Poster Session II -- RISW 2025

01: Advancing Biopharmaceutical Research & Decision Making with Synthetic Survival Data

9:45 AM - 10:30 AM

Co-authors: Julia Brischtel (Boehringer Ingelheim Pharma GmbH & Co. KG), Dea Maulidya (Boehringer Ingelheim)

genAI synthetic survival data synthetic patients survival analysis clinical developement machine learning

02: Application of Causal Machine Learning to Enrichment Clinical Trials

9:45 AM - 10:30 AM

Co-authors: Sijie Yao (Moffitt Cancer Center), Jun Yin (Moffitt Cancer Center), Biwei Cao (H Lee Moffitt.Cancer Center and Research Institute), Xuefeng Wang

causal machine learning enrichment designs clinical trials

03: Leveraging Deep-learning for Efficient Estimation in Accelerated Aging Models: Implications for Drug Development and Patient Outcomes

9:45 AM - 10:30 AM

Co-authors: Emmanuel DJEGOU (Missouri S&T), Akim Adekpedjou (Missouri S&T)

Accelerated Life Models Deep Learning Recurrent Event Analysis Effective Age Processes Censoring Drug Development

04: Sentiment Analysis of Tweets Using Machine Learning and Deep Learning Methods

9:45 AM - 10:30 AM

Co-authors: Shuo Xu (University of California San Diego), Shuo Xu (University of California San Diego), Zhongyan Wang (New York University), Yuchen Cao (Northeastern University)

Machine Learning Deep Learning Sentiment Analysis Emotions

05: ADVANCING SPATIO-TEMPORAL MODELING: A HIERARCHICAL GAUSSIAN APPROACH USING THE PROJECTION-BASED INTRINSIC CONDITIONAL AUTO-REGRESSION (PICAR)

9:45 AM - 10:30 AM

Co-authors: Kyei Afari (University of Nebraska Medical Centre), Yeongjin Gwon (University of Nebraska Medical Center)

Spatio-temporal modeling, Hierarchical Gaussian models Projection based Intrinsic Conditional Auto-regression (PICAR)PM2.5 concentrations, Drought conditions, Groundwater storage Eigenvectors, Moran’s operator, Singular Value Decomposition B-splines, Kronecker product, Markov Chain Monte Carlo

06: Informative Missingness: A Strategy for Proper Handling of Data Missingness in Longitudinal Models of Repeated Measures

9:45 AM - 10:30 AM

Co-authors: Thomas Jensen (Berry Consultants)

joint model informative censoring longitudinal modeling survival analysis missing not at random

07: A Bayesian Likely Responder Approach for the Analysis of Randomized Controlled Trials

9:45 AM - 10:30 AM

Co-authors: Annan Deng (New York University School of Medicine)

Causal inference Precision medicine Treatment effect heterogeneity Data-driven subgroup analysis

08: Enhanced Simulated Treatment Comparison Through Direct Marginalization

9:45 AM - 10:30 AM

Co-authors: Zilin Wang (University of Arizona), Lifeng Lin, Haitao Chu (Pfizer)

Indirect treatment comparison marginal treatment effect simulated treatment comparison

10: Advances in Centralized Statistical Monitoring: Scientific and Business Perspectives

9:45 AM - 10:30 AM

Co-authors: Zhongkai Wang (Gilead Sciences), Rakhi Kilaru (PPD™ clinical research business of Thermo Fisher Scientific), Susan Talbot (Amgen)

Quality Tolerance Limits Centralized Statistical Monitoring Quality by Design Central Monitoring Risk based quality management Critical to Quality Factors

11: Establish a Regulatory Compliant R Environment (CRE)

9:45 AM - 10:30 AM

Co-authors: Tailiang Xie (CIMS Global), Peng Zhang (CIMS Global)

R for clinical trials Open-sourced approach Regulatory Compliant R Environment (CRE)

12: A Bayesian Quasi-likelihood Design for Identifying the Minimum Effective Dose and Maximum Utility Dose in Dose-ranging Studies

9:45 AM - 10:30 AM

Co-authors: Feng Tian (Bristol Myers Squibb), Ying Yuan (The University of Texas MD Anderson Cancer Center), Ruitao Lin (University of Texas, MD Anderson Cancer Center)

Bayesian adaptive design Dose finding,Risk-benefit tradeoff Phase 2 trials Minimum effective dose Maximum utility dose

13: A Generalized Phase I/II Dose Optimization Trial Design with Multi-categorical and Multi-graded Outcomes

9:45 AM - 10:30 AM

Co-authors: Tianyu Guan (Brock University), Richard Yan (Simon Fraser University), Haolun Shi (Simon Fraser University), Ruitao Lin (University of Texas, MD Anderson Cancer Center), Xiaolei Lin (Fudan University)

Phase I/II trials dose optimization optimal biological dose Bayesian quasi-likelihood multi-grade outcomes utility

14: A Novel Statistical Model for Adaptive Phase II Clinical Trial Design

9:45 AM - 10:30 AM

Co-authors: Lujun Zhang (University of Minnesota), Steffen Ventz (University of Minnesota)

Phase II Trial Adaptive Enrichment Design Hierarchical Bayesian Model

15: Exploring the effect of the number of concurrent treatments on operating characteristics in platform trials

9:45 AM - 10:30 AM

Co-authors: Kaustubh Nimkar, Byron Gajewski (University of Kansas Medical Center), Kert Viele (Berry Consultants)

Patient oriented Simulation study Clinical trial design Time trends Response adaptive randomization

16: PKBOIN-12: Integrating Pharmacokinetics into Bayesian Dose-Finding for Oncology Drug Development

9:45 AM - 10:30 AM

Co-authors: Hao Sun (Bristol Myers Squibb), Jieqi Tu

Bayesian optimal interval design model-assisted dose-finding design optimal biological dose pharmacokinetics risk-benefit trade-off

17: Regional Consistency Evaluation and Sample Size Calculation under Two MRCTs

9:45 AM - 10:30 AM

Co-authors: Kunhai Qing (School of Statistics, East China Normal University), Ping Yang (The Chinese University of Hong Kong), Xinru Ren (School of Statistics, East China Normal University), Shuping Jiang (BARDS, MSD China), Menggang Yu (University of Michigan), Jin Xu (East China Normal University)

consistency assessment MRCT sample size calculation

18: ROSE: Randomized Optimal Selection Design for Dose Optimization

9:45 AM - 10:30 AM

Co-authors: Shuqi Wang (The University of Texas MD Anderson Cancer Center), Ying Yuan (The University of Texas MD Anderson Cancer Center), Suyu Liu (UT MD Anderson Cancer Center)

Dose optimization Optimal design Randomization Selection design

19: Simulation-driven Clinical Scores

9:45 AM - 10:30 AM

Co-authors: Matteo Vestrucci (Berry Consultants)

Simulations UMSARS Rating scale Power

20: Ensure the statistical validity in the context of open-source and Large Language Model (LLM)

9:45 AM - 10:30 AM

Co-authors: Tailiang Xie (CIMS Global), Peng Zhang (CIMS Global)

R Open-source LLM statistical validity Shiny Quarto

21: Simulating the Impact of Localized Intervention Strategies on Epidemic Dynamics with Agent-Based Modeling

9:45 AM - 10:30 AM

Co-authors: Elizabeth Amona (Virginia Commonwealth University), Ryad Ghanam (Virginia Commonwealth University, Doha, Qatar), Edward Boone (Virginia Commonwealth University), Indranil Sahoo (Virginia Commonwealth University)

Agent Based Model Uncertainty Quantification Localized Interventions Analysis Bayesian Statistics Epidemiology

22: Proarrhythmic (Torsade De Pointes (TdP)) Risk Classification of Drugs Using In-Vitro Data

9:45 AM - 10:30 AM

Co-authors: Jing Sun (FDA), Dalong Huang (FDA/CDER), Sheng Yuan

Torsade de Points (TdP)IC50 dose-response Monte Carlo

23: Causal Inference and Adaptive Design for Evaluating Effectiveness of Medical Tests and Devices

9:45 AM - 10:30 AM

Co-authors: Wenxin Zhang (UC Berkeley), Rachael Phillips (University of California, Berkeley), Mark Van Der Laan (UC Berkeley)

medical tests and devices diagnostics causal inference adaptive design

24: Simulation Assessment of "Treatment Failure" Definitions under Composite Strategy for Continuous Endpoints in Clinical Trials

9:45 AM - 10:30 AM

Co-authors: Jingchen Ren, Yanxi Liu, Xin Wang (AbbVie)