Dr. Elektra Papadopoulos currently serves as Director, Patient Experience Data & Strategy (Immunology/Oncology) at AbbVie. Prior to joining AbbVie in 2021, Elektra had a longstanding career at the US Food and Drug Administration (FDA) starting as a medical officer in the Center for Biologics Evaluation and Research in 2001.
Andrew Bottomley (PhD) is a research psychologist, who works at the EORTC, in Brussels, undertaking RCTs and Health Related Quality of Life (HRQOL) research. He is an Assistant Director at the EORTC and is also the Head of the QOL Department for over two decades. This post involves working at an international level, developing HRQOL and Patient Reported Outcomes (PRO) research policies and instrument methodology in the cancer clinical trials arena. Dr. Bottomley works to develop all EORTC tools and the department is a central hub coordinating centre to manage, develop and distribute EORTC QOL tools, such as the EORTC QLQ-C30 and all modules.
Bernhard Holzner, PhD, M.Eng., is a clinical psychologist, psychotherapist and clinical researcher. He is the academic leader of SISAQOL-IMI Work Package 4, which focuses on developing recommendations for the graphical representation of patient-reported outcome (PRO) data from cancer clinical trials. Being the founder and leader of the Patient-Reported Outcome (PRO) working group at the Medical University of Innsbruck, Bernhard has been involved in a wide range of PRO research activities over the last 25 years and has built up extensive expertise in the development of PRO measures, their electronic assessment as well as in the use and reporting of PRO data.
Jinma Ren, MD, PhD, is a director of biostatistics in Health Economics & Outcomes Research (HEOR) Statistics Group at Pfizer. He has provided statistical support to oncology, vaccine, and other therapeutic areas for health technology assessment and regulatory purposes. Jinma has 15+ years of outcomes research experience from both academia and industry, and he serves on the editorial board of two major journals. Prior to joining industry, he was a research associate professor at University of Illinois College of Medicine at Peoria.
Corneel Coens is currently working as a lead statistician at the EORTC Headquarters (Brussels, Belgium). As part of his tasks for the EORTC Quality of Life Department, he is involved in various aspects of Quality of Life in many oncological clinical trials ranging from instrument validation to design, analysis and reporting of QoL endpoints. He is one of the lead investigators in the international SISAQOL initiative. He is also the designated study statistician for the EORTC Gynaecological Cancer Group since 2001. He is a regular contributor for various EORTC educational courses such as “Clinical Trial Statistics for Non-Statisticians” and has been course director for the Joint FECS/AACR/ASCO Workshop “Methods in Clinical Cancer Research”.
Saskia le Cessie
Prof. Saskia le Cessie is a medical statistician working at the departments of Clinical Epidemiology and Biomedical Data Sciences of Leiden University Medical Center. Her research in medical statistics and epidemiological methods is generally inspired by collaboration with medical researchers. The focus of her current research is on epidemiological and statistical methods for observational studies. This involves (1) collaboration in research projects of clinical epidemiologists and other clinical researchers in order to provide cutting edged statistical analyses in observational clinical studies and (2) to perform research on statistical methodology for epidemiological studies. This has resulted in many publications (>350) as co-author on (bio) medical papers and in papers in methodological journals on causal inference, prediction models, mediation analysis, instrumental variables and meta analysis. She is a member of the Dutch Health Council, an associate editor of Clinical Trials and a member of the Steering Group of the STRATOS initiative, which aims to provide guidance in the design and analysis of observational studies.
Dr. Satrajit Roychoudhury
Dr. Satrajit Roychoudhury is a Senior Director and a member of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and consulting group in Novartis. He started his career as a research statistician in Schering Plough Research Institute (now Merck Co.). He has 14+ years of extensive experience in working with different phases of clinical trial. He has co-authored several publications/book chapters in this area and provided statistical training in major conferences. His area of research includes survival analysis, use of model-based approaches and Bayesian methods in clinical trials. Satrajit was a recipient of a Young Statistical Scientist Award from the International Indian Statistical Association in 2019. He served as the industry co-chair for ASA Biopharmaceutical Section Regulatory-Industry Workshop in 2018.
Anders Ingelgaard, PhD, is PRO Evidence Lead in the therapeutic area oncology, market access, in Boehringer Ingelheim. Anders co-leads the Work Package 1 as the industry representative.
He has a background in clinical psychology. Anders has 10 years’ experience in academic research, teaching and consulting related to quality of work life and organisational psychology. He has experience of leading several international research groups and also line management experience. Since over 20 years Anders has worked in pharmaceutical and medical device industry as PRO specialist. He has experience in developing and implementing questionnaires in clinical studies, writing protocols, analysis plans and developing publications in several disease areas. He has in-depth experience in the regulatory, payer and reimbursement environment of PROs and market access. He is piloting several projects including new ways to include patients’ experience data related to tolerability in early phases and to introduce embedded interviews and wearables in clinical trials. He supports and complements the SISAQoL-IMI EORTC team with industry experience and general know-how in PRO development.
Jane Chang, MPH (Senior Director, Value & Evidence Lead for Genitourinary Cancers, Pfizer Oncology). She has over 15 years of experience HEOR within the pharmaceutical industry supporting products in a broad range of therapeutic areas including Oncology, Neuroscience, Dermatology, and Rheumatology in both global and US roles. Jane graduated from University of Michigan, Ann Arbor, with both her BS in Microbiology and MPH in Health Management and Policy. She then completed a 2-year outcomes research fellowship with Duke University and Novartis before being employed at Novartis and later at Bayer. In her 8 and half years at Bayer, Jane implemented market access strategy and HEOR plans for multiple oncology compounds in development and also during product launch. She has received multiple recognition awards at Bayer for her leadership and team work. At Pfizer, Jane has been supporting an Alliance immuno-oncology compound for the past 5 years leading the HEOR strategy and plans for several indications including implementing PROs into clinical trials.
Silene ten Seldam
Silene ten Seldam, BSc, MSc, is a research assistant working in the evidence generation unit at Myeloma Patients Europe. Silene works to ensure that patient and family views are represented in research and decision making. Silene co-leads WP8 within SISAQOL-IMI.
Johannes M. Giesinger
Johannes M. Giesinger, PhD, is a clinical psychologist with a degree in biostatistics, who is leading the SISAQOL-IMI work package 6 on developing recommendations for clinically meaningful change objectives in cancer clinical trials. He has been engaged in research in patient-reported outcomes for 15 years conducting methodological and clinical studies, primarily in the oncological field. A number of his previous projects have focused on facilitating the interpretation of patient-reported outcomes.
Kristin Bjordal has, since 2014, been the head of the regional Research Support Services, Oslo University Hospital, Norway, and a professor and the University of Oslo. Before that, she was working as senior consultant and head of unit in medical oncology and radiotherapy at the Norwegian Radium Hospital.
She started her research in 1990 and her PhD “Quality of life in patients treated for head and neck cancer, methodological and clinical issues”, University of Oslo 1996, was strongly influenced by the EORTC. Since 1990, she has been actively involved in various projects in the EORTC Quality of Life Group, such as the development of module development guidelines and the EORTC QLQ-HN35 and the start of the Item bank – later Item library. The last couple of years, she has been the co-chair of the PMDC (project and module development committee) and member of the Executive Committee of the EORTC Quality of Life Group.
She really enjoys discussions and collaborations with students and colleagues and is now happy to be able to use these experiences in this large SISAQOL-IMI-project. As the co-chair of WP7, the main challenge will be to facilitate a process that will end up with a widely recognized consensus-based international recommendation for analysis and interpretation of PRO results.
Dr. Elektra Papadopoulos currently serves as Director, Patient Experience Data & Strategy (Immunology/Oncology) at AbbVie. Prior to joining AbbVie in 2021, Elektra had a longstanding career at the US Food and Drug Administration (FDA) starting as a medical officer in the Center for Biologics Evaluation and Research in 2001. She transitioned to the Center for Drug Evaluation and Research in 2005 as a medical officer in the Division of Dermatology and Dental Products. In 2007, she joined the Study Endpoints Team in the Office of New Drugs where she developed her expertise in the critical evaluation of clinical outcome assessments (COAs) to support medical product development across multiple therapeutic areas and held multiple leadership positions. In these roles, she led efforts to modernize and expand FDA policy on COAs and promote use of patient-centered outcome
Martin Taphoorn obtained his MD at Leiden University and subsequently specialized in Clinical Neurology in Amsterdam VU Medical Center, where he also wrote his PhD thesis “Treatment of primary and metastatic brain tumours; beneficial and adverse effects”. He further specialised in Clinical neuro-oncology at University Medical Center Utrecht and during a sabbatical leave he visited MD Anderson Cancer Center Houston Texas (Dr. Levin) and Memorial Sloan-Kettering Cancer Center New York (Dr. DeAngelis).
From 2003 he is neurologist/neuro-oncologist at Haaglanden Medical Center The Hague, where he was head of the residency program of Neurology, and at Leiden University Medical Center. He obtained a Professorship in Neuro-Oncology at the Free University in Amsterdam and later on at Leiden University. From 2009-2011 he was president of the Netherlands Society of Neurology.
He is actively involved in both the EORTC Brain Tumor Group and EORTC Quality of Life Group, as well as in EANO and SNO and has authored over 250 peer-reviewed articles. His research activities are focused on clinical outcomes in neuro-oncology (cognition, epilepsy, imaging, health-related quality of life, end of life).
Martin J.B. Taphoorn MD, PhD, neurologist and professor in neuro-oncology, Leiden University Medical Center and Haaglanden Medical Center, The Hague, The Netherlands.
Michael Schlichting is Director Biostatistics at Merck KGaA. Global. He is biostatistical lead for several oncology compounds since 1995, a PRO subject matter expert, and lead HTA biostatistician.
Paul Cislo earned his PhD in Biostatistics from Yale University and obtained18 year of pharmaceutical experience. Nine of those years in the pharmaceutical industry, he has providing reimbursement and health economic and outcomes research (HEOR) strategy support for oncology products; which included strategy and statistical analysis planning for clinical trial-based patient reported outcomes (PRO) for products to treat breast cancer, lymphoma, prostate cancer, bladder cancer, kidney cancer, and lung cancer. For the other nine years in industry, he has provided statistical support for all aspects of outcomes research, including patient reported outcomes across a wide range of therapeutic areas. He is currently co-leading work package 5 (Independent validation and feasibility) with Dr. Martin Taphoorn and contributing to work packages 2 (Methodological work for cancer RCTs) and 7 (Develop international recommendations for analysis and interpretation of PRO results) for this SISAQOL initiative.
Vivek Pawar, PhD, is an Executive Director in the Global Evidence and Value Development (GEVD) function at EMD Serono. He leads the oncology development unit within the GEVD team with accountabilities for integrating HTA/payer evidentiary requirements into the clinical development of the company’s oncology portfolio. His team is also responsible for generating the relative effectiveness value package to meet global payer needs and facilitate fast patient access following regulatory approval. Patient-centered outcomes (inclusive of PROs) are a key component of this value package. He previously worked at Bayer HealthCare as well as in health economics consulting at United Health Group. He is looking forward to bring his pharmaceutical industry perspective to WP7 and through this contribute towards ultimately improving health care decision making for patients.
Madeline Pe, PhD, is a Specialist in Quality of Life at the EORTC and co-leads Work Package 1.
She has trained in research methodology and statistics for psychological and behavioural outcomes. Madeline has over 8 years of experience developing questionnaires, setting up studies and analysing patient/participant-reported data in different research fields, including education and mental health. Her various research experiences arm her with a broad knowledge of research methodologies and approaches that is useful in advancing the methodological practices in quality of life research. She is one of the scientific leads for the SISAQOL Consortium and is lead author in several SISAQOL publications. Additionally, she is involved in coordinating, and providing scientific and methodological support for various quality of life research activities in EORTC.
Ahu Alanya, PhD, is a Specialist in Quality of Life at the EORTC Headquarters and the project manager for the SISAQOL-IMI. Ahu Alanya co-leads Work Package 1.
She also holds a part-time guest lecturer position at the University of Leuven Master of Statistics program. She has background in survey design and methodology, quantitative analysis in the social sciences and cross-cultural research.