Daniel G. Polhamus, Ph.D

Group Leader Statistics, Principal Scientist II

Dan joined Metrum in September, 2010 and is an applied statistician with an emphasis on Bayesian biostatistics, clinical trial design, and high performance statistical computing. His dissertation topic was adaptive design for heterogeneous time-to-event data in a Bayesian decision theory framework.

Recent publications by this scientist

Pharmacometric-Pharmacoeconomic Modeling and Simulation in Atopic Dermatitis: Informing Early Drug Development Decisions for a Hypothetical New Therapeutic.

December 6, 2024

Presented at ACoP 2024. Early drug development decision making, such as the definition and assessment of target product profile characteristics, rarely includes pharmacoeconomic (PE) considerations. The disciplines of phamacometrics (PM) and PE are closely aligned and intersect at the goal of a quantitative understanding of the system. Connection of these two disciplines is a logical extension of typical PM objectives and should lead to a more complete and accurate understanding of the probability of success for new therapeutics.

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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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Exposure–efficacy relationship of vedolizumab subcutaneous and intravenous formulations in Crohn’s disease and ulcerative colitis

March 6, 2024

This posthoc analysis of the GEMINI and VISIBLE studies in ulcerative colitis (UC) and Crohn’s Disease (CD) assessed exposure−efficacy of vedolizumab intravenous (IV) and subcutaneous (SC).

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