| Preliminary Invited Sessions for the 1st ISBS Symposium Please come back for update (Last Updated on 01/28/2008) Back to Program | |
| Pre-clinical discovery Coordinator(s): Amit Bhattacharyya (GSK) | |
| 1. Genomics and Genetics Data Analysis in Drug Discovery | |
| 2. Statistical Issues in Biopharmaceutical Technologies | |
| 3. Statistical Analysis of High-Throughput Biotechnology Data | |
| Pharmacokinetics and pharmacodynamics (PK/PD) Coordinator(s): Harry Yang (MedImmune), Mike Smith (Pfizer) | |
| 1. Clinical Pharmacology / Bioequivalence / Bridging Strategies / Global Development | |
| 2. PK/PD Modeling and Simulation | |
| Early development and experimental medicine Coordinator(s): Amit Bhattacharyya (GSK) | |
| 1. Multiple Testing in Microarray Data Analyses | |
| 2. Statistical analysis of Genotoxicity /Mutagenicity Data | |
| Chemistry, manufacturing and control (CMC) Coordinator(s): Amit Bhattacharyya (GSK), Tim Schofield (Merck) | |
| 1. Analytical Methods | |
| 2. Quality by Design | |
| 3. Method Transfer | |
| Clinical development (clinical trials) Coordinator(s): Mingxiu Hu (Millennium), Jose Pinheiro (Novartis), Martin Posch (Vienna), Ivan Chan (Merck) | |
| 1. Application of Adaptive Design: Case Studies | |
| 2. Innovative Designs in Clinical Trials | |
| 3. Missing Data | |
| 4. Multiple Comparison and Multiple Testing | |
| 5. Longitudinal Data Analysis | |
| 6. Adaptive Designs: Paradigm Shift in Clinical Development | |
| 7. Bayesian Analysis of Clinical Trial Data | |
| 8. Clinical Trial Simulation | |
| 9. Design and Operational Issues in Flexible Designs | |
| 10. Use of Bomarkers in Clinical Trials | |
| 11. Adaptive Dose-Finding Designs in Phase I/II Trials | |
| 12. Dose Response Assessments: Trial Designs and Data Analyses | |
| 13. Multiple Regional Trials and Bridging Studies | |
| 14. Noninferiority and Equivalence Testing | |
| 15. Issues and Challenges in Active Control Trials | |
| 16. Survival Analysis | |
| 17. Confirmatory Adaptive Designs | |
| 18. The Recent Development of Statistical Evaluation of Surrogate Markers | |
| 19. PK/PD and HIV/AIDS Modeling | |
| 20. Design, Multiple Testing and Missing Data | |
| 21. Adaptive Randomization in Clinical Trials | |
| 22. Pharmaceutical Safety | |
| 23. Missing Data in Longitudinal Studies | |
| 24. Design and Analysis of Targeted and Drug Combination Therapies: From Preclinical Studies to Clinical Trials | |
| 25. Advances in Lifetime Data Analysis | |
| 26. Drug Development in Asia | |
| 27. Thresholding Regression and Related Topics | |
| 28. Statistical Issues in Evaluating Therapeutic Effects | |
| 29. Quality of Clinical Trials- Clinician's Views on Statistical Issue | |
| 30. Statistical Methods for Drug Safety Assessment | |
| 31. Design and Sample Size Considerations with Multiple Endpoints in Clinical Trials | |
| Post-licensure safety monitoring and pharmacovigilance Coordinator(s): Jie Chen (Merck) | |
| 1. Statistial Issues in Worldwide Drug Safety and Pharmacovigilance | |
| Pharmacoepidemiology Coordinator(s): Wei Shen (Lilly), Greg Wei (Pfizer) | |
| 1. Pharmacoepidemiology and Post-Approval Safety Monitoring | |
| 2. Advanced Methods in Causal Inferences Based on Observational Data | |
| Pharmacoeconomics and outcome research Coordinator(s): Ning Li (FDA) | |
| 1. Advances in Pharmacoeconomics | |
| Pharmacogenomics, Pharmacogenetics and System Biology Coordinator(s): Jihao Zhou (Allergan) | |
| 1. Pharmacogenomics and Pharmacogenetics | |
| 2. Pharmacogenomics and System Biology | |
| 3. Statistics in Pharmacogenomics | |
| Regulatory sciences and statistics Coordinator(s): Mark Rothmann (FDA), Bill Wang (Merck), Ning Li (FDA) | |
| 1. Flexible Designs: Industry and Regulatory Considerations | |
| 2. Implementations of ICH E14 in Cardiac Repolarization Assessment: Challenges and Opportunities | |
| Globalization and outsourcing Coordinator(s): Greg Wei (Pfizer), Bill Wang (Merck), Wei Shen (Lilly), Frank Shen (Roche) | |
| 1. Panel Discussion: Global Statistics Operation and Outsourcing | |
| 2. Panel Discussion: Statistical Education - Comparison of Programs across the Gobe | |
| 3. Regulatory and Statistical Issues in Supporting Global Drug Development | |
| Regulatory issues on traditional (herbal) medicine Coordinator(s): Ning Li (FDA) | |
| 1. Regulatory Issues in Traditional (Herbal) Medicine | |
| Innovative statistical programming, computation, and simulation Coordinator(s): Torsten Hothorn (Erlangen) | |
| 1. Some Challenges in Statistical Programming | |
| 2. Statistical Computing Issue - Quality Control and Standards | |
| 3. Statistical Programming Challenges in Clinical Trial Development Processes | |
| 4. Innovative SAS Programming in Pharmaceutical Research | |
| 5. CDISC | |
| Information and statistical consulting Coordinator(s): Ning Li (FDA) | |
| 1. Statistics and Clinical Data Management in China | |
| Other Coordinator(s): TBD | |
| 1. Statistics as a Profession | |
| 2. Biopharmaceutical Portfolio Management | |