Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
Scientific Meetings
PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
Training Courses
PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
Journal Club
PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
Webinars
PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
Careers Meetings
PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
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.