Marissa Chmiola

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.

On January 1, the countdown to 2030 officially began with the implementation of the new global development goals. To mark this occasion, GHTC launched a four-part video series exploring the role of global health innovation in achieving the Sustainable Development Goals (SDGs). The series features interviews with global health thought leaders, advocates, researchers, product developers, and policymakers filmed on the sidelines of the United Nations General Assembly. As 2016 ushers in a new era of development, strong and sustained investment in research and development (R&D) for new vaccines, drugs, diagnostics, devices, and other health technologies are key to tackling the world’s most pressing health challenges and accelerating progress toward ending poverty and achieving the global goals. Why is health R&D critical to achieving the SDGs? This video explores why R&D for new health technologies is key to tackling the world’s most pressing health issues.   What can we do to accelerate health innovation to reach SDGs? GHTC asks experts how health R&D can be accelerated to achieve the SDGs. What innovations have the greatest potential to transform global health? GHTC ask experts to reflect on what next-generation health technologies they believe will drive dramatic improvements in global health. Why does global health innovation matter to you personally? GHTC asks experts about why they care personally about health R&D.

On Wednesday evening, GHTC was joined on Capitol Hill by congressional champions—Congressman Adam Smith (WA-9) and Congresswoman Betty McCollum (MN-4)—and global health community members for a reception celebrating US leadership in global health research and development (R&D) and the launch of the 2015 G-FINDER report, which tracks investment in neglected disease R&D.A message repeated throughout the evening was that the United States’ world-leading investment in global health R&D has been critical to catalyzing the development of technologies that have driven enormous health gains worldwide.Congressman Adam Smith (WA-9) speaks at GHTC briefing. Photo: GHTC/Marissa ChmiolaCongressman Smith opened his remarks by noting that the evening should be about celebration, citing the incredible, but often overlooked progress made in global health over the past several decades—progress driven in part by advancements in the development of new vaccines, drugs, and other health technologies. Yet, he also spoke to the critical need to sustain US investments in health R&D to further accelerate these gains. The Congressman pointed out that US global health R&D investments not only benefit people in the world’s poorest places, but can lead to new insights and innovations that improve access to care for people here in the United States. Congresswoman Betty McCollum (MN-9). Photo: GHTC/Marissa Chmiola Congresswoman McCollum emphasized that global health is a bipartisan issue in Congress. “Every member of Congress knows no child should die of a vaccine preventable disease,” she said. The Congresswoman noted that global health is a foundational element on which all other development gains are built. Discussing her own experience as a mother and grandmother, she talked about the universal desire shared by parents in all parts of the world to see their children survive and thrive, and the role the US government can play in helping make that possible through innovation.In anticipation of the launch of the G-FINDER report the following day, Dr. Nick Chapman, director of research at Policy Cures and the report’s lead author, previewed key findings from this year’s report. The report found that funding for neglected disease R&D increased in 2014, but that increase was entirely the result of increases in funding for Ebola R&D in response to the West African Ebola crisis. Non-Ebola R&D funding actually decreased slightly from the previous calendar year. Dr. Nick Chapman of policy cures previews findings from the report. Photo: GHTC/Marissa Chmiola Dr. Chapman also emphasized the critical role the US plays in neglected disease R&D, noting that the “US government is the single most important funder of global health R&D.” This year’s report found that the US government was responsible for 71 percent of all investment in neglected disease R&D. While Dr. Chapman said this leadership should be celebrated, he also noted that US investment has largely been on the decline over the last several years with non-Ebola R&D investment declining in 2014 to the lowest level since the survey began in 2007. Given the US’s dominant role in this area, continued cuts or stagnation in US funding could lead to significant detrimental impacts on neglected disease R&D overall. Wendy Taylor, director of the USAID Center for Accelerating Innovation and Impact. Photo: GHTC/Marissa Chmiola Wendy Taylor, director of the Center for Accelerating Innovation and Impact at the US Agency for International Development (USAID) echoed statements from other speakers on the need to sustain health R&D investment, emphasizing that the gains we are seeing now in global health are the result of investments made decades ago. She highlighted the importance of partnerships in advancing product development, citing USAID’s work with the private sector and product development partnerships, and the importance of sourcing innovative ideas from all over, highlighting success stories from USAID’s Saving Lives at Birth Grand Challenge Program.

It’s that time of year when Americans chow down on turkey with family and friends and express gratitude for the many things in life for which they are most thankful. In the spirit of Thanksgiving, GHTC asked our members and staff to share what they are most thankful for when it comes to research, development, and delivery of lifesaving global health technologies. Here’s what they had to say: