The U.S. FDA’s Center for Drug Evaluation and Research (CDER) has announced the establishment of the CDER Quantitative Medicine (QM) Center of Excellence (CoE). This center focuses on the development and application of exposure-based, biological, and quantitative modeling and simulation approaches using data from nonclinical, clinical, and real-world sources. These methods aim to inform drug development, regulatory decisions, and patient care.

The QM CoE will unify efforts from various CDER offices, including the Office of Generic Drugs, Office of New Drugs, Office of Pharmaceutical Quality, and Office of Translational Sciences. The objectives of the QM CoE are:

  • Developing and promoting QM-related policies and best practices.
  • Enhancing outreach to scientific societies, patient advocacy groups, and other stakeholders.
  • Coordinating education and training initiatives within CDER.

By integrating QM approaches, the CoE aims to improve the efficiency of drug development, tackle complex issues, and enable the delivery of optimized treatments. This integration is expected to streamline drug development processes, accelerate the availability of safe and effective medicines, and enhance public health. 1

Read more about the Center here.

References

  1. Research, C. F. D. E. A. (2024, May 2). CDER Quantitative Medicine Center of Excellence (QM COE). U.S. Food And Drug Administration. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-quantitative-medicine-center-excellence-qm-coe

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