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Symposium

PMx

C4A - Leveraging Real-World Data in Pharmacometrics: Augmenting Clinical Trials and Advancing Research in Understudied Populations

Tuesday, October 21, 2025
9:00 AM - 10:30 AM MDT
Location: Colorado B-D

Disclosure(s):
Erick Velasquez, PhD: No financial relationships to disclose
Rui Zhu, PhD: No relevant disclosure to display
Simon Dagenais, PhD, MSc: No relevant disclosure to display
Alice S. Tang, PhD: No relevant disclosure to display

Description of session (include background & scientific importance): Traditional clinical trials often face limitations in terms of patient diversity, duration and real world-applicability. To address these challenges, large-scale electronic health records, insurance/pharmacy claims and other real-world data (RWD) sources create an opportunity to complement and enhance traditional clinical trials. Pharmacometrics and machine learning methods are uniquely poised to take advantage of RWD sources to gain insight about factors that impact drug safety/efficacy and translate them to underrepresented populations in clinical trials. This symposium session will highlight a few state-of-the-art pharmacometric, statistical and ML approaches that take advantage of RWD to inform clinical decision making in understudied populations. Following the presentations, a panel discussion is planned with the aim of providing different perspectives (industry and academic) and spark dialogue on novel approaches to expand traditional clinical trials to understudied populations using RWD.

Learning Objectives:

  • Upon completion, participants will be able to: Evaluate RWD-PBPK integration for drug-drug interactions in rare diseases. Analyze transformer and LLM applications in low-resource settings. Assess LLM potential for extracting data from clinical notes. Examine extending adult drug approvals to pediatric populations using RWD. Critique RWD's role in complementing trials and providing evidence in pediatrics. Synthesize strategies for leveraging RWD to advance research in understudied populations.

Presentations:

  • 9:00 AM - 9:20 AM MDT
    Integrating Real-World Data and PBPK Modeling to Optimize Drug-Drug Interaction Assessments in Rare Diseases

    Speaker: Rui Zhu, PhD – Genentech

  • 9:20 AM - 9:40 AM MDT
    Leveraging Real-World Data to Extend Adult Drug Approvals to Pediatric Populations: A Pharmacometric Approach

    Speaker: Simon Dagenais, PhD, MSc (he/him/his) – Pfizer

  • 9:40 AM - 10:00 AM MDT
    Harnessing Real-World Data to Advance Pharmacometrics in Understudied Populations: Computational Strategies, Study Design, and Machine Learning Approaches

    Speaker: Alice S. Tang, PhD – UCSF

  • 10:00 AM - 10:30 AM MDT
    Panel - Leveraging Real-World Data in Pharmacometrics: Augmenting Clinical Trials and Advancing Research in Understudied Populations

    Panelist: Rui Zhu, PhD – Genentech

    Panelist: Simon Dagenais, PhD, MSc (he/him/his) – Pfizer

    Panelist: Alice S. Tang, PhD – UCSF