Eun-Kyung Lim †‡§, Taekhoon Kim ∥⊥§, Soonmyung Paik #∇, Seungjoo Haam ○, Yong-Min Huh *†, and Kwangyeol Lee *∥
∥ Department of Chemistry, Korea University, Seoul 136-701, Korea
† Department of Radiology, Yonsei University, Seoul 120-752, Korea
# Severance Biomedical Research Institute, Yonsei University College of Medicine, Seoul 120-749, Korea
∇ Division of Pathology, NSABP Foundation, Pittsburgh, Pennsylvania 15212, United States
○ Department of Chemical and Biomolecular Engineering, Yonsei University, Seoul 120-749, Korea
‡ BioNanotechnology Research Center, Korea Research Institute of Bioscience and Biotechnology, Daejeon 305-806, Korea
⊥ Electronic Materials Laboratory, Samsung Advanced Institute of Technology, Mt. 14-1, Nongseo-Ri, Giheung-Eup, Yongin-Si, Gyeonggi-Do 449-712, Korea
§These authors contributed equally to this work.
*Corresponding authors
In 2004, the U.S. Food and Drug Administration (FDA) released an important report entitled “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products”. This “Critical Path Initiative” directly reflects the FDA’s great interest to modernize the manufacturing process of FDA-regulated products. In particular, the FDA reported the declining number of approved innovative medical products and strongly requested a concerted effort to modernize scientific tools.(1-3) On the other hand, John Funkhouser, the Chief Executive Officer of PharmaNetics, used the term “Theranostics” for the first time in 1998 as a concept of “the ability to affect therapy or treatment of a disease state”. Accordingly, theranostics as a treatment strategy for individual patients encompasses a wide range of subjects, including personalized medicine, pharmacogenomics, and molecular imaging, in order to develop an efficient new targeted therapy and optimize drug selection via a better molecular understanding. Furthermore, theranostics aims to monitor the response to the treatment, to increase drug efficacy and safety, and to eliminate the unnecessary treatment of patients, resulting in significant cost savings for the overall healthcare system.(2) Therefore, the emerging science of theranostics seems to provide a unique opportunity to pharmaceutical and diagnostics companies to meet the regulatory and financial constraints imposed by the FDA.(1, 2)