In today’s interview, we’re speaking with Dr. In-seok Park, Ph.D., the esteemed President of KoNECT. Dr. Park, who assumed his role in February 2023, has a rich history in public service spanning three decades. His expertise in health policy and international relations is crucial in guiding KoNECT toward its mission of advancing clinical trials and new drug development in South Korea. Dr. Park’s leadership is instrumental in driving KoNECT’s vision of enhancing Korea’s standing in the global healthcare sector.
What Makes KoNECT an Ideal Partner for Clinical Trials in South Korea?
KoNECT, established in 2014 and funded by the Ministry of Health and Welfare, specializes in advancing South Korea’s clinical trial capabilities. It supports domestic and international clinical trial projects, offering training and certification for clinical trial professionals and managing critical clinical trial-related information. We offer extensive support to global pharmaceutical companies, including feasibility reports and assistance in participant connections for clinical trials in Korea. Additionally, they provide crucial regulatory guidance, and access to a vast network of clinical sites and medical professionals. This comprehensive approach facilitates the smooth entry and execution of multi-regional clinical trials in Korea, making it an increasingly attractive destination for global pharmaceutical research and development.
Can You Discuss KoNECT’s Leadership and Vision?Joining KoNECT in February 2023, I brought nearly 30 years of experience in public service, including pivotal roles in health, pension, and childcare policy, and positions within the Office of the President and other key government areas. This diverse background, enriched by international relations experience, guides my leadership approach.
We are dedicated to deeply understanding and addressing the needs of clinical trial stakeholders. We focus on ‘publicity’ by promoting public health, advancing the Korean health industry, and enhancing ‘professionalism’ within KoNECT by establishing a comprehensive framework for clinical trials in Korea. These efforts are geared towards making substantial contributions to the development of public health and the Korean health industry, ensuring that our clinical trial framework benefits all involved parties.
How is KoNECT Addressing the Decentralized Clinical Trials (DCT) Paradigm?
KoNECT is at the forefront of integrating decentralized clinical trials (DCT) in South Korea. They focus on the DCT Program to incorporate global DCT technologies and practices, enhancing the clinical trial system to make it more patient-centered and efficient. Their efforts include forming a public-private collaborative body to develop models & guidelines for Korean-style DCTs and showcasing Korea’s global IT and medical powerhouse capability.
With the rapid evolution of medical technology and shifting global health priorities, how is KoNECT adapting its strategies to stay ahead in the clinical trials sector?
KoNECT is actively engaging in ‘Smart Clinical Trial R&D’ as a government project. We are benchmarking countries with flexible regulatory environments and aiming to establish a smart clinical trial environment in Korea. This includes rapidly incorporating global technologies like DCT, DTx, Advanced Regenerative Medicine And Advanced Biological Products, and clinical trial data into the Korean landscape. These efforts involve KoNECT and collaboration with all individuals working in healthcare institutions, pharmaceutical companies, CROs, regulatory agencies, and patients, striving together for these initiatives.
What challenges does KoNECT face in balancing the need for innovative clinical trial methodologies with the stringent regulatory environment in South Korea?
We face the challenge of aligning innovative clinical trial methodologies with stringent safety and accuracy standards set by Korean regulatory authorities. To address this, we’ve formed a consultative body with experts from government, industry, academia, and research institutes to develop and implement guidelines for conducting clinical trials in Korea. However, aligning regulations with the progress in new environments and technologies poses a considerable challenge. The evolution of medical culture, public health culture, and public awareness must harmonize with the operational landscape of clinical trials.
In a highly competitive global landscape, what steps is KoNECT taking to ensure South Korea remains a preferred destination for clinical trials, especially against emerging markets?
KoNECT has played a pivotal role in the rapid development of COVID-19 treatments and vaccines, demonstrating South Korea’s capability to handle global health challenges. We’re extending our clinical trial participation platform to cover all disease areas, facilitating rapid and large-scale clinical trials. Also we are actively engaged in a multifaceted approach, encompassing the establishment of a research network for multi-regional clinical trials, the utilization of medical big data, including EMR, and the implementation of decentralized clinical trials. .Additionally, the Ministry of Food and Drug Safety’s GIFT initiative is helping to expedite the commercialization of innovative biopharmaceuticals, enhancing South Korea’s appeal as a clinical trial destination.
What Makes the KoNECT International Conference Stand Out?
The KoNECT International Conference stands out as it addresses the current clinical trial landscape, regulatory changes, and emerging technologies and fosters a unique global networking and collaboration environment. It brings together a diverse group of professionals, including key stakeholders from pharmaceutical and biotech companies, CROs, and academia, facilitating a rich exchange of ideas and best practices. This conference is a hub for knowledge sharing and forming strategic partnerships, crucial for advancing global clinical research.
What are KoNECT’s Future Goals?
KoNECT’s future goals extend beyond just elevating Korea as a leading global destination for clinical trials and new drug development. They are committed to fostering innovation and excellence in clinical research. This involves embracing advanced technologies, adapting to the evolving landscape of global health challenges, and continuously improving the infrastructure and processes for clinical trials. By actively engaging with international partners and stakeholders, KoNECT aims to ensure that South Korea remains at the forefront of medical research and innovation, contributing significantly to global healthcare advancements.