The day the news broke, Steve Brooke remembers being at his desk on the fourth floor of PATH’s Seattle headquarters. The announcement he saw on PATH’s website bore the headline: “PATH welcomes news that millions more women can access Sayana® Press.”
Steve smiled and pumped his fist in the air. “We’re in,” he thought. “We’re going to get a real shot at this.”
On that day in 2014, the Bill & Melinda Gates Foundation, Pfizer Inc., and the Children’s Investment Fund Foundation (CIFF) announced a new collaboration and price agreement to ensure that women in the world’s poorest countries would have access to Sayana Press, a groundbreaking new contraceptive option.
It was the culmination of a nearly 30-year journey—full of “starts, stops, and near-death experiences,” Steve recalls—as PATH and our partners developed the technologies, collaborations, and evidence base that paved the way for the introduction of Sayana Press.
Steve, a longtime commercialization officer for PATH, is equal parts determined deal-maker, back-channel broker, and enthusiastic advocate for women’s access to family planning.
Since arriving at PATH in 1990, he has been part of a dedicated group of PATH scientists, technology developers, and business experts working with industry and technical partners and global organizations to make Sayana Press possible.
Together, they turned an idea once languishing on the shelves of a major pharmaceutical company into a lifesaving innovation that promises to transform women’s access to family planning and increase control over their own health.
Steve arrived at PATH with an MBA from Northwestern University and experience as a marketing manager for a medical device company that made components for artificial limbs. He was interested in the then-unusual idea of for-profit and nonprofit partners collaborating to bring new products to market in a way that made business sense while reaching consumers at the farthest margins of the economy.
He joined a PATH team tackling an urgent issue: How to keep syringes and needles from being reused and transmitting HIV, hepatitis B, and other bloodborne pathogens. The World Health Organization had estimated that the percentage of injections given with reused syringes and needles was as high as 75 percent in some countries.
One of the concepts proposed by PATH—a prefilled, single-dose syringe and needle in an all-in-one package—took its inspiration from a device prototype that had been developed by pharmaceutical manufacturer Merck, but subsequently shelved.
PATH collaborated with Merck to learn from its experience, and Merck eventually turned over its intellectual property to PATH.
But Merck’s small, squeezable tube was susceptible to reuse. So with funding from the US Agency for International Development (USAID), the PATH team invented and patented a new design with a collapsible plastic bubble and a special one-way valve that automatically disabled the syringe.
And the radically simple Uniject™ injection system was born.
PATH worked with a small medical device company to further develop the technology and scale it up for manufacturing. Through a series of field studies, PATH and our partners demonstrated that both tetanus toxoid and hepatitis B vaccines could be successfully delivered in the Uniject injection system in low-income countries.
That got the attention of BD, the world’s largest syringe manufacturer. In 1996, Steve led negotiations that resulted in PATH licensing the technology to BD, which now works with pharmaceutical companies around the world to package vaccines, injectable contraceptives, and other medicines in this easy-to-use device.
To date, more than 140 million units have been procured to deliver birth doses of hepatitis B vaccine in Indonesia, micronutrients in Japan, animal vaccines in Latin America, and more than half a million doses of Sayana Press in sub-Saharan Africa and Asia.
From the beginning, Steve and the PATH team believed Uniject could improve access to both vaccines and contraceptives.
With BD now manufacturing the empty Uniject units in bulk, the team began making the case to vaccine and pharmaceutical companies to invest in making their products available in Uniject.
For example, the team created a business and technical analysis to demonstrate how Pfizer’s Depo-Provera® injectable contraceptive could be delivered through Uniject, in addition to a standard syringe and vial. That work was once again supported by USAID.
There were serious setbacks along the way, including a series of pharmaceutical company mergers that slowed things down by several years.
Then, a lucky break. Depo-Provera was about to become a generic drug, and Pfizer wanted to differentiate its product in the market. A pharmaceutical company previously acquired by Pfizer had developed a new, lower-dose formulation that could be delivered subcutaneously—just under the skin—instead of intramuscularly.
“That work was pivotal in allowing Sayana Press to emerge,” Steve says.
Steve describes PATH’s role at this point as “a really good general contractor or an orchestra leader.”
“We may not be the leading technical experts of any particular piece of a project, but we can envision the bigger picture over the longer term and help the players come together,” he says.
He played matchmaker between BD and Pfizer during a series of intense negotiations, serving as a back-channel contact for both companies.
He also helped orchestrate early rounds of the long and delicate dance among Pfizer and various international donors who supply contraceptives to low-income countries.
As Pfizer began to focus on manufacturing scale-up and regulatory approval, the company needed to make significant investments in Sayana Press, but did not yet have purchasing commitments from donors.
“There’s a notion in economics where people may collectively agree on an action, but there’s a disadvantage to anyone making the first move,” Steve says.
Donors don’t want to make long-term commitments to buy a new product before they understand the market for the product and see evidence of its value and impact.
Manufacturers may be reluctant to make up-front investments and offer affordable pricing for low-income countries without assurances that donors will purchase the product.
“There’s a solution that’s win-win, but it’s hard to find sometimes,” Steve says.
With the new price agreement and the launch of the first pilot introductions, 2014 marked a turning point for Sayana Press. Global leaders had earlier committed to a goal of expanding access to family planning information, services, and supplies to reach an additional 120 million women and girls in 69 of the world’s poorest countries by 2020.
The new price agreement guaranteed that Sayana Press would be sold for US$1 per dose to purchasers in low-income countries, building on the momentum of Sayana Press pilot introductions being coordinated by PATH in Burkina Faso, Niger, Senegal, and Uganda.
Sayana Press would never have reached the market without the important contributions of dozens of cross-sector partners over the past three decades.
Years of work go into “making something so elegantly simple come to life.”
In addition to our product development partners, BD and Pfizer Inc., critical funding and partnership has been provided by USAID, Bill & Melinda Gates Foundation, the United Kingdom Department for International Development, CIFF, and the United Nations Population Fund.
When the work faced funding gaps that threatened to derail the project, individual donors and family foundations stepped in at key moments to ensure its future.
For instance, a funding gap threatened to halt production of the first trial batch of Sayana Press in late 2011. A gift from the Frankel Foundation allowed PATH to commit to cornerstone funding for purchase of the trial run, leading Pfizer to complete the trial run and move into regular production.
“Once PATH brings a pilot project to fruition, there is access to support from large funders,” says Dr. Jon Younger, medical advisor to the family foundation. “When a project is in trouble—that’s when we felt that we could really have a huge impact.”
A series of gifts from donor Stephanie Evans, an early backer of the project, kick-started research in Ethiopia that helped determine whether women would consider the option of self-injecting Sayana Press. The results—a resounding yes—helped call attention to the potential of a woman-controlled delivery option.
Steve and the many partners who worked with him to bring Sayana Press to market believe it will revolutionize women’s health.
It also illustrates the long and difficult journey that new health technologies must navigate before they reach the people who need them most.
“Today’s ‘quick wins’ are built on years of work,” Steve says. “For many people, Sayana Press might be perceived as an overnight success. But there’s a lot of behind-the-scenes complexity to make something so elegantly simple come to life.”
—Written by Jolayne Houtz