Program

Confirmed Speakers:

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”