Year |
Title |
Disease Area |
Modality |
Pipeline Stage |
2024 |
Quantitative Systems Pharmacology Modeling of Adeno-Associated Virus Gene Therapies: Mechanistic Identification of Species-Translation Using Preclinical and Clinical Data (Chapter 4 in Development of Gene Therapies, eds. Avery McIntosh, Oleksandr Sverdlov) |
Rare diseases - hemophelia B |
Gene therapy |
Preclinical, Clinical |
2024 |
In vitro evaluation of myelosuppressive effects of ATRi tuvusertib and ATMi lartesertib (M4076), alone and in combination. |
Cancer - various |
Small molecule |
Discovery |
2024 |
Achieving Uniform Vector Genome Transduction in the Brain Tissue after Intraparenchymal Delivery of Adeno Associated Virus Gene Therapy Using Computational Fluid Dynamics and Quantitative Systems Pharmacology Modeling |
Neuorlogical - Huntington's disease |
Gene therapy |
Preclinical, Clinical |
2022 |
Translational PK/PD/efficacy modeling and efficacious human dose prediction for a first-in-class MUC1-EGFR (M1231) bispecific antibody drug conjugate |
Cancer - various |
ADC |
Preclinical, Clinical |
2021 |
Developing a robust Quantitative Systems Pharmacology model of adeno-associated virus (AAV) based gene therapy for clinical applications |
Rare diseases - hemophelia B |
Gene therapy |
Preclinical, Clinical |
2020 |
A Physiologically-Based Pharmacokinetic Model for the Prediction of "Half-Life Extension" and "Catch and Release" Monoclonal Antibody Pharmacokinetics |
Various |
mAb |
Preclinical, Clinical |
2020 |
Use of translational modeling and simulation for quantitative comparison of PF-06804103, a new generation HER2 ADC, with Trastuzumab-DM1 |
Cancer |
ADC |
Preclinical, Clinical |
2020 |
A Quantitative Systems Pharmacology Model of Gaucher Disease Type 1 Provides Mechanistic Insight Into the Response to Substrate Reduction Therapy With Eliglustat |
Lysosomal diseases - Gaucher |
mAb |
Preclinical, Clinical |
2020 |
Quantitative Systems Pharmacology Dissection of IL-4/IL-13 Contribution to Human Allergic IgE Production |
Allergic diseases such as asthma |
mAb |
Clinical |
2020 |
Development of a QSP model for ADAMTS13 and von Willebrand factor interactions |
Rare diseases - thrombotic thrombocytopenic purpura (TTP) |
mAb |
Preclinical, Clinical |
2020 |
Hereditary angioedema (HAE) prophylaxis with plasma kallikrein inhibitors: Role of target binding kinetics, pharmacokinetics and treatment adherence |
Rare diseases - hereditary angioedema (HAE) |
mAb |
Preclinical, Clinical |
2019 |
A Physiologically-Based Pharmacokinetic Model for the Prediction of Monoclonal Antibody Pharmacokinetics From In Vitro Data |
Various |
mAb |
Preclinical, Clinical |
2019 |
Integrated efficacy-safety QSP model of acute myeloid leukemia (AML) generates insights into the role of clinical dose schedules on cytopenia |
Allergic diseases such as asthma |
Oncology - acute myeloid leukemia (AML) |
Clinical |
2019 |
A mechanism-based translational mathematical model for gastrointestinal toxicity |
Oncology - gastrointestinal toxicity |
Small molecule |
Preclinical, Clinical |
2018 |
Systems Pharmacology Model of Gastrointestinal Damage Predicts Species Differences and Optimizes Clinical Dosing Schedules |
Cancer - gastrointestinal (GI) adverse events (AEs) |
Small molecule |
Preclinical, Clinical |
2018 |
Quantitative Systems Pharmacology Modeling of Acid Sphingomyelinase Deficiency and the Enzyme Replacement Therapy Olipudase Alfa Is an Innovative Tool for Linking Pathophysiology and Pharmacology |
Lysosomal diseases - acid sphingomyelinase deficiency (ASMD) |
mAb |
Clinical |
2016 |
Preclinical to Clinical Translation of Antibody-Drug Conjugates Using PK/PD Modeling: a Retrospective Analysis of Inotuzumab Ozogamicin |
Oncology - B cell malignancies including non-Hodgkin's lymphoma (NHL) and acute lymphocytic leukemia (ALL) |
ADC |
Preclinical, Clinical |
2015 |
Bridging the gap between in vitro and in vivo: Dose and schedule predictions for the ATR inhibitor AZD6738 |
Oncology - many diseases, including ataxia telangiectasia (AT), chronic lymphocytic leukemia (CLL) and colorectal cancer (CRC) |
Small molecule |
Discovery, Preclinical, Clinical |
2015 |
Modeling population heterogeneity in viral dynamics for chronic hepatitis C infection: Insights from Phase 3 telaprevir clinical studies |
Virology - hepatits C virus (HCV) |
Small molecule |
Clinical |
2015 |
Optimization of an Aminothiazine Ring Formation: Integrating Modeling with Experiments to Maximize Yield by Minimizing Impurity Formation |
Various |
Small molecule |
Drug synthesis and manufacturing |
2014 |
Modeling Tablet Dissolution in Complex Hydrodynamic Environments |
Various |
Small molecule |
Drug synthesis and manufacturing |
2014 |
Modeling Population Heterogeneity in Viral Dynamics for Chronic Hepatitis C Infection: Insights from Phase 3 Telaprevir Clinical Studies |
Virology - hepatits C virus (HCV) |
Small molecule |
Clinical |
2014 |
A Theoretical Approach to Modeling Renal Pharmacokinetics |
Various |
Small molecule |
Preclinical, Clinical |
2012 |
A Viral Dynamic Model for Treatment Regimens with Direct-acting Antivirals for Chronic Hepatitis C Infection |
Virology - hepatits C virus (HCV) |
Small molecule |
Preclinical, Clinical |
2011 |
Comprehensive mechanism-based antibody pharmacokinetic modeling |
Various |
mAb |
Preclinical, Clinical |
2010 |
A Multi-Variant, Viral Dynamic Model of Genotype 1 HCV to Assess the in vivo Evolution of Protease-Inhibitor Resistant Variants |
Virology - hepatits C virus (HCV) |
Small molecule |
Preclinical, Clinical |
2010 |
Modeling, Optimization, and Applications of Kinetic Mechanisms with OpenChem |
Various |
Small molecule |
Drug synthesis and manufacturing |
2009 |
Input-output behavior of ErbB signaling pathways as revealed by a mass action model trained against dynamic data |
Cancer - various |
mAb |
Discovery |