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Luncheon and Round Table Discussions
Session Chair(s)
Cristiana Mayer, DRSc, PhD
Head of Biostatistics, Johnson & Johnson Vision, United States
Attendees registered prior to the Early Bird rate deadline (April 18) will have an opporunity to pre-select their preferred tables to join.
Speaker(s)
Annie Lin
Pharmacovigilance Supervisor, Baxter, China
Session Co-Chair
Mouna Akacha, PhD
Group Head of Statistical Methodology, Novartis Pharma AG, Switzerland
Session Co-Chair
Shyla Jagannatha, PhD
Scientific Director, Janssen Pharmaceuticals Inc., United States
Session Co-Chair
Min Min, PhD
Mathematical Statistician, OB, OTS, CDER, FDA, United States
Table 1: Innovative Strategies to Address Complex Study Design and Analysis Issues in Rare Disease Clinical Development
Cristiana Mayer, DRSc, PhD
Head of Biostatistics, Johnson & Johnson Vision, United States
Table 2: Modeling and Simulation in Drug Development: Best Practices and Current Challenges
Zhong Gao, PhD
Mathematical Statistician, FDA, United States
Table 3: Statistical Issues in Biomarker Discovery, Validation, and Utilization in Clinical Trials
Mouna Akacha, PhD
Group Head of Statistical Methodology, Novartis Pharma AG, Switzerland
Table 4: Choosing Measures of Treatment Benefit: Estimands and Beyond
Sue-Jane Wang, PhD, MA, MS
Mathematician Statistician, FDA, United States
Table 5: Biomarkers, How are they Discovered or Developed, and for What?
Shyla Jagannatha, PhD
Scientific Director, Janssen Pharmaceuticals Inc., United States
Table 6: Adaptive Predictive Enrichment Design: Experiences and Challenges
Changming Xia
Mathematical Statistician, FDA, United States
Table 7: Weighing Findings in Subgroup Analysis
Frank Bretz, PhD
Distinguished Quantitative Research Scientist, Novartis , Switzerland
Table 8: Multiple Endpoints in Clinical Trials
Jimmy C. Wong
Statistical Analyst, Office of Biostatistics, OTS, CDER, FDA, United States
Table 9: Developing Standardized Tools for the Analysis of Clinical Trials
Steve Wilson, PhD
Senior Staff Fellow, OB, OTS, CDER, FDA, United States
Table 10: Communication and Collaboration: Scientific Working Groups
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