience with numerous types of modeling techniques, including Markov and other stochastic models, simulation, statistical analysis, linear and nonlinear programming, robust optimization, and various types of sensitivity analysis. Dr. Davis has developed models and analyses in the areas of HIV, hepatitis C, cystic fibrosis, herpes zoster, influenza, pneumococcal disease, respiratory syncytial virus, severe asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, spinal surgery, cytomegalovirus, and organ transplantation. Her research has been presented at various professional conferences and published in peer- reviewed journals.
Prompt Engineering for HEOR: Practical Skills and Use Cases for HEOR Professionals
Session Type: Short Course
Topics: Methodological & Statistical Research
Level: Introductory
Separate registration required.
Prompt engineering—the art and science of designing effective inputs for generative AI—has become a critical skill for health economists and outcomes researchers. Mastery of prompt engineering can significantly enhance productivity, accuracy, and innovation in HEOR, unlocking the full potential of large language models (LLMs) and other AI tools. This course delivers a comprehensive introduction to prompt engineering, tailored specifically for the HEOR context. Participants will gain hands-on experience with practical prompt strategies for systematic literature reviews (SLRs), economic modeling, real-world evidence generation, and more. The curriculum also addresses current best practices and common pitfalls, equipping attendees to confidently apply prompt engineering in regulated and high-stakes settings.
PREREQUISITE: Basic knowledge of systematic literature reviews and economic modeling will be helpful. No prior knowledge or use of AI is required.
Speakers
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Rachael Fleurence, MSc, PhD
Value Analytics Labs, Boston, MA, United States
Rachael L. Fleurence, PhD, MSc, is the head of Evidence and AI Solutions, at Value Analytics Lab, a life sciences consultancy. A health economist by training, she previously served as senior advisor to Dr. Francis Collins at the National Institutes of Health, where she led a national initiative to eliminate Hepatitis C in the US. She also served as an advisor to the National Institute of Biomedical Imaging and Bioengineering (NIBIB), focusing on artificial intelligence and machine learning. Previously, Dr. Fleurence was a senior health policy advisor in the Biden-Harris White House and Senior Advisor to the NIH Director. She played a key role in the federal COVID-19 response, leading the “Say Yes! COVID Test” program and serving on White House pandemic policy groups. Prior to her federal service, she led the National Evaluation System for health Technology Coordinating Center (NESTcc) and PCORnet at PCORI and spent several years in the private sector in health economics and outcomes research (HEOR) consulting. Dr. Fleurence has received multiple NIH Director’s Awards, the HHS Secretary’s Award for Distinguished Service, and the National Champion for Global Hepatitis Elimination award. She co-led the ISPOR Task Force on EHR Data for Health Technology Assessment, serves on the ISPOR Working Group on Generative AI, and is an associate editor for Value in Health. She also sits on the boards of CTTI (the Clinical Trials Transformation Initiative) and ICN (the ImproveCareNow network). She holds degrees from Cambridge University, ESSEC Business School (Paris), and the University of York (UK).
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Jag Chhatwal, PhD
Harvard Medical School / Massachusetts General Hospital, Boston, MA, United States
Jag Chhatwal, PhD, is the director of the Institute for Technology Assessment at Massachusetts General Hospital and an associate professor at Harvard Medical School. He also serves as core faculty at the Center for Health Decision Science, Harvard T.H. Chan School of Public Health. Dr. Chhatwal has co-authored more than 125 original research articles and editorials in leading peer-reviewed journals. His research has informed health policy decisions at prominent organizations including the White House, the World Health Organization, and the CDC, and has been featured in major media outlets such as CNN, Forbes, National Public Radio, The New York Times, and The Wall Street Journal. Dr. Chhatwal serves as an associate editor of Value in Health and as guest editor for its special issue on artificial intelligence. He is also a member of the ISPOR Generative AI Working Group.
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Dalia Dawoud, BSc, MSc, PhD
Cairo University, Cairo, Egypt
Dalia Dawoud, PhD, is the director of PEHTA Consulting Ltd. She is also a professor at the Faculty of Pharmacy, Cairo University. She has over 15 years’ experience as a health economist and researcher. Her work is largely focused on the application of HEOR in HTA and clinical guideline development. She worked at leading organizations including NICE, where she led a portfolio of HORIZON Europe projects such as HTx, IMI EHDEN and SUSTAIN HTA, and the Royal College of Physicians, London. She is widely published in the areas of health economics and outcomes research and serves as associate editor for Value in Health and as director on ISPOR Board of Directors (2023-2026). She is also a member of the ISPOR AI Working Group.
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Turgay Ayer, PhD
Value Analytics Labs, Boston, MA, United States
Turgay Ayer, PhD, holds the Virginia C. and Joseph C. Mello Chair and serves as the research director for Healthcare Analytics and Business Intelligence at the Center for Health & Humanitarian Systems at Georgia Tech. He is also the chief technology officer at Value Analytics Labs. Dr. Ayer holds a courtesy appointment at Emory Medical School where he teaches Big Data Analytics courses and serves as a Senior Scientist at the Centers for Disease Control and Prevention (CDC). Dr. Ayer’s research focuses on health economics modeling (HEOR), real-world evidence, data science, machine learning, econometric modeling, and healthcare analytics. He has published over 80 peer-reviewed journal papers and more than 300 conference abstracts, with his work featured in top-tier business, engineering, medical, and health policy journals. His research has attracted substantial attention from major media outlets, including The Wall Street Journal, The Washington Post, US News, and NPR. A recognized expert in HEOR, Dr. Ayer has been at the forefront of applying generative AI to navigate healthcare systems and support better decision-making. He has contributed significantly to the development of advanced models for predicting healthcare outcomes and designing innovative cost-effectiveness analysis frameworks. Under his leadership, Value Analytics Labs has focused on the development of cutting-edge technologies, including ValueGen.AI, to enhance healthcare analytics and improve the efficiency of healthcare decision-making processes.
Using LLMs to Simplify Real-World Evidence Research
Session Type: Short Course
Topics: Real World Data & Information Systems
Level: Intermediate
Separate registration required.
This course introduces how large language models (LLMs) can enhance real-world evidence (RWE) research, highlighting practical applications and best practices. Participants will explore how LLMs streamline tasks such as literature reviews, clinical documentation analysis, patient phenotyping, and data interpretation through real-world examples.
Significant focus is given to interactive exercises that provide hands-on experience with LLM-assisted workflows, including synthesizing literature, interpreting complex data, and efficiently reviewing reports. Ethical and regulatory considerations critical to the responsible use of AI in healthcare research are also addressed, emphasizing transparency, bias mitigation, and compliance.
The course concludes by considering future AI trends, such as multimodal integration and evolving regulatory environments, preparing participants to effectively integrate these advancements into their research strategies. Participants who wish to gain hands-on experience must bring their laptops with Microsoft Excel for Windows installed.
PREREQUISITE: This course assumes that participants are familiar with the standing challenges and opportunities for RWE in research.
Speakers
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Dan Drozd, MSc, MD
PicnicHealth, San Francisco, CA, United States
Daniel R. Drozd, MD, MSc, is the chief medical officer at PicnicHealth. Prior to joining PicnicHealth he was on faculty at the University of Washington in the Department of Allergy & Infectious Diseases where he led research into the use of electronic health record data to power observational research and enhance the understanding of the chronic burden of HIV infection. At PicnicHealth he oversees scientific collaborations with PicnicHealth’s industry and academic partners and works extensively with both the product and commercial teams. Prior to attending medical school, he worked for numerous technology start-ups as an engineer and at the University of Washington in the Clinical Informatics Research Group where he led the development of a large EHR data integration platform used to power HIV real-world research.
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Troy Astorino
PicnicHealth, San Francisco, CA, United States
Troy Astorino is the co-founder and chief technology officer at PicnicHealth. With deep AI expertise from MIT and SpaceX, Troy co-founded PicnicHealth to make it easier to capture patient-centered data and improve healthcare. As the CTO, he leads product development, overseeing engineering, product, and design. Troy's expertise lies in AI-driven observational research and data quality. He has developed a system that continuously audits and improves data accuracy, ensuring that research insights generated by PicnicHealth address research questions with the highest level of reliability.
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Kieran Mace, PhD
Plinth Analytics, Chicago, IL, United States
Kieran Mace is a passionate data scientist and entrepreneur who combines deep technical expertise with exceptional leadership abilities. As the co-founder and CEO of Plinth Analytics, he leads a boutique real-world data science consultancy dedicated to improving lives through analytics.
His career spans critical roles at the intersection of healthcare, data science, and technology, where he has consistently delivered innovative solutions to complex problems. From developing novel pan-tumor prognostic models at Genentech to building clinical data transformation pipelines at PicnicHealth, Kieran has demonstrated an exceptional ability to translate complex data into actionable insights.
With a PhD in Computational Biology/Biomedical Informatics from UCSF and extensive experience in clinical RWD, genomics, systems biology, and software engineering, Kieran brings both technical depth and strategic vision to every project. His research has been published in prestigious journals including Cell, PLoS One, and ACS Synthetic Biology, with his work cited over 1,400 times in scientific literature.
Kieran excels at building and leading high-performing teams, believing deeply that "there is nothing better than achieving something together that we could not achieve alone." His collaborative approach and ability to communicate complex concepts to diverse stakeholders make him particularly effective at bridging the gap between technical implementation and business impact.
Valuation of Innovative Drugs
Session Type: Short Course
Topics: Health Policy & Regulatory
Level: Intermediate
Separate registration required.
The value of medical innovation depends on the perspective. Registration authorities (EMA, FDA) mainly consider the clinical value of the medical innovation, whereas national health authorities take a broader perspective by including clinical, economic criteria, and potential other criteria like equity and social values. Value-based pricing is the most widely accepted approach in the pricing and reimbursement process in Europe, which varies from the narrow concept based on the incremental cost-effectiveness ratio (ICER) threshold to broader approaches. Value-based pricing determines the maximum price from the national payer perspective. This price should exceed the minimum price for the investor acting in the international financial market, which is based on economic valuation theory. Finally, there are other stakeholders, eg, patients, physicians’ healthcare insurers, employers, with their specific assessment of the value of medical innovation varying from, respectively, quality of life, effectiveness, budget impact, and costs of lost productivity. This course offers an overview of the perspectives of the relevant stakeholders and their respective data requirements for value assessment of innovative drugs. The course will then describe in-depth description of the various value-based pricing methods, eg, ICER, multicriteria decision analysis (MCDA), comparative effectiveness research (CER), and relative effectiveness (RE). We include examples of orphan drugs and ATMPs which are most striking to illustrate the concepts, but we also include value assessment for more traditional innovative drugs in broad indications. Familiarity with health economic evaluation is desirable, but the course assumes little or no familiarity with economic valuation theory.
Speakers
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Lou Garrison, PhD
The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, Seattle, WA, United States
Lou Garrison, PhD, is professor emeritus in The Comparative Health Outcomes, Policy, and Economics Institute in the School of Pharmacy at the University of Washington, where he joined the faculty in 2004.
For the first 13 years of his career, Dr. Garrison worked in non-profit health policy at Battelle and then the Project HOPE Center for Health Affairs, where he was the Director from 1989-1992. Following this, he worked as an economist in the pharmaceutical industry for 12 years. From 2002-2004, he was vice president and head of Health Economics & Strategic Pricing in Roche Pharmaceuticals, based in Basel, Switzerland.
Dr. Garrison received a BA in Economics from Indiana University, and a PhD in Economics from Stanford University. He has more than 150 publications in peer-reviewed journals. His research interests include national and international health policy issues related to personalized medicine, benefit-risk analysis, and other topics, as well as the economic evaluation of pharmaceuticals, diagnostics, and other technologies.
Dr. Garrison was elected as ISPOR President for July 2016-June 2017, following other leadership roles since 2005. He recently co-chaired the ISPOR Special Task Force on US Value Frameworks. He was selected in 2017 by PharmaVOICE as being among “100 of the Most Inspiring People” in the industry. He recently received the PhRMA Foundation and Personalized Medicine Coalition 2018 Value Assessment Challenge First-Prize Award as lead author on a paper on “A Strategy to Support the Efficient Development and Use of Innovations in Personalized and Precision Medicine.”
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Marlene Gyldmark, PhD
Basel, Switzerland
In her current role, Marlene leads the EU HTA organizational readiness at BeiGene in the Global Value, Access, and Pricing group.
Marlene’s prior life science industry experience includes vice president global head Access Evidence at Idorsia, Switzerland; global head Health Policy and Outcomes Research at Roche Diabetes Care, Switzerland; global head Modelling, Outcomes Research, Statistics and Epidemiology, Roche Pharma, Switzerland; health economist at Pfizer Denmark, and Pricing and Economic Analyst at Novo Nordisk, Denmark. Before joining the life science industry, she worked as a researcher in the Danish Hospital Institute, Denmark and at University of Copenhagen, Denmark.
Since 1996 Marlene has been an external lecturer at University of Copenhagen, Denmark.
Other work experiences include serving as a member of the board of directors (2000-2012) at EASE Consulting, Denmark and member of the board of the Institute of Neurodiversity (2021- 2025). She has been a long-term member of ISPOR and served as member of the Board of Directors between 2021-2024. Currently, Marlene also acts as a Copenhagen Goodwill ambassador.
She holds a master’s in economics and policy sciences from University of Copenhagen, Denmark, and a MPhil in health economics from York University, UK.
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Afschin Gandjour
Frankfurt am Main, Germany
Afschin Gandjour is a medical doctor, health economist, and philosopher. His research focuses on cost-effectiveness analysis, decision modeling, and value-based pricing of pharmaceuticals.
Gandjour received an MD from Hannover Medical School in Germany, an MBA from Duke University, a PhD in health economics from the University of Cologne in Germany, and an MA in philosophy from the University of Düsseldorf in Germany. He held faculty positions at the University of Cologne Medical School, Baylor College of Medicine, and Louisiana State University Pennington. In terms of research productivity, he ranks among the top professors in business administration in Germany (#20 in 2022 based on Wirtschaftswoche magazine).
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Mark J Nuijten, MBA, PhD, MD
A2M - Minerva, bergen op zoom, Netherlands
Mark Nuijten is a medical doctor, health economist, valuation economist, and healthcare publicist. He is a visiting professor at Ben-Gurion University in Israel, setting up the department on Clinical and Economic Valuation of Medical Innovation. He has become a leading health policy and economics expert over the last 2 decades, reflected in more than 200 publications and leading positions in scientific societies and editorial boards. Dr. Nuijten was board director of ISPOR (2002-2004) and chair of the Management Board of Value in Health (2002-2004). He was a member of the Editorial Advisory Board of Value in Health. He obtained his PhD in health economics (2003) on the thesis “In search for more confidence in health economic modelling” at the Erasmus University, Rotterdam.
Mark Nuijten is founder of A2M (Ars Accessus Medica) and founding partner of the Minerva International Health Economic Network. He was trained as a physician and worked in clinical research before obtaining his international MBA from Erasmus University, Rotterdam, where he later was a senior staff member. Prior to setting up Ars Accessus Medica, Dr. Nuijten was the founding managing director of the IQVIA Quintiles office in the Netherlands, which included European responsibility for the policy and health economic division.
He is a pioneer in the field of healthcare innovation in biotechnology and has been the first classical health economist successfully applying and developing Discounted Cash Flow methodologies for valuation of biotechnology innovation (eg, a pricing model to assess prices of expensive orphan drugs from an investor’s perspective—published in a Nature journal). He also developed an integrated valuation model, an interactive dynamic tool for the economic valuation of R&D projects, which can be used to optimize the initial clinical program (eg, indication, comparator, outcomes, and study design), and the associated pricing and market access pricing strategy.
Causal Inference and Causal Estimands from Target Trial Emulations Using Evidence from Real-World Observational Studies and Clinical Trials
Session Type: Short Course
Topics: Real World Data & Information Systems
Level: Advanced
Separate registration required.
In recent years, real-world evidence (RWE) has been increasingly used to inform regulatory, payer, and health technology assessment (HTA) decisions, as well as clinical guideline development. In addition, it has been recognized that the analysis of hypothetical estimands in clinical trials is necessary when the standard intention-to-treat (ITT) analysis does not answer the decision problem, usually because of treatment switching. An innovative framework for causal inference methods, target trial emulation, causal estimands and causal modeling guides the design and analysis of observational studies and clinical trials. This course will (1) introduce causal principles, causal diagrams (directed acyclic graphs; DAGs), and target trial emulation to avoid self-inflicted biases (eg, time-zero bias, immortal time bias), (2) provide an overview of causal methods for baseline confounding (multivariate regression, propensity scores) and time-varying confounding (eg, g-formula, marginal structural models with inverse probability of treatment weighting, and rank-preserving structural failure-time models with g-estimation), (3) propose appropriate estimands to ensure decision problems are directly addressed when analyzing observational data or data from clinical trials affected by treatment switching, (4) present lessons learned from applied case examples in HTA, such as single arm-trials with external control arms or trials affected by treatment switching, (5) provide recommendations regarding the use of causal inference methods and estimands and their application in causal modeling, and (6) discuss acceptance and barriers from an HTA agency perspective. The target audience includes all stakeholders and researchers from all fields in health and healthcare.
PREREQUISITE: Students are expected to have a basic knowledge in epidemiologic studies and methods (including the concept of confounding).
Speakers
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Uwe Siebert, MPH, MSc, ScD, MD
UMIT TIROL - University for Health Sciences and Technology; Harvard Chan School of Public Health, Hall in Tirol, Austria
Uwe Siebert, MD, MPH, MSc, ScD, is a professor of Public Health, Medical Decision Making and Health Technology Assessment (HTA), chair of the Department of Public Health, Health Services Research and HTA at UMIT TIROL-University for Health Sciences and Technology in Austria and director of the Division for HTA in the ONCOTYROL–Center for Personalized Cancer Medicine in Austria. He is also adjunct professor of Epidemiology and Health Policy & Management at the Harvard T.H. Chan School of Public Health and Affiliated Researcher in the Program on Cardiovascular Research at the Institute for Technology Assessment and Department of Radiology at the Massachusetts General Hospital, Harvard Medical School, Boston.
After medical school, he worked for several years as a physician in international public health projects in West Africa, Brazil, and Germany. He then earned an MPH at the Munich School of Public Health and completed an MSc in Epidemiology and a ScD in Health Policy and Management with a concentration in decision sciences at the Harvard School of Public Health.
His research interests include applying real-world evidence-based quantitative, causal and translational methods from public health, epidemiology, artificial intelligence, comparative effectiveness research, health services and outcomes research, economic evaluation, modeling, and health data a d decision science in the framework of health care policy advice and HTA as well as in the clinical context of routine health care, clinical guideline development, public health policies and patient guidance. His research focuses on cancer, infectious disease, cardiovascular disease, neurological disorders, and others.
He has been leading projects/work packages in several EU FP7, H2020 and Horizon Europe projects (eg, ELSA-GEN, BiomarCaRE, MedTecHTA, DEXHELPP, EUthyroid, FORECEE, MDS-RIGHT, RECETAS, CORE-MD, EUREGIO-EFH, CIDS, OnCoVID, 4D PICTURE, CATALYSE). He teaches HTA, health economics, modeling, epidemiology, causal inference and target trial emulation, and data and decision science for academia, industry, and health authorities in Europe, North and South America, and Asia. He directs the Continuing Education Program on Health Technology Assessment & Decision Sciences (htads.org).
He has served as member of the ISPOR Directors Board and as president of the Society for Medical Decision Making (SMDM). He is a leadership member of the ISPOR Personalized/Precision Medicine SIG, a member of the Latin America Consortium Advisory Committee of ISPOR, and co-chair of the ISPOR-SMDM Modeling Good Research Practices Task Force. He is a member of the Oncology Advisory Council and the National Committee for Cancer Screening of the Austrian Federal Ministry of Health.
He has authored more than 400 publications (> 30,000 citations, H index > 80), and is editor of the European Journal of Epidemiology. Further information Internet: http://htads.org, umit-tirol.at/dph, hsph.harvard.edu/uwe-siebert, Twitter: @UweSiebert9, LinkedIn: uwe-siebert9.
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Felicitas Kuehne, PhD
Hall in Tirol, Austria
Felicitas Kühne is a senior scientist and deputy coordinator at the Institute of Public Health, Medical Decision Making and Health Technology Assessment at the Department of Public Health, Medical Decision Making and Health Technology Assessment, UMIT TIROL - University for Health Sciences and Health Technology in Hall in Tirol, Austria. She is co-leading the Program on Causal Inference in Science and is the director of the HTADS course “Causal Inference for Assessing Effectiveness in Real-World Data and Clinical Trials: A Practical Hands-on Workshop”. Further, Felicitas Kühne is an outcomes research manager at Pfizer Pharma GmbH, Germany.
Felicitas Kühne holds a doctoral degree in Health Technology Assessment from UMIT TIROL as well as a master’s degree in health policy and management from the Harvard TH Chan School of Public Health, Boston, USA. She received her state approval as physiotherapist from the Georg-August-University of Göttingen, Germany and participated in Health-Economic Program of the University of Cologne, Germany. Before she started her position at UMIT TIROL in 2011, she worked as a consultant for pharmaceutical companies and healthcare providers, conducting several decision-analytic, real-world evidence, epidemiologic, and costing studies in a variety of disease areas.
Her research interests include evaluating public health interventions by applying advanced evidence-based quantitative methods from epidemiology, comparative effectiveness research, health services and outcomes research, economic evaluation, machine learning, and decision sciences. Her current substantive research focuses on identifying synergies of causal inference and decision science. The main disease areas are cardiovascular diseases, cancer, and infectious diseases including HIV/AIDS, hepatitis C, and pneumococcal disease. She teaches courses in decision-analytic modeling, economic evaluation, analysis of big data, and advanced causal epidemiologic methods at several universities and for industry in Europe and the USA.
She has authored several publications including textbook chapters and scientific articles and disseminated her finding at several conferences. She received financial support for her studies and research from several national and international organizations.
Felicitas Kühne is an active advisory board member for a NIMHD K01 award as well as a member of the editorial board of the journal of Medical Decision Making (MDM) and the journal of MDM Policy & Practice (MDM P&P). She is a member of the Working Group "Medical Decision Making" of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS). She is also a member of the Professional Society for Health Economics and Outcomes Research (ISPOR), and the Society for Medical Decision Making (SMDM).
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Nicholas Latimer, MSc, PhD
SCHARR, University of Sheffield, Sheffield, United Kingdom
Nick joined the University of Sheffield in June 2008. Previously he worked as a research officer and analyst at NERA Economic Consulting, a Health Economics Fellow at Queen Mary, University of London (QMUL), and a Health Economist at Roche Products Ltd.
Nick has worked on several clinical trials, NICE Technology Appraisals and Public Health guidelines, and consultancy projects. Much of his work focuses on survival analysis and adjusting for treatment switching in clinical trials and he has completed NIHR Doctoral and Post-Doctoral Research Fellowships on these topics. In 2019, Nick began a Senior Research Fellowship funded by Yorkshire Cancer Research in which he is investigating the application of causal inference techniques to estimate comparative effectiveness from cancer registry datasets. He has authored NICE Decision Support Unit technical support documents on survival analysis (TSD14, 2011; TSD21, 2020), treatment switching (TSD16, 2014; TSD24, 2024), and partitioned survival analysis (TSD19, 2017), and was a member of Technology Appraisal Committee B for 5 years.
https://www.sheffield.ac.uk/scharr/sections/heds/staff/latimer_n
