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