SUPPLEMENTARY INFORMATION:

I. Background

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: (1) drug development, (2) regulatory decision-making, and (3) patient care. The technical scope includes pharmaco-statistical modeling, mechanistic modeling, biomarker-endpoint development, artificial intelligence and machine learning, and clinical trial simulations and in silico predictions. Within CDER, QM approaches have been used to inform premarket product review, post-market product assessment, policy development, and policy implementation.

While CDER has been at the forefront of advancing QM over the decades, the efforts in outreach and education, scientific and regulatory initiatives, and operations have largely been decentralized. Recognizing the opportunity for synergy, CDER has begun a coordinated QM effort that maximally leverages its subject matter ( printed page 80258) experts, functional areas, and collective regulatory experience across different offices.

II. Objectives of QM CoE

The QM CoE will facilitate and coordinate the continuous evolution and consistent application of QM for drug development and regulatory decision-making to advance therapeutic medical product development, inform regulatory decision-making, and promote public health, by:

• spearheading QM-related policy development and best practices to facilitate the consistent use of QM approaches during the drug development and regulatory assessment;
• providing strategic direction for CDER's QM activities; and
• coordinating CDER's efforts around QM education, training, and community engagement.

III. Anticipated Outcomes of QM CoE

The QM CoE will harmonize existing activities and identify and initiate new activities in the areas of multidisciplinary education and exchange, science policy development and implementation, knowledge management, and community engagement. The centralization of QM efforts across CDER within the CoE will allow for operational optimization and consistent application of QM approaches to advance therapeutic medical product development, inform regulatory decision-making, and promote public health.

89 FR 80257