By Michele Stokes, Vice President of Asia-Pacific Region, Catalent Pharma Solutions
Why study sponsors need to be sensitive about cultural and business norms in various countries and regions.
Successfully navigating the rich and diverse Asia-Pacific business and cultural environment can prove tricky for Western study sponsors with limited experience in this region. Although geographically clustered, the more than 40 countries located within the region can vary significantly in terms of language spoken and business practices. Study sponsors should understand and be sensitive to the cultural and business norms of each country included in their study. This approach is vital for anticipating and avoiding costly clinical supply issues or delays, despite careful adherence with all applicable regulatory and Customs requirements.
The importance of having a local representative on the ground in certain Asia-Pacific countries.
Generally speaking, most countries in the Asia-Pacific region require a local person on the ground. The culture in Asia is dependent on relationships and trust; this is best achieved through direct contact with a local person and having a reduced response time to queries. In addition, having multiple local personnel representing several business areas, such as project management is also essential.
Language: English is spoken across the region, but consider using native language resources or personnel.
English is typically the language of business across the Asia-Pacific region, to some degree. However, there may be areas where English is not spoken at all. Consider using the resources of sponsor companies for studies in specific regions.
In addition, offering local language customer service and project management to support Asia-Pacific customers can expand business opportunities outside of the APAC region. There is a difference between being able to read and write a language and being able to speak it, especially when the topic is technical.
Managing clinical supplies in the Asia-Pacific region differ from the United States and Europe.
Some of the smaller customers in the Asia-Pacific region may not have a lot of expertise or experience in managing clinical studies. Thus, they may be more dependent on their service partners for advice, especially when their studies span across countries into the United States and Europe.
There are some key differences, though, in managing expectations across the Asia-Pacific region. These can start with the initial discussions and continue through to production supply. In China, for example, the focus is price and customer relationships. They will use this connection to negotiate on price or vice versa.
In Japan, the focus is on quality, customer experience, and trust. Japanese customers need to trust you to give you business. The expected quality and service levels are higher in Japan.
Like China, customers in Singapore are focused on relationship and price. However, they are usually a little bit more risk adverse and prefer to stick with one partner they can trust.
Countries that pose the greatest challenge to Western sponsors.
It’s important to understand that all countries across the region have differences regarding importation rules, taxes, documentation requirements, and more. Working with a company that is experienced in managing these complexities—and has a track record of successfully navigating them—is important. From a country perspective, Singapore will be easiest to work with because there is a greater English-speaking population. China is one of the hardest because of constant changes in regulations.
Recently, however, the Chinese FDA has been trying to create a better environment for businesses conducting clinical studies in China. For example, the Chinese FDA has proposed new rules to accelerate foreign drug approvals. Gone are the requirements whereby foreign drug makers could only start a clinical trial in China after they entered Phase II testing elsewhere. Also, in 2016, there was an exercise conducted to examine the data integrity of their trials. Out of 1,600 applications, more than 1,100 were withdrawn. This shows the stringent quality check established by the government.
Moving product in and out of China can also be a very complex process. Our facility in Shanghai is located in one of the free trade zones, which can help sponsors defer taxes because duties and taxes are only paid when the goods are imported into China.
Japan also has complexities that are uncommon in Western studies. Physicians have power over the trials and the sponsor may find it difficult to meet their requirements. At minimum, the services must be precise, punctual, and accurate.
Overall, by being patient and listening to the local needs, clinical trials can run smoothly across the Asia-Pacific region.
Catalent Pharma Solutions has three major regional facilities in China, Singapore, and Japan and they have been actively engaged in managing clinical studies in the region for more than 15 years through our Singapore facility.
In the past few years they have invested heavily in broadening their footprint in the region with an expanded Singapore facility of more than 20,000 square feet including increased packaging, storage and distribution offerings. They are currently building new packaging and storage capabilities in Japan and Shanghai.
Catalent also has dedicated and experienced business development teams in Singapore, Japan, and Korea, and China.