2019 Midwest Biopharmaceutical Statistics Workshop

We are pleased to announce that the 2019 MBSW will be held from May 20-22, 2019, at Renaissance Indianapolis North Hotel, 11925 N. Meridian St., Carmel, IN 46032.

Book your group rate for Midwest Biopharmaceutical Statistics Workshop

The theme of this year’s workshop is Statistics: Making an Impact.

Special Plenary Speaker: Dr. Aloka Chakravarty, Director, Office of Biostatistics, CDER FDA

Special Plenary Speaker: Dr. Stephen Ruberg, Distinguished Statistical Scientist, Analytix Thinking, LLC

Registration will be open in mid-February (fees go up after May 1, 2019). Stay tuned for program update. We look forward to seeing you in Indianapolis!

2019 Short Courses

1. An Introduction to Biomarkers for Statisticians – A Brief Guide to Utilizing the Most Appropriate Analytical Tools


  • Ena Bromley, BioStat Solutions, Inc.
  • Lin Li, BioStat Solutions, Inc.


The development in molecular biology and translation research has led us into the era of precision medicine.? Biomarkers are playing an increasingly important role in clinical research and drug development.? You may have heard some of these terms – APOE-ε4, PAM50, PD-L1, CD4, or HDL – all of these are biomarkers.? Then, what are biomarkers?? Why do they matter?? Which analytical tools are most appropriate in the design, analysis, and interpretation of biomarker data?

In this short course, biostatisticians and data scientists will be introduced to several common types of biomarkers, such as DNA, RNA, and proteins.? Topics that will be covered include familiarization with basic terminology, definitions, data structure, and statistical considerations around data quality control.? Attendees will also be introduced to predictive biomarkers, prognostic biomarkers, and pharmacodynamic biomarkers among others through illustration and visualization.? Typical biomarker analyses will be demonstrated through applications of commonly used statistical tools and methods.

Audience: Statisticians, data scientists

Required: Basic understanding of biology and statistics

2. Accelerating Drug Discovery Through Precision Medicine and Innovative Designs – Concepts, Rationales, and Case Studies


  • Sandeep Menon, Pfizer Inc. / Boston University / Tuffs University School of Medicine
  • Weidong Zhang, Pfizer Inc.


Precision medicine has paved the way for a new era of delivering tailored treatment options to patients according to their biological profiles. Advancement of the biotechnologies such as next generation sequencing (NGS) technology and other omics technologies have enabled us to interrogate a patient?s many molecular biomarkers and associate them with disease and drug responses.? In addition, incorporation of biomarker information in the innovative clinical trial design has presented drug developers unprecedented opportunities to bring successful drugs to patients in need.

The first part of this course will focus on the concepts of precision medicine, biomarker discovery, and their applications in clinical trials.? Comprehensive review of omics data and major technologies will be presented.? Statistical considerations and challenges, such as data normalization, dimension reduction, biomarker threshold development, and using biomarkers for decision making in clinical development, will be discussed in detail.

The second part of this course will focus on the strategy of the study design that is important to assessment of biomarker performance and reliability and will eventually lead to regulatory acceptance.? A general overview of the concept and statistical methodologies and designs related to precision medicine will be presented.? Specifically, we will discuss various designs including adaptive designs available at our disposal and its merits and limitations.

Audience: Statisticians, data scientists

Required: Basic understanding of biology, drug development , and/or clinical trials.

2017 Plenary Speakers Announced

We proudly to present two Plenary Speakers on Monday, May 22:

1. “Open Access and Data Sharing: Where are we on the Clinical Data Disclosure and Transparency Journey?” —Frank Rockhold, Duke University

2. “Biostatisticians and 21st Century Drug Development: Staying Relevant and Looking Forward” —Steve Wilson, FDA

2016 Midwest Biopharmaceutical Statistics Workshop

The 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW)


2016 Draft Program

Founders and Chairmen Emeritus: Charles B Sampson, Eli Lilly (retired), and Mir Masoom Ali, Ball State University

Workshop Chair: Ray Liu (Takeda)

Theme: The power and 3 I’s of Statistics : Innovation, Integrity and Impact

1st Plenary: Challenge. Change. Engage: Three Secret Formulae for Driving an Impactful Innovation (Dr. Frank Shen, Abbvie)

2nd Plenary: Significance Tests and Confidence Interval Approaches – Where Is the Duality (Dr. Yi Tsong, FDA)

Banquet Speaker: Accelerating Analytics With External Data (Dr. Charles Schick, Atigeo)

Short Course #1: An Introduction to Shiny, R Markdown, and HTML Widgets for R with Application in Drug Development (Phil Bowsher, RStudio)

Short Course #2: Graphical Approaches to Multiple Testing (Dong Xi, Novartis)

Special presentation on Wednesday morning: Leadership of Statisticians and programmers in the Future of Big Data and Computing (Pandu Kulkarni, Lilly)

Registration is Open!