Kevin Lorick, OIR


Kevin Lorick is currently a reviewer in the Molecular Pathology and Cytology Branch within the Division of Molecular genetics and Pathology in the Office of In Vitro Diagnostics and Radiologic Health (OIR) where he is involved in Regulation of the total product life cycle of diagnostic devices.  In the post market, he is involved with manufacturing review and compliance actions involving general In Vitro diagnostic products.  In the premarket, he primarily focuses on review of cancer diagnostic and monitoring tests. He is co-chair of the Nanotechnology Review Network, has been involved in guidance development efforts and is the OIR representative to the CDRH Nanotechnology Specialty Task Group.

Kevin Lorick has a B.S. in Biological Chemistry from the University of Chicago and received his Ph.D in Molecular and Cellular Biology from Tulane University where he focused on Environmental Toxicology associated with Dioxin Receptors.  Kevin did his post-doctoral work at the NCI in Bethesda looking at the Biochemistry of T-cell Receptors and RING Finger Proteins.  He later moved to NCI-Frederick where he worked on Drug development associated with the Ubiquitin-Proteasome system and Parkinson’s disease.  Kevin spent two years working for Intrexon Corporation as the Senior Director of Bioassay Design before joining FDA in 2008.
(Updated Sept. 2014)

Abstract:

This talk will give an overview of the CDRH regulatory framework and see where nanotechnology products may lie within this framework. An attempt will be made to look at device review in various product areas throughout the total product life cycle (TPLC). It will also attempt to address the unique challenges of material characterization in nanotechnology when compared to other materials and of the manufacturing aspects that should be kept in mind.