Part I: Specification and Sampling Acceptance Tests -- Statistical Considerations in Setting Quality Specification Limits Using Quality Data -- Counting Test and Parametric Two One-Sided Tolerance Interval Test for Content Uniformity Using Large Sample Sizes -- Part II: Analytical Biosimilar and Process Validation -- Sample Size Consideration for Equivalent Test of Tier-1 Quality Attributes for Analytical Biosimilarity Assessment -- A Probability Based Equivalence Test of NIR Versus HPLC Analytical Methods in a Continuous Manufacturing Process Validation Study -- A Further Look at the Current Equivalence Test for Analytical Similarity Assessment -- Shiny Tools for Sample Size Calculation in Process Performance Qualification of Large Molecules -- Part III: Continuous Process -- Risk Evaluation of Registered Specifications and Internal Release Limits Using a Bayesian Approach -- Development of Statistical Computational Tools Through Pharmaceutical Drug Development and Manufacturing Life Cycle -- Application of Advanced Statistical Tools to Achieve Continuous Analytical Verification: A Risk Assessment Case of the Impact of Analytical Method Performance on Process Performance Using a Bayesian Approach -- Part IV: Clinical Trial Design and Analysis -- Exact Inference for Adaptive Group Sequential Designs -- A Novel Framework for Bayesian Response-Adaptive Randomization -- Sample Size Determination Under Non-proportional Hazards -- Adaptive Three-Stage Clinical Trial Design for a Binary Endpoint in the Rare Disease Setting -- Part V: Biomarker-Driven Trial Design -- Clinical Trial Designs to Evaluate Predictive Biomarkers: What’s Being Estimated? -- Biomarker Enrichment Design Considerations in Oncology Single Arm Studies -- Challenges of Bridging Studies in Biomarker Driven Clinical Trials: The Impact of Companion Diagnostic Device Performance on Clinical Efficacy -- Part VI: Application of Novel Data Modality -- Parallel-Tempered Feature Allocation for Large-Scale Tumor Heterogeneity with Deep Sequencing Data -- Analysis of T-Cell Immune Responses as Measured by Intracellular Cytokine Staining with Application to Vaccine Clinical Trials -- Project Data Sphere and the Applications of Historical Patient Level Clinical Trial Data in Oncology Drug Development -- Novel Test for the Equality of Continuous Curves with Homoscedastic or Heteroscedastic Measurement Errors -- Quality Control Metrics for Extraction-Free Targeted RNA-Seq Under a Compositional Framework -- Part VII: Omics Data Analysis -- Leveraging Omics Biomarker Data in Drug Development: With a GWAS Case Study -- A Simulation Study Comparing SNP Based Prediction Models of Drug Response.