Tutorials

BASS XIX Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Russell Reeve	Model-Based Drug Development
M-2	Jeffrey Morris	Modeling High-Dimension Functioning and Image Data
M-3	Ying Yuan	Bayesian Optimal Interval Design for Phase I Clinical Trial
M-4	Roy Sabo	A Bayesian Adaptive Allocation Method for Clinical Trial and Dual Objectives
M-5	Cory Heilmann	Use of Bayesian Evidence Synthesis Techniques Across Phases of Drug Development
M-6	Doug Faries	Comparative Effectiveness Analysis from Observational Data
M-7	Joe Cappelleri	Network Meta-Analysis for Comparative Effectiveness Research
M-8	Susan Duke	Graphs are Statistical Methods Too! The Case for Graphics in Safety and Benefit-Risk Analysis
Keynote Address	Christy Chuang-Stein	Career in Pharmaceutical Industry: Exciting, Challenging and Rewarding
T-1	Melvin Munsaka	Statistical Analysis of Safety Data – A Survey of Some Analysis Methods
T-2	Frank Rockhold	Enhancing the Way We Quantify and Communicate Benefit to Risk in the Pre and Post Approval Arena
T-3	Jesse Berlin	Opportunities and Challenges for Using Networks of Observational Healthcare Data for Medical Product Safety Surveillance
T-4	Zhenzhen Xu	Propensity Scoring Matching in Cluster Randomized Trials
T-5	Xiaolong Luo	A Multiple Comparison Procedure for Hypotheses with Gatekeeping Structures
T-6	Colleen Twomey	21st Century Drug Development: The Road to Consistency and Transparency
W-1	Aloka Chakravarty	Quantitative Safety Evaluation at CDER
W-2	Estelle Russek-Cohen	Safety Throughout the Life Cycle of Vaccines
W-3	Mark Levenson	Quantitative Safety Assessment During the Post-Marketing Phase: Examples at FDA/CDER
W-4	Christy Chuang-Stein	Safety Assessment of Pharmaceutical Products

BASS XVIII Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Inna Perevozskaya	Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines
M-2	Vlad Dragalin	Complex Adaptive Designs in Drug Development
M-3	Kyle Wathen	Utilizing Prediction and Simulation to Guide Clinical Trial Design
M-4	Stephanie Green	Optimizing Phase 1 and 2 Clinical Trials Design
M-5	Vivian Shih and Paul Gallo	Viewpoints on Setting Clinical Trial Futility Criteria
M-6	Bob Noble	Phase 2B Design Considerations Assessing Dose Response Modeling
M-7	Changlu Liu	A Decision-Theoretic Bayes Factor Approach for Dose Finding in Phase I Oncology Trials
M-8	Frank Rockhold	Access to Anonymised Patient Level Data: Experiences from GSK
Keynote Address	ShaAvhree Buckman-Garner	Leveraging Innovation and Change through Regulatory Science Initiatives
T-1	Joe Cappelleri	Interpretation of Patient-Reported Outcomes
T-2	Jesse Berlin	Harnessing Next-Generation Informatics for Personalizing Medicine: Personalization of Care and Research
T-3	Kevin Gan	An Extended Longitudinal Model and Graphic for Benefit Risk Analysis
T-4	Richard Simon	An Overview of Adaptive Biomarker-driven Clinical Trial Designs
T-5	Lisa McShane	Assessment of Omics-based Predictor Readiness for Use in a Clinical Trial
T-6	Edward Korn	Design of Phase II Clinical Trials with a Potential Predictive Biomarker
T-7	Boris Freidlin	Phase III Design Considerations for Molecularly Targeted Agents
T-8	Lisa LaVange, Lisa McShane, Dionne Price, Rajeshwari Sridhara, Shenghui Tang	Master Protocols and their Role in Drug Development
W-1	Mohammad Huque and Kathleen Fritsch	Multiplicity Problems in Clinical Trials – A Regulatory Perspective

BASS XVII Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Xiaolong Luo and Peter S. Ouyang	A Process View of Statistics for Clinical Trials: ANOVA, Product-Limit and Adaptive Design
M-2	Qing Liu, Pilar Lim, Barry Schwab and Jaskaran Singh	Adaptive Doubly-Randomized Delayed-Start Design and Applications to Anti-Depressant Drug Development
M-3	Alex Sverdlov	Covariate-Adjusted Response-Adaptive Randomization Designs for Phase III Survival Trials
M-4	Shanhong Guan	Sample Size Re-estimation in a Two-stage Design Using p-Value Combination Tests
M-5	Tom Stiger	Failure-time Mixture Models for Analyzing Time to Response
M-6	Jihong Chen and Jane Qian	Enrollment and Endpoint Projection in Oncology Clinical Trials
M-7	Yoko Tanaka	Statistical Considerations in Multi-Regional Clinical Trials
Keynote Address	Mohammad Huque	Multiplicity Problems in Controlled Clinical Trials: Regulatory Perspective
T-1	Adam Hamm	Implementing the Continous Reassessment Method (CRM) in a Phase I Oncology Trial
T-2	Laszlo Endrenyi	Scaled Average Bioequivalence: An Approach to Resolve a Difficult Problem
T-3	George Y. H. Chi and Gang Li	A New Development and Perspective on the Design, Analysis & Interpretation of Non-inferiority Trials
T-4	David Nelson and Carlos Alatorre	Methodological Considerations in Comparative Effectiveness Research
T-5	Mark Reimers	Estimation Issues in High-throughput Data Analysis
W-1	Par Karlsson	Multiple Testing in a Partitioning Framework
W-2	Mohamed Alosh	Recent Developments in Addressing Multiplicity Issues in Clinical Trials
W-3	Mohammad Huque	Decomposition of a Composite Endpoint for Assessing Treatment Benefits for its Components

BASS XVI Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Yuan Ji	Dose Finding in Oncology Clinical Trials Based on Unit Probability Mass
M-2	Alex Sverdlov	Implementing Response-Adaptive Randomization in Multi-Armed Survival Trial
M-3	Martin King	Evaluating Probability of Success in Oncology Clinical Trial
M-4	Matthew Somerville	Design and Analysis of a Cancer Prevention Trial: Plans and Results
M-5	Greg Cicconetti	Comparing Conditional and Predictive Power to Assess Futility in a Phase III Program with Two Studies
M-6	Rebecca Brown	Setting Alpha Levels for Testing Key Secondary Endpoints in Trials with Interim Assessments When the Primary and Secondary Endpoints Are Correlated
M-7	Nitai D. Mukhopadhyay	Efficient Sampling of Inverse Correlation Matrices and its Applications with Baysian Modelling of Gene Interaction in Early Phase Genomic Experiment
Keynote Address	Shein-Chung Chow	Controversial Issues in Clinical Trials
T-1	Stephen J. Ruberg	The Mean Ain't What It Used To Be
T-2	Karl E. Peace	Subgroup Data Analysis of Clinical Trials-Issues and Methods
T-3	Larry Leon	Analysis of Aid Dose Selection in Phase 2 Virology Clinical Trials
T-4	Michael O'Connell	Statistical Graphics for Exploratory Review and Reporting in Clinical Trials
T-5	Cristiana Gassmann-Mayer	Statistical Assessment and Analyses of Suicidality Data in Clinical Trials
T-6	David Manner	Using Statistical Principles to Implement FDA Guidance on Cardiovascular Risk Assessment for Diabetes Drugs
W-1	George Rochester	Safety Planning Throughout the Product Life-cycle
W-2	Antonio Paredes	On Methodologies Associated with Met-analysis
W-3	Mark Van der Laan	Target Maximum Likelihood Super Learning : Application to Causal Effects in Safety Analysis

BASS XV Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Susan Parker and Lixin Lang	Phase I Oncology Designs: Comparisons and Extensions
M-2	Zixing Fang	Analyzing Phase 2 Proof-of-Concept Clinical Trials with Baseline and Post-Treatment Measurements
M-3	Yuan Ji	Bayesian Adaptive Designs for Early Phase Clinical Trials
M-4	Shumei S. Sun	A Double Blind, Two-Arm Placebo Controlled Trial of Alendronate in Patients with Gaucher's Disease
M-5	Yin Yin	Qualification in the Internal Decision Making Process
M-6	Andreas Sashegyi	Application of Learning Maps in Pharmaceutical Research and Development
M-7	Patrick Peterson	PISC Expert Team White Paper: Toward a Consistent Standard of Evidence when Evaluating the Efficacy of an Experiment Treatment from a Randomized, Active-controlled Trial
Keynote Address	Donald A. Berry	New Developments in Bayesian Clinical Trials
T-1	David Raunig	Imaging Basics
T-2	Yonghua Wang	Statistical Considerations of Using Medicine Imaging Techniques in Clinical Trials
T-3	Takashi Sozu	Power and Sample Size Calculations in Clinical Trials with Multiple Co-primary Endpoints
T-4	Yonghua Wang	Effective Use of Data in Incomplete Crossover Designs: Theory and Application
T-5	Iiya Lipkovich	Identification of Promising Subgroups in the Retrospective Analysis of Clinical Trials
T-6	Ramses Sadek	Patient Reported Outcome/Quality of Life Assessment in Clinical Trials
W-1	Jerald Schindler	Adaptive Trials: Unlocking the Opportunity and the Competitive Advantage
W-2	Steven Bai	Sample Size Re-estimation
W-3	George Kordzakhia	Bonferroni-Based Tree-Structured Gatekeeping Testing Procedures

BASS XIV Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Mike Davenport	An Adaptive Dose Finding Design (DOSEFIND): Using a Nonlinear Dose Response Model
M-2	Susan Willavize	Dose Response Modeling for Combination Drug Products
M-3	Neal Thomas	Bayesian Analysis of Dose Response
M-4	Jason Liao	Concordance Analysis in the Biopharmaceutical Industry
M-5	Yongming Qu	Surrogate Markers Validation: What should be Considered?
M-6	Craig Trost	An Introduction to Pathodynamics from the View of Liver Homeostatis Using the Ornstein-Uhlenbeck Process
M-7	Jonathan S. Schildcrout	Analyses of Longitudinal Clinical Lab Data with Latent Mixture Models
M-8	Michael O'Connell	Statistical Modeling and Graphical Analysis of Safety Data in Clinical Trials
Keynote Address	Mitchell Gail	Absolute Risk: Clinical Application and Contoversies
T-1	Vlad Dragalin	Adaptive Modeling-based Designs in Clinical Drug Development
T-2	Quan Hong	A New Method for Steady State Assessment Based on Nonlinear Mixed Effect Modeling
T-3	Cancelled	Cancelled
T-4	Robb Muirhead	Moving Beyond QT in Assessing the Arrhythmic Liability of Drugs
T-5	Anthony Segreti	Strategies for Meta-Analyses of Randomized Controlled Trials Based on Individual Patient Data
T-6	Edit Kurali	Statistical Issues in Predictive Toxicology
W-1	Guoxing Soon	Handling Missing Data in Clinical Trials -Design and Analysis Issues with Examples from the Anti-viral Area
W-2	Mohamed Alosh	Analysis of Longitudinal Count Data with Possibility of Dropouts
W-3	Thamba Valappil	An Overview of Causal Inference and its Applications in Clinical Trials
W-4	Adam Meyers	Developing an Analytic Road Map for Incomplete Longitudinal Clinical Trial

BASS XIII Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
Keynote Address	Greg Campbell	The World of Medical Devices and Its Increasing Impact on Pharmaceutical Statistics
M-1	Stephan Ogenstad	Simulation for Designing and Analyzing Clinical Trials
M-2	Dejun Tang	Comparison of Statistical Analysis Methods Using Modeling and Simulations in Modern Protocol Design
M-3	Naitee Ting	Dose Finding in Drug Development : Study Design Considerations
M-4	Mark J. Van der Laan	Resampling Based Multiple Testing: Controlling Proportion of False Positives
M-5	Michael O'Connell	Standardized Graphics for Safety Using S-Plus Software
M-6	Ralph Raymond and Frank Shen	Model Based Adaptive Design
M-7	Tim Montague	Bioequivalence Trials Designed Using Adaptive Methodologies
T-1	Rong Liu	A comparison of Methods for Longitudinal Data Missing due to Truncation
T-2	Julia Wang and Akiko Okamoto	Rescue Behavior and Imputation Strategies in Analgesic Studies
T-3	Robert E. Johnson and Heather J. Hoffman	Multivariate Assays with Values Below the Lower Limit of Quantitation: Parametric Estimation by Imputation and Maximum Likelihood
T-4	Andrew Strahs	Variability in Gene Expression in Healthy Volunteers
T-5	Shein-Chung Chow	Adaptive Design Methods in Clinical Trials
W-1	Mohammad Huque	On Some Statistical Considerations in Planning and Testing of Multiple Endpoints in Clinical Trials
W-2	Gouxing (Greg) Soon	Issues and Considerations for Composite Endpoints Use in Clinical Trials
W-3	Atiar Rahman	Recent Results Concerning Multiplicities in Animal Carcinogenicity Studies
W-4	Alex Dmitrienko	Tree-structured Gatekeeping Procedures in Clinical Trials with Multiple Objectives

BASS XII Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Kwan Lee	Biomarker Discovery from High Dimensional Data
M-2	Wayne Anderson	The Impact of Genomic Research on Drug Discovery and Development
M-3	Xiaohong Huang	Borrowing Information from Relevant Microarray Studies for Sample Classification Using Weighted Penalized Partial Least Squares
M-4	Scott Chasalow	Building Prognostic Models Using High-Dimensional SNP Data
M-5	Russ Wolfinger	Improved Statistical Analysis of Data from Genetics, Microarrays, and Proteomics
M-6	Tom Braun	Determining a Maximum-Tolerated Schedule of a Cytotoxic Agent
M-7	Peter Thall	Some Bayesian Methods for Clinical Trial Design and Analysis
Keynote Address	Carl Peck	Advances in Modeling and Simulation and the Impact on Drug Development and Regulation
T-1	Ken Wilkins	Allowing for Possibly Non-Ignorable Non-Response when Analyzing Longitudinal Outcomes in Clinical Trials: An Alternate Approach
T-2	Daniel O. Scharfstein	A sensitive Analysis Paradigm for Randomized Trials with Missing or Censored Outcome Data
T-3	Robert Goldberg-Alberts	Two Methods for Analyzing Adverse Events
T-4	David Huang	Bayesian Approach for the Design/Analysis of a Study for Handling a Rare Event Concept
T-5	Frank Bretz and Jose Pinheiro	Combining Multiple Comparisons and Modeling Techniques in Dose Response Studies
T-6	Frank Harrell	Statistical Graphics for Exploring Data Presenting Information, and Understanding Statistical Models
T-7	Leonard Oppenheimer	Learning More From Extension Studies
W-1	David Ross	Current Development and Statistical Issues in the Office of Oncology
W-2	Rajeshwari Sridhara	Statistical Challenges in Oncology Drug Development
W-3	Mark Rothmann	On Some Statistical Issues Involving Clinical Trials in Oncology

BASS XI Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Kao-Tai Tsai	Cancer Research: Design, Analysis, and Recent Advances
M-2	Das D. Purkayastha	Topic 1: An Analysis of Expected Survival Differential in a Lung Cancer Trial: An Iterative Procedure with a Censored Regression Model Topic 2: Determination of the Best Linear Unbiased Estimates (BLUES) of Incomplete Data for the Analysis of Repeated Measurements in Clinical Trials
M-3	Qiming Liao	End Point in HIV Clinical Trials
M-4	Qing Liu	Optimizing Late Stage Clinical Development: A Cost-Effective Approach
M-5	V. Devanarayan	Statistical Consideration in Biomarker Method Development and Validation
M-6	Gang Chen, Kevin Liu, George Chi and Yong-Cheng Wang	Topic 1: Margin Selection, Sample Size and Tests in the Design of Non-inferiority Trials Topic 2: Statistical Method for Active Control Non-inferiority Trials with a Time to Event Endpoint
T-1	Michael J. Brown and Robb J. Muirhead	Multiple Primary Endpoints in Clinical Trials
T-2	Keaven Anderson and Kevin Liu	Topic 1: Comparison of Optimized Group Sequential and Adaptive Designs Topic 2: Benefit-Risk Evaluation of Multi-stage Adaptive Designs
T-3	Janet Wittes	Methods for Incorporating Flexibility in Clinical Trials
T-4	William R. Meyers and William A. Brenneman	Using Robust Parameter Design in Industrial Experiments
Keynote Address	Janet Wittes	A Brief for Breaking our Rules
W-1	Charles Anello, H .M. James Hung and Yi Tsong	FDA Session on Drug Development Issues: Critical Path, Clinical Trial Design, and Manufacturing and Quality Control

BASS X Tutorials and Keynote Address presentations:

Session	Speaker	Presentation
M-1	Vern Chinchilli	Unusual Clinical Trial Designs in the Asthma Clinical Research Network
M-2	Karl Peace	Unusual and Interesting Applications from Three Decades of Biostatical Consulting
M-3	John Andersen	Expanding the Sphere of Influence of the Consulting Statistician
M-4	Viswanathan Ramakrishnan	Normal Mixture Models for Gene Cluster Identification in Two Dimensional Microarray Data
M-5	Gordon Lan	A Heuristic Approach to the Analysis of Survival Data
T-1	Qing Liu	Phase II/III Combination Design to Accelerate Drug Development
T-2	Kathy Cronin and Ram Tiwari	New Development in Population Based Survival
T-3	Gary Koch and Catherine Tangen	Nonparametric Analysis of Covariance and Its Role in Non-inferiority Clinical Trials
T-4	Gary Koch	Some Statistical Strategies for Analyzing Confirmatory Studies Involving One or More Occurences of One or More Types of Primary Endpoints
Keynote Address	Nancy Geller	Dilemmas In Monitoring Clinical Trials
W-1	Robert Temple, Robert O'Neill, Susan Ellenberg and Karen Midthun	Joint Special FDA CDER/CBER Session