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

A Modern Curriculum for Training Scientists in Model-Informed Drug Development: Progress Report on FDA Grant to Train Regulatory Scientists

July 17, 2024

The paper details a collaborative initiative funded by the FDA, where the Critical Path Institute and partners created didactic e-learning materials on model-informed drug development (MIDD) for non-modeling audiences. The curriculum, enriched with case studies from multinational pharmaceutical companies, includes 13 hours of training videos and is currently being beta-tested by FDA reviewers. Future plans involve expanding the content, offering 1:1 mentorship sessions, and providing broader access to the learning management system to support global stakeholders and the evolving MIDD community.

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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.

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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.

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