Date: Tuesday 2nd July 2024 Time: 14:00-15:30 BST | 15:00-16:30 CEST Location: Online via Zoom Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians. What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
Speaker details
Speaker
Biography
Rachid Abbas
Rachid Abbas is a statistician in Roche's Product Development department since 2020.
With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
Angeliki Thanaspoulou
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019.
She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
Marcel Wolbers
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
Scientific Meetings
PSI EIWG Webinar: Estimands framework in action, the Alzheimer's disease case
Date: Tuesday 2nd July 2024 Time: 14:00-15:30 BST | 15:00-16:30 CEST Location: Online via Zoom Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians. What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
Speaker details
Speaker
Biography
Rachid Abbas
Rachid Abbas is a statistician in Roche's Product Development department since 2020.
With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
Angeliki Thanaspoulou
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019.
She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
Marcel Wolbers
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
Training Courses
PSI EIWG Webinar: Estimands framework in action, the Alzheimer's disease case
Date: Tuesday 2nd July 2024 Time: 14:00-15:30 BST | 15:00-16:30 CEST Location: Online via Zoom Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians. What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
Speaker details
Speaker
Biography
Rachid Abbas
Rachid Abbas is a statistician in Roche's Product Development department since 2020.
With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
Angeliki Thanaspoulou
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019.
She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
Marcel Wolbers
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
Journal Club
PSI EIWG Webinar: Estimands framework in action, the Alzheimer's disease case
Date: Tuesday 2nd July 2024 Time: 14:00-15:30 BST | 15:00-16:30 CEST Location: Online via Zoom Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians. What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
Speaker details
Speaker
Biography
Rachid Abbas
Rachid Abbas is a statistician in Roche's Product Development department since 2020.
With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
Angeliki Thanaspoulou
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019.
She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
Marcel Wolbers
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
Webinars
PSI EIWG Webinar: Estimands framework in action, the Alzheimer's disease case
Date: Tuesday 2nd July 2024 Time: 14:00-15:30 BST | 15:00-16:30 CEST Location: Online via Zoom Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians. What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
Speaker details
Speaker
Biography
Rachid Abbas
Rachid Abbas is a statistician in Roche's Product Development department since 2020.
With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
Angeliki Thanaspoulou
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019.
She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
Marcel Wolbers
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
Careers Meetings
PSI EIWG Webinar: Estimands framework in action, the Alzheimer's disease case
Date: Tuesday 2nd July 2024 Time: 14:00-15:30 BST | 15:00-16:30 CEST Location: Online via Zoom Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians. What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
Speaker details
Speaker
Biography
Rachid Abbas
Rachid Abbas is a statistician in Roche's Product Development department since 2020.
With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
Angeliki Thanaspoulou
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019.
She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
Marcel Wolbers
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
Upcoming Events
PSI Book Club: Change: How organisations achieve hard-to-image results in uncertain and volatile times
Organizations have to adapt to the transforming landscape of our industry to ensure they continue to be successful in the future. Many of us are feeling the impact of organizational change. By reading John P Kotter’s book we can understand about organizational change and learn how to thrive, rather than just survive, through change.
Change, by John P Kotter (and his team), is a summary of all that he has learned over his decades of research and leading change. His book describes why many current approaches to change are inadequate and explains why new solutions need to give people a voice and a role in a new, change-embracing organization.
Develop your understanding of organisational change and become empowered to be part of your organisation’s change, by reading Change by John P Kotter and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply knowledge from the book in-between sessions.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Book Club: Another Door Opens – Book Club Special Event
This is a Book Club Special Event in response to the changes in our industry and as a supportive move to create community and connection for those navigating redundancy and uncertainty. Read the book in advance of the book club session then join the zoom call to discuss ideas. There will be breakout groups to connect with others, exchange experiences of how the book has helped, and offer support.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
PSI Training Course: Propensity Scores: Practical Application in Non-randomised Studies
The course will introduce the topic of propensity scores and the use of external data. Covering the topics of matching and weighting as well as more advance topics of high dimension propensity scores, multi-valued treatments, double robustness and time-varying scenarios. There will be the opportunity to participate in some hands on practical exercises in R.
Making Estimands Work - Practical Approaches with Implementation in Data Standards
This event will discuss the impact of the estimand framework on data flow and data handling for analysis datasets (ADaM). What are the considerations to produce data sets suitable for estimation of estimands and traceability of the occurrence of intercurrent events. This webinar will include tips for best practice, based on the White paper Implementation of ICH E9(R1) Estimands Framework using Data Standards.
PSI/EFSPI Biomarker SIG Webinar: Statistical Methods for ctDNA Data
This webinar will describe what ctDNA is and what the key challenges are for analysing it. We will then summarise and review methods that were published over the last few years for analysing ctDNA data.
This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.
PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics
Date: Wednesday 4th November 2026
A careers talk about medical statistics and how it plays a crucial role in developing new medicines. Learn about the field of medical statistics and how it plays a crucial role in developing groundbreaking new medicines, vaccines and healthcare products.
Date: 18 November 2026
This is an excellent opportunity for students to find out more about the field of medical statistics, talk to people from different organisations and make contacts for the future. All students currently studying for a mathematics or statistics-related BSc, MSc or PhD are invited to attend, and we welcome interest from exhibitors too.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
In this vital role you will generate evidence to meet Health Technology Assessment (HTA) requirements, while ensuring that the analyses performed meet required standards and are robust and valid.
Bristol Myers Squibb - Director, Statistical Methodology and Innovation
Lead the development of innovative statistical methods, provides expert consulting, oversees tools and software, and mentors team members while collaborating cross-functionally to address complex drug development challenges.
Phastar – Associate Director, Statistics – Real World Evidence (RWE)
As an Associate Director, Statistics (RWE) you will focus on supporting one of our key pharmaceutical clients within our FSP function. This will be a hands-on technical role, with oversight responsibilities and cross-functional exposure.
Phastar – Principal Statistician – Real World Evidence (RWE)
We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at Principal level.
We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at either Senior or Principal levels.
This position is deal for a statistician who values ownership, collaboration, and using data to enable confident development decisions and to support regulatory submissions.
