Online Program Home
My Program

CC = Colorado Convention Center   H = Hyatt Regency Denver at Colorado Convention Center
* = applied session       ! = JSM meeting theme

Activity Details

571 Wed, 7/31/2019, 2:00 PM - 3:50 PM CC-210/212
Special Topics and Case Studies in Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Oluyemi Oyeniran, JNJ
2:05 PM Analysis of Multiple Outcome Measures with Applications to Disability Improvement in Multiple Sclerosis
Wenting Cheng, Biogen; Yangqing Deng, University of Minnesota; Lili Yang, Biogen; Shifang Liu, Biogen; Chunlei Ke, Biogen
2:20 PM Use of Extended Kaplan-Meier and Time-Dependent Cox Model in EU Submission of Kymriah
Jufen Chu
2:35 PM Assessing Similarity of Curves: An Application in Assessing Similarity Between Pediatric and Adult Exposure-Response Curves

Yodit Seifu, Merck; Mathangi Gopalakrishnan, University of Maryland; Junshan Qiu, FDA/CDER; Junjing Lin, AbbVie; Margaret Gamalo-Siebers, Eli Lilly
2:50 PM Making an Impact: the Filing Story of ZINPLAVA
Alison Pedley
3:05 PM Assessing Similarity to Support Pediatric Extrapolation

Forrest Williamson, Eli Lilly
3:20 PM Dealing with Issues of Pediatric Clinical Trials
Aobo Wang, Merck
3:35 PM Evaluation of Impacts of Concomitant Use of Acetylcholinesterase Inhibitors and Memantine on Cognitive Decline in ADNI Data
Hui Zheng, AbbVie Inc.; Weining Robieson, AbbVie Inc.; Deli Wang, AbbVie; Hana Florian, AbbVie