Kathleen Eggleson holds a B.S. in Biological Sciences from the University of Notre Dame and a Ph.D. in Molecular Microbiology and Microbial Pathogenesis from Washington University in St. Louis. Her current research for NDnano includes scientific, biomedical, ethical, and societal considerations.
Founded as a diagnostic company in 1988, Dr. Tamarkin re-focused CytImmune to cancer nanomedicines and co-invented its technology platform, covered in over 90 patents. CytImmune’s first nanomedicine was successfully tested in a Phase I cancer patient study; Phase II testing is planned for Q4 2012.
Description
This session will provide an overview on FDA's approach on regulating products with nanotechnology. There will also be a focus on industry case studies on experiences and challenges with nanotechnology development.
Learning Objectives: Describe the current landscape of nanomedicines from a regulator's perspective Identify evolving trends that can impact regulatory decision making Discuss case studies on nanotechnology development.