Evidence map›Paper›PMID 39508122›Full record

ArticleCPT: pharmacometrics & systems pharmacology2025

An integrated quantitative systems pharmacology virtual population approach for calibration with oncology efficacy endpoints.

Nathan Braniff, Tanvi Joshi, Tyler Cassidy, Michael Trogdon, Rukmini Kumar, Kamrine Poels, Richard Allen, Cynthia J Musante, Blerta Shtylla

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. New approach methodologies (NAMs) for preclinical and translational evaluation of mRNA-lipid nanoparticle (LNP) therapeutics.Journal of controlled release : official journal of the Controlled Release Society · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Nathan BraniffPharmacometrics & Systems Pharmacology, Pfizer Inc., La Jolla, California, USA.
Tanvi JoshiVantage Research Inc., Lewes, Delaware, USA.ORCID 0000-0002-9729-8979
Tyler CassidyPharmacometrics & Systems Pharmacology, Pfizer Inc., Cambridge, Massachusetts, USA.
Michael TrogdonPharmacometrics & Systems Pharmacology, Pfizer Inc., La Jolla, California, USA.
Rukmini KumarVantage Research Inc., Lewes, Delaware, USA.
Kamrine PoelsPharmacometrics & Systems Pharmacology, Pfizer Inc., La Jolla, California, USA.ORCID 0000-0002-7220-2213
Richard AllenPharmacometrics & Systems Pharmacology, Pfizer Inc., Cambridge, Massachusetts, USA.
Cynthia J MusantePharmacometrics & Systems Pharmacology, Pfizer Inc., Cambridge, Massachusetts, USA.ORCID 0000-0002-3003-0169
Blerta ShtyllaPharmacometrics & Systems Pharmacology, Pfizer Inc., La Jolla, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In drug development, quantitative systems pharmacology (QSP) models are becoming an increasingly important mathematical tool for understanding response variability and for generating predictions to inform development decisions. Virtual populations are essential for sampling uncertainty and potential variability in QSP model predictions, but many clinical efficacy endpoints can be difficult to capture with QSP models that typically rely on mechanistic biomarkers. In oncology, challenges are particularly significant when connecting tumor size with time-to-event endpoints like progression-free survival while also accounting for censoring due to consent withdrawal, loss in follow-up, or safety criteria. Here, we expand on our prior work and propose an extended virtual population selection algorithm that can jointly match tumor burden dynamics and progression-free survival times in the presence of censoring. We illustrate the core components of our algorithm through simulation and calibration of a signaling pathway model that was fitted to clinical data for a small molecule targeted inhibitor. This methodology provides an approach that can be tailored to other virtual population simulations aiming to match survival endpoints for solid-tumor clinical datasets.

Indexed as

Antineoplastic AgentsNeoplasmsNetwork PharmacologyAlgorithmsCalibrationComputer SimulationDrug DevelopmentHumansModels, BiologicalProgression-Free SurvivalTumor BurdenAntineoplastic Agents

Identifiers

PMID39508122
PMCPMC11812934

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.