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
PSI Mentoring 2025
Date: Ongoing 6 month cycle beginning late April/early May 2024
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 Training Course: Mixed Models and Repeated Measures
This course is presented through lectures and practical sessions using SAS code. It is suitable for statisticians working on clinical trials, who already have a good understanding of linear and generalised linear models.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This is an interactive online training workshop providing an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum with inputs from estimand experts, case studies, quizzes and opportunity for discussions. You will develop an estimand in a therapeutic area of interest to your company. In an online break-out room, you will join a series of team discussions to implement the estimand framework in a case study, aligning estimands, design, conduct, analysis, (assumptions + sensitivity analyses) to the clinical objective and therapeutic setting.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.