New report on investment in R&D for HIV prevention highlights 2014 global funding trends

In this guest post, Heather Ignatius—senior policy and advocacy officer at PATH—writes about a new bipartisan piece of legislation to accelerate progress towards ending preventable child and maternal deaths. More than 30 diverse organizations including PATH are calling on members of Congress to support the legislation, and you can add your voice to the call by joining their virtual “chain” of people around the world who believe we must do all we can to #SaveMomandKids. The Reach Act aims to accelerate an end to preventable maternal and child deaths. Photo: PATH/Gabe Bienczycki Today Senator Susan Collins (R-ME) and Senator Chris Coons (D-DE) introduced a new bipartisan piece of legislation that could help save the lives of women and children around the world. This legislation—the Reach Every Mother and Child Act (Reach Act)—aims to end preventable maternal, newborn, and child deaths within a generation by putting into place US policies to reach more women and children with lifesaving programs and support the development, introduction, and scale-up of high-impact interventions in low-income countries. Reach Act reaffirms America’s commitment to end preventable maternal, newborn, and child deaths In 2012, the United States, the governments of Ethiopia and India, and UNICEF led the Child Survival Call to Action, committing to end preventable child and maternal deaths by 2035—a commitment that has since been endorsed by 175 partner governments around the world. The Reach Act would make it the policy of the United States to make good on that promise and put in place a coordinated, whole-of-government strategy to achieve it. The legislation calls for the US to set ambitious, outcome-based targets for reducing child and maternal deaths and track and report progress toward them annually. It also calls for improved coordination across US government agencies, establishes a maternal and child survival coordinator position at the US Agency for International Development (USAID) to oversee activities, and would expand the use of innovative financing mechanisms that will help countries overcome financial hurdles and obtain more resources to strengthen health programs, ultimately moving countries towards greater self-sustainability in confronting their own health challenges. Reach Act ensures innovation is part of the US government strategy to achieve this aim Improvements in maternal and child health have been one of the greatest success stories in international development. Since 1990, deaths of mothers and children under the age of five worldwide have been nearly cut in half—meaning every day 17,000 more children live and 700 more mothers survive childbirth compared to just two decades ago. Central to that progress has been research and development (R&D) of new and innovative health products. For example, new vaccines, drugs, diagnostics, and other health innovations have led to 4.2 million fewer child deaths in 2013 compared to 1990, according to a report by the Institute for Health Metrics and Evaluation. Advances in maternal and child health have been driven by the development of new approaches and innovative technologies. Many of these breakthroughs—such as bed nets to prevent malaria, oral rehydration therapy to treat diarrheal disease, and antiretrovirals to treat HIV and AIDS—were supported or piloted by US government funded programs, demonstrating the power of US investment in innovation to save the lives of mothers and children. Ending preventable maternal, newborn, and child deaths is an ambitious goal, but it’s also an achievable one—and investing in health innovation can help us get there. According to the Lancet Commission on Investing in Health, the world can achieve a “grand convergence”—reducing maternal and child deaths in low-income countries to low levels within a generation—by increasing investment in the R&D of new technologies and the scale-up of existing technologies. The Reach legislation would ensure that R&D is a critical part of the US approach to ending preventable maternal, newborn, and child deaths. As the lead US agency working in maternal, newborn, and child health, USAID has long placed global health R&D and innovation at the core of its activities to end extreme poverty and build resilient societies. The agency has helped to support the development and introduction of a range of affordable and cost-effective technologies including easy-to-use diagnostic tests for HIV and AIDS, malaria, and tuberculosis; innovative contraceptive technologies; treatments to reduce neonatal infection and postpartum hemorrhage; and vaccines against leading childhood killers like meningitis. The agency has sought to harness expertise and resources across sectors and geographies to catalyze the development of health technologies to improve maternal and child health. Through programs like the Saving Lives at Birth: A Grand Challenge for Development, USAID has advanced innovative solutions for maternal and child health, such as simple pouches to deliver drugs to reduce mother-to-child transmission of HIV and AIDS and devices to help babies take their first breath. The Reach Act challenges policymakers at USAID and other US agencies to continue to think long-term about the role innovation could play in achieving an end to preventable maternal, child, and newborn deaths. The GHTC staff has joined the global chain to #SaveMomsandKids Innovation will be necessary to bend the curve Last year in its Acting on the Call report, USAID articulated a roadmap to achieve the vision of ending preventable and maternal deaths in 24 priority countries, setting an interim milestone of saving 15 million children and 600,000 women by 2020. If achieved, meeting this milestone would mean that US programs would be exceeding the impact targets set in 2012. The development and introduction of new health technologies can further accelerate progress toward this goal—helping us bend the curve more steeply and saving more lives, more rapidly. Now is the time for Congress to turn ambition into action. The Reach Act can help us realize a world where every kid everywhere lives to celebrate his or her fifth birthday and no mother dies as a result of pregnancy or childbirth. Read a fact sheet about the legislation. Watch a video of Sen. Collins and Coons introducing the legislation. To support the legislation, join the social media campaign using the hashtag #SaveMomsandKids.

Wendy Taylor of USAID introducing the other event partners. Photo: Marissa Chmiola/GHTC Last Wednesday 53 teams of innovators gathered at the International Trade Center in Washington, DC, for the Saving Lives at Birth DevelopmentXChange—an event resembling a cross between a science fair and an episode of Shark Tank. There were no baking soda volcanoes or smiley sponges to be found, rather innovative ideas to advance the health of pregnant women and newborns in poor communities around the world. And at stake was not a blue ribbon or a chance to take home Mr. Wonderful’s money, but something much more important—the chance to save the lives of mothers and their babies. Saving lives at birth through innovation This DevelopmentXChange served as the final stage of competition in the 5th annual Saving Lives at Birth Grand Challenges Program, a contest sponsored by the US Agency for International Development (USAID), the government of Norway, Grand Challenges Canada, and the UK Department of International Development, which aims to identify and advance groundbreaking and cost-effective solutions to improve maternal and newborn health. Innovators from around the world compete for grants to develop, test, and bring their ideas to scale. The competition covers three areas—technology development, service delivery, and demand creation. The program started in 2011 as a way to “leapfrog” solutions in the underserved area of research. “We recognized that the area of maternal and neonatal health is an area that had really not seen the type of innovation we need to save the lives of mothers and newborn around the time of birth and in the hardest to reach areas,” said Wendy Taylor, director of the Center for Accelerating Innovation and Impact at USAID. “So we put together the Saving Lives at Birth Grand Challenge…and called on the brightest minds across the world, engineers and entrepreneurs, scientists and students, to come up with new, groundbreaking ideas, new ways to prevent and treat mothers and newborns and save their lives in the most risky time—the 48 hours around the time of birth.” The response to this call has been tremendous. Since 2011, the program has provided over US$47 million in funding to 81 innovative tools and approaches, and many of the program’s successes are already having an impact as they begin to scale. To date, Saving Lives at Birth–supported innovations have been delivered to over 1.5 million women and newborns, saving at least 4,000 lives. This year the Saving Lives at Birth competition received more than 750 submissions, over half of which came from low-and middle-income countries (LMICs). Fifty-three teams were chosen to compete as finalists at the DevelopmentXChange. At the conclusion of the event, 17 award nominees were selected with additional nominees in the transition-to-scale category to be announced later this year. GHTC member projects featured as finalists Among the 53 finalists were 10 projects from GHTC member organizations: Validation of low-cost, user-friendly strip test for preeclampsia/eclampsia screening PATH Brandon Troy Leader showcases his team's innovation. Photo: GHTC/Courtney Carson Dr. Brandon Troy Leader and his team at PATH are developing a low-cost, easy-to-use strip to test for proteinuria—a key indicator of preeclampsia/eclampsia—during pregnancy. Preeclampsia is a serious health risk to both mothers and infants and accounts for at least 16 percent of maternal deaths in low-resource settings. Current diagnostics are either time-consuming and expensive—requiring 24 hour urine analysis—or inaccurate—relying on analysis of protein levels in urine which can fluctuate with fluid intake. Both of these tools are impractical for use in secondary health centers, where most women in LMICs receive treatment. The team’s innovative dipstick promises to deliver a quick, low-cost, and highly accurate test that will allow more women in low-resource settings to be diagnosed and appropriately monitored for preeclampsia/eclampsia. The strip tests for a new protein-to-creatinine (PR/CR) marker and uses a product specifically designed for this single application. It is available at less than $0.10 a strip—the current cost of the inaccurate protein-urine analysis diagnostic. In lab tests, the PR/CR strips showed 85 percent sensitivity, indicating that with appropriate clinical trials, the product could be quickly rolled out to communities in need. The team was seeking a Saving Lives at Birth validation award to test the PR/CR strips in a clinical trial with over 20,000 women and accelerate the product’s introduction into low-resource settings. Advancing introduction of new screening test for preeclampsia PATH To address the unmet need for effective screening and treatment of preeclampsia in low-resource settings, PATH is preparing for a large-scale evaluation of its innovative glycosylated fibronectin (GlyFN) test. The test targets the GlyFN biomarker, which occurs at higher concentration in the blood than other preeclampsia biomarkers and offers excellent sensitivity and specificity. Small scale tests indicate that the GlyFN test predicts preeclampsia in the third trimester of pregnancy with a sensitivity of 97 percent and specificity of 93 percent. The GlyFN test is innovative not only for its use of an easier to detect biomarker, but also for its accuracy and sensitivity in diagnosis. The PATH team was seeking a Saving Lives at Birth award to perform the first operational evaluations of the GlyFN test, refine training materials with users in the field, and implement a prospective-cohort study in Karnataka, India. Developing a model for national scale-up of the Pratt Pouch to prevent mother-to-child HIV transmission Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) A syringe typically used to measure ARV dosage and the Pratt Pouch which could replace it. Photo: GHTC/Marissa Chmiola Dr. Edward Bitarakwate and his team at EGPAF Uganda are seeking to develop a model for the national scale-up of an innovative product to prevent mother-to-child HIV transmission known as the Pratt Pouch. About 1.5 million HIV positive women give birth each year. It’s possible to prevent mother-to-child HIV transmission if antiretrovirals (ARVs) are administered during labor and for several weeks following delivery. Unfortunately, many mothers don’t give birth in health facilities so their infants fail to receive ARVs during this critical period, and those who do are currently sent home with bottles of liquid ARVs and a syringe to measure appropriate doses to administer to their child. Keeping these syringes clean can prove difficult for new moms in low-resource settings, and the viscosity of the liquid ARVs makes it challenging to measure accurate doses. The Pratt Pouch addresses these challenges—it’s an easy to tear open package containing a premeasured dose of ARVs which can be stored safely for up to 12 months at any temperature. Dr. Bitarakwate described the pouch as a “ketchup packet” for ARVs, noting that the pouch is an adaptation of technology used in the food industry to package ketchup. The pouch was developed by a team of engineers at Duke University with support from a previous Saving Lives at Birth grant. Small pilot tests of the product in individual health care settings have demonstrated promise, so Dr. Bitarakwate is seeking funding to work with the Ugandan government to integrate the product into the country’s health system and create an effective model for national scale-up of the product. Reducing birth complications by increasing access to noninvasive, cloud-connected anemia screening diagnostic device PATH Masimo's Pronto-7 anemia screening device. Photo: PATH/Patrick McKern Iron-deficiency anemia affects half of all pregnant women in LMICs and can lead to poor pregnancy outcomes including preterm births, low birth weight, and maternal mortality, contributing to one-fifth of maternal deaths. However, anemia often goes undetected, as methods commonly used throughout sub-Saharan Africa require a blood draw, which can be prohibitive to patients and must be administered by highly-trained health professionals. PATH consulted more than 100 nurses, doctors, and other health professionals in sub-Saharan Africa, hearing repeatedly “noninvasive is the future” of diagnostics. PATH has partnered with California-based diagnostic manufacturer Masimo to create a noninvasive, easy-to-use, cloud-connected diagnostic device, using the “FDA-approved guts” of Masimo’s Pronto-7 hemoglobin test. Rather than drawing blood, the health worker merely asks the patient to place their finger on the sensor (see photo) and the results are available within a minute. PATH will use Masimo’s equipment and technology, but will develop a device that is more durable and even easier to read—enabling use by lower-skilled professionals. Andy Beddoe, a product development officer at PATH, explained that diagnostics that require disposable parts are more dependent on a robust supply chain. This device, however, will require no such disposables, and will use cloud-enabled software, allowing the manufacturer to “sell tests like you would cell phone minutes,” troubleshoot, or calibrate it remotely. Beddoe believes each device could last three to four years, administering more than 50,000 tests. The software could also be used for data collection and could be adapted for use in other diagnostics. A pediatric-friendly ARV dosage form: validation of palatability, flexibility, and accurate dosing of LPV/r PATH “[We’re] targeting the most vulnerable population infected with HIV,” explains Dr. Manjari Lal, senior research officer in Vaccine and Pharmaceutical Technologies at PATH, in discussing her project. Less than a quarter of HIV-positive children in LMICs are receiving ARVs, and for most families, the current treatment method involves breaking adult doses into two, crushing up one half, and mixing it with food. Lal’s team is working to transform lopinavir/ritonavir (LPV/r)—the first-line treatment for pediatric HIV—into a product that is palatable, heat-stable, and that allows for flexible dosing. The team is developing a freeze-dried, fast-dissolving tablet, which allows a parent to mix the medicine with water—as children often struggle with pills that must be swallowed. According to Lal, palatability is a major consideration for pediatric treatments, as infants won’t hesitate to spit out bitter medicines. The treatment is currently in the preclinical phase, and must go through animal studies and clinical trials with human adults before it is ready for use in children. Scaling an Integrated Human Milk Bank and Breastfeeding promotion program in Kenya PATH Human milk provides important nutritional and disease-preventing properties for infants and is particularly critical for those who are born preterm or have low birth weight. Unfortunately, some mothers are unable to produce milk or do so in the quantity needed to feed their newborn. While it’s preferable for infants to receive their own mother’s fresh milk through breastfeeding or hand expression, in cases when that is not possible, the World Health Organization recommends the administration of human donor milk. The idea of milk banks were developed to meet this need. These banks accept donor milk, screen and process it for safety, and disseminate it to mothers in need. PATH was seeking a grant to scale-up and evaluate the impact of an innovative and integrated human milking banking approach known as Mother and Baby Friendly Initiative Plus (MBFI+). Unlike stand-alone milk banks, the MBFI+ approach creates “hubs” that provide both lactation support and milk banking at the same facility. Kimberly Amundson—program officer on PATH’s Maternal and Child Health and Nutrition Team which is leading the project—describes MBFI+ as a “self-reinforcing cycle of supporting breastfeeding for all infants.” Mothers come into the facilities for lactation support, and are then able to donate any excess milk they may produce to those who need it, and those infants who receive donor milk often go on to be able to breastfeed just fine with their own mother. The team hopes to introduce the approach at two hospitals in Kenya, evaluate its effectiveness and potential cost savings, and position the approach for national adoption. Clinical validation of a novel, affordable uterine balloon tamponade, developed in Africa, to reduce maternal deaths due to postpartum hemorrhage. PATH Postpartum hemorrhage, or severe bleeding after childbirth, is the leading cause of maternal mortality, resulting in 125,000 deaths annually. However, with just a condom and a catheter—materials readily found in health clinics—the risk can be drastically reduced. The condom—connected to the catheter—is inserted into the uterus and slowly filled with water, inducing uterine contractions and ultimately slowing or stopping the bleeding. While such a device, known as a uterine balloon tamponade, is readily available in high-income countries, it can be used just once and can cost as much as $400. PATH and partners have worked to develop a device—designed and manufactured in Sou Africa with input from health professionals—that costs just a few dollars. While condoms work well, they vary greatly and the thickness of  a condom can impact the pressure exerted by the device. This uterine balloon tamponade involves a reusable bag that is filled with water and held at a certain height—depending on how much pressure is needed—connected to a reusable catheter which is in turn connected to the disposable, standardized balloon. The device has been successfully tested and with widespread introduction, an estimated 169,000 deaths could be prevented over the next fifteen years. PATH was seeking funding to conduct a clinical validation study of the product and develop a commercialization strategy to increase access to the product in LMICs. Use of a low-cost simulation model to expand postpartum intrauterine device services Jhpiego The Mama-U simulator at the Jhpiego display. Photo: GHTC/Marissa Chmiola Over 90,000 maternal deaths can be prevented each year through family planning use. Yet, many women who have just given birth don’t receive access to long-acting family planning methods like intrauterine contraceptive devices (IUCDs) because there are not enough health providers trained to properly administer IUCDs to women with postpartum bodies; and many women incorrectly believe the product may not stay in place given the changes to their bodies resulting from birth. Under a previous grant, Jhpiego found that using a postpartum body simulator called the Mama-U was effective for training workers and improving service delivery. According to Dr. Fauzia Assad, a medical doctor working with Jhpiego Pakistan, the Mama-U offers benefits over existing approaches to training for postpartum IUCD training. “It’s cost-effective, just $50 versus $600 for the usual model, culturally appropriate, easy to take along, very portable, easy to understand, and it offers the same level of difficulty one would experience with an actual patient because it has a similar feel and tension.” In earlier testing, Jhpiego found the product was not only helpful in training providers, but counselors found it helpful in educating patients, dispelling patient concerns, and increasing client use of IUCDs. Jhpiego was seeking a grant to build on past learning and show that the Mama-U can improve quality of services and patient uptake and change the way postpartum IUCD training, counseling, and services are delivered. Projecting Health India PATH People typically find it easier to learn a process if they see it demonstrated, rather than just hearing or reading about it. This is why the Projecting Health India program is using video as a medium through which to promote health behaviors. Projecting Health India a community-based, video education project, which trains communities in India to create and produce videos addressing a variety of health topics—including birth preparedness, breastfeeding, and family planning—which are shown at community mothers’ groups and village health days. The videos feature local actors and health workers and aren’t distributed outside the district for which they were produced. Michelle Desmond, a monitoring and evaluation officer at PATH involved with the program, described the approach “as hyperlocal” which is key to the program’s effectiveness. “Literature on behavior change shows that if you can empathize with a person you see practicing a healthy behavior, you are more likely to practice it yourself,” said Desmond. “So in these videos women are seeing people who sound like them, who look like them, who are in the same situation as them practicing these health behaviors.” After realizing that the videos were so popular that women were finding ways to transfer them onto their mobile phones to rewatch and share, Projecting Health partnered with mobile phone vendors in India to allow the videos to be easily loaded onto phones, providing an additional way for these videos to be distributed to harder to reach mothers. PATH was seeking a Saving Lives at Birth grant to scale up this project in government systems throughout the state of Uttar Pradesh. NIFTY: A Neonatal Intuitive Feeding Technology for preterm infants who have difficulty breastfeeding PATH A demonstration of feeding using the NIFTY cup. Photo: GHTC/Marissa Chmiola In high-resource settings, infants who struggle with breastfeeding can be fed with breast milk through tubes or bottles, however such technologies can be expensive, difficult-to-use, or unsanitary in low-resource settings. In LMICs, the World Health Organization recommends the use of small cups for infants with feeding difficulties, including preterm infants, infants who have lost their mother due to complications in pregnancy or childbirth, and children with cleft palates. There is currently no product on the market specifically designed for this purpose, and the metal or glass cups that are often used can be inefficient, or can cause injury to the infant’s mouth including cuts. To address these limitations, PATH and its partners created the NIFTY™ cup which is made of silicone, making it soft and durable. The cup can also be boiled without causing any damage—making it easy to sterilize. The cup also has a reservoir on the lip of the cup, making it easy to control the amount of milk delivered and prevent waste. The NIFTY™ cup costs just $1.25 to produce. This innovation was chosen as one of the 17 competition award nominees. The team at PATH will use the funding to test the NIFTY™ cup in hospital settings in Ethiopia and work with private-sector partners throughout the sub-Saharan market to commercialize the cup. Innovation is happening around the world In visiting the DevelopmentXChange, it was clear that innovation is happening in all corners of the globe and lifesaving ideas can come from anywhere and anyone. Saving Lives at Birth demonstrates the power of bringing governments, foundations, academic institutions, and for-profit companies together to address our most pressing health challenges. GHTC congratulates both our members and the other teams who were selected as finalists and award nominees—your work continues to inspire us. Authored by Marissa Chmiola, GHTC’s communications officer with support from Courtney Carson, senior policy and advocacy associate, and Kat Kelley, senior program assistant.