Dr. Yooni Kim, the vice president of clinical services at Novotech, says Australia and South Korea are emerging as bubbling clinical research hubs in the Asia-Pacific (APAC) region.
At the ongoing Outsourcing in Clinical Trials UK and Ireland conference, Kim led a session on “Unlocking APAC potential to enhance your clinical program.” The event, held 11 – 12 June, gathered clinical trial professionals to debate issues within the sector. At Kim’s talk, she highlighted the 142 European biotech companies that have conducted single-country or multinational clinical trials in the APAC region between 2019 and 2023, saying that the region has become the “fastest-growing global market for pharmaceutical sales”.
In particular, Kim highlighted South Korea’s “attractive” government frameworks for clinical research. For example, the Korea Health Industry Development Institute (KHIDI) has created a national artificial intelligence (AI) platform that integrates data from several healthcare institutes to support clinical trials, match patients with studies, and monitor trial progress. Moreover, Samsung Medical Center is also growing partnerships with AI startups for data analysis and patient outreach, she adds.
“Australia also has a very streamlined process,” says Kim, calling attention to the region’s six – eight-week trial start-up timeline for private sites. This includes the period needed for an application to go from an Ethics committee submission to approval. Furthermore, the country does not require a clinical trial application (CTA) or an investigational new drug (IND) application to conduct a study. Several biotech companies begin clinical trials in Australia as they simultaneously prepare US IND submissions, and choose to run their earlier phase studies in Australia before transitioning to the US for the later stages, said Kim. This makes the country particularly attractive as the US agencies accept clinical data from Australia for subsequent regulatory submissions, she adds.
In 2024, the Australian government initiated its Clinical Trials Activity Initiative that aimed to provide $750m over 10 years between 2024/2025 and 2033/2034. The government plans to aid clinical trials addressing rare cancers, rare diseases, unmet needs, and bring investigator-led international clinical studies to Australia, as per the government website. The country has been taking actions to improve its global appeal as a clinical research superpower for several years, introducing a research and development (R&D) refund scheme with up to 43.5% cash refunds that was launched in July 2021.
