2024 Program
Statistical Excellence in Drug Development
Monday
Plenary Speakers
- James Travis, CDER, FDA
My experiences with Bayesian methods and complex innovative designs as a regulator. - Jean-Pierre Wery, President & CEO, SideWinder Therapeutics
The Critical Role of Modeling in Pre-Clinical and Translational Research
Short Course
½ Day
- Phil Bowsher and Rich Iannone, RStudio
Open-Source Drug Development: ADAM, TLGs & Interactivity with R.
- David Kerr and Walter Boyle, Cytel Inc.
A Statistician’s Guide to DMC – Overview, Standards, and Best Practices.
Tuesday
Banquet Speaker
- Scott Clark, PhD
ASA Fellow Retired, Eli Lilly and Company
Reflections and Projections on Statistical Leadership
Tentative Program – Confirmed Speakers
DAY 1 AM - Monday
Short Courses (Maintained if at least 10 participants)
-
David Kerr and Walter Boyle
Cytel Inc
-
Phil Bowsher and Rich Iannone
RStudio
DAY 2 AM - Tuesday
Clinical 1: Modern Design Approaches
-
Brad Carlin
Cencora - Pharmalex
Bayesian Adaptive Dual Objective Phase I-II designs for Personalized Dose-Finding with Combination Therapies
-
Fei Chen
Johnson & Johnson Innovative Medicine
Advancing Pediatric Clinical Trials through Case Studies: Extrapolation, Bayesian Methods and Regulatory Perspectives
-
Zhantao Lin
Eli Lilly and Company
Design considerations for two-stage enrichment clinical trials
-
Giorgio Paulon
Berry Consultants, LLC
ENRICH: A Novel Approach to Clinical Trials in ICH
COMPUTATION & VISUALIZATION
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Phil Bowsher
Healthcare and Life SciencesX at POSIT
Making an Interactive Shiny App with GenAI…Five Ways
-
Matt Becker
SAS Institute
Visualizing Insights, Empowering Discoveries: SAS Viya Unleashed in Biopharmaceutical Analytics
-
Dr. Yingjie Victor Chen
Purdue University
Human Perception for Information Visualization Design
-
Robert Adams
Bayer AG
Topline Results Dashboard with R Markdown & Flexdashboard
AI/ML
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Jacob Gagnon
Biogen
A Large Language Model (LLM)-powered Workflow Applied to Pharmaceutical Informed Consent
-
Sydeaka Watson
Eli Lilly and Company
Navigating the Landscape: A Framework for Evaluating Large Language Models (LLMs) in Biostatistics
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Jim Box
SAS
Exploring Bias in AI and Machine Learning
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Michael Man
Eli Lilly and Company
Leverage AI to build end-to-end workflow for research, analysis, and reporting
HTA statistics, Benefit-Risk, HEOR
-
Saurabh Mukhopadhyay
AbbVie
Novel yet Practical Bayesian Quantification of Benefit-Risk Balance of Medical Products
-
Richard Payne
Eli Lilly
Bayesian Benefit Risk Analysis Using the brisk R Package
-
Hongwei Wang
AbbVie
Recent Developments and Innovations in Health Technology Assessment
DAY 2 PM - Tuesday
Clinical 2: Meta-analyses and indirect treatment comparisons
-
Wenshan Han
Florida State University
Tipping point analyses for the between-group correlation in an arm-based evidence synthesis
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Tim Hanson
Medtronic
Alternatives to Normal-Normal Meta Analysis
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Jennifer Proper
Eli Lilly and Company
Advances in Meta-analysis
-
Haitao Chu
Pfizer Inc.
A comprehensive review and shiny application on the matching-adjusted indirect comparison
RWE
-
Gene Olinger
Oya
Revolutionizing Infectious Disease Management through Real World Evidence
-
Pengyue Zhang
Indiana University
Real-world evidence for pharmacovigilance and drug repurposing
-
Mingyang Shan
Eli Lilly and Company
Sensitivity analysis for evaluating treatment effects from real world data
-
Adam Luo
Abbvie
Historical data borrowing for predictive biomarker identification
BIOMARKERS & PRECLINICAL
-
Dongyan Yan
Eli Lilly and Company
Bayesian-frequentist hybrid inference framework for single cell RNA-seq analyses
-
Dr. Haixu Tang
Indiana University
Molecular Representation Learning for Biological Metrology
-
James Meeney
Cencora – Pharmalex
Leveraging Generative AI Technology for Accelerated Analysis of Scientific Publications in Pre-clinical Medical Research
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Adam Luo
Abbvie
Historical data borrowing for predictive biomarker identification
-
Guoqiao Wang
WASHU
Amyloid Reduction as a Surrogate Biomarker in Alzheimer's Disease Clinical Trials: Exploring the Path Forward Following FDA Guidelines
CMC
-
Richard Montes
Alnylam Pharmaceuticals
Frequentist and Bayesian tolerance intervals for setting specification limits for left-censored gamma distributed drug quality attributes
-
José Núñez Ares
EFFEX
OMARS designs, bridging the gap between screening and optimization experimental designs
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Bruno Boulanger
Cencora – Pharmalex
Reliably Assessing Comparability in Autologous Cell Therapy Change Protocols: A Compliance Perspective
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Jeff Gardner
DataPharm
An Overview of Statistical Approaches for Classifying Product Quality Attributes as "Stability-Indicating"
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Tim Kramer
Eli Lilly and Company
Low Correlation Designs for Demonstrating Proven Acceptable Ranges and Informing Design Spaces
DAY 3 AM - Wednesday (3 hour session)
Clinical 3: Advanced questions
-
Jing Su
Indiana University School of Medicine
Causal Inference in treatment effect estimation using longitudinal real-world data for precision medicine.
-
Yixin Fang
AbbVie
Two basic strategies of conducting causal inference in real-world studies
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Eric Laber
Duke University
Optimal treatment regimes for behavioral interventions using multiple surrogate outcomes
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Yu-Hsiang Shu, Hsin-Yu Hsu, Yu-Chen Su
Inari Medical
Power Performance for Testing a Composite Outcome with Correlated Endpoints using the Finkelstein-Schoenfeld Test
Computation & Visualization 2
-
John LaBore, Josh Horstman
SAS Institute, Nested Loop Consulting
Going from SAS v9 Programming to SAS Viya Programming: What's the Same, What's Different
-
Richard Vinisko
Boehringer Ingelheim United States
R-shiny application for visualizing cough count data collected from a wearable device
-
Melodie Rush
SAS Institute
Why Do I Have Missing Data and How Do I Fix it?
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Melvin Munsaka
AbbVie
Leveraging Visual Analytics in Drug Safety and Benefit-Risk in Multi-Regional Clinical Trials
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
-
Yi Shi
IUPUI
Early and Precise Detection of Adverse Drug Events from Real-world Data
