2025 Midwest Biopharmaceutical Statistics Workshop
Data and Beyond - A Deeper Dive
Monday
Plenary Speakers
- “Immunobridging Approach for Recent COVID-19 Pre-exposure Prophylaxis (PrEP) EUA Application”, Dr. Wen Zeng, CDER, FDA
- “Innovations in Real World Data and AI in Drug Development”, Dr. Aloka Chakravarty, VP-Clinical Data Insights and Advanced Analytics, Eli Lilly
- “Reshaping the Role of Statisticians in the Era of Evolving AI/ML Approaches in Clinical Trials”, Dr. Abie Ekangaki, Sr. VP & Global Head of Biometrics, Premier Research
Short Course
½ Day
- “Causal inference and AI/ML in pharmaceutical statistics”, Dr. Yixin Fang, AbbVie
- “Hand-on Short Course on Enhancing the DMC Package Using Open Source Software”, Dr. Melvin Munsaka, AbbVie
Tuesday
Banquet Speaker
- Robert Rachford, Founder, Better Biostatistics
“Biostatisticians in an AI-filled world: How to Ensure We Thrive in an Evolving Landscape”
Tentative Program
DAY 1 AM - Monday
Short Courses (Maintained if at least 10 participants)
-
Melvin Munsaka
AbbVie
DAY 2 AM - Tuesday
Clinical 1: Applications of simulation-informed trial design (Chair: Mitch Thomann, Boehringer Ingelheim)
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Mitch Thomann
Boehringer Ingelheim
Evaluation of Outcomes of Bayesian Simulations with Informative Priors
-
Kyle Wathen
Cytel
Harnessing the Power of Combining East with R
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Kristine Meyer
Boehringer Ingelheim
A Simulation Study to Evaluate the Statistical Efficiency of Different Endpoint Strategies for Multi-System Diseases
-
Will Landau
Lilly
Accelerating clinical trial simulation in R with {targets}
CMC: Commercial Process and Quality (Chairs: Richard Li, Lilly, and Jeff Gardner, DataPharm)
-
Kofi Adragni
Lilly
Some perspective on the use of Arrhenius model to predict drug shelf life
-
Areti Manola and Stan Altan
J&J
Adjusting for heterogeneity in nonlinear models with 2 CMC applications
-
Wendy Tseng
JMP
Analyzing Functional Data in a Point-and-Click User Interface
-
Sam Gardner
Lilly
Dissolution method specification risk assessment
AI/ML (Chair: Ena Bromley, Oyanalytika)
-
Raul Cruz
Indiana University
A machine learning early warning system for diarrhoeal disease to combat health threats of climate change in the Asia-Pacific region
-
Haining Wang and Jing Su
Indiana University
LLM thinking fast and slow: knowledge extraction to facilitate phenotyping using drug records in real-world data
-
Phil Bowsher
Posit (RStudio)
AI Assistance for R Session Based Data Exploration & Visualisation
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Tristan Olinger
Oyanalytika
Bringing Order to Clinical Data Chaos with AI
RWE/HTA (Chair: Hongwei Wang, AbbVie)
-
Haitao Chu
Pfizer
A critical assessment of matching-adjusted indirect comparisons in relation to target populations
-
Hongwei Wang
AbbVie
Decentralized Clinical Trials in the Era of Real-World Evidence Generation
-
Denise Yi
Servier
Multi-level Network Meta-Regression with a Survival Outcome and an Application to NSCLC
-
Runjia Li
Lilly
A Doubly Robust Instrumental Variable Approach for Estimating Average Treatment Effects in Time-to-Event Data with Unmeasured Confounding: Application to Real-World Data on ICU Patients with Septic Shock
DAY 2 PM - Tuesday
Clinical 2: Advances in Statistical Methodologies for Dose Finding and Dose Response (Chair: Ran Liao, Lilly)
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Malik Rettiganti
Lilly
Implementing a two-step approach for dose response modeling in early phase clinical trials
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Yong Zang
Indiana University
A Bayesian adaptive dose optimization design incorporating immune response
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Maire Kudela
Pfizer
Dose-Response Analysis from a Quantitative Benefit-Risk Perspective
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Zhen Zhang
Otsuka Pharmaceutical
AI-Driven Endpoint Optimization in Dose-Finding Studies
RWE/HTA (Chair: Hongwei Wang, AbbVie)
-
Zuoyi Zhang
AbbVie
Use on Mortality in Patients with Idiopathic Pulmonary Fibrosis
-
Herbert Pang
Roche
Causal approaches for the design and long-term treatment effect estimations of hybrid randomized clinical trials with longitudinal outcomes
-
Jiangqiong Li
Indiana University
Health disparity in alcohol-associated hepatitis in the post-pandemic era: Real-world evidence from Optum claims and All of Us EMR data
-
Yixin Fang
AbbVie
Sensitivity Analysis in driving real-world evidence from the analysis of real-world data
Programming and Visualization (Chair: Melvin munsaka, Abbvie)
-
Wendy Tseng
JMP
Interrogate Your Data with a Mouse – Using JMP’s point-and-click interface to understand and seek answers of your data
-
Joshua Horstman/Richann Watson
Nested Loop Counsulting/DataRich Consulting
Perfect Patient Profiles in SAS® using ODS Statistical Graphics
-
John Labore
SAS
Tapping the Power of SAS PRX Functions
-
Melvin Munsaka
AbbVie
Open-Source Software in the Analysis and Reporting of Clinical Trials Data - A Focus on Meta-Analysis.
CMC: Advanced Nonlinear Modeling (Chairs: Richard Li, Lilly, and Jeff Gardner, DataPharm)
-
Jeff Gardner
DataPharm
What Exactly Is 'Stability-Indicating'? Analytical vs. Statistical Perspectives
-
Aotian Yang
Genentech
Analysis of Residual Moisture During Pharmaceutical PPQ
-
Steven Walfish
Iovance
Guard Bands: Protecting You Against Measurement Uncertainty
-
Alson Look
Regeneron
The current role of acceptance sampling in pharmaceutical manufacturing
DAY 3 AM - Wednesday
Clinical 3: Borrowing control information from historical studies in clinical trials (Chair: Indrajit Ghosh, Lilly)
-
Kristine Broglio
AstraZeneca
Precision and bias of common methods for augmenting control arms in clinical trials
-
Lily Haine
Lilly
Could borrowing in interim futility analyses allow us a more efficient trial design without inflating type 1 error?
-
Leon Shi
Pfizer
Optimizing External Data Borrowing in Clinical Trials: A Bayesian Perspective with Weight Constraints
-
Panel Discussion
TBD
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RWE/HTA (Chair: Hongwei Wang, AbbVie)
-
Iris (Yiwen) Lu
University of Pennsylvania
Debiased Trial Emulation: Negative Control Outcomes guided Causal Machine Learning for Evidence Generation and Drug Discovery using Real-world Data
-
Mingyang Shan
Lilly
Combing open-label extension studies with external controls as an alternative to traditional model extrapolation to estimate long term treatment effects
-
Panel Discussion
TBD
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Pre-Clinical and BioMarker
-
Reuben Retnam
Takeda
Robust Multi-Object Tracking for Home-Cage Behavioral Phenotyping Studies
-
Carrie Li
AbbVie
Additive Gaussian Process Models with Applications in In Vivo Digital Biomarker Studies
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TBD
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Poster (Monday 4:30pm - 5:30pm)
-
Min Lin
University of Connecticut
Propensity-score integrated borrowing-by-parts power prior to leverage external control data for randomized controlled trials in rare diseases
-
Shengyang Li
Purdue University
Decision-Focused Content Selection from Clinical Notes: A model for Dementia Risk Prediction
-
Yining Li
Indiana University Indianapolis
BIT: A Bayesian Optimal Adaptive Clinical Trial Design for Integrated Therapies
-
Zhiqi Zhang
Indiana University School of Medicine
Development of a Polygenic Score for Recovery Time After Concussion: A Concussion Assessment, Research, and Education (CARE) Consortium Study
-
Chengyun Li
Indiana University Indianapolis
Estimation of Heterogeneous Causal Mediation Effects in the Presence of High Dimensional Covariates
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TBD
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Student Session - Career Panel (Co-chairs: Bing Liu and Yanzhu Lin, Lilly)
-
Sarah Striker
Lilly
TBD
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Hongwei Wang
AbbVie
TBD
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