CONFERENCE INFORMATION

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Dear Colleagues,

We are pleased to announce the opening of the Call for Abstracts for oral presentations for the 12th Statistics Workshop, entitled “From Data to Patients – CMC Statisticians’ Contributions to Quality, Safety, and Efficacy of Pharmaceutical Products.”

This in-person meeting will take place in Rockville, Maryland, USA, on October 20–22, 2026.


SAVE THE DATE

Every analysis, model, and decision in Chemistry, Manufacturing, and Controls (CMC) ultimately serves one goal—improving patient outcomes. CMC statisticians play a central role in this mission, ensuring that pharmaceutical products meet the highest standards of quality, safety, and efficacy.

Like chefs transforming ingredients into a finished dish, statisticians transform data—using their expertise in methodology and software—into insights that support sound scientific and regulatory decision-making. In a highly regulated environment, this work is rigorously evaluated by global health authorities, reinforcing the importance of analytical rigor, transparency, and clear communication. As Dr. Ji-Hyun Lee, former ASA President, noted, behind every data point is a patient’s story, reminding us of the direct connection between statistical excellence and patient well-being.

This workshop embraces the “big tent” vision of statistics, highlighting how diverse statistical approaches across the CMC lifecycle contribute to better science and better outcomes for patients.

CONFERENCE THEMES

The scientific program will focus on four core areas:

  • Data
    The early and strategic role statisticians can play in shaping data systems, improving data quality, and managing and leveraging increasingly complex CMC datasets.
  • Software
    The importance of reliable statistical software—both point-and-click and code-based—and their appropriate use in producing sound analyses within a regulated environment.
  • Methodologies
    Advances and best practices in statistical methodology within CMC, including:
    • The fundamental role of frequentist statistics in CMC decision-making
    • The growing influence of Bayesian methods for uncertainty quantification, inference, and modeling
    • The potential of artificial intelligence and machine learning for predictive modeling and process optimization
  • Regulatory Review
    Perspectives from global health authorities on key statistical considerations in regulatory submissions and interactions.

DEADLINE

The Call for Abstracts is now closed.

LOGISTIC DETAILS

Please address your abstract to secretariat@iabs.org 

Submit an abstract (in English) not more than 300 words (excluding title, authors, and affiliation), indicating which core area you would like to be considered for.

Valid format :

  • PDF
  • Word

Should you require any further information or support, please feel free to reach out to secretariat@iabs.org


Looking forward to receiving your proposals.


The Organizing Committee

 

To read the scientific committee member's biosketch, click on their name.

Timo Bailer
Timo Bailer
Boerhinger Ingelheim
Fang Chen
Fang Chen
SAS
Catherine Cheng
Catherine Cheng
Novartis
Irina Gershgorin
Irina Gershgorin
Biotech Legend
Ashley Giambrone
Ashley Giambrone
Regeneron
Jennifer Kirk
Jennifer Kirk
FDA/CBER
Ruojia Li
Ruojia Li
BMS
Jia Liu
Jia Liu
Pfizer
Brooke Marshall
Brooke Marshall
Eli Lilly & Co.
Oluyemi Oyeniran
Oluyemi Oyeniran
Johnson & Johnson Innovative Medicine
Laura Pack
Laura Pack
Moderna Inc.
Jose Ramirez
Jose Ramirez
Kite Pharma
Christopher Thompson
Christopher Thompson
AstraZeneca
Jie Zhao
Jie Zhao
Merck

To read the speaker's biosketch, click on their name.

Stan Altan
Stan Altan
JJIM
Rick Burdick
Rick Burdick
Adsurgo Consulting
Sara Cook
Sara Cook
IliaCook Statistical Consulting, LLC.
Max Kuhn
Max Kuhn
Posit
Ji-Hyun Li
Ji-Hyun Li
University of Florida
Brenda Ramirez
Brenda Ramirez
Kite Pharma

Abstracts are uploaded upon receipt.

Day 1 – Tuesday, October 20

Keynote: More Than Numbers: How Everyday Statisticians Shape Science
Prof. Ji-Hyun Lee, University of Florida
Abstract

 

Transforming Clinical Research with Generative AI in SAS Viya
Pankaj Attri
Abstract

Day 2 – Wednesday, October 21

The fundamental role of frequentist statistics in CMC decision making
Rick Burdick, Burdick Statistical Consulting, LLC
Abstract

Day 3 – Thursday, October 22

Workshop 2 by R: AI Tooling for Data Analysis
Max Kuhn, Posit
Abstract

Access to meeting’s slides is given to meeting’s participants for a period of 4 weeks after the meeting.
Login and password are sent by email to participants right after the meeting.
Afterwards the slides are only accessible to IABS members, using their Member Login and Password.

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