Growing Competent Future Leaders in the Biohealth Industry

2021-06-14 Academic

The College of Pharmacy became the research leader in drug efficacy evaluation for the Cultivating Competence in Regulatory Science Project by the Ministry of Food and Drug Safety

Over the next five years, the College of Pharmacy will receive a total of 2.5 billion KRW to train master’s- and doctorate-level professionals in regulatory science. This is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of diverse products. The significance of the regulatory science in the rapidly expanding field of bio-health industry continues to grow stronger. Businesses and academic institutions work together to implement the new project aimed at cultivating competent future leaders in new industries related to regulatory science, such as pharmaceuticals, medical devices, and health supplements.

In the second semester of 2021, the College of Pharmacy will offer a new regulatory science major at the graduate school for master’s and doctorate degrees that will introduce a new phase of innovation to the regulatory process regarding drug efficacy evaluation. Professor Hae Sun Suh at the Department of Pharmacy, the research head of the project, stressed, “The College of Pharmacy has education and research capabilities in clinical trials, healthcare big data, and biotech entrepreneurship. Leveraging our capacity, we have thoroughly prepared ourselves to support the project. Competent professionals produced by the project can help find an effective and strategic way to develop new drugs, which will play a key role in the nation’s advancement.

Three tracks in place: biopharmaceuticals, clinical pharmacology, and healthcare big data
Department Chair Eun Kyoung Chung explained: “Regulatory science experts are in demand not only in novel/variant infectious diseases, advanced biopharmaceuticals, and regenerative medicine but also in pharmacometrics, which will innovate clinical trials, modeling/simulation, healthcare big data, and real-world data. My college will encourage students to choose from three sub-majors, reflecting the needs of the Ministry of Food and Drug Safety. Each sub-major is designed to provide unique basic and intensive courses. Also added are problem-based, project-based, and other self-directed learning programs. Many businesses helped us to invite field experts as visiting instructors, and their special lectures have become a precious part of our curriculum.”

From the beginning, the project’s curriculum was designed for blended learning (hybrid learning that combines both traditional classroom and online courses). Therefore, it offers on-the-job training opportunities as well as classes led by invited expatriate lecturers who are working at the U.S. FDA or other such organizations. Students in the Master's program are encouraged to do internships with businesses, and doctoral candidates are also invited. The project designers studied some U.S. cases and then arranged a training-to-placement fellowship program to help students pursue their desired careers. New doctors are allowed to participate in the program for at least a year or two. More programs are in the pipeline to assist their entry into workforce in accordance with the agreements with pharmaceutics and government agencies.

Improving students’ research capability is another goal. Professor Suh noted, “Research capability enables the review of new drugs. Our students can strengthen their research capabilities to the utmost while dealing with advanced biopharmaceuticals and gene therapy; clinical pharmacology, pharmacometrics, and other clinical fields; healthcare big data; and real-world data.”

The addition of the Regulatory Science Department is rejuvenating the graduate school. “Clinical and social pharmacy is attracting more students than ever; however, its novelty suggests fewer career paths, which may discourage prospective students. The newly added Regulatory Science major provides them with broader career options,” said Professor Chung.

Professor Suh added, “Sufficient infrastructure is essential to a successful landing of the new major in graduate school. Support from the University and the entire Kyung Hee community is essential to ensure improved education quality. I expect our good start will lead to follow-up projects.”

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