PATH points to power of $120M core boost with new vaccine initiative

SAN FRANCISCO — The global health organization PATH announced the launch of a new initiative on maternal immunization on Monday, following news last week that the NGO’s Center for Vaccine Innovation and Access has been awarded a $120 million grant by the Bill & Melinda Gates Foundation.

The Advancing Maternal Immunization (AMI) program is a collaboration between stakeholders from around the world to provide pregnant women with vaccines to protect their babies from infectious diseases. PATH will coordinate the program along with the World Health Organization.

It is the first of a number of new commitments that are likely to be made in the wake of the Gates Foundation award, which allows the NGO to attract top vaccine development and introduction experts who are uniquely positioned to take on such ambitious projects. PATH representatives pointed to the power of stable and portfolio-based funding in allowing this to happen.

“Core funding like what we’ve received from the Gates Foundation for PATH’s Center for Vaccine Innovation and Access is critical to moving the needle on our most important metric: improving lives through better health,” said Dr. Bruce Innis, global head of respiratory infections and maternal immunization at PATH and an AMI strategic leadership team member.

“It also allows us to take on long-term commitments that advance new areas of vaccine innovation,” such as helping to coordinate AMI, he said. Previously senior vaccine development leader for influenza and dengue vaccines at GlaxoSmithKline, Innis is one of four high-profile hires the funding has so far made possible.

PATH, a Seattle-based organization dedicated to global health innovation, has been a key partner of the Gates Foundation — now the largest foundation in the world in terms of funding global health priorities, including vaccination. PATH was the recipient of the foundation’s first global health grant in 1995 and has received more than $2.5 billion from the foundation in total.

Trevor Mundel, president of global health at the Gates Foundation, has explained that part of the motivation behind the most recent boost to PATH was to provide the organization with stable funding over a long period for its work to develop vaccines for more than a dozen diseases.

Devex spoke with David Kaslow, global head of PATH’s Center for Vaccine Innovation and Access, about what the investment will mean for the organization’s ability to take on diseases in low-resource settings.

“There are a number of different problems that come up with the highly focused, project-based funding, and this is a solution to that, allowing donors to still have tight control over certain projects, but allowing us to have the talent, line of sight and infrastructure we need to work in 2017,” he said.

Originally, product development models consisted of long-duration grants. This was the model that resulted in MenAfriVac®, the first vaccine in history to be designed specifically for Africa as a result of Gates Foundation funding for PATH and WHO to eliminate the meningitis epidemic.

“What’s happened over time — and understandably, because it gives the donor significant control over assets — is more focused, shorter duration, project-based funding, rather than portfolio-based funding, and on our side of that it has become more and more difficult to handle,” he said.

About three years ago, the PATH team met to discuss the consequences of this funding trend, one of which has been problems in recruiting and retaining the talent they need. The reliance on project-based funding meant the organization had a hard time pulling the people they wanted away from the positions they were in because the pitch was “come work at PATH for six months and we’ll cobble together funding to pay for your time and hopefully we’ll get another grant in six months,” Kaslow said.

The new grant from Gates has allowed PATH to attract the likes of Innis, alongside other immunization experts who previously worked with the National Institutes of Health, Merck, and the U.S. Food and Drug Administration. It has been able to bring together expertise across every stage of vaccine research, development and introduction, Kaslow explained. While the grant was not announced until last week, the first phase of funding kicked in 18 months ago. It enabled the center to bring in a range of experts to work with developing country vaccine manufacturers, he said, so that teams composed of all disciplines could work across a broad portfolio on disease areas such as malaria, or functional areas such as manufacturing and supply.

“The other benefit is line of sight,” Kaslow said. “Our job at PATH is not done when the vial ends up on the tarmac. It is done when the work actually has an impact — when we cover individuals that need this vaccine, when we get immunization rates where they need to be. Having that line of sight — people in the project team who understand the complexities we face — is critically important, so we don’t end up with bright shiny objects ending up on tarmacs not going anywhere.”

The move from small project grants to a $120 million investment from the Gates Foundation allows PATH to make infrastructure-type investments, such as those needed for the move from paper to electronic documents for the FDA, while also providing the organization with the flexibility to manage its resources more like a business, Kaslow added.

“When you have project-funded activities, you are not incentivized to kill a project that has a decreasing probability of technical and regulatory success and move those resources to a project with an increasing probability of technical and regulatory success,” he explained. “This allows us the flexibility to do that.”

There is a widely recognized “valley of death” in product development, in which a scientist can do basic research but has a hard time derisking that work to encourage the commercial sector to pick it up. But there is another valley of death when it comes to, for example, malaria vaccines for low-resource settings, Kaslow said. This funding allows the Center for Vaccine Innovation and Access to help answer questions such as whether it is feasible to give four doses of the RTS,S malaria vaccine in real-life settings from a public health perspective, rather than leaving it to policymakers with limited budgets.

With its $120 million boost, it seems PATH’s Seattle neighbor has been listening to its concerns, responding with funding that aims to set its partner up for success in the long and costly process of vaccine development.

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