FDA launches new Quantitative Medicine Center of Excellence
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has announced the establishment of a new quantitative medicine (QM) Center of Excellence to promote the uptake of modeling and simulation approaches in drug development and assessment.The agency defines QM as “the application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care.”
FDA told Focus that the center builds on existing quantitative approaches to facilitate drug development and review, such as model-informed drug development (MIDD), complex innovative trial design (CID), and the Fit-for-Purpose initiative.
The aim of the center is to develop QM-related policy and best practices to ensure consistent use of QM approaches during drug development and assessment; to launch outreach efforts to scientific societies and patient advocacy groups; and to coordinate QM education and training programs.
CDER Director Patrizia Cavazzoni said that “for decades, CDER has been at the forefront of advancing QM approaches to inform premarket product review and post-market product assessment. Given the tremendous growth in QM, we see many opportunities to strengthen collaboration across CDER by centrally coordinating outreach, education, scientific and regulatory policy, to facilitate the consistent use of QM approaches during drug development and to inform regulatory decision making.”
FDA also told Focus that the center of excellence will be a “CDER-wide enterprise” governed by a director, an executive board chair, a board project manager, and an executive board consisting of leaders from the Office of Generic Drugs, the Office of New Drugs, the Office of Pharmaceutical Quality, and Office of Translational Sciences.
When asked to quantify how many new drug applications contain QM or modeling approaches, FDA said that “currently all new drug applications contain some element of QM to help address a variety of drug development, regulatory, and therapeutic questions.” In drug development, modeling and simulation approaches are used for clinical trial planning, dose optimization, predicting clinical outcomes, predicting product safety, evaluating relationships between drug concentrations and adverse events, and supporting evidence of effectiveness.
The announcement is FDA’s latest effort to establish centers of excellence to promote research and collaboration on topics of interest. It joins the Office of Pharmaceutical Quality (OPQ) Center for Excellence, established in November 2023; the Digital Health Center of Excellence established in September 2020; and the Oncology Center of Excellence (OCE) established in January 2017.
FDA will host a workshop on 25 April to discuss the new center of excellence and solicit feedback.
Announcement
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.