PSI EIWG Webinar: Estimands in Oncology - How and Why
Date: Tuesday 1st & Wednesday 2nd June 2021
Time: 1st 15:00-16:30 BST | 2nd 09:00-10:30 BST
Speakers: Kaspar Rufibach (Roche), Stefan Englert (AbbVie), Giovanna Andreaola, MD (Novartis), Paul Bycott (Pfizer), Feng Liu (AstraZeneca), Jonathan Siegel (Bayer), Sammi Tang (Servier) and Jiawei Wei (Novartis).
Hosted by the Estimands Implementation Working Group (EIWG) and PSI on behalf of EFSPI and EFPIA.
Who is this event intended for? Clinicians, Investigators, Regulatory Experts, Medical Writers, Ethics Committees, Statisticians.
What is the benefit of attending? Through a case study you will understand the benefits of using the estimand framework to describe the diversity of patient journeys addressing the right questions in clinical trials.
You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
Please note: this event takes place on both the 1st & 2nd June, but will entail exactly the same content. The sessions will run in order to accommodate for different timezones, so please note that places are limited for each session.
To register for the 1st June session, please click here.
To register for the 2nd June session, please click here.
A year on after the final ICH E9 estimands addendum was published, we bring estimands to life. Members of the Estimands in Oncology special interest group will describe how the estimand framework provides a common language to describe the diversity of patient journeys and why it is important to address the right question in clinical trials.
You will be guided through a case study and interactively deepen the knowledge to gain hands-on experience in developing estimands. You will be introduced to the background and disease context of the case study, the concept of an estimand, and important clinical events (increased dropout rate and crossover therapy) that occurred in the trial and affected interpretation of the results. Using non-technical language and clear graphical presentation of the concepts, you will experience how the estimand framework provides a common language to describe the diversity of patient journeys and why it is important to address the right question in clinical trials.
The targeted learning outcomes are as follows:
• Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
o have a common language to describe the diversity of patient journeys
o address the right question in clinical trials
• Be able to construct an estimand, including identification of relevant intercurrent events and application of relevant strategies to address them
• Gain insights from a cross-industry international working group on estimands in oncology.
Kaspar Rufibach is an Expert Statistical Scientist in Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry, regulatory agencies, and the academic community in various working groups and collaborations. He has co-founded and co-leads the European special interest group “Estimands in oncology” (sponsored by PSI and EFSPI, which also has the status as an ASA scientific working group, a subsection of the ASA biopharmaceutical section) that currently has 61 members representing 33 companies and several Health Authorities and works on various topics around estimands in oncology. Kaspar’s research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands and causal inference, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Stefan Englert, Ph.D
Stefan has a Ph.D. in statistics with 9+ years of experience in oncology drug development for solid tumors and hematologic malignancies spanning from first-in-human clinical trials to post marketing support. Since January 2015 Stefan works for AbbVie Germany supporting mainly the early oncology pipeline. Stefan also worked for Stemcentrx, a startup company in the San Francisco Bay Area. Prior to this, Stefan was at Boehringer Ingelheim Pharma supporting mainly global regulatory interactions and NDA submissions.
On top of his project work, Stefan works as a University lecturer and is in close cooperation on methodological research with the University of Heidelberg, Germany. He leads the clinical engagement task force of the cross-industry international working group on estimands in oncology (www.oncoestimand.org). This group has the aim to develop basic introductory material that can be used by all study team members to educate themselves on Oncology estimands as well as translate key messages from the working group to a non-statistical audience.
Giovanna Andreola, MD
Giovanna is a board-certified oncologist with several years of clinical experience in hematology and stem cell transplantation.
Since 2016 she has been working in drug development initially with Pfizer and since 2018 with Novartis, focusing on immunotherapy and cell therapy for patients with lymphoma, mainly in late phase development.
Since 2020, in close collaboration with statisticians, she has been contributing to the activities of the Estimand Workstream at Novartis which has the aim to introduce and educate on estimand different teams throughout the company.
Paul Bycott, Dr.P.H
Paul has a Dr.P.H. in biostatistics from U.C.L.A. with 24 years of pharmaceutical experience predominately in oncology. His experience ranges from early oncology drug development all the way through full late-stage development in both solid tumors and hematological malignancies. He has participated in several regulatory meetings and led statistical efforts for multiple oncology NDA submissions. He has also chaired and/or participated on internal governance body committees within Pfizer charged with technical review of clinical development plans, study designs, and protocols. He is currently the Head of the Breast Cancer Franchise for statistics at Pfizer.
Externally, he is a current member of the ASA BIOP Master Protocol Scientific Workgroup and the cross-industry international working group on estimands in oncology as well as a member of the Parallel Session Organizing Committee for the 2021 BIOP Regulatory-Industry Statistics Workshop.
Feng Liu, Ph.D
Feng Liu has a Ph.D. in medical statistics with 20+ years of experience in pharmaceutical drug development spanning from pre-clinical, phase I-III clinical trials to post marketing support. He is currently a statistical science director leading lung indication in HER2 ADC program at Astrazeneca and has tracked record of leading and delivering innovative design in various TA as well as supporting global regulatory interactions and NDA submissions.
He is a member of the cross-industry international working group on estimands in oncology (www.oncoestimand.org) and also book review editor in pharmaceutical statistics.
Jonathan Siegel is Director of Oncology Clinical Statistics US at Bayer, based in Whippany, NJ. He joined Bayer in 2012, and is a project statistican responsible for development of multiple oncology compounds from Phase I through post-marketing.
He has a Master’s degree in statistics from Western Michigan University, and graduate work in mathematical statistics at the University of Michigan. He has over 20 years’ experience in pharmaceutical oncology in multiple companies. At Bristol-Myers Squibb he worked on trial design issues related to delayed effects of ipilimumab, the first approved cancer immunotherapy. He is the past Secretary of LIDA, now ASA’s Lifetime Data Science Science (LiDS) section, and leads the Pharmaceutical Industry Working Group on Estimands in Oncology censoring mechanisms subteam. His research interests include survival analysis, bias issues, immunotherapy, and a systems approach to oncology research and trial design bridging boundaries between statistical and clinical sciences.
Dr. Rui (Sammi) Tang is a leading expert of biostatistics in the biotech/pharmaceutical industry and she is currently the Head of Biostatistics, Programming and Medical Writing Department at Servier Pharmaceuticals US. Prior to join Servier she was the Biostatistics Therapeutic Area head of Oncology, Transplants, Ophthalmology and prematurity neonates programs at Shire pharmaceutical. Sammi’s research interests are primarily in the area of adaptive clinical trial design and statistical issues in precision medicine. She has authored more than 35 articles in peer-reviewed scientific journals on methodology, study design, data analysis and reporting and is a co-inventor of several patents. Sammi is co-founder of DahShu which is a 501(c)(3) non-profit organization, founded to promote research and education of 5000 members. She is leading teams in the DIA(Drug Information Association) Innovative design scientific working group of oncology drug development and small population working group for rare disease statistical methodology development. She is also an active member in ASA(American Statistics Association) and ICSA(International Chinese Statistics Association) to serve the biostatistics and data science professional community.
Sammi graduated from the University of Michigan Technology University with a PhD in statistics Genetics.
Jiawei Wei, Ph.D
Dr. Jiawei Wei joined Novartis in 2011, where she is currently a Director Statistical Consultant in the Advanced Methodology and Data Science group. She is interested in supporting the methodological development in various areas of pharmaceutical statistics, including estimand, recurrent event data, multiple testing, etc. Before joining Novartis, Jiawei got her PhD in statistics from Texas A&M University in 2010, and then one-year assistant professor. Jiawei is awarded leading scientist at Novartis, she is associate editor of Statistics in Biopharmaceutical Research, and a part time advisor at Fudan University in China.
Jiawei leads Estimands Task Force for Novartis China Global Drug Development, and offers regular trainings on Estimand to clinical and other functions. She is a subject matter expert of the ICH M11 & E9 (R1) sub-team, and incorporates the ‘Estimand framework’ in the envisaged protocol template.