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CDER Establishes New Quantitative Medicine Center of Excellence

[03/25/2024] FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the new CDER Quantitative Medicine (QM) Center of Excellence (CoE).

QM involves the development and 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. These approaches contribute to the totality of understanding of a drug's benefits and risks, helping to advance therapeutic medical product development and inform regulatory decision-making.

The goal of this CoE is to facilitate and coordinate the continuous evolution and consistent application of QM across CDER.

“For decades, CDER has been at the forefront of advancing QM approaches to inform premarket product review and post-market product assessment,” said Patrizia Cavazzoni, M.D., director of CDER. “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.”

CDER’s QM CoE will be a center-wide effort and will:

  • Spearhead QM-related policy development and best practices to facilitate the consistent use of QM approaches during drug development and regulatory assessment
  • Facilitate systematic outreach to scientific societies, patient advocacy groups, and other key stakeholders
  • Coordinate CDER’s efforts around QM education and training

Drug development is a multifaceted, complex, high-risk endeavor involving a range of scientific, financial, and regulatory challenges. Innovative technologies, tools, and approaches are increasingly utilized to improve drug development efficiency throughout the lifecycle, address complex issues and enable optimized treatments reaching patients. By fostering integration of QM approaches across CDER, the CoE can help advance therapeutic medical product development and inform regulatory decision-making. As a result, the QM CoE is expected to help streamline and accelerate drug development and speed the delivery of safe, effective, therapeutically optimized medicines to the public.

On April 25, CDER will host a public workshop on QM and will share more about the new CoE. To register, please visit Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence.

 
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