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, Clinical Data Insights and Advanced Analytics, Eli Lilly

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)

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
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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
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TBD
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COMPUTATION & VISUALIZATION

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TBD
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AI/ML (Chair: Ena Bromley)

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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
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Haining Wang and Jing Su
Indiana University
LLM thinking fast and slow: knowledge extraction to facilitate phenotyping using drug records in real-world data
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TBD
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RWE/HTA (Chair: Hongwei Wang, AbbVie)

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Haitao Chu
Pfizer
A critical assessment of matching-adjusted indirect comparisons in relation to target populations
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Mingyang Shan
Lilly
Combining open-label extension studies with external controls as an alternative to traditional model extrapolation to estimate long term treatment effects
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Lingsong Zhang
Purdue
Scale-Space Inference of Causal Effects Based on Propensity Scores

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
TBD
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Yong Zang
Indiana University
TBD
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Zhen Zhang
Otsuka Pharmaceutical
TBD
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Roger Zoh
Indiana University
A Bayes factor function for high dimensional MANOVA using random projections with application to gene set testing

RWE/HTA (Chair: Hongwei Wang, AbbVie)

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Zuoyi Zhang
AbbVie
Use on Mortality in Patients with Idiopathic Pulmonary Fibrosis
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Herbert Pan
Roche
Causal approaches for the design and long-term treatment effect estimations of hybrid randomized clinical trials with longitudinal outcomes
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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
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Hongwei Wang
Abbvie
TBD

BIOMARKERS & PRECLINICAL

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CMC

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Jeff Gardner
DataPharm
What Exactly Is 'Stability-Indicating'? Analytical vs. Statistical Perspectives
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Aotian Yang
Genentech
Analysis of Residual Moisture During Pharmaceutical PPQ
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TBD
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Clinical 3: Borrowing control information from historical studies in clinical trials (Chair: Indrajit Ghosh, Lilly)

DAY 3 AM - Wednesday

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Kristine Broglio
AstraZeneca
Precision and bias of common methods for augmenting control arms in clinical trials
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Lily Haine
Lilly
Could borrowing in interim futility analyses allow us a more efficient trial design without inflating type 1 error?
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Leon Shi
Pfizer
Optimizing External Data Borrowing in Clinical Trials: A Bayesian Perspective with Weight Constraints
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TBD
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RWE/HTA

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Iris (Yiwen) Lu
University of Pennsylvania
TBD
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Helen Li
Lilly
TBD
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Denise Yi
Servier
Indirect treatment comparison (Title TBD)
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TBD
TBD
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2024 Poster

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Yunyi Li
Indiana University
Deep Learning of Sparse Irregularly Observed Multivariate Longitudinal Data
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Jason Mao
Indiana University
Variable selection in a regularized multi-state model for health status transitions using electronic health records data
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Apu Chandra Das
University of Nebraska Medical Center
Identifying Predictive Combinations of Biomarkers for Early Cancer Detection with Stability Selection in Combination with Ensemble Learning
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Minmin Pan
Indiana University
Identifying Genetic Variants for Alzheimer’s Disease and Comorbid Conditions
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Yi Shi
IUPUI
Early and Precise Detection of Adverse Drug Events from Real-world Data

Student Session - Career Panel (Co-chairs: Bing Liu and Yazhu Lin, Lilly)

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Sarah Striker
Lilly
TBD
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