Mathematical Approaches for Predicting Risks Early-On in Drug R&D
Published in Pharma Tech Outlook Magazine
A systems pharmacology model for gene therapy in sickle cell disease
Collaboration with CSL Behring - Published in CPT: Pharmacometrics Systems Pharmacology
Virtual clinical trial simulations for a novel KRASG12C inhibitor (ASP2453) in non-small cell lung cancer
Collaboration with Astellas Pharma - Published in CPT: Pharmacometrics Systems Pharmacology
Systematic in silico analysis of clinically tested drugs for reducing amyloid-beta plaque accumulation in Alzheimer's disease
Published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association
Abstract
Despite strong evidence linking amyloid beta (Aβ) to Alzheimer's disease, most clinical trials have shown no clinical efficacy for reasons that remain unclear. To understand why, we developed a quantitative systems pharmacology (QSP) model for seven therapeutics: aducanumab, crenezumab, solanezumab, bapineuzumab, elenbecestat, verubecestat, and semagacestat.
Quantitative modeling predicts competitive advantages of a next generation anti‐NKG2A therapy over monalizumab for the treatment of cancer
Collaboration with KSQ Therapeutics - Published in CPT: Pharmacometrics Systems Pharmacology
Model-Informed Drug Development of the Masked Anti-PD-L1 Antibody CX-072
Collaboration with CytomX Therapeutics - Published in Clinical Pharmacology & Therapeutics
Abstract
CX‑072 is an anti‑PD‑L1 (programmed death ligand 1) Probody therapeutic (Pb‐Tx) designed to be preferentially activated by proteases in the tumor microenvironment and not in healthy tissue. Here, we report the model‐informed drug development of CX‐072. A quantitative systems pharmacology (QSP) model that captured known mechanisms of Pb‐Tx activation, biodistribution, elimination, and target engagement was used to inform clinical translation.
Mechanistic PKPD Models of Protein Therapeutics for Early Clinical Development
Abstract
Mechanistic PKPD models support FIH trial design, development of targeted immunotherapies, and understanding complex PK properties and covariates.
Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology
Abstract
Bispecific antibodies (bsAbs) have become an integral component of the therapeutic research strategy to treat cancer. In addition to clinically validated immune cell re‐targeting, bsAbs are being designed for tumor targeting and as dual immune modulators. Explorative preclinical and emerging clinical data indicate potential for enhanced efficacy and reduced systemic toxicity.
Fibrinolytic Therapy for Refractory COVID‐19 Acute Respiratory Distress Syndrome: Scientific Rationale and Review
Collaboration with MIT - Published in Research and Practice in Thrombosis and Haemostasis
QSP Model of Colonic Motility
Collaboration with Takeda - Published in Journal of Pharmacokinetics and Pharmacodynamics