With over 30 years of experience in public office working in public health and pharmaceutical policy, food and drug safety regulations, national health and welfare policy, and overseas missions as a civil servant, Dr Bae Byuongjun now serves as president of the Korea National Enterprise for Clinical Trials (KoNECT). In this role, Dr Bae aims to bolster Korea’s already-enviable reputation as one of Asia’s top destinations for clinical research and ensure that his nation stays ahead of the competition in Asia-Pacific and beyond in terms of regulatory science and new drug development.
KoNECT will serve the role of Korea’s national control tower for clinical trials so that the process of clinical trials is safe and efficient
Dr Bae Byuongjun, KoNECT
In his role as president of KoNECT, Dr Bae identifies four key areas of focus to ensure that Korea stays ahead of the competition in Asia in terms of efficient clinical trial processes and top-notch clinical trial quality. A slowdown in the growth of the global clinical trial industry coupled with the rapid rise of capability in emerging nations and the advent of new technology means that traditional powerhouses such as Korea need a clear strategy to remain ahead of the game.
“To this end, first, we will continue to keep up our efforts in broadening patients’ access to innovative new drugs,” outlines Dr Bae. “KoNECT will serve the role of Korea’s national control tower for clinical trials so that the process of clinical trials is safe and efficient.”
“Second, we will support new drug development by enhancing Korea’s clinical trial competitiveness,” he continues. To tackle the difficulties working-level researchers find in the clinical trial process of drug development, ‘The Committee of National Competitiveness Reinforcement Plan for Clinical Trials’ engaging the industry, academia, and government will be formed to devise the ‘The Second National Competitiveness Reinforcement Plan.’ Furthermore, the training of clinical trial professionals will be expanded to ensure higher clinical trial performance.”
“Third, we will build a better support system for clinical trials to promote public health clinical research. KoNECT is an affiliated organization to the Korean Ministry of Health and Welfare and was entrusted as a ‘National Center for Clinical Research Service (Clinical Trial Coordinating Center)’ this year. Given such a role, we aim to introduce a support system to promote clinical trials in Korea for public health.”
“Fourth, we will bring about a reduction in clinical trial costs and times by using clinical trial real world data (RWD) and new clinical trial technologies. Globally, we are welcoming the era of the fourth industrial revolution. In Korea, the national assembly recently passed the so-called *’three data privacy laws’ [the Personal Information Protection Act (‘PIPA’), the Act on the Promotion of Information and Communications Network Utilization and Information Protection (‘Network Act’) and the Act on the Use and Protection of Credit Information (‘Credit Information Act’) – Ed.] and these facts highlight the importance of collecting and utilizing medical and clinical trial data.”
Dr Bae concludes, “By fully acknowledging such conditions, we plan to discover innovative clinical trial projects based on data acquired by applying fourth industrial revolution technologies with clinical trials. One example would be establishing clinical trial management systems (CTMS) at hospital clinical trial sites by carrying out projects that aim to form smart clinical trial centre platforms. In the end, such efforts will lead to a reduction in clinical trial cost and time.”
A Vision for Korea
With these objectives in place, Dr Bae envisions an enduring importance for Korea within international regulatory science and new drug development.
“Korea’s drug development history goes back a long way,” he exclaims. “The first-ever locally developed new drug was approved in 1999. Since then, local companies in Korea has never ceased developing new drugs. As a result, at least one or two new drugs developed by local pharma companies are approved annually. Thanks to this commitment to new drug development, we are seeing first approval on a couple of biosimilar products in the global market developed by Korean pharma companies.”
We are confident that Korean pharma companies/sites/investigators will play a major role in the development of new drugs in the future
Dr Bae Byuongjun, KoNECT
Dr Bae continues, “Another recent successful drug development by a Korean pharma company is SK Pharm’s epilepsy treatment XCOPRI®, which recently gained US FDA approval. The success story continues with a couple more local pharma companies closing a global deal on product licenses with global pharma companies.”
“Recently, we have also seen more and more start-up/bio venture companies enter the industry. Their key focus is on developing new drugs that will be approved globally. We already see that the nation’s clinical industry is accumulating more and more global study experience as local pharma companies continuously hone their new drug development efforts and capabilities. The Korean government is also providing strong support to that end.”
He closes, “We are confident that Korean pharma companies/sites/investigators will play a major role in the development of new drugs in the future, especially regarding innovative new drugs that will address unmet medical needs. This is evident in the fact that the Korean Ministry of Food and Drug Safety (MFDS) is leading the evolution of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.”