Practical Guidance1. "Sample Size Re-estimation Designs In Confirmatory Clinical Trials - Current State, Statistical Considerations, and Practical Guidance", Yili Pritchett, MedImmune2. "Applications of Sample Size Re-Estimation in Confirmatory Clinical Trials", Jon David Sparks, Eli Lilly3. "Emerging Methods for Estimation and Hypothesis Testing for Designs Using Sample Size Re-estimation", Cyrus Mehta, CytelDIAGNOSTICS: NGS Based Genomic Diagnostics in Precision Medicine4. "Regulatory Considerations for NGS-Based Tests", Sharon Liang, FDA5. "Companion Diagnostics on an NGS-Based Assay: Methodology and Analytical Validation", James Sun, Foundation Medicine6. "Sequence Counts as Compositional Data: Metrics for Sample Quality, Sequencing Integrity, and Batch Effects in Targeted NGS", Bonnie LaFleur, HTG Molecular Diagnostics7. "Statistical Challenges in Genetic Diagnosis of Rare Diseases With Known Monogenic Causes", Hyun Min Kang, University of MichiganBIOEQUIVELENCE: Bioequivalence and Biosimilar8. "Equivalence Test of Analytical Biosimilarity", Yi Tsong, Xiaoyu Dong, Meiyu Shen, Yu-Ting Weng, FDA9. "Bioequivalence evaluation of sparse sampling data using bootstrap resampling method ", Meiyu Shen, Huaixiang Li, Guoying Sun, FDA10. "Setting Equivalence Acceptance Criteria for Demonstration of Analytical Similarity", Harry Yang, Steven Novick, Rick Burdick, MedImmuneMANUFACTURING: Continuous Manufacturing11. "Some Statistical Issues Associated With Monitoring and Control of Blend Potency at the Feed Frame Using NIR Spectroscopy", Tim Kramer, Eli Lilly12. "A Probability Based Equivalence Test of NIR vs HPLC Analytical Methods in a Continuous Manufacturing Process", Areti Manola, Janssen13. "Sampling Considerations for UDU Release Testing in Continuous Manufacturing", Plinio De los Santos, Merck CLINICAL: Modeling and Simulation in the Pharmaceutical Industry 14. "Synergistic Opportunities with Pharmacometricians and Statisticians", Alan Hartford, Abbvie15. "Precision in Model Prediction", Matt Rotelli, Eli Lilly16. "Application of Dose Scaling Method in Similarity Assessment", Yaning Wang, FDABIOMARKERS: Precision Medicine, Biomarker, and Subgroup Identification in Drug Development 17. "The VG (Virtual Twins and GUIDE) Method for Subgroup Identification", Qi Tang, Abbvie18. "Subgroup Identification in a Learn-and-Confirm Paradigm", Lei Shen, Eli Lilly19. "Statistical Issues in Co-Developing Drug Therapy and Diagnostic Test Using Biomarker Enrichment Design", Hong Tian, Janssen20. "Cross-Validated STEPP Analysis for Biomarker Subgroup Determination Problems", Gu Mi, Eli Lilly STATISTICAL PROGRAMMING AND DATA VISUALIZATION: Best Practice in Programming and Visualization 21. "Good Practices and Implementation Methods for Optimally Stratified Randomization", Jonathan Chipman, Vanderbilt University.22. "Zero-Inflated Models for RNA-Seq Count Data", Munni Begum, Ball State University 23. "Moving from Data Collection to Data Visualization and Analytics: Leveraging CDISC SDTM Standards to Support Data Marts", Steve Kirby, Chiltern International 24. "Concepts and Strategies for Developing Effective Data Visuals", Becky Bates, GCE Solutions25. "A Shiny New World of Programming and Visualization", Michael Man, Eli LillyMANUFACTURING: Comparability and Biosimilarity 26. "A Further Look at the Current Equivalence Test for Analytical Similarity Assessment", Aili Cheng, Pfizer27. "Using the Confidence Interval on Effect Size to Demonstrate Analytical Similarity Between Reference and Biosimilar Products", Rick Burdick, Elion Labs28. "Statistical Methods for Comparability Assessment in Drug Development", Yuanyuan Duan, Abbvie29. "Analytical Similarity Assessment: Practical Challenges and Statistical Perspectives", Richard O. Montes, Hospira, a Pfizer companyCLINICAL: Statistical Approaches to Address Multiplicity Testing in Clinical Trials 30. "Confident Biomarker Identification by Assessing Efficacy in Subgroups and Their Mixtures", Jason Hsu, Ohio State, Eli Lilly31. "Multiple Error Rates in Assessing Efficacy in Subgroups and Their Mixtures", Haiyan Xu, Janssen32. "The Closure Principle Revisited: Looking Back at a 40 Years Old (and Wise) Principle With Special Reference to Multiple Endpoints in Clinical Trials", Dror Rom, ProsoftClinicalBIOMARKERS: Unleashing the Power of Statistics in Drug Discovery Research33. "Leveraging Omics Data in Drug Development - Get Ready for the Show! ", Weidong Zhang, Pfizer34. "Statistical modeling for Tumor Regrowth Experiments in Xenograft Studies", Cong Li, Takeda35. "Bayesian Inference of Tumor Heterogeneity in Human Cancers", Yuan Ji, University of Chicago36. "Transcriptomic Biomarkers Research at Eli Lilly With Applications in Autoimmune Conditions", Guilherme V. Rocha, Eli Lilly ANALYTICAL METHODS: Continued Validation and Verification of Analytical Methods37. "Analytical Development Using Quality by Design", Tim Schofield, GSK38. "Statistical Approaches for Assessment of Parallelism for Bioassays", Xiaoyu (Cassie) Dong, FDA39. "Method Validation Based on Total Error", Jason Zhang, MedImmuneMANUFACTURING: Internal Release Limit and Control Limit 40. "Setting Release Limits: A comparison of Frequentist and Bayesian Approaches", Niels Vaever Hartvig, Novo Nordisk41. "Risk Evaluation of Shelf-Life Specifications and Internal Release Control Using a Bayesian Approach", Yijie Dong, BMS42. "Setting Control Limits Using Bayesian Methods When Most Observations Are Below the Limit of Quantitation", Steve Novick, MedImmune43. "Effective use of Release and Control Limits to Manage Manufacturing and Patient Risks", Tim Schofield, GSK
