Department of Clinical Pharmacology and Therapeutics of Seoul National University college of Medicine and Hospital focuses on establishing infrastructure of clinical trial, developing regulatory policies, reviewing regulatory guidelines, and approaching multi-omics conducting national tasks organized by the government such as Ministry of Science, Ministry of Food and Drug Safety, and the Ministry of Health and Welfare.

New clinical trial technologies
  • Development of advanced convergence clinical trials (2014.11.01-2017.03.31)

- The objective: By converging advanced clinical trial technology, a platform is established that generates information of new drug candidate materials efficiently early in clinical development as integrating a system.

  • New drug development bio-imaging convergence technology center (2014.07.01-2019.09.30)

- Part 2: A research on the Development and Clinical Application of the new Bio-imaging Convergence technology for the Rapid Development of New Drugs

-The objective: To diagnose the status of new drug development bio-imaging technology, develop new technology, and implement clinical application of new technology that can contribute to the rapid speed of new drug development in South Korea using new drug development bio-imaging. In addition, to establish customized new drug development bio-imaging technology centered on the field demands.

- Part 3: Development of policies for licensing utilization of bio-imaging data

- The objective: to develop a Korean-style regulatory system for clinical trials and drug development using bio-imaging data. To lead standardization of bio-imaging data that can from the initial stage of drug development affect regulatory agencies' decision, and lead the development of medicines using bio-imaging by utilizing them efficiently.

  • Verification of the concept of micro-tracing ideal testing technology and convergence to maximize the efficiency of biological medicine development(2017.04.01-2018.12.31)

- The objective: Development of micro-tracing clinical testing technology, proof of convergence concept, dissemination of the domestic technology to maximize the efficiency of biological medicine development

Multi-omics approach
  • Medicinal Genetic Center: Drug-induced Response Research Center (2011.07.01-2015.03.31)

- The objective: By identifying genetic factors that can predict various drug-induced reactions in advance, confirming their clinical efficacy, the medical institution implements personalized drug treatment based on drug-genetic research for Koreans.

Infrastructure and regulation
  • Future environmental safety (2016.02.16-2016.11.30)

- The objective: To investigate and analyze the status of technological application and research and development of the technical trends and medications regulatory agencies for domestic and international drug performance assessment. The policy, industrial and technological demands related to safety assessment technology are investigated and evaluated.

- The objective: to select medication safety assessment technologies developed and introduced by The Ministry of Food and Drug Safety, prioritizes them suggesting a long-term R&D road map. In addition, to suggest the long-term project plans consistent with the mid- and long-term R&D road map and new research task proposals (RFP, request for proposal) with budget requirements.

  • Research on safety management projects such as medicines (2016.02.16-2016.11.30)

- The second generation: research on the safety management of bio-medicines

- The objective: to suggest comprehensive and systematic direction for the mid- and long-term future of medication safety management and draw on core promotion tasks, preparing plans for systematic detailed project planning and supports.

- The objective: To review the appropriate project size and set a baseline for securing the budget by analyzing the validation and expected effects of key new projects.

  • Analysis of global clinical cases and establishment of models for gene and stem cell therapies (2015.11.01-2019.07.31)

- The objective: To investigate global clinical development cases that successfully performed clinical trials of gene therapy and stem cell therapy, high-tech biologic drugs, and aggregate the results of systematic analysis into the database.

- The objective: To secure domestic clinical researchers in the relevant field and experts in Clinical Research Organization (CRO) and secure domestic R&D capabilities by having them interact directly or indirectly with global counterparts.

- The objective: To identify and spread success of domestic global advanced bio-medicine with deriving standard guidelines based on it as categorizing locally developed gene therapy agents, strategies and performance goals for successful global clinical development of stem cell therapies

Informative & miscellaneous
  • Development of a model for a disease-knowledge generation using complex medical information (2011.09.07-2018.08.31)
  • Data Science and Data Science Research Center (SRC) the second task under 3 controls (Resolving diseases using large-capacity combined medical information)

-The objective: To effectively use and analyze the large amount of complex medical information accumulated in the hospital information system with a new perspective, improve understanding of diseases and contribute to patients' care and the public health.

Other research tasks
  • Development of genetic-based quantitative drug response prediction models and individual personalized pharmacotherapy (2015.12.10-2018.11.30)
  • Development of individualized optimal pharmacotherapy with voriconazole by using a pharmacogenomic-based drug model (2015.11.01-2018.10.31)
  • Metabolic study to build individual CYP3A metabolic predictive models in pregnant women and renal impairment patients (2014.05.01-2017.04.30)
  • Development and modeling of metabolic bio-metrics to measure changes in healthy habits of children and adolescents (2013.11.01-2016.08.31)
  • Safety validation study of off-label use (2012.05.07-2015.10.31)