Drugs

CDER Quantitative Medicine CoE Explained

The newly launched CDER Quantitative Medicine (QM) Center of Excellence (CoE) provides the organizational framework to foster collaboration and cooperation in QM efforts across CDER and facilitate engagement with all stakeholders to advance therapeutic medical product development, inform regulatory decision-making, and promote public health, That’s the explanation provided by QM CoE lead Rajanikenth Madabusi in a new online CDER Conversation.

Madabushi says the CoE 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; and
coordinate CDER’s efforts around QM education and training.

He says 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.

“By continuing to foster the integration and broader adoption of QM approaches across CDER,” Madabushi writes, “the CoE can help advance drug development and inform regulatory decision-making. As a result, the QM CoE is anticipated to help streamline drug development and accelerate the delivery of safe, effective, therapeutically optimized medicines to the public.”

He says that in the future the CoE plans to:

identify and prioritize gaps in knowledge and determine areas of further research and development in CDER;
develop a strategic plan and develop task forces to achieve its goals;
create additional opportunities to engage with the QM CoE in public forums;
provide additional education and training opportunities for all stakeholders involved in drug development and review; and
develop a repository of case studies of when and how quantitative approaches helped streamline drug development, such as by informing clinical trial design, optimizing drug dosages, helping determine patient populations, or improving benefit/safety profiles.

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