AIMS SIG - Open-Source Lunch Bites
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.
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.
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
This webinar is free to both Members of PSI and Non-Members.
To register for this event, please click here.
|
Speaker |
Biography |
Sue McKendrick, PPD Clinical Research Services |
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
|
|
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
|
|
![]() Judith Anzures-Cabrera, Roche Products Ltd |
|
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.
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
This webinar is free to both Members of PSI and Non-Members.
To register for this event, please click here.
|
Speaker |
Biography |
Sue McKendrick, PPD Clinical Research Services |
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
|
|
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
|
|
![]() Judith Anzures-Cabrera, Roche Products Ltd |
|
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.
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
This webinar is free to both Members of PSI and Non-Members.
To register for this event, please click here.
|
Speaker |
Biography |
Sue McKendrick, PPD Clinical Research Services |
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
|
|
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
|
|
![]() Judith Anzures-Cabrera, Roche Products Ltd |
|
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.
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
This webinar is free to both Members of PSI and Non-Members.
To register for this event, please click here.
|
Speaker |
Biography |
Sue McKendrick, PPD Clinical Research Services |
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
|
|
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
|
|
![]() Judith Anzures-Cabrera, Roche Products Ltd |
|
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.
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
This webinar is free to both Members of PSI and Non-Members.
To register for this event, please click here.
|
Speaker |
Biography |
Sue McKendrick, PPD Clinical Research Services |
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
|
|
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
|
|
![]() Judith Anzures-Cabrera, Roche Products Ltd |
|
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.
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
This webinar is free to both Members of PSI and Non-Members.
To register for this event, please click here.
|
Speaker |
Biography |
Sue McKendrick, PPD Clinical Research Services |
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
|
|
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
|
|
![]() Judith Anzures-Cabrera, Roche Products Ltd |
|