FDA seeks feedback on quantitative medicine network
The US Food and Drug Administration (FDA) is seeking stakeholder feedback to create a Quantitative Medicine Innovation Network (QMIN), a cross-sector platform that uses quantitative medicine approaches to accelerate drug development and regulatory science and improve clinical decision-making.
On 4 August, FDA published a request for information for stakeholders to propose ideas that can be used to develop the QMIN. More specifically, the agency said it wants input on mechanisms for continuous collaboration with stakeholders; how regulators can support collaborative efforts such as research and demonstration projects that use quantitative medicine to solve high-priority issues; and mechanisms to leverage expertise to promote the use of quantitative medicine.
"The proposed mission for the QMIN is to connect FDA scientists, academia, industry, healthcare providers, patient groups, and other regulatory partners in driving the development and application of quantitative medicine to tackle critical unmet needs of the community by fundamentally transforming drug development and clinical care," said FDA. "Quantitative medicine approaches integrate mathematical and computational models with biological, clinical, and statistical data to inform drug development, regulatory, and clinical decisions.
"These approaches have the potential to improve the efficiency of drug development, optimize treatment strategies, and ultimately improve patient outcomes," the agency added.
The proposed QMIN is being spearheaded by the Quantitative Medicine Center of Excellence at FDA's Center for Drug Evaluation and Research, which was established in 2024 to promote the uptake of modeling and simulation approaches in drug development and review. The center's objective is to promote drug development using quantitative medicine, which employs new computational models and statistical tools and reduces animal testing. (RELATED: FDA launches new Quantitative Medicine Center of Excellence, Regulatory Focus 28 March 2024)
FDA said the QMIN is intended to be a collaborative, multi-stakeholder ecosystem that brings together diverse expertise to translate quantitative medicine approaches across the drug discovery ecosystem, enabling the rapid translation of information to bring treatments to patients faster. The agency said it wants detailed feedback on several issues, including which areas of quantitative medicine would benefit from the network, whether the network should prioritize a limited number of high-impact areas, how the network should define its role relative to other similar efforts, and more.
Regulators also asked for detailed feedback on the operating model QMIN should use and the priority use cases it should work on. They asked which use cases to focus on as the project begins, how to select them, and which metrics to use to evaluate success.
The request for information comes a few weeks after the Duke-Margolis Institute for Health Policy and FDA announced they are co-hosting a virtual public meeting on 1 September to discuss establishing the QMIN. They said the meeting will allow participants to discuss scientific and regulatory gaps that the network can address to drive quantitative medicine research.
Stakeholders can comment on the request for information on www.regulations.gov under docket no. FDA-2026-N-7605 until 3 November.
