Japanese companies are carrying out a greater amount of clinical trial work in the US and Europe than ever before. One of the reasons for this trend has been to give local clinicians experience of working with Japanese products as they are developed. This will be important if Japanese companies are to be successful in these major medical markets as they are so fiercely competitive.
The US is of particular interest given that it is the largest market in the world and because companies are relatively free in terms of pricing their products. This allows them to recoup their R&D investment and plough the money back into research.
Japanese companies have also looked abroad for conducting clinical research because they believe that the relevant infrastructure in Japan is lagging behind, a recently published study on Japanese pharmaceutical market notes. For example, the incentives in the US hospital system for clinical research within the industry continued to be better than those in Japan. According to observers, formal systems need to be established that would help promote clinical research based in Japan.
In 1985 fewer than 5 Japanese companies were operating in North America but by 2000 this had reached 40 companies. One of the challenges that Japanese companies have faced as they have expanded abroad has been to ensure that they hire the right type of staff. Foreign staff are becoming increasingly important to Japanese companies. For example, in North America, the number of employees working for Japanese companies was 4,550 in 1998 but by 2000 this number had reached over 6,000 and represented 30 per cent of the worldwide workforce. In Europe, the number of employees working for Japanese companies in 2000 represented over a quarter of their total global workforce.
However, many experts feel that the innovative ability of the Japanese pharmaceutical industry is often overlooked. This is because US and European pharmaceutical companies are considered to be the leading companies in terms of new drug development. The Pharmaceutical Research and Manufacturers of America (PhRMA) remarks that eight of the current top ten worldwide prescription pharmaceutical products have their origins in US R&D, with the other two having their origins in European R&D.
Around 15 per cent of global pharmaceutical R&D is attributable to the Japanese industry and the increasing level of clinical development indicates their commitment to developing new products. For example, in its 1996 survey of its member companies, the Japan Pharmaceutical Manufacturers Association (JPMA) found that 17 respondent companies were carrying out 23 clinical studies, but in its 2000 survey, 18 respondent companies reported that they were running 42 clinical studies.
In absolute terms Japanese pharmaceutical R&D may not have been as productive as that of the US and Europe but there can be little doubt that it has been responsible for important therapies on the world market. Some of the notable drugs that have their origins in Japan include Bristol-Myers Squibb's Pravachol (pravastatin) for high cholesterol, TAP's anti-ulcer drug Prevacid (lansoprazole) and Daiichi's antibiotic Levaquin (levofloxacin). More recent examples include AstraZeneca's lipid-lowering drug Crestor (rosuvastatin calcium) that originated at Shionogi; Bristol-Myers Squibb's Abilify (aripiprazole) for schizophrenia, which is the result of a collaboration with Otsuka; and Eisai's Alzheimer drug Aricept (donepezil hydrochloride), which is co-marketed with Pfizer.
This clearly indicates the innovative strengths of Japanese pharmaceutical companies. For example, in 2001, a year when a number of major western companies failed to contribute to the global industry output of 31 new drugs, Japan's Mitsubishi Pharma Corporation launched two brand new drugs. Interestingly, far from being "me-too" products these were truly innovative products targeting poorly served medical areas. Radicut (edavarone) was launched for acute-stage cerebral infarction and Cleanal (fudosteine) for chronic obstructory pulmonary disease (COPD).
Potential employers need to be aware of the skills required from employees that will give their organisations an advantage over their rivals. However, equally, employers need to balance these factors with employees' need to work in a stable and satisfying corporate environment. Responding to such issues can make the difference between retaining a valuable member of staff and perhaps losing them to a rival company. An example of this is Takeda's scheme to financially reward employees for their innovative research ideas.
For Japanese companies entering new markets, Contract Research Organisations (CROs) can help in the supply of staff. As they already work in the area of clinical research, and frequently with Japanese companies, they understand what is involved in managing and monitoring clinical trials. Furthermore, their personnel have often been through a specialised internal training programme before going out on contract. Thus by using the contract personnel division of a CRO, some of the risk can be taken out of the process of identifying and employing new staff. As the pharmaceutical industry operates on an international basis, employing staff with appropriate language skills and knowledge of how regulations and practices vary between countries are an invaluable asset.
Although candidates need to have the technical skills required for clinical research, it must be remembered that human judgement continues to play a vital role in the success of a project. As companies grow larger and the chains of command become increasingly stretched, the presence of talented individuals who can effectively communicate ideas and results can make the difference when it comes to the success of a company's performance in clinical development. As CROs are involved in clinical research themselves, they will be fully aware of factors such as intellectual and human capital within R&D organizations.
Japanese companies are likely to continue to look to the US and Europe for much of their clinical research needs. Although the capacity for innovation is clear, Japanese companies will need to attract the right kind of scientific and commercial staff in order to be successful. Making use of agencies that fully understand the clinical development process can help companies meet their staffing objectives, experts aver.