Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Scientific Meetings
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Training Courses
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Journal Club
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Webinars
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Careers Meetings
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Upcoming Events
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.
Topic: R Package Basics.
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 month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.
Date: Ongoing 6 month cycle beginning late April/early May 2026
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event!
Haven’t read the book yet? Pick up a copy today and join us.
Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.