"Clinical Trials Ultimately 'Tests'... Will Become a Tutor Helping Success"

Interview with Yoon Seok-min, CEO of EPSIK
"Actively Supporting Clinical Trials Abroad in the US, Australia, Taiwan, and More"

Yoon Seok-min, CEO of EPSIK

[Asia Economy Reporter Lee Chun-hee] One of the industries gaining attention alongside the rapid growth of the pharmaceutical and bio industries is the Contract Research Organization (CRO) industry. Clinical trials are an essential process in new drug development. However, it is difficult for small and medium-sized biotech companies, rather than large pharmaceutical companies (Big Pharma), to independently carry out the numerous processes involved, including meeting the indicators required to prove the efficacy and safety of drugs.

On the 8th, Seokmin Yoon, CEO of EPS International Korea (EPSIK), stated, "Now, as the pharmaceutical and bio industries grow, this is a major turning point for the growth of the domestic CRO industry," adding, "Since clinical trials are ultimately 'tests,' we aim to be a tutor who helps conduct these tests well." Yoon is regarded as a pioneer of the domestic private CRO industry, having established DreamCIS, Korea's first private CRO, in 2000, and then ADM Korea in 2003. In April, he acquired a majority stake (50.1%) in EPSIK, the Korean branch of the global CRO company EPS from Japan. He emphasized, "Since I first entered the CRO industry, EPS has been my role model," and said that they will maintain a joint venture (JV) structure with EPS while continuing their cooperative relationship.

Yoon explained, "EPS focuses on Japan and China, while EPSIK leads other global markets," adding, "Cooperation will continue in areas such as multinational clinical trials." This is also why Yoon’s attention is more focused overseas than domestically. He said, "It is true that domestic CRO companies still find it difficult to expand abroad," and added, "Since we can actively utilize EPS’s abundant infrastructure and high-level systems, we will actively support conducting clinical trials directly in countries such as the United States, Australia, the Philippines, Taiwan, and Hong Kong."

Yoon also mentioned Korea’s unique competitiveness. He said, "Having worked in the CRO industry for over 20 years, I have judged that Koreans are much more diligent and honest," explaining, "The competitiveness a CRO must have is how diligently and honestly it performs the outsourced tasks entrusted to it, so we possess the most fundamental capabilities." This means that rather than being overly friendly to new drug developers who commission clinical trials, it is the CRO’s responsibility to maintain honesty and diligence by quickly sharing and disclosing any risk factors that arise.

Yoon Seok-min, CEO of EPSIK

As the chairman of the Korea Clinical CRO Association, Yoon pointed to the designation system for clinical trial institutions as the biggest obstacle hindering the growth of the domestic CRO industry. There are only 207 medical institutions nationwide authorized to conduct clinical trials for pharmaceuticals in Korea, most of which are large general hospitals. This is because clinical trials can only be conducted after meeting Good Clinical Practice (GCP) standards in advance and receiving designation from the Ministry of Food and Drug Safety.

He lamented, "This regulation exists only in our country," adding, "While foreign countries allow clinical trials even at local clinics, it is impossible here, so the domestic CRO market is now close to saturation." Yoon argued, "If the institution designation system is abolished, it could bring development not only to the CRO industry but also to various industries such as drug and specimen transportation," and insisted, "The institution designation system must be abolished."

In addition to EPSIK, Yoon operates other clinical-related companies such as GOSM and DataTeams. GOSM is a Site Management Organization (SMO) that dispatches professional clinical trial research personnel to trial institutions, and DataTeams is a company that analyzes clinical data comprehensively, including not only final results but also process data. He said, "It is no exaggeration to say that overseas, clinical trials are conducted by professional personnel dispatched by SMOs," adding, "Since the primary role of doctors is treatment, SMO professionals need to assist them." Regarding DataTeams, he added, "Because clinical trials are 'tests,' there is a tendency to focus only on clinical results," and said, "If we create a 'Minority Report' that reviews whether there are points to reconsider even in successful trials, it will provide a foundation for better clinical trials."