The FDA’s Center for Drug Evaluation and Research (CDER) has established a new Quantitative Medicine (QM) Center of Excellence to drive the integration of quantitative modeling, simulation, and systems biology approaches across all areas of drug development and regulatory review.
What is Quantitative Medicine?
Quantitative medicine leverages exposure-based, biological, and quantitative modeling and simulation methods derived from nonclinical, clinical, and real-world data sources. These techniques provide a holistic understanding of a drug’s benefits and risks to inform regulatory decision-making throughout the product lifecycle.
The Role of the QM Center of Excellence
The goal of CDER’s QM Center of Excellence (CoE) is to facilitate the consistent evolution and application of quantitative medicine practices center wide. Key objectives include:
- Developing QM-related policies, best practices, and standards
- Coordinating QM education, training, and external stakeholder outreach
- Enabling the systematic integration of modeling and simulation for more efficient drug development
By integrating quantitative modeling and simulation techniques, the center hopes to streamline drug development, optimizing treatments and accelerating the delivery of safe, effective medicines to patients. ✨
📆 On April 25, CDER will host a public workshop on QM and will share more about the new CoE.
🔗 To register, please visit https://www.fda.gov/drugs/news-events-human-drugs/streamlining-drug-development-and-improving-public-health-through-quantitative-medicine-introduction
Read the original blog post from the FDA on this new Quantitative Medicine initiative. – CDER Establishes New Quantitative Medicine Center of Excellence | FDA
