The Journal The Authority on Global Business in Japan

Japan has a long legacy of scientific excellence and leadership in global health programs. The country introduced discussion of infectious diseases to the G8 Summit’s agenda in Okinawa in 2000, a move that paved the way for the establishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) two years later. Today, Japan is the fifth-largest contributor.

Infectious diseases, particularly those termed the Big Three—HIV/AIDS, malaria, and tuberculosis—have been an international priority since the establishment of the United Nations’ Millennium Development Goals in 2000. Many healthcare-oriented nonprofits, such as the Global Fund, aim to eliminate these threats that are so prevalent in the developing world. One such organization, the Global Health Innovative Technology (GHIT) Fund, has adopted a novel approach to fighting disease.

Launched in Japan just three-and-a-half years ago, GHIT was founded on the principle of open innovation—also referred to as product development partnership. This approach to research and development (R&D) facilitates tie-ups between Japanese and international entities from the public, private, and civil/nonprofit sectors to streamline drug development.

ORIGINS
The Bill & Melinda Gates Foundation is among the nine founding partners of GHIT. Hannah Kettler, senior program officer, Life Science Partnerships at the foundation, commented: “The Global Health Innovative Technology Fund is a unique partnership model that brings together the government of Japan and private funds, and leverages Japan’s industry and academic expertise to fight infectious diseases in developing countries. Public–private partnerships like this are essential to developing new global health tools, and we are thrilled to support the important work of the fund.”

The United Nations Development Programme (UNDP) is also a founding partner. Dr. Mandeep Dhaliwal, director of the HIV, Health and Development Group, said: “It remains important that governments scale up their investments in promoting innovation in new medicines, vaccines, and diagnostics—as well as the building of resilient and sustainable health systems in low- and middle-income countries—so that universal health coverage and good health and well-being can be attained for all. UNDP salutes the vision and leadership of the government of Japan in supporting both innovation and access to health technologies.”

GHIT’s founders also include the Ministry of Foreign Affairs of Japan, the Ministry of Health, Labour and Welfare, and five Japanese pharmaceutical firms: Astellas Pharma Inc.; Daiichi Sankyo Co., Ltd.; Eisai Co., Ltd.; Shionogi & Co., Ltd.; and Takeda Pharmaceutical Co., Ltd. The fund was conceived in a conversation between GHIT CEO Dr. BT Slingsby and Dr. Tachi Yamada, a US physician who envisioned “Japan’s first truly international nonprofit.” At the time of founding, Slingsby—who was involved with the project from day one—worked for Eisai, where he developed new business models for R&D and oversaw market access in the developing world. He possesses both a strong business background—having aided numerous start-ups in Japan and the United States—as well as medical expertise, with a Medical Doctorate from George Washington University.

Slingsby described the origins of the fund, which are rooted in business practices, namely leveraging the principles of product development used in the private sector for public purposes.

“Our internal management practices reflect those of the private sector, affecting how we define strategy, structure the organization, etc.; this is one of the reasons we have grown so quickly,” he said. By September 2013, GHIT’s first year of operation, the fund had logged $8.8 million in investment into novel R&D using Japanese innovation. By March 2016, the figure had risen to $96 million.

Affiliate Partner GlaxoSmithKline K.K. (GSK) took part in the GHIT Fund as one of the first global pharmaceutical companies to contribute to Japanese research and development to fight neglected diseases around the world. “GSK is a science-led global healthcare company and has three world-leading businesses that research, develop, and manufacture innovative pharmaceutical, vaccine, and consumer healthcare products,” Communications Division Head Yukimi Ito told The Journal. “We wish to contribute to innovations originating from Japan as the company is committed to widening access to drugs, so that more people can benefit, no matter where they live in the world or what they can afford to pay.”

Merck, the world’s oldest pharmaceutical and chemical company, said that there are two important relationships with GHIT—one as a leader of a consortium developing a new pediatric formulation of praziquantel, a drug used to treat parasitic worm infections, and more recently, its role as an affiliate partner. As this collaboration will expand investment into research and development for neglected diseases worldwide, it perfectly aligns with Merck’s contributions to improving the health of underserved populations.

“As a partner of GHIT, we are part of a network of global and Japanese partners with proven excellence in global health,” Head of Corporate Communication Japan Ritsuko Shibagaki told The Journal. “This represents an important aspect for our current and future programs on infectious diseases, considering that our operating model is based on partnerships and collaborations with leading global health institutions and organizations. By joining forces with GHIT, our overall ability to provide the most vulnerable populations with suitable health solutions should increase.”

50-PLUS PROJECTS
Investments managed by GHIT are stringently selected and monitored to ensure that product development milestones are met and donor dollars are not wasted. All 50-plus projects currently in its portfolio include drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases such as Chagas. According to UN figures, three in seven people worldwide are at risk of developing infectious diseases; one in seven are already infected.

Multiple investments involve partners from the United States. Currently, one of GHIT’s top-funded projects to fight malaria brings together the expertise of Eisai, St. Jude Children’s Hospital in Memphis, Tenn., and Swiss nonprofit Medicines for Malaria Venture (MMV). The product under development is a single, multi-component drug that would cure an affected patient after just one exposure to malaria, and provide substantial post-treatment protection from reinfection. Each partner has a well-defined role: Eisai will handle manufacturing of the pharmaceutical ingredients; St. Jude’s will manage the project and carry out initial studies at its facility; MMV will oversee the next phase of studies and define the drug protocol.

Discussing the product development partnership model of R&D, Slingsby explains: “Products to treat infectious diseases are not naturally generated by the market. That is why we exist. A lack of profit [for pharmaceutical companies] necessitates a public–private model to propel R&D in this space.

“The science is also very difficult. Maybe a company has the technology to develop an effective malaria treatment, but has no skilled scientists in that field; thus, we facilitate international partnerships. Or perhaps a research institute needs funding for a promising venture; we can provide that. These links define the virtual health/open innovation approach.”

Shigetaka Komori, chairman and CEO of Fujifilm Corporation—a GHIT partner—applauds the open innovation approach. “The Ebola crisis reinforced for us both the urgent need for global health innovation as well as how effectively industry and the global health community can mobilize together to create and deliver new solutions. Partnering with the GHIT Fund helps us engage even more meaningfully in global health over the long term, enabling us to leverage our history of innovation,” he said.

GSK’s Ito said, “Our commitment to open innovation, widening access, and transparency is aligned with the vision of the GHIT Fund and we believe this partnership will certainly add value to the research and development initiatives from Japan.”

A pillar of GHIT’s mission is providing products that are “accessible and affordable to the poorest of the poor.” Founders believe that improved access to healthcare in the world’s poverty-stricken nations will have a direct impact on the economic potential of such countries. Healthy citizens are better prepared to innovate and work; thus, health makes wealth.

Ko-Yung Tung, senior counsellor at Morrison Foerster LLP, serves on the Board of Directors at GHIT. As previous general counsel of the World Bank, Tung oversaw the establishment of the Global Fund. He notes how GHIT is particularly valuable in its provision of grants to R&D projects addressing neglected tropical diseases, which are not pursued by commercial pharma companies. Morrison Foerster is a sponsor of the fund, providing legal services and advice in accordance with its pro bono mission to help those who are marginalized.

“GHIT is a unique public–private partnership that is vigorously supported by the Japanese government as part of the third arrow of Abenomics. Though it’s been in existence for only three years, GHIT has already shown impressive results,” Tung told The Journal.

“From 1995 to 2004, a total of 1,556 new drugs were approved in the US. Only 1.3 percent of these new treatments were developed to fight infectious diseases in developing nations,” explained Miyoko Tanaka, director of communication and public affairs, Medical Company, Johnson & Johnson K.K. “We envision a world where everyone has the means to be healthy and can thrive. We are committed to using our capabilities, expertise, resources, and partnerships to fulfill our role in making the world a better, healthier place for generations to come.”

Tanaka added: “We hope that our partnership with the fund enables the organization to continue investing in new, innovative technology for neglected diseases, as well as promising candidates that have recently entered clinical trials, or will eventually enter late-stage trials.”

None of the fund’s managed products have hit the market yet, but several are in later stages of development such as clinical trials. Within the next few years, Slingsby said, we should see the launch of some exciting new technologies. In the private pharmaceutical sector, vaccines and treatments can take a decade or more to go to market. GHIT strives to get its products into the hands of people who need them most within five to 10 years.

Global Health Innovative Technology CEO BT Slingsby speaks at the 2016 Annual Partners Meeting in Tokyo.

SCIENCE POWERHOUSE
Apart from its open innovation approach, GHIT is distinct in its close collaboration with the Japanese government. In addition, each investment (grant) application must include at least one Japanese and one international partner. Projects may include as few as two or as many as six partners.

Because it is a matching fund, every dollar committed by the government is matched by donors, be they private-sector companies or civil foundations. Tung highlights how, at the 2015 G7 Ise-Shima Summit, the Japanese government specifically named GHIT as an important initiative in a joint declaration on global health. It also doubled its funding commitment to projects fighting disease in the developing world.

“The Japanese government has always been very committed to global health and international cooperation, seeking to approach problems through innovation. Innovation comes from science, and Japan is a science powerhouse. The potential for innovation is enormous here, but it’s questionable how much that has been realized in healthcare products; that is our role at GHIT. The government’s decision to invest in R&D specific to global health is rather novel, yet has become a prominent pillar of current government policy,” Slingsby adds.

The Japanese government’s investment in the GHIT Fund is a direct realization of the country’s 2013 Strategy on Global Health Diplomacy, which is closely linked to the Healthcare and Medical Strategy, launched the same year.

Kumi Sato, president and CEO of COSMO PR and American Chamber of Commerce in Japan Chairman Emeritus, serves as an advisor to the fund. Her company, which focuses on the healthcare field, supports nonprofits such as GHIT with similar missions.

“Global health is a concept that was, until recently, relatively unknown or misunderstood. Given the importance of the topic, we wanted to be part of efforts to build the awareness needed for GHIT’s success. This is one of the reasons why I am personally excited to be involved with this organization,” Sato told The Journal.

“As one of the first funds of its type in the country, GHIT demonstrates that the government recognizes the importance of this kind of new collaborative model, and gives Japan the ability to deploy investment into the field. In fulfilling a purpose previously unmet here—a public–private partnership designed to tackle the most complex challenges of global health—GHIT serves as a catalyst for substantive change, and the results of that change will speak for themselves.”

Brandi Goode is a freelance writer and editor based in Manila, and previously Editor-in-Chief of The Journal.
At the 2015 G7 Ise-Shima Summit, the Japanese government specifically named GHIT as an important initiative in a joint declaration on global health.