NISS-Merck Virtual Meet-up on Bayesian Statistics in Drug Development

The agenda for the meet-up is as follows:

Frank Harrell, (Vanderbilt University)

"Fundamental Advantages of Bayes in Drug Development"

Amy Xia, (Amgen)

"Bayesian Applications for Extrapolation from Adult to Pediatric Data" 

Telba Irony, (FDA)

"The Value of Bayesian Approaches in the Regulatory Setting" 

About the Speakers

Frank Harrell (Vanderbilt University):  Dr. Harrell received his PhD in Biostatistics from UNC in 1979. Since 2003 he has been Professor of Biostatistics, Vanderbilt University School of Medicine, and was the department chairman from 2003-2017. He is Expert Statistical Advisor for the Office of Biostatistics for FDA CDER. He is Associate Editor of Statistics in Medicine, a member of the Scientific Advisory Board for Science Translational Medicine, and a member of the Faculty of 1000 Medicine. He is a Fellow of the American Statistical Association and winner of the Association's WJ Dixon Award for Excellence in Statistical Consulting for 2014. His specialties are development of accurate prognostic and diagnostic models, model validation, clinical trials, observational clinical research, cardiovascular research, technology evaluation, pharmaceutical safety, Bayesian methods, quantifying predictive accuracy, missing data imputation, and statistical graphics and reporting.

Amy Xia (Amgen): Amy Xia is Vice President, Biostatistics, Design & Innovation at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies in the past two decades. Currently, she heads up the Biostatistics and Design & Innovation organizations in the Center for Design and Analysis at Amgen, providing leadership and holistic vision for strategic drug development and driving innovative program/study designs across Amgen’s portfolios for evidence generation and decision-making. Amy’s research interests include Bayesian and adaptive designs, safety biostatistics, meta-analysis and innovative approaches for pediatrics/rare diseases drug development. She currently is the Vice-Chair for the DIA Bayesian Scientific Working Group.  Amy is an ASA Fellow. She received her PhD in Biostatistics from the University of Minnesota, and her medical degree from Peking University, China.

Telba Irony (FDA:CBER): Dr. Irony is deputy directory of biostatistics and epidemiology at the FDA’s Center for Biologics Evaluation and Research. She earned her PhD in industrial engineering and operations research from U. California Berkeley. She is a fellow of the American Statistical Association. In 2014, she won the Excellence in Analytical Science Award of the FDA "for spearheading innovative regulatory science studies, culminating in the release of novel guidance documents; supporting complex policy decision-making; and changing the submission review paradigm". She has long been a proponent of Bayesian statistics.