Marissa Chmiola

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:  

PATH/Dan Chang New rapid diagnostics are urgently needed to prevent unnecessary use of antibiotics and curb the growing problem of antimicrobial resistance, according to a new report from the United Kingdom’s Review on Antimicrobial Resistance (AMR). The report calls for greater investment to develop and support adoption of quicker and more precise diagnostics tests. Antibiotic overuse and growing resistance The rise of drug-resistant bacteria poses a significant health threat to people around the world. Unnecessary use of antibiotics is helping drive this rise in resistance, but since the 1940s, there has been little improvement in the way bacterial infections are diagnosed. The report points out that most antibiotic prescriptions are issued by medical professionals who are making a diagnosis empirically without using a diagnostic test. The fact that diagnostic tests are relatively expensive but antibiotics are cheap means it is less expensive for doctors and their patients to skip the test and issue the antibiotic prescription in case it proves helpful. Diagnostic tests are also time-consuming. It can take 36 or more hours to identify whether a person has an infection, so doctors often put sick patients on a treatment before a diagnosis can be confirmed. The scale of this problem can be quite dramatic: The report highlights one study on patients with respiratory problems which found that more than two-thirds of courses of antibiotics were likely to have been inappropriately prescribed for conditions other than infections or for infections caused by viruses, which aren’t responsive to antibiotics. Rapid diagnostic tests—which will allow doctors to identify within minutes whether an infection is present—can prevent unnecessary prescription, and more refined tests—which enable doctors to identify the exact strain of the bacterial infection and the antibiotics to which it is resistant or susceptible—will enable doctors to more precisely prescribe narrow-spectrum antibiotics, which will help slow the development of resistance. Incentivizing development of diagnostics A CDC scientists examines antibiotic resistant bacteria. CDC/ Melissa Dankel While new rapid diagnostics are urgently needed, the report points out that there is little commercial incentive for drug developers to invest in diagnostics, since their use would lead to decreases in the number of antibiotics purchased. The report proposes the use of “Diagnostics Market Stimulus pots” that would provide a revenue stream for developers of products that meet a recognized area of need. These developers would receive “top-off” payments when products are purchased by healthcare providers, thus raising the commercial benefit of investing in diagnostic development to match the societal need for these products. The report also calls for greater investment in early stage research, referring to its previous report which called for an AMR innovation fund of US$2 billion over five years to boost funding for such research. “For far too long we haven't recognized the huge cost to society of increasing resistance when we use antibiotics that we don’t need—such as antibiotics for flu which have no effect except to increase the chances of superbugs developing," said Lord Jim O'Neill, chairman of the AMR review. "To avoid the tragedy of 10 million people dying every year by 2050, the world needs rapid diagnostics to improve our use of antibiotics. They are essential to get patients the right treatment, cut down on the huge amount of unnecessary use, and make our drugs last for longer." A diagnostic “wish list” To inform investment efforts in diagnostic research and development, the report includes a “wish list” of diagnostics that could be game changers in curbing antibiotic resistance. Below are of few of those identified in the report: Rapid diagnostics that could be used at home to indicate bacterial or viral infections. These would potentially reduce visits to the doctor and so reduce healthcare resource consumption. Biomarker panels to distinguish whether patients admitted via A&E [accident and emergency] for pneumonia or fever have bacterial infections or not. A bedside test that would reliably exclude any infection. This should reduce the empirical use of antimicrobials and could also often be used as part of the treatment protocol for sepsis.

Maximilian Geigenmueller, advocacy officer at the Berlin office of DSW, answers questions about the German PDP funding call. Earlier this month, Germany’s Federal Ministry of Education and Research (BMBF) the renewal of the German funding program for product development partnerships (PDPs) conducting research and development (R&D) for health technologies to combat poverty-related and neglected diseases (PRNDs). The call for proposals for €50 million over five years (2016–2021) is expected to be published shortly. GHTC Breakthroughs blog is joined by Maximilian Geigenmueller, advocacy officer at the Berlin office of Deutsche Stiftung Weltbevoelkerung (DSW)—an international development organization that conducts global healthR&D advocacy—to learn more about this funding call and its importance in advancing R&D for lifesaving global health technologies. Q: Why is this funding call significant among efforts to advance global health R&D? A: This funding call is very significant in the sense that it ensures the continuation of German PDP funding. The first funding round was considered to be a pilot, and it was by no means a given that there would be a second one. Germany was late in joining the group of governments funding PDPs in 2011, when the United States and United Kingdom had already been funding the model for years. Germany also started out at a small scale—€20 million over four years. Over the duration of this time, it was gradually increased to over €26 million, which I think was an indication that the German government began to understand and increasingly appreciate the PDP model. This was further reinforced by an independent evaluation of the first funding round which was very positive. I think with this second call Germany has established itself as a PDP supporter in the medium and long term—albeit at a still rather modest funding level. Q: How does this second funding call differ from the first? A: First of all, there will be more money: €50 million over five years from 2016 to 2021, which is still not quite what we had hoped for but almost double the first funding round. Secondly, this call will be open for proposals not only on the 17 neglected tropical diseases (NTDs) and malaria, which were included in the first funding round, but also HIV and AIDS and tuberculosis (TB). Q: The announcement of this funding call occurred at the G7 Research Ministers conference which Germany chaired. How does this funding call reflect Germany’s broader global health priorities? And how does it align or differ with the priorities agreed upon at the G7 conference? Photo: PATH/Jennifer Fox A: I think the German government finally decided it was time to take on a leadership role in global health that appropriately reflects the country’s economic and financial standing in the world. I am sure the Ebola crisis—an outbreak of an infectious disease spreading at a breathtaking rate with no immediate treatment available and relatively close to home—had a lot to do with it. The prioritization of PRNDs/NTDs, antimicrobial resistance, and Ebola on the G7 agenda has given a lot of visibility to health issues in the international debate this year. For a while it looked like the G7 were leaving out the big three diseases of poverty—HIV and AIDS, malaria, and TB—and would only discuss NTDs, particularly as the G7 leaders’ summit communiqué only referred to NTDs. Fortunately, at the G7 Research Minister Conference in Berlin on October 8–9, the ministers of research included not only NTDs but also explicitly mentioned malaria, tuberculosis, HIV and AIDS, and several other infectious diseases. There are some interesting commitments in the communiqué, such as better coordination of research efforts. Germany’s Minister of Research Johanna Wanka has offered to host a brainstorming workshop on this in 2016. Also, the communiqué states the intent to develop a joint G7 pilot research activity for R&D projects to build research capacities in high PRND/NTD burden countries. Combined with the Japanese 2016 G7 presidency which is very likely to have health as one of its priorities as well, I think we have a good chance that health is going to stay at the center of the international agenda for a while. Q: As a global health R&D advocate, what excites and disappoints you about this funding call? A: I am excited about it being out and that there is significantly more budget available this time. It is of course not enough, not by a long shot, but maybe there will be some top-ups to the second funding round, as was the case in the first funding round when Germany started out with €20 million and ended up with €26 million. There is also the prospect of institutionalizing German PDP funding, moving away from providing limited funding for a number of years to making it a permanent feature in the German budget, but this is most likely only going to happen at the end of the second funding round. What was also really exciting was the process of ensuring this second funding round happened. I think all advocates—PDPs, nonprofits, philanthropic organizations, and others—did a great job in keeping global health R&D in the political debate. For example, during the summer the All Parliamentary Group on Population and Development of the German Bundestag wrote a letter to Chancellor Angela Merkel voicing their support for global health R&D and the PDP model, which was signed by 19 members of parliament (MP). I think nineteen MPs coming together from three out of the four parties in the Bundestag to sign a letter in support of a measure which represents only a minuscule share of the research ministry’s annual budget is fairly remarkable.