Marissa Chmiola

USAID's 2015 Health-Related Research and Development Progress Report. Photo: USAIDLast month the US Agency for International Development (USAID) released its annual Health-Related Research and Development Progress Report detailing the agency’s research and development (R&D) activities to address global health challenges.Breakthroughs Blog is joined by Neal Brandes—team leader for USAID’s Health Research Program (HaRP) in the Bureau for Global Health—to learn more about the report and USAID’s ongoing support for global health R&D. The HaRP team coordinates the cross-bureau effort to produce this publication and has been advocating collaborative and coordinated research and research utilization efforts to accelerate the research-to-use process.Q: GHTC is always excited to dig into this great report each year. Can you highlight for our readers what is new in this year’s report with regard to new programmatic developments at USAID or major scientific developments in USAID-supported biomedical R&D? NB: There are many new developments that we’re excited about in this year’s report. To highlight just a few: The Ebola epidemic this past year emphasized the need for processes to solicit new ideas and rapid solutions based on sound evidence. This year’s report highlights the exciting products of the Fighting Ebola Grand Challenge, as well as the ongoing good works to produce innovations through the Saving Lives at Birth Grand Challenge. On the newborn front, we report on the progress on care of newborns with possibly severe infection or sepsis—one of the leading preventable causes of death. The World Health Organization (WHO) recommends that sick newborns be referred to hospitals for in-patient care, but also recognizes there are significant barriers to families in low- and middle-income settings accessing that essential care. A multicountry and multidonor initiative supported research establishing that newborns unable to access hospital care can be treated by a trained health worker in lower-level health facilities. This treatment is provided on an outpatient basis with a shorter course of antibiotics. The WHO has recently updated its guidance based upon this new evidence, and we are already in the midst of implementation research to test, adapt, and support its effective and safe application in real-world health systems. Finally, there was encouraging progress on research to combat the HIV and AIDS epidemic. Findings from two dapivirine ring trials are highlighted. These are landmark studies because they are the first to test the efficacy of a woman-controlled method of HIV prevention that uses a nongel microbicide.  Q: This year’s report marks the end of USAID’s 2011–2015 Health Research Strategy. Looking back at the last five years of USAID-supported biomedical R&D, what are some of the most exciting and impactful developments or innovations that have resulted? Are there disappointments or areas in which not as much progress was made as the agency had hoped? NB: Research operates across a continuum. Fortunately, in recent years we’ve had the opportunity to witness some of these efforts come to fruition. For example, take the chlorhexidine story. Chlorhexidine was an early effort to invest in a promising idea through a managed research-to-use process. We began with a careful assessment and then a modest series of concurrent proof-of-principle studies; research utilization efforts; and collaborative efforts with governments, universities, nongovernmental organizations, and pharmaceutical companies that demonstrated the potential and established a foundation to save lives. Nepal was both an early adopter and a global champion for the results of this work. Today these efforts have led to global engagement, rigorous introduction, and scale-up planning in 10 countries. We also understand that the nature of research involves uncertainty and planning for failure. Because of the commitment of our partners and the agency’s culture of learning, we are able to see setbacks as opportunities to improve our processes and extract value from our missteps that will improve the next efforts to address complex challenges.Q: The report illustrates how USAID is working with other US agencies across the continuum of R&D to develop new tools to combat tuberculosis (TB) as part of the US government TB strategy. Could you tell us more about how USAID is coordinating with other US agencies to advance development of critically needed tools in other health areas?A lab technician test tuberculosis samples at a lab in Bandung's Public Health Laboratory. Photo: USAID IndonesiaNB: We work with many stakeholders, foremost of which are the host governments. Because we are stewards of the public’s money, we collaborate with US government agencies as well as other donor development agencies such as the United Kingdom Department for International Development and philanthropies on almost every area of our portfolio—whether it’s to keep each other informed to ensure our efforts are aligned and coordinated or coordinating cofunding to advance the R&D agenda with a goal of advancing research investments to save lives. For example, our malaria portfolio consists of many operational research projects that are done through the President’s Malaria Initiative—a joint effort between USAID and the US Centers for Disease Control and Prevention (CDC). The Ebola Grand Challenge efforts were based on a coordinated partnership with USAID, the White House Office of Science and Technology, CDC, and the US Department of Defense. To introduce new tools and measurements in behavior science (like Big Data), we are working with the White House Social and Behavior Science team.Q: Why is it important for USAID to continue to play a strong role in health research, and what’s next for USAID in this area? Should we expect a 2016–2021 strategy, and how might it look similar to or different from the current strategy? NB: We still have many health challenges ahead of us, and our success is dependent on garnering strong evidence to inform decision-making and action. USAID has the advantage as a development agency to provide technical leadership and an on-the-ground presence working in conjunction with our partner countries and other stakeholders to accelerate the application and development of science and innovation.We are actively discussing our new research strategy. Like our previous strategies, it will address the unique needs of each of our technical areas. However, we are also working together to articulate a number of broad principles that define our work—placing emphasis on how our work includes implementation science, innovation, and partnerships.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Could a US Food and Drug Administration (FDA) approved drug to fight Zika already exist? A new research paper suggests it could be possible. A group of researchers at the University of Texas Medical Branch at Galveston screened 774 FDA-approved drugs to see if they could protect isolated human cells from the virus and found that 24 of the drugs showed some ability to block Zika from infecting certain cell types. Due to the lag time between when a pregnant woman contracts the virus and when the virus passes from mother to fetus, if scientists could find a drug to halt infection, a woman could take it as soon as infection is discovered and prevent the virus from reaching her fetus. Using an existing drug already shown to be safe could help expedite the research and regulatory process to bring it to market. A chemist at the University of Albany has developed at tiny, edible QR bar code he believes could be a solution to fighting the problem of counterfeit drugs. Made of edible materials, the code is smaller than 200 micrometers, or around the size of a dust particle, and can be printed on the surfaces of capsules or embedded in pills. The code, which is able to be read by a cell phone microscope available for about US$10, could contain manufacturing information such as the product number and production date. In low- and middle-income countries, counterfeit drug sales are a major health challenge. Up to 30 percent of drugs on the market are counterfeit. A new study has found that infection with the worm Wucheria bancrofti—which cause lymphatic filariasis—increases risk of HIV infection by two-to threefold. The study followed 1,055 individuals in southwest Tanzania and found that those with the worm infection had a 3.2-fold increased risk of HIV infection in the age group 14 to 25 and a 2.4-fold increased risk in those between 25 to 45 years. The study adds to a growing collection of scientific literature linking infection with neglected tropical diseases with increased HIV infection risk. A new public-private partnershipwill deploy more than $350 million over the next five years to encourage pharmaceutical companies to develop new antibiotics to combat the growing problem of drug resistance. The partnership—Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X)—is a joint initiative of the Boston University School of Law, the Biomedical Advanced Research Authority, the Wellcome Trust, and the Antimicrobial Resistance Centre. With few large pharmaceutical companies in the antibiotic development market today, the program will focus on researchers and smaller biotech firms who may be interested in developing new antibiotics but have little access to funding. The program will provide grants to these developers as well as business and research support through one of four accelerator sites, which will aid these developers with mentoring, business strategy, and other coaching.

A typical pitch for venture capital investment highlights three topics: the problem a technology solves, the size of the market, and the profit potential of the product. But at the pitches I witnessed from innovators last Thursday at the Saving Lives at Birth DevelopmentXChange, this formula was turned on its head. While the discussion focused on problem solving, the questions being asked were not how large the market, but how great the need, and not how much money can be made, but how many lives could be saved.The DevelopmentXChange marked the final stage of competition in the 6th annual Saving Lives at Birth Grand Challenge, a prize program sponsored by the US Agency of International Development, the government of Norway, the Bill & Melinda Gates Foundation, Grand Challenges Canada, the UK Department of International Development, and the Korea International Cooperation Agency to identify and advance transformative, cost-effective solutions to improve maternal and newborn health. The program operates much like a venture capital firm. Innovators apply and pitch their ideas, and the program determines whether to issue them grants to develop, test, and bring their ideas to scale.This year the program received more than 650 applications from 78 countries, with 49 teams chosen as finalists to compete at this year’s DevelopmentXChange and showcase their innovations. At the conclusion of the event, Saving Lives at Birth announced the selection of 12 winning teams in the validation and seed grant categories, who will receive more than $3.4 million in funding to move their projects forward. Award winners in the transition-to-scale category will be announced later this year.  GHTC members featured among finalistsAmong the 48 finalists were five promising innovations from GHTC member organizations, profiled below: Finalization and validation of a postpartum screening tool focused on identifying risk factors for maternal infection as part of routine, predischarge service delivery Jhpiego Despite widespread availability of treatment, postpartum infections account for 11 percent of maternal deaths worldwide. A number of risk factors are strongly associated with postpartum infection, and symptoms usually manifest within 48 hours after birth. In Uganda, women are increasingly giving birth in hospitals; however, they are often discharged early due to overcrowding.To address this challenge, Jhpiego has developed a simple screening tool to assess a woman’s risk of postpartum infection. The tool is a checklist of the key risk factors, composed of eight yes or no questions. The assessment is easy to use, and the results are even easier to interpret. If the tool proves to be predictive of postpartum infection, it could be used by health workers, including nurses and midwives, to make evidence-based decisions on whether a new mother can be safely discharged or whether she should remain in the hospital for an additional 48 hours. At Saving Lives at Birth, Jhpiego was seeking funding to finalize and validate the tool—to determine its predictive value—by rolling it out in two regional referral hospitals in Uganda. If successful, Jhpiego plans to partner with the ministry of health to expand its use across public- and private-sector hospitals.Field validation of a new protein-to-creatinine (PrCr) strip test: An impactful new tool to improve diagnosis of preeclampsia at the front lines of antenatal care in low-resource settingsPATH At least 16 percent of maternal mortality worldwide is attributable to preeclampsia, a dangerous condition that can cause organ failure, seizures, and maternal and newborn death. Screening for preeclampsia—which is characterized by high blood pressure and protein in urine (proteinuria)—ideally occurs as part of the care a woman receives during pregnancy. Throughout the day, the concentration of urine often fluctuates, and so, too, does the concentration of protein in the urine. Consequently, the gold standard for diagnosing proteinuria involves collecting and analyzing urine samples over 24 hours. However, this approach is unrealistic in many low-resource settings, and current diagnosis involves a protein-only dipstick test that catches just 51 to 68 percent of cases.PATH has developed a simple, low-cost protein-to-creatinine strip test to improve the accuracy of preeclampsia screening in low-resource settings and was seeking funding through the Saving Lives at Birth program to evaluate the feasibility and efficacy of the diagnostic test in Ghana. The test is nearly identical to the commonly used protein-only test. However, where the existing tool only tests for protein concentration, the new device also tests for creatinine concentration. By comparing the concentration of both protein and creatinine, a health worker can control for how diluted or concentrated the urine is at the time. PATH has confirmed that the diagnostic strip remains effective when stored for at least four months at 37 to 45°C, and the tool costs just pennies on the dollar. Due to its similarity to the existing protein-only test, rollout of the test should be straightforward, requiring very little additional training.Developing a Rapid Integrated Sepsis Risk Calculator (RISC) to detect and manage severe sepsis in newbornsPATH PATH's Rapid Integrated Sepsis Risk Calculator. Photo: Matthew Robinson/GHTCSepsis kills an estimated 421,000 infants in the first 28 days of life in low- and middle-income countries every year. To address this glaring need, the World Health Organization (WHO) recently published guidelines for diagnosis and treatment of possible serious bacterial infection (PSBI), which will require primary-level health care providers to be versed in sepsis detection and management. Many providers do not currently have the necessary training or tools.The RISC is a smartphone or tablet-based app and off-the-shelf device measuring oxygen saturation levels in the blood that enables even primary-level providers to identify sick infants and either provide the correct treatment or refer them to higher-level care. The app incorporates algorithms that walk the provider step by step through the diagnostic process, increasing provider confidence and greatly improving the accuracy of diagnoses. Because the app will be built using Open Data Kit (ODK) free open-source software and off-the-shelf hardware, it will be highly cost-effective and adaptable. The app also works offline, which is critical in remote primary care facilities. The team was seeking a Saving Lives at Birth seed award to complete the development of the ODK app and conduct a pilot evaluation of RISC’s usability, feasibility, and acceptability in Ghana.Development and evaluation of the RELI Delivery System—an innovative, simplified, low-cost infusion pump for obstetric and newborn emergenciesPATH With a few pumps of a handle, a health worker can power an intravenous fluid infusion pump for an entire work shift, all without the use of electricity or batteries. That’s the idea behind PATH’s RELI Delivery System—an innovative, low-cost infusion pump for obstetric and newborn care. Controlled intravenous delivery of medicines like antibiotics or anesthesia is the gold standard of care for many diseases and conditions, but it’s often not feasible in low-resource settings. Existing infusion pumps cost thousands of dollars to purchase and maintain, require substantial training to operate, and require electricity or batteries. PATH designed the RELI System to overcome many of these barriers to access in low-resource settings. The device, which requires no electricity or batteries, is powered pneumatically, through air pressure. It requires about two minutes of pumping to generate the power needed to operate the device for an entire 12-hour shift. The system also has a simple-to-use interface and can be manufactured inexpensively, with an expected retail price at less than $100 a machine. With the seed grant it won through the program, PATH plans to take the device to the field to solicit user feedback and then refine the design for further field testing.  Outpatient treatment of neonatal sepsis by rectal administration of gentamicinPATH Neonatal sepsis is a leading cause of infant death worldwide. WHO recommends treatment of the condition with intramuscular injection of the commonly used antibiotic gentamicin. But in many low-resource settings, this is easier said than done. Neonatal dosing is extremely sensitive—just a fraction of a difference in dose size can affect effectiveness and safety—so administration requires a highly trained health worker. Additionally, many health providers may not have access to safe injection devices or may be inclined to reuse needles, promoting the spread of the disease.Unfortunately, gentamicin is not effective when delivered orally, so PATH is exploring the feasibility of an alternative method of gentamicin delivery—rectal delivery. As a needle-free method of administration, rectal delivery could improve access to gentamicin by making it safer for the product to be administered by lower-level health workers, increasing dose accuracy, and removing the risks associated with injections. Existing scientific literature suggests rectal delivery could be a biologically viable option for gentamicin. PATH was seeking a grant to conduct further lab studies to assess how different additives or formulations can improve uptake of gentamicin in colon cells and conduct stakeholder interviews to assess feasibility of the concept.The innovation effectGHTC congratulates both our members and the other teams who were selected as finalists and award winners.This year’s prize winners will join the growing community of over 93 innovators supported by the Saving Lives at Birth program. Many of these innovations are beginning to have an impact as they are brought to scale. To date, the program has supported 1.5 million women and newborns and saved nearly 10,000 lives.The Saving Lives at Birth program has made it clear that by putting innovation at the center of global health, we can accelerate the pace of change and transform lives, faster.Kat Kelley, senior program assistant, and Matthew Robinson, MA, policy officer, contributed to this article.

Editor’s note: This is the second post in a two-part series on the history of GHTC and lessons learned by the organization in coalition building. The series coincides with the launch of a case study examining GHTC as a model of successful coalition building in the global health space. The first post explores the history of GHTC. "If everyone is moving forward together, then success takes care of itself." ~ Henry Ford Inspiring words. But if you have ever worked with a group before, you know, getting everyone moving forward together is a task that is easier said than done. Through our over a decade of experience building and operating a coalition for global health research and development (R&D) advocacy, GHTC staff and members have learned a lot about what it takes to enable a group of organizations to work together effectively as a coalition to enact policy change. While there is no silver bullet that guarantees smooth sailing in building a coalition, there are value systems and operating structures that can be put in place from the start to make the journey less choppy. From interviews with current and former staff and members, we’ve pulled together a list of what we think are the top eight keys to success for building an effective coalition. 1. Establish a core set of shared principles  You can only move forward together if you first agree on what direction to take. GHTC learned this early in our coalition’s formation. As GHTC achieved initial success and membership ballooned, it became increasingly challenging for the coalition to achieve consensus and agree on areas of advocacy to pursue. To counter this paralysis, GHTC established terms of reference to define the principles that would guide the coalition’s advocacy agenda and a membership application requiring all members to endorse those terms. “Having terms of reference and a clear vision for members is key,” said Kaitlin Christenson, former founding director of GHTC. “It helps members understand what they can expect from the secretariat of [the] coalition and agree on issues of focus—what the coalition’s purpose is and is not and what it will and will not pursue.” Establishing these principles early ensured that GHTC’s work could move forward in areas of agreement, rather than stagnating around sources of dissension. 2. Pursue membership diversity While it is important to agree to a set of common principles, it is equally as critical to ensure that a wide range of perspectives is represented among a coalition’s membership. GHTC has benefitted from a broad membership base of global health R&D actors and stakeholders who have experience in different health and technology areas and across the continuum of product development. Not only does this ensure that GHTC truly represents the voice of the global health R&D community, but it expands the coalition’s understanding of complex policy issues, enabling GHTC to knowledgably speak to and advocate for policies that could strengthen global health R&D. 3. Identify the right convening organization It is critical to choose a convening organization or secretariat that not only has resources to serve as a convener, but also one whose interests are best aligned with the coalition’s mission and best insulate the coalition from internal schisms.As GHTC’s founding members worked to transition from an ad-hoc group of collaborators to a formalized coalition, PATH was selected to serve as secretariat. This choice was strategic. PATH was the only member that conducts R&D across a large number of technology platforms and health and disease areas. Thus, the selection of PATH as convener helped protect the coalition from fracturing along the lines of disease or health area and has ensured that its activities do not promote the importance of one member’s perspective or area of R&D over another. This has helped engender critical trust between the secretariat staff and coalition members. 4. Elect a representative steering committee Establishment of a representative steering committee has been critical to GHTC’s ability to make informed decisions and translate those decisions quickly and efficiently into action. GHTC’s steering committee is elected by members with seats on the committee reserved for different types of GHTC member organizations (product developers, advocacy organizations, etc.), thus ensuring it is representative of the breadth of the coalition’s membership. The committee is a critical forum and mechanism for strategy development and guidance without depending on consensus from every coalition member for every decision. 5. Remain transparent and member driven Decision-making within GHTC’s organizational structure is an intentionally transparent process—every GHTC member has the opportunity to offer an opinion on a decision or policy position through surveys, calls for feedback, or open discussion, even if it means that GHTC avoids taking a stance in an issue area in response to member disagreements. As a result, members have remained engaged and invested in GHTC’s work, preserving the strength of the coalition’s collective voice. “GHTC is very good at giving its members a chance to provide input,” said Jodie Curtis, executive vice president at District Policy Group and a consultant who works closely with GHTC. “There are no hidden agendas, no sense that GHTC [secretariat staff] wants to hold all the power; it is a very transparent organization.” To remain member driven, GHTC staff prioritize regular communication with members through regular meetings and more informal interactions. 6. Secure a dedicated staff and source of funding In its earlier days the coalition was constrained because its members were not able to dedicate the consistent amount of time and resources needed to maximize its effectiveness. In 2009, PATH received a grant from the Bill & Melinda Gates Foundation to fund GHTC which enabled it to hire full-time, dedicated staff to manage day-to-day activities. Having this dedicated staff allows GHTC’s members to focus on contributing to the coalition’s overall strategy and advocacy content and amplifying its work and ensures all members have the capacity to remain up to date on and involved in the coalition’s activities. 7. Conduct active education and relationship-building efforts A coalition is only as strong as its connections and relationships. GHTC’s staff prioritizes relationship building with key decision-makers and their staff, meeting regularly with them and organizing meetings and events where they can interface with GHTC members. Members also appreciate the direct access these relationship-building efforts offer them. “As a member, it certainly helped to have others who were strolling the halls of Congress more frequently than we were and who knew how to get a lot of things done in DC,” said Holly Wong, principal deputy assistant secretary for Global Affairs at the US Department of Health and Human Services and former vice president at IAVI—a GHTC member. “It was like having an extra staffer to run those advocacy activities for us.” 8. Stay connected to the broader advocacy community While GHTC maintains its focus on R&D advocacy, its staff and members are constantly working to understand the broader global health landscape, including development aid infrastructure and systemic issues, and to make sure the coalition has a seat at the right tables it needs to exercise influence. GHTC attends external functions and joins other coalitions and working groups as a member, not only to ensure that the voice of global health R&D is heard in these forums, but also to learn more about what is happening in other areas of the field and how it can shape its priorities to better support the changing environment. “To be effective, a coalition needs to make an effort to be an active member of the broader global health sector,” said Christenson.

Editor’s note: This is the first post in a two-part series on the history of GHTC and lessons learned by the organization in coalition building. The series coincides with the launch of a case study examining GHTC as a model of successful coalition building in the global health space. Last month GHTC celebrated an important milestone: seven years ago in May, we received our first grant from the Bill & Melinda Gates Foundation. It was a critical moment that allowed the coalition to dramatically scale up our staff and activities and develop into the organization we are today. Passing this milestone made us realize that GHTC has spent the past seven years so focused on looking forward, that we haven’t taken any time to look back—to reflect on where we’ve come from and what we’ve achieved. So we reached out to former and current staff and members to help us tell the story of the birth of GHTC. The spark for GHTC’s creation: PDPs come together Following the failure of the Vaccine for the New Millennium Act (VNMA)—which aimed to incentivize greater private-sector engagement in neglected disease research and development (R&D)—to pass the Senate in 2001, the Gates Foundation sponsored a meeting of the product development partnerships (PDPs) it funded. The goal: to strategize other policy solutions to increase public- and private-sector funding for global health R&D. Out of this meeting, GHTC’s predecessor was born. The PDPs decided to form a working group—called the Incentives Working Group (IWG)—to collaborate to develop and champion policy solutions to support global health R&D. While deciding to work together does not seem like a radical choice, at the time it was a new way of doing business for the organizations involved. In a world of limited donor funding, each PDP and advocacy organization had been largely focused on securing support for its own products, priorities, or health areas. This left systematic and cross-cutting challenges for R&D largely unaddressed. The IWG was the first step toward changing that approach. “Before GHTC, there was no platform for organizations to work together toward common R&D advocacy goals. There wasn’t a place for people to come together to understand and discuss the barriers that they all faced...there was no voice for advocacy for R&D.” ~ Rachel Wilson, founder and principal of Catalysts for Change, former senior director of Advocacy and Public Policy at PATH, and a key player in the development of GHTC Two early wins generate momentum In the first half of the decade, two critical health crises—the 2001 anthrax attacks and a severe flu vaccine shortage—captured the attention of the American public and provided legislative opportunity for the IWG to further its aims. In response to fears of future bioterror threats like anthrax, Congress introduced the Project Bio Shield Act to incentivize pharmaceutical companies to develop treatments for potential bioterror agents. IWG members recognized the potential of this bill to generate new R&D financing for other health threats, like neglected global infectious diseases, and successfully advocated for the bill’s expansion to address other neglected diseases. The act was signed into law in 2004. Around the same time, a severe flu vaccine shortage in the United States prompted Senators Richard Lugar (R-IN) and John Kerry (D-MA) to reintroduce the VNMA. This time, IWG worked closely with the senators’ offices to draft and introduce language into the bill to establish a new idea to incentivize private-sector investment in neglected disease R&D known as an advance market commitment (AMC)—a mechanism which would provide an up-front financial commitment to subsidize the future purchase of a vaccine or health product not yet developed and available. While the group succeeded in getting the AMC language into the bill, unfortunately the legislation once again failed to pass Congress in 2005. Though disappointed with the result, the IWG members would shortly have a new incentive mechanism to champion. In 2006, the academic and health community was abuzz with a new idea proposed by researchers at Duke University—the creation of a priority review voucher (PRV) to incentivize product developers to invest in R&D for neglected diseases in exchange for expedited regulatory review of a future product at the US Food and Drug Administration (FDA). IWG joined other partners in advocating for legislation that would put PRVs into practice. In 2007, the FDA Amendments Act was passed with an amendment creating the first PRV. With two key legislative wins under its belt, it was clear to IWG members that the model of working together to advocate with one collective voice was producing powerful results. But finding time, resources, and consensus to move forward remained major challenges. “There was a significant need for someone to help keep the momentum going, because keeping a handful of people working together on an ad hoc basis is not sustainable.” ~ Mitchell Warren, executive director at AVAC and key player in the development of GHTC IWG rebranded: GHTC is formalized Recognizing these challenges, IWG’s core active members began taking steps to transition this ad-hoc collaborative effort into a formal coalition. In 2007, the group officially named itself the Global Health Technologies Coalition, and PATH offer to serve as secretariat to help bring structure, capacity, and permanence to the group’s activities. GHTC in its official capacity was soon put to the test in early 2008, when the President’s Emergency Plan for AIDS Relief (PEPFAR) was up for reauthorization. GHTC members recognized this as a legislative opportunity to potentially expand PEPFAR programming to not only focus on increased access to HIV and AIDS interventions, but also on developing new tools and technologies to fight the epidemic. After an extensive advocacy effort to engage with policymakers and educate them about the importance of R&D and AMCs, GHTC members and partners succeeded in getting their desired language around AMCs incorporated into the reauthorization bill, which was signed into law in July 2008. Having the PEPFAR bill reflect the importance of R&D was a significant win for the new organization. “Without the coalition, these policy achievements really wouldn’t have happened, because you needed a critical mass of groups pushing together saying ‘this is important to all of us.’” ~ Peg Willingham, head of Global Advocacy & Policy at HarvestPlus, former senior director at Aeras, and longtime GHTC member On the heels of this success, GHTC ramped up efforts to expand its membership base, and PATH submitted a proposal to the Gates Foundation seeking independent funding to expand GHTC’s efforts, which it secured in early 2009. With new funding, GHTC was able to hire a director and a small staff to support its activities. But with expansion and increased capacity came new challenges. As GHTC membership ballooned, it became more difficult for coalition members to reach consensus and agree on areas of advocacy to pursue. To confront these challenges, GHTC developed “terms of reference” to clearly define the principles that would guide the group’s advocacy efforts which all members had to endorse and established an elected steering committee to provide strategic guidance to the coalition. While putting these practices in place initially cost GHTC some of its members, it was a critical action that enabled the coalition to remain focused and unified in its advocacy and grow into the coalition it is today. “Since its formalization, GHTC’s focus has been unwavering; it’s been protected by members and staff in a way that is greatly appreciated by the global health community. GHTC’s ability and willingness to focus on single issues and not sway in the context of a very dynamic political environment is something that fellow advocates, industry, and government representatives truly value.” ~ Kaitlin Christenson, PATH strategy advisor and first coalition director of GHTC GHTC today: Growing presence and lasting impact “GHTC is a force multiplier; it amplifies and really helps the greater cause in a way the individual groups simply couldn’t do by themselves.” ~ Peg Willingham Fourteen years after its inception as the IWG and nine years after its establishment as the GHTC, the coalition continues to serve as an influential voice in the global health field and remains the only cross-platform and cross–health areas advocacy coalition for global health R&D. Today GHTC has more than 25 active members, a full-time staff of five, and the coalition is increasingly expanding its efforts to engage not only with US actors but also multilateral organizations. The coalition has achieved many remarkable policy successes in its short history and in doing so it has laid the groundwork for future progress, proving the power of working together and speaking with one voice. “Over the last decade, GHTC has evolved into a powerful and trusted voice in the global health community. The organization now has a strong foundation of success to build upon as we continue to advance innovation to save lives.” ~ Erin Will Morton, current director of GHTC

Euvichol® produced by EuBiologics. Photo: IVI In January, GHTC member International Vaccine Institute (IVI) announced that a new oral cholera vaccine it developed in partnership with Korean biotech company EuBiologics, Co. Ltd.—Euvichol®—received prequalification from the World Health Organization (WHO), paving the way for the vaccine to be purchased by global procurement bodies like Gavi, the Vaccine Alliance and UNICEF. GHTC’s Breakthrough blog is joined by Jerome Kim, IVI’s Director General, to learn more about this exciting development which will ease global supply limitations of the oral cholera vaccine and expand affordable access in countries where the disease is endemic. Tell us why this breakthrough is so critical. Cholera is a potentially fatal diarrheal diseases that affects between 1.4 million and 4.3 million people each year and causes as many as 142,000 deaths annually in low-income countries. Cholera is endemic in more than 50 countries, with outbreaks often occurring during humanitarian or natural disasters. Oral vaccines against cholera have existed since the 1990s as a potential tool to stem outbreaks. However, because the disease primarily affects poor communities there wasn’t a stable market to create demand for vaccine production at an affordable cost for these countries. To create a stable market for the vaccine, WHO created an oral cholera vaccine stockpile in 2013 to make the vaccine available at an affordable price for vaccinations in epidemic situations and endemic countries. In recent years, increasing demand for the vaccine created supply pressures on the stockpile and limited more extensive implementation of the vaccine. The prequalification of Euvichol® by WHO means a third oral cholera vaccine producer has entered the market. This will significantly increase the number of oral cholera vaccines doses available worldwide and address global shortages. Euvichol® is also expected to help bring down costs and expand access. How did the vaccine come to be developed and prequalified? The prequalification of Euvichol® is the culmination of a five-year long partnership between IVI and Eubiologics, a Korean biotech company. IVI worked with partners in Vietnam, Sweden, India, and the United States to develop a reformulated oral cholera vaccine to meet the needs of low-income countries. IVI originally transferred the technology to an Indian biotechnology company Shantha Biotechnics. Shantha licensed the vaccine in India under the name Shanchol™ in 2009 and received WHO prequalification for the product in 2011. To strengthen the cholera vaccine market further, in 2010, IVI transferred the technology for the vaccine to Eubiologics, as a second producer and manufacturer. Eubiologics advanced the product through clinical trials, receiving licensure from the Korean Ministry of Food and Safety in January 2015. This paved the way for the product to receive WHO prequalification in December, 2015. The development of Euvichol® was supported by the Bill & Melinda Gates Foundation, the Republic of Korea, and Sweden. The Global Health Investment Fund (an impact investment fund sponsored by the Gates Foundation and other partners), Korea-Seoul Life Science Fund, Korea Investment Global Frontier Fund, and Green Cross Corporation also provided funding to Eubiologics. The creation of Euvichol® is a great example of how the contributions of public, nonprofit, and commercial partners can be leveraged to advance technology development for diseases impacting the poor. What’s next for the vaccine? EuBiologics has initiated production of 6 million doses of the vaccine for 2016, which is expected to double WHO’s stockpile. IVI will continue to work with the WHO and partners to promote uptake of the vaccine and make sure it is available and used in places where it is needed most.