[Interview] Eli Lilly clinical chief maps Korea’s path to a global top-three trial hub

The Korean government aims to position the country as the world’s third-largest clinical trial hub by 2030, bolstering its global competitiveness.

Key strategies include expanding research infrastructure, regulatory innovation, and strengthening global cooperation. Against this backdrop, how do leaders at multinational pharmaceutical companies that design and operate global clinical trials view Korea's research environment?

Janelle Sabo, senior vice president for clinical capabilities at Eli Lilly, recently visited Korea to examine the Ministry of Food and Drug Safety (MFDS) and its clinical trial ecosystem.

In an interview with Korea Biomedical Review, Sabo moved beyond simply evaluating Korea's regulatory authorities. Building on her observations, she offered specific suggestions on changes Korea should pursue to achieve its national goal of becoming a “clinical trial powerhouse.”

Janelle Sabo, senior vice president for clinical capabilities at Eli Lilly, discussed the Korean clinical research environment in an interview with Korea Biomedical Review.

‘Korea's regulatory authorities are already innovative’

Sabo assessed the MFDS as “a regulatory authority with solid fundamentals that has already introduced innovative systems.” She noted that Korea's regulatory environment has indeed made significant progress over the past five to 10 years.

Sabo said she was particularly impressed by the MFDS's “attitude toward innovation” during discussions. The MFDS showed strong interest in new clinical approaches, such as decentralized clinical trials (DCT), and reached consensus on the potential of digital technology for patient monitoring. As Sabo sees it, this indicates that Korean regulators are not merely conservative “approval bodies” but also share an understanding of the changing clinical trial paradigm.

However, her assessment was not entirely positive. “Korea is not the country with the longest Investigational New Drug (IND) approval period in the world,” she said. “Compared to the recent global environment, however, it is becoming relatively longer.”

The crucial point is not the absolute approval period; rather, the global clinical trial environment is rapidly changing. According to Sabo, recent global clinical trials are increasingly designed with shorter patient enrollment periods, and in most disease areas outside oncology, recruitment periods are now often compressed to “weeks” rather than months.

“In Korea, delayed trial starts can reduce enrollment periods to just four to eight weeks, causing missed global clinical trial opportunities,” she noted.

In global clinical trials, ‘speed equals opportunity’

Sabo explained that this phenomenon is less about regulatory issues and more intertwined with the structural characteristics of global clinical trials. Most global trials adopt a “competitive enrollment strategy.” That is, countries that complete preparations first begin patient enrollment, and once the target patient number is filled, enrollment opportunities for other countries automatically diminish.

Sabo pointed out that in Korea, extensive data submissions prolong preparation time, review cycles are difficult to predict, and the overall review schedule is relatively lengthy. She emphasized that these factors combined inevitably delay clinical trial preparation.

When these three factors combine, Korea struggles to become the “first country to begin enrollment” in global clinical trials. Consequently, the patient enrollment period shortens, creating a vicious cycle that further disadvantages Korea's clinical trial outcomes.

‘Not a structural problem but an alignment problem’

An interesting point was her assessment of Korea's regulatory structure, where the Investigational New Drug (IND) application and the New Drug Application (NDA) are separate processes. In Korea, clinical trial approval and new drug licensing review operate as separate procedures. In contrast, some countries adopt an integrated model where collaboration with the licensing department begins during the clinical phase.

“Different models can be applied in different countries, and both can be effective,” Sabo said, meaning that the choice of structure itself is not the core issue.

What she emphasized was “alignment” between stages, rather than the structure itself. She explained that if each stage—clinical trial departments, new drug approval review departments, and GMP inspections—is more closely coordinated, and the entire schedule is managed as a single flow, the speed of delivering new drugs to patients can be improved regardless of the model.

Janelle Sabo proposed institutional improvement measures to help Korea become a global top-three nation in clinical trials.

Realistic proposals for becoming the ‘top-3 clinical trial power’

Sabo outlined three clear recommendations for Korea to become a global top-three nation in clinical trials.

First, she recommended clearly differentiating data submission requirements by clinical phase. Because early- and late-stage trials require different types and amounts of data, distinguishing them would help companies accelerate submission preparations.

Second, Sabo advised implementing “innovative measures to shorten review timelines” specifically for late-stage clinical trials. She clarified that this should focus on streamlining the review process rather than simply increasing personnel.

Finally, Sabo emphasized the need to expand cooperation between the MFDS and industry to support the growth of decentralized clinical trials (DCT) and community-based research. She recommended three key actions: clearly define the roles of researchers and companies, reduce burdens when adopting new technologies, and facilitate patient recruitment.

While not denying Korea's regulatory authorities' fundamental capabilities, she stressed that if the goal is to become a top-three nation in global clinical trials, a leap beyond the current level is necessary.

As global clinical trials become increasingly fast-paced and competitive, achieving Korea's goal of becoming a “top-three global clinical trial nation” appears to require not only institutional innovation but also meticulous adjustments to operational methods.

Although this challenge may yield only visible results in the long term, from the perspective of global big pharma, it is likely to be the turning point that determines the next leap forward for Korean clinical trials.