The FDA’s Center for Drug Evaluation and Research on Wednesday officially launched a new center of excellence to better coordinate simulation and modeling work, covering everything from drug development and review, post-market surveillance and policy development.
Known as the Quantitative Medicine Center of Excellence, it was first unveiled in March. Everything from pharmaco-statistical modeling, mechanistic modeling, biomarker-endpoint development, artificial intelligence and machine learning, and clinical trial simulations and in silico predictions will be included, according to a notice in the Federal Register Wednesday.
CDER says it’s been at the forefront of quantitative medicine for decades, but wants to better centralize its efforts around outreach and education, scientific and regulatory initiatives, and operations. The center will be led by officials from the Office of Generic Drugs, Office of New Drugs, Office of Pharmaceutical Quality, and Office of Translational Sciences, the FDA said, and can serve as a forum for discussing specific product development issues when necessary.
“Recognizing the opportunity for synergy, CDER has begun a coordinated [quantitative medicine] effort that maximally leverages its subject matter experts, functional areas, and collective regulatory experience across different offices,” the agency said.
The creation of this center of excellence comes after the launch of FDA’s Digital Health Center of Excellence, which followed in the footsteps of Rick Pazdur’s Oncology Center of Excellence.