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 1st &\; Wednesday 2nd June 2021\nTime: 1st 15: 00-16:30 BST | 2nd 09:00-10:30 BST\nSpeakers: \;Kaspar Rufibach (Roche )\, \;Stefan Englert (AbbVie)\, \;Giovanna Andreaola\, MD (Novarti s)\, \;Paul Bycott (Pfizer)\, \;Feng Liu (AstraZeneca)\, \;Jon athan Siegel (Bayer)\, \;Sammi Tang (Servier) and \;Jiawei Wei (No vartis).\nHosted by the Estimands Implementation Working Group (EIWG) and PSI on behalf of EFSPI and EFPIA.\n\nWho is this event intended for? \ ;Clinicians\, Investigators\, Regulatory Experts\, Medical Writers\, Ethic s Committees\, Statisticians.\nWhat is the benefit of attending? \;Thr ough a case study you will understand the benefits of using the estimand f ramework to describe the diversity of patient journeys addressing the righ t questions in clinical trials. \;\nRegistration\nYou can now register for this event. This event is \;free of charge \;to both Members and Non Members of PSI.\nPlease note: \;this event takes place on both the 1st &\; 2nd June\, but will entail exactly the same content. The s essions will run in order to accommodate for different timezones\, so plea se note that places are limited for each session.\n\nTo register for the 1 st June session\, please click here.\nTo register for the 2nd June session \, please click here.\nOverview\nA year on after the final ICH E9 estimand s addendum was published\, we \;bring estimands to life. Members of th e Estimands in Oncology special interest group will describe how the estim and framework provides a common language to describe the diversity of pati ent journeys and why it is important to address the right question in clin ical trials. \;\n\nYou will be guided through a case study and interac tively deepen the knowledge to gain hands-on experience in developing esti mands. You will be introduced to the background and disease context of the case study\, the concept of an estimand\, and important clinical events ( increased dropout rate and crossover therapy) that occurred in the trial a nd affected interpretation of the results. Using non-technical language an d clear graphical presentation of the concepts\, you will experience how t he estimand framework provides a common language to describe the diversity of patient journeys and why it is important to address the right question in clinical trials. \;\n\nThe targeted learning outcomes are as follo ws:\n&bull\; Recognize the benefits of following the estimand framework (I CH E9 (R1) addendum) in the context of a clinical trial\, in order to:\n&n bsp\;  \;  \; o have a common language to describe the diversity o f patient journeys\n \;  \;  \; o address the right question i n clinical trials\n&bull\; Be able to construct an estimand\, including id entification of relevant intercurrent events and application of relevant s trategies to address them\n&bull\; Gain insights from a cross-industry int ernational working group on estimands in oncology.\nSpeaker details\n\n\n\ n \n \n \n Speaker\n \n \n Biography\n \n \n \n \n \n Kaspar Rufibach\n (Roche)\n \n \n Kaspar Rufibach is an Expert Statistical Scientist in Roche's Methods\, Collaboration\, and Outreach group and loca ted in Basel. He does methodological research\, provides consulting to Roc he statisticians and broader project teams\, gives biostatistics trainings for statisticians and non-statisticians in- and externally\, mentors stud ents\, and interacts with external partners in industry\, regulatory agenc ies\, and the academic community in various working groups and collaborati ons. He has co-founded and co-leads the European special interest group &l dquo\;Estimands in oncology&rdquo\; (sponsored by PSI and EFSPI\, which al so has the status as an ASA scientific working group\, a subsection of the ASA biopharmaceutical section) that currently has 61 members representing 33 companies and several Health Authorities and works on various topics a round estimands in oncology. Kaspar&rsquo\;s research interests are method s to optimize study designs\, advanced survival analysis\, probability of success\, estimands and causal inference\, estimation of treatment effects in subgroups\, and general nonparametric statistics. Before joining Roche \, Kaspar received training and worked as a statistician at the Universiti es of Bern\, Stanford\, and Zurich.\n \n \n \n \n \n Stefan Englert\, Ph.D\n (A bbVie)\n \n \n Stefan has a Ph.D. in stat istics with 9+ years of experience in oncology drug development for solid tumors and hematologic malignancies spanning from first-in-human clinical trials to post marketing support. Since January 2015 Stefan works for AbbV ie Germany supporting mainly the early oncology pipeline. Stefan also work ed for Stemcentrx\, a startup company in the San Francisco Bay Area. Prior to this\, Stefan was at Boehringer Ingelheim Pharma supporting mainly glo bal regulatory interactions and NDA submissions.\n On top of hi s project work\, Stefan works as a University lecturer and is in close coo peration on methodological research with the University of Heidelberg\, Ge rmany. He leads the clinical engagement task force of the cross-industry i nternational working group on estimands in oncology (www.oncoestimand.org) . This group has the aim to develop basic introductory material that can b e used by all study team members to educate themselves on Oncology estiman ds as well as translate key messages from the working group to a non-stati stical audience.\n \n \n \n \n \n Giovanna Andreola\, MD\n (Novartis)\n \n \n Giovanna is a board-certified oncologist w ith several years of clinical experience in hematology and stem cell trans plantation. \n Since 2016 she has been working in drug developm ent initially with Pfizer and since 2018 with Novartis\, focusing on immun otherapy and cell therapy for patients with lymphoma\, mainly in late phas e development.\n Since 2020\, in close collaboration with stati sticians\, she has been contributing to the activities of the Estimand Wor kstream at Novartis which has the aim to introduce and educate on estimand different teams throughout the company.\n \n \n \n \n \n Paul Bycott\, Dr.P.H\n (Pfizer)\n \n \n Paul has a Dr.P.H. in biostatistics from U.C.L.A. with 24 years of pharmaceutical experience pre dominately in oncology. His experience ranges from early oncology drug dev elopment all the way through full late-stage development in both solid tum ors and hematological malignancies. He has participated in several regulat ory meetings and led statistical efforts for multiple oncology NDA submiss ions. He has also chaired and/or participated on internal governance body committees within Pfizer charged with technical review of clinical develop ment plans\, study designs\, and protocols. He is currently the Head of th e Breast Cancer Franchise for statistics at Pfizer.\n Externall y\, he is a current member of the ASA BIOP Master Protocol Scientific Work group and the cross-industry international working group on estimands in o ncology as well as a member of the Parallel Session Organizing Committee f or the 2021 BIOP Regulatory-Industry Statistics Workshop.\n \n \n \n \n \n Feng Liu\, Ph.D \n (AstraZeneca)\n \n \n Feng Liu has a Ph.D. in medical statistics with 20+ years of experience in phar maceutical drug development spanning from pre-clinical\, phase I-III clini cal trials to post marketing support. He is currently a statistical scienc e director leading lung indication in HER2 ADC program at Astrazeneca and has tracked record of leading and delivering innovative design in various TA as well as supporting global regulatory interactions and NDA submission s. \n He is a member of the cross-industry international workin g group on estimands in oncology (www.oncoestimand.org) and also book revi ew editor in pharmaceutical statistics.\n \n \n \ n \n \n Jonathan Siegel\n (Bay er)\n \n \n Jonathan Siegel is Director o f Oncology Clinical Statistics US at Bayer\, based in Whippany\, NJ. He jo ined Bayer in 2012\, and is a project statistican responsible for developm ent of multiple oncology compounds from Phase I through post-marketing.\n He has a Master&rsquo\;s degree in statistics from Western Mich igan University\, and graduate work in mathematical statistics at the Univ ersity of Michigan. He has over 20 years&rsquo\; experience in pharmaceuti cal oncology in multiple companies. At Bristol-Myers Squibb he worked on t rial design issues related to delayed effects of ipilimumab\, the first ap proved cancer immunotherapy. He is the past Secretary of LIDA\, now ASA&rs quo\;s Lifetime Data Science Science (LiDS) section\, and leads the Pharma ceutical Industry Working Group on Estimands in Oncology censoring mechani sms subteam. His research interests include survival analysis\, bias issue s\, immunotherapy\, and a systems approach to oncology research and trial design bridging boundaries between statistical and clinical sciences.\n \n \n \n \n \n Sam mi Tang\n (Servier)\n \n \n Dr . Rui (Sammi) Tang is a leading expert of biostatistics in the biotech/pha rmaceutical industry and she is currently the Head of Biostatistics\, Prog ramming and Medical Writing Department at Servier Pharmaceuticals US. Prio r to join Servier she was the Biostatistics Therapeutic Area head of Oncol ogy\, Transplants\, Ophthalmology and prematurity neonates programs at Shi re pharmaceutical. Sammi&rsquo\;s research interests are primarily in the area of adaptive clinical trial design and statistical issues in precision medicine. She has authored more than 35 articles in peer-reviewed scienti fic journals on methodology\, study design\, data analysis and reporting a nd is a co-inventor of several patents. Sammi is co-founder of DahShu whic h is a 501(c)(3) non-profit organization\, founded to promote research and education of 5000 members. She is leading teams in the DIA(Drug Informati on Association) Innovative design scientific working group of oncology dru g development and small population working group for rare disease statisti cal methodology development. She is also an active member in ASA(American Statistics Association) and ICSA(International Chinese Statistics Associat ion) to serve the biostatistics and data science professional community. \ n Sammi graduated from the University of Michigan Technology Un iversity with a PhD in statistics Genetics.\n \n \n \n \n \n Jiawei Wei\, Ph.D\n (Novartis)\n \n \n Dr. Jiawei Wei joine d Novartis in 2011\, where she is currently a Director Statistical Consult ant in the Advanced Methodology and Data Science group. She is interested in supporting the methodological development in various areas of pharmaceu tical statistics\, including estimand\, recurrent event data\, multiple te sting\, etc. Before joining Novartis\, Jiawei got her PhD in statistics fr om Texas A&\;M University in 2010\, and then one-year assistant profess or. Jiawei is awarded leading scientist at Novartis\, she is associate edi tor of Statistics in Biopharmaceutical Research\, and a part time advisor at Fudan University in China.\n Jiawei leads Estimands Task For ce for Novartis China Global Drug Development\, and offers regular trainin gs on Estimand to clinical and other functions. She is a subject matter ex pert of the ICH M11 &\; E9 (R1) sub-team\, and incorporates the &lsquo\ ;Estimand framework&rsquo\; in the envisaged protocol template.\n \n \n \n\n DTEND:20210602T093000Z DTSTAMP:20261009T110202Z DTSTART:20210601T140000Z LOCATION: SEQUENCE:0 SUMMARY:PSI EIWG Webinar: Estimands in Oncology - How and Why UID:RFCALITEM639271405222655942 X-ALT-DESC;FMTTYPE=text/html:Date: Tuesday 1st &\; Wedn esday 2nd June 2021
\nTime: 1st 15: 00-16:30 BST | 2nd 09:00-10:30 BST
\nSpeaker s: \;Kaspar Rufibach (Roche)\, \;Stefan Englert (AbbVie)\, \;Giovanna Andreaola\, MD (Novartis)\,&nb sp\;Paul Bycott (Pfizer)\, \;Feng Liu (AstraZeneca)\ , \;Jonathan Siegel (Bayer)\, \;Sammi Tang (Servier) and \;Jiawei Wei (Novartis).
\nHosted by the Estima nds Implementation Working Group (EIWG) and PSI on behalf of EFSPI and EFP IA.
\n
\nWho is this event intended for? \; Clinicians\, Investigators\, Regulatory Experts\, Medical Writers\, Ethics Committees\, Statisticians.
\nWhat is the benefit of attendi ng? \;Through a case study you will understand the benefits o f using the estimand framework to describe the diversity of patient journe ys addressing the right questions in clinical trials. \;
\n

Re gistration

\n

You can now register for this event. This event is&nbs p\;free of charge \;to both Members and Non Members of PSI.
\nPlease note: \;this event takes place on both the 1st &\; 2nd June\, but will entail exactly the same content. The sessions will run in order to accommodate for different timezones\, so please note that places are limited for each session.
\n
\nTo register for the 1st June session\, please click here.
\nTo register for the 2n d June session\, please click here.

\n

Overview

\n

A year on after the final ICH E9 estimands addendum was published\, we \;bring estimands t o life. Members of the Estimands in Oncology special interest group will d escribe how the estimand framework provides a common language to describe the diversity of patient journeys and why it is important to address the r ight question in clinical trials. \;
\n
\nYou will be guided through a case study and interactively deepen the knowledge to gain hands -on experience in developing estimands. You will be introduced to the back ground and disease context of the case study\, the concept of an estimand\ , and important clinical events (increased dropout rate and crossover ther apy) that occurred in the trial and affected interpretation of the results . Using non-technical language and clear graphical presentation of the con cepts\, you will experience how the estimand framework provides a common l anguage to describe the diversity of patient journeys and why it is import ant to address the right question in clinical trials. \;
\n
\nThe targeted learning outcomes are as follows:
\n&bull\; Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial\, in order to:
\n \;  \; &nb sp\; o have a common language to describe the diversity of patient journey s
\n \;  \;  \; o address the right question in clinical trials
\n&bull\; Be able to construct an estimand\, including identif ication of relevant intercurrent events and application of relevant strate gies to address them
\n&bull\; Gain insights from a cross-industry in ternational working group on estimands in oncology.

\n

Speaker detai ls

\n\n
\n\n \n \n \n \n \n \n \n \n \n \n \n \n

Stefan has a Ph.D. in statistics with 9+ years of experience in oncology drug development for solid tumors and hematologic malignancies spanning from first-in-human cl inical trials to post marketing support. Since January 2015 Stefan works f or AbbVie Germany supporting mainly the early oncology pipeline. Stefan al so worked for Stemcentrx\, a startup company in the San Francisco Bay Area . Prior to this\, Stefan was at Boehringer Ingelheim Pharma supporting mai nly global regulatory interactions and NDA submissions.

\n < p>On top of his project work\, Stefan works as a University lecturer and i s in close cooperation on methodological research with the University of H eidelberg\, Germany. He leads the clinical engagement task force of the cr oss-industry international working group on estimands in oncology (www.onc oestimand.org). This group has the aim to develop basic introductory mater ial that can be used by all study team members to educate themselves on On cology estimands as well as translate key messages from the working group to a non-statistical audience.

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n < tr>\n \n \n \n \n \n \n \n \n \n \n \n
\n

Speaker

\n 		\n

Biography

\n
\n

Kasparedit

\n

Kaspar Rufibach
\n (Roche)

\n 		\n

Kaspar Rufibach is an Expert Statistical S cientist in Roche's Methods\, Collaboration\, and Outreach group and locat ed in Basel. He does methodological research\, provides consulting to Roch e statisticians and broader project teams\, gives biostatistics trainings for statisticians and non-statisticians in- and externally\, mentors stude nts\, and interacts with external partners in industry\, regulatory agenci es\, and the academic community in various working groups and collaboratio ns. He has co-founded and co-leads the European special interest group &ld quo\;Estimands in oncology&rdquo\; (sponsored by PSI and EFSPI\, which als o has the status as an ASA scientific working group\, a subsection of the ASA biopharmaceutical section) that currently has 61 members representing 33 companies and several Health Authorities and works on various topics ar ound estimands in oncology. Kaspar&rsquo\;s research interests are methods to optimize study designs\, advanced survival analysis\, probability of s uccess\, estimands and causal inference\, estimation of treatment effects in subgroups\, and general nonparametric statistics. Before joining Roche\ , Kaspar received training and worked as a statistician at the Universitie s of Bern\, Stanford\, and Zurich.

\n
\n

Ste fanedit

\n

Stefan Englert\, Ph.D\n (AbbVie)

\n
\n

Giova nnaedit

\n

Giovanna Andreola\, M D
\n (Novartis)

\n 		\n

Giovanna is a board-certified oncologist with several years of clinical experience in he matology and stem cell transplantation.

\n

Since 2016 sh e has been working in drug development initially with Pfizer and since 201 8 with Novartis\, focusing on immunotherapy and cell therapy for patients with lymphoma\, mainly in late phase development.

\n

Sinc e 2020\, in close collaboration with statisticians\, she has been contribu ting to the activities of the Estimand Workstream at Novartis which has th e aim to introduce and educate on estimand different teams throughout the company.

\n
\n

Pauledit\n

Paul Bycott\, Dr.P.H
\n (Pfizer)

\n 		\n

Paul has a Dr.P.H. in biostatistics from U.C.L.A. wi th 24 years of pharmaceutical experience predominately in oncology. His ex perience ranges from early oncology drug development all the way through f ull late-stage development in both solid tumors and hematological malignan cies. He has participated in several regulatory meetings and led statistic al efforts for multiple oncology NDA submissions. He has also chaired and/ or participated on internal governance body committees within Pfizer charg ed with technical review of clinical development plans\, study designs\, a nd protocols. He is currently the Head of the Breast Cancer Franchise for statistics at Pfizer.

\n

Externally\, he is a current mem ber of the ASA BIOP Master Protocol Scientific Workgroup and the cross-ind ustry international working group on estimands in oncology as well as a me mber of the Parallel Session Organizing Committee for the 2021 BIOP Regula tory-Industry Statistics Workshop.

\n
\n

Fenge dit

\n

Feng Liu\, Ph.D
\n (AstraZeneca)

\n 		\n

Feng Liu has a Ph.D. in me dical statistics with 20+ years of experience in pharmaceutical drug devel opment spanning from pre-clinical\, phase I-III clinical trials to post ma rketing support. He is currently a statistical science director leading lu ng indication in HER2 ADC program at Astrazeneca and has tracked record of leading and delivering innovative design in various TA as well as support ing global regulatory interactions and NDA submissions.

\n

He is a member of the cross-industry international working group on est imands in oncology (www.oncoestimand.org) and also book review editor in p harmaceutical statistics.

\n
\n

Jonathaned it

\n

Jonathan Siegel
\n (Bayer)

\n 		\n

Jonathan Siegel is Director o f Oncology Clinical Statistics US at Bayer\, based in Whippany\, NJ. He jo ined Bayer in 2012\, and is a project statistican responsible for developm ent of multiple oncology compounds from Phase I through post-marketing.

\n

He has a Master&rsquo\;s degree in statistics from Weste rn Michigan University\, and graduate work in mathematical statistics at t he University of Michigan. He has over 20 years&rsquo\; experience in phar maceutical oncology in multiple companies. At Bristol-Myers Squibb he work ed on trial design issues related to delayed effects of ipilimumab\, the f irst approved cancer immunotherapy. He is the past Secretary of LIDA\, now ASA&rsquo\;s Lifetime Data Science Science (LiDS) section\, and leads the Pharmaceutical Industry Working Group on Estimands in Oncology censoring mechanisms subteam. His research interests include survival analysis\, bia s issues\, immunotherapy\, and a systems approach to oncology research and trial design bridging boundaries between statistical and clinical science s.

\n
\n

Sammiedit

\ n

Sammi Tang
\n (Servier)

\n 		\n

Dr. Rui (Sammi) Tang is a leading expert of biostatistics in the biotech/pharmaceutical industry and she is currently the Head of Biostati stics\, Programming and Medical Writing Department at Servier Pharmaceutic als US. Prior to join Servier she was the Biostatistics Therapeutic Area h ead of Oncology\, Transplants\, Ophthalmology and prematurity neonates pro grams at Shire pharmaceutical. Sammi&rsquo\;s research interests are prima rily in the area of adaptive clinical trial design and statistical issues in precision medicine. She has authored more than 35 articles in peer-revi ewed scientific journals on methodology\, study design\, data analysis and reporting and is a co-inventor of several patents. Sammi is co-founder of DahShu which is a 501(c)(3) non-profit organization\, founded to promote research and education of 5000 members. She is leading teams in the DIA(Dr ug Information Association) Innovative design scientific working group of oncology drug development and small population working group for rare dise ase statistical methodology development. She is also an active member in A SA(American Statistics Association) and ICSA(International Chinese Statist ics Association) to serve the biostatistics and data science professional community.

\n

Sammi graduated from the University of Mic higan Technology University with a PhD in statistics Genetics.

\n
\n

Jiaweiedit

\n

Jiawei Wei\, Ph.D
\n (Novartis)

\n 		\n

Dr. Jiawei Wei joined Novartis in 2 011\, where she is currently a Director Statistical Consultant in the Adva nced Methodology and Data Science group. She is interested in supporting t he methodological development in various areas of pharmaceutical statistic s\, including estimand\, recurrent event data\, multiple testing\, etc. Be fore joining Novartis\, Jiawei got her PhD in statistics from Texas A&\ ;M University in 2010\, and then one-year assistant professor. Jiawei is a warded leading scientist at Novartis\, she is associate editor of Statisti cs in Biopharmaceutical Research\, and a part time advisor at Fudan Univer sity in China.

\n

Jiawei leads Estimands Task Force for N ovartis China Global Drug Development\, and offers regular trainings on Es timand to clinical and other functions. She is a subject matter expert of the ICH M11 &\; E9 (R1) sub-team\, and incorporates the &lsquo\;Estiman d framework&rsquo\; in the envisaged protocol template.

\n < /td>\n
\n
END:VEVENT END:VCALENDAR