Contributed Poster Presentations: Biopharmaceutical Section -- JSM 2024

01 A basket trial design accounting for baseline risk across strata

10:30 AM - 11:15 AM

Akari Naito (University Hospital, Kyoto Prefectural University of Medicine)

Co-authors: Kei Fujikawa (intellim Corporation), Go Horiguchi (Kyoto Prefectural University of Medicine), Mitsuko Nakata (Kyoto Prefectural University of Medicine), Satoshi Teramukai (Kyoto Prefectural University of Medicine)

02 A Bayesian Finite Mixture Model Approach for Clustering Mixed-type Variables and Censored Biomarkers

10:30 AM - 11:15 AM

Yueting Wang (University of Pittsburgh)

Co-authors: Shu Wang (FDA), Jonathan Yabes, Chung-Chou Chang (University of Pittsburgh)

03 A Bayesian Semi-mechanistic Dose-finding Design for Phase I Drug Combination Trials in Oncology

10:30 AM - 11:15 AM

Chao Yang

Co-authors: Yisheng Li (University of Texas MD Anderson Cancer Center)

04 A Dependent Dirichlet Process Mixture Model for Borrowing Historical Controls with Survival Outcome

10:30 AM - 11:15 AM

Tomohiro Ohigashi

Co-authors: Kazushi Maruo (University of Tsukuba), Takashi Sozu (Tokyo University of Science), Masahiko Gosho (University of Tsukuba)

05 A Pseudo Observations Approach for Identifying Optimal Cutpoints in Predictive Biomarkers

10:30 AM - 11:15 AM

Di Ran

Co-authors: Gina D'Angelo (AstraZeneca), Sarwar Mozumder (AstraZeneca), Darren Scott (AstraZeneca)

06 A Semi-Competing Risks Frailty Framework for Jointly Modeling Survival and Hospitalization Outcomes

10:30 AM - 11:15 AM

Huihua Li (Pfizer)

Co-authors: Chang Xu (University of Michigan), Haitao Chu (Pfizer)

07 A Tutorial in Gaining Power in RCTs Using Prognostic Covariate Adjustment for Linear Models

10:30 AM - 11:15 AM

Emilie Højbjerre-Frandsen (Novonordisk)

Co-authors: Rasmus Waagepetersen (Aalborg University), Claus Dethlefsen (Novo Nordisk and Aalborg University)

08 Algorithmic Process Optimization in Pharmaceutical Development

10:30 AM - 11:15 AM

Yuting Xu (Merck Sharp & Dohme)

Co-authors: Kevin Stone (Merck & Co.)

09 Analysis of Time-to-Event (TTE) Endpoints When Time Starts Mid-trial

10:30 AM - 11:15 AM

Kevin Gleason (AbbVie)

Co-authors: Sandra Lovell (AbbVie)

10 Bayesian Method of Borrowing Study-Level Historical Longitudinal Control Data for Mixed-effects Models with Repeated Measures

10:30 AM - 11:15 AM

Hong Li

11 Bayesian solutions for assessing differential effects in biomarker positive and negative subgroups

10:30 AM - 11:15 AM

Fanni Zhang

Co-authors: Dan Jackson (AstraZeneca), Carl-Fredrik Burman (AstraZeneca R&D), Linda Sharples (London School of Hygiene and Tropical Medicine)

12 Borrowing-by-part Multisource Exchangeability Models for the dynamic and parameter-specific information borrowing of Gaussian endpoint from external controls

10:30 AM - 11:15 AM

Kai Wang

Co-authors: Han Cao (Department of Biostatistics, Peking University First Hospital), Chen Yao (Peking University Clinical Research Institute)

13 Cautionary note on regional consistency evaluation in MRCTs with binary outcomes

10:30 AM - 11:15 AM

Gosuke Homma

14 Choosing Functional Forms For Treatment In Marginal Structural Models: A Simulation Study

10:30 AM - 11:15 AM

Bret Zeldow

Co-authors: Craig Parzynski

16 Data Monitoring Committee (DMC) Industry Utilization Trends

10:30 AM - 11:15 AM

Joy Hsu (Cytel)

Co-authors: Ying Gao (Axio, a Cytel company)

17 Deep learning-based ranking method for subgroup and predictive biomarkers identification

10:30 AM - 11:15 AM

Zihuan Liu

18 Discussion on delayed treatment effect in non-oncology studies

10:30 AM - 11:15 AM

sheldon wang

19 Dose-finding Design and Analysis Using MCP-Mod

10:30 AM - 11:15 AM

Angela Aijun Gao (Alexion, Astrazeneca Rare Disease)

Co-authors: Shiling Ruan (Karuna Therapeutics), Sheetal Solanki (Cytel), Qun Lin (Alexion, AZ)

20 Duo Criterion Dose Finding Design Accounting for Dose Limiting Toxicity and Tolerability

10:30 AM - 11:15 AM

Yunlong Yang (MDACC)

21 Effect Modification by Acute Change in a Biomarker

10:30 AM - 11:15 AM

Ransmond Berchie (University of Utah)

Co-authors: Tom Greene (University of Utah), Hiddo Lambers Heerspink (Groningen University), Lesley Inker (Tufts University)

22 Evaluating the validity of standard sample size formulas for small cluster randomized trials

10:30 AM - 11:15 AM

Zhuoran Hou (Duke University School of Medicine Dept. of Biostatistics & Bioinformation)

Co-authors: Xueqi Wang (Yale School of Medicine), David Arthur (Duke University), Shifeng Sun (Duke University School of Medicine), Alyssa Platt (Duke University School of Medicine), Elizabeth L Turner (Duke University)

23 Exact Confidence Interval of Observed Proportion with Weighted Strata and its Application

10:30 AM - 11:15 AM

Ruji Yao (Merck & Co., Inc.)

Co-authors: Amarjot Kaur (Merck & Co., Inc.), Qing Li (Merck & Co., Inc.)

24 Incorporating Participants' Welfare into Sequential Multiple Assignment Randomized Trials

10:30 AM - 11:15 AM

Xinru Wang

Co-authors: Nina Deliu (MEMOTEF Department, Sapienza University of Rome, Rome, Italy), Yusuke Narita (Department of Economics and Cowles Foundation, Yale University), Bibhas Chakraborty (Duke-NUS Medical School, National University of Singapore)

25 Information-Based Group Sequential Design for Post-Market Safety Monitoring of Medical Products

10:30 AM - 11:15 AM

Carrie Nielson (Gilead Sciences)

Co-authors: Zhiwei Zhang (Gilead Sciences), Ching-Yi Chuo, Zhishen Ye

26 Meta-analysis Application on Concentration–QTc Modelling for Moxifloxacin in Assay Sensitivity

10:30 AM - 11:15 AM

Dalong Huang (FDA/CDER)

Co-authors: Xutong Zhao (FDA), Jing Sun

27 Methods to Analyze Shedding Data in Vaccine Studies

10:30 AM - 11:15 AM

Kenneth Liu

Co-authors: Ziqiang Chen (Merck)