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Symposium

QSP/ PBPK

C4B - Scaling Peaks Unclimbed: How QSP is Shaping the Future Landscape of MIDD in Diseases Beyond Oncology

Tuesday, October 21, 2025
9:00 AM - 10:30 AM MDT
Location: Willow Lake 3 - 5

Disclosure(s):
Weirong Wang, PhD: No financial relationships to disclose
Ryan Suderman, PhD: No financial relationships to disclose
Vivaswath S. Ayyar, PhD: No relevant disclosure to display
Melissa Hallow, PhD: No relevant disclosure to display
Tao Peng, PhD: No relevant disclosure to display
Anna Sher, MD/PhD: No relevant disclosure to display

Description of session (include background & scientific importance): Quantitative Systems Pharmacology (QSP) has been instrumental in modern drug development, guiding therapeutic strategies and regulatory decisions. However, much of its documented success has been concentrated on Oncology, with over a third of all QSP-related scientific publications and FDA regulatory submissions focused on this area. Yet, the potential of QSP extends far beyond. Emerging applications in other areas such as Immunology, Infectious Diseases, Neurodegeneration, and Cardiorenal diseases are unlocking new frontiers where QSP-driven Model-Informed Drug Development (MIDD) is streamlining drug development and optimizing clinical decision-making.

This symposium will showcase cutting-edge applications of QSP in key growth areas beyond oncology, highlighting its expanding role across pharmaceutical pipelines. Discussions will emphasize three critical factors for successfully applying QSP beyond Oncology:

1. Mechanistic Insight – Structuring biological networks, parameterizing key disease mediators, and linking them quantitatively with clinical endpoints.

2. Model & Virtual Population Qualification – Model qualification against diverse and expanding clinical trial datasets.

3. Risk-Informed Model Credibility Assessment – Establishing confidence in QSP models to drive regulatory and clinical decisions.

A panel of experts from academia and industry will share insights into autoimmune, anti-infective, and cardiorenal systems pharmacology.
Through curated talks and engaging panel discussion, this session will illustrate how contemporary QSP approaches are being applied to new disease areas, inspiring future innovation, and expanding QSP-informed decision-making across a broader spectrum of indications. This session is well-positioned to directly address feedback provided from attendees during the QSP-SIG sponsored symposium and gathering at ACOP2024 (Phoenix, AZ).

Learning Objectives:

  • 1. Clarify latest advances and challenges in QSP-driven drug development across three areas: Immunology (Rheumatoid Arthritis), Infectious Diseases (human immunodeficiency virus (HIV), Ebola), and Cardiorenal Pathology (chronic kidney disease [CKD] and heart failure). 2. Appreciate how disease models should continuously evolve by assimilating large swaths of scientific knowledge and trial data to improve decision-making during clinical development. 3. Understand key aspects to establish a ‘credible’ QSP model and its importance during risk-informed model credibility assessment. 4. Demonstrate and discuss how disease QSP models, once established, are expandable to evaluate multiple assets, therapeutic targets, and key R&D questions.

Presentations:

  • 9:00 AM - 9:15 AM MDT
    Expanding Horizons: Shaping the Future Landscape of MIDD Across Disease Areas

    Speaker: Vivaswath S. Ayyar, PhD (he/him/his) – GSK

  • 9:15 AM - 9:35 AM MDT
    Quantitative Systems Pharmacology for Cardiorenal Drug Development: Integrating Safety and Efficacy Predictions in patients with multiple comorbidities and comedications

    Speaker: Melissa Hallow, PhD – Cardiorenal QSP, LLC

  • 9:35 AM - 9:55 AM MDT
    Paving New Paths in Immunology: Development and Credibility Assessment of a Disease QSP Model for Rheumatoid Arthritis (RA)

    Speaker: Tao Peng, PhD – J&J Innovative Medicine

  • 9:55 AM - 10:15 AM MDT
    Past, Present and Future of Tackling Infectious Diseases and Vaccine Through the Lens of QSP and QST

    Speaker: Anna Sher, MD/PhD (she/her/hers) – QSP - Precision Medicine