BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Date: Tuesday 3rd June 2025\nTime: \;14:00 - 15:15 BST\nLoc ation: \;Online via Zoom\n\nWho is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.\n\ nWhat is the benefit of attending?: Attendees will have a better understan ding of applying the estimand framework in clinical pharmacology trials.\n Overview\nAre you involved in designing or writing clinical pharmacology p rotocols? Then don't miss this webinar! We'll focus on the core concepts o f estimands\, specifically aimed at clinical trial development teams &ndas h\; no heavy statistical jargon required.\nJoin the expert authors of a re cent paper [1] as they introduce the game-changing concepts of the &ldquo\ ;estimand framework&rdquo\; [2]\, "intercurrent events" [2]\, and the esti mand 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.\nWe'll dive into a practic al case study &ndash\; a bioequivalence trial &ndash\; to illustrate how t he estimand framework can eliminate ambiguity and bring greater transparen cy to the key clinical questions you're investigating. Beyond this specifi c example\, we'll discuss the broader impact of estimands on various clini cal pharmacology trials.\nCome ready to learn and ask questions! The prese nters will be joined by some of their co-authors for an interactive Q&\ ;A session after the presentation.\nReferences:\n[1] \;Applying the es timand framework to clinical pharmacology trials with a case study in bioe quivalence - Lynggaard - 2025 - British Journal of Clinical Pharmacology - Wiley Online Library\n[2] International Council for Harmonisation of Tech nical Requirements for Pharmaceuticals for Human Use. Addendum on Estimand s and Sensitivity Analysis in Clinical Trials to the Guideline on Statisti cal Principles for Clinical Trials E9(R1). \;https://database.ich.org/ sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published Novembe r 2019\nCost\nThis webinar is free to both Members of PSI and Non-Members. \nRegistration\nTo register for this event\, please \;click here.\nSpe aker details\n\n\n\n\n \n \n \n Speaker\n \n \n Biography\n \n \n \n \n Sue McKendrick\, PPD Clinical Researc h Services\n \n \n \n Sue McKe ndrick is a Statistical Science Director with over 30 years of industry ex perience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. \; She has presented on esti mands at various conferences over the last 5 years and led a recent PSI wo rkshop on estimands. \; Sue leads the Estimand Working Group at PPD an d has practical experience of dozens of studies with estimands.\n \ n \n \n \n Mark Baird\, PPD Clinic al Research Services\n  \;\n \n \n \n \n Mark Baird is Director of Clinical Ph armacology at PPD&trade\; clinical research business of Thermo Fisher Scie ntific and has over 23 years&rsquo\; experience manging global teams and p roviding oversight and guidance across all aspects of clinical pharmacolog y study design\, data collection\, PK/PD analysis and reporting.\n \n \n \n \n Helle Lynggaard\, Nov o Nordisk\n \n \n Helle Lynggaard is a ke y driver in implementing estimands in Novo Nordisk studies. Helle is an ac tive member of many EIWG sub-teams including Estimands in Clinical Pharmac ology and Early Phase Trials.\n \n \n \n \n \n David Wright\, AstraZeneca\n &nb sp\;\n \n \n \n \n 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 Biost atistics Working Party and led the revision of the CHMP guideline on missi ng data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.\ n \n \n \n \n \n Judith Anzures-Cabrera\, Roche Products Ltd\n \n \n \n Judith Anzures-Cabrera\, a statistician with 16 years at Roche\, has worked on several therapeutic areas\, focusing on Par kinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche\, she worked at the MRC Biostatistics Unit in Cambridge and obtaine d her PhD from the University of Warwick.\n \n \n \n\ n\n\n\n DTEND:20250603T151500Z DTSTAMP:20260905T085411Z DTSTART:20250603T140000Z LOCATION: SEQUENCE:0 SUMMARY:PSI Webinar: Applying the Estimand Framework to Clinical Pharmacolo gy Trials with a Case Study in Bioequivalance UID:RFCALITEM639241952519048966 X-ALT-DESC;FMTTYPE=text/html:Date: Tuesday 3rd June 2025\nTime: \;14:00 - 15:15 BST
\nLocati on: \;Online via Zoom
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\nWho is this even t intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
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\nWhat is the benefi t of attending?: Attendees will have a better understanding of ap plying the estimand framework in clinical pharmacology trials.\n

Overvi ew

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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 &nd ash\; no heavy statistical jargon required.

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Join the expert author s of a recent paper [1] as they introduce the game-changing concepts of th e &ldquo\;estimand framework&rdquo\; [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\, le ading to clearer objectives and more meaningful results.

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We'll div e into a practical case study &ndash\; a bioequivalence trial &ndash\; to illustrate how the estimand framework can eliminate ambiguity and bring gr eater transparency to the key clinical questions you're investigating. Bey ond this specific example\, we'll discuss the broader impact of estimands on various clinical pharmacology trials.

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Come ready to learn and a sk questions! The presenters will be joined by some of their co-authors fo r an interactive Q&\;A session after the presentation.

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Referenc es:
\n[1] \;Applying the estimand frame work to clinical pharmacology trials with a case study in bioequivalence - Lynggaard - 2025 - British Journal of Clinical Pharmacology - Wiley Onlin e Library

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[2] International Council for Harmonisation of Techn ical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistic al Principles for Clinical Trials E9(R1). \;https://database.ich.org/sites/default/files/E9-R1_Step 4_Guideline_2019_1203.pdf. Published November 2019

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Cost

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This webinar is free to both Members of PSI and Non-Members.

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Registration

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To register for this event\, please \;click here.

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Speaker details

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Speaker

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Biography

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sm-headshot
\n Sue McKendrick\, PPD Clinical Research Services
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\n 		\n Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of d rug development including extensive experience in PK/PD. \; She has pr esented 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 estima nds.
\n Mark
\n Mark Baird\, PPD Clinical Research Services
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\n Mark Baird is Director o f Clinical Pharmacology at PPD&trade\; clinical research business of Therm o Fisher Scientific and has over 23 years&rsquo\; experience manging globa l teams and providing oversight and guidance across all aspects of clinica l pharmacology study design\, data collection\, PK/PD analysis and reporti ng.
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Helle_headshot_NOV_2022
\n Helle Lynggaard\, Novo Nordisk
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\n 		Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle i s an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
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\n David Wright\, Astra Zeneca
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\n David Wright is Head of Statistical Innovation at AstraZenec a. Previously David worked for the MHRA for 16 years where he was the Chai r of the Biostatistics Working Party and led the revision of the CHMP guid eline on missing data in confirmatory clinical trials. This work sparked h is interest in Estimands particularly on how to use the proposed framework in practice.
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\n J udithACProfile
\n Judith Anzures-Cabrera\, Roche Products Ltd		\n \n
\n Judith Anzures-Cabrera\, a statistician with 16 years at Roche\, h as worked on several therapeutic areas\, focusing on Parkinson's Disease s ince 2019. Judith represents Roche at the EIWG. Prior to Roche\, she worke d at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
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