Novotech, a global clinical Contract Research Organization (CRO), has formed a strategic partnership with Kyungpook National University Hospital (KNUH) and Acrostar, a Site Management Organization (SMO) service provider, to enhance clinical trial capabilities in South Korea. The collaboration, formalized through a Memorandum of Understanding (MOU), will support trials across KNUH's network, including its Advanced Clinical Trials Center, main campus, and Chilgok KNUH.
This partnership comes at a pivotal time, aligning with significant amendments to South Korea's Advanced Regenerative Bio Act that have expanded the scope of regenerative medicine applications in the country.
Expanding Access to Regenerative Medicine
The recent amendments to the Advanced Regenerative Bio Act represent a substantial shift in South Korea's approach to regenerative medicine. Previously, these advanced therapies were limited to treating severe, rare, and incurable diseases. Now, the scope has broadened to include general diseases, significantly expanding potential applications.
The regulatory changes also allow patients outside of clinical trials to access regenerative medicine services. Additionally, the range of applicable technologies has grown substantially, encompassing cell and gene therapies (CGT) and tissue engineering.
"The Advanced Clinical Trials Center will oversee trials for all diseases treated at KNUH, strengthening our role as a leader in clinical research and regenerative medicine," said Prof. Hyungran Yoon, Director of the Advanced Clinical Trials Center. "The partnership agreement with Novotech will expand their capacity to offer innovative treatment opportunities both domestically and internationally."
Streamlined Approval Process for Innovative Therapies
One of the most significant changes in the regulatory framework involves the approval process for cell and gene therapies. Previously, CGTs required formal drug approval before clinical application. Under the new regulations, CGTs in clinical trials can be utilized upon review committee approval, creating a more efficient pathway for innovative treatments to reach patients.
Dr. Yooni Kim, Managing Director, Asia-Pacific at Novotech, emphasized the strategic advantages of the partnership: "This partnership combines Novotech's global expertise with KNUH's specialized capabilities to offer cutting-edge treatment solutions and streamlined trial operations. By leveraging this synergy, we aim to boost South Korea's position on the global stage in regenerative medicine and enhance clinical trial excellence worldwide."
Comprehensive Clinical Trial Framework
The partnership establishes a structured approach to clinical research across KNUH's network. Early-stage clinical trials will primarily be conducted at the Advanced Clinical Trials Center, which opened in November 2023. Late-stage trials will be managed within KNUH's broader hospital system.
This collaboration marks Acrostar's first partnership in South Korea. Daniel Kim, Director of Acrostar Asia-Pacific, expressed enthusiasm about the development: "Through this collaboration, we will actively support the site and ensure the smooth progress of clinical trials from a site management perspective."
Strengthening South Korea's Position in Global Clinical Research
The strategic alliance between Novotech, Acrostar, and KNUH represents a significant step forward for clinical research in South Korea. The partnership leverages Novotech's extensive experience in clinical trials—having managed over 5,000 clinical projects ranging from Phase I to Phase IV trials—with KNUH's medical expertise and newly expanded capabilities in regenerative medicine.
Founded in 1997, Novotech has established itself as a leading CRO focused on partnering with biotech and small to mid-size companies to accelerate therapeutic development. The company has received numerous industry recognitions, including the Fierce CRO 2024 Excellence Award in Clinical Trial Management and Global Operations and the Frost & Sullivan 2024 Global Biotech CRO of the year award.
With a presence in 34 office locations and a team of over 3,000 professionals worldwide, Novotech brings substantial resources to this partnership, potentially accelerating South Korea's emergence as a hub for advanced clinical trials and regenerative medicine research.
