Marc R. Gastonguay, Ph.D.

Chairman, Board of Directors, Senior Fellow II

Marc founded Metrum Research Group as a mission driven company in 2004. He has dedicated nearly 30 years to science, advocacy, innovation, and education in the discipline of pharmacometrics. His experience with mathematical modeling and simulation spans problems in biomedical research and development across industrial, government, and academic settings.

Recent publications by this scientist

Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics

February 20, 2024

This research delves into the significance of transitioning from intravenous (i.v.) to subcutaneous (s.c.) administration of biologics in enhancing patient convenience and treatment outcomes. It emphasizes the role of model-informed drug development (MIDD) in facilitating this transition, providing insights into crucial clinical pharmacology and regulatory considerations. Key aspects highlighted include comprehensive pharmacokinetic evaluations, exposure-response profiling, comparability studies, and safety assessments, with MIDD strategies aiding in expediting the shift to s.c. dosing, thereby improving patient adherence and clinical efficacy.

Read Article

Training the next generation of pharmacometric modelers: a multisector perspective

September 25, 2023

The demand for pharmacometricians has outpaced academic supply, with increasing investments in on-the-job training. Despite growth in academic programs, the expanding scope of pharmacometrics and emerging fields like machine learning pose challenges. Leading experts from diverse sectors offer recommendations for effectively training future pharmacometricians, ensuring their ability to navigate this evolving discipline.

Download PDF

Therapeutics Development in Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA): Extrapolation, Dose Selection and Clinical Trial Design; Workshop Proceedings and Recent Updates

July 24, 2023

Stakeholders met to address persistent challenges facing development of therapeutics for polyarticular JIA (pJIA), which result in fewer approved therapies for children with pJIA than adults with rheumatoid arthritis (RA) and long lag times from adult RA approval to pediatric labeling.

Read Article