Western pharmaceutical and biotech companies are increasingly moving to Asia—at least to do their clinical trials. While the upside of doing trials in Asia is compelling, companies are learning to consider a whole set of factors before they make the move, including the striking cultural differences that can exist between Western and Asian workers.  

Potential benefits to be gained include access to more diverse patient pools, decreased costs, and faster recruitment times. At CHI's Drug Development in Asia conference, held recently in Boston, several speakers highlighted some important aspects to consider when deciding whether to conduct clinical studies in Eastern countries. 

Amgen's Robyn Murphy (Senior Project Manager, R&D Strategic Operations) emphasized how crucial it is to thoroughly scope out a geographic region of interest. Murphy identified the drivers for Amgen's R&D expansion into new countries as the need to access new scientific talent as well as patients, decrease program timelines through faster patient recruitment, and reduce costs primarily from lower wages and per-patient costs. Murphy also cited internal competition for clinical-trial patient pools as another factor fueling the need for expansion of Amgen's clinical trial presence.  

Amgen uses an extensive list of criteria to assess a given country's clinical research environment. These include patient access, trial startup time, supply chain availability, the country's standards on IP protection and confidentiality, clinical trial infrastructure, trial costs, and others. Amgen has evaluated clinical trial environments in Japan, China, Hong Kong, Taiwan, South Korea, the Philippines, Thailand, Singapore, Malaysia, Indonesia, and India. Murphy emphasized that the requisite primary research is a long-term process. Says Murphy, it is equally important "to match the unmet needs of a country to the target indications in your company's pipeline." 

Cultural Considerations 

Jeffrey Winkelhake, Vice President of International Operations at Sino Biopharmaceuticals, offered interesting insights into some of the socio-cultural differences that exist between Chinese and Western workers, making it challenging to establish partnerships between their respective companies. For example, Chinese law dictates that children must care for their elderly parents. Combined with the single-child family rule, this confers a lot of pressure to that offspring. Hence, the productivity of a Chinese employee is potentially higher as this mandate compels the Chinese to adopt a success-versus-happiness orientation.  

Besides being hard working, Chinese employees exhibit long-term loyalty toward their employers. This loyalty can be so strong that an entire group within a company will leave if their leader does (or is fired).  

Another challenge is the fact that language differences extend beyond just words to include entire concepts. For example, "young" foreign managers tend to be ignored. Hence, when managing in China, foreigners must be cognizant of such cultural differences and adjust their managerial styles accordingly. In addition, many senior Chinese managers don't speak English and may not have university educations. 

When partnering with Chinese companies, it is critical to realize that the Chinese tend to begin business by trusting no one. Says Winkelhake, the "Chinese need to stop competing against each other and start thinking on an international basis." 

Key Differences between Countries 

Alpna Seth, Senior Director of Global Sourcing at Biogen Idec, proffered her personal observations of key differences between conducting trials in India and China. Echoing Winkelhake, Seth warns, "Don't underestimate the cultural differences between India, China, and the US." She says companies shouldn't do clinical trials in Eastern countries exclusively for purposes of cutting costs; rather, one goal of going into these countries is to get patients faster. One interesting fact, according to Seth, is that the Indian population is more heterogeneous and considered to be closer to Caucasians genetically vis-à-vis the Chinese. 

China and India have followed two very different approaches to economic development. Whereas in China there is a lot more government backing and regulation, Seth described India as "organized" chaos. Yet China lags nearly a decade behind India in terms of its development of knowledge-intensive industries (including pharma and biotechnology). It is making significant strides, however, and Seth warns not to underestimate China's ability to catch up.  

Finally, many countries are deterred from doing clinical trials in China due to the long regulatory approval timelines for IND approval by the SFDA. (The SFDA is the Chinese equivalent to the US FDA.) Seth gave one example of a Chinese company that is actually doing clinical trials in Canada for that reason. 

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