Ramon I. Garcia, Ph.D.

Senior Scientist I

Ramon joined Metrum in January 2017. He obtained his Ph.D. in Biostatistics from the University of North Carolina where his dissertation topic was “variable selection in models with missing data using a Bayesian framework”. Ramon did research at the EPA where he investigated identifiability and estimation of physiologically based pharmacokinetic models. Ramon’s interests include model selection and estimation of nonlinear mixed effects models and Bayesian analysis of pharmacokinetic models.

Recent publications by this scientist

Exposure–Response Relationships in Patients with Non-Small-Cell Lung Cancer and Other Solid Tumors Treated with Patritumab Deruxtecan (HER3-DXd)

April 14, 2025

This paper contributes to the oncology MIDD field by using robust exposure-response modeling to identify the optimal dosing regimen for HER3-DXd in EGFR-mutated NSCLC. Analyzing data from over 700 patients across four studies, it demonstrates that 5.6 mg/kg Q3W offers a favorable balance of efficacy and safety. The analysis incorporates patient covariates and compares fixed and up-titration regimens, supporting data-driven selection. These methods align closely with the goals of Project Optimus, emphasizing the importance of modeling and simulation in selecting doses that are both effective and tolerable, rather than defaulting to the maximum tolerated dose.

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Bayesian sparse regression for exposure–response analyses of efficacy and safety endpoints to justify the clinical dose of valemetostat for adult T-cell leukemia/lymphoma

October 2, 2024

The developed models characterized E–R relationships and covariate effects for efficacy and safety endpoints. The efficacious and safe exposure range was established and supported the clinical dose of 200 mg. The utility of logistic regressions in a Bayesian framework with spike and slab priors, in which all the covariate effects were included and simultaneously estimated, was demonstrated.

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Population exposure–response analysis supports efficacy outcomes of garadacimab in patients with hereditary angioedema

June 26, 2024

Presented at ASCPT Annual Meeting 2024. Garadacimab (anti-activated factor XII monoclonal antibody) demonstrated efficacy for the prevention of hereditary angioedema (HAE) attacks with a favorable safety profile in Phase 2, pivotal Phase 3 (VANGUARD), and Phase 3 open-label extension studies. In this exposure-response (ER) analysis, the efficacy of garadacimab and effect of covariates on attack rate (number of attacks/month) were assessed to support garadacimab dosing in patients with HAE.

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