Contributed Papers

Integrating PK/PD and Biomarkers: Enhancing Precision in Clinical Trials

Sun, Aug 3, 2:00 PM - 3:50 PM Room CC-209C Music City Center

Angela ZhuChair

Biopharmaceutical Section

7 Presentations

Adjustment for physical activity in high-frequency biosensor data

2:05 PM - 2:20 PM

Co-authors: Zhenzhong Wang (Eli Lilly and Company), David Matteson (Cornell University), Zhenzhong Wang (Eli Lilly and Company)

biosensor data spline method high frequency adjustment for physical activity

Assessing Statistical Techniques for Comparing Biomarkers with Values Below Detection

2:20 PM - 2:35 PM

Co-authors: Clifford Crafford (St. Jude), Clifford Crafford (St. Jude), Sedigheh Mirzaei (St. Jude Children's Research Hospital), Kevin Krull (Department of Psychology and Biobehavioral Science, St. Jude Children’s Research Hospital), Ebenezer George (University of Memphis), Deo Kumar Srivastava (St. Jude Children's Research Hospital)

Censored data Below the Limit of Detection Biomarkers Lognormal Robustness Interleukin 6

Considerations for Biomarker Development when Optimizing Pharmaceutical Portfolios

2:35 PM - 2:50 PM

Co-authors: Zoran Antonijevic, Zoran Antonijevic

biomarker development optimal decision probability of success differentiation cost and complexity market size

Enhancing Assay Sensitivity in Chronic Pain Clinical Trials Through Placebo Lead-in Design

2:50 PM - 3:05 PM

Co-authors: Yan Dong (Eli Lilly and Company), Yan Dong (Eli Lilly and Company)

Placebo lead-in, enrichment design, signal detection, chronic pain clinical trial

Statistical Considerations in Analysis of Bounded Bioanalytical Data

3:05 PM - 3:20 PM

Co-authors: Jorge Quiroz (Merck Research Laboratories), Jingwei Xiong (Merck Research Laboratories), Jorge Quiroz (Merck Research Laboratories), Heliang Shi (Pfizer), Satrajit Roychoudhury (Pfizer Inc.)

Fiducial-based tolerance interval Fiducial prediction interval Specification Kumaraswamy distribution

Within-subject and between-subject correlations in Nanostring DSP spatial genomics data

3:20 PM - 3:35 PM

Co-authors: Minya Pu, Yuan Sui (Salk Institute for Biological Studies, La Jolla, California, United States), Minya Pu, Tony Hunter (Salk Institute for Biological Studies, La Jolla, California, United States), Charles Berry

Spatial genomics Spatial sequencing Gene expression Pancreatic cancer

Considerations in Clinical Study Design with Gene Expression Endpoints

3:35 PM - 3:50 PM

Co-authors: Kyungin Kim (Sanofi), Kyungin Kim (Sanofi)

Clinical trial design sample size calculation Gene expression Gene signature