| [Interview] Soohyun Lew, Chief Medical Officer of JNPMEDI
| CRO Supporting All Stages of Drug Development…PMS, OS, and More
| Global Clinical Trials Considering Various Regulatory Environments
The adoption of digital technologies is accelerating to maximize clinical trial efficiency. Utilizing suitable EDC (Electronic Data Capture) systems for each clinical trial plays a crucial role in enhancing the accuracy and reliability of data in the drug development process.
In this evolving landscape, JNPMEDI announced the recruitment of Vice President Soohyun Lew in June, demonstrating its commitment as a CRO (Contract Research Organization) to support domestic medical product development companies in their global market expansion. Dr. Lew, a family medicine specialist, has over 20 years of experience in the pharmaceutical and biotechnology industry, including roles in both global and domestic pharmaceutical companies and CROs.
Young Doctor met with Dr. Lew to discuss the rapidly changing CRO industry, trends in digital innovation in clinical trials, and JNPMEDI's future plans.
Dr. Soohyun Lew spoke with Young Doctor about the rapidly evolving CRO industry and trends in clinical trials.
▶ Please introduce yourself briefly.
After a brief tenure as a professor at Severance Hospital, I entered the industry in 2010 as the Medical Director at GE Healthcare Korea. Subsequently, I served as the Medical Director at Novartis Korea, and worked on clinical research and development at domestic pharmaceutical companies such as Yungjin Pharm. Additionally, I held CEO positions at CROs such as SeoulCRO and DreamCIS.
▶ What is your current role and goal at JNPMEDI?
As the Chief Medical Officer (CMO), I am responsible for formulating and executing strategies for new drug development and clinical trials. While the role of medical affairs traditionally focused on designing clinical trial protocols and analyzing results, it has recently expanded to include overall new drug development, commercialization, and technology transfer strategies.
The ultimate goal for both our clients and JNPMEDI is not only to obtain regulatory approval for pharmaceuticals and medical devices but also to quickly and effectively provide medical products to patients suffering from diseases. To this end, we are utilizing EDC systems and AI-based algorithms to enhance the efficiency and quality of clinical trials.
▶ JNPMEDI is known for its support of the development and approval of digital therapeutics through decentralized clinical trials (DCT), such as for Welt’s digital therapeutic device. Hence, there is a strong perception of JNPMEDI as a solution company for decentralized clinical trials.
It is true that JNPMEDI started as an EDC system provider, but since last year, we have been offering full-scope CRO services, supporting everything from substance discovery to preclinical, clinical, and commercialization stages. In the short term, we are particularly targeting PMS (Post-Marketing Surveillance) and OS (Observational Studies). These studies generate vast amounts of data, and efficiently organizing and deriving results from this data is highly beneficial for our clients. Additionally, we provide consulting services, discussing new drug development strategies with our clients. JNPMEDI is a partner in new drug development.
▶ What is the competitive edge of JNPMEDI’s clinical trial solutions, including the EDC system?
It’s difficult to compare EDC systems from different companies directly, as each system is tailored to specific situations. The requirements for developing oncology drugs or treatments for rare diseases vary. However, JNPMEDI’s EDC system, the 'Maven Clinical Cloud,' handles data collection, monitoring, and analysis on a single platform. This means it can manage all stages of a clinical trial integrally, unlike other solutions that require separate systems for different phases.
JNPMEDI supports remote monitoring and DCT to increase patient accessibility to clinical trials and maximize trial efficiency. We also offer customized solutions tailored to the specific needs of each client, optimizing support for each project. As mentioned, the appropriate EDC system depends on the indication or the type of pharmaceutical/medical device. JNPMEDI reflects client demands and feedback as much as possible to facilitate efficient and successful clinical trials.
▶ One of the hot topics in the CRO industry recently is supporting domestic companies in entering overseas markets. What advice do you provide to clients in this regard?
To grow the company and increase revenue, targeting North America, which accounts for over half of the global pharmaceutical market, is inevitable. Many researchers want to conduct clinical trials in Korea and obtain approval domestically, but this can make international expansion difficult. It’s challenging to get FDA approval in the US with only domestic clinical trial data. The same goes for licensing out. Many biotech companies want to license out new drug candidates to global pharmaceutical companies, but it’s unlikely that they will accept just domestic clinical trial results.
Expanding on the topic of global market entry, China’s regulatory agency is very independent, with little interaction with other regulatory agencies. Therefore, conducting clinical trials in China solely due to the large patient pool can lead to isolation within China. We recommend conducting trials in China only when targeting East Asian patients, as there are few patients in Korea, and costs are high in Japan.
Eastern Europe or Australia, which were once popular for their low costs, may not have their clinical data immediately recognized by the US FDA. It’s crucial to consider the regulatory environment of each country carefully when conducting clinical trials abroad.
▶ What is the vision and direction of JNPMEDI?
Our goal is to continuously develop JNPMEDI’s EDC system to maximize clinical trial efficiency. JNPMEDI is a company that seeks the success of new drug development through clinical trials. Our aim is to shorten clinical trial durations and improve quality through fast and efficient systems, ultimately providing better treatment options to patients. We will continue striving to realize this vision.
| [Interview] Soohyun Lew, Chief Medical Officer of JNPMEDI
| CRO Supporting All Stages of Drug Development…PMS, OS, and More
| Global Clinical Trials Considering Various Regulatory Environments
The adoption of digital technologies is accelerating to maximize clinical trial efficiency. Utilizing suitable EDC (Electronic Data Capture) systems for each clinical trial plays a crucial role in enhancing the accuracy and reliability of data in the drug development process.
In this evolving landscape, JNPMEDI announced the recruitment of Vice President Soohyun Lew in June, demonstrating its commitment as a CRO (Contract Research Organization) to support domestic medical product development companies in their global market expansion. Dr. Lew, a family medicine specialist, has over 20 years of experience in the pharmaceutical and biotechnology industry, including roles in both global and domestic pharmaceutical companies and CROs.
Young Doctor met with Dr. Lew to discuss the rapidly changing CRO industry, trends in digital innovation in clinical trials, and JNPMEDI's future plans.
Dr. Soohyun Lew spoke with Young Doctor about the rapidly evolving CRO industry and trends in clinical trials.
▶ Please introduce yourself briefly.
After a brief tenure as a professor at Severance Hospital, I entered the industry in 2010 as the Medical Director at GE Healthcare Korea. Subsequently, I served as the Medical Director at Novartis Korea, and worked on clinical research and development at domestic pharmaceutical companies such as Yungjin Pharm. Additionally, I held CEO positions at CROs such as SeoulCRO and DreamCIS.
▶ What is your current role and goal at JNPMEDI?
As the Chief Medical Officer (CMO), I am responsible for formulating and executing strategies for new drug development and clinical trials. While the role of medical affairs traditionally focused on designing clinical trial protocols and analyzing results, it has recently expanded to include overall new drug development, commercialization, and technology transfer strategies.
The ultimate goal for both our clients and JNPMEDI is not only to obtain regulatory approval for pharmaceuticals and medical devices but also to quickly and effectively provide medical products to patients suffering from diseases. To this end, we are utilizing EDC systems and AI-based algorithms to enhance the efficiency and quality of clinical trials.
▶ JNPMEDI is known for its support of the development and approval of digital therapeutics through decentralized clinical trials (DCT), such as for Welt’s digital therapeutic device. Hence, there is a strong perception of JNPMEDI as a solution company for decentralized clinical trials.
It is true that JNPMEDI started as an EDC system provider, but since last year, we have been offering full-scope CRO services, supporting everything from substance discovery to preclinical, clinical, and commercialization stages. In the short term, we are particularly targeting PMS (Post-Marketing Surveillance) and OS (Observational Studies). These studies generate vast amounts of data, and efficiently organizing and deriving results from this data is highly beneficial for our clients. Additionally, we provide consulting services, discussing new drug development strategies with our clients. JNPMEDI is a partner in new drug development.
▶ What is the competitive edge of JNPMEDI’s clinical trial solutions, including the EDC system?
It’s difficult to compare EDC systems from different companies directly, as each system is tailored to specific situations. The requirements for developing oncology drugs or treatments for rare diseases vary. However, JNPMEDI’s EDC system, the 'Maven Clinical Cloud,' handles data collection, monitoring, and analysis on a single platform. This means it can manage all stages of a clinical trial integrally, unlike other solutions that require separate systems for different phases.
JNPMEDI supports remote monitoring and DCT to increase patient accessibility to clinical trials and maximize trial efficiency. We also offer customized solutions tailored to the specific needs of each client, optimizing support for each project. As mentioned, the appropriate EDC system depends on the indication or the type of pharmaceutical/medical device. JNPMEDI reflects client demands and feedback as much as possible to facilitate efficient and successful clinical trials.
▶ One of the hot topics in the CRO industry recently is supporting domestic companies in entering overseas markets. What advice do you provide to clients in this regard?
To grow the company and increase revenue, targeting North America, which accounts for over half of the global pharmaceutical market, is inevitable. Many researchers want to conduct clinical trials in Korea and obtain approval domestically, but this can make international expansion difficult. It’s challenging to get FDA approval in the US with only domestic clinical trial data. The same goes for licensing out. Many biotech companies want to license out new drug candidates to global pharmaceutical companies, but it’s unlikely that they will accept just domestic clinical trial results.
Expanding on the topic of global market entry, China’s regulatory agency is very independent, with little interaction with other regulatory agencies. Therefore, conducting clinical trials in China solely due to the large patient pool can lead to isolation within China. We recommend conducting trials in China only when targeting East Asian patients, as there are few patients in Korea, and costs are high in Japan.
Eastern Europe or Australia, which were once popular for their low costs, may not have their clinical data immediately recognized by the US FDA. It’s crucial to consider the regulatory environment of each country carefully when conducting clinical trials abroad.
▶ What is the vision and direction of JNPMEDI?
Our goal is to continuously develop JNPMEDI’s EDC system to maximize clinical trial efficiency. JNPMEDI is a company that seeks the success of new drug development through clinical trials. Our aim is to shorten clinical trial durations and improve quality through fast and efficient systems, ultimately providing better treatment options to patients. We will continue striving to realize this vision.