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.
March 18, 2026
Regulatory submissions for new drugs (NDAs/BLAs) increasingly rely on
pharmacometric (PK/PD) analyses to support dosing, labeling, and design of
post-approval trial commitments.
More frequently, MIDD related activities (data cleaning/prep, analysis,
summary document preparation) are on the filing critical path (CP) following
completion of the final registration studies, with delays directly impacting
time to file. These delays impact overall medicine value.
Accelerating MIDD related CP activities via methods standardization,
process automation, and proactive planning offers a potential mechanism for
increasing speed without compromising quality
March 18, 2026
Project Rationale
QDF Components QDF Components
Competitive Landscape
MIDD Enhanced Valuations
Rising costs, uncertain reimbursement, competition, and declining success rates have
reduced drug R&D productivity and investment over the last decade.
Proposed strategies to improve R&D productivity include four key factors: 1) leveraging all
data sources; 2) utilizing quantitative models; 3) elimination of information silos across R&D
and commercial organizations; and 4) application of decision frameworks to reduce
cognitive bias and improve decision making.1
A QDF for a drug development program in atopic dermatitis (AD) was developed to: 1) link
MIDD models aligned with a target product profile (TPP) to risk-adjusted net present value
(rNPV); and 2) integrate context-sensitive large language models (LLMs) to incorporate
non-structured data from novel sources into the decision-making framework in a responsible
manner.
May 27, 2025
A companion poster to the ASCPT print copy, this visual presentation emphasizes the simulation approach used to evaluate individualized dosing strategies and their economic implications. Results underscore the importance of reducing discontinuation rates to enhance value.