[Insight & Opinion] "The 'Second Semiconductor' Bioindustry Desperately Needs Innovation"

Published 30 Jun.2023 13:31(KST)

President Yoon Suk-yeol reportedly declared at the export strategy meeting that he will nurture the bioindustry as the second semiconductor sector. The plan envisions universities, companies, research institutes, and hospitals forming clusters to globally grow the bioindustry, dreaming of a Korean-style Boston Bio Cluster. Reviewing the details, the focus remains on research and development. Keywords include joint research, combining technical personnel, establishing graduate schools, opening medical artificial intelligence (AI) courses, and leading R&D projects. These mainly fall under the Ministry of Science and ICT’s role.

If the global bioindustry market, expected to grow to 2,000 trillion won within five years, is desired, the government’s role in removing obstacles across the entire process?from research and development to manufacturing, clinical trials, and treatment?is more urgent than just R&D. The domestic bio workforce has already reached world-class levels. However, looking at those working in this field, it is regrettable that they seem to be waiting for regulations to be lifted or researching ways to circumvent regulations, engaging in activities that ideally should not be done.

Since human life is involved, it is natural that all processes must be conducted under strict regulations. However, thinking more proactively, innovation is necessary to improve medical services and save even one more life, such as patients with incurable diseases. The president reportedly toured the Boston Bio Cluster during his visit to the U.S., but the core of that region is not the visible research infrastructure and environment but the bold experimentation and innovation throughout the entire process from research to treatment. It is hoped that the process of boldly adopting research outcomes in that cluster region for medical use and further developing them into industry will be examined.

Our problem is not a lack of research and development capability but low societal acceptance of innovation and being bound by various regulations that prevent movement. If a free environment is provided, the private sector will foresee the future before the government, and enormous investments are waiting.

It has been over ten years since advocating for non-face-to-face medical treatment, and only now is it being partially allowed, albeit in a distorted form. Digital therapeutics are being developed in various fields combined with digital technology, but adoption in medical practice is still far off. Before talking about medical big data and AI, there must first be discussion on how to open and share medical data. Stem cell therapy is a representative regulated area. Although it is said that efficacy and safety have not yet been verified, more boldness is needed for patients waiting for a last resort.

Patients with incurable diseases such as Buerger’s disease, spinal injuries, degenerative arthritis, and Alzheimer’s dementia wait for regulations to be lifted while harvesting, culturing, and storing their own stem cells. Although significant private investment is being made, many fields remain at the research stage, and development and approval have not been completed, limiting them to clinical trial levels.

Because of strict illegal prohibitions, rumors have emerged that even the president received illegal treatments, and there are cases where cells initially cultured domestically are further cultured in Japan and treatments are performed at Japanese medical institutions. Of course, this is under the supervision of Japan’s Ministry of Health, Labour and Welfare. In Japan, under the Regenerative Medicine Act, the Ministry thoroughly supervises while expanding doctors’ discretion and patients’ choices. This law enables rapid and safe treatments in fields where safety has already been secured, leading to the emergence of numerous regenerative medicine products in the market. To truly nurture the medical bioindustry as the second semiconductor sector, bolder and more innovative approaches are needed, akin to the American Westward expansion era.