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
“TBD”, 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

“TBD”, POSIT

Thursday

Banquet Speaker

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

Tentative Program

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

TBD

POSIT

TBD

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: Statistical Applications in Pharmaceutical Manufacturing: Stability and QC and Commercial (Chairs: Richard Li, Lilly)

Heshan

AbbVie

TBD

Sam Gardner

Lilly

TBD

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

TBD

Kaysen Lu

Merck

Actigraphy-Based Assessment of Daily Rest-Activity RhythmsActigraphy-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 and Hongwei Wang, AbbVie)

Miles Xi

AbbVie

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

Lingsong Zhang

Purdue University

TBD

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

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

TBD

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

TBD

FDA

FDA Review Experience with R Pilots

TBD

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

Mai Duong

AbbVie

Generating Interactive Drug Clinical Reports Using Large Language Models and Quarto

DJ Penix*, John LaBore

Pinnacle Solution

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

TBD

FDA

CVARS - An E2E Drug Safety Analytics Approach Using Open Source

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

TBD

Yanzhu Lin

Lilly

TBD

Epidemiology: Safety and Epidemiology (Chairs: Simone Pinheiro, AbbVie )

Simone Pinheiro

AbbVie

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

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

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

Yong Chen

U 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

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

Whitney Su

Duke University

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

TBD

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

Ann Marie Weideman

Lilly

TBD

Hongwei Wang

AbbVie

TBD

Sarah Striker

Lilly

TBD