Study on the Technology Trends and Development Plan of Bioimaging for New Drug Development

Abstract

With change of medical paradigm toward patient-focused and personalized medication, the focus has changed from treatment of diseases to prevention of diseases. Owing to the increase in chronic diseases and population aging, the Korean pharmaceutical market size has rapidly increased, making the pharmaceutical industry the next-generation strategic sector. However, when considering the scale of investments, has indicated very low success rate. In addition, it took very long time to develop a new drug, leading to such undesirable outcomes (approval of small number of new drugs and decreased productivity, compared to R&D investment). Therefore, the need for development of new drug development strategies and introduction of new concept to increase the efficiency of the new drug development and to reduce the devel-opment cost has been highlighted. Accordingly, it is necessary to assure paradigm shift and coherent linking of pre-clinical and clinical studies, in order to correctly select candidate drugs for clinical studies. In order to overcome limitations of clin-ical studies, developed countries have expanded supports and investments in development of techniques for clinical eval-uation and improvement of clinical program. Techniques obtained from such activities will be primarily used in establishing regulatory requirements as well as international standards. One of such alternative techniques for clinical evaluations is “bioimaging technique”. The bioimaging technique is a non-invasive technique to show living organism s structural and functional images. It can visualize normal biological processes, pathological processes and pharmacological responses to treatments and enable objective measurement and evaluation. It includes X-ray, CT, MRI, PET and others widely used in medical examinations. In this study, the bioimaging technique and its utilization are carefully investigated and regulatory trends in foreign countries are analyzed to identify current status in Korea. In addition, suggestions have provided to activate research of bioimaging technique in Korea and improve the system for review and evaluation of medicinal products.