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Professor Bae Seung-Jin's Team from the College of Pharmacy Selected for the Food and Drug Safety Ministry's R&D Project

  • Date2024.04.03
  • 15565

Professor Bae Seung-jin's team at the College of Pharmacy was selected for two specific projects in the first round of the 2024 Food and Drug Safety Ministry's (hereinafter referred to as MFDS) funded R&D projects, hosted by the Korea Health Industry Development Institute (KHIDI), demonstrating the excellence of their research capabilities.

As the government strives to expand the entrance of medical products into the global market through support for biopharmaceuticals and medical device regulatory science, Professor Bae Seung-jin's team was selected as the leading organization for the "Regulatory Support for Innovation in Medical Product Regulatory Science Technology Development" project and the "Regulatory Science Talent Development and Global Collaboration Research" project to advance regulatory science. As a result, the research team will receive a total of 1.9 billion KRW in funding for the next five years to proceed with regulatory science research and global cooperation projects.

Regulatory science is an applied science field that enables regulatory decision-making on clinical trials and product approvals for medical products such as biopharmaceuticals, pharmaceuticals, and medical devices, using scientific validity and evidence. Based on regulatory science, rapid development of various platforms for new drugs and innovative medical devices is taking place.

약학대학 배승진 교수팀, 식품의약품안전처 출연연구개발사업 동시 선정

Professor Bae Seung-jin(middle) and the research team

In the “Regulatory Support for Innovation in Medical Product Regulatory Science Technology Development" project, the research team will conduct studies on the correlation between intermediate and final indicators of the efficacy of bio-anticancer agents, the appropriateness of applying quality of life measurement tools such as EQ-5D to cancer patients, and the analysis of characteristics of immune anticancer agent response groups. Professor Bae Seung-jin plans to collaborate with the College of Pharmacy at National Cheng Kung University in Taiwan to conduct research using big data analysis and surveys based on domestic cancer public sample databases and Taiwan's cancer registration data.

The "Regulatory Science Talent Development and Global Collaboration Research" project will be jointly conducted by Professor Choi Nam-kyung of the Convergence Health Department at EWHA and the Korea Regulatory Science Center, in collaboration with the College of Pharmacy at Washington University in the United States and Keio National University in Japan. They will explore various recent research methodologies in regulatory science, and investigate ways to apply them. Additionally, they will perform studies on the safety and efficacy of products subject to expedited review using real-world data (RWD) and real-world evidence (RWE).

Through this research, a systematic evaluation of the safety and efficacy of recently introduced high-cost cell therapies will be provided, at the same time presenting a framework for safe access to pharmaceuticals for the public, and providing objective and scientific evaluation tools for the overseas expansion of domestically developed anticancer biosimilars and biopharmaceuticals, thus laying the groundwork for the development of the domestic pharmaceutical industry.