Quantitative Pharmacology (QP) Network

Session Description

This session represents the annual meeting of the ASCPT Quantitative Pharmacology (QP) Network and includes an introduction to the Network and its activities. The presentations by Piet van der Graff, PharmD, PhD, and Jin Y. Jin, PhD, will be a Point/ Counterpoint format on the topic of Quantitative Systems Pharmacology (QSP) in Drug Development.

The pharmaceutical industry is actively applying QSP to make internal decisions and guide drug development. To facilitate the eventual development of a common framework for assessing the credibility of QSP models for clinical drug development, scientists from US Food and Drug Administration and the pharmaceutical industry organized a full-day virtual Scientific Exchange on July 1, 2020. Model transparency, including details on expert knowledge and data used for model development, was identified as a major factor for robust model assessment. Case studies demonstrated some commonalities in the workflow of QSP model development, calibration, and validation but differ in the size, scope, and complexity of QSP models, in the acceptance criteria for model calibration and validation, and in the algorithms/approaches used for creating virtual patient populations. Though efforts are being made to build the credibility of QSP models and the confidence is increasing in applying QSP for internal decisions at the clinical stages of drug development, there are still many challenges facing QSP application to late-stage drug development.

This session will present two sides of this debate, with recorded presentations from both speakers followed by a brief commentary on validation of mechanistic models from Karen Rowland Yeo, PhD. The live Q&A will allow each speaker to “debate” on their view of QSP in drug development while also taking questions from the virtual audience.

Learning Objectives

1. To gain an appreciation of the application of QSP modelling as part of an integrated clinical M&S strategy in drug development.

2. To recognize current industry perspectives on the regulatory acceptance of QSP models.

Session Schedule

12:30 PM - 12:35 PM ET
Quantitative Pharmacology Network Annual Review, Update, and Session Introduction
Michael Tortorici, PharmD, PhD

12:35 PM - 12:50 PM ET
The Unique Contribution of QSP to MIDD: Industry and Regulatory Acceptance
Piet Van der Graaf, PharmD, PhD

12:50 PM - 1:00 PM ET
Utility of Quantitative Systems Pharmacology Modeling as Part of an Integrated Clinical M&S Strategy – Where Are We?
Jin Jin, PhD

1:00 PM - 1:10 PM ET
Perspective on Validation of Complex Quantitative Models
Karen Rowland Yeo, PhD

1:10 PM - 1:30 PM ET
Live Q&A
All Speakers