Legend: CC = Colorado Convention Center H = Hyatt Regency Denver at Colorado Convention Center
Activity Details
605 * !
Thu, 8/1/2019,
8:30 AM -
10:20 AM
CC-603
Innovations in Use of Historical Control Data in Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section , Section on Medical Devices and Diagnostics, Biometrics Section, Section on Statistical Consulting, Statistics and Pharmacometrics Interest Group
Organizer(s): Steven Schwager, Cornell University
Chair(s): Steven Schwager, Cornell University
8:35 AM
Exploring External Controls Using Prior Clinical Trial Data
Presentation
Pallavi Mishra-Kalyani, US Food and Drug Administration
8:55 AM
Composite Likelihood Approach for Incorporating the Entropy Balance Weighting of Real World Data (RWD) in Uncontrolled and Randomized-Controlled Trials (RCTs)
Guanglei Yu, Eli Lilly and Company ; Margaret Gamalo-Siebers, Eli Lilly; Yuanyuan Bian, Eli Lilly and Company
9:15 AM
Incorporation of Historical Information in Pediatric Trials
Presentation
James Travis, FDA
9:35 AM
Real World Data for Oncology Drug Development: Promise and Pitfalls
Presentation
Catherine Tuglus, Amgen ; Qui Tran, Amgen; Chris Holland, Immunocore
9:55 AM
Strengthening Clinical Trials Through Synthetic Control Arms
Antara Majumdar, Medidata Solutions ; Ruthie Davi, Medidata Solutions; Steven Schwager, Medidata Solutions
10:15 AM
Floor Discussion
607
Thu, 8/1/2019,
8:30 AM -
10:20 AM
CC-607
Effective Application of Modeling, Simulation and Knowledge Sharing in Drug Development — Topic Contributed Papers
Statistics and Pharmacometrics Interest Group
Organizer(s): Mike Smith, Pfizer; Stacey Tannenbaum, Astellas
Chair(s): Bret Musser, Regeneron
8:35 AM
Integration of Pharmacometrics and Statistics to Support Study Design Optimization
Presentation
Michael Heathman, Metrum Research Group
8:55 AM
Meta-Data and Software for Bayesian Emax Dose Response Models
Presentation
Neal Thomas, Pfizer
9:15 AM
Adaptive Borrowing of Adult Data for Pediatric Trials: Collaborative Research at the Intersection of Pharmacometrics and Statistics
Chyi-Hung Hsu, Janssen, R&D
9:35 AM
Trial Simulations to Support Proof of Concept Study Design: Application to Immunology
John Gibbs, AbbVie
9:55 AM
Discussant: Gary Rosner, Johns Hopkins University
10:15 AM
Floor Discussion
