Entrepreneur in Residence & Chairman, 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.
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.
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.
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.