FDA’s CDER Establishes New Quantitative Medicine Center of Excellence

The U.S. Food and Drug Administration’s (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. This new CoE will bring together staff and leadership from the Office of Generic Drugs, Office of New Drugs, Office of Pharmaceutical Quality, and Office of Translational Sciences in CDER. The goal of this CDER QM CoE is to facilitate and coordinate the continuous evolution and consistent application of QM across the Center. 

 CDER’s QM CoE will conduct the following activities: 

• 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.

The Office of Clinical Pharmacology (OCP) is pleased to offer this e-mail subscription service on quantitative methods, including model-informed drug development. This is a free service from FDA to provide occasional updates on application of model-informed approaches, policy development and best practices in the area of quantitative medicine, outreach and engagement activities, and resources as they become available.

Subscribe today and select Model-Informed Drug Development under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by the Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.