🧑💻 By Yong Lee, Maeil Ilbo
| Presents Vision Backed by Executives Involved in International Standard-Setting, Including ICH Members
| Actively Engaged in Developing Latest International Guidelines, Establishing Practice-Linked Training Through Industry-Academia Collaboration
| “Advancing as a Differentiated, Execution-Driven CRO”
The global pharmaceutical market has entered a period of volatility, intensified by U.S. President Donald Trump’s “America First” policy. With the possibility of steep tariffs on imported drugs and rising pressure to cut domestic drug prices, Korea’s pharmaceutical and biotech industries now face significant new challenges.
According to industry officials on the 13th, calls are growing for Korea to systematically foster its Contract Research Organization (CRO) sector and build global collaboration networks to strengthen domestic R&D capabilities. CROs are no longer viewed merely as service providers, but are emerging as core engines driving the future of the nation’s pharmaceutical and biotech industries. This shift has prompted an industry-wide restructuring to establish the necessary infrastructure.
One example is JNPMEDI, a Korean AI-driven clinical trial consulting firm, which is not only following international standards but actively contributing to their design. Through extensive industry-academia collaboration, the company has built a unique position as an “execution-driven CRO,” connecting global standards directly to practical application.
JNPMEDI’s strength stems from its execution team, which includes members of the International Council for Harmonisation (ICH), as well as experts serving as adjunct professors at leading Korean universities. This enables the company to maintain a professional education system rooted in the latest international guidelines while securing competencies that help shape industry standards.
Notably, SooHyun Lew, Chief Medical Officer at JNPMEDI, was appointed last year as an expert committee member of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), earning international recognition for his expertise. As a permanent observer to ICH, IFPMA plays a key role in global pharmaceutical regulation. Its expert committee members participate in ICH assemblies and working groups, contributing to the development and revision of international guidelines. With more than 30 years of experience in clinical trials and the pharmaceutical/medical device sectors, Lew has offered expert feedback in ICH working groups, including those developing non-clinical safety testing guidelines for oligonucleotide-based therapies.
This demonstrates that JNPMEDI’s expertise goes far beyond interpreting global standards. It reflects a capability to strategically design clinical trials that can directly support the new drug development efforts of Korean pharmaceutical companies.
Furthermore, the company’s global standard-setting expertise is being translated into real-world practice through active industry-academia partnerships with major Korean universities.
JNPMEDI has signed Memorandums of Understanding (MOUs) with Korea University, Hallym University, Chung-Ang University, and Dongguk University, advancing collaboration across joint research, clinical workforce training, and scholarship and development fund support.
Executives at JNPMEDI also serve as adjunct professors, providing practical, guideline-based education that cultivates talent capable of leading future industry standards.
"Through this structure, integrating “standard design,” “industry-academia collaboration,” and “practical execution,” JNPMEDI has firmly established itself as a “practice-oriented CRO,” covering the entire spectrum from standard-based strategic design to execution-driven digital clinical trials and the development of clinical talent and technology.”
CEO KwunHo Jeong stated, “We aim not only to possess expertise but to actively establish standards, advance them through research, and ensure their effective adoption in real-world settings. As an execution-driven organization, we will set a new benchmark in Korea’s CRO market.” He added, “JNPMEDI will continue leveraging its differentiated execution capabilities to improve clinical trial success rates, cultivate future pharmaceutical and biotech talent, strengthen Korea’s healthcare competitiveness, and elevate its global standing as a ‘K-Pharma & Bio Clinical Hub’.”
Meanwhile, JNPMEDI has officially launched its “Dedicated Compliance Service Team” to support compliance management and minimize legal risks for pharmaceutical, biotech, and medical device companies in Korea. Led by JaeHyun Lee, formerly of Kim & Chang, and QA Team Leader HyunKwon Choi, formerly of Pfizer HQ, the team monitors regulatory changes, interprets complex legal requirements, provides guidance on allowable expenditures, and supports documentation—all aimed at preventing potential legal violations.
📌Original Article : https://www.m-i.kr/news/articleView.html?idxno=1248989
🧑💻 By Yong Lee, Maeil Ilbo
| Presents Vision Backed by Executives Involved in International Standard-Setting, Including ICH Members
| Actively Engaged in Developing Latest International Guidelines, Establishing Practice-Linked Training Through Industry-Academia Collaboration
| “Advancing as a Differentiated, Execution-Driven CRO”
The global pharmaceutical market has entered a period of volatility, intensified by U.S. President Donald Trump’s “America First” policy. With the possibility of steep tariffs on imported drugs and rising pressure to cut domestic drug prices, Korea’s pharmaceutical and biotech industries now face significant new challenges.
According to industry officials on the 13th, calls are growing for Korea to systematically foster its Contract Research Organization (CRO) sector and build global collaboration networks to strengthen domestic R&D capabilities. CROs are no longer viewed merely as service providers, but are emerging as core engines driving the future of the nation’s pharmaceutical and biotech industries. This shift has prompted an industry-wide restructuring to establish the necessary infrastructure.
One example is JNPMEDI, a Korean AI-driven clinical trial consulting firm, which is not only following international standards but actively contributing to their design. Through extensive industry-academia collaboration, the company has built a unique position as an “execution-driven CRO,” connecting global standards directly to practical application.
JNPMEDI’s strength stems from its execution team, which includes members of the International Council for Harmonisation (ICH), as well as experts serving as adjunct professors at leading Korean universities. This enables the company to maintain a professional education system rooted in the latest international guidelines while securing competencies that help shape industry standards.
Notably, SooHyun Lew, Chief Medical Officer at JNPMEDI, was appointed last year as an expert committee member of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), earning international recognition for his expertise. As a permanent observer to ICH, IFPMA plays a key role in global pharmaceutical regulation. Its expert committee members participate in ICH assemblies and working groups, contributing to the development and revision of international guidelines. With more than 30 years of experience in clinical trials and the pharmaceutical/medical device sectors, Lew has offered expert feedback in ICH working groups, including those developing non-clinical safety testing guidelines for oligonucleotide-based therapies.
This demonstrates that JNPMEDI’s expertise goes far beyond interpreting global standards. It reflects a capability to strategically design clinical trials that can directly support the new drug development efforts of Korean pharmaceutical companies.
Furthermore, the company’s global standard-setting expertise is being translated into real-world practice through active industry-academia partnerships with major Korean universities.
JNPMEDI has signed Memorandums of Understanding (MOUs) with Korea University, Hallym University, Chung-Ang University, and Dongguk University, advancing collaboration across joint research, clinical workforce training, and scholarship and development fund support.
Executives at JNPMEDI also serve as adjunct professors, providing practical, guideline-based education that cultivates talent capable of leading future industry standards.
"Through this structure, integrating “standard design,” “industry-academia collaboration,” and “practical execution,” JNPMEDI has firmly established itself as a “practice-oriented CRO,” covering the entire spectrum from standard-based strategic design to execution-driven digital clinical trials and the development of clinical talent and technology.”
CEO KwunHo Jeong stated, “We aim not only to possess expertise but to actively establish standards, advance them through research, and ensure their effective adoption in real-world settings. As an execution-driven organization, we will set a new benchmark in Korea’s CRO market.” He added, “JNPMEDI will continue leveraging its differentiated execution capabilities to improve clinical trial success rates, cultivate future pharmaceutical and biotech talent, strengthen Korea’s healthcare competitiveness, and elevate its global standing as a ‘K-Pharma & Bio Clinical Hub’.”
Meanwhile, JNPMEDI has officially launched its “Dedicated Compliance Service Team” to support compliance management and minimize legal risks for pharmaceutical, biotech, and medical device companies in Korea. Led by JaeHyun Lee, formerly of Kim & Chang, and QA Team Leader HyunKwon Choi, formerly of Pfizer HQ, the team monitors regulatory changes, interprets complex legal requirements, provides guidance on allowable expenditures, and supports documentation—all aimed at preventing potential legal violations.
📌Original Article : https://www.m-i.kr/news/articleView.html?idxno=1248989