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Many infants have difficulty breastfeeding and must rely on cup feeding. Photo: PATH/Amy MacIver Breast milk is the perfect first food for newborns; it provides nutrients and energy that infants need and contains substances that strengthen their immune systems. Ideally, newborns are breastfed within their first hour of life with breastfeeding continuing for their first several months of life. However, some babies are not able to breastfeed—preterm babies often do not have the fine motor skills and babies born with facial anomalies like cleft palates cannot breastfeed. And in some cases, babies who are orphaned or have mothers too sick to breastfeed who must be fed with donor milk. In high-resource settings, these infants could have breast milk fed to them through feeding tubes or specially-designed bottles, but in low-resource settings these solutions are impractical and often unsafe in areas where reliable clean water is not available. Tubes must be inserted by a trained medical professional and are often not available in low-resource settings; while bottles are expensive—particularly those that adapted for use by infants with cleft palates— and difficult for mothers to keep free of bacteria due to their crevices. For infants in low-resource settings who cannot breastfeed, the World Health Organization recommends hand expression of breast milk and use of a small cup to feed newborns. Cups are easier to clean so reduce the risk of infection, and cup feeding has been shown in some studies to improve the transition of preterm infants to exclusive breastfeeding. The problem? There is no cup designed specifically for the job, and the household cups many mothers use have some serious drawbacks that can put their baby’s health at risk. A solution? A group of innovators from the University of Washington, Seattle Children’s Hospital Craniofacial Center, and PATH have invented the NIFTY™ cup—a simple-to-use, easy-to-clean, inexpensive cup designed specifically for delivering breast milk to infants. Your average cup won’t do for breastfeeding Because there is no standard cup designed for the purpose, mothers who need to cup feed typically use whatever small cups or devices they have on hand. For example, in India mothers typically use a miniature gravy-boat like device called a paladai—originally used to burn oil during religious ceremonies—that have sharp-edged metal spouts and can cause oral cuts or injuries to an infant. A young infant being cup fed with a mug in Kenya. Photo: PATH/Evelyn Hockstein In other areas of the world, mothers use coffee mugs, shot glasses, medicines cups, or whatever small cups they can find. Unfortunately, the relatively wide rims of these cups can make it difficult for a mother to maintain a consistent flow of milk to her newborn which can be problematic and even dangerous. Too much milk too fast can cause a newborn to aspirate, while too little milk can mean the baby does not get sufficient nutrition. “These infants are getting an erratic, inconsistent, sometimes too rapid flow [of milk] or not enough access to milk while they are feeding,” explained Christy McKinney, PhD, MPH, a clinical assistant professor at the University of Washington who helped design the NIFTY™ cup, “So the infants don’t get enough nutrients within the short amount of time to grow and fight infection.” During lengthy cup feedings, an infant can actually expend more energy trying to feed than it takes in, which can lead to a rapid decline in health. Another problem with standard cups is spillage. “About a third of milk is spilled at each feeding, said McKinney, “If you are trying to feed and hand expressing your breast milk, it’s a pretty painful experience to have a third of that spilled and wasted every time you are feeding, which can be 12 times a day for a newborn.” The NIFTY™ cup: a game changer for cup feeding A demonstration of feeding using the NIFTY cup. Photo: Marissa Chmiola/GHTC McKinney and her collaborators kept these drawbacks in mind as they set out to create the perfect cup for cup feeding. The NIFTY™ cup was designed with a unique reservoir that can hold a bolus of milk at its end. McKinney called this reservoir a “game changer.” It reduces spillage and allows the milk to be constantly available to the infant. McKinney explained that unlike a spout which only allows milk to be poured into an infant’s mouth, the unique reservoir of the NIFTY™ cup enables cup feeding to become a two-way street just like traditional breastfeeding or bottle feeding. “The mother is making sure that the reservoir is filled and then the infant gets to help pace the feed,” said McKinney, “That pacing results in a much calmer infant. They don’t run the risk of aspirating from too much milk poured into their mouth; instead, they can get the milk they need at the rate they want it, which allows for a calmer, integrated feeding experience between mother and infant.” The NIFTY™ cup inventors also made the cup out of silicone, which offers several advantages: The cup is soft and easy to squeeze, it prevents mouth injuries, it’s durable, and it can be boiled, which makes it easy to sterilize. Because the NIFTY™ has a reservoir that controls the flow of milk, the cup can be sized much larger than other cups used for cup feeding. This allow mothers to directly hand express the milk into the NIFTY™ cup rather than using multiple cups which in turn reduces spillage and opportunities for contamination. In addition, the NIFTY™ cup contains tracking markers on the side to monitor milk intake, it’s ergonomically designed for comfort, and it can be affordably produced at less than $1.00 per cup. In short, the NIFTY™ cup offers more advantages for mothers and infants than any other available cup. The long road to innovation For McKinney it has been over a five-year odyssey to turn the NIFTY™ cup from idea to reality. Inspired by her time as a Peace Corp volunteer in Ethiopia and having just completed her PhD studying craniofacial anomalies and beginning her new post-doctoral position, McKinney was looking for ways she could help children in low-resource settings with oral clefts. She saw feeding as the most problematic area and an area most in need of innovation. “So I just thought it would be nice to come up with an idea to feed these infants with,” said McKinney. With this concept in mind, McKinney began searching for a partner who could help make such an idea possible. She discussed the idea with Dr. Michael Cunningham, the director of the Seattle Children’s Hospital Craniofacial Center, where she completed her PhD, and they approached GHTC member PATH, based in Seattle. “We reached out to PATH…and there was sufficient interest to say let’s try and make this work,” said McKinney. Together they developed a design team which included McKinney (an epidemiologist); Dr. Cunningham (a craniofacial pediatrician); a social scientist, engineer, and commercialization officer from PATH; and an occupational therapist/lactation consultant from Seattle Children’s Hospital. Together, with funding from PATH and the Seattle Children’s Hospital Craniofacial Center, the team designed their first prototype cup. A product can only have impact if it meets end-user needs and people are actually interested in obtaining it. To make sure both applied to the NIFTY™ cup prototype, the team set out to test drive the cup in low-resource settings. With support from a nonprofit Transforming Faces—which supports care for children with oral clefts in South India—and additional funding from the University of Washington CoMotion, McKinney and the team took the NIFTY™ cup to Sri Ramachandra University in South India to do formative design work in both the cleft center and the Neonatal Intensive Care Unit. They introduced the cup to mothers and health providers including lactation consultants, watched the product in use, and conducted surveys to gauge interest in the product and to inform design. The NIFTY™ cup was a big hit. “I was really excited that they liked it more than what they were using,” said McKinney, “I didn’t quite know what to expect on that, but they are really excited to get it commercialized.” Armed with valuable feedback from South India, McKinney and the team regrouped and are doing a minor redesign of the product which will be complete this summer. Last month, the team won a grant from the Saving Lives at Birth Challenge. With this funding, the NIFTY™ cup developers plan to conduct a clinical study in Ethiopia to evaluate the product’s effectiveness compared to standard cups being used, and also develop a market shaping strategy for introducing the product. While it could still be some time before the product is widely available to those who need it, McKinney and the rest of the team are energized by the NIFTY™ cup’s lifesaving potential and the support they are receiving to continue development and introduction. “I’m so excited. This little idea has percolated so long, and people have finally seen the value it can bring,” said McKinney.

Sabin Vaccine Institute—a member of GHTC—and Texas Children’s Hospital Center for Vaccine Development received a US$1.8 million grant to expedite the research and development of the first therapeutic vaccine for Chagas disease, which is currently undergoing preclinical research by the same team. Chagas is caused by the parasite Trypanosoma cruzi, which attacks and feeds on human tissue, resulting in heart or digestive disorders in nearly one-third of those infected. The disease is endemic throughout Latin America and in recent years has moved into the United States. The grant comes from the Robert J. Kleberg, Jr. and Helen C. Kleberg Foundation, which works to improve the quality of life in southern Texas, where investigators estimate there are anywhere from tens to hundreds of thousands of Chagas cases in humans. The Critical Path Institute (C-Path)—a nonprofit that facilitates cross-sector partnerships to expedite drug development and regulatory approval—has formed a Pre-Launch Consortium tasked with establishing and operating a Global Pediatric Clinical Trials Network. The Consortium will be comprised of representatives from academia, the public and private sectors, the pharmaceutical industry, foundations, and child health advocacy groups and will determine the structure and leadership of the Network, which will be nonprofit and independent from C-Path. The Network is intended to be a resource, providing technical expertise and using its global infrastructure to advance the development and approval of pediatric treatments across diseases and conditions, phases of trials, and types of studies. The Network’s resources will be available to all product developers, both for- and not-for-profit. Photo: CDC Dr. Rebecca Richards-Kortum and Dr. Maria Oden, professors of Bioengineering at Rice University, are working to create a “Nursery of the Future” to save the lives of babies born prematurely in low-resource settings. Prematurity is the leading cause of death for children under five years old. In hospitals in high-income countries, expensive computer monitors are used to alert staff when a baby stops breathing, so that they can wake the infant and trigger him or her to keep breathing. As a low-cost, innovative alternative, the team has successfully tested a band that wraps around an infant’s belly and vibrates—using motors similar to those in cell phones—when the baby stops breathing, waking it directly. Next, Richards-Kortum and Oden want to develop low-cost alternatives for infant warmers, oxygen concentrators, and serum bilirubin tests—all expensive equipment used in hospitals in high-income countries. Their eventual goal is to create an entire nursery that costs less than US$10,000. A new study suggests that “leaky” vaccines, which decrease the severity of an infection rather than prevent it entirely, could lead to the evolution of more virulent pathogens. The basic premise is that when a pathogen is able to survive in a vaccinated person, it grows stronger, and the vaccinated person can then become an asymptomatic carrier of the more deadly version of the pathogen. The study, led by Dr. Andrew Read, a professor of Biology and Entomology and Pennsylvania State University, applied the theory to Marek’s disease, a poultry disease against which farmers regularly vaccinate their chickens. Read’s team demonstrated that, when infected with different strains of Marek’s disease virus, vaccinated chickens were effective carriers, and that those infected with highly virulent strains were able to spread the disease to a greater number of unvaccinated chickens. Read believes that “we are entering the era of leaky vaccines in humans,” as researchers develop partially effective vaccines for complicated viruses such as malaria or HIV and AIDS. However, vaccine researcher Dr. Adrian Hill of Oxford University argues that the theory is plausible but unlikely, referring to Marek’s disease as “the only example of this happening” and noting that the development of natural immunity in a population could have the same effect.

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.

In this guest post, the HIV Vaccines & Microbicides Resource Tracking Working Group—comprised of AVAC as secretariat, the International AIDS Vaccine Initiative , and UNAIDS—discusses its new report examining investment in research and development (R&D) for HIV prevention options. Investment in R&D for HIV prevention fell slightly, from US$1.26 billion to $1.25 billion, between 2013 and 2014 and has largely been stagnant for nearly a decade, according to a new report from the HIV Vaccines & Microbicides Resource Tracking Working Group which looks at year-over-year spending on HIV prevention R&D and trends spanning the last 15 years. The report, HIV Prevention Research & Development Funding Trends 2000–2014: Investment Priorities to Fund Innovation in an Evolving Global Health and Development Landscape, provides detailed information on funding for R&D on HIV prevention options—including preventive HIV and AIDS vaccines, microbicides, pre-exposure prophylaxis (PrEP), the use of AIDS treatment by people living with HIV to reduce transmission, the use of AIDS treatment to prevent infections in infants born to women living with HIV, voluntary medical male circumcision, and female condoms. In addition to funding information for R&D for HIV prevention options, the report also provides an update on investment in HIV cures, therapeutic vaccines, herpes (HSV-2) vaccines, and multipurpose prevention technology research. Despite the slight decline in funding, HIV prevention R&D is still delivering important advances. The 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention held in Vancouver from July 20-22, showcased results for a range of groundbreaking research that has been supported over the past several years, including the Strategic Timing of Antiretroviral Treatment (START) trial, the HPTN 052 antiretroviral (ARV) treatment as prevention trial, and several groundbreaking oral PrEP trials. Results from studies of a vaginal ring containing the ARV dapivirine are expected in the next 12 months. Several different HIV and AIDS vaccine candidates, neutralizing antibodies, and long-acting injectable ARVs are currently in studies that could lead to multiple efficacy trials starting over the next two years. Robust ongoing investment will be critical to advancing these promising products through the R&D process. Through their research and analysis, the Working Group identified four key findings about the state of funding for HIV prevention R&D which are highlighted in the report: R&D investment is expanding beyond research to rollout: Since the Working Group began tracking investments in HIV prevention, a number of options have moved through the pipeline from research to rollout. The importance of investing in products beyond bench science and clinical trials is shown through the recent rollout and scale-up of options such as voluntary medical male circumcision and female condoms, and—in the demonstration project phase—PrEP. Majority of investment is from several large funders: The United States remained the largest public-sector funder of HIV prevention R&D, spending a total of $868 million in 2014—66 percent of the total investment. Combined, the US government and the Bill & Melinda Gates Foundation accounted for 83 percent of all HIV prevention R&D funding. Expanding and diversifying this investment base could bring in new perspectives and capacity and better assure sustained and consistent funding, reducing the potential negative impact of reductions by one or two primary funders. Increasingly important to HIV prevention is research into how to deliver HIV prevention products and ensure that those products meet the needs of, and reach, end users. Early investment to ensure the uptake of products is a growing part of HIV prevention R&D. Decrease in number of philanthropic funders engaged: While the total amount of philanthropic funding increased in 2014, the number of philanthropic funders engaged in HIV prevention research has been steadily declining since 2010. In 2014, 16 philanthropic funders invested in HIV prevention research, down from 30 in 2010. Development funding priorities are changing: The Millennium Development Goals and the United Nations Declaration of Commitment on HIV and AIDS galvanized increased investment in HIV and AIDS. This in turn led to greater overall HIV prevention R&D investment—an increase of threefold between 2001 and 2014. With the new Sustainable Development Goals set to be decided in September and global financing and development also in a period of transition, it remains to be seen whether HIV prevention R&D, and global health R&D as a whole, will receive a prominent place in the new international development agenda. For further analysis of HIV prevention funding trends, visit the Working Group's website at www.hivresourcetracking.org to download HIV Prevention Research & Development Funding Trends 2000–2014: Investing in innovation in an evolving global health and development landscape and to view additional Working Group reports, as well as graphics and PowerPoint slides.