2026 Midwest Biopharmaceutical Statistics Workshop

Shaping the Future of Medicine Through Data and AI

Wednesday

Plenary Speakers

“Communication, Collaboration, and Critical Thinking – The Keys to Unlocking Opportunities for Statisticians in Drug Development”, Dr. Kati Ramseyer, Head of Global Brand Development-Incretin NILEX, Eli Lilly and Company
“Opportunities and Challenges with AI in Regulatory Environments“, Dr. Paul Schuette, Deputy Division Director, Division of Analytics and Informatics, FDA

Short Course

½ Day

“Practical Large Language Models (LLMs): Foundations and Applications“, Drs. Jiang Bian, Xing He, Haining Wang, Indiana University

“RStudio & Positron Hands-on Workshop: Advancements in AI for Statistical Programming“, Phil Bowsher, POSIT

Thursday

Banquet Speaker

Dr. Yuan Luo, Northwestern University, “EPIC Multi-Modal AI for Drug Discovery”

Program at-a-glance

Short Courses (Maintained if at least 10 participants)

DAY 1 AM - Wednesday

Jiang Bian, Xing He, Haining Wang

Indiana University

Practical Large Language Models (LLMs): Foundations and Applications

Phil Bowsher

POSIT

RStudio & Positron Hands-on Workshop: Advancements in AI for Statistical Programming

DAY 2 AM - Thursday

Clinical 1: Adaptive Bayesian Methods for Dose Finding and Evidence Borrowing (Chair: Yong Zang, Indiana University)

Saijun Zhao

Indiana University

Longitudinal self-adaptive borrowing

Jeremiah Jones

Lilly

Combination therapy dose finding

Zhen Zhang

Otsuka Pharmaceutical

Adaptive Bayesian methods and recent topic on evidence borrowing

Bruno Larvo

LARVOL

Integrated Framework for Rapid Oncology Clinical Trial Evidence Synthesis

CMC: Process Development & Assay Stability (Chairs: Richard Li, Lilly)

Steven Walfish

Iovance Biotherapeutics

Monitoring Assays: Control Samples, Reference Stability, Assay Stability, Bridging References

Kofi Adragni

Lilly

Assessing Double-Regression Estimations in Arrhenius Modeling for Time-Temperature Matrix Computation of Drug Products

Andrea Biasi Coombs

JMP

Combining Bayesian Optimization and DOE to Define Design Space

Meng John Zhao

Lilly

A Bayesian based Stability Platform Framework for Oligonucleotides

BIOMARKERS/PRE-CLINICAL/DISCOVERY: Analytical frameworks for assessing digital biomarkers in biomedical research (Chair: Carmen D. Tekwe, Indiana University)

Caihong Qin*, Lan Xue, Roger Zoh, Carmel Tekwe

Indiana University

Neural network-based approaches to modeling subject-specific activity distributions from wearable devices”

Marta Karas

Takeda Health

Digital health in drug development

Kaysen Lu

Merck

Actigraphy-Based Assessment of Daily Rest-Activity Rhythms

Roger S. Zoh*, Xiaoxin Yu, Joseph Yang, Carmel D. Tekwe

Indiana University

A neural network-based AFT model with functional covariates subject to measurement error

REAL WORLD EVIDENCE: Real-World Evidence Strategies for Clinical and Regulatory Success (Chair:Zuoyi Zhang, AbbVie)

Miles Xi

AbbVie

Statistical Methods and AI Enabled Analytics in Real World Evidence Supporting FDA Drug Safety Labeling Changes

Lingsong Zhang

Purdue University

Advances on time-to-event prediction using machine learning methods

Xiaochun Li

Indiana University

Digitally Interrupted: A Difference-in-Differences Analysis of a Hospital Cyberattack and Its Impact on Operational Performance

Haitao Chu

Pfizer

Pushing the Boundaries: Innovations in Indirect Treatment Comparisons and Health Technology Assessment

STAT PROGRAMMING/AI: Practical Use of Open-Source Tools and Infusing Statistical Programming and Visual Analytics Using Large Language Models (Chair: Melvin Munsaka, AbbVie)

Phil Bowsher

Posit

Leveraging Large Language Models in the R Studio and Positron Environments to Enhance Statistical Programming Activities

Hye Soo Cho

FDA

FDA Review Experience with R Pilots

Jiang (Jessica) Hu

FDA

CVARS - An E2E Drug Safety Analytics Approach Using Open Source

DJ Penix and John LaBore

Pinnacle Solution

Retrieval-Augmented Generation in Regulated Biopharmaceutical Environments: A Perspective on Knowledge-Grounded AI

DAY 2 PM - Thursday

Clinical 2: Applied Machine Learning for Clinical and Regulatory Decision-Making; (Chair: Maria Kudela, Pfizer)

Hiya Banerjee

Lilly

Clinical endpoint adjudication by AI

Prosenjit Kundu

Pfizer

Comparative Effectiveness of Treatment Regimens in Moderate-to-Severe Atopic Dermatitis: Integrated Analyses Across Heterogeneous Study Designs using Causal Techniques

Tianyu Zhan

AbbVie

A general, flexible, and harmonious deep-learning-assisted framework to construct interpretable functions in regression analysis

Jack Knorr

Lilly

A Pragmatic Statistician's Case Reviews of AI Use in Drug Development

REAL WORLD EVIDENCE: Digital twins, external control, AI (Chair: Haito Chu, Pfizer)

Yong Chen

Univ. of Pennsylvania

XYZ – A Unified Framework Modernizing Drug Development with Real-World Data and AI

Hongwei Wang

AbbVie

Accounting for unobserved confounders via negative control

Saurabh Mukhopadhyay

AbbVie

Adaptive Bayesian Borrowing with Prospective Specification: Ensuring Congruent Integration of Historical Controls

Satrajit Roychoudhury

Pfizer

From Averages to Individuals: Multi-task Learning for Heterogeneous Real-World Data

Biomarker (Chair: Yanzhu Lin, Lilly)

Hong Wang

Sanofi

Interpretable Deep Learning-Based Multi-biomarkers Integration Model for Response Prediction

Yuan Ji

U. of Chicago/Bayesoft Inc.

SIMBA - A Bayesian Decision Framework for the Identification of Optimal Biomarker Subgroups for Cancer Basket Clinical Trial

Miles Xi

AbbVie

A Hybrid Two Stage Workflow Linking Biomarker Evidence to Individualized Treatment Policies

Yanzhu Lin

Lilly

To Pool or Not to Pool: Risks of Ignoring Data Structure in Regularized Biomarker Models

CMC: Medical Device (Chair: Richard Li, Lilly )

Aili Cheng*, Kang Liu, Ke Wang

Pfizer

Navigating Ambiguity, Complexity, and Cross-Functional Needs

Yenny Webb Vargas

Genetech

Enhancing Patient-Centered Care: Bridging Pharma and Medical Device Technologies Through Collaborative Statistical Practices

Craig Bernier

J&J

Sampling Rationale Challenges in Combination Products

Panel Discussion

TBD

DAY 3 AM - Friday

Clinical 3: Innovations in Clinical Trial Methodology: From Digital Health to AI-Enhanced Analysis (Chair: Ran Liao, Lilly)

Liuqing (Jasmine) Yang

AbbVie

Advancing the Analysis of Daily Digital Health Data in Clinical Trials Using Two-Level MMRM and Functional Data Analysis Methods

Ruitao Lin, Tuo Wang

MD Anderson

Decentralized clinical trial

Hui Zhang

Northwestern University

Dealing with Messy Data: Clinical and Biomedical Examples

Tom (Zhiyuan) Chen

Hill Research

Med-ICE: Enhancing Factual Accuracy in Medical AI through Autonomous Multi-Agent Consensus

STAT PROGRAMMING/AI: Practical Use of Open-Source Tools and Infusing Statistical Programming and Visual Analytics Using Large Language Models (Chair: Melvin Munsaka, AbbVie)

Lihui Zhao

Northwestern University

Dynamic Risk Prediction with Deep Neural Network

James Austrow

Cleveland Clinic

4. “A Faster Algorithm for the Finkelstein-Schoenfeld Test and Composite Outcome Measures

Richard Zink

JMP

Recurrence: An Analysis of Adverse Events Whose Time Has Come in the Evaluation of Patient Safety in Clinical Trials

Mai Duong

AbbVie

Generating Interactive Drug Clinical Reports Using Large Language Models and Quarto

BIOMARKERS/PRE-CLINICAL/DISCOVERY (chair: Miles Xi, AbbVie)

Xiaoqing Huang

Indiana University

Change Point Mixed-Effect Model Identifies Early Plasma Proteomic Changes in Alzheimer’s Disease

Yijie Wang

Indiana University

Addressing the Small-n, Large-p Challenge in Sparse Learning

Dongyan Yan

Lilly

Transfer learning from mouse to human using trVAE and scGPT

Keela Dai

Lilly

Accelerating Drug Target Discovery with LLM-Based Multi-Agent Collaboration

Special Virtual/in-person session on EPIDEMIOLOGY: Unresolved Issues and Methodological Challenges in the Analysis of Real-World Evidence (Chair: Simone Pinheiro, AbbVie)

Tianming Gao

AbbVie

In-person: Target Trial Emulation for Real-World Evidence: A Bridge Between Observational Studies and Randomized Trials

Gerd Rippen

IQVIA Germany

Integrating Target Trial Emulation and the Estimand Framework

Hana Lee

FDA

Regulatory Perspectives on Methodological Frameworks for Real-World Evidence

Satrajit Roychoudhury

Lauren Deng

Targeted Learning Approaches for Causal Inference in Real-World Data

Poster (Monday 4:30pm - 5:30pm)

Whitney Su

Duke University

Spline-Based Joint Modeling of PFS and Cumulative Incidence with Interval and Right Censoring

Hongyi (Tom) Liu

University of Michigan

Precision Mapping of Tissue Microenvironments: Spatially-Regularized Deconvolution via Empirical Bayes Total Variation

Carly Middleton

University of Louisville

Critical success factors for study success with correlated primary endpoints

Arkobrato Gupta

Ohio State University

A Statistical Framework for the Integrative Analysis of Spatial TCR-seq and Spatial Transcriptomics Data

Souvik Paul

University of Illinois Chicago

A Bayesian Method for Pattern Discovery in Longitudinal Vaginal Microbiome Data

Asteria Herbert Chilambo

Carnegie Mellon University

Doubly Robust Estimation of Treatment Effects with Missing Outcomes in Longitudinal Studies

Nabasmita Talukdar

Michigan State University

Screening and Validating Drug Efficacy in MCI-to-AD Progression through EHR-Based Analysis

Wen-Hung Wang

Purdue University

Extended Fiducial Inference for Statistical Models with Unknown Noise Distributions

Tong Zhang

University of Illinois at Chicago

Approximate Multi-Source Exchangeability Based Borrowing on Hybrid Control Trials

Quynh Long Khuong

University of Pennsylvania

Fusion Design to Assess Placebo-controlled Effects in Non-Inferiority Trials

Student Session - Career Panel (Co-chairs: Ann Marie Weideman and sarah STriker, Lilly)

Ann Marie Weideman

Lilly

Mocked interviewer

Hongwei Wang

AbbVie

Mocked interviewer

Sarah Striker

Lilly

Mocked interviewer

Maria Kudela

Pfizer

Mocked interviewer

Melvin Munsaka

AbbVie

Mocked interviewer

David Manner

Lilly

Mocked interviewer

TBD