2002

BASS IX Tutorials and Keynote Address presentations:

SessionSpeakerPresentation
M-1Gordon LanOverruling of the Sequential Boundary and Sample Size Estimation
M-2Pat Darken and Matt SomervilleExamining Assumptions in the General Linear and Cox Regression Models: A Guide for the Pharmaceutical Industry Statistician
M-3Chen-Sheng Lin and Kalyanee Viraswami-AppannaA Comparison of Multiple Intensity Models with Cox Proportional Models and Annualized-Rate Method for Patients with Multiple Failure Outcomes
M-4Amy Ma and Akiko OkamatoAnalysis of Recurrent Events and Application to Clinical Trials
M-5Doug FariesImprovement in Clinical Trial Designs: Lead-Ins, Blinding and Rating Scales
T-1Christopher Schmid and Joseph CappelleriUsing Meta-Analysis to Explore Differences in Study Effects
T-2Robb Muirhead and Eve PickeringApplication of Multivariate Reference Regions to Clinical Laboratory Data
T-3R. K. ElswickSample Size and Power in the Mixed Model
T-4William DuMouchelDrug Adverse Event Surveillance Using the Multiple-Item Gamma Poisson Shrinker(MGPS)
Keynote AddressSusan EllenbergAssessing Risk: Old and New Challenges for the FDA
W-1Stan LinToward Better Clinical Designs Through Modern Simulation
W-2Rafia Bhore and Mohammad HuqueTime Dependence of Serious Adverse Events in the Assessment of Safety
W-3Raji Sridhara, George Chi and Robert O'NeillEvaluating Surrogate Endpoints Using Sensitivity and Specificity Analyses

11:15 AM

Session I: Gene and Cell Therapy –

Drug Target Discovery for Genetic Disorders Leveraging Multi-Omics Data and Comparability Assessment for Manufacturing Changes in CGT, presented by Dr. Lira Pi, Pharmalex;  

Challenges of Underdosing Control in Dose-Escalation Studies for DNA-Based Gene Therapies, presented by Quang Nguyen, Regenereon