Taking its cue from the US Food and Drug Administration’s Microarray Quality Control project, a team of Japanese pharmacogenomics companies, array vendors, and government supporters recently banded together to form the Japan Microarray Consortium.
According to the parties involved in JMAC, the consortium could help set standards for array technology in the Japanese array market and bolster partnerships that could lead to diagnostic opportunities for PGx firms and biochip manufacturers. JMAC’s long-term objective is to capitalize on Japan’s success in the electronics and nanotechnology industries to develop its array technology to a point that it can become viable in the global marketplace.
At the center of JMAC is its coordinator, MediBIC Group, a Tokyo-based PGx company with a presence in China and India whose activities include drug development, biomarker development support, and investing and incubating businesses. MediBIC spokesperson Eiko Ishikawa told BioArray News in an e-mail last week that MediBIC decided to host JMAC because it would increase the firm’s contact with platform suppliers, like JMAC members Toshiba, Toray Industries, and Yokogawa Electric. Altogether 11 companies are involved in JMAC, as well as the Japanese Ministry of Economy, Trade, and Industry.
“Working with these companies is essential since they have the necessary technologies for the manufacturing of biochips,” Ishikawa wrote, noting that an “ideal collaboration” under the partnership would involve one of the JMAC partners manufacturing chips based on genetic markers that MediBIC discovers. “Our ultimate goal is to materialize personalized medicine by assisting clinical trials that entail PGx tests,” Ishikawa added.
Beyond its own interests, MediBIC sees JMAC as a vehicle to develop the Japanese bioarray market, which currently depends on chips manufactured by American firms like Affymetrix, Illumina, or Agilent Technologies. While individual Japanese firms may view each other as competitors, the guiding principle for JMAC is that in order for these firms to succeed globally, they must set standards and introduce successful products in their home market first.
According to Ishikawa, one advantage of this group approach is that the participating companies will share the costs of validating diagnostic and predictive applications for microarrays, which will enable them all to reduce the amount of time and money spent on product development.
In another expected advantage for the Japanese array market, JMAC will look to establish standards, such as a validation procedure for diagnostic chips that MediBIC believes could accelerate biochip development toward in vitro diagnostics. “Without an alliance, each company would usually need to use their own resources for product development,” Ishikawa wrote.
JMAC also sees technology and procedure standardization as key to advancing arrays into the clinical arena. “Standardization is essential in order to generate reliable and precise data [for] doctors, clinical laboratories, and patients by using biochips,” Ishikawa wrote. She added that the standardization goals of JMAC will not only target measurement but also “all the steps from sample selection to assessment during diagnosis.”
MediBIC will guide the consortium by acting as a project-management office. Ishikawa said that MediBIC will coordinate JMAC’s standardization working groups and that the company intends to support the consortium’s validation studies through the same testing networks it uses for clinical trials of internally developed pharmacogenetic diagnostics.
Members of JMAC plan to target the Japanese market first with the arrays that come out of the alliance, Ishikawa wrote. In the near future, however, “JMAC will aim at global markets [and] will proactively express its opinion on global standardization movements,” she wrote.
A Place for Japan
Japan’s weak presence in the global biochip market is a cause for consternation for some. Unlike other technology-driven markets, like automobiles or electronics, the Japanese chip market is dominated by American brands. Affymetrix, for example, does about 15 percent of its annual business — roughly $37 million — in Japan.
Nevertheless, there is an active array R&D community in Japan, and companies like Canon, Toray, Toshiba, Yokogawa Electric, and NGK Insulators have racked up relatively large intellectual property portfolios related to their biochip inventions over the years.
Still, IP has allegedly been an issue in the past for Japanese firms. For example, after concluding several licensing deals in Japan, Michael Bennett, vice president of licensing at Oxford Gene Technology, told BioArray News last year that “there’s been an element of confusion in the Japanese microarray market” regarding IP and that the IP issue is “one of the reasons that, for a country that has such a large population and large gross domestic product, the microarray market is relatively small” (see BAN 8/15/2006).
Ishikawa told BioArray News this week in an e-mail that it is up to the individual members of JMAC to assess their own IP situations, but that JMAC “make it easier for the participating companies to discuss IP issues together.”
To date, Japanese array players like Canon, known for its digital cameras and printers, or Hitachi, known for its consumer electronics, have focused on partnerships in the domestic market with government or academic researchers. For example, in the past Canon has partnered with Japan’s New Energy and Industrial Technology Development Organization on developing a colon cancer diagnostic prototype (see BAN 4/6/2005).
“Japanese companies have excellent [fundamental] technology, but the application development is behind the US and European market.”
Beyond these kinds of partnerships have been inter-company licensing and cooperative agreements. For example, Toshiba licensed some of its chip-related patent estate to start-up Antara Biosciences last year (see BAN 3/21/2006). Also last year DNA Chip Research and Toray partnered to launch yeast and human genome chips using Toray’s 3D Gene platform (see BAN 6/6/2006).
According to Yoshi Yamagata, a Toray Industries spokesperson, the company expects to benefit from JMAC participation. “Japanese companies have excellent [fundamental] technology, but the application development is behind the US and European market,” he wrote in an e-mail to BioArray News last week.
Like MediBIC, Toray also sees JMAC membership as being in its business interest. “Toray is a manufacturer of 3D Gene but we don't have [research] in the diagnostic field,” Yamagata wrote. “We need to make a business relationship with those companies to expand our microarray business. Through the approach of the JMAC, we expect to establish our status and strengthen our presence in the microarray industry,” he added.
Ishikawa echoed these comments, noting that the consortium hopes to make the Japanese biochip industry as “well accepted” worldwide as the nation’s automobile, electronics, and nanotechnology industries.
Canon on the Sidelines
While the full list of JMAC members has not been published, Yamagata wrote that it includes NGK Insulators, Toshiba, Yokogawa Electric, Toray Industries, MediBIC, and approximately 11 other firms. One name not on that list is Canon, which has developed its own partnerships through the years to exploit its bubblejet-printed biochip manufacturing technology.
According to Canon spokesman Richard Berger, the company has “still not decided whether or not to participate in that consortium [and is] currently debating whether or not to participate.”
Berger told BioArray News in an e-mail last week that Canon is still active on the biochip front, though. The company recently announced a partnership with the Research Institute of Japan's National Cancer Center to develop a biochip that would “nearly double the accuracy with which the likelihood of stomach cancer recurrence could be predicted,” he wrote.
Berger wrote that the chip uses a panel of six related gene types to predict cancer recurrence and that “production of the chips will be realized through the cooperation of Sumitomo Bakelite with clinical testing to begin possibly as early as next year.”