Preliminary Scientific Program 

07:30 – 08:15 AM Registration / Breakfast

08:15 – 12:00 AM Keynote Session 1

Chair: Gajanan Bhat, Chair, 2023 OC Biostatistics Symposium

08:15 – 08:45 AM Welcome and Introduction

8:45 - 9:30 AM Keynote Address 1

Zhenming Shun, Daiichi-Sankyo - Challenges and opportunities in oncology drug development - why we need to be innovative and creative

9:30 - 10:15 AM Keynote Address 2

Siddique Abbasi, Amgen - The Rapid Evolution of Obesity Therapeutics 

10:15 - 10:30 AM Break

10:30 - 11:15 AM Keynote address 3

Harpreet Singh, CDER, FDA - Regulatory perspective of oncology drug development

11:15 – 12:00 Q&A and Discussions

12:00 - 1 PM Lunch

1:00 - 2:45 PM Statistics/Clinical 1

Theme: Adaptive Designs

Chair: Vivian Zhuang, FDA

• Navneet Hakhu, UCI, Adaptive randomization in time-to-event clinical trials

• Li Huang, PHASTAR, Statistical methodology for safety study using real-world data (RWD)

• Vivian Zhuang, FDA, An adaptive design with liquid biopsy data to benchmark a novel statistical method

• Spencer Woody, Amgen, Biomarker-driven response adaptive platform trials

1:00 - 2:45 PM Data Science/Analytics 1

Theme: Focus on Standards and Analytical Tools

Chair: Nicole Lee, Abbvie

• Sunil Gupta, PointCross, Better CDISC standards with metadata programming

• Anthony Chow, CDISC, Improving efficiency and reproducibility of large-scale clinical trials: Introducing the analysis results standards (ARS)

• Bhavin Busa, Clymb Clinical/Brian Ramos, Edwards Lifesciences, TFL designer pilot project-enhancing statistical analysis and reporting in collaboration with Edwards Lifesciences

2:45 - 3:00 PM Break

3:00 - 4:45 PM Statistics/Clinical 2

Theme: Real-World Evidence Based Development

Chair: Kitty Guo, Abbvie

• CG Wang, Regeneron, Leveraging RWD and RWE in clinical trial design and analysis and its causal implications

• Jonathan Kowalski, Lumanity, Real-world Evidence and Drug Development: Implications of the Inflation Reduction Act

• Phil Hall, Roseann White, Edwards Lifesciences, FDA advisory committee meeting-a statistician's survival guide

• Mary Margaret Ryan, UW Madison, Sequential sampling in prospective observational studies

3:00 - 4:45 PM Data Science/Analytics 2

Theme: Modern Analytic Tools and Processes

Chair: Sunil Gupta, PointCross

• Simon Heap, PHASTAR, From numbers to narratives: statistical exploration of clinical data with Qlik

• Min Zhang, Autobahn Therapeutics, Variable selection for integrative analysis of genome-wide association studies

• Jeff Cao, Viitai, Enhancing efficiency and data accuracy through real time collaborations between biostatisticians and statistical programmers in clinical studies

• Tomas Hovorka, Edwards, Empowering statistical analysis: Leveraging ChatGPT for clinical trial data and reporting

Day 1 Evening 5:00 - 7:00 PM Reception

7:30 - 8:15 AM Registration and Breakfast

8:15 - 9:45 AM Keynote Session 2

Chair: Gajanan Bhat, Chair, 2023 OC Biostatistics Symposium

8:15 - 9:00 AM Keynote Address 4

Jaime Wheeler, Edwards Lifesciences, The Best Healthcare is the Kind You Can Afford - Accelerating the Medical Device Product Development Process

9:00 - 9:45 AM Keynote Address 5

Aditya Rajagopal, Chromacode, Thinking Like a Ten-year Old: How Curiosity and Naïve Perspectives Can Enable Significant Breakthroughs

9:45 - 10:00 AM - Poster Award Ceremony

10:00 - 10:15 AM Break

10:15 - 12:00 PM Statistical/Clinical 3

Theme: Medical Device/Diagnostics Development

Chair: Vivian Huang, Edwards Lifesciences

• Charlie Ahn, Edwards Lifesciences, Impact of informative censoring on the Kaplan-Meier estimate

• Yanglu Zhao, Edwards Lifesciences, Interpretation of ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials

• Se Yoon Lee, Edwards Lifesciences, Important statistical issues in Bayesian medical device trials in regulatory settings

• Bruce Ho, Bayezene AI, Investigative Study of Selective Patient Genomic Profile Targeting Unseen Drugs

10:15 - 12:00 PM Academic Research 1

Theme: Advanced Statistical Methods for Biomedical Data

Chair: Weixin Yao, UCR

• Damla Sentuk, UCLA, Multivariate spatiotemporal functional principal component analysis for modeling hospitalization and mortality rates in the dialysis population

• Weining Shen, UCI, A Bayesian approach for selecting relevant historical data to study long-term outcomes

• Weng Kee Wong, UCLA, Nature-inspired meta-heuristic algorithm for generating optimal experimental designs

• Bing Han, Kaiser Permanente, Assessing covariate balance in the finite study population setting

12:00 - 1:00 PM Lunch

1:00 - 2:45 PM Statistics/Clinical 4

Theme: Artificial Intelligence/Machine Learning Related Topics

Chair: Andrew Yan,

• Arsela Prelaj, Istituto Nazionale Tumari, Milan Italy, Explanable survival machine learning analysis for predicting overall survival in NSCLC patients treated with immune checkpoint inhibitors

• Zhaoxia Yu, UCI, Robust Statistical Methods for Clustered Data, with Applications to Single-Cell RNA-seq Data

• Yu Deng, Abbvie, Transformer-based large language models and ChatGPT in adverse drug event detection

• Jie Shen, Abbvie, Unleashing the potential of digital health data through machine learning

1:00 - 2:45 PM Academic Research 2

Theme: Panel Discussions - Opportunities for Graduates, Change in Industry Dynamics

Chair: Olga Korosteleva, CSU Long Beach

• Kim Phan, Edwards

• Larry Shen, WuxiAppTec

• Ha Dang, Johnson and Johnson

• Lindsay Fitzgerald-DeHoog, Hoag Hospital

• Gajanan Bhat, Celyxa, Inc.

2:45 - 3:00 PM Break

3:00 - 4:45 PM Statistics/Clinical 5

Theme: Bayesian and Regression Designs, Sponsored by Jim Press Fund, UCR

Chair: Xinping Cui, UCR

• Frank Shen, BMS, Bayesian approach to dose finding session on generalized toxicity dose escalation: moving beyond binary toxicity

• Ziyi Song, UCI, Hierarchical Shrinkage Partition priors with an Application to Mouse Tracking Data

• Xiao Yu, Edwards, Regression modeling with time dependent covariates in clinical trial

• Michele Guindani, UCLA, Understanding Heterogeneity in Neuroimaging

3:00 - 4:45 PM Data Science/Analytics 3

Theme: Application of Artificial Intelligence and Machine Learning in Biomedical Studies

Chair: Weining Shen, UCI

• Yinfei Kong, CSUF, Statistical inference of heterogeneous treatment effect based on single-index model

• Giorgio Saladino, Bain and Company, Opportunities for the use of generative AI in the healthcare sector

• Louis Ehwerhemuepha, CHOC, Applied Statistical Analyses and Machine Learning in Pediatric Research at CHOC

• Wenzhuo Zhou, UCI, A model-agnostic graph neural network for integrating local and global information

Poster Sessions: 10:00 AM - 4:00 PM