In the Asia-Pacific region, South Korea is an established market with a diverse patient pool that, for the most part, is treatment naive. When it comes to robustness and accountability, South Korea is listed (alongside Hong Kong, Singapore and Taiwan) as a Tier Two country, making it a reliable place for companies to conduct clinical trials. However, as is the case with most countries, Korea faces a number of challenges, especially in its clinical supply chain. Below, CTA puts together three considerations companies should factor when running trials in the East Asian country.
Overcoming manufacturing barriers
In Korea, a majority of pharma companies utilise their own facilities to manufacture their drugs, giving priority to commercial drugs over drugs used in clinical trials (IPs). With commercial drugs produced on a larger scale, the benefits of producing drugs direct to market has obvious financial value companies from a practical point of view. As a result, persuading facilities to place more emphasis on producing IPs is a considerable challenge for your average clinical trial lead.
For any clinical trial, a delay in manufacturing can impact a study in a multitude of ways – from patient retention to the trial protocol. When patient recruitment slows and more IPs are needed on site, it’s difficult for planning teams to gain priority when commercial production requires more time due to the complex nature of their distribution channels.
Therefore, for large pharma companies, clinical supply teams must work closely with their manufacturing counterparts before and during the study to iron out any potential issues that may occur over the course. Nevertheless, for smaller companies, this may not be an option, so it’s important sponsors consider their outsourcing options that can best aid your supply team.
One of the core requirements for any company conducting studies in Korea is that they store their drugs at a qualified GSP depot. According to experts, qualified depots are tough to find for a number of reasons. Logistically, drug shipments are handled by service providers, but there are caveats to bringing onboard local providers. There is a sufficient lack of vendors with expertise in handling and storing IPs (this is especially the case with temperature maintained products). What’s more, high turnovers are particularly common within local vendors, which only serve to exacerbate the issue.
Throw into the mix the logistical challenge of supplying to new, untapped markets, it’s important sponsors reach out to local vendors with regionalised knowledge as having that support can help operations run more smoothly.
Temperature maintenance; minimizing cost of temperature and tracking technology
Among all the challenges that come with shipping products, temperature excursion remains a significant barrier for clinical supply teams. Once an excursion occurs, it’s critical the shipment is returned to the sponsor. Although that incurs a huge cost to the sponsor, it must be accounted for. Therefore, sponsors must ensure they have greater control over the temperature of their shipments by investing in greater technology.
One option could be to track your IP shipment automatically, which would save time and improve efficiency. While sponsors and providers are required to stay in constant contact throughout the process, the ability to track your shipment in real time would allow sponsors to keep up to date should issues arise in customs.
*For a more in depth take on the Korean clinical supply chain, read Gwong-Cheung Hur’s A journey through the clinical trial supply chain in Korea here
(Adapted from ‘A journey through the clinical trial supply chain in Korea’)
Ramani Aiyer, Clinical Trials in Asia