Quantitative systems pharmacology for rare disease drug development

JPF Bai, J Wang, Y Zhang, L Wang, X Jiang - Journal of Pharmaceutical …, 2023 - Elsevier
Though hundreds of drugs have been approved by the US Food and Drug Administration
(FDA) for treating various rare diseases, most rare diseases still lack FDA-approved …

Systems‐based digital twins to help characterize clinical dose–response and propose predictive biomarkers in a phase I study of bispecific antibody, mosunetuzumab …

ME Susilo, CC Li, K Gadkar… - Clinical and …, 2023 - Wiley Online Library
Phase I oncology clinical trials often comprise a limited number of patients representing
different disease subtypes who are divided into cohorts receiving treatment (s) at different …

Virtual populations for quantitative systems pharmacology models

Y Cheng, R Straube, AE Alnaif, L Huang, TA Leil… - Systems Medicine, 2022 - Springer
Quantitative systems pharmacology (QSP) places an emphasis on dynamic systems
modeling, incorporating considerations from systems biology modeling and …

Modeling clinical phenotype variability: consideration of genomic variations, computational methods, and quantitative proteomics

JPF Bai, LR Yu - Journal of Pharmaceutical Sciences, 2023 - Elsevier
Advances in biomedical and computer technologies have presented the modeling
community the opportunity for mechanistically modeling and simulating the variability in a …

Evaluation framework for systems models

S Braakman, P Pathmanathan… - CPT: pharmacometrics & …, 2022 - Wiley Online Library
As decisions in drug development increasingly rely on predictions from mechanistic systems
models, assessing the predictive capability of such models is becoming more important …

Digital twins elucidate critical role of Tscm in clinical persistence of TCR-engineered cell therapy

LR Joslyn, W Huang, D Miles, I Hosseini… - NPJ Systems Biology …, 2024 - nature.com
Despite recent progress in adoptive T cell therapy for cancer, understanding and predicting
the kinetics of infused T cells remains a challenge. Multiple factors can impact the …

Towards a comprehensive assessment of QSP models: what would it take?

IP Androulakis - Journal of pharmacokinetics and pharmacodynamics, 2022 - Springer
Abstract Quantitative Systems Pharmacology (QSP) has emerged as a powerful ensemble of
approaches aiming at developing integrated mathematical and computational models …

Integrated systems modeling of severe asthma: exploration of IL‐33/ST2 antagonism

K Gadkar, J Feigelman, S Sukumaran… - CPT …, 2022 - Wiley Online Library
Asthma is a complex, heterogeneous disease with a high unmet medical need, despite
therapies targeting a multitude of pathways. The ability to quantitatively integrate preclinical …

Preclinical and translational pharmacology of afucosylated anti‐CCR8 antibody for depletion of tumour‐infiltrating regulatory T cells

G Gampa, P Spinosa, J Getz, Y Zhong… - British Journal of …, 2024 - Wiley Online Library
Background and Purpose RO7502175 is an afucosylated antibody designed to eliminate C–
C motif chemokine receptor 8 (CCR8)+ Treg cells in the tumour microenvironment through …

Multiscale, mechanistic model of Rheumatoid Arthritis to enable decision making in late stage drug development

D Bedathuru, M Rengaswamy… - NPJ Systems Biology …, 2024 - nature.com
Rheumatoid Arthritis (RA) is a chronic autoimmune inflammatory disease that affects about
0.1% to 2% of the population worldwide. Despite the development of several novel …