Japan's innovation for global health - GHIT's catalytic role.

The global fight against infectious diseases, both emerging and re-emerging, endures. Japan's commitments and reputation as a good global citizen and its responsibility to uphold domestic and international human security mean that it is in Japan's best interest to leverage its innovative and technological capabilities for global infectious disease prevention and control. The Global Health Innovative Technology Fund (GHIT Fund), an international non-profit organization based in Tokyo, Japan, was established by the Japanese government, multiple Japanese pharmaceutical companies, and the Bill & Melinda Gates Foundation as the first fund of its kind, with an aim to tackle the global burden of infectious diseases by facilitating and funding global health R&D of drugs, vaccines, and diagnostics. Since its inception in 2013, the GHIT Fund has invested more than 209 million USD in more than 90 projects, which consist of collaborations among Japanese and non-Japanese entities, six of which have already progressed to clinical stage development. Japan will continue to play a major role in the global health arena by further advancing R&D innovations for infectious diseases.

Global health landscape challenges triggered by COVID-19.

The COVID-19 pandemic highlighted the vulnerability of every aspect of the globalized world, including R&D. Potentially critical R&D areas have been neglected because of the lack of market-driven incentives. However, new initiatives are emerging to address the present crisis of COVID-19 and possibly future similar incidents that will threaten humanity. In this paper, the global health landscape of R&D is discussed in terms of research focus and funding, illustrating under-funding in communicable diseases with the exception of three major infections: HIV/AIDS, tuberculosis, and malaria. The initiatives triggered by the COVID-19 pandemic and the novel emphasis on "access" are discussed. Finally, the authors propose a new funding model to address R&D in the case of market failure, by forming alliance between government, industry, and international philanthropic organization (GHIT model), and define clear strategy of enhancing access as the way forward.

Reassessing therapeutic antibodies for neglected and tropical diseases.

In the past two decades there has been a significant expansion in the number of new therapeutic monoclonal antibodies (mAbs) that are approved by regulators. The discovery of these new medicines has been driven primarily by new approaches in inflammatory diseases and oncology, especially in immuno-oncology. Other recent successes have included new antibodies for use in viral diseases, including HIV. The perception of very high costs associated with mAbs has led to the assumption that they play no role in prophylaxis for diseases of poverty. However, improvements in antibody-expression yields and manufacturing processes indicate this is a cost-effective option for providing protection from many types of infection that should be revisited. Recent technology developments also indicate that several months of protection could be achieved with a single dose. Moreover, new methods in B cell sorting now enable the systematic identification of high-quality antibodies from humanized mice, or patients. This Review discusses the potential for passive immunization against schistosomiasis, fungal infections, dengue, and other neglected diseases.

Hit and lead criteria in drug discovery for infectious diseases of the developing world.

Reducing the burden of infectious diseases that affect people in the developing world requires sustained collaborative drug discovery efforts. The quality of the chemical starting points for such projects is a key factor in improving the likelihood of clinical success, and so it is important to set clear go/no-go criteria for the progression of hit and lead compounds. With this in mind, the Japanese Global Health Innovative Technology (GHIT) Fund convened with experts from the Medicines for Malaria Venture, the Drugs for Neglected Diseases initiative and the TB Alliance, together with representatives from the Bill &Melinda Gates Foundation, to set disease-specific criteria for hits and leads for malaria, tuberculosis, visceral leishmaniasis and Chagas disease. Here, we present the agreed criteria and discuss the underlying rationale.