First step toward training specialists in “clinical translation” for the advanced regenerative biopharma industry; Seoul metropolitan area education consortium planned

[Financial News] As the advanced regenerative biopharma industry enters the commercialization stage, with South Korea’s first domestically developed CAR-T therapy among the products receiving approval, industry-hospital collaboration has begun to train specialists in “clinical translation”—connecting research outcomes to actual patient treatment. The practical training model uses manufacturing facilities and hands-on training equipment already owned by hospitals and companies as training venues.
The Association for the Advanced Regenerative Medicine Industry (CARM) signed a memorandum of understanding (MOU) in writing on the 5th with five organizations—Kangstem Biotech, Seoul National University Hospital, Sartorius Korea Biotech, Ewha Womans University Mokdong Hospital, and GeneMedicine—to develop a professional workforce for the advanced regenerative biopharma industry.
The agreement is intended to lay the groundwork for the association’s “Workforce Development Program for the Advanced Regenerative Biopharma Industry Based on On-Site Demand.” The association is developing practical, industry-focused curricula that reflect workforce needs at companies, medical institutions, and other workplaces across the industry, and is working to establish an “Education Consortium for Workforce Development in the Advanced Regenerative Biopharma Industry” that brings together industrial and clinical infrastructure in the Seoul metropolitan area.
Advanced biopharmaceuticals such as cell and gene therapies use living cells or genetic material as raw materials. For research outcomes to lead to patient treatment, they must pass through nonclinical (animal testing), clinical (human trials), and approval stages, with manufacturing, quality, and safety data prepared along the way. As the industry enters the commercialization stage, with South Korea’s first domestically developed CAR-T therapy approved last April, on-the-ground demand is also growing for practical professionals who can manage this process.
In particular, companies developing advanced biopharmaceuticals, contract development and manufacturing organizations (CDMOs), cell processing facilities, and clinical institutions have repeatedly called for specialists across the entire development lifecycle, including GMP (Good Manufacturing Practice) and CMC (chemistry, manufacturing, and controls), manufacturing processes, nonclinical and clinical trials, regulatory affairs (RA), standard operating procedure (SOP) management, and preparation of the Common Technical Document (CTD). This demand is concentrated in the Seoul metropolitan area. As of last June, 158 (70.9%) of the 223 advanced regenerative medicine practice institutions nationwide were located in the Seoul metropolitan area.
The association plans to link its program with existing statutory and practical training run by public institutions, while supplementing it with practical training focused on clinical translation and based at hospitals and companies in the Seoul metropolitan area. The target audience will also expand from essential personnel at regenerative medicine institutions to development, manufacturing, quality, and regulatory affairs staff at advanced biopharmaceutical companies. The curriculum will cover the entire development lifecycle, from process development through nonclinical and clinical stages, manufacturing, quality, and regulatory affairs.
Another notable feature is that no new training facilities will be built. The program will make direct use of participating organizations’ existing cell processing and GMP manufacturing facilities, training and hands-on practice facilities, and equipment. Industry and medical institution experts with practical experience will serve as instructors, combining theory with hands-on training.
Each participating organization will have a distinct role. Seoul National University Hospital and Ewha Womans University Mokdong Hospital will provide clinical settings and expertise as research-oriented hospitals and advanced regenerative medicine practice institutions; Kangstem Biotech will provide its stem cell GMP center; Sartorius Korea Biotech will provide infrastructure for cell culture and process development training and practice; and GeneMedicine will provide its gene therapy GMP manufacturing facility. Key areas of cooperation include: jointly developing curricula that reflect industry needs; providing training facilities and hands-on practice infrastructure; connecting expert instructors and training networks; and promoting the program and recruiting trainees. The association plans to use real-world industry cases, work documents, facilities, and equipment in its training to develop people who can enter the workforce immediately after completing the program.
Bae Byung-jun, CARM chairman, said, “Developing a professional workforce that meets the needs of the industry is above all important to ensuring the sustained growth and global competitiveness of the advanced regenerative biopharma industry.” He added, “With this agreement as a starting point, we will actively connect the expertise and infrastructure of companies and medical institutions to develop practical talent needed by the industry and systematically build a foundation for workforce development in the advanced regenerative biopharma industry.”
Ko Young-il, director of Seoul National University Hospital’s Advanced Cell and Gene Therapy Center, said, “This collaboration, which connects the hospital’s clinical settings and infrastructure with industry workforce development, is a meaningful starting point for accelerating the clinical translation of research outcomes.” He added, “We will work closely together to ensure that hospital staff, as well as company personnel in development, manufacturing, and regulatory affairs, acquire skills they can put to immediate use in the field.”
The association plans to continue expanding its collaboration, starting with these five organizations, to companies and institutions with industrial and medical infrastructure in the Seoul metropolitan area. It aims to diversify its training offerings by linking each organization’s areas of expertise and infrastructure, and to grow the initiative into an education consortium spanning the industry as a whole.
Meanwhile, the program is currently seeking to secure funding in the 2027 budget as it undergoes review by the Health and Welfare Committee of the National Assembly and the Special Committee on Budget and Accounts. If the program is approved, the training schedule and each institution’s role will be specified. 

[email protected] Jung Myung-jin, Medical Correspondent Reporter