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. 2021 Dec;10(12):1479-1484.
doi: 10.1002/psp4.12709. Epub 2021 Nov 3.

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration

Jane P F Bai  1 , Justin C Earp  1 , Jeffry Florian  1 , Rajanikanth Madabushi  1 , David G Strauss  1 , Yaning Wang  1 , Hao Zhu  1
Affiliations

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration

Jane P F Bai et al. CPT Pharmacometrics Syst Pharmacol. 2021 Dec.

Abstract

Quantitative systems pharmacology (QSP) has been proposed as a scientific domain that can enable efficient and informative drug development. During the past several years, there has been a notable increase in the number of regulatory submissions that contain QSP, including Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applications (BLAs) to the US Food and Drug Administration. However, there has been no comprehensive characterization of the nature of these regulatory submissions regarding model details and intended applications. To address this gap, a landscape analysis of all the QSP submissions as of December 2020 was conducted. This report summarizes the (1) yearly trend of submissions, (2) proportion of submissions between INDs and NDAs/BLAs, (3) percentage distribution along the stages of drug development, (4) percentage distribution across various therapeutic areas, and (5) nature of QSP applications. In brief, QSP is increasingly applied to model and simulate both drug effectiveness and safety throughout the drug development process across disease areas.

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Conflict of interest statement

The authors declared no competing interests for this work.

Figures

FIGURE 1
FIGURE 1
The yearly trend of quantitative systems pharmacology submissions since 2013
FIGURE 2
FIGURE 2
Applications of quantitative systems pharmacology across various therapeutic areas. Submissions in disease areas of anesthesiology, addiction medicine, pain medicine, hepatology and nutrition, dermatology and dentistry, and medical imaging and radiation medicine were grouped together into the “Others” category
FIGURE 3
FIGURE 3
(a) Percentage distribution of quantitative systems pharmacology submissions along the drug development stages (the “Supplements” category includes efficacy and safety submissions following NDA/BLA approval for marketing, postmarket requirement, and postmarket commitment submissions). In the preclinical‐to‐phase I category, there was only one preclinical submission. (b) Proportion of quantitative systems pharmacology submissions between INDs and NDAs/BLAs. BLA, Biologics License Application; IND, Investigational New Drug Application; NDA, New Drug Application; PIND, Pre‐Investigational New Drug
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