Date: Thursday 10th December 2020 Time: 15:00 - 16:00 GMT Speaker: Scott Patterson (Sanofi)
Who is this event intended for? Statisticians interested in the statistics of crisis vaccine clinical studies, like those being done for COVID-19.
What is the benefit of attending? Those attending will learn of several statistical observations on crisis vaccine clinical development that are important to an understanding of data generated in COVID-19 vaccine development and other crisis clinical vaccine programs.
You can now register for this event. Registration will close at 12:00 on 9th December 2020.
This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen.
Statistical Observations on SARS-CoV-2 & Crisis Vaccine Clinical Testing.
Traditional vaccine clinical development is an undertaking involving meticulous, multiple studies in multiple populations at risk of infection and disease over multiple years. SARS-CoV-2 and COVID-19 vaccine development is following this traditional development pathway, but accelerated Phase I-II-III clinical programs are being applied (c.f., USA FDA guidances 2020). This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis (1976, 2009). Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such crisis programs, will be discussed.
Scott Patterson (Sanofi)
Scott Patterson PhD, PStat is currently the head of Statistical Innovation at Sanofi Pasteur, the vaccines’ division of Sanofi. He and co-author Professor Byron Jones wrote `Bioequivalence and Statistics in Clinical Pharmacology’ now in its second edition. Scott has over 25 years of professional experience in biostatistics, and he and his family reside in Pennsylvania, USA.
PSI Webinar: Innovative approaches in the development of pediatric medicines
Do you want to learn more about innovative approaches for the development of pediatric medicines? Then join this PSI webinar on December 8. We have organized an exciting webinar with very knowledgeable speakers who will share their thoughts, ideas and experiences, including case studies, on a range of issues relating to historical data, Bayesian methodology, and partial and full extrapolation approaches in the context of developing pediatric medicines.
PSI EIWG Webinar: PIONEERing estimands in Clinical Research
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