FDA Lecture: FDA Division of Applied Regulatory Science: Bridging the Gap Between Scientific Innovation and Drug Regulation

Alexandre Ribeiro, PhD
Staff Fellow (Biological Scientist)
CDER, U.S. Food and Drug Administration

Abstract

The US Food and drug Administration (FDA) established a strategic plan in 2011 for developing regulatory science dedicated to new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. Following this goal, the Division of Applied Regulatory Science was formed in the Center for Drug Evaluation and Research (CDER) with the mission of bringing new science into the drug regulatory process and bridging the gap between scientific innovation and drug review. The Division focuses on mission-critical applied research and in supporting the review effort in CDER with specialized consultations in fields that mirror the different research projects that are developed in the Division: in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses. Here we will generally highlight research projects being developed in the Division and focus on the evaluation of hepatic and cardiac cellular systems as drug development tools. Heart and liver are the main targets of drug toxic effects and modeling the physiological performance of these tissues in drug regulatory contexts can predict clinical adverse earlier in the drug development pipeline. For toxicology and pharmacology regulatory uses, cellular systems must operate robustly, produce reproducible results and reliably provide mechanistic insight on drug effects. This field stands on the need to standardize microdevices for culturing cellular systems, set quality control parameters for cells to use and define drug development contexts of use. For addressing many of these needs, the Division collaborates with Offices throughout CDER, across the FDA, other government agencies, academia, and industry.