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Keyword Search Criteria: drug development returned 18 record(s)
Sunday, 07/29/2018
MIDD: Perspectives and Possibilities
Dionne Price, Food and Drug Administration
2:05 PM

Use of Real-World in Clinical Drug Development
Xiuyu Julie Cong, Boehringer Ingelheim Pharmaceuticals Inc; Susan Wang, Boehringer Ingelheim Pharmaceuticals Inc.
3:05 PM

A Case Study on Model Based Meta-Analysis (MBMA) for Drug Development Decisions
Guohui Liu, Takeda Pharmaceuticals Inc ; Zhaoyang Teng, Takeda pharmaceuticals international, Co; Zhaowei Hua, Takeda Pharmaceuticals International Co.; Neeraj Gupta, Takeda pharmaceuticals international, Co; Richard Labotka, Takeda pharmaceuticals international, Co
3:35 PM

Practical Bayesian Modeling and Subgroup Inference in Alzheimer's Drug Development
Brad Carlin, University of Minnesota; Patrick Schnell, Ohio State University; Mark Fiecas, University of Minnesota; Peter Müller, University of Texas Austin; Qi Tang, Sanofi; Walter Offen, AbbVie
5:05 PM

Monday, 07/30/2018
Assessing Treatment Benefit in Patient-Centric Study Designs
Jagadish Gogate, Johnson & Johnson-Janssen R&D


An Application of 2-In-1 Adaptive Phase 2/3 Design for Expedited Oncology Drug Development
Xinqun (Maggie) Chen, Merck & Co., Inc.; Linda Sun, Merck & Co., Inc.; Cong Chen, Merck & Co.
2:05 PM

Extrapolation in Pediatric Drug Development: an Evolving Science
Yeruk Mulugeta, FDA; Lynne Yao, US FDA
2:05 PM

Critical Steps for Composite Endpoint Analysis
Jerry J. Li, Merck & Co., Inc.
2:20 PM

Tuesday, 07/31/2018
Bayesian Methods in Real-World Evidence for Medicinal Product Development: Can Prior Distributions Provide a Platform for Creating Real-World Evidence?
John Loewy, Dataforethought


Optimal Approach for Addressing Multiple Stakeholders' Requirements in Drug Development
Zoran Antonijevic
8:55 AM

Benefit Cost Ratio Analysis in Oncology Drug Development: Single Arm Vs RCT
Thomas Jemielita, Merck & Co.; Cong Chen, Merck & Co.
9:15 AM

Assessment of Biomarkers and Surrogate Endpoints in Drug Development
Ivan Chan, AbbVie Inc; Shu-Chih Su, Merck Research Labs
10:55 AM

Statistical Graphics in Drug Development: Dose-Finding to Dossier Submission
Suddhasatta Acharyya, Novartis pharmaceuticals corporation
11:50 AM

Wednesday, 08/01/2018
Exposure-Response Analysis with Random Forest
Zifang Guo, Merck; Thomas Jemielita, Merck & Co.; John Kang, Merck


Exposure-Response Analysis with Random Forest
Zifang Guo, Merck; Thomas Jemielita, Merck & Co.; John Kang, Merck
10:00 AM

On Randomized Controlled Trials with Integrated Real World Evidence for Drug Development in Rare Diseases
Qing Liu, Amicus Therapeutics, Inc
11:15 AM

Bayes in Drug Development for Rare Diseases
John Scott, FDA
11:35 AM

Thursday, 08/02/2018
Statistical Challenges and Opportunities in Drug Development for Rare Diseases
Guowen Sun, BioMarin; Keith Gregg, BioMarin; Peter Slasor, BioMarin; Chito Hernandez, BioMarin Pharmaceutical Inc.
9:50 AM