Chris Sasiela has been the regulatory specialist for the Office of Translational Alliances and Coordination (OTAC) of the National Heart, Lung, and Blood Institute (NHLBI) since 2012. In this role, she develops and delivers seminars and workshops related to the design of regulatory strategies for devices, diagnostics, and therapeutics, providing technology-specific advice to biomedical innovators at multiple points throughout their product life-cycle. Sasiela also serves as the NHLBI’s regulatory expert on matters related to comparative effectiveness research, new translational technology development, and approval or clearance of advanced technology platforms.
Prior to joining the NHLBI, Chris received her early regulatory training at FDA, and directed the Regulatory Affairs and Services team for a contract organization managing more than 20 INDs conducted at over 120 sites in four economic regions.
Sasiela earned a bachelor’s in chemistry from Whittier College and a Ph.D. in pharmaceutical sciences from the University of Maryland, School of Pharmacy.