Innovation in Quantitative Medicine Summit

September 1, 2026 — 12:00PM–4:30PM

Virtual via Zoom

Contact Information

Margolis Events Team

margolisevents@duke.edu

Materials

Draft Agenda_Innovation in Quantitative Medicine Summit 8.13.2026.pdf (363.02 KB)

Innovation in Quantitative Medicine Summit banner graphic

The Duke-Margolis Institute for Health Policy and the U.S. Food and Drug Administration's Quantitative Medicine Center of Excellence will co-convene a virtual workshop on September 1, 2026, to inform the establishment of the Quantitative Medicine Innovation Network (QMIN). The QMIN will bring together academic institutions, industry sponsors, contract research organizations, regulators, and patient advocates in a sustained, cross-sector collaboration to advance the science and regulatory application of quantitative medicine with the goal of fundamentally transforming drug development and clinical care.

Click for more information regarding CDER's Quantitative Medicine Center of Excellence

Quantitative Medicine Center of Excellence Fact Sheet

CDER is requesting information to inform the development of a Quantitative Medicine Innovation Network (QMIN). Please use this link to submit comments prior to November 3, 2026

CDER Request for Information

This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U19FD006602 totaling $5,192,495 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

Innovation in Quantitative Medicine

Question Form

This is not the registration page. To register for this event, please click here.

Responses to the webform questions will help us understand stakeholder perspectives on the meeting topics and discussion.

Full Name

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Which of the following best describes your experience with quantitative medicine approaches in drug development or regulatory science? Select all that apply.

I actively develop or apply QM methods (e.g., PBPK, pharmacometrics, QSP, mechanistic modeling, AI/ML) in my work

I work alongside QM specialists and use their outputs to inform decisions, but do not build models myself

I am familiar with QM concepts but have limited direct experience applying them

I am relatively new to quantitative medicine and attending to build foundational understanding

Where should QMIN concentrate its efforts for greatest transformative potential, such that a coordinated cross-sector effort could most effectively close the gap between current capability and real-world impact? Some areas for consideration: disease-specific contexts where the complexity of the problem makes quantitative medicine uniquely capable of achieving breakthroughs that conventional methods cannot; disease-agnostic methodological advances such as model-informed trial design or quantitative frameworks for underserved populations that could accelerate drug development and improve patient care broadly; at the intersection of drug development and clinical practice, such as model-informed precision dosing or bridging trial evidence to real-world patient populations.

In your experience, where do quantitative medicine approaches face the greatest barriers to realizing full potential (e.g., gaps in tools, standards, or infrastructure)?

What is one significant advancement in quantitative medicine that a well-resourced, multi-stakeholder network would be uniquely positioned to help achieve?

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Innovation in Quantitative Medicine Summit

Duke-Margolis Planning Team

Brian Canter, PhD

Cameron Joyce, MPA

Molly Shields