> JAPANESE

How is the Gates Foundation is helping to bridge that funding gap?

The Foundation is not the only entity funding that transition, but we are uniquely focused not only on the best science and moving it forward but also on product outcomes and identifying the best partners. We focus on questions like: How do you get global health-related projects and products through the value chain? What's the best way to use and leverage our funding to also attract other public and private resources? How do you de-risk the perception of those opportunities for other investors that might be not only traditional donors, who tend not to fund research and development at all, but also the private investors that are reluctant to take the risk on something that's perceived to have such low return on investment? We're well placed to use our money, but we can't afford to pay for everything. So, the question is: How do we mitigate risks for other types of funders so that they can come in and do their part?

People talk a lot about needing companies in the mix because they're the best established as innovators in doing the work and ensuring that products ultimately reach the people who need them. But there's also real value in having for-profit investors involved from the standpoint of their ability to evaluate and manage risk and to oversee and assess the capabilities of the organizations and hold them accountable. Attracting other types of funders is of real importance, and that kind of engagement with the donors is the type of work that the foundation is well placed to do.

How have you seen the global health R&D innovation funding landscape shift over the past several decades? Why does the shift matter? What's possible today that wasn't 10 or 20 years ago?

In the late 1990s and early 2000s, especially foundations like Rockefeller as well as Gates placed importance on the development of new products, technologies, vaccines, and diagnostics through public private partnerships. Not too long ago, there was a sense that global health R&D was exclusively reliant on charity and luck, on the benevolence of individual sciences, or on companies doing something, such as a skunk project, or scientists working in suboptimal arrangements without access to the best technologies and partners. But that assumption changed in the mid-90s when the first product development partnerships (PDPs) were first funded—IAVI being the first in 1995—and there was a shift toward organizing partners, research, and research dollars around the development of global health products as opposed to the development of science.

Along with the development of those PDPs—and philanthropic funding coming into the mix and making global health a priority—perhaps even more important was the engagement of aid agencies that did not traditionally fund R&D. Unlike traditional research funders, e.g. NIH, aid agencies are focused on health/development outcomes and as product development portfolios become more outcome oriented, several them – USAID (United States Agency for International Development), UK's DFID (Department for International Development), and most recently Japan's MOFA via GHIT – started to invest in product development as well.

The Gates Foundation is a funder and a founding partner of GHIT. Can you talk a little about the Foundation's hoped-for return on that investment?

As I mentioned earlier, the Foundation invests in outcomes, not just capacities. We see GHIT as a vehicle through which the combination of Japanese government financial resources and company capabilities and their own financial resources can translate into real progress for our portfolio for global health priority products.

I realize GHIT is also a mechanism for bringing academic scientists' and companies' earlier-stage research into the global health community. It's a bet on the impact that that research and science can have on solving our global health challenges. While we welcome the availability of compounds and some of the work that has been under way, the real question here is whether by bringing Japanese pharma companies into the PDP and global health landscape there might be an opportunity to bring them in as longer-term partners as some of their early projects start to advance. Although that's our hope, it's a little out of GHIT's scope, and it's not a requirement that they do that.

The Japanese companies are staying with projects as they go through one, two, or three rounds of GHIT funding. I'm quite optimistic that, at least in individual product examples, there will be continuity. I think a big deal is maintaining a relationship between the project, the team that has the real know-how, and the partner that's helping advance it. We have an expectation that that will be facilitated through GHIT.

Has GHIT made it easier to partner with Japanese entities on global health R&D?

I think that has certainly been the case. Partnering with Japan was not easy in the early days of the PDPs. At the outset of GHIT, there was, inevitably, a whole bunch of stuff on the shelf, which allowed for quick wins. The global pharmaceutical companies were making compound libraries available for screening, and the Japanese industry members of GHIT have partnered with some of the PDPs to make the Japanese compound libraries available, and brought resources in very quickly. Beyond that, I think we'll have to see.

One example that demonstrates the need to do more than just have RFPs was in the Gates Foundation Grand Challenge, where the Foundation has an interest in figuring out how to tap into the science capabilities and the entrepreneurs of Japan. I think what GHIT learned by offering to be a sponsor of the Grand Challenge Explorations in the first round was that just offering RFPs isn't sufficient. It involved going in and translating—not just language-wise but also in terms of “How does this work?” Maybe we all underestimated a little bit the investment required to create and support new networks of researchers responding to and participating in global RFPs.

The availability of the funding in and of itself in some of that early research wasn't enough, and GHIT is now following up to do much more active training and engagement with scientists, entrepreneurs, and researchers to help enable their excitement about the opportunity to participate.

Speaking of partners, you've facilitated and led the charge in a lot of partnerships for the Foundation. You played a major role in the London Declaration on Neglected Tropical Diseases. Do you have an archetype in your mind of what successful 21st century R&D partnerships for global health look like?

I certainly think the openness of different partners to recognize each other for who they are – their motivations, their limitations – is critical. This means investing the time to understand the business models of the companies and the other partners and then align and modify your concepts for what incentives might work to improve global health with what you learn about their business models.

An outcome of the foundation's and our partners' work over the past years has been to figure out how we can be more impactful with our funding. You can offer to subsidize the cost of doing product development, but that may not be enough or even relevant for some organizations. Companies might say: "Hey, we've got plenty of cash, but for us the big issue is that the markets are really uncertain. Or we are not malaria experts and don't know how to apply know how to malaria. Or, we've never done clinical trials or worked much in Africa. The clinical development and regulatory pathways are a total mystery to us.”

When you invest in understanding the set of risks, then you can build collaborations around bringing the appropriate tools to the table in that conversation. If you take the London Declaration as an example, that was a place where many companies already had their own programs but they lack a strong platform on which to stand as an industry together with other partners. The platform is important to demonstrate what they are doing, how their contributions fit with others to realize impact, where the remaining gaps were and what potential next steps were for the companies, other partners or both. Such collaboration involves bringing the different partners to the table united by a shared goal, to figure out "How do we solve this together?"

Today (as opposed to 20 years ago), we have a broader toolkit of incentives, financial and otherwise, from which to draw to help de-risk global health opportunities for companies These tools help enhances the ability to build coalitions, including companies, to focus on addressing the health needs of the poorest in developing countries.

Looking ahead now over the next five years, what are your hopes and expectations for the role Japan will continue to play in helping to transform the global health innovation funding landscape?

I do hope and have expectations that the Japanese pharma companies will seek out and be proactive in thinking about "What else can we do for global health?" Some companies are probably in that league, and others are thinking through what—beyond the individual projects—they can do, what kind of footprint they as a company can they have in global health broadly, and how they can work in global health to have a real impact.

The role of the CEOs is also a critical piece. Good partnership requires full commitment at the leadership level that empowers their teams within the organizations to prioritize and commit time to global health work. In the case of GHIT, I see CEOs investing time and attention to their role as members and take pride in it. As leadership turns over, I hope there will be continuity in the importance placed on the global health work.

As for the government, they have demonstrated the importance of investing in global health product development systems through their support of GHIT. The success of what Japan does is very much related to how Japanese assets and other things are integrated into a global construct. Japan has a role amongst peers on the G8 and G20 to reinforce the importance of that message.

How would you summarize the most valuable contributions of GHIT?

In a word: leverage. Leveraging across the different funders, and Japanese expertise and global health R&D capabilities. The philanthropic, for-profit, and government triad is an extremely valuable partnership that differentiates GHIT from lots of other organizations in terms of both their role in governance and their optimization of each other's capabilities and funding.

The affiliations and positions listed in this interview are at the time of publication of the interview in 2017.