institutes, and verifies them in nonclinical and clinical trials to create new commercial products. TR is defined as bridge research that leads to practical applications
such as medicines and medical technologies for physical experiments or therapeutic
interventions.
In recent years, the development of genome science and regenerative medicine
has led to substantial progress in basic research for the realization of new therapeutic
methods using genes and cells, but most results have not been put to practical use.
We infer that various issues are unique to the system in Japan. This chapter
introduces a successful, but challenging, industry-university joint research case in
Japan, and highlights the various issues raised from this case.
1.2 Present Situation of TR in Japan
The probability of success in drug development is quite low, and often more than
10 years of research and development (R&D) and more than 100–200 million USD
of R&D expenses are required (Ohno, Nagai, & Fukushima, 2010). Patents have a
very large impact on R&D. In general, consumer products involve hundreds to
thousands of patents per product, and then one basic patent and many peripheral
patents are required to bring one product to commercialization. The patent application should be filed before marketing, which inevitably results in increased time and
effort because the patent examination period in Japan is extremely long. In the case
of pharmaceuticals, therefore, counterfeit products may circulate in the market
before patent examination results are obtained. In other words, in the field of drug
R&D, the flow of formulating and promoting R&D strategies based on patent
strategies is challenging, and under such circumstances, many Japanese pharmaceutical companies face fierce international competition.
A “government initiative” has led to the adoption of treatment themes in various
fields in Japan, including research themes for treatment seeds and the establishment
of clinical trial bases. However, the government initiative covers therapeutic drugs
and treatment methods for a wide range of diseases and fosters an environment that
promotes extrapolation into any area from the seeds to patients care, with the
proposition of bridging research from basic to clinical. Furthermore, in terms of
government funds, the impression that the total budget is relatively small cannot be
denied. In today’s internationally competitive environment, the strategy of industry,
government, and academia working together to launch new therapeutic drugs,
devices, and treatment methods must shift significantly (Tanaka, 2010).
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K. Fujitani et al.
such as medicines and medical technologies for physical experiments or therapeutic
interventions.
In recent years, the development of genome science and regenerative medicine
has led to substantial progress in basic research for the realization of new therapeutic
methods using genes and cells, but most results have not been put to practical use.
We infer that various issues are unique to the system in Japan. This chapter
introduces a successful, but challenging, industry-university joint research case in
Japan, and highlights the various issues raised from this case.
1.2 Present Situation of TR in Japan
The probability of success in drug development is quite low, and often more than
10 years of research and development (R&D) and more than 100–200 million USD
of R&D expenses are required (Ohno, Nagai, & Fukushima, 2010). Patents have a
very large impact on R&D. In general, consumer products involve hundreds to
thousands of patents per product, and then one basic patent and many peripheral
patents are required to bring one product to commercialization. The patent application should be filed before marketing, which inevitably results in increased time and
effort because the patent examination period in Japan is extremely long. In the case
of pharmaceuticals, therefore, counterfeit products may circulate in the market
before patent examination results are obtained. In other words, in the field of drug
R&D, the flow of formulating and promoting R&D strategies based on patent
strategies is challenging, and under such circumstances, many Japanese pharmaceutical companies face fierce international competition.
A “government initiative” has led to the adoption of treatment themes in various
fields in Japan, including research themes for treatment seeds and the establishment
of clinical trial bases. However, the government initiative covers therapeutic drugs
and treatment methods for a wide range of diseases and fosters an environment that
promotes extrapolation into any area from the seeds to patients care, with the
proposition of bridging research from basic to clinical. Furthermore, in terms of
government funds, the impression that the total budget is relatively small cannot be
denied. In today’s internationally competitive environment, the strategy of industry,
government, and academia working together to launch new therapeutic drugs,
devices, and treatment methods must shift significantly (Tanaka, 2010).
140
K. Fujitani et al.