Strategies for Successful Application of QSP Platform Models for Clinical Development and Regulatory Engagement

MIDD

QSP

Program strategies and efficiencies

Regulatory interactions

Quant Med. 2026 Jul 31;1(3):125-132.

Wang W, Chang S, Tao M, Ratushny AV, Rao R, Hosseini I, Shtylla B, Macias WL, Jin J, Cucurull-Sanchez L, Zaph S, Schmidt BJ

How can we expand QSP’s role in high-impact clinical decision-making? In this paper, real-world case studies and panel discussions are used to entertain this burning question. It outlines practical strategies for establishing model credibility, mitigating risk, and proactively engaging with regulatory agencies.

Key highlights from the paper:

● Distills real-world insights and panel discussions from an ACoP 2024 session organized by the ISoP QSP Special Interest Group.

● Reviews four regulatory case studies, including pediatric label extensions (e.g., Xenpozyme®), dose optimization for cell therapies and T-cell redirecting bispecifics, and treatment duration for antivirals (e.g., Paxlovid).

● Outlines practical strategies for model quality assessment, context-relevant clinical validation, risk mitigation, and early regulatory communication.

● Explores pathways under emerging frameworks like ICH M15 to help transition QSP from a complementary approach to a routine, high-impact component of drug approvals.

Given the evolving regulatory landscape and limited formal guidance for high-risk MIDD scenarios, this publication provides a valuable framework for QSP models – especially to support decision-making where direct clinical evidence is limited.