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The US Agency for International Development (USAID) is the nation’s lead foreign assistance agency. Throughout its 50-year history, USAID has worked with other government agencies, the private sector, and nongovernmental organizations to support the development and introduction of affordable health products appropriate for addressing the diseases and health issues in developing countries. Today, the GHTC is launching a new blog series to highlight the impact of USAID’s commitment to global health research and development (R&D). The series will showcase stories from individuals who have benefited from the agency’s support and investment in R&D—as well as people whose lives would vastly improve if USAID were to expand its support for health R&D into new areas. Our first post is by Ted Prusik, senior vice president of Temptime. Temptime is a New Jersey-based company that has made a huge impact in global health with support from USAID. Ted Prusik is a senior vice president at Temptime, a New Jersey-based company that has made a huge impact in global health with support from USAID. Credit: Temptime. Q: Temptime has a long history of working with USAID to improve global health. How did this partnership begin, and what have been some of the global health research successes you’ve achieved with USAID support? Temptime’s history is a wonderful case study on the effectiveness of US investments in efforts to solve critical global health problems. In the early 1980s Temptime, then called Lifelines, developed a unique technology that gradually changes color when exposed to time and temperature. The original idea was to use this unique chemistry for food spoilage applications. At the same time, the World Health Organization (WHO), USAID and the global health nonprofit PATH identified a pressing need to improve the effectiveness of immunization programs in the developing world. Vaccines are heat sensitive. Exposure to excessive heat can result in the loss of efficacy, leaving children who are vaccinated with heat damaged vaccines vulnerable to disease. But vaccines are stable enough to withstand some exposure to heat. Immunization program managers faced the following issues: How to better protect children from receiving a heat-damaged vaccine that was no longer efficacious? How to prevent the wastage that is common in immunization programs when health care workers presume that the vaccine is heat damaged even when it is not? USAID, WHO, and PATH recognized that the answer was a time-temperature indicator, put on each unit of vaccine, that would clearly signal when the vaccine had been exposed to a pre-determined heat load. The technology that Temptime was working to develop for the food industry was a potential solution for this application: scientifically based, predictable, easy to read, and cost effective. The application of the Temptime technology to the need identified by USAID, WHO, and PATH resulted in the development of the vaccine vial monitor, or VVM, specifically designed for oral polio vaccine. The VVM is a small circular indicator that is applied on each vial of vaccine and clearly indicates whether or not that specific vial has been exposed to excessive heat. Q: Temptime also has a notable track record of working with other partners to improve global public health. How have your partnerships with nonprofit organizations like PATH helped you to maximize investments from government agencies like USAID? The VVM is an illustration of how public-private partnerships are one of the most effective ways to deploy new technologies to support global health and how successful partnerships work. In the case of the VVM, each party brought something unique to the development. PATH, WHO, and USAID were able to clearly define the health need because of their on-the-ground presence in developing countries. From this knowledge, they were able to specify key technology requirements needed to successfully develop and deploy the VVM. Industry as a private partner could then focus its resources and capabilities on what it does best: developing and manufacturing scientifically proven, time-temperature monitoring devices. Often, while a technology exists to address the basic market need, adaptation of that technology is required to truly solve the specific global health problem. Having the knowledge of the product specifications from public sector experts on the ground—as well as the commitment to deploy the technology once it is developed—takes much of the risk away from the private sector investment. Q: Temptime products created with USAID support—like the VVM—have proven tremendously successful at saving lives and improving health worldwide. What have been some of the most notable public health benefits of the VVM? PATH estimates that between 2002 and 2012, VVMs allowed health workers to recognize and replace more than 860 million doses of overexposed vaccine and to deliver 1.45 billion more doses in remote settings—helping to save more than 150,000 lives and reduce illness for countless others. The original intent and benefit of the VVM was to ensure that vaccines overexposed to heat not be administered to children. But the introduction of this technology through the USAID/PATH/WHO/Temptime partnership has had a multiplier effect in public health programs. For example, because the VVM contributes to the effectiveness of vaccination programs, it also plays an important role in improving health outcomes and reducing health care costs. In India, for example, there are 366 million children under age 14. If 5 percent of these children received temperature-damaged vaccines that were no longer efficacious, the ongoing medical costs to treat these children for the contracted disease would exceed $1 billion annually. By contributing to the effectiveness of immunization programs, the VVM improves outcomes and frees up dollars that can be spent on other key health initiatives. Q: New tools developed for global health needs often help improve health right here at home. What have been some of the domestic health benefits of the VVM? In the case of the PATH/USAID/WHO/Temptime partnership, there were also multiple benefits to US public health. The original investment by USAID enabled Temptime to develop a technology platform that could be leveraged for other important applications. The same technology that protects children in immunization programs is used on ready-to-eat meals and rapid skin decontamination lotion for US troops. Temptime over the years has also developed new technologies that are used to support patient protection in the US. These include freeze monitoring technology used on the H1N1 vaccine in 2009, currently used in each shipment of vaccine to participating providers in the US Vaccine for Children program, as well as numerous pharmaceuticals and medical devices. Q: Temptime’s experience also demonstrates that investments in global health research and development not only help save lives around the world—they’re also a smart economic investment. What impact has USAID funding had on Temptime’s ability to create jobs, expand your business and contribute to the domestic economy? Beyond the public health benefits worldwide, new health tools and the partnerships that develop them bring benefits to US industry. In the case of Temptime, we have built a small but growing company that continues to hire and develop people. We also manufacture all of our technologies in the US and export them globally, so in our own humble way we are contributing to the improvement of the US trade deficit.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. President Barack Obama on Wednesday signed legislation into law that averts the majority of the so-called "fiscal cliff.” The law defers decisions on sequestration by two months, meaning that lawmakers will debate sequestration at the same time as they tackle a debate on the overall federal budget plans for 2013 and 2014. The law also “keeps researchers on tenterhooks for at least another two months by delaying mandatory spending cuts that could threaten science funding.” A new article examines the international military sector's role in global health activities, which "has gained visibility in recent years." According to the article, the military provides support for a range of activities, including “medical research and development to peacekeeping operations while providing normative, technical assistance, and coordinating roles.” Devex examines possible policy changes that Sen. John Kerry (D-Mass.) will bring to the State Department if confirmed as the next Secretary of State. Approvals from the US Food and Drug Administration for new drugs hit 16-year high in 2012. The agency approved 39 new drugs in 2012, including a new treatment for multi-drug resistant tuberculosis. Researchers announced that they have developed a therapeutic vaccine that can temporarily halt the growth of HIV in patients. There is an alarming rise in resistance to artemisinin in Thailand, which is currently the front-line drug in the treatment of malaria. Doctors fear it could be the start of the global spread of malaria drug resistance, underscoring the need for research into new treatments for the disease.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. During an event to mark the 25th annual World AIDS Day, President Obama announced that the National Institutes of Health will redirect some AIDS research funds to expand research to find a cure for HIV. The Drugs for Neglected Diseases initiative recently marked its 10-year anniversary with the launch of a report that looks at lessons learned from a decade of research for neglected disease treatments. A new report finds that global health disparities could be eliminated in a generation by increased investments in research for new vaccines, drugs, and other tools to combat diseases such as HIV and AIDS, malaria, and tuberculosis. Pharmaceutical company Pfizer announced that it will broaden access to information from its clinical trials to independent researchers and patients who take part in the studies. African health experts and leaders met recently to discuss the need for improved regulatory systems on the continent to monitor pharmaceutical products. A World Health Organization committee met this week to narrow down a shortlist of 24 research proposals from across the world that aim to tackle diseases that disproportionately affect low-income countries.

In this guest post, Anupama Dathan—health research assistant for ONE—writes about a new report that examines global commitments to ending the AIDS pandemic. With world leaders calling for ambitious goals like an AIDS-free generation and achieving the beginning of the end of AIDS, ONE and many of its partners in the scientific and advocacy communities have been working to define this vision. Also known as the AIDS tipping point, the beginning of the end of AIDS occurs when the number of people newly added to treatment in any given year is equal to or exceeds the number of people newly infected with HIV. To track global progress towards this point, ONE recently released a new report, called The Beginning of the End? Tracking Global Commitments on AIDS. This new report is the second in a series of annual AIDS accountability reports. The good news in the report is that the world is making steady progress. 1.6 million people around the world received AIDS treatment for the first time in 2012, compared with 2.3 million people who were newly infected. At first glance, this is a vast improvement from just a decade ago, when the epidemic was raging out of control, as more than 3 million people were newly infected per year and almost no one was added to treatment. A new report from ONE finds that funding needs to be scaled up appropriately to support research on new, diverse HIV and AIDS interventions. Credit: PATH And though it is a vast improvement, a closer look also reveals it is very one-sided. Despite a reduction in the number of new HIV infections, most of the progress stems from an annual accelerations in the number of people newly accessing treatment each year. Truly ending the AIDS epidemic will be next to impossible without also dramatically reducing new HIV infections, a feat that requires renewed attention to HIV prevention measures. This is why ONE is calling for increased funding and support for HIV research and development (R&D). AIDS treatment mechanisms, such as antiretroviral drugs (ARVs), came into existence thanks to focused, well-funded research. This same focus must now be paid to HIV prevention. Unfortunately, we are headed in the opposite direction. Instead of well-funded research, we’re seeing a steady decline in HIV R&D funding, something that has hindered the development of new prevention tools that could combat HIV even more effectively. A few promising trials of tools and products are in progress, but funding needs to be scaled up appropriately to support research on new, diverse interventions. Innovations like an HIV preventive vaccine have yet to be found. Arguments can be made that the focus should be on improving access to existing prevention mechanisms—pre-exposure prophylaxis, male and female condoms, prevention of mother-to-child transmission, to name a few. While this is a valid point, existing mechanisms are only part of the solution. A recent study estimated that depending on its characteristics and level of coverage, an AIDS vaccine could reduce the number of new infections by five to 10 million between 2020 and 2030 while also saving between $46 billion to $95 billion in averted costs of ARV provision. More research is also needed to test recently discovered prevention mechanisms, including the use of treatment-as-prevention. It’s encouraging to see the progress the world is making towards the beginning of the end of AIDS, but we need to remember that treatment alone isn’t enough. More research into effective ways to prevent AIDS is urgently needed, which is why ONE calls for increased R&D funding in this latest report. Without it, the path to the end of AIDS will be longer, more expensive, and, most of all, will cost many millions more lives.