Label-based flow cytometry allows the quantification of target features of interest by attaching fluorophores (labels) to antibodies and measuring the resulting fluorescence at the relevant wavelengths. This is widely used for cell sorting, i.e., determining cell types. Image flow cytometry is a technology which enables single cell images in cell sorting experiments. Problematically, directly using this data for classification involves manual inspection of many thousands of images.... Details
When: March 31, 2020
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Designs of clinical trials with time to event primary endpoints usually rely on hazards being constant over time. A major challenge in immuno-oncology is the delayed onset of benefit with such therapies and the presence of non-proportional hazards. The impact of this needs to be accounted for in sample size calculations, analysis methodology and reporting. At this meeting, we will examine possible strategies to handle such features, which may not be fully known when the trial is... Details
When: April 1, 2020
Where: Cambridge
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Have you ever wondered what it takes to be successful as a statistician or data scientist in the healthcare/pharma industry and what can give you the extra edge to develop your career? Come and listen to these industry leaders views on how to be successful and the advantages of being part of the PSI community.
When: April 23, 2020
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Given the current situation, pretty much everyone is working remotely from home. Some people are used to working remotely either on a regular or full-time basis this, whilst for many this is a new experience. Remote working, whether chosen or forced, has pros and cons for the company, manager and the statistician. Based on over 15 years’ experience working from home as a contractor and more recently as a manager of homebased statisticians and programmers, this Webinar will give some ... Details
When: April 28, 2020
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PSI are pleased to offer a series of online webinars which will feature some of the content that was due to be presented at this year's conference. The webinars will run over a four-day period, week commencing 8th June, the same week in which the conference was due to take place. Once registered, individual links to each webinar will be distributed the working day prior to the session.
When: June 8–11, 2020
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The 2020 PSI Annual General Meeting will soon be upon us and this year, we're going virtual! In a World that's now reliant on digital adaptation, we've done just that and are therefore delighted to inform that this year's AGM will be held virtually on Tuesday 9th June from 13:00 - 14:00 BST. Join us between Conference webinars to also hear about the key achievements from 2019, the impacts and adaptations stemming from COVID-19, and what there is to look forward to with PSI, through... Details
When: June 9, 2020
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Since 15 years the scientific literature repeatedly underline the important lack of reproducibility and replicability of studies in biomedical research. As a consequence, several scientific organizations (journal, scientific societies, universities, national agencies) have identified some root causes to this issue and proposed good research practices to improve the replicability of the results. The misuse of statistical concepts, from design of studies to analysis of data to... Details
When: July 15, 2020
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This webinar will feature presentations from 3 speakers on the topic of Using Visualisations to Help Make Decisions: •Caroline Caudan - Interactive statistical monitoring to optimize review of potential study issue with R-Shiny •Paolo Eusebi - Effective visualization of uncertainty – Where we are and where to go •Michael O’Kelly - Subgroup analysis: a look at the SEAMOS approach (Standardised Effects Adjusted for Multiple Overlapping Subgroups) These presentations were originally... Details
When: September 3, 2020
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A protocol of a clinical trial with a design that allows testing multiple drugs and/or multiple subpopulations in parallel is called master protocol. Master protocols have been used in the pharmaceutical industry for some time now and examples include the I-SPY 2 trial and the Lung-MAP trial. For this webinar, PSI brings together experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies. The speakers will recapitulate terminology surrounding... Details
When: September 23, 2020
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Patient preference studies are becoming more frequently used in drug development. In this webinar you will hear an introduction to what a patient preference study is as well as an overview of where this type of study can inform regulatory decision making. This will be followed by 2 examples looking at potential approaches to eliciting patient preference demonstrating how such studies can be designed and... Details
When: October 13, 2020
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The Vaccine SIG is proud to bring you this webinar, which will feature two presentations on topics relating to methodological developments in vaccines research. We are delighted to be joined by Frank Harrell who will present 'Sequential Bayesian Designs for Rapid Learning in COVID-19 Therapeutic Trials'; and also by Dean Follmann, who will present on 'Statistical Aspects of COVID-19 Vaccine Trials'. Join us for this insightful and highly topical... Details
When: October 15, 2020
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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.
When: November 5, 2020
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The deployment of biomarkers in drug development and diagnostics has many challenges ranging from analytical validation, in vivo study design, to the translation to human utility and financial considerations. In this Webinar focus will be given to safety biomarkers. Statistical issues in data science that nonclinical statisticians might encounter along the way will be discussed.
When: November 25, 2020
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A general introduction to the topic of combining sexes for statistical analysis in Toxicology. It will also discuss guideline recommendations pertaining to this topic.
When: December 1, 2020
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Since the introductio of ICH-E6 R2 Addendum sponsors must introduce formal Quality Risk Management and define Quality Tolerance Limits to their clnical development programs. This webinar will cover an introduction to those concepts, recent developments and examples of how companies are defining QTL's in practice.
When: December 2, 2020
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