Dear AAPS Pharmaceutical Quality team,
AAPS is considering a response to the FDA docket on Quantitative Medicine Innovation Network (QMIN), which has announced a Request for Information (RFI). More information is below. Does the PQ community wish to provide information? From my review, this guidance is not directly relevant to PQ and may not be something we wish to recommend nor volunteer for. However I wanted to ask the group whether:
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Does this impact the PQ community and do we feel AAPS should respond? Yes/No
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If yes, who from the PQ team would volunteer their expertise to represent PQ on the Response Team?
Please let me know by EOB August 14.
Thank you,
Joe
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The FDA has announced a Request for Information regarding the Quantitative Medicine Innovation Network (QMIN), issued by the Center for Drug Evaluation and Research in partnership with the CDER Quantitative Medicine Center of Excellence. Comments should be submitted by 3 November 2026.
The notice is here: [Federal Register Link] (Docket FDA-2026-N-7605).
QMIN is envisioned as a multi-stakeholder network to accelerate the translation of quantitative approaches across the drug discovery, development, regulation, and utilization continuum. The RFI seeks input on three topics: identifying community needs and establishing mechanisms for continuous engagement; supporting collaborative demonstration projects or research addressing high-priority areas through quantitative medicine approaches; and exploring mechanisms to leverage community expertise and capacity to promote quantitative medicine innovation and adoption.
This would be of particular interest to our modeling and simulation members, and also to the group that worked on the NAM guidance response - the RFI names NAMs integration alongside disease modeling and trial simulation when asking which areas of quantitative medicine would most benefit from a coordinated, cross-sector network. Given that we have recent, organized experience on NAMs, that may be a strong contribution for AAPS to make here.
It touches topics across several communities:
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- Modeling and simulation - disease modeling, trial simulation, PBPK, quantitative systems pharmacology, and model-informed drug development
- New approach methodologies - NAMs integration into quantitative frameworks and regulatory decision-making
- Clinical pharmacology and translational science - dose optimization, exposure-response, and special-population extrapolation
- Biostatistics and data sciences - trial design, real-world evidence, and analytical infrastructure
- Regulatory sciences - regulatory acceptance pathways, qualification mechanisms, and precedent
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Joseph Thomas
Quality Intelligence and Advocacy Lead
Sanofi
Framingham MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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