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ViewAttendees 8
Symposium

General Pharmacometrics

C2C - High-impact Applications of Model-based Meta-analyses (MBMA) in Drug Development

Sunday, October 19, 2025
2:00 PM - 3:30 PM MDT
Location: Red Rock 8/9

Disclosure(s):
Matthew L. Zierhut, PhD, MBA: No relevant disclosure to display
Monica Simeoni, PhD: No relevant disclosure to display
Hongtao Yu, PhD: No financial relationships to disclose
Mats O. Karlsson, PhD, FISoP, FACCP: No relevant disclosure to display

Description of session (include background & scientific importance): Synthesizing results from multiple clinical trials (a.k.a. meta-analysis) is widely considered to be at the top of the hierarchy of evidence pyramid. However, when heterogeneity in outcomes exists across studies (e.g., caused by differing study designs), traditional meta-analysis commonly reduces the number of included studies to lessen the influence of heterogeneity on analysis conclusions. Model-based meta-analysis (MBMA) is a broad meta-analytic methodology that aims to explain between-trial heterogeneity using pharmacologic and statistical models. By integrating more comprehensive clinical trial information, an MBMA can be effectively used to simulate and predict unobserved scenarios. Thus, MBMA is a valuable drug development tool that can aid in clinical decision-making across all stages of drug development, from identifying appropriate differentiation targets and informing trial design to quantifying the probability of successful development and influencing health economics and reimbursement decisions. MBMA is an integrated component of the model-informed drug development (MIDD) toolbox.

This symposium session will focus on the diverse applications and impact of MBMA, while highlighting critical methodological details. Presentations will demonstrate how MBMA can be applied to inform critical decisions across multiple disease areas. These examples will explore multiple concepts and methodologies, including quantifying appropriate differentiation targets based on approved and not-yet-approved drugs, understanding how drugs’ efficacy translates across indications, and combining aggregate data with individual patient data. A panel discussion will follow, with the goal to engage with the audience and clarify any confusion about distinct MBMA methodologies or MBMA in general. Panelists’ perspectives will represent both industry and academia.

Learning Objectives:

  • Upon completion, participant will be able to: - Define model-based meta-analysis (MBMA) and describe how it can be applied at various stages of drug development - Understand differences in distinct MBMA methodologies like disease progression modelling and comparative effects models - Understand potential benefits of combined analysis of aggregate data and individual patient level data and be able to address challenges when implementing such analyses - Identify specific opportunities where general MBMA concepts can be applied to their own drug development experiences

Presentations:

  • 2:00 PM - 2:20 PM MDT
    Tackling pain: a platform MBMA approach Session title: High-impact Applications of Model-based Meta-analyses (MBMA) in Drug Development

    Speaker: Monica Simeoni, PhD (she/her/hers) – GSK

  • 2:20 PM - 2:40 PM MDT
    Model-Based Meta-Analysis Leveraging Publicly Available Data to Support Drug Development in Weight-management

    Speaker: Hongtao Yu, PhD (he/him/his) – AstraZeneca

  • 2:40 PM - 3:00 PM MDT
    Combining aggregate and individual level data – opportunities and considerations Session title: High-impact Applications of Model-based Meta-analyses (MBMA) in Drug Development

    Speaker: Mats O. Karlsson, PhD, FISoP, FACCP (he/him/his) – Uppsala University

  • 3:00 PM - 3:30 PM MDT
    Panel - High-impact Applications of Model-based Meta-analyses (MBMA) in Drug Development

    Panelist: Matthew L. Zierhut, PhD, MBA (he/him/his) – Certara

    Panelist: Monica Simeoni, PhD (she/her/hers) – GSK

    Panelist: Hongtao Yu, PhD (he/him/his) – AstraZeneca

    Panelist: Mats O. Karlsson, PhD, FISoP, FACCP (he/him/his) – Uppsala University