Disruptions of Clinical Trials & Estimands
– John Scott, FDA
“An overview of estimands and how Bayes can help”
– Silvia Calderazzo, Division of Biostatistics DKFZ (German Cancer Research Center):
“Coping with Information Loss and the Use of Auxiliary Sources of Data for Unplanned Clinical Trial Disruptions”
Causal Inference
– Jason Roy, Rutgers School of Public Health
“A Bayesian Semiparametric Model for Sequential Treatment Decisions in Continuous Time”
– Jonathan French, Metrum
“Using DAGs to Inform Pharmacometric Modeling”
Rare Disease & Pediatric Extension
– Satrajit Roychoudhury, Pfizer
“Robust Bayesian Approaches for Basket Trial Design with Rare Cancer Indications”
– Meg Gamalo, Pfizer
“Bounded Weights in Power Priors: Application to the Extrapolation Framework in Pediatric Drug Development”
– Mark Rothmann, FDA
“Drug development and decision-making in pediatric settings leveraging adult results”
– James Travis, FDA
“Hierarchical Models in the Analysis of Master protocols for Rare Diseases”
RWE
– Lei Nie, FDA.
“Bayesian dynamic borrowing methods in clinical trials”
– Heng Li, FDA.
“Utilizing real-world data to expedite a traditional clinical study: A Bayesian strategy”
– Bradley Carlin, PharmaLex
“Bayesian Approaches for Utilizing Real World Evidence (RWE) in Biopharmaceutical Development”
– Fan Li, Duke University
“Title to be confirmed”
CMC
– Paul Faya, Eli Lilly
“ Bayesian statistics in CMC”
– Tianhui Zhang, AstraZeneca
“ Bayesian statistics for continuous assay qualification”
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