Date: Thursday 5th November 2020 Time: 14:00 - 16:00 GMT (15:00 - 17:00 CET, 09:00 - 11:00 EST) Speakers:John Scott(FDA), Andreas Brandt (BfArM), Vladimir Dragalin(JNJ) andEvgeny Degtyarev (Novartis).
Who is this event intended for? The event is intended for statisticians involved in the design of clinical trials (particularly Phase II and III) in all therapeutic areas, from industry, CROs and academia. What is the benefit of attending? The audience will gain insight into the use of estimands in practice and regulatory considerations.
You can now register for this event. Registration will close at 12:00 on 4th November 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance, including the following aspects:
Experience with proposals submitted to FDA and EMA on implementation of Estimands
How the estimands framework facilitates interaction with clinicians in different therapeutic areas
Common problems where the Estimands framework can help advance research
Where further discussions and research is required, and particularly where industry and regulators can collaborate
Issues related to alignment between different estimators to a given estimand
Special considerations of estimand framework in COVID-19 vaccine trials
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics.
Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology.
Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QSTechnical Excellence and Program Strategy) AdvisoryCommittee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research.
Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org).
Joint PSI, EFSPI & ASA BIOP Webinar: Estimands
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
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